[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[From the U.S. Government Publishing Office]


          21



          Food and Drugs



[[Page i]]

PARTS 100 TO 169

          Revised as of April 1, 1996
          CONTAINING
          A CODIFICATION OF DOCUMENTS
          OF GENERAL APPLICABILITY
          AND FUTURE EFFECT

          AS OF APRIL 1, 1996
          With Ancillaries
          Published by
          the Office of the Federal Register
          National Archives and Records
          Administration

          as a Special Edition of
          the Federal Register



[[Page ii]]


                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 1996



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



[[Page iii]]




                            Table of Contents


                                                                    Page
  Explanation.................................................       v
  Title 21:
    Chapter I--Food and Drug Administration, Department of 
        Health and Human Services (Continued).................       3
  Finding Aids:
    Material Approved for Incorporation by Reference..........     547
    Table of CFR Titles and Chapters..........................     553
    Alphabetical List of Agencies Appearing in the CFR........     569
    List of CFR Sections Affected.............................     579

[[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, 1996), 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

    Each volume of the Code contains amendments published in the Federal 
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 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
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. Many agencies have begun publishing numerous OMB 
control numbers as

[[Page vi]]

amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

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 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
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.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I), and Acts Requiring Publication 
in the Federal Register (Table II). A list of CFR titles, chapters, and 
parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.


[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408.
SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
M-F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours 
a day. For payment by check, write to the Superintendent of Documents, 
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Customer Service call 202-512-1803.

                              Richard L. Claypoole,
                                    Director,
                          Office of the Federal Register.

April 1, 1996.

[[Page viii]]




[[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-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, 1996.

    The Table of Exempt Prescription Products to part 1308 appears in 
the volume containing part 1300-end.

    Redesignation tables for Chapter I--Food and Drug Administration 
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.

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

[[Page x]]

[GRAPHIC] [TIFF OMITTED] TFRORDR.FRM



[[Page 1]]

                                                                     HN




                        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

  Cross References: Food Safety and Inspection Service, Meat and Poultry 
Inspection, Department of Agriculture: See Meat and Poultry Inspection, 
9 CFR chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  United States Customs Service, Department of the Treasury: See Customs 
Duties, 19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I.

  Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury: 
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.

[[Page 2]]


[[Page 3]]





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




                           (Parts 100 to 169)

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

                SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
Part                                                                Page
100             General.....................................           5
101             Food labeling...............................          13
102             Common or usual name for nonstandardized 
                    foods...................................         152
103             Quality standards for foods with no identity 
                    standards...............................         159
104             Nutritional quality guidelines for foods....         168
105             Foods for special dietary use...............         173
106             Infant formula quality control procedures...         175
107             Infant formula..............................         181
108             Emergency permit control....................         190
109             Unavoidable contaminants in food for human 
                    consumption and food-packaging material.         200
110             Current good manufacturing practice in 
                    manufacturing, packing, or holding human 
                    food....................................         206
113             Thermally processed low-acid foods packaged 
                    in hermetically sealed containers.......         216
114             Acidified foods.............................         241
123             Fish and fishery products...................         247
129             Processing and bottling of bottled drinking 
                    water...................................         255
130             Food standards: General.....................         260
131             Milk and cream..............................         268
133             Cheeses and related cheese products.........         297
135             Frozen desserts.............................         349
136             Bakery products.............................         356
137             Cereal flours and related products..........         360
139             Macaroni and noodle products................         377
145             Canned fruits...............................         388
146             Canned fruit juices.........................         428

[[Page 4]]

150             Fruit butters, jellies, preserves, and 
                    related products........................         442
152             Fruit pies..................................         450
155             Canned vegetables...........................         452
156             Vegetable juices............................         474
158             Frozen vegetables...........................         477
160             Eggs and egg products.......................         480
161             Fish and shellfish..........................         485
163             Cacao products..............................         502
164             Tree nut and peanut products................         510
165             Beverages...................................         513
166             Margarine...................................         531
168             Sweeteners and table sirups.................         534
169             Food dressings and flavorings...............         538

  Editorial Note: For nomenclature changes to chapter I see 59 FR 14366, 
Mar. 28, 1994.

[[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

100.120  Artificially red-dyed yellow varieties of sweet potatoes.
100.130  Combinations of nutritive and nonnutritive sweeteners in ``diet 
          beverages.''
100.135  Disposition of incubator reject eggs.
100.140  Label declaration of salt in frozen vegetables.
100.145  Notice to packers of comminuted tomato products.
100.150  Notice to packers and shippers of shelled peanuts.
100.155  Salt and iodized salt.
100.160  Tolerances for moldy and insect-infected cocoa beans.

    Authority: Secs. 201, 301, 307, 402, 403, 409, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 337, 342, 343, 348, 
371).

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



                 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)

[[Page 6]]

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.
    (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 Dockets Management Branch in the following 
form:

    (Date) ----------------
    Dockets Management Branch,
    Food and Drug Administration,
    Department of Health and Human Services,
    rm. 1-23, 12420 Parklawn Dr.,
    Rockville, MD 20857.

   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.

[[Page 7]]

    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.

                         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 Dockets 
Management Branch, stamped with the date of filing, and assigned a 
docket number. The docket number identifies the file established by the 
Dockets Management Branch 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 Dockets Management Branch 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 Dockets 
Management Branch 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.

[[Page 8]]

    (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 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,
200 C St. SW.,
Washington, DC 20204.
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, 200 C St. SW., Washington, DC 20204, 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 Secs. 20.61, 20.64, and 20.88 
of this chapter.
    (j) Definitions. (1) Informal enforcement actions include warning 
letters, recalls, detentions, or other administrative

[[Page 9]]

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 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]



                        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. 100.120   Artificially red-dyed yellow varieties of sweet potatoes.

    (a) It has been the practice of some growers, packers, and 
distributors of yellow varieties of sweet potatoes to artificially color 
the skins of such potatoes with a red dye. Surveys made by the Food and 
Drug Administration and letters received by the Administration from 
consumers reveal that this practice can deceive those persons who prefer 
the naturally red varieties of sweet potatoes. Also, representatives of 
the red sweet potato industry have alleged that some consumers refuse to 
purchase any red sweet potatoes since they cannot distinguish between 
the naturally red ones and those artificially colored with red dye.
    (b) The Food and Drug Administration concludes, therefore, that 
yellow varieties of sweet potatoes artificially colored with a red dye 
are adulterated within the meaning of section 402(b) of the Federal 
Food, Drug, and Cosmetic Act.
    (c) The Food and Drug Administration will consider appropriate 
regulatory action regarding such adulterated sweet potatoes shipped in 
interstate commerce if the act of adulterating the potatoes occurs after 
90 days following the date of publication of this statement of policy in 
the Federal Register.



Sec. 100.130   Combinations of nutritive and nonnutritive sweeteners in ``diet beverages.''

    As a result of the removal of cyclamic acid and its salts from the

[[Page 10]]

list of substances generally recognized as safe (part 182 of this 
chapter) by an order published in the Federal Register of October 21, 
1969 (34 FR 17063), the Commissioner of Food and Drugs has received 
inquiries as to the proper composition and labeling, from the standpoint 
of application of the Federal Food, Drug, and Cosmetic Act, of so-called 
``diet beverages'' that will be made from mixtures of nutritive 
sweeteners and saccharin or its salts. The Commissioner concludes that:
    (a) Any ``diet beverage'' or diet beverage base made with 
combinations of nutritive and nonnutritive sweeteners must be so 
formulated that each ingredient is one which is generally recognized as 
safe and is not a food additive as defined in section 201(s) or a color 
additive as defined in section 201(t) of the act, or if it is a food 
additive or a color additive as so defined, is used in accordance with a 
regulation established pursuant to section 409 or 721 of the act.
    (b) The product is to be so formulated that its caloric value is at 
least 50 percent less than the caloric value of the comparable product 
made without artificial sweeteners. In no case shall the beverage 
provide more than 6 calories per fluid ounce.
    (c) If it is to be marketed under a name heretofore used on a 
product represented to have no, or only a few, calories per serving, the 
name shall be modified by the word ``new'' for at least 1 year following 
the time such product is introduced in a given market.
    (d) (1) The label must bear a complete statement of ingredients 
except that spices, flavorings, and colorings may be designated as such 
without naming each.
    (2) The label must bear a statement of the caloric content per fluid 
ounce, the carbohydrate content per fluid ounce, a statement of the 
percentage of saccharin or saccharin salt used, and the statement 
``Contains ------ mg saccharin (or saccharin salt, as the case may be) 
per ounce, a nonnutritive artificial sweetener.''
    (3) To further avoid injury through inadvertent use by diabetics in 
the belief that the product does not contain carbohydrates, the label of 
a beverage containing sugar(s) must bear the statement ``Contains 
sugar(s); not for use by diabetics without advice of a physician.''
    (4) To avoid confusion by diabetics, the label of a beverage 
containing sorbitol, mannitol, or other hexitol, must bear the statement 
``Contains carbohydrates, not for use by diabetics without advice of a 
physician''. To further avoid confusion of these beverages with those 
sweetened solely with nonnutritive artificial sweeteners which have been 
marketed in containers bearing prominent statements such as ``sugar 
free'', ``sugarless'', or ``no sugar'', the labels of beverages 
containing hexitols must not bear these or similar statements.
    (e) Bottlers of diet drinks have on hand large stocks of returnable 
lithographed bottles bearing statements indicating that the beverages 
contain cyclamates and/or declarations such as ``sugar free'', ``less 
than 1 calorie per bottle'', or ``less than 2 calories per bottle'' 
which bottles were formerly used for artificially sweetened beverages 
containing cyclamates. The Food and Drug Administration will not object 
to continued use of these bottles under the following conditions:
    (1) The bottles when filled with beverages made with combinations of 
nutritive and nonnutritive sweeteners may be marketed only:
    (i) In multiunit cartons labeled prominently on each principal 
display panel with the information set forth in paragraphs (c) and (d) 
of this section and with a prominent, forthright notice that any 
information on bottles which is contrary to that on the cartons should 
be disregarded because it is incorrect. To assure adequate prominence 
and conspicuousness, the following statements should stand out in marked 
contrast with other labeling: The statement of caloric content and 
carbohydrate content per fluid ounce, the statement required by 
paragraph (d) (3) or (4) of this section as applicable, and the notice 
to disregard any information on bottles which is contrary to that on the 
cartons. These statements may be made to stand out by means such as 
setting them forth in boxes, printing in bold capitals on lines

[[Page 11]]

separated from other printed labeling, using colors that contrast with 
those used for other label statements, or other similar means.
    (ii) In vending machines bearing durable labeling which includes all 
of the information required to appear on cartons set forth with the same 
degree of prominence.
    (2) In addition, the bottles must bear caps labeled prominently with 
the words ``Contains Sugar'' or ``Contains Carbohydrates'', and accurate 
statements of the caloric content and carbohydrate content per fluid 
ounce.



Sec. 100.135   Disposition of incubator reject eggs.

    (a) Investigations by the Food and Drug Administration and a number 
of State regulatory agencies have revealed that incubator reject eggs, 
removed as infertile or otherwise unhatchable during hatching 
operations, are being diverted for human food use. Such eggs are 
regarded as adulterated within the meaning of section 402(a)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) because they 
are unfit for food.
    (b) The introduction or delivery for introduction into interstate 
commerce of adulterated eggs is prohibited under section 301(a) of the 
aforesaid act (21 U.S.C. 331(a)) unless they have been broken, crushed, 
or smashed and then denatured with kerosene, creolin, or other suitable 
denaturant to preclude their diversion to human food channels.



Sec. 100.140   Label declaration of salt in frozen vegetables.

    (a) In a number of diseases or disease conditions it is important to 
restrict the intake of sodium. Sodium occurs in all natural foods, but 
added salt makes the most important contribution to the total sodium 
intake in the diet. Most fresh vegetables are of low sodium content and 
consumers generally regard frozen vegetables as being free of added salt 
and suitable for use in low-sodium diets. While salt may not be added 
directly as a seasoning ingredient during the processing of frozen 
vegetables, the use of salt brine in quality separation of such 
vegetables as peas and lima beans preparatory to freezing may contribute 
substantial amounts of salt to the finished article. The failure of the 
labels of frozen vegetables to declare the presence of salt has been the 
basis of complaints to the Food and Drug Administration.
    (b) Section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act 
requires the label of a fabricated food to bear the common or usual name 
of each ingredient present. The Department of Health and Human Services 
regards any frozen vegetable containing salt, added directly or 
indirectly, as misbranded in violation of section 403(i)(2) of the 
Federal Food, Drug, and Cosmetic Act unless its label names salt as an 
ingredient.



Sec. 100.145   Notice to packers of comminuted tomato products.

    (a) It has long been known that tomato rot may be caused by one or 
more of the following: Fungus diseases, bacterial diseases, virus 
diseases, and certain nonparasitic diseases. Only the fungus rots are 
characterized by the presence of mold filaments. Mold counts on 
comminuted tomato products are not increased by incorporating within the 
product tomato rot caused by bacteria, virus, or nonparasitic factors. 
Although high mold counts on these products reveal that large amounts of 
rotten material are present, low mold counts do not necessarily 
demonstrate absence of the type of rot caused by the tomato diseases 
that are not characterized by mold filaments.
    (b) Inspections of canneries engaged in the packing of comminuted 
tomato products show that most packers effectively trim, sort out, and 
discard rotten tomatoes from the raw stock. Some packers, however, do 
not properly eliminate rotten tomato material, and a few packers 
deliberately use rotten tomatoes in these foods, provided the mold count 
remains low. Some packers, on occasion, have mixed tomato products 
having a high mold count with tomato products containing little or no 
mold, so as to produce a blend with a low mold count.
    (c) Packers of comminuted tomato products who rely upon the mold 
count as the sole or primary control

[[Page 12]]

procedure, to the neglect of adequate sorting and trimming, may produce 
products with low mold counts which contain substantial amounts of rot.
    (d) It is the purpose of this announcement to advise all canners of 
tomato products that:
    (1) Although high mold count is conclusive evidence of inclusion of 
substantial amounts of rot, mold count is not the only way of 
establishing that comminuted tomato products contain decomposed tomato 
material.
    (2) Where factory observations or other evidence reveals that 
comminuted tomato products contain rot not caused by mold, such rot, as 
well as that caused by mold, will be taken into account in applying the 
provisions of the Federal Food, Drug, and Cosmetic Act against 
adulteration.
    (3) The blending of tomato products adulterated with tomato rot, of 
whatever kind, with tomato products made from sound tomatoes, or with 
other sound food, renders the blend adulterated.



Sec. 100.150   Notice to packers and shippers of shelled peanuts.

    (a) Investigations by the Food and Drug Administration have shown 
that a number of interstate shipments of shelled peanuts in bags holding 
from approximately 100 to 125 pounds each have failed to bear labeling 
as required by the terms of the Federal Food, Drug, and Cosmetic Act.
    (b) Shelled peanuts in sacks, whether or not shipped in carload 
lots, should bear the following information required by the law on food 
in package form:
    (1) The name of the product.
    (2) An accurate statement of net weight.
    (3) The name and place of business of the packer or distributor.
    (c) The information required by paragraph (b) of this section should 
be conspicuously set forth. It may be printed or stenciled on each bag 
or, if desired, placed on tags which are securely attached to each bag.
    (d) The net weight marked on the bags must be the correct net weight 
of the peanuts at the time they are delivered to the carrier for 
interstate shipment. The tare weight of the bag should not be included 
in the weight declaration.



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 Secs. 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. 101.105 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. 101.105 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 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.

[[Page 13]]

    (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]



Sec. 100.160   Tolerances for moldy and insect-infested cocoa beans.

    On and after February 22, 1963, shipments of cocoa beans offered for 
entry into the United States must meet a tolerance of 6 percent total 
moldy and insect-infested, including insect-damaged, beans, but not more 
than 4 percent of either moldy or insect-infested, including insect-
damaged, beans. This statement of policy supersedes the notice issued 
August 27, 1931, addressed to shippers, importers, and dealers in cocoa 
beans and manufacturers of chocolate and cocoa products and the 
statement of policy issued June 22, 1961, in this section.



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.
101.8  Labeling of food with number of servings.
101.9  Nutrition labeling of food.
101.10  Nutrition labeling of restaurant foods.
101.11  Saccharin and its salts; retail establishment notice.
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 and notice statements.
101.18  Misbranding of food.

             Subpart B--Specific Food Labeling Requirements

101.22  Foods; labeling of spices, flavorings, colorings and chemical 
          preservatives.
101.29  Labeling of kosher and kosher-style foods.
101.30  Percentage juice declaration for foods purporting to be 
          beverages that contain fruit or vegetable juice.
101.33  Label declaration of D-erythroascorbic acid when it is an 
          ingredient of a fabricated food.

   Subpart C--Specific Nutrition Labeling Requirements and Guidelines

101.36  Nutrition labeling of dietary supplements of vitamins and 
          minerals (eff. 7-5-95).
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,'' and 
          ``more.''
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 and osteoporosis.
101.73  Health claims: dietary lipids and cancer.
101.74  Health claims: sodium and hypertension.

[[Page 14]]

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.

Subpart F--Specific Requirements for Descriptive Claims that are Neither 
                Nutrient Content Claims nor Health Claims

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

          Subpart G--Exemptions From Food Labeling Requirements

101.100  Food; exemptions from labeling.
101.103  Petitions requesting exemptions from or special requirements 
          for label declaration of ingredients.
101.105  Declaration of net quantity of contents when exempt.
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

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15 
U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 343, 348, 
371).

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



                      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 the principal display panel is too small

[[Page 15]]

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 pursuant to Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 
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 
Secs. 101.105(h) (1) and (2) and 101.15.
    (1) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a surface area that can 
bear an information panel and/or an alternate principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 101.1 is 
less than 10 square inches.
    (iii) The label information includes:
    (a) Nutrition labeling in accordance with Sec. 101.9.
    (b) A full list of ingredients in accordance with regulations in 
this part and the policy expressed in Sec. 101.6.
    (iv) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than three sixty-fourths inch in height.
    (2) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a single ``obvious 
principal display panel'' as this term is defined in Sec. 101.1 and has 
no other available surface area for an information panel or alternate 
principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 101.1 is 
less than 12 square inches and bears all labeling appearing on the 
package.
    (iii) The label information includes:
    (a) Nutrition labeling in accordance with Sec. 101.9.
    (b) A full list of ingredients in accordance with regulations in 
this part and the policy expressed in Sec. 101.6.
    (iv) The information required by paragraph (b) of this section 
appears on the single, obvious principal display panel in accordance 
with the provisions of this paragraph (c) except that the type size is 
not less than one thirty-second inch in height.
    (3) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a total surface area 
available to bear labeling of less than 12 square inches.
    (ii) The label information includes:
    (a) Nutrition labeling in accordance with Sec. 101.9.
    (b) A full list of ingredients in accordance with regulations in 
this part and the policy expressed in Sec. 101.6.
    (iii) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than one thirty-second inch in height.
    (4)(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

[[Page 16]]

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 warning required by Sec. 100.130 of this chapter.
    (ii) The statement of ingredients.
    (iii) The name and address of the manufacturer, packer, or 
distributor.
    (iv) The statement of identity.
    (5) Individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended 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 label information includes a full list of ingredients in 
accordance with regulations in this part and the policy expressed in 
Sec. 101.6 of this chapter; and
    (iv) 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. 101.9(j)(13) and (j)(17), all 
information required to appear on the principal display panel or on the 
information panel pursuant to 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. 101.9(j)(17), 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 pursuant to 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.

[[Page 17]]

    (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 Secs. 101.4, 101.5, 101.8, 101.9, 
101.13, 101.17, 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 pursuant to 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]



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.
    (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.

[[Page 18]]

    (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.

[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]

    Effective Date Note: At 60 FR 67174, Dec. 28, 1995, in Sec. 101.3, 
paragraph (e)(4)(ii) was revised, effective January 1, 1997. For the 
convenience of the reader, the superseded text is set forth below.
Sec. 101.3  Identity labeling of food in packaged form.

                                * * * * *

    (e) * * *
    (4) * * *
    (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) and 
the Reference Daily Intake (RDI) of any vitamin or mineral listed under 
Sec. 101.9(c)(8)(iv).

                                * * * * *



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.
    (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.,

[[Page 19]]

``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''.
    (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

[[Page 20]]

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 Secs. 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 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

[[Page 21]]

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.''
    (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.

[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]

[[Page 22]]



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. 101.8   Labeling of food with number of servings.

    (a) The label of any package of a food that bears a representation 
as to the number of servings contained in such package shall bear in 
immediate conjunction with such statement, and in the same size type as 
is used for such statement, a statement of the net quantity (in terms of 
weight, measure, or numerical count) of each such serving; however, such 
statement may be expressed in terms that differ from the terms used in 
the required statement of net quantity of contents (for example cups, 
tablespoons) when such differing term is common to cookery and describes 
a constant quantity. Such statement shall not be misleading in any 
particular. Where nutrition labeling information is required in 
accordance with the provisions of Sec. 101.9, however, the statement of 
the net quantity of each serving shall be consistent with the 
requirements for serving size expression set forth in that section 
(e.g., 10 1-cup (240 milliliters) servings). A statement of the number 
of units in a package is not in itself a statement of the number of 
servings.
    (b) If there exists a voluntary product standard promulgated 
pursuant to the procedures found in 15 CFR part 10 by the Department of 
Commerce, quantitatively defining the meaning of the term ``serving'' 
with respect to a particular food, then any label representation as to 
the number of servings in such packaged food shall correspond with such 
quantitative definition. (Copies of published standards are available 
upon request from the National Bureau of Standards, Department of 
Commerce, Washington, DC 20234.)

[42 FR 14308, Mar. 15, 1977, as amended at 58 FR 2291, Jan. 6, 1993]



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

[[Page 23]]

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.
    (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 200 percent or more of the reference amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single-eating occasion.
    (E) For products that have reference amounts of 100 grams (g) (or 
milliliter (mL)) or larger and are individual units within a 
multiserving package, if a unit contains more than 150 percent but less 
than 200 percent of the reference amount, the manufacturer may

[[Page 24]]

decide whether to declare the individual unit as 1 or 2 servings.
    (F) 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.
    (G) The serving size for products that naturally vary in size (e.g., 
pickles, shellfish, whole fish, and fillet of fish) 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.
    (H) 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).
    (I) 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

[[Page 25]]

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, 
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 in whole number of tablespoons for quantities less than 1/4 
cup but greater than or equal to 2 tablespoons (tbsp), 1, 1 1/3, 1 1/2, 
or 1 2/3 tbsp for quantities less than 2 tbsp but greater than or equal 
to 1 tbsp, and teaspoons in whole number of teaspoons for quantities 
less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in 
1/4-tsp increments for quantities less than 1 tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If 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)(G) 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 and that 
contains less than 200 percent of the applicable reference amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving except for products that 
have reference amounts of 100 g (or mL) or larger, manufacturers may 
decide whether a package that contains more than 150 percent but less 
than 200 percent of the reference amount is 1 or 2 servings. Packages 
sold individually that contain 200 percent or more of the applicable 
reference amount may be labeled as a single-serving if the entire

[[Page 26]]

content of the package can reasonably be consumed at a single-eating 
occasion.
    (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 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 
guideline entitled, ``Guidelines for Determining the Gram Weight of the 
Household Measure.'' The guideline can be obtained from the Office of 
Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
    (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, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the reference amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement.
    (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

[[Page 27]]

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 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 
in a multiserving container 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.
    (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, ``Energy Value of Foods--Basis and Derivation,'' by A. L. 
Merrill and B. K. Watt, United States Department of Agriculture (USDA) 
Handbook No. 74 (slightly revised, 1973), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is 
available from the Office of Food Labeling (HFS-150), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or may be inspected at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.;

[[Page 28]]

    (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, 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);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA Handbook No. 74 
(slightly revised 1973) pp. 9-11, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of 
this incorporation by reference is given in paragraph (c)(1)(i)(A) of 
this section;
    (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; or
    (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, 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).
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section in 
a serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat in a serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section. Except as provided for in paragraph (f) of this section, if 
``Calories from fat'' is not required and, as a result, not declared, 
the statement ``Not a significant source of calories from fat'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size.
    (iii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section 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 from fat as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat in a serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (1/2) gram increment below 5 grams and to the nearest gram increment 
above 5 grams. If the serving contains less than 0.5 gram, the content 
shall be expressed as zero.
    (i) ``Saturated fat,'' or ``Saturated'': A statement of the number 
of grams of saturated fat 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 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 in the same type size. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 (1/2) 
gram increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat in a serving 
defined as cis,cis-methylene-interrupted

[[Page 29]]

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.
    (iii) ``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, 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) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium in a specified serving of food may be declared 
voluntarily, except that when a claim is made about potassium content, 
label declaration shall be required. Potassium content shall be 
expressed as zero when the serving contains less than 5 milligrams of 
potassium, to the nearest 5-milligram increment when the serving 
contains less than or equal to 140 milligrams of potassium, and to the 
nearest 10-milligram increment when the serving contains more than 140 
milligrams.
    (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

[[Page 30]]

gram, the content may be expressed as zero. 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.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber 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 content shall be indented under dietary fiber and expressed to the 
nearest gram except that if a serving contains less than 1 gram, the 
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be 
used as an alternative, and if the serving contains less than 0.5 gram, 
the content may be expressed as zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars in a 
serving, except that 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 sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of sugars'' shall be placed at 
the bottom of the table of nutrient values in the same type size. Sugars 
shall be defined as the sum of all free mono- and disaccharides (such as 
glucose, fructose, lactose, and sucrose). Sugars content shall be 
indented and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less then 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (iii) ``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 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 then 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrates may be declared voluntarily. Other 
carbohydrates shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it shall 
be defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars. Other carbohydrate content shall be indented 
and expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.

[[Page 31]]

    (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 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 for infants, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on the 
basis of the factor of 6.25 times the nitrogen content of the food as 
determined by the appropriate method of analysis as given in the 
``Official Methods of Analysis of the AOAC International'' (formerly the 
Association of Official Analytical Chemists), 15th Ed. (1990), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, except when the official procedure for a specific food requires 
another factor. Copies may be obtained from AOAC, 2200 Wilson Blvd., 
suite 400, Arlington, VA 22201-3301, or may be inspected at the Office 
of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as Percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for use by infants 
or children under 4 years of age. When such a declaration is provided, 
it shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column headed ``Percent Daily Value,'' and 
expressed to the nearest whole percent. However, the percentage of the 
RDI for protein shall not be declared if the food is represented or 
purported to be for use by infants 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 ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1990, except that when official AOAC 
procedures described in section (c)(7) of this paragraph require a 
specific food factor other than 6.25, that specific factor shall be 
used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation'' as published by the Food and Agriculture 
Organization of the United Nations/World Health Organization is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-150), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or may be inspected at the Office of the

[[Page 32]]

Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. 
For foods represented or purported for infants, the corrected amount of 
protein (grams) per serving is equal to the actual amount of protein 
(grams) per serving multiplied by the relative protein quality value. 
The relative protein quality value shall be determined by dividing the 
subject 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 Daily 
Reference Value (DRV) or RDI, a value of 50 grams of protein shall be 
the DRV for adults and children 4 or more years of age, and the RDI for 
protein for children less than 4 years of age, infants, pregnant women, 
and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, 
respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d), (e), and (f) of this section, foods 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For foods represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented by separate 
declarations according to paragraph (e) of this section based on the RDI 
values for infants from birth to 12 months of age and for children under 
4 years of age. Similarly, the percent of Daily Value based on both the 
RDI values for pregnant women and for lactating women shall be declared 
separately on foods represented or purported to be for use by both 
pregnant and lactating women. When such dual declaration is used on any 
label, it shall be included in all labeling, and equal prominence shall 
be given to both values in all such labeling. All other foods shall use 
the RDI for adults and children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added as a 
nutrient supplement, or when a claim is made about them. Other vitamins 
and minerals need not be declared if neither the nutrient nor the 
component is otherwise referred to on the label or in labeling or 
advertising and the vitamins and minerals are:
    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin, and niacin in enriched flour) and that standardized food is 
included as an ingredient (i.e., component) in another 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. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients).'' Alternatively, except as provided for in 
paragraph (f) of this section, if vitamin A, vitamin C, calcium, or iron 
is present in amounts less than 2 percent of the RDI, label declaration 
of the nutrient(s) is not required if the statement ``Not a significant 
source of __________ (listing the vitamins or minerals omitted)'' is 
placed

[[Page 33]]

at the bottom of the table of nutrient values. Either statement shall be 
in the same type size as nutrients that are indented.
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams

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

Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--either Folic acid or Folacin may be used.
Calories--Energy

    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally, the statement of percent shall be presented in 
parenthesis following the declaration of vitamin A and the percent 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.
    (9) For the purpose of labeling with a percent of the DRV, the 
following DRV's are established for the following food components based 
on the reference caloric intake of 2,000 calories:

                                                                        
------------------------------------------------------------------------
                                        Unit of                         
         Food component               measurement             DRV       
------------------------------------------------------------------------
Fat.............................  gram (g)..........  65                
Saturated fatty acids...........  do................  20                
Cholesterol.....................  milligrams (mg)...  300               
Total carbohydrate..............  grams (g).........  300               
Fiber...........................  do................  25                
Sodium..........................  milligrams (mg)...  2,400             
Potassium.......................  do................  3,500             
Protein.........................  grams (g).........  50                
------------------------------------------------------------------------

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on foods in the following format, as shown in 
paragraph (d)(12) of this section, except on foods 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 and children less than 4 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 urges 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) 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)(3), (d)(5), (d)(7), and 
(d)(8) of this section shall be in type size no smaller than 8 point. 
Except for the

[[Page 34]]

heading ``Nutrition Facts,'' the information required in paragraphs 
(d)(4), (d)(6), and (d)(9) of this section and all other information 
contained within the nutrition label shall be in type size no smaller 
than 6 point. When provided, the information described in paragraph 
(d)(10) of this section shall also be in type no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total 
Carbohydrate,'' and ``Protein''), and the percentage amounts required by 
paragraph (d)(7)(ii) of this section shall be highlighted by bold or 
extra bold type or other highlighting (reverse printing is not permitted 
as a form of highlighting) that prominently distinguishes it from other 
information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text shall 
separate ``Amount Per Serving'' from the calorie statements required in 
paragraph (d)(5) of this section and shall separate each nutrient and 
its corresponding percent Daily Value required in paragraphs (d)(7)(i) 
and (d)(7)(ii) of this section from the nutrient and percent Daily Value 
above and below it, as shown in paragraph (d)(12) of this section.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size larger than all 
other print size in the nutrition label and, except for labels presented 
according to the format provided for in paragraph (d)(11) of this 
section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section, as shown in 
paragraph (d)(12) of this section.
    (3) Information on serving size shall immediately follow the heading 
as shown in paragraph (d)(12) of this section. Such information shall 
include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section.
    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single serving 
containers as defined in paragraph (b)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar as shown in paragraph (d)(12) of this 
section.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in one line, leaving 
sufficient space between the declaration of ``Calories'' and ``Calories 
from fat'' to allow clear differentiation, or, if ``Calories from 
saturated fat'' is declared, in a column with total ``Calories'' at the 
top, followed by ``Calories from fat'' (indented), and ``Calories from 
saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar as shown in paragraph (d)(12) of this section. The 
position of this column heading shall allow for a list of nutrient names 
and amounts as described in paragraph (d)(7) of this section to be to 
the left of, and below, this column heading. The column headings 
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted 
for ``% Daily Value.''
    (7) Except as provided for in paragraph (j)(13) 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 vitamins and minerals, shall be declared as 
follows:
    (i) The name of each nutrient, as specified in paragraph (c) of this 
section, shall be given in a column and followed immediately by the 
quantitative amount by weight for that nutrient appended with a ``g'' 
for grams or ``mg'' for milligrams as shown in paragraph (d)(12) of this 
section.
    (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

[[Page 35]]

in paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column described 
in paragraph (d)(7)(i) of this section for which a DRV has been 
established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns as shown in paragraph (d)(12) 
of this section, except that when more than four vitamins and minerals 
are declared, they may be declared vertically with percentages listed 
under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state:
    Percent Daily Values are based on a 2,000 calorie diet.
    Your daily values may be higher or lower depending on your calorie 
needs.

------------------------------------------------------------------------
                                   Calories:       2,000        2,500   
------------------------------------------------------------------------
Total fat.....................  Less than.....  65 g         80 g       
Saturated fat.................  Less than.....  20 g         25 g       
Cholesterol...................  Less than.....  300 mg       300 mg     
Sodium........................  Less than.....  2,400 mg     2,400 mg   
Total carbohydrate............  ..............  300 g        375 g      
Dietary fiber.................  ..............  25 g         30 g       
------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and a value of 65 g in the column headed ``2,500''.
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.
    (iv) The abbreviations established in paragraph (j)(13)(ii)(B) of 
this section may be used within the footnote.
    (10) Caloric conversion information on a per gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9) 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 iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set off 
by a line that distinguishes it and sets it apart from the 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 iron, 
the nutrition label may be presented in a tabular display as shown 
below.

[[Page 36]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.351



[[Page 37]]

    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR01JA93.352


[[Page 38]]


    (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 under the 
``Nutrition Facts'' title, and both the quantitative amount by weight 
(i.e., g/mg amounts) and the percent Daily Value for each nutrient shall 
be listed in separate columns under the name of each food. The following 
sample label illustrates an aggregate display.
[GRAPHIC] [TIFF OMITTED] TR01JA93.353

    (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

[[Page 39]]

100 grams) as provided for in paragraph (b) of this section, or for two 
or more groups for which RDI's are established (e.g., both infants and 
children less than 4 years of age) as 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 subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same food (e.g., ``Mix'' and ``Baked''), the combinations of food, the 
units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the reference amount in Sec. 101.12(b) shall be to the 
left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of the 
same food, for combinations of food, or for different units, total 
calories and calories from fat (and calories from saturated fat, when 
declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the product 
as packaged and according to the label serving size based on the 
reference amount in Sec. 101.12(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the reference amount in Sec. 101.12(b) or as a footnote.
    (A) If such additional quantitative information is given immediately 
adjacent to the required quantitative information, it shall be declared 
for all nutrients listed and placed immediately following and 
differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the nutrition 
label identifying the form(s) of the product for which quantitative 
information is presented.
    (4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this 
section shall be presented under the subheading ``% DAILY VALUE'' and in 
columns directly under the column headings set forth in paragraph (e)(1) 
of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

[[Page 40]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.354


    (f) The declaration of nutrition information may be presented in the 
simplified format set forth herein when a food product contains 
insignificant amounts of seven or more of the following: Calories, total 
fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary 
fiber, sugars, protein,

[[Page 41]]

vitamin A, vitamin C, calcium, and iron; except that for foods intended 
for children less than 2 years of age to which Sec. 101.9(j)(5)(i) 
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, sugars, protein, vitamin A, vitamin C, calcium, and iron.
    (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) Calories from fat and 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 
Sec. 101.9(f) and calories from fat that are present in insignificant 
amounts) shall be included at the bottom of the nutrition label.
    (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. When the footnote is omitted, an asterisk 
shall be placed at the bottom of the label followed by the statement 
``Percent Daily Values are based on a 2,000 calorie diet'' and, if the 
term ``Daily Value'' is not spelled out in the heading, a statement that 
``DV'' represents ``Daily Value.''
    (g) 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 chosenshipping 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,'' 15th Ed. 
(1990), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) or 1 CFR part 51 or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures. 
The availability of this incorporation by reference is given in 
paragraph (c)(7) of this section.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to class II requirements unless the same nutrient is 
also added.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated 
or monounsaturated fat, or potassium shall be deemed to be misbranded 
under section 403(a) of the Federal

[[Page 42]]

Food, Drug, and Cosmetic Act (the act) unless it meets the following 
requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label.
    Provided, That no regulatory action will be based on a determination 
of a nutrient value 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, sugars, total fat, 
saturated 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 a vitamin, mineral, protein, total 
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or 
monounsaturated fat, or potassium over labeled amounts are acceptable 
within current good manufacturing practice. Reasonable deficiencies of 
calories, sugars, total fat, saturated 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.
    (8) Compliance with the provisions set forth in paragraphs (g)(1) 
through (g)(6) of this section may be provided by use of an FDA approved 
data base 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 data 
base 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. 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 data bases may be 
found in the ``FDA Nutrition Labeling Manual--A Guide for Developing and 
Using Data Bases,'' available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204.
    (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-150), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204.
    (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,

[[Page 43]]

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.
    (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, 1 ounce for solid foods, 2 fluid ounces for 
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may 
be used as the standard serving size for purposes of nutrition labeling 
of foods subject to this paragraph. 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 (g)(6) of this section. Proposals for such 
categories may be submitted in writing to the Office of Food Labeling 
(HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204.
    (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 one set of Percent Daily 
Values for the cereal as sold (e.g., per ounce), and another set 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 one set of Percent Daily Values for the dry mix (per serving) and 
another set for the serving of the final cake when prepared): 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.

[[Page 44]]

    (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 manufacturer, packer, or 
distributor 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 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) 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) Food products which 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. Claims or other nutrition information 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) 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

[[Page 45]]

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) 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 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. 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.'' 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 and children less than 2 years of age shall 
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and 
except that such labeling shall not include calories from fat (paragraph 
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)), 
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)), 
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 4 years of age shall 
bear nutrition labeling, except that:
    (A) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (B) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns.
    (C) The heading ``Percent Daily Value'' required in paragraph (d)(6) 
of this section shall be placed immediately below the quantitative 
information by weight for protein;
    (D) Percent of Daily Value for protein, vitamins, and minerals shall 
be listed immediately below the heading ``Percent Daily Value''; and
    (E) Such labeling shall not include the footnote specified in 
paragraph (d)(9) of this section.
    (6) Dietary supplements of vitamins or minerals that have an RDI as 
established in paragraph (c)(8)(iv) of this section or a DRV as 
established in paragraph (c)(9) of this section shall be labeled in 
compliance with Sec. 101.36, except that dietary supplements of vitamins 
or minerals in food in conventional form (e.g., breakfast cereals), of 
herbs, and of other similar nutritional substances shall conform to the 
labeling of this section.
    (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

[[Page 46]]

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 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. 
Claims or other nutrition information 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 uppercase 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)(5).
    (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.

[[Page 47]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.355


    (2) The following sample label illustrates the linear display. When 
nutrition information is given in a linear fashion, bolding is required 
only on the title ``Nutrition Facts`` and is allowed voluntarily for the 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR01JA93.356

    (B) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
    (C) Omitting the footnote required in paragraph (d)(9) of this 
section and placing another asterisk at the bottom of the label followed 
by the statement ``Percent Daily Values are based on a 2,000 calorie 
diet`` and, if the term ``Daily Value'' is not spelled out in the 
heading, a statement that ``DV'' represents ``Daily Value.''
    (D) 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

[[Page 48]]

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 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.
    (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 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 a balanced diet of ordinary foods cannot supply adequate 
amounts of nutrients.
    (3) 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.
    (4) 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.
    (5) That the food has dietary properties when such properties are of 
no significant value or need in human nutrition.
    (6) That a natural vitamin in a food is superior to an added or 
synthetic vitamin or to differentiate in any way between vitamins 
naturally present from those added.

[58 FR 2175, Jan. 6, 1993, as amended at 58 FR 2227, 2533, Jan. 6, 1993; 
58 FR 17104, Apr. 1, 1993; 58 FR 17328-17331, Apr. 2, 1993; 58 FR 44048, 
44076, Aug. 18, 1993; 58 FR 59363, Nov. 9, 1993; 58 FR 60109, Nov. 15, 
1993; 59 FR 371, Jan. 4, 1994; 59 FR 62317, Dec. 5, 1994; 60 FR 17205, 
Apr. 5, 1995; 60 FR 30788, June 12, 1995; 60 FR 67174, Dec. 28, 1995; 61 
FR 8779, Mar. 5, 1996; 61 FR 14479, Apr. 2, 1996]

    Effective Date Notes: 1. At 60 FR 67174, Dec. 28, 1995, in 
Sec. 101.9, paragraph (c)(8)(iv) was revised, effective January 1, 1997. 
For the convenience of the reader, the superseded text is set forth 
below.
Sec. 101.9  Nutrition labeling of food.

                                * * * * *

    (c) * * *
    (8) * * *
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units.
Vitamin C, 60 milligrams.
Calcium, 1.0 gram.
Iron, 18 milligrams.
Vitamin D, 400 International Units.
Vitamin E, 30 International Units.
Thiamin, 1.5 milligrams.
Riboflavin, 1.7 milligrams.
Niacin, 20 milligrams.
Vitamin B6, 2.0 milligrams.
Folate, 0.4 milligrams.
Vitamin B12, 6.0 micrograms.
Biotin, 0.3 milligram.
Pantothenic acid, 10 milligrams.
Phosphorus, 1.0 gram.
Iodine, 150 micrograms.
Magnesium, 400 milligrams.
Zinc, 15 milligrams.
Copper, 2.0 milligrams.

                                * * * * *

    2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.9, in paragraph 
(c)(8)(v) the entry which read ``Folate--Folacin'' was revised to read 
as set forth above in the text, effective April 19, 1996.

[[Page 49]]



Sec. 101.10  Nutrition labeling of restaurant foods.

    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 on menus). 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. Nutrient levels may be determined by 
nutrient data bases, 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.

[58 FR 2410, Jan. 6, 1993; 58 FR 17341, Apr. 2, 1993]



Sec. 101.11  Saccharin and its salts; retail establishment notice.

    Each retail establishment (except restaurants) that sells food that 
contains saccharin shall display the following notice in the locations 
set forth in paragraph (b) of this section:
[GRAPHIC] [TIFF OMITTED] TR01JA93.357

Each notice shall be displayed prominently, in a manner highly visible 
to consumers (e.g., not shielded by other store signs or merchandise 
displays) and set up to reduce the likelihood

[[Page 50]]

that a notice will be torn, defaced, or removed.
    (a) The notice shall be printed in a combination of red and black 
ink on white card stock and be at least 11 by 14 inches. The background 
of the bold heading, ``Saccharin Notice,'' and the boxed warning 
statement shall be bright red and the lettering, white. The remaining 
background shall be white with black ink. All lettering shall be in 
gothic typeface.
    (b) Except as provided in paragraph (c) of this section, each retail 
establishment that sells food that contains saccharin shall display a 
notice in each of the following three locations:
    (1) Near the entrance to the retail establishment and arranged so 
that consumers are likely to see the notice upon entering.
    (2) Centrally located in the area of the retail establishment in 
which soft drinks containing saccharin are displayed. If there is more 
than one such place, then in the area where the greatest quantity of 
diet soft drinks are displayed.
    (3) In the area in the establishment in which the largest quantity 
of saccharin-containing foods (including saccharin sold in package form 
as a sugar substitute) are displayed, other than the area where diet 
soft drinks are displayed.
    (c) The following are exceptions to the requirements set forth in 
paragraph (b) of this section:
    (1) A retail establishment with 3,200 square feet or less of floor 
space shall display at least one notice. The notice shall be located 
near the entrance to the retail establishment and arranged so that 
consumers are likely to see the notice upon entering.
    (2) A retail establishment with more than 3,200 but less than 10,000 
square feet of floor space shall display at least two notices. The first 
notice shall be located near the entrance to the retail establishment 
and arranged so that consumers are likely to see the notice upon 
entering. The second notice shall be centrally located in the area of 
the retail establishment in which soft drinks containing saccharin are 
displayed. If there is more than one such place, then in the area where 
the greatest quantity of diet soft drinks are displayed. If diet soft 
drinks are not sold, then in the area of the establishment in which the 
largest quantity of saccharin-containing foods (including saccharin sold 
in package form as a sugar substitute) are displayed.
    (3) A large retail establishment, e.g., department store, whose 
primary business consists of selling nonfood items (i.e., the proportion 
of food sold is extremely small compared to other items) shall display 
at least one notice. The notice shall be located in the area of the 
establishment in which foods containing saccharin are displayed. If 
there is more than one such area, then a notice shall be displayed in 
each area.
    (d) Each manufacturer of saccharin-containing food who customarily 
delivers his products directly to retail establishments shall make 
available at least three notices to each retail establishment in which 
his products are sold. Each manufacturer shall also arrange to supply 
additional notices to a retail establishment that asks for them.
    (e) Manufacturers who do not customarily deliver their saccharin-
containing food products directly to retail establishments may fulfill 
their obligation to provide notices either in the manner set forth in 
paragraph (d) of this section or by participating in, and performing the 
actions required by, a trade association coordinated program that meets 
the following requirements:
    (1) The coordinating association shall have filed notice of the 
program with the Food and Drug Administration, including the 
association's name, mailing address, telephone number, and contact 
person.
    (2) Each manufacturer participating in the program shall file notice 
of its participation with the coordinating association, including its 
name, mailing address, telephone number, and contact person.
    (3) The association shall ensure that retail establishment notices, 
in the form specified in this section, are readily available to 
participating manufacturers.
    (4) The association shall take affirmative steps to coordinate with 
retail establishments, their trade associations,

[[Page 51]]

and the trade press to disseminate information about the applicable 
requirements of the Saccharin Study and Labeling Act and these 
regulations, the existence of the association coordinated program, and 
the availability of notices through the program.
    (5) Each manufacturer shall, in consultation with the association, 
communicate with its contacts in the distributional chain to inform them 
of the applicable requirements of the Saccharin Study and Labeling Act 
and these regulations, and the continued availability of notices.
    (6) Each manufacturer shall ensure that notices are promptly 
provided on request to any retail establishment carrying its products.
    (7) The association shall consult with participating manufacturers 
concerning the implementation and progress of the program and shall 
disseminate information to facilitate the conduct of the program based 
on such consultations or consultation with the Food and Drug 
Administration.
    (8) The association shall, on request, permit the Food and Drug 
Administration to have access to the participation notices filed by 
manufacturers, samples showing the form of retail establishment notices 
made available, and typical communication materials used by the 
association in the course of the program.

[43 FR 8795, Mar. 3, 1978]



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 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.

[[Page 52]]

    (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: 
                    Infant and Toddler Foods 1,2,3,4                    
------------------------------------------------------------------------
      Product category          Reference amount      Label statement5  
------------------------------------------------------------------------
Cereals, dry instant........  15 g................  ------ cup (------  
                                                     g)                 
Cereals, prepared, ready-to-  110 g...............  ------ cup(s) (------
 serve.                                               g)                
Other cereal and grain        7 g for infants and   ------ cup(s) (------
 products, dry ready-to-eat,   20 g for toddlers      g) for ready-to-  
 e.g., ready-to-eat cereals,   for ready-to-eat      eat cereals; ------
 cookies, teething biscuits,   cereals; 7 g for      piece(s) (------ g)
 and toasts.                   all others.           for others         
Dinners, desserts, fruits,    15 g................  ------ tbsp(s)      
 vegetables or soups, dry                            (------ g); ------ 
 mix.                                                cup(s) (------ g)  
Dinners, desserts, fruits,    110 g...............  ------ cup(s) (------
 vegetables or soups, ready-                          g); ------ cup(s) 
 to-serve, junior type.                              (------ mL)        
Dinners, desserts, fruits,    60 g................  ------ cup(s) (------
 vegetables or soups, ready-                          g); ------ cup(s) 
 to-serve, strained type.                            (------ mL)        
Dinners, stews or soups for   170 g...............  ------ cup(s) (------
 toddlers, ready-to-serve.                            g); ------ cup(s) 
                                                     (------ mL)        
Fruits for toddlers, ready-   125 g...............  ------ cup(s) (------
 to-serve.                                            g)                
Vegetables for toddlers,      70 g................  ------ cup(s) (------
 ready-to- serve.                                     g)                
Eggs/egg yolks, ready-to-     55 g................  ------ cup(s) (------
 serve.                                               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.                                            
\2\ Unless otherwise noted in the Reference amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of   
  the product (i.e., heat and serve, brown and serve). If not listed    
  separately, the reference amount for the unprepared form (e.g., dry   
  cereal) 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\Copies of the list of products for each product category are         
  available from the Office of Food Labeling (HFS-150), Center for Food 
  Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
  SW., Washington, DC 20204.                                            
\5\ The label statements are meant to provide guidance to manufacturers 
  on the presentation of serving size information on the label, but they
  are not required. 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 Supply1,2,3,4                       
------------------------------------------------------------------------
      Product category          Reference amount      Label statement5  
------------------------------------------------------------------------
Bakery products:                                                        
    Biscuits, croissants,     55 g................  ------ piece(s) (----
     bagels, tortillas, soft                         -- g)              
     bread sticks, soft                                                 
     pretzels, corn bread,                                              
     hush puppies.                                                      
    Breads (excluding sweet   50 g................  ------ piece(s) (----
     quick type), rolls.                             -- g) 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     ....................  ....................
     coffee cakes.                                                      
    Brownies................  40 g................  ------ piece(s) (----
                                                     -- g) for distinct 
                                                     pieces; fractional 
                                                     slice (------ g)   
                                                     for bulk           
    Cakes, heavy weight       125 g...............  ------ piece(s) (----
     (cheese cake; pineapple                         -- g) for distinct 
     upside-down cake;                               pieces (e.g.,      
     fruit, nut, and                                 sliced or          
     vegetable cakes with                            individually       
     more than or equal to                           packaged products);
     35 percent of the                               ------ fractional  
     finished weight as                              slice (------ g)   
     fruit, nuts, or                                 for large discrete 
     vegetables or any of                            units              
     these combined)6.                                                  
    Cakes, medium weight      80 g................  ------ piece(s) (----
     (chemically leavened                            -- g) for distinct 
     cake with or without                            pieces (e.g.,      
     icing or filling except                         cupcake); ------   
     those classified as                             fractional slice (--
     light weight cake;                              ---- g) for large  
     fruit, nut, and                                 discrete units     
     vegetable cake with                                                
     less than 35 percent of                                            
     the finished weight as                                             
     fruit, nuts, or                                                    
     vegetables or any of                                               
     these combined; light                                              
     weight cake with icing;                                            
     Boston cream pie;                                                  
     cupcake; eclair; cream                                             
     puff)7.                                                            

[[Page 53]]

                                                                        
    Cakes, light weight       55 g................  ------ piece(s) (----
     (angel food, chiffon,                           -- g) for distinct 
     or sponge cake without                          pieces (e.g.,      
     icing or filling)8.                             sliced or          
                                                     individually       
                                                     packaged products);
                                                     ------ fractional  
                                                     slice (------ g)   
                                                     for large discrete 
                                                     units              
    Coffee cakes, crumb       55 g................  ------ piece(s) (----
     cakes, doughnuts,                               -- g) for sliced   
     Danish, sweet rolls,                            bread and distinct 
     sweet quick type                                pieces (e.g.,      
     breads, muffins,                                doughnut); 2 oz (56
     toaster pastries.                               g/visual unit of   
                                                     measure) for bulk  
                                                     products (e.g.,    
                                                     unsliced bread)    
    Cookies.................  30 g................  ------ piece(s) (----
                                                     -- g)              
    Crackers that are         15 g................  ------ piece(s) (----
     usually not used as                             -- g)              
     snack, melba toast,                                                
     hard bread sticks, ice                                             
     cream cones9.                                                      
    Crackers that are         30 g................  ------ piece(s) (----
     usually used as snacks.                         -- g)              
    Croutons................  7 g.................  ------ tbsp(s)      
                                                     (------ g); ------ 
                                                     cup(s) (------ g); 
                                                     ------ piece(s)    
                                                     (------ g) for     
                                                     large pieces       
    French toast, pancakes,   110 g prepared for    ------ piece(s) (----
     variety mixes.            french toast and      -- g); ------      
                               pancakes; 40 g dry    cup(s) (------ g)  
                               mix for variety       for dry mix        
                               mixes.                                   
    Grain-based bars with or  40 g................  ------ piece(s) (----
     without filling or                              -- g)              
     coating, e.g.,                                                     
     breakfast bars, granola                                            
     bars, rice cereal bars.                                            
    Ice cream cones--see      ....................  ....................
     crackers.                                                          
    Pies, cobblers, fruit     125 g...............  ------ piece(s) (----
     crisps, turnovers,                              --g) for distinct  
     other pastries.                                 pieces; ------     
                                                     fractional slice (--
                                                     ---- g) for large  
                                                     discrete units     
    Pie crust...............  1/6 of 8 inch crust;  1/6 of 8 inch crust 
                               1/8 of 9 inch crust.  (------ g); 1/8 of 
                                                     9 inch crust (------
                                                      g)                
    Pizza crust.............  55 g................  ------ fractional   
                                                     slice (------ g)   
    Taco shells, hard.......  30 g................  ------ shell(s) (----
                                                     -- g)              
    Waffles.................  85 g................  ------ piece(s) (----
                                                     -- g)              
Beverages:                                                              
    Carbonated and            240 mL..............  8 fl oz (240 mL)    
     noncarbonated                                                      
     beverages, wine                                                    
     coolers, water.                                                    
    Coffee or tea, flavored   240 mL prepared.....  8 fl oz (240 mL)    
     and sweetened.                                                     
Cereal and Other Grain                                                  
 Products:                                                              
    Breakfast cereals (hot    1 cup prepared; 40 g  ------ cup(s) (------
     cereal type), hominy      plain dry cereal;      g)                
     grits.                    55 g flavored,                           
                               sweetened dry                            
                               cereal.                                  
    Breakfast cereals, ready- 15 g................  ------ cup(s) (------
     to-eat, weighing less                            g)                
     than 20 g per cup,                                                 
     e.g., plain puffed                                                 
     cereal grains.                                                     
    Breakfast cereals, ready- 30 g................  ------ cup(s) (------
     to-eat weighing 20 g or                          g)                
     more but less than 43 g                                            
     per cup; high fiber                                                
     cereals containing 28 g                                            
     or more of fiber per                                               
     100 g.                                                             
    Breakfast cereals, ready- 55 g................  ------ piece(s) (----
     to-eat, weighing 43 g                           -- g) for large    
     or more per cup;                                distinct pieces    
     biscuit types.                                  (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,       140 g prepared; 45 g  ------ cup(s) (------
     barley, plain.            dry.                   g)                
    Pastas, plain...........  140 g prepared; 55 g  ------ cup(s) (------
                               dry.                   g); ------        
                                                     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-    25 g................  ------ cup(s) (------
     eat, e.g., fried canned                          g)                
     chow mein noodles.                                                 
    Starches, e.g.,           10 g................  ------ tbsp (------ 
     cornstarch, potato                              g)                 
     starch, tapioca, etc..                                             
    Stuffing................  100 g...............  ------ cup(s) (------
                                                      g)                
Dairy Products and                                                      
 Substitutes:                                                           
    Cheese, cottage.........  110 g...............  ------ cup (------  
                                                     g)                 
    Cheese used primarily as  55 g................  ------ cup (------  
     ingredients, e.g., dry                          g)                 
     cottage cheese, ricotta                                            
     cheese.                                                            

[[Page 54]]

                                                                        
    Cheese, grated hard,      5 g.................  ------ tbsp (------ 
     e.g., Parmesan, Romano.                         g)                 
    Cheese, all others        30 g................  ------ piece(s) (----
     except those listed as                          -- g) for distinct 
     separate categories--                           pieces;------      
     includes cream cheese                           tbsp(s) (------ g) 
     and cheese spread.                              for cream cheese   
                                                     and cheese spread; 
                                                     1 oz (28 g/visual  
                                                     unit of measure)   
                                                     for bulk           
    Cheese sauce--see sauce                                             
     category.                                                          
    Cream or cream            15 mL...............  1 tbsp (15 mL)      
     substitutes, fluid.                                                
    Cream or cream            2 g.................  ------ tsp (------  
     substitutes, powder.                            g)                 
    Cream, half & half......  30 mL...............  2 tbsp (30 mL)      
    Eggnog..................  120 mL..............  1/2 cup (120 mL); 4 
                                                     fl oz (120 mL)     
    Milk, condensed,          30 mL...............  2 tbsp (30 mL)      
     undiluted.                                                         
    Milk, evaporated,         30 mL...............  2 tbsp (30 mL)      
     undiluted.                                                         
    Milk, milk-based drinks,  240 mL..............  1 cup (240 mL); 8 fl
     e.g., instant                                   oz (240 mL)        
     breakfast, meal                                                    
     replacement, cocoa.                                                
    Shakes or shake           240 mL..............  1 cup (240 mL); 8 fl
     substitutes, e.g.,                              oz (240 mL)        
     dairy shake mixes,                                                 
     fruit frost mixes.                                                 
    Sour cream..............  30 g................  ------ tbsp (------ 
                                                     g)                 
    Yogurt..................  225 g...............  ------ cup (------  
                                                     g)                 
Desserts:                                                               
    Ice cream, ice milk,      1/2 cup-includes the  ------ piece(s) (----
     frozen yogurt, sherbet:   volume for coatings   -- g) for          
     all types, bulk and       and wafers for the    individually       
     novelties (e.g., bars,    novelty type          wrapped or packaged
     sandwiches, cones).       varieties.            products; 1/2 cup  
                                                     (------ g) for     
                                                     others             
    Frozen flavored and       85 g................  ------ piece(s) (----
     sweetened ice and pops,                         -- g) for          
     frozen fruit juices:                            individually       
     all types, bulk and                             wrapped or packaged
     novelties (e.g., bars,                          products; ------   
     cups).                                          cup(s) (------ g)  
                                                     for others         
    Sundae..................  1 cup...............  1 cup (------ g)    
    Custards, gelatin or      1/2 cup.............  ------ piece(s) (----
     pudding.                                        -- g) for distinct 
                                                     unit (e.g.,        
                                                     individually       
                                                     packaged products);
                                                     1/2 cup (------ g) 
                                                     for bulk           
Dessert Toppings and                                                    
 Fillings:                                                              
    Cake frostings or icings  35 g................  ------ 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                                             
     nondairy whipped                                                   
     toppings.                                                          
    Pie fillings............  85 g................  ------ cup(s) (------
                                                      g)                
Egg and Egg Sustitutes:                                                 
    Egg mixtures, e.g., egg   110 g...............  ------ piece(s) (----
     foo young, scrambled                            -- g) for discrete 
     eggs, omelets.                                  pieces; ------     
                                                     cup(s) (------ g)  
    Eggs (all sizes)9.......  50 g................  1 large, medium,    
                                                     etc. (------ g)    
    Egg substitutes.........  An amount to make 1   ------ cup(s) (------
                               large (50 g) egg.      g); ------ cup(s) 
                                                     (------ mL)        
Fats and Oils:                                                          
    Butter, margarine, oil,   1 tbsp..............  1 tbsp (------ g); 1
     shortening.                                     tbsp (15 mL)       
    Butter replacement,       2 g.................  ------ tsp(s) (------
     powder.                                          g)                
    Dressings for salads....  30 g................  ------ tbsp (------ 
                                                     g); ------ tbsp    
                                                     (------ mL)        
     Mayonnaise, sandwich     15 g................  ------ tbsp (------ 
     spreads, mayonnaise-                            g)                 
     type dressings.                                                    
    Spray types.............  0.25 g..............  About ------ seconds
                                                     spray (------ g)   
Fish, Shellfish, Game                                                   
 Meats10, and Meat or                                                   
 Poultry Substitutes:                                                   
    Bacon substitutes,        15 g................  ------ piece(s) (----
     canned anchovies,11                             -- g) for discrete 
     anchovy pastes, caviar.                         pieces; ------     
                                                     tbsp(s) (------ g) 
                                                     for others         
    Dried, e.g., jerky......  30 g................  ------ piece(s) (----
                                                     -- g)              
    Entrees with sauce,       140 g cooked........  ------ cup(s) (------
     e.g., fish with cream                            g); 5 oz (140 g/  
     sauce, shrimp with                              visual unit of     
     lobster sauce.                                  measure) if not    
                                                     measurable by cup  
    Entrees without sauce,    85 g cooked; 110 g    ------ piece(s) (----
     e.g., plain or fried      uncooked12.           -- g) for discrete 
     fish and shellfish,                             pieces; ------     
     fish and shellfish cake.                        cup(s) (------ g); 
                                                     ------ oz (------ g/
                                                     visual unit of     
                                                     measure) if not    
                                                     measurable by cup13

[[Page 55]]

                                                                        
    Fish, shellfish or game   55 g................  ------ piece(s) (----
     meat10, canned11.                               -- g) for discrete 
                                                     pieces; ------     
                                                     cup(s) (------ g); 
                                                     2 oz (56 g/------  
                                                     cup) for products  
                                                     that are difficult 
                                                     to measure the g   
                                                     weight of cup      
                                                     measure (e.g.,     
                                                     tuna); 2 oz (56 g/--
                                                     ---- pieces) for   
                                                     products that      
                                                     naturally vary in  
                                                     size (e.g.,        
                                                     sardines)          
    Substitute for luncheon   55 g................  ------ piece(s) (----
     meat, meat spreads,                             -- g) for distinct 
     Canadian bacon,                                 pieces (e.g.,      
     sausages and                                    slices, links); ----
     frankfurters.                                   -- cup(s) (------  
                                                     g); 2 oz (56 g/    
                                                     visual unit of     
                                                     measure) for       
                                                     nondiscrete bulk   
                                                     product            
    Smoked or pickled11       55 g................  ------ piece(s) (----
     fish, shellfish, or                             -- g) for distinct 
     game meat10; fish or                            pieces (e.g.,      
     shellfish 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                                            
     category.                                                          
Fruits and Fruit Juices:                                                
    Candied or pickled11....  30 g................  ------ piece(s) (----
                                                     -- g)              
    Dehydrated fruits--see    ....................  ....................
     snacks category.                                                   
    Dried...................  40 g................  ------ piece(s) (----
                                                     -- g) for large    
                                                     pieces (e.g.,      
                                                     dates, figs,       
                                                     prunes); ------    
                                                     cup(s) (------ g)  
                                                     for small pieces   
                                                     (e.g., raisins)    
    Fruits for garnish or     4 g.................  1 cherry (------ g) 
     flavor, e.g.,                                                      
     maraschino cherries11.                                             
    Fruit relishes, e.g.,     70 g................  ------ cup(s) (------
     cranberry sauce,                                 g)                
     cranberry relish.                                                  
    Fruits used primarily as  30 g................  See footnote 13     
     ingredients, avocado.                                              
    Fruits used primarily as  55 g................  ------ piece(s) (----
     ingredients, others                             -- g) for large    
     (cranberries, lemon,                            fruits; ------     
     lime).                                          cup(s) (------ g)  
                                                     for small fruits   
                                                     measurable by cup13
    Watermelon..............  280 g...............  See footnote 13     
    All other fruits (except  140 g...............  ------ piece(s) (----
     those listed as                                 -- g) for large    
     separate categories),                           pieces (e.g.,      
     fresh, canned, or                               strawberries,      
     frozen.                                         prunes, apricots,  
                                                     etc.); ------      
                                                     cup(s) (------ g)  
                                                     for small pieces   
                                                     (e.g., blueberries,
                                                     raspberries,       
                                                     etc.)13            
    Juices, nectars, fruit    240 mL..............  8 fl oz (240 mL)    
     drinks.                                                            
    Juices used as            5 mL................  1 tsp (5 mL)        
     ingredients, e.g.,                                                 
     lemon juice, lime juice.                                           
Legumes:                                                                
    Bean cake (tofu)11,       85 g................  ------ piece(s) (----
     tempeh.                                         -- 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 (------  
                               sauce or canned in    g)                 
                               liquid and refried                       
                               beans prepared; 90                       
                               g for others                             
                               prepared; 35 g dry.                      
Miscellaneous Category:                                                 
    Baking powder, baking     1 g.................  ------ tsp (------  
     soda, pectin.                                   g)                 
    Baking decorations,       1 tsp or 4 g if not   ------ piece(s) (----
     e.g., colored sugars      measurable by         -- g) for discrete 
     and sprinkles for         teaspoon.             pieces;1 tsp (------
     cookies, cake                                    g)                
     decorations.                                                       
    Batter mixes, bread       30 g................  ------ tbsp(s)      
     crumbs.                                         (------ g);------  
                                                     cup(s) (------ g)  
    Cooking wine............  30 mL...............  2 tbsp (30 mL)      
    Dietary supplements not   The maximum amount    ------ tablet(s),   
     in conventional food      recommended, as       ------ capsule(s), 
     form..                    appropriate, on the   ------ packet(s), --
                               label for             ---- tsp(s) (------
                               consumption per       g), etc.           
                               eating occasion or,                      
                               in the absence of                        
                               recommendations, 1                       
                               unit, e.g., tablet,                      
                               capsule, packet,                         
                               teaspoonful, etc..                       
    Drink mixers (without     Amount to make 240    ------ fl oz (------
     alcohol).                 mL drink (without     mL)                
                               ice).                                    
    Chewing gum9............  3 g.................  ------ piece(s) (----
                                                     -- g)              

[[Page 56]]

                                                                        
    Meat, poultry and fish    Amount to make one    ------ tsp(s) (------
     coating mixes, dry;       reference amount of    g); ------ tbsp(s)
     seasoning mixes, dry,     final dish.           (------ g)         
     e.g., chili seasoning                                              
     mixes, pasta salad                                                 
     seasoning mixes.                                                   
    Salad and potato          7 g.................  ------ tbsp(s)      
     toppers, e.g., salad                            (------ g)         
     crunchies, salad                                                   
     crispins, substitutes                                              
     for bacon bits.                                                    
    Salt, salt substitutes,   1 g.................  ------ tsp(s) (------
     seasoning salts (e.g.,                           g);------ piece(s)
     garlic salt).                                   (------ g) for     
                                                     discrete pieces    
                                                     (e.g., individually
                                                     packaged products) 
    Spices, herbs (other      1/4 tsp or 0.5 g if   1/4 tsp (------ g); 
     than dietary              not measurable by     ------ piece(s)    
     supplements).             teaspoon.             (------ g) if not  
                                                     measurable by      
                                                     teaspoons (e.g.,   
                                                     bay leaf)          
Mixed Dishes:                                                           
    Measurable with cup,       1 cup..............  1 cup (------ g)    
     e.g., casseroles, hash,                                            
     macaroni and cheese,                                               
     pot pies, spaghetti                                                
     with sauce, stews, etc..                                           
    Not measurable with cup,  140 g, add 55 g for   ------ piece(s) (----
     e.g., burritos, egg       products with gravy   -- g) for discrete 
     rolls, enchiladas,        or sauce topping,     pieces; ------     
     pizza, pizza rolls,       e.g., enchilada       fractional slice (--
     quiche, all types of      with cheese sauce,    ---- g) for large  
     sandwiches.               crepe with white      discrete units     
                               sauce14.                                 
Nuts and Seeds:                                                         
    Nuts, seeds, and          30 g................  ------ piece(s) (----
     mixtures, all types:                            -- g) for large    
     sliced, chopped,                                pieces (e.g.,      
     slivered, and whole.                            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     15 g................  ------ tbsp(s)      
     flours.                                         (------ g); ------ 
                                                     cup (------ g)     
Potatoes and Sweet Potatoes/                                            
 Yams:                                                                  
    French fries, hash        70 g prepared; 85 g   ------ piece(s) (----
     browns, skins, or         for frozen            -- g) for large    
     pancakes.                 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,          140 g...............  ------ piece(s) (----
     stuffed, or with sauce.                         -- g) for discrete 
                                                     pieces (e.g.,      
                                                     stuffed potato);   
                                                     ------ cup(s)      
                                                     (------ g)         
    Plain, fresh, canned, or  110 g for fresh or    ------ piece(s) (----
     frozen.                   frozen; 125 g for     -- g) for discrete 
                               vacuum packed; 160    pieces;------      
                               g for canned in       cup(s) (------ g)  
                               liquid.               for sliced or      
                                                     chopped products   
Salads:                                                                 
    Gelatin salad...........  120 g...............  ------ cup (------  
                                                     g)                 
    Pasta or potato salad...  140 g...............  ------ cup(s) (------
                                                      g)                
    All other salads, e.g.,   100 g...............  ------ cup(s) (------
     egg, fish, shellfish,                            g)                
     bean, fruit, or                                                    
     vegetable salads.                                                  
Sauces, Dips, Gravies and                                               
 Condiments:                                                            
    Barbecue sauce,           2 tbsp..............  2 tbsp (------ g); 2
     hollandaise sauce,                              tbsp (30 mL)       
     tartar 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         125 g...............  ------ cup (------  
     sauces, e.g., spaghetti                         g); ------ cup (----
     sauce.                                          -- mL)             
    Minor main entree sauces  1/4 cup.............  1/4 cup (------ g); 
     (e.g., pizza sauce,                             1/4 cup (60 mL)    
     pesto 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,                            tbsp (15 mL)       
     soy sauce, vinegar,                                                
     teriyaki sauce,                                                    
     marinades.                                                         
    Minor condiments, e.g.,   1 tsp...............  1 tsp (------ g); 1 
     horseradish, hot                                tsp (5 mL)         
     sauces, mustards,                                                  
     worcestershire sauce.                                              

[[Page 57]]

                                                                        
Snacks:                                                                 
    All varieties, chips,     30 g................  ------ cup(s) (------
     pretzels, popcorns,                              g) for small      
     extruded snacks, fruit-                         pieces (e.g.,      
     based snacks (e.g.,                             popcorn) ------    
     fruit chips,) grain-                            piece(s) (------ g)
     based snack mixes.                              for large pieces   
                                                     (e.g., large       
                                                     pretzels; pressed  
                                                     dried fruit sheet);
                                                     1 oz (28 g/visual  
                                                     unit of measure)   
                                                     for bulk products  
                                                     (e.g., potato      
                                                     chips)             
Soups:                                                                  
    All varieties...........  245 g...............  ------ cup (------  
                                                     g); ------ cup (----
                                                     -- mL)             
Sugars and Sweets:                                                      
    Baking candies (e.g.,     15 g................  ------ piece(s) (----
     chips).                                         -- g) for large    
                                                     pieces; ------     
                                                     tbsp(s) (------ g) 
                                                     for small pieces; 1/
                                                     2 oz (14 g/visual  
                                                     unit of measure)   
                                                     for bulk products  
    Hard candies, breath      2 g.................  ------ piece(s) (----
     mints.                                          -- g)              
    Hard candies, roll-type,  5 g.................  ------ piece(s) (----
     mini-size in dispenser                          -- g)              
     packages.                                                          
    Hard candies, others....  15 g................  ------ piece(s) (----
                                                     -- g) for large    
                                                     pieces;------      
                                                     tbsp(s) (------ g) 
                                                     for ``mini-size''  
                                                     candies measurable 
                                                     by tablespoon; 1/2 
                                                     oz (14 g/visual    
                                                     unit of measure)   
                                                     for bulk products  
    All other candies.......  40 g................  ------ piece(s) (----
                                                     -- g); 1 1/2 oz (42
                                                     g/visual unit of   
                                                     measure) for bulk  
                                                     products           
    Confectioner's sugar....  30 g................  ------ cup (------  
                                                     g)                 
    Honey, jams, jellies,     1 tbsp..............  1 tbsp (------ g); 1
     fruit butter, molasses.                         tbsp (15 mL)       
    Marshmallows............  30 g................  ------ cup(s) (------
                                                      g) for small      
                                                     pieces; ------     
                                                     piece(s) (------ g)
                                                     for large pieces   
    Sugar...................  4 g.................  ------ tsp (------  
                                                     g) ; ------        
                                                     piece(s) (------ g)
                                                     for discrete pieces
                                                     (e.g., sugar cubes,
                                                     individually       
                                                     packaged products) 
    Sugar substitutes.......  An amount equivalent  ------ tsp(s) (------
                               to one reference       g) for solids; ----
                               amount for sugar in   -- drop(s) (------ 
                               sweetness.            g) for liquid;     
                                                     ------ piece(s)    
                                                     (------ g) (e.g.,  
                                                     individually       
                                                     packaged products) 
    Syrups..................  30 mL for syrups      2 tbsp (30 mL) for  
                               used primarily as     syrups used        
                               an ingredient         primarily as an    
                               (e.g., light or       ingredient; 1/4 cup
                               dark corn syrup);     (60 mL) for all    
                               60 mL for all         others             
                               others.                                  
Vegetables:                                                             
    Vegetables primarily      4 g.................  ------ piece(s) (----
     used for garnish or                             -- g); ------      
     flavor, e.g., pimento,                          tbsp(s) (------ g) 
     parsley.                                        for chopped        
                                                     products           
    Chili pepper, green       30 g................  ------ piece(s) (----
     onion.                                          -- g)13; ------    
                                                     tbsp(s) (------ g);
                                                     ------ cup(s)      
                                                     (------ g) for     
                                                     sliced or chopped  
                                                     products           
    All other vegetables      85 g for fresh or     ------ piece(s) (----
     without sauce: fresh,     frozen; 95 g for      -- g) for large    
     canned, or frozen.        vacuum packed; 130    pieces (e.g.,      
                               g for canned in       brussel sprouts); --
                               liquid, cream-style   ---- cup(s) (------
                               corn, canned or       g) for small pieces
                               stewed tomatoes,      (e.g., cut corn,   
                               pumpkin, or winter    green peas); 3 oz  
                               squash.               (84 g/visual unit  
                                                     of measure) if not 
                                                     measurable by cup13
    All other vegetables      110 g...............  ------ piece(s) (----
     with sauce: fresh,                              -- g) for large    
     canned, or frozen.                              pieces (e.g.,      
                                                     brussel 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)    
    Olives11................  15 g................  ------ piece(s) (----
                                                     -- g); ------      
                                                     tbsp(s) (------ g) 
                                                     for sliced products
    Pickles, all types11....  30 g................  1 oz (28 g/visual   
                                                     unit of measure)   
    Pickle relishes.........  15 g................  ------ tbsp (------ 
                                                     g)                 
    Vegetable pastes, e.g.,   30 g................  ------ tbsp (------ 
     tomato paste.                                   g)                 

[[Page 58]]

                                                                        
    Vegetable sauces or       60 g................  ------ cup (------  
     purees, e.g, tomato                             g); ------ cup (----
     sauce, tomato puree.                            -- mL)             
------------------------------------------------------------------------
\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 Argiculture.              
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of   
  the product (i.e., heat and serve, 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\ Copies of the list of products for each product category are        
  available from the Office of Food Labeling (HFS-150), Center for Food 
  Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
  SW., Washington, DC 20204.                                            
\5\ The label statements are meant to provide guidance to manufacturers 
  on the presentation of serving size information on the label, but they
  are not required. 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).                              
\6\ Includes cakes that weigh 10 g or more per cubic inch.              
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than  
  10 g per cubic inch.                                                  
\8\ Includes cakes that weigh less than 4 g per cubic inch.             
\9\ Label serving size for ice cream cones and eggs 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.                                       
\10\ 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.         
\11\ 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).
\12\ 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(b)(j)(11).           
\13\ For raw fruit, vegetables, and fish, manufacturers should follow   
  the label statement for the serving size specified in Appendices A and
  B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
  Nutrition Labeling; and Identification of the 20 Most Frequently      
  Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial  
  Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6, 
  1992).                                                                
\14\ 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 but 
not the unprepared form, then the reference amount for the unprepared 
product shall be determined using the following rules:
    (1) Except as provided for in paragraph (c)(2) of this section, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the reference amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the reference amount for the prepared product as 
established in paragraph (b) of this section.
    (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

[[Page 59]]

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(e).
    (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 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) For bulk products (e.g., peanut butter and jelly), the reference 
amount for the combined product shall be the reference amount, as 
established in paragraph (b) of this section, for the ingredient that is 
represented as the main ingredient plus proportioned amounts of all 
minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units (e.g., cracker and cheese pack, 
pancakes and syrup, cake and frosting), the reference amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the reference amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the reference amounts are in compatible units, they shall be 
summed (e.g., 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, the weights of the 
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus 
the gram 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

[[Page 60]]

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.
    (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. 25.24 of this 
chapter or an environmental assessment under Sec. 25.31 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

[[Page 61]]

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]



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 foods in conventional food form and dietary 
supplements of vitamins, minerals, herbs, and other similar nutritional 
substances (dietary supplements).
    (b) A claim that expressly or implicitly characterizes the level of 
a nutrient (nutrient content claim) of the type required in nutrition 
labeling under Sec. 101.9, with the exception of such claims on 
restaurant menus, 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 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

[[Page 62]]

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. 101.105(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) The label or labeling of a food for which a nutrient content 
claim is made shall contain prominently and in immediate proximity to 
such claim, the following referral statement: ``See --------------------
------------ for nutrition information'' with the blank filled in with 
the identity of the panel on which nutrition labeling is located, except 
that when such a claim appears on the panel that bears nutrition 
information the referral statement may be omitted.
    (1) The referral statement ``See [appropriate panel] for nutrition 
information'' 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. 101.105(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 referral 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)(5), in which case the referral 
statement may be in type of not less than one thirty-second of an inch.
    (2) The referral 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 Secs. 101.54 and 
101.62). If the nutrient content claim appears on more than one panel of 
the label, the referral statement shall be adjacent to the claim on each 
panel except for the panel that bears the nutrition information where it 
may be omitted.
    (3) If a single panel of a food label or labeling contains multiple 
nutrient content claims or a single claim repeated several times, a 
single referral statement may be made. The statement shall be adjacent 
to the claim that is printed in the largest type on that panel.
    (h) In place of the referral statement described in paragraph (g) of 
this section,
    (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 reference amount 
customarily consumed, per labeled serving, or, for a

[[Page 63]]

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 
disclose, as part of the referral statement, that the nutrient exceeding 
the specified level is present in the food as follows: ``See 
[appropriate panel] for information about [nutrient requiring 
disclosure] and other nutrients,'' e.g., ``See side panel for 
information about total fat and other nutrients.''
    (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.
    (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. 101.105(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 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,'' ``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

[[Page 64]]

    (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 
(g)(1) 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;
    (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:

[[Page 65]]

    (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 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 (g)(1) 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

[[Page 66]]

403(r)(2) of the act (e.g., the referral statement also required by 
Sec. 101.13(g) and 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) 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.
    (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 (except on menus) 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 the appropriate definition in subpart D of this part, except 
that:
    (i) Such claim is exempt from the requirements for disclosure 
statements in paragraphs (g) and (h) of this section and 
Secs. 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), (g), 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]



Sec. 101.14  Health claims: general requirements.

    (a) Definitions. For purposes of this section, the following 
definitions apply:

[[Page 67]]

    (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) Dietary supplement means a food, not in conventional food form, 
that supplies a component to supplement the diet by increasing the total 
dietary intake of that component.
    (5) Disqualifying nutrient levels means the levels of total fat, 
saturated fat, cholesterol, or sodium in a food above 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.
    (6) 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 in 
conventional food form or dietary supplement form, 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

[[Page 68]]

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:
    (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

[[Page 69]]

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 
(except if the claim is made on a menu) or in other establishments in 
which food that is ready for 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) and (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 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 of vitamins or minerals, in accordance with Sec. 101.36. The 
requirements of the introductory text of paragraph (d)(3) of this 
section are effective as of May 8, 1993, except:
    (i)--(ii) [Reserved]
    (iii) For dietary supplements of vitamins, minerals, herbs, or other 
similar nutritional substances for which the requirements of paragraph 
(d)(3) of this section will be effective July 5, 1994.
    (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)(5) 
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 referral 
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

[[Page 70]]

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]



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 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 and notice 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:


[[Page 71]]


    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) Self-pressurized containers with a chlorofluorocarbon 
propellant. (1) In addition to the warning required by paragraphs (a) 
and (b) of this section, the label on each package of a food in a self-
pressurized container in which the propellant consists in whole or in 
part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon) 
shall bear the following warning:

    Warning--Contains a chlorofluorocarbon that may harm the public 
health and environment by reducing ozone in the upper atmosphere.

    (2) The warning required by paragraph (c)(1) of this section shall 
appear on an appropriate panel with such prominence and conspicuousness 
as to render it likely to be read and understood by ordinary individuals 
under normal conditions of purchase. The warning may appear on a firmly 
affixed tag, tape, card, or sticker or similar overlabeling attached to 
the package. The warning shall comply in all other respects with 
Sec. 101.2, e.g., type-size requirements.
    (3) The warning required by paragraph (c)(1) of this section is 
applicable only to self-pressurized containers that use 
chlorofluorocarbons in whole or in part as a propellant to expel from 
the container liquid or solid material different from the propellant, 
but the warning is not applicable to the use of chlorofluorocarbon as a 
stabilizer in food toppings and spreads.
    (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

[[Page 72]]

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.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977; 
49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984]



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 
Secs. 172.515(b) and 182.60 of this chapter except where these are 
derived from natural sources.

[[Page 73]]

    (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, 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 Secs. 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

[[Page 74]]

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.
    (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,

[[Page 75]]

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.''
    (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 used 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

[[Page 76]]

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 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 Secs. 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

[[Page 77]]

name as specified in part 74 or part 82 of this chapter.
    (2) Color additives not subject to certification 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 with the name of the color additive listed in the 
applicable regulation in part 73 of this chapter.
    (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]



Sec. 101.29   Labeling of kosher and kosher-style foods.

    The term ``kosher'' should be used only on food products that meet 
certain religious dietary requirements. The precise significance of the 
phrase ``kosher style'' as applied to any particular product by the 
public has not been determined. There is a likelihood that the use of 
the term may cause the prospective purchaser to think that the product 
is ``kosher.'' Accordingly, the Food and Drug Administration believes 
that use of the phrase should be discouraged on products that do not 
meet the religious dietary requirements.



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.

[[Page 78]]

    (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 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, or the title phrase 
``Nutrition Facts'' 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. 101.105(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  
                             Juice                               percent
                                                                  juice1
------------------------------------------------------------------------
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

[[Page 79]]

                                                                        
Grapefruit.....................................................    310.0
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.........................................................    311.8
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......................................................    311.8
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-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]



Sec. 101.33   Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food.

    (a) The article d-erythroascorbic acid (d-araboascorbic acid, d-
erythro-3-keto-hexonic acid lactone) has sometimes been designated as d-
isoascorbic acid. However, this designation is capable of misleading 
purchasers of food in which it is used as an ingredient because of the 
similarity of such designation to the chemical name and the common name 
of vitamin C, which is ascorbic acid. Ascorbic acid (vitamin C) is 
capable of preventing the deficiency disease scurvy, but d-isoascorbc 
acid is ineffective for this purpose.
    (b) The Joint Committee on Nomenclature of the American Institute of 
Nutrition and the Society of Biological Chemists has considered this 
matter, and pursuant to the Committee's recommendation the respective 
scientific organizations approved a resolution to drop the use of the 
designation d-isoascorbic acid and to adopt as a common name the name 
erythorbic acid for d-erythroascorbic acid.
    (c) The compound d-erythroascorbic acid is not specified as an 
ingredient of any food for which a standard has been established. For 
foods other than those for which standards have been established, 
section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act requires

[[Page 80]]

that ingredients be listed on labels by their common or usual names. If 
the label on a food that contains d-erythroascorbic acid designates that 
ingredient by the name erythorbic acid, the requirement that the label 
bear the common or usual name of the ingredient will be regarded as 
having been met.



   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 of vitamins and minerals.

    (a) The label of a dietary supplement of a vitamin or mineral that 
has a Reference Daily Intake (RDI) as established in 
Sec. 101.9(c)(8)(iv) or a Daily Reference Value (DRV) as established in 
Sec. 101.9(c)(9), shall bear nutrition labeling in accordance with this 
regulation, as illustrated in paragraph (c)(9) of this section, unless 
an exemption is provided for the product in paragraph (f) of this 
section. Dietary supplements of herbs or other similar nutritional 
substances shall bear nutrition labeling in accordance with Sec. 101.9.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the headings and 
format specified, under the heading of ``Nutrition Facts''. The 
nutrition information shall be enclosed in a box by use of lines, shall 
be all black or one color type, and shall be printed on a white or other 
neutral contrasting background whenever practical.
    (1) The subheading ``Serving Size'' shall be placed under the 
heading and aligned on the left side of the nutrition label. The serving 
size shall be determined in accordance with Sec. 101.9(b) and 
Sec. 101.12(b), Table 2. Serving size shall be expressed using a term 
that is appropriate for the form of the supplement, such as ``tablets,'' 
``capsules,'' ``packets,'' or ``teaspoonfuls.''
    (2) 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.
    (3) A listing of all nutrients required in Sec. 101.9(c) that are 
present in the dietary supplement in quantitative amounts by weight that 
exceed the amount that can be declared as zero in Sec. 101.9(c). Those 
nutrients that are not present, or present in amounts that would be 
declared as zero, shall not be declared. In addition, potassium shall be 
declared except when present in quantitative amounts by weight that 
allow a declaration of zero. The name of each nutrient listed shall be 
immediately followed by the quantitative amount by weight of the 
nutrient. Nutrient names and quantitative amounts shall be presented in 
a column under the heading ``Amount Per Serving'' and aligned on the 
left side of the nutrition label. The heading ``Amount Per Serving'' 
shall be separated from other information on the label by a bar above 
and beneath it, except that when calories are listed, the bar shall be 
placed beneath the calorie declaration. When the serving size of the 
product is one unit (e.g., 1 tablet), a heading consistent with the 
declaration of serving size, such as ``Amount per Tablet'' or ``Each 
Tablet Contains,'' may be used in place of the heading ``Amount per 
Serving.'' Other appropriate terms, such as capsule, packet, or 
teaspoonful, may be used in place of the term ``Serving.''
    (i) These amounts shall be expressed in the increments specified in 
Sec. 101.9(c), except that the amounts of vitamins and minerals, 
excluding sodium and potassium, declared on the nutrition label shall be 
the actual amount of the vitamin or mineral included in the dietary 
supplement, using the units of measure and the levels of significance 
given in Sec. 101.9(c). In declaring the amounts of vitamins and 
minerals, 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 
copper is given in whole milligrams, but the quantitative amount may be 
declared in tenths of a milligram). Amounts for chloride and manganese 
shall be expressed in mg,

[[Page 81]]

and, amounts for chromium, molybdenum, selenium, and vitamin K shall be 
expressed in micrograms. These values shall be expressed in whole 
numbers.
    (ii) Nutrients that are present shall be listed in the order 
specified in Sec. 101.9(c); except that, when present, vitamin K shall 
follow vitamin E; calcium and iron shall follow pantothenic acid; 
selenium shall follow zinc; and manganese, chromium, molybdenum, 
chloride, sodium, and potassium shall follow copper. 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, vitamin B12, biotin, pantothenic acid, calcium, iron, 
phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, 
chromium, molybdenum, chloride, sodium, and potassium. A bar shall 
separate the last nutrient to be listed from the bottom of the nutrition 
label, as shown in the sample labels in paragraph (c)(9) of this 
section.
    (iii) If the product contains two or more separately packaged 
dietary supplements of vitamins and minerals (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 may be presented 
as specified in this paragraph in individual nutrition labels or in one 
aggregate nutrition label with separate columns declaring the 
quantitative amounts for each package as illustrated in paragraph 
(c)(9)(iii) of this section.
    (iv) The percent of vitamin A that is present as beta-carotene may 
be declared, to the nearest whole percent, immediately adjacent to or 
beneath the nutrient name (e.g., ``Vitamin A 5000 IU (90 percent as 
beta-carotene)''), except that the declaration is required when a claim 
is made about beta-carotene. The amount of beta-carotene in terms of 
international units (IU) may be included in parentheses following the 
percent statement (e.g., ``Vitamin A 5000 IU (90 percent (4500 IU) as 
beta-carotene)'').
    (v) The following synonyms may be added in parenthesis immediately 
following the name of these nutrients: Vitamin C (ascorbic acid), 
thiamin (vitamin B1), riboflavin (vitamin B2), folate--either folic acid 
or folacin may be used, and calories (energy). Energy content per 
serving may be expressed in kilojoules units, added in parentheses 
immediately following the statement of caloric content.
    (vi) All nutrients shall be displayed with uniform type size, style, 
color, and prominence.
    (4) A listing of the percent of the Daily Value (i.e., the percent 
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established 
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the 
nutrition label, except that the percent for protein may be omitted as 
provided in Sec. 101.9(c)(7), no percent shall be given for sugars, and 
for labels of dietary supplements of vitamins and minerals that are 
represented or purported to be for use by infants, children less than 4 
years of age, or pregnant or lactating women, no percent shall be given 
for vitamin K, selenium, manganese, chromium, molybdenum, or chloride. 
This information shall be presented in one column aligned under the 
heading of ``% Daily Value'' and to the right of the column of nutrient 
names and 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'' or placed beneath this 
heading and the bar underneath it, except that ``% Daily Value'' shall 
be placed beneath this bar when calorie information is required to be 
declared. Calorie information shall be placed beneath ``Amount Per 
Serving'' and above the bar.
    (i) The percent of Daily Value 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 RDI or DRV for 
the specified nutrient and multiplying by 100, except that the percent 
for protein shall be calculated as specified in Sec. 101.9(c)(7)(ii). 
The numerical value shall be followed by the symbol for percent (i.e., 
%).
    (ii) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that ``Less than 1%'' may be used 
in place of

[[Page 82]]

``0%'' when the declaration of the quantitative amount by weight is a 
value greater than zero.
    (iii) The percent of Daily Value for vitamins and minerals shall be 
based on RDI values for adults and children 4 or more years of age 
unless the product is represented or purported to be for use by infants, 
children less than 4 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 (c)(9)(ii) of this section.
    (iv) If the product contains two or more separately packaged dietary 
supplements of vitamins and minerals (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 percent of Daily Value may be presented as 
specified in paragraph (b)(4) of this section in individual nutrition 
labels or in one aggregate nutrition label with separate columns 
declaring the percent of Daily Value for each package as illustrated in 
paragraph (c)(9)(iii) of this section.
    (v) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, the value 
shall be followed by an asterisk that refers to another asterisk at the 
bottom of the nutrition label that states ``Percent Daily Values are 
based on a 2,000 calorie diet.''
    (vi) When no percent is given for sugars, or for labels of dietary 
supplements of vitamins and minerals that are represented or purported 
to be for use by infants, children less than 4 years of age, or pregnant 
or lactating women, when no percent is given for vitamin K, selenium, 
manganese, chromium, molybdenum, or chloride, an asterisk shall be 
placed in the ``Percent Daily Value'' column that shall refer to another 
asterisk that is placed at the bottom of the nutrition label and 
followed by the statement ``Daily Value not established.''
    (c) Nutrition information specified in this section shall be 
presented as follows:
    (1) The title of ``Nutrition 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 highlighted (reverse printing is not permitted 
as a form of highlighting) to distinguish them from other information.
    (2) All information within the nutrition label shall utilize a 
single easy-to-read type style.
    (3) All information within the nutrition label shall utilize upper 
and lower case 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.
    (4) All information within the nutrition label shall have at least 
one point leading (i.e., space between two lines of text).
    (5) Letters should never touch.
    (6) All information within the nutrition label on packages that have 
a total surface area available to bear labeling of less than 12 square 
inches shall have type size no smaller than 4.5 point; packages that 
have from 12 to 40 square inches of surface area available to bear 
labeling shall have type size no smaller than 6 point; and packages with 
more than 40 square inches of surface area available to bear labeling 
shall have type size no smaller than 8 point, except that on packages 
with more than 40 square inches of available surface area, type size no 
smaller than 6 point may be used for the listing of information on beta-
carotene, as specified in paragraph (b)(3)(iv) of this section, for the 
headings required by paragraphs (b)(3) and (b)(4) of this section (i.e., 
``Amount Per Serving'' and ``% Daily Value''), and for the footnote 
required by paragraph (b)(4)(v) of this section.
    (7) A hairline rule that is centered between the lines of text shall 
separate each nutrient and its corresponding percent Daily Value 
required in paragraph (b)(4) of this section from the nutrient and 
percent Daily Value above and beneath it, as shown in paragraph (c)(9) 
of this section, and shall separate

[[Page 83]]

``Amount Per Serving'' from the calorie statement, when the listing of 
calories is required.
    (8) 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.
    (9) The following sample labels are presented for the purpose of 
illustration:
    (i) Multiple vitamin.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.358
    

[[Page 84]]


    (ii) Multiple vitamin for children and adults.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.359
    

[[Page 85]]


    (iii) Multiple vitamins in packets.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.360
    
    (10) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (c)(9) 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 shall be set off by a line that 
distinguishes it and sets it apart from the nutrients and percent of 
Daily Value information given to the left. The following sample label 
illustrates this display:

[[Page 86]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.361


    (d)(1) Compliance with this section shall be determined in 
accordance with Sec. 101.9(g)(1) through (g)(8).
    (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 Food 
Labeling (HFS-150), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204.
    (e) Except as provided in paragraph (g) of this section, the 
location of nutrition information on a label shall be in compliance with 
Sec. 101.2.
    (f)(1) Dietary supplements of vitamins or minerals are exempt from 
this section when they are offered for sale by a manufacturer, packer, 
or distributor 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 on a label or labeling or in advertising.
    (2) For purposes of the 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.
    (g) Dietary supplements of vitamins and minerals shall be subject to 
the special labeling conditions specified in Sec. 101.9(j)(5)(i) and 
(j)(5)(ii) for food, other than infant formula, represented or purported 
to be specifically for infants and children less than 2 years of age and 
4 years of age, respectively; in Sec. 101.9(j)(9) for food products 
shipped in bulk form that are not for distribution

[[Page 87]]

to consumers; in Sec. 101.9(j)(13) for foods in small or intermediate-
sized packages; in Sec. 101.9(j)(15) for foods in multiunit food 
containers; and, in Sec. 101.9(j)(16) for foods sold in bulk containers.
    (h) Dietary supplements of vitamins and minerals shall be subject to 
the misbranding provisions of Sec. 101.9(k).

[59 FR 373, Jan. 4, 1994; 59 FR 24039, May 10, 1994, as amended at 60 FR 
67175, Dec. 28, 1995; 61 FR 8779, Mar. 5, 1996; 61 FR 10280, Mar. 13, 
1996]

    Effective Date Notes: 1. At 60 FR 67175, Dec. 28, 1995, in 
Sec. 101.36, paragraphs (b)(3) introductory text, (i), (ii), (b)(4) 
introductory text, and (vi) were revised, effective January 1, 1997. At 
61 FR 10280, Mar. 13, 1996, in Sec. 101.36(b)(3)(ii) the terms ``vitamin 
B6'' and ``vitamin B12'' was corrected to make the numbers subscript, 
effective January 1, 1997. For the convenience of the reader, the 
superseded text is set forth below.
Sec. 101.35  Nutrition labeling of dietary supplements of vitamins and 
minerals.

                                * * * * *

    (b) * * *
    (3) A listing of all nutrients required in Sec. 101.9(c) that are 
present in the dietary supplement in quantitative amounts by weight that 
exceed the amount that can be declared as zero in Sec. 101.9(c). Those 
nutrients that are not present, or that are present in amounts that 
would be declared as zero, shall not be declared. In addition, 
potassium, vitamin K, chloride, chromium, fluoride, manganese, 
molybdenum, and selenium shall be declared, except when present in 
quantitative amounts by weight that allow a declaration of zero. The 
name of each nutrient listed shall be immediately followed by the 
quantitative amount by weight of the nutrient. Nutrient names and 
quantitative amounts shall be presented in a column under the heading of 
``Amount Per Serving'' and aligned on the left side of the nutrition 
label. The heading ``Amount Per Serving'' shall be separated from other 
information on the label by a bar above and beneath it, except that when 
calories are listed, the bar shall be placed beneath the calorie 
declaration. When the serving size of the product is one unit (e.g., one 
tablet), a heading consistent with the declaration of the serving size, 
such as ``Amount Per Tablet'' or ``Each Tablet Contains,'' may be used 
in place of the heading ``Amount Per Serving.'' Other appropriate terms, 
such as capsule, packet, or teaspoonful, may be used in place of the 
term ``Serving.''
    (i) These amounts shall be expressed in the increments specified in 
Sec. 101.9(c), except that the amounts of vitamins and minerals, 
excluding sodium and potassium, declared on the nutrition label shall be 
the actual amount of the vitamin or mineral included in the dietary 
supplement, using the units of measure and the levels of significance 
given in Sec. 101.9(c). In declaring the amounts of vitamins and 
minerals, 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 
copper is given in whole milligrams (mg), but the quantitative amount 
may be declared in tenths of a mg). Amounts for chloride, fluoride, and 
manganese shall be expressed in mg, and, amounts for chromium, 
molybdenum, selenium, and vitamin K shall be expressed in micrograms. 
These values shall be expressed in whole numbers, except that tenths may 
be used for fluoride.
    (ii) Nutrients that are present shall be listed in the order 
specified in Sec. 101.9(c); except that, when present, vitamin K shall 
follow vitamin E; calcium and iron shall follow pantothenic acid; 
selenium shall follow zinc; and manganese, fluoride, chromium, 
molybdenum, chloride, sodium, and potassium shall follow copper. 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, vitamin B12, biotin, pantothenic acid, calcium, 
iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, 
fluoride, chromium, molybdenum, chloride, sodium, and potassium. A bar 
shall separate the last nutrient to be listed from the bottom of the 
nutrition label, as shown in the sample labels in paragraph (c)(9) of 
this section.

                                * * * * *

    (4) A listing of the percent of the Daily Value (i.e., the percent 
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established 
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the 
nutrition label, except that the percent for protein may be omitted as 
provided in Sec. 101.9(c)(7) and no percent shall be given for sugars, 
vitamin K, chloride, chromium, fluoride, manganese, molybdenum, and 
selenium. This information shall be presented in one column aligned 
under the heading of``% Daily Value'' and to the right of the column of 
nutrient names and 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'' or placed beneath this 
heading and the bar underneath it, except that ``% Daily Value'' shall 
be placed beneath this bar when calorie information is required to be 
declared. Calorie information

[[Page 88]]

shall be placed beneath ``Amount Per Serving'' and above the bar.

                                * * * * *

    (vi) When no percent is given for sugars, vitamin K, chloride, 
chromium, fluoride, manganese, molybdenum, or selenium, an asterisk 
shall be placed in the ``% Daily Value'' column that shall refer to 
another asterisk that is placed at the bottom of the nutrition label and 
is followed by the statement ``Daily Value not established.''

                                * * * * *

    2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.36, paragraph (b)(3)(v) 
was amended by removing the words ``folate (folacin)'' and by adding in 
their place the words ``folate--either folic acid or folacin may be 
used'', effective April 19, 1996.



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);
    (2) Be presented in content and format that are consistent with 
Sec. 101.45(b); and
    (3) Include data that have been provided by FDA (see 
Sec. 101.45(i)), that have been accepted by FDA (see Sec. 101.45 (c), 
(f), and (g)), or that are consistent with Sec. 101.45 (d) and (e) and 
have not been found to be out of compliance after a review under 
Sec. 101.9(e) (see Sec. 101.45(h)).
    (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

[[Page 89]]

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.



Sec. 101.44  Identification of the 20 most frequently consumed raw fruit, vegetables, and fish in the United States.

    (a) The 20 most frequently consumed raw fruit are: Banana, apple, 
watermelon, orange, cantaloupe, grape, grapefruit, strawberry, peach, 
pear, nectarine, honeydew melon, plum, avocado, lemon, pineapple, 
tangerine, sweet cherry, kiwifruit, and lime.
    (b) The 20 most frequently consumed raw vegetables are: Potato, 
iceberg lettuce, tomato, onion, carrot, celery, sweet corn, broccoli, 
green cabbage, cucumber, bell pepper, cauliflower, leaf lettuce, sweet 
potato, mushroom, green onion, green (snap) bean, radish, summer squash, 
and asparagus.
    (c) The 20 most frequently consumed raw fish are: Shrimp, cod, 
pollack, catfish, scallop, Atlantic/coho salmon, flounder, sole, oyster, 
orange roughy, Atlantic/Pacific and jack mackerel, ocean perch, 
rockfish, whiting, clam, haddock, blue crab, rainbow trout, halibut, and 
lobster.



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

    Nutrition labeling for raw fruit, vegetables, and fish listed in 
Sec. 101.44 should be presented to the public in the following manner:
    (a) Nutrition labeling information should be displayed at the point 
of purchase by an appropriate means, including by affixing it to the 
food, by posting a sign, or by making the information readily available 
in brochure, notebook, or leaflet form in close proximity to the foods. 
The nutrition labeling information may also be supplemented by a video, 
live demonstration, or other media.
    (b) Nutrition information should be provided on the label or in 
labeling in accordance with Sec. 101.9, as modified by the following 
guidelines:
    (1) The percent U.S. RDA for protein, thiamin, riboflavin, and 
niacin may be declared in the nutrition labeling. Declaration of complex 
carbohydrates, sugars, dietary fiber, saturated fat, and cholesterol is 
also voluntary.
    (2) Nutrition labeling information may be presented on individual 
labels or in charts in vertical columns or in lines. When lines are 
used, any subcomponents declared should be listed parenthetically after 
principal components (e.g., saturated fat should be parenthetically 
listed after fat).
    (3) Declaration of the number of servings per container need not be 
included in nutrition labeling of raw fruit, vegetables, and fish.
    (4) The nutrition label data should be based on raw edible portion 
for fruit and vegetables and on a 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).
    (c) Nutrient data and proposed nutrient values for nutrition 
labeling for raw fruit, vegetables, and fish may be submitted to the 
Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, for review and 
evaluation. The data and nutrient values for nutrition labeling are 
appropriate for use if they are accepted by the Food and Drug 
Administration (FDA). The submission to FDA should include information 
on the source of the data (names of investigators, name of organization, 
place of analysis, dates of analyses), number of samples, sampling 
scheme, analytical methods, statistical treatment of the data, and 
proposed quantitative label declarations. The nutrient values for the 
nutrition labeling should be determined in accordance with FDA guidance.
    (d) Composite data that reflect representative nutrient levels for 
various varieties, species, cultivars; seasons; and geographic regions 
may be used to label raw fruit, vegetables, and fish. Alternatively, 
data that reflect a specific variety, species, cultivar; season; or 
geographic region may be used to label raw fruit, vegetables, and fish; 
the nutrition labeling information for such

[[Page 90]]

variety, etc., should provide food names and descriptions for the fruit, 
vegetables, and fish that appropriately reflect the samples analyzed for 
nutrient values.
    (e) The FDA manual ``Compliance Procedures for Nutrition Labeling'' 
(or subsequent revisions of this manual) should be used to develop 
nutrition label values from data base values. The manual is available 
from the Division of Nutrition.
    (f) If the agency's Center for Food Safety and Applied Nutrition 
agrees to all aspects of a submitted data base, FDA will notify a 
submitter in writing of its acceptance of the nutrient data and nutrient 
values for nutrition labeling. FDA's acceptance will be for a period of 
10 years or until other data for the same food are submitted to FDA and 
found to be superior. Those obtaining data base and nutrient value 
acceptance from FDA are responsible for continued maintenance of the 
data base. FDA will renew its acceptance of a data base upon request 
after 10 years unless the data have been superseded by other data on the 
same food or there have been demonstrated changes in agricultural or 
industry practices. When agricultural or industry practices change 
(e.g., a change occurs in a predominant variety produced), or when FDA 
monitoring suggests that the data base or nutrient values are no longer 
representative of the item sold in this country, FDA will take steps to 
revoke its acceptance of the data base and nutrient values. A revised 
data base and proposed nutrient values may be submitted to FDA for 
acceptance.
    (g) If the nutrition information is in accordance with an FDA-
accepted data base, the nutrient values have been computed following FDA 
guidelines, and the food has been handled in accordance with current 
good manufacturing practices to prevent nutrient loss, a nutrition label 
will not be subject to the agency compliance review under Sec. 101.9(e).
    (h) Organizations may use data bases that they believe validly 
reflect the nutrient content of raw fruit, vegetables, and fish; 
however, labeling computed from data bases not reviewed, evaluated, and 
accepted by the agency is subject to the compliance procedures of 
Sec. 101.9(e).
    (i) FDA will publish, and provide an opportunity for comment on, 
updates of the nutrition labeling data for the 20 most frequently 
consumed raw fruit, vegetables, and fish (or a notice that the data sets 
have not changed from the previous publication) at least every 2 years 
in the Federal Register. FDA accepted data for other raw fruit, 
vegetables, and fish, or for other nutrients, are available from the 
Center for Food Safety and Applied Nutrition (HFS-150), 200 C St. SW., 
Washington, DC 20204.

[55 FR 60890, Nov. 27, 1991, as amended at 61 FR 14479, Apr. 2, 1996]



      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,'' and ``more.''

    (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 or in the 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 to characterize the level of any substance that is 
not a vitamin or mineral, provided that the food contains 20 percent or 
more of the RDI or the DRV

[[Page 91]]

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 or in labeling of 
foods except meal products as described in Sec. 101.13(l) main dish 
products as described in Sec. 101.13(m), and dietary supplements of 
vitamins or minerals to characterize the level of any substance that is 
not a vitamin or mineral, 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 the referral statement required in Sec. 101.13(g) (e.g., 
``contains [x amount] of total fat per serving. See [appropriate panel] 
for nutrition information'').
    (e) ``More'' claims. (1) A relative claim using the terms ``more,'' 
``fortified,'' ``enriched,'' ``added,'' and ``extra'' may be used on the 
label or in labeling of foods to describe the level of protein, 
vitamins, minerals,

[[Page 92]]

dietary fiber, or potassium except as limited by Sec. 101.13(j)(1)(i) 
and 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 to characterize the level of any substance that is 
not a vitamin or mineral, 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,'' and ``extra'' 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.

[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]



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'');
    (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.

[[Page 93]]

    (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 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

[[Page 94]]

    (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 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

[[Page 95]]

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

[[Page 96]]

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

[[Page 97]]

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 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
    (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 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)(4) 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]



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

[[Page 98]]

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 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:

[[Page 99]]

    (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 (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.
    (b) ``Fat content claims.'' (1) The terms ``fat free,'' ``free of 
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial 
source of fat,'' ``negligible source of fat,'' or ``dietarily 
insignificant source of fat'' may be used on the label or in labeling of 
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

[[Page 100]]

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.,

[[Page 101]]

``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.
    (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 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

[[Page 102]]

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

[[Page 103]]

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'').
    (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 cutomarily 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 
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 the referral 
statement required in Sec. 101.13(g) 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

[[Page 104]]

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, 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

[[Page 105]]

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 the referral 
statement required in Sec. 101.13(g) 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

[[Page 106]]

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 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 the referral 
statement required in Sec. 101.13(g) 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):
    (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

[[Page 107]]

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 the referral 
statement required in Sec. 101.13(g) 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 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

[[Page 108]]

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 the referral 
statement required in Sec. 101.13(g) 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 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 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;
    (3) 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
    (4) The term defined in paragraph (e)(3) 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]



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

    (a) General requirements. An implied nutrient content claim can only 
be

[[Page 109]]

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,'' ``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 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) Claims about a food that suggest 
that the food because of its nutrient content may be useful in 
maintaining healthy dietary practices and that are made in association 
with an explicit claim or

[[Page 110]]

statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'') 
are implied nutrient content claims covered by this paragraph.
    (2) The term ``healthy'' or any derivative of the term ``healthy,'' 
such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'' may be 
used on the label or in labeling of a food, other than raw, single 
ingredient seafood or game meat products, main dish products as defined 
in Sec. 101.13(m), and meal products as defined in Sec. 101.13(l), as an 
implied nutrient content claim to denote foods that are useful in 
constructing a diet that is consistent with dietary recommendations 
provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and, before January 1, 
1998, contains 480 milligrams (mg) sodium or less per reference amount 
customarily consumed, and per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium 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);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, after January 1, 1998, contains 360 
mg sodium 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);
    (iii) Cholesterol is not present at a level exceeding the disclosure 
level as described in Sec. 101.13(h);
    (iv) The food, other than a raw fruit or vegetable, contains at 
least 10 percent of the Reference Daily Intake (RDI) or Daily Reference 
Value (DRV) per reference amount customarily consumed of vitamin A, 
vitamin C, calcium, iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(2)(iv) of this section 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
    (vi) The food complies with definitions and declaration requirements 
established in part 101 of this chapter for any specific nutrient 
content claim on the label or in labeling.
    (3) The term ``healthy'' or its derivatives may be used on the label 
or in labeling of raw, single ingredient seafood or game meat as an 
implied nutrient content claim provided that:
    (i) The food 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;
    (ii)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, before January 1, 1998, 
contains 480 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium 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);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, and per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or

[[Page 111]]

2 tablespoons or less and, after January 1, 1998, contains 360 mg sodium 
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);
    (iii) The food contains at least 10 percent of the RDI or DRV per 
reference amount customarily consumed of vitamin A, vitamin C, calcium, 
iron, protein, or fiber;
    (iv) Where compliance with paragraph (d)(3)(iii) of this section 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
    (v) The food complies with definitions and declaration requirements 
established in this part for any specific nutrient content claim on the 
label or in labeling.
    (4) The term ``healthy'' or its derivatives may be used on the label 
or in labeling of main dish products, as defined in Sec. 101.13(m), and 
meal products, as defined in Sec. 101.13(l) as an implied nutrient 
content claim provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) Before January 1, 1998, sodium is not present at a level 
exceeding 600 mg per labeled serving, or
    (B) After January 1, 1998, sodium is not present at a level 
exceeding 480 mg per labeled serving;
    (iii) Cholesterol is not present at a level exceeding 90 mg per 
labeled serving;
    (iv) The food contains at least 10 percent of the RDI or DRV per 
labeled serving of two (for main dish products) or three (for meal 
products) of the following nutrients--vitamin A, vitamin C, calcium, 
iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(4)(iv) of this section 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
    (vi) The food complies with definitions and declaration requirements 
established in this part for any specific nutrient content claim on the 
label or in labeling.

[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]



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;
    (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

[[Page 112]]

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 FDA's 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 the Food and 
Drug Administration. 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 
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

[[Page 113]]

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. 25.24 of this chapter or 
an environmental assessment under Sec. 25.31 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 the Commissioner of Food and Drugs, 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 Food Labeling (HFS-150)
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 Association of Official Analytical Chemists 
International (AOAC International) methods where available. If no AOAC 
International method is available, the petitioner shall submit the assay 
method used, and data establishing the validity of the method for 
assaying the nutrient in the particular food. The validation data 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

[[Page 114]]

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. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 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, the 
Commissioner of Food and Drugs 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. A petition that has been denied 
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 the Commissioner of Food 
and Drugs 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. The Commissioner of Food and Drugs 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.
    (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 Food Labeling (HFS-150)
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 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. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------

[[Page 115]]

    (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

[[Page 116]]

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, the Commissioner of Food and Drugs 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, the Commissioner of Food and Drugs 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 Food Labeling (HFS-150)
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.
    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. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 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) The Commissioner of Food and Drugs 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), the Commissioner of Food and 
Drugs 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 the Commissioner of Food and Drugs 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.

(Information collection requirements in this section were approved by 
the Office of Management and Budget (OMB) and assigned OMB control 
number ------------)

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 
FR 44033, Aug. 18, 1993]



           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 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

[[Page 117]]

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 Food Labeling (HFS-150),
200 C St. SW.,
Washington, DC 20204,
    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 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

[[Page 118]]

representative samples using methods from the Association of Official 
Analytical Chemists (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. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 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. A petition that has been denied 
without filing will not be made available to the public. A filed 
petition 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

[[Page 119]]

days of the date of filing. The proposal will also announce the 
availability of the petition for public review.

[58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59 
FR 425, Jan. 4, 1994]



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 cancer.
    (b) Dietary fiber and cardiovascular disease.
    (c) Antioxidant vitamins and cancer.
    (d) Zinc and immune function in the elderly.
    (e) Omega-3 fatty acids and coronary heart disease.

[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]



Sec. 101.72  Health claims: calcium and osteoporosis.

    (a) Relationship between calcium and osteoporosis. An inadequate 
calcium intake contributes to low peak bone mass and 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. An 
adequate intake of calcium 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 an adequate calcium intake 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. Maintenance 
of an adequate intake of calcium 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.
    (b) Significance of calcium. Calcium intake is not the only 
recognized risk factor in the development of osteoporosis, a 
multifactorial bone disease. Other factors including a person's sex, 
race, hormonal status, family history, body stature, level of exercise, 
general diet, and specific life style choices such as smoking and excess 
alcohol consumption affect the risk of osteoporosis.
    (1) Heredity and being female are two key factors identifying those 
individuals at risk for the development of osteoporosis. Hereditary risk 
factors include race: Notably, Caucasians and Asians are characterized 
by low peak bone mass at maturity. Caucasian women, particularly those 
of northern European ancestry, experience the highest incidence of 
osteoporosis-related bone fracture. American women of African heritage 
are characterized by the highest peak bone mass and lowest incidence of 
osteoporotic fracture, despite the fact that they have low calcium 
intake.
    (2) Maintenance of an adequate intake of calcium throughout life is 
particularly important for a subpopulation of individuals at greatest 
risk of developing osteoporosis and for whom adequate dietary calcium 
intake may have the most important beneficial effects on bone health. 
This target subpopulation includes adolescent and young adult Caucasian 
and Asian American women.
    (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 with a reduced risk of osteoporosis may be made on 
the label or lableing of a food describe in paragraph (c)(2)(ii) of this 
section, provided that:
    (A) The claim makes clear that adequate calcium intake throughout 
life is not the only recognized risk factor in this multifactorial bone 
disease by

[[Page 120]]

listing specific factors, including sex, race, and age that place 
persons at risk of developing osteoporosis and stating that an adequate 
level of exercise and a healthful diet are also needed;
    (B) The claim does not state or imply that the risk of osteoporosis 
is equally applicable to the general United States population. The claim 
shall identify the populations at particular risk for the development of 
osteoporosis. These populations include white (or the term 
``Caucasian'') women and Asian women in their bone forming years 
(approximately 11 to 35 years of age or the phrase ``during teen or 
early adult years'' may be used). The claim may also identify menopausal 
(or the term ``middle-aged'') women, persons with a family history of 
the disease, and elderly (or ``older'') men and women as being at risk;
    (C) The claim states that adequate calcium 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. When reference is made to persons 
with a family history of the disease, menopausal women, and elderly men 
and women, the claim may also state that adequate calcium intake is 
linked to reduced risk of osteoporosis through the mechanism of slowing 
the rate of bone loss;
    (D) The claim does not attribute any degree of reduction in risk of 
osteoporosis to maintaining an adequate calcium intake throughout life; 
and
    (E) The claim states that a total dietary intake greater than 200 
percent of the recommended daily intake (2,000 milligrams (mg) of 
calcium) has no further known benefit to bone health. This requirement 
does not apply to foods that contain less than 40 percent of the 
recommended daily intake of 1,000 mg of calcium per day or 400 mg of 
calcium per reference amount customarily consumed as defined in 
Sec. 101.12 (b) or per total daily recommended supplement intake.
    (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(c);
    (B) The calcium content of the product shall be assimilable;
    (C) Dietary supplements shall meet the United States Pharmacopeia 
(U.S.P.) standards for disintegration and dissolution applicable to 
their component calcium salts, except that dietary supplements for which 
no U.S.P. 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 information from 
paragraphs (a) and (b) of this section.
    (2) The claim may include information on the number of people in the 
United States who have osteoporosis. 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 
``Dietary Guidelines for Americans.''
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between calcium and 
osteoporosis:

       Model Health Claim Appropriate for Most Conventional Foods:

    Regular exercise and a healthy diet with enough calcium helps teen 
and young adult white and Asian women maintain good bone health and may 
reduce their high risk of osteoporosis later in life.

 Model Health Claim Appropriate for Foods Exceptionally High in Calcium 
                      and Most Calcium Supplements:

    Regular exercise and a healthy diet with enough calcium helps teen 
and young adult white and Asian women maintain good bone health and may 
reduce their high risk of osteoporosis later in life. Adequate calcium 
intake is important, but daily intakes above about 2,000 mg are not 
likely to provide any additional benefit.

[58 FR 2676, Jan. 6, 1993; 58 FR 17101, Apr. 1, 1993]



Sec. 101.73  Health claims: dietary lipids and cancer.

     (a) Relationship between fat and cancer. (1) Cancer is a 
constellation of

[[Page 121]]

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'';
    (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.

[[Page 122]]

    (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 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,

[[Page 123]]

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:
    (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

[[Page 124]]

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.
    (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 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. The food shall meet all of the nutrient 
content requirements of Sec. 101.62 for a ``low saturated fat,'' ``low 
cholesterol,'' and ``low fat'' food; 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.

[[Page 125]]

    (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- 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]



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

[[Page 126]]

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.
    (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

[[Page 127]]

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 
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

[[Page 128]]

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;''
    (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 claims 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

[[Page 129]]

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]



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

[[Page 130]]

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
    (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.

[[Page 131]]

    (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 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,

[[Page 132]]

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 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. The claim shall not state that a specified amount of 
folate per serving from one source is more effective in reducing the 
risk of neural tube defects than a lower amount per serving from another 
source.
    (H) The claim shall state that folate needs to be consumed as part 
of a healthful diet.

[[Page 133]]

    (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 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

[[Page 134]]

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]

    Effective Date Note: At 61 FR 8779, Mar. 5, 1996, Sec. 101.79 was 
revised, effective April 19, 1996. For the convenience of the reader, 
the superseded text is set forth below.
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 (g)) 
folic acid daily had a reduced risk of having a child with a neural tube 
defect. (Products that contain this level of folic acid are drugs.) In 
addition, based on its review of a Hungarian intervention trial that 
used a multivitamin and multimineral preparation containing 800 
g (0.8 mg) of folic acid, and its review of the observational 
studies that reported use of multivitamins containing 0 to 1,000 
g 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., 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 the results of 
several observational studies, the Public Health Service has estimated 
that about 50 percent of neural tube defect-affected pregnancies in the 
United

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States (e.g., about 1,250) may be averted annually if all women consume 
adequate amounts of folate daily (i.e., 0.4 mg) throughout their 
childbearing years.
    (c) Requirements. The label or labeling of food in conventional food 
form or dietary supplements may contain a folate/neural tube defect 
health claim provided that:
    (1) General requirements. The health claim for a food or supplement 
meets all of the general requirements of Sec. 101.14 for health claims, 
except that a food or dietary supplement 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 foods in conventional food form or of dietary supplements 
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,'' or 
``spina bifida or anencephaly, birth defects of the brain or spinal 
cord;''
    (D) Multifactorial nature. The claim shall state that neural tube 
defects have many causes and shall not imply that folate intake is the 
only recognized risk factor for neural tube defects.
    (E) Prevalence. In specifying the prevalence of neural tube defects 
among women in the general population, the claim shall state that such 
birth defects ``which, while not widespread, are extremely significant'' 
or ``* * * birth defects * * * that, while not widespread, are extremely 
significant.''
    (F) Reduction in risk. The claim shall not attribute any specific 
degree of reduction in risk of neural tube defects, including mention of 
the Public Health Service estimate that 50 percent of neural tube 
defects may be averted annually, to 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 folic acid during their childbearing 
years.
    (G) Safe upper limit of daily intake. Claims on fortified foods in 
conventional form and on dietary supplements that contain more than 25 
percent of the RDI for folate (100 g per serving or per unit) 
shall state that 1 mg folate per day is the safe upper limit of intake 
(e.g., ``Folate consumption should be limited to 1,000 g per 
day from all sources.'')
    (H) The claim. The claim shall not state that a specified amount of 
folate (e.g., 400 g in a dietary supplement) is more effective 
in reducing the risk of neural tube defects than a lower amount (e.g., 
100 g in a breakfast cereal or from diets rich in fruits and 
vegetables).
    (ii) Nature of the food--(A) Requirements. The food or supplement 
shall meet or exceed the requirements for a good source of folate as 
defined in Sec. 101.54;
    (B) Diets adequate in folate. The claim shall identify diets 
adequate in folate by using phrases such as ``* * * diets that include 2 
to 4 servings per day of fruits) including citrus fruits and juices), 3 
to 5 servings of vegetables (including dark green leafy vegetables and 
legumes), 6 to 11 servings of enriched grain products (such as breads, 
rice, and pasta) and fortified cereals. Such diets provide many 
essential minerals and vitamins, including folate. Women who do not eat 
well-balanced diets or who may be concerned about their diets may choose 
to obtain folate from dietary supplements.''; or ``Adequate amounts of 
folate, a B vitamin, can be obtained from diets rich in fruits, 
including citrus fruits and juices, vegetables, including dark green 
leafy vegetables and legumes, enriched grain products, including breads, 
rice, and pasta, fortified cereals, or a dietary supplement.''; or 
``Adequate amounts of folate, a B vitamin, can be obtained from diets 
rich in fruits, dark green leafy vegetables and legumes, enriched grain 
products, fortified cereals, or from dietary supplements.''
    (C) Dietary supplements. Dietary supplements shall meet the United 
States Pharmacopeia (U.S.P.) standards for disintegration and 
dissolution, except that if there are no applicable U.S.P. 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 in 
conventional food form or dietary supplements that contain more than 100 
percent of the RDI for vitamin A as retinol or preformed vitamin A or 
vitamin D.
    (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;
    (ii) Relationship between folate and neural tube defects. The claim 
may include statements from paragraphs (a) and (b) of this

[[Page 136]]

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.
    (iv) Daily value. The claim may identify the daily value level of 
400 g of folate per day as the target intake goal.
    (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) Example 1. Women who consume adequate amounts of folate, a B 
vitamin, daily throughout their childbearing years may reduce their risk 
of having a child with a neural tube birth defect. Such birth defects, 
while not widespread, are very serious. They can have many causes. 
Adequate amounts of folate can be obtained from diets rich in fruits, 
dark green leafy vegetables and legumes, enriched grain products, 
fortified cereals, or a supplement. Folate consumption should be limited 
to 1,000 g per day from all sources.
    (2) Example 2. Women who consume adequate amounts of folate daily 
throughout their childbearing years may reduce their risk of having a 
child with a birth defect of the brain and spinal cord. Such birth 
defects, while not widespread, are very serious. They can have many 
causes. Adequate amounts of folate, a B vitamin, can be obtained from 
diets rich in fruits, dark green leafy vegetables and legumes, enriched 
grain products, fortified cereals, or a supplement. Women who have had a 
child with a spinal cord birth defect should consult a physician before 
becoming pregnant. Folate consumption should be limited to 1,000 
g per day from all sources.
    (3) Example 3. Women who take steps to ensure that their folate 
intake is adequate throughout their childbearing years may reduce their 
risk of having a child with a neural tube defect. Such birth defects, 
while not widespread, are very serious. They can have many causes. 
Adequate amounts of folate, a B vitamin, can be obtained from diets rich 
in citrus fruits and juices, dark green leafy vegetables and legumes, 
enriched grain products such as breads, rice, and pasta, fortified 
cereal, or a supplement. Folate consumption should be limited to 1,000 
g per day from all sources.
    (4) Example 4. Women who take steps to ensure that their folate 
intake is at least 400 g daily throughout their childbearing 
years may reduce their risk of having a child with spina bifida or 
anencephaly, birth defects of the brain or spinal cord that, while not 
widespread, are very serious. These birth defects can have many causes. 
Adequate amounts of folate, a B vitamin, can be obtained from diets rich 
in fruits, including citrus fruits and juices, vegetables, including 
dark green leafy vegetables and legumes, enriched grain products, 
including breads, rice, and pasta, fortified cereals, or from a 
supplement. Women who have had a pregnancy affected with a neural tube 
defect should consult a physician before becoming pregnant. Folate 
consumption should be limited to 1,000 g per day from all 
sources.

    (5) Example 5. Some women who consume the Daily Value of folate (400 
g) throughout their childbearing years may reduce their risk of 
having a child affected with spina bifida or anencephaly, birth defects 
of the brain or spinal cord that, while not widespread, are very 
serious. These birth defects can have many causes. Women of childbearing 
age should choose well-balanced diets that include 2 to 4 servings per 
day of fruits (including citrus fruits and juices), 3 to 5 servings of 
vegetables (including dark green leafy vegetables and legumes), 6 to 11 
servings of enriched grain products (such as breads, rice, and pasta) or 
fortified cereals throughout their childbearing years. Such diets 
provide many essential minerals and vitamins, including folate. Women 
who may be concerned about their diets may choose to obtain folate from 
a supplement. Folate consumption should be limited to 1,000 g 
per day from all sources.

    (e) Effective date. For fortified foods, this regulation is 
effective on the date the food additive regulation on the use of folic 
acid that was proposed on October 14, 1993, becomes effective.

[59 FR 434, Jan. 4, 1994]



Subpart F--Specific Requirements for Descriptive Claims that are Neither 
                Nutrient Content Claims nor Health Claims



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

[[Page 137]]

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).
    (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

[[Page 138]]

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 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, 
potasssium 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 Association of Official Analytical Chemists, P.O. Box 
540, Benjamin Franklin Station, Washington, DC 20044, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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)

[[Page 139]]

(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 
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

[[Page 140]]

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 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

[[Page 141]]

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:
    (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]



Sec. 101.103   Petitions requesting exemptions from or special requirements for label declaration of ingredients.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition pursuant 
to part 10 of this chapter may issue a proposal to amend Sec. 101.4 to 
specify the manner in which an ingredient(s) shall be declared, i.e., by 
specific or class name, or Sec. 101.100 to exempt an ingredient(s) from 
the requirements for label declaration.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



Sec. 101.105   Declaration of net quantity of contents when exempt.

    (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

[[Page 142]]

statement shall be in terms of fluid 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

[[Page 143]]

that will be expelled when the instructions for use as shown on the 
container 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

[[Page 144]]

or decimal fraction of the pound, or in the case of fluid measure, it 
shall be 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                             pint pt                           
ounce oz                              quart qt                          
pound lb                              fluid fl                          
gallon gal                                                              
                                                                        

    (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

[[Page 145]]

same quantity, intended to be sold as part of the multiunit retail 
package but capable of being individually sold in full compliance with 
all requirements of the regulations in this part. Open multiunit retail 
packages that do not obscure the number of units 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]



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 graphics and other formats for presenting nutrition 
and other related food labeling information that is consistent with the 
current quantitative system in Secs. 101.9 and 101.25 and with 
Secs. 105.66, 105.67, and 105.69 of this chapter.
    (b) Any firm that intends to undertake a labeling experiment that 
requires exemptions from certain requirements of Secs. 101.9 and 101.25 
and Secs. 105.66, 105.67, and 105.69 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:

[[Page 146]]

    (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;
    (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 Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn 
Dr., Rockville, MD 20857. 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]

 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, Association of Official Analytical 
Chemists) 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.

[[Page 147]]

    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). 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=(32.03xVBxNx1000)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 148]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.362


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

[[Page 149]]

[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 150]]

      Appendix B to Part 101--Graphic Enhancements Used by the FDA

[[Page 150]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.364



[[Page 151]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.365


[58 FR 17332, Apr. 2, 1993]

[[Page 152]]



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: Secs. 201, 403, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 343, 371).

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



                      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 153]]

    (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 consist of the 
term ``peanut spread''

[[Page 154]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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-150), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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.
    (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

[[Page 155]]

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]



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 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 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 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:
    (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

[[Page 157]]

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, decolored 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]

    Effective Date Note: Section 102.33, was added at 45 FR 39250, June 
10, 1980, effective July 1, 1981. The compliance date was extended to 
July 1, 1982, at 45 FR 80497, Dec. 5, 1980, and further extended to July 
1, 1984, at 48 FR 2736, Jan. 21, 1983. At 49 FR 26541, June 27, 1984, 
the effective date for compliance was extended indefinitely.



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 158]]



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 159]]



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


[42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995]



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 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS--Table of Contents




                      Subpart A--General Provisions

Sec.
103.3  Definitions.
103.5  General principles.

                     Subpart B--Standards of Quality

103.35  Bottled water.

    Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 349, 371, 
379e).



                      Subpart A--General Provisions



Sec. 103.3   Definitions.

    (a) A lot is:
    (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.

[[Page 160]]

    (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), taken one 
from each of 10 different randomly chosen shipping cases to be 
representative of a given lot, unless otherwise specified in a specific 
quality 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.

[42 FR 14325, Mar. 15, 1977]



Sec. 103.5   General principles.

    (a) The quality of a food depends upon numerous characteristics 
including but not limited to the levels of microorganisms and such 
physical factors as turbidity, color, flavor, and odor. Such 
characteristics are indicative of the quality of the raw materials and 
ingredients, the degree of quality control used in manufacture, 
processing, and packing, and the conditions of distribution and storage. 
The diversity of raw materials, food processing, and distribution 
practices, as well as the variation in quality factors important to 
consumers, requires that individual standards of quality be established 
for different types of food.
    (b)(1) The label of a food that fails to meet the requirements of an 
applicable standard of quality promulgated pursuant to this part 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 whichever of the following are 
applicable:
    (i) ``Contains Excessive Bacteria''.
    (ii) ``Excessively Turbid''.
    (iii) ``Abnormal Color''.
    (iv) The phrase specified in the applicable standard of quality to 
describe any other quality deviation.
    (2) The statement of substandard quality shall appear on the 
principal display panel or panels and shall immediately and 
conspicuously precede or follow, without intervening written, printed or 
graphic matter, the name of the food.
    (c) Product descriptions included in a standard of quality 
promulgated pursuant to this part are intended only to designate the 
class of foods to which the standards apply, and are not standards of 
identity for the products involved. Should a standard of identity later 
be established for any of these foods, the standard of quality will be 
recodified to appear in the same part of the regulations.
    (d) The food characteristics included in a standard of quality 
published in this part relate only to the quality of the food and not to 
compliance with any of the adulteration provision of section 402 of the 
act. Compliance with a standard of quality promulgated pursuant to this 
part does not excuse failure to observe either the requirement of 
section 402(a)(4) of the act that food may not be prepared, packed, or 
held under insanitary conditions, or the provisions of parts 110 and 129 
of this chapter requiring that food manufacturers must observe current 
food manufacturing practices. For example, evidence obtained through 
factory inspection indicating such a violation renders the food 
unlawful, even though the food contains levels of microorganisms lower 
than those prescribed by an applicable standard.
    (e) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
establish, amend, or repeal, under subpart B of this part, a regulation 
prescribing a standard of quality for a food pursuant to part 10 of this 
chapter.

[42 FR 14325, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
44 FR 12172, Mar. 6, 1979]



                     Subpart B--Standards of Quality



Sec. 103.35   Bottled water.

    (a) Definitions. (1) Bottled water is defined as water that is 
sealed in bottles or other containers and intended for human 
consumption. Bottled water does not include mineral water or any type of 
soft drink commonly known as soda water, which is made by absorbing 
carbon dioxide in potable water.

[[Page 161]]

    (2) 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.
    (3) Total Trihalomethanes (TTHM) means the sum of the concentration 
in milligrams per liter of the trihalomethane compounds 
(trichloromethane [chloroform], dibromochloromethane, 
bromodichloromethane and tribromomethane [bromoform]), rounded to two 
significant figures.
    (b) Microbiological quality. Bottled water shall, when a sample 
consisting of analytical units of equal volume is examined by the 
methods 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 (copies may be 
obtained from the Center for Food Safety and Applied Nutrition (HFS-
300), 200 C St., SW., Washington, DC 20204, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC), meet the following standards of microbiological 
quality:
    (1) Multiple-tube fermentation 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 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.
    (c) 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), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (b) of this section), meet the following 
standards of physical quality:
    (1) The turbidity shall not exceed 5 units.
    (2) The color shall not exceed 15 units.
    (3) The odor shall not exceed threshold odor No. 3.
    (d) Chemical quality. (1)(i) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (d)(1)(ii) of this section, meet 
standards of chemical quality and shall not contain chemical substances 
in excess of the following concentrations:

            Substance--Concentration in Milligrams per Liter            
Arsenic......................................................     0.05  
Chloride.....................................................   250.0   
Iron.........................................................     0.3   
Manganese....................................................     0.05  
Phenols......................................................     0.001 
Sulfate......................................................   250.0   
Total dissolved solids.......................................   500.0   
Zinc.........................................................     5.0   
Organics:                                                               
  Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy-                           
   1,4,4a,5,6,7,8,8a-0cta-hydro-1,4-endo, endo-5,8-dimethano            
   naphthalene)..............................................     0.0002
  Total Trihalomethanes......................................     0.10  
                                                                        

    (ii) Analyses conducted to determine compliance with paragraph 
(d)(1)(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,'' 15th Ed. (1980), or ``Methods for 
Chemical Analysis of Water and Wastes,'' Environmental Monitoring and 
Support Laboratory, EPA-600/4-82-055, March 1983, U.S. Environmental 
Protection Agency, both of which are incorporated by reference. Analyses 
for organic substances shall be determined by appropriate methods 
described in ``Methods for Organochlorine Pesticides in Industrial 
Effluents'' and ``Methods for Chlorinated Phenoxy Acid Herbicides in 
Industrial Effluents,'' November 28, 1973, which are incorporated by 
reference, and ``Part I: The Analysis of Trihalomethanes in Finished 
Waters by the Purge and Trap Method,'' Method 501.1 and ``Part II: The 
Analysis of Trihalomethanes in Drinking Water by Liquid/Liquid 
Extraction,'' Method 501.2 in 40 CFR part 141, appendix C (45

[[Page 162]]

FR 68672; November 29, 1979). The availability of these incorporations 
by reference are given in paragraph (b) of this section.
    (2)(i) 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 ( deg.   concentration
                            F)                             in 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  
------------------------------------------------------------------------

    (ii) Imported bottled water to which no fluoride is added shall not 
contain fluoride in excess of 1.4 milligrams per liter.
    (iii) 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 ( deg.   concentration
                            F)                             in 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  
------------------------------------------------------------------------

    (iv) Imported bottled water to which fluoride is added shall not 
contain fluoride in excess of 0.8 milligram per liter.
    (3) Having consulted with the U.S. Environmental Protection Agency 
(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 (d)(3)(v), (d)(3)(vi), and 
(d)(3)(vii) of this section, shall not contain the following chemical 
contaminants in excess of the concentrations specified in paragraphs 
(d)(3)(i), (d)(3)(ii), (d)(3)(iii), and (d)(3)(iv) of this section.
    (i) The allowable levels for inorganic substances are as follows:


                                                                        
------------------------------------------------------------------------
                                            Concentration milligrams per
                Contaminant                    liter (or as specified)  
------------------------------------------------------------------------
Barium....................................  2                           
Cadmium...................................  0.005                       
Chromium..................................  0.1                         
Copper....................................  1.0                         
Lead......................................  0.005                       
Mercury...................................  0.002                       
Nitrate...................................  10 (as nitrogen)            
Nitrite...................................  1 (as nitrogen)             
Total Nitrate and Nitrite.................  10 (as nitrogen)            
Selenium..................................  0.05                        
------------------------------------------------------------------------


    (ii) 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 (95-50-01)...................                      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
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
1,1,1-Trichloroethane (71-55-6)................                     0.20
Trichloroethylene (79-01-6)....................                    0.005
Vinyl chloride (75-01-4).......................                    0.002
Xylenes (1330-20-7)............................                       10
------------------------------------------------------------------------

    (iii) The allowable levels for pesticides and other synthetic 
organic chemicals are as follows:

------------------------------------------------------------------------
                                                           Concentration
                Contaminant (CAS Reg. No.)                 in milligrams
                                                             per liter  
------------------------------------------------------------------------
Alachlor (15972-60-8)....................................       0.002   
Atrazine (1912-24-9).....................................       0.003   
Carbofuran (1563-66-2)...................................       0.04    
Chlordane (57-74-9)......................................       0.002   
1,2-Dibromo-3-chloropropane (96-12-8)....................       0.0002  
2,4-D (94-75-7)..........................................       0.07    
Ethylene dibromide (106-93-4)............................       0.00005 

[[Page 163]]

                                                                        
Heptachlor (76-44-8).....................................       0.0004  
Heptachlor epoxide (1024-57-3)...........................       0.0002  
Lindane (58-89-9)........................................       0.0002  
Methoxychlor (72-43-5)...................................       0.04    
Pentachlorophenol (87-86-5)..............................       0.001   
PCB's (as decachlorobiphenyl) (1336-36-3)................       0.0005  
Toxaphene (8001-35-2)....................................       0.003   
2,4,5-TP (Silvex) (93-72-1)..............................       0.05    
------------------------------------------------------------------------

    (iv) The allowable levels for certain chemicals for which EPA has 
established secondary maximum contaminant levels in its drinking water 
regulations are as follows:

------------------------------------------------------------------------
                                                           Concentration
                       Contaminant                         in milligrams
                                                             per liter  
------------------------------------------------------------------------
Aluminum.................................................          0.2  
Silver...................................................          0.1  
------------------------------------------------------------------------

    (v) Analyses to determine compliance with the requirements of 
paragraph (d)(3)(i) of this section shall be conducted in accordance 
with an applicable method or applicable revisions to the methods listed 
in paragraphs (d)(3)(v)(A) through (d)(3)(v)(H) 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, U.S. Department of Commerce, 
5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
    (A) Barium shall be measured using the following methods:
    (1) 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
    (2) 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 (d)(3)(v) of this section.
    (3) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 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. Copies of this publication are available from the National 
Technical Information Service, U.S. Department of Commerce, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
    (B) Cadmium shall be measured using the following methods:
    (1) 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 (d)(3)(v) of this section.
    (2) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 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 (d)(3)(v)(A)(3) of this section.
    (C) Chromium shall be measured using the following methods:

[[Page 164]]

    (1) 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 (d)(3)(v) of this section.
    (2) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 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 (d)(3)(v)(A)(3) of this section.
    (D) Mercury shall be measured using the following methods:
    (1) 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
    (2) 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 this incorporation by reference is given in 
paragraph (d)(3)(v) of this section.
    (E) Nitrate and/or nitrite shall be measured using the following 
methods:
    (1) Method 353.3--''Spectrophotometric, cadmium reduction,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (2) Method 353.2--''Colorimetric, automated, cadmium reduction,'' 
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 (d)(3)(v) of this section.
    (3) 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 the National Technical Information Service, U.S. 
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 200 C St. SW, Washington, DC, or 
at the Office of the Federal Register, 800 North Capitol St. NW., suit 
700, Washington, DC.
    (4) Method 353.1--''Colorimetric, automated, hydrazine reduction,'' 
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 (d)(3)(v) of this section.
    (F) Selenium shall be measured using the following methods:
    (1) 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
    (2) 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 (d)(3)(v) of this section.
    (G) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (1) Method 220.2--Atomic absorption; furnace technique, in ``Methods 
for 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 or
    (2) Method 220.1--Atomic absorption; direct aspiration, in ``Methods 
for 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 
(d)(3)(v) of this section.
    (3) Method 200.7--entitled ``Determination of Metals and Trace 
Elements in Water and Wastes by Inductively Coupled Plasma-Atomic 
Emission Spectrometry,'' Revision 3.3, April 1991, U.S. EPA, 
Environmental Monitoring and Support Laboratory (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

[[Page 165]]

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, 5825 Port Royal Rd., Springfield, 
VA 22161, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
    (4) Method 200.8--entitled, ``Determination of Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' 
Revision 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,'' 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 (d)(3)(v)(G)(3) of 
this section.
    (5) Method 200.9--entitled, ``Determination of Trace Elements by 
Stabilized Temperature Graphite Furnace Atomic Absorption 
Spectrometry,'' Revision 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,'' 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 (d)(3)(v)(G)(3) of 
this section.
    (H) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (1) Method 239.2--Atomic absorption; furnace technique, from 
``Methods for 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 (d)(3)(v) of this section.
    (2) Method 200.8--entitled, ``Determination of Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' 
Revision 4.4, April 1991. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' 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 (d)(3)(v)(G)(3) of this 
section.
    (3) Method 200.9--from ``Determination of Trace Elements by 
Stabilized Temperature Graphite Furnace Atomic Absorption 
Spectrometry,'' Revision 1.2, April 1991. The revision is contained in 
the manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(G)(3) 
of this section.
    (vi) Analyses to determine compliance with the requirements of 
paragraphs (d)(3)(ii) and (d)(3)(iii) of this section shall be conducted 
in accordance with an applicable method or applicable revisions to the 
methods listed in paragraphs (d)(3(vi)(A) through (d)(3)(vi)(M) 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, 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 Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
    (A) Method 502.1--``Volatile Halogenated Organic Compounds in Water 
by Purge and Trap Gas Chromatography,'' revision 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
    (B) Method 502.2--``Volatile Organic Compounds in Water by Purge and 
Trap Capillary Column Gas Chromatography with Photoionization and

[[Page 166]]

Electrolytic Conductivity Detectors in Series,'' revision 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
    (C) Method 503.1--``Volatile Aromatic and Unsaturated Organic 
Compounds in Water by Purge and Trap Gas Chromatography,'' revision 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
    (D) Method 524.1--``Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' revision 
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
    (E) Method 524.2--``Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' 
revision 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
    (F) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-
Chloropropane (DBCP) in Water by Microextraction and Gas 
Chromatography,'' revision 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
    (G) Method 505--``Analysis of Organohalide Pesticides and Commercial 
Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and 
Gas Chromatography,'' revision 2.0, 1989 (applicable to alachlor, 
atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene and as a screen for polychlorinated biphenyl's 
(PCB's)), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or
    (H) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' revision 2.0, 1989 (applicable to alachlor and 
atrazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (I) Method 508--``Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector,'' revision 3.0, 
1989 (applicable to chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene, 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
    (J) Method 508A--``Screening for Polychlorinated Biphenyls by 
Perchlorination and Gas Chromatography,'' revision 1.0, 1989 (used to 
quantitate PCB's as decachlorobiphenyl if detected in Methods 505 or 508 
in paragraph (d)(3)(vi)(G) or (d)(3)(vi)(I) of this section, 
respectively), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (K) Method 515.1--``Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector,'' revision 5.0, 
May 1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol), 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51, or
    (L) Method 525.1--``Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry,'' revision 2.2, May 1991 (applicable 
to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, 
lindane, methoxychlor, and pentachlorophenol), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (M) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization,'' revision 3.0, 1989 (applicable to carbofuran), 
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 (d)(3)(vi) of this section.
    (vii) Analyses to determine compliance with the requirements of 
paragraph (d)(3)(iv) of this section shall be

[[Page 167]]

conducted in accordance with an applicable method and applicable 
revisions to the methods listed in paragraphs (d)(3)(vii)(A) and 
(d)(3)(vii)(B) 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 (d)(3)(v) of this section.
    (A) Aluminum shall be measured using the following methods:
    (1) Method 202.1--``Atomic absorption technique; direct 
aspiration,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.
    (2) 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 (d)(3)(v) of this section.
    (3) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, in ``Methods for the 
Determination of Metals in Environmental Samples,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of the incorporation by reference is given in 
paragraph (d)(3)(v)(A)(3) of this section.
    (4) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, 
April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) of 
this section.
    (5) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision 
1.2, April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) of 
this section.
    (B) Silver shall be measured using the following methods:
    (1) Method 272.1--``Atomic absorption, direct aspiration,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (2) 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 (d)(3)(v) of this section.
    (3) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL, in ``Methods 
for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section.
    (4) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, 
April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) of 
this section.
    (5) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision 
1.2, April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) of 
this section.
    (e) Radiological quality. (1) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (e)(2) of this section, meet standards of 
radiological quality as follows:

[[Page 168]]

    (i) The bottled water shall not contain a combined radium-226 and 
radium-228 activity in excess of 5 picocuries per liter of water.
    (ii) 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.
    (iii) 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.
    (2) Analyses conducted to determine compliance with paragraph (e)(1) 
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), and ``Interim Radiochemical 
Methodology for Drinking Water,'' Environmental Monitoring and Support 
Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environmental 
Protection Agency, both of which are incorporated by reference. The 
availability of these incorporations by reference is given in paragraph 
(b) of this section.
    (f) Label statements. Bottled water, the quality of which is below 
that prescribed by this section, shall be labeled with a statement of 
substandard quality as follows:
    (1) When the microbiological quality of bottled water is below that 
prescribed by paragraph (b) of this section, the label shall bear the 
statement of substandard quality specified in Sec. 103.5(b).
    (2) When the physical, chemical, and/or radiological quality of 
bottled water is below that prescribed by paragraphs (c) through (e) 
respectively of this section, the label shall bear the statement of 
substandard quality specified in Sec. 103.5(b) except that, as 
appropriate, instead of or in addition to the words ``Contains Excessive 
Bacteria'' the following statement(s) shall be used:
    (i) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal 
Odor'' if the bottled water fails to meet the requirements of paragraph 
(c) (1), (2), and/or (3), respectively, of this section.
    (ii) ``Contains Excessive Chemical Substances'', if the bottled 
water fails to meet any of the requirements of paragraph (d) of this 
section. The specific chemical(s) may be declared in lieu of the words 
``Chemical Substances'' in the statement ``Contains Excessive Chemical 
Substances''. When a specific chemical is declared, that name by which 
the chemical(s) is designated in paragraph (d) of this section shall be 
used. Example: ``Contains Excessive Copper''.
    (iii) ``Excessively Radioactive'' if the bottled water fails to meet 
the requirements of paragraph (e) of this section.
    (g) Adulteration. Bottled water containing a substance at a level 
considered injurious to health under section 402(a)(1) of the act is 
deemed to be adulterated, regardless of whether or not the bottled water 
bears a label statement of substandard quality prescribed by paragraph 
(f) of this section.

[42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979; 46 
FR 41037, Aug. 14, 1981; 47 FR 11821, Mar. 19, 1982; 49 FR 10090, Mar. 
19, 1984; 54 FR 400, Jan. 6, 1989; 54 FR 24891, June 12, 1989; 58 FR 
381, Jan. 5, 1993; 59 FR 26937, May 25, 1994; 59 FR 61535, Dec. 1, 1994; 
61 FR 14479, Apr. 2, 1996]

    Effective Date Note: At 60 FR 57123, Nov. 13, 1995, Sec. 103.35 was 
removed and reserved, effective May 13, 1996.



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




                      Subpart A--General Provisions

Sec.
104.5  General principles.
104.19  Petitions.

                     Subpart B--Fortification Policy

104.20  Statement of purpose.

           Subpart C--Specific Nutritional Quality Guidelines

104.47  Frozen ``heat and serve'' dinner.

    Authority: Secs. 201, 403, 701(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 343, 371(a)).


[[Page 169]]


    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 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. 101.105 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 
Secs. 101.3 and 102.5(a) of this chapter.
    (2) The label of the product shall bear nutrition labeling in 
accordance with Secs. 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(e) 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]



Sec. 104.19   Petitions.

    The Commissioner of Food and Drugs, on his own initiative, on the 
advice of the National Academy of Sciences or other experts, or on 
behalf of any interested person who has submitted a petition, may issue 
a proposal to issue, amend, or revoke a regulation prescribing a 
nutritional quality guideline for a class of foods, pursuant to part 10 
of this chapter.

[42 FR 14327, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



                     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

[[Page 170]]

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 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:

[[Page 171]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
               Nutrient                  Unit of measurement          DRV or RDI1        Amount per 100 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 (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...............................  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 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]

[[Page 172]]



           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:

------------------------------------------------------------------------
                                                    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, B12, mcg...............................         .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

[[Page 173]]

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.
105.67  Certain label statements relating to food for use in the diet of 
          diabetics.
105.69  Foods used to regulate sodium intake.

                          Subpart C  [Reserved]

              Subpart D--Standards of Identity  [Reserved]

    Authority: Secs. 201, 401, 403, 409, 411, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (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 distinguised 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 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.

[[Page 174]]

    (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 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

[[Page 175]]

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]



Sec. 105.67  Label statement relating to food for use in the diet of diabetics.

    (a) A food that purports to be represented for special dietary use 
because of usefulness in the diet of diabetics shall bear nutrition 
labeling in compliance with Sec. 101.9 of this chapter, unless exempt 
under that section, and the statement ``Diabetics: This product may be 
useful in your diet on the advice of a physician. This food is not a 
reduced calorie food.'' If the food is useful in maintaining or reducing 
calorie intake or body weight and labeled in conformity with 
Sec. 105.66, the last sentence may be eliminated.
    (b) A food shall not be represented to be useful in the diets of 
diabetics if such representation is false or misleading.
    (c) The term ``diabetic,'' ``for diabetics,'' ``diabetes,'' or the 
like, shall not be included as part of the name of any food, or 
otherwise be included on the labeling more prominently than the 
statement required by paragraph (a) of this section.
    (d) The term ``dietetic,'' ``diet,'' or the like, shall not be 
included in the labeling of a food solely because of its possible 
usefulness in the diet of diabetics.
    (e) A food shall not purport to be or be represented for special 
dietary use because of usefulness in the diet of diabetics solely by 
virtue of its being a food useful in reducing or maintaining caloric 
intake or body weight.

[43 FR 43259, Sept. 22, 1978]



Sec. 105.69   Foods used to regulate sodium intake.

    If a food purports to be or is represented for special dietary use 
by man by reason of its use as a means of regulating the intake of 
sodium or salt (sodium chloride), the label shall bear either nutrition 
labeling or a statement of the number of milligrams of sodium in a 
specified serving (portion) of such food, in conformance with the 
applicable provisions of Sec. 101.9 of this chapter.

[49 FR 15534, Apr. 18, 1984]



                          Subpart C  [Reserved]



              Subpart D--Standards of Identity  [Reserved]



PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents




                      Subpart A--General Provisions

Sec.
106.1  Status and applicability of the quality control procedures 
          regulation.
106.3  Definitions.

 Subpart B--Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas

106.20  Ingredient control.
106.25  In-process control.
106.30  Finished product evaluation.
106.90  Coding.

                     Subpart C--Records and Reports

106.100  Records.

                  Subpart D--Notification Requirements

106.120  New formulations and reformulations.

    Authority: Secs. 201, 412, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 350a, 371).

    Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 106.1  Status and applicability of the quality control procedures regulation.

    (a) The criteria set forth in Secs. 106.20, 106.25, 106.30, 106.90, 
and 106.100 shall apply in determining whether an infant formula meets 
the safety, quality, and nutrient requirements of section 412 of the act 
and the requirements of regulations promulgated under section 412(a)(2) 
of the act.
    (b) The failure to comply with any regulation set forth in 
Secs. 106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the 
manufacturing, processing, and packaging of an infant formula shall

[[Page 175]]

render such formula adulterated under section 412(a)(1)(C) of the act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.



Sec. 106.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
act are applicable to such terms when used in this part. The following 
definitions shall also apply:
    (a) Indicator nutrient. An indicator nutrient is a nutrient whose 
concentration is measured during the manufacture of an infant formula to 
confirm complete addition and/or uniform distribution of a premix or 
other substance of which the indicator nutrient is a part.
    (b) In-process batch. An in-process batch is a combination of 
ingredients at any point in the manufacturing process before packaging.
    (c) Manufacturer. A manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula and/or packages the product in a 
container for distribution.
    (d) Nutrient. A nutrient is any vitamin, mineral, or other substance 
required in accordance with the table set out in section 412(g) of the 
act or by regulations promulgated under section 412(a)(2)(A) of the act.
    (e) Nutrient premix. A nutrient premix is a combination of 
ingredients containing two or more nutrients. A nutrient premix either 
may be received from a supplier or be prepared by an infant formula 
manufacturer.



 Subpart B--Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas



Sec. 106.20  Ingredient control.

    (a) Except as provided in Sec. 106.20(b), no analysis before use in 
manufacturing is needed for ingredients that are generally stable in 
shipping and storage, and that either are received under a supplier's 
guarantee or certification that the mixture has been analyzed as to 
nutrient composition or are labeled as having nutrient compositions 
complying with specifications in the U.S. Pharmacopeia, the National 
Formulary, the Food Chemicals Codex, or other similar recognized 
standards.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec. 106.30(b)(1) before release of product for commercial or 
charitable distribution, the following shall apply:
    (1) When an ingredient is relied upon as a source of a nutrient(s) 
and when evidence indicates that such nutrient(s) in that ingredient is 
likely to be affected adversely by shipping or storage conditions, the 
manufacturer shall analyze that ingredient for each relied-upon nutrient 
that may be affected, using validated analytical methods.
    (2) Ingredients, including nutrient premixes, that are either 
without a supplier's guarantee or certification, or not labeled as 
complying with prescribed standards, shall be sampled and analyzed for 
each relied-upon nutrient by the manufacturer, except that ingredients 
used as a major source of protein or fat need not be analyzed for each 
relied-upon nutrient if the manufacturer has records to show that each 
relied-upon nutrient is present at a reasonably constant level. Nutrient 
premixes prepared by the infant formula manufacturer shall be sampled 
and analyzed for each relied-upon nutrient. Nutrient premixes which are 
received from suppliers shall be sampled and analyzed for each relied-
upon nutrient unless the supplier has sampled and analyzed each batch of 
premix for each relied-upon nutrient and has so certified in writing.



Sec. 106.25  In-process control.

    (a) For each infant formula, a master manufacturing order shall be 
prepared and approved by a responsible official of the manufacturer. The 
manufacturer shall establish a quality control system that assures and 
verifies the addition of each ingredient specified in the manufacturing 
order.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec. 106.30(b)(1), the manufacturer shall analyze each in-process 
batch for:
    (1) Solids;
    (2) Protein, fat, and carbohydrates (carbohydrates either by 
analysis or by mathematical difference);

[[Page 177]]

    (3) The indicator nutrient(s) in each nutrient premix;
    (4) Each nutrient added independently of nutrient premixes during 
formulation of the product, except for linoleic acid, vitamin D, vitamin 
K, choline, inositol, and biotin; and
    (5) Solids or an appropriate nutrient to confirm proper dilution 
when final dilution is made after performance of the analyses in 
paragraph (b) (1) through (4) of this section.



Sec. 106.30  Finished product evaluation.

    (a) The manufacturer shall establish criteria for sampling and 
testing to ensure that each batch of infant formula meets the nutrient 
requirements of section 412(g) of the act or of regulations promulgated 
under section 412(a)(2) of the act before release of product for 
commercial or charitable distribution.
    (b)(1) Immediate analysis. Before release of product for commercial 
or charitable distribution, the manufacturer shall analyze 
representative samples of each batch of finished product for:
    (i) Specific nutrient(s) to assess process degradation; and
    (ii) All nutrients not previously analyzed for by the manufacturers, 
unless each in-process batch is analyzed for nutrients as specified in 
Sec. 106.25(b) and the ingredients are analyzed as specified in 
Sec. 106.20(b). No analyses are needed for linoleic acid, vitamin D, 
vitamin K, choline, inositol, and biotin; and for nutrients that are 
added as a part of a nutrient premix analyzed by the manufacturer or 
having a supplier's guarantee or certification and for which an 
indicator nutrient(s) was analyzed by the manufacturer.
    (2) Periodic analysis. The manufacturer shall sample at least one 
newly processed finished product batch every 3 months and shall analyze 
representative samples for all nutrients except those that the 
manufacturers measured in the immediate analysis of that product batch.
    (3) Stability analysis. Using representative samples collected from 
finished product batches, the manufacturer shall conduct stability 
analysis for selected nutrients with sufficient frequency to 
substantiate the maintenance of nutrient content throughout the shelf 
life of the product.
    (c) The manufacturer shall evaluate new formulations and the effect 
of changes in ingredients or processing conditions that could affect the 
level of nutrients by means of a testing program designed to confirm 
uniformity of batches and to determine the effects of such changes. The 
following shall apply:
    (1) A minor change is a minor reduction in nutrient levels, a minor 
increase in levels of nutrients that are subject to maximum limits 
established under section 412(g) of the act or in regulations 
established under section 412(a)(2) of the act, or any other change 
where experience or theory would not predict a possible significant 
adverse impact on nutrient levels or nutrient availability. After a 
minor change the manufacturer shall analyze representative samples for 
all nutrients so changed and those possibly affected by the change.
    (2) A major change is 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 
availability of nutrients. After a major change the manufacturer shall 
analyze representative samples for osmolality, all nutrients, and the 
biological quality of the protein. A protein biological quality analysis 
is not necessary for a formulation change that is not expected to have 
an adverse effect on the biological quality of the protein. Vitamin D 
shall be determined by the rat bioassay method as prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208, ``Vitamin D 
(30)--Official Final Action,'' which is incorporated by reference. 
Copies are available from the Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. Before release of 
the product for commercial or charitable distribution, the manufacturer 
shall have completed all appropriate analyses except that shipment of 
the product need not be

[[Page 178]]

delayed until results of the vitamin D bioassay and, if required, a 
protein biological quality bioassay are complete, provided such 
bioassays have been initiated, and if another analysis for the vitamin D 
has been run and the protein content has been determined by a suitable 
method. The biological quality of the protein shall be determined by an 
appropriate modification of the AOAC bioassay method of analysis. The 
manufacturer shall analyze additional samples from the same batch for 
vitamin D, by any suitable method, and for the biological quality of the 
protein. The manufacturer shall perform such analyses at least annually 
for a period not to exceed the expected shelf life of the product.
    (d) A simple adjustment in the level of an ingredient to accommodate 
inconsistencies in processing is considered to be neither a minor nor a 
major change.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989]



Sec. 106.90  Coding.

    The manufacturer shall code all infant formulas in conformity with 
the coding requirements that are applicable to thermally processed low-
acid foods packaged in hermetically sealed containers as prescribed in 
Sec. 113.60(c).



                      Subart C--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 (the act).
    (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 act.
    (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 act and 
Sec. 107.100 of this chapter.
    (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 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) The manufacturer shall maintain all records necessary to ensure 
proper nutrient quality control in the manufacture of infant formula 
products. Such records shall include the results of any testing 
conducted to verify that each nutrient required by section 412(i) of the 
act or Sec. 107.100 of this chapter is present in each batch of infant 
formula at the appropriate concentration. This requirement pertains to 
ingredients, in process batch and finished product from the time of 
manufacture through its expiration date.
    (f) The manufacturer shall maintain all records necessary to ensure 
required nutrient content at the final product stage. Such records shall 
include, but are not limited to, testing results for vitamins A, B1 
(thiamine), C, and E for each batch of infant

[[Page 179]]

formula. ``Final product stage'' means the point in the manufacturing 
process prior to distribution at which the infant formula is homogenous 
and not subject to further degradation from the manufacturing process.
    (g) The manufacturer shall maintain all records pertaining to 
distribution of the infant formula. Such records shall include, but not 
be limited to, 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 maintain all records pertaining to 
regularly scheduled audits, including audit plans and procedures. Audit 
plans identify the specific manufacturing and quality control procedures 
to be reviewed. Audit procedures are the methods used to review the 
manufacturing and quality control procedures. Records of audits shall 
include the information and data necessary for a determination as to 
whether the manufacturer complies with the current good manufacturing 
practices and quality procedures identified in parts 106, 107, 109, 110, 
and 113 of this chapter. The records shall include written assurances 
from the manufacturer that regularly scheduled audits are being 
conducted by appropriately trained individuals who do not have any 
direct responsibility for the manufacture or production of infant 
formula, and that the complete audit plans and procedures for the firm 
have been followed. The actual written reports of the audits need not be 
made available.
    (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 an FDA 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. 106.120(b).
    (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.
    (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.

[[Page 180]]

    (5) The manufacturer shall include in a complaint file the following 
information concerning the complaint:
    (i) The name of the infant formula;
    (ii) The batch 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 an FDA 
official.
    (vi) All actions taken to follow up 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 Sec. 106.100(k)(6), 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) Records required under this part may be retained either as 
original records or as true copies such as photocopies, microfilm, 
microfiche, or other accurate reproductions of the original records. 
Where reduction techniques, such as microfilming are used, suitable 
reader and photocopying equipment shall be readily available.
    (n) Production control, product testing, testing results, 
complaints, and distribution records necessary to verify compliance with 
parts 106, 107, 109, 110, and 113 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 batch of infant formula.

[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992]



                  Subpart D--Notification Requirements



Sec. 106.120  New formulations and reformulations.

    (a) Information required by section 412(b)(2) and (3) of the act 
shall be submitted to Center for Food Safety and Applied Nutrition (HFS-
450), Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
    (b) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of the act) 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 may not provide the nutrients required by section 412(g) of 
the act and by regulations promulgated under section 412(a)(2) of the 
act, or when there is an infant formula that is otherwise adulterated or 
misbranded and that may present risk to human health. This notification 
shall be made, by telephone, to the Director of the

[[Page 181]]

appropriate Food and Drug Administration district office specified in 
Sec. 5.115. After normal business hours (8 a.m. to 4:30 p.m.) the FDA 
emergency number, 202-737-0448, shall be used. The manufacturer shall 
send a followup written confirmation to the Center for Food Safety and 
Applied Nutrition (HFS-605), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, and to the appropriate Food and Drug 
Administration district office specified in Sec. 5.115.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996]



PART 107--INFANT FORMULA--Table of Contents




                      Subpart A--General Provisions

Sec.
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: Secs. 201, 403, 412, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 343, 350a, 371).

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



                      Subpart A--General Provisions



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 manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula or packages the infant formula in 
containers for distribution.
    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]



                           Subpart B--Labeling



Sec. 107.10  Nutrient information.

    (a) The labeling of infant formulas, as defined in section 201(aa) 
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 of each of the following nutrients 
supplied by 100 kilocalories:

------------------------------------------------------------------------
                 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.                         

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  Vitamin K...............................  Micrograms.                 
  Thiamine (Vitamin B 1)..................  Do.                         
  Riboflavin (Vitamin B 2.................  Do.                         
  Vitamin B 6.............................  Do.                         
  Vitamin B 12............................  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.                         
  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 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 National Academy of Sciences through 
its development of a recommended dietary allowance or an estimated safe 
and adequate daily dietary intake range, or has been identified as 
essential by the Food and Drug Administration through a Federal Register 
publication or establishment of a U.S. Recommended Daily Allowance, and 
(ii) is provided at a level considered in these publications as having 
biological significance, when these levels are known.

(Information Collection requirements were approved by the Office of 
Management and Budget under control number 0910-0159)



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 183]]

[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''.

(Collection of information requirements were approved by the Office of 
Management and Budget (OMB) and assigned OMB control number 0910-0159)



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), Secs. 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 
Secs. 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

[[Page 184]]

and are not intended to be separated 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

[[Page 185]]

clinically serious or life-threatening 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 may exist 
and so notifies the

[[Page 186]]

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 Center for 
Food Safety and Applied Nutrition (HFS-450), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204.
    (2) The manufacturer shall promptly notify FDA when the manufacturer 
has knowledge (as defined in section 412(c)(2) of the 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 FDA district office specified in Sec. 5.115. After 
normal business hours (8 a.m. to 4:30 p.m.), the FDA emergency number, 
202-737-0448, shall be used. The manufacturer shall send a followup 
written confirmation to the Center for Food Safety and Applied Nutrition 
(HFS-605), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, and to the appropriate FDA district office specified in 
Sec. 5.115.

(Information Collection requirements were approved by the Office of 
Management and Budget under control number 0910-0158)

[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996]



                    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:

------------------------------------------------------------------------
                                                        Minimum  Maximum
            Nutrients              Unit of measurement   level    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   

[[Page 187]]

                                                                        
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  .......
Niacin1..........................  ......do...........   250     .......
Folic acid (folacin).............  ......do...........     4     .......
Pantothenic acid.................  ......do...........   300     .......
Biotin 2.........................  ......do...........     1.5   .......
Vitamin C (ascorbic acid)........  Milligrams.........     8     .......
Choline2.........................  ......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...........................  Micrograms.........    60     .......
Iodine...........................  ......do...........     5       75   
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.                   

In addition to the specifications established in the table in this 
paragraph for vitamins and minerals, the following also apply:
    (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]



                    Subpart E--Infant Formula Recalls

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



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

[[Page 188]]

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 
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 Sec. 5.115 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)

[[Page 189]]

directed to consignees, distributors, retailers, and members of the 
public.



Sec. 107.240   Notification requirements.

    (a) Notification of a violative infant formula. A manufacturer shall 
promptly notify the Food and Drug Administration when the manufacturer 
has knowledge (as defined in section 412(e)(2) of the Federal Food, 
Drug, and Cosmetic Act (the act)) 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 
act and by regulations promulgated under section 412(i)(2) of the act; 
or
    (2) May be otherwise adulterated or misbranded.
    (b) Method of notification. The notification made pursuant to 
Sec. 107.240(a) shall be made, by telephone, to the Director of the 
appropriate Food and Drug Administration district office specified in 
Sec. 5.115 of this chapter. After normal business hours (8 a.m. to 4:30 
p.m.), FDA's emergency number, 202-857-8400, shall be used. The 
manufacturer shall send written confirmation of the notification to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, and to the 
appropriate Food and Drug Administration district office specified in 
Sec. 5.115 of this chapter.
    (c) Reports about an infant formula recall--(1) 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.
    (2) Initial written report.  Within 14 days after the recall has 
begun, the recalling firm shall provide a written report to the 
appropriate Food and Drug Administration district office. The report 
shall contain relevant information, including the following cumulative 
information concerning the infant formula that is being recalled:
    (i) Number of consignees notified of the recall, and date and method 
of notification, including, for a recall pursuant to Sec. 107.200 
information about the notice provided for retail display and the request 
for its display.
    (ii) Number of consignees responding to the recall communication and 
quantity of recalled infant formula on hand at the time it was received.
    (iii) Quantity of recalled infant formula returned or corrected by 
each consignee contacted and the quantity of recalled infant formula 
accounted for.
    (iv) Number and results of effectiveness checks that were made.
    (v) Estimated timeframes for completion of the recall.
    (3) Status reports. The recalling firm shall submit to the 
appropriate Food and Drug Administration 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.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996]



Sec. 107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the recall to the appropriate Food and Drug Administration district 
office listed in Sec. 5.115 of this chapter for transmittal to the 
Center for Food Safety and Applied Nutrition (HFS-605), 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 Center for Food Safety and Applied 
Nutrition (HFS-605), of the request for termination. The recalling firm 
shall 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 a notification unless it 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:

[[Page 190]]

    (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]



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 guidelines 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.



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.

(Collection of information requirements in this section were approved by 
the Office of Management and Budget under OMB control number 0910-0188)



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: Secs. 402, 404, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 344, 371).

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



                      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.
    (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

[[Page 191]]

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), 200 C St. SW., 
Washington, DC 20204. 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]



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.



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

[[Page 192]]

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 Commisioner 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 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

[[Page 193]]

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 Secs. 114.10, 114.80(a) (1) and (2), and (b), 
114.83, 114.89, and 114.100 (b), (c), and (d) 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.

[[Page 194]]

    (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-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 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, 200 C St. 
SW., Washington, DC 20204. Commercial processors presently so engaged 
shall register within 120 days after the effective date of this 
regulation. Foreign processors shall register within 120 days after the 
effective date of this regulation or before any offering of foods for 
import into the United States, whichever is later. 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 2541a (food canning establishment process filing form for 
all methods except aseptic). Forms are available from the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or at 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, 200 C St. SW., Washington, DC 20204.
    (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 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

[[Page 195]]

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, 
warehousing, 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 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

[[Page 196]]

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]



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 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-618), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 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, 200 C St. SW., Washington, DC 20204. 
Commercial processors presently so engaged shall register not later than 
July 13, 1973. 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

[[Page 197]]

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 2541a (food canning establishment process filing for all 
methods except aseptic), or Form FDA 2541c (food canning establishment 
process filing for aseptic systems). These forms are available from the 
LACF Registration Coordinator (HFS-618), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or at any Food and Drug Administration district 
office. The completed form(s) shall be submitted to the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204.
    (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 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 Center for Food Safety and Applied Nutrition (HFS-
617), Food and Drug Administration, 200 C St. SW., Washington, DC 20204 
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

[[Page 198]]

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 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

[[Page 199]]

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 Animal and Plant Health 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 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]

[[Page 200]]



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.
109.5  Petitions.
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: Secs. 201, 306, 402, 406, 408, 409, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 336, 342, 346, 346a, 348, 
371).

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



                      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.



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 Dockets Management 
Branch 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

[[Page 201]]

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. 109.5  Petitions.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition, may 
issue a proposal to establish, revoke, or amend a regulation under this 
part. Any such petition shall include an adequate factual basis to 
support the petition, shall be in the form set forth in Sec. 10.65 of 
this chapter, and will be published in the Federal Register for comment 
if it contains reasonable grounds for the proposed regulation.



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.
    (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

[[Page 202]]

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 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.

[[Page 203]]

    (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. 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

[[Page 204]]

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 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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    (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

[[Page 205]]

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 Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (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, 
200 C St. SW., Washington, DC 20204. 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, 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 Dockets 
Management Branch, Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857.

[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]

    Editorial 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.

[[Page 206]]



    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: Secs. 402, 701, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health 
Service Act (42 U.S.C. 264).

    Source: 51 FR 24475, June 19, 1986, unless otherwise noted.



                      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 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.

[[Page 207]]

    (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).
    (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

[[Page 208]]

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 24475, 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 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

[[Page 209]]

(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 equip- ment 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 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;

[[Page 210]]

    (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 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 24475, 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.

[[Page 211]]

    (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 
unproteced 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.
    (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

[[Page 212]]

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 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, guidelines,

[[Page 213]]

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, guidelines, 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.
    (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

[[Page 214]]

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.
    (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

[[Page 215]]

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.



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.
    (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, 200 C St. SW., 
Washington, DC 20204.

[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996]

[[Page 216]]



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: Secs. 402, 701, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health 
Service Act (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 presterilized 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 microorganisms 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

[[Page 217]]

holding period in a heated section may follow the initial heating 
period.
    (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 Secs. 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 218]]

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) Indicating mercury-in-glass thermometer. Each retort 
shall be equipped with at least one mercury-in-glass thermometer whose 
divisions are easily readable to 1 deg. F and whose temperature range 
does not exceed 17 deg. F per inch of graduated scale. Thermometers 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks that specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers 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 diameter opening and equipped with a \1/16\-inch or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the thermometer bulb. The bleeders for external wells 
shall emit steam continuously during the entire processing period. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each still retort shall have an 
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2 deg. F within a range of 10 deg. F 
of the processing temperature. Each chart shall have a working scale of 
not more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
which provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder which emits steam continuously during the 
processing period. 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 should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. The steam controller may be air-operated and actuated by a 
temperature sensor positioned near the mercury-in-glass thermometer in 
the retort; 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

[[Page 219]]

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 this pipe, that is, within 45 deg. on either 
side of the top center. Horizontal still retorts over 30 feet 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\1/2\ to 
2 times the cross-sectional area of the smallest restriction in the 
steam inlet line.
    (8) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eighth inch 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 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 apart along 
the top. Bleeders may be installed at positions other than those 
specified above, 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., 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 holes on 2-inch centers. If 
dividers are used between the layers of containers, they should be 
perforated as above. 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 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

[[Page 220]]

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 are given in paragraph (a)(12)(i)(a) through (d) and (ii)(a) and 
(b) of this section.
    (i) Venting horizontal retorts. (a) Venting through multiple 1-inch 
vents discharging directly to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR01JA93.369

    Specifications. One 1-inch vent for every 5 feet of retort length, 
equipped with a gate or plug cock valve and discharging to atmosphere; 
end vents not more than 2\1/2\ feet from ends of retort.
    Venting method. Vent valves should be wide open for at least 5 
minutes and to at least 225 deg. F, or at least 7 minutes and to at 
least 220 deg. F.

    (b) Venting through multiple 1-inch vents discharging through a 
manifold to atmosphere.
[GRAPHIC] [TIFF OMITTED] TR01JA93.370

    Specifications. One 1-inch vent for every 5 feet of retort length; 
and vents not over 2\1/2\ feet from ends of retort: Size of manifold--
for retorts less than 15 feet in length, 2\1/2\ inches; for retorts 15 
feet and over in length, 3 inches.
    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, or for at least 
8 minutes and to at least 220 deg. F.

    (c) Venting through water spreaders.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.371
    
    Size of vent and vent valve. For retorts less than 15 feet in 
length, 2 inches; for retorts 15 feet and over in length, 2\1/2\ inches.
    Size of water spreader. For retorts less than 15 feet in length, 
1\1/2\ inches; for retorts 15 feet and over in length, 2 inches. 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.
    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, or for 
at least 7 minutes and to at least 220 deg. F.

    (d) Venting through a single 2\1/2\-inch top vent (for retorts not 
exceeding 15 feet in length).
[GRAPHIC] [TIFF OMITTED] TR01JA93.372

    Specifications: A 2\1/2\-inch vent equipped with a 2\1/2\-inch gate 
or plug cock valve and located within 2 feet of the center of the 
retort.
    Venting method: Vent gate or plug cock valve should be wide open for 
at least 4 minutes and to at least 220 deg. F.

    (ii) Venting vertical retorts. (a) Venting through a 1\1/2\-inch 
overflow.

[[Page 221]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.373


    Specifications. A 1\1/2\-inch overflow pipe equipped with a 1\1/2\-
inch gate or plug cock valve and with not more than 6 feet of 1\1/2\-
inch pipe beyond the valve before break to the atmosphere or to a 
manifold header.
    Venting method. Vent gate or plug cock valve should be wide open for 
at least 4 minutes and to at least 218 deg. F, or for at least 5 minutes 
and to at least 215 deg. F.

    (b) Venting through a single 1-inch side or top vent.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.374
    
    Specifications. A 1-inch vent in lid or top side, equipped with a 1-
inch gate or plug cock valve and discharging directly into the 
atmosphere or to a manifold header.
    Venting method. Vent gate or plug cock valve should be wide open for 
at least 5 minutes and to at least 230 deg. F, or for at least 7 minutes 
and to at least 220 deg. F.

    (iii) Other installations and operating procedures that deviate from 
the above specifications 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.
    (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) Indicating mercury-in-glass thermometer. Each retort 
shall be equipped with at least one mercury-in-glass thermometer whose 
divisions are easily readable to 1 deg. F and whose temperature range 
does not exceed 17 deg. F per inch of graduated scale. Thermometers 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks which specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date when it was last tested for accuracy. A thermometer 
that has a divided mercury column or that cannot be adjusted to the 
standard shall be repaired or replaced before further use of the retort. 
Thermometers

[[Page 222]]

shall be installed where they can be accurately and easily read. Bulbs 
of indicating thermometers shall be located in such a position that they 
are beneath the surface of the water throughout the process. On 
horizontal retorts, this entry should be made in the side at the center, 
and the thermometer bulbs shall be inserted directly into the retort 
shell. In both vertical and horizontal retorts, the thermometer bulbs 
shall extend directly into the water a minimum of at least 2 inches 
without a separable well or sleeve. The mercury thermometer--not the 
recorder chart--shall be the reference instrument for indicating the 
processing temperature.
    (2) Temperature-recording device. Each still retort shall have an 
accurate temperature-recording device. Graduations on the temperature-
recording devices shall not exceed 2 deg. F within a range of 10 deg. F 
of the processing temperature. Each chart shall have a working scale of 
not more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
which provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The recording-thermometer bulb 
should be located adjacent to the bulb of the mercury-in-glass 
thermometer, except in the case of a vertical retort equipped with a 
combination recorder-controller. In such vertical retorts, the 
temperature recorder-control bulb shall be located at the bottom of the 
retort below the lowest crate rest in such a position that the steam 
does not strike it directly. In horizontal retorts, the temperature 
recorder-control bulb 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 control bulb. Air-
operated temperature controllers should have adequate filter systems to 
ensure a supply of clean, dry air.
    (3) Pressure gages. (i) Each retort should be equipped with a 
pressure gage, which should be graduated in divisions of 2 pounds 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. This may 
be a recording-controlling instrument when combined with a recording 
thermometer.
    (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\1/2\-inch 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 holes on 2-inch centers. If 
divider plates are used between the layers of containers, they should be 
perforated as above. 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.

[[Page 223]]

    (8) Drain valve. A nonclogging, water-tight valve shall be used. 
Screens should be installed over all drain openings.
    (9) Water level indicator. There shall be a means of determining the 
water level in the retort during operation, e.g., by using a 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.
    (10)(i) 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 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.
    (ii) Water circulation. When a water circulating system is used for 
heat distribution, is 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-section area of the outlet line from the pump. The suction outlets 
should be protected with nonclogging screens to keep debris from 
entering the circulating system. The pump shall be equipped with a pilot 
light or other signaling device to warm the operator when it is not 
running, and with a bleeder to remove air when starting operations. 
Alternative methods for circulation of water in the retort may be used 
when established by a competent authority as adequate for even heat 
distribution.
    (11) 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.
    (12) Retort headspace. The headspace necessary to control the air 
pressure should be maintained between the water level and the top of the 
retort shell.
    (13) Vertical and horizontal still retorts. Vertical and horizontal 
still retorts should follow the arrangements in the diagrams below 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, that demonstrates that the heat distribution is 
adequate.

[[Page 224]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.375



            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.
    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 bulb.
    N--Thermometer.
    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.


[[Page 225]]


    (14) 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) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1 deg. F and 
whose temperature range does not exceed 17 deg. F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard 
used, method used, and person performing the test should be maintained. 
Each thermometer should have a tag, seal, or other means of identity 
that includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs in indicating thermometers 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 diameter opening, and equipped with a \1/16\-inch or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the thermometer bulb. The bleeders for external wells 
shall emit steam continuously during the entire processing period. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2 deg. F within a range of 10 deg. F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means of preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder opening emitting steam continuously during the 
processing period. 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 should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. A

[[Page 226]]

steam controller activated by the steam pressure of the retort is 
acceptable if it is carefully maintained mechanically so that it 
operates satisfactorily.
    (5) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eight inch or larger and shall be wide open during the entire 
process, including the come-up-time. Bleeders shall be located within 
approximately 1 foot 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 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, 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 marked on the 
recording chart 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 or 
more below the specified temperature, or alternatively,

[[Page 227]]

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 marked on the recording chart and entered on the other 
production records required in this chapter. If the alternative 
procedure of emptying the retort is followed, the subsequent handing 
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, 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 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) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1 deg. F and 
whose temperature range does not exceed 17 deg. F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard 
used, method used, and person performing the test should be maintained. 
Each thermometer should have a tag, seal, or other means of identity 
that includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers 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-diameter opening, and equipped with a \1/16\-inch or 
larger bleeder opening so located as to provide a full flow of steam 
past the length of the thermometer bulb. The bleeder for external wells 
shall emit steam continuously during the entire processing period. The 
mercury thermometer--not the recorder chart--

[[Page 228]]

shall be the reference instrument for indicating the processing 
temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2 deg. F within a range of 10 deg. F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. Each temperature-recorder bulb well shall have a \1/16\-
inch or larger bleeder opening emitting steam continuously during the 
processing period. 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, which should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer. A steam controller activated by the steam pressure of the 
retort is acceptable if it is mechanically maintained so that it 
operates satisfactorily.
    (5) Bleeders. Bleeders, except those for thermometer wells, shall be 
one-eighth inch or larger and shall be wide open during the entire 
process, including the come-up-time. Bleeders shall be located within 
approximately 1 foot 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 apart along the top. Bleeders may be installed at 
positions other than those specified above, 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 containing drainage of condensate during 
the retort operation.
    (7) Retort speed timing. The rotational speed of the retort shall be 
specified in the schedules 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 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 schedules 
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

[[Page 229]]

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) Indicating mercury-in-glass 
thermometer. Each retort shall be equipped with at least one mercury-in-
glass thermometer whose divisions are easily readable to 1 deg. F and 
whose temperature range does not exceed 17 deg. F per inch of graduated 
scale. Thermometers shall be tested for accuracy against a known 
accurate standard thermometer upon installation and at least once a year 
thereafter, or more frequently if necessary, to ensure their accuracy. 
Records of thermometer accuracy checks which specify date, standard use, 
method used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. Bulbs of indicating thermometers shall be installed either 
within the retort shell or in external wells attached to the retort. The 
mercury thermometer--not the recorder chart--shall be the reference 
instrument for indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2 deg. F within a range of 10 deg. F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustment, is a satisfactory means for preventing unauthorized 
changes. This recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the retort shell or in a well attached 
to the shell. 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 which should be graduated in divisions of 2 pounds or less.
    (4) Steam controller. Each retort shall be equipped with an 
automatic steam controller to maintain the retort temperature. This may 
be a recording-controlling instrument when combined with a recording 
thermometer.
    (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

[[Page 230]]

adjustment, is a satisfactory means of preventing unauthorized changes.
    (6) Air supply and controls. Means shall be provided for introducing 
compressed air at the proper pressure and rate, which 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.
    (7) 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 vaccum 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) Indicating mercury-in-glass thermometer. Each 
retort shall be equipped with at least one mercury-in-glass thermometer 
whose divisions are easily readable to 1 deg. F and whose temperature 
range does not exceed 17 deg. F per inch of graduated scale. Thermometer 
shall be tested for accuracy against a known accurate standard 
thermometer upon installation and at least once a year thereafter, or 
more frequently if necessary, to ensure their accuracy. Records of 
thermometer accuracy checks which specify date, standard used, method 
used, and person performing the test should be maintained. Each 
thermometer should have a tag, seal, or other means of identity that 
includes the date on which it was last tested for accuracy. A 
thermometer that has a divided mercury column or that cannot be adjusted 
to the standard shall be repaired or replaced before further use of the 
retort. Thermometers shall be installed where they can be accurately and 
easily read. The thermometer 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 mercury-in-
glass thermometer shall be located in each hydrostatic water leg in a 
position near the bottom automatic recorder. The mercury thermometer--
not the recorder chart--shall be the references instrument for 
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an accurate 
temperature-recording device. Graduations on the temperature-recording 
devices shall not exceed 2 deg. F within a range of 10 deg. F of the 
processing temperature. Each chart shall have a working scale of not 
more than 55 deg. F per inch within a range of 20 deg. F of the 
processing temperature. The temperature chart shall be adjusted to agree 
as nearly as possible with, but to be in no event higher than, the known 
accurate mercury-in-glass thermometer during the process time. A means 
of preventing unauthorized changes in adjustment shall be provided. A 
lock, or a notice from management posted at or near the recording device 
that provides a warning that only authorized persons are permitted to 
make adjustments, is a satisfactory means for preventing unauthorized 
changes. The recorder may be combined with the steam controller and may 
be a recording-controlling instrument. The temperature-recorder bulb 
shall be installed either within the steam dome or in a well attached to 
the dome. Each temperature-recorder bulb well shall have a \1/16\-inch 
or larger bleeder opening which emits steam continuously during the 
processing period. Additional temperature-recorder bulbs shall be 
installed in the

[[Page 231]]

hydrostatic water legs if the scheduled process specified maintenance of 
particular temperatures in the hydrostatic water legs. 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 which should be graduated in divisions of 2 pounds or less.
    (4) Recording of temperatures. Temperatures indicated by the 
mercury-in-glass thermometer or thermometers shall be entered on a 
suitable form during processing operations. Temperatures shall be 
recorded by an accurate automatic recorder or recorders 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 recording-controlling instrument when combined with a recording 
thermometer. A steam controller activated by the steam pressure of the 
retort is acceptable if it is carefully mechanically maintained so that 
it operates satisfactorily.
    (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 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 mercury-in-glass 
thermometer or an equivalent temperature-indicating device, such as a 
thermocouple-recorder. Mercury-in-glass thermometers shall have 
divisions that are easily readable to 1 deg. F and whose temperature 
range does not exceed 17 deg. F per inch of graduated scale. 
Thermometers and temperature-indicating devices shall be tested for 
accuracy against a known accurate standard thermometer upon installation 
and at least once a year thereafter, or more frequently if necessary, to 
ensure their accuracy. Records of accuracy checks which specify date, 
standard used, method used, and person performing the test should be 
maintained. Each thermometer and

[[Page 232]]

temperature-indicating device should have a tag, seal, or other means of 
identity that includes the date on which it was last tested for 
accuracy. A thermometer that has a divided mercury column or that cannot 
be adjusted to essential agreement with the standard shall be repaired 
or replaced. Thermometers and temperature-indicating devices shall be 
installed where they can be accurately and easily read. The temperature-
indicating device shall be the reference instrument for indicating the 
processing temperature.
    (b) Temperature-recording device. There shall be an accurate 
temperature recording device on each product sterilizer. The device 
shall be installed in the product at the holding-tube outlet between the 
holding tube and the inlet to the cooler. Temperature-recording devices 
shall have graduations that do not exceed 2 deg. F within a range of 
10 deg. F of the processing temperature. Each chart shall have a working 
scale of not more than 55 deg. F per inch within a range of 20 deg. F of 
the desired product-sterilization temperature. The temperature chart 
shall be adjusted to agree as nearly as possible with, but to be in no 
event higher than, a known accurate mercury-in-glass thermometer. A 
means of preventing unauthorized changes in adjustment shall be 
provided. A lock; or a notice from management posted at or near the 
recording device that provides a warning that only authorized persons 
are permitted to make adjustments, is a satisfactory means for 
preventing unauthorized changes.
    (c) Temperature recorder-controller. An accurate temperature 
recorder-controller shall be located in the product sterilizer at the 
final heater outlet. It shall be capable of ensuring that the desired 
product sterilization temperature is maintained. The chart graduations 
shall not exceed 2 deg. F within a range of 10 deg. F of the desired 
product sterilization temperature. 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, there shall be an accurate differential 
pressure recorder-controller installed on the regenerator. The scale 
divisions shall not exceed 2 pounds per square inch on the working scale 
of not more than 20 pounds per square inch per inch. The controller 
shall be tested for accuracy against a known accurate standard pressure 
indicator upon installation and at least once every 3 months of 
operation thereafter, or more frequently if necessary, to ensure its 
accuracy. 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.
    (f) Metering pump. A metering pump 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 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.
    (g) Product holding tube. The product-sterilizing holding tube shall 
be designed to give continous 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 0.25 inch per foot.
    (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

[[Page 233]]

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 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 and shall 
be reprocessed or destroyed. 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 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 recorder in holding tube outlet; temperature 
recorder-controller at final heater outlet; differential pressure 
recorder-controller, if a product-to-product regenerator is used; 
product flow rate as established by the metering pump 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 seam 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

[[Page 234]]

accomplished continuously. Automatic 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 and 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.
    (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, 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.

[[Page 235]]

    (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.



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 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 wrinkle)   Countersink.                      
Thickness by micrometer               ..................................
------------------------------------------------------------------------


[[Page 236]]


    (c) Can double seam terminology:
    [GRAPHIC] [TIFF OMITTED] TR01JA93.376
    

[[Page 237]]


    (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.
    (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. When cans are handled on belt conveyors, 
the conveyors should be so constructed as 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. Automatic equipment used in handling filled containers 
should be so designed and operated as to preserve the can seam or other 
container closure integrity.



               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 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,

[[Page 238]]

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. 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, 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 prepared and 
shall be permanently retained by the person or organization making the 
determination.



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

[[Page 239]]

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 
written record of these checks should be made.
    (c) The initial temperature of the contents of the containers to be 
processed shall be 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.
    (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 recording-temperature charts should reasonably 
correspond to the time of day on the written 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.



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 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

[[Page 240]]

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 mercury-in-glass 
and recording thermometer 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 recorder; product temperature in the final 
heater outlet as indicated by the temperature recorder-controller; 
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 metering pump 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.
    (7) Other systems. Critical factors specified in the formulation of 
the product or in the scheduled process.
    (b) Recording thermometer charts shall be identified by date, retort 
number, and other data as necessary, so they can be correlated with the 
written 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 that 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 the recording thermometer chart(s), 
shall be signed or initialed and dated by the reviewer.
    (c) Written records of all container closure examinations shall 
specify the

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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.
    (d) 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.
    (e) Copies of all records provided for in this part, except those 
required under Sec. 113.83 establishing scheduled 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.



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: Secs. 402, 701, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health 
Service Act (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.

[[Page 242]]

    (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]



Sec. 114.5  Current good manufacturing practice.

    The criteria in Secs. 114.10, 114.80, 114.83, 114.89, and 114.100, 
as well as the criteria in part 110 of this chapter, apply in 
determining whether an article of acidified food is adulterated (1) 
within the meaning of section 402(a)(3) of the act (21 U.S.C. 342(a)(3)) 
in that it 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 (21 
U.S.C. 342(a)(4)) 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.



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

[[Page 243]]

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 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

[[Page 244]]

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 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 
plus-minus0.05 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 plus-minus0.01 pH unit and a reproducibility of 
plus-minus0.005 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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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

[[Page 245]]

(for example, 4.0) for the temperature observed. Rinse the electrodes 
with 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 plus-minus0.3 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 plus-minus1.5 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 246]]

    (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 Potassium Hydroxide Phthalate 
Method,'' which is also incorporated by reference and

[[Page 247]]

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]



                     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 guidelines 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.



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: Secs. 201, 402, 403, 406, 409, 701, 704, 721, 801, 903 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 346, 
348, 371, 374, 379e, 381, 393); secs. 301, 307, 361 of the Public Health 
Service Act (42 U.S.C. 241, 242l, 264).

    Source: 60 FR 65197, Dec. 18, 1995, unless otherwise noted.

    Effective Date Note: At 60 FR 65197, Dec. 18, 1995, part 123 was 
added, effective December 18, 1997.



                      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 part 110 of this 
chapter are applicable to such terms when used in this part, except 
where they are herein redefined. 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

[[Page 248]]

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.
    (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,

[[Page 249]]

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.



Sec. 123.5  Current good manufacturing practice.

    (a) Part 110 of this chapter applies 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.



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 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;

[[Page 250]]

    (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).
    (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

[[Page 251]]

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: 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

[[Page 252]]

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 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

[[Page 253]]

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 that are both appropriate to the 
plant and the food being processed and relate to the following:
    (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.



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:

[[Page 254]]

    (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;
    (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

[[Page 255]]

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 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: Secs. 402, 409, 701, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 348, 371, 374); sec. 361 of the Public 
Health Service Act (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 part 110 of this chapter, as well as the 
criteria in Secs. 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.

[[Page 256]]



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 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,

[[Page 257]]

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 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 microbiological 
contaminants at least once each week. This sampling is in addition to 
any performed by govermnnt agencies having jusisdiction. Records of 
approval of the source water by government agencies having jusisdiction 
and of sampling and analyses for which the plant is responsible 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) The finished bottled water must comply with bottled water 
quality standards (21 CFR 165.110(b)) and section 402(a)(1) of the 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]

    Effective Date Note: At 60 FR 57123, Nov. 13, 1995, in Sec. 129.35, 
paragraphs (a)(3)(ii) and (iii) were revised, and paragraph (a)(4) was 
added, effective May 13, 1996. For the convenience of the reader, the 
superseded text is set forth below.
Sec. 129.35  Sanitary facilities.

                                * * * * *

    (a) * * *
    (3) * * *
    (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. 103.35 of this chapter.

[[Page 258]]

    (iii) Analysis of the samples may be performed for the plant by 
competent commercial laboratories.

                                * * * * *



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 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.

[[Page 259]]

    (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 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:

[[Page 260]]

    (1) For bacteriological purposes, take and analyze at least once a 
week 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.
    (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 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 Secs. 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]

    Effective Date Note: At 60 FR 57124, Nov. 13, 1995, in Sec. 129.80, 
paragraph (g) introductory text was revised, effective May 13, 1996. For 
the convenience of the reader, the superseded text is set forth below.
Sec. 129.80  Processes and controls.

                                * * * * *

    (g) Compliance procedures. A quality standard for bottled drinking 
water, excluding mineral water, is established in Sec. 103.35 of this 
chapter. To assure that the plant'a production of bottled drinking water 
complies with the applicable standards, laws, and regulations of the 
govenrment agency or agencies having jusisdiction, the plant will 
analyze product samples as follows:

                                * * * * *



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: Secs. 201, 306, 401, 403, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 336, 341, 343, 371).

    Source: 42 FR 14357, Mar. 15, 1977, unless otherwise noted.



                      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

[[Page 261]]

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 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

[[Page 262]]

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 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, 
1111 North 19th St., Suite 210, Arlington, VA 22209, or available for 
inspection at the Office of the Federal Register, 800 North Capitol St. 
NW., Suite 700, Washington, DC.
    (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]



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)

[[Page 263]]

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 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

[[Page 264]]

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]



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.

[[Page 265]]

    (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 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

[[Page 266]]

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 Chief, Food 
Standards Branch, Office of Food Labeling, Center for Food Safety and 
Applied Nutrition (HFS-158), 200 C St. SW., Washington, DC 20204, 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.
    (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.

[[Page 267]]

    (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, 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]



             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

[[Page 268]]

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.

    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.
131.122  Sweetened condensed skimmed milk.
131.123  Lowfat dry milk.
131.125  Nonfat dry milk.
131.127  Nonfat dry milk fortified with vitamins A and D.
131.130  Evaporated milk.
131.132  Evaporated skimmed milk.
131.135  Lowfat milk.
131.136  Acidified lowfat milk.
131.138  Cultured lowfat milk.
131.143  Skim milk.
131.144  Acidified skim milk.
131.146  Cultured skim 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.
131.185  Sour half-and-half.
131.187  Acidified sour half-and-half.
131.200  Yogurt.
131.203  Lowfat yogurt.
131.206  Nonfat yogurt.

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

    Source: 42 FR 14360, Mar. 15, 1977, unless otherwise noted.



                      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 (Secs. 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

[[Page 269]]

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 
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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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

[[Page 270]]

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) 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street NW., suite 700, Washington, DC.
    (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

[[Page 271]]

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 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, 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 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (1) Milkfat content--section 16.059, ``Roese-Gottlieb Method 
(Reference

[[Page 272]]

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 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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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

[[Page 273]]

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 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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. 131.122  Sweetened condensed skimmed milk.

    (a) Description. Sweetened condensed skimmed milk is the food 
obtained by the partial removal of water only from a mixture of skim 
milk and safe and suitable nutritive carbohydrate sweeteners. The 
finished food contains not more than 0.5 percent by weight of milkfat 
unless otherwise indicated and not less than 24 percent by weight of 
total milk solids. The quantity of nutritive carbohydrate sweeteners 
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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (d) Nomenclature. The name of the food is ``Sweetened condensed 
skimmed milk.'' The word ``homogenized'' may appear on the label if the 
food has been homogenized. If the milkfat content is

[[Page 274]]

over 0.5 percent by weight, the name of the food shall be accompanied by 
the statement ``Contains ------------ % milkfat'', the blank to be 
filled in with the fraction ``\1/2\'', or multiple thereof, closest to 
the actual milkfat content of the product. The name of the food shall be 
accompanied by a declaration of the presence of any characterizing 
flavoring, as specified in Sec. 101.22 of ths 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. 131.123  Lowfat dry milk.

    (a) Description. Lowfat dry milk is the product obtained by removal 
of water only from pasteurized lowfat milk, as defined in 
Sec. 131.135(a), which may have been homogenized. Alternatively, lowfat 
dry 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 lowfat dry milk is equivalent in 
composition to that obtained by the method described in the first 
sentence of this paragraph. It contains not less than 5 percent but less 
than 20 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. Lowfat dry milk contains added vitamin A as prescribed by 
paragraph (b) of this section.
    (b) Vitamin addition. (1) Vitamin A shall be present in such 
quantity that, when prepared according to label directions, each quart 
of the reconstituted product contains 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 contains 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 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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 ``Lowfat dry 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

[[Page 275]]

the whole number closest to the actual fat content of the food.
    (2) The phrase ``vitamin A'' or ``vitamin A added'', and if vitamin 
D is added, the phrase ``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 19835, May 9, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 48 
FR 13024, Mar. 29, 1983; 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700 Washington, DC.
    (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 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.

[[Page 276]]

    (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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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]



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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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

[[Page 277]]

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. 131.132  Evaporated skimmed milk.

    (a) Description. Evaporated skimmed milk is the liquid food obtained 
by the partial removal of water only from skim milk. It contains not 
less than 20 percent by weight of total milk solids, and not more than 
0.5 percent by weight of milkfat unless otherwise indicated. Evaporated 
skimmed milk contains added vitamins A and D as prescribed by paragraph 
(b) of this section. It may be 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) 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 manufacturing practice.
    (c) Optional ingredients. The following safe and suitable 
ingredients may be used:
    (1) Carriers for vitamin A and D.
    (2) Emulsifiers.
    (3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when 
permitted by, and complying with 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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 skimmed 
milk.'' The phrase ``vitamins A and D'' or ``vitamins A and D added'', 
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 of the height of the letters used in such name. 
If the milkfat content is over 0.5 percent by weight, the name of the 
food shall be accompanied by the statement, ``Contains ------------ % 
milkfat'', the blank to be filled in with the fraction ``\1/2\'', or 
multiple thereof, closest to the actual milkfat content of the product. 
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.
    (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 21671, 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. 131.135   Lowfat milk.

    (a) Description. Lowfat milk is milk from which sufficient milkfat 
has been removed to produce a food having, within limits of good 
manufacturing practice, one of the following milkfat

[[Page 278]]

contents: \1/2\, 1, 1\1/2\, or 2 percent. Lowfat milk is pasteurized or 
ultra-pasteurized, contains added vitamin A as prescribed by paragraph 
(b) of this section, and contains not less than 8\1/4\ percent milk 
solids not fat. Lowfat milk may be homogenized.
    (b) Vitamin addition. (1) 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) Addition of vitamin D is optional. If added, vitamin D shall be 
present in such quantity that each 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) Concentrated skim milk, nonfat dry milk, or other milk derived 
ingredients 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.
    (3) When one or more of the optional milk derived ingredients in 
paragraph (c)(2) of this section are used, emulsifiers, stabilizers, or 
both, in an amount not more than 2 percent by weight of the solids in 
such ingredients.
    (4) 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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (1) Milkfat content--``Fat, Roese-Gottlieb Method--Official Final 
Action,'' section 16.059.
    (2) Milk solids not fat content (or total nonfat solids content)--
Calculated by subtracting the milkfat 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 ``Lowfat milk''. The name 
of the food shall appear on the label in type of uniform size, style, 
and color. 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 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, to indicate the actual fat content 
of the food.
    (ii) The phrase ``vitamin A'' or ``vitamin A added'', or, if vitamin 
D is added, the phrase ``vitamins A and D added''. The word ``vitamin'' 
may be abbreviated ``vit.''.
    (iii) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (iv) The phrase ``with added milk solids not fat'' if the food 
contains not less than 10 percent milk-derived nonfat solids.
    (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 45 FR 81737, Dec. 12, 1980; 
47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24893, 
June 12, 1989; 58 FR 2890, Jan. 6, 1993]

[[Page 279]]



Sec. 131.136  Acidified lowfat milk.

    (a) Description. Acidified lowfat milk is the food produced by 
souring one or more of the optional dairy ingredients specified in 
paragraph (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 lowfat milk contains not less than 0.5 percent nor more than 
2.0 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 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 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 dairy ingredients 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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

[[Page 280]]

Action,'' or by an equivalent potentiometric method.
    (g) Nomenclature. The name of the food is ``acidified lowfat 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 lowfat milk'', 
``acidified acidophilus lowfat 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 lowfat 
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 ``---- % 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 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.
    (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 9936, Jan. 30, 1981, as amended at 47 FR 11823, Mar. 19, 1982; 47 
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2890, Jan. 6, 1993]



Sec. 131.138  Cultured lowfat milk.

    (a) Description. Cultured lowfat 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 lowfat milk 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 0.5 
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 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, dried malt extract; malt sirup, dried malt sirup; honey;

[[Page 281]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 ``cultured lowfat 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, e.g., ``kefir cultured lowfat milk'', ``acidophilus 
cultured lowfat 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 
lowfat 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 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.
    (iii) The word ``sweetened'' if nutritive carbohydrate sweetner 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 9936, Jan. 30, 1981, as amended at 47 FR 11824, Mar. 19, 1982; 47 
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2891, Jan. 6, 1993]



Sec. 131.143   Skim milk.

    (a) Description. Skim milk is milk from which sufficient milkfat has 
been removed to reduce its milkfat content to less than 0.5 percent. 
Skim milk that is in final package form for beverage use shall have been 
pasteurized or ultra-pasteurized, shall contain added vitamin A as 
prescribed by paragraph (b) of this section, and shall contain not less 
than 8\1/4\ percent milk solids not fat. Skim milk may be homogenized.
    (b) Vitamin addition. (1) Vitamin A shall be present in such 
quantity that

[[Page 282]]

each quart of the food contains not less than 2000 International Units 
thereof within limits of good manufacturing practice.
    (2) Addition of vitamin D is optional. If added, vitamin D shall be 
present in such quantity that each 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) Concentrated skim milk, nonfat dry milk, or other milk derived 
ingredients 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.
    (3) When one or more of the optional milk derived ingredients in 
paragraph (c)(2) of this section are used, emulsifiers, stabilizers, or 
a combination of both, in an amount not more than 2 percent by weight of 
the solids in such ingredients.
    (4) 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 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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (1) Milkfat content--``Fat, Roese-Gottlieb Method--Official Final 
Action,'' section 16.059.
    (2) Milk solids not fat content (or total nonfat solids content)--
Calculated by subtracting the milkfat 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 ``Skim milk'' or 
alternatively ``Nonfat milk''. The name of the food shall appear on the 
label in type of uniform size, style, and color. 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 of the height of the letters 
used in such name:
    (i) The phrase ``vitamin A'' or ``vitamin A added'', or, if vitamin 
D is added, the phrase ``vitamins A and D'' or ``vitamins A and D 
added''. The word ``vitamin'' may be abbreviated ``vit.''.
    (ii) The word ``ultra-pasteurized'' if the food has been ultra-
pasteurized.
    (iii) The phrase ``with added milk solids not fat'' if the food 
contains not less than 10 percent milk-derived nonfat solids.
    (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 45 FR 81737, Dec. 12, 1980. 
Redesignated at 46 FR 9934, Jan. 30, 1981, and amended at 47 FR 11824, 
Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 
58 FR 2891, Jan. 6, 1993]



Sec. 131.144  Acidified skim milk.

    (a) Description. Acidified skim milk is the food produced by souring 
one or more of the optional dairy ingredients specified in paragraph (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

[[Page 283]]

organisms. One or more of the other opitonal 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 skim milk 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 0.5 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 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 sweetners 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 dairy ingredients 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 conttent 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 skim milk'' or 
alternatively, ``acidified nonfat milk''. The full name of the food 
shall appear on the principal display panel of the food in type of 
uniform size, style and color. The name of the food shall be accompanied 
by a declaration indicating the

[[Page 284]]

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 skim milk'', 
``acidified acidophilus skim milk'', or when characterizing ingredients 
such as those in paragraph (e)(6), (7), (8), and (9) of this section are 
used, the food may be named ``acidified skim milk buttermilk'' or 
alternatively ``acidified nonfat 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 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 9937, Jan. 30, 1981, as amended at 47 FR 11824, Mar. 19, 1982; 47 
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 
12, 1989; 58 FR 2891, Jan. 6, 1993]



Sec. 131.146  Cultured skim milk.

    (a) Description. Cultured skim 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 skim milk 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 0.5 percent, expressed as lactic 
acid. The food may be homogenized and shall be pasterurized or ultra-
pasterurized 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 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, 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.

[[Page 285]]

    (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 are available from the Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 ``cultured skim milk'' or 
alternatively, ``cultured nonfat 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, e.g., ``kefir 
cultured nonfat milk'', ``acidophilus cultured nonfat milk'', or when 
characterizing ingredients such as those in paragraph (d) (6), (7), (8), 
and (9) of this section, and lactic acid-producing organisms are used 
the food may be named ``cultured skim milk buttermilk'' or alternatively 
``cultured nonfat 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 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 9937, Jan. 30, 1981, as amended at 47 FR 11824, 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. 131.147  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 that, when prepared 
according to label directions, each quart of the reconstituted product 
shall contain not

[[Page 286]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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 Secs. 131.123(a), 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.
    (3) Anticaking agents.
    (4) Antioxidants.
    (5) Nutritive carbohydrate sweeteners.

[[Page 287]]

    (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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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]



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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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:
    (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

[[Page 288]]

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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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), 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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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

[[Page 289]]

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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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 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

[[Page 290]]

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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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.
    (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

[[Page 291]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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.
    (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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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.

[[Page 292]]

    (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. 131.185   Sour half-and-half.

    (a) Description. Sour half-and-half results from the souring, by 
lactic acid producing bacteria, of pasteurized half-and-half. Sour half-
and-half contains not less than 10.5 percent but 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 10.5 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 8.4 percent 
milkfat. Sour half-and-half 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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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 half-and-half'' or 
alternatively ``Cultured sour half-and-half''. 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. 131.187   Acidified sour half-and-half.

    (a) Description. Acidified sour half-and-half results from the 
souring of pasteurized half-and-half with safe and suitable acidifiers, 
and with or without addition of lactic acid producing bacteria. 
Acidified sour half-and-half contains not less than 10.5 percent but 
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 10.5 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 8.4 
percent milkfat. Acidified sour half-and-half has a titratable acidity 
of not

[[Page 293]]

less than 0.5 percent, calculated as lactic acid.
    (b) Optional ingredients. (1) Safe and suitable ingredients to 
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 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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, Washington, DC 20044, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (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 half-and-
half''. 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 10093, 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, 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

[[Page 294]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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

[[Page 295]]

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, 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.
    (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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 ``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 296]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or available for inspection at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 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

[[Page 297]]

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.
133.131  Lowfat 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.
133.180  Pasteurized process cheese spread with fruits, vegetables, or 
          meats.
133.181  Provolone cheese.
133.182  Soft ripened cheeses.

[[Page 298]]

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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

    Source: 42 FR 14366, Mar. 15, 1977, unless otherwise noted.



                      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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington, VA 22201-3301, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC):
    (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]



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

[[Page 299]]

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

[[Page 300]]

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 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 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. 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 
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.

[[Page 301]]

During storage the surface of the cheese may be scraped to remove 
surface growth of undesirable microorganisms. Antimycotics may be 
applied to the 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

[[Page 302]]

is then cured to develop the characteristics of brick 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) 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

[[Page 303]]

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.
    (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 304]]

    (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.
    (d) Low sodium cheddar cheese is subject to Sec. 105.69 of this 
chapter.

[48 FR 2743, Jan. 21, 1983]



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

[[Page 305]]

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 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 306]]



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.
    (f) Low sodium colby cheese is subject to Sec. 105.69 of this 
chapter.

[42 FR 14366, Mar. 15, 1977, as amended at 58 FR 2892, Jan. 6, 1993]



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

[[Page 307]]

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 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,

[[Page 308]]

colby cheese, granular cheese, or any mixture of two or more of these, 
such 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.

[[Page 309]]

    (6) 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.
    (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

[[Page 310]]

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. 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

[[Page 311]]

as required by the applicable sections 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 of parts 101 and 130 of 
this chapter,

[[Page 312]]

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. 133.131   Lowfat cottage cheese.

    Lowfat cottage cheese is the food prepared from the same ingredients 
and in the same manner prescribed in Sec. 133.128 for cottage cheese and 
complies with all the provisions of Sec. 133.128 (including requirements 
for the label statement of ingredients), except that:
    (a) Its content of milkfat is not less than 0.5 percent and not more 
than 2 percent by weight, within limits of good manufacturing practice.
    (b) Its moisture content is not more than 82.5 percent.
    (c) The name of the food consists of the following two phrases which 
shall appear together:
    (1) The words ``lowfat cottage cheese'' which shall appear in type 
of the same size and style.
    (2) The words ``------ % milkfat'', the blank being filled in with 
the fraction ``\1/2\'' or multiple thereof closest to 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.

[42 FR 14366, Mar. 15, 1977, as amended at 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]

[[Page 313]]



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 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:

[[Page 314]]

    (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:
    (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.

[[Page 315]]

    (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 
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 roquefortii, 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 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.

[[Page 316]]

    (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 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

[[Page 317]]

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 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.

[[Page 318]]

    (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 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.

[[Page 319]]

    (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 
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;

[[Page 320]]

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
    (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

[[Page 321]]

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 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

[[Page 322]]

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]



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.

[[Page 323]]

    (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 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]

[[Page 324]]



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 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.
    (ii) 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 surfact 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

[[Page 325]]

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 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]

[[Page 326]]



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 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 of 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 mess. 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]

[[Page 327]]



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, 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

[[Page 328]]

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.
    (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

[[Page 329]]

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]



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

[[Page 330]]

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 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

[[Page 331]]

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.
    (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

[[Page 332]]

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 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

[[Page 333]]

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 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 
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 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

[[Page 334]]

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 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

[[Page 335]]

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]



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

[[Page 336]]

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 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,

[[Page 337]]

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 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 spread.
    (f) The other optional ingredients referred to in paragraph (a) of 
this section are:
    (1)(i) One or any mixture of two or more of the following: Carob 
bean gum, gum karaya, gum tragacanth, guar gum, gelatin, sodium 
carboxymethylcellulose (cellulose gum), carrageenan, oat gum, algin 
(sodium alginate), propylene 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.

[[Page 338]]

    (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, 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.

[[Page 339]]

    (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''.
    (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

[[Page 340]]

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 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

[[Page 341]]

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.
    (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 ``Pecorina''; 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 roquefortii, 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.

[[Page 342]]

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:
    (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

[[Page 343]]

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 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

[[Page 344]]

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 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

[[Page 345]]

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 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,

[[Page 346]]

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) 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.

[[Page 347]]

    (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 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

[[Page 348]]

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 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.

[[Page 349]]

    (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]



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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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
------------------------------------------------------------------------



[[Page 350]]

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.
    (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

[[Page 351]]

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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (f) Nomenclature. (1) The name of the food is ``ice cream''; except 
that when 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 
(e)(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

[[Page 352]]

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 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]



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,

[[Page 353]]

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 
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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington,

[[Page 354]]

VA 22201-3301, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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.
    (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]



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

[[Page 355]]

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 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

[[Page 356]]

statment required by paragraph (f)(2) (i) and (ii) of this section, as 
apprpriate, 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, 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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

    Source: 42 FR 14400, Mar. 15, 1977, unless otherwise noted.



                      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.

[[Page 357]]

    (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.
    (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.

[[Page 358]]

    (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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (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]



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 
thiamine, 1.1 milligrams of riboflavin, 15 milligrams of niacin, 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         OSH           
                               hydrochloride.   Cl                      
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

[[Page 359]]

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 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 14245, Apr. 1, 1996]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 136.115, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 136.115  Enriched bread, rolls, and buns.
    (a) * * *
    (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.

                                * * * * *



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.

[[Page 360]]



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 may be 
obtained from the Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (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]



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.

[[Page 361]]

137.211  White corn flour.
137.215  Yellow corn flour.
137.220  Durum flour.
137.225  Whole durum flour.
137.230  Corn grits.
137.235  Enriched corn grits.
137.240  Quick grits.
137.245  Yellow grits.
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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

    Source: 42 FR 14402, Mar. 15, 1977, unless otherwise noted.



                          Subpart A--[Reserved]



  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 -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 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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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''.

[[Page 362]]

When the optional ingredient -amylase obtained from Aspergillus 
oryzae'' is used, it may alternatively be declared in the list of 
ingredients as ``Fungal alpha-amylase,'' ``Fungal -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 
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

[[Page 363]]

statement of ingredients, prescribed for flour by Sec. 137.105, except 
that:
    (a) It contains in each pound 2.9 milligrams of thiamine, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 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 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         C12H17ClN4        337.28 
                               chloride         OS.           
                               hydrochloride.   HCl                     
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]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 137.165, 
paragraph (a) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.165  Enriched flour.

                                * * * * *

    (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.

                                * * * * *



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 Secs. 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.

[[Page 364]]

    (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 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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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

[[Page 365]]

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 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 thiamine, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 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.     337.28 
                               chloride         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;

[[Page 366]]

    (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]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 137.185, 
paragraph (a) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.185  Enriched self-rising flour.

                                * * * * *

    (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.

                                * * * * *



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 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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.

[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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.

[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 
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

[[Page 367]]

contain harmless preparations of -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 ``''-amylase obtained from Aspergillus oryzae'' is 
used, it may alternatively be declared in the list of ingredients as 
``Fungal alpha-amylase,'' ``Fungal -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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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]

[[Page 368]]



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 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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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. 137.230   Corn grits.

    (a) Grits, corn grits, hominy grits, is the food prepared by so 
grinding and

[[Page 369]]

sifting cleaned white corn, with removal of corn bran and germ, that:
    (1) On a moisture-free basis its crude fiber content is not more 
than 1.2 percent and its fat content is not more than 2.25 percent; and
    (2) When tested by the method prescribed in paragraph (b)(2) of this 
section not less than 95 percent passes through a No. 10 sieve but not 
more than 20 percent through a No. 25 sieve.
    (b)(1) For the purposes of this section moisture, fat, and crude 
fiber are determined by methods therefor referred to in 
Sec. 137.250(b)(1).
    (2) The method referred to in paragraph (a) of this section is as 
follows: Use No. 10 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 ``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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. Attach bottom pan to No. 25 sieve. Fit the No. 10 sieve into the No. 
25 sieve. Pour 100 grams of sample into the No. 10 sieve, attach cover 
and hold assembly in a slightly inclined position, shake the sieves by 
striking the sides against one 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 separately the material remaining 
on the No. 10 sieve and in the pan, and calculate each weight as percent 
of sample. The percent of sample passing through a No. 10 sieve shall be 
determined by subtracting from 100 percent the percent remaining on the 
No. 10 sieve. The percent of material in the pan shall be considered as 
the percent passing through a No. 25 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. 137.235   Enriched corn grits.

    (a) Enriched corn grits are the foods, each of which conforms to the 
definition and standard of identity prescribed for grits, yellow grits, 
or quick cooking grits by Secs. 137.230, 137.240, and 137.245, except 
that:
    (1) It contains in each pound not less than 2.0 mg. and not more 
than 3.0 mg. of thiamine, 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 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 mg. and not more 
than 750 mg. of calcium (Ca). Iron and calcium may be added only in 
forms which are harmless and assimilable. The vitamins referred to in 
paragraph (a)(1) of this section may be combined with harmless 
substances to render them insoluble in water if the water-insoluble 
products are assimilable. The substances referred to in this 
subparagraph and in paragraphs (a) (1) and (2) 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 admixture of such substances 
with the kind of corn grits 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 grits is the word 
``Enriched'' followed by the name of the kind of corn grits 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 2877, Jan. 6, 1993]


[[Page 370]]


    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 136.235, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.235Enriched corn grits.
    (a) * * *
    (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);

                                * * * * *



Sec. 137.240   Quick grits.

    (a) Quick grits, quick cooking grits are the foods, each of which 
conforms to the definition and standard of identity prescribed for a 
kind of grits by Secs. 137.230 or 137.245, except that in process of 
preparation the grits are lightly steamed and slightly compressed so as 
to fracture the particles.
    (b) The name of each kind of grits is ``Quick'' or ``Quick cooking'' 
followed by the name of the kind of grits used which is prescribed in 
the definition and standard of identity therefor.



Sec. 137.245   Yellow grits.

    Yellow grits, yellow corn grits, yellow hominy grits, conforms to 
the definition and standard of identity prescribed by Sec. 137.230 for 
grits except that cleaned yellow corn is used instead of cleaned white 
corn.



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.
    (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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC):
    (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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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

[[Page 371]]

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 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 Secs. 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 mg. and not more 
than 3.0 mg. of thiamine, 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, 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''

[[Page 372]]

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]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 136.260, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.260Enriched corn meals.
    (a) * * *
    (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);

                                * * * * *



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.
    (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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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-

[[Page 373]]

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.



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:

[[Page 374]]

    (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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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 and not 
more than 2.5 milligrams of thiamine, not less than 1.2 milligrams and 
not more than 1.5 milligrams of riboflavin, not less than 16.0 
milligrams and not more than 20.0 milligrams of niacin or niacinamide, 
and not less than 13.0 milligrams 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.
    (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''.

[[Page 375]]

    (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]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 137.305, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.305  Enriched farina.
    (a) * * *
    (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).

                                * * * * *



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 and not more than 4.0 milligrams of 
thiamine; not less than 1.2 milligrams and not more than 2.4 milligrams 
of riboflavin; not less than 16 milligrams and not more than 32 
milligrams of niacin or niacinamide; and not less than 13 milligrams and 
not more than 26 milligrams 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 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

[[Page 376]]

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 be obtained from the Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC. 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).

[[Page 377]]

    (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]

    Effective Date Note: At 61 FR 8796, Mar. 5, 1996, in Sec. 137.350, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 137.350  Enriched rice.
    (a) * * *
    (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).

                                * * * * *



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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 378]]

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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (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]



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 mg. and 
not more than 5 mg. of thiamine, 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, 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

[[Page 379]]

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]

    Effective Date Note: At 61 FR 8797, Mar. 5, 1996, in Sec. 139.115, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 139.115  Enriched macaroni products.
    (a) * * *
    (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 not less than 13 mg and not more 
than 16.5 mg of iron (Fe);

                                * * * * *



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 
Secs. 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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700,

[[Page 380]]

Washington, DC), 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 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]

    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:

[[Page 381]]

    (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 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. 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.
    (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

[[Page 382]]

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 
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 milligrams 
and not more than 5 milligrams of thiamine, not less than 1.7 milligrams 
and not more than 2.2 milligrams of riboflavin, not less than 27 
milligrams and not more than 34 milligrams of niacin or niacinamide, and 
not less than 13 milligrams and not more than 16.5 milligrams 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]

    Effective Date Note: At 61 FR 8797, Mar. 5, 1996, in Sec. 139.122, 
the first sentence of paragraph (a)(3) was revised, effective January 1, 
1998. For the convenience of the reader, the revised text is set forth 
below.
Sec. 139.122Enriched nonfat milk macaroni products.
    (a) * * *
    (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). * * *

                                * * * * *



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

[[Page 383]]

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 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

[[Page 384]]

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 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

[[Page 385]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. The total solids 
of noodle products contains not less than 5.5 percent by weight of the 
solids of egg, or egg yolk.
    (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]



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 mg. and 
not more than 5 mg. of thiamine, 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, 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;

[[Page 386]]

    (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 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]

    Effective Date Note: At 61 FR 8797, Mar. 5, 1996, in Sec. 139.155, 
paragraph (a)(1) was revised, effective January 1, 1998. For the 
convenience of the reader, the revised text is set forth below.
Sec. 139.155Enriched noodle products.
    (a) * * *
    (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);

                                * * * * *



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

[[Page 387]]

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.
    (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

[[Page 388]]

``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.
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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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,

[[Page 389]]

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 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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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

[[Page 390]]

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.
    (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]



     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

[[Page 391]]

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 Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 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

[[Page 392]]

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:

                   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]



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.

[[Page 393]]

    (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 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

[[Page 394]]

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 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

[[Page 395]]

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.
    (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

[[Page 396]]

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 ``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

[[Page 397]]

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.
    (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:

[[Page 398]]

    (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''; ``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.

[[Page 399]]

    (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 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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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

[[Page 400]]

``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 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]



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

[[Page 401]]

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 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.

[[Page 402]]

    (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 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

[[Page 403]]

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, 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.

[[Page 404]]

    (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 ``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.

[[Page 405]]

    (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 Notes,'' which is incorporated by reference. Copies may be 
obtained from the Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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

[[Page 406]]

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 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]



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.

[[Page 407]]

    (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.
    (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

[[Page 408]]

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.
    (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

[[Page 409]]

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 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 Association of Official Analytical Chemists, 
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC), 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.

[[Page 410]]

    (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.
    (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

[[Page 411]]

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 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]



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

[[Page 412]]

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.
    (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''.

[[Page 413]]

    (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 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

[[Page 414]]

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 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

[[Page 415]]

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''; (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.

[[Page 416]]

    (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 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

[[Page 417]]

``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 suar 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 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,

[[Page 418]]

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 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'';

[[Page 419]]

    (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, 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.

[[Page 420]]

    (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 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''

[[Page 421]]

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.
    (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

[[Page 422]]

    (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.
    (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

[[Page 423]]

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 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

[[Page 424]]

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''.
    (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

[[Page 425]]

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 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.

[[Page 426]]

    (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 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

[[Page 427]]

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]



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

[[Page 428]]

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 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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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

[[Page 429]]

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) 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

[[Page 430]]

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 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 Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC. 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]

[[Page 431]]



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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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]



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 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]

[[Page 432]]

    (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 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,''

[[Page 433]]

Journal of the Association of Official Analytical Chemists,'' vol. 59 p. 
368 (1976). Copies are available from the Association of Official 
Analytical Chemists, 1111 N. 19th St., Suite 210, Arlington, VA 22209, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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]



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.
    (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]

[[Page 434]]



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 
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

[[Page 435]]

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 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

[[Page 436]]

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 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

[[Page 437]]

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 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

[[Page 438]]

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 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

[[Page 439]]

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 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, dimethylpolysiloxane 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.

[[Page 440]]

    (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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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 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

[[Page 441]]

                                                                        
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]



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 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''.

[[Page 442]]

    (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.
150.141  Artificially sweetened fruit jelly.
150.160  Fruit preserves and jams.
150.161  Artificially sweetened fruit preserves and jams.

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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:
    (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.

[[Page 443]]

    (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 Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 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.

[[Page 444]]

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]



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 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

[[Page 445]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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]



Sec. 150.141   Artificially sweetened fruit jelly.

    (a) The artificially sweetened fruit jellies for which definitions 
and standards of identity are prescribed by this section are the jellied 
foods made from a fruit juice ingredient as specified in paragraph (b) 
of this section and an artificial sweetening ingredient as specified in 
paragraph (c) of this section, with a jelling ingredient as specified in 
paragraph (d) of this section. Water may be added. The quantity of the 
fruit juice ingredient, calculated as set out in Sec. 150.140(b), 
amounts to not less than 55 percent by weight of the finished food. The 
article is sealed in containers and so processed by heat, either before 
or after sealing, as to prevent spoilage. Such food may also contain one 
or more of the following optional ingredients:
    (1) Spice, spice oil, spice extract.
    (2) A vinegar, lemon juice, lime juice, citric acid, lactic acid, 
malic acid, tartaric acid, fumaric acid, or any combination of two or 
more of these, in a quantity which reasonably compensates for 
deficiency, if any, of the

[[Page 446]]

natural acidity of the fruit juice ingredient.
    (3) Sodium citrate, sodium acetate, sodium tartrate, monosodium 
phosphate, disodium phosphate, trisodium phosphate, sodium potassium 
tartrate, potassium citrate, potassium acid tartrate, or any combination 
thereof, in an amount not exceeding 2 ounces avoirdupois per 100 pounds 
of the finished food.
    (4) Sodium hexametaphosphate in an amount not exceeding 8 ounces 
avoirdupois per 100 pounds of the finished food.
    (5) Purified calcium chloride, calcium citrate, calcium gluconate, 
calcium lactate, calcium sulfate, monocalcium phosphate, potassium 
chloride, or any combination of two or more of these salts, in a 
quantity reasonably necessary to enable the jelling ingredients to 
produce a jellied finished product.
    (6) Ascorbic acid, sorbic acid, sodium sorbate, potassium sorbate, 
sodium propionate, calcium propionate, sodium benzoate, benzoic acid, 
methylparaben (methyl-p-hydroxybenzoate), propylparaben (propyl-p-
hydroxybenzoate), or any combination of two or more of these, in a 
quantity reasonably necessary as a preservative, but not to exceed 0.1 
percent by weight of the finished food.
    (b) The fruit juice ingredient referred to in paragraph (a) of this 
section is any one, or any combination of two, three, four, or five of 
the fruit juice ingredients complying with the requirements of 
Sec. 150.140(c). Except as paragraph (d) of this section permits the use 
of pectin, carrageenan, or salts of carrageenan standardized with 
nutritive sweetener, no nutritive sweetening ingredient is added, either 
directly or indirectly, to the fruit juice ingredient used to make 
artificially sweetened fruit jelly.
    (c) The artificial sweetening ingredients referred to in paragraph 
(a) of this section are saccharin, sodium saccharin, calcium saccharin, 
or any combination of two or more of these.
    (d) The jelling ingredients referred to in paragraph (a) of this 
section are pectin, agar-agar, carob bean gum (also called locust bean 
gum), guar gum, gum karaya, gum tragacanth, algin (sodium alginate), 
sodium carboxymethylcellulose (cellulose gum), methylcellulose (meeting 
U.S.P. requirements and with methoxy content not less than 27.5 percent 
and not more than 31.5 percent on a dry-weight basis), carrageenan or 
salts of carrageenan complying with the requirements of Sec. 172.620 or 
Sec. 172.626 of this chapter, or any combination of two or more of 
these. Pectin may be standardized with a nutritive sweetening 
ingredient, but such sweetening ingredient shall not amount to more than 
44 percent by weight of the standardized pectin and the quantity of such 
standardized pectin used shall not exceed 3 percent by weight of the 
finished food. Carrageenan or salts of carrageenan may be standardized 
with a nutritive sweetening ingredient, but such sweetening ingredient 
shall not amount to more than 25 percent by weight of the standardized 
carrageenan or salts of carrageenan and the quantity of such 
standardized carrageenan or salts of carrageenan used shall not exceed 2 
percent by weight of the finished food.
    (e) The name of each artificially sweetened fruit jelly for which a 
definition and standard of identity is prescribed by this section 
consists of the words ``artificially sweetened'', immediately followed 
by the name prescribed by Sec. 150.140(e)(1) for the fruit jelly which 
corresponds in its fruit ingredient to the artificially sweetened 
article. The words ``artificially sweetened'' shall be prominently and 
conspicuously displayed in letters not smaller than the largest letter 
used in any other word in the name of the food.
    (f)(1) The jelling ingredient used shall be named on the label by a 
statement ``------------ added'' or ``with added ------------'', the 
blank being filled in with the common name of the jelling ingredient 
used; for example, ``pectin and methylcellulose added''.
    (2) When one of the optional ingredients specified in paragraph 
(a)(1) of this section is used, the label shall bear the statement ``--
---------- added'' or ``with added --------'', the blank being filled in 
with the words ``spice'', ``spice oil'', or ``spice extract'' as 
appropriate, but in lieu of the word ``spice'' in such statement the 
common name of the spice may be used.

[[Page 447]]

    (3) When the optional ingredient specified in paragraph (a)(4) of 
this section is used, the label shall bear the words ``sodium 
hexametaphosphate added'' or ``with added sodium hexametaphosphate''.
    (4) When any optional ingredient listed in paragraph (a)(6) of this 
section is used, the label shall bear the statement ``------------ added 
as a preservative'', the blank being filled in with the common name of 
the preservative ingredient used as designated in paragraph (a)(6) of 
this section.
    (g) Wherever the name of the food appears on the label of the 
artificially sweetened fruit jelly so conspicuously as to be easily seen 
under customary conditions of purchase, the words and statements 
specified in this section, showing the optional ingredients used, shall 
immediately and conspicuously precede or follow such name, without 
intervening written, printed, or graphic matter, except that the 
varietal name of the fruit source of the fruit juice ingredient used in 
preparing such jelly 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 14445, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]



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, 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.

[[Page 448]]

    (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 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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (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:

[[Page 449]]

    (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]



Sec. 150.161   Artificially sweetened fruit preserves and jams.

    (a) The artificially sweetened fruit preserves or artificially 
sweetened fruit jams for which definitions and standards of identity are 
prescribed by this section are the viscous or semisolid foods made from 
a fruit ingredient as specified in paragraph (b) of this section and an 
artificial sweetening ingredient as specified in paragraph (c) of this 
section, and with or without water and a jelling ingredient as specified 
in paragraph (d) of this section. The quantity of the fruit ingredient 
amounts to not less than 55 percent by weight of the finished food. The 
article is sealed in containers and so processed by heat, either before 
or after sealing, as to prevent spoilage. Such food may also contain one 
or more of the following optional ingredients:
    (1) Spice, spice oil, spice extract.
    (2) A vinegar, lemon juice, lime juice, citric acid, lactic acid, 
malic acid, tartaric acid, fumaric acid, or any combination of two or 
more of these, in a quantity which reasonably compensates for 
deficiency, if any, of the natural acidity of the fruit ingredient.
    (3) Sodium citrate, sodium acetate, sodium tartrate, monosodium 
phosphate, disodium phosphate, trisodium phosphate, sodium potassium 
tartrate, potassium citrate, potassium acid tartrate, or any combination 
thereof, in an amount not exceeding 2 ounces avoirdupois per 100 pounds 
of the finished food.
    (4) Sodium hexametaphosphate in an amount not exceeding 8 ounces 
avoirdupois per 100 pounds of the finished food.
    (5) Purified calcium chloride, calcium citrate, calcium gluconate, 
calcium lactate, calcium sulfate, monocalcium phosphate, potassium 
chloride, or any combination of two or more of these salts, in a 
quantity reasonably necessary to enable the jelling ingredients to 
produce a jelled finished product.
    (6) Ascorbic acid, sorbic acid, sodium sorbate, potassium sorbate, 
sodium propionate, calcium propionate, sodium benzoate, benzoic acid, 
methylparaben (methyl-p-hydroxybenzoate), propylparaben (propyl-p-
hydroxybenzoate), or any combination of two or more of these, in a 
quantity reasonably necessary as a preservative but not to exceed 0.1 
percent by weight of the finished food.
    (b) The fruit ingredient referred to in paragraph (a) of this 
section is any one, or any combination of two, three, four, or five of 
the fruit ingredients complying with the requirements of Sec. 150.160 
(b) and (c). Except as paragraph (d) of this section permits the use of 
pectin, carrageenan, or salts of carrageenan standardized with nutritive 
sweetener, no nutritive sweetening ingredient is added, either directly 
or indirectly, to the fruit ingredient used to make artificially 
sweetened fruit preserves or artificially sweetened fruit jam.
    (c) The artificial sweetening ingredients referred to in paragraph 
(a) of this section are saccharin, sodium saccharin, calcium saccharin, 
or any combination of two or more of these.
    (d) The jelling ingredients referred to in paragraph (a) of this 
section are pectin, agar-agar, carob bean gum (also called locust bean 
gum), guar gum, gum karaya, gum tragacanth, algin (sodium alginate), 
sodium carboxymethylcellulose (cellulose gum), methylcellulose (meeting 
U.S.P. requirements and with methoxy content not less than 27.5 percent 
and not more than 31.5 percent on a dry-weight basis), carrageenan or 
salts of carrageenan complying with the requirements of Sec. 172.620 or 
Sec. 172.626 of this chapter, or any combination of two or more of 
these. Pectin may be standardized with a nutritive sweetening 
ingredient, but such sweetening ingredient shall not amount to more

[[Page 450]]

than 44 percent by weight of the standardized pectin and the quantity of 
such standardized pectin used shall not exceed 3 percent by weight of 
the finished food. Carrageenan or salts of carrageenan may be 
standardized with a nutritive sweetening ingredient, but such sweetening 
ingredient shall not amount to more than 25 percent by weight of the 
standardized carrageenan or salts of carrageenan and the quantity of 
such standardized carrageenan or salts of carrageenan used shall not 
exceed 2 percent by weight of the finished food.
    (e) The name of each artificially sweetened fruit preserve or 
artificially sweetened fruit jam for which a definition and standard of 
identity is prescribed by this section consists of the words 
``artificially sweetened'' immediately followed by the name prescribed 
by Sec. 150.160(e)(1) for the fruit preserves or jams which correspond 
in fruit ingredient to the artificially sweetened article. The words 
``artificially sweetened'' shall be prominently and conspicuously 
displayed in letters not smaller than the largest letter used in any 
other word in the name of the food.
    (f)(1) The jelling ingredient used shall be named on the label by a 
statement ``------------ added'' or ``with added ------------'', the 
blank being filled in with the common name of the jelling ingredient 
used.
    (2) When one of the optional ingredients specified in paragraph 
(a)(1) of this section is used, the label shall bear the statement, ``--
---------- added'' or ``with added ------------'', the blank being 
filled in with the words ``spice'', ``spice oil'', or ``spice extract'' 
as appropriate, but in lieu of the word ``spice'' in such statement the 
common name of the spice may be used.
    (3) When the optional ingredient specified in paragraph (a)(4) of 
this section is used, the label shall bear the words ``sodium 
hexametaphosphate added'' or ``with added sodium hexametaphosphate''.
    (4) When any optional ingredient listed in paragraph (a)(6) of this 
section is used, the label shall bear the statement ``------------ added 
as a preservative'', the blank being filled in with the common name by 
which the preservative ingredient used is designated in paragraph (a)(6) 
of this section.
    (g) Wherever the name of the food appears on the label of the 
artificially sweetened fruit preserve or artificially sweetened fruit 
jam so conspicuously as to be easily seen under customary conditions of 
purchase, the words and statements specified in this section, showing 
the optional ingredients used, shall immediately and conspicuously 
precede or follow such name without intervening written, printed, or 
graphic matter, except that the varietal name of the fruit used in 
preparing such preserve or jam 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 14445, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]



PART 152--FRUIT PIES--Table of Contents




    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 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

[[Page 451]]

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: ``too few cherries'', or ``blemished 
cherries''. Such alternative statement shall immediately and 
conspicuously precede or follow, without intervening

[[Page 452]]

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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (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.

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

[[Page 453]]

                                                                        
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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or are 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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]



   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

[[Page 454]]

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'', 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.

[[Page 455]]

    (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 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),''

[[Page 456]]

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 Association of Official 
Analytical Chemists, Inc., 2200 Wilson Blvd., suite 400, Arlington, VA 
22201-3301, or may be examined at the Office of the Federal Register, 
800 North Capitol St. NW., Seventh Floor, suite 700, Washington, DC. 
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 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\

[[Page 457]]

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 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.

[[Page 458]]

    (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]



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.
    (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.

[[Page 459]]

    (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 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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC. 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

[[Page 460]]

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 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

[[Page 461]]

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]



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

[[Page 462]]

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.''
    (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.

[[Page 463]]

    (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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (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 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]


[[Page 464]]


    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 
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.

[[Page 465]]

    (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:
    (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 cm2 (2.3 square inches) which is 
equivalent to 6.8 cm2 (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 cm2 (0.54 square inch) which is 
equivalent to 1.6 cm2 (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:

[[Page 466]]

    (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 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

[[Page 467]]

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 4.2  0.2. 
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 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

[[Page 468]]

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 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

[[Page 469]]

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 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 20 1 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

[[Page 470]]

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 20  
1 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, 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.                        

[[Page 471]]

                                                                                                                
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.                             
----------------------------------------------------------------------------------------------------------------

    (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

[[Page 472]]

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 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.

[[Page 473]]

    (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.
    (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

[[Page 474]]

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: Secs. 201, 401, 403, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (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 plus-minus200 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 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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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

[[Page 475]]

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)         -------------------------
                                                                        
------------------------------------------------------------------------
                                                 Net weight equal to or 
                                                 less than 1 kg (2.2 lb)
                                                                        
                                               -------------------------
                                                     n            c     
                                                                        
                                               -------------------------
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)
                                                                        
                                                                        
                                               -------------------------
                                                     n            c     
                                                                        
                                               -------------------------
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)     
                                                                        
                                               -------------------------
                                                     n            c     
                                                                        
                                               -------------------------
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]

[[Page 476]]



   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-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''.

[[Page 477]]

    (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: Secs. 201, 401, 403, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (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.                                                 

    (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

[[Page 478]]

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.
    (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;

[[Page 479]]

    (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 100plus-minus2 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.plus-minus10 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 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

[[Page 480]]

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 substand- ard 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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 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

[[Page 481]]

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 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

[[Page 482]]

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 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

[[Page 483]]

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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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]



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]



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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC. 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

[[Page 484]]

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]



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''.
    (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 microorga-nisms.
    (b) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the

[[Page 485]]

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.
161.131  Extra large oysters.
161.132  Large oysters.
161.133  Medium oysters.
161.134  Small oysters.
161.135  Very small oysters.
161.136  Olympia oysters.
161.137  Large Pacific oysters.
161.138  Medium Pacific oysters.
161.139  Small Pacific oysters.
161.140  Extra small Pacific 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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

    Source: 42 FR 14464, Mar. 15, 1977, unless otherwise noted.



                      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 
Secs. 161.131 to 161.140, inclusive.
    (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

[[Page 486]]

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. 161.131   Extra large oysters.

    Extra large oysters, oysters counts (or plants), extra large raw 
oysters, raw oysters counts (or plants), extra large shucked oysters, 
shucked oysters counts (or plants), are of the species Ostrea virginica 
and conform to the definition and standard of identity prescribed for 
oysters by Sec. 161.130 and are of such size that 1 gallon contains not 
more than 160 oysters and a quart of the smallest oysters selected 
therefrom contains not more than 44 oysters.



Sec. 161.132   Large oysters.

    Large oysters, oysters extra selects, large raw oysters, raw oysters 
extra selects, large shucked oysters, shucked oysters extra selects, are 
of the species Ostrea virginica and conform to the definition and 
standard of identity prescribed for oysters by Sec. 161.130 and are of 
such size that 1 gallon contains more than 160 oysters but not more than 
210 oysters; a quart of the smallest oysters selected therefrom contains 
not more than 58 oysters, and a quart of the largest oysters selected 
therefrom contains more than 36 oysters.



Sec. 161.133   Medium oysters.

    Medium oysters, oysters selected, medium raw oysters, raw oysters 
selects, medium shucked oysters, shucked oysters selects, are of the 
species Ostrea virginica and conform to the definition and standard of 
identity prescribed for oysters by Sec. 161.130 and are of such size 
that 1 gallon contains more than 210 oysters, but not more than 300 
oysters; a quart of the smallest oysters selected therefrom contains not 
more than 83 oysters, and a quart of the largest oysters selected 
therefrom contains more than 46 oysters.



Sec. 161.134   Small oysters.

    Small oysters, oysters standards, small raw oysters, raw oysters 
standards, small shucked oysters, shucked oysters standards, are of the 
species Ostrea virginica and conform to the definition and standards of 
identity prescribed for oysters by Sec. 161.130 and are of such size 
that 1 gallon contains more than 300 oysters but not more than 500 
oysters; a quart of the smallest oysters selected therefrom contains not 
more than 138 oysters and a quart of the largest oysters selected 
therefrom contains more than 68 oysters.



Sec. 161.135   Very small oysters.

    Very small oysters, very small raw oysters, very small shucked 
oysters are of the species Ostrea virginica and conform to the 
definition and standard of identity prescribed for oysters by 
Sec. 161.130 and are of such size that 1 gallon contains more than 500 
oysters, and a quart of the largest oysters selected therefrom contains 
more than 112 oysters.



Sec. 161.136   Olympia oysters.

    Olympia oysters, raw Olympia oysters, shucked Olympia oysters, are 
of

[[Page 487]]

the species Ostrea lurida and conform to the definition and standard of 
identity prescribed for oysters in Sec. 161.130.



Sec. 161.137   Large Pacific oysters.

    Large Pacific oysters, large raw Pacific oysters, large shucked 
Pacific oysters, are of the species Ostrea gigas and conform to the 
definitions and standards of identity prescribed for oysters by 
Sec. 161.130 and are of such size that 1 gallon contains not more than 
64 oysters, and the largest oyster in the container is not more than 
twice the weight of the smallest oyster therein.



Sec. 161.138   Medium Pacific oysters.

    Medium Pacific oysters, medium raw Pacific oysters, medium shucked 
Pacific oysters, are of the species Ostrea gigas and conform to the 
definition and standard of identity prescribed for oysters by 
Sec. 161.130 and are of such size that 1 gallon contains more than 64 
oysters and not more than 96 oysters, and the largest oyster in the 
container is not more than twice the weight of the smallest oyster 
therein.



Sec. 161.139   Small Pacific oysters.

    Small Pacific oysters, small raw Pacific oysters, small shucked 
Pacific oysters, are of the species Ostrea gigas and conform to the 
definition and standard of identity prescribed for oysters by 
Sec. 161.130 and are of such size that 1 gallon contains more than 96 
oysters and not more than 144 oysters, and the largest oyster in the 
container is not more than twice the weight of the smallest oyster 
therein.



Sec. 161.140   Extra small Pacific oysters.

    Extra small Pacific oysters, extra small raw Pacific oysters, extra 
small shucked Pacific oysters, are of the species Ostrea gigas and 
conform to the definition and standard of identity prescribed for 
oysters by Sec. 161.130 and are of such size that 1 gallon contains more 
than 144 oysters, and the largest oyster in the container is not more 
than twice the weight of the smallest oyster therein.



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 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

[[Page 488]]

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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC. 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]



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.     
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

[[Page 489]]

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) (a) 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''.
    (b) Whenever the form of pack is that described in paragraph 
(a)(3)(v) of this section and words describing the form of pack are 
declared on the label, the label shall also bear the statements required 
by Sec. 105.69 of this chapter.
    (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 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.

[[Page 490]]

    (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]



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.
    (vi) Flavorings.
    (vii) Sodium bisulfite.
    (viii) Calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate), 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.

[[Page 491]]

    (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  
                                                                shrimpa 
------------------------------------------------------------------------
Extra large or jumbo........................................           5
Large.......................................................           5
Medium......................................................           5
Small.......................................................          10
Tiny........................................................          15
------------------------------------------------------------------------
aGrams 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 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

[[Page 492]]

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 Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC. 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)

[[Page 493]]

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]

    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 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

[[Page 494]]

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 Association 
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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 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 debreaded sample)/(Weight of sample) 
x 100+2
    (h) The method for determining percentage of shrimp material for

[[Page 495]]

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 
plus-minus2 deg.F.
    (ix) Copper sulfate crystals (CuSo4. 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 debreaded 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]



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 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

[[Page 496]]

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.
    (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

[[Page 497]]

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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC. 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 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

[[Page 498]]

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 and 560 m. The 
filter does not pass appreciable visible radiation of wavelengths below 
540 m or above 570 m. 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 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, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (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 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;

[[Page 499]]

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

[[Page 506]]

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 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

[[Page 500]]

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 plus-minus5 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 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

[[Page 501]]

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 
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.

[[Page 502]]

    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]



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.
163.130  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: Secs. 201, 301, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 341, 343, 348, 371, 
379e).

    Source: 58 FR 29529, May 21, 1993, unless otherwise noted.


[[Page 503]]





                      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 Association of Official 
Analytical Chemists International, 2200 Wilson Blvd., suite 400, 
Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700 Washington, DC.
    (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.



    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 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

[[Page 504]]

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 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.

[[Page 505]]



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.
    (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

[[Page 506]]

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).
    (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

[[Page 507]]

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. 163.130  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 508]]

    (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 509]]

    (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 510]]

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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 511]]

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 512]]



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 513]]

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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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]



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: Secs. 201, 401, 403, 403A, 409, 410, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 343A, 
348, 349, 371, 379e).

    Source: 60 FR 57124, Nov. 13, 1995, unless otherwise noted.

    Effective Date Note: At 60 FR 57124, Nov. 13, 1995, part 165 was 
added, effective May 13, 1996.



                      Subpart A--General Provisions



Sec. 165.3  Definitions.

    (a) A lot is:

[[Page 514]]

    (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 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC), may be ``purified water'' 
or ``demineralized water.'' Alternatively, the water may be called 
``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

[[Page 515]]

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'' <71> in 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 Center for Food 
Safety and Applied Nutrition's Library, 200 C St. SW., Washington, DC, 
or at the Office of the Federal Register, 800 North Capitol St. NW., 
suite 700, Washington, DC), 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 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.

[[Page 516]]

    (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 trihalomethane (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.
    (2) Microbiological quality. Bottled water shall, when a sample 
consisting of analytical units of equal volume is examined by the 
methods 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, 1015 15th St., NW., Washington, DC 
20005, or a copy may be examined at the Office of the Federal Register, 
800 North Capitol St., NW., suite 700, Washington, DC, or at the Center 
for Food Safety and Applied Nutrition's Library, 200 C St., SW., 
Washington, DC), meet the following standards of microbiological 
quality:
    (i) Multiple-tube fermentation 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
    (ii) Membrane filter 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.
    (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), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (b)(2) of this section), meet the 
following standards of physical quality:
    (i) The turbidity shall not exceed 5 units.
    (ii) The color shall not exceed 15 units.\1\
    (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     
------------------------------------------------------------------------
Arsenic...............................................            0.05  
Chloride\1\...........................................          250.0   
Iron\1\...............................................            0.3   
Manganese\1\..........................................            0.05  
Phenols...............................................            0.001 
Sulfate\1\............................................          250.0   
Total dissolved solids\1\.............................          500.0   
Zinc \1\..............................................            5.0   
Organics:                                                               
  Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy 1, 4, 4a,                  
   5, 6, 7, 8, 8a-octa-hydro-1,4-endo, endo-5,8-                        
   dimethane naphthalene).............................            0.0002
    Total Trihalomethanes.............................            0.10  
------------------------------------------------------------------------
\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

[[Page 517]]

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, 1015 Fifteenth St., NW., Washington DC 20005, and examined 
at the Office of the Federal Register, 800 North Capitol St., NW., suite 
700, Washington DC, or the Center for Food Safety and Applied 
Nutrition's Library, 200 C St. NW., Washington DC. 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 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 milligrams
                Contaminant                 per liter  (or as specified)
------------------------------------------------------------------------
Antimony \1\..............................  .006.                       
Barium....................................  2.                          
Beryllium \1\.............................  0.004.                      
Cadmium...................................  0.005.                      
Chromium..................................  0.1.                        
Copper....................................  1.0.                        
Cyanide \1\...............................  0.2.                        
Lead......................................  0.005.                      
Mercury...................................  0.002.                      
Nickel \1\................................  0.1.                        
Nitrate...................................  10 (as nitrogen).           
Nitrite...................................  1 (as nitrogen).            
    Total Nitrate and Nitrite.............  10 (as nitrogen).           
Selenium..................................  0.05.                       

[[Page 518]]

                                                                        
Thallium \1\..............................  0.002.                      
------------------------------------------------------------------------
\1\ Stayed until further notice. See Sec.  165.110(b)(4)(iii)           
  (G)(3)(iv).                                                           

    (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    
Dinoseb (88-85-7).....................................           0.007  
Diquat (85-00-7)\1\...................................           0.02   
Endothall (145-73-3) \1\..............................           0.1    
Endrin (72-20-8)......................................           0.002  
Ethylene dibromide (106-93-4).........................           0.00005
Glyphosate (1071-53-6) \1\............................           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) \1\.................    3 x 10-8      
Toxaphene (8001-35-2).................................           0.003  
2,4,5-TP (Silvex) (93-72-1)...........................           0.05   
------------------------------------------------------------------------
\1\ Stayed until further notice. See Sec.  165.110(b)(4)(iii)           
  (G)(3)(iv).                                                           

    (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:

------------------------------------------------------------------------
                                                        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)(13) 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 Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
200 C Street SW., Washington, DC 20204, or at the Office of the Federal 
Register, 800 North Capitol Street NW., suite 700, Washington, DC.
    (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

[[Page 519]]

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, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C Street SW., Washington, DC 20204, or at the Office 
of the Federal Register, 800 North Capitol Street NW., suite 700, 
Washington, DC.
    (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 Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 200 C Street SW., Washington, DC 20204, or 
at the Office of the Federal Register, 800 North Capitol Street NW., 
suite 700, Washington, DC.
    (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,

[[Page 520]]

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.
    (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,

[[Page 521]]

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 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 Center for Food Safety and Applied Nutrition's Library, 
200 C Street SW., Washington, DC 20204, or at the Office of the Federal 
Register, 800 North Capitol Street NW., suite 700, Washington, DC.
    (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.

[[Page 522]]

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 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, 5825 Port Royal Rd., 
Springfield, VA 22161, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 200 C 
Street SW., Washington, DC 20204, or at the Office of the Federal 
Register, 800 North Capitol Street NW., suite 700, Washington, DC.
    (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--``Spectrophotometric, 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:

[[Page 523]]

    (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.
    (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)(20) 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, which are incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies of these publications are available from NTIS, U.S. Department of 
Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or may be examined 
at the Center for Food Safety and Applied Nutrition's Library, Food and 
Drug Administration, 200 C St. SW., Washington, DC, or at the Office of 
the Federal Register, 800 North Capitol St. NW., suite 700, Washington, 
DC.
    (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 
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- 
Chloropropane (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

[[Page 524]]

    (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-ethylhexyl) 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 
Perchlorination 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, hexachlorocyclopentadiene, 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 
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

[[Page 525]]

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 Center 
for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (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, 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.

[[Page 526]]

    (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
    (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.

[Note: the allowable levels in Sec. 165.110 for the chemicals antimony, 
beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate, and 
dioxin are stayed until further notice.]
    (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) 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)

[[Page 527]]

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.
    (d) Adulteration. Bottled water containing a substance at a level 
considered injurious to health under section 402(a)(1) 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.

[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]

    Effective Date Note: At 61 FR 13264, Mar. 26, 1996, Sec. 165.110 was 
amended in the table in paragraph (b)(4)(i)(A) by removing the entries 
for ``Sulfate'' and ``Endrin * * *'', by alphabetically adding new 
entries in the tables in paragraphs (b)(4)(iii)(A) ``Antimony, 
Beryllium, Cyanide, Nickel, Thallium'', (b)(4)(iii)(B) ``Dichloromethane 
(75-09-2), 1,2,4-Trichlorobenzene (120-82-1), 1,1,2-Trichloroethane (79-
00-5)'', (b)(4)(iii)(C) ``Benzo(a)pyrene (50-32-8), Dalapon (75-99-0), 
Di(2-ethylhexyl)adipate (103-23-1), Dinoseb (88-85-7), Diquat (85-00-7), 
Endothall (145-73-3), Endrin (72-20-8), Glyphosate (1071-53-6), 
Hexachlorobenzene (118-74-4), Hexachlorocyclopentadiene (77-47-4), 
Oxamyl (23135-22-0), Picloram (1918-02-1), Simazine (122-34-9), 
2,3,7,8,-TCDD (Dioxin) (1746-01-6)'', and (b)(4)(iii)(D) ``Sulfate'', 
and by revising paragraphs (b)(4)(iii)(E), (b)(4)(iii)(F), and 
(b)(4)(iii)(G), effective September 23, 1996. For the convenience of the 
user, the superseded text is set forth as follows:
Sec. 165.110  Bottled water.

                                * * * * *

    (b) * * *
    (4) * * *
    (iii) * * *
    (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)(13) 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 (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, U.S. 
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 200 C St., SW., Washington, DC, 
or at the Office of the Federal Register, 800 North Capitol St. NW., 
suite 700, Washington, DC.
    (1) [Reserved]
    (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)(A) 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. 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, 5825 Port Royal Rd., 
Springfield, VA 22161, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 200 C 
St., SW., Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
    (3) [Reserved]
    (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. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development,(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)(2)(iii) 
of this section.

[[Page 528]]

    (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. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, (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)(iii) 
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, in ``Methods 
for 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, or
    (ii) Method 220.1--Atomic Absorption; direct aspiration, in 
``Methods for 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.
    (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. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, (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, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples,'' 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)(7)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 
1.2, April 1991. The revision is contained in the manual entitled 
``Methods for the Determination of Metals in Environmental Samples,'' 
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)(2)(iii) of this 
section.
    (7) [Reserved]
    (8) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 239.2--Atomic Absorption; furnace technique, in ``Methods 
for 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)(2)(iii) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4, 
April 1991. The revision is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples,'' 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)(7)(iii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 1.2, 
April 1991. The revision is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples,'' 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)(2)(iii) 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 this incorporation by reference is given in 
paragraph (b)(4)(iii)(E) of this section.
    (10) [Reserved]
    (11) Nitrate and/or nitrite shall be measured using the following 
methods:
    (i) Method 353.3--``Spectrophotometric cadmium reduction,'' which is 
incorporated by

[[Page 529]]

reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (ii) Method 353.2--``Colorimetric, automated, cadmium reduction,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51.
    (iii) Method 300.0--``The Determination of Inorganic Anions in Water 
by Ion chromatography,'' 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, Port Royal Rd., Springfield, VA 22161, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, Food and 
Drug Administration, 200 C St. SW., Washington, DC.
    (iv) Method 353.1--``Colorimetric, automated, hydrazine reduction,'' 
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.
    (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) [Reserved]
    (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)(20) of this section and described, unless otherwise 
noted, in ``Methods for the Determination of Organic Compounds in 
Drinking Water,'' Office of Research and Development, Environmental 
Monitoring Systems Laboratory EPA/600/4-88/039, December 1988, 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 Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (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 
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-
Chloropropane (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 Micro-Extraction and 
Gas Chromatography,'' Rev. 2.0, 1989 (applicable to alachlor, atrazine, 
chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, 
toxaphene and as a screen for polychlorinated biphenyl's (PCB's)), which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (8) [Reserved]
    (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 and 
atrazine), 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, 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 
Perchlorination

[[Page 530]]

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, May 
1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol), 
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, and pentachlorophenol), 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), 
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)(F) of this section.
    (15) [Reserved]
    (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) and (b)(4)(iii)(G)(2) 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.
    (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) 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. The revision is contained in 
``Methods for the Determination of Metals in Environmental Samples,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of the incorporation by reference is 
given in paragraph (b)(4)(iii)(E)(2)(iii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in ``Methods for the Determination 
of Metals in Environmental Samples,'' 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)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev. 
1.2, April 1991. The revision is contained in ``Methods for the 
Determination of Metals in Environmental Samples,'' 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)(7)(iii) of this section.
    (2) Silver shall be measured using the following methods:
    (i) Method 272.1--``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 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 Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in 
``Methods for the Determination of Metals in Environmental Samples,'' 
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)(iii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in ``Methods for the Determination 
of Metals in Environmental Samples,'' 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)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev. 
1.2, April 1991, in ``Methods for

[[Page 531]]

the Determination of Metals in Environmental Samples,'' 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)(iii) of this section.
    (3)-(4) [Reserved]
    (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.
    (ii) Analyses conducted to determine compliance with 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,'' 15th Ed. (1980), and ``Interim 
Radiochemical Methodology for Drinking Water,'' U.S. EPA, EMSL, EPA-600/
4-75-008 (Revised), March 1976, both of which are incorporated by 
reference. The availability of these incorporations by reference is 
given in paragraph (b)(2) of this section.

                                * * * * *



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: Secs. 201, 401, 403, 407, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (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.

[[Page 532]]

    (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, 
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 Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC. 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

[[Page 533]]

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 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]

[[Page 534]]



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.

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (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]



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.

[[Page 535]]

    (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 ``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 Association of Official Analytical Chemists, 2200 Wilson Blvd., 
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (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]



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 
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 
400, Arlington, VA 22201-3301, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.

[[Page 536]]

    (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 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]



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.

[[Page 537]]

    (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]



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 Secs. 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 
Secs. 168.130, 168.140, or 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 
Secs. 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''.

[[Page 538]]

    (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 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: Secs. 201, 401, 403, 409, 701, 721 of the Federal Food, 
Drug, and Cosmetic Act (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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC. 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

[[Page 539]]

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]



  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

[[Page 540]]

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 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

[[Page 541]]

added in accordance with Sec. 172.810 of this chapter.
    (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]

[[Page 542]]



Sec. 169.177   Vanilla flavoring.

    (a) Vanilla flavoring 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 
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

[[Page 543]]

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 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 545]]



                              FINDING AIDS




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

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 546]]


[[Page 547]]

........................................................................

[[Page 553]]



            Material Approved for Incorporation by Reference

                      (Revised as of April 1, 1996)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


21 CFR CHAPTER I (PARTS 100 TO 169)

FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES


American Public Health Association

  1015 15th St., NW, Washington, DC 20005
Standard Methods for the Examination of Water and 
  Wastewater, 15th Ed. (1980), ``Methods For 
  Organochlorine Pesticides Industrial Effluents''         165.110(b)(4)
Standard Methods for the Examination of Water and 
  Wastewater, 15th Ed. (1980) ``Methods for 
  Chlorinated Phenoxy Acid Herbicides in 
  Industrial Effluents''..........................         165.110(b)(4)


American Society for Testing and Materials

  1916 Race St. Philadelphia, PA 19103

  NOTE: The following ASTM standards are available from University 
  Microfilm International, 300 N. Zeeb Rd., Ann Arbor, MI 48106.
ASTM E 11-70 Table 1, Annual Book of ASTM 
  Standards, Part 30 (1972).......................            137.105(a)


AOAC International (Association of Official Analytical Chemists)

  481 N. Frederick Ave. Suite 500, Gaithersburg, MD 20877-2417
Official Methods of Analysis, 15th Ed. (1990).....     101.9(c)(7)(ii); 
                                                                (g)(2); 
                                                      155.120(b)(2)(i); 
                                                                163.5(b)
Official Methods of Analysis, 14th Ed., 1984, 
  including the 4th Supplement (1988).............            168.122(d)
Official Methods of Analysis, 14th Ed., 1984......   101.100(a); 130.9; 
                                                                 160.145

[[Page 548]]

Official Methods of Analysis, 13th Ed., 1980...... 101.9; 101.25(e)(3); 
                                                     102.23; 102.33(b); 
                                                       105.65(c)(4)(i); 
                                                       106.30(b)(3)(i), 
                                                          (ii); 114.90; 
                                                   131.110; 131.111(f); 
                                                   131.112(e); 131.115; 
                                                      131.120; 131.122; 
                                                      131.123; 131.125; 
                                                      131.127; 131.130; 
                                                      131.132; 131.135; 
                                                            131.136(f); 
                                                   131.138(e); 131.143; 
                                                            131.144(f); 
                                                   131.146(e); 131.147; 
                                                      131.149; 131.150; 
                                                      131.155; 131.157; 
                                                      131.160; 131.162; 
                                                   131.170(f); 131.180; 
                                                      131.185; 131.187; 
                                                            131.200(d); 
                                                            131.203(d); 
                                                     131.206(d); 133.5; 
                                                      135.110; 135.130; 
                                                      136.110; 136.160; 
                                                      137.105; 137.180; 
                                                      137.190; 137.200; 
                                                      137.211; 137.230; 
                                                      137.250; 137.270; 
                                                      137.300; 139.110; 
                                                      139.150; 145.110; 
                                                      145.135; 145.145; 
                                                      146.113; 146.114; 
                                                               146.120; 
                                                         146.132(a)(1); 
                                                      146.185; 150.110; 
                                                      150.140; 150.160; 
                                                        155.3; 155.130; 
                                                     155.170(b)(1)(vi); 
                                                        156.3; 160.180; 
                                                      161.145; 161.173; 
                                                      161.175; 161.190; 
                                                      163.111; 163.112; 
                                                      164.150; 166.110; 
                                                      168.111; 168.120; 
                                                          168.122; 169.3
Official Methods of Analysis, 12th Ed., 1975......     163.110; 163.5(a)

  NOTE: The following materials are available through the Food and Drug 
  Administration at the addresses indicated.

[[Page 549]]

Division of Food Chemistry and Technology, Center for Food Safety and 
Applied Nutrition (HFF-210), Food and Drug Administration

  200 C St. SW., Washington, DC 20204
Analytical Methodology for Polychlorinated 
  Biphenyls (June 1979)...........................                109.30
Comparative Anatomy and Systematics of the Tunas, 
  ``Gennus Thunnus'' Fishery Bulletin Vol. 66, No. 
  1, (1967) pp. 65-130............................         161.190(a)(2)
Comparison of the Bluefin tuna, Gennus Thunnus--
  Bureau of Marine Fisheries, Fish Bulletin No. 
  77, 1950........................................         161.190(a)(2)
``Descriptive Study of Certain Tuna-Like Fishes,'' 
  by H.C. Godsil, State of California, Department 
  of Fish and Game, Fish Bulletin No. 97..........         161.190(a)(2)
Systematic Study of the Pacific Tunas, Fish 
  Bulletin No. 60, (1944).........................         161.190(a)(2)
Test procedures for Determination of Permeability 
  of Food Packaging, Inner Wraps (September 1976, 
  revised May 1983)...............................                109.30
Methods for Chemical Analysis of Water and Wastes, 
  Environmental Monitoring and Support Laboratory, 
  EPA-600/4-82-055, March 1983, U.S. Environmental 
  Protection Agency...............................      103.35(d)(1)(ii)
Interim Radiochemical Methodology for Drinking 
  Water, Environmental Monitoring and Support 
  Laboratory, EPA 600-4-75-008 (Revised), March 
  1976, EPA.......................................          103.35(e)(2)
Standard Methods for the Examination of Water and 
  Wastewater (15th Ed.) (1980)....................      103.35(b), (c), 
                                                        (d)(1)(ii), and 
                                                                  (e)(2)


Center for Food Safety and Applied Nutrition (HFF-260), Food and Drug 
Administration

  200 C St. SW., Washington, DC 20204
``Energy Value of Foods--Basis and Derivation'' 
  USDA Handbook No. 74, 1955......................           101.9(c)(3)
USDA Handbook 74, ``Energy Value of Foods ... 
  Basis and Derivation'' (Slightly Revised 1973), 
  A. L. Merrill and B. K. Watt....................   101.9(c)(1)(i)(A), 
                                                          (c)(1)(i)(B), 
                                                          (c)(1)(i)(C), 
                                                       (c)(1)(i)(E) and 
                                                                  (c)(6)
``Folic Acid Activity of Some Milk Foods for 
  Babies,'' Journal of Dairy Research 35:85-90 
  (1968)..........................................          102.23(c)(5)
Journal of the Optical Society of America, Vol. 
  33, p. 406 (1943)...............................    161.190(a)(7)(iii)
``Protein Quality Evaluation, Sections 5.4.1, 
  7.2.1 and 8.00, Report of the Joint FAO/WHO 
  Expert Consultation on Protein Quality 
  Evaluation,'' Rome, 1990........................    101.9(c)(7)(ii)(B)
``Total Dietary Fiber in Foods, Enzymatic 
  Gravimetric Method, First Action,'' Journal of 
  the Association of Official Analytical Chemists 
  68:399, 1985, as amended at 69:370, 1986........                 101.9


National Technical Information Service

  U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 
  22161
Methods for Chemical Analysis of Water and Wastes, 
  U.S. EPA Environmental Monitoring and Support 
  Laboratory, EPA/600/4-79-020, March 1983:.......
  Method 220.1--Atomic Absorption; direct 
  aspiration......................................          103.35(d)(3)
  Method 220.2--Atomic Absorption; furnace 
  technique.......................................          103.35(d)(3)
  Method 239.2--Atomic Absorption; furnace 
  technique.......................................          103.35(d)(3)

[[Page 550]]

Methods for the Determination of Metals in 
  Environmental Samples, Office of Research and 
  Development, (EPA/600/4-91/010, June 1991:......
  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............................          103.35(d)(3)
  Method 200.8--Determination of Trace Elements in 
  Water and Wastes by Industively Coupled Plasma--
  Mass Spectrometry, Rev. 4.4, April 1991.........          103.35(d)(3)
  Method 200.9--Determination of Trace Elements by 
  Stabilized Temperature Graphite Furnace Atomic 
  Absorption Spectrometry, Rev. 1.2, April 1991...          103.35(d)(3)
Methods for the Determination of Organic Compounds 
  in Drinking Water, Office of Research and 
  Development, Environmental Monitoring Systems 
  Laboratory, EPA/600/4-88/039, December 1988:....
  Method 502.1--Volatile Halogenated Organic 
  Compounds in Water by Purge and Trap Gas 
  Chromatography..................................          103.35(d)(3)
  Method 502.2--Volatile Organic Compounds in 
  Water by Purge and Trap Capillary Column Gas 
  Chromatography with Photoionization and 
  Electrolytic Conductivity Detectors in Series...          103.35(d)(3)
  Method 503.1--Volatile Aromatic and Unsaturated 
  Organic Compounds in Water by Purge and Trap Gas 
  Chromatography..................................          103.35(d)(3)
  Method 524.1--Measurement of Purgeable Organic 
  Compounds in Water by Packed Column Gas 
  Chromatography/Mass Spectrometry................          103.35(d)(3)
  Method 524.2--Measurement of Purgeable Organic 
  Compounds in Water by Capillary Column Gas 
  Chromatography/Mass Spectrometry................          103.35(d)(3)
The Determination of Inorganic Anions in Water by 
  Ion Chromatography--Method 300.0, EPA, EMSL 
  (EPA/600/4-84/017, March 1984................... 103.35(d)(3)(v)(E)(3)


Environmental Protection Agency, Environmental Monitoring and Support 
Laboratory (EMSL), Cincinnati, OH 45258, available from the National 
Technical Information Service, U.S. Department of Commerce

  Port Royal Rd., Springfield, VA 22161
Interim Radiochemical Methodology For Drinking 
  Water (600/4-75-008), Revised March 1976........     165.110(b)(5)(ii)
Methods for Chemical Analysis of Water and Wastes 
  (EPA-600/4-79-020), March 1983:.................
  Method 208.2--Atomic Absorption, furnace 
  technique....................................... 165.110(b)(4)(iii)(E) 
                                                                  (2)(i)
  Method 208.1--Atomic Absorption, direct 
  aspiration...................................... 165.110(b)(4)(iii)(E) 
                                                                 (2)(ii)
  Method 213.2--Atomic Absorption; furnace 
  technique....................................... 165.110(b)(4)(iii)(E) 
                                                                  (4)(i)
  Method 218.2--Atomic Absorption; furnace 
  technique....................................... 165.110(b)(4)9iii)(E) 
                                                                  (5)(i)
  Method 245.1--Manual cold vapor technique....... 165.110(b)(4)(iii)(E) 
                                                                  (9)(i)
  Method 245.2--Automated cold vapor technique.... 165.110(b)(4)(iii)(E) 
                                                                 (9)(ii)
  Method 353.3--Spectrophotometric, cadmium 
  reduction....................................... 165.110(b)(4)(iii)(E) 
                                                                 (11)(i)

[[Page 551]]

  Method 353.2--Colorimetric automated, cadmium 
  reduction.......................................     165.110(b)(4)(E) 
                                                                (11)(ii)
  Method 300.0--The Determination of Inorganic 
  Anions in Water by Ion Chromatography...........   165.110(b)(4)(iii) 
                                                               (11)(iii)
  Method 353.1--Colorimetric automated, hydrazine 
  reduction....................................... 165.110(b)(4)(iii)(E) 
                                                                (11)(iv)
  Method 270.2--Atomic Absorption, furnace 
  technique....................................... 165.110(b)(4)(iii)(E) 
                                                                 (12)(i)
  Method 270.3--Atomic Absorption, gaseous hydride 165.110(b)(4)(iii)(E) 
                                                                (12)(ii)
  Method 202.1--Atomic Absorption technique; 
  direct aspiration............................... 165.110(b)(4)(iii)(G) 
                                                                  (1)(i)
  Method 202.2--Atomic Absorption; furnace 
  technique....................................... 165.110(b)(4)(iii)(G) 
                                                                 (1)(ii)
  Method 272.1--Atomic Absorption; direct 
  aspiration...................................... 165.110(b)(4)(iii)(G) 
                                                                  (2)(i)
  Method 272.2--Atomic Absorption; furnace 
  technique....................................... 165.110(b)(4)(iii)(G) 
                                                                 (2)(ii)
  Method 220.2--Atomic Absorption; furnace 
  technique....................................... 165.110(b)(4)(iii)(E) 
                                                                  (6)(i)
  Method 220.1--Atomic Absorption; direct 
  aspiration...................................... 165.110(b)(4)(iii)(E) 
                                                                 (6)(ii)
  Method 239.2--Atomic Absorption; furnace 
  technique.......................................     165.110(b)(4)(E) 
                                                                  (8)(i)
Methods for the Determination of Organic Compounds 
  in Drinking Water (EPA/600/4-88/039), December 
  1988:...........................................
  Method 502.1--Volatile Halogenated Organic 
  Compounds in Water by Purge and Trap Gas 
  Chromatography, Rev. 2.0, 1989..................   165.110(b)(4)(iii) 
                                                                  (F)(1)
  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..................................   165.110(b)(4)(iii) 
                                                                  (F)(2)
  Method 503.1--Volatile Aromatic and Unsaturated 
  Organic Compounds in Water by Purge and Trap Gas 
  Chromatography, Rev. 2.0, 1989..................   165.110(b)(4)(iii) 
                                                                  (F)(3)
  Method 524.1--Measurement of Purgeable Organic 
  Compounds in Water by Packed Column Gas 
  Chromatography/Mass Spectrometry, Rev. 3.0, 1989   165.110(b)(4)(iii) 
                                                                  (F)(4)
  Method 524.2--Measurement of Purgeable Organic 
  Compounds in Water by Capillary Column Gas 
  Chromatography/Mass Spectrometry, Rev. 3.0, 1989   165.110(b)(4)(iii) 
                                                                  (F)(5)
  Method 504--1,2-Dibromoethane (EDB) and 1,2-
  Dibromo-3-Chloropropane (DBCP) in Water by 
  Microextraction and Gas Chromatography, Rev. 
  2.0, 1989.......................................   165.110(b)(4)(iii) 
                                                                  (F)(6)
  Method 505--Analysis of Organohalide Pesticides 
  and Commercial Polychlorinated Biphenyl (PCB) 
  Products in Water by Microextraction and Gas 
  Chromatography, Rev. 2.0, 1989..................   165.110(b)(4)(iii) 
                                                                  (F)(7)
  Method 507--Determination of Nitrogen- and 
  Phosphorus-Containing Pesticides in Water by Gas 
  Chromatography with a Nitrogen-Phosphorus 
  Detector, Rev. 2.0, 1989........................   165.110(b)(4)(iii) 
                                                                  (F)(9)

[[Page 552]]

  Method 508--Determination of Chlorinated 
  Pesticides in Water by Gas Chromatography with 
  an Electron Capture Detector, Rev. 3.0, 1989....   165.110(b)(4)(iii) 
                                                                 (F)(10)
  Method 508A--Screening for Polychlorinated 
  Biphenyls by Perchlorination and Gas 
  Chromatography, Rev. 1.0, 1989..................   165.110(b)(4)(iii) 
                                                                 (F)(11)
  Method 515.1--Determination of Chlorinated Acids 
  in Water by Gas Chromatography with an Electron 
  Capture Detector, Rev. 5.0, May 1991............   165.110(b)(4)(iii) 
                                                                 (F)(12)
  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................   165.110(b)(4)(iii) 
                                                                 (F)(13)
  Method 531.1--Measurement of N-
  Methylcarbamoyloximes and N-Methylycarbamates in 
  Water by Direct Aqueous Injection HPLC with Post 
  Column Derivatization, Rev. 3.0, 1989...........   165.110(b)(4)(iii) 
                                                                 (F)(14)


Environmental Protection Agency, Office of Research and Development, 
Washington, DC 20460, available from the National Technical Information 
Service, U.S. Department of Commerce

  Port Royal Rd., Springfield, VA 22161
Methods for Determination of Metals in 
  Environmental Samples (EPA/600/4-91/010), June 
  1991:...........................................
  Method 200.7--Determination of Metals and Trace 
  Elements in Water and Wastes by Inductively 
  Coupled Plasma-Atomic Emission Spectrometry..... 165.110(b)(4)(iii)(E) 
                                                              (2)(iii), 
                                                         (b)(4)(iii)(E) 
                                                   (4)(ii), (E)(5)(iii), 
                                                           (E)(6)(iii), 
                                                           (G)(1)(iii), 
                                                             (G)(2)(iii)
  Method 200.8--Determination of Trace Elements in 
  Water and Wastes by Inductively Coupled Plasma-
  Mass Spectrometry, Rev. 4.4, April 1991.........  165.110(b)(4)(E)(6) 
                                                         (iv), (8)(ii), 
                                                            (G)(1)(iv), 
                                                              (G)(2)(iv)
  Method 200.9--Determination of Trace Elements in 
  Stabilized Temperature Graphite Furnace Atomic 
  Absorption Spectrometry, Rev. 1.2, April 1991...     165.110(b)(4)(E) 
                                                                (6)(v), 
                                                     (b)(4)(E)(8)(iii), 
                                                    (G)(1)(v), (G)(2)(v)


United States Pharmacopeial Convention

  12601 Twinbrook Pkwy, Rockville, MD 20852
United States Pharmacopeia, 23d Revision, dated 
  January, 1995...................................         165.110(a)(2)


                                                                    Chap.

[[Page 553]]



                    Table of CFR Titles and Chapters



                     (Revised as of March 29, 1996)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                          Title 2--[Reserved]

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  General Accounting Office (Parts 1--99)
        II  Federal Claims Collection Standards (General 
                Accounting Office--Department of Justice) (Parts 
                100--299)

                   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  Advisory Committee on Federal Pay (Parts 1400--1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
       VII  Advisory Commission on Intergovernmental Relations 
                (Parts 1700--1799)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3202)
      XXVI  Department of Defense (Part 3601)

[[Page 554]]

       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)
    LXXVII  Office of Management and Budget (Part 8701)

                          Title 6--[Reserved]

                         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 Consumer Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)

[[Page 555]]

        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
       XXI  Foreign Economic Development Service, Department of 
                Agriculture (Parts 2100--2199)
      XXII  Office of International Cooperation and Development, 
                Department of Agriculture (Parts 2200--2299)
       XXV  Office of the General Sales Manager, 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, Department of Agriculture (Parts 
                2900--2999)
       XXX  Office of Finance and Management, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  [Reserved]
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of Agriculture (Parts 3400--
                3499)
     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)
     XXXIX  Economic Analysis Staff, Department of Agriculture 
                (Parts 3900--3999)
        XL  Economics Management Staff, Department of Agriculture 
                (Parts 4000--4099)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 556]]

                    Title 8--Aliens and Nationality

         I  Immigration and Naturalization Service, Department of 
                Justice (Parts 1--499)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Meat and Poultry 
                Inspection, Department of Agriculture (Parts 300--
                399)

                           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)
        XI  United States Enrichment Corporation (Parts 1100--
                1199)
        XV  Office of the Federal Inspector for the Alaska Natural 
                Gas Transportation System (Parts 1500--1599)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Thrift Depositor Protection Oversight Board (Parts 
                1500--1599)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700-1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

[[Page 557]]

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)

                    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  Office of Commercial Space Transportation, Department 
                of Transportation (Parts 400--499)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)

                 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 Export Administration, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
       XII  United States Travel and Tourism Administration, 
                Department of Commerce (Parts 1200--1299)
      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)

[[Page 558]]

                    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  United States Customs Service, Department of the 
                Treasury (Parts 1--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Employment Standards Administration, Department of 
                Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training, Department of Labor 
                (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

[[Page 559]]

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development, International 
                Development Cooperation Agency (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Information Agency (Parts 500--599)
        VI  United States Arms Control and Disarmament Agency 
                (Parts 600--699)
       VII  Overseas Private Investment Corporation, International 
                Development Cooperation Agency (Parts 700--799)
        IX  Foreign Service Grievance Board Regulations (Parts 
                900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Board for International Broadcasting (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)

                          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)

[[Page 560]]

         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 and Section 202 Direct Loan Program) 
                (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--999)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3699)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--799)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Part 1001)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--799)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Bureau of Alcohol, Tobacco and Firearms, Department of 
                the Treasury (Parts 1--299)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--199)

[[Page 561]]

       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)

                            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 Programs, 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  Pension and Welfare Benefits Administration, 
                Department of Labor (Parts 2500--2599)
      XXVI  Pension Benefit Guaranty Corporation (Parts 2600--
                2699)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
        VI  Bureau of Mines, Department of the Interior (Parts 
                600--699)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

[[Page 562]]

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
       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)
      XXIX  Presidential Commission on the Assignment of Women in 
                the Armed Forces (Part 2900)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)

[[Page 563]]

            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799)
        XI  National Institute for Literacy (Parts 1100-1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                        Title 35--Panama Canal

         I  Panama Canal Regulations (Parts 1--299)

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
       XIV  Assassination Records Review Board (Parts 1400-1499)

             Title 37--Patents, Trademarks, and Copyrights

         I  Patent and Trademark Office, Department of Commerce 
                (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

[[Page 564]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--799)
         V  Council on Environmental Quality (Parts 1500--1599)

          Title 41--Public Contracts and Property Management

            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans 
                Employment and Training, Department of Labor 
                (Parts 61-1--61-999)
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99)
            Subtitle F--Federal Travel Regulation System
       301  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 (Parts 303-1--303-2)
       304  Payment from a Non-Federal Source for Travel Expenses 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)

[[Page 565]]

        IV  Health Care Financing Administration, Department of 
                Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10005)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency (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, 
                General Administration (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  ACTION (Parts 1200--1299)

[[Page 566]]

      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
      XXII  Christopher Columbus Quincentenary Jubilee Commission 
                (Parts 2200--2299)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Saint Lawrence Seaway Development Corporation (Great 
                Lakes Pilotage), Department of Transportation 
                (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)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  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)

[[Page 567]]

        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  United States Information Agency (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)
        22  Small Business Administration (Parts 2200--2299)
        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)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Part 
                5452)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Research and Special Programs Administration, 
                Department of Transportation (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Highway Administration, Department of 
                Transportation (Parts 300--399)

[[Page 568]]

        IV  Coast Guard, Department of Transportation (Parts 400--
                499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)

                   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 Regulatory Agencies (Fishing and 
                Whaling) (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)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR



[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]
36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Prepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Prepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Prepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]

        IV  Health Care Financing Administration, Department of 
                Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10005)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency (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, 
                General Administration (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  ACTION (Parts 1200--1299)

[[Page 566]]
ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]        IV  Health Care Financing Administration, Department of                 Health and Human Services (Parts 400--499)         V  Office of Inspector General-Health Care, Department of                 Health and Human Services (Parts 1000--1999)                   Title 43--Public Lands: Interior            Subtitle A--Office of the Secretary of the Interior                 (Parts 1--199)            Subtitle B--Regulations Relating to Public Lands         I  Bureau of Reclamation, Department of the Interior                 (Parts 200--499)        II  Bureau of Land Management, Department of the Interior                 (Parts 1000--9999)       III  Utah Reclamation Mitigation and Conservation                 Commission (Parts 10000--10005)             Title 44--Emergency Management and Assistance         I  Federal Emergency Management Agency (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,                 General Administration (Parts 1--199)            Subtitle B--Regulations Relating to Public Welfare        II  Office of Family Assistance (Assistance Programs),                 Administration for Children and Families,                 Department of Health and Human Services (Parts                 200--299)       III  Office of Child Support Enforcement (Child Support                 Enforcement Program), Administration for Children                 and Families, Department of Health and Human                 Services (Parts 300--399)        IV  Office of Refugee Resettlement, Administration for                 Children and Families Department of Health and                 Human Services (Parts 400--499)         V  Foreign Claims Settlement Commission of the United                 States, Department of Justice (Parts 500--599)        VI  National Science Foundation (Parts 600--699)       VII  Commission on Civil Rights (Parts 700--799)      VIII  Office of Personnel Management (Parts 800--899)         X  Office of Community Services, Administration for                 Children and Families, Department of Health and                 Human Services (Parts 1000--1099)        XI  National Foundation on the Arts and the Humanities                 (Parts 1100--1199)       XII  ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts                 3400--3499)        35  Panama Canal Commission (Parts 3500--3599)        44  Federal Emergency Management Agency (Parts 4400--4499)        51  Department of the Army Acquisition Regulations (Parts                 5100--5199)        52  Department of the Navy Acquisition Regulations (Parts                 5200--5299)        53  Department of the Air Force Federal Acquisition                 Regulation Supplement (Parts 5300--5399)        54  Defense Logistics Agency, Department of Defense (Part                 5452)        57  African Development Foundation (Parts 5700--5799)        61  General Services Administration Board of Contract                 Appeals (Parts 6100--6199)        63  Department of Transportation Board of Contract Appeals                 (Parts 6300--6399)        99  Cost Accounting Standards Board, Office of Federal                 Procurement Policy, Office of Management and                 Budget (Parts 9900--9999)                       Title 49--Transportation            Subtitle A--Office of the Secretary of Transportation                 (Parts 1--99)            Subtitle B--Other Regulations Relating to                 Transportation         I  Research and Special Programs Administration,                 Department of Transportation (Parts 100--199)        II  Federal Railroad Administration, Department of                 Transportation (Parts 200--299)       III  Federal Highway Administration, Department of                 Transportation (Parts 300--399)[[Page 568]]        IV  Coast Guard, Department of Transportation (Parts 400--                499)         V  National Highway Traffic Safety Administration,                 Department of Transportation (Parts 500--599)        VI  Federal Transit Administration, Department of                 Transportation (Parts 600--699)       VII  National Railroad Passenger Corporation (AMTRAK)                 (Parts 700--799)      VIII  National Transportation Safety Board (Parts 800--999)         X  Surface Transportation Board, Department of                 Transportation (Parts 1000--1399)                   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 Regulatory Agencies (Fishing and                 Whaling) (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)        VI  Fishery Conservation and Management, National Oceanic                 and Atmospheric Administration, Department of                 Commerce (Parts 600--699)                      CFR Index and Finding Aids            Subject/Agency Index            List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]        IV  Health Care Financing Administration, Department of                 Health and Human Services (Parts 400--499)         V  Office of Inspector General-Health Care, Department of                 Health and Human Services (Parts 1000--1999)                   Title 43--Public Lands: Interior            Subtitle A--Office of the Secretary of the Interior                 (Parts 1--199)            Subtitle B--Regulations Relating to Public Lands         I  Bureau of Reclamation, Department of the Interior                 (Parts 200--499)        II  Bureau of Land Management, Department of the Interior                 (Parts 1000--9999)       III  Utah Reclamation Mitigation and Conservation                 Commission (Parts 10000--10005)             Title 44--Emergency Management and Assistance         I  Federal Emergency Management Agency (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,                 General Administration (Parts 1--199)            Subtitle B--Regulations Relating to Public Welfare        II  Office of Family Assistance (Assistance Programs),                 Administration for Children and Families,                 Department of Health and Human Services (Parts                 200--299)       III  Office of Child Support Enforcement (Child Support                 Enforcement Program), Administration for Children                 and Families, Department of Health and Human                 Services (Parts 300--399)        IV  Office of Refugee Resettlement, Administration for                 Children and Families Department of Health and                 Human Services (Parts 400--499)         V  Foreign Claims Settlement Commission of the United                 States, Department of Justice (Parts 500--599)        VI  National Science Foundation (Parts 600--699)       VII  Commission on Civil Rights (Parts 700--799)      VIII  Office of Personnel Management (Parts 800--899)         X  Office of Community Services, Administration for                 Children and Families, Department of Health and                 Human Services (Parts 1000--1099)        XI  National Foundation on the Arts and the Humanities                 (Parts 1100--1199)       XII  ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes            Parallel Tables of Statutory Authorities and Rules            List of CFR Titles, Chapters, Subchapters, and Parts            Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federlation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]
      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
      XXII  Christopher Columbus Quincentenary Jubilee Commission 
                (Parts 2200--2299)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Saint Lawrence Seaway Development Corporation (Great 
                Lakes Pilotage), Department of Transportation 
                (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)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  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)

[[Page 567]]

        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  United States Information Agency (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)
        22  Small Business Administration (Parts 2200--2299)
        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)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Part 
                5452)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Research and Special Programs Administration, 
                Department of Transportation (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Highway Administration, Department of 
                Transportation (Parts 300--399)

[[Page 568]]

        IV  Coast Guard, Department of Transportation (Parts 400--
                499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)

                   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 Regulatory Agencies (Fishing and 
                Whaling) (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)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR



[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and PlaSec. - centspara. deg.'-   -- !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. - centspara. deg.'-   _ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. - centspara. deg.'-   #_ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. --- centspara. deg.'-   _ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~l Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300--5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700--5799) 61 General Services Administration Board of Contract Appeals (Parts 6100--6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300--6399) 99 Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget (Parts 9900--9999) Title 49--Transportation Subtitle A--Office of the Secretary of Transportation (Parts 1--99) Subtitle B--Other Regulations Relating to Transportation I Research and Special Programs Administration, Department of Transportation (Parts 100--199) II Federal Railroad Administration, Department of Transportation (Parts 200--299) III Federal Highway Administration, Department of Transportation (Parts 300--399)[[Page 568]] IV Coast Guard, Department of Transportation (Parts 400-- 499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500--599) VI Federal Transit Administration, Department of Transportation (Parts 600--699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700--799) VIII National Transportation Safety Board (Parts 800--999) X Surface Transportation Board, Department of Transportation (Parts 1000--1399) 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 Regulatory Agencies (Fishing and Whaling) (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) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600--699) CFR Index and Finding Aids Subject/Agency Index List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] IV Health Care Financing Administration, Department of Health and Human Services (Parts 400--499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000--1999) Title 43--Public Lands: Interior Subtitle A--Office of the Secretary of the Interior (Parts 1--199) Subtitle B--Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior (Parts 200--499) II Bureau of Land Management, Department of the Interior (Parts 1000--9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000--10005) Title 44--Emergency Management and Assistance I Federal Emergency Management Agency (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, General Administration (Parts 1--199) Subtitle B--Regulations Relating to Public Welfare II Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services (Parts 200--299) III Office of Child Support Enforcement (Child Support Enforcement Program), Administration for Children and Families, Department of Health and Human Services (Parts 300--399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400--499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500--599) VI National Science Foundation (Parts 600--699) VII Commission on Civil Rights (Parts 700--799) VIII Office of Personnel Management (Parts 800--899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000--1099) XI National Foundation on the Arts and the Humanities (Parts 1100--1199) XII ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federlation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300--1399) XVI Legal Services Corporation (Parts 1600--1699) XVII National Commission on Libraries and Information Science (Parts 1700--1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800-- 1899) XXI Commission on Fine Arts (Parts 2100--2199) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200--2299) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400--2499) XXV Corporation for National and Community Service (Parts 2500--2599) Title 46--Shipping I Coast Guard, Department of Transportation (Parts 1-- 199) II Maritime Administration, Department of Transportation (Parts 200--399) III Saint Lawrence Seaway Development Corporation (Great Lakes Pilotage), Department of Transportation (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) III National Telecommunications and Information Administration, Department of Commerce (Parts 300--399) Title 48--Federal Acquisition Regulations System 1 Federal Acquisition Regulation (Parts 1--99) 2 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)[[Page 567]] 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 United States Information Agency (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) 22 Small Business Administration (Parts 2200--2299) 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) 34 Department of Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition \DISC\OUT\21V2.BCK<Sec. - centspara. deg.'-
36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and PlaSec21V2.BCKnus>--`abcdefghijklmnopqrstuvwxyz{|}~l Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300--5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700--5799) 61 General Services Administration Board of Contract Appeals (Parts 6100--6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300--6399) 99 Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget (Parts 9900--9999) Title 49--Transportation Subtitle A--Office of the Secretary of Transportation (Parts 1--99) Subtitle B--Other Regulations Relating to Transportation I Research and Special Programs Administration, Department of Transportation (Parts 100--199) II Federal Railroad Administration, Department of Transportation (Parts 200--299) III Federal Highway Administration, Department of Transportation (Parts 300--399)[[Page 568]] IV Coast Guard, Department of Transportation (Parts 400-- 499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500--599) VI Federal Transit Administration, Department of Transportation (Parts 600--699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700--799) VIII National Transportation Safety Board (Parts 800--999) X Surface Transportation Board, Department of Transportation (Parts 1000--1399) 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 Regulatory Agencies (Fishing and Whaling) (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) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600--699) CFR Index and Finding Aids Subject/Agency Index List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] IV Health Care Financing Administration, Department of Health and Human Services (Parts 400--499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000--1999) Title 43--Public Lands: Interior Subtitle A--Office of the Secretary of the Interior (Parts 1--199) Subtitle B--Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior (Parts 200--499) II Bureau of Land Management, Department of the Interior (Parts 1000--9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000--10005) Title 44--Emergency Management and Assistance I Federal Emergency Management Agency (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, General Administration (Parts 1--199) Subtitle B--Regulations Relating to Public Welfare II Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services (Parts 200--299) III Office of Child Support Enforcement (Child Support Enforcement Program), Administration for Children and Families, Department of Health and Human Services (Parts 300--399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400--499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500--599) VI National Science Foundation (Parts 600--699) VII Commission on Civil Rights (Parts 700--799) VIII Office of Personnel Management (Parts 800--899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000--1099) XI National Foundation on the Arts and the Humanities (Parts 1100--1199) XII ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federlation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300--1399) XVI Legal Services Corporation (Parts 1600--1699) XVII National Commission on Libraries and Information Science (Parts 1700--1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800-- 1899) XXI Commission on Fine Arts (Parts 2100--2199) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200--2299) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400--2499) XXV Corporation for National and Community Service (Parts 2500--2599) Title 46--Shipping I Coast Guard, Department of Transportation (Parts 1-- 199) II Maritime Administration, Department of Transportation (Parts 200--399) III Saint Lawrence Seaway Development Corporation (Great Lakes Pilotage), Department of Transportation (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) III National Telecommunications and Information Administration, Department of Commerce (Parts 300--399) Title 48--Federal Acquisition Regulations System 1 Federal Acquisition Regulation (Parts 1--99) 2 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)[[Page 567]] 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 United States Information Agency (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) 22 Small Business Administration (Parts 2200--2299) 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) 34 Department of Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition \DISC\OUT\21V2.BCK<Sec. - centspara. deg.'-36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and PlaSec21V2.BCKnus>--`abcdefghijklmnopqrstuvwxyz{|}~l Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300--5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700--5799) 61 General Services Administration Board of Contract Appeals (Parts 6100--6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300--6399) 99 Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget (Parts 9900--9999) Title 49--Transportation Subtitle A--Office of the Secretary of Transportation (Parts 1--99) Subtitle B--Other Regulations Relating to Transportation I Research and Special Programs Administration, Department of Transportation (Parts 100--199) II Federal Railroad Administration, Department of Transportation (Parts 200--299) III Federal Highway Administration, Department of Transportation (Parts 300--399)[[Page 568]] IV Coast Guard, Department of Transportation (Parts 400-- 499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500--599) VI Federal Transit Administration, Department of Transportation (Parts 600--699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700--799) VIII National Transportation Safety Board (Parts 800--999) X Surface Transportation Board, Department of Transportation (Parts 1000--1399) 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 Regulatory Agencies (Fishing and Whaling) (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) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600--699) CFR Index and Finding Aids Subject/Agency Index List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] IV Health Care Financing Administration, Department of Health and Human Services (Parts 400--499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000--1999) Title 43--Public Lands: Interior Subtitle A--Office of the Secretary of the Interior (Parts 1--199) Subtitle B--Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior (Parts 200--499) II Bureau of Land Management, Department of the Interior (Parts 1000--9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000--10005) Title 44--Emergency Management and Assistance I Federal Emergency Management Agency (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, General Administration (Parts 1--199) Subtitle B--Regulations Relating to Public Welfare II Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services (Parts 200--299) III Office of Child Support Enforcement (Child Support Enforcement Program), Administration for Children and Families, Department of Health and Human Services (Parts 300--399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400--499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500--599) VI National Science Foundation (Parts 600--699) VII Commission on Civil Rights (Parts 700--799) VIII Office of Personnel Management (Parts 800--899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000--1099) XI National Foundation on the Arts and the Humanities (Parts 1100--1199) XII ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agr. - centspara. deg.'-   -- !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. - centspara. deg.'-   _ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. - centspara. deg.'-   #_ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~Sec. --- centspara. deg.'-   _ !"#$%&'()*+,-./0123456789:;<=>@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]---`abcdefghijklmnopqrstuvwxyz{|}~l Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]]36, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Managem21V2.BCK Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300--5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700--5799) 61 General Services Administration Board of Contract Appeals (Parts 6100--6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300--6399) 99 Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget (Parts 9900--9999) Title 49--Transportation Subtitle A--Office of the Secretary of Transportation (Parts 1--99) Subtitle B--Other Regulations Relating to Transportation I Research and Special Programs Administration, Department of Transportation (Parts 100--199) II Federal Railroad Administration, Department of Transportation (Parts 200--299) III Federal Highway Administration, Department of Transportation (Parts 300--399)[[Page 568]] IV Coast Guard, Department of Transportation (Parts 400-- 499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500--599) VI Federal Transit Administration, Department of Transportation (Parts 600--699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700--799) VIII National Transportation Safety Board (Parts 800--999) X Surface Transportation Board, Department of Transportation (Parts 1000--1399) 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 Regulatory Agencies (Fishing and Whaling) (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) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600--699) CFR Index and Finding Aids Subject/Agency Index List of Agency Pent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] IV Health Care Financing Administration, Department of Health and Human Services (Parts 400--499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000--1999) Title 43--Public Lands: Interior Subtitle A--Office of the Secretary of the Interior (Parts 1--199) Subtitle B--Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior (Parts 200--499) II Bureau of Land Management, Department of the Interior (Parts 1000--9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000--10005) Title 44--Emergency Management and Assistance I Federal Emergency Management Agency (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, General Administration (Parts 1--199) Subtitle B--Regulations Relating to Public Welfare II Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services (Parts 200--299) III Office of Child Support Enforcement (Child Support Enforcement Program), Administration for Children and Families, Department of Health and Human Services (Parts 300--399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400--499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500--599) VI National Science Foundation (Parts 600--699) VII Commission on Civil Rights (Parts 700--799) VIII Office of Personnel Management (Parts 800--899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000--1099) XI National Foundation on the Arts and the Humanities (Parts 1100--1199) XII ACTION (Parts 1200--1299)[[Page 566]]ent Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regu1V2.BCKrepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR[[Page 556952Alphabetical List of Agencies Appearing in the CFR80(Revised as of March 29, 1996)82CFR Title, Subtitle or81Agency82Chapter0270ACTION7245, XII70Administrative Committee of the Federal Register721, I70Advanced Research Projects Agency7232, I70Advisory Commission on Intergovernmental Relations725, VII70Advisory Committee on Federal Pay725, IV70Advisory Council on Historic Preservation7236, VIII70African Development Foundation7222, XV71Federal Acquisition Regulation7248, 5770Agency for International Development7222, II71Federal Acquisition Regulation7248, 770Agricultural Marketing Service727, I, IX, X, XI70Agricultural Research Service727, V70Agriculture Department71Agricultural Marketing Service727, I, IX, X, XI71Agricultural Research Service727, V71Animal and Plaroperty Management Regulations (Parts 109-1--109-99)6011461Department of the Interior (Parts 114-1--114-99)6011561Environmental Protection Agency (Parts 115-1--115-99)6012861Department of Justice (Parts 128-1--128-99)62Subtitle D--Other Provisions Relating to Property Management [Reserved]62Subtitle E--Federal Information Resources Management Regulations System6020161Federal Information Resources Management Regulation (Parts 201-1--201-99)62Subtitle F--Federlation (Parts 201-1--201-99)62Subtitle F--Federal Travel Regulation System6030161Travel Allowances (Parts 301-1--301-99)6030261Relocation Allowances (Parts 302-1--302-99)6030361Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1--303-2)6030461Payment from a Non-Federal Source for Travel Expenses (Parts 304-1--304-99)53Title 42--Public Health60I61Public Health Service, Department of Health and Human Services (Parts 1--199)(565]] XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300--1399) XVI Legal Services Corporation (Parts 1600--1699) XVII National Commission on Libraries and Information Science (Parts 1700--1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800-- 1899) XXI Commission on Fine Arts (Parts 2100--2199) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200--2299) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400--2499) XXV Corporation for National and Community Service (Parts 2500--2599) Title 46--Shipping I Coast Guard, Department of Transportation (Parts 1-- 199) II Maritime Administration, Department of Transportation (Parts 200--399) III Saint Lawrence Seaway Development Corporation (Great Lakes Pilotage), Department of Transportation (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) III National Telecommunications and Information Administration, Department of Commerce (Parts 300--399) Title 48--Federal Acquisition Regulations System 1 Federal Acquisition Regulation (Parts 1--99) 2 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)[[Page 567]] 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 United States Information Agency (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) 22 Small Business Administration (Parts 2200--2299) 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) 34 Department of Education Acquisition Regulation (Parts 3400--3499) 35 Panama Canal Commission (Parts 3500--3599) 44 Federal Emergency Management Agency (Parts 4400--4499) 51 Department of the Army Acquisition Regulations (Parts 5100--5199) 52 Department of the Navy Acquisition Regulations (Parts 5200--5299) 53 Department of the Air Force Federal Acquisition \DISC\OUT\21V2.BCK<Sec. - centspara. deg.'-
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