[Title 9 CFR ]
[Code of Federal Regulations (annual edition) - January 1, 2000 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    9


          Parts 200 to End

                         Revised as of January 1, 2000

Animals and Animal Products





          Containing a Codification of documents of general 
          applicability and future effect
          As of January 1, 2000
          With Ancillaries
          Published by:
          Office of the Federal Register
          National Archives and Records
          Administration

A Special Edition of the Federal Register



[[Page ii]]

                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2000



               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 9:
          Chapter II--Grain Inspection, Packers and Stockyards 
          Administration (Packers and Stockyards Programs), 
          Department of Agriculture                                  3
          Chapter III--Food Safety and Inspection Service, 
          Department of Agriculture                                 73
  Finding Aids:
      Material Approved for Incorporation by Reference........     777
      Table of CFR Titles and Chapters........................     779
      Alphabetical List of Agencies Appearing in the CFR......     797
      List of CFR Sections Affected...........................     807



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

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

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

[[Page v]]



                               EXPLANATION

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

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

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

LEGAL STATUS

    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, January 1, 2000), 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.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
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). 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.

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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
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                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

January 1, 2000.



[[Page ix]]



                               THIS TITLE

    Title 9--Animals and Animal Products is composed of two volumes. The 
first volume contains chapter I--Animal and Plant Health Inspection 
Service, Department of Agriculture (parts 1-199). The second volume 
contains chapter II--Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs), Department of 
Agriculture and chapter III--Food Safety and Inspection Service, 
Department of Agriculture (part 200-end). The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of January 1, 2000.

    For this volume, Jonn V. Lilyea 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]]





[[Page 1]]



                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS




                  (This book contains part 200 to end)

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



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

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

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

[[Page 3]]



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




  --------------------------------------------------------------------
Part                                                                Page
200             [Reserved]
201             Regulations under the Packers and Stockyards 
                    Act.....................................           5
202             Rules of practice governing proceedings 
                    under the Packers and Stockyards Act....          29
203             Statements of general policy under the 
                    Packers and Stockyards Act..............          48
204             Organization and functions..................          59
205             Clear title--protection for purchasers of 
                    farm products...........................          63



  Editorial Note: Nomenclature changes to Chapter II appear at 60 FR 
8465, Feb. 14, 1995.

[[Page 5]]

                           PART 200 [RESERVED]



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




                               Definitions

Sec.
201.1  Meaning of words.
201.2  Terms defined.

                             Administration

201.3  Authority.

                     Applicability of Industry Rules

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

                              Registration

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

                     Schedules of Rates and Charges

201.17  Requirements for filing tariffs.

                       General Bonding Provisions

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

                 Market Agency, Dealer and Packer Bonds

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

                            Proceeds of Sale

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

                          Accounts and Records

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

                             Trade Practices

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

                                Services

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

                          Inspection of Brands

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

                                 General

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

                Poultry--Packers and Live Poultry Dealers

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

[[Page 6]]

201.200  Sale of livestock to a packer on credit.

    Authority: 7 U.S.C. 204, 228, 7 CFR 2.17(e), 2.56.

                               Definitions



Sec. 201.1  Meaning of words.

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

[19 FR 4524, July 22, 1954]



Sec. 201.2  Terms defined.

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

[46 FR 50510, Oct. 14, 1981]

                             Administration



Sec. 201.3  Authority.

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

[19 FR 4524, July 22, 1954]

                     Applicability of Industry Rules



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

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

[[Page 7]]

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


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

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

                              Registration



Sec. 201.10  Requirements and procedures.

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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



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

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


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

[49 FR 33003, Aug. 20, 1984]

                     Schedules of Rates and Charges



Sec. 201.17  Requirements for filing tariffs.

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

[[Page 8]]

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 33003, Aug. 20, 1984]

                       General Bonding Provisions



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)

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



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

    Fully executed duplicates of bonds, trust fund agreements, and trust 
agreements maintained under the regulations in this part, and fully 
executed duplicates of all endorsements, amendments, riders, indemnity 
agreements, and other attachments thereto, and photographically 
reproduced copies of any letter of credit or amendment thereto, shall be 
filed with the Regional Supervisor for the region in

[[Page 9]]

which the registrant, packer, or person applying for registration 
resides, or in the case of a corporation, where the corporation has its 
home office: Provided, that if such registrant, packer, or person does 
not engage in business in such area, the foregoing documents shall be 
filed with the Regional Supervisor for the region in which the place of 
business of the registrant or packer or person is located.

(Approved by the Office of Management and Budget under control number 
0590-0001)

[56 FR 2128, Jan. 22, 1991]

                 Market Agency, Dealer and Packer Bonds



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

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


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

[48 FR 8806, Mar. 2, 1983]



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

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

[[Page 10]]

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


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

[48 FR 8806, Mar. 2, 1983]

[[Page 11]]



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

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

[47 FR 32695, July 29, 1982]



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

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

[41 FR 53774, Dec. 9, 1976]



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

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

[[Page 12]]

based or if suit thereon is commenced less than 120 days or more than 
547 days from the date of the transaction on which the claim is based;
    (e) The proceeds of the bond or bond equivalent, as the case may be, 
shall not be used to pay fees, salaries, or expenses for legal 
representation of the surety or the principal.

[56 FR 2128, Jan. 22, 1991]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)

[47 FR 32695, July 29, 1982, as amended at 54 FR 26349, June 23, 1989; 
61 FR 36279, July 10, 1996]

                            Proceeds of Sale



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

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

[[Page 13]]

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


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

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



Sec. 201.42  Custodial accounts for trust funds.

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

(Approved by the Office of Management and Budget under control number 
0590-0001)

[47 FR 32696, July 29, 1982, as amended at 54 FR 26349, June 23, 1989]

                          Accounts and Records



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

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

[[Page 14]]

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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

[[Page 15]]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[44 FR 45360, Aug. 2, 1979, as amended at 54 FR 26349, June 23, 1989]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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



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

    (a) Livestock. When livestock is weighed for the purpose of purchase 
or sale, a scale ticket shall be issued which shall be serially numbered 
and used in numerical sequence. Sufficient copies shall be executed to 
provide a copy to all parties to the transaction. In instances where the 
weight values are automatically recorded directly on the account of 
purchase, account of sale or other basic record, this record may serve 
in lieu of a scale ticket. When livestock is purchased on a carcass 
weight or carcass grade and weight basis, the hot carcass weights shall 
be recorded using a scale equipped with a printing device, and such 
printed weights shall be retained as part of the person or firm's 
business records to substantiate settlement on each transaction. Scale 
tickets issued under this section shall show:
    (1) The names and location of the agency performing the weighing 
service,
    (2) The date of the weighing;
    (3) The name of the buyer and seller or consignor, or a designation 
by which they may be readily identified;
    (4) The number of head;
    (5) Kind of livestock;
    (6) Actual weight of each draft of livestock; and
    (7) The name, initials, or number of the person who weighed the 
livestock, or if required by State law, the signature of the weigher.
    (b) Poultry. When live poultry is weighed for the purpose of 
purchase, sale, acquisition, or settlement by a live poultry dealer, a 
scale ticket shall be issued which shall show:
    (1) The name of the agency performing the weighing service;
    (2) The name of the live poultry dealer;
    (3) The name and address of the grower, purchaser, or seller;
    (4) The name or initials or number of the person who weighed the 
poultry, or if required by State law, the signature of the weigher;
    (5) The location of the scale;
    (6) The gross weight, tare weight, and net weight;
    (7) The date and time gross weight and tare weight are determined;
    (8) The number of poultry weighed;
    (9) The weather conditions;
    (10) Whether the driver was on or off the truck at the time of 
weighing; and
    (11) The license number of the truck or the truck number; provided, 
that when live poultry is weighed on a scale other than a vehicle scale, 
the scale

[[Page 16]]

ticket need not show the information specified in paragraphs (b)(9)-(11) 
of this section. Scale tickets issued under this paragraph shall be at 
least in duplicate form and shall be serially numbered and used in 
numerical sequence. One copy shall be furnished to the grower, 
purchaser, or seller, and one copy shall be furnished to or retained by 
the live poultry dealer.

(Approved by the Office of Management and Budget under control number 
0590-0001)

[61 FR 36281, July 10, 1996]

                             Trade Practices



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

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

[54 FR 16355, Apr. 24, 1989]



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

    When livestock or live poultry is bought, sold, acquired, or settled 
on a weight basis, settlement therefor shall be on the basis of the 
actual weight on the scale ticket. If the actual weight used is not 
obtained on the date and at the place of transfer of possession, this 
information shall be disclosed with the date and location of the 
weighing on the accountings, bills, or statement issued. Any adjustment 
to the actual weights shall be fully and accurately explained on the 
accountings, bills, or statements issued and records shall be maintained 
to support such adjustment.

(Approved by the Office of Management and Budget under control number 
0590-0001)

[61 FR 36281, July 10, 1996]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001.)


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

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



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

    (a) Market agencies selling on commission. No market agency selling 
consigned livestock shall enter into any agreement, relationship or 
association with dealers or other buyers which has

[[Page 17]]

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 6085, Feb. 17, 1984, as amended at 60 FR 42779, Aug. 17, 1995]



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

    No packer subject to the Act shall have an ownership interest in, 
finance, or participate in the management or operation of a market 
agency selling livestock on a commission basis, nor shall such a market 
agency permit a packer to have an ownership interest in, finance, or 
participate in the management or operation of such market agency.


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

[49 FR 32844, Aug. 17, 1984]



Sec. 201.69  Furnishing information to competitor buyers.

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

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



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

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

[24 FR 3183, Apr. 24, 1959]

                                Services



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

    (a) All scales used by stockyard owners, market agencies, dealers, 
packers, and live poultry dealers to weigh livestock, livestock 
carcasses, or live poultry for the purpose of purchase, sale, 
acquisition, or settlement shall be installed, maintained, and operated 
to insure accurate weights. Such scales shall meet applicable 
requirements contained in the General Code, Scale Code, and Weights Code 
of the 1996 edition of National Institute of Standards and Technology 
Handbook 44, ``Specifications, Tolerances, and Other Technical 
Requirements for Weighing and Measuring Devices,'' which is hereby 
incorporated by reference. This incorporation by reference was approved 
by the Director of the Federal Register on January 11, 1989. These 
materials are incorporated as they exist on the date of approval and a 
notice of any change in these materials will be published in the Federal 
Register. This handbook is for sale by the Superintendent of Documents, 
U.S. Government Printing Office, Washington, DC 20402. It is also

[[Page 18]]

available for inspection at the Office of the Federal Register 
Information Center, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (b) All scales used by stockyard owners, market agencies dealers, 
packers, and live poultry dealers to weigh livestock or live poultry for 
the purpose of purchase, sale, acquisition, or settlement and all scales 
used for the purchase, sale, acquisition, or settlement of livestock on 
a carcass weight basis shall be equipped with a printing device which 
shall be used for recording weight values on a scale ticket or other 
document used for this purpose.
    (c) All vehicle scales used to weigh livestock or live poultry for 
purposes of purchase, sale, acquisition or settlement shall be of 
sufficient length and capacity to weigh the entire vehicle as a unit: 
Provided, That a trailer may be uncoupled from the tractor and weighed 
as a single unit.
    (d) No scales shall be operated or used by any stockyard owner, 
market agency, dealer, packer, or live poultry dealer to weigh 
livestock, livestock carcasses or live poultry for purposes of purchase, 
sale, acquisition or settlement unless it has been found upon test and 
inspection, as specified in Sec. 201.72 of the regulations, to be in a 
condition to give accurate weight. If a scale is inspected or tested and 
found incorrect or inaccurate or if any repairs, adjustments or 
replacements are made to a scale, it shall not be used until it has been 
inspected and tested and met all accuracy requirements specified in the 
regulations.


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

[49 FR 37374, Sept. 24, 1984, as amended at 61 FR 36282, July 10, 1996]



Sec. 201.72  Scales; testing of.

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 37374, Sept. 24, 1984, as amended at 54 FR 16355, Apr. 24, 1989]



Sec. 201.73  Scale operators to be qualified.

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

[54 FR 16356, Apr. 24, 1989]



Sec. 201.73-1  Instructions for weighing livestock.

    Stockyard operators, market agencies, dealers, and packers who 
operate scales on which livestock is weighed in purchase or sales 
transactions are responsible for the accurate weighing of

[[Page 19]]

such livestock. They shall supply copies of the instructions in this 
section to all persons who perform weighing operations for them and 
direct such person to familiarize themselves with the instructions and 
to comply with them at all times. This section shall also apply to any 
additional weighers who are employed at any time. Weighers must 
acknowledge their receipt of these instructions and agree to comply with 
them, by signing in duplicate, P&SA Form 215 provided by the Packers and 
Stockyards Programs. One copy of the form is to be filed with a regional 
office of the Packers and Stockyards Programs and the other retained by 
the agency employing the weighers.
    (a) Balancing the empty scale. (1) The empty scale shall be balanced 
each day before weighing begins, and maintained in correct balance which 
weighing operations continue. The zero balance shall be verified at 
intervals of not more than 15 drafts or 15 minutes, whichever is 
completed first. In addition, the zero balance of the scale shall be 
verified whenever a weigher resumes weighing duties after an absence 
from the scale and also whenever a load exceeding half the scale 
capacity or 10,000 pounds (whichever is less) has been weighed and is 
followed by a load of less than 1,000 pounds, verification to occur 
before the weighing of the load of less than 1,000 pounds.
    (2) The time at which the empty scale is balanced or its zero 
balance verified shall be recorded on scale tickets or other permanent 
records. Balance tickets must be filed with other scale tickets issued 
on that date.
    (3) Before balancing the empty scale, the weigher shall assure 
himself that the scale gates are closed and that no persons or animals 
are on the scale platform or in contact with the stock rack, gates, or 
platform. If the scale is balanced with persons on the scale platform, 
the zero balance shall be verified whenever there is a change in such 
persons. When the scale is properly balanced and ready for weighing, the 
weigher shall so indicate by an appropriate signal.
    (4) Weighbeam scales shall be balanced by first seating each poise 
securely in its zero notch and then moving the balance ball to such 
position that a correct zero balance is obtained. A scale equipped with 
a balance indicator is correctly balanced when the pointer comes to rest 
at zero. A scale not equipped with a balance indicator is correctly 
balanced if the weighbeam, when released at the top or bottom of the 
trig loop, swings freely in the trig loop in such manner that it will 
come to rest at the center of the trig loop.
    (5) Dial scales shall be balanced by releasing all drop weights and 
operating the balance ball or other balancing device to obtain a correct 
zero balance. The indicator must visually indicate zero on the dial and 
the ticket printer must record a correct zero balance.
    (6) Electronic digital scales should be properly warmed up before 
use. In most cases, it is advisable to leave the electric power on 
continuously. The zero load balance shall be verified by recording the 
zero balance on a scale ticket. The main indicating element and the 
remote visual weight display shall indicate zero when the balance is 
verified. The proper procedure for balancing this type of scale will 
vary according to the manufacturer. Refer to the operator's manual for 
specific instructions.
    (b) Weighing the load. (1) Before weighing a draft of livestock, the 
weigher shall assure himself that the entire draft is on the scale 
platform with the gates closed and that no persons or animals off the 
scale are in contact with the platform, gates, or stock rack.
    (i) On a weighbeam scale with a balance indicator, the weight of a 
draft shall be determined by seating the poises at such positions that 
the pointer will come to rest within the central target area or within 
\1/4\ (0.25) inch of the zero mark.
    (ii) On a weighbeam scale without a balance indicator, the weight 
shall be determined by seating the poises at such positions that the 
weighbeam, when released from the top or bottom of the trig loop, will 
swing freely and come to rest at the approximate center of the trig 
loop.

[[Page 20]]

    (iii) On a dial scale, the weight is indicated automatically when 
the indicator moves around the dial face and comes to rest.
    (iv) On an electronic digital scale, the weight of a draft is 
indicated automatically when the weight value indicated stabilized.
    (2) The correct weight of a livestock draft is the value in pounds 
indicated when a correct load balance is obtained. The weigher should 
always concentrate his attention upon the beam tip, balance indicator or 
dial indicator while weighing and not concern himself with reading the 
visible weight indications until correct load balance is obtained. On 
electronic digital scales, the weigher should concentrate on the pulsing 
or flickering of weight values to assure that the unit indicates a 
stable weight before activating the print button.
    (c) Recording the weight. (1) The weight of each draft shall be 
recorded immediately after the load balance is obtained and before any 
poises are moved or the load is removed from the scale platform. The 
weigher shall make certain that the printed weight record agrees with 
the weight value visually indicated when correct load balance is 
obtained. He shall also assure himself that the printed weight value is 
distinct and legible.
    (2) The weight printing device on a scale shall be operated only to 
produce a printed or impressed record of the weight value while the 
livestock load is on the scale and correctly balanced. If the weight 
value is not printed clearly and correctly, the ticket shall be marked 
void and a new one printed before the livestock is removed from the 
scale.
    (d) Scale tickets. (1) Scale tickets used to record the weight 
values of livestock in purchase or sales transactions shall be used, at 
any given scale, in the order of their consecutive serial numbers unless 
otherwise marked to show the order of their use. All tickets shall show 
the date of the weighing and the name or initials of the weigher 
performing the weighing service.
    (2) No scale tickets shall be destroyed or otherwise disposed of 
because they are soiled, damaged, incorrectly executed, or voided. They 
shall be preserved and filed to comprise a complete serial number 
sequence.
    (3) No scale ticket shall be used to record the weight of a 
livestock draft for ``catch-weight,'' inventory, transportation charge 
or other nonsale purposes unless the ticket is clearly marked to show 
why the weight was determined.
    (4) When weight values are recorded by means of automatic recording 
equipment directly on the accounts of sale or other basic records, such 
record may serve in lieu of a scale ticket.
    (e) Weigher's responsibilities. (1) The primary responsibility of a 
weigher is to determine and accurately record the weight of livestock 
drafts without prejudice or favor to any person or agency and without 
regard for livestock ownership, price, condition, fill, shrink, or other 
considerations. A weigher shall not permit the representations or 
attitudes of any persons or agencies to influence his judgment or action 
in performing his duties.
    (2) Unused scale tickets, or those which are partially executed but 
without a printed weight value, shall not be left exposed or accessible 
to unauthorized personnel. All such tickets shall be kept under lock 
when the weigher is not at his duty station.
    (3) Accurate weighing and correct weight recording require that a 
weigher shall not permit his operations to be hurried to the extent that 
inaccurate weights or incorrect weight records may result. Each draft of 
livestock must be weighed accurately to the nearest minimum weight value 
that can be indicated or recorded. Manual operations connected with 
balancing, weighing, and recording shall be performed with the care 
necessary to prevent damage to the accurately machined and adjusted 
parts of weighbeams, poises, and printing devices.
    (4) Livestock owners, buyers, or others having legitimate interest 
in a livestock draft must be permitted to observe the balancing, 
weighing, and recording procedures, and a weigher shall not deny them 
that right or withhold from them any information pertaining to the 
weight of that draft. He shall check the zero balance of the scale or

[[Page 21]]

reweigh a draft of livestock when requested by such parties.
    (f) Sensitivity control. (1) A scale must be sensitive in response 
to platform loading if it is to yield accurate weights. It, therefore, 
is the duty of a weigher to assure himself that interferences, weighbeam 
friction, or other factors do not impair sensitivity. He should satisfy 
himself, at least twice each day, that the scale is sufficiently 
sensitive, and if the following requirements are not met, he should 
report the facts to his superior or employer immediately.
    (2) A weighbeam scale with a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the pointer at the center 
of the target, movement of the fractional poise one graduation will 
change the indicator rest point \1/4\ inch (0.25) or the width of the 
central target area, whichever is greater.
    (3) A weighbeam scale without a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the weighbeam at the 
center of the trig loop, movement of the fractional poise two 
graduations will cause the weighbeam to come to rest at the bottom of 
the trig loop.
    (4) Adjustable damping devices are incorporated in balance 
indicators and in dial scales to absorb the effects of load impact and 
assist in bringing the indicator to rest. The weigher should be familiar 
with the location and adjustment of these damping devices and should 
keep them adjusted so that the pointer will oscillate freely through at 
least one complete cycle of movement before coming to rest at its 
original position.
    (5) Friction at weighbeam bearings may reduce the sensitivity of the 
scale, cause sluggish weighbeam action and affect weighing accuracy. A 
weigher should inspect the weighbeam assembly daily to make certain that 
there is clearance between the weighbeam and the pivot bearings.
    (6) Interferences or binding of the scale platform, stock rack, 
gates or other ``live'' parts of the scale are common causes of weighing 
inaccuracy. A weigher should satisfy himself, at the beginning of each 
weighing period, that all such ``live'' parts have sufficient clearance 
to prevent interferences.
    (g) General precautions. (1) The poises of weighbeam scales are 
carefully adjusted and sealed to a definite weight at the factory and 
any change in that weight seriously affects weighing accuracy. A 
weigher, therefore, should be certain that poise parts do not become 
broken, loose or lost and that no material is added to a poise. 
Balancing or weighing shall not be performed while a scale ticket is in 
the slot of a weighbeam poise.
    (2) Stops are provided on scale weighbeams to prevent movement of 
poises back of the zero graduation when balancing or weighing. When the 
stops become worn or broken and allow a poise to be set behind the zero 
position, this condition should be reported and corrected without delay.
    (3) Foreign objects or loose material in the form of nuts, bolts, 
washers or other material on any part of the weighbeam assembly, 
including the counter-balance hanger or counter-balance weights, are 
potential sources of weighing error. Loose balancing material must be 
enclosed in the shot cup of the counter-balance hanger, and counter-
balance weights must not be of the slotted type which can readily be 
removed.
    (4) Whenever for any reason a weigher has reason to believe that a 
scale is not functioning properly or not yielding correct weight values, 
he shall discontinue weighing, report the facts to the parties 
responsible for scale maintenance, and request inspection, test, or 
repair of the scale.
    (5) When a scale has been adjusted, modified, or repaired in any 
manner which may affect the accuracy of weighing or weight recording, 
the weigher shall not use the scale until it has been tested and 
inspected and found to be accurate.
    (6) Count-off men, gate men, or others assigned to open or close 
scale gates or to drive livestock on or off the scale, shall perform 
those functions as directed by the weigher's signals or spoken 
instructions. They shall prevent persons or animals off the scale from 
being in contact with any part of the scale platform, stock rack, or 
gates while the scale is being balanced or

[[Page 22]]

used for weighing. They shall not open gates or remove livestock from 
the scale until directed by the weigher.

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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



Sec. 201.76  Reweighing.

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

[54 FR 16356, Apr. 24, 1989]



Sec. 201.81  Suspended registrants.

    No stockyard owner, packer, market agency, or dealer shall employ 
any person who has been suspended as a registrant to perform activities 
in connection with livestock transactions subject to the jurisdiction of 
the Secretary under the Act during the period of such suspension: 
Provided, That the provisions of this section shall not be construed to 
prohibit the employment of any person who has been suspended as a 
registrant until such time as the person demonstrates solvency or 
obtains the bond required under the Act and regulations. No such person 
shall be employed, however, until after the expiration of any specified 
period of suspension contained in the order of suspension.


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

[49 FR 37374, Sept. 24, 1984]



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

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

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

                          Inspection of Brands



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

    (a) Application for authorization. Any department or agency or duly-
organized livestock association of any State in which branding or 
marking of livestock as a means of establishing ownership prevails by 
custom or statute, which desires to obtain an authorization to charge 
and collect a fee for the inspection of brands, marks, and other 
identifying characteristics of livestock, as provided in section 317 of 
the Act, shall file with the Administrator an application in writing for 
such authorization. In case two or more applications for authorization 
to collect a fee for the inspection of brands, marks, and other 
identifying characteristics of livestock are received from the same 
State, a hearing will be held to determine which applicant is best 
qualified.
    (b) Registration and filing of schedules. Upon the issuance of an 
authorization to an agency or an association, said agency or association 
shall register as a market agency in accordance with the provisions of 
Sec. 201.10, except that no bond need be filed or maintained, and shall 
file a schedule of its rates and charges for performing the service in 
the manner and form prescribed by Sec. 201.17.
    (c) Reciprocal arrangements. Any authorized agency or association 
may make arrangements with an association or associations in the same or 
in another State, where branding or marking livestock prevails by custom 
or statute, to perform inspection service at stockyards on such terms 
and conditions as may be approved by the

[[Page 23]]

Administrator: Provided, That such arrangements will tend to further the 
purpose of the Act and will not result in duplication of charges or 
services.
    (d) Maintenance of identity of consignments. All persons having 
custody at the stockyard of livestock subject to inspection shall 
preserve the identity of the consignment until inspection has been 
completed by the authorized inspection agency. Agencies authorized to 
conduct such inspection shall perform the work as soon after receipt of 
the livestock as practicable and as rapidly as is reasonably possible in 
order to prevent delay in marketing, shrinkage in weight, or other 
avoidable losses.

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 33005, Aug. 20, 1984]

                                 General



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)

[54 FR 16356, Apr. 24, 1989, as amended at 54 FR 26349, June 23, 1989]



Sec. 201.95  Inspection of business records and facilities.

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

(Approved by the Office of Management and Budget under control number 
0590-0001)

[54 FR 16356, Apr. 24, 1989, as amended at 54 FR 26349, June 23, 1989]



Sec. 201.96  Unauthorized disclosure of business information prohibited.

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

[54 FR 16356, Apr. 24, 1989]



Sec. 201.97  Annual reports.

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

[[Page 24]]

waive the filing of such reports in particular cases.

(Approved by the Office of Management and Budget under Control No. 0590-
0001)

[54 FR 16356, Apr. 24, 1989]



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

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

[61 FR 36282, July 10, 1996]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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

                Poultry--Packers and Live Poultry Dealers



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

    (a) Contracts; contents. Each live poultry dealer who enters into a 
growout (feeding) contract with a poultry grower shall furnish the 
grower a true written copy of the contract, which shall clearly specify:
    (1) The duration of the contract and conditions for the termination 
of the contract by each of the parties; and

[[Page 25]]

    (2) All terms relating to the payment to be made to the poultry 
grower, including among others, where applicable, the following:
    (i) The party liable for condemnations, including those resulting 
from plant errors;
    (ii) The method for figuring feed conversion ratios;
    (iii) The formula or method used to convert condemnations to live 
weight;
    (iv) The per unit charges for feed and other inputs furnished by 
each party; and
    (v) The factors to be used when grouping or ranking poultry growers.
    (b) Settlement sheets; contents; supporting documents. Each live 
poultry dealer, who acquires poultry pursuant to a contract with a 
poultry grower, shall prepare a true and accurate settlement sheet 
(final accounting) and furnish a copy thereof to the poultry grower at 
the time of settlement. The settlement sheet shall contain all 
information necessary to compute the payment due the poultry grower. For 
all such arrangements in which the weight of birds affects payment, the 
settlement sheet shall show, among other things, the number of live 
birds marketed, the total weight and the average weight of the birds, 
and the payment per pound.
    (c) Condemnation and grading certificates. Each live poultry dealer, 
who acquires poultry pursuant to a contract with a poultry grower which 
provides that official U.S. Department of Agriculture condemnations or 
grades, or both, are a consideration affecting payment to the grower, 
shall obtain an official U.S. Department of Agriculture condemnation or 
grading certificate, or both, for the poultry and furnish a copy thereof 
to the poultry grower prior to or at the time of settlement.
    (d) Grouping or ranking sheets. Where the contract between the live 
poultry dealer and the poultry grower provides for payment to the 
poultry grower based upon a grouping or ranking of poultry growers 
delivering poultry during a specified period, the live poultry dealer 
shall furnish the poultry grower, at the time of settlement, a copy of a 
grouping or ranking sheet which shows the grower's precise position in 
the grouping or ranking sheet for that period. The grouping or ranking 
sheet need not show the names of other growers, but shall show the 
actual figures upon which the grouping or ranking is based for each 
grower grouped or ranked during the specified period.
    (e) Live poultry purchases. Each live poultry dealer who purchases 
live poultry shall prepare and deliver a purchase invoice to the seller 
at time of settlement. The purchase invoice shall contain all 
information necessary to compute payment due the seller. When U.S. 
Department of Agriculture condemnations or U.S. Department of 
Agriculture grades, or both, of poultry purchased affect final payment, 
copies of official U.S. Department of Agriculture condemnation 
certificates or grading certificates, or both, shall be furnished to the 
seller at or prior to the time of settlement.


(Approved by the Office of Management and Budget under control number 
0590-0001)

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



Sec. 201.108-1  Instructions for weighing live poultry.

    Live poultry dealers who operate scales on which live poultry is 
weighed for purposes of purchase, sale, acquisition, or settlement are 
responsible for the accurate weighing of such poultry. They shall supply 
copies of the instructions in this section to all persons who perform 
weighing operations for them and direct such persons to familiarize 
themselves with the instructions and to comply with them at all times. 
This section shall also apply to any additional weighers who are 
employed at any time. Weighers must acknowledge their receipt of these 
instructions and agree to comply with them by signing in duplicate, a 
form provided by the Packers and Stockyards Programs, Grain Inspection, 
Packers and Stockyards Administration. One copy of this form is to be 
filed with a regional office of the Packers and Stockyards Programs, 
Grain Inspection, Packers and Stockyards Administration and the other 
copy retained by the Agency employing the weighers. The following 
instructions shall be applicable to the weighing of live poultry on all 
scales,

[[Page 26]]

except that paragraph (c)(1) of this section is only applicable to the 
weighing of live poultry on vehicle scales.
    (a) Balancing the empty scale. (1) The scale shall be maintained in 
zero balance at all times. The empty scale shall be balanced each day 
before weighing begins and thereafter its zero balance shall be verified 
before any poultry is weighed. In addition, the zero balance of the 
scale shall be verified whenever a weigher resumes weighing duties after 
an absence from the scale.
    (2) Before balancing the empty scale, the weigher shall notify 
parties outside the scale house of his/her intention and shall be 
assured that no persons or vehicles are in contact with the platform. 
When the empty scale is balanced and ready for weighing, the weigher 
shall so indicate by appropriate signal.
    (3) Weighbeam scales shall be balanced by first seating each poise 
securely in its zero notch and then moving the balance ball to such 
position that a correct zero balance is obtained. A scale equipped with 
a balance indicator is correctly balanced when the indicator comes to 
rest in the center of the target area. A scale not equipped with a 
balance indicator is correctly balanced if the weighbeam, when released 
at the top or bottom of the trig loop, swings freely in the trig loop in 
such manner that it will come to rest at the center of the trig loop.
    (4) Dial scales shall be balanced by releasing all drop weights and 
operating the balance ball or other balancing device to obtain a correct 
zero balance. The indicator must visibly indicate zero on the dial 
reading face and the ticket printer must record a correct zero balance. 
``Balance tickets'' shall be filed with other scale tickets issued on 
that date.
    (5) Electronic digital scales should be properly warmed up before 
use. In most cases it is advisable to leave the electric power on 
continuously. The zero balance shall be verified by recording the zero 
balance on a scale ticket. The main indicating element and the remote 
visual weight display shall indicate zero when the balance is verified. 
The proper procedure for balancing this type of scale will vary 
according to the manufacturer. Refer to the operator's manual for 
specific instructions.
    (6) A balance ball or other balancing device shall be operated only 
when balancing the empty scale and shall not be operated at any time or 
for any other purpose.
    (7) The time at which the empty scale is balanced or its zero 
balance verified shall be marked on scale tickets or other permanent 
records.
    (b) Sensitivity control. (1) A scale must be sensitive in response 
to platform loading if it is to yield accurate weights. It, therefore, 
is the duty of a weigher to assure himself that interferences, weighbeam 
friction, or other factors do not impair sensitivity. He shall satisfy 
himself, at least twice each day, that the scale is sufficiently 
sensitive, and, if the following requirements are not met, he must 
report the facts to his superior or employer immediately.
    (2) A weighbeam scale with a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the indicator at the 
center of the target, movement of the fractional poise one graduation 
will change the indicator rest point (\1/4\) inch (0.25) or the width of 
the central target area, whichever is greater.
    (3) A weighbeam scale without a balance indicator is sufficiently 
sensitive if, when the scale is balanced with the weighbeam at the 
center of the trig loop, movement of the fractional poise two 
graduations will cause the weighbeam to come to rest at the bottom of 
the trig loop.
    (4) Adjustable damping devices are incorporated in balance 
indicators and in dial scales to absorb the effects of load impact and 
to bring the indicator to rest. The weigher must be familiar with the 
location and adjustment of these damping devices and keep them so 
adjusted that when the indicator is displaced from a position of rest, 
it will oscillate freely through at least one complete cycle of movement 
before coming to rest at its original position.
    (5) Friction at weighbeam bearings may reduce the sensitiveness of 
the scale, cause sluggish weighbeam action and affect weighing accuracy. 
A weigher must inspect the weighbeam assembly daily to make certain that 
there is

[[Page 27]]

clearance between the weighbeam and the pivot bearings.
    (6) Interferences or binding of the scale platform, or other 
``live'' parts of the scale, are common causes of weighing inaccuracy. A 
weigher shall satisfy himself, at the beginning of each weighing period, 
that all such ``live'' parts have sufficient clearance to prevent 
interference.
    (c) Weighing the load. (1) Vehicle scales used to weigh live poultry 
shall be of sufficient length and capacity to weigh an entire vehicle as 
a unit; provided, that a trailer may be uncoupled from a tractor and 
weighed as a single unit. Before weighing a vehicle, either coupled or 
uncoupled, the weigher shall be assured that the entire vehicle is on 
the scale platform and that no persons are on the scale platform.
    (i) On a weighbeam scale with a balance indicator the weight of a 
vehicle shall be determined by moving the poises to such positions that 
the indicator will come to rest within the central target area.
    (ii) On a weighbeam scale without a balance indicator the weight 
shall be determined by moving the poises to such positions that the 
weighbeam, when released from the top or bottom of the trig loop, will 
swing freely in the trig loop and come to rest at the approximate center 
of the trig loop.
    (iii) On a dial scale the weight of a vehicle is indicated 
automatically when the indicator revolves around the dial face and comes 
to rest.
    (iv) On an electronic digital scale the weight of a vehicle is 
indicated automatically when the weight value indicated is stable.
    (2) The correct weight is the value in pounds indicated by a 
weighbeam, dial or digital scale when a stable load balance is obtained. 
In any case, the weigher should concentrate on the beam tip, balance 
indicator, dial or digital indicator while weighing and not be concerned 
with reading the visible weight indications until a stable load balance 
is obtained. On electronic digital scales, the weigher should 
concentrate on the pulsing or flickering of weight values to assure that 
the unit indicates a stable weight before activating the print button.
    (d) Recording the weight. (1) The gross or tare weight shall be 
recorded immediately after the load balance is obtained and before any 
poises are moved or load removed from the scale platform. The weigher 
shall make certain that the printed weight record agrees with the weight 
value visibly indicated on the weighbeam, dial or digital indicator when 
correct load balance is obtained. The weigher shall also assure that the 
printed weight value is sufficiently distinct and legible.
    (2) The weight printing device on a scale shall be operated only to 
produce a printed or impressed record of the weight while the load is on 
the scale and correctly balanced. If the weight is not printed clearly 
and correctly, the ticket shall be marked void and a new one printed 
before the load is removed from the scale.
    (e) Weigher's responsibilities. (1) The primary responsibility of a 
weigher is to determine and record the true weight of live poultry 
without prejudice or favor to any person or agency and without regard 
for poultry ownership, price, condition, shrink, or other 
considerations. A weigher shall not permit the representations or 
attitudes of any persons or agencies to influence their judgment or 
action in performing his/her duties.
    (2) Scale tickets issued shall be serially numbered and used in 
numerical sequence. Sufficient copies shall be executed to provide a 
copy to all parties to the transaction. Unused scale tickets or those 
which are partially executed shall not be left exposed or accessible to 
other parties. All such tickets shall be kept under lock when the 
weigher is not at his duty station.
    (3) Accurate weighing and weight recording require that a weigher 
shall not permit operations to be hurried to the extent that inaccurate 
weights or incorrect weight records may result. The gross, tare and net 
weights must be determined accurately to the nearest minimum graduation. 
Manual operations connected with balancing, weighing, and recording 
shall be performed with the care necessary to prevent damage to the 
accurately machined and adjusted parts of

[[Page 28]]

weighbeams, poises, and printing devices. Rough handling of these parts 
shall be avoided.
    (4) Poultry growers, live poultry dealers, sellers, or others having 
legitimate interest in a load of poultry are entitled to observe the 
balancing, weighing, and recording procedures. A weigher shall not deny 
such persons that right or withhold from them any information pertaining 
to the weight. The weigher shall check the zero balance of the scale or 
reweigh a load of poultry when requested by such parties or duly 
authorized representatives of the administrator.
    (f) General precautions. (1) The poises of weighbeam scales are 
carefully adjusted and sealed to a definite weight at the factory and 
any change in that weight seriously affects weighing accuracy. A 
weigher, therefore, shall observe if poise parts are broken, loose or 
lost or if material is added to a poise and shall report any such 
condition to his/her superior or employer. Balancing or weighing shall 
not be performed while a scale ticket is in the slot of a weighbeam 
poise.
    (2) Stops are provided on scale weighbeams to prevent movement of 
poises back of the zero graduation when balancing or weighing. When the 
stops become worn or broken and allow a poise to be set behind the zero 
position, this condition must be reported by the weigher to their 
superior or employer and corrected without delay.
    (3) Motion detection circuits are a part of electronic scales. They 
are designed to prevent the printing of weight values if the load has 
not stabilized within prescribed limits. The weighmaster's duty is to 
print the actual weight of the load within these limits. This requires 
printing the actual weight of the load, not one of the other weights 
that may be within the motion detection limits.
    (4) Foreign objects or loose material in the form of nuts, bolts, 
washers, or other material on any part of the weighbeam assembly, 
including the counter-balance hanger or counter-balance weights, are 
potential sources of weighing error. Loose balancing material must be 
enclosed in the shot cup of the counter-balance hanger and counter-
balance weights must not be of the slotted type which can readily be 
removed.
    (5) Whenever, for any reason, a weigher has reason to believe that a 
scale is not functioning properly or not yielding correct weight values, 
the weigher shall discontinue weighing, report the facts to the parties 
responsible for scale maintenance and request inspection, test or repair 
of the scale.
    (6) When a scale has been adjusted, modified, or repaired in any 
manner which can affect the accuracy of weighing or weight recording, 
the weigher shall not use the scale until it has been tested and 
inspected and found to be accurate.

[37 FR 4955, Mar. 8, 1972, as amended at 61 FR 36282, July 10, 1996]



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

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

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

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

    (2) Such packer retains such acknowledgment, together with all other 
documents, if any, setting forth the terms of such credit sales on which 
the purchaser and seller have agreed, and such dealer or market agency 
retains a copy thereof, in his records for such time as is required by 
any law, or by written notice served on such person by the 
Administrator, but not less than

[[Page 29]]

two calendar years from the date of expiration of the written agreement 
referred to in such acknowledgment; and
    (3) Such seller receives a copy of such acknowledgment.
    (b) Purchasing livestock for which payment is to be made by a draft 
which is not a check, shall constitute purchasing such livestock on 
credit within the meaning of paragraph (a) of this section. (See also 
Sec. 201.43(b)(1).)
    (c) The provisions of this section shall not be construed to permit 
any transaction prohibited by Sec. 201.61(a) relating to financing by 
market agencies selling on a commission basis.

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

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



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




            Rules of Practice Applicable to Rate Proceedings

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

         Rules of Practice Applicable to Reparation Proceedings

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

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

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

            Rules of Practice Applicable to Rate Proceedings

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



Sec. 202.1  Applicability of other rules.

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



Sec. 202.2  Definitions.

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

[[Page 30]]



Sec. 202.3  Institution of proceedings.

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



Sec. 202.4  Answer and reply.

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



Sec. 202.5  Hearing.

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



Sec. 202.6  Taking no position on the merits.

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



Sec. 202.7  Modification or vacation of final order.

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

         Rules of Practice Applicable to Reparation Proceedings



Sec. 202.101  Rule 1: Meaning of words.

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

[[Page 31]]



Sec. 202.102  Rule 2: Definitions.

    Terms defined in the Act shall mean the same in these rules as in 
the Act. In addition, and except as may be provided otherwise in these 
rules:
    Act means the Packers and Stockyards Act, 1921, and legislation 
supplementary thereto and amendatory thereof, 7 U.S.C. 181 et seq.;
    Agency means those divisions and offices of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
of the Department which are charged with administration of the Act;
    Agency Head means the Administrator, Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs) of the 
Department, or any officer or employee of the Agency to whom authority 
is lawfully delegated to act for the Administrator;
    Complainant means the party who files a complaint and claims 
reparation, or on whose behalf a complaint is filed and reparation is 
claimed, in a reparation proceeding;
    Department means the United States Department of Agriculture;
    Docketing of a reparation proceeding means transmittal of papers to 
the Hearing Clerk and assignment of a docket number as provided in Rule 
8, Sec. 202.108, of these rules;
    Hearing means that part of a reparation proceeding which involves 
the submission of evidence for the record and means either an oral or a 
written hearing;
    Hearing Clerk means the Hearing Clerk of the Department (see 7 CFR 
2.25(a)(3));
    Judicial Officer means the official of the Department delegated 
authority by the Secretary, pursuant to the Act of April 4, 1940 (7 
U.S.C. 450c-450g) and Reorganization Plan No. 2 of 1953, to perform the 
function involved (see 7 CFR 2.35);
    Mail means to deposit an item in the United States mail with postage 
affixed and addressed as necessary to cause it to be delivered to the 
address shown by ordinary mail, or by certified or registered mail if 
specified.
    Presiding Officer means any attorney who is employed in the Office 
of the General Counsel of the Department and is assigned so to act in a 
reparation proceeding;
    Re-mail means to mail by ordinary mail to an address an item that 
has been returned after being sent to the same address by certified or 
registered mail.
    Reparation proceeding or Proceeding means a proceeding under the Act 
before the Secretary, in which an order for the payment of money is 
claimed and in which the Secretary is not a party of record;
    Report means the report to the Judicial Officer of the presiding 
officer's recommended findings of fact and conclusions with respect to 
all material issues of fact, law or discretion, as well as the reasons 
or basis therefor, and order, in a reparation proceeding.
    Respondent means the party against whom a complaint is filed and 
reparation is claimed, in a reparation proceeding;
    Secretary means the Secretary of Agriculture of the United States, 
or any officer or employee of the Department to whom authority is 
lawfully delegated to act for the Secretary;

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



Sec. 202.103  Rule 3: Beginning a reparation proceeding.

    (a) Filing. A reparation proceeding is begun by filing a complaint. 
Any interested person (including any agency of a state or territory 
having jurisdiction over persons subject to the Act in such state or 
territory) desiring to complain of anything done or omitted to be done 
by any stockyard owner, market agency, or dealer in violation of 
sections 304, 305, 306, or 307, or of an order of the Secretary made 
under title III, of the Act, may file a complaint to begin a reparation 
proceeding.
    (b) Form. The complaint must be in writing, state the facts of the 
matter complained of, identify each person complained against 
(respondent), and identify each person who complains against such 
respondent and claims reparation from such respondent. It may be on a 
printed form supplied by the Agency, or may be a formal document, or may 
be a letter, mailgram, or telegram. It may be typewritten or

[[Page 32]]

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

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

[[Page 33]]



Sec. 202.104  Rule 4: Agency action.

    (a) Informal disposition. If there appears to be any reasonable 
ground for doing so, the Agency Head shall investigate the matter 
complained of. If the Agency Head reasonably believes that there are not 
sufficient facts to form the basis for further proceeding, the matter 
may be dropped, without prejudice to subsequent court action on the same 
cause of action; if it is dropped, the person filing the complaint shall 
be informed. If the statements in the complaint, and information 
obtained in the investigation, seem to warrant such action, the Agency 
Head may make an effort to obtain the consent of the parties to an 
amicable or informal adjustment of the matter by communication with the 
parties or their attorneys or representatives. Such communication may be 
written or oral or both.
    (b) Service of complaint. If the matter is not disposed of as 
provided in paragraph (a), the complaint, together with any amendment 
which has been filed, shall be served on the respondent with a notice 
that an answer is required.
    (c) Service of report of investigation. A report prepared by the 
Agency, of its investigation of the matter complained of, and 
supplements to such a report, may be served on the parties and made a 
part of the record of the proceeding. Whether such a report or 
supplement shall be prepared, and whether it shall be served on the 
parties and made a part of the record, and its contents, shall be in the 
discretion of the Agency Head. The Judicial Officer shall consider 
information in such a report or supplement as part of the evidence in 
the proceeding, to the extent that such information is relevant and 
material to the proceeding. Any party may submit evidence in rebuttal of 
such information as is provided generally in these rules for the 
submission of evidence. Oral testimony, to the extent credible, shall be 
given greater weight as evidence than such information.



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

    (a) Filing; number of copies. Prior to docketing of a proceeding 
under these rules, all documents and papers other than the initial 
complaint, filed in the proceeding, shall be filed with the Agency. 
After such docketing of a proceeding, all such documents and papers 
shall be filed with the hearing clerk, Provided, That all such documents 
and papers, except a petition for disqualification of a presiding 
officer, shall be filed with the presiding officer if the parties have 
been served with written notice to do so. Each such document or paper 
shall be filed in quadruplicate with an extra copy for each party in 
excess of two, except as otherwise provided in these rules. Any document 
or paper not filed in the required number of copies, except an initial 
complaint, may be returned to the party filing it.
    (b) Effective date of filing. Any document or paper other than an 
initial complaint, filed in a proceeding under these rules, shall be 
deemed to be filed at the time when it reaches the headquarters of the 
Department in Washington DC, or, if authorized to be filed with an 
officer or employee of the Department at any place outside the District 
of Columbia, it shall be deemed to be filed at the time when it reaches 
the office of such officer or employee.
    (c) Additional time for filing. The time for the filing of any 
document or paper other than an initial complaint, in a proceeding under 
these rules, may upon request be extended as reasonable, by the agency 
head prior to docketing of the proceeding, or by the presiding officer, 
or by the judicial officer; notice of any extension of time shall be 
served on all parties. After docketing of the proceeding, in all 
instances in which time permits, notice of a request for extension of 
time shall be given to parties other than the one filing such request, 
with opportunity to submit views concerning the request.
    (d) Computation of time. Saturdays, Sundays, and Federal holidays 
shall be included in computing the time allowed for the filing of any 
document or paper: Provided, That, when such time expires on a Saturday, 
Sunday, or Federal holiday, such time shall be extended to include the 
next following business day.
    (e) Who shall make service. Copies of all documents or papers 
required or authorized by the rules in this part to be filed with the 
Agency shall be served on the parties by the Agency, and copies of all 
documents or papers required

[[Page 34]]

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

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

[[Page 35]]



Sec. 202.106  Rule 6: Answer.

    (a) Filing and service. Within 20 days after service on a 
respondent, of a complaint or amendment of a complaint, such person 
shall file an answer in writing, signed by such person or by the 
attorney or representative of such person. If a respondent desires an 
oral hearing, a request for it should be included with the answer of 
such person. If any answer or amended answer is filed, it shall be 
served on the complainant.
    (b) Required contents. If a respondent desires to make a defense, 
the answer of such person shall contain a precise statement of the facts 
which constitute the grounds of defense, and shall specifically admit, 
deny, or explain each of the allegations of the complaint, except that, 
if the respondent is without knowledge, such answer shall state that. If 
a respondent does not desire to make a defense, the answer of such 
person shall contain an admission of all the allegations of the 
complaint, or an admission of liability to the complainant in the full 
amount claimed by the complainant as reparation, or both. An answer may 
be stricken for failure to comply with these requirements; notice of an 
order so striking an answer shall be served on the parties; within 20 
days after service on a respondent of such a notice, such person shall 
file an answer which complies with these requirements.
    (c) Setoff, counterclaim or cross-claim. The answer may assert a 
setoff, counterclaim, or cross-claim, or any combination thereof. No 
counterclaim or cross-claim shall be considered unless it is based on a 
violation for which the act authorizes reparation to be ordered to be 
paid, and filed within 90 days after accrual of the cause of action 
alleged therein: Provided, That a counterclaim not filed within such 
time limit may be considered if based on a transaction complained of in 
the complaint. Any cross-claim asserted against a co-respondent, based 
on a violation for which the act authorizes reparation to be ordered to 
be paid, and filed within 90 days after accrual of the cause of action 
alleged therein, shall be served on such person as a complaint; within 
20 days after such service, such person shall file an answer thereto in 
compliance with the above requirements for an answer to a complaint.
    (d) Failure to file. If a respondent fails to file an answer as 
required above, such persons shall be deemed to have admitted all the 
allegations of the complaint or cross-claim against such person, and to 
have consented to the issuance of a final order in the proceeding, based 
on all evidence in the record. For this purpose, the evidence in the 
record may include information contained in a report of investigation 
made a part of the record pursuant to rule 4(c), Sec. 202.104(c), and 
evidence received in a hearing, oral or written, held subsequent to the 
expiration of the time for filing such answer, but shall not be limited 
to such information and evidence. Such a respondent shall not be 
entitled to service provided in these rules, of any notice or document 
except the final order in the proceeding.



Sec. 202.107  Rule 7: Reply.

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

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



Sec. 202.108  Rule 8: Docketing of proceeding.

    Promptly following receipt of the answer, or the reply (if the 
answer asserts a counterclaim or a setoff), or following the expiration 
of the period of time prescribed above for the filing of the answer or 
of the reply, the agency

[[Page 36]]

head shall transmit all of the papers which have been filed in the 
proceeding (including the investigation report if any has been served on 
the parties) to the hearing clerk, who shall assign a docket number to 
the proceeding. Thereafter the proceeding shall be referred to by such 
number. The hearing clerk shall promptly transmit all such papers to the 
Office of the General Counsel for assignment of a presiding officer.



Sec. 202.109  Rule 9: Depositions.

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

[[Page 37]]

same as the officer, time, place, and manner suggested in the 
application.
    (4) The deposition shall be conducted in the manner (telephone, 
audio-visual telecommunication, or personal attendance of those who are 
to participate in the deposition) agreed to by the parties.
    (5) If the parties cannot agree on the manner in which the 
deposition is to be conducted:
    (i) The deposition shall be conducted by telephone unless the 
presiding officer determines that conducting the deposition by audio-
visual telecommunication:
    (A) Is necessary to prevent prejudice to a party;
    (B) Is necessary because of a disability of any individual expected 
to participate in the deposition; or
    (C) Would cost less than conducting the deposition by telephone.
    (ii) If the deposition is not conducted by telephone, the deposition 
shall be conducted by audio-visual telecommunication unless the 
presiding officer determines that conducting the deposition by personal 
attendance of any individual who is expected to participate in the 
deposition:
    (A) Is necessary to prevent prejudice to a party;
    (B) Is necessary because of a disability of any individual expected 
to participate in the deposition; or
    (C) Would cost less than conducting the deposition by telephone or 
audio-visual telecommunication.
    (e) Qualifications of officer. No deposition shall be made except 
before an officer authorized by the law of the United States or by the 
law of the place of the examination to administer oaths, or before an 
officer authorized by the Secretary to administer oaths, or before the 
presiding officer. No deposition shall be made before an officer who is 
a relative (within the third degree by blood or marriage), employee, 
attorney, or representative of any party (or an employee of an attorney 
or representative of any party), or who is financially interested in the 
result of the proceeding.
    (f) Procedure on examination. The deponent shall be examined under 
oath or affirmation, and the testimony of the deponent shall be recorded 
by the officer, or by some person under the direction and in the 
presence of the officer. If the examination is on interrogatories, they 
shall be propounded by the officer. If the examination is oral, the 
deponent shall be examined first by the party at whose instance the 
deposition is taken, or the representative of such party, and shall be 
subject to cross-examination by any other party or the representative 
thereof who is present at the examination; the officer shall propound 
any interrogatories filed with the officer by parties not present or 
represented at the examination.
    (g) Certification and filing by officer. The officer shall certify 
on the transcript or recording that the deponent was duly sworn by the 
officer and that the transcript or recording is a true record of the 
deponent's testimony, with such exceptions as the certificate shall 
specify. The officer shall then securely seal the transcript or 
recording, together with three copies of the transcript or recording, 
with an extra copy for each party in excess of two, in an envelope, and 
mail the same by registered or certified mail to the presiding officer.
    (h) Service; correction. After the transcript or recording is 
received by the presiding officer, it shall promptly be served on all 
parties. Any party, within 20 days after such service, may file a 
written motion proposing corrections to the transcript or recording. Any 
such motion shall be served on each party other than the one filing it, 
who shall have 10 days to file a written response to it. Any such 
response shall be served on each party other than the one filing it. 
Such documents, if filed, shall be a part of the record of the 
proceeding if any portion of the transcript or recording is made a part 
of the record. All portions of the transcript or recording which are not 
referred to in any such motion shall be presumed to be accurate except 
for obvious typographical errors.
    (i) Use. If a written hearing is held, a transcript or recording, of 
a deposition ordered and taken in accord with this section, may be made 
a part of the record as evidence by any party, by written motion filed 
with such party's

[[Page 38]]

evidence. If an oral hearing is held, except as otherwise provided in 
these rules, such a transcript or recording may be made a part of the 
record as evidence, on written motion filed by any party, or oral motion 
of any party made at the oral hearing, if no party objects after 
reasonable notice and opportunity to do so, or if the presiding officer 
finds that the evidence is otherwise admissible and:
    (1) That the witness is dead;
    (2) That the witness is unable to attend or testify for any good 
reason including age, sickness, infirmity, or imprisonment;
    (3) That the party offering the transcript or recording has tried 
without success to procure the attendance of the witness by subpoena; or
    (4) That such exceptional circumstances exist as to make it 
desirable, in the interests of justice and with due regard to the 
importance of presenting the testimony orally before the presiding 
officer, to allow the transcript or recording to be used.

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

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



Sec. 202.110  Rule 10: Prehearing conference.

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

No transcript or recording of such a conference shall be made, but the 
presiding officer shall prepare and file for the record a written 
summary if any action is taken at the conference, which shall 
incorporate any written stipulations or agreements made by the parties 
at the conference or as a result of the conference.
    (b) Manner of the prehearing conference. (1) The prehearing 
conference shall be conducted by telephone or correspondence unless the 
presiding officer determines that conducting the prehearing conference 
by audio-visual telecommunication:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to participate in the prehearing conference; or
    (iii) Would cost less than conducting the prehearing conference by 
telephone or correspondence. If the presiding officer determines that a 
prehearing conference conducted by audio-visual telecommunication would 
measurably increase the United States Department

[[Page 39]]

of Agriculture's cost of conducting the prehearing conference, the 
prehearing conference shall be conducted by personal attendance of any 
individual who is expected to participate in the prehearing conference, 
by telephone, or by correspondence.
    (2) If the prehearing conference is not conducted by telephone or 
correspondence, the prehearing conference shall be conducted by audio-
visual telecommunication unless the presiding officer determines that 
conducting the prehearing conference by personal attendance of any 
individual who is expected to participate in the prehearing conference:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to participate in the prehearing conference; or
    (iii) Would cost less than conducting the prehearing conference by 
audio-visual telecommunication.

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



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

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

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



Sec. 202.112  Rule 12: Oral hearing.

    (a) Time, place, and manner. (1) If and when the proceeding has 
reached the stage where an oral hearing is to be held, the presiding 
officer shall set a

[[Page 40]]

time, place, and manner for oral hearing. The time shall be set based 
upon careful consideration to the convenience of the parties. The place 
shall be set in accordance with paragraph (a)(2) of this section and 
careful consideration to the convenience of the parties. The manner in 
which the hearing is to be conducted shall be determined in accordance 
with paragraphs (a)(3) and (a)(4) of this section.
    (2) The place shall be set in accordance with paragraphs (e) and (f) 
of section 407 of the Act, if applicable. In essence, under paragraphs 
(e) and (f) of section 407 of the Act, if the complainant and the 
respondent, or all of the parties, if there are more than two, have 
their principal places of business or residence within a single unit of 
local government, a single geographical area within a State, or a single 
State, the oral hearing is to be held as near as possible to such places 
of business or residence, depending on the availability of an 
appropriate location for conducting the hearing. If the parties have 
such places of business or residence distant from each other, then 
paragraphs (e) and (f) of section 407 of the Act are not applicable.
    (3) The oral hearing shall be conducted by audio-visual 
telecommunication unless the presiding officer determines that 
conducting the oral hearing by personal attendance of any individual who 
is expected to participate in the hearing:
    (i) Is necessary to prevent prejudice to a party;
    (ii) Is necessary because of a disability of any individual expected 
to participate in the hearing; or
    (iii) Would cost less than conducting the hearing by audio-visual 
telecommunication. If the presiding officer determines that a hearing 
conducted by audio-visual telecommunication would measurably increase 
the United States Department of Agriculture's cost of conducting the 
hearing, the hearing shall be conducted by personal attendance of any 
individual who is expected to participate in the hearing or by 
telephone.
    (4) The presiding officer may, in his or her sole discretion or in 
response to a motion by a party to the proceeding, conduct the hearing 
by telephone if the presiding officer finds that a hearing conducted by 
telephone:
    (i) Would provide a full and fair evidentiary hearing;
    (ii) Would not prejudice any party; and
    (iii) Would cost less than conducting the hearing by audio-visual 
telecommunication or personal attendance of any individual who is 
expected to participate in the hearing.
    (b) Notice. (1) A notice stating the time, place, and manner of oral 
hearing shall be served on each party prior to the time of the oral 
hearing. The notice shall state whether the oral hearing will be 
conducted by telephone, audio-visual telecommunication, or personal 
attendance of any individual expected to participate in the hearing. If 
any change is made in the time, place, or manner of the oral hearing, a 
notice of the change shall be served on each party prior to the time of 
the oral hearing as changed, unless the change is made during the course 
of an oral hearing and shown in the transcript or on the recording. Any 
party may waive such notice, in writing, or orally on the record at an 
oral hearing and shown in the transcript or on the recording.
    (2) If the presiding officer orders an oral hearing, any party may 
move that the hearing be conducted by telephone or personal attendance 
of any individual expected to attend the hearing rather than by audio-
visual telecommunication. Any motion that the hearing be conducted by 
telephone or personal attendance of any individual expected to attend 
the hearing must be accompanied by a memorandum in support of the motion 
stating the basis for the motion and the circumstances that require the 
hearing to be conducted other than by audio-visual telecommunication.
    (3) Within 10 days after the presiding officer issues a notice 
stating the manner in which the hearing is to be conducted, any party 
may move that the presiding officer reconsider the manner in which the 
hearing is to be conducted. Any motion for reconsideration must be 
accompanied by a memorandum in support of the motion stating the basis 
for the motion and the circumstances that require the hearing

[[Page 41]]

to be conducted other than in accordance with the presiding officer's 
notice.
    (c) Failure to appear. If any party to the proceeding, after being 
duly notified, fails to appear at the oral hearing in person or by 
counsel or other representative, such party shall be deemed to have 
waived the right to add any further evidence to the record in the 
proceeding, or to object to the admission of any evidence; if the 
parties who are present are all adverse to such party, they shall have 
an election to present evidence, in whole or in part, in the form of 
oral testimony before the presiding officer, affidavits, or depositions.
    (d) Order of proceeding. Complainant shall proceed first, if present 
at the commencement of the oral hearing.
    (e) Written statements of direct testimony. (1) Except as provided 
in paragraph (e)(2) of this section, each party must exchange with all 
other parties a written narrative verified statement of the oral direct 
testimony that the party will provide at any hearing to be conducted by 
telephone; the direct testimony of each employee or agent of the party 
that the party will call to provide oral direct testimony at any hearing 
to be conducted by telephone; and the direct testimony of each expert 
witness that the party will call to provide oral direct testimony at any 
hearing to be conducted by telephone. The written direct testimony of 
witnesses shall be exchanged by the parties at least 10 days prior to 
the hearing. The oral direct testimony provided by a witness at a 
hearing conducted by telephone will be limited to the presentation of 
the written direct testimony, unless the presiding officer finds that 
oral direct testimony which is supplemental to the written direct 
testimony would further the public interest and would not constitute 
surprise.
    (2) The parties shall not be required to exchange testimony in 
accordance with this paragraph if the hearing is scheduled to begin less 
than 20 days after the presiding officer's notice stating the time of 
the hearing.
    (f) Evidence--(1) In general. The testimony of witnesses at an oral 
hearing shall be on oath or affirmation and subject to cross-
examination. Any witness other than a party may be examined separately 
and apart from all other witnesses, in the discretion of the presiding 
officer. The presiding officer shall exclude evidence which is 
immaterial, irrelevant, or unduly repetitious, or which is not of the 
sort on which responsible persons are accustomed to rely, insofar as 
practicable.
    (2) Objections. If a party objects to the admission of any evidence 
or to the limitation of the scope of any examination or cross-
examination or to any other ruling of the presiding officer, such party 
shall state briefly the grounds of such objection, and the presiding 
officer shall rule on it. The transcript or recording shall include 
argument or debates on objections, except as ordered by the presiding 
officer, and shall include the ruling of the presiding officer. 
Objections not made before the presiding officer may not subsequently be 
relied on in the proceeding.
    (3) Offer of proof. Whenever evidence is excluded by the presiding 
officer, the party offering such evidence may make an offer of proof. 
The offer of proof shall consist of a brief statement, which shall be 
included in the transcript or recording, describing the evidence 
excluded. If the evidence consists of a brief oral statement, it shall 
be included in full in the transcript or recording. If the evidence 
consists of an exhibit, it shall be marked for identification and 
inserted in the record. In either such event, if the judicial officer 
decides that the presiding officer's ruling in excluding the evidence 
was erroneous and prejudicial, such evidence shall be considered a part 
of the record. If the taking of such evidence will consume a 
considerable length of time at the hearing, the presiding officer shall 
not allow the insertion of such evidence in full and, if the judicial 
officer decides that the presiding officer's ruling in excluding the 
evidence was erroneous and prejudicial, the hearing shall be reopened to 
permit the taking of such evidence.
    (4) Depositions and affidavits. Except as is otherwise provided in 
these rules, admission of the deposition of any witness shall be subject 
to the provisions of rule 9, Sec. 202.109, and affidavits, and 
statements under penalty of perjury as provided in 28 U.S.C. 1746, Pub. 
L. 94-

[[Page 42]]

550, may be admitted only if the evidence is otherwise admissible and no 
party objects.
    (5) Department records. A true copy of any written entry in any 
record of the Department, made by an officer or employee of the 
Department in the course of the official duty of such officer or 
employee, and relevant to the issues involved in the hearing, shall be 
admissible as prima facie evidence of the facts stated in the record of 
the Department, without the production of such officer or employee.
    (6) Exhibits. (i) For each exhibit offered by a party, copies in 
addition to the original shall be filed with the presiding officer for 
the use of all other parties to the proceeding, except where the 
presiding officer finds that the furnishing of copies is impracticable. 
The presiding officer shall tell the parties the number of copies 
required to be filed, make the proper distribution of the copies, and 
have this noted on the record.
    (ii) If the testimony of a witness refers to any document, the 
presiding officer shall determine whether it shall be produced at the 
hearing and made a part of the record as an exhibit, or whether it shall 
be incorporated in the record by reference.
    (iii) If relevant and material matter is embraced in a document 
containing irrelevant or immaterial matter, such irrelevant or 
immaterial matter shall be designated by the party offering the document 
in evidence, and shall be segregated and excluded, insofar as 
practicable.
    (g) Subpoenas--(1) Issuance. The attendance and testimony of 
witnesses and the production of documentary evidence, from any place in 
the United States, on behalf of any party to the proceeding, may be 
required by subpoena at any designated place for oral hearing. Subpoenas 
may be issued by the presiding officer, on a written application filed 
by a party, showing the grounds and necessity thereof, and, with respect 
to subpoenas for the production of documentary evidence, showing their 
competency, relevancy, and materiality and the necessity for their 
production. Subpoenas may be issued on the motion of the presiding 
officer.
    (2) Service; proof of service. A subpoena may be served by any 
natural person over the age of 18 years. The party at whose instance a 
subpoena is issued shall be responsible for serving it, however, at the 
request of such party the Secretary will attempt to serve it.
    (h) Oral argument. The presiding officer shall permit oral argument 
by the parties or their counsel who are present at an oral hearing, but 
may limit such argument to any extent that the presiding officer finds 
necessary for the expeditious or proper disposition of the case.
    (i) Transcript or recording. (1) Hearings to be conducted by 
telephone shall be recorded verbatim by electronic recording device. 
Hearings conducted by audio-visual telecommunication or the personal 
attendance of any individual who is expected to participate in the 
hearing shall be transcribed, unless the presiding officer finds that 
recording the hearing verbatim would expedite the proceeding and the 
presiding officer orders the hearing to be recorded verbatim. The 
presiding officer shall certify that to the best of his or her knowledge 
and belief any recording made pursuant to this paragraph with exhibits 
that were accepted into evidence is the record of the hearing.
    (2) If a hearing is recorded verbatim, a party requests the 
transcript of a hearing or part of a hearing, and the presiding officer 
determines that the disposition of the proceeding would be expedited by 
a transcript of the hearing or part of a hearing, the presiding officer 
shall order the verbatim transcription of the recording as requested by 
the party.
    (3) Parties to the proceeding who desire copies of the transcript or 
recording of the oral hearing may make arrangements with the reporter, 
who will furnish and deliver such copies direct to such parties, upon 
receipt from such parties of payment for the transcript or recording, at 
the rate provided by the contract between the reporter and the 
Department for such reporting service.
    (j) Filing, and presiding officer's certificate, of the transcript 
or recording. As soon as practicable after the close of the oral 
hearing, the reporter shall transmit to the presiding officer the

[[Page 43]]

original transcript or recording of the testimony, and as many copies of 
the transcript or recording as may be required by paragraph (j) of this 
section for the area offices of the Agency and as may be required for 
the Washington office of the Agency. At the same time the reporter shall 
also transmit a copy of the transcript or recording to each party who 
shall have arranged and paid for it, as provided in paragraph (h) of 
this section. Upon receipt of the transcript or recording, the presiding 
officer shall attach to the original transcript or recording a 
certificate stating that, to the best of the presiding officer's 
knowledge and belief, the transcript or recording is a true, correct, 
and complete transcript or recording of the testimony given at the 
hearing and that the exhibits mentioned in it are all the exhibits 
received in evidence at the hearing, with such exceptions as the 
certificate shall specify. Such certificate shall be served on each 
party and a copy thereof shall be attached to each copy of the 
transcript or recording received by the presiding officer. In accordance 
with such certificate the presiding officer shall note, on the original 
transcript or recording, each correction detailed in such certificate by 
adding or crossing out (but without obscuring the texts as orginally 
transcribed or recorded) at the appropriate places any words necessary 
to make the text conform to the correct meaning, as certified by the 
presiding officer. The presiding officer shall send the copies of the 
transcript or recording to the hearing clerk who shall send them to the 
Agency.
    (k) Keeping of copies of the transcript or recording. During the 
period in which the proceeding has an active status in the Department, a 
copy of the transcript or recording shall be kept at the area office of 
the Agency most convenient to the respondent; however, if there are two 
or more respondents and they are located in different regions, such copy 
of the transcript or recording shall be kept at the area office of the 
Agency nearest to the place where the hearing was held. In addition, a 
copy of the transcript or recording shall be kept at the area office of 
the Agency most convenient to the complainant. Any such copy shall be 
available for examination during official hours of business at the area 
office, but shall remain the property of the Department and shall not be 
removed from such office.

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



Sec. 202.113  Rule 13: Written hearing.

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

[[Page 44]]

notice shall be served promptly on the respondent.
    (d) Respondent's evidence. After expiration of the time for the 
filing of complainant's evidence, the respondent shall be served with 
notice of an opportunity to file evidence. Within 20 days after such 
service, the respondent may file evidence. What the respondent files in 
response to that notice shall be served promptly on the complainant.
    (e) Complainant's rebuttal. If the respondent files anything 
pursuant to paragraph (d) of this section, the complainant shall be 
served with notice of an opportunity to file evidence in rebuttal of 
what the respondent has filed. Within 20 days after such service, the 
complainant may file such evidence, which shall be confined strictly to 
rebuttal of what the respondent has filed. What the complainant files in 
response to that notice shall be served promptly on the respondent.
    (f) Failure to file. Failure to file any evidence authorized under 
this section, within the time prescribed, shall constitute a waiver of 
the right to file such evidence.
    (g) Extension of time for depositions. If any party timely files an 
application for an order for the taking of testimony by deposition 
pursuant to rule 9, Sec. 202.109, time for the filing of such party's 
evidence shall be extended as reasonable, to permit consideration of the 
application, and taking of depositions if ordered.
    (h) Investigation report. No provision of this rule 13 shall change 
the status of an investigation report served on the parties and made a 
part of the record pursuant to rule 4, Sec. 202.104.

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



Sec. 202.114  Rule 14: Post-hearing procedure.

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

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



Sec. 202.115  Rule 15: Submission for final consideration.

    (a) Report. The presiding officer, with the assistance and 
collaboration of such employees of the Department as may be assigned for 
the purpose, shall prepare a report. The report shall be prepared on the 
basis of the evidence in the record, including the investigation report 
if one is prepared by the agency head and served on the parties, and any 
allegations admitted or deemed to be admitted, and any stipulations. The 
report shall be prepared in the form of a final order for signature by 
the judicial officer, and shall be filed with the hearing clerk. The 
report shall not be served on the parties unless and until it is signed 
by the judicial officer.
    (b) Record. At the same time as the report is filed with the hearing 
clerk, the record shall also be filed with the hearing clerk. The record 
shall include: Pleadings; motions and requests filed and rulings 
thereon; the investigation report if one is prepared by the agency head 
and served on the parties; the transcript or recording of an oral 
hearing, and exhibits received, if an oral hearing was held; evidence 
filed by the parties if a written hearing was held; documents filed in 
connection with pre-hearing conferences; any proposed findings of fact, 
conclusions and orders, statements of objections, and briefs; any 
stipulations; and proof of service.
    (c) Submission to judicial officer. Unless the hearing clerk 
reasonably believes that the record is not complete and in proper order, 
the record and the

[[Page 45]]

report shall be submitted to the judicial officer for decision.
    (d) Oral argument. There shall be no right to oral argument other 
than that provided in rule 12(h), Sec. 202.112(h).

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



Sec. 202.116  Rule 16: Issuance of order.

    (a) As soon as practicable after the receipt of the record and 
report from the hearing clerk, the judicial officer, on the basis of and 
after due consideration of the record, shall issue an order in the 
proceeding, which shall be served on the parties.
    (b) If the judicial officer deems it advisable to do so, the order 
may be made a tentative order. In such event, a presiding officer shall 
be assigned and the tentative order shall be served on each party, and 
each party shall have 20 days in which to file written exceptions to it, 
and arguments or briefs in support of such exceptions. If no party 
timely files exceptions, the tentative order shall automatically become 
the final order in the proceeding, and notice of such fact shall be 
served on the parties. If any party timely files such exceptions, they 
shall be handled in the same manner as a petition filed under rule 17, 
Sec. 202.117.



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

    (a) Filing of petition--(1) To reopen a hearing. Any party may file 
a petition to reopen a hearing to take further evidence, at any time 
prior to the issuance of the final order, or prior to a tentative order 
becoming final. Such a petition must state the nature and purpose of the 
evidence to be offered, show that it is not merely cumulative, and state 
a good reason why it was not offered at the hearing if oral, or filed in 
the hearing if written.
    (2) To rehear or reargue a proceeding or reconsider an order. Any 
party may file a petition to rehear or reargue a proceeding or 
reconsider an order of the judicial officer, at any time within 20 days 
after service on such party of such order. Such a petition must specify 
the matters claimed to have been erroneously decided, and the basis for 
the petitioner's claim that such matters were erroneously decided.
    (3) To set aside a default order. Any respondent against whom an 
order is issued by the judicial officer, upon failure to file an answer 
as required, may file a petition to set aside such order, at any time 
within 20 days after service on such respondent of such order. Such a 
petition must state a good reason why an answer was not filed as 
required.
    (b) Brief or memorandum of law. If such a petitioner wishes to file 
a brief or memorandum of law in support of such a petition, it must be 
filed with such petition.
    (c) Procedure. A presiding officer shall be assigned upon the filing 
of any such petition, or upon notice to the hearing clerk (which may be 
written or oral, or by telephone) that any party intends to file any 
such petition. The party filing any such petition shall be referred to 
as the complainant or respondent, depending on the original designation 
of such party in the proceeding; such party shall have the burden of 
establishing that such petition should be granted. If a petition to 
reopen is timely filed, the order shall not be issued pending decision 
whether to grant or deny the petition. If a petition to rehear or 
reargue or reconsider, or to set aside a default order, is timely filed, 
operation of the order shall be stayed automatically pending decision 
whether to grant or deny it; if such a petition is not timely filed, 
operation of the order shall not be stayed unless the Judicial Officer 
shall determine otherwise.
    (d) Service; answer. No such petition shall be granted unless it, 
with the brief or memorandum of law in support of it, if any, is first 
served on each party to the proceeding other than the one filing it. 
Each such other party, within 20 days after such service on such party, 
may file an answer to such petition. If any such party wishes to file a 
brief or memorandum of law in support of such an answer, it must be 
filed with such answer. Any such answer, with the brief or memorandum of 
law in support of it, if any, shall be served on each party to the 
proceeding other than the one filing it. Any such

[[Page 46]]

petition may be denied without such service.
    (e) Submission for decision; service of order. The presiding officer 
shall prepare a recommendation with respect to the petition, and submit 
it to the judicial officer for decision. Such a recommendation shall be 
prepared in the form of a final order for signature by the judicial 
officer. It shall not be served on the parties unless and until it is 
signed by the judicial officer. The order of the judicial officer shall 
be served on the parties.
    (f) Practice upon decision. If the judicial officer decides to 
reopen a hearing, or to rehear or permit reargument of a proceeding, or 
to set aside a default order, a presiding officer shall be assigned and 
the rules of practice shall be followed thereafter as applicable.



Sec. 202.118  Rule 18: Presiding officer.

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

[[Page 47]]

for disqualification of the presiding officer, which shall set forth 
with particularity the grounds of alleged disqualification. Any such 
petition shall be filed with the hearing clerk, who shall immediately 
transmit it to the judicial officer and inform the presiding officer. 
The record of the proceeding also shall immediately be transmitted to 
the judicial officer. After such investigation or hearing as the 
judicial officer deems necessary, the judicial officer shall either deny 
the petition or direct that another presiding officer be assigned to the 
proceeding. The petition, and notice of the order of the judicial 
officer, shall be made a part of the record and served on the parties; 
if any record is made on such a petition, it shall be a part of the 
record of the proceeding.

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



Sec. 202.119  Rule 19: Fees of witnesses.

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



Sec. 202.120  Rule 20: Official notice.

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



Sec. 202.121  Rule 21: Intervention.

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



Sec. 202.122  Rule 22: Ex parte communications.

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

[[Page 48]]

not given, but it shall not include a request for a status report on any 
matter or the proceeding.



Sec. 202.123  Rule 23: Action by Secretary.

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



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




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

    Authority: 7 CFR 2.17(e), 2.56



Sec. 203.1  [Reserved]



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

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

[[Page 49]]

in unmanufactured form, poultry or poultry products.


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

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



Sec. 203.3  [Reserved]



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

    (a) Records to be kept. Section 401 of the Packers and Stockyards 
Act (7 U.S.C. 221) provides, in part, that every packer, live poultry 
dealer, stockyard owner, market agency, and dealer shall keep such 
accounts, records, and memoranda as fully and correctly disclose all 
transactions involved in his business, including the true ownership of 
such business by stockholding or otherwise. In order to properly 
administer the P&S Act, it is necessary that records be retained for 
such periods of time as may be required to permit the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
a reasonable opportunity to examine such records. Section 401 of the Act 
does not, however, provide for the destruction or disposal of records. 
Therefore, the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) has formulated this policy statement 
to provide guidance as to the periods of time after which records may be 
disposed of or destroyed.
    (b) Records may be disposed of after two years except as otherwise 
provided. Except as provided in paragraph (c) of this section, each 
packer, live poultry dealer, stockyard owner, market agency, and dealer 
may destroy or dispose of accounts, records, and memoranda which 
contain, explain, or modify transactions in its business subject to the 
Act after such accounts, records, and memoranda have been retained for a 
period of two full years; Provided, That the following records made or 
kept by a packer may be disposed of after one year: cutting tests; 
departmental transfers; buyers' estimates; drive sheets; scale tickets 
received from others; inventory and products in storage; receiving 
records; trial balances; departmental overhead or expense 
recapitulations; bank statements, reconciliations and deposit slips; 
production or sale tonnage reports (including recapitulations and 
summaries of routes, branches, plants, etc.); buying or selling pricing 
instructions and price lists; correspondence; telegrams; teletype 
communications and memoranda relating to matters other than contracts, 
agreements, purchase or sales invoices, or claims or credit memoranda; 
and Provided further, That microfilm copies of records may be 
substituted for and retained in lieu of the actual records.
    (c) Retention for longer periods may be required. The periods 
specified in paragraph (b) of this section shall be extended if the 
packer, live poultry dealer, stockyard owner, market agency, or dealer 
is notified in writing by the Administrator that specified records 
should be retained for a longer period pending the completion of any 
investigation or proceedings under the Act.
    (d) Unauthorized disposal of records. If it is found that any person 
subject to the Act has disposed of accounts, records, and memoranda 
which are necessary to fully and correctly disclose all transactions in 
its business prior to the periods specified in this statement, 
consideration will be given to the issuance of a complaint charging a 
violation of section 401 of the Act and seeking an appropriate order. 
The administrative proceeding initiated will be conducted in accordance 
with the Rules of Practice Governing Formal Adjudicatory Proceedings 
Instituted by the Secretary (7 CFR 1.130 et seq.).

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 6085, Feb. 17, 1984, as amended at 54 FR 16357, Apr. 24, 1989]



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

    It has become a practice in certain areas of the country for market 
agencies, engaged in the business of selling consigned livestock on a 
commission basis, to pay certain of the business or personal expenses 
incurred by buyers

[[Page 50]]

attending livestock sales conducted by such market agencies, such as, 
expenses for meals, lodging, travel, entertainment and long distance 
telephone calls. Investigation by the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs), discloses 
that this practice tends to become a method of competition between 
similarly engaged market agencies and results in undue and unreasonable 
cost burdens on such market agencies and the livestock producers who 
sell their livestock through such market agencies.
    It is the view of the Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs) that it constitutes 
violations of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 
181 et seq.), for any market agency engaged in the business of selling 
consigned livestock on a commission basis, to pay, directly or 
indirectly, any personal or business expenses of livestock buyers 
attending sales conducted by such market agency. In the future, if any 
market agency engages in such practice, consideration will be given by 
the Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) to the issuance of a complaint charging the market 
agency with violation of the Act. In the formal administrative 
proceeding initiated by any such complaint, the Judicial Officer of the 
Department will determine, after full hearing, whether the market agency 
has violated the Act and should be ordered to cease and desist from 
continuing such violation, and whether the registration of such market 
agency should be suspended for a reasonable period of time.


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

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



Sec. 203.6  [Reserved]



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

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

[[Page 51]]

Packers and Stockyards Administration (Packers and Stockyards Programs) 
area office as soon as possible. However, a concerted effort on the part 
of both buyer and seller to negotiate clear and complete contracts will 
greatly reduce misunderstandings which can result in the filing of 
complaints with the Administration.
    (c) If the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) has reason to believe that any packer 
unjustifiably (1) has refused to pay the contractual price for meat or 
meat food products purchased, (2) has refused to accept a shipment of 
meat or meat food products, or (3) has failed to ship meat or meat food 
products in accordance with the terms of the contract specifications, 
consideration will be given to the issuance of a complaint charging the 
packer with violation of section 202 of the Act. In the formal 
administrative proceeding initiated by any such complaint, the Judicial 
Officer of the Department will determine, upon the basis of the record 
in the proceeding, whether the packer has violated the Act and should be 
ordered to cease and desist from continuing such violation.


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

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



Secs. 203.8--203.9  [Reserved]



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

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

[[Page 52]]

(per books); (2) amounts due a custodial account for shippers' proceeds; 
(3) accounts payable within one year from date of balance sheet; (4) 
notes payable or portions thereof due and payable within one year from 
date of balance sheet; (5) accruals such as taxes, wages, social 
security, unemployment compensation, etc., due and payable as of the 
date of the balance sheet; and (6) all other liabilities whose regular 
and ordinary liquidation is expected to occur within one year.


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

[32 FR 6901, May 5, 1967]



Sec. 203.11  [Reserved]



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

    (a) Section 304 of the Packers and Stockyards Act (7 U.S.C. 205) 
provides that: ``All stockyard services furnished pursuant to reasonable 
request made to a stockyard owner or market agency at such stockyard 
shall be reasonable and nondiscriminatory and stockyard services which 
are furnished shall not be refused on any basis that is unreasonable or 
unjustly discriminatory * * *.''
    (b) Section 305 of the Act (7 U.S.C. 206) states that: ``All rates 
or charges made for any stockyard services furnished at a stockyard by a 
stockyard owner or market agency shall be just, reasonable, and 
nondiscriminatory * * *.''
    (c) Section 307 (7 U.S.C. 208) provides that: ``It shall be the duty 
of every stockyard owner and market agency to establish, observe, and 
enforce just, reasonable, and nondiscriminatory regulations and 
practices in respect to the furnishing of stockyard services * * *.''
    (d) Section 312(a) (7 U.S.C. 213(a)) provides that: ``It shall be 
unlawful for any stockyard owner, market agency, or dealer to engage in 
or use any unfair, unjustly discriminatory, or deceptive practice or 
device in connection with determining whether persons should be 
authorized to operate at the stockyards, or with the receiving, 
marketing, buying, or selling on a commission basis or otherwise, 
feeding, watering, holding, delivery, shipment, weighing or handling, in 
commerce, of livestock.''
    (e) Section 301(b) (7 U.S.C. 201(b)) defines ``stockyard services'' 
as any ``services or facilities furnished at a stockyard in connection 
with the receiving, buying, or selling on a commission basis or 
otherwise, marketing, feeding, watering, holding, delivery, shipment, 
weighing, or handling, in commerce, of livestock.''
    (f) It is the view of the Grain Inspection, Packers and Stockyards 
Administration (Packers and Stockyards Programs) that it is a violation 
of sections 304, 307, and 312(a) of the Act for a stockyard owner or 
market agency to discriminate, in the furnishing of stockyard services 
or facilities or in establishing rules or regulations at the stockyard, 
because of race, religion, color, or national origin of those persons 
using the stockyard services or facilities. Such services and facilities 
include, but are not limited to, the restaurant, restrooms, drinking 
fountains, lounge accommodations, those furnished for the selling, 
weighing, or other handling of the livestock, and facilities for 
observing such services.
    (g) If the Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) has reason to believe that any 
stockyard owner or market agency has so discriminated in the furnishing 
of stockyard services or facilities, consideration will be given to the 
issuance of a complaint charging the stockyard or market agency with 
violations of the Act.


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

[33 FR 17621, Nov. 26, 1968]



Sec. 203.13  [Reserved]



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

                             The Guidelines

    1. Who is a customer? (a) A customer is a person who buys for resale 
directly from the

[[Page 53]]

packer, or through the packer's agent or broker; and in addition, a 
customer is any buyer of the packer's product for resale who purchases 
from or through a wholesaler or other intermediate reseller.

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

    (b) Competing customers are all businesses that compete in the 
resale of the packer's products of like grade and quality at the same 
functional level of distribution, regardless of whether they purchase 
direct from the packer or through some intermediary.
    Example: A packer sells directly to some independent retailers, 
sells to the headquarters of chains and of retailer-owned cooperatives, 
and also sells to wholesalers. The direct-buying independent retailers, 
the headquarters of chains and of retailer-owned cooperatives, and the 
wholesalers' independent retailer customers are customers of the packer. 
Individual retail outlets which are part of the chains or members of the 
retailer-owned cooperatives are not customers of the packer.

    2. Definition of services. Services are any kind of advertising or 
promotion of a packer's product, including but not limited to, 
cooperative advertising, handbills, window and floor displays, 
demonstrators and demonstrations, customer coupons, and point of 
purchase activity.

    3. Need for a plan. If a packer makes payments or furnishes 
services, it should do so under a plan that meets several requirements. 
If there are many competing customers to be considered, or if the plan 
is at all complex, the packer would be well advised to put its plan in 
writing. The requirements are:

    (a) Proportionally equal terms--The payments or services under the 
plan should be made available to all competing customers on 
proportionally equal terms. This means that payments or services should 
be made proportionately on some basis that is fair to all customers who 
compete in the resale of the packer's products. No single way to achieve 
the proper proportion is prescribed, and any method that treats 
competing customers on proportionally equal terms may be used. 
Generally, this can best be done by basing the payments made or the 
services furnished on the dollar volume or on the quantity of goods 
purchased during a specified period. Other methods which are fair to all 
competing customers are also acceptable.
     Example 1: A packer may properly offer to pay a specified part (say 
50 percent) of the cost of local advertising up to an amount equal to a 
set percentage (such as 5 percent) of the dollar volume of such 
purchases during a specified time.
    Example 2: A packer may properly place in reserve for each customer 
a specified amount of money for each unit purchased and use it to 
reimburse those customers for the cost of advertising and promoting the 
packer's product during a specified time.
    Example 3: A packer's plan should not provide an allowance on a 
basis that has rates graduated with the amount of goods purchased, as 
for instance, 1 percent of the first $1,000 purchases per month, 2 
percent on second $1,000 per month, and 3 percent on all over that.
    (b) Packer's duty to inform--The packer should take reasonable 
action, in good faith, to inform all its competing customers of the 
availability of its promotional program. Such notification should 
include all the relevant details of the offer in time to enable 
customers to make an informed judgment whether to participate. Where 
such one-step notification is impracticable, the packer may, in lieu 
thereof, maintain a continuing program of first notifying all competing 
customers of the types of promotions offered by the packer and a 
specific source for the customer to contact in order to receive full and 
timely notice of all relevant details of the packer's promotions. Such 
notice should also inform all competing customers that the packer offers 
advertising allowances and/or other promotional assistance that are 
usable in a practical business sense by all retailers regardless of 
size. When a customer indicates its desire to be put on the notification 
list, the packer should keep that customer advised of all promotions 
available in its area as long as the customer so desires. The packer may 
make the required notification by any means it chooses; but in order to 
show later that it gave notice to a certain customer, it is in a better 
position to do so if it was given in writing or a record was prepared at 
the time of notification showing date, person notified, and contents of 
notification.
    If more direct methods of notification are impracticable, a packer 
may employ one or more of the following methods, the sufficiency of 
which will depend upon the complexity of its own distribution system. 
Different packers may find that different notification methods are most 
effective for them:

[[Page 54]]

    (1) The packer may enter into contracts with its wholesaler, 
distributors or other third parties which conform to the requirements of 
item 5, infra.
    (2) The packer may place appropriate announcements on product 
containers or inside thereof with conspicuous notice of such enclosure 
on the outside.
    (3) The packer may publish notice of the availability and essential 
features of a promotional plan in a publication of general distribution 
in the trade.
    Example 1: A packer has a wholesaler-oriented plan directed to 
wholesalers distributing its products to retailing customers. It should 
notify all the competing wholesalers distributing its products of the 
availability of this plan, but the packer is not required to notify 
retailing customers.
    Example 2: A packer who sells on a direct basis to some retailers in 
an area, and to other retailers in the area through wholesalers, has a 
plan for the promotion of its products at the retail level. If the 
packer directly notifies not only all competing direct purchasing 
retailers but also all competing retailers purchasing through the 
wholesalers as to the availability, terms and conditions of the plan, 
the packer is not required to notify its wholesalers.
    Example 3: A packer regularly engages in promotional programs and 
the competing customers include large direct purchasing retailers and 
smaller customers who purchase through wholesalers. The packer may 
encourage, but not coerce, the retailer purchasing through a wholesaler 
to designate a wholesaler as its agent for receiving notice of, 
collecting, and using promotional allowances for the customer. If a 
wholesaler or other intermediary by written agreement with a retailer is 
actually authorized to collect promotional payments from suppliers, the 
packer may assume that notice of and payment under a promotional plan to 
such wholesaler or intermediary constitutes notice and payment to the 
retailer.
    (A packer should not rely on a written agreement authorizing an 
intermediary to receive notice of and/or payment under a promotional 
plan for a retailer if the packer knows, or should know, that the 
retailer was coerced into signing the agreement. In addition, a packer 
should assume that an intermediary is not authorized to receive notice 
of and/or payment under a promotional plan for a retailer unless there 
is a written authorization signed by such retailer.)
    (c) Availability to all competing customers--The plan should be such 
that all types of competing customers may participate. It should not be 
tailored to favor or discriminate against a particular customer or class 
of customers but should, in its terms, be usable in a practical business 
sense by all competing customers. This may require offering all such 
customers more than one way to participate in the plan or offering 
alternative terms and conditions to customers for whom the basic plan is 
not usable and suitable. The packer should not, either expressly or by 
the way the plan operates, eliminate some competing customers, although 
it may offer alternative plans designed for different customer classes. 
If it offers alternative plans, all of the plans offered should provide 
the same proportionate equality and the packer should inform competing 
customers of the various alternative plans.
    When a packer, in good faith, offers a basic plan, including 
alternatives, which is reasonably fair and nondiscriminatory and 
refrains from taking any steps which would prevent any customer, or 
class of customers, from participating in its program, it shall be 
deemed to have satisfied its obligation to make its plan functionally 
available to all customers, and the failure of any customer or customers 
to participate in the program shall not be deemed to place the packer in 
violation of the provisions of the Packers and Stockyards Act.
    Example 1: A packer offers a plan of short term store displays of 
varying sizes, including some which are suitable for each of its 
competing customers and at the same time are small enough so that each 
customer may make use of the promotion in a practical business sense. 
The plan also calls for uniform, reasonable certification of performance 
by the retailer. Because they are reluctant to process a reasonable 
amount of paperwork, some small retailers do not participate. This fact 
is not deemed to place a packer in violation of Item 3(c) and it is 
under no obligation to provide additional alternatives.
    Example 2: A packer offers a plan for cooperative advertising on 
radio, television, or in newspapers of general circulation.\1\ Because 
the purchases of some of its customers are too small, this offer is not 
``functionally available'' to them. The packer should offer them 
alternative(s) on proportionally equal terms that are usable by them and 
suitable for their business.
---------------------------------------------------------------------------

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

    (d) Need to understand terms--In informing customers of the details 
of a plan, the packer should provide them sufficient information to give 
a clear understanding of the exact terms of the offer, including all 
alternatives, and the conditions upon which payment will be made or 
services furnished.

[[Page 55]]

    (e) Checking customer's use of payments--The packer should take 
reasonable precautions to see that services it is paying for are 
furnished and also that it is not overpaying for them. Moreover, the 
customer should expend the allowance solely for the purpose for which it 
was given. If the packer knows or should know that what it pays or 
furnishes is not being properly used by some customers, the improper 
payments or services should be discontinued.\2\
---------------------------------------------------------------------------

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

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

[[Page 56]]

on proportionally equal terms to its competitors engaged in the resale 
of the same packer's products may be in violation of the provisions of 
the Act. Also, customers (subject to the Packers and Stockyards Act) 
that make unauthorized deductions from purchase invoices for alleged 
advertising or other promotional allowances may be proceeded against 
under the provisions of the Act.
    Example: A customer subject to the Act should not induce or receive 
an allowance in excess of that offered in the packer's advertising plan 
by billing the packer at ``vendor rates'' or for any other amount in 
excess of that authorized in the packer's promotion program.
    7. Meeting competition. A packer charged with discrimination under 
the provisions of the Packers and Stockyards Act may defend its actions 
by showing that the payments were made or the services were furnished in 
good faith to meet equally high payments made by a competing packer to 
the particular customer, or to meet equivalent services furnished by a 
competing packer to the particular customer. This defense, however, is 
subject to important limitations. For instance, it is insufficient to 
defend solely on the basis that competition in a particular market is 
very keen, requiring that special allowances be given to some customers 
if a packer is ``to be competitive.''
    8. Cost justification. It is no defense to a charge of unlawful 
discrimination in the payment of an allowance or the furnishing of a 
service for a packer to show that such payment or service could be 
justified through savings in the cost of manufacture, sale, or delivery.

(Approved by the Office of Management and Budget under control number 
0590-0001)

[58 FR 52886, Oct. 13, 1993; 58 FR 58902, Nov. 4, 1993]



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

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


(Approved by the Office of Management and Budget under control number 
0590-0001)

[54 FR 16357, Apr. 24, 1989]



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

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

    I do not intend to be present at the point of transfer of possession 
of livestock sold by me to (name of packer, market agency, or dealer) 
for the purpose of receiving a check in payment for such livestock.
    I hereby direct (name of packer, market agency, or dealer) to make 
payment for livestock purchased from me, by mailing a

[[Page 57]]

check for the full amount of the purchase price before the close of the 
next business day following the purchase of livestock and transfer of 
possession thereof or, in the case of a purchase on a ``carcass'' or 
``grade and yield'' basis, not later than the close of the first 
business day following determination of the purchase price.
    This does not constitute an extension of credit to (name of packer, 
market agency or dealer). This is subject to cancellation by me at any 
time, and if not cancelled by (date), it shall terminate on that date.


If the seller, for reasons other than not being present to receive 
payment, prefers to have the packer, market agency, or dealer make 
payment by mailing a check within the time limit as provided in section 
409(a), he may use the above form but should not include the statement 
in the first sentence that he does not intend to be present.
    (b) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) believes that such an agreement would 
not constitute an extension of credit within the meaning of section 206 
of the Act because it would not give the purchaser any more time to 
issue a check than is provided in section 409(a).

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[42 FR 49929, Sept. 28, 1977, as amended at 49 FR 39516, Oct. 9, 1984]



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

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

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 33004, Aug. 20, 1984]



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

    (a) In its administration of the Packers and Stockyards Act, the 
Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) has sought to promote and maintain open and fair 
competition in the livestock and packing industries, and to prevent 
unfair or anticompetitive practices when they are found to exist. It is 
the opinion of the Administration that the ownership or operation of 
custom feedlots by packers presents problems which may, under some 
circumstances, result in violations of the Packers and Stockyards Act.
    (b) Packers contemplating entering into such arrangements with 
custom feedlots are encouraged to consult with the Administration prior 
to the commencement of such activities. Custom feedlots are not only 
places of production, but are also important marketing

[[Page 58]]

centers, and in connection with the operation of a custom feedlot, it is 
customary for the feedlot operator to assume responsibility for 
marketing fed livestock for the accounts of feedlot customers. When a 
custom feedlot is owned or operated by a packer, and when such packer 
purchases fed livestock from the feedlot, this method of operation 
potentially gives rise to a conflict of interest. In such situations, 
the packer's interest in the fed livestock as a buyer is in conflict 
with its obligations to feedlot customers to market their livestock to 
the customer's best advantage. Under these circumstances, the packer 
should take appropriate measures to eliminate any conflict of interest. 
At a minimum, such measures should insure:
    (1) That feedlot customers are fully advised of the common ties 
between the feedlot and the packer, and of their rights and options with 
respect to the marketing of their livestock;
    (2) That all feedlot customers are treated equally by the packer/
custom feedlot in connection with the marketing of fed livestock; and
    (3) That marketing decisions rest solely with the feedlot customer 
unless otherwise expressly agreed.
    (c) Packer ownership or operation of custom feedlots may also give 
rise to competitive problems in some situations. Packers contemplating 
or engaging in the business of operating a custom feedlot should 
carefully review their operations to assure that no restriction of 
competition exists or is likely to occur.
    (d) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) does not consider the existence of 
packer/custom feedlot relationships, by itself, to constitute a 
violation of the Act. In the event it appears that a packer/custom 
feedlot arrangement gives rise to a violation of the Act, an 
investigation will be made on a case-by-case basis, and, where 
warranted, appropriate action will be taken.

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 33004, Aug. 20, 1984]



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

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

[[Page 59]]

case-by-case basis and, where warranted, appropriate action will be 
taken.

(Approved by the Office of Management and Budget under control number 
0590-0001)


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

[49 FR 32845, Aug. 17, 1984; 54 FR 26349, June 23, 1989]



PART 204--ORGANIZATION AND FUNCTIONS--Table of Contents




                           Public Information

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

    Authority: 5 U.S.C. 552.

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

                           Public Information



Sec. 204.1  Introduction.

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



Sec. 204.2  Organization.

    (a) The Grain Inspection, Packers and Stockyards Administration 
(Packers and Stockyards Programs) consists of a headquarters office 
located in the South Building of the U.S. Department of Agriculture in 
Washington, DC, and 12 regional offices. The Washington headquarters 
office is organized to include the Office of the Administrator and two 
Divisions, the Packer and Poultry Division and the Livestock Marketing 
Division.
    (b) Office of the Administrator. This office has overall 
responsibility for administering the provisions of the Packers and 
Stockyards Act, 1921, as amended and supplemented (7 U.S.C. 181 et 
seq.), for enforcement of the Truth-in-Lending Act (15 U.S.C. 1601-1665) 
with respect to any activities subject to the Packers and Stockyards Act 
and for executing assigned civil defense and defense mobilization 
activities. These responsibilities include formulation of current and 
long-range programs relating to assigned functions; execution of the 
policies and programs administered by the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards Programs); review and 
evaluation of program operations for uniform, effective, and efficient 
administration of the Packers and Stockyards Act; and maintenance of 
relations and communications with producer and industry groups.
    (1) Administrator. The Secretary of Agriculture has delegated 
responsibility for administration of the Packers and Stockyards Act to 
the Administrator who is responsible for the general direction and 
supervision of programs and activities assigned to the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
except such activities as are reserved to the Judicial Officer (32 FR 
7468). The Administrator reports to the Assistant Secretary for 
Marketing and Inspection Services.
    (2) Deputy Administrator. The Deputy Administrator assists the 
Administrator in the overall responsibility for the general direction 
and supervision of programs and activities assigned to the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (3) Assistant to the Administrator. The Assistant to the 
Administrator participates with the Administrator and Deputy 
Administrator in the development and analysis of policies and programs, 
and directs the management support services and related activities of 
the Grain Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (4) Director, Industry Analysis Staff. The Director of the Industry 
Analysis Staff participates with the Administrator and Deputy 
Administrator in

[[Page 60]]

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


[[Page 61]]


Atlanta--Room 338, 1720 Peachtree Street, NW., Atlanta, Georgia 30309 
(Alabama, Florida, Georgia, South Carolina)
Bedford--Turnpike Road, Box 101E, Bedford, Virginia 25423 (District of 
Columbia, Delaware, Maryland, North Carolina, Virginia, West Virginia)
Denver--208 Livestock Exchange Building, Denver, Colorado 80216 
(Colorado, Montana, New Mexico, Utah, Wyoming)
Fort Worth--Room 8A36, Federal Building, 819 Taylor Street, Fort Worth, 
Texas 76102 (Oklahoma, Texas)
Indianapolis--Room 434 Federal Building and U.S. Courthouse, 46 E. Ohio 
Street, Indianapolis, Indiana 46204 (Illinois, Indiana, Kentucky, 
Michigan, Ohio)
Kansas City--828 Livestock Exchange Building, Kansas City, Missouri 
64102 (Kansas, Missouri)
Lawndale--15000 Aviation Boulevard, Room 2W6, P.O. Box 6102, Lawndale, 
California 90261 (Arizona, California, Hawaii, Nevada)
Memphis--Room 459, Federal Building, 167 Main Street, Memphis, Tennessee 
38103 (Arkansas, Louisiana, Mississippi, Tennessee)
North Brunswick--825 Georges Road, Room 303, North Brunswick, New Jersey 
08902 (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New 
York, Pennsylvania, Rhode Island, Vermont)
Omaha--909 Livestock Exchange Building, Omaha, Nebraska 68107 (Iowa, 
Nebraska)
Portland--9370 S.W. Greenburg Road, Suite E, Portland, Oregon 97223 
(Alaska, Idaho, Oregon, Washington)
South St. Paul--208 Post Office Building, Box 8, South St. Paul, 
Minnesota 55075 (Minnesota, North Dakota, South Dakota, Wisconsin)



Sec. 204.3  Delegation of authority.

    (a) Deputy Administrator. Under the direction of the Administrator, 
the Deputy Administrator is hereby delegated authority to perform all 
the duties and exercise all the functions and powers which are now or 
which may hereafter be, vested in the Administrator (including the power 
of redelegation).
    (b) Division Directors. The Directors of the Industry Analysis 
Staff, the Livestock Marketing Division, and the Packer and Poultry 
Division, under administrative and technical direction of the 
Administrator and the Deputy Administrator, are hereby individually 
delegated authority, in connection with the respective functions 
assigned to each of said organizational units in Sec. 204.2 to perform 
all the duties and to exercise all the functions and powers which are 
now, or which may hereafter be, vested in the Administrator (including 
the power of redelegation) except such authority as is reserved to the 
Administrator and Deputy Administrator under paragraph (g) of this 
section.
    (c) Regional Supervisors. (1) The Regional Supervisors of the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs) are hereby individually delegated authority under 
the provisions of section 402 of the Packers and Stockyards Act, 1921, 
as amended (7 U.S.C. 222), to issue special orders pursuant to the 
provisions of section 6(b) of the Federal Trade Commission Act (15 
U.S.C. 46(b)), and, with respect thereto, to issue notices of default 
provided for in section 10 of the Federal Trade Commission Act (15 
U.S.C. 50); to notify persons deemed to be subject to the bonding 
requirements in 7 U.S.C. 204 of their obligations to file bonds or trust 
fund agreements in conformity with regulations issued under this chapter 
including authority to determine that a bond is inadequate under 
Sec. 201.30(f) of this chapter and to give notice to the person of the 
amount of bond required; to notify persons deemed to be subject to the 
reporting requirements in Sec. 201.97 of this chapter of their 
obligations to file annual reports; and to grant reasonable requests for 
extensions of 30 days or less for the filing of such annual reports.
    (2) The Regional Supervisors are hereby individually delegated 
authority, when there is reason to believe that there is a question as 
to the true ownership of livestock sold by any person, to disclose 
information relating to such questionable ownership to any interested 
person.
    (d) Investigative employees. All employees of the Grain Inspection, 
Packers and Stockyards Administration (Packers and Stockyards Programs) 
assigned to or responsible for investigations in the enforcement of the 
Packers and Stockyards Act, 1921, as amended (7 U.S.C. 181 et seq.), or 
the enforcement of the Truth-in-Lending Act (15 U.S.C. 1601-1665), with 
respect to any activities subject to the Packers

[[Page 62]]

and Stockyards Act, are hereby individually delegated authority under 
the Act of January 31, 1925, 43 Stat. 803, 7 U.S.C. 2217, to administer 
to or take from any person an oath, affirmation, or affidavit whenever 
such oath, affirmation, or affidavit is for use in any prosecution or 
proceeding under or in the enforcement of the aforementioned Acts. This 
authority may not be redelegated and will automatically expire upon the 
termination of the employment of such employees with the Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs).
    (e) Concurrent authority. No delegation prescribed herein shall 
preclude the Administrator or Deputy Administrator from exercising any 
of the powers or functions or from performing any of the duties 
conferred upon them, and any such delegation is subject at all times to 
withdrawal or amendment by the Administrator or Deputy Administrator or 
the Division Director responsible for the function involved.
    (f) Prior delegations. All prior delegations and redelegations of 
authority relating to any function or activity covered by these 
delegations of authority shall remain in effect except as they are 
inconsistent herewith or are hereafter amended or revoked. Nothing 
herein shall affect the validity of any action heretofore taken under 
prior delegations or redelegations of authority or assignment of 
functions.
    (g) Reservations of authority. It is hereby reserved to the 
Administrator and Deputy Administrator authority with respect to 
proposed rulemaking and final action for the issuance of regulations 
(Sec. 201.1 of this chapter et seq.), rules of practice governing 
proceedings (Sec. 202.1 of this chapter et seq.), and statements of 
general policy (Sec. 203.1 of this chapter et seq.), and the issuance of 
moving papers as prescribed in the rules of practice governing formal 
adjudicatory administrative proceedings instituted by the Secretary (7 
CFR part 1, subpart H, Sec. 1.133); and the authority to make final 
determinations in accordance with the provisions of 7 CFR part 1, 
subpart A, as to the availability of official records and information 
made or obtained in connection with the administration of the Packers 
and Stockyards Act which are considered exempt from disclosure under 
Sec. 204.7 of this part. Further, authority to issue subpoenas (7 U.S.C. 
222 and 15 U.S.C. 49) is reserved to the Administrator and Deputy 
Administrator.



Sec. 204.4  Public inspection and copying.

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



Sec. 204.5  Indexes.

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



Sec. 204.6  Requests for records.

    (a) Requests for records under 5 U.S.C. 552(a)(3) shall be made in 
accordance with 7 CFR 1.3(a). Authority to make determinations regarding 
initial requests in accordance with 7 CFR 1.4(c) is delegated to the 
Freedom of Information Act Officer of the Grain Inspection, Packers and 
Stockyards Administration (Packers and Stockyards

[[Page 63]]

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



Sec. 204.7  Appeals.

    Any person whose request under Sec. 204.6 of this part is denied 
shall have the right to appeal such denial in accordance with 7 CFR 
1.3(e). Appeals shall be addressed to the Administrator, Grain 
Inspection, Packers and Stockyards Administration (Packers and 
Stockyards Programs), U.S. Department of Agriculture, Washington, DC 
20250.



PART 205--CLEAR TITLE--PROTECTION FOR PURCHASERS OF FARM PRODUCTS--Table of Contents




                               Definitions

Sec.
205.1  Definitions.

                               Regulations

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

                          Interpretive Opinions

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

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

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

                               Definitions



Sec. 205.1  Definitions.

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

[[Page 64]]

    (i) UCC or Uniform Commercial Code means the Uniform Commercial Code 
prepared under the joint sponsorship of the American Law Institute and 
the National Conference of Commissioners on Uniform State Laws, and in 
effect in most States of the United States at the time of enactment of 
Pub. L. 99-198.

                               Regulations



Sec. 205.101  Certification--request and processing.

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

[[Page 65]]

must contain relevant new information consistent with the requirements 
specified elsewhere in this section.

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



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

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



Sec. 205.103  EFS--minimum information.

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



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

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



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

    (a) The master list must contain all the information on all the 
EFS's filed in the system, so arranged that it is possible to deliver to 
any registrant all such information relating to any product, produced in 
any county or parish (or all counties or parishes), for any crop year, 
covered by the system. The system must be able to deliver all such 
information to any registrant, either in alphabetical order by the word 
appearing first in the name of each person subjecting a product to a 
security interest (see Sec. 205.102), in numerical order by social 
security number (or, if other than a natural person, IRS taxpayer 
identification number) of each such person, or in both alphabetical and 
numerical orders, as requested by the registrant.
    (b) Section (c)(2)(E) requires the portion to be distributed in 
``written or printed form.'' This means recording on paper by any 
technology in a form that can be read by humans without special 
equipment. The system may, however, honor requests from registrants to 
substitute recordings on

[[Page 66]]

any medium by any technology including, but not limited to, electronic 
recording on tapes or discs in machine-readable form, and on 
photographic recording on microfiche. It also includes, if requested by 
registrants, electronic transmissions whereby registrants can print 
their own paper copies.
    (c) After distribution of a portion of a master list, there can be 
supplementary distribution of a portion showing only changes from the 
previous one. However, if this is done, cumulative supplements must be 
distributed often enough that readers can find all the information given 
to them for any one crop year in no more than three distributions.

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



Sec. 205.106  Farm products.

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



Sec. 205.107  Crop year.

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

                          Interpretive opinions



Sec. 205.201  System operator.

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



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

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

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

[[Page 67]]



Sec. 205.203  Place of filing EFS.

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



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

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



Sec. 205.205  Fees.

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



Sec. 205.206  Farm products.

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

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



[[Page 68]]


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



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

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



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

    (a) The provisions in the Section regarding registration of ``buyers 
of farm products, commission merchants, and selling agents,'' 
``regular'' distribution of ``portions'' of the master list, furnishing 
of ``oral confirmation * * * on request,'' and the effect of all this, 
that is, subsections (c)(2) (D), (E) and (F), (e) (2) and (3), and 
(g)(2) (C) and (D), must be read together.
    (b) The Section does not require such persons to register. Not 
registering with a particular system operator has the effect, under 
subsections (e)(2) and (g)(2)(C), of making such persons, whether they 
are inside or outside the State covered by that system, subject to 
security interests shown on that system's master list whether or not 
such persons know about them, so that such persons for their own 
protection will need to query the system operator about any seller 
``engaged in farming operations,'' of a farm product produced in the 
State covered by that system, with whom they deal.
    (c) The effect of registration by such persons with a particular 
system is to get them on the list for regular distribution of portions 
of that system's master list, the portions to be determined by the 
registration. They are subject only to security interests shown on the 
portions which they receive, and are not subject to such interests as 
are shown on the master list but not shown on portions which they 
receive. Also, if a particular security interest is shown on the master 
list, but has been placed on it since the last regular distribution of 
portions of that list to registrants, registrants would not be subject 
to that security interest. These conclusions are based on the provisions 
in subsections (e)(3)(A) and (g)(2)(D)(i) that such persons are subject 
to a security interest only if they receive ``written notice * * * that 
specifies both the seller and the farm product.''

[[Page 69]]

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

[[Page 70]]



Sec. 205.209  Amendment or continuation of EFS.

    (a) The ``material change,'' required by subsection (c)(4)(E) to be 
reflected in an amendment to an EFS and master list entry, is whatever 
change would render the master list entry no longer informative as to 
what is subject to the security interest in question. That will vary 
from case to case. The basis for this is the purpose for which the 
information is supplied, that is, to make information available, to a 
buyer, commission merchant, or selling agent who proposes to enter into 
a transaction in a product, whether it is subject to a security 
interest. The requirement to amend arises when the information already 
made available no longer serves the purpose and other information is 
needed in order to do so.
    (b) Where an owner of a product makes a change, such as planting a 
different crop or purchasing different animals from what was 
represented, without informing the secured party, so that the master 
list entry is rendered not informative, but the EFS and master list are 
not amended through no fault of the secured party, the Section is silent 
as to the consequences. However, see the legislative history cited in 
Sec. 205.208(f).
    (c) The amendment must be filed in the same manner as the original 
filing. Note the requirement of section (c)(4)(E). The amendment may be 
filed electronically provided a State allows electronic filing of 
financing statements without the signature of the debtor under 
applicable State law under provisions of the Uniform Commercial Code. An 
electronically filed amendment need not be signed. However, if an 
original or reproduced paper document is filed, the amendment must be 
signed by the secured party and the debtor, and be filed by the secured 
party.
    (d) An effective financing statement remains effective for a period 
of 5 years from the date of filing and may be continued in increments of 
5-year periods beyond the initial 5-year filing period by refiling an 
effective financing statement or by filing a continuation statement 
within 6 months before expiration of the effective financing statement. 
A continuation statement may be filed electronically or as a paper 
document, and need not contain the signature of the debtor.

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



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

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



Sec. 205.211  Applicability of court decisions under the UCC.

    (a) Court decisions under the Uniform Commercial Code (UCC), about 
the scope of the ``farm products'' exception in Section 9-307(1) 
thereof, and interpreting the terms therein, particularly ``person 
engaged in farming operations'' which is not defined in the Section, are 
applicable to an extent in interpreting the Section. The basis of

[[Page 71]]

this is the legislative intent of the Section to pre-empt State laws 
reflecting that ``farm products'' exception, as shown in the House 
Committee Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 
1985, at pages 108 et seq.
    (b) That UCC Section 9-307(1) reads as follows:

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



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

    The terms ``buyer in ordinary course of business'' and ``security 
interest'' are defined in subsections (c) (1) and (7). There are 
differences between those definitions and the UCC definitions of the 
same terms. In interpreting those differences, the following would be 
pertinent:
    (a) The legislative intent discussed above in Sec. 205.211, to pre-
empt State laws reflecting the ``farm products'' exception; and
    (b) The legislative intent shown in subsections (a) and (b) that 
certain persons take free and clear of certain interests of a ``secured 
lender'' ``when the seller fails to repay the lender,'' unless such 
persons have information about such interests made available to them as 
provided in the Section.



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

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



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

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

[[Page 72]]

would be in doubt as to whether they could safely rely on the same 
system.

[[Page 73]]



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




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

 SUBCHAPTER A--AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND 
 POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION
Part                                                                Page
300             Agency mission and organization.............          75
301             Definitions.................................          76
302             Application of inspection and other 
                    requirements............................          83
303             Exemptions..................................          83
304             Application for inspection; grant of 
                    inspection..............................          92
305             Official numbers; inauguration of 
                    inspection; withdrawal of inspection; 
                    reports of violation....................          94
306             Assignment and authorities of program 
                    employees...............................          95
307             Facilities for inspection...................          96
308             Sanitation..................................         101
309             Ante-mortem inspection......................         107
310             Post-mortem inspection......................         114
311             Disposal of diseased or otherwise 
                    adulterated carcasses and parts.........         132
312             Official marks, devices and certificates....         141
313             Humane slaughter of livestock...............         146
314             Handling and disposal of condemned or other 
                    inedible products at official 
                    establishments..........................         152
315             Rendering or other disposal of carcasses and 
                    parts passed for cooking................         156
316             Marking products and their containers.......         156
317             Labeling, marking devices, and containers...         162
318             Entry into official establishments; 
                    reinspection and preparation of products         237
319             Definitions and standards of identity or 
                    composition.............................         319
320             Records, registration, and reports..........         339
321             Cooperation with States and territories.....         342
322             Exports.....................................         342
325             Transportation..............................         344

[[Page 74]]

327             Imported products...........................         355
329             Detention; seizure and condemnation; 
                    criminal offenses.......................         374
331             Special provisions for designated States and 
                    Territories; and for designation of 
                    establishments which endanger public 
                    health and for such designated 
                    establishments..........................         376
335             Rules of practice governing proceedings 
                    under the Federal Meat Inspection Act...         382
350             Special services relating to meat and other 
                    products................................         386
351             Certification of technical animal fats for 
                    export..................................         389
352             Exotic animals; voluntary inspection........         396
354             Voluntary inspection of rabbits and edible 
                    products thereof........................         403
355             Certified products for dogs, cats, and other 
                    carnivora; inspection, certification, 
                    and identification as to class, quality, 
                    quantity, and condition.................         428
362             Voluntary poultry inspection regulations....         439
381             Poultry products inspection regulations.....         444
                       SUBCHAPTERS B-C [RESERVED]
    SUBCHAPTER D--FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE 
                               PROVISIONS
390             Freedom of information......................         672
391             Fees and charges for inspection services and 
                    laboratory accreditation................         674
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
               ACT AND THE POULTRY PRODUCTS INSPECTION ACT
416             Sanitation..................................         675
417             Hazard Analysis and Critical Control Point 
                    (HACCP) Systems.........................         679
500             Rules of Practice...........................         723
                SUBCHAPTER I--EGG PRODUCTS INSPECTION ACT
590             Inspection of eggs and egg products (Egg 
                    Products Inspection Act)................         727

[[Page 75]]





 SUBCHAPTER A--AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND 
 POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION


PART 300--AGENCY MISSION AND ORGANIZATION--Table of Contents




Sec.
300.1  Purpose.
300.2  FSIS responsibilities.
300.3  FSIS organization.
300.6  Access to establishments and other places of business.


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

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



Sec. 300.1  Purpose.

    This part describes the duties and organization of the Food Safety 
and Inspection Service (FSIS), an agency of the United States Department 
of Agriculture (USDA).



Sec. 300.2  FSIS responsibilities.

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



Sec. 300.3  FSIS organization.

    (a) General. The organization of FSIS reflects the agency's primary 
regulatory responsibilities: implementation of the FMIA, the PPIA, and 
the EPIA.
    (b) Headquarters. FSIS has four principal components or offices, 
each of which is under the direction of a Deputy Administrator. The 
Deputy Administrators, along with their staffs, and the Administrator, 
along with the Office of the Administrator and three staff offices that 
report to the Administrator, are located at U.S. Department of 
Agriculture headquarters in Washington, DC.
    (1) Program offices. FSIS's headquarters offices are the Office of 
Public Health and Science, which provides scientific analysis, advice, 
data, and recommendations on matters involving public health and 
science; the Office of Management, which provides centralized 
administrative and support services; the Office of Policy, Program 
Development and Evaluation, which develops and recommends domestic and 
international policy activities; and the Office of Field Operations, 
which manages regulatory oversight and inspection (see paragraph (c) of 
this section).

[[Page 76]]

    (2) Staff offices. The Administrator's staff offices are the Food 
Safety Executive Management and Coordination Staff, the Legislative 
Liaison Staff, and the Food Safety Education and Communications Staff.
    (c) Field. FSIS's field structure consists of eighteen district 
offices and a technical center.
    (1) District offices. Each district office, under the direction of a 
District Manager, manages a farm-to-table food safety program of 
regulatory oversight and inspection in a district consisting of a State 
or several States and territories.
    The locations of the district offices and the districts' geographic 
boundaries are as follows:

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

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



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

    (a) General. Upon presentation of credentials--
    (1) Persons subject to provisions of the FMIA or the PPIA must 
afford representatives of the Secretary access to establishments that 
slaughter or otherwise prepare livestock products or process poultry 
products and to other places of business subject to regulation 
thereunder; and
    (2) Persons subject to provisions of the EPIA must afford 
representatives of the Secretary access as specified in part 590 of this 
chapter.
    (b) [Reserved]



PART 301--DEFINITIONS--Table of Contents




Sec.
301.1  Meaning of terms.
301.2  Definitions.

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



Sec. 301.1  Meaning of terms.

    As used in this subchapter, unless otherwise required by the 
context, the singular form shall also import the plural and the 
masculine form shall also import the feminine, and vice versa.

[35 FR 15554, Oct. 3, 1970]



Sec. 301.2  Definitions.

    As used in this subchapter, unless otherwise required by the 
context, the following terms shall be construed, respectively, to mean:
    The Act. The Federal Meat Inspection Act, as amended, (34 Stat. 
1260, as amended, 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 21 U.S.C., 
sec. 601 et seq.).

[[Page 77]]

    Administrator. The Administrator of the Food Safety and Inspection 
Service or any officer or employee of the Department to whom authority 
has heretofore been delegated or may hereafter be delegated to act in 
his/her stead.
    Adulterated. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If it bears or contains any such poisonous or deleterious 
substance which may render it injurious to health; but in case the 
substance is not an added substance, such article shall not be 
considered adulterated under this clause if the quantity of such 
substance in or on such article does not ordinarily render it injurious 
to health;
    (2)(i) If it bears or contains (by reason of administration of any 
substance to the live animal or otherwise) any added poisonous or added 
deleterious substance (other than one which is:
    (A) A pesticide chemical in or on a raw agricultural commodity;
    (B) A food additive; or
    (C) A color additive which may, in the judgment of the 
Administrator, make such article unfit for human food;
    (ii) If it is, in whole or in part, a raw agricultural commodity and 
such commodity bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408 of the Federal Food, Drug, and 
Cosmetic Act;
    (iii) If it bears or contains any food additive which is unsafe 
within the meaning of section 409 of the Federal Food, Drug, and 
Cosmetic Act;
    (iv) If it bears or contains any color additive which is unsafe 
within the meaning of section 706 of the Federal Food, Drug, and 
Cosmetic Act: Provided, That an article which is not deemed adulterated 
under paragraphs (aa)(2) (ii), (iii), or (iv) of this section shall 
nevertheless be deemed adulterated if use of the pesticide chemical food 
additive, or color additive in or on such article is prohibited by the 
regulations in this subchapter in official establishments;
    (3) If it consists in whole or in part of any filthy, putrid, or 
decomposed substance or is for any other reason unsound, unhealthful, 
unwholesome, or otherwise unfit for human food;
    (4) If it has been prepared, packed, or held under unsanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health;
    (5) If it is, in whole or in part, the product of an animal which 
has died otherwise than by slaughter;
    (6) If its container is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the contents 
injurious to health;
    (7) If it has been intentionally subjected to radiation, unless the 
use of the radiation was in conformity with a regulation or exemption in 
effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic 
Act;
    (8) If any valuable constituent has been in whole or in part omitted 
or abstracted therefrom; or if any substance has been substituted, 
wholly or in part therefor; or if damage or inferiority has been 
concealed in any manner; or if any substance has been added thereto or 
mixed or packed therewith so as to increase its bulk or weight, or 
reduce its quality or strength, or make it appear better or of greater 
value than it is; or,
    (9) If it is margarine containing animal fat and any of the raw 
material used therein consisted in whole or in part of any filthy, 
putrid, or decomposed substance, or is otherwise adulterated.
    Anesthesia. Loss of sensation or feeling.
    Animal food. Any article intended for use as food for dogs, cats, or 
other animals derived wholly, or in part, from the carcass or parts or 
products of the carcass of any livestock, except that the term animal 
food as used herein does not include:
    (1) Processed dry animal food or
    (2) Livestock or poultry feeds manufactured from processed livestock 
byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and 
feed grade animal fat).
    Animal food manufacturer. Any person engaged in the business of 
manufacturing or processing animal food.
    Area. One or more circuits under the supervision of an area 
supervisor.
    Area Supervisor. The official in charge of an area.

[[Page 78]]

    Artificial coloring. A coloring containing any dye or pigment, which 
dye or pigment was manufactured by a process of synthesis or other 
similar artifice, or a coloring which was manufactured by extracting a 
natural dye or natural pigment from a plant or other material in which 
such dye or pigment was naturally produced.
    Artificial flavoring. A flavoring containing any sapid or aromatic 
constituent, which constituent was manufactured by a process of 
synthesis or other similar artifice.
    Biological residue. Any substance, including metabolites, remaining 
in livestock at time of slaughter or in any of its tissues after 
slaughter as the result of treatment or exposure of the livestock to a 
pesticide, organic or inorganic compound, hormone, hormone-like 
substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or 
other therapeutic or prophylactic agent.
    Capable of use as human food. This term applies to any carcass, or 
part or product of a carcass, of any livestock, unless it is denatured 
or otherwise identified as required by the applicable provisions of 
Secs. 314.3, 314.10, 325.11, and 325.13 of this subchapter to deter its 
use as a human food, or it is naturally inedible by humans; e.g., hoofs 
or horns in their natural state.
    Captive bolt. A stunning instrument which when activated drives a 
bolt out of a barrel for a limited distance.
    Carbon dioxide. A gaseous form of the chemical formula 
CO2.
    Carbon dioxide concentration. Ratio of carbon dioxide gas and 
atmospheric air.
    Carcass. All parts, including viscera, of any slaughtered livestock.
    Chemical preservative. Any chemical that, when added to a meat or 
meat food product, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices or substances added to meat and meat food products 
by exposure to wood smoke.
    Other definitions, if any, that are applicable only for purposes of 
a specific part of the regulations in this subchapter, are set forth in 
such part.
    Circuit. One or more official establishments included under the 
supervision of a circuit supervisor.
    Circuit supervisor. The supervisor of a circuit.
    Commerce. Commerce between any State, any Territory, or the District 
of Columbia, and any place outside thereof; or within any Territory not 
organized with a legislative body, or the District of Columbia.
    Consciousness. Responsiveness of the brain to the impressions made 
by the senses.
    Cutting up. Any division of any carcass or part thereof, except that 
the trimming of carcasses or parts thereof to remove surface 
contaminants is not considered as cutting up.
    Dead livestock. The body (cadaver) of livestock which has died 
otherwise than by slaughter.
    The Department. The United States Department of Agriculture.
    Dying, diseased, or disabled livestock. Livestock which has or 
displays symptoms of having any of the following:
    (1) Central nervous system disorder;
    (2) Abnormal temperature (high or low);
    (3) Difficult breathing;
    (4) Abnormal swellings;
    (5) Lack of muscular coordination;
    (6) Inability to walk normally or stand;
    (7) Any of the conditions for which livestock is required to be 
condemned on ante-mortem inspection in accordance with the regulations 
in part 309 of this subchapter.
    Edible. Intended for use as human food.
    Experimental animal. Any animal used in any research investigation 
involving the feeding or other administration of, or subjection to, an 
experimental biological product, drug, or chemical or any 
nonexperimental biological product, drug, or chemical used in a manner 
for which it was not intended.
    Exposure time. The period of time an animal is exposed to an 
anesthesia-producing carbon dioxide concentration.
    Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved 
June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or 
supplementary thereto.

[[Page 79]]

    Firm. Any partnership, association, or other unincorporated business 
organization.
    Food Safety and Inspection Service. The Food Safety and Inspection 
Service of the Department.
    Further processing. Smoking, cooking, canning, curing, refining, or 
rendering in an official establishment of product previously prepared in 
official establishments.
    Immediate container. The receptacle or other covering in which any 
product is directly contained or wholly or partially enclosed.
    Import Field Office (IFO). The office of the supervisor of import 
inspection activities for a particular importing field area. The areas 
are as follows:

    IFO #1. Boston, MA--Covering the States of Massachusetts, New York 
(excluding New York City), Connecticut, Rhode Island, Vermont, New 
Hampshire and Maine.
    IFO #2. New York, NY--Covering the areas of New York City and 
northern New Jersey.
    IFO #3. Philadelphia, PA--Covering the State of Pennsylvania and the 
area of southern New Jersey.
    IFO #4. Baltimore, MD--Covering the States of Maryland, Delaware, 
West Virginia, Virginia and Kentucky.
    IFO #5. Charleston, SC--Covering the States of Tennessee, North 
Carolina, South Carolina, Georgia and Florida (excluding south Florida).
    1IFO 6. Miami, FL--Covering the areas of southern Florida, Puerto 
Rico and the Virgin Islands.
    1IFO 7. New Orleans, LA--Covering the States of Louisiana, 
Mississippi, Alabama, Arkansas, Texas, Oklahoma, Kansas, New Mexico and 
Colorado.
    1IFO 8. San Pedro, CA--Covering the States of Hawaii, Arizona, 
Utah, Nevada, the area of southern California, American Samoa, Guam, and 
the Northern Marianas.
    1IFO 9. Tacoma, WA--Covering the States of Washington, Oregon, 
Idaho, Montana, Wyoming, North Dakota, South Dakota, Alaska, and 
Nebraska, and the area of northern California.
    1IFO 10. Detroit, MI--Covering the States of Michigan, Wisconsin, 
Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio.

    Import Supervisor. The official in charge of import inspection 
activities within each of the import field offices.
    Inedible. Adulterated, uninspected, or not intended for use as human 
food.
    Inhumane slaughter or handling in connection with slaughter. 
Slaughter or handling in connection with slaughter not in accordance 
with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 through 
1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 
Stat. 1069) and part 313 of this subchapter.
    ``Inspected and passed'' or ``U.S. Inspected and Passed'' or ``U.S. 
Inspected and Passed by Department of Agriculture'' (or any authorized 
abbreviation thereof). This term means that the product so identified 
has been inspected and passed under the regulations in this subchapter, 
and at the time it was inspected, passed, and identified, it was found 
to be not adulterated.
    Inspector. An inspector of the Program.
    Inspector in charge. A designated program employee who is in charge 
of one or more official establishments within a circuit and is 
responsible to the circuit supervisor or his/her designee.
    Label. A display of written, printed, or graphic matter upon the 
immediate container (not including package liners) of any article.
    Labeling. All labels and other written, printed, or graphic matter:
    (1) Upon any article or any of its containers or wrappers, or
    (2) Accompanying such article.
    Livestock. Cattle, sheep, swine, goat, horse, mule, or other equine.
    Meat. (1) The part of the muscle of any cattle, sheep, swine, or 
goats, which is skeletal or which is found in the tongue, in the 
diaphragm, in the heart, or in the esophagus, with or without the 
accompanying and overlying fat, and the portions of bone, skin, sinew, 
nerve, and blood vessels which normally accompany the muscle tissue and 
which are not separated from it in the process of dressing. It does not 
include the muscle found in the lips, snout, or ears. This term, as 
applied to products of equines, shall have a meaning comparable to that 
provided in this paragraph with respect to cattle, sheep, swine, and 
goats.
    (2) The product derived from the mechanical separation of the 
skeletal muscle tissue from the bones of livestock using the advances in 
mechanical meat/bone separation machinery and meat recovery systems that 
do not crush, grind, or pulverize bones, and

[[Page 80]]

from which the bones emerge comparable to those resulting from hand-
deboning (i.e., essentially intact and in natural physical conformation 
such that they are recognizable, such as loin bones and rib bones, when 
they emerge from the machinery) which meets the criteria of no more than 
0.15 percent or 150 mg/100 gm of product for calcium (as a measure of 
bone solids content) within a tolerance of 0.03 percent or 30 mg.
    Meat broker. Any person engaged in the business of buying or selling 
carcasses, parts of carcasses, meat or meat food products of livestock 
on commission, or otherwise negotiating purchases or sales of such 
articles other than for his/her own account or as an employee of another 
person.
    Meat byproduct. Any part capable of use as human food, other than 
meat, which has been derived from one or more cattle, sheep, swine, or 
goats. This term, as applied to products of equines, shall have a 
meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Meat food product. Any article capable of use as human food which is 
made wholly or in part from any meat or other portion of the carcass of 
any cattle, sheep, swine, or goats, except those exempted from 
definition as a meat food product by the Administrator in specific cases 
or by the regulations in part 317 of this subchapter, upon a 
determination that they contain meat or other portions of such carcasses 
only in a relatively small proportion or historically have not been 
considered by consumers as products of the meat food industry, and 
provided that they comply with any requirements that are imposed in such 
cases or regulations as conditions of such exemptions to assure that the 
meat or other portions of such carcasses contained in such articles are 
not adulterated and that such articles are not represented as meat food 
products. This term, as applied to food products of equines, shall have 
a meaning comparable to that provided in this paragraph with respect to 
cattle, sheep, swine, and goats.
    Misbranded. This term applies to any carcass, part thereof, meat or 
meat food product under one or more of the following circumstances:
    (1) If its labeling is false or misleading in any particular;
    (2) If it is offered for sale under the name of another food;
    (3) If it is an imitation of another food, unless its label bears, 
in type of uniform size and prominence, the word ``imitation'' and 
immediately thereafter, the name of the food imitated;
    (4) If its container is so made, formed, or filled as to be 
misleading;
    (5) If in a package or other container unless it bears a label 
showing:
    (i) The name and place of business of the manufacturer, packer, or 
distributor; and
    (ii) An accurate statement of the quantity of the contents in terms 
of weight, measure, or numerical count; except as otherwise provided in 
part 317 of this subchapter with respect to the quantity of contents;
    (6) If any word, statement, or other information required by or 
under authority of the Act to appear on the label or other labeling is 
not prominently placed thereon with such conspicuousness (as compared 
with other words, statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use;
    (7) If it purports to be or is represented as a food for which a 
definition and standard of identity or composition has been prescribed 
by the regulations in part 319 of this subchapter unless:
    (i) It conforms to such definition and standard, and
    (ii) Its label bears the name of the food specified in the 
definition and standard and, insofar as may be required by such 
regulations, the common names of optional ingredients (other than 
spices, flavoring, and coloring) present in such food;
    (8) If it purports to be or is represented as a food for which a 
standard or standards of fill of container have been prescribed by the 
regulations in part 319 of this subchapter, and it falls below the 
standard of fill of container applicable thereto, unless its label 
bears, in such manner and form as such

[[Page 81]]

regulations specify, a statement that it falls below such standard;
    (9) If it is not subject to the provisions of paragraph (vv)(7)(ii) 
of this section unless its label bears:
    (i) The common or usual name of the food, if any there be, and
    (ii) In case it is fabricated from two or more ingredients, the 
common or usual name of each such ingredient, except as otherwise 
provided in part 317 of this subchapter;
    (10) If it purports to be or is represented for special dietary 
uses, unless its label bears such information concerning its vitamin, 
mineral, and other dietary properties as is required by the regulations 
in part 317 of this subchapter.
    (11) If it bears or contains any artificial flavoring, artificial 
coloring, or chemical preservative, unless it bears a label stating that 
fact; except as otherwise provided by the regulations in part 317 of 
this subchapter; or
    (12) If it fails to bear, directly thereon or on its containers, 
when required by the regulations in part 316 or 317 of this subchapter, 
the inspection legend and, unrestricted by any of the foregoing, such 
other information as the Administrator may require in such regulations 
to assure that it will not have false or misleading labeling and that 
the public will be informed of the manner of handling required to 
maintain the article in a wholesome condition.
    Nonfood compound. Any substance proposed for use in official 
establishments, the intended use of which will not result, directly or 
indirectly, in the substance becoming a component or otherwise affecting 
the characteristics of meat food and meat products, excluding labeling 
and packaging materials as covered in part 317 of the subchapter.
    Official certificate. Any certificate prescribed by the regulations 
in this subchapter for issuance by an inspector or other person 
performing official functions under the Act.
    Official device. Any device prescribed by the regulations in part 
312 of this subchapter for use in applying any official mark.
    Official establishment. Any slaughtering, cutting, boning, meat 
canning, curing, smoking, salting, packing, rendering, or similar 
establishment at which inspection is maintained under the regulations in 
this subchapter.
    Official import inspection establishment. This term means any 
establishment, other than an official establishment as defined in 
paragraph (zz) of this section, where inspections are authorized to be 
conducted as prescribed in Sec. 327.6 of this subchapter.
    Official inspection legend. Any symbol prescribed by the regulations 
in this subchapter showing that an article was inspected and passed in 
accordance with the Act.
    Official mark. The official inspection legend or any other symbol 
prescribed by the regulations in this subchapter to identify the status 
of any article or animal under the Act.
    Packaging material. Any cloth, paper, plastic, metal, or other 
material used to form a container, wrapper, label, or cover for meat 
products.
    Person. Any individual, firm, or corporation.
    Pesticide chemical, food additive, color additive, raw agricultural 
commodity. These terms shall have the same meanings for purposes of the 
Act and the regulations in this subchapter as under the Federal Food, 
Drug, and Cosmetic Act.
    Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or 
otherwise manufactured or processed.
    Process authority. A person or organization with expert knowledge in 
meat production process control and relevant regulations. This 
definition does not apply to subpart G of part 318.
    Process schedule. A written description of processing procedures, 
consisting of any number of specific, sequential operations directly 
under the control of the establishment employed in the manufacture of a 
specific product, including the control, monitoring, verification, 
validation, and corrective action activities associated with production. 
This definition does not apply to subpart G of part 318.
    Product. Any carcass, meat, meat byproduct, or meat food product, 
capable of use as human food.
    Program. The organizational unit within the Department having the 
responsibility for carrying out the provisions of the Act.

[[Page 82]]

    Program employee. Any inspector or other individual employed by the 
Department or any cooperating agency who is authorized by the Secretary 
to do any work or perform any duty in connection with the Program.
    Regional Director. The official \1\ in charge of the program within 
each of the following regions:
---------------------------------------------------------------------------

    \1\ The addresses of the Regional Directors are as follows:
    Northeastern Region--Seventh Floor, 1421 Cherry Street, 
Philadelphia, PA 19102.
    Southeastern Region--Room 299 South, 1718 Peachtree Street, NW., 
Atlanta, GA 30309.
    North Central Region--607 East Second Street, Des Moines, IA 50309.
    Southwestern Region--Room 5-F41, 1100 Commerce Street, Dallas, TX 
75201.
    Western Region--Room 620 Central Avenue, Building 2C, Alameda, CA 
94501.

    Northeastern Region--Connecticut, Delaware, District of Columbia, 
Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, 
Pennsylvania, Rhode Island, Vermont, and Virginia (except for 
Northwestern part).
    Southeastern Region-- Alabama, Florida, Georgia, Kentucky, 
Mississippi, North Carolina, South Carolina, Tennessee, Virginia 
(Northwestern), West Virginia, Puerto Rico, and the Virgin Islands.
    North Central Region-- Illinois, Indiana, Iowa, Michigan, Minnesota, 
Ohio, and Wisconsin.
    Southwestern Region-- Arkansas, Kansas, Louisiana, Missouri, 
Nebraska, New Mexico, Oklahoma, and Texas.
    Western Region-- Alaska, Arizona, California, Colorado, Hawaii, 
Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, 
Washington, and Wyoming, American Samoa, Guam, and the Northern Mariana 
Islands.

    Renderer. Any person engaged in the business of rendering carcasses 
or parts or products of the carcasses of any livestock except rendering 
conducted under inspection or exemption under Title I of the Act.
    Secretary. The Secretary of Agriculture of the United States or his/
her delegate.
    Shipping container. The outside container (box, bag, barrel, crate, 
or other receptacle or covering) containing or wholly or partly 
enclosing any product packed in one or more immediate containers.
    State. Any State of the United States or the Commonwealth of Puerto 
Rico.
    Supervision. The controls, as prescribed in instructions to Program 
employees, to be exercised by them over particular operations to insure 
that such operations are conducted in compliance with the Act and the 
regulations in this subchapter.
    Surgical anesthesia. A state of unconsciousness measured in 
conformity with accepted surgical practices.
    Territory. Guam, the Virgin Islands of the United States, American 
Samoa, and any other territory or possession of the United States, 
excluding the Canal Zone.
    U.S. Condemned. This term means that the livestock so identified has 
been inspected and found to be in a dying condition, or to be affected 
with any other condition or disease that would require condemnation of 
its carcass.
    U.S. Inspected and Condemned (or any authorized abbreviation 
thereof). This term means that the carcass, viscera, other part of 
carcass, or other product so identified has been inspected, found to be 
adulterated, and condemned under the regulations in this subchapter.
    U.S. Passed for Cooking. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be cooked or rendered as prescribed by the regulations in part 315 of 
this chapter.
    U.S. Passed for Refrigeration. This term means that the meat or meat 
byproduct so identified has been inspected and passed on condition that 
it be refrigerated or otherwise handled as prescribed by the regulations 
in part 311 of this subchapter.
    U.S. Retained. This term means that the carcass, viscera, other part 
of carcass, or other product, or article so identified is held for 
further examination by an inspector to determine its disposal.
    U.S. Suspect. This term means that the livestock so identified is 
suspected of being affected with a disease or condition which may 
require its condemnation, in whole or in part, when slaughtered, and is 
subject to further examination by an inspector to determine its 
disposal.

[[Page 83]]

    United States. The States, the District of Columbia, and the 
Territories of the United States.

[35 FR 15554, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 301.2, 
see the List of CFR Sections Affected in the Finding Aids section of 
this volume.



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




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

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



Sec. 302.1  Establishments requiring inspection.

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

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



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

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

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



Sec. 302.3  Livestock and products entering official establishments.

    All livestock and all products entering any official establishment 
and all products prepared, in whole or in part, therein, shall be 
inspected, handled, stored, prepared, packaged, marked, and labeled as 
required by the regulations in this subchapter.

[35 FR 15556, Oct. 3, 1970]



PART 303--EXEMPTIONS--Table of Contents




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

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



Sec. 303.1  Exemptions.

    (a) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply 
to:
    (1) The slaughtering by any individual of livestock of his own 
raising, and the preparation by him and transportation in commerce of 
the carcasses, parts thereof, meat and meat food products of such 
livestock exclusively for use by him and members of his household and 
his nonpaying guests and employees;

[[Page 84]]

    (2) The custom slaughter by any person of cattle, sheep, swine, or 
goats delivered by the owner thereof for such slaughter, and the 
preparation by such slaughterer and transportation in commerce of the 
carcasses, parts thereof, meat and meat food products of such livestock, 
exclusively for use, in the household of such owner, by him and members 
of his household and his nonpaying guests and employees; nor to the 
custom preparation by any person of carcasses, parts thereof, meat or 
meat food products derived from the slaughter by any individual of 
cattle, sheep, swine, or goats of his own raising or from game animals, 
delivered by the owner thereof for such custom preparation, and 
transportation in commerce of such custom prepared articles, exclusively 
for use in the household of such owner, by him and members of his 
household and his nonpaying guests and employees: Provided, That the 
following requirements are met by such custom operator;
    (i) Establishments that conduct custom operations must be maintained 
and operated in accordance with the provisions of Secs. 416.1 through 
416.6, except for: Sec. 416.2(g)(2) through (6) of this chapter, 
regarding water reuse and any provisions of part 416 of this chapter 
relating to inspection or supervision of specified activities or other 
action by a Program employee. If custom operations are conducted in an 
official establishment, however, all of the provisions of Part 416 of 
this chapter of shall apply to those operations.
    (ii) If the custom operator prepares or handles any products for 
sale, they are kept separate and apart from the custom prepared products 
at all times while the latter are in his custody;
    (iii) The custom prepared products are plainly marked ``Not for 
Sale'' as provided in Sec. 316.16 of this subchapter, immediately after 
being prepared and are kept so identified until delivered to the owner; 
and
    (iv) If exempted custom slaughtering or other preparation of 
products is conducted in an official establishment, all facilities and 
equipment in the official establishment used for such custom operations 
shall be thoroughly cleaned and sanitized before they are used for 
preparing any products for sale.
    (b)(1) The exempted custom prepared products shall be prepared and 
handled in accordance with the provisions of Secs. 318.5, 318.6, 318.7, 
318.10, and 318.300 through 318.311 of this subchapter and shall not be 
adulterated as defined in paragraph 1(m) of the Act: Provided, That the 
provisions of Secs. 318.5, 318.6, 318.10, and 318.300 through 318.311 
relating to inspection or supervision of specified activities or other 
action by a Program inspector, and the provisions of Sec. 318.6(b)(9) 
and (10), shall not apply to the preparation and handling of such 
exempted products.
    (2) The exempted custom prepared products shall comply with the 
requirements of Secs. 316.16 and 317.16 of this subchapter.
    (3) The custom operators claiming exemption under paragraph (a)(2) 
of this section shall keep records, in addition to records otherwise 
required by part 320 of this subchapter, showing the numbers and kinds 
of livestock slaughtered on a custom basis, the quantities and types of 
products prepared on a custom basis, and the names and addresses of the 
owners of the livestock and products.
    (4) Articles capable of use as human food, resulting from the 
exempted custom slaughter or other preparation of products shall be 
promptly denatured or otherwise identified in accordance with 
Sec. 325.13 of this subchapter and not removed from the establishment 
where the custom operations are conducted until so identified, unless 
they are delivered to the owner of the articles for use in accordance 
with paragraph (a)(2) of this section.
    (c) It has been determined that it is impracticable to provide 
inspection of the preparation of products at establishments in any 
unorganized Territory at which livestock are slaughtered or their 
products are prepared for distribution solely within such jurisdiction 
and that exempting such establishments from requirements of the Act for 
such inspections under the conditions stated in this section will 
otherwise facilitate enforcement of the Act. Therefore, such inspection 
requirements of the Act and of the regulations in this subchapter shall 
not apply at such establishments if they are operated in accordance with 
the

[[Page 85]]

regulations in part 416, Secs. 416.1 through 416.5 of this chapter. 
However, the Administrator may refuse, withdraw, or modify any exemption 
under this paragraph when he determines in any specific case in 
accordance with the applicable rules of practice that such action is 
necessary to effectuate the purposes of this Act.
    (d)(1) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply to 
operations of types traditionally and usually conducted at retail stores 
and restaurants, when conducted at any retail store or restaurant or 
similar retail-type establishment for sale in normal retail quantities 
or service of such articles to consumers at such establishments.
    (2) For purposes of paragraph (d)(1) of this section:
    (i) Operations of types traditionally and usually conducted at 
retail stores and restaurants are the following:
    (a) Cutting up, slicing, and trimming carcasses, halves, quarters, 
or wholesale cuts into retail cuts such as steaks, chops, and roasts, 
and freezing such cuts;
    (b) Grinding and freezing products made from meat;
    (c) Curing, cooking, smoking, rendering or refining of livestock 
fat, or other preparation of products, except slaughtering or the retort 
processing of canned products;
    (d) Breaking bulk shipments of products;
    (e) Wrapping or rewrapping products.
    (ii) Any quantity or product purchased by a consumer from a 
particular retail supplier shall be deemed to be a normal retail 
quantity if the quantity so purchased does not in the aggregate exceed 
one-half carcass. The following amounts of product will be accepted as 
representing one-half carcass of the species identified:

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

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

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

    (c) Only federally or State inspected and passed product is handled 
or used in the preparation of any product, except that product resulting 
from the custom slaughter or custom preparation of product may be 
handled or used in accordance with paragraph (a)(2) and (b) of this 
section but not for sale;
    (d) No sale of product is made in excess of a normal retail quantity 
as defined in paragraph (d)(2)(ii) of this section;
    (e) The preparation of products for sale to household consumers is 
limited to traditional and usual operations as defined in paragraph 
(d)(2)(i) of this section; and
    (f) The preparation of products for sale to other than household 
consumers is limited to traditional and usual operations as defined in 
paragraph (d)(2)(i) (a), (b), (d), and (e) of this section. (A retail 
store at which custom slaughtering or preparation of products is 
conducted is not thereby disqualified from exemption as a retail store 
under this paragraph (d).)
    (iv) Restaurants. (a) A restaurant is any establishment where:

[[Page 86]]

    (1) Product is prepared only for sale or service in meals or as 
entrees directly to individual consumers at such establishments;
    (2) Only federally or State inspected and passed product or such 
product prepared at a retail store exempted under paragraph (d)(2)(iii) 
of this section is handled or used in the preparation of any product;
    (3) No sale of product is made in excess of a normal retail quantity 
as defined in paragraph (d)(2)(ii) of this section; and
    (4) The preparation of product is limited to traditional and usual 
operations as defined in paragraph (d)(2)(i) of this section.
    (b) The definition of a restaurant includes a caterer which delivers 
or serves product in meals, or as entrees, only to individual consumers 
and otherwise meets the requirements of this paragraph.
    (c) For purposes of this paragraph, operations conducted at a 
restaurant central kitchen facility shall be considered as being 
conducted at a restaurant if the restaurant central kitchen prepares 
meat or meat food products that are ready to eat when they leave such 
facility (i.e., no further cooking or other preparation is needed, 
except that they may be reheated prior to serving if chilled during 
transportation), transported directly to a receiving restaurant by its 
own employees, without intervening transfer or storage, maintained in a 
safe, unadulterated condition during transportation, and served in meals 
or as entrees only to customers at restaurants, or through vending 
machines, owned or operated by the same person that owns or operates 
such facility, and which otherwise meets the requirements of this 
paragraph: Provided, That the requirements of Secs. 320.1 through 320.4 
of this subchapter apply to such facility. Provided further, That the 
exempted facility may be subject to inspection requirements under the 
Act for as long as the Administrator deems necessary, if the 
Administrator determines that the sanitary conditions or practices of 
the facility or the processing procedures or methods at the facility are 
such that any of its meat or meat food products are rendered 
adulterated. When the Administrator has made such determination and 
subjected a restaurant central kitchen facility to such inspection 
requirements, the operator of such facility shall be afforded an 
opportunity to dispute the Administrator's determination in a hearing 
pursuant to rules of practice which will be adopted for this proceeding.
    (v) Similar retail-type establishment: Any establishment which is a 
combination retail store and restaurant; any delicatessen which meets 
the requirements for a retail store or restaurant as prescribed in 
paragraphs (d)(2) (iii) or (iv) of this section; or other establishment 
as determined by the Administrator in specific cases.
    (vi) Consumer: Any household consumer, hotel, restaurant, or similar 
institution as determined by the Administrator in specific cases.
    (3) Whenever any complaint is received by the Administrator from any 
person alleging that any retail store claiming exemption under this 
paragraph (d), in any designated State or organized Territory that is 
identified under section 205 of the Act (as one that does not have or is 
not exercising adequate authority with respect to recordkeeping 
requirements) has been operated in violation of the conditions 
prescribed in this section for exemption, and the Administrator, upon 
investigation of the complaint, has reason to believe that any such 
violation has occurred, he shall so notify the operator of the retail 
store and afford him reasonable opportunity to present his views 
informally with respect to the matter. Thereafter, if the Administrator 
still has reason to believe that such a violation has occurred, and that 
a requirement that the operator keep records concerning the operations 
of the retail store would effectuate the purposes of the Act, the 
Administrator shall order the operator to maintain complete, accurate, 
and legible records of total monthly purchases and of total monthly 
sales of meat, meat byproducts, and meat food products, in terms of 
dollar values of the products involved. Such records shall separately 
show total sales to household consumers and total sales to other 
consumers and shall be maintained for the

[[Page 87]]

period prescribed in Sec. 320.3 of this subchapter. If the operator 
maintains copies of bills of lading, receiving and shipping invoices, 
warehouse receipts, or similar documents which give the information 
required herein, additional records are not required by this 
subparagraph.
    (e)(1) The requirements of the Act and the regulations in this 
subchapter for inspection of the preparation of products do not apply to 
meat pizzas containing meat food product ingredients which were 
prepared, inspected, and passed in a cured or cooked form as ready-to-
eat (i.e., no further cooking or other preparation is needed) in 
compliance with the requirements of the Act and these regulations; and 
the meat pizzas are to be served in public or private nonprofit 
institutions, provided that the meat pizzas are ready-to-eat (i.e., no 
further cooking or other preparation is needed, except that they may be 
reheated prior to serving if chilled during transportation), transported 
directly to the receiving institution by employees of the preparing 
firm, receiving institution, or a food service management company 
contracted to conduct food service at the public or private nonprofit 
institution, without intervening transfer or storage.
    (2) The definitions at Chapter 1, 1-102, except 1-102(z) and the 
provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-
302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-
508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-
203, and 6-105, part IV, of the Food and Drug Administration's Food 
Service Sanitation Manual (1976 Recommendations), DHEW Publication No. 
(FDA) 78-2081, which is incorporated by reference, shall apply to the 
facilities and operations of businesses claiming this exemption. (These 
materials are incorporated as they exist on the date of approval. This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be purchased from the Superintendent of Documents, U.S. Government 
Printing Office, Washington, DC 20402. It is also available for 
inspection at the Office of the Federal Register Information Center, 
suite 700, 800 North Capitol Street, NW., Washington, DC, or the FSIS 
Hearing Clerk, room 3171, South Building, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250.)
    (3) Facilities and operations of businesses claiming this exemption 
shall also conform to the following requirements:
    (i) Manual cleaning and sanitizing. (A) For manual washing, rinsing 
and sanitizing of utensils and equipment, a sink with not fewer than 
three compartments shall be provided and used. Sink compartments shall 
be large enough to permit the accommodation of the equipment and 
utensils, and each compartment of the sink shall be supplied with hot 
and cold potable running water. Fixed equipment and utensils and 
equipment too large to be cleaned in sink compartments shall be washed 
manually or cleaned through pressure spray methods.
    (B) Drain boards or easily movable dish tables of adequate size 
shall be provided for proper handling of soiled utensils prior to 
washing and for cleaned utensils following sanitizing and shall be 
located so as not to interfere with the proper use of the dishwashing 
facilities.
    (C) Equipment and utensils shall be preflushed or prescraped and, 
when necessary, presoaked to remove gross food particles and soil.
    (D) Except for fixed equipment and utensils too large to be cleaned 
in sink compartments, manual washing, rinsing and sanitizing shall be 
conducted in the following sequence:
    (1) Sinks shall be cleaned prior to use.
    (2) Equipment and utensils shall be thoroughly washed in the first 
compartment with a hot detergent solution that is kept clean.
    (3) Equipment and utensils shall be rinsed free of detergent and 
abrasives with clean water in the second compartment.
    (4) Equipment and utensils shall be sanitized in the third 
compartment according to one of the methods prescribed in paragraph 
(e)(3)(i)(E) (1) through (4) of this section.
    (E) The food-contact surfaces of all equipment and utensils shall be 
sanitized by:

[[Page 88]]

    (1) Immersion for at least \1/2\ minute in clean, hot water at a 
temperature of at least 170  deg.F; or
    (2) Immersion for at least 1 minute in a clean solution containing 
at least 50 parts per million of available chlorine as a hypochlorite 
and at a temperature of at least 75  deg.F; or
    (3) Immersion for at least 1 minute in a clean solution containing 
at least 12.5 parts per million of available iodine and having a pH not 
higher than 5.0 and at a temperature of at least 75  deg.F; or
    (4) Immersion in a clean solution containing any other chemical 
sanitizing agent allowed under 21 CFR 178.1010 that will provide the 
equivalent bactericidal effect of a solution containing at least 50 
parts per million of available chlorine as a hypochlorite at a 
temperature of at least 75  deg.F for 1 minute; or
    (5) Treatment with steam free from materials or additives other than 
those specified in 21 CFR 173.310 in the case of equipment too large to 
sanitize by immersion, but in which steam can be confined; or
    (6) Rinsing, spraying, or swabbing with a chemical sanitizing 
solution of at least twice the strength required for that particular 
sanitizing solution under paragraph (e)(3)(i)(E)(4) of this section in 
the case of equipment too large to sanitize by immersion.
    (F) When hot water is used for sanitizing, the following facilities 
shall be provided and used:
    (1) An integral heating device or fixture installed in, on, or under 
the sanitizing compartment of the sink capable of maintaining the water 
at a temperature of at least 170  deg.F; and
    (2) A numerically scaled indicating thermometer, accurate to 
3  deg.F, convenient to the sink for frequent checks of 
water temperature; and
    (3) Dish baskets of such size and design to permit complete 
immersion of the tableware, kitchenware, and equipment in the hot water.
    (G) When chemicals are used for sanitization, they shall not have 
concentrations higher than the maximum permitted under 21 CFR 178.1010 
and a test kit or other device that accurately measures the parts per 
million concentration of the solution shall be provided and used.
    (ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing 
may be done by spray-type or immersion dishwashing machines or by any 
other type of machine or device if it is demonstrated that it thoroughly 
cleans and sanitizes equipment and utensils. These machines and devices 
shall be properly installed and maintained in good repair.
    Machines and devices shall be operated in accordance with 
manufacturers' instructions, and utensils and equipment placed in the 
machine shall be exposed to all dishwashing cycles. Automatic detergent 
dispensers, wetting agent dispensers, and liquid sanitizer injectors, if 
any, shall be properly installed and maintained.
    (B) The pressure of final rinse water supplied to spray-type 
dishwashing machines shall not be less than 15 nor more than 25 pounds 
per square inch measured in the water line immediately adjacent to the 
final rinse control valve. A \1/4\-inch IPS valve shall be provided 
immediately up stream from the final rinse control valve to permit 
checking the flow pressure of the final rinse water.
    (C) Machine or water line mounted numerically scaled indicating 
thermometers, accurate to 3  deg.F, shall be provided to 
indicate the temperature of the water in each tank of the machine and 
the temperature of the final rinse water as it enters the manifold.
    (D) Rinse water tanks shall be protected by baffles, curtains, or 
other effective means to minimize the entry of wash water into the rinse 
water. Conveyors in dishwashing machines shall be accurately timed to 
assure proper exposure times in wash and rinse cycles in accordance with 
manufacturers' specifications attached to the machines.
    (E) Drain boards shall be provided and be of adequate size for the 
proper handling of soiled utensils prior to washing and of cleaned 
utensils following sanitization and shall be so located and constructed 
as not to interfere with the proper use of the dishwashing facilities. 
This does not preclude the use of easily movable dish tables for the 
storage of soiled utensils or

[[Page 89]]

the use of easily movable dishtables for the storage of clean utensils 
following sanitization.
    (F) Equipment and utensils shall be flushed or scraped and, when 
necessary, soaked to remove gross food particles and soil prior to being 
washed in a dishwashing machine unless a prewashcycle is a part of the 
dishwashing machine operation. Equipment and utensils shall be placed in 
racks, trays, or baskets, or on conveyors, in a way that food-contact 
surfaces are exposed to the unobstructed application of detergent wash 
and clean rinse waters and that permits free draining.
    (G) Machines (single-tank, stationary-rack, door-type machines and 
spray-type glass washers) using chemicals for sanitization may be used: 
Provided, That,
    (1) The temperature of the wash water shall not be less than 120 
deg.F.
    (2) The wash water shall be kept clean.
    (3) Chemicals added for sanitization purposes shall be automatically 
dispensed.
    (4) Utensils and equipment shall be exposed to the final chemical 
sanitizing rinse in accordance with manufacturers' specifications for 
time and concentration.
    (5) The chemical sanitizing rinse water temperature shall be not 
less than 75  deg.F nor less than the temperature specified by the 
machine's manufacturer.
    (6) Chemical sanitizers used shall meet the requirements of 21 CFR 
178.1010.
    (7) A test kit or other device that accurately measures the parts 
per million concentration of the solution shall be available and used.
    (H) Machines using hot water for sanitizing may be used provided 
that wash water and pumped rinse water shall be kept clean and water 
shall be maintained at not less than the following temperatures:

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

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

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

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

    (3) Single-tank, conveyor machine:

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

    (4) Multitank, conveyor machine:

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

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

    (I) All dishwashing machines shall be thoroughly cleaned at least 
once a day or more often when necessary to maintain them in a 
satisfactory operating condition.
    (iii) Steam. Steam used in contact with food or food-contact 
surfaces shall be free from any materials or additives other than those 
specified in 21 CFR 173.310.
    (4) For purposes of this paragraph, the term ``private nonprofit 
institution'' means ``a corporation, and any community chest, fund, or 
foundation, organized and operated exclusively for religious, 
charitable, scientific, testing for public safety, literary, or 
educational purposes, or to foster national or international amateur 
sports competition (but only if no part of its activities involve the 
provision of athletic facilities or equipment), or for the prevention of 
cruelty to children or animals, no part of the net earnings of which 
inures to the benefit of any private shareholder or individual, no 
substantial part of the activities of which is carrying on propaganda, 
or otherwise attempting, to influence legislation, and which does not 
participate in, or intervene in (including the publishing or 
distribution of statements), any political campaign on behalf of (or in 
opposition to) any candidate for public office.''
    (5) The Administrator may withdraw or modify the exemption set forth 
in Sec. 303.1(e)(1) for a particular establishment when he or she 
determines that such action is necessary to ensure food safety and 
public health. Before such action is taken, the owner or operator of the 
particular establishment shall be notified, in writing, of the reasons 
for

[[Page 90]]

the proposed action and shall be given an opportunity to respond, in 
writing, to the Administrator within 20 days after notification of the 
proposed action. The written notification shall be served on the owner 
or operator of the establishment in the manner prescribed in section 
1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). 
In those instances where there is conflict of any material fact, the 
owner or operator of the establishment, upon request, shall be afforded 
an opportunity for a hearing with respect to the disputed fact, in 
accordance with rules of practice which shall be adopted for the 
proceeding. However, such withdrawal or modification shall become 
effective pending final determination in the proceeding when the 
Administrator determines that an imminent threat to food safety or 
public health exists, and that such action is, therefore, necessary to 
protect the public health, interest or safety. Such withdrawal or 
modification shall be effective upon oral or written notification, 
whichever is earlier, to the owner or operator of the particular 
establishment as promptly as circumstances permit. In the event of oral 
notification, written confirmation shall be given to the owner or 
operator of the establishment as promptly as circumstances permit. This 
withdrawal or modification shall continue in effect ending the 
completion of the proceeding and any judicial review thereof, unless 
otherwise ordered by the Administrator.
    (f) The adulteration and misbranding provisions of the Act and the 
regulations in this subchapter, other than the requirement of the 
official inspection legend, apply to articles which are exempted from 
inspection or not required to be inspected under this section. This 
includes the requirement that any pork and any product containing pork 
be prepared only in compliance with any applicable requirement for the 
destruction of trichina as provided in Sec. 318.10 of this subchapter.
    (g) The Administrator may extend the requirements of titles I and IV 
of the Act to any establishment in any State or organized Territory at 
which products are prepared for distribution solely within such 
jurisdiction, if he determines in accordance with the provisions of 
paragraph 301(c)(1) of the Act that it is producing adulterated products 
which would clearly endanger the public health.
    (h) The Administrator may in specific classes of cases waive for 
limited periods any provisions of the regulations in this subchapter in 
order to permit appropriate and necessary action in the event of a 
public health emergency or to permit experimentation so that new 
procedures, equipment, and/or processing techniques may be tested to 
facilitate definite improvements: Provided, That such waivers of the 
provisions of such regulations are not in conflict with the purposes or 
provisions of the Act.

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

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

    Effective Date Note: At 64 FR 56415, Oct. 20, 1999, Sec. 303.1, 
paragraph (a)(2)(i) was revised and paragraph (c) was amended by 
removing the phrase ``in part 308 of this subchapter, except 
Secs. 308.1, 308.2, and 308.15'' from the second sentence and adding in 
its place the phrase ``in part 416, Secs. 416.1 through 416.5 of this 
chapter'', effective Jan. 25, 2000. For the convenience of the user, the 
superseded text is set forth as follows;

Sec. 303.1   Exemptions.

    (a) * * *
    (2) * * *
    (i) The establishment in which the custom operations are conducted 
is maintained and operated in accordance with the provisions of 
Secs. 308.4 through 308.11, 308.13, 308.14, and 308.3 (except 
Sec. 308.3(d) (2) and (3), of this subchapter: Provided, That the 
provisions of said sections relating to inspection or supervision of 
specified activities or other action by a Program employee shall not 
apply to the preparation and handling of such exempted products: 
Provided, further, That the requirement of Sec. 308.4 for separate 
facilities for men and women workers shall not apply to such 
establishments when the majority of the workers in the establishment are 
related by blood or marriage and this arrangement will not conflict with 
municipal or State requirements, and the requirement of Sec. 308.4 for 
separation of toilet soil lines from house drainage lines to a point 
outside the buildings will

[[Page 91]]

not apply to such establishments when positive acting backflow devices 
are installed: And provided, further, That the requirements of 
Sec. 308.13 for paved driveways, approaches, yards, pens, and alleys 
shall not apply to such establishments. However, if custom operations 
are conducted in an official establishment, all of the provisions of 
part 308 shall apply to such establishment.

                                * * * * *



Sec. 303.2  Experimentation: Intensity of inspection coverage.

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

[[Page 92]]

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

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

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

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



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




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

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



Sec. 304.1  Application for inspection.

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

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



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

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

[[Page 93]]

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

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

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

    Effective Date Notes: 1. At 64 FR 56415, Oct. 20, 1999, 
Sec. 304.2(b) was amended by removing the phrase ``308'' in the first 
sentence, and adding the phrase ``Part 416, Secs. 416.1 through 416.6 of 
this chapter'' in its place, effective Jan. 25, 2000.
    2. At 64 FR 66545, Nov. 29, 1999, Sec. 304.2 section heading and the 
last sentence in paragraph (b) were revised, paragraphs (c) and (e) were 
removed and paragraph (d) was redesignated as (c), effective Jan. 25, 
2000. For the convenience of the user, the superseded text is set forth 
as follows:

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

                                * * * * *

    (b) * * * When inspection is refused for any reason, the applicant 
shall be informed of the action and the reasons therefor and afforded an 
opportunity to present his views.
    (c) Inspection may also be refused in accordance with section 401 of 
the Act and the applicable rules of practice.

                                * * * * *

    (e) Inspection may be refused in accordance with humane slaughter 
and handling provisions of the Act (21 U.S.C. 603(b)) and the applicable 
rules of practice.
    3. At 65 FR 2284, Jan. 14, 2000, Sec. 304.2, the first sentence of 
paragraph (b) was amended by removing the phrase ``of this subchapter'' 
after the phrase ``parts 305, 307, and 416, Secs. 416.1 through 416.6 of 
this chapter'', effective Jan. 25, 2000.



Sec. 304.3  Conditions for receiving inspection.

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

[[Page 94]]

plan, in accordance with Sec. 417.4 of this chapter.

[61 FR 38864, July 25, 1996]



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




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

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

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



Sec. 305.1  Official numbers; subsidiaries and tenants.

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

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



Sec. 305.2  Separation of official establishments.

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



Sec. 305.3  Sanitation and adequate facilities.

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



Sec. 305.4  Inauguration of inspection.

    When inspection is granted, the circuit supervisor shall, at or 
prior to the inauguration of inspection, inform the operator of the 
establishment of the requirements of the regulations in this subchapter. 
If the establishment, at the time inspection is inaugurated, contains 
any product which has not theretofore been inspected, passed, and marked 
in compliance with the regulations in this subchapter, the identity of 
the same shall be maintained, and it shall not be distributed in 
commerce, or otherwise subject to the requirements of such regulations, 
or dealt with as inspected and passed under the regulations. The 
establishment shall

[[Page 95]]

adopt and enforce all necessary measures and shall comply with all such 
directions as the circuit supervisor may prescribe, for carrying out the 
purposes of this section.



Sec. 305.5  Withdrawal of inspection; statement of policy.

    (a) The Administrator is authorized to withdraw inspection from an 
official establishment where the sanitary conditions are such that its 
products are rendered adulterated, or for failure of the operator to 
destroy condemned products as required by the Act and the regulations in 
this subchapter. Inspection may be withdrawn in accordance with section 
401 of the Act and the applicable rules of practice.
    (b) The assignment of inspectors may be temporarily suspended, in 
whole or in part, by the Administrator to the extent it is determined 
necessary to avoid impairment of the effective conduct of the program 
when the operator of any official establishment or any subsidiary 
therein, or any officer, employee, or agent of any such operator or any 
subsidiary therein, acting within the scope of his office, employment, 
or agency, threatens to forcibly assault or forcibly assaults, 
intimidates, or interferes with any program employee in or on account of 
the performance of his official duties under the act, unless promptly 
upon the incident being brought by an authorized supervisor of the 
program employee to the attention of the operator of the establishment 
the operator (1) satisfactorily justifies the incident, (2) takes 
effective steps to prevent a recurrence, or (3) provides acceptable 
assurance that there will not be any recurrences. Such suspension shall 
remain in effect until one of such actions is taken by the operator: 
Provided, That upon request of the operator he shall be afforded an 
opportunity for an expedited hearing to show cause why the suspension 
should be terminated.
    (c) Inspection service may be temporarily suspended, in whole or in 
part, at an official establishment, by the Administrator, to the extent 
that it is determined necessary to prevent in-humane slaughtering or 
handling in connection with slaughter of livestock as defined in 
Sec. 301.2(kk) (9 CFR 301.2(kk)). The Administrator shall notify the 
operator of an establishment orally or in writing, as promptly as 
circumstances permit, of such suspension and the reasons therefor. Such 
suspension shall remain in effect until the operator of the 
establishment takes effective steps to prevent a recurrence, or provides 
other satisfactory assurances that there will not be any recurrences. 
Upon request, the operator shall be afforded an opportunity for a 
hearing to show cause why the suspension should be terminated.

[38 FR 9794, Apr. 20, 1973, as amended at 44 FR 68813, Nov. 30, 1979; 53 
FR 49848, Dec. 12, 1988]

    Effective Date Note: At 64 FR 66545, Nov. 29, 1999, Sec. 305.5 was 
removed, effective Jan. 25, 2000.



Sec. 305.6  Reports of violations.

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



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




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

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

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



Sec. 306.1  Designation of circuit supervisor and assistants.

    The Administrator shall designate a circuit supervisor of the 
inspection in each circuit, and assign to said inspector such assistants 
as may be necessary.



Sec. 306.2  Program employees to have access to establishments.

    For the purpose of any examination or inspection necessary to 
prevent the

[[Page 96]]

use in commerce of any adulterated product, Program employees shall have 
access at all times, by day or night, whether the establishment is 
operated or not, to every part of any official establishment to which 
they are assigned. Access to establishments is also authorized in 
accordance with section 202 of the Act and the regulations in part 320 
of this subchapter.



Sec. 306.3  Badge as identification of inspectors.

    Each inspector will be furnished with a numbered official badge, 
which he shall not allow to leave his possession, and which he shall 
wear in such manner and at such times as the Administrator may 
prescribe. This badge shall be sufficient identification to entitle him 
to admittance at all regular entrances and to all parts of the 
establishment and premises to which he is assigned.



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

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



Sec. 306.5  Appeals.

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

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



PART 307--FACILITIES FOR INSPECTION--Table of Contents




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

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

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



Sec. 307.1  Facilities for Program employees.

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

[[Page 97]]

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



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

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

[[Page 98]]

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

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

    Effective Date Note: At 64 FR 56415, Oct. 20, 1999, Sec. 307.2, 
paragraph (l) was revised, effective Jan. 25, 2000. For the convenience 
of the user, the superseded text is set forth as follows:

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

                                * * * * *

    (l) Sanitary facilities and accommodations as prescribed by 
Sec. 308.4 of this subchapter.

                                * * * * *



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

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

[64 FR 56415, Oct. 20, 1999]

    Effective Date Note: At 64 FR 56415, Oct. 20, 1999 Sec. 307.3 was 
revised, effective Jan. 25, 2000. For the convenience of the user, the 
superseded text is set forth as follows:

[[Page 99]]

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

    Inspectors shall furnish their own work clothing and implements, 
such as flashlights and triers, for conducting inspection and shall 
cleanse their hands and implements as prescribed by Sec. 308.8 of this 
subchapter.



Sec. 307.4  Schedule of operations.

    (a) No operations requiring inspection shall be conducted except 
under the supervision of a Program employee. All slaughtering of animals 
and preparation of products shall be done with reasonable speed, 
considering the official establishment's facilities.
    (b) A shift is a regularly scheduled operating period, exclusive of 
mealtime. One lunch period is the only official authorized interruption 
in the inspector's tour of duty once it begins. Lunch periods may be 30 
minutes, 45 minutes, or in any case may not exceed one hour in duration. 
Once established, the lunch period must remain relatively constant as to 
time and duration. Lunch periods for inspectors shall not, except as 
provided herein, occur prior to 4 hours after the beginning of scheduled 
operations nor later than 5 hours after operations begin. In plants 
where a company rest break of not less than 30 minutes is regularly 
observed, approximately midpoint between start of work and the lunch 
period, and the inspector is allowed this time to meet his personal 
needs, the lunch period may be scheduled as long as 5\1/2\ hours after 
the beginning of scheduled operations.
    (c) Official establishments, importers, and exporters shall be 
provided inspection service, without charge, up to 8 consecutive hours 
per shift during the basic workweek subject to the provisions of 
Sec. 307.5: Provided, That any additional shifts meet requirements as 
determined by the Administrator or his designee. The basic workweek 
shall consist of 5 consecutive 8-hour days within the administrative 
workweek Sunday through Saturday, excluding the lunch period; except 
that, when possible, the Department shall schedule the basic workweek so 
as to consist of 5 consecutive 8-hour days Monday through Friday, 
excluding lunch period. The Department may depart from the basic 
workweek in those cases where maintaining such a schedule would 
seriously handicap the Department in carrying out its function. These 
provisions are applicable to all official establishments except in 
certain cases as provided in Sec. 318.4(h) of this subchapter.
    (d)(1) Each official establishment shall submit a work schedule to 
the area supervisor for approval. In consideration of whether the 
approval of an establishment work schedule shall be given, the area 
supervisor shall take into account the efficient and effective use of 
inspection personnel. The work schedule must specify daily clock hours 
of operation and lunch periods for all departments of the establishment 
requiring inspection.
    (2) Establishments shall maintain consistent work schedules. Any 
request by an establishment for a change in its work schedule involving 
an addition or elimination of shifts shall be submitted to the area 
supervisor at least 2 weeks in advance of the proposed change. Frequent 
requests for change shall not be approved: Provided, however, minor 
deviations from a daily operating schedule may be approved by the 
inspector in charge, if such request is received on the day preceding 
the day of change.
    (3) Request for inspection service outside an approved work schedule 
shall be made as early in the day as possible for overtime work to be 
performed within that same workday; or made prior to the end of the 
day's operation when such a request will result in overtime service at 
the start of the following day: Provided, That an inspector may be 
recalled to his assignment after completion of his daily tour of duty 
under the provisions of Sec. 307.6(b).

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



Sec. 307.5  Overtime and holiday inspection service.

    (a) The management of an official establishment, an importer, or an 
exporter shall reimburse the Program, at the rate specified in 
Sec. 391.3, for the cost of the inspection service furnished on any 
holiday as specified in paragraph (b) of this section; or for more than 
8 hours on any day, or more than 40

[[Page 100]]

hours in any administrative workweek Sunday through Saturday.
    (b) Holidays for Federal employees shall be New Year's Day, January 
1; Birthday of Martin Luther King, Jr., the third Monday in January; 
Washington's Birthday, the third Monday in February; Memorial Day, the 
last Monday in May; Independence Day, July 4; Labor Day, the first 
Monday in September; Columbus Day, the second Monday in October; 
Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in 
November; Christmas Day, December 25. When any of the above-listed 
holidays falls outside the basic workweek, the nearest workday within 
that week shall become a holiday.

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



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

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

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



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

    (a) General. Electrical stimulating (EST) equipment is equipment 
that provides electric shock treatment to carcasses for the purpose of 
accelerating rigor mortis of facilitating blood removal. These 
provisions do not apply to electrical equipment used to stun and/or 
slaughter animals or to facilitate hide removal. Electrical stimulating 
equipment consists of two separate pieces--the control system and the 
applicator. The EST control system contains the circuitry to generate 
pulsed DC or AC voltage for stimulation and is separate from the 
equipment used to apply the voltage to the carcass. The voltage is 
applied by inserting a probe that penetrates the carcass or is inserted 
in the rectum, placing a clamp in the nose, a carcass rub-bar, a 
conveyor with energized surfaces traveling with the carcass, or any 
other acceptable method.
    (b) Safety requirements--(1) Circuits, grounding. Either a bonded 
grounding conductor shall lead from each section of the carcass rail 
within the stimulating enclosure to the service ground, or the secondary 
voltage (stimulating circuit) shall be insulated from the service 
ground. If the stimulating section of the carcass rail and carcass drive 
mechanisms are insulated from the service ground then the stimulating 
rail or the return path shall be electrically bonded to the transformer 
secondary to isolate the stimulation voltage.
    (2) Enclosure. Electrical stimulation shall occur in an area that 
will prevent persons from contacting an energized surface. If the area 
is surrounded by physical barriers, the enclosure shall be either 
electrically grounded or it shall be made of materials that do not 
conduct electricity. The interior of the stimulating area shall be 
visible from the start switch so the operator can be assured that there 
is no person, equipment or material present that should not be there 
prior to starting the stimulating sequence. If light or sound beam 
sensors form the enclosure, the stimulating equipment shall be 
automatically shut off when the sensor signals are broken.
    (3) Mandatory Warning Devices and Signals. The following warning 
devices or signals shall be installed at each opening to the stimulating 
area through which a person would normally enter:

[[Page 101]]

    (i) A red light that flashes distinctly during the operating cycle 
of the stimulating equipment.
    (ii) An ANSI Z53.1-Color Code sign reading (a) ``Danger Electrical 
Hazard'' for stimulating voltage below 50 or (b) ``Danger High Voltage'' 
for stimulating voltage above 50.
    (iii) An emergency stop button.
    (4) Optional Warning Device--Horn or Bell. If a warning horn or bell 
is installed, the signal shall be audible above background noises in the 
vicinity, and it shall sound for at least 1 second before each manual 
stimulation or before the carcass chain is started in an automatic 
system.
    (c) Operation--
    (1) Training. Only persons who have received safety instruction by 
the equipment manufacturer or designee may operate electrical 
stimulating equipment.
    (2) Cleaning and Maintenance. To prevent an electrical shock to 
personnel, the electricity supplied to the stimulating surfaces shall be 
locked-off when cleaning, mechanical inspection, maintenance or testing 
are performed.
    (3) Water. To prevent an electrical shock, personnel shall not spray 
streams of water on energized carcasses or on energized stimulating 
surfaces.
    (d) Special provisions for manually operated equipment.
    (1) Stimulating probes or clamps shall be stored in a sanitary 
container which is insulated with a material approved by the 
Administrator.\1\
---------------------------------------------------------------------------

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

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

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

    Effective Date Note: At 64 FR 56415, Oct. 20, 1999 Sec. 307.7 was 
amended by revising paragraph (a), effective Jan. 25, 2000. For the 
convenience of the user, the superseded text is set forth as follows:

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

    (a) General. Electrical stimulating (EST) equipment is equipment 
that provides electric shock treatment to carcasses for the purpose of 
accelerating rigor mortis of facilitating blood removal. These 
provisions do not apply to electrical equipment used to stun and/or 
slaughter animals or to facilitate hide removal. Electrical stimulating 
equipment consists of two separate pieces--the control system and the 
applicator. The EST control system contains the circuitry to generate 
pulsed DC or AC voltage for stimulation and is separate from the 
equipment used to apply the voltage to the carcass. The voltage is 
applied by inserting a probe that penetrates the carcass or is inserted 
in the rectum, placing a clamp in the nose, a carcass rub-bar, a 
conveyor with energized surfaces traveling with the carcass, or any 
other method found to be acceptable by the Administrator. The 
Administrator will evaluate EST equipment to determine its acceptability 
for its proposed use before it is installed in an official establishment 
as set forth in Sec. 308.5 of this subchapter.

                                * * * * *



PART 308--Sanitation--Table of Contents




Sec.
308.1  Examination and specifications for equipment and sanitation prior 
          to granting inspection.
308.2  [Reserved]
308.3  Establishments; sanitary condition; requirements.
308.4  Sanitary facilities and accomodations; specific requirements.
308.5  Equipment and utensils to be easily cleaned; those for inedible 
          products to be so marked; PCB-containing equipment.
308.6  Scabbards for knives.
308.7  Rooms, compartments, etc., to be clean and sanitary.
308.8  Operations, procedures, rooms, clothing, utensils, etc., to be 
          clean and sanitary.
308.9  Protective handling of products.
308.10  Slack barrels and similar containers and means of conveyance 
          used for product; paper in contact with the product.
308.11  Burlap wrapping for meat.
308.12  Second-hand tube, barrels, and other containers.
308.13  Inedible operating and storage rooms; outer premises, docks, 
          driveways, approaches, pens, alleys, etc.; flybreeding 
          material; other conditions.
308.14  Employment of diseased persons.
308.15  Tagging insanitary equipment, utensils, rooms or compartments.
308.16  Sanitation requirements for electrical stimulating 
          (EST)equipment.


[[Page 102]]


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

    Source: 35 FR 15561, Oct. 3, 1970, unless otherwise noted.

    Effective Date Note: At 64 FR 56415, Oct. 20, 1999, Part 308 was 
removed and reserved, effective Jan. 25, 2000.



Sec. 308.1  Examination and specifications for equipment and sanitation prior to granting inspection.

    Prior to inauguration of inspection, an examination of the 
establishment and premises shall be made by a Program employee and the 
requirements for sanitation and the necessary facilities for inspection 
shall be specified by him in accordance with the regulations in this 
part and part 307 of this subchapter.



Sec. 308.2  [Reserved]



Sec. 308.3  Establishments; sanitary conditions; requirements.

    (a) Official establishments shall be maintained in sanitary 
condition, and to this end the requirements of this section shall be 
complied with. The provisions of part 416 of this chapter apply to all 
establishments, Starttime Saturday, February 05, 2000 09:51:42except 
establishments that are exempt in accordance with Sec. 303.1 of this 
chapter.
    (b) There shall be abundant light, of good quality and well 
distributed, and sufficient ventilation for all rooms and compartments 
to insure sanitary condition.
    (c) There shall be an efficient drainage and plumbing system for the 
establishment and premises, and all drains and gutters shall be properly 
installed with traps and vents approved by the circuit supervisor.
    (d)(1) The water supply shall be ample, clean, and potable, with 
adequate facilities for its distribution in the plant and its protection 
against contamination and pollution. Every establishment shall make 
known and, whenever required by the circuit supervisor, shall afford 
opportunity for inspection of the source of its water supply, the 
storage facilities, and the distribution system. Equipment using potable 
water shall be so installed as to prevent back-siphonage into the 
potable water system. Nonpotable water is permitted only in those parts 
of official establishments where no edible product is handled or 
prepared, and then only for limited purposes such as on ammonia 
condensors not connected with the potable water supply, in vapor lines 
serving inedible product rendering tanks, in connection with equipment 
used for hashing and washing inedible products preparatory to tanking, 
and in sewer lines for moving heavy solids in the sewage. Nonpotable 
water is not permitted for washing floors, areas, or equipment involved 
in trucking materials to and from edible product departments nor is it 
permitted in hog scalding vats, dehairing machines, or vapor lines 
serving edible product rendering equipment, or for cleanup of shackling 
pens, bleeding areas, or runways within the slaughtering department. In 
all cases, nonpotable waterlines shall be clearly identified and shall 
not be cross-connected with the potable water supply unless this is 
necessary for fire protection and such connection is of a type with an 
adequate break to assure against accidental contamination, and is 
approved by local authorities and by the circuit supervisor.
    (2) The circuit supervisor may permit the reuse of water in vapor 
lines leading from deodorizers used in the prepartion of lard and 
similar edible product and in equipment where such water is used to 
thermally process canned product packed in heremetically sealed 
containers, provided:
    (i) The reuse is for the identical original purpose.
    (ii) All pipelines, reservoirs, tanks, cooling towers, and like 
equipment employed in handling the reused water are so constructed and 
installed so they can be cleaned and drained, and are kept clean.
    (3) Approval for the reuse of water other than specified in 
paragraph (d)(2) of this section or in Sec. 318.305(h) shall be obtained 
from the Administrator in specific cases.
    (4) An ample supply of water at not less than 180 deg. F. shall be 
furnished and used for the cleaning of inspection equipment, floors, and 
walls which are

[[Page 103]]

subject to contamination by the dressing or handling of diseased 
carcasses, their viscera, and other parts. Whenever necessary to 
determine compliance with this requirement, conveniently located 
thermometers shall be installed by the operator of the official 
establishment to show the temperature of the water at the point of use.
    (5) Hot water for cleaning rooms and equipment other than those 
mentioned in paragraph (d)(4) of this section shall be delivered under 
pressure to sufficient convenient outlets and shall be of such 
temperature as to accomplish a thorough cleanup.
    (e) The floors, walls, ceilings, partitions, posts, doors, and other 
parts of all structures shall be made of such materials, construction, 
and finish as will make them susceptible of being readily and thoroughly 
cleaned. The floors will be kept watertight. The rooms and compartments 
used for edible product shall be separate and distinct from those used 
for inedible product.
    (f) Rails should be located and passageway space provided so that 
exposed product does not come in contact with posts, walls, and other 
fixed parts of the building, or with barrels, boxes, and other 
containers trafficked through holding and operating areas. Exposed 
product shall not be placed or stored beneath carcasses in coolers or 
holding areas.
    (g) The rooms and compartments in which any product is prepared or 
handled shall be free from dust and from odors from dressing and toilet 
rooms, catch basins, hide cellars, casing rooms, inedible tank and 
fertilizer rooms and livestock pens.
    (h) Every practicable precaution shall be taken to exclude flies, 
rats, mice, and other vermin from official establishments. The use of 
poisons for any purpose in rooms or compartments where any unpacked 
product is stored or handled is forbidden, except under such 
restrictions and precautions as are prescribed by the regulaions in this 
part or by the circuit supervisor in specific cases. The use of 
pesticides, rodenticides, and similar pest control substances in hide 
cellars, inedible product departments, outbuildings, or similar places, 
or in storerooms containing canned or tierced products is not forbidden 
but only those approved by the Administrator may be used.\1\ So called 
rat viruses shall not be used in any part of an establishment or the 
premises thereof.
---------------------------------------------------------------------------

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

    (i) Dogs and cats shall be excluded from the interior of official 
establishments; however, dogs may be permitted on the outer premises for 
guard purposes.

[35 FR 15561, Oct. 3, 1970, as amended at 51 FR 45619, Dec. 19, 1986; 61 
FR 38864, July 25, 1996; 62 FR 26217, May 13, 1997]



Sec. 308.4  Sanitary facilities and accomodations; specific requirements.

    Adequate sanitary facilities and accomodations shall be furnished by 
every official establishment. Of these, the following are specifically 
required;
    (a) Dressing rooms, toilet rooms, and urinals shall be sufficient in 
number, ample in size, and conveniently located. The rooms shall be 
provided with facilities to provide abundant light of good quality and 
well distributed. They shall be properly ventilated, and meet all 
requirements of the regulations in this part as to sanitary construction 
and equipment. They shall be separate from the rooms in which the 
products are prepared, stored, or handled. Where both sexes are 
employed, separate facilities shall be provided.
    (b) Acceptable lavatories, including running hot and cold water, 
soap, and towels, shall be placed in or near toilet and urinal rooms and 
also at such other places in the establishment as may be essential to 
assure cleanliness of all persons handling any product.
    (c) Toilet soil lines shall be separate from house drainage lines to 
a point outside the building and drainage from toilet bowls and urinals 
shall not be discharged into a grease catch basin.
    (d) Properly located facilities shall be provided for cleansing and 
disinfecting utensils and hands of all persons handling any product.

[[Page 104]]



Sec. 308.5   Equipment and utensils to be easily cleaned; those for inedible products to be so marked; PCB-containing equipment.

    (a) Equipment and utensils used for preparing or otherwise handling 
any edible product or ingredient thereof in any official establishment 
shall be of such material and construction as will facilitate their 
thorough cleaning and insure cleanliness in the preparation and handling 
of all edible products and otherwise avoid adulteration and misbranding 
of such products. In addition to these requirements, equipment and 
utensils shall not in anyway interfere with or impede inspection 
procedures. Recepticals used for handling inedible material shall be of 
such material and construction that their use will not result in 
adulteration of any edible product or in insanitary conditions at the 
establishment, and they shall bear conspicuous and distinctive markings 
to identify them as only for such use and shall not be used for handling 
any edible product.
    (b) New or replacement equipment or machinery (including any 
replacement parts) brought on to the premises of any official 
establishment shall not contain liquid polychlorinated biphenyls (PCBs) 
in concentrations above 50 parts per million by weight of the liquid 
medium. This provision applies to both food processing and nonfood 
processing equipment and machinery, and any replacement parts for such 
equipment and machinery. Totally enclosed capacitors containing less 
than 3 pounds of PCBs are exempted from this prohibition.

[40 FR 25439, June 16, 1975, as amended at 40 FR 60053, Dec. 31, 1975; 
45 FR 68918, Oct. 17, 1980; 62 FR 45024, Aug. 25, 1997]



Sec. 308.6  Scabbards for knives.

    Scabbards and similar devices for the temporary retention of knives, 
steels, triers, etc., by workers and others at official establishments 
shall be constructed for rust-resisting metal or other impervious 
material, shall be of a type that may be readily cleaned, and shall be 
kept clean.



Sec. 308.7  Rooms, compartments, etc., to be cleaned and sanitary.

    Rooms, compartments, places, equipment, and utensils used for 
preparing, storing, or otherwise handling any product, and all other 
parts of the establishment, shall be kept clean and in sanitary 
condition. There shall be no handling or storing of materials which 
create an objectionable condition in rooms, compartments, or places 
where any product is prepared, stored, or otherwise handled.



Sec. 308.8  Operations, procedures, rooms, clothing, utensils, etc., to be clean and sanitary.

    (a) Operations and procedures involving the preparation, storing, or 
handling of any product shall be strictly in accord with clean and 
sanitary methods.
    (b) Rooms and compartments in which inspections are made and those 
in which livestock are slaughtered or any product is prepared shall be 
kept sufficiently free of steam and vapors to enable Program employees 
to make inspections and to insure clean operations. The walls, ceilings, 
and overhead structure of rooms and compartments in which product is 
prepared, handled, or stored shall be kept reasonably free from moisture 
to prevent dripping and contamination of product.
    (c) Butchers and others who dress or handle diseased carcasses or 
parts shall, before handling or dressing other cacasses or parts, 
cleanse their hands with liquid soap and hot water, and rinse them in 
clean water. Implements used in dressing diseased carcasses shall be 
thoroughly cleansed with hot water having a minimum temperature of 180 
deg.F. or in a disinfectant\2\ approved by the Administrator, followed 
by rinsing in clean water. The employees of the establishment who handle 
any product shall keep their hands clean, and in all cases after 
visiting the toilet rooms or urinals shall wash their hands before 
handling any product or implements used in preparation of product.
---------------------------------------------------------------------------

    \2\ A list of approved disinfectants is available upon request to 
the Scientific Services, Meat and Poultry Inspection, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.

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

[[Page 105]]

    (d) Aprons, frocks, and other outer clothing worn by persons who 
handle any product shall be made of material that is readily cleansed. 
Clean garments shall be worn at the start of each working day and the 
garments shall be changed during the day when required by the inspector 
in charge.
    (e) Such practices as spitting on whetstones; spitting on the floor; 
placing skewers, tags, or knives in the mouth; inflating lungs or 
casings with air from the mouth; or testing with air from the mouth such 
receptacles as tierces, kegs or casks, containing or intended as 
containers of any product, are prohibited. Only mechanical means may be 
used for such testing. Care shall be taken to prevent the contamination 
of product with perspiration, hair, cosmetics, medications, and similar 
substances.
    (f) Equipment or substances which generate gases or odors shall not 
be used in official establishments except as permitted by the 
regulations in this part or by the circuit supervisor in specific cases 
in which he determines that such use will not result in adulteration of 
any product.



Sec. 308.9  Protective handling of products.

    Products will be protected from contamination from any source such 
as dust, dirt, or insects during storage, loading, or unloading at and 
transportation from official establishments.



Sec. 308.10  Slack barrels and similar containers and means of conveyance used for product; paper in contact with product.

    (a) When necessary to avoid contamination of product with wood 
splinters or similar contaminants, slack barrels and similar containers 
and the cargo space of trucks, railroad cars, or other means of 
conveyance shall be lined with suitable material of good quality before 
packing.
    (b) Slack barrels and similar containers and trucks, railroad cars, 
and other means of conveyance in which any product is transported shall 
be kept in a clean and sanitary condition.
    (c) Paper used for covering or lining slack barrels and similar 
containers and the cargo space of trucks, railroad cars, or other means 
of conveyance shall be of a kind which does not tear during use but 
remains intact when moistened by the product and does not disintegrate.



Sec. 308.11  Burlap wrapping for meat.

    Since burlap used without any other material as a wrapping for meat 
deposits lint on the meat and does not sufficiently protect it from 
outside contamination, the use of burlap as a wrapping for meat will not 
be permitted unless the meat is first wrapped with a good grade of paper 
or cloth of a kind which will prevent contamination with lint or other 
foreign matter.



Sec. 308.12  Second-hand tubs, barrels, and other containers.

    Second-hand tubs, barrels, and boxes intended for use as containers 
of any product shall be inspected when received at the official 
establishment and before they are cleaned. Those showing evidence of 
misuse rendering them unfit to serve as containers for food products 
shall be rejected. The use of those showing no evidence of previous 
misuse may be allowed after they have been thoroughly and properly 
cleaned. Steaming, after thorough scrubbing and rinsing, is essential to 
cleaning tubs and barrels.

[35 FR 15561, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 41 
FR 23700, June 11, 1976]



Sec. 308.13  Inedible operating and storage rooms; outer premises, docks, driveways, approaches, pens, alleys, etc., flybreeding material; other conditions.

    All operating and storage rooms and departments of official 
establishments used for inedible materials shall be maintained in 
acceptably clean condition. The outer premises of every official 
establishment, including docks and areas where cars and vehicles are 
loaded, and the driveways, approaches, yards, pens, and alleys shall be 
properly paved and drained and kept in clean and orderly condition. All 
catch basins on the premises shall be of such construction and location 
and shall be given such attention as will insure their being kept in 
acceptable condition as regards odors and cleanliness.

[[Page 106]]

Catch basins shall not be located in departments where any product is 
prepared, handled or stored. The accumulation on the premises of 
official establishments of any material in which flies may breed, such 
as hog hair, bones, paunch contents, or manure, is forbidden. No other 
conditions that may result in adulteration of product or interfere with 
inspection shall be allowed in any official establishment or on its 
premises.



Sec. 308.14  Employment of diseased persons.

    No operator of an official establishment or other person preparing 
product in an official establishment shall employ, in any department 
where product is handled or prepared, any person showing evidence of a 
communicable disease in a transmissible stage, or known to be a carrier 
of such a disease, or while affected with boils, sores, infected wounds, 
or other abnormal sources of microbiological contaminants.



Sec. 308.15  Tagging insanitary equipment, utensils, rooms or compartments.

    When, in the opinion of a Program employee, any equipment, utensil, 
room, or compartment at an official establishment is unclean or its use 
would be a violation of any of the regulations in this subchapter, he 
will attach a ``U.S. Rejected'' tag thereto. No equipment, utensil, 
room, or compartment so tagged shall again be used until made 
acceptable. Such tag so attached shall not be removed by anyone other 
than a Program employee.



Sec. 308.16  Sanitation requirements for electrical stimulating (EST) equipment.

    (a)Hide-on stimulation. Automatic and manually operated equipment 
may be used to apply electrical stimulation to the hide-on surface of 
slaughtered carcasses provided no opening cuts other than a stick wound 
or foot removal have been made in the carcass. If the hide is penetrated 
by electrodes, the penetrated tissue shall be trimmed. Disinfection of 
electrodes between each hide-on carcass stimulation is not necessary.
    (b) Hide-off stimulation. (1) Automatic or manually operated 
equipment may be used to apply electrical stimulation to carcasses after 
complete hide removal. Partially skinned carcasses shall not be 
stimulated.
    (2) If stimulation is applied before the carcass has been inspected, 
the carcass contact surfaces of the equipment shall be disinfected with 
a disinfectant approved by the Administrator\1\ before stimulation of 
the next carcass. In the event that carcass contact surfaces of the 
equipment cannot be cleaned and disinfected between carcass 
stimulations, those surfaces shall be immediately removed from contact 
with the exposed carcass and cleaned and disinfected before carcass 
contact is resumed.
---------------------------------------------------------------------------

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

    (3) If stimulation is applied after the cacass has been inspected, 
carcass contact of the surfaces of the equipment need not be disinfected 
with a disinfectant approved by the Administrator before stimulation of 
the next cacass. Carcass contact surfaces shall be maintained in a clean 
and sanitary condition.
    (c) Preventing product contamination.Carcass contamination of edible 
tissue by stomach contents, feces and/or urine is unacceptable. To 
prevent such occurences, any of the following optional procedures may be 
used before stimulation to prevent this contamination:
    (1) Leave the sphincter muscles intact;
    (2) Cut the rectum and the urethra free from surrounding tissue and 
securely tie each off;
    (3) Partially open the mid-line and/or saw the brisket to reduce 
pressure on the visceral organs; or
    (4) Any other pressure-relieving or discharge-restricting 
alternative acceptable to the Administrator. Alternatives should be 
presented in writing, through the inspector-in-charge, to the program 
for approval.

[[Page 107]]

    (d) Cleaning. All equipment must be thoroughly cleaned at least 
daily.

[53 FR 46443, Nov. 17, 1988]



PART 309--ANTE-MORTEM INSPECTION--Table of Contents




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

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

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



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

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



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

    (a) Any livestock which, on ante-mortem inspection, do not clearly 
show, but are suspected of being affected with any disease or condition 
that, under part 311 of this subchapter, may cause condemnation of the 
carcass on post-mortem inspection, and any livestock which show, on 
ante-mortem inspection, any disease or condition that, under part 311 of 
this subchapter would cause condemnation of only part of the carcass on 
post-mortem inspection, shall be so handled as to retain its identity as 
a suspect until it is given final post-mortem inspection, when the 
carcass shall be marked and disposed of as provided in parts 310 and 311 
of this subchapter, or until it is disposed of as otherwise provided in 
this part.
    (b) All seriously crippled animals and animals commonly termed 
``downers,'' shall be identified as U.S. Suspects and disposed of as 
provided in Sec. 311.1 of this subchapter unless they are required to be 
classed as condemned under Sec. 309.3.
    (c) Livestock which have reacted to a test for leptospirosis, or 
anaplasmosis, but which show no symptoms of the disease, shall be 
identified as U.S. Suspects and disposed of as provided in Sec. 311.10 
of this subchapter.
    (d) Livestock which are known to have reacted to the tuberculin test 
shall be identified as U.S. Suspects and disposed of as provided in 
Sec. 311.2 of this subchapter, except that livestock bearing an official 
``USDA Reactor'' or similar State reactor tag shall not be tagged as 
U.S. Suspects.

[[Page 108]]

    (e) Any cattle found on ante-mortem inspection to be affected with 
epithelioma of the eye or of the orbital region to a lesser extent than 
as described in Sec. 309.6 shall be identified as a U.S. Suspect and 
disposed of as provided in Sec. 311.12 of this subchapter.
    (f) Cattle found on ante-mortem inspection to be affected with 
anasarca to a lesser extent than as described in Sec. 309.8 shall be 
identified as U.S. Suspects and disposed of as provided in Sec. 311.8 of 
this subchapter or paragraph (g) of this section.
    (g) Any livestock suspected of being affected with anasarca may be 
set apart and held for treatment under Program or other responsible 
official supervision approved by the area supervisor. If at the 
expiration of the treatment period the livestock upon examination is 
found to be free from disease, it may be released for any purpose. 
Otherwise, it shall be identified as U.S. Suspect and disposed of as 
provided in Sec. 311.8 of this subchapter or condemned and disposed of 
as provided in Sec. 309.8, whichever is appropriate.
    (h) All hogs suspected on ante-mortem inspection of being affected 
with swine erysipelas shall be identified as U.S. Suspects and disposed 
of as provided in Sec. 311.5 of this subchapter or paragraph (i) of this 
section.
    (i) A hog suspected of being affected with swine erysipelas may be 
set apart and held for treatment under Program or other responsible 
official supervision approved by the area supervisor. If at the 
expiration of the treatment period the animal upon examination is found 
to be free from disease, it may be released for any purpose. Otherwise, 
it shall be identified as U.S. Suspect and disposed of as provided in 
Sec. 311.5 of this subchapter, or condemned and disposed of as provided 
in Sec. 309.13, whichever is appropriate.
    (j) Any livestock which is affected with vesicular exanthema or 
vesicular stomatitis, but which has recovered to the extent that the 
lesions are in process of healing, the temperature is within normal 
range, and the livestock shows a return to normal appetite and activity, 
shall be identified as U.S. Suspect and disposed of as provided in 
Sec. 311.32 of this subchapter, except that if desired, such livestock 
may be set apart and held under supervision of a Program employee or 
other official designated by the area supervisor for treatment. If the 
livestock is set aside for treatment, the U.S. Suspect identification 
device will be removed by a Program employee, following such treatment, 
if the livestock is found to be free from any such disease. Such 
livestock found to be free from any such disease may be released for 
slaughter or for purposes other than slaughter, provided that in the 
latter instance, the operator of the official establishment or the owner 
of the animal shall first obtain permission from the local, State, or 
Federal livestock sanitary official having jurisdiction over the 
movement of such livestock.
    (k) Livestock which are offered for ante-mortem inspection under 
this part, and which are regarded by the inspector as immature, shall be 
identified as U.S. Suspects and, if slaughtered, the disposition of 
their carcasses shall be determined by the post-mortem findings in 
connection with the ante-mortem conditions. If not slaughtered as 
suspects, such livestock shall be held under supervision of a Program 
employee or other official designated by the area supervisor, and after 
sufficient development may be released for slaughter or may be released 
for any other purpose, provided they have not been exposed to any 
infectious or contagious disease. If such exposure occurs, permission 
should be obtained from the nearest Veterinary Services unit of the 
Animal and Plant Health Inspection Service prior to release of such 
livestock.
    (l) Livestock previously condemned for listeriosis, if released for 
slaughter under Sec. 309.13(b) shall be identified as a U.S. Suspect in 
accordance with Sec. 309.13(c).
    (m) Each animal required by this part to be treated as a U.S. 
Suspect shall be identified as such by or under the supervision of a 
Program employee with an official device in accordance with Sec. 309.18. 
No such device shall be removed except by a Program employee.
    (n) Each animal identified as a U.S. Suspect on ante-mortem 
inspection shall be set apart and shall be slaughtered separately from 
other livestock

[[Page 109]]

at that establishment unless disposed of as otherwise provided in this 
part.
    (o) Each animal identified as a U.S. Suspect on ante-mortem 
inspection, when presented for slaughter shall be accompanied with a 
form MP 402-2 on which the inspector at the establishment shall record 
the U.S. Suspect identification number and any other identifying tag 
numbers present and a brief description of the animal and of the disease 
or condition for which the animal was classed as a suspect, including 
its temperature when the temperature of such animal might have a bearing 
on the disposition of the carcass on post-mortem inspection.
    (p) When any animal identified as a U.S. Suspect is released for any 
purpose or reason, as provided in this part, the official identification 
device shall be removed only by a Program employee and he shall report 
his action to the area supervisor. When a suspect is to be released 
under the provisions of this part for a purpose other than slaughter, 
the operator of the official establishment or the owner of the animal 
shall first obtain permission for the removal of such animal from the 
local, State or Federal livestock sanitary official having jurisdiction.

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



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

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



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

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

[[Page 110]]

said unit to determine whether the animal is, in fact, infected with 
such disease. If it is found on such tests to be infected, the animal 
shall be disposed of in accordance with paragraph (a) of this section. 
Otherwise, the animal shall be identified as a U.S. Suspect and disposed 
of as provided in Sec. 311.10 of this subchapter.

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



Sec. 309.5  Swine; disposal because of hog cholera.

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

[40 FR 27225, June 27, 1975]



Sec. 309.6  Epithelioma of the eye.

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



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

    (a) Any livestock found on ante-mortem inspection to be affected 
with anthrax shall be identified as U.S. Condemned and disposed of in 
accordance with Sec. 309.13.
    (b) No other livestock of a lot in which anthrax is found on ante-
mortem inspection shall be slaughtered and presented for post-mortem 
inspection until it has been determined by a careful ante-mortem 
inspection that no anthrax infected livestock remains in the lot.
    (c) Apparently healthy livestock (other than hogs) from a lot in 
which anthrax is detected, and any apparently healthy livestock which 
have been treated with anthrax biologicals which do not contain living 
anthrax organisms, may be slaughtered and presented for post-mortem 
inspection if they have been held not less than 21 days following the 
last treatment or the last death of any livestock in the lot. 
Alternatively, if desired, all apparently healthy livestock of the lot 
may be segregated and held for treatment by a State licensed 
veterinarian under supervision of a Program employee or other official 
designated by the area supervisor. No anthrax vaccine (live organisms) 
shall be used on the premises of an official establishment.
    (d) Livestock which have been injected with anthrax vaccines (live 
organisms) within 6 weeks, and those bearing evidence of reaction to 
such treatment, such as inflammation, tumefaction, or edema at the site 
of the injection, shall be condemned on ante-mortem inspection, or such 
animals may be held under supervision of a Program employee or other 
official designated by the area supervisor until the expiration of the 
6-week period and the disappearance of any evidence of reaction to the 
treatment.
    (e) When livestock are found on ante-mortem inspection to be 
affected with anthrax, all exposed livestock pens and driveways of the 
official establishment shall be cleaned and disinfected by promptly and 
thoroughly removing and burning all straw, litter, and manure. This 
shall be followed immediately by a thorough disinfection of the exposed 
premises by soaking the ground, fences, gates, and all exposed material 
with a 5 percent solution of sodium hydroxide or commercial lye prepared 
as outlined in Sec. 310.9(e)(1) of this subchapter, or other 
disinfectant that may

[[Page 111]]

be approved in specific cases by the Administrator specifically for this 
purpose.



Sec. 309.8  Cattle affected with anasarca and generalized edema.

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



Sec. 309.9  Swine erysipelas.

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



Sec. 309.10  Onset of parturition.

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



Sec. 309.11  Vaccine livestock.

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



Sec. 309.12  Emergency slaughter; inspection prior to.

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



Sec. 309.13  Disposition of condemned livestock.

    (a) Except as otherwise provided in this part, livestock identified 
as U.S. Condemned shall be killed by the official establishment, if not 
already dead. Such animals shall not be taken into the official 
establishment to be slaughtered or dressed; nor shall they be conveyed 
into any department of the establishment used for edible products; but 
they shall be disposed of in the manner provided for condemned carcasses 
in part 314 of this subchapter. The official U.S. Condemned tag shall 
not be removed from, but shall remain on the carcass until it goes into 
the tank, or is otherwise disposed of as prescribed in part 314 of this 
subchapter, at which time such tag may be removed by a Program employee 
only. The number of such tag shall be reported to the veterinary medical 
officer by the inspector who affixed it, and also by the inspector who 
supervised the tanking of the carcass.
    (b) Any livestock condemned on account of ketosis, swine erysipelas, 
vesicular diseases, grass tetany, transport tetany, parturient paresis, 
anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory 
condition including pneumonia, enteritis, and peritonitis may be set 
apart and held for treatment under supervision of a Program employee or 
official designated by the area supervisor. The U.S. Condemned 
identification tag will be removed by a Program employee following 
treatment under such supervision if the animal is found to be free from 
any such disease.
    (c) Livestock previously affected with listeriosis, including those 
released for slaughter after treatment under paragraph (b) of this 
section, shall be identified as U.S. Suspect.
    (d) When livestock under the provisions of this section is to be 
released for a purpose other than slaughter, the operator of the 
official establishment or the owner of the livestock shall first obtain 
permission for the movement of such livestock from the local, State, or 
Federal livestock sanitary official having jurisdiction.



Sec. 309.14  Brucellosis-reactor goats.

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



Sec. 309.15  Vesicular diseases.

    (a) Immediate notification shall be given by the inspector to the 
local, State, and Federal livestock sanitary officials having 
jurisdiction when any

[[Page 112]]

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



Sec. 309.16  Livestock suspected of having biological residues.

    (a) Except as provided by paragraph (d) of this section, livestock 
suspected of having been treated with or exposed to any substance that 
may impart a biological residue which would make the edible tissues 
unfit for human food or otherwise adulterated shall be handled in 
compliance with the provisions of this paragraph. They shall be 
identified at official establishments as ``U.S. Condemned.'' These 
livestock may be held under the custody of a Program employee, or other 
official designated by the Administrator, until metabolic processes have 
reduced the residue sufficiently to make the tissues fit for human food 
and otherwise not adulterated. When the required time has elapsed, the 
livestock, if returned for slaughter, must be re-examined on ante-mortem 
inspection. To aid in determining the amount of residue present in the 
tissues, officials of the Program may permit the slaughter of any such 
livestock for the purpose of collecting tissues for analysis for the 
residue. Such analysis may include the use of inplant screening 
procedures designed to detect the presence of antimicrobial residues in 
any species of livestock.
    (b) All carcasses and edible organs and other parts thereof, in 
which are found any biological residues which render such articles 
adulterated, shall be marked as ``U.S. Condemned'' and disposed of in 
accordance with Sec. 314.1 or Sec. 314.3 of this chapter.
    (c) [Reserved]
    (d) Calves shall not be presented for ante-mortem inspection in an 
official establishment except under the provisions of this paragraph.
    (1) Definitions. For purposes of this paragraph, the following 
definitions shall apply:
    (i) Calf. A calf up to 3 weeks of age or up to 150 pounds.
    (ii) Certified calf. A calf that the producer and all other 
subsequent custodians of the calf certify in writing has not been 
treated with any animal drug while in his or her custody or has been 
treated with one or more drugs in accordance with FDA approved label 
directions while in his or her custody and has been withheld from 
slaughter for the period(s) of time specified by those label directions.
    (iii) Healthy calf. A calf that an inspector determines shows no 
visual signs of disease or treatment of disease at ante-mortem 
inspection.
    (iv) Producer. The owner of the calf at the time of its birth.
    (v) Sick calf. A calf that an inspector on ante-mortem inspection 
determines has either signs of treatment or signs of disease.
    (vi) Veterinary medical officer. An inspector of the Program that 
has obtained a Doctor of Veterinary Medicine degree which is recognized 
by the Program.
    (2) General requirements. (i) The identity of the producer of each 
calf presented for ante-mortem inspection shall be made available by the 
official establishment to the inspection prior to the animal being 
presented for ante-mortem inspection.
    (ii) The inspector shall segregate the calves presented for ante-
mortem inspection at the establishment and identify each calf as one of 
the following: (a) Certified, (B) noncertified, or (C) previous residue 
condemnation.
    (3) Certified group. (i) For a calf to be considered certified, the 
producer and all other subsequent custodians of the calf must certify in 
writing that while the calf was in his or her custody, the calf was not 
treated with animal drugs or was treated with one or more drugs in 
accordance with FDA approved label directions and was withheld from 
slaughter for the period(s) of time specified by those label directions. 
All prior

[[Page 113]]

certifications must be presented with the animal at the time of 
slaughter. The certifications shall contain a list of the calves with 
accompanying identification numbers, as required by paragraph (d)(3)(ii) 
of this section, followed by the following language:

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

Executed on_____________________________________________________________
        (date of certification)

_______________________________________________________________________
(signature of certifier)

_______________________________________________________________________
(typed or printed name and address of certifier)

_______________________________________________________________________
(business of certifier)

    (ii) Each calf must be identified by use of backtag, eartag, or 
other type of secure identification which displays a number which shall 
be recorded on all written certifications.
    (iii) The inspector shall have segregated for veterinary medical 
officer examination any certified calf which he or she determines to 
show any sign of disease or which is not identified individually. Such 
animal will be tagged as ``U.S. Suspect'' and its carcass will be 
retained on post-mortem inspection and handled in accordance with 
Sec. 310.21 (c) and (d).
    (iv) The inspector shall handle the remaining carcasses of healthy 
animals in accordance with Sec. 310.21(c) and (d).
    (4) Noncertified group. On ante-mortem inspection, the inspector 
shall have segregated for veterinary medical officer examination any 
calf which he or she determines to show any sign of disease. Such animal 
will be tagged as ``U.S. Suspect'' and its carcass will be retained on 
post-mortem inspection and handled in accordance with Sec. 310.21(c). 
The inspector shall handle the remaining carcasses of healthy animals in 
accordance with Sec. 310.21(c).
    (5) Calves from producers with previous residue condemnation. On 
ante-mortem inspection, the inspector shall have segregated for 
veterinary medical officer examination any calf which he or she 
determines to show any sign of disease. Such animal will be tagged as 
``U.S. Suspect'' and its carcass will be retained on post-mortem 
inspection and handled in accordance with Sec. 310.21(e). The inspector 
shall handle the remaining carcasses of healthy animals in accordance 
with Sec. 310.21(e).
    (e) The name of each and all person(s) who sold or consigned each 
swine to the establishment shall be made available by the establishment 
to any Program employee or other authorized employee of the United 
States Department of Agriculture upon that employee's request and 
presentation of his or her official credentials. Swine identification, 
by means approved by the Animal and Plant Health Inspection Service, 
USDA, under part 71 of this title, must be maintained throughout post-
mortem inspection, in accordance with Sec. 310.23(a) of this subchapter.


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

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



Sec. 309.17  Livestock used for research.

    (a) No livestock used in any research investigation involving an 
experimental biological product, drug, or chemical shall be eligible for 
slaughter at an official establishment unless:
    (1) The operator of such establishment, the sponsor of the 
investigation, or the investigator has submitted to the Program, or the 
Veterinary Services unit of the Animal and Plant Health Inspection 
Service of the Department of Agriculture or to the Environmental 
Protection Agency or to the Food and Drug Administration of the 
Department of Health, Education, and

[[Page 114]]

Welfare, data or a summary evaluation of the data which demonstrates 
that the use of such biological product, drug, or chemical will not 
result in the products of such livestock being adulterated, and a 
Program employee has approved such slaughter;
    (2) Written approval by the Deputy Administrator, Meat and Poultry 
Inspection Field Operations is furnished the area supervisor prior to 
the time of slaughter;
    (3) In the case of an animal administered any unlicensed, 
experimental veterinary biologic product regulated under the Virus-Serum 
Toxin Act (21 U.S.C. 151 et seq.), the product was prepared and 
distributed in compliance with Part 103 of the regulations issued under 
said Act (part 103 of this title), and used in accordance with the 
labeling approved under said regulations;
    (4) In the case of an animal administered any investigational drug 
regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 
U.S.C. 301 et seq.), the drug was prepared and distributed in compliance 
with the applicable provisions of part 135 of the regulations issued 
under said Act (21 CFR part 135), and used in accordance with the 
labeling approved under said regulations;
    (5) In the case of an animal subjected to any experimental economic 
poison under section 2(a) of the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (7 U.S.C. 135 et seq.), the product was 
prepared and distributed in accordance with Sec. 362.17 of the 
regulations issued under said Act (7 CFR 362.17), and used in accordance 
with the labeling approved under said regulations.
    (6) In the case of an animal administered or subjected to any 
substance that is a food additive or pesticide chemical under the 
Federal Food, Drug, and Cosmetic Act, supra, there has been compliance 
with all tolerance limitations established by said Act and the 
regulations promulgated thereunder (21 CFR 1.1 et seq.), and all other 
restrictions and requirements imposed by said Act and said regulations 
will be complied with at the time of slaughter.
    (b) The inspector in charge may deny or withdraw the approval for 
slaughter of any livestock subject to the provision of this section when 
he deems it necessary to assure that all products prepared at the 
official establishment are free from adulteration.



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

    (a) All livestock required by this part to be identified as U.S. 
Suspects shall be tagged with a serially numbered metal ear tag bearing 
the term ``U.S. Suspect,'' except as provided in Sec. 309.2(d) and 
except that cattle affected with epithelioma of the eye, antinomycosis, 
or actinobacillosis to such an extent that the lesions would be readily 
detected on post-mortem inspection, need not be individually tagged on 
ante-mortem inspection with the U.S. Suspect tag, provided that such 
cattle are segregated and otherwise handled as U.S. Suspects.
    (b) In addition, identification of U.S. Suspect swine must include 
the use of tattoos specified by the inspector to maintain the identity 
of the animals through the dehairing equipment when such equipment is 
used.
    (c) All livestock required by this part to be identified as U.S. 
Condemned shall be tagged with a serially numbered metal ear tag bearing 
the term ``U.S. Condemned.''
    (d) The devices described in paragraphs (a), (b), and (c) of this 
section shall be the official devices for identification of livestock 
required to be identified as U.S. Suspect or U.S. Condemned as provided 
in this part.



PART 310--POST-MORTEM INSPECTION--Table of Contents




Sec.
310.1  Extent and time of post-mortem inspection; post-mortem inspection 
          staffing standards.
310.2  Identification of carcass with certain severed parts thereof and 
          with animal from which derived.
310.3  Carcasses and parts in certain instances to be retained.
310.4  Identification of carcasses and parts; tagging.
310.5  Condemned carcasses and parts to be so marked; tanking; 
          separation.
310.6  Carcasses and parts passed for cooking; marking.
310.7  Removal of spermatic cords, pizzles and preputial diverticuli.

[[Page 115]]

310.8  Passing and marking of carcasses and parts.
310.9  Anthrax; carcasses not to be eviscerated; disposition of affected 
          carcasses; hides, hoofs, horns, hair, viscera and contents, 
          and fat; handling of blood and scalding vat water; general 
          cleanup and disinfection.
310.10  Carcasses with skin or hide on; cleaning before evisceration; 
          removal of larvae of Hypodermae, external parasites and other 
          pathological skin conditions.
310.11  Cleaning of hog carcasses before incising.
310.12  Sternum to be split; abdominal and thoracic viscera to be 
          removed.
310.13  Inflating carcasses or parts thereof; transferring caul or other 
          fat.
310.14  Handling of bruised parts.
310.15  Disposition of thyroid glands and laryngeal muscle tissue.
310.16  Disposition of lungs.
310.17  Inspection of mammary glands.
310.18  Contamination of carcasses, organs, or other parts.
310.19  Inspection of kidneys.
310.20  Saving of blood from livestock as an edible product.
310.21  Carcasses suspected of containing sulfa and antibiotic residues; 
          sampling frequency; disposition of affected carcasses and 
          parts.
310.22  [Reserved]
310.23  Identification of carcasses and parts of swine.
310.24  [Reserved]
310.25  Contamination with microorganisms; process control verification 
          criteria and testing; pathogen reduction standards.

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

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



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

    (a) A careful post-mortem examination and inspection shall be made 
of the carcasses and parts thereof of all livestock slaughtered at 
official establishments. Such inspection and examination shall be made 
at the time of slaughter unless, because of unusual circumstances, prior 
arrangements acceptable to the Administrator have been made in specific 
cases by the circuit supervisor for making such inspection and 
examination at a later time.
    (b)(1) The staffing standards on the basis of the number of 
carcasses to be inspected per hour are outlined in the following tables. 
Standards for multiple inspector lines are based on inspectors rotating 
through the different types of inspection stations during each shift to 
equalize the workload. The inspector in charge shall have the authority 
to require the establishment to reduce slaughter line speeds where, in 
his judgment, the inspection procedure cannot be adequately performed at 
the current line speed because of particular deficiencies in carcass 
preparation and presentation by the plant at the higher speed, or 
because the health condition of the particular animals indicates a need 
for more extensive inspection.
    (2) Cattle inspection. For all cattle staffing standards, an ``a'' 
in the ``Number of Inspectors by Stations'' column means that one 
inspector performs the entire inspection procedure and a ``b'' means 
that one inspector performs the head and lower carcass inspection and a 
second inspector performs the viscera and upper carcass 
inspection.1
---------------------------------------------------------------------------

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

    (i) Inspection Using the Viscera Truck.

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


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

[[Page 116]]

 
78 to 81.......................................      1       2        1
82 to 134......................................      2       2        1
------------------------------------------------------------------------

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

[[Page 117]]



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


[[Page 118]]

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

[[Page 119]]



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


[[Page 120]]

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

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


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

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

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


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

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

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

[[Page 121]]

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


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

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

                         Table 3.--Two Inspectors--Staffing Standards for Sows and Boars
----------------------------------------------------------------------------------------------------------------
                                                                   Maximum inspection rates (head per hour)
                                                             ---------------------------------------------------
                                                                              Line Configuration
                                                             ---------------------------------------------------
       Distance walked \1\ in feet by inspector B is--        Carcass,\2\  Viscera,\2\    Head,\2\     Head,\2\
                                                                  head         head       viscera      viscera
                                                              viscera,\3\  carcass,\3\  carcass,\3\  carcass,\3\
                                                                 heads        heads        heads        heads
                                                                detached     detached     detached     attached
----------------------------------------------------------------------------------------------------------------
                                                 Without Mirror
 
----------------------------------------------------------------------------------------------------------------
0 to 5......................................................     144-248      144-254      144-267      144-267
6 to 10.....................................................     144-235      144-240      144-253      144-253
11 to 15....................................................     144-222      144-227      144-239      144-239
16 to 20....................................................     144-211      144-215      144-226      144-226
21 to 25....................................................     144-201      144-205      144-214      144-214
 
                                                   With Mirror
 
----------------------------------------------------------------------------------------------------------------
0 to 5......................................................     144-248      144-292      144-305      144-292
6 to 10.....................................................     144-235      144-273      144-291      144-280
11 to 15....................................................     144-222      144-256      144-272      144-268
16 to 20....................................................     144-211      144-241      144-255      144-255
21 to 25....................................................     144-201      144-228      144-240      144-240
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that Inspector B will have to walk between work stations during one
  inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\ Inspector A.
\3\ Inspector B.

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

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

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

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

[[Page 122]]



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

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

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



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

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



Sec. 310.4  Identification of carcasses and parts; tagging.

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

[[Page 123]]

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



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

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



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

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



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

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



Sec. 310.8  Passing and marking of carcasses and parts.

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



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

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

[[Page 124]]

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

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

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

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



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

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

[[Page 125]]



Sec. 310.11  Cleaning of hog carcasses before incising.

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



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

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



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

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

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

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

[54 FR 36756, Sept. 5, 1989, as amended at 55 FR 29565, July 20, 1990]



Sec. 310.14  Handling of bruised parts.

    When only a portion of a carcass is to be condemned on account of 
slight

[[Page 126]]

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



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

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

[53 FR 45890, Nov. 15, 1988]



Sec. 310.16  Disposition of lungs.

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

[36 FR 11639, June 17, 1971]



Sec. 310.17  Inspection of mammary glands.

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



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

    (a) Carcasses, organs, and other parts shall be handled in a 
sanitary manner to prevent contamination with fecal material, urine, 
bile, hair, dirt, or foreign matter; however, if contamination occurs, 
it shall be promptly removed in a manner satisfactory to the inspector.
    (b) Brains, cheek meat, and head trimmings from animals stunned by 
lead, sponge iron, or frangible bullets shall not be saved for use as 
human food but shall be handled as described in Sec. 314.1 or Sec. 314.3 
of this subchapter.

[[Page 127]]



Sec. 310.19  Inspection of kidneys.

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



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

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

[64 FR 72174, Dec. 23, 1999]

    Effective Date Note: At 64 FR 72174, Dec. 23, 1999, Sec. 310.20 was 
revised, effective Jan. 24, 2000. For the convenience of the user, the 
superseded text is set forth as follows:

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

    Blood may be saved for edible purposes at official establishments 
provided it is derived from livestock, the carcasses of which are 
inspected and passed, and the blood is collected, defibrinated, and 
handled in a manner so as not to render it adulterated under the Federal 
Meat Inspection Act and regulations issued pursuant thereto. The 
defibrination of blood intended for human food purposes shall not be 
done with the hands. Anticoagulants specified in Sec. 318.7(c)(4) of 
this subchapter may be used in lieu of defibrination.



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

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

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

    (1) Any carcass from a calf tagged as ``U.S. Suspect'' at the time 
of ante-mortem inspection, except that calves whose carcasses are 
condemned for pathology shall not be tested for drug residues.
    (2) Any carcass which he/she finds has either lesions of disease 
which is not condemned because of these lesions

[[Page 128]]

or a sign of treatment of disease at the time of post-mortem inspection,
    (3) Any carcass of a calf from a producer whose calf or calves have 
previously been condemned for residues as prescribed in paragraph (e) of 
this section, and
    (4) Carcasses from healthy-appearing certified and noncertified 
calves, as determined by the veterinary medical officer during ante-
mortem inspection, will be selected for testing as set forth below:

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

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

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

[[Page 129]]



Sec. 310.22  [Reserved]



Sec. 310.23  Identification of carcasses and parts of swine.

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

[53 FR 40387, Oct. 14, 1988]



Sec. 310.24  [Reserved]



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

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

[[Page 130]]

total of all livestock. Very low volume establishments that collect 
samples by sponging shall collect at least one sample per week, starting 
the first full week of operation after June 1 of each year, and continue 
sampling at a minimum of once each week the establishment operates until 
June 1 of the following year or until 13 samples have been collected, 
whichever comes first. Very low volume establishments collecting samples 
by excising tissue from carcasses shall collect one sample per week, 
starting the first full week of operation after June 1 of each year, and 
continue sampling at a minimum of once each week the establishment 
operates until one series of 13 tests meets the criteria set forth in 
paragraph (a)(5)(i) of this section.
    (B) Upon the establishment's meeting requirements of paragraph 
(a)(2)(v)(A) of this section, weekly sampling and testing is optional, 
unless changes are made in establishment facilities, equipment, 
personnel or procedures that may affect the adequacy of existing process 
control measures, as determined by the establishment or FSIS. FSIS 
determinations that changes have been made requiring resumption of 
weekly testing shall be provided to the establishment in writing.
    (3) Analysis of samples. Laboratories may use any quantitative 
method for analysis of E. coli that is approved as an AOAC Official 
Method of the AOAC International (formerly the Association of Official 
Analytical Chemists) 2 or approved and published by a 
scientific body and based on the results of a collaborative trial 
conducted in accordance with an internationally recognized protocol on 
collaborative trials and compared against the three tube Most Probable 
Number (MPN) method and agreeing with the 95 percent upper and lower 
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------

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

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

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

    (ii) Establishments sponging carcasses shall evaluate E. coli test 
results using statistical process control techniques.
    (6) Failure to meet criteria. Test results that do not meet the 
criteria described in paragraph (a)(5) of this section are an indication 
that the establishment

[[Page 131]]

may not be maintaining process controls sufficient to prevent fecal 
contamination. FSIS shall take further action as appropriate to ensure 
that all applicable provisions of the law are being met.
    (7) Failure to test and record. Inspection shall be suspended in 
accordance with rules of practice that will be adopted for such 
proceedings upon a finding by FSIS that one or more provisions of 
paragraphs (a) (1)-(4) of this section have not been complied with and 
written notice of same has been provided to the establishment.
    (b) Pathogen reduction performance standard; Salmonella.
    (1) Raw meat product performance standards for Salmonella. An 
establishment's raw meat products, when sampled and tested by FSIS for 
Salmonella, as set forth in this section, may not test positive for 
Salmonella at a rate exceeding the applicable national pathogen 
reduction performance standard, as provided in Table 2:

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

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

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

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

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

    Effective Date Note: At 64 FR 66553, Nov. 29, 1999, Sec. 310.25 was 
amended by revising the

[[Page 132]]

section heading, the first sentence of paragraph (a)(1) introductory 
text, paragraphs (a)(2)(ii), (a)(2)(iii) and the first sentence of 
(a)(2)(v)(A), effective Jan. 25, 2000. For the convenience of the user, 
the superseded text is set forth as follows:

Sec. 310.25  Contamination with microorganisms; pathogen reduction 
          performance standards for Salmonella.

    (a) * * * 
    (1) Each official establishment that slaughters cattle and/or swine 
shall test for Escherichia coli Biotype 1 (E. coli).* * * 

                                * * * * *

    (2) * * * 
    (ii) Sample collection. The establishment shall collect samples from 
all chilled swine or cattle carcasses, except those boned before 
chilling (hot-boned), which must be sampled after the final wash. 
Samples shall be collected by either sponging or excising tissue from 
three sites on the selected carcass. On cattle carcasses, establishments 
shall sponge or excise tissue from the flank, brisket and rump, except 
for hide-on calves, in which case establishments shall take samples by 
sponging from inside the flank, inside the brisket, and inside the rump; 
on swine carcasses, establishments shall sponge or excise tissue from 
the ham, belly and jowl areas. 1
     1 A copy of FSIS's ``Guidelines for E. coli Testing for 
Process Control verification in Cattle and Swine Slaughter 
Establishments'' is available for inspection in the FSIS Docket Room.
    (iii) Sampling frequency. Slaughter establishments, except very low 
volume establishments as defined in paragraph (a)(2)(v) of this section, 
shall take samples at a frequency proportional to the volume of 
production at the following rates:
    Cattle: 1 test per 300 carcasses, but at a minimum one sample each 
week of operation.
    Swine: 1 test per 1000 carcasses, but at a minimum one sample each 
week of operation.
    (iii) Sampling frequency. Samples shall be taken at a frequency 
proportional to a slaughter establishment's volume of production, at the 
following rates:

Bovines: 1 test per 300 carcasses
Swine: 1 test per 1,000 carcasses

                                * * * * *

    (v) * * * 
    (A) Very low volume establishments annually slaughter no more than 
6,000 cattle, 20,000 swine, or a combination of cattle and swine not 
exceeding 6,000 cattle and 20,000 total of both types.

                                * * * * *



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




Sec.
311.1  Disposal of diseased or otherwise adulterated carcasses and 
          parts; general.
311.2  Tuberculosis.
311.3  Hog cholera.
311.5  Swine erysipelas.
311.6  Diamond-skin disease.
311.7  Arthritis.
311.8  Cattle carcasses affected with anasarca or generalized edema.
311.9  Actinomycosis and actinobacillosis.
311.10  Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in 
          cattle, blackleg, bluetongue, hemorrhagic septicemia, 
          icterohematuria in sheep, infectious bovine rhinotracheitis, 
          leptospirosis, malignant epizootic catarrh, strangles, purpura 
          hemorrhagica, azoturia, infectious equine encephalomyelitis, 
          toxic encephalomyelitis (forage poisoning), infectious anemia 
          (swamp fever), dourine, acute influenza, generalized 
          osteoporosis, glanders (farcy), acute inflammatory lameness, 
          extensive fistula, and unhealed vaccine lesions.
311.11  Neoplasms.
311.12  Epithelioma of the eye.
311.13  Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.
311.14  Abrasions, bruises, abscesses, pus, etc.
311.15  Brucellosis.
311.16  Carcasses so infected that consumption of the meat may cause 
          food poisoning.
311.17  Necrobacillosis, pyemia, and septicemia.
311.18  Caseous lymphadenitis.
311.19  Icterus.
311.20  Sexual odor of swine.
311.21  Mange or scab.
311.22  Hogs affected with urticaria, tinea tonsurans, demodex 
          follicurlorum, or erythema.
311.23  Tapeworm cysts (cysticercus bovis) in cattle.
311.24  Hogs affected with tapeworm cysts.
311.25  Parasites not transmissible to man; tapeworm cysts in sheep; 
          hydatid cysts; flukes; gid bladder-worms.
311.26  Emaciation.
311.27  Injured animals slaughtered at unusual hours.
311.28  Carcasses of young calves, pigs, kids, lambs, and foals.

[[Page 133]]

311.29  Unborn and stillborn animals.
311.30  Livestock suffocated and hogs scalded alive.
311.31  Livers affected with carotenosis; livers designated as 
          ``telangiectatic,'' ``sawdust,'' or ``spotted.''
311.32  Vesicular diseases.
311.33  Listeriosis.
311.34  Anemia.
311.35  Muscular inflammation, degeneration, or infiltration.
311.36  Coccidioidal granuloma.
311.37  Odors, foreign and urine.
311.38  Meat and meat byproducts from livestock which have been exposed 
          to radiation.
311.39  Biological residues.

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

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



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

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



Sec. 311.2  Tuberculosis.

    The following principles shall apply to the disposition of carcasses 
of livestock based on the difference in the pathogenesis of tuberculosis 
in swine, cattle, sheep, goats, and equines.
    (a) Carcasses condemned. The entire carcass of swine, cattle, sheep, 
goats, and equines shall be condemned if any of the following conditions 
occur:
    (1) When the lesions of tuberculosis are generalized (tuberculosis 
is considered to be generalized when the lesions are distributed in a 
manner made possible only by entry of the bacilli into the systemic 
circulation);
    (2) When on ante mortem inspection the animal is observed to have a 
fever found to be associated with an active tuberculosis lesion on post 
mortem inspection;
    (3) When there is an associated cachexia;
    (4) When a tuberculosis lesion is found in any muscle or 
intermuscular tissue, or bone, or joint, or abdominal organ (excluding 
the gastrointestinal tract) or in any lymph node as a result of draining 
a muscle, bone, joint, or abdominal organ (excluding the 
gastrointestinal tract);
    (5) When the lesions are extensive in tissues of either the thoracic 
or the abdominal cavity;
    (6) When the lesions are multiple, acute, and actively progressive; 
or
    (7) When the character or extent of the lesions otherwise is not 
indicative of a localized condition.
    (b) Organs or other parts condemned. An organ or other part of a 
swine, cattle, sheep, goat, or equine carcass affected by localized 
tuberculosis shall

[[Page 134]]

be condemned when it contains lesions of tuberculosis or when the 
corresponding lymph node contains lesions of tuberculosis.
    (c) Carcasses of cattle passed without restriction for human food. 
Carcasses of cattle may be passed without restriction for human food 
only when the carcass of an animal not identified as a reactor to a 
tuberculin test administered by an Animal and Plant Health Inspection 
Service, State, or accredited veterinarian 1 is found free of 
tuberculosis lesions during postmortem inspection.
---------------------------------------------------------------------------

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

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

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



Sec. 311.3  Hog cholera.

    (a) The carcasses of all hogs affected with hog cholera shall be 
condemned.
    (b) Inconclusive but suspicious symptoms of hog cholera observed 
during the ante-mortem inspection of a U.S. suspect shall be duly 
considered in connection with post-mortem findings and when the carcass 
of such a suspect shows lesions in the kidneys and the lymph nodes which 
resemble lesions of hog cholera, they shall be regarded as those of hog 
cholera and the carcass shall be condemned.
    (c) When lesions resembling those of hog cholera occur in kidneys 
and lymph nodes of carcasses of hogs which appeared normal on ante-
mortem inspection, further inspection of such

[[Page 135]]

carcasses shall be made for corroborative lesions. If on such further 
inspection, characteristic lesions of hog cholera are found in some 
organ or tissue in addition to those in the kidneys or in the lymph 
nodes or in both, then all lesions shall be regarded as those of hog 
cholera and the carcass shall be condemned. Immediate notification shall 
be given by the inspector to the official in the Veterinary Services 
unit of the Animal and Plant Health Inspection Service who has 
responsibility for control of swine diseases in the State where the 
swine are located.

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



Sec. 311.5  Swine erysipelas.

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



Sec. 311.6  Diamond-skin disease.

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



Sec. 311.7  Arthritis.

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



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

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



Sec. 311.9  Actinomycosis and actinobacillosis.

    (a) The definition of generalization as outlined for tuberculosis in 
Sec. 311.2(a) shall apply for actinomycosis and actinobacillosis, and 
carcasses of livestock with generalized lesions of either such disease 
shall be condemned.
    (b) Carcasses of livestock in a well-nourished condition showing 
uncomplicated localized lesions of actinomycosis or actinobacillosis may 
be passed for human food after the infected organs or other infected 
parts have been removed and condemned, except as provided in paragraphs 
(c) and (d) of this section.
    (c) Heads affected with actinomycosis or actinobacillosis, including 
the tongue, shall be condemned, except that when the disease of the jaw 
is slight, strictly localized, and without suppuration, fistulous 
tracts, or lymph node involvement, the tongue, if free from disease, may 
be passed, or, when the disease is slight and confined to the lymph 
nodes, the head including the tongue, may be passed for human food after 
the affected nodes have been removed and condemned.
    (d) When the disease is slight and confined to the tongue, with or 
without involvement of the corresponding lymph nodes, the head may be 
passed for human food after removal and condemnation of the tongue and 
corresponding lymph nodes.

[[Page 136]]



Sec. 311.10  Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria 
             in cattle, blackleg, bluetongue, hemorrhagic septicemia, 
             icterohematuria in sheep, infectious bovine rhinotracheitis, 

             leptospirosis, malignant epizootic catarrh, strangles, 
             purpura hemorrhagica, azoturia, infectious equine 
             encephalomyelitis, toxic encephalomyelitis (forage poisoning), 
             infectious anemia (swamp fever), dourine, acute influenza, 
             generalized osteoporosis, glanders (farcy), acute inflammatory 
             lameness, extensive fistula, and unhealed vaccine lesions.

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

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



Sec. 311.11  Neoplasms.

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



Sec. 311.12  Epithelioma of the eye.

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



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

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



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

    All slight, well-limited abrasions on the tongue and inner surface 
of the lips and mouth, when without lymph node involvement, shall be 
carefully excised,

[[Page 137]]

leaving only sound, normal tissue, which may be passed for human food. 
Any organ or other part of a carcass which is badly bruised or which is 
affected by an abscess, or a suppurating sore shall be condemned; and 
when the lesions are of such character or extent as to affect the whole 
carcass, the whole carcass shall be condemned. Portions of carcasses 
which are contaminated by pus or other diseased material shall be 
condemned.



Sec. 311.15  Brucellosis.

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



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

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



Sec. 311.17  Necrobacillosis, pyemia, and septicemia.

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



Sec. 311.18  Caseous lymphadenitis.

    (a) A thin carcass showing well-marked lesions in the viscera and 
the skeletal lymph nodes, or a thin carcass showing extensive lesions in 
any part shall be condemned.
    (b) A thin carcass showing well-marked lesions in the viscera with 
only slight lesions elsewhere or showing well-marked lesions in the 
skeletal lymph nodes with only slight lesions elsewhere may be passed 
for cooking.
    (c) A thin carcass showing only slight lesions in the skeletal lymph 
nodes and in the viscera may be passed for human food without 
restriction.
    (d) A well-nourished carcass showing well-marked lesions in the 
viscera and with only slight lesions elsewhere or showing well-marked 
lesions confined to the skeletal lymph nodes with only slight lesions 
elsewhere may be passed for human food without restriction.
    (e) A well-nourished carcass showing well-marked lesions in the 
viscera and the skeletal lymph nodes may be

[[Page 138]]

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



Sec. 311.19  Icterus.

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



Sec. 311.20  Sexual odor of swine.

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



Sec. 311.21  Mange or scab.

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



Sec. 311.22  Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

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



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

    (a) Except as provided in paragraph (b) of this section, carcasses 
of cattle affected with lesions of cysticercus bovis shall be disposed 
of as follows:
    (1) Carcasses of cattle displaying lesions of cysticercus bovis 
shall be condemned if the infestation is extensive or if the musculature 
is edematous or discolored. Carcasses shall be considered extensively 
infested if in addition to finding lesions in at least two of the usual 
inspection sites, namely the heart, diaphragm and its pillars, muscles 
of mastication, esophagus, tongue, and musculature exposed during normal 
dressing operations, they are found in at least two of the sites exposed 
by (i) an incision made into each round exposing the musculature in 
cross section, and (ii) a transverse incision into each forelimb 
commencing 2 or 3 inches above the point of the olecranon and extending 
to the humerus.
    (2) Carcasses of cattle showing one or more tapeworm lesions of 
cysticercus bovis but not so extensive as indicated in paragraph (a)(1) 
of this section, as determined by a careful examination, including 
examination of, but not limited to, the heart, diaphragm and its 
pillars, muscles of mastication, esophagus, tongue, and musculature 
exposed during normal dressing operations, may be passed for human food 
after removal and condemnation of the lesions with surrounding tissues: 
Provided, That the carcasses, appropriately identified by retained tags, 
are held in cold storage under positive control of a USDA Food Inspector 
at a temperature not higher than 15  deg.F. continuously for a period of 
not less than 10 days, or in the case of boned meat derived from such 
carcasses, the meat, when in boxes, tierces, or other containers, 
appropriately identified by retained tags, is held under positive 
control of a Program Inspector at a temperature of not higher than 15 
deg.F. continuously for a period of not less than 20 days. As an 
alternative to retention in cold storage as provided in this 
subparagraph, such carcasses and meat may be heated throughout to a 
temperature of at least 140  deg.F. under positive control of a Program 
Inspector.

[[Page 139]]

    (b) Edible viscera and offal shall be disposed of in the same manner 
as the rest of the carcass from which they were derived unless any 
lesion of cysticercus bovis is found in these byproducts, in which case 
they shall be condemned.

[36 FR 4591, Mar. 10, 1971]



Sec. 311.24  Hogs affected with tapeworm cysts.

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



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

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



Sec. 311.26  Emaciation.

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

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



Sec. 311.27  Injured animals slaughtered at unusual hours.

    When it is necessary for humane reasons to slaughter an injured 
animal at night or on Sunday or a holiday when the inspector cannot be 
obtained, the carcass and all parts shall be kept for inspection, with 
the head and all viscera except the stomach, bladder, and intestines 
held by the natural attachments. If all parts are not so kept for 
inspection, the carcass shall be condemned. If, on inspection of a 
carcass slaughtered in the absence of an inspector, any lesion or other 
evidence is found indicating that the animal was sick or diseased, or 
affected with any

[[Page 140]]

other condition requiring condemnation of the animal on ante-mortem 
inspection, or if there is lacking evidence of the condition which 
rendered emergency slaughter necessary, the carcass shall be condemned.



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

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



Sec. 311.29  Unborn and stillborn animals.

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



Sec. 311.30  Livestock suffocated and hogs scalded alive.

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



Sec. 311.31  Livers affected with carotenosis; livers designated as ``telangiectatic,'' ``sawdust,'' or ``spotted.''

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



Sec. 311.32  Vesicular diseases.

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



Sec. 311.33  Listeriosis.

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



Sec. 311.34  Anemia.

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



Sec. 311.35  Muscular inflammation, degeneration, or infiltration.

    (a) If muscular lesions are found to be distributed in such a manner 
or to be of such character that removal is impractical, the carcass 
shall be condemned.

[[Page 141]]

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



Sec. 311.36  Coccidioidal granuloma.

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



Sec. 311.37  Odors, foreign and urine.

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



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

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



Sec. 311.39  Biological residues.

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



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




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

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

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



Sec. 312.1  General.

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

[[Page 142]]



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

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

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

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

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

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

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

[[Page 143]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.004

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

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



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

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

[GRAPHIC] [TIFF OMITTED] TC11SE91.005

[GRAPHIC] [TIFF OMITTED] TC11SE91.055

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

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

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

[[Page 144]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.006

[GRAPHIC] [TIFF OMITTED] TC11SE91.007

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



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

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



Sec. 312.5  Official seals for transportation of products.

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

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

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



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

    (a) The official marks required by parts 310 and 416 of this chapter 
for use in post-mortem inspection and identification of adulterated 
products and insanitary equipment and facilities are:
    (1) The tag (Form MP-427) which is used to retain carcasses and 
parts of carcasses in the slaughter department;

[[Page 145]]

it is black and white, and bears the legend ``U.S. Retained.''
    (2) The ``U.S. Retained'' mark which is applied to products and 
articles as prescribed in part 310 of this subchapter by means of a 
paper tag (Form MP-35) bearing the legend ``U.S. Retained.''
    (3) The ``U.S. Rejected'' mark which is used to identify insanitary 
buildings, rooms, or equipment as prescribed in part 416, section 6, of 
this chapter and is applied by means of a paper tag (Form MP-35) bearing 
the legend ``U.S. Rejected.''
    (4) The ``U.S. Passed for Cooking'' mark is applied on products 
passed for cooking as prescribed in part 310 of this subchapter by means 
of a brand and is in the following form:
[GRAPHIC] [TIFF OMITTED] TC11SE91.009

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

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

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

    Effective Date Notes: 1. At 64 FR 56415, Oct. 20, 1999, Sec. 312.6 
intro text of (a) and paragraph (a)(3) were revised, effective Jan. 25, 
2000. For the convenience of the user, the superseded text is set forth 
as follows:

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

    (a) The official marks required by parts 308 and 310 of this 
subchapter for use in post-mortem inspection and identification of 
adulterated products and insanitary equipment and facilities are:

                                * * * * *

    2. At 65 FR 2284, Jan. 14, 2000, Sec. 312.6 paragraph (a)(3) was 
revised, effective Jan. 25, 2000. For the convenience of the user, the 
superseded text is set forth as follows:
    (a) * * *

                                * * * * *

    (3) The ``U.S. Rejected'' mark which is used to identify insanitary 
buildings, rooms, or equipment as prescribed in part 308 of this 
subchapter and is applied by means of a paper tag (Form MP-35) bearing 
the legend ``U.S. Rejected''.

                                * * * * *



Sec. 312.7  [Reserved]



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

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

    \1\ The number ``529893'' is given as an example only. The number of 
the offical export certificate will be shown in lieu thereof.
---------------------------------------------------------------------------

      
    [GRAPHIC] [TIFF OMITTED] TC11SE91.011
    

Any rubber stamp approved by the Administrator, in the manner provided 
for in part 317 of this subchapter, and bearing the official mark 
prescribed in this paragraph shall be an official device for the 
purposes of the Act.
    (b) The official export certificate required by part 322 of this 
subchapter is

[[Page 146]]

a paper certificate form for signature by a Program employee, bearing a 
letterhead and the seal of the United States Department of Agriculture, 
with a certification that meat or meat food products described on the 
form is from animals that received ante-mortem and post-mortem 
inspection and were found sound and healthy and that it has been 
inspected and passed as provided by law and the regulations of the 
Department of Agriculture and is sound and wholesome. The certificate 
also bears a serial number such as ``No. 184432.''

[35 FR 15573, Oct. 3, 1970, as amended at 42 FR 11825, Mar. 1, 1977; 47 
FR 29823, July 9, 1982]



Sec. 312.9  Official detention marks and devices.

    The official mark for articles and livestock detained under part 329 
of this subchapter shall be the designation ``U.S. Detained'' and the 
official device for applying such mark shall be the official ``U.S. 
Detained'' tag (FSIS Form 8400-2) as prescribed in Sec. 329.2 of this 
subchapter.

[55 FR 47842, Nov. 16, 1990]



Sec. 312.10  Official mark for maintaining the identity and integrity of samples.

    The official mark for use in sealing containers of samples submitted 
under any requirements in this subchapter and section 202 of the Federal 
Meat Inspection Act shall bear the designation ``Sample Seal'' 
accompanied by the official USDA logo as shown below. Any seal approved 
by the Administrator for applying such mark shall be deemed an official 
device for purposes of the Act. Such device shall be supplied to 
inspectors, compliance officers, and other designated Agency officials 
by the United States Department of Agriculture.
[GRAPHIC] [TIFF OMITTED] TC11SE91.012


[52 FR 41958, Nov. 2, 1987]



PART 313--HUMANE SLAUGHTER OF LIVESTOCK--Table of Contents




Sec.
313.1  Livestock pens, driveways and ramps.
313.2  Handling of livestock.
313.5  Chemical; carbon dioxide
313.15  Mechanical; captive bolt.
313.16  Mechanical; gunshot.
313.30  Electrical; stunning or slaughtering with electric current.
313.50  Tagging of equipment, alleyways, pens or compartments to prevent 
          inhumane slaughter or handling in connection with slaughter.
313.90  [Reserved]

    Authority: 7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    Source: 44 FR 68813, Nov. 30, 1979, unless otherwise noted.



Sec. 313.1  Livestock pens, driveways and ramps.

    (a) Livestock pens, driveways and ramps shall be maintained in good 
repair. They shall be free from sharp or protruding objects which may, 
in the opinion of the inspector, cause injury or pain to the animals. 
Loose boards, splintered or broken planking, and unnecessary openings 
where the head, feet, or legs of an animal may be injured shall be 
repaired.
    (b) Floors of livestock pens, ramps, and driveways shall be 
constructed and

[[Page 147]]

maintained so as to provide good footing for livestock. Slip resistant 
or waffled floor surfaces, cleated ramps and the use of sand, as 
appropriate, during winter months are examples of acceptable 
conctruction and maintenance.
    (c) U.S. Suspects (as defined in Sec. 301.2(xxx)) and dying, 
diseased, and disabled livestock (as defined in Sec. 301.2(y)) shall be 
provided with a covered pen sufficient, in the opinion of the inspector, 
to protect them from the adverse climatic conditions of the locale while 
awaiting disposition by the inspector.
    (d) Livestock pens and driveways shall be so arranged that sharp 
corners and direction reversal of driven animals are minimized.

[44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]



Sec. 313.2  Handling of livestock.

    (a) Driving of livestock from the unloading ramps to the holding 
pens and from the holding pens to the stunning area shall be done with a 
minimum of excitement and discomfort to the animals. Livestock shall not 
be forced to move faster than a normal walking speed.
    (b) Electric prods, canvas slappers, or other implements employed to 
drive animals shall be used as little as possible in order to minimize 
excitement and injury. Any use of such implements which, in the opinion 
of the inspector, is excessive, is prohibited. Electrical prods attached 
to AC house current shall be reduced by a transformer to the lowest 
effective voltage not to exceed 50 volts AC.
    (c) Pipes, sharp or pointed objects, and other items which, in the 
opinion of the inspector, would cause injury or unnecessary pain to the 
animal shall not be used to drive livestock.
    (d) Disabled livestock and other animals unable to move.
    (1) Disabled animals and other animals unable to move shall be 
separated from normal ambulatory animals and placed in the covered pen 
provided for in Sec. 313.1(c).
    (2) The dragging of disabled animals and other animals unable to 
move, while conscious, is prohibited. Stunned animals may, however, be 
dragged.
    (3) Disabled animals and other animals unable to move may be moved, 
while conscious, on equipment suitable for such purposes; e.g., stone 
boats.
    (e) Animals shall have access to water in all holding pens and, if 
held longer than 24 hours, access to feed. There shall be sufficient 
room in the holding pen for animals held overnight to lie down.
    (f) Stunning methods approved in Sec. 313.30 shall be effectively 
applied to animals prior to their being shackled, hoisted, thrown, cast, 
or cut.



Sec. 313.5  Chemical; carbon dioxide.

    The slaughtering of sheep, calves and swine with the use of carbon 
dioxide gas and the handling in connection therewith, in compliance with 
the provisions contained in this section, are hereby designated and 
approved as humane methods of slaughtering and handling of such animals 
under the Act.
    (a) Administration of gas, required effect; handling. (1) The carbon 
dioxide gas shall be administered in a chamber in accordance with this 
section so as to produce surgical anesthesia in the animals before they 
are shackled, hoisted, thrown, cast, or cut. The animals shall be 
exposed to the carbon dioxide gas in a way that will accomplish the 
anesthesia quickly and calmly, with a minimum of excitement and 
discomfort to the animals. In swine, carbon dioxide may be administered 
to induce death in the animals before they are shackled, hoisted, 
thrown, cast, or cut.
    (2) The driving or conveying of the animals to the carbon dioxide 
chamber shall be done with a minimum of excitement and discomfort to the 
animals. Delivery of calm animals to the anesthesia chamber is essential 
since the induction, or early phase, of anesthesia is less violent with 
docile animals. Among other things this requires that, in driving 
animals to the anesthesia chamber, electrical equipment be used as 
little as possible and with the lowest effective voltage.
    (3) On emerging from the carbon dioxide tunnel, the animals shall be 
in a state of surgical anaesthesia and shall remain in this condition 
throughout shackling, sticking, and bleeding, except for swine in which 
death has been

[[Page 148]]

induced by the administration of carbon dioxide. Asphyxia or death from 
any cause shall not be produced in animals before bleeding, except for 
swine in which death has been induced by the administration of carbon 
dioxide.
    (b) Facilities and procedures--(1) General requirements for gas 
chambers and auxiliary equipment; operator. (i) The carbon dioxide gas 
shall be administered in a tunnel which is designed to permit the 
effective exposure of the animal. Two types of tunnels, based on the 
same principle, are in common use for carbon dioxide anesthesia. They 
are the ``U'' type tunnel and the ``Straight Line'' type tunnel, and are 
based on the principle that carbon dioxide gas has a higher specific 
gravity than air. The tunnels are open at both ends for entry and exit 
of animals and have a depressed central section. Anesthetizing, or, in 
the case of swine, death-inducing, carbon dioxide concentrations are 
maintained in the central sections of the tunnels. Effective 
anaesthetization is produced in these central sections. Animals are 
driven from holding pens through pathways constructed of large-diameter 
pipe or smooth metal and onto continuous conveyor devices that move the 
animals through the tunnels. The animals are either compartmentalized on 
the conveyors by mechanical impellers synchronized with the conveyor or 
they are otherwise prevented from crowding. While impellers are used to 
compartmentalize the animals, mechanically or manually operated gates 
are used to move the animals onto the conveyors. Surgically 
anaesthetized animals, or killed swine, are moved out of the tunnels by 
the same continuous conveyors that moved them into and through the 
carbon dioxide gas.
    (ii) Flow of animals into and through the carbon dioxide chamber is 
dependent on one operator. The operation or stoppage of the conveyor is 
entirely dependent upon this operator. It is necessary that he be 
skilled, attentive, and aware of his responsibility. Overdosages and 
death of animals can be brought about by carelessness of this 
individual.
    (2) Special requirements for gas chamber and auxiliary equipment. 
The ability of anesthetizing equipment to perform with maximum 
efficiency is dependent on its proper design and efficient mechanical 
operation. Pathways, compartments, gas chambers, and all other equipment 
used must be designed to accommodate properly the species of animals 
being anesthetized. They shall be free from pain-producing restraining 
devices. Injury of animals must be prevented by the elimination of sharp 
projections or exposed wheels or gears. There shall be no unnecessary 
holes, spaces or openings where feet or legs of animals may be injured. 
Impellers or other devices designed to mechanically move or drive 
animals or otherwise keep them in motion or compartmentalized shall be 
constructed of flexible or well padded rigid material. Power activated 
gates designed for constant flow of animals to anesthetizing equipment 
shall be so fabricated that they will not cause injury. All equipment 
involved in anesthetizing animals shall be maintained in good repair.
    (3) Gas. Maintenance of a uniform carbon dioxide concentration and 
distribution in the anesthesia chamber is a vital aspect of producing 
surgical anesthesia. This may be assured by reasonably accurate 
instruments which sample and analyze carbon dioxide gas concentration 
within the chamber throughout anesthetizing operations. Gas 
concentration shall be maintained uniform so that the degree of 
anesthesia in exposed animals will be constant. Carbon dioxide gas 
supplied to anesthesia chambers may be from controlled reduction of 
solid carbon dioxide or from a controlled liquid source. In either case 
the carbon dioxide shall be supplied at a rate sufficient to anesthetize 
adequately and uniformly the number of animals passing through the 
chamber. Sampling of gas for analysis shall be made from a 
representative place or places within the chamber and on a continuing 
basis. Gas concentrations and exposure time shall be graphically 
recorded throughout each day's operation. Neither carbon dioxide nor 
atmospheric air used in the anesthesia chambers shall contain noxious or 
irritating gases. Each day before equipment is used for anesthetizing 
animals, proper care shall be taken to mix adequately the gas and air 
within the chamber. All gas producing and

[[Page 149]]

control equipment shall be maintained in good repair and all indicators, 
instruments, and measuring devices must be available for inspection by 
Program inspectors during anesthetizing operations and at other times. 
An exhaust system must be provided so that, in case of equipment 
failure, non-uniform carbon dioxide concentrations in the gas tunnel or 
contamination of the ambient air of the establishment will be prevented.

[44 FR 68813, Nov. 30, 1979, as amended at 59 FR 21640, Apr. 26, 1994]



Sec. 313.15  Mechanical; captive bolt.

    The slaughtering of sheep, swine, goats, calves, cattle, horses, 
mules, and other equines by using captive bolt stunners and the handling 
in connection therewith, in compliance with the provisions contained in 
this section, are hereby designated and approved as humane methods of 
slaughtering and handling of such animals under the Act.
    (a) Application of stunners, required effect; handling. (1) The 
captive bolt stunners shall be applied to the livestock in accordance 
with this section so as to produce immediate unconsciousness in the 
animals before they are shackled, hoisted, thrown, cast, or cut. The 
animals shall be stunned in such a manner that they will be rendered 
unconscious with a minimum of excitement and discomfort.
    (2) The driving of the animals to the stunning area shall be done 
with a minimum of excitement and discomfort to the animals. Delivery of 
calm animals to the stunning areas is essential since accurate placement 
of stunning equipment is difficult on nervous or injured animals. Among 
other things, this requires that, in driving animals to the stunning 
areas, electrical equipment be used as little as possible and with the 
lowest effective voltage.
    (3) Immediately after the stunning blow is delivered the animals 
shall be in a state of complete unconsciousness and remain in this 
condition throughout shackling, sticking and bleeding.
    (b) Facilities and procedures--(1) General requirements for stunning 
facilities; operator. (i) Acceptable captive bolt stunning instruments 
may be either skull penetrating or nonpenetrating. The latter type is 
also described as a concussion or mushroom type stunner. Penetrating 
instruments on detonation deliver bolts of varying diameters and lengths 
through the skull and into the brain. Unconsciousness is produced 
immediately by physical brain destruction and a combination of changes 
in intracranial pressure and acceleration concussion. Nonpenetrating or 
mushroom stunners on detonation deliver a bolt with a flattened circular 
head against the external surface of the animal's head over the brain. 
Diameter of the striking surface of the stunner may vary as conditions 
require. Unconsciousness is produced immediately by a combination of 
acceleration concussion and changes in intracranial pressures. A 
combination instrument utilizing both penetrating and nonpenetrating 
principles is acceptable. Energizing of instruments may be accomplished 
by detonation of measured charges of gunpowder or accurately controlled 
compressed air. Captive bolts shall be of such size and design that, 
when properly positioned and activated, immediate unconsciousness is 
produced.
    (ii) To assure uniform unconsciousness with every blow, compressed 
air devices must be equipped to deliver the necessary constant air 
pressure and must have accurate, constantly operating air pressure 
gauges. Gauges must be easily read and conveniently located for use by 
the stunning operator and the inspector. For purposes of protecting 
employees, inspectors, and others, it is desirable that any stunning 
device be equipped with safety features to prevent injuries from 
accidental discharge. Stunning instruments must be maintained in good 
repair.
    (iii) The stunning area shall be so designed and constructed as to 
limit the free movements of animals sufficiently to allow the operator 
to locate the stunning blow with a high degree of accuracy. All chutes, 
alleys, gates and restraining mechanisms between and including holding 
pens and stunning areas shall be free from pain-producing features such 
as exposed bolt ends, loose boards, splintered or broken planking, and 
protruding sharp metal of any kind. There shall be no unnecessary holes 
or other openings where feet

[[Page 150]]

or legs of animals may be injured. Overhead drop gates shall be suitably 
covered on the bottom edge to prevent injury on contact with animals. 
Roughened or cleated cement shall be used as flooring in chutes leading 
to stunning areas to reduce falls of animals. Chutes, alleys, and 
stunning areas shall be so designed that they will comfortably 
accommodate the kinds of animals to be stunned.
    (iv) The stunning operation is an exacting procedure and requires a 
well-trained and experienced operator. He must be able to accurately 
place the stunning instrument to produce immediate unconsciousness. He 
must use the correct detonating charge with regard to kind, breed, size, 
age, and sex of the animal to produce the desired results.
    (2) Special requirements. Choice of instrument and force required to 
produce immediate unconsciousness varies, depending on kind, breed, 
size, age, and sex of the animal. Young swine, lambs, and calves usually 
require less stunning force than mature animals of the same kind. Bulls, 
rams, and boars usually require skull penetration to produce immediate 
unconsciousness. Charges suitable for smaller kinds of livestock such as 
swine or for young animals are not acceptably interchanged for use on 
larger kinds or older livestock, respectively.



Sec. 313.16  Mechanical; gunshot.

    The slaughtering of cattle, calves, sheep, swine, goats, horses, 
mules, and other equines by shooting with firearms and the handling in 
connection therewith, in compliance with the provisions contained in 
this section, are hereby designated and approved as humane methods of 
slaughtering and handling of such animals under the Act.
    (a) Utilization of firearms, required effect; handling. (1) The 
firearms shall be employed in the delivery of a bullet or projectile 
into the animal in accordance with this section so as to produce 
immediate unconsciousness in the animal by a single shot before it is 
shackled, hoisted, thrown, cast, or cut. The animal shall be shot in 
such a manner that they will be rendered unconscious with a minimum of 
excitement and discomfort.
    (2) The driving of the animals to the shooting areas shall be done 
with a minimum of excitement and discomfort to the animals. Delivery of 
calm animals to the shooting area is essential since accurate placement 
of the bullet is difficult in case of nervous or injured animals. Among 
other things, this requires that, in driving animals to the shooting 
areas, electrical equipment be used as little as possible and with the 
lowest effective voltage.
    (3) Immediately after the firearm is discharged and the projectile 
is delivered, the animal shall be in a state of complete unconsciousness 
and remain in this condition throughout shackling, sticking and 
bleeding.
    (b) Facilities and procedure--(1) General requirements for shooting 
facilities; operator. (i) On discharge, acceptable firearms dispatch 
free projectiles or bullets of varying sizes and diameters through the 
skull and into the brain. Unconsciousness is produced immediately by a 
combination of physical brain destruction and changes in intracranial 
pressure. Caliber of firearms shall be such that when properly aimed and 
discharged, the projectile produces immediate unconsciousness.
    (ii) To assure uniform unconsciousness of the animal with every 
discharge where small-bore firearms are employed, it is necessary to use 
one of the following type projectiles: Hollow pointed bullets; frangible 
iron plastic composition bullets; or powdered iron missiles. When 
powdered iron missiles are used, the firearms shall be in close 
proximity with the skull of the animal when fired. Firearms must be 
maintained in good repair. For purposes of protecting employees, 
inspectors and others, it is desirable that all firearms be equipped 
with safety devices to prevent injuries from accidental discharge. 
Aiming and discharging of firearms should be directed away from 
operating areas.
    (iii) The provisions contained in Sec. 313.15(b)(1)(iii) with 
respect to the stunning area also apply to the shooting area.
    (iv) The shooting operation is an exacting procedure and requires a 
well-trained and experienced operator. He must be able to accurately 
direct the

[[Page 151]]

projectile to produce immediate unconsciousness. He must use the correct 
caliber firearm, powder charge and type of ammunition to produce the 
desired results.
    (2) Special requirements. Choice of firearms and ammunition with 
respect to caliber and choice of powder charge required to produce 
immediate unconsciousness of the animal may vary depending on age and 
sex of the animal. In the case of bulls, rams, and boars, small bore 
firearms may be used provided they are able to produce immediate 
unconsciousness of the animals. Small bore firearms are usually 
effective for stunning other cattle, sheep, swine, and goats, and 
calves, horses, and mules.



Sec. 313.30  Electrical; stunning or slaughtering with electric current.

    The slaughtering of swine, sheep, calves, cattle, and goats with the 
use of electric current and the handling in connection therewith, in 
compliance with the provisions contained in this section, are hereby 
designated and approved as humane methods of slaughtering and handling 
of such animals under the Act.
    (a) Administration of electric current, required effect; handling. 
(1) The electric current shall be administered so as to produce, at a 
minimum, surgical anesthesia, i.e., a state where the animal feels no 
painful sensation. The animals shall be either stunned or killed before 
they are shackled, hoisted, thrown, cast, or cut. They shall be exposed 
to the electric current in a way that will accomplish the desired result 
quickly and effectively, with a minimum of excitement and discomfort.
    (2) The driving or conveying of the animals to the place of 
application of electric current shall be done with a minimum of 
excitement and discomfort to the animals. Delivery of calm animals to 
the place of application is essential to ensure rapid and effective 
insensibility. Among other things, this requires that, in driving 
animals to the place of application, electrical equipment be used as 
little as possible and with the lowest effective voltage.
    (3) The quality and location of the electrical shock shall be such 
as to produce immediate insensibility to pain in the exposed animal.
    (4) The stunned animal shall remain in a state of surgical 
anesthesia through shackling, sticking, and bleeding.
    (b) Facilities and procedures; operator--(1) General requirements 
for operator. It is necessary that the operator of electric current 
application equipment be skilled, attentive, and aware of his or her 
responsibility.
    (2) Special requirements for electric current application equipment. 
The ability of electric current equipment to perform with maximum 
efficiency is dependent on its proper design and efficient mechanical 
operation. Pathways, compartments, current applicators, and all other 
equipment used must be designed to properly accommodate the species of 
animals being anesthetized. Animals shall be free from pain-producing 
restraining devices. Injury of animals must be prevented by the 
elimination of sharp projections or exposed wheels or gears. There shall 
be no unnecessary holes, spaces or openings where feet or legs of 
animals may be injured. Impellers or other devices designed to 
mechanically move or drive animals or otherwise keep them in motion or 
compartmentalized shall be constructed of flexible or padded material. 
Power activated gates designed for constant flow of animals shall be so 
fabricated that they will not cause injury. All equipment used to apply 
and control the electrical current shall be maintained in good repair, 
and all indicators, instruments, and measuring devices shall be 
available for inspection by Program inspectors during the operation and 
at other times.
    (3) Electric current. Each animal shall be given a sufficient 
application of electric current to ensure surgical anesthesia throughout 
the bleeding operation. Suitable timing, voltage and current control 
devices shall be used to ensure that each animal receives the necessary 
electrical charge to produce immediate unconsciousness. The current 
shall be applied so as to avoid the

[[Page 152]]

production of hemorrhages or other tissue changes which could interfere 
with inspection procedures.

[44 FR 68813, Nov. 30, 1979, as amended at 50 FR 25202, June 18, 1985]



Sec. 313.50  Tagging of equipment, alleyways, pens, or compartments to prevent inhumane slaughter or handling in connection with slaughter.

    When an inspector observes an incident of inhumane slaughter or 
handling in connection with slaughter, he/she shall inform the 
establishment operator of the incident and request that the operator 
take the necessary steps to prevent a recurrence. If the establishment 
operator fails to take such action or fails to promptly provide the 
inspector with satisfactory assurances that such action will be taken, 
the inspector shall follow the procedures specified in paragraph (a), 
(b), or (c) of this section, as appropriate.
    (a) If the cause of inhumane treatment is the result of facility 
deficiencies, disrepair, or equipment breakdown, the inspector shall 
attach a ``U.S. Rejected'' tag thereto. No equipment, alleyway, pen or 
compartment so tagged shall be used until made acceptable to the 
inspector. The tag shall not be removed by anyone other than an 
inspector. All livestock slaughtered prior to such tagging may be 
dressed, processed, or prepared under inspection.
    (b) If the cause of inhumane treatment is the result of 
establishment employee actions in the handling or moving of livestock, 
the inspector shall attach a ``U.S. Rejected'' tag to the alleyways 
leading to the stunning area. After the tagging of the alleyway, no more 
livestock shall be moved to the stunning area until the inspector 
receives satisfactory assurances from the establishment operator that 
there will not be a recurrence. The tag shall not be removed by anyone 
other than an inspector. All livestock slaughtered prior to the tagging 
may be dressed, processed, or prepared under inspection.
    (c) If the cause of inhumane treatment is the result of improper 
stunning, the inspector shall attach a ``U.S. Rejected'' tag to the 
stunning area. Stunning procedures shall not be resumed until the 
inspector receives satisfactory assurances from the establishment 
operator that there will not be a recurrence. The tag shall not be 
removed by anyone other than an inspector. All livestock slaughtered 
prior to such tagging may be dressed, processed, or prepared under 
inspection.



Sec. 313.90  [Reserved]



PART 314--HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE PRODUCTS AT OFFICIAL ESTABLISHMENTS--Table of Contents




Sec.
314.1  Disposition of condemned products at official establishments 
          having tanking facilities; sealing of tanks.
314.2  Tanking and other facilities for inedible products to be separate 
          from edible product facilities.
314.3  Disposition of condemned products at official establishments 
          having no tanking facilities.
314.4  Suppression of odors in preparing inedible products.
314.5  Inedible rendered fats prepared at official establishments.
314.6  Inedible fats from outside official establishments.
314.7  Carcasses of livestock condemned on ante-mortem inspection not to 
          pass through edible product areas.
314.8  Dead animal carcasses.
314.9  Specimens for educational, research, and other nonfood purposes; 
          permits for, required.
314.10  Livers condemned because of parasitic infestation and for other 
          causes; conditions for disposal for purposes other than human 
          food.
314.11  Handling of certain condemned products for purposes other than 
          human food.

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

    Source: 35 FR 15575, Oct. 3, 1970, unless otherwise noted.



Sec. 314.1  Disposition of condemned products at official establishments having tanking facilities; sealing of tanks.

    (a) Carcasses, parts of carcasses, and other products condemned at 
official establishments having facilities for tanking shall, except as 
provided in paragraph (c) of this section or elsewhere in this part, be 
disposed of by tanking as follows:

[[Page 153]]

    (1) The lower opening of the tank shall first be sealed securely by 
a Program employee, except when permanently connected with a blow line; 
then the condemned products shall be placed in the tank in his presence, 
after which the upper opening shall also be sealed securely by such 
employee, who shall then see that the contents of the tank are subjected 
to sufficient heating for sufficient time to effectively destroy the 
contents for human food purposes.
    (2) The use of equipment such as crushers or hashers for pretanking 
preparation of condemned products in the inedible products department 
has been found to give inedible character and appearance to the 
material. Accordingly, if condemned products are so crushed or hashed, 
conveying systems, rendering tanks, and other equipment used in the 
further handling of crushed or hashed material need not be locked or 
sealed during the tanking operations. If the rendering tanks or other 
equipment contain condemned material not so crushed or hashed, the 
equipment shall be sealed as prescribed in paragraph (a)(1) of this 
section. If the crushed or hashed material is not rendered in the 
establishment where produced, it shall be denatured as provided for in 
Sec. 314.3 before leaving such establishment.
    (b) The seals of tanks shall be broken only by a Program employee 
and only after the contents of the tanks have been treated as provided 
in paragraph (a) of this section. The rendered fat derived from 
condemned material shall be held until a Program employee shall have had 
an opportunity to determine whether it conforms with the requirements of 
this section. Samples shall be taken by Program employees as often as is 
necessary to determine whether the rendered fat is effectually 
denatured.
    (c) Carcasses of animals condemned under Sec. 309.3 of this 
subchapter may be disposed of as provided in Sec. 314.3, in lieu of 
tanking, with the approval of the inspector.



Sec. 314.2  Tanking and other facilities for inedible products to be separate from edible product facilities.

    All tanks and equipment used for rendering, otherwise preparing, or 
storing inedible products must be in rooms or compartments separate from 
those used for preparing or storing edible products. There may be a 
connection between rooms or compartments containing inedible products 
and those containing edible products as long as it does not cause the 
adulteration of edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]

    Effective Date Note: At 64 FR 56416, Oct. 20, 1999 Sec. 314.2 was 
revised, effective Jan. 25, 2000. For the convenience of the user, the 
superseded text is set forth as follows:

Sec. 314.2  Tanking and other facilities for inedible products to be 
          separate from edible product facilities.

    All tanks and equipment used for rendering, otherwise preparing, or 
storing inedible products shall be in rooms or compartments separate 
from those used for preparing or storing edible products. There shall be 
no connection between rooms or compartments containing inedible products 
and those containing edible products, except that there may be one 
connecting doorway between the slaughtering or viscera separating 
department and the tank charging room of the inedible products rendering 
department. Pipes and chutes installed in accordance with such 
arrangements as are permitted by part 308 of this subchapter, or as may 
be approved by the Administrator in specific cases, may be used to 
convey inedible and condemned material from edible product departments 
to inedible product departments.



Sec. 314.3  Disposition of condemned products at official establishments having no tanking facilities.

    (a) Carcasses, parts of carcasses, and other products condemned at 
an official establishment which has no facilities for tanking shall, 
except as provided in paragraph (b) of this section or elsewhere in this 
part, be destroyed in the presence of an inspector by incineration, or 
denatured with crude carbolic acid, or cresylic disinfectant, or a 
formula consisting of one part FD&C No. 3 green coloring, 40 parts 
water, 40 parts liquid detergent, and 40 parts oil of citronella or any 
other proprietary material approved by the Administrator in specific 
cases. When such product is to be denatured, it shall be freely slashed 
before the denaturing agent is applied, except that, in the case of dead 
animals that have not been dressed, the denaturant may be

[[Page 154]]

applied by injection. The denaturant must be deposited in all portions 
of the carcass or product to the extent necessary to preclude its use 
for food purposes.
    (b) All carcasses and parts condemned on account of anthrax, as 
identified in Sec. 310.9(b) of this subchapter, at official 
establishments which are not equipped with tanking facilities shall be 
disposed of by (1) complete incineration, or (2) by thorough denaturing 
with crude carbolic acid, or cresylic disinfectant, and then disposed of 
in accordance with the requirements of the particular State or municipal 
authorities, who shall be notified immediately by the area supervisor.



Sec. 314.4  Suppression of odors in preparing inedible products.

    Tanks, fertilizer driers, and other equipment used in the 
preparation of inedible product must be operated in a manner that will 
suppress odors incident to such preparation which could adulterate 
edible product or create insanitary conditions.

[64 FR 56416, Oct. 20, 1999]

    Effective Date Note: At 64 FR 56416, Oct. 20, 1999, Sec. 314.4 was 
revised, effective Jan. 25, 2000. For the convenience of the user, the 
superseded text is set forth as follows:

Sec. 314.4  Suppression of odors in preparing inedible products.

    Tanks, fertilizer driers, and other equipment used in the 
preparation of inedible product shall be properly equipped with 
condensers and other appliances which will acceptably suppress odors 
incident to such preparation.



Sec. 314.5  Inedible rendered fats prepared at official establishments.

    Except as provided in Sec. 325.11(b) of this subchapter, rendered 
animal fat derived from condemned or other inedible materials at 
official establishments shall be denatured to effectually distinguish it 
from an edible product, either with low grade offal during the rendering 
or by adding to, and mixing thoroughly with, such fat, denaturing oil, 
No. 2 fuel oil, or brucine dissolved in a mixture of alcohol and pine 
oil or oil of rosemary, and may be shipped in commerce in accordance 
with Sec. 325.11(c) of this subchapter.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]



Sec. 314.6  Inedible fats from outside official establishments.

    Except as provided in Sec. 325.11(b) of this subchapter, inedible 
fats from outside the premises of any official establishment shall not 
be received into an official establishment except into the tank room 
provided for inedible products, and then only when they have been 
denatured in accordance with Sec. 314.5 and are marked in accordance 
with Sec. 316.15 of this subchapter, and when their receipt into the 
tank room produces no insanitary condition on the premises; nor shall 
such fats be received in such volume as interferes with prompt disposal 
of condemned or other inedible material produced at the establishment. 
When received, they shall not enter any room or compartment used for 
edible products.

[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]



Sec. 314.7  Carcasses of livestock condemned on ante-mortem inspection not to pass through edible product areas.

    Carcasses of livestock which have been condemned on ante-mortem 
inspection shall not be taken through rooms or compartments in which an 
edible product is prepared, handled, or stored.



Sec. 314.8  Dead animal carcasses.

    (a) With the exception of dead livestock which have died en route 
and are received with livestock for slaughter at an official 
establishment, no dead animal or part of the carcass of any livestock 
that died otherwise than by slaughter may be brought on the premises of 
an official establishment unless advance permission therefore is 
obtained from the circuit supervisor.
    (b) Under no circumstances shall the carcasses of any animal which 
has died otherwise than by slaughter, or any part thereof, be brought 
into any room or compartment in which any edible product is prepared, 
handled, or stored.

[[Page 155]]



Sec. 314.9  Specimens for educational, research, and other nonfood purposes; permits for, required.

    (a) Specimens of condemned or other inedible materials, including 
embryos and specimens of animal parasites, may be released for 
educational, research, or other nonfood purposes under permit issued by 
the inspector in charge: Provided, That the person desiring such 
specimens makes a written application to the inspector in charge for 
such permit on Form MP-403-10 and arranges with and receives permission 
from the official establishment to obtain the specimens. Permits shall 
be issued for a period not longer than 1 year. The permit may be revoked 
by the inspector in charge if the specimens are not used as stated in 
the application, or if the collection or handling of the specimens 
interferes with inspection or the maintenance of sanitary conditions in 
the establishment.
    (b) The specimens referred to in paragraph (a) of this section shall 
be collected and handled only at such time and place and in such manner 
as not to interfere with the inspection or to cause any objectionable 
condition and shall be identified as inedible when they leave the 
establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 38 FR 18665, July 13, 1973; 39 
FR 36000, Oct. 7, 1974]



Sec. 314.10  Livers condemned because of parasitic infestation and for other causes; conditions for disposal for purposes other than human food.

    (a) Livers condemned on account of hydatid cysts shall be disposed 
of by tanking pursuant to the provisions of Sec. 314.1 of this 
subchapter if condemned at official establishments having facilities for 
tanking; otherwise they shall be destroyed pursuant to the provisions of 
Sec. 314.3 of this subchapter.
    (b) Livers condemned because of parasites other than hydatid cysts; 
and livers condemned because of telangiectasis, angioma, ``sawdust'' 
condition, cirrhosis, carotenosis, or other nonmalignant change, benign 
abscesses, or contamination, when these conditions are not associated 
with infectious diseases in the carcasses, may be shipped from an 
official establishment only for purposes other than human food, and only 
if all tissue affected with abscesses is removed and destroyed within 
the establishment, and all livers are processed and denatured, with any 
agent prescribed in Sec. 325.13(a)(1) or (2) or (5), and in accordance 
with Sec. 325.13(a)(6) of this subchapter. This provision for movement 
from an official establishment is made solely under the Federal Meat 
Inspection Act and is not intended to relieve or modify any other 
applicable requirements under any other law regarding the movement of 
such articles, for purposes other than use as human food.
    (c) Livers condemned because of conditions described in paragraph 
(b) of this section shall be in containers plainly marked ``inedible''.

[41 FR 23701, June 11, 1976]



Sec. 314.11  Handling of certain condemned products for purposes other than human food.

    Condemned carcasses of animals affected with one or more of the 
following conditions may be shipped from an official establishment only 
for purposes other than human food and only if permission therefor is 
obtained from the circuit supervisor: Anasarca, Ocular Squamous Cell 
Carcinoma (after removal of neoplastic tissue), emaciation, eosinophilic 
myositis, immaturity, nonseptic bruises and injuries, and 
sarcosporidiosis. This provision also applies to unborn calves and to 
products such as paunches and udders when they have not been handled as 
required under this subchapter for products for human food purposes; 
provided, such articles have not been condemned for other pathological 
reasons. Such permission will be granted only if all parts to be so used 
will be promptly handled, freely slashed and adequately identified as 
required by Sec. 325.13(a)(2) of this subchapter. The slashing, 
identification and packing of the product shall be accomplished in an 
inedible product area under the supervision of an inspector. Facilities 
must be adequate so that the carcasses or parts saved under these 
provisions are not contaminated with pus, manure, septic, or toxic 
materials, or similar substances. The operation must not result

[[Page 156]]

in insanitary conditions within the establishment.

[35 FR 15575, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 36 
FR 11903, June 23, 1971]



PART 315--RENDERING OR OTHER DISPOSAL OF CARCASSES AND PARTS PASSED FOR COOKING--Table of Contents




Sec.
315.1  Carcasses and parts passed for cooking; rendering into lard or 
          tallow.
315.2  Carcasses and parts passed for cooking; utilization for food 
          purposes after cooking.
315.3  Disposal of products passed for cooking if not handled according 
          to this part.

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



Sec. 315.1  Carcasses and parts passed for cooking; rendering into lard or tallow.

    Carcasses and parts passed for cooking may be rendered into lard in 
accordance with Sec. 319.702 of this subchapter or rendered into tallow, 
provided such rendering is done in the following manner:
    (a) When closed rendering equipment is used, the lower opening, 
except when permanently connected with a blowline, shall first be sealed 
securely by a Program employee; then the carcasses or parts shall be 
placed in such equipment in his presence, after which the upper opening 
shall be securely sealed by such employee. When the product passed for 
cooking in the tank does not consist of a carcass or whole primal part, 
the requirements for sealing shall be at the discretion of the circuit 
supervisor. Such carcasses and parts shall be cooked for a time 
sufficient to render them effectually into lard or tallow, provided all 
parts of the products are heated to a temperature not lower than 170 
deg.F. for a period of not less than 30 minutes.
    (b) At establishments not equipped with closed rendering equipment 
for rendering carcasses and parts passed for cooking into lard and 
tallow, such carcasses or parts may be rendered in open kettles under 
the direct supervision of a Program employee. Such rendering shall be 
done during regular hours of work and in compliance with the 
requirements as to temperature and time specified in paragraph (a) of 
this section.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 25420, June 13, 1978]



Sec. 315.2  Carcasses and parts passed for cooking; utilization for food purposes after cooking.

    Carcasses and parts passed for cooking may be used for the 
preparation of meat food products, provided all such carcasses or parts 
are heated to a temperature not lower than 170  deg.F. for a period of 
not less than 30 minutes either before being used in or during the 
preparation of the finished product.

[37 FR 2661, Feb. 4, 1972]



Sec. 315.3  Disposal of products passed for cooking if not handled according to this part.

    Products passed for cooking if not handled and processed in 
accordance with the provisions of this part, shall be disposed of in 
accordance with Sec. 314.1 or Sec. 314.3 of this subchapter.

[35 FR 15577, Oct. 3, 1970. Redesignated at 37 FR 2661, Feb. 4, 1972]



PART 316--MARKING PRODUCTS AND THEIR CONTAINERS--Table of Contents




Sec.
316.1  Authorization required to make devices bearing official marks.
316.2  Approval required for official marks.
316.3  Use of official marks prohibited except under supervision of 
          Program employee; removal of official marks, when required.
316.4  Marking devices; to be furnished by official establishments; 
          control of.
316.5  Branding ink; to be furnished by official establishments; 
          approval by Program; color.
316.6  Products not to be removed from official establishments unless 
          marked in accordance with the regulations.
316.7  Marking devices not to be false or misleading; style and size of 
          lettering; approval required.
316.8  Unmarked inspected products; moved between official 
          establishments; moved in commerce.
316.9  Products to be marked with official marks.
316.10  Marking of meat food products with official inspection legend 
          and ingredient statement.
316.11  Special markings for certain meat food products.

[[Page 157]]

316.12  Marking of equine carcasses and parts thereof.
316.13  Marking of outside containers.
316.14  Marking tank cars and tank trucks used in transportation of 
          edible products.
316.15  Marking outside containers of inedible grease, etc.
316.16  Custom prepared products to be marked ``Not for Sale.''

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

    Source: 35 FR 15577, Oct. 3, 1970, unless otherwise noted.



Sec. 316.1  Authorization required to make devices bearing official marks.

    No brand manufacturer, printer or other person shall cast, print, 
lithograph, or otherwise make or cause to be made any device containing 
any official mark or simulation thereof without prior written authority 
therefor from the Administrator as provided for in part 317 of this 
subchapter.



Sec. 316.2  Approval required for official marks.

    No device containing any official mark shall be made or caused to be 
made for use on any product until it has been approved by the 
Administrator as provided for in part 317 of this subchapter.



Sec. 316.3  Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required.

    (a) No person shall affix or place, or cause to be affixed or 
placed, the official inspection legend or any other official mark, or 
any abbreviation or simulation of any official mark, to or on any 
product, or container thereof, except under the supervision of a Program 
employee, or as authorized by part 317 of this subchapter in connection 
with the manufacture of containers.
    (b) No person shall fill, or cause to be filled, in whole or in 
part, with any product, any container bearing or intended to bear any 
official mark, or any abbreviation or simulation of any official mark, 
except under the supervision of a Program employee.
    (c) Product bearing any official mark shall not be canned, cooked, 
cured, smoked, salted, packed, rendered, or otherwise prepared by any 
person for commercial purposes unless:
    (1) Such preparation is performed at an official establishment; or
    (2) Such preparation is conducted under State or other governmental 
inspection and the prepared product is marked to show that fact; or
    (3) The official marks are removed, defaced, or otherwise destroyed 
before or during such preparation; or
    (4) The preparation of the product consists solely of cutting up 
operations at any establishment exempted from inspection under paragraph 
301(c)(2) of the Act or equal provisions of a law of a State or 
organized Territory or at any establishment in an unorganized Territory 
exempted under paragraph 23(b) of the Act.



Sec. 316.4  Marking devices; to be furnished by official establishments; control of.

    (a) The operator of each official establishment or official import 
inspection establishment shall furnish such ink brands, burning brands, 
and any other device for marking products with official marks as the 
Administrator may determine is necessary for marking products at such 
establishment. The official inspection legend on such a device shall be 
as prescribed in part 312 of this subchapter.
    (b) All official devices for marking products with the official 
inspection legend, or other official inspection marks, including self-
locking seals, shall be used only under supervision of a Program 
employee, and, when not in use for marking shall be kept locked in 
properly equipped locks or compartments, the keys of which shall not 
leave the possession of a Program employee, or the locker or compartment 
shall be sealed with an official seal of the Department as prescribed in 
part 312 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 46 
FR 38072, July 24, 1981]



Sec. 316.5  Branding ink; to be furnished by official establishments; approval by Program; color.

    (a) The operator of each official establishment shall furnish all 
ink for marking products with the official marks at such establishment. 
Such ink

[[Page 158]]

must be made with harmless ingredients that are approved for the purpose 
by the Administrator. Samples of inks shall be submitted to the Program 
laboratory from time to time as may be deemed necessary by the inspector 
in charge.
    (b) Only ink approved for the purpose shall be used to apply ink 
brands bearing official marks to carcasses of cattle, sheep, swine, or 
goats and fresh meat cuts derived therefrom. Any ink containing F.D. & 
C. Violet No. 1 shall not be considered an approved ink within the 
meaning of this paragraph.
    (c) Green ink shall not be used to apply marks to carcasses of 
cattle, sheep, swine, or goats or fresh meat cuts derived therefrom.
    (d) Except as provided in paragraphs (b) and (c) of this section, 
branding ink of any color, approved for the purpose by the Administrator 
in specific cases, may be used to apply ink brands, bearing official 
marks, to processed meat cuts derived from cattle, sheep, swine, or 
goats.
    (e) Only green ink approved for the purpose shall be used to apply 
ink brands bearing official marks to carcasses and parts of carcasses 
and meat cuts derived from horses, mules, and other equines.
    (f) Ink used must assure legibility and permanence of the markings 
and the color of ink shall provide acceptable contrast with the color of 
the product to which it is applied.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 9088, Apr. 10, 1973]



Sec. 316.6  Products not to be removed from official establishments unless marked in accordance with the regulations.

    No person shall remove or cause to be removed from an official 
establishment any products which the regulations in this subchapter 
require to be marked in any way unless they are clearly and legibly 
marked in compliance with such regulations.



Sec. 316.7  Marking devices not to be false or misleading; style and size of lettering; approval required.

    No brand or other marking device shall be false or misleading. The 
letters and figures thereon shall be of such style and type as will make 
a clear and legible impression. All markings to be applied to products 
in an official establishment shall be approved prior to use by the 
Administrator as provided for in Sec. 317.3 of this subchapter, except 
that official markings prescribed by the Federal meat grading 
regulations (7 CFR 53.19) need not be submitted to the Administrator for 
approval.



Sec. 316.8  Unmarked inspected products; moved between official establishments; moved in commerce.

    (a) Unmarked products which have been inspected and passed but do 
not bear the official inspection legend may be transported in compliance 
with part 325 of this subchapter from one official establishment to 
another official establishment, for further processing, in a railroad 
car, truck, or other closed container, if the railroad car, truck, or 
container is sealed with an official seal of the Department (as 
prescribed in part 312 of this subchapter) bearing the official 
inspection legend.
    (b) Products which have been inspected and passed but do not bear 
the official inspection legend may be removed from an official 
establishment in closed containers bearing the official inspection 
legend and all other information required by this part and part 317 of 
this subchapter: Provided, That upon removal from such closed container 
the product may not be further transported in commerce unless such 
removal is made under the supervision of a Program employee and such 
product is reinspected by a Program employee and packed under his 
supervision in containers bearing the official inspection legend and all 
other information required by this part and part 317 of this subchapter: 
And provided further, That unmarked product shall not be brought into an 
official establishment in an open container.



Sec. 316.9  Products to be marked with official marks.

    (a) Each carcass which has been inspected and passed in an official 
establishment shall be marked at the time of inspection with the 
official inspection legend containing the number of the official 
establishment.

[[Page 159]]

    (b) Except as provided otherwise in Sec. 316.8, each primal part of 
a carcass and each liver, beef tongue, and beef heart which has been 
inspected and passed shall be marked with the official inspection legend 
containing the number of the official establishment before it leaves the 
establishment in which it is first inspected and passed, and each such 
inspected and passed product shall be marked with the official 
inspection legend containing the number of the official establishment 
where it was last prepared. Additional official marks of inspection may 
be applied to products as desired to meet local conditions. Primal parts 
are the wholesale cuts of carcasses as customarily distributed to 
retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank 
are primal parts of beef carcasses. Veal, mutton, and goat primal parts 
are the leg; flank, loin, rack, breast, and shoulder. The ham, belly, 
loin, shoulder, and jowl are pork primal parts. Equine primal parts are 
the round, flank, loin, rib, plate, brisket, chuck, and shank.
    (c) Beef livers shall be marked with the official inspection legend 
containing the number of the official establishment, at which the cattle 
involved were slaughtered, on the convex surface of the thickest portion 
of the organ.
    (d) Inspected and passed parts of carcasses which are not marked 
with the official inspection legend under this section shall not enter 
any official establishment or be sold, transported, or offered for sale 
or transportation, in commerce, except as provided in Sec. 316.8.

[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 23720, Dec. 14, 1971]



Sec. 316.10  Marking of meat food products with official inspection legend and ingredient statement.

    (a) Inspected and passed sausages and other products in casings or 
in link form, of the ordinary ``ring'' variety or larger shall be marked 
with the official inspection legend and list of ingredients in 
accordance with part 317 of this subchapter. The official marks required 
by this section shall be branded near each end of the sausage or similar 
product prepared in casings when the product is of a size larger than 
that customarily sold at retail intact.
    (b) Inspected and passed sausage and other products, in casings or 
in link form, of the smaller varieties, shall bear one or more official 
inspection legends and one or more lists of ingredients in accordance 
with part 317 of this subchapter on each kilogram (2.205 lbs.) of 
product, except where such products leave the official establishment 
completely enclosed in properly labeled immediate containers having a 
capacity of 5 kilograms (11.025 lbs.) or less and containing a single 
kind of product: Provided, That such products in properly labeled closed 
containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to 
another official establishment for further processing or to a 
governmental agency, need only have the official inspection legend and 
list of ingredients shown twice throughout the contents of the 
container. When such products are shipped to another official 
establishment for further processing, the inspector in charge at the 
point of origin shall identify the shipment to the inspector in charge 
at destination by means of Form MP 408-1.
    (c) The list of ingredients may be applied by stamping, printing, 
using paper bands, tags, or tissue strips, or other means approved by 
the Administrator in specific cases.
    (d) All cured products shall be marked with the list of ingredients 
in accordance with part 317 of this subchapter.

[35 FR 15577, Oct. 3, 1970, as amended at 37 FR 16863, Aug. 22, 1972; 38 
FR 4385, Feb. 14, 1973; 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, 
1979]



Sec. 316.11  Special markings for certain meat food products.

    (a) Meat food products prepared in casing or link form (whether or 
not thereafter subdivided), other than sausage, which possess the 
characteristics of or resemble sausage, shall bear on each link or piece 
the word ``imitation'' prominently displayed: Provided, That the 
following need not be so marked if they bear on each link or piece the 
name of the product in accordance with Sec. 317.2 of this subchapter: 
Such products as coppa, capocollo,

[[Page 160]]

lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts 
of meat which are prepared without added substance other than curing 
materials or condiments; meat rolls, bockwurst, and similar products 
which do not contain cereal or vegetables; headcheese, souse, sulze, 
scrapple, blood pudding, and liver pudding; and other products such as 
loaves, chili con carne, and meat and cheese products when prepared with 
sufficient cheese to give definite characteristics to the finished 
products: And provided further, That imitation sausage packed in 
properly labeled containers having a capacity of 3 pounds or less and of 
a kind usually sold at retail intact, need not bear the word 
``imitation'' on each link or piece if no other marking or labeling is 
applied directly to the product.
    (b) When cereal, vegetable starch, starchy vegetable flour, soy 
flour, soy protein concentrate, isolated soy protein, dried milk, nonfat 
dry milk, or calcium reduced dried skim milk is added to sausage in 
casing or in link form within the limits prescribed in part 319 of this 
subchapter, the products shall be marked with the name of each added 
ingredient, as for example ``cereal added,'' ``potato flour added,'' 
``cereal and potato flour added,'' ``soy flour added,'' ``isolated soy 
protein added,'' ``nonfat dry milk added,'' ``calcium reduced dried skim 
milk added,'' or ``cereal and nonfat dry milk added,'' as the case may 
be.
    (c)(1) When product is placed in a casing to which artificial 
coloring is thereafter applied, as permitted in part 318 of this 
subchapter, the product shall be legibly and conspicuously marked by 
stamping or printing on the casing the words ``artificially colored.''
    (2) If a casing is removed from product at an official establishment 
and there is evidence of artificial coloring on the surface of the 
product, the product from which the casing has been removed shall be 
marked by stamping directly thereon the words ``artificially colored.''
    (3) The casing containing product need not be marked to show that it 
is colored if it is colored prior to its use as a covering for the 
product, and the coloring is of a kind and so applied as not to be 
transferable to the product and not to be misleading or deceptive in any 
respect.
    (d) When an approved artificial smoke flavoring or an approved smoke 
flavoring is added to the formula of any meat food product as permitted 
in part 318 of this subchapter, the product shall be legibly and 
conspicuously marked with the words ``Artificial Smoke Flavoring Added'' 
or ``Smoke Flavoring Added,'' whichever may be applicable.
    (e) Subject to the provisions in paragraph (a) of this section, in 
the case of sausage of the smaller varieties, the markings prescribed in 
this section may be limited to links bearing the official inspection 
legend, and such markings shall not be required if the sausages are 
packed in properly labeled containers having a capacity of 3 pounds or 
less and of a kind usually sold at retail intact. Further, all markings 
otherwise required by this section (except those required by paragraph 
(a) of this section) may be omitted from the casings of sausage and 
other meat food products when these products are to be processed in 
sealed metal containers properly labeled in accordance with the 
requirements in part 317 of this subchapter.
    (f) When an approved antioxidant is added to any meat food product 
as permitted in parts 318 and 319 of this subchapter, the products shall 
be legibly and conspicuously marked in an approved manner identifying 
the specific antioxidant used by its common name or approved 
abbreviation and the purpose for which it is added, such as, ``BHA, BHT, 
and Propylgallate added to help protect flavor.''
    (g) Sausage of the dry varieties treated with potassium sorbate or 
propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of 
this subchapter shall be marked as prescribed in Sec. 317.8(b)(28) of 
this subchapter).



Sec. 316.12  Marking of equine carcasses and parts thereof.

    (a) All inspected and passed equine carcasses and parts thereof 
prepared at any establishment shall be conspicuously marked at the time 
of inspection with the official inspection legend as prescribed in 
Sec. 312.3 of this subchapter

[[Page 161]]

and with other information prescribed for marking products in this part.
    (b) All equine carcasses and meat and other parts thereof shall be 
marked to show the kinds of animals from which they were derived, before 
the products are sold, transported, offered for sale or transportation, 
or received for transportation in commerce.



Sec. 316.13  Marking of outside containers.

    (a) Except as otherwise provided in part 325 of this subchapter, 
when any inspected and passed product for domestic commerce is moved 
from an official establishment, the outside container shall bear an 
official inspection legend as prescribed in part 312 of this subchapter.
    (b) When any product prepared in an official establishment for 
domestic commerce has been inspected and passed and is enclosed in a 
cloth or other wrapping, such wrapping shall bear the official 
inspection legend and official establishment number applied by the 
approved 2\1/2\-inch rubber brand in the form prescribed in part 312 of 
this subchapter: Provided, That the rubber brand may be omitted if the 
official inspection legend and official establishment number on the 
product itself are clearly legible through the wrapping or the wrapping 
is labeled in accordance with part 317 of this subchapter: Provided 
further, That plain unprinted wrappings, such as stockinettes, 
cheesecloth, paper, and crinkled paper bags, for properly marked 
products, which are used solely to protect the product against soiling 
or excessive drying during transportation or storage, need not bear the 
official inspection legend.
    (c) The outside containers of products for export shall be marked in 
compliance with part 322 of this subchapter as well as this part.
    (d) Slack barrels used as outside containers of products shall have 
a cloth or paper top covering bearing the official inspection legend 
containing the official establishment number. At the time of removal of 
the covering, the official inspection legend shall be destroyed.
    (e) The outside containers of any product which has been inspected 
and passed for cooking, pork which has been refrigerated as provided in 
Sec. 318.10(c) of this subchapter, and beef which has been inspected and 
passed for refrigeration shall bear the markings and tag prescribed in 
Sec. 325.7(b) of this subchapter.
    (f) The outside containers of glands and organs which are not used 
for human food purposes, such as those described in Sec. 325.19 of this 
subchapter, shall be plainly marked with the phrase ``For pharmaceutical 
purposes,'' ``For organotherapeutic purposes'' or ``For technical 
purposes,'' as appropriate, with no reference to inspection, and need 
not bear other markings otherwise required under the regulations in this 
subchapter.
    (g) Stencils, box dies, labels, and brands may be used on shipping 
containers of properly labeled products and on such immediate 
containers, of properly marked products, as tierces, barrels, drums, 
boxes, crates, and large-size fiber-board containers, without approval 
as provided for in Sec. 317.3 of this subchapter: Provided, That the 
stencils, box dies, labels, and brands are not false or misleading and 
are approved by the inspector in charge. The official inspection legend 
for use with such markings shall be approved by the Administrator as 
provided for in part 317 of this subchapter.
    (h) The outside containers of livers prepared as described in 
Sec. 314.10(b), shall be marked as prescribed in Sec. 314.10(c) of this 
subchapter.
    (i) The outside containers of any equine product shall be marked to 
show the kinds of animals from which derived, when the products are 
sold, transported, offered for sale or transported, or received for 
transportation in commerce.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978]



Sec. 316.14  Marking tank cars and tank trucks used in transportation of edible products.

    Each tank car and each tank truck carrying inspected and passed 
product from an official establishment shall bear a label containing the 
name of the product in accordance with Sec. 317.2 of this subchapter, 
the official inspection legend containing the number of the official 
establishment and the words

[[Page 162]]

``date of loading,'' followed by a suitable space in which the date the 
tank car or tank truck is loaded shall be inserted. The label shall be 
located conspicuously and shall be printed on material of such character 
and so affixed as to preclude detachment or effacement upon exposure to 
the weather. Before the car or truck is removed from the place where it 
is unloaded, the carrier shall remove or obliterate such label.

[53 FR 28634, July 29, 1988]



Sec. 316.15  Marking outside containers of inedible grease, etc.

    (a) Outside containers of inedible grease, inedible tallow, or other 
inedible animal fat, or mixture of any such articles, resulting from 
operations at any official establishment shall be marked conspicuously 
with the word ``inedible'' prior to removal from the point of filling. 
Containers, such as tierces, barrels, and half barrels shall have both 
ends painted white with durable paint, if necessary, to provide a 
contrasting background, and the word ``inedible'' shall be marked 
thereon in letters not less than 2 inches high, while on tank cars and 
tank trucks the letters shall be not less than 4 inches high.
    (b) Inspected rendered animal fat which is intended not to be used 
for human food may also be marked ``inedible'' if handled as provided in 
paragraph (a) of this section and part 314 of this subchapter.



Sec. 316.16  Custom prepared products to be marked ``Not for Sale.''

    Carcasses and parts therefrom that are prepared on a custom basis 
under Sec. 303.1(a)(2) of this subchapter shall be marked at the time of 
preparation with the term ``Not for Sale'' in letters at least three-
eighths inch in height, except that such products need not be so marked 
if in immediate containers properly labeled in accordance with the 
regulations in Sec. 317.16 of this subchapter. Ink used for marking such 
products must comply with the requirements of Sec. 316.5.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973]



PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents




                           Subpart A--General

Sec.
317.1  Labels required; supervision by Program employee.
317.2  Labels: definition; required features.
317.3  Approval of abbreviations of marks of inspection; preparation of 
          marking devices bearing inspection legend without advance 
          approval prohibited; exception.
317.4  Labeling approval.
317.5  Generically approved labeling.
317.6  Approved labels to be used only on products to which they are 
          applicable.
317.7  Products for foreign commerce; printing labels in foreign 
          language permissible; other deviations.
317.8  False or misleading labeling or practices generally; specific 
          prohibitions and requirements for labels and containers.
317.9  Labeling of equine products.
317.10  Reuse of official inspection marks; reuse of containers bearing 
          official marks, labels, etc.
317.11  Labeling, filling of containers, handling of labeled products to 
          be only in compliance with regulations.
317.12  Relabeling products; requirements.
317.13  Storage and distribution of labels and containers bearing 
          official marks.
317.14-317.15  [Reserved]
317.16  Labeling and containers of custom prepared products.
317.17  Interpretation and statement of labeling policy for cured 
          products; special labeling requirements concerning nitrate and 
          nitrite.
317.18  Quantity of contents labeling.
317.19  Definitions and procedures for determining net weight 
          compliance.
317.20  Scale requirements for accurate weights, repairs, adjustments, 
          and replacement after inspection.
317.21  Scales: testing of.
317.22  Handling of failed product.
317.23  [Reserved]
317.24  Packaging materials.

                      Subpart B--Nutrition Labeling

317.300  Nutrition labeling of meat or meat food products.
317.301  [Reserved]
317.302  Location of nutrition information.
317.303-317.307  [Reserved]
317.308  Labeling of meat or meat food products with number of servings.
317.309  Nutrition label content.
317.310-317.311  [Reserved]
317.312  Reference amounts customarily consumed per eating occasion.
317.313  Nutrient content claims; general principles.

[[Page 163]]

317.314-317.342  [Reserved]
317.343  Significant participation for voluntary nutrition labeling.
317.344  Identification of major cuts of meat products.
317.345  Guidelines for voluntary nutrition labeling of single-
          ingredient, raw products.
317.346-317.353  [Reserved]
317.354  Nutrient content claims for ``good source,'' ``high,'' and 
          ``more''.
317.355  [Reserved]
317.356  Nutrient content claims for ``light'' or ``lite''.
317.357-317.359  [Reserved]
317.360  Nutrient content claims for calorie content.
317.361  Nutrient content claims for the sodium content.
317.362  Nutrient content claims for fat, fatty acids, and cholesterol 
          content.
317.363  Nutrient content claims for ``healthy''.
317.364-317.368  [Reserved]
317.369  Labeling applications for nutrient content claims.
317.370-317.379  [Reserved]
317.380  Label statements relating to usefulness in reducing or 
          maintaining body weight.
317.381-317.399  [Reserved]
317.400  Exemption from nutrition labeling.

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

    Source: 35 FR 15580, Oct. 3, 1970, unless otherwise noted.



                           Subpart A--General



Sec. 317.1  Labels required; supervision by Program employee.

    (a) When, in an official establishment, any inspected and passed 
product is placed in any receptacle or covering constituting an 
immediate container, there shall be affixed to such container a label as 
described in Sec. 317.2 except that the following do not have to bear 
such a label.
    (1) Wrappings of dressed carcasses and primal parts in an 
unprocessed state, bearing the official inspection legend, if such 
wrappings are intended solely to protect the product against soiling or 
excessive drying during transportation or storage, and the wrappings 
bear no information except company brand names, trade marks, or code 
numbers which do not include any information required by Sec. 317.2;
    (2) Uncolored transparent coverings, such as cellophane, which bear 
no written, printed, or graphic matter and which enclose any unpackaged 
or packaged product bearing all markings required by part 316 of this 
subchapter which are clearly legible through such coverings;
    (3) Animal and transparent artificial casings bearing only the 
markings required by part 316 of this subchapter;
    (4) Stockinettes used as ``operative devices'', such as those 
applied to cured meats in preparation for smoking, whether or not such 
stockinettes are removed following completion of the operations for 
which they were applied;
    (5) Containers such as boil-in bags, trays of frozen dinners, and 
pie pans which bear no information except company brand names, 
trademarks, code numbers, directions for preparation and serving 
suggestions, and which are enclosed in a consumer size container that 
bears a label as described in Sec. 317.2;
    (6) Containers of products passed for cooking or refrigeration and 
moved from an official establishment under Sec. 311.1 of this 
subchapter.
    (b) Folders and similar coverings made of paper or similar 
materials, whether or not they completely enclose the product and which 
bear any written, printed, or graphic matter, shall bear all features 
required on a label for an immediate container.
    (c) No covering or other container which bears or is to bear a label 
shall be filled, in whole or in part, except with product which has been 
inspected and passed in compliance with the regulations in this 
subchapter, which is not adulterated and which is strictly in accordance 
with the statements on the label. No such container shall be filled, in 
whole or in part, and no label shall be affixed thereto, except under 
supervision of a Program employee.



Sec. 317.2  Labels: definition; required features.

    (a) A label within the meaning of this part shall mean a display of 
any printing, lithographing, embossing, stickers, seals, or other 
written, printed, or graphic matter upon the immediate container (not 
including package liners) of any product.
    (b) Any word, statement, or other information required by this part 
to appear on the label must be prominently

[[Page 164]]

placed thereon with such conspicuousness (as compared with other words, 
statements, designs, or devices, in the labeling) and in such terms as 
to render it likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use. In order to meet this 
requirement, such information must appear on the principal display panel 
except as otherwise permitted in this part. Except as provided in 
Sec. 317.7, all words, statements, and other information required by or 
under authority of the Act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of products distributed solely in Puerto Rico, Spanish may be 
substituted for English for all printed matter except the USDA 
inspection legend.
    (c) Labels of all products shall show the following information on 
the principal display panel (except as otherwise permitted in this 
part), in accordance with the requirements of this part or, if 
applicable, part 319 of this subchapter:
    (1) The name of the product, which in the case of a product which 
purports to be or is represented as a product for which a definition and 
standard of identity or composition is prescribed in part 319 of this 
subchapter, shall be the name of the food specified in the standard, and 
in the case of any other product shall be the common or usual name of 
the food, if any there be, and if there is none, a truthful descriptive 
designation, as prescribed in paragraph (e) of this section;
    (2) If the product is fabricated from two or more ingredients, the 
word ``ingredients'' followed by a list of the ingredients as prescribed 
in paragraph (f) of this section;
    (3) The name and place of business of the manufacturer, packer, or 
distributor for whom the product is prepared, as prescribed in paragraph 
(g) of this section;
    (4) An accurate statement of the net quantity of contents, as 
prescribed in paragraph (h) of this section;
    (5) An official inspection legend and, except as otherwise provided 
in paragraph (i) of this section, the number of the official 
establishment, in the form required by part 312 of this subchapter;
    (6) Any other information required by the regulations in this part 
or part 319 of this subchapter.
    (d) The principal display panel shall be the part of a label that is 
most likely to be displayed, presented, shown, or examined under 
customary conditions of display for sale. Where packages bear alternate 
principal display panels, information required to be placed on the 
principal display panel shall be duplicated on each principal display 
panel. The principal display panel shall be large enough to accommodate 
all the mandatory label information required to be placed thereon by 
this part and part 319 of this subchapter with clarity and 
conspicuousness and without obscuring of such information by designs or 
vignettes or crowding. In determining the area of the principal display 
panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and 
shoulders and necks of bottles or jars. The principal display panel 
shall be:
    (1) In the case of a rectangular package, one entire side, the area 
of which is at least the product of the height times the width of that 
side.
    (2) In the case of a cylindrical or nearly cylindrical container:
    (i) An area that is 40 percent of the product of the height of the 
container times the circumference of the container, or
    (ii) A panel, the width of which is one-third of the circumference 
and the height of which is as high as the container: Provided, however, 
That if there is immediately to the right or left of such principal 
display panel, a panel which has a width not greater than 20 percent of 
the circumference and a height as high as the container, and which is 
reserved for information prescribed in paragraphs (c) (2), (3), and (5), 
such panel shall be known as the ``20 percent panel'' and such 
information may be shown on that panel in lieu of showing it on the 
principal display panel.
    (3) In the case of a container of any other shape, 40 percent of the 
total surface of the container.
    (e) Any descriptive designation used as a product name for a product 
which has no common or usual name shall clearly and completely identify 
the

[[Page 165]]

product. Product which has been prepared by salting, smoking, drying, 
cooking, chopping, or otherwise shall be so described on the label 
unless the name of the product implies, or the manner of packaging shows 
that the product was subjected to such preparation. The unqualified 
terms ``meat,'' ``meat byproduct,'' ``meat food product,'' and terms 
common to the meat industry but not common to consumers such as 
``picnic,'' ``butt,'' ``cala,'' ``square,'' ``loaf,'' ``spread,'' 
``delight,'' ``roll,'' ``plate,'' ``luncheon,'' and ``daisy'' shall not 
be used as names of a product unless accompanied with terms descriptive 
of the product or with a list of ingredients, as deemed necessary in any 
specific case by the Administrator in order to assure that the label 
will not be false or misleading.
    (f)(1) The list of ingredients shall show the common or usual names 
of the ingredients arranged in the descending order of predominance, 
except as otherwise provided in this paragraph.
    (i) The terms spice, natural flavor, natural flavoring, flavor and 
flavoring may be used in the following manner:
    (A) The term ``spice'' means any aromatic vegetable substance in the 
whole, broken, or ground form, with the exceptions of onions, garlic and 
celery, whose primary function in food is seasoning rather than 
nutritional and from which no portion of any volatile oil or other 
flavoring principle has been removed. Spices include the spices listed 
in 21 CFR 182.10, and 184.
    (B) The term ``natural flavor,'' ``natural flavoring,'' ``flavor'' 
or ``flavoring'' means the essential oil, oleoresin, essence or 
extractive, protein hydrolysate, distillate, or any product or roasting, 
heating or enzymolysis, which contains the flavoring constituents 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or any other edible 
portion of a plant, meat, seafood, poultry, eggs, dairy products, or 
fermentation products thereof, whose primary function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in 21 CFR 182.10, 
182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 
172.510. The term natural flavor, natural flavoring, flavor or flavoring 
may also be used to designate spices, powered onion, powdered garlic, 
and powdered celery.
    (ii) The term ``corn syrup'' may be used to designate either corn 
syrup or corn syrup solids.
    (iii) The term ``animal and vegetable fats'' or ``vegetable and 
animal fats'' may be used to designate the ingredients of mixtures of 
such edible fats in product designated ``compound'' or ``shortening.'' 
``Animal fats'' as used herein means fat derived from inspected and 
passed cattle, sheep, swine, or goats.
    (iv) When a product is coated with pork fat, gelatin, or other 
approved substance and a specific declaration of such coating appears 
contiguous to the name of the product, the ingredient statement need not 
make reference to the ingredients of such coating.
    (v) When two meat ingredients comprise at least 70 percent of the 
meat and meat byproduct ingredients of a formula and when neither of the 
two meat ingredients is less than 30 percent by weight of the total meat 
and meat byproducts used, such meat ingredients may be interchanged in 
the formula without a change being made in the ingredients statement on 
labeling materials: Provided, That the word ``and'' in lieu of a comma 
shall be shown between the declaration of such meat ingredients in the 
statement of ingredients.
    (vi)(A) Product ingredients which are present in individual amounts 
of 2 percent or less by weight may be listed in the ingredients 
statement in other than descending order of predominance: Provided, That 
such ingredients are listed by their common or usual names at the end of 
the ingredients statement and preceded by a quantifying statement, such 
as ``Contains __________ percent of __________ ,'' ``Less than 
__________percent of __________ .'' The percentage of the ingredient(s) 
shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 
percent, or 0.5 percent, as appropriate. No ingredient to which the 
quantifying statement applies may be present in an amount greater than 
the stated threshold. Such a quantifying statement may

[[Page 166]]

also be utilized when an ingredients statement contains a listing of 
ingredients by individual components. Each component listing may utilize 
the required quantifying statement at the end of each component 
ingredients listing.
    (B) Such ingredients may be adjusted in the product formulation 
without a change being made in the ingredients statement on the 
labeling, provided that the adjusted amount complies with 
Sec. 318.7(c)(4) and part 319 of this subchapter, and does not exceed 
the amount shown in the quantifying statement. Any such adjustments to 
the formulation shall be provided to the inspector-in-charge.
    (2) On containers of frozen dinners, entrees, pizzas, and similar 
consumer packaged products in cartons the ingredient statement may be 
placed on the front riser panel: Provided, That the words ``see 
ingredients'' followed immediately by an arrow is placed on the 
principal display panel immediately above the location of such statement 
without intervening print or designs.
    (3) The ingredient statement may be placed on the 20 percent panel 
adjacent to the principal display panel and reserved for required 
information, in the case of a cylindrical or nearly cylindrical 
container.
    (4) The ingredients statement may be placed on the information 
panel, except as otherwise permitted in this subchapter.
    (g)(1) The name or trade name of the person that prepared the 
product may appear as the name of the manufacturer or packer without 
qualification on the label. Otherwise the name of the distributor of the 
product shall be shown with a phrase such as ``Prepared for * * *''. The 
place of business of the manufacturer, packer, or distributor shall be 
shown on the label by city, State, and postal ZIP code when such 
business is listed in a telephone or city directory, and if not listed 
in such directory, then the place of business shall be shown by street 
address, city, State, and postal ZIP code.
    (2) The name and place of business of the manufacturer, packer, or 
distributor may be shown:
    (i) On the principal display panel, or
    (ii) On the 20 percent panel adjacent to the principal display panel 
and reserved for required information, in the case of a cylindrical or 
nearly cylindrical container, or
    (iii) On the front riser panel of frozen food cartons, or
    (iv) On the information panel.
    (h)(1) The statement of net quantity of contents shall appear on the 
principal display panel of all containers to be sold at retail intact, 
in conspicuous and easily legible boldface print or type in distinct 
contrast to other matter on the container, and shall be declared in 
accordance with the provisions of this paragraph.
    (2) The statement as it is shown on a label shall not be false or 
misleading and shall express an accurate statement of the quantity of 
contents of the container. Reasonable variations caused by loss or gain 
of moisture during the course of good distribution practices or by 
unavoidable deviations in good manufacturing practices will be 
recognized. Variations from stated quantity of contents shall be as 
provided in Sec. 317.19. The statement shall not include any term 
qualifying a unit of weight, measure, or count such as ``jumbo quart,'' 
``full gallon,'' ``giant quart,'' ``when packed,'' ``minimum,'' or words 
of similar importance.
    (3) The statement shall be placed on the principal display panel 
within the bottom 30 percent of the area of the panel in lines generally 
parallel to the base: Provided, That on packages having a principal 
display panel of 5 square inches or less, the requirement for placement 
within the bottom 30 percent of the area of the label panel shall not 
apply when the statement meets the other requirements of this paragraph 
(h). In any case, the statement may appear in more than one line. The 
terms ``net weight'' or ``net wt.'' shall be used when stating the net 
quantity of contents in terms of weight, and the term ``net contents'' 
or ``content'' when stating the net quantity of contents in terms of 
fluid measure.
    (4) Except as provided in Sec. 317.7, the statement shall be 
expressed in terms of avoirdupois weight or liquid measure. Where no 
general consumer usage to the contrary exists, the statement shall be in 
terms of liquid measure, if

[[Page 167]]

the product is liquid, or in terms of weight if the product is solid, 
semisolid viscous or a mixture of solid and liquid. For example, a 
declaration of \3/4\-pound avoirdupois weight shall be expressed as 
``Net Wt. 12 oz.'' except as provided for in paragraph (h)(5) of this 
section for random weight packages; a declaration of 1\1/2\ pounds 
avoirdupois weight shall be expressed as ``Net Wt. 24 oz. (1 lb. 8 
oz.),'' ``Net Wt. 24 oz. (1\1/2\ lb.),'' or ``Net Wt. 24 oz. (1.5 
lbs.).''
    (5) On packages containing 1 pound or 1 pint and less than 4 pounds 
or 1 gallon, the statement shall be expressed as a dual declaration both 
in ounces and (immediately thereafter in parentheses) in pounds, with 
any remainder in terms of ounces or common or decimal fraction of the 
pound, or in the case of liquid measure, in the largest whole units with 
any remainder in terms of fluid ounces or common or decimal fractions of 
the pint or quart, except that on random weight packages the statement 
shall be expressed in terms of pounds and decimal fractions of the 
pound, for packages over 1 pound, and for packages which do not exceed 1 
pound the statement may be in decimal fractions of the pound in lieu of 
ounces. Paragraph (h)(9) of this section permits certain exceptions from 
the provisions of this paragraph for margarine packages, random weight 
consumer size packages, and packages of less than \1/2\ ounce net 
weight. Pargraph (h)(12) of this section permits certain exceptions from 
the provision of this paragraph for multi-unit packages.
    (6) The statement shall be in letters and numerals in type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform of all packages of substantially the 
same size by complying with the following type specifications:
    (i) Not less than one-sixteenth inch in height on packages, the 
principal display panel of which has an area of 5 square inches or less;
    (ii) Not less than one-eighth inch in height on packages, the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches;
    (iii) Not less than three-sixteenths inch in height on packages, the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches;
    (iv) Not less than one-quarter inch in height on packages, the 
principal display panel of which has an area of more than 100 but not 
more than 400 square inches.
    (v) Not less than one-half inch in height on packages, the principal 
display panel of which has an area of more than 400 square inches.
    (7) The ratio of height to width of letters and numerals shall not 
exceed a differential of 3 units to 1 unit (no more than 3 times as high 
as it is wide). Heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards. When fractions are used, each component numeral shall meet 
one-half the height standards.
    (8) The statement shall appear as a distinct item on the principal 
display panel and shall be separated by a space at least equal to the 
height of the lettering used in the statement from other printed label 
information appearing above or below the statement and by a space at 
least equal to twice the width of the letter ``N'' of the style of type 
used in the quantity of contents statement from other printed label 
information appearing to the left or right of the statement. It shall 
not include any term qualifying a unit of weight, measure, or count such 
as, ``jumbo quart,'' ``full gallon,'' ``giant quart,'' ``when packed,'' 
``Minimum'' or words of similar import.
    (9) The following exemptions from the requirements contained in this 
paragraph (h) are hereby established:
    (i) Individually wrapped, random weight consumer size packages 
shipped in bulk containers (as specified in paragraph (h)(11) of this 
section) and meat products that are subject to shrinkage through 
moisture loss during good distribution practices and are designated as 
gray area type of products as defined under Sec. 317.19 need not bear a 
net weight statement when shipped from an official establishment, 
provided that a net weight shipping statement which meets the 
requirements of paragraph (h)(2) of this section is applied to

[[Page 168]]

their shipping container prior to shipping it from the official 
establishment. Net weight statements so applied to the shipping 
container are exempt from the type size, dual declaration, and placement 
requirements of this paragraph, if an accurate statement of net weight 
is shown conspicuously on the principal display panel of the shipping 
container. The net weight also shall be applied directly to random 
weight consumer size packages prior to retail display and sale. The net 
weight statement on random weight consumer size packages for retail sale 
shall be exempt from the type size, dual declaration, and placement 
requirements of this paragraph, if an accurate statement of net weight 
is shown conspicuously on the principal display panel of the package.
    (ii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight and random weight consumer size packages shall be 
exempt from the requirements of this paragraph if they are in a shipping 
container and the statement of net quantity of contents on the shipping 
container meets the requirements of paragraph (h)(2) of this section;
    (iii) Individually wrapped and labeled packages of less than \1/2\ 
ounce net weight bearing labels declaring net weight, price per pound, 
and total price, shall be exempt from the type size, dual declaration, 
and placement requirements of this paragraph, if an accurate statement 
of net weight is shown conspicuously on the principal display panel of 
the package.
    (iv) Margarine in 1 pound rectangular packages (except packages 
containing whipped or soft margarine or packages that contain more than 
four sticks) is exempt from the requirements of paragraphs (h) (3) and 
(5) of this section regarding the placement of the statement of the net 
quantity of contents within the bottom 30 percent of the principal 
display panel and that the statement be expressed both in ounces and in 
pounds, if the statement appears as ``1 pound'' or ``one pound'' in a 
conspicuous manner on the principal display panel.
    (v) Sliced shingle packed bacon in rectangular packages is exempt 
from the requirements of paragraphs (h)(3) and (h)(5) of this section 
regarding the placement of the statement of the net quantity of contents 
within the bottom 30 percent of the principal display panel, and that 
the statement be expressed both in ounces and in pounds, if the 
statement appears in a conspicuous manner on the principal display 
panel.
    (10) Labels for containers which bear any representation as to the 
number of servings contained therein shall bear, contiguous to such 
representation, and in the same size type as is used for such 
representation, a statement of the net quantity of each such serving.
    (11) As used in this section, a ``random weight consumer size 
package'' is one which is one of a lot, shipment or delivery of packages 
of the same product with varying weights and with no fixed weight 
pattern.
    (12) On a multiunit retail package, a statement of the net quantity 
of contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and in parentheses, the total net quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as required by paragraph (h)(5) of this section. 
For the purposes of this section, ``multiunit retail package'' means a 
package containing two or more individually packaged units of the 
identical commodity and in the same quantity, with the individual 
packages intended to be sold as part of the multiunit retail package but 
capable of being individually sold in full compliance with all 
requirements of the regulations in this part. Open multiunit retail 
packages that do not obscure the number of units and the labeling 
thereon are not subject to this paragraph if the labeling of each 
individual unit complies with the requirements of paragraphs (h) (2), 
(3), (6), and (8) of this section.
    (i) The official establishment number of the official establishment 
in which the product was processed under inspection shall be placed as 
follows:

[[Page 169]]

    (1) Within the official inspection legend in the form required by 
part 312 of this subchapter; or
    (2) Outside the official inspection legend elsewhere on the exterior 
of the container or its labeling, e.g., the lid of a can, if shown in a 
prominent and legible manner in a size sufficient to insure easy 
visibility and recognition and accompanied by the prefix ``EST''; or
    (3) Off the exterior of the container, e.g., on a metal clip used to 
close casings or bags, or on the back of a paper label of a canned 
product, or on other packaging or labeling material in the container, 
e.g., on aluminum pans and trays placed within containers, when a 
statement of its location is printed contiguous to the official 
inspection legend, such as ``EST. No. on Metal Clip'' or ``Est. No. on 
Pan'', if shown in a prominent and legible manner in a size sufficient 
to insure easy visibility and recognition; or
    (4) On an insert label placed under a transparent covering if 
clearly visible and legible and accompanied by the prefix ``EST''.
    (j) Labels of any product within any of the following paragraphs 
shall show the information required by such paragraph for such product:
    (1) A label for product which is an imitation of another food shall 
bear the word ``imitation'' immediately preceding the name of the food 
imitated and in the same size and style of lettering as in that name and 
immediately thereafter the word ``ingredients:'' and the names of the 
ingredients arranged in the order of their predominance.
    (2) If a product purports to be or is represented for any special 
dietary use by man, its label shall bear a statement concerning its 
vitamin, mineral, and other dietary properties upon which the claim for 
such use is based in whole or in part and shall be in conformity with 
regulations (21 CFR part 125) established pursuant to sections 403, and 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
    (3) When an artificial smoke flavoring or an smoke flavoring is 
added as an ingredient in the formula of a meat food product, as 
permitted in part 318 of this subchapter, there shall appear on the 
label, in prominent letters and contiguous to the name of the product, a 
statement such as ``Artificial Smoke Flavoring Added'' or ``Smoke 
Flavoring Added,'' as may be applicable, and the ingredient statement 
shall identify any artificial smoke flavoring or smoke flavoring so 
added as an ingredient in the formula of the meat food product.
    (4) When any other artificial flavoring is permitted under part 318 
of this subchapter to be added to a product, the ingredient statement 
shall identify it as ``Artificial Flavoring.''
    (5) When artificial coloring is added to edible fats as permitted 
under part 318 of this subchapter such substance shall be declared on 
the label in a prominent manner and contiguous to the name of the 
product by the words ``Artificially colored'' or ``Artificial coloring 
added'' or ``With added artificial coloring.'' When natural coloring 
such as annatto is added to edible fats as permitted under part 318 of 
this subchapter, such substance shall be declared on the label in the 
same manner by a phrase such as ``Colored with annatto.''
    (6) When product is placed in a casing to which artificial coloring 
is applied as permitted under part 318 of this subchapter, there shall 
appear on the label, in a prominent manner and contiguous to the name of 
the product, the words, ``Artificially colored.''
    (7) If a casing is removed from product at an official establishment 
and there is evidence of artificial coloring on the surface of the 
product, there shall appear on the label, in a prominent manner and 
contiguous to the name of product, the words ``Artificially colored.''
    (8) When a casing is colored prior to its use as a covering for 
product and the color is not transferred to the product enclosed in the 
casing, no reference to color need appear on the label but no such 
casing may be used if it is misleading or deceptive with respect to 
color, quality, or kind of product, or otherwise.
    (9) Product which bears or contains any other artificial coloring, 
as permitted under part 318 of this subchapter, shall bear a label 
stating that fact on the immediate container or if there is none, on the 
product.

[[Page 170]]

    (10) When an antioxidant is added to product as permitted under part 
318 of this subchapter, there shall appear on the label in prominent 
letters and contiguous to the name of the product, a statement 
identifying the officially approved specific antioxidant by its common 
name or abbreviation thereof and the purpose for which it is added, such 
as, ``BHA, BHT, and Propylgallate added to help protect flavor.''
    (11) Containers of meat packed in borax or other preservative for 
export to a foreign country which permits the use of such preservative 
shall, at the time of packing, be marked ``for export,'' followed on the 
next line by the words ``packed in preservative,'' or such equivalent 
statement as may be approved for this purpose by the Administrator and 
directly beneath this there shall appear the word ``establishment'' or 
abbreviation thereof, followed by the number of the establishment at 
which the product is packed. The complete statement shall be applied in 
a conspicuous location and in letters not less than 1 inch in height.
    (12) Containers of other product packed in, bearing, or containing 
any chemical preservative shall bear a label stating that fact.
    (13)(i) On the label of any ``Mechanically Separated (Species)'' 
described in Sec. 319.5(a) of this subchapter, the name of such product 
shall be followed immediately by the phrase ``for processing'' unless 
such product has a protein content of not less than 14 percent and a fat 
content of not more than 30 percent.
    (ii) When any ``Mechanically Separated (Species)'' described in 
Sec. 319.5 of this subchapter is used as an ingredient in the 
preparation of a meat food product and such ``Mechanically Separated 
(Species)'' contributes 20 mg or more of calcium to a serving of such 
meat food product, the label of such meat food product shall state the 
calcium content of such meat food product, determined and expressed as 
the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a 
serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and 
(e), as part of any nutrition information included on such label, or if 
such meat food product does not bear nutrition labeling information, as 
part of a prominent statement in immediate conjunction with the list of 
ingredients, as follows: ``A ------ serving contains ----% of the U.S. 
RDA of calcium'', with the blanks to be filled in, respectively, with 
the quantity of such product that constitutes a serving and the amount 
of calcium provided by such serving: Provided, That, calcium content 
need not be stated where (a) the percent of the U.S. RDA of calcium to 
be declared would not differ from the percent of the U.S. RDA that would 
be declared if the meat food product contained only hand deboned 
ingredients or (b) the calcium content of a serving of the meat food 
product would be 20 percent of the U.S. RDA or more if the meat food 
product contained only hand deboned ingredients.
    (k) Packaged products which require special handling to maintain 
their wholesome condition shall have prominently displayed on the 
principal display panel of the label the statement: ``Keep 
Refrigerated,'' ``Keep Frozen,'' ``Perishable Keep Under 
Refrigeration,'' or such similar statement as the Administrator may 
approve in specific cases. Products that are distributed frozen during 
distribution and thawed prior to or during display for sale at retail 
shall bear the statement on the shipping container: ``Keep Frozen.'' The 
consumer-size containers for such products shall bear the statement 
``Previously Handled Frozen for Your Protection, Refreeze or Keep 
Refrigerated.'' For all perishable canned products the statement shall 
be shown in upper case letters one-fourth inch in height for containers 
having a net weight of 3 pounds or less, and for containers having a net 
weight over 3 pounds, the statement shall be in upper case letters at 
least one-half inch in height.
    (l) Safe handling instructions shall be provided for: All meat and 
meat products of cattle, swine, sheep, goat, horse, other equine that do 
not meet the requirements contained in Sec. 318.17, or that have not 
undergone other processing that would render them ready-to-eat; and all 
comminuted meat patties not heat processed in a manner that conforms to 
the time and temperature combinations in the Table for

[[Page 171]]

Permitted Heat-Processing Temperature/Time Combinations For Fully-Cooked 
Patties in Sec. 318.23, except as exempted under paragraph (l)(4) of 
this section.
    (1)(i) Safe handling instructions shall accompany every meat or meat 
product, specified in this paragraph (l) destined for household 
consumers, hotels, restaurants, or similar institutions and shall appear 
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such 
conspicuousness (as compared with other words, statements, designs or 
devices in the labeling) as to render it likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (ii) The safe handling information shall be presented on the label 
under the heading ``Safe Handling Instructions'' which shall be set in 
type size larger than the print size of the rationale statement and 
handling statements as discussed in paragraphs (l)(2) and (l)(3) of this 
section. The safe handling information shall be set off by a border and 
shall be one color type printed on a single color contrasting background 
whenever practical.
    (2) The labels of the meat and meat products specified in this 
paragraph (l) shall include the following rationale statement as part of 
the safe handling instructions, ``This product was prepared from 
inspected and passed meat and/or poultry. Some food products may contain 
bacteria that could cause illness if the product is mishandled or cooked 
improperly. For your protection, follow these safe handling 
instructions.'' This statement shall be placed immediately after the 
heading and before the safe handling statements.
    (3) Meat and meat products, specified in this paragraph (l), shall 
bear the labeling statements:
    (i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. 
(Any portion of this statement that is in conflict with the product's 
specific handling instructions, may be omitted, e.g., instructions to 
cook without thawing.) (A graphic illustration of a refrigerator shall 
be displayed next to the statement.);
    (ii) Keep raw meat and poultry separate from other foods. Wash 
working surfaces (including cutting boards), utensils, and hands after 
touching raw meat or poultry. (A graphic illustration of soapy hands 
under a faucet shall be displayed next to the statement.);
    (iii) Cook thoroughly. (A graphic illustration of a skillet shall be 
displayed next to the statement.); and
    (iv) Keep hot foods hot. Refrigerate leftovers immediately or 
discard. (A graphic illustration of a thermometer shall be displayed 
next to the statement.)
    (4) Meat or meat products intended for further processing at another 
official establishment are exempt from the requirements prescribed in 
paragraphs (l)(1) through (l)(3) of this section.
    (m)(1) The information panel is that part of a label that is the 
first surface to the right of the principal display panel as observed by 
an individual facing the principal display panel, with the following 
exceptions:
    (i) If the first surface to the right of the principal display panel 
is too small to accommodate the required information or is otherwise 
unusable label space, e.g., folded flaps, tear strips, opening flaps, 
heat-sealed flaps, the next panel to the right of this part of the label 
may be used.
    (ii) If the package has one or more alternate principal display 
panels, the information panel is to the right of any principal display 
panel.
    (iii) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (2) (i) Except as otherwise permitted in this part, all information 
required to appear on the principal display panel or permitted to appear 
on the information panel shall appear on the same panel unless there is 
insufficient space. In determining the sufficiency of the available 
space, except as otherwise prescribed in this part, any vignettes, 
designs, and any other nonmandatory information shall not be considered. 
If there is insufficient space for all required information to appear on 
a single panel, it may be divided between

[[Page 172]]

the principal display panel and the information panel, provided that the 
information required by any given provision of this part, such as the 
ingredients statement, is not divided and appears on the same panel.
    (ii) All information appearing on the information panel pursuant to 
this section shall appear in one place without intervening material, 
such as designs or vignettes.

[35 FR 15580, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 317.2, 
see the List of Sections Affected in the Finding Aids section of this 
volume.



Sec. 317.3  Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; 
          exception.

    (a) The Administrator may approve and authorize the use of 
abbreviations of marks of inspection under the regulations in this 
subchapter. Such abbreviations shall have the same force and effect as 
the respective marks for which they are authorized abbreviations.
    (b) Except for the purposes of preparing and submitting a sample or 
samples of the same to the Administrator for approval, no brand 
manufacturer, printer, or other person shall cast, print, lithograph, or 
otherwise make any marking device containing any official mark or 
simulation thereof, or any label bearing any such mark or simulation, 
without the written authority therefor of the Administrator. However, 
when any such sample label, or other marking device, is approved by the 
Administrator, additional supplies of the approved label, or marking 
device, may be made for use in accordance with the regulations in this 
subchapter, without further approval by the Administrator. The 
provisions of this paragraph apply only to labels, or other marking 
devices, bearing or containing an official inspection legend shown in 
Sec. 312.2(b), Sec. 312.3(a) (only the legend appropriate for horse meat 
food products) or Sec. 312.3(b) (only the legend appropriate for other 
(nonhorse) equine meat food products), or any abbreviations, copy or 
representation thereof.
    (c) No brand manufacturer or other person shall cast or otherwise 
make, without an official certificate issued in quadruplicate by a 
Program employee, a brand or other marking device containing an official 
inspection legend, or simulation thereof, shown in Sec. 312.2(a), 
Sec. 312.3(a) (only the legend appropriate for horse carcasses and parts 
of horse carcasses), Sec. 312.3(b) (only the legend appropriate for 
other equine (nonhorse) carcasses and parts of other (nonhorse) equine 
carcasses) or Sec. 312.7(a).
    (1) The certificate is a Food Safety and Inspection Service form for 
signature by a Program employee and the official establishment ordering 
the brand or other marking device, bearing a certificate serial number 
and a letterhead and the seal of the United States Department of 
Agriculture. The certificate authorizes the making of only the brands or 
other marking devices of the type and quantity listed on the 
certificate.
    (2) After signing the certificate, the Program employee and the 
establishment shall each keep a copy, and the remaining two copies shall 
be given to the brand or other marking device manufacturer.
    (3) The manufacturer of the brands or other marking devices shall 
engrave or otherwise mark each brand or other marking device with a 
permanent identifying serial number unique to it. The manufacturer shall 
list on each of the two copies of the certificate given to the 
manufacturer the number of each brand or other marking device authorized 
by the certificate. The manufacturer shall retain one copy of the 
certificate for the manufacturer's records and return the remaining copy 
with the brands or other marking devices to the Program employee whose 
name and address are given on the certificate as the recipient.
    (4) In order that all such brands or other marking devices bear 
identifying numbers, within one year after June 24, 1985, an 
establishment shall either replace each such brand or other marking 
device which does not bear an identifying number, or, under the 
direction of the inspector-in-charge, mark such

[[Page 173]]

brand or other marking device with a permanent identifying number.


(Recordkeeping requirements approved by the Office of Management and 
Budget under control number 0583-0015)

[35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]



Sec. 317.4  Labeling approval.

    (a) No final labeling shall be used on any product unless the sketch 
labeling of such final labeling has been submitted for approval to the 
Food Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, and approved by such division, accompanied by FSIS form, 
Application for Approval of Labels, Marking, and Devices, except for 
generically approved labeling authorized for use in Sec. 317.5(b). The 
management of the official establishment or establishment certified 
under a foreign inspection system, in accordance with part 327 of this 
subchapter, must maintain a copy of all labeling used, along with the 
product formulation and processing procedure, in accordance with part 
320 of this subchapter. Such records shall be made available to any duly 
authorized representative of the Secretary upon request.
    (b) The Food Labeling Division shall permit submission for approval 
of only sketch labeling, as defined in Sec. 317.4(d), for all products, 
except as provided in Sec. 317.5(b) (2)-(9) and except for temporary use 
of final labeling as prescribed in paragraph (f) of this section.
    (c) All labeling required to be submitted for approval as set forth 
in Sec. 317.4(a) shall be submitted in duplicate to the Food Labeling 
Division, Regulatory Programs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250. A parent company for a 
corporation may submit only one labeling application (in duplicate form) 
for a product produced in other establishments that are owned by the 
corporation.
    (d) ``Sketch'' labeling is a printer's proof or equivalent which 
clearly shows all labeling features, size, location, and indication of 
final color, as specified in Sec. 317.2. FSIS will accept sketches that 
are hand drawn, computer generated or other reasonable facsimiles that 
clearly reflect and project the final version of the labeling. 
Indication of final color may be met by: submission of a color sketch, 
submission of a sketch which indicates by descriptive language the final 
colors, or submission with the sketch of previously approved final 
labeling that indicates the final colors.
    (e) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within, 
containers and coverings of product shall be submitted for approval in 
the same manner as provided for labeling in Sec. 317.4(a), except that 
such devices which contain no reference to product and bear no 
misleading feature shall be used without submission for approval as 
prescribed in Sec. 317.5(b)(7).
    (f)(1) Consistent with the requirements of this section, temporary 
approval for the use of a final label or other final labeling that may 
otherwise be deemed deficient in some particular may be granted by the 
Food Labeling Division. Temporary approvals may be granted for a period 
not to exceed 180 calendar days, under the following conditions:
    (i) The proposed labeling would not misrepresent the product;
    (ii) The use of the labeling would not present any potential health, 
safety, or dietary problems to the consumer;
    (iii) Denial of the request would create undue economic hardship; 
and
    (iv) An unfair competitive advantage would not result from the 
granting of the temporary approval.
    (2) Extensions of temporary approvals may also be granted by the 
Food Labeling Division provided that the applicant demonstrates that new 
circumstances, meeting the above criteria, have developed since the 
original temporary approval was granted.
    (g) The inspector-in-charge shall approve meat carcass ink brands 
and meat food product ink and burning brands, which comply with parts 
312 and 316 of this subchapter.

[60 FR 67454, Dec. 29, 1995]



Sec. 317.5  Generically approved labeling.

    (a)(1) An official establishment or an establishment certified under 
a foreign inspection system, in accordance with

[[Page 174]]

part 327 of this subchapter, is authorized to use generically approved 
labeling, as defined in paragraph (b) of this section, without such 
labeling being submitted for approval to the Food Safety and Inspection 
Service in Washington or the field, provided the labeling is in 
accordance with this section and shows all mandatory features in a 
prominent manner as required in Sec. 317.2, and is not otherwise false 
or misleading in any particular.
    (2) The Food Safety and Inspection Service shall select samples of 
generically approved labeling from the records maintained by official 
establishments and establishments certified under foreign inspection 
systems, in accordance with part 327 of this subchapter, as required in 
Sec. 317.4, to determine compliance with labeling requirements. Any 
finding of false or misleading labeling shall institute the proceedings 
prescribed in Sec. 335.12.
    (b) Generically approved labeling is labeling which complies with 
the following:
    (1) Labeling for a product which has a product standard as specified 
in part 319 of this subchapter or the Standards and Labeling Policy Book 
and which does not contain any special claims, such as quality claims, 
nutrient content claims, health claims, negative claims, geographical 
origin claims, or guarantees, or which is not a domestic product labeled 
in a foreign language;
    (2) Labeling for single-ingredient products (such as beef steak or 
lamb chops) which does not contain any special claims, such as quality 
claims, nutrient content claims, health claims, negative claims, 
geographical origin claims, or guarantees, or which is not a domestic 
product labeled with a foreign language;
    (3) Labeling for containers of products sold under contract 
specifications to Federal Government agencies, when such product is not 
offered for sale to the general public, provided that the contract 
specifications include specific requirements with respect to labeling, 
and are made available to the inspector-in-charge;
    (4) Labeling for shipping containers which contain fully labeled 
immediate containers, provided such labeling complies with Sec. 316.13;
    (5) Labeling for products not intended for human food, provided they 
comply with part 325 of this subchapter;
    (6) Meat inspection legends, which comply with parts 312 and 316 of 
this subchapter;
    (7) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within 
containers, and coverings of products, provided such devices contain no 
reference to product and bear no misleading feature;
    (8) Labeling for consumer test products not intended for sale; and
    (9) Labeling which was previously approved by the Food Labeling 
Division as sketch labeling, and the final labeling was prepared without 
modification or with the following modifications:
    (i) All features of the labeling are proportionately enlarged or 
reduced, provided that all minimum size requirements specified in 
applicable regulations are met and the labeling is legible;
    (ii) The substitution of any unit of measurement with its 
abbreviation or the substitution of any abbreviation with its unit of 
measurement, e.g., ``lb.'' for ``pound,'' or ``oz.'' for ``ounce,'' or 
of the word ``pound'' for ``lb.'' or ``ounce'' for ``oz.'';
    (iii) A master or stock label has been approved from which the name 
and address of the distributor are omitted and such name and address are 
applied before being used (in such case, the words ``prepared for'' or 
similar statement must be shown together with the blank space reserved 
for the insertion of the name and address when such labels are offered 
for approval);
    (iv) Wrappers or other covers bearing pictorial designs, emblematic 
designs or illustrations, e.g., floral arrangements, illustrations of 
animals, fireworks, etc. are used with approved labeling (the use of 
such designs will not make necessary the application of labeling not 
otherwise required);
    (v) A change in the language or the arrangement of directions 
pertaining to the opening of containers or the serving of the product;
    (vi) The addition, deletion, or amendment of a dated or undated 
coupon, a

[[Page 175]]

cents-off statement, cooking instructions, packer product code 
information, or UPC product code information;
    (vii) Any change in the name or address of the packer, manufacturer 
or distributor that appears in the signature line;
    (viii) Any change in the net weight, provided the size of the net 
weight statement complies with Sec. 317.2;
    (ix) The addition, deletion, or amendment of recipe suggestions for 
the product;
    (x) Any change in punctuation;
    (xi) Newly assigned or revised establishment numbers for a 
particular establishment for which use of the labeling has been approved 
by the Food Labeling Division, Regulatory Programs;
    (xii) The addition or deletion of open dating information;
    (xiii) A change in the type of packaging material on which the label 
is printed;
    (xiv) Brand name changes, provided that there are no design changes, 
the brand name does not use a term that connotes quality or other 
product characteristics, the brand name has no geographic significance, 
and the brand name does not affect the name of the product;
    (xv) The deletion of the word ``new'' on new product labeling;
    (xvi) The addition, deletion, or amendment of special handling 
statements, provided that the change is consistent with Sec. 317.2(k);
    (xvii) The addition of safe handling instructions as required by 
Sec. 317.2(l);
    (xviii) Changes reflecting a change in the quantity of an ingredient 
shown in the formula without a change in the order of predominance shown 
on the label, provided that the change in quantity of ingredients 
complies with any minimum or maximum limits for the use of such 
ingredients prescribed in parts 318 and 319 of this subchapter;
    (xix) Changes in the color of the labeling, provided that sufficient 
contrast and legibility remain;
    (xx) A change in the product vignette, provided that the change does 
not affect mandatory labeling information or misrepresent the content of 
the package;
    (xxi) A change in the establishment number by a corporation or 
parent company for an establishment under its ownership;
    (xxii) Changes in nutrition labeling that only involve quantitative 
adjustments to the nutrition labeling information, except for serving 
sizes, provided the nutrition labeling information maintains its 
accuracy and consistency;
    (xxiii) Deletion of any claim, and the deletion of non-mandatory 
features or non-mandatory information; and
    (xxiv) The addition or deletion of a direct translation of the 
English language into a foreign language for products marked ``for 
export only.''

[60 FR 67455, Dec. 29, 1995]



Sec. 317.6  Approved labels to be used only on products to which they are applicable.

    Labels shall be used only on products for which they are approved, 
and only if they have been approved for such products in accordance with 
Sec. 317.3: Provided, That existing stocks of labels approved prior to 
the effective date of this section and the quantity of which has been 
identified to the circuit supervisor as being in storage on said date at 
the official establishment or other identified warehouse for the account 
of the operator of the official establishment may be used until such 
stocks are exhausted, but not later than 1 year after the effective date 
of this section unless such labels conform to all the requirements of 
this part and part 319 of this subchapter. The Administrator may upon 
the show of good cause grant individual extension of time as he deems 
necessary.



Sec. 317.7  Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Labels to be affixed to packages of products for foreign commerce 
may be printed in a foreign language and may show the statement of the 
quantity of contents in accordance with the usage of the country to 
which exported and other deviations from the form of labeling required 
under this part may be approved for such product by the Administrator in 
specific cases: Provided,
    (a) That the proposed labeling accords to the specifications of the 
foreign purchaser,

[[Page 176]]

    (b) That it is not in conflict with the laws of the country to which 
the product is intended for export, and
    (c) That the outside container is labeled to show that it is 
intended for export; but if such product is sold or offered for sale in 
domestic commerce, all the requirements of this subchapter apply. The 
inspection legend and the establishment number shall in all cases appear 
in English but in addition, may appear literally translated in a foreign 
language.



Sec. 317.8  False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.

    (a) No product or any of its wrappers, packaging, or other 
containers shall bear any false or misleading marking, label, or other 
labeling and no statement, word, picture, design, or device which 
conveys any false impression or gives any false indication of origin or 
quality or is otherwise false or misleading shall appear in any marking 
or other labeling. No product shall be wholly or partly enclosed in any 
wrapper, packaging, or other container that is so made, formed, or 
filled as to be misleading.
    (b) The labels and containers of product shall comply with the 
following provisions, as applicable:
    (1) Terms having geographical significance with reference to a 
locality other than that in which the product is prepared may appear on 
the label only when qualified by the word ``style,'' ``type,'' or 
``brand,'' as the case may be, in the same size and style of lettering 
as in the geographical term, and accompanied with a prominent qualifying 
statement identifying the country, State, Territory, or locality in 
which the product is prepared, using terms appropriate to effect the 
qualification. When the word ``style'' or ``type'' is used, there must 
be a recognized style or type of product identified with and peculiar to 
the area represented by the geographical term and the product must 
possess the characteristics of such style or type, and the word 
``brand'' shall not be used in such a way as to be false or misleading: 
Provided, That a geographical term which has come into general usage as 
a trade name and which has been approved by the Administrator as being a 
generic term may be used without the qualifications provided for in this 
paragraph. The terms ``frankfurter,'' ``vienna,'' ``bologna,'' ``lebanon 
bologna,'' ``braunschweiger,'' ``thuringer,'' ``genoa,'' ``leona,'' 
``berliner,'' ``holstein,'' ``goteborg,'' ``milan,'' ``polish,'' 
``italian,'' and their modifications, as applied to sausages, the terms 
``brunswick'' and ``irish'' as applied to stews and the term ``boston'' 
as applied to pork shoulder butts need not be accompanied with the word 
``style,'' ``type,'' or ``brand,'' or a statement identifying the 
locality in which the product is prepared.
    (2) Such terms as ``farm'' or ``country'' shall not be used on 
labels in connection with products unless such products are actually 
prepared on the farm or in the country: Provided, That if the product is 
prepared in the same way as on the farm or in the country these terms, 
if qualified by the word ``style'' in the same size and style of 
lettering, may be used: Provided further, That the term ``farm'' may be 
used as part of a brand designation when qualified by the word ``brand'' 
in the same size and style of lettering, and followed with a statement 
identifying the locality in which the product is prepared: And Provided 
further, That the provisions of this paragraph shall not apply to 
products prepared in accordance with Sec. 319.106 of this subchapter. 
Sausage containing cereal shall not be labeled ``farm style'' or 
``country style,'' and lard not rendered in an open kettle shall not be 
designated as ``farm style'' or ``country style.''
    (3) The requirement that the label shall contain the name and place 
of business of the manufacturer, packer, or distributor shall not 
relieve any establishment from the requirement that its label shall not 
be misleading in any particular.
    (4) The term ``spring lamb'' or ``genuine spring lamb'' is 
applicable only to carcasses of new-crop lambs slaughtered during the 
period beginning in March and terminating not beyond the close of the 
week containing the first Monday in October.

[[Page 177]]

    (5)(i) Coverings shall not be of such color, design, or kind as to 
be misleading with respect to color, quality, or kind of product to 
which they are applied. For example, transparent or semitransparent 
coverings for such articles as sliced bacon or fresh (uncooked) meat and 
meat food products shall not bear lines or other designs of red or other 
color which give a false impression of leanness of the product. 
Transparent or semitransparent wrappers, casings, or coverings for use 
in packaging cured, cured and smoked, or cured and cooked sausage 
products, and sliced ready-to-eat meat food products may be color tinted 
or bear red designs on 50 percent of such wrapper or covering: Provided, 
That the transparent or semitransparent portion of the principal display 
panel is free of color tinting and red designs: And provided further, 
That the principal display panel provides at least 20 percent 
unobstructed clear space, consolidated in one area so that the true 
nature and color of the product is visible to the consumer.
    (ii) Packages for sliced bacon that have a transparent opening shall 
be designed to expose, for viewing, the cut surface of a representative 
slice. Packages for sliced bacon which meet the following specifications 
will be accepted as meeting the requirements of this subparagraph 
provided the enclosed bacon is positioned so that the cut surface of the 
representative slice can be visually examined:
    (a) For shingle-packed sliced bacon, the transparent window shall be 
designed to reveal at least 70 percent of the length (longest dimension) 
of the representative slice, and this window shall be at least 1\1/2\ 
inches wide. The transparent window shall be located not more than five-
eighths inch from the top or bottom edge of a 1-pound or smaller package 
and not more than three-fourths inch from either the top or bottom edge 
of a package larger than 1 pound.
    (b) For stack-packed sliced bacon, the transparent window shall be 
designed to reveal at least 70 percent of the length (longest dimension) 
of the representative slice and be at least 1\1/2\ inches wide.
    (6) The word ``fresh'' shall not be used on labels to designate 
product which contains any sodium nitrate, sodium nitrite, potassium 
nitrate, or potassium nitrite, or which has been salted for 
preservation.
    (7)(i) No ingredient shall be designated on the label as a spice, 
flavoring, or coloring unless it is a spice, flavoring, or coloring, as 
the case may be. An ingredient that is both a spice and a coloring, or 
both a flavoring and a coloring, shall be designated as ``spice and 
coloring'', or ``flavoring and coloring'', as the case may be, unless 
such ingredient is designated by its common or usual name.
    (ii) Any ingredient not designated in Sec. 317.2(f)(1)(i) of this 
part whose function is flavoring, either in whole or in part, must be 
designated by its common or usual name. Those ingredients which are of 
livestock and poultry origin must be designated by names that include 
the species and livestock and poultry tissues from which the ingredients 
are derived.
    (8) As used on labels of product, the term ``gelatin'' shall mean 
(i) the jelly prepared in official establishments by cooking pork skins, 
tendons, or connective tissue from inspected and passed product, and 
(ii) dry commercial gelatin or the jelly resulting from its use.
    (9) Product (other than canned product) labeled with the term 
``loaf'' as part of its name:
    (i) If distributed from the official establishment in consumer size 
containers may be in any shape;
    (ii) If distributed in a container of a size larger than that sold 
intact at retail the product shall be prepared in rectangular form, or 
as in paragraph (b)(9)(iii) of this section;
    (iii) If labeled as an ``Old Fashioned Loaf'' shall be prepared in a 
traditional form, such as rectangular with rounded top or circular with 
flat bottom and rounded top.
    (10) The term ``baked'' shall apply only to product which has been 
cooked by the direct action of dry heat and for a sufficient time to 
permit the product to assume the characteristics of a baked article, 
such as the formation of a brown crust on the surface, rendering out of 
surface fat, and the

[[Page 178]]

caramelization of the sugar if applied. Baked loaves shall be heated to 
a temperature of at least 160  deg.F. and baked pork cuts shall be 
heated to an internal temperature of at least 170  deg.F.
    (11) When products such as loaves are browned by dipping in hot 
edible oil or by a flame, the label shall state such fact, e.g., by the 
words ``Browned in Hot Cottonseed Oil'' or ``Browned by a Flame,'' as 
the case may be, appearing as part of the product name.
    (12) The term ``meat'' and the names of particular kinds of meat, 
such as beef, veal, mutton, lamb, and pork, shall not be used in such 
manner as to be false or misleading.
    (13) The word ``ham,'' without any prefix indicating the species of 
animal from which derived, shall be used in labeling only in connection 
with the hind legs of swine. Ham shanks as such or ham shank meat as 
such or the trimmings accruing in the trimming and shaping of hams shall 
not be labeled ``ham'' or ``ham meat'' without qualification. When used 
in connection with a chopped product the term ``ham'' or ``ham meat'' 
shall not include the skin.
    (14) The terms ``shankless'' and ``hockless'' shall apply only to 
hams and pork shoulders from which the shank or hock has been completely 
removed, thus eliminating the entire tibia and fibula, or radius and 
ulna, respectively, together with the overlying muscle, skin, and other 
tissue.
    (15) Such terms as ``meat extract'' or ``extract of beef'' without 
qualification shall not be used on labels in connection with products 
prepared from organs or other parts of the carcass, other than fresh 
meat. Extracts prepared from any parts of the carcass other than fresh 
meat may be properly labeled as extracts with the true name of the parts 
from which prepared. In the case of extract in fluid form, the word 
``fluid'' shall also appear on the label, as, for example, ``fluid 
extract of beef.''
    (16) [Reserved]
    (17) When any product is enclosed in a container along with a 
packing substance such as brine, vinegar, or agar jelly, a declaration 
of the packing substance shall be printed prominently on the label as 
part of the name of the product, as for example, ``frankfurts packed in 
brine,'' ``lamb tongue packed in vinegar,'' or ``beef tongue packed in 
agar jelly,'' as the case may be. The packing substance shall not be 
used in such a manner as will result in the container being so filled as 
to be misleading.
    (18) ``Leaf lard'' is lard prepared from fresh leaf fat.
    (19) When lard or hardened lard is mixed with rendered pork fat or 
hardened rendered pork fat, the mixture shall be designated as 
``rendered pork fat'' or ``hardened rendered pork fat,'' as the case may 
be.
    (20) Oil, stearin, or stock obtained from beef or mutton fats 
rendered at a temperature above 170  deg.F. shall not be designated as 
``oleo oil,'' ``oleo stearin,'' or ``oleo stock,'' respectively.
    (21) When not more than 20 percent of beef fat, mutton fat, oleo 
stearin, vegetable stearin, or hardened vegetable fat is mixed with lard 
or with rendered pork fat, there shall appear on the label, contiguous 
to and in the same size and style of lettering as the name of the 
product, the words ``beef fat added,'' ``mutton fat added,'' ``oleo 
stearin added,'' ``vegetable stearin added,'' or ``hardened vegetable 
fat added,'' as the case may be. If more than 20 percent is added, the 
product name shall refer to the particular animal fat or fats used, such 
as, ``Lard and Beef Fat.'' The designation ``vegetable fat'' is 
applicable to vegetable oil, vegetable stearin, or a combination of such 
oil and stearin, whereas the designations ``vegetable oil'' and 
``vegetable stearin'' shall be applicable only to the oil and the 
stearin respectively, when used in meat food products.
    (22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar 
products, shall be labeled to show that the bones remain in the product, 
if such is the case. The designation ``semi-boneless'' shall not be used 
if less than 50 percent of the total weight of bones has been removed.
    (23) When monoglycerides, diglycerides, and/or polyglycerol esters 
of fatty acids are added to rendered animal fat or a combination of such 
fat and vegetable fat, there shall appear on the label in a prominent 
manner and contiguous to the name of the product a statement such as 
``With

[[Page 179]]

Monoglycerides and Diglycerides Added,'' or ``With Diglycerides and 
Monoglycerides,'' or ``With Polyglycerol Esters of Fatty Acids'' as the 
case may be.
    (24) Section 407 of the Federal Food, Drug, and Cosmetic Act 
contains provisions with respect to colored margarine or colored 
oleomargarine (21 U.S.C. 347) which are set forth herein as footnote. 
\1\
---------------------------------------------------------------------------

    \1\ ``Sec. 407(a) Colored oleomargarine or colored margarine which 
is sold in the same State or Territory in which it is produced shall be 
subject in the same manner and to the same extent to the provisions of 
this Act as if it had been introduced in interstate commerce.
    (b) No person shall sell, or offer for sale, colored oleomargarine 
or colored margarine unless--
    (1) Such oleomargarine or margarine is packaged,
    (2) The net weight of the contents of any package sold in a retail 
establishment is one pound or less,
    (3) There appears on the label of the package (A) The word 
`oleomargarine' or `margarine' in type or lettering at least as large as 
any other type or lettering on such label, and (B) A full and accurate 
statement of all the ingredients contained in such oleomargarine, or 
margarine, and
    (4) Each part of the contents of the package is contained in a 
wrapper which bears the word `oleomargarine' or `margarine' in type or 
lettering not smaller than 20-point type.
    The requirements of this subsection shall be in addition to and not 
in lieu of any of the other requirements of this Act.
    (c) No person shall possess in a form ready for serving colored 
oleomargarine or colored margarine at a public eating place unless a 
notice that oleomargarine or margarine is served is displayed 
prominently and conspicuously in such place and in such manner as to 
render it likely to be read and understood by the ordinary individual 
being served in such eating place or is printed or is otherwise set 
forth on the menu in type or lettering not smaller than that normally 
used to designate the serving of other food items. No person shall serve 
colored oleomargarine or colored margarine at a public eating place, 
whether or not any charge is made therefor, unless (1) each separate 
serving bears or is accompanied by labeling identifying it as 
oleomargarine or margarine, or (2) each separate serving thereof is 
triangular in shape.
    (d) Colored oleomargarine or colored margarine when served with 
meals at a public eating place shall at the time of such service be 
exempt from the labeling requirements of section 343 of this Act (except 
subsection (a) and (f) of section 343 of this title) if it complies with 
the requirements of subsection (b) of this section.
    (e) For the purpose of this section colored oleomargarine or colored 
margarine is oleomargarine or margarine having a tint or shade 
containing more than one and six tenths degrees of yellow or of yellow 
and red collectively, but with an excess of yellow over red, measured in 
terms of Lovibond tintometer scale or its equivalent'' (21 U.S.C. 347).
---------------------------------------------------------------------------

    (25) When approved proteolytic enzymes as permitted in part 318 of 
this subchapter are used on steaks or other raw meat cuts, there shall 
appear on the label, in a prominent manner, contiguous to the product 
name, the statement, ``Tenderized with [approved enzyme],'' to indicate 
the use of such enzymes. Any other approved substance which may be used 
in the solution shall also be included in the statement.
    When approved inorganic chlorides as permitted in part 318 of this 
subchapter are used on steaks or other raw meat cuts there shall appear 
on the label in a prominent manner, contiguous to the product name, the 
statement, ``Tenderized with (names of approved inorganic chloride(s))'' 
to indicate the use of such inorganic chlorides. Any other approved 
substance which may be in the solution shall also be included in the 
statement.
    (26) When dimethylpolysiloxan is added as an antifoaming agent to 
rendered fats, its presence shall be declared on the label contiguous to 
the name of the product. Such declaration shall read 
``Dimethylpolysiloxan Added.''
    (27) When pizzas are formulated with crust containing calcium 
propionate or sodium propionate, there shall appear on the label 
contiguous to the name of the product the statement ``-------- added to 
retard spoilage of crust'' preceded by the name of the preservative.
    (28) Sausage of the dry varieties treated with potassium sorbate or 
propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of 
this subchapter, shall be marked or labeled with a statement disclosing 
such treatment and the purpose thereof, such as ``dipped in a potassium 
sorbate solution to retard mold growth.''

[[Page 180]]

    (29) Meat of goats shall be identified as goat meat or chevon.
    (30) The term ``Chitterlings'' shall apply to the large intestines 
of swine, or young bovine animals when preceded with the word ``Calf'' 
or ``Veal.'' Meat food products that contain chitterlings or calf or 
veal chitterlings, in accordance with Sec. 318.6(b)(8) of this 
subchapter shall be identified with product names that refer to such 
ingredients, as for instance, ``Chitterling Loaf,'' ``Chitterling Pie,'' 
or ``Calf Chitterlings and Gravy,'' and shall be packed in containers 
having a capacity of 3 pounds or less and of a kind usually sold at 
retail intact and bearing such other information as is required by this 
part.
    (31) Products that contain blood from livestock as permitted by part 
318 of this subchapter shall be labeled with a name that includes the 
term ``blood,'' and the specific kind of blood shall be declared in the 
ingredient statement, e.g., ``Swine blood,'' in the manner required by 
this part.
    (32) A calendar date may be shown on labeling when declared in 
accordance with the provisions of this subparagraph:
    (i) The calendar date shall express the month of the year and the 
day of the month for all products and also the year in the case of 
products hermetically sealed in metal or glass containers, dried or 
frozen products, or any other products that the Administrator finds 
should be labeled with the year because the distribution and marketing 
practices with respect to such products may cause a label without a year 
identification to be misleading.
    (ii) Immediately adjacent to the calendar date shall be a phrase 
explaining the meaning of such date, in terms of ``packing'' date, 
``sell by'' date, or ``use before'' date, with or without a further 
qualifying phrase, e.g., ``For Maximum Freshness'' or ``For Best 
Quality'', and such phrases shall be approved by the Administrator as 
prescribed in Sec. 317.4.
    (33) [Reserved]
    (34) The terms ``All,'' ``Pure,'' ``100%,'' and terms of similar 
connotation shall not be used on labels for products to identify 
ingredient content, unless the product is prepared solely from a single 
ingredient.
    (35) When agar-agar is used in canned jellied meat food products, as 
permitted in part 318 of this subchapter, there shall appear on the 
label in a prominent manner, contiguous to the product name, a statement 
to indicate the use of agar-agar.
    (36) When sodium alginate, calcium carbonate, and lactic acid and 
calcium carbonate (or glucono delta-lactone) are used together in a dry 
binding matrix in restructured, formed meat food products, as permitted 
in part 318 of this subchapter, there shall appear on the label 
contiguous to the product name, a statement to indicate the use of 
sodium alginate, calcium carbonate and lactic acid and calcium carbonate 
(or glucono delta-lactone).
    (37)  [Reserved]

[35 FR 15580, Oct. 3, 1970]

    Editorial Note: For Federal Register citations affecting Sec. 317.8, 
see the List of CFR Sections Affected in the Finding Aids section of 
this volume.



Sec. 317.9  Labeling of equine products.

    The immediate containers of any equine products shall be labeled to 
show the kinds of animals from which derived when the products are sold, 
transported, offered for sale or transportation or received for 
transportation in commerce.



Sec. 317.10  Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.

    (a) No official inspection legend or other official mark which has 
been previously used shall be used again for the identification of any 
product, except as provided for in paragraph (b) of this section.
    (b) All stencils, marks, labels, or other labeling on previously 
used containers, whether relating to any product or otherwise, shall be 
removed or obliterated before such containers are used for any product, 
unless such labeling correctly indicates the product to be packed 
therein and such containers are refilled under the supervision of a 
Program employee.

[[Page 181]]



Sec. 317.11  Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.

    (a) No person shall in any official establishment apply or affix, or 
cause to be applied or affixed, any label to any product prepared or 
received in such establishment, or to any container thereof, or fill any 
container at such an establishment, except in compliance with the 
regulations in this subchapter.
    (b) No covering or other container shall be filled, in whole or in 
part, at any official establishment with any product unless it has been 
inspected and passed in compliance with the regulations in this 
subchapter, is not adulterated, and is strictly in accordance with the 
statements on the label, and such filling is done under the supervision 
of a Program employee.
    (c) No person shall remove, or cause to be removed from an official 
establishment any product bearing a label unless such label is in 
compliance with the regulations in this subchapter, or any product not 
bearing a label required by such regulations.



Sec. 317.12  Relabeling products; requirements.

    When it is claimed by an official establishment that any of its 
products which bore labels bearing official marks has been transported 
to a location other than an official establishment, and it is desired to 
relabel the product because the labels have become mutilated or 
otherwise damaged, a request for relabeling the product shall be sent to 
the Administrator, accompanied with a statement of the reasons therefor. 
Labeling material intended for relabeling inspected and passed product 
shall not be transported from an official establishment until permission 
has been received from the Administrator. The relabeling of inspected 
and passed product with labels bearing any official marks shall be done 
under the supervision of a Program inspector. The official establishment 
shall reimburse the Program, in accordance with the regulations of the 
Department, for any cost involved in supervising the relabeling of such 
product.



Sec. 317.13  Storage and distribution of labels and containers bearing official marks.

    Labels, wrappers, and containers bearing any official marks, with or 
without the establishment number, may be transported from one official 
establishment to any other official establishment provided such 
shipments are made with the prior authorization of the inspector in 
charge at point of origin, who will notify the inspector in charge at 
destination concerning the date of shipment, quantity, and type of 
labeling material involved. No such material shall be used at the 
establishment to which it is shipped unless such use conforms with the 
requirements of this subchapter.



Secs. 317.14-317.15  [Reserved]



Sec. 317.16  Labeling and containers of custom prepared products.

    Products that are custom prepared under Sec. 303.1(a)(2) of this 
subchapter must be packaged immediately after preparation and must be 
labeled (in lieu of information otherwise required by this part 317) 
with the words ``Not For Sale'' in lettering not less than three-eighth 
inch in height. Such exempted custom prepared products or their 
containers may bear additional labeling provided such labeling is not 
false or misleading.

[37 FR 4071, Feb. 26, 1972]



Sec. 317.17  Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.

    (a) With respect to sections 1(n) (7), (9), and (12) of the Act and 
Sec. 317.2, any substance mixed with another substance to cure a product 
must be identified in the ingredients statement on the label of such 
product. For example, curing mixtures composed of such ingredients as 
water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite 
or other permitted substances which are added to any product, must be 
identified on the label of the product by listing each such ingredient 
in accordance with the provisions of Sec. 317.2.

[[Page 182]]

    (b) Any product, such as bacon and pepperoni, which is required to 
be labeled by a common or usual name or descriptive name in accordance 
with Sec. 317.2(c)(1) and to which nitrate or nitrite is permitted or 
required to be added may be prepared without nitrate or nitrite and 
labeled with such common or usual name or descriptive name when 
immediately preceded with the term ``Uncured'' as part of the product 
name in the same size and style of lettering as the product name, 
provided that the product is found by the Administrator to be similar in 
size, flavor, consistency, and general appearance to such product as 
commonly prepared with nitrate or nitrite, or both.
    (c)(1) Products described in paragraph (b) of this section or 
Sec. 319.2 of this subchapter, which contain no nitrate or nitrite shall 
bear the statement ``No Nitrate or Nitrite Added.'' This statement shall 
be adjacent to the product name in lettering of easily readable style 
and at least one-half the size of the product name.
    (2) Products described in paragraph (b) of this section and 
Sec. 319.2 of this subchapter shall bear, adjacent to the product name 
in lettering of easily readable style and at least one-half the size of 
the product name, the statement ``Not Preserved--Keep Refrigerated Below 
40  deg.F. At All Times'' unless they have been thermally processed to 
Fo 3 or more; they have been fermented or pickled to pH of 
4.6 or less; or they have been dried to a water activity of 0.92 or 
less.
    (3) Products described in paragraph (b) of this section and 
Sec. 319.2 of this subchapter shall not be subject to the labeling 
requirements of paragraphs (b) and (c) of this section if they contain 
an amount of salt sufficient to achieve a brine concentration of 10 
percent or more.

[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]



Sec. 317.18  Quantity of contents labeling.

    Sections 317.18 through 317.22 of this part prescribe the procedures 
to be followed for determining net weight compliance and prescribe the 
reasonable variations from the declared net weight on the labels of 
immediate containers of products in accordance with Sec. 317.2(h) of 
this part.

[55 FR 49834, Nov. 30, 1990]



Sec. 317.19  Definitions and procedures for determining net weight compliance.

    (a) For the purpose of Secs. 317.18 through 317.22 of this part, the 
reasonable variations allowed, definitions, and procedures to be used in 
determining net weight and net weight compliance are described in the 
National Institute of Standards and Technology (NIST) Handbook 133, 
``Checking the Net Contents of Packaged Goods,'' Third Edition, 
September 1988, and Supplements 1, 2, 3, and 4 dated September 1990, 
October 1991, October 1992, and October 1994, respectively, which are 
incorporated by reference, with the exception of the NIST Handbook 133 
and Supplements 1, 3, and 4 requirements listed in paragraphs (b) and 
(c) of this section. Those provisions incorporated by reference herein, 
are considered mandatory requirements. This incorporation was approved 
by the Director of the Federal Register in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. (These materials are incorporated as they 
exist on the date of approval.) A notice of any change in the Handbook 
cited herein will be published in the Federal Register. Copies may be 
purchased from the Superintendent of Documents, U.S. Government Printing 
Office, Washington, DC 20402. It is also available for inspection at the 
Office of the Federal Register Information Center, 800 North Capitol 
Street NW., suite 700, Washington, DC 20408.
    (b) The following NBS Handbook 133 requirements are not incorporated 
by reference.

                    Chapter 2--General Considerations

2.13.1  Polyethylene Sheeting and Film
2.13.2  Textiles
2.13.3  Mulch

        Chapter 3--Methods of Test for Packages Labeled by Weight

3.11.  Aerosol Packages
3.14.  Glazed Raw Seafood and Fish
3.15.  Canned Coffee
3.16.  Borax
3.17.  Flour

[[Page 183]]

        Chapter 4--Methods of Test for Packages Labeled by Volume

4.7.  Milk
4.8.  Mayonnaise and Salad Dressing
4.9.  Paint, Varnish, and Lacquers--Nonaerosol
4.11.  Peat Moss
4.12.  Bark Mulch
4.15.  Ice Cream Novelties

Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4.  Polyethylene Sheeting
5.5.  Paper Plates
5.6.  Sanitary Paper Products
5.7.  Pressed and Blown Glass Tumblers and Stemware

              Appendix D: Package Net Contents Regulations

D.1.1.  U.S. Department of Health and Human Services, Food and Drug 
          Administration
D.1.2.  Department of Agriculture, Food Safety and Inspection Service
D.1.3.  Federal Trade Commission
D.1.4.  Environmental Protection Agency
D.1.5.  U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and 
          Firearms

    (c) The following requirements of Supplement 1, dated September 
1990, Supplement 3, dated October 1992, and Supplement 4, dated 1994, of 
NIST Handbook 133 are not incorporated by reference.

                              Supplement 1

                    Chapter 2  General Considerations

2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch

        Chapter 3  Methods of Test for Packages Labeled by Weight

3.11.4. Exhausting the Aerosol Container

        Chapter 4  Methods of Test for Packages Labeled by Volume

4.6.4. Method D: Determining the Net Contents of Compressed Gas in 
          Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume

Chapter 5  Methods of Test for Packages Labeled by Count, Length, Area, 
                Thickness, or Combinations of Quantities

5.4. Polyethylene Sheeting

                              Supplement 3

        Chapter 3  Methods of Test for Packages Labeled by Weight

3.17. Flour and Dry Pet Food

Chapter 5  Methods of Test for Packages Labeled by Count, Length, Area, 
                 Thickness, or Combination of Quantities

5.4. Polyethylene Sheeting
5.5. Paper Plates
5.8. Baler Twine

Appendix A.  Forms and Worksheets

                              Supplement 4

3.11  Aerosol Packages
3.11.1  Equipment
3.11.2  Preparation for Test
3.11.3  The Determination of Net Contents: Part 1
3.11.4  Exhausting the Aerosol Container
3.11.5  The Determination of Net Contents: Part 2

Appendix A.  Report Forms

[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, March 9, 1995]



Sec. 317.20  Scale requirements for accurate weights, repairs, adjustments, and replacement after inspection.

    (a) All scales used to weigh meat products sold or otherwise 
distributed in commerce in federally inspected meat establishments shall 
be installed, maintained and operated to insure accurate weights. Such 
scales shall meet the applicable requirements contained in National 
Institute of Standards and Technology Handbook 44, ``Specifications, 
Tolerances, and Other Technical Requirements for Weighing and Measuring 
Devices'', 1999 Edition, November 1998, which is incorporated by 
reference. This incorporation was approved by the Director of the 
Federal Register in accordance with 5 U.S.C.. 552(a) and 1 CFR part 51. 
(These materials are incorporated as they exist on the date of 
approval.) Copies may be purchased from the Superintendent of Documents, 
U.S. Government Printing Office, Washington, DC 20402. It is also 
available for inspection at the Office of the Federal Register 
Information Center, 800 North Capitol Street NW., suite 700, Washington, 
DC 20408.
    (b) All scales used to weigh meat products sold or otherwise 
distributed in commerce or in States designated under section 301(c) of 
the Federal

[[Page 184]]

Meat Inspection Act, shall be of sufficient capacity to weigh the entire 
unit and/or package.
    (c) No scale shall be used at a federally inspected establishment to 
weigh meat products unless it has been found upon test and inspection, 
as specified in NIST Handbook 44, to provide accurate weight. If a scale 
is reinspected or retested and found to be inaccurate, or if any 
repairs, adjustments or replacements are made to a scale, it shall not 
be used until it has been inspected and tested by a USDA official, or a 
State or local government weights and measures official, or State 
registered or licensed scale repair firm or person, and it must meet all 
accuracy requirements as specified in NIST Handbook 44. If a USDA 
inspector has put a retain tag on a scale it can only be removed by a 
USDA inspector. As long as the tag is on the scale, it shall not be 
used.

[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, Mar. 9, 1995; 64 
FR 53187, Oct. 1, 1999]



Sec. 317.21  Scales: testing of.

    (a) The operator of each official establishment that weighs meat 
food products shall cause such scales to be tested for accuracy, in 
accordance with the technical requirements of NIST Handbook 44, at least 
once during the calendar year. In cases where the scales are found not 
to maintain accuracy between tests, more frequent tests may be required 
and monitored by an authorized USDA program official.
    (b) The operator of each official establishment shall display on or 
near each scale a valid certification of the scale's accuracy from a 
State or local government's weights and measures authority or from a 
State registered or licensed scale repair firm or person, or shall have 
a net weight program under a Total Quality Control System or Partial 
Quality Control Program in accordance with Sec. 318.4 of this 
subchapter.

[55 FR 49834, Nov. 30, 1990, as amended at 62 FR 45024, Aug. 25, 1997]



Sec. 317.22  Handling of failed product.

    Any lot of product which is found to be out of compliance with net 
weight requirements upon testing in accordance with Sec. 317.19 shall be 
handled as follows:
    (a) A lot tested in an official establishment and found not to 
comply with net weight requirements may be reprocessed and must be 
reweighed and remarked to satisfy the net weight requirements of this 
section and be reinspected, in accordance with the requirements of this 
part.
    (b) A lot tested outside of an official establishment and found not 
to comply with net weight requirements must be reweighed and remarked 
with a proper net weight statement, provided that such reweighing and 
remarking shall not deface, cover, or destroy any other marking or 
labeling required under this subchapter and the net quantity of contents 
is shown with the same prominence as the most conspicuous feature of a 
label.

[55 FR 49834, Nov. 30, 1990]



Sec. 317.23  [Reserved]



Sec. 317.24  Packaging materials.

    (a) Edible products may not be packaged in a container which is 
composed in whole or in part of any poisonous or deleterious substances 
which may render the contents adulterated or injurious to health. All 
packaging materials must be safe for their intended use within the 
meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as 
amended (FFDCA).
    (b) Packaging materials entering the official establishment must be 
accompanied or covered by a guaranty, or statement of assurance, from 
the packaging supplier under whose brand name and firm name the material 
is marketed to the official establishment. The guaranty shall state that 
the material's intended use complies with the FFDCA and all applicable 
food additive regulations. The guaranty must identify the material, 
e.g., by the distinguishing brand name or code designation appearing on 
the packaging material shipping container; must specify the applicable 
conditions of use, including temperature limits and any other pertinent 
limits specified under the FFDCA and food additive regulations; and must 
be signed by an authorized official of the supplying firm. The guaranty 
may be limited to a specific

[[Page 185]]

shipment of an article, in which case it may be part of or attached to 
the invoice covering such shipment, or it may be general and continuing, 
in which case, in its application to any article or other shipment of an 
article, it shall be considered to have been given at the date such 
article was shipped by the person who gives the guaranty. Guaranties 
consistent with the Food and Drug Administration's regulations regarding 
such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The 
management of the establishment must maintain a file containing 
guaranties for all food contact packaging materials in the 
establishment. The file shall be made available to Program inspectors or 
other Department officials upon request. While in the official 
establishment, the identity of all packaging materials must be traceable 
to the applicable guaranty.
    (c) The guaranty by the packaging supplier will be accepted by 
Program inspectors to establish that the use of material complies with 
the FFDCA and all applicable food additive regulations.
    (d) The Department will mmnitor the use of packaging material in 
official establishments to assure that the requirements of paragraph (a) 
of this section are met, and may question the basis for any guaranty 
described under paragraph (b) of this section. Official establishments 
and packaging suppliers providing written guaranties to those official 
establishments will be permitted an opportunity to provide information 
tm designated Department officials as needed to verify the basis for any 
such guaranty. The required information will include, but is not limited 
to, manufacturing firm's name, trade name or code designation for the 
material, complete chemical composition, and use. Selection of a 
material for review does not in itself affect a material's 
acceptability. Materials may continue to be used during the review 
period. However, if information requested from the supplier is not 
provided within the time indicated in the request--a minimum of 30 
days--any applicable guaranty shall cease to be effective, and approval 
to continue using the specified packaging material in official 
establishments may be denied. The Administrator may extend this time 
where reasonable grounds for extension are shown, as, for example, where 
data must be obtained from suppliers.
    (e) The Administrator may disapprove for use in official 
establishmelts packaging materials whose use cannot be confirmed as 
complying with FFDCA and applicable food additive regulations. Before 
approval to use a packaging material is finally denied by the 
Administrator, the affected official establishment and the supplier of 
the material shall be given notice and the opportunity to present their 
views to the Administrator. If the official establishment and the 
supplier do not accept the Administrator's determination, a hearing in 
accordance with applicable rules of practice will be held to resolve 
such dispute. Approval to use the materials pending the outcome of the 
presentation of views or hearing shall be denied if the Administrator 
determines that such use may present an imminent hazard to public 
health.
    (f) Periodically, the Administrator will issue to inspectors a 
listing, by distinguishing brand name or code designation, of packaging 
materials that have been reviewed and that fail to meet the requirements 
of paragraph (a) of this section. Listed materials will not be permitted 
for use in official establishments. If a subsequent review of any 
material indicates that it meets the requirements of paragraph (a), the 
material will be deleted from the listing.
    (g) Nothing in this section shall affect the authority of Program 
inspectors to refuse a specific material if he/she determines the 
material may render products adulterated or injurious to health.

[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]



                      Subpart B--Nutrition Labeling

    Source: 58 FR 664, Jan. 6, 1993, unless otherwise noted.

[[Page 186]]



Sec. 317.300  Nutrition labeling of meat or meat food products.

    (a) Nutrition labeling shall be provided for all meat or meat food 
products intended for human consumption and offered for sale, except 
single-ingredient, raw products, in accordance with the requirements of 
Sec. 317.309; except as exempted under Sec. 317.400 of this subpart.
    (b) Nutrition labeling may be provided for single-ingredient, raw 
meat or meat food products in accordance with the requirements of 
Secs. 317.309 and 317.345. Significant participation in voluntary 
nutrition labeling shall be measured by the Agency in accordance with 
Secs. 317.343 and 317.344 of this subpart.

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]



Sec. 317.301  [Reserved]



Sec. 317.302  Location of nutrition information.

    (a) Nutrition information on a label of a packaged meat or meat food 
product shall appear on the label's principal display panel or on the 
information panel, except as provided in paragraphs (b) and (c) of this 
section.
    (b) Nutrition information for gift packs may be shown at a location 
other than on the product label, provided that the labels for these 
products bear no nutrition claim. In lieu of on the product label, 
nutrition information may be provided by alternate means such as product 
label inserts.
    (c) Meat or meat food products in packages that have a total surface 
area available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not provide sufficient 
space to accommodate all required information may use any alternate 
panel that can be readily seen by consumers for the nutrition 
information. In determining the sufficiency of available space for the 
nutrition information, the space needed for vignettes, designs, and 
other nonmandatory label information on the principal display panel may 
be considered.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 
176, Jan. 3, 1995]



Secs. 317.303-317.307  [Reserved]



Sec. 317.308  Labeling of meat or meat food products with number of servings.

    The label of any package of a meat or meat food product that bears a 
representation as to the number of servings contained in such package 
shall meet the requirements of Sec. 317.2(h)(10).

[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]



Sec. 317.309  Nutrition label content.

    (a) All nutrient and food component quantities shall be declared in 
relation to a serving as defined in this section.
    (b)(1) The term ``serving'' or ``serving size'' means an amount of 
food customarily consumed per eating occasion by persons 4 years of age 
or older, which is expressed in a common household measure that is 
appropriate to the product. When the product is specially formulated or 
processed for use by infants or by toddlers, a serving or serving size 
means an amount of food customarily consumed per eating occasion by 
infants up to 12 months of age or by children 1 through 3 years of age, 
respectively.
    (2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of 
this section and for products that are intended for weight control and 
are available only through a weight-control or weight-maintenance 
program, serving size declared on a product label shall be determined 
from the ``Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply'' (Reference Amount(s)) that appear in 
Sec. 317.312(b) using the procedures described in this paragraph (b). 
For products that are both intended for weight control and available 
only through a weight-control program, a manufacturer may determine the 
serving size that is consistent with the meal plan of the program. Such 
products must bear a statement, ``for sale only through the ______ 
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display 
panel. However, the Reference Amounts in Sec. 317.312(b) shall be used 
for purposes of evaluating whether weight-

[[Page 187]]

control products that are available only through a weight-control 
program qualify for nutrition claims.
    (3) The declaration of nutrient and food component content shall be 
on the basis of the product ``as packaged'' for all products, except 
that single-ingredient, raw products may be declared on the basis of the 
product ``as consumed'' as set forth in Sec. 317.345(a)(1). In addition 
to the required declaration on the basis of ``as packaged'' for products 
other than single-ingredient, raw products, the declaration may also be 
made on the basis of ``as consumed,'' provided that preparation and 
cooking instructions are clearly stated.
    (4) For products in discrete units (e.g., hot dogs, and individually 
packaged products within a multi-serving package), and for products 
which consist of two or more foods packaged and presented to be consumed 
together where the ingredient represented as the main ingredient is in 
discrete units (e.g., beef fritters and barbecue sauce), the serving 
size shall be declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, the 
serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category.
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size.
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit.
    (iv) If a unit weighs 200 percent or more of the Reference Amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single eating occasion.
    (v) For products that have Reference Amounts of 100 grams (or 
milliliter) or larger and are individual units within a multi-serving 
package, if a unit contains more than 150 percent but less than 200 
percent of the Reference Amount, the manufacturer may decide whether to 
declare the individual unit as 1 or 2 servings.
    (vi) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., beef fritters and 
barbecue sauce), the serving size may be the number of discrete units 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount for the combined product as determined 
in Sec. 317.312(c).
    (vii) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (5) For products in large discrete units that are usually divided 
for consumption (e.g., pizza), for unprepared products where the entire 
contents of the package is used to prepare large discrete units that are 
usually divided for consumption (e.g. pizza kit), and for products which 
consist of two or more foods packaged and presented to be consumed 
together where the ingredient represented as the main ingredient is a 
large discrete unit usually divided for consumption, the serving size 
shall be the fractional slice of the ready-to-eat product (e.g., \1/8\ 
quiche, \1/4\ pizza) that most closely approximates the Reference Amount 
for the product category. The serving size may be the fraction of the 
package used to make the Reference Amount for the unprepared product 
determined in Sec. 317.312(d) or the fraction of the large discrete unit 
represented as the main ingredient plus proportioned minor ingredients 
used to make the Reference Amount of the combined product determined in 
Sec. 317.312(c). In expressing the fractional slice, manufacturers shall 
use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that can be 
generated by further division by 2 or 3.
    (6) For nondiscrete bulk products (e.g., whole roast beef, marinated 
beef tenderloin, large can of chili), and for products which consist of 
two or more foods packaged and presented to be

[[Page 188]]

consumed together where the ingredient represented as the main 
ingredient is a bulk product (e.g., roast beef and gravy), the serving 
size shall be the amount in household measure that most closely 
approximates the Reference Amount for the product category and may be 
the amount of the bulk product represented as the main ingredient plus 
proportioned minor ingredients used to make the Reference Amount for the 
combined product determined in Sec. 317.312(c).
    (7) For labeling purposes, the term ``common household measure'' or 
``common household unit'' means cup, tablespoon, teaspoon, piece, slice, 
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household 
equipment used to package food products (e.g., jar or tray). In 
expressing serving size in household measures, except as specified in 
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following 
rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 1 
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1 
tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce increments most 
closely approximating the Reference Amount with rounding indicated by 
the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and meal-type products and for 
individually packaged products within multi-serving containers (e.g., 
can, box, package, meal, or dinner). A description of the individual 
unit shall be used for other products in discrete units (e.g., chop, 
slice, link, or patty).
    (v) For unprepared products where the entire contents of the package 
is used to prepare large discrete units that are usually divided for 
consumption (e.g., pizza kit), the fraction or portion of the package 
may be used.
    (vi) For products that consist of two or more distinct ingredients 
or components packaged and presented to be consumed together (e.g., ham 
with a glaze packet), the nutrition information may be declared for each 
component or as a composite. The serving size may be provided in 
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) 
of this section.
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz 
in weight means 28 grams (g).
    (viii) When a serving size, determined from the Reference Amount in 
Sec. 317.312(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving size up to the next incremental 
size.
    (8) A product that is packaged and sold individually and that 
contains less than 200 percent of the applicable Reference Amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving, except for products that 
have Reference Amounts of 100 g (or mL) or larger, manufacturers may 
decide whether a package that contains more than 150 percent but less 
than 200 percent of the Reference Amount is 1 or 2 servings. Packages 
sold individually that contain 200 percent or more of the applicable 
Reference Amount may be labeled as a single-serving if the entire 
content of the package can reasonably be consumed at a single-eating 
occasion.
    (9) A label statement regarding a serving shall be the serving size 
expressed in common household measures as set forth in paragraphs (b)(2) 
through (b)(8) of this section and shall be followed by the equivalent 
metric

[[Page 189]]

quantity in parenthesis (fluids in milliliters and all other foods in 
grams), except for single-serving containers.
    (i) For a single-serving container, the parenthetical metric 
quantity, which will be presented as part of the net weight statement on 
the principal display panel, is not required except where nutrition 
information is required on a drained weight basis according to paragraph 
(b)(11) of this section. However, if a manufacturer voluntarily provides 
the metric quantity on products that can be sold as single-servings, 
then the numerical value provided as part of the serving size 
declaration must be identical to the metric quantity declaration 
provided as part of the net quantity of contents statement.
    (ii) The gram or milliliter quantity equivalent to the household 
measure should be rounded to the nearest whole number except for 
quantities that are less than 5 g (mL). The gram (mL) quantity between 2 
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) 
quantity less than 2 g (mL) should be expressed in 0.1-g (mL) 
increments.
    (iii) In addition, serving size may be declared in ounce, in 
parenthesis, following the metric measure separated by a slash where 
other common household measures are used as the primary unit for serving 
size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity 
equivalent to the metric quantity should be expressed in 0.1-oz 
increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, and oz for ounce.
    (10) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.
    (i) The number of servings shall be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
shall be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term ``about'' (e.g., about 2 servings; 
about 3.5 servings).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size (e.g., pickled pigs feet), the manufacturer may 
state the typical number of servings per container (e.g., usually 5 
servings).
    (iii) For random weight products, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the Reference Amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement (e.g., varied 
(approximately 8 servings per pound)).
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving containers), 
the number of servings shall be the number of individual packages within 
the total package.
    (v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying 
the number of individual multi-serving units in the total package by the 
number of servings in each individual unit.
    (11) The declaration of nutrient and food component content shall be 
on the basis of product as packaged or purchased with the exception of 
products that are packed or canned in water, brine, or oil but whose 
liquid packing medium is not customarily consumed. Declaration of the 
nutrient and food component content of products that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (12) Serving size for meal-type products as defined in 
Sec. 317.313(l) shall be the entire content (edible portion only) of the 
package.
    (13) Another column of figures may be used to declare the nutrient 
and food component information in the same format as required by 
Sec. 317.309(e),

[[Page 190]]

    (i) Per 100 grams, 100 milliliters, or 1 ounce of the product as 
packaged or purchased.
    (ii) Per one unit if the serving size of a product in discrete units 
in a multi-serving container is more than one unit.
    (14) If a product consists of assortments of meat or meat food 
products (e.g., variety packs) in the same package, nutrient content 
shall be expressed on the entire package contents or on each individual 
product.
    (15) If a product is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare the nutrient contents on the basis of the product as 
consumed for the product alone (e.g., a cream soup mix may be labeled 
with one set of Daily Values for the dry mix (per serving), and another 
set for the serving of the final soup when prepared (e.g., per serving 
of cream soup mix and 1 cup of vitamin D fortified whole milk)): 
Provided, That the type and quantity of the other ingredients to be 
added to the product by the user and the specific method of cooking and 
other preparation shall be specified prominently on the label.
    (c) The declaration of nutrition information on the label or in 
labeling of a meat or meat food product shall contain information about 
the level of the following nutrients, except for those nutrients whose 
inclusion, and the declaration of amounts, is voluntary as set forth in 
this paragraph. No nutrients or food components other than those listed 
in this paragraph as either mandatory or voluntary may be included 
within the nutrition label. Except as provided for in paragraph (f) or 
(g) of this section, nutrient information shall be presented using the 
nutrient names specified and in the following order in the formats 
specified in paragraph (d) or (e) of this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parenthesis immediately following 
the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,'' 
by A. L. Merrill and B. K. Watt, United States Department of Agriculture 
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), 
which is incorporated by reference. Table 13 of the ``Energy Value of 
Foods--Basis and Derivation,'' Agriculture Handbook No. 74 is 
incorporated as it exists on the date of approval. This incorporation by 
reference was approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for 
inspection at the Office of the Federal Register, suite 700, 800 North 
Capitol Street, NW., Washington, DC, or at the office of the FSIS Docket 
Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., 
Washington, DC. Copies of the incorporation by reference are available 
from the Product Assessment Division, Regulatory Programs, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Room 329, West 
End Court Building, Washington, DC 20250-3700;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973), 
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture 
Handbook No. 74 is incorporated as it exists on the date of approval. 
This incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
(The availability of this incorporation by reference is given in 
paragraph (c)(1)(i)(A) of this section.);

[[Page 191]]

    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA's Agriculture Handbook 
No. 74 (Slightly revised February 1973), pages 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. (The availability of this incorporation by reference is given 
in paragraph (c)(1)(i)(A) of this section.); or
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of 21 CFR, or by other means, as 
appropriate.
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section 
per serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat per serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section.
    (iii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section per serving may be 
declared voluntarily, expressed to the nearest 5-calorie increment, up 
to and including 50 calories, and the nearest 10-calorie increment above 
50 calories, except that amounts less than 5 calories may be expressed 
as zero. This statement shall be indented under the statement of 
calories from fat as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat per serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number of 
grams of saturated fat per serving defined as the sum of all fatty acids 
containing no double bonds, except that label declaration of saturated 
fat content information is not required for products that contain less 
than 0.5 gram of total fat per serving if no claims are made about fat 
or cholesterol content, and if ``calories from saturated fat'' is not 
declared. Saturated fat content shall be indented and expressed as grams 
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
to the nearest gram increment above 5 grams. If the serving contains 
less than 0.5 gram, the content shall be expressed as zero.
    (A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of grams 
of stearic acid per serving may be declared voluntarily, except that 
when a claim is made about stearic acid, label declaration shall be 
required. Stearic acid content shall be indented under saturated fat and 
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and 
the nearest gram increment above 5 grams. If the serving contains less 
than 0.5 gram, the content shall be expressed as zero.
    (B) [Reserved]
    (ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat per serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may 
be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a product other than one that meets the 
criteria in Sec. 317.362(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat per serving 
defined as cis-monounsaturated fatty

[[Page 192]]

acids may be declared voluntarily, except that when polyunsaturated fat 
is declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a product other than one that meets the 
criteria in Sec. 317.362(b)(1) for a claim for ``fat free,'' label 
declaration of monounsaturated fat is required. Monounsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content per 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not required 
for products that contain less than 2 milligrams of cholesterol per 
serving and make no claim about fat, fatty acids, or cholesterol 
content, or such products may state the cholesterol content as zero. If 
the product contains 2 to 5 milligrams of cholesterol per serving, the 
content may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium 
per serving expressed as zero when the serving contains less than 5 
milligrams of sodium, to the nearest 5-milligram increment when the 
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140 
milligrams.
    (5) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium per serving may be declared voluntarily, except 
that when a claim is made about potassium content, label declaration 
shall be required. Potassium content shall be expressed as zero when the 
serving contains less than 5 milligrams of potassium, to the nearest 5-
milligram increment when the serving contains 5 to 140 milligrams of 
potassium, and to the nearest 10-milligram increment when the serving 
contains greater than 140 milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate per serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or, if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the product. This 
calculation method is described in USDA's Agriculture Handbook No. 74 
(Slightly revised February 1973), pages 2 and 3, which is incorporated 
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated 
as it exists on the date of approval. This incorporation by reference 
was approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this 
incorporation by reference is given in paragraph (c)(1)(i)(A) of this 
section.)
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber per serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required, or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be expressed 
as zero.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber per serving may be declared voluntarily 
except when a

[[Page 193]]

claim is made on the label or in labeling about insoluble fiber, label 
declaration shall be required. Insoluble fiber content shall be indented 
under dietary fiber and expressed to the nearest gram, except that if a 
serving contains less than 1 gram, the statement ``Contains less than 1 
gram'' or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars per 
serving, except that label declaration of sugars content is not required 
for products that contain less than 1 gram of sugars per serving if no 
claims are made about sweeteners, sugars, or sugar alcohol content. 
Sugars shall be defined as the sum of all free mono- and disaccharides 
(such as glucose, fructose, lactose, and sucrose). Sugars content shall 
be indented and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols per serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
product, sugar alcohol content shall be declared. For nutrition labeling 
purposes, sugar alcohols are defined as the sum of saccharide 
derivatives in which a hydroxyl group replaces a ketone or aldehyde 
group and whose use in the food is listed by FDA (e.g., mannitol or 
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of 
the term ``sugar alcohol,'' the name of the specific sugar alcohol 
(e.g., ``xylitol'') present in the product may be used in the nutrition 
label, provided that only one sugar alcohol is present in the product. 
Sugar alcohol content shall be indented and expressed to the nearest 
gram, except that if a serving contains less than 1 gram, the statement 
``Contains less then 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrate per serving may be declared voluntarily. 
Other carbohydrate shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it shall 
be defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars. Other carbohydrate content shall be indented 
and expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein per 
serving expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero. When the 
protein in products represented or purported to be for adults and 
children 4 or more years of age has a protein quality value that is a 
protein digestibility-corrected amino acid score of less than 20 
expressed as a percent, or when the protein in a product represented or 
purported to be for children greater than 1 but less than 4 years of age 
has a protein quality value that is a protein digestibility-corrected 
amino acid score of less than 40 expressed as a percent, either of the 
following shall be placed adjacent to the declaration of protein content 
by weight: The statement ``not a significant source of protein,'' or a 
listing aligned under the column headed ``Percent Daily Value'' of the 
corrected amount of protein per serving, as determined in paragraph 
(c)(7)(ii) of this section, calculated as a percentage of the Daily 
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, 
for protein and expressed as percent of Daily Value. When the protein 
quality in a product as measured by

[[Page 194]]

the Protein Efficiency Ratio (PER) is less than 40 percent of the 
reference standard (casein) for a product represented or purported to be 
for infants, the statement ``not a significant source of protein'' shall 
be placed adjacent to the declaration of protein content. Protein 
content may be calculated on the basis of the factor of 6.25 times the 
nitrogen content of the food as determined by appropriate methods of 
analysis in accordance with Sec. 317.309(h), except when the procedure 
for a specific food requires another factor.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for infants or 
children under 4 years of age. When such a declaration is provided, it 
shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column headed ``Percent Daily Value,'' and 
expressed to the nearest whole percent. However, the percentage of the 
RDI for protein shall not be declared if the product is represented or 
purported to be for infants and the protein quality value is less than 
40 percent of the reference standard.
    (ii) The corrected amount of protein (grams) per serving for 
products represented or purported to be for adults and children 1 or 
more years of age is equal to the actual amount of protein (grams) per 
serving multiplied by the amino acid score corrected for protein 
digestibility. If the corrected score is above 1.00, then it shall be 
set at 1.00. The protein digestibility-corrected amino acid score shall 
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in 
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is 
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report 
of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' as published by the Food and Agriculture Organization of 
the United Nations/World Health Organization, is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the 
Office of the Federal Register, suite 700, 800 North Capitol Street, 
NW., Washington, DC, or at the office of the FSIS Docket Clerk, Room 
3171, South Building, 14th and Independence Avenue, SW., Washington, DC. 
Copies of the incorporation by reference are available from the Product 
Assessment Division, Regulatory Programs, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Room 329, West End Court 
Building, Washington, DC 20250-3700. For products represented or 
purported to be for infants, the corrected amount of protein (grams) per 
serving is equal to the actual amount of protein (grams) per serving 
multiplied by the relative protein quality value. The relative protein 
quality value shall be determined by dividing the subject product's 
protein PER value by the PER value for casein. If the relative protein 
value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, and the RDI for protein for children less than 4 
years of age, infants, pregnant women, and lactating women shall be 16 
grams, 14 grams, 60 grams, and 65 grams, respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d) through (g) of this section, products 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For products represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented

[[Page 195]]

by separate declarations according to paragraph (e) of this section 
based on the RDI values for infants from birth to 12 months of age and 
for children under 4 years of age. Similarly, the percent of Daily Value 
based on both the RDI values for pregnant women and for lactating women 
shall be declared separately on products represented or purported to be 
for use by both pregnant and lactating women. When such dual declaration 
is used on any label, it shall be included in all labeling, and equal 
prominence shall be given to both values in all such labeling. All other 
products shall use the RDI for adults and children 4 or more years of 
age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added, or when a 
claim is made about them. Other vitamins and minerals need not be 
declared if neither the nutrient nor the component is otherwise referred 
to on the label or in labeling or advertising and the vitamins and 
minerals are:
    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin, and niacin in enriched flour) and that standardized food is 
included as an ingredient (i.e., component) in another product; or
    (B) Included in a product solely for technological purposes and 
declared only in the ingredients statement. The declaration may also 
include any of the other vitamins and minerals listed in paragraph 
(c)(8)(iv) of this section when they are naturally occurring in the 
food. The additional vitamins and minerals shall be listed in the order 
established in paragraph (c)(8)(iv) of this section.
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C, 
calcium, or iron is present in amounts less than 2 percent of the RDI, 
label declaration of the nutrient(s) is not required if the statement 
``Not a significant source of ______ (listing the vitamins or minerals 
omitted)'' is placed at the bottom of the table of nutrient values.
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams

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

Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally,

[[Page 196]]

the statement of percent shall be presented in parenthesis following the 
declaration of vitamin A and the percent of Daily Value of vitamin A in 
the product (e.g., ``Percent Daily Value: Vitamin A 50 (90 percent as 
beta-carotene)''). When declared, the percentages shall be expressed in 
the same increments as are provided for vitamins and minerals in 
paragraph (c)(8)(iii) of this section.
    (9) For the purpose of labeling with a percent of the DRV, the 
following DRV's are established for the following food components based 
on the reference caloric intake of 2,000 calories:

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

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on products in the following format, except 
on products on which dual columns of nutrition information are declared 
as provided for in paragraph (e) of this section, on those products on 
which the simplified format is permitted to be used as provided for in 
paragraph (f) of this section, on products for infants and children less 
than 4 years of age as provided for in Sec. 317.400(c), and on products 
in packages that have a total surface area available to bear labeling of 
40 or less square inches as provided for in paragraph (g) of this 
section.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) A single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section, 
and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and 
(d)(8) of this section shall be in type size no smaller than 8 point. 
Except for the heading ``Nutrition Facts,'' the information required in 
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other 
information contained within the nutrition label shall be in type size 
no smaller than 6 point. When provided, the information described in 
paragraph (d)(10) of this section shall also be in type no smaller than 
6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate, 
and Protein), and the percentage amounts required by paragraph 
(d)(7)(ii) of this section shall be highlighted by bold or extra bold 
type or other highlighting (reverse printing is not permitted as a form 
of highlighting) that prominently distinguishes it from other 
information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text shall 
separate ``Amount Per Serving'' from the calorie statements required in 
paragraph (d)(5) of this section and shall separate each nutrient and 
its corresponding percent of Daily Value required in paragraphs 
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent 
of Daily Value above and below it.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size larger than all 
other print size in the nutrition label and, except for labels presented 
according to the format provided for in paragraph (d)(11) of this 
section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section.
    (3) Information on serving size shall immediately follow the 
heading. Such information shall include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(9) of this section.

[[Page 197]]

    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single-serving 
containers as defined in paragraph (b)(8) of this section.
    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in one line, leaving 
sufficient space between the declaration of ``Calories'' and ``Calories 
from fat'' to allow clear differentiation, or, if ``Calories from 
saturated fat'' is declared, in a column with total ``Calories'' at the 
top, followed by ``Calories from fat'' (indented), and ``Calories from 
saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar. The position of this column heading shall allow for a 
list of nutrient names and amounts as described in paragraph (d)(7) of 
this section to be to the left of, and below, this column heading. The 
column headings ``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may 
be substituted for ``% Daily Value.''
    (7) Except as provided for in paragraph (g) of this section, and 
except as permitted by Sec. 317.400(d)(2), nutrient information for both 
mandatory and any voluntary nutrients listed in paragraph (c) of this 
section that are to be declared in the nutrition label, except vitamins 
and minerals, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of this 
section, shall be given in a column and followed immediately by the 
quantitative amount by weight for that nutrient appended with a ``g'' 
for grams or ``mg'' for milligrams.
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column described 
in paragraph (d)(7)(i) of this section for which a DRV has been 
established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns, except that when more than 
four vitamins and minerals are declared, they may be declared vertically 
with percentages listed under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state: Percent Daily Values are based on a 
2,000 calorie diet. Your daily values may be higher or lower depending 
on your calorie needs.

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

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and value of 65 g in the column headed ``2,500.''
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.

[[Page 198]]

    (iv) The abbreviations established in paragraph (g)(2) of this 
section may be used within the footnote.
    (10) Caloric conversion information on a per-gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9), separated from that information by a 
hairline. This information may be presented horizontally (i.e., 
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically 
in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9) of this section, the information required in paragraph 
(d)(9) may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent of Daily Value information. The 
caloric conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length of 
the nutrition label.
    (ii) If the space beneath the mandatory declaration of iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set off 
by a line that distinguishes it and sets it apart from the percent of 
Daily Value information given to the left. The caloric conversion 
information provided for in paragraph (d)(10) of this section may be 
presented beneath either side or along the full length of the nutrition 
label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 inches) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of iron, 
the nutrition label may be presented in a tabular display in which the 
footnote required by paragraph (d)(9) of the section is given to the far 
right of the label, and additional vitamins and minerals beyond the four 
that are required (i.e., vitamin A, vitamin C, calcium, and iron) are 
arrayed horizontally following declarations of the required vitamins and 
minerals.
    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section:

[[Page 199]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.013

    (13)(i) Nutrition labeling on the outer label of packages of meat or 
meat food products that contain two or more products in the same 
packages (e.g., variety packs) or of packages that are used 
interchangeably for the same type of food (e.g., meat salad containers) 
may use an aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph

[[Page 200]]

(d) of this section to the maximum extent possible, except that the 
identity of each food shall be specified to the right of the ``Nutrition 
Facts'' title, and both the quantitative amount by weight (i.e., g/mg 
amounts) and the percent Daily Value for each nutrient shall be listed 
in separate columns under the name of each food.
    (14) When nutrition labeling appears in a second language, the 
nutrition information may be presented in a separate nutrition label for 
each language or in one nutrition label with the information in the 
second language following that in English. Numeric characters that are 
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both 
languages.
    (e) Nutrition information may be presented for two or more forms of 
the same product (e.g., both ``raw'' and ``cooked'') or for common 
combinations of foods as provided for in paragraph (b) of this section, 
or for different units (e.g., per 100 grams) as provided for in 
paragraph (b) of this section, or for two or more groups for which RDI's 
are established (e.g., both infants and children less than 4 years of 
age) as provided for in paragraph (c)(8)(i) of this section. When such 
dual labeling is provided, equal prominence shall be given to both sets 
of values. Information shall be presented in a format consistent with 
paragraph (d) of this section, except that:
    (1) Following the subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same product (e.g., ``raw'' and ``roasted''), the combinations of foods, 
the units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the Reference Amount in Sec. 317.312(b) shall be to the 
left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of the 
same product, for combinations of foods, or for different units, total 
calories and calories from fat (and calories from saturated fat, when 
declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the product 
as packaged and according to the label serving size based on the 
Reference Amount in Sec. 317.312(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the Reference Amount in Sec. 317.312(b) or as a footnote.
    (A) If such additional quantitative information is given immediately 
adjacent to the required quantitative information, it shall be declared 
for all nutrients listed and placed immediately following and 
differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the nutrition 
label identifying the form(s) of the product for which quantitative 
information is presented.

[[Page 201]]

    (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 202]]

[GRAPHIC] [TIFF OMITTED] TC11SE91.014

    (f)(1) Nutrition information may be presented in a simplified format 
as set forth herein when any required nutrients, other than the core 
nutrients

[[Page 203]]

(i.e., calories, total fat, sodium, total carbohydrate, and protein), 
are present in insignificant amounts. An insignificant amount shall be 
defined as that amount that may be rounded to zero in nutrition 
labeling, except that for total carbohydrate, dietary fiber, sugars and 
protein, it shall be an amount less than 1 gram.
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, sodium, and 
protein;
    (ii) Any of the following that are present in more than 
insignificant amounts: Calories from fat, saturated fat, cholesterol, 
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are added in fortified or fabricated foods.
    (3) Other nutrients that are naturally present in the product in 
more than insignificant amounts may be voluntarily declared as part of 
the simplified format.
    (4) Any required nutrient, other than a core nutrient, that is 
present in an insignificant amount may be omitted from the tabular 
listing, provided that the following statement is included at the bottom 
of the nutrition label, ``Not a significant source of ________.'' The 
blank shall be filled in with the appropriate nutrient or food 
component. Alternatively, amounts of vitamins and minerals present in 
insignificant amounts may be declared by the use of an asterisk (or 
symbol) that is placed at the bottom of the table of nutrient values and 
that is followed by the statement ``Contains less than 2 percent of the 
Daily Value of this (these) nutrient (nutrients).''
    (5) Except as provided for in paragraph (g) of this section and in 
Sec. 317.400(c) and (d), nutrient information declared in the simplified 
format shall be presented in the same manner as specified in paragraphs 
(d) or (e) of this section, except that the footnote required in 
paragraph (d)(9) of this section is not required. When the footnote is 
omitted, an asterisk shall be placed at the bottom of the label followed 
by the statement ``Percent Daily Values are based on a 2,000 calorie 
diet'' and, if the term ``Daily Value'' is not spelled out in the 
heading, a statement that ``DV'' represents ``Daily Value.''
    (g) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements of 
paragraphs (c) through (f) of this section and Sec. 317.302(a) by one or 
more of the following means:
    (1)(i) Presenting the required nutrition information in a tabular or 
linear (i.e., string) fashion, rather than in vertical columns if the 
product has a total surface area available to bear labeling of less than 
12 square inches, or if the product has a total surface area available 
to bear labeling of 40 or less square inches and the package shape or 
size cannot accommodate a standard vertical column or tabular display on 
any label panel. Nutrition information may be given in a linear fashion 
only if the package shape or size will not accommodate a tabular 
display.
    (ii) When nutrition information is given in a linear display, the 
nutrition information shall be set off in a box by the use of a 
hairline. The percent Daily Value is separated from the quantitative 
amount declaration by the use of parenthesis, and all nutrients, both 
principal components and subcomponents, are treated similarly. Bolding 
is required only on the title ``Nutrition Facts'' and is allowed for 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
    (2) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

    (3) Omitting the footnote required in paragraph (d)(9) of this 
section and placing another asterisk at the bottom

[[Page 204]]

of the label followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet'' and, if the term ``Daily Value'' is not 
spelled out in the heading, a statement that ``DV'' represents ``Daily 
Value.''
    (4) Presenting the required nutrition information on any other label 
panel.
    (h) Compliance with this section shall be determined as follows:
    (1) A production lot is a set of food production consumer units that 
are from one production shift. Alternatively, a collection of consumer 
units of the same size, type, and style produced under conditions as 
nearly uniform as possible, designated by a common container code or 
marking, constitutes a production lot.
    (2) The sample for nutrient analysis shall consist of a composite of 
a minimum of six consumer units, each from a production lot. 
Alternatively, the sample for nutrient analysis shall consist of a 
composite of a minimum of six consumer units, each randomly chosen to be 
representative of a production lot. In each case, the units may be 
individually analyzed and the results of the analyses averaged, or the 
units would be composited and the composite analyzed. In both cases, the 
results, whether an average or a single result from a composite, will be 
considered by the Agency to be the nutrient content of a composite. All 
analyses shall be performed by appropriate methods and procedures used 
by the Department for each nutrient in accordance with the ``Chemistry 
Laboratory Guidebook,'' or, if no USDA method is available and 
appropriate for the nutrient, by appropriate methods for the nutrient in 
accordance with the 1990 edition of the ``Official Methods of Analysis'' 
of the AOAC International, formerly Association of Official Analytical 
Chemists, 15th ed., which is incorporated by reference, unless a 
particular method of analysis is specified in Sec. 317.309(c), or, if no 
USDA, AOAC, or specified method is available and appropriate, by other 
reliable and appropriate analytical procedures as so determined by the 
Agency. The ``Official Methods of Analysis'' is incorporated as it 
exists on the date of approval. This incorporation by reference was 
approved by the Director of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC 
International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is 
also available for inspection at the Office of the Federal Register 
Information Center, suite 700, 800 North Capitol Street, NW., 
Washington, DC.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to Class II requirements unless the same nutrient is 
also added, which would make the total amount of such nutrient subject 
to Class I requirements.
    (4) A product with a label declaration of a vitamin, mineral, 
protein, total carbohydrate, dietary fiber, other carbohydrate, 
polyunsaturated or monounsaturated fat, or potassium shall be deemed to 
be misbranded under section 1(n) of the Federal Meat Inspection Act (21 
U.S.C. 601(n)(1)) unless it meets the following requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label; Provided, 
That no regulatory action will be based on a determination of a nutrient 
value which falls below this level by an amount less than the 
variability generally recognized for the analytical method used in that 
product at the level involved, and inherent nutrient variation in a 
product.
    (5) A product with a label declaration of calories, sugars, total 
fat, saturated fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 1(n) of the Federal Meat Inspection Act (21 
U.S.C. 601(n)(1)) if the nutrient content of the composite is greater 
than 20

[[Page 205]]

percent in excess of the value for that nutrient declared on the label; 
Provided, That no regulatory action will be based on a determination of 
a nutrient value which falls above this level by an amount less than the 
variability generally recognized for the analytical method used in that 
product at the level involved, and inherent nutrient variation in a 
product.
    (6) The amount of a vitamin, mineral, protein, total carbohydrate, 
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated 
fat, or potassium may vary over labeled amounts within good 
manufacturing practice. The amount of calories, sugars, total fat, 
saturated fat, cholesterol, or sodium may vary under labeled amounts 
within good manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.
    (8) The management of the establishment must maintain records to 
support the validity of nutrient declarations contained on product 
labels. Such records shall be made available to the inspector or any 
duly authorized representative of the Agency upon request.
    (9) The compliance provisions set forth in paragraph (h) (1) through 
(8) of this section shall not apply to single-ingredient, raw meat 
(including ground beef) products, including those that have been 
previously frozen, when nutrition labeling is based on the most current 
representative data base values contained in USDA's National Nutrient 
Data Bank or its published form, the Agriculture Handbook No. 8 series 
available from the Government Printing Office.


(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept. 
10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995]



Secs. 317.310-317.311  [Reserved]



Sec. 317.312  Reference amounts customarily consumed per eating occasion.

    (a) The general principles followed in arriving at the reference 
amounts customarily consumed per eating occasion (Reference Amount(s)), 
as set forth in paragraph (b) of this section, are:
    (1) The Reference Amounts are calculated for persons 4 years of age 
or older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These Reference Amounts 
are based on data set forth in appropriate national food consumption 
surveys.
    (2) The Reference Amounts are calculated for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants up to 12 months of age or by children 1 
through 3 years of age, respectively. These Reference Amounts are based 
on data set forth in appropriate national food consumption surveys. Such 
Reference Amounts are to be used only when the product is specially 
formulated or processed for use by an infant or by a child under 4 years 
of age.
    (3) An appropriate national food consumption survey includes a large 
sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, the mean, median, and mode of the consumed amount per eating 
occasion were considered.
    (5) When survey data were insufficient, FSIS took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.
    (6) Because they reflect the amount customarily consumed, the 
Reference Amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.

[[Page 206]]

    (7) The Reference Amount is based on the major intended use of the 
product (e.g., a mixed dish measurable with a cup as a main dish and not 
as a side dish).
    (8) The Reference Amounts for products that are consumed as an 
ingredient of other products, but that may also be consumed in the form 
in which they are purchased (e.g., ground beef), are based on use in the 
form purchased.
    (9) FSIS sought to ensure that foods that have similar dietary 
usage, product characteristics, and customarily consumed amounts have a 
uniform Reference Amount.
    (b) The following Product Categories and Reference Amounts shall be 
used as the basis for determining serving sizes for specific products:

 Table 1.--Reference Amounts Customarily Consumed per Eating Occasion--
                     Infant and Toddler Foods 1,2,3
------------------------------------------------------------------------
                                                               Reference
                      Product category                          amount
------------------------------------------------------------------------
Infant & Toddler Foods:
  Dinner Dry Mix............................................        15 g
  Dinner, ready-to-serve, strained type.....................        60 g
  Dinner, soups, ready-to-serve junior type.................       110 g
  Dinner, stew or soup ready-to-serve toddlers..............       170 g
  Plain meats and meat sticks, ready-to-serve...............        55 g
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
  Amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve). If not listed separately, the
  Reference Amount for the unprepared form (e.g., dehydrated cereal) is
  the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures established by regulation.


 Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion--
                      General Food Supply 1,2,3,4,5
------------------------------------------------------------------------
                                   Reference amount    Reference amount
        Product category        ----------------------------------------
                                    Ready-to-serve       Ready-to-cook
------------------------------------------------------------------------
Egg mixtures, (western style     110 g                n/a.
 omelet, souffle, egg foo young
 .
Lard, margarine, shortening....  1 tbsp               n/a.
Salad and potato toppers; e.g.,  7 g                  n/a.
 bacon bits.
Bacon (bacon, beef breakfast     15 g                 54 g=bacon. 30 g =
 strips, pork breakfast strips,                        breakfast strips.
 pork rinds).
Dried; e.g., jerky, dried beef,  30 g                 n/a.
 Parma ham sausage products
 with a moisture/protein ratio
 of less than 2:1; e.g.,
 pepperoni.
Snacks; e.g., meat snack food    30 g                 n/a.
 sticks.
Luncheon meat, bologna,          55 g                 n/a.
 Canadian style bacon, pork
 pattie crumbles, beef pattie
 crumbles, blood pudding,
 luncheon loaf, old fashioned
 loaf, berlinger, bangers,
 minced luncheon roll,
 thuringer, liver sausage,
 mortadella, uncured sausage
 (franks), ham and cheese loaf,
 P&P loaf, scrapple souse, head
 cheese, pizza loaf, olive
 loaf, pate, deviled ham,
 sandwich spread, teawurst,
 cervelet, Lebanon bologna,
 potted meat food product, taco
 fillings, meat pie fillings.
Linked meat sausage products,    55 g                 n/a. 75 g=uncooked
 Vienna sausage, frankfurters,                         sausage.
 pork sausage, imitation
 frankfurters, bratwurst,
 kielbasa, Polish sausage,
 summer sausage, mettwurst,
 smoked country sausage, smoked
 sausage, smoked or pickled
 meat, pickled pigs feet.
Entrees without sauce, cuts of   85 g                 114 g.
 meat including marinated,
 tenderized, injected cuts of
 meat, beef patty, corn dog,
 croquettes, fritters, cured
 ham, dry cured ham, dry cured
 cappicola, corned beef,
 pastrami, country ham, pork
 shoulder picnic, meatballs,
 pureed adult foods.
Canned meats, canned beef,       55 g                 n/a.
 canned pork. \4\.
Entrees with sauce, barbecued    140 g                n/a.
 meats in sauce.
Mixed dishes NOT measurable      140 g (plus 55 g     n/a.
 with a cup; \5\ e.g., burrito,   for products with
 egg roll, enchilada, pizza,      sauce toppings)
 pizza roll, quiche, all types
 of sandwiches, cracker and
 meat lunch type packages,
 gyro, stromboli, burger on a
 bun, frank on a bun, calzone,
 taco, pockets stuffed with
 meat, foldovers, stuffed
 vegetables with meat, shish
 kabobs, empanada.
Mixed dishes measurable with a   1 cup                n/a.
 cup; e.g., meat casserole,
 macaroni and cheese with meat,
 pot pie, spaghetti with sauce,
 meat chili, chili with beans,
 meat hash, creamed chipped
 beef, beef ravioli in sauce,
 beef stroganoff, Brunswick
 stew, goulash, meat stew,
 ragout, meat lasagna, meat
 filled pasta.
Salads--pasta or potato, potato  140 g                n/a.
 salad with bacon, macaroni and
 meat salad.
Salads--all other meat, salads,  100 g                n/a.
 ham salad.
Soups--all varieties...........  245 g                n/a.
Major main entree type sauce;    125 g                n/a.
 e.g., spaghetti sauce with
 meat, spaghetti sauce with
 meatballs.
Minor main entree sauce; e.g.,   \1/4\ cup            n/a.
 pizza sauce with meat, gravy.
Seasoning mixes dry, bases,      ...................  ..................
 extracts, dried broths and
 stock/juice, freeze dry trail
 mix products with meat..

[[Page 207]]

 
As reconstituted:
  Amount to make one Reference
   Amount of the final dish;
   e.g.,
    Gravy......................  \1/4\ cup            n/a.
    Major main entree type       125 g                n/a.
     sauce.
    Soup.......................  245 g                n/a.
    Entree measurable with a     1 cup                n/a.
     cup.
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-78 and the
  1987-88 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or
  exclusive. Examples are provided to assist manufacturers in
  identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., lunch meat with cheese and crackers), the 
Reference Amount for the combined product shall be determined using the 
following rules:
    (1) For bulk products, the Reference Amount for the combined product 
shall be the Reference Amount, as established in paragraph (b) of this 
section, for the ingredient that is represented as the main ingredient 
plus proportioned amounts of all minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units, the Reference Amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the Reference Amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the Reference Amounts are in compatible units, they shall be 
summed (e.g., ingredients in equal volumes such as tablespoons). If the 
Reference Amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., grams of one ingredient plus 
gram weight of tablespoons of a second ingredient).
    (d) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a Reference Amount for the product in the prepared 
form, then the Reference Amount for the unprepared product shall be 
determined using the following rules:
    (1) Except as provided for in paragraph (d)(2) of this section, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the Reference Amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
Reference Amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the Reference Amount for the prepared product as 
established in paragraph (b) of this section.
    (e) The Reference Amount for an imitation or substitute product or 
altered product as defined in Sec. 317.313(d), such as a ``low calorie'' 
version, shall be the same as for the product for which it is offered as 
a substitute.
    (f) The Reference Amounts set forth in paragraphs (b) through (e) of 
this section shall be used in determining whether a product meets the 
criteria for nutritional claims. If the serving

[[Page 208]]

size declared on the product label differs from the Reference Amount, 
and the product meets the criteria for the claim only on the basis of 
the Reference Amount, the claim shall be followed by a statement that 
sets forth the basis on which the claim is made. That statement shall 
include the Reference Amount as it appears in paragraph (b) of this 
section followed, in parentheses, by the amount in common household 
measure if the Reference Amount is expressed in measures other than 
common household measures.
    (g) The Administrator, on his or her own initiative or on behalf of 
any interested person who has submitted a labeling application, may 
issue a proposal to establish or amend a Product Category or Reference 
Amount identified in paragraph (b) of this section.
    (1) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (2) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (3) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (4) Data accompanying the labeling application, such as food 
consumption data, shall be submitted on separate sheets, suitably 
identified. If such data has already been submitted with an earlier 
labeling application from the applicant, the present labeling 
application must provide the data.
    (5) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (6) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her pertinent to the evaluation of the labeling 
application.
    (7) Labeling applications for a new Reference Amount and/or Product 
Category shall be accompanied by the following data which shall be 
submitted in the following form to the Director, Food Labeling Division, 
Regulatory Programs, Food Safety and Inspection Service, Washington, DC 
20250:

_______________________________________________________________________
(Date)

    The undersigned, ____________ submits this labeling application 
pursuant to 9 CFR 317.312 with respect to Reference Amount and/or 
Product Category.
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement of the objective of the labeling application;
    (ii) A description of the product;
    (iii) A complete sample product label including nutrition label, 
using the format established by regulation;
    (iv) A description of the form in which the product will be 
marketed;
    (v) The intended dietary uses of the product with the major use 
identified (e.g., ham as a luncheon meat);
    (vi) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the use;
    (vii) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (viii) The names of the most closely-related products (or in the 
case of foods for special dietary use and imitation or substitute foods, 
the names of the products for which they are offered as substitutes);

[[Page 209]]

    (ix) The suggested Reference Amount (the amount of edible portion of 
food as consumed, excluding bone, skin or other inedible components) for 
the population group for which the product is intended with full 
description of the methodology and procedures that were used to 
determine the suggested Reference Amount. In determining the Reference 
Amount, general principles and factors in paragraph (a) of this section 
should be followed.
    (x) The suggested Reference Amount shall be expressed in metric 
units. Reference Amounts for foods shall be expressed in grams except 
when common household units such as cups, tablespoons, and teaspoons are 
more appropriate or are more likely to promote uniformity in serving 
sizes declared on product labels. For example, common household measures 
would be more appropriate if products within the same category differ 
substantially in density such as mixed dishes measurable with a cup.
    (A) In expressing the Reference Amount in grams, the following 
general rules shall be followed:
    (1) For quantities greater than 10 grams, the quantity shall be 
expressed in nearest 5 grams increment.
    (2) For quantities less than 10 grams, exact gram weights shall be 
used.
    (B) [Reserved]
    (xi) A labeling application for a new subcategory of food with its 
own Reference Amount shall include the following additional information:
    (A) Data that demonstrate that the new subcategory of food will be 
consumed in amounts that differ enough from the Reference Amount for the 
parent category to warrant a separate Reference Amount. Data must 
include sample size, and the mean, standard deviation, median, and modal 
consumed amount per eating occasion for the product identified in the 
labeling application and for other products in the category. All data 
must be derived from the same survey data.
    (B) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the product identified in the labeling application from 
the rest of the products in the category.
    (xii) In conducting research to collect or process food consumption 
data in support of the labeling application, the following general 
guidelines should be followed.
    (A) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.
    (B) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (C) The study protocol should identify potential biases and describe 
how potential biases are controlled for or, if not possible to control, 
how they affect interpretation of results.
    (D) The methodology used to collect or process data including study 
design, sampling procedures, materials used (e.g., questionnaire, 
interviewer's manual), procedures used to collect or process data, 
methods or procedures used to control for unbiased estimates, and 
procedures used to correct for nonresponse, should be fully documented.
    (xiii) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule.

      Yours very truly,

      Applicant_________________________________________________________

      By________________________________________________________________
            (Indicate authority)

    (8) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (9) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (10) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
Reference Amount and/or Product Category is false or misleading. The 
notification letter shall inform the applicant that the applicant may 
submit a written statement by way of answer to the notification, and 
that the applicant shall have the right to request a hearing with 
respect to the merits or validity of the Administrator's decision to 
deny the use of the proposed Reference Amount and/or Product Category.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the

[[Page 210]]

initial determination to be correct, the Administrator shall file with 
the Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (11) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
Reference Amount and/or Product Category. The proposal shall also 
summarize the labeling application, including where the supporting 
documentation can be reviewed. The Administrator's proposed rule shall 
seek comment from consumers, the industry, consumer and industry groups, 
and other interested persons on the labeling application and the use of 
the proposed Reference Amount and/or Product Category. After public 
comment has been received and reviewed by the Agency, the Administrator 
shall make a determination on whether the proposed Reference Amount and/
or Product Category shall be approved for use on the labeling of meat 
food products.
    (i) If the Reference Amount and/or Product Category is denied by the 
Administrator, the Agency shall notify the applicant, in writing, of the 
basis for the denial, including the reason why the Reference Amount and/
or Product Category on the labeling was determined by the Agency to be 
false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed Reference 
Amount and/or Product Category.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of an answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the Reference Amount and/or Product Category is approved, 
the Agency shall notify the applicant, in writing, and shall also 
publish in the Federal Register a final rule amending the regulations to 
authorize the use of the Reference Amount and/or Product Category.


(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR 
47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 
1995]



Sec. 317.313  Nutrient content claims; general principles.

    (a) This section applies to meat or meat food products that are 
intended for human consumption and that are offered for sale.

[[Page 211]]

    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec. 317.309, may not be made on a label 
or in labeling of that product unless the claim is made in accordance 
with the applicable provisions in this subpart.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount (e.g., 
``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, may 
be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be made 
on products intended specifically for use by infants and children less 
than 2 years of age unless the claim is specifically provided for in 
subpart B of this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this subpart and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec. 317.309 to be 
declared in nutrition labeling, and that appears as part of the 
nutrition label, is not a nutrient content claim and is not subject to 
the requirements of this section. If such information is declared 
elsewhere on the label or in labeling, it is a nutrient content claim 
and is subject to the requirements for nutrient content claims.
    (d) A ``substitute'' product is one that may be used interchangeably 
with another product that it resembles, i.e., that it is 
organoleptically, physically, and functionally (including shelf life) 
similar to, and that it is not nutritionally inferior to unless it is 
labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec. 317.2(h) for the net quantity 
of contents statement, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the nutrient, 
only products that have been specially processed, altered, formulated, 
or reformulated so as to lower the amount of the nutrient in the 
product, remove the nutrient from the product, or not include the 
nutrient in the product, may bear such a claim (e.g., ``low sodium beef 
noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the product inherently meets the criteria and 
shall clearly refer to all products of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``lard, a sodium 
free food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not be 
unduly prominent in type style compared to the statement of identity.
    (g) Labeling information required in Secs. 317.313, 317.354, 
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is

[[Page 212]]

not otherwise specified, is required to be in letters and/or numbers no 
less than \1/16\ inch in height, except as permitted by 
Sec. 317.400(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec. 317.309 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a statement 
about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is consistent with a 
definition for a claim, as provided in subpart B of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 10 
g of fat per serving;''
    (2) The use of the statement on the product implicitly characterizes 
the level of the nutrient in the product and is not consistent with such 
a definition, but the label carries a disclaimer adjacent to the 
statement that the product is not ``low'' in or a ``good source'' of the 
nutrient, such as ``only 200 milligrams (mg) sodium per serving, not a 
low sodium product.'' The disclaimer must be in easily legible print or 
type and in a size no less than required by Sec. 317.2(h) for the net 
quantity of contents, except where the size of the claim is less than 
two times the required size of the net quantity of contents statement, 
in which case the disclaimer statement shall be no less than one-half 
the size of the claim but no smaller than \1/16\-inch minimum height, 
except as permitted by Sec. 317.400(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec. 317.362(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
product. These statements shall be known as ``relative claims'' and 
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' 
claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a market 
leader. Firms using such a reference nutrient value as a basis for a 
claim, are required to provide specific information upon which the 
nutrient value was derived, on request, to consumers and appropriate 
regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' and 
``more'' claims, the reference product may be the same as that provided 
for ``light'' in paragraph (j)(1)(ii)(A) of this section or it may be 
the manufacturer's regular product, or that of another manufacturer, 
that has been offered for sale to the public on a regular basis for a 
substantial period of time in the same geographic area by the same 
business entity or by one entitled to use its trade name, provided the 
name of the competitor is not used on the labeling of the product. The 
nutrient values used to determine the claim when comparing a single 
manufacturer's product to the labeled product shall be either

[[Page 213]]

the values declared in nutrition labeling or the actual nutrient values, 
provided that the resulting labeling is internally consistent (i.e., 
that the values stated in the nutrition information, the nutrient values 
in the accompanying information, and the declaration of the percentage 
of nutrient by which the product has been modified are consistent and 
will not cause consumer confusion when compared), and that the actual 
modification is at least equal to the percentage specified in the 
definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by which the nutrient has been modified, (e.g., 
``50 percent less fat than `reference product' '' or ``\1/3\ fewer 
calories than `reference product' ''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec. 317.2(h) for net quantity of contents, except where the 
size of the claim is less than two times the required size of the net 
quantity of contents statement, in which case the referral statement 
shall be no less than one-half the size of the claim, but no smaller 
than \1/16\-inch minimum height, except as permitted by 
Sec. 317.400(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the statement 
of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the requirement for a ``low'' claim for that 
nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat `product' 
''). This statement of identity must be immediately followed by the 
comparative statement such as ``contains 35 percent less fat than 
`reference product'.'' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
    (l) For purposes of making a claim, a ``meal-type product'' shall be 
defined as a product that:
    (1) Makes a significant contribution to the diet by weighing at 
least 6 ounces, but no more than 12 ounces per serving (container), and
    (2) Contains ingredients from two or more of the following four food 
groups:
    (i) Bread, cereal, rice and pasta group,
    (ii) Fruits and vegetables group,
    (iii) Milk, yogurt, and cheese group, and
    (iv) Meat, poultry, fish, dry beans, eggs, and nuts group, and
    (3) Is represented as, or is in a form commonly understood to be a 
breakfast, lunch, dinner, meal, main dish, entree, or pizza. Such 
representations may be made either by statements, photographs, or 
vignettes.
    (m) [Reserved]
    (n) Nutrition labeling in accordance with Sec. 317.309, shall be 
provided for any food for which a nutrient content claim is made.
    (o) Compliance with requirements for nutrient content claims shall 
be in accordance with Sec. 317.309(h).
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec. 317.312(b) through

[[Page 214]]

(e) shall be used in determining whether a product meets the criteria 
for a nutrient content claim. If the serving size declared on the 
product label differs from the reference amount customarily consumed, 
and the amount of the nutrient contained in the labeled serving does not 
meet the maximum or minimum amount criterion in the definition for the 
descriptor for that nutrient, the claim shall be followed by the 
criteria for the claim as required by Sec. 317.312(f) (e.g., ``very low 
sodium, 35 mg or less per 55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec. 317.2(h) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the criteria statement shall be no less than one-half the size of the 
claim but no smaller than \1/16\-inch minimum height, except as 
permitted by Sec. 317.400(d)(2).
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that appear as part of a brand name that was in use prior to 
November 27, 1991, may continue to be used as part of that brand name, 
provided they are not false or misleading under section 1(n) of the Act 
(21 U.S.C. 601(n)(1)).
    (2) [Reserved]
    (3) A statement that describes the percentage of a vitamin or 
mineral in the food, including foods intended specifically for use by 
infants and children less than 2 years of age, in relation to a 
Reference Daily Intake (RDI) as defined in Sec. 317.309 may be made on 
the label or in the labeling of a food without a regulation authorizing 
such a claim for a specific vitamin or mineral.
    (4) The requirements of this section do not apply to infant formulas 
and medical foods, as described in 21 CFR 101.13(q)(4).
    (5) [Reserved]
    (6) Nutrient content claims that were part of the name of a product 
that was subject to a standard of identity as of November 27, 1991, are 
not subject to the requirements of paragraph (b) of this section whether 
or not they meet the definition of the descriptive term.
    (7) Implied nutrient content claims may be used as part of a brand 
name, provided that the use of the claim has been authorized by FSIS. 
Labeling applications requesting approval of such a claim may be 
submitted pursuant to Sec. 317.369.

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 
1, 1994; 60 FR 187, Jan. 3, 1995]



Secs. 317.314-317.342  [Reserved]



Sec. 317.343  Significant participation for voluntary nutrition labeling.

    (a) In evaluating significant participation for voluntary nutrition 
labeling, FSIS will consider only the major cuts of single-ingredient, 
raw meat products, as identified in Sec. 317.344, including those that 
have been previously frozen.
    (b) FSIS will judge a food retailer to be participating at a 
significant level if the retailer provides nutrition labeling 
information for at least 90 percent of the major cuts of single-
ingredient, raw meat products, listed in Sec. 317.344, that it sells, 
and if the nutrition label is consistent in content and format with the 
mandatory program, or nutrition information is displayed at point-of-
purchase in an approriate manner.
    (c) To determine whether there is significant participation by 
retailers under the voluntary nutrition labeling guidelines, FSIS will 
select a representative sample of companies allocated by type and size.
    (d) FSIS will find that significant participation by food retailers 
exists if at least 60 percent of all companies that are evaluated are 
participating in accordance with the guidelines.
    (e) FSIS will evaluate significant participation of the voluntary 
program every 2 years beginning in May 1995.
    (1) If significant participation is found, the voluntary nutrition 
labeling guidelines shall remain in effect.
    (2) If significant participation is not found, FSIS shall initiate 
rulemaking to require nutrition labeling on those products under the 
voluntary program.



Sec. 317.344  Identification of major cuts of meat products.

    The major cuts of single-ingredient, raw meat products are: Beef 
chuck

[[Page 215]]

blade roast, beef loin top loin steak, beef rib roast large end, beef 
round eye round steak, beef round top round steak, beef round tip roast, 
beef chuck arm pot roast, beef loin sirloin steak, beef round bottom 
round steak, beef brisket (whole, flat half, or point half), beef rib 
steak small end, beef loin tenderloin steak, ground beef regular without 
added seasonings, ground beef about 17% fat, pork loin chop, pork loin 
country style ribs, pork loin top loin chop boneless, pork loin rib 
chop, pork spareribs, pork loin tenderloin, pork loin sirloin roast, 
pork shoulder blade steak, pork loin top roast boneless, ground pork, 
lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb rib 
roast, lamb loin chop, lamb leg (whole, sirloin half, or shank half), 
veal shoulder arm steak, veal shoulder blade steak, veal rib roast, veal 
loin chop, and veal cutlets.

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994]



Sec. 317.345  Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    (a) Nutrition information on the cuts of single-ingredient, raw meat 
products, including those that have been previously frozen, shall be 
provided in the following manner:
    (1) If a retailer or manufacturer chooses to provide nutrition 
information on the label of these products, these products shall be 
subject to all requirements of the mandatory nutrition labeling program, 
except that nutrition labeling may be declared on the basis of either 
``as consumed'' or ``as packaged.'' In addition, the declaration of the 
number of servings per container need not be included in nutrition 
labeling of single-ingredient, raw meat products (including ground 
beef), including those that have been previously frozen.
    (2) A retailer may choose to provide nutrition information at the 
point-of-purchase, such as by posting a sign, or by making the 
information readily available in brochures, notebooks, or leaflet form 
in close proximity to the food. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media. If 
a nutrition claim is made on point-of-purchase materials all of the 
requirements of the mandatory nutrition labeling program apply. However, 
if only nutrition information--and not a nutrition claim--is supplied on 
point-of-purchase materials:
    (i) The requirements of the mandatory nutrition labeling program 
apply, but the nutrition information may be supplied on an ``as 
packaged'' or ``as consumed,'' basis;
    (ii) The listing of percent of Daily Value for the nutrients (except 
vitamins and minerals specified in Sec. 317.309(c)(8)) and footnote 
required by Sec. 317.309(d)(9) may be omitted; and
    (iii) The point-of-purchase materials are not subject to any of the 
format requirements.
    (b) [Reserved]
    (c) The declaration of nutrition information may be presented in a 
simplified format as specified in Sec. 317.309(f) for the mandatory 
nutrition labeling program.
    (d) The nutrition label data should be based on either the raw or 
cooked edible portions of meat cuts with external cover fat at trim 
levels reflecting current marketing practices. If data are based on 
cooked portions, the methods used to cook the products must be specified 
and should be those which do not add nutrients from other ingredients 
such as flour, breading, and salt. Additional nutritional data may be 
presented on an optional basis for the raw or cooked edible portions of 
the separable lean of meat cuts.
    (e) Nutrient data that are the most current representative data base 
values contained in USDA's National Nutrient Data Bank or its published 
form, the Agriculture Handbook No. 8 series, may be used for nutrition 
labeling of single-ingredient, raw meat products (including ground 
beef), including those that have been previously frozen. These data may 
be composite data that reflect different quality grades of beef or other 
variables affecting nutrient content. Alternatively, data that reflect 
specific grades or other variables may be used, except that if data are 
used on labels attached to a product which is labeled as to grade of 
meat or other variables, the data must represent the product in the 
package when

[[Page 216]]

such data are contained in the representative data base. When data are 
used on labels attached to a product, the data must represent the edible 
meat tissues present in the package.
    (f) If the nutrition information is in accordance with paragraph (e) 
of this section, a nutrition label or labeling will not be subject to 
the Agency compliance review under Sec. 317.309(h), unless a nutrition 
claim is made on the basis of the representative data base values.
    (g) Retailers may use data bases that they believe reflect the 
nutrient content of single-ingredient, raw meat products (including 
ground beef), including those that have been previously frozen; however, 
such labeling shall be subject to the compliance procedures of paragraph 
(e) of this section and the requirements specified in this subpart for 
the mandatory nutrition labeling program.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 
FR 189, Jan. 3, 1995]



Secs. 317.346-317.353  [Reserved]



Sec. 317.354  Nutrient content claims for ``good source,'' ``high,'' and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a product in 
relation to the Reference Daily Intake (RDI) or Daily Reference Value 
(DRV) established for that nutrient (excluding total carbohydrate) in 
Sec. 317.309(c), may only be made on the label or in labeling of the 
product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in labeling of 
products, except meal-type products as defined in Sec. 317.313(l), 
provided that the product contains 20 percent or more of the RDI or the 
DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of broccoli in this meal is 
high in vitamin C'').
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling of 
products, except meal-type products as described in Sec. 317.313(l), 
provided that the product contains 10 to 19 percent of the RDI or the 
DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of sweet potatoes in this meal 
is a good source of fiber'').
    (d) Fiber claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, i.e., that the product is high in 
fiber, a good source of fiber, or that the product contains ``more'' 
fiber, and the product is not ``low'' in total fat as defined in 
Sec. 317.362(b)(2) or, in the case of a meal-type product, is not 
``low'' in total fat as defined in Sec. 317.362(b)(3), then the labeling 
shall disclose the level of total fat per labeled serving size (e.g., 
``contains 12 grams (g) of fat per serving''); and
    (2) The disclosure shall appear in immediate proximity to such claim 
and be in a type size no less than one-half the size of the claim.
    (e) ``More'' claims. (1) A relative claim using the terms ``more'' 
and ``added'' may be used on the label or in labeling to describe the 
level of protein, vitamins, minerals, dietary fiber, or potassium in a 
product, except meal-type

[[Page 217]]

products as defined in Sec. 317.313(l), provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per reference amount 
customarily consumed than an appropriate reference product as described 
in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than `reference 
product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 1 g per serving; `this product' contains 4 g per serving'').
    (2) A relative claim using the terms ``more'' and ``added'' may be 
used on the label or in labeling to describe the level of protein, 
vitamins, minerals, dietary fiber, or potassium in meal-type products as 
defined in Sec. 317.313(l), provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per 100 g of product than an 
appropriate reference product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 ounces 
(oz) than does `reference product' ''), and
    (B) Quantitative information comparing the level of the nutrient in 
the meal-type product per specified weight with that of the reference 
product that it replaces is declared adjacent to the most prominent 
claim or to the nutrition information (e.g., ``fiber content of 
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3 
oz'').

[60 FR 189, Jan. 3, 1995]



Sec. 317.355  [Reserved]



Sec. 317.356  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the terms ``light'' or 
``lite'' to describe a product may only be made on the label or in 
labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in labeling of products, except meal-type products as 
defined in Sec. 317.313(l), without further qualification, provided 
that:
    (1) If the product derives 50 percent or more of its calories from 
fat, its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to an appropriate reference product 
as described in Sec. 317.313(j)(1); or
    (2) If the product derives less than 50 percent of its calories from 
fat:
    (i) The number of calories is reduced by at least one-third (33\1/3\ 
percent) per reference amount customarily consumed compared to an 
appropriate reference product as described in Sec. 317.313(j)(1); or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (3) As required in Sec. 317.313(j)(2) for relative claims:
    (i) The identity of the reference product and the percent (or 
fraction) that the calories and the fat were reduced are declared in 
immediate proximity to the most prominent such claim (e.g.,

[[Page 218]]

``\1/3\ fewer calories and 50 percent less fat than the market 
leader''); and
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference product that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
    (iii) If the labeled product contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a product for which the 
reference product meets the definition of ``low fat'' and ``low 
calorie.''
    (c)(1)(i) A product for which the reference product contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the terms ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference product; and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``lite `this product'--500 milligrams (mg) sodium per 
serving; regular `reference product'--1,000 mg sodium per serving'').
    (2)(i) A product for which the reference product contains more than 
40 calories or more than 3 g fat per reference amount customarily 
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if 
it is reduced by 50 percent or more in sodium content compared to the 
reference product, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., or ``lite `this product'--170 mg sodium per serving; 
regular `reference product'--350 mg per serving'').
    (3) Except for meal-type products as defined in Sec. 317.313(l), a 
``light in sodium'' claim may not be made on a product for which the 
reference product meets the definition of ``low in sodium.''
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in labeling of a meal-type product as defined in Sec. 317.313(l), 
provided that:
    (i) The product meets the definition of:
    (A) ``Low in calories'' as defined in Sec. 317.360(b)(3); or
    (B) ``Low in fat'' as defined in Sec. 317.362(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that the product meets the definition of ``low 
in sodium'' as defined in Sec. 317.361(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (3) The term ``light'' or ``lite'' may be used in the brand name of 
a product to describe the sodium content, provided that:

[[Page 219]]

    (i) The product is reduced by 50 percent or more in sodium content 
compared to the reference product;
    (ii) A statement specifically stating that the product is ``light in 
sodium'' or ``lite in sodium'' appears:
    (A) Contiguous to the brand name; and
    (B) In uniform type size, style, color, and prominence as the 
product name; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim; and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the terms ``light'' or ``lite'' may not be used to refer to a 
product that is not reduced in fat by 50 percent, or, if applicable, in 
calories by \1/3\ or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the 
product such as texture or color and the information (e.g., ``light in 
color'' or ``light in texture'') so stated, clearly conveys the nature 
of the product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular product to 
reflect a physical or organoleptic attribute to the point where it has 
become part of the statement of identity, such use of the term ``light'' 
shall not be considered a nutrient content claim subject to the 
requirements in this part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference product as described in Sec. 317.313(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec. 317.361(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition information and the information 
required to accompany a relative claim shall appear on the label or 
labeling as specified in Sec. 317.313(j)(2).

[60 FR 189, Jan. 3, 1995]



Secs. 317.357-317.359  [Reserved]



Sec. 317.360  Nutrient content claims for calorie content.

    (a) General requirements. A claim about the calorie or sugar content 
of a product may only be made on the label or in labeling of the product 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietarily insignificant source of calories'' may be used on the label 
or in labeling of products, provided that:
    (i) The product contains less than 5 calories per reference amount 
customarily consumed and per labeled serving size; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in calories'' 
may be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 317.313(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does 
not provide

[[Page 220]]

more than 40 calories per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and does not provide more than 40 calories per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 120 calories or less per 100 g of product; 
and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in labeling of products, 
except meal-type products as defined in Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., lower 
calorie `product'--``33\1/3\ percent fewer calories than our regular 
`product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 150 
to 100 calories per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent fewer calories per 100 
g of product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``calorie 
reduced `product', 25% less calories per ounce (oz) (or 3 oz) than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 110 
calories per 3 oz to 80 calories per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of products if the reference product 
meets the definition for ``low calorie.''
    (c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free 
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably 
be expected to be regarded by consumers as terms that represent that the 
product contains no sugars or sweeteners, e.g.,

[[Page 221]]

``sugar free,'' or ``no sugar,'' as indicating a product which is low in 
calories or significantly reduced in calories. Consequently, except as 
provided in paragraph (c)(2) of this section, a product may not be 
labeled with such terms unless:
    (i) The product contains less than 0.5 g of sugars, as defined in 
Sec. 317.309(c)(6)(ii), per reference amount customarily consumed and 
per labeled serving size or, in the case of a meal-type product, less 
than 0.5 g of sugars per labeled serving size;
    (ii) The product contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible 
amount of sugar,'' or ``adds a dietarily insignificant amount of 
sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie product,'' ``not a low 
calorie product,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec. 317.309(c)(6)(ii), or 
any other ingredient that contains sugars that functionally substitute 
for added sugars is added during processing or packaging;
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice;
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a product, and a functionally 
insignificant increase in sugars results;
    (iv) The product that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the product is not ``low 
calorie'' or ``calorie reduced'' (unless the product meets the 
requirements for a ``low'' or ``reduced calorie'' product) and that 
directs consumers' attention to the nutrition panel for further 
information on sugar and calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a product, including products intended specifically for 
infants and children less than 2 years of age, is unsweetened or 
contains no added sweeteners in the case of a product that contains 
apparent substantial inherent sugar content, e.g., juices.
    (4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less sugars per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``this 
product contains 25 percent less sugar than our regular product''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been lowered from 8 g 
to 6 g per serving'').
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less sugars per 100 g 
of product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:

[[Page 222]]

    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sugar `product'--25% less sugar than our regular `product' ''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sugar content has been reduced from 17 g 
per 3 oz to 13 g per 3 oz'').

[60 FR 191, Jan. 3, 1995]



Sec. 317.361  Nutrient content claims for the sodium content.

    (a) General requirements. A claim about the level of sodium in a 
product may only be made on the label or in labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietarily 
insignificant source of sodium'' may be used on the label or in labeling 
of products, provided that:
    (i) The product contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product, less than 5 mg of sodium per labeled 
serving size;
    (ii) The product contains no ingredient that is sodium chloride or 
is generally understood by consumers to contain sodium unless the 
listing of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible 
amount of sodium'' or ``adds a dietarily insignificant amount of 
sodium''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``very low sodium'' or ``very low in sodium'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec. 317.313(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and 
contains 35 mg or less sodium per reference amount customarily consumed; 
or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,'' 
``contains a small amount of sodium,'' or ``low source of sodium'' may 
be used on the

[[Page 223]]

label and in labeling of products, except meal-type products as defined 
in Sec. 317.313(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 140 mg or less sodium per 100 g of product; 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may 
be used on the label or in labeling of products, except meal-type 
products as defined in Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less sodium per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product', 50 percent less sodium than regular `product' ''); and
    (B) Quantitative information comparing the level of sodium in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been lowered from 300 
to 150 mg per serving'').
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (7) The terms defined in paragraph (b)(6) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less sodium per 100 g 
of product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``reduced 
sodium `product'--30% less sodium per 3 oz than our `regular product' 
''); and
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in labeling of products if the nutrient content 
of the reference product meets the definition for ``low sodium.''

[[Page 224]]

    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers 
to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of products only if the product is ``sodium free'' as defined in 
paragraph (b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of products only if:
    (i) No salt is added during processing;
    (ii) The product that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the product is not sodium free, the statement, ``not a 
sodium free product'' or ``not for control of sodium in the diet'' 
appears adjacent to the nutrition information of the product bearing the 
claim.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a product intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the product and is not false or otherwise misleading.

[60 FR 192, Jan. 3, 1995]



Sec. 317.362  Nutrient content claims for fat, fatty acids, and cholesterol content.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a product may only be made on the label or in 
labeling of products if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 317.313; and
    (3) The product for which the claim is made is labeled in accordance 
with Sec. 317.309.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 
``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial source 
of fat,'' ``negligible source of fat,'' or ``dietarily insignificant 
source of fat'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 0.5 gram (g) of fat per reference 
amount customarily consumed and per labeled serving size or, in the case 
of a meal-type product, less than 0.5 g of fat per labeled serving size;
    (ii) The product contains no added ingredient that is a fat or is 
generally understood by consumers to contain fat unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of 
fat,'' or ``adds a dietarily insignificant amount of fat''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount 
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the 
label and in labeling of products, except meal-type products as defined 
in Sec. 317.313(l), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 
or less of fat per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 3 g or less of fat per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), of 
all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the

[[Page 225]]

particular brand to which the label attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 3 g or less of total fat per 100 g of 
product and not more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference product as 
described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat--50 percent less fat than our regular `product' ''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving size with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g to 
4 g per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less fat per 100 g of 
product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat `product', 33 percent less fat per 3 oz than our regular `product' 
''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent such claim or to the 
nutrition information (e.g., ``fat content has been reduced from 8 g per 
3 oz to 5 g per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low fat.''
    (6) The term ``______ percent fat free'' may be used on the label or 
in labeling of products, provided that:
    (i) The product meets the criteria for ``low fat'' in paragraph 
(b)(2) or (b)(3) of this section;
    (ii) The percent declared and the words ``fat free'' are in uniform 
type size; and
    (iii) A ``100 percent fat free'' claim may be made only on products 
that meet the criteria for ``fat free'' in paragraph (b)(1) of this 
section, that contain less than 0.5 g of fat per 100 g, and that contain 
no added fat.
    (iv) A synonym for ``______ percent fat free'' is ``______ percent 
lean.''
    (c) Fatty acid content claims. (1) The terms ``saturated fat free,'' 
``free of saturated fat,'' ``no saturated fat,'' ``zero saturated fat,'' 
``without saturated fat,'' ``trivial source of saturated fat,'' 
``negligible source of saturated fat,'' or ``dietarily insignificant 
source of saturated fat'' may be used on the label or in labeling of 
products, provided that:
    (i) The product contains less than 0.5 g of saturated fat and less 
than 0.5 g trans fatty acids per reference amount customarily consumed 
and per labeled

[[Page 226]]

serving size or, in the case of a meal-type product, less than 0.5 g of 
saturated fat and less than 0.5 g trans fatty acids per labeled serving 
size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain saturated fat unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of saturated fat,'' ``adds a negligible amount 
of saturated fat,'' or ``adds a dietarily insignificant amount of 
saturated fat;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' or ``a little saturated fat'' may be used on the label or in 
labeling of products, except meal-type products as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 1 g or less of saturated fat per reference 
amount customarily consumed and not more than 15 percent of calories 
from saturated fat; and
    (ii) If the product meets these conditions without benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 1 g or less of saturated fat per 100 g and 
less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in labeling of products, except meal-type products as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', contains 50 percent less saturated 
fat than the national average for `product' ''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 
g per serving'').
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains at least 25 percent less saturated fat per 
100 g of product than an appropriate reference product as described in 
Sec. 317.313(j)(1); and
    (ii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat

[[Page 227]]

`product','' ``50 percent less saturated fat than our regular `product' 
''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``saturated fat content has been reduced 
from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient content 
of the reference product meets the definition for ``low saturated fat.''
    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible 
source of cholesterol,'' or ``dietarily insignificant source of 
cholesterol'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 2 milligrams (mg) of cholesterol 
per reference amount customarily consumed and per labeled serving size 
or, in the case of a meal-type product as defined in Sec. 317.313(l), 
less than 2 mg of cholesterol per labeled serving size;
    (ii) The product contains no ingredient that is generally understood 
by consumers to contain cholesterol, unless the listing of the 
ingredient in the ingredients statement is followed by an asterisk that 
refers to the statement below the list of ingredients, which states: 
``Adds a trivial amount of cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol'';
    (iii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed or, in the case of a meal-type 
product as defined in Sec. 317.313(l), 2 g or less of saturated fat per 
labeled serving size; and
    (iv) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches; or
    (v) If the product meets these conditions only as a result of 
special processing, alteration, formulation, or reformulation, the 
amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and for 
which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``cholesterol free 
`product', contains 100 percent less cholesterol than `reference 
product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``contains no cholesterol compared with 
30 mg in one serving of `reference product' '').
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
labeling of products, except meal-type products as defined in 
Sec. 317.313(l), provided that:
    (i)(A) If the product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed; and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; or
    (B) If the product has a reference amount customarily consumed of 30 
g or less or 2 tbsp or less:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), of 
all nutrients per reference amount customarily consumed, the per-50-g 
criterion refers to the ``as prepared'' form); and

[[Page 228]]

    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed.
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches; or
    (iii) If the product contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and for 
which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``low 
cholesterol `product', contains 85 percent less cholesterol than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 
mg per serving'').
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product contains 20 mg or less of cholesterol per 100 g of 
product;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' may be used on the label or in labeling of 
products or products that substitute for those products as specified in 
Sec. 317.313(d), excluding meal-type products as defined in 
Sec. 317.313(l), provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and for 
which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25 percent 
less cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 
mg per serving'').
    (iv) Claims described in paragraph (d)(4) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec. 317.313(l), provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec. 317.313(j)(1) and for 
which it substitutes as described in Sec. 317.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;

[[Page 229]]

    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) As required in Sec. 317.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference product that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``cholesterol content has been reduced from 
35 mg per 3 oz to 25 mg per 3 oz).
    (iv) Claims described in paragraph (d)(5) of this section may not be 
made on the label or in labeling of a product if the nutrient content of 
the reference product meets the definition for ``low cholesterol.''
    (e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may be 
used on the label or in labeling of a product, provided that the product 
contains less than 10 g of fat, 4.5 g or less of saturated fat, and less 
than 95 mg of cholesterol per 100 g of product and per reference amount 
customarily consumed for individual foods, and per 100 g of product and 
per labeled serving size for meal-type products as defined in 
Sec. 317.313(l).
    (2) The term ``extra lean'' may be used on the label or in labeling 
of a product, provided that the product contains less than 5 g of fat, 
less than 2 g of saturated fat, and less than 95 mg of cholesterol per 
100 g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined in Sec. 317.313(l).

[60 FR 193, Jan. 3, 1995]



Sec. 317.363  Nutrient content claims for ``healthy.''

    (a) The term ``healthy,'' or any other derivative of the term 
``health,'' may be used on the labeling of any meat or meat food 
product, provided that the product is labeled in accordance with 
Sec. 317.309 and Sec. 317.313.
    (b)(1) The product shall meet the requirements for ``low fat'' and 
``low saturated fat,'' as defined in Sec. 317.362, except that single-
ingredient, raw products may meet the total fat and saturated fat 
criteria for ``extra lean'' in Sec. 317.362.
    (2) The product shall not contain more than 60 milligrams (mg) of 
cholesterol per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 
g, and, for dehydrated products that must be reconstituted with water or 
a diluent containing an insignificant amount, as defined in 
Sec. 317.309(f)(1), of all nutrients, the per-50-g criterion refers to 
the prepared form, except that:
    (i) A meal-type product, as defined in Sec. 317.313(l), and 
including meal-type products that weigh more than 12 ounces (oz) per 
serving (container), shall not contain more than 90 mg of cholesterol 
per labeled serving size; and
    (ii) Single-ingredient, raw products may meet the cholesterol 
criterion for ``extra lean''in Sec. 317.362.
    (3) The product shall not contain more than 360 mg of sodium, except 
that it shall not contain more than 480 mg of sodium effective through 
January 1, 2003, per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for 
dehydrated products that must be reconstituted with water or a diluent 
containing an insignificant amount, as defined in Sec. 317.309(f)(1), of 
all nutrients, the per-50-g criterion refers to the prepared form, 
except that:
    (i) A meal-type product, as defined in Sec. 317.313(l), and 
including meal-type products that weigh more than 12 oz per serving 
(container), shall not contain more than 480 mg of sodium, except that 
it shall not contain more than 600 mg of sodium effective through 
January 1, 2003, per labeled serving size; and

[[Page 230]]

    (ii) The requirements of this paragraph (b)(3) do not apply to 
single-ingredient, raw products.
    (4) The product shall contain 10 percent or more of the Reference 
Daily Intake or Daily Reference Value as defined in Sec. 317.309 for 
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference 
amount customarily consumed prior to any nutrient addition, except that:
    (i) A meal-type product, as defined in Sec. 317.313(l), and 
including meal-type products that weigh at least 6 oz but less than 10 
oz per serving (container), shall meet the level for two of the 
nutrients per labeled serving size; and
    (ii) A meal-type product, as defined in Sec. 317.313(l), and 
including meal-type products that weigh 10 oz or more per serving 
(container), shall meet the level for three of the nutrients per labeled 
serving size.

[59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 
7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999]



Secs. 317.364-317.368  [Reserved]



Sec. 317.369  Labeling applications for nutrient content claims.

    (a) This section pertains to labeling applications for claims, 
express or implied, that characterize the level of any nutrient required 
to be on the label or in labeling of product by this subpart.
    (b) Labeling applications included in this section are:
    (1) Labeling applications for a new (heretofore unauthorized) 
nutrient content claim,
    (2) Labeling applications for a synonymous term (i.e., one that is 
consistent with a term defined by regulation) for characterizing the 
level of a nutrient, and
    (3) Labeling applications for the use of an implied claim in a brand 
name.
    (c) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (d) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and Inspection 
Service. However, any reference to unpublished information furnished by 
a person other than the applicant will not be considered unless use of 
such information is authorized (with the understanding that such 
information may in whole or part be subject to release to the public) in 
a written statement signed by the person who submitted it. Any reference 
to published information should be accompanied by reprints or 
photostatic copies of such references.
    (e) If nonclinical laboratory studies accompany a labeling 
application, the applicant shall include, with respect to each 
nonclinical study included with the application, either a statement that 
the study has been, or will be, conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of chapter 1, 
title 21, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (f) If clinical investigations accompany a labeling application, the 
applicant shall include, with respect to each clinical investigation 
included with the application, either a statement that the investigation 
was conducted in compliance with the requirements for institutional 
review set forth in part 56 of chapter 1, title 21, or was not subject 
to such requirements in accordance with Sec. 56.194 or Sec. 56.105, and 
that it was conducted in compliance with the requirements for informed 
consents set forth in part 50 of chapter 1, title 21.
    (g) The availability for public disclosure of labeling applications, 
along with supporting documentation, submitted to the Agency under this 
section will be governed by the rules specified in subchapter D, title 
9.
    (h) The data specified under this section to accompany a labeling 
application shall be submitted on separate sheets, suitably identified. 
If such data has already been submitted with an earlier labeling 
application from the

[[Page 231]]

applicant, the present labeling application must provide the data.
    (i) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (j) The labeling application shall include a statement signed by the 
person responsible for the labeling application, that to the best of his 
or her knowledge, it is a representative and balanced submission that 
includes unfavorable information, as well as favorable information, 
known to him or her pertinent to the evaluation of the labeling 
application.
    (k)(1) Labeling applications for a new nutrient content claim shall 
be accompanied by the following data which shall be submitted in the 
following form to the Director, Food Labeling Division, Regulatory 
Programs, Food Safety and Inspection Service, Washington, DC 20250.

_______________________________________________________________________
(Date)

    The undersigned, __________, submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the claim and 
its proposed use).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the nutrient content claim and the 
nutrient that the term is intended to characterize with respect to the 
level of such nutrient. The statement shall address why the use of the 
term as proposed will not be misleading. The statement shall provide 
examples of the nutrient content claim as it will be used on labels or 
labeling, as well as the types of products on which the claim will be 
used. The statement shall also specify the level at which the nutrient 
must be present or what other conditions concerning the product must be 
met for the appropriate use of the term in labels or labeling, as well 
as any factors that would make the use of the term inappropriate.
    (ii) A detailed explanation supported by any necessary data of why 
use of the food component characterized by the claim is of importance in 
human nutrition by virtue of its presence or absence at the levels that 
such claim would describe. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed and why such benefit is not available through the use of 
existing terms defined by regulation. If the claim is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group, and scientific data sufficient 
for such purpose, and data and information to the extent necessary to 
demonstrate that consumers can be expected to understand the meaning of 
the term under the proposed conditions of use.
    (iii) Analytical data that demonstrates the amount of the nutrient 
that is present in the products for which the claim is intended. The 
assays should be performed on representative samples in accordance with 
317.309(h). If no USDA or AOAC methods are available, the applicant 
shall submit the assay method used, and data establishing the validity 
of the method for assaying the nutrient in the particular food. The 
validation data shall include a statistical analysis of the analytical 
and product variability.
    (iv) A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption, and any corresponding changes in 
nutrient intake. The analysis shall specifically address the intake of 
nutrients that have beneficial and negative consequences in the total 
diet. If the claim is intended for a specific group within the 
population, the analysis shall specifically address the dietary 
practices of such group, and shall include data sufficient to 
demonstrate that the dietary analysis is representative of such group.

      Yours very truly,

      Applicant_________________________________________________________

      By________________________________________________________________
            (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
nutrient content claim is false or misleading. The notification letter

[[Page 232]]

shall inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the proposed 
nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register a 
proposed rule to amend the regulations to authorize the use of the 
nutrient content claim. The proposal shall also summarize the labeling 
application, including where the supporting documentation can be 
reviewed. The Administrator's proposed rule shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
proposed nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a determination 
on whether the proposed nutrient content claim shall be approved for use 
on the labeling of meat and meat food products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed nutrient 
content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make final determination for the Secretary. Any such 
determination by the Secretary shall be conclusive unless, within 30 
days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
final rule amending the regulations to authorize the use of the claim.
    (l)(1) Labeling applications for a synonymous term shall be 
accompanied by

[[Page 233]]

the following data which shall be submitted in the following form to the 
Director, Food Labeling Division, Regulatory Programs, Food Safety and 
Inspection Service, Washington, DC 20250:

_______________________________________________________________________
(Date)

    The undersigned, ____________ submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the synonymous 
term and its proposed use in a nutrient content claim that is consistent 
with an existing term that has been defined under subpart B of part 
317).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the synonymous term, the existing term 
defined by a regulation with which the synonymous term is claimed to be 
consistent, and the nutrient that the term is intended to characterize 
the level of. The statement shall address why the use of the synonymous 
term as proposed will not be misleading. The statement shall provide 
examples of the nutrient content claim as it will be used on labels or 
labeling, as well as the types of products on which the claim will be 
used. The statement shall also specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed term is requested, including whether the existing 
defined term is inadequate for the purpose of effectively characterizing 
the level of a nutrient. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed, and why such benefit is not available through the use of 
existing terms defined by regulation. If the claim is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group, scientific data sufficient for 
such purpose, and data and information to the extent necessary to 
demonstrate that consumers can be expected to understand the meaning of 
the term under the proposed conditions of use.

      Yours very truly,

      Applicant_________________________________________________________

      By________________________________________________________________
            (Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
synonymous term is false or misleading. The notification letter shall 
inform the applicant that the applicant may submit a written statement 
by way of answer to the notification, and that the applicant shall have 
the right to request a hearing with respect to the merits or validity of 
the Administrator's decision to deny the use of the proposed synonymous 
term.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the claim is approved, the Agency shall notify the applicant, 
in writing, and shall publish in the Federal

[[Page 234]]

Register a notice informing the public that the synonymous term has been 
approved for use.
    (m)(1) Labeling applications for the use of an implied nutrient 
content claim in a brand name shall be accompanied by the following data 
which shall be submitted in the following form to the Director, Food 
Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, Washington, DC 20250:

_______________________________________________________________________
(Date)

    The undersigned, ____________ submits this labeling application 
pursuant to 9 CFR 317.369 with respect to (statement of the implied 
nutrient content claim and its proposed use in a brand name).
    Attached hereto, in quadruplicate, or on a computer disc copy, and 
constituting a part of this labeling application, are the following:
    (i) A statement identifying the implied nutrient content claim, the 
nutrient the claim is intended to characterize, the corresponding term 
for characterizing the level of such nutrient as defined by a 
regulation, and the brand name of which the implied claim is intended to 
be a part. The statement shall address why the use of the brand-name as 
proposed will not be misleading. The statement shall provide examples of 
the types of products on which the brand name will appear. It shall also 
include data showing that the actual level of the nutrient in the food 
would qualify the label of the product to bear the corresponding term 
defined by regulation. Assay methods used to determine the level of a 
nutrient shall meet the requirements stated under labeling application 
format in paragraph (k)(1)(iii) of this section.
    (ii) A detailed explanation supported by any necessary data of why 
use of the proposed brand name is requested. This explanation shall also 
state what nutritional benefit to the public will derive from use of the 
brand name as proposed. If the branded product is intended for a 
specific group within the population, the analysis shall specifically 
address nutritional needs of such group and scientific data sufficient 
for such purpose.

      Yours very truly,

      Applicant_________________________________________________________

      By________________________________________________________________

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall inform 
the applicant that the labeling application is undergoing Agency review 
and that the applicant shall subsequently be notified of the Agency's 
decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
implied nutrient content claim is false or misleading. The notification 
letter shall inform the applicant that the applicant may submit a 
written statement by way of answer to the notification, and that the 
applicant shall have the right to request a hearing with respect to the 
merits or validity of the Administrator's decision to deny the use of 
the proposed implied nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.

[[Page 235]]

    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish a notice of the labeling 
application in the Federal Register seeking comment on the use of the 
implied nutrient content claim. The notice shall also summarize the 
labeling application, including where the supporting documentation can 
be reviewed. The Administrator's notice shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
implied nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a determination 
on whether the implied nutrient content claim shall be approved for use 
on the labeling of meat food products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, including 
the reason why the claim on the labeling was determined by the Agency to 
be false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed implied 
nutrient content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
notice informing the public that the implied nutrient content claim has 
been approved for use.


(Paperwork requirements were approved by the Office of Management and 
Budget under control number 0583-0088)

[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60 
FR 196, Jan. 3, 1995]



Secs. 317.370-317.379  [Reserved]



Sec. 317.380  Label statements relating to usefulness in reducing or maintaining body weight.

    (a) General requirements. Any product that purports to be or is 
represented for special dietary use because of usefulness in reducing 
body weight shall bear:
    (1) Nutrition labeling in conformity with Sec. 317.309 of this 
subpart, unless exempt under that section, and
    (2) A conspicuous statement of the basis upon which the product 
claims to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any product subject to paragraph 
(a) of this section that achieves its special dietary usefulness by use 
of a nonnutritive ingredient (i.e., one not utilized in normal 
metabolism) shall bear on its label a statement that it contains a 
nonnutritive ingredient and the percentage by weight of the nonnutritive 
ingredient.
    (2) A special dietary product may contain a nonnutritive sweetener 
or other ingredient only if the ingredient is safe for use in the 
product under the applicable law and regulations of this chapter. Any 
product that achieves its special dietary usefulness in reducing or 
maintaining body weight through the use of a nonnutritive sweetener 
shall bear on its label the statement required by paragraph (b)(1) of 
this section, but need not state the percentage by weight of the 
nonnutritive sweetener. If a nutritive sweetener(s) as well

[[Page 236]]

as nonnutritive sweetener(s) is added, the statement shall indicate the 
presence of both types of sweetener; e.g., ``Sweetened with nutritive 
sweetener(s) and nonnutritive sweetener(s).''
    (c) ``Low calorie'' foods. A product purporting to be ``low 
calorie'' must comply with the criteria set forth for such foods in 
Sec. 317.360.
    (d) ``Reduced calorie'' foods and other comparative claims. A 
product purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such foods in Sec. 317.360(b) (4) and (5).
    (e) ``Label terms suggesting usefulness as low calorie or reduced 
calorie foods''. (1) Except as provided in paragraphs (e)(2) and (e)(3) 
of this section, a product may be labeled with terms such as ``diet,'' 
``dietetic,'' ``artificially sweetened,'' or ``sweetened with 
nonnutritive sweetener'' only if the claim is not false or misleading, 
and the product is labeled ``low calorie'' or ``reduced calorie'' or 
bears another comparative calorie claim in compliance with the 
applicable provisions in this subpart.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the product is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other product that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free'' and ``no added sugar''. Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec. 317.360(c).

[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 
FR 47627, Sept. 10, 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. 3, 
1995]



Secs. 317.381-317.399  [Reserved]



Sec. 317.400  Exemption from nutrition labeling.

    (a) The following meat or meat food products are exempt from 
nutrition labeling:
    (1) Food products produced by small businesses provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (i) A food product, for the purposes of the small business 
exemption, is defined as a formulation, not including distinct flavors 
which do not significantly alter the nutritional profile, sold in any 
size package in commerce.
    (ii) For purposes of this paragraph, a small business is any single-
plant facility or multi-plant company/firm that employs 500 or fewer 
people and produces no more than the following amounts of pounds of the 
product qualifying the firm for exemption from this subpart:
    (A) During the first year of implementation of nutrition labeling, 
from July 1994 to July 1995, 250,000 pounds or less,
    (B) During the second year of implementation of nutrition labeling, 
from July 1995 to July 1996, 175,000 pounds or less, and
    (C) During the third year of implementation and subsequent years 
thereafter, 100,000 pounds or less.
    (iii) For purposes of this paragraph, calculation of the amount of 
pounds shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years or where 
products have been produced for less than 2 years, reasonable estimates 
must indicate that the annual pounds produced will not exceed the 
amounts specified.
    (2) Products intended for further processing, provided that the 
labels for these products bear no nutrition claim or nutrition 
information,
    (3) Products that are not for sale to consumers, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (4) Products in small packages that are individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear

[[Page 237]]

no nutrition claims or nutrition information,
    (5) Products custom slaughtered or prepared,
    (6) Products intended for export, and
    (7) The following products prepared and served or sold at retail 
provided that the labels or the labeling of these products bear no 
nutrition claims or nutrition information:
    (i) Ready-to-eat products that are packaged or portioned at a retail 
store or similar retail-type establishment; and
    (ii) Multi-ingredient products (e.g., sausage) processed at a retail 
store or similar retail-type establishment.
    (b) Restaurant menus generally do not constitute labeling or fall 
within the scope of these regulations.
    (c)(1) Foods represented to be specifically for infants and children 
less than 2 years of age shall bear nutrition labeling as provided in 
paragraph (c)(2) of this section, except such labeling shall not include 
calories from fat, calories from saturated fat, saturated fat, stearic 
acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
    (2) Foods represented or purported to be specifically for infants 
and children less than 4 years of age shall bear nutrition labeling 
except that:
    (i) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (ii) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns;
    (iii) The heading ``Percent Daily Value'' required in 
Sec. 317.309(d)(6) shall be placed immediately below the quantitative 
information by weight for protein;
    (iv) The percent of the Daily Value for protein, vitamins, and 
minerals shall be listed immediately below the heading ``Percent Daily 
Value''; and
    (v) Such labeling shall not include the footnote specified in 
Sec. 317.309(d)(9).
    (d)(1) Products in packages that have a total surface area available 
to bear labeling of less than 12 square inches are exempt from nutrition 
labeling, provided that the labeling for these products bear no 
nutrition claims or other nutrition information. The manufacturer, 
packer, or distributor shall provide, on the label of packages that 
qualify for and use this exemption, an address or telephone number that 
a consumer can use to obtain the required nutrition information (e.g., 
``For nutrition information call 1-800-123-4567'').
    (2) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in a type size no smaller than 6 point 
or all upper case type of \1/16\-inch minimum height, except that 
individual serving-size packages of meat products that have a total area 
available to bear labeling of 3 square inches or less may provide all 
required information in a type size no smaller than \1/32\-inch minimum 
height.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 
FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]



PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents




                           Subpart A--General

Sec.
318.1  Products and other articles entering official establishments.
318.2  Reinspection, retention, and disposal of meat and poultry 
          products at official establishments.
318.3  Designation of places of receipt of products and other articles 
          for reinspection.
318.4  Preparation of products to be officially supervised; 
          responsibilities of official establishments; plant operated 
          quality control.
318.5  Requirements concerning procedures.
318.6  Requirements concerning ingredients and other articles used in 
          preparation of products.
318.7  Approval of substances for use in the preparation of products.
318.8  Preservatives and other substances permitted in product for 
          export only; handling; such product not to be used for 
          domestic food purposes.
318.9  Samples of products, water, dyes, chemicals, etc., to be taken 
          for examination.
318.10  Prescribed treatment of pork and products containing pork to 
          destroy trichinae.

[[Page 238]]

318.11  [Reserved]
318.12  Manufacture of dog food or similar uninspected article at 
          official establishments.
318.13  Mixtures containing product but not amendable to the Act.
318.14  Adulteration of product by polluted water; procedure for 
          handling.
318.15  Tagging chemicals, preservatives, cereals, spices, etc., ``U.S. 
          retained.''
318.16  Pesticide chemicals and other residues in products.
318.17  Requirements for the production of cooked beef, roast beef, and 
          cooked corned beef products.
318.18  Handling of certain material for mechanical processing.
318.19  Compliance procedure for cured pork products.
318.20  Use of animal drugs.
318.21  Accreditation of chemistry laboratories.
318.22  Determination of added water in cooked sausages.
318.23  Heat-processing and stabilization requirements for uncured meat 
          patties.
318.24  Compliance procedures for meat derived from advanced meat/bone 
          separation machinery and recovery systems.

Subparts B--F  [Reserved]

                 Subpart G--Canning and Canned Products

318.300  Definitions.
318.301  Containers and closures.
318.302  Thermal processing.
318.303  Critical factors and the application of the process schedule.
318.304  Operations in the thermal processing area.
318.305  Equipment and procedures for heat processing systems.
318.306  Processing and production records.
318.307  Record review and maintenance.
318.308  Deviations in processing.
318.309  Finished product inspection.
318.310  Personnel and training.
318.311  Recall procedure.

    Authority: 7 U.S.C. 38f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.



                           Subpart A--General

    Source: 35 FR 15586, Oct. 3, 1970, unless otherwise noted.



Sec. 318.1  Products and other articles entering official establishments.

    (a) Except as otherwise provided in paragraphs (g) and (h) of this 
section or Sec. 318.12, no product shall be brought into an official 
establishment unless it has been prepared only in an official 
establishment and previously inspected and passed by a Program employee, 
and is identified by an official inspection legend as so inspected and 
passed. Notwithstanding the foregoing provisions of this subparagraph, 
product imported in accordance with part 327 of this subchapter and not 
prepared in the United States outside an official establishment, may 
enter any official establishment subject in other respects to the same 
restrictions as apply to domestic product. Products received in an 
official establishment during the Program employees absence shall be 
identified and maintained in a manner acceptable to such employee. 
Product entering any official establishment shall not be used or 
prepared thereat until it has been reinspected in accordance with 
Sec. 318.2. Any product originally prepared at any official 
establishment may not be returned into any part of such establishment, 
except the receiving area approved under Sec. 318.3, until it has been 
reinspected by the inspector.
    (b) No slaughtered poultry or poultry product shall be brought into 
an official establishment unless it has been (1) previously inspected 
and passed and is identified as such in accordance with the requirements 
of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the 
regulations thereunder, and has not been prepared other than in an 
establishment inspected under said Act, or (2) has been inspected and 
passed and is identified as such in accordance with the requirements of 
a State law.
    (c) Every article for use as an ingredient in the preparation of 
meat food products, when entering any official establishment and at all 
times while it is in such establishment, shall bear a label showing the 
name of the article, the amount or percentage therein of any substances 
restricted by this part or part 317 of this subchapter, and a list of 
ingredients in the article if composed of two or more ingredients: 
Provided, That in the case of articles received in tank car lots, only 
one such label shall be used to identify each lot. In addition, the 
label must show the name and address of the shipper.
    (d) To ensure the safe use of preparations used in hog scalding 
water or in

[[Page 239]]

the denuding of tripe, the label or labeling on containers of such 
preparations shall bear adequate directions to ensure use in compliance 
with any limitations prescribed in 21 CFR Chapter I, Subchapter A or 
Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.
    (e) Dyes, chemicals, or other substances the use of which is 
restricted to certain products may be brought into or kept in an 
official establishment only if such products are prepared thereat. No 
prohibited dye, chemical, preservative, or other substance shall be 
brought into or kept in an official establishment.
    (f) [Reserved]
    (g) Glands and organs, such as cotyledons, ovaries, prostate glands, 
tonsils, spinal cords, and detached lymphatic, pineal, pituitary, 
parathyroid, suprarenal, pancreatic and thyroid glands, used in 
preparing pharmaceutical, organotherapeutic, or technical products and 
which are not used as human food (whether or not prepared at official 
establishments) may be brought into and stored in edible product 
departments of inspected establishments if packaged in suitable 
containers so that the presence of such glands and organ will in no way 
interfere with the maintenance of sanitary conditions or constitute an 
interference with inspection. Glands or organs which are regarded as 
human food products, such as livers, testicles, and thymus glands, may 
be brought into official establishments for pharmaceutical, 
organotherapeutic or technical purposes, only if U.S. inspected and 
passed and so identified. Lungs and lung lobes derived from livestock 
slaughtered in any establishment may not be brought into any official 
establishment except as provided in Sec. 318.12(a).
    (h)(1) Carcasses of game animals, and carcasses derived from the 
slaughter by any person of livestock of his own raising in accordance 
with the exemption provisions of paragraph 23(a) of the Act, and parts 
of such carcasses, may be brought into an official establishment for 
preparation, packaging, and storing in accordance with the provisions of 
Sec. 303.1(a)(2) of this subchapter.
    (2) Meat, meat byproducts, and meat food products bearing official 
marks showing that they were inspected and passed under State inspection 
in any State not designated in Sec. 331.2 of this subchapter may be 
received by official establishments for storage and distribution solely 
in intrastate commerce. The presence of such State inspected products 
must not create any unsanitary condition or otherwise result in 
adulteration of any products at the official establishment or interfere 
with the conduct of inspection under this subchapter. In addition, such 
State inspected products must be stored separately and apart from the 
federally inspected products in the official establishment.
    (i) The operator of the official establishment shall furnish such 
information as is necessary to determine the origin of any product or 
other article entering the official establishment. Such information 
shall include, but is not limited to, the name and address of the seller 
or supplier, transportation company, agent, or broker involved in the 
sale or delivery of the product or article in question.
    (j) Any product or any poultry or poultry product or other article 
that is brought into an official establishment contrary to any provision 
of this section may be required by the Administrator to be removed 
immediately from such establishment by the operator thereof, and failure 
to comply with such requirement shall be deemed a violation of this 
regulation. If any slaughtered poultry or poultry products or other 
articles are received at an official establishment and are suspected of 
being adulterated or misbranded under the Poultry Products Inspection 
Act or the Federal Food, Drug, and Cosmetic Act, or applicable State 
laws, the appropriate governmental authorities will be notified.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 
FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 
1984; 64 FR 72174, Dec. 23, 1999]

    Effective Date Note: At 64 FR 72174, Dec. 23, 1999, Sec. 318.1, 
paragraph (d) was revised, effective Jan. 24, 2000. For the convenience 
of the user, the superseded text is set forth as follows:

[[Page 240]]

Sec. 318.1  Products and other articles entering official 
          establishments.

                                * * * * *

    (d) Containers of preparations which enter any official 
establishment for use in hog scalding water or in denuding of tripe 
shall bear labels showing the chemical names of the preparations. In the 
case of any preparation containing any of the chemicals which are 
specifically limited by Sec. 318.7(c)(4) as to amount permitted to be 
used, the labels on the containers must also show the percentage of each 
such chemical in the preparation and must provide dilution directions 
which prescribe the maximum allowable use concentration of the 
preparations.

                                * * * * *



Sec. 318.2  Reinspection, retention, and disposal of meat and poultry products at official establishments.

    (a) All products and all slaughtered poultry and poultry products 
brought into any official establishment shall be identified by the 
operator of the official establishment at the time of receipt at the 
official establishment and shall be subject to reinspection by a Program 
employee at the official establishment in such manner and at such times 
as may be deemed necessary to assure compliance with the regulations in 
this subchapter.
    (b) All products, whether fresh, cured, or otherwise prepared, even 
though previously inspected and passed, shall be reinspected by Program 
employees as often as they may deem necessary in order to ascertain that 
they are not adulterated or misbranded at the time they enter or leave 
official establishments and that the requirements of the regulations in 
this subchapter are complied with.
    (c) Reinspection may be accomplished through use of statistically 
sound sampling plans that assure a high level of confidence. The circuit 
supervisor shall designate the type of plan and the program employee 
shall select the specific plan to be used in accordance with 
instructions issued by the Administrator. 1
---------------------------------------------------------------------------

    1 Further information concerning sampling plans which have 
been adopted for specific products may be obtained from the Circuit 
Supervisors of Program circuits. These sampling plans are developed for 
individual products by the Washington staff and will be distributed for 
field use as they are developed. The type of plan applicable depends on 
factors such as whether the product is in containers, stage of 
preparation, and procedures followed by the establishment operator. The 
specific plan applicable depends on the kind of product involved, such 
as liver, oxtails, etc.
---------------------------------------------------------------------------

    (d) A U.S. retained tag shall be placed by a Program employee at the 
time of reinspection at any official establishment on all products which 
are suspected on such reinspection of being adulterated or misbranded, 
and such products shall be held for further inspection. Such tags shall 
be removed only by authorized Program employees. When further inspection 
is made, if the product is found to be adulterated, all official 
inspection legends or other official marks for which the product is 
found to be ineligible under the regulations in this subchapter, shall 
be removed or defaced and the product will be subject to condemnation 
and disposal in accordance with part 314 of this subchapter, except that 
a determination regarding adulteration may be deferred if a product has 
become soiled or unclean by falling on the floor or in any other 
accidental way or if the product is affected with any other condition 
which the inspector deems capable of correction, in which case the 
product shall be cleaned (including trimming if necessary) or otherwise 
handled in a manner approved by the inspector to assure that it will not 
be adulterated or misbranded and shall then be presented for 
reinspection and disposal in accordance with this section. If upon final 
inspection, the product is found to be neither adulterated nor 
misbranded, the inspector shall remove the U.S. retained tag. If a 
product is found upon reinspection to be misbranded, it shall be held 
under a U.S. retained tag, or a U.S. detention tag as provided in part 
329 of this subchapter, pending correction of the misbranding or 
issuance of an order under section 7 of the Act to withhold from use the 
labeling or container of the product, or the institution of a judicial 
seizure action under section 403 of Act or other appropriate action. The 
inspector shall make a complete record

[[Page 241]]

of each transaction under this paragraph and shall report his action to 
---------------------------------------------------------------------------
the area supervisor.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 318.3  Designation of places of receipt of products and other articles for reinspection.

    Every official establishment shall designate, with the approval of 
the circuit supervisor, a dock or place at which products and other 
articles subject to reinspection under Sec. 318.2 shall be received, and 
such products and articles shall be received only at such dock or place.



Sec. 318.4  Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.

    (a) All processes used in curing, pickling, rendering, canning, or 
otherwise preparing any product in official establishments shall be 
supervised by Program employees unless such preparation is conducted as 
a custom operation exempted from inspection under Sec. 303.1(a)(2) of 
this subchapter in any official establishment or consists of operations 
that are exempted from inspection under Sec. 303.1(d) of this subchapter 
and are conducted in a retail store in an establishment subject to 
inspection only because the State or Territory in which the 
establishment is located is designated under paragraph 301(c) of the 
Act. No fixtures or appliances, such as tables, trucks, trays, tanks, 
vats, machines, implements, cans, or containers of any kind, shall be 
used unless they are of such materials and construction as will not 
contaminate or otherwise adulterate the product and are clean and 
sanitary. All steps in the preparation of edible products shall be 
conducted carefully and with strict cleanliness in rooms or compartments 
separate from those used for inedible products.
    (b) It shall be the responsibility of the operator of every official 
establishment to comply with the Act and the regulations in this 
subchapter. In order to carry out this responsibility effectively, the 
operator of the establishment shall institute appropriate measures to 
assure the maintenance of the establishment and the preparation, 
marking, labeling, packaging and other handling of its products strictly 
in accordance with the sanitary and other requirements of this 
subchapter. The effectiveness of such measures will be subject to review 
by the Department.
    (c) Applying for Total Plant Quality Control. Any owner or operator 
of an official establishment preparing meat food product who has a total 
plant quality control system or plan for controlling such product, after 
ante-mortem and post-mortem inspection, through all stages of 
preparation, may request the Administrator to evaluate it to determine 
whether or not that system is adequate to result in product being in 
compliance with the requirements of the Act and therefore qualify as a 
U.S. Department of Agriculture (USDA) Total Plant Quality Control 
Establishment. Such a request shall, as a minimum, include:
    (1) A letter to the Administrator from the establishment owner of 
operator stating the company's basis and purpose for seeking an approved 
quality control system and willingness to adhere to the requirements of 
the system as approved by the Department; that all the establishment's 
data, analyses, and information generated by its quality control system 
will be maintained to enable the Department to monitor compliance and 
available to Department personnel; that plant quality control personnel 
will have authority to halt production or shipping of product in cases 
where the submitted quality control system requires it; and that the 
owner or operator (or his/her designee) will be available for 
consultation at any time Department personnel consider it necessary.
    (2) In the case of an establishment having one or more full-time 
persons whose primary duties are related to the quality control system, 
an organizational chart showing that such people ultimately report to an 
establishment official whose quality control responsibilities are 
independent of or not predominantly production responsibilities. In the 
case of an establishment which does not have full-time quality control 
personnel, information indicating the nature of the duties and 
responsibilities of the person who will be

[[Page 242]]

responsible for the quality control system.
    (3) A list identifying those parts and sections of the Federal meat 
inspection regulations which are applicable to the operations of the 
establishment applying for approval of a quality control system. This 
list shall also identify which part of the quality control system will 
serve to maintain compliance with the applicable regulations.
    (4) Detailed information concerning the manner in which the system 
will function. Such information should include, but not necessarily be 
limited to, questions of raw material control, the critical check or 
control points, the nature and frequency of tests to be made, the nature 
of charts and other records that will be used, the length of time such 
charts and records will be maintained in the custody of the official 
establishment, the nature of deficiencies the quality control system is 
designed to identify and control, the parameters or limits which will be 
used, and the points at which corrective action will occur and the 
nature of such corrective action--ranging from least to most severe: 
Provided, That, subsequent to approval of the total plant quality 
control system by the Administrator, the official establishment may 
produce a new product for test marketing provided labeling for the 
product has been approved by the Administrator, the inspector in charge 
has determined that the procedures for preparing the product will assure 
that all Federal requirements are met, and the production for test 
marketing does not exceed 6 months. Such new product shall not be 
produced at that establishment after the 6-month period unless approval 
of the quality control system for that product has been received from 
the Administrator.
    (d) Partial Quality Control Programs. (1) Any owner or operator of 
an official establishment preparing meat food products who is required 
to have a quality control program for a product operation, or part of an 
operation shall make the written program and data and information 
generated by the program available to Program employees.
    (2)(i) This quality control program shall include, as appropriate 
for the operation which the program concerns, detailed information on: 
raw material control, the critical check or control points, the nature 
and frequency of tests to be made, the charts and records that will be 
used, the length of time such charts and records will be maintained in 
the custody of the official establishment, the limits that will be used 
and the points at which corrective action will be taken to prevent 
recurrence of a loss of control, and the nature of the corrective 
action--ranging from the least to the most severe.
    (ii) This quality control program shall ensure that the product, 
operation, or part of an operation which it concerns is in control and 
that applicable product or label limits are being met. Process control 
is to be determined by generally recognized statistical process control 
procedures.
    (e) Evaluation and Approval of Total Plant Quality Control. (1) The 
Administrator shall evaluate the material presented in accordance with 
the provisions of paragraph (c) of this section. If it is determined by 
the Administrator, on the basis of the evaluation, that the total 
quality control system will result in finished products controlled in 
this manner being in full compliance with the requirements of the Act 
and regulations thereunder, the total quality control system will be 
approved and plans will be made for implementation under departmental 
supervision.
    (2) In any situation where the system is found by the Administrator 
to be unacceptable, formal notification shall be given to the applicant 
of the basis for the denial. The applicant will be afforded an 
opportunity to modify the system in accordance with the notification. 
The applicant shall also be afforded an opportunity to submit a written 
statement in response to this notification of denial and a right to 
request a hearing with respect to the merits or validity of the denial. 
If the applicant requests a hearing and the Administrator, after review 
of the answer, determines the initial determination to be correct, he 
shall file with the Hearing Clerk of the Department the notification, 
answer and the request for hearing, which shall constitute the complaint 
and answer in the proceeding, which shall thereafter be conducted in 
accordance with Rules of

[[Page 243]]

Practice which shall be adopted for this proceeding.
    (3) The establishment owner or operator shall be responsible for the 
effective operation of the approved total plant quality control system 
to assure compliance with the requirements of the Act and regulations 
thereunder. The Secretary shall continue to provide the Federal 
inspection necessary to carry out his responsibilities under the Act.
    (f) Labeling Logo. Owners and operators of official establishments 
having a total plant quality control system approved under the 
provisions of paragraph (c) of this section, may only use, as a part of 
any labeling, the following logo. Any labeling bearing the logo and any 
wording of explanation with respect to this logo shall be approved as 
required by parts 316 and 317 of this subchapter.
[GRAPHIC] [TIFF OMITTED] TC11SE91.015

    (g) Termination of Total Plant Quality Control. (1) The approval of 
a total plant quality control system may be terminated at any time by 
the owner or operator of the official establishment upon written notice 
to the Administrator.
    (2) The approval of a total plant quality control system may be 
terminated upon the establishment's receipt of a written notice from the 
Administrator under the following conditions:
    (i) If adulterated or misbranded meat food product is found by the 
Administrator to have been prepared for or distributed in commerce by 
the subject establishment. In such case, opportunity will be provided to 
the establishment owner or operator to present views to the 
Administrator within 30 days of the date of terminating the approval. In 
those instances where there is conflict of facts, a hearing, under 
applicable Rules of Practice, will be provided to the establishment 
owner or operator to resolve the conflict. The Administrator's 
termination of approval shall remain in effect pending the final 
determination of the proceeding.
    (ii) If the establishment fails to comply with the quality control 
system or program to which it has agreed after being notified by letter 
from the Administrator or his designee. Prior to such termination, 
opportunity will be provided to the establishment owner or operator to 
present views to the Administrator within 30 days of the date of the 
letter. In those instances where there is a conflict of facts, a 
hearing, under applicable Rules of Practice, will be provided to the 
establishment owner or operator to resolve the conflict. The 
Administrator's termination of quality control approval shall remain in 
effect pending the final determination of the proceeding.
    (3) If approval of the total establishment quality control system 
has been terminated in accordance with the provisions of this section, 
an application and request for approval of the same or a modified total 
establishment quality control system will not be evaluated by the 
Administrator for at least 6 months from the termination date.
    (h)(1) Operating Schedule Under Total Plant Quality Control. An 
official establishment with an approved total plant quality control 
system may request approval for an operating schedule of up to 12 
consecutive hours per shift. Permission will be granted provided that:
    (i) The official establishment has satisfactorily operated under a 
total plant quality control system for at least 1 year.
    (ii) All products prepared and packaged, or processed after the end 
of 8 hours of inspection shall only be a continuation of the processing 
monitored by the inspector and being conducted during the last hour of 
inspection.
    (iii) All immediate containers of products prepared and packaged 
shall

[[Page 244]]

bear code marks that are unique to any period of production beyond the 8 
hours of inspection. The form of such code marks will remain constant 
from day to day, and a facsimile of the code marks and their meaning 
shall be provided to the inspector.
    (2) Application. Applications shall be submitted to the Regional 
Director and shall specify how the conditions in Sec. 318.4(h)(1) have 
been or will be met.
    (3) Monitoring by Inspectors. In order to verify that an 
establishment is preparing and shipping product in accordance with the 
approved total plant quality control system and the Act and regulations 
after the 8 hours of inspection, the official establishment may be 
provided overtime inspection services at the discretion of the circuit 
supervisor and charged for such services.


(Reporting requirements were approved by the Office of Management and 
Budget under control number 0583-0015)

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 
FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 
25, 1997; 62 FR 54759, Oct. 22, 1997]



Sec. 318.5  Requirements concerning procedures.

    (a)(1) Care shall be taken to assure that product is not adulterated 
when placed in freezers. If there is doubt as to the soundness of any 
frozen product, the inspector will require the defrosting and 
reinspection of a sufficient quantity thereof to determine its actual 
condition.
    (2) Frozen product may be defrosted in water or pickle in a manner 
and with the use of facilities which are acceptable to the inspector. 
Before such product is defrosted, a careful examination shall be made to 
determine its condition. If necessary, this examination shall include 
defrosting of representative samples by means other than in water or 
pickle.
    (b) Product, such as pork tenderloins, brains, sweetbreads, stew, or 
chop suey, shall not be packed in hermetically sealed metal or glass 
containers, unless subsequently heat processed or otherwise treated to 
preserve the product in a manner approved by the Administrator in 
specific cases.
    (c) Care shall be taken to remove bones and parts of bones from 
product which is intended for chopping.
    (d) Heads for use in the preparation of meat food products shall be 
split and the bodies of the teeth, the turbinated and ethmoid bones, ear 
tubes, and horn butts removed, and the heads then thoroughly cleaned.
    (e) Kidneys for use in the preparation of meat food products shall 
first be freely sectioned and then thoroughly soaked and washed. All 
detached kidneys, including beef kidneys with detached kidney fat, shall 
be inspected before being used in or shipped from the official 
establishment.
    (f) Cattle paunches and hog stomachs for use in the preparation of 
meat food products shall be thoroughly cleaned on all surfaces and parts 
immediately after being emptied of their contents, which shall follow 
promptly their removal from the carcasses.
    (g) Clotted blood shall be removed from hog hearts before they are 
shipped from the official establishment or used in the preparation of 
meat food products.
    (h) Beef rounds, beef bungs, beef middles, beef bladders, calf 
rounds, hog bungs, hog middles, and hog stomachs which are to be used as 
containers of any meat food product shall be presented for inspection, 
turned with the fat surface exposed.
    (i) Portions of casings which show infection with Oesophagostomum or 
other nodule-producing parasite, and weasands infected with the larvae 
of Hypoderma lineatum, shall be rejected, except that when the 
infestation is slight and the nodules and larvae are removed, the casing 
or weasand may be passed.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]



Sec. 318.6  Requirements concerning ingredients and other articles used in preparation of products.

    (a) All ingredients and other articles used in the preparation of 
any product shall be clean, sound, healthful, wholesome, and otherwise 
such as will not result in the product being adulterated. Official 
establishments shall furnish inspectors accurate information on all

[[Page 245]]

procedures involved in product preparation including product composition 
and any changes in such procedures essential for inspectional control of 
the product.
    (b)(1) The only animal casings that may be used as containers of 
product are those from cattle, sheep, swine, or goats.
    (2) Casings for products shall be carefully inspected by Program 
employees. Only those casings which have been carefully washed and 
thoroughly flushed with clean water immediately before stuffing and are 
suitable for containers, are clean, and are passed on such inspection 
shall be used, except that preflushed animal casings packed in salt or 
salt and glycerine solution or other approved medium may be used without 
additional flushing provided they are found to be clean and otherwise 
acceptable and are thoroughly rinsed before use.
    (3) Hog and sheep casings intended for use as containers of product 
may be treated by soaking in or applying thereto sound, fresh pineapple 
juice or papain or bromelin or pancreatic extract to permit the enzymes 
contained in these substances to act on the casings to make them less 
resistant. The casings shall be handled in a clean and sanitary manner 
throughout and the treatment shall be followed by washing and flushing 
the casings with water sufficiently to effectively remove the substance 
used and terminate the enzymatic action.
    (4) On account of the invariable presence of bone splinters, 
detached spinal cords shall not be used in the preparation of edible 
product other than for rendering where they constitute a suitable raw 
material.
    (5) Testicles if handled as an edible product may be shipped from 
the official establishment as such, but they shall not be used as an 
ingredient of a meat food product.
    (6) Tonsils shall be removed and shall not be used as ingredients of 
meat food products.
    (7) Blood from livestock prepared in accordance with Sec. 310.20 of 
this subchapter may be used as an ingredient of a meat food product for 
which a standard is prescribed in part 319 of this subchapter, if 
permitted by such standard, and may be used in any meat food product for 
which no such standard is prescribed in part 319 of this subchapter if 
it is a common and usual ingredient of such product.
    (8) Intestines shall not be used as ingredients in any meat food 
product for which a standard is prescribed in part 319 of this 
subchapter and shall not be used in other products unless the products 
are labeled in accordance with Sec. 317.8(b)(3) of this subchapter.
    (9) Poultry products and egg products (other than shell eggs) which 
are intended for use as ingredients of meat food products shall be 
considered acceptable for such use only when identified as having been 
inspected and passed for wholesomeness by the Department under the 
regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to 
be sound and otherwise acceptable when presented for use. Poultry 
products and egg products (other than shell eggs) which have not been so 
inspected and passed for wholesomeness shall not be used in the 
preparation of such meat food products.
    (10) Dry milk products which are intended for use as ingredients of 
meat food products shall be considered acceptable for such use only when 
produced in a plant approved by the Department under the regulations in 
7 CFR part 58, and when found to be sound and otherwise acceptable when 
presented for use. Dry milk products prepared in a plant not so approved 
shall not be used in the preparation of such meat food products.
    (11) [Reserved]
    (12) Ingredients for use in any product may not bear or contain any 
pesticide chemical or other residues in excess of level permitted in 
Sec. 318.16.
    (13) Use of ``Mechanically Separated (Kind of Poultry),'' as defined 
in Sec. 381.173 of this chapter, in the preparation of meat food 
products shall accord with Sec. 381.174 and all other applicable 
provisions of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38 
FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 
11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, 
Nov. 3, 1995]

[[Page 246]]



Sec. 318.7  Approval of substances for use in the preparation of products.

    (a)(1) No substance may be used in the preparation of any product 
unless it is approved in paragraph (c)(4) of this section or elsewhere 
in part 318 or in part 319 of this subchapter, or by the Administrator 
in specific cases.
    (2) Approval of new substances or new uses or new levels of use of 
approved substances may be granted by the Administrator if:
    (i) The substance has been previously approved by the Food and Drug 
Administration (FDA) for use in meat or meat food products as a food 
additive, color additive, or as a substance generally recognized as safe 
and is listed in title 21 of the Code of Federal Regulations, parts 73, 
74, 81, 172, 173, 179, 182 or 184.
    (ii) Its use is in compliance with applicable FDA requirements; and
    (iii) The Administrator has determined that:
    (A) The use of the substance will not render the product in which it 
is used adulterated or misbranded or otherwise not in compliance with 
the requirements of the Act; and
    (B) Its use is functional and suitable for the product and it is 
permitted for use at the lowest level necessary to accomplish the stated 
technical effect as determined in specific cases.
    (3) Whenever the Administrator determines that approval of a new 
substance or new use or new level of use of an approved substance should 
be granted in accordance with paragraph (a)(2) of this section, the 
Administrator shall issue a final rule amending the chart of substances 
in paragraph (c)(4) of this section to include the additional substance 
or new use of the substance, and any technical effect or change in level 
of use of the substance.
    (4) No product shall bear or contain any substance which would 
render it adulterated or misbranded, or which is not approved in part 
318 or part 319 of this subchapter, or by the Administrator in specific 
cases.
    (b) Requirements for the use of nitrite and sodium ascorbate or 
sodium erythorbate (isoascorbate) in bacon. Nitrates shall not be used 
in curing bacon.
    (1) Pumped bacon. With respect to bacon injected with curing 
ingredients and massaged bacon: sodium nitrite shall be used at 120 
parts per million (PPM) ingoing or an equivalent amount of potassium 
nitrite shall be used (148 PPM ingoing); and 550 PPM of sodium ascorbate 
or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or 
sodium erythorbate have a molecular weight of approximately 198. 
Hydrated forms of these substances shall be adjusted to attain the 
equivalent of 550 PPM of sodium ascorbate or sodium erythorbate.
    (2) The Department shall collect samples of pumped bacon from 
producing plants and analyze them for the level of nitrosamines by the 
Thermal Energy Analyzer (TEA). In the event that a TEA analysis 
indicates that a confirmable level of nitrosamines might be present, 
additional samples shall be collected and analyzed by gas 
chromatography. Presumptive positive results must be confirmed by mass 
spectrometry before being considered positive. If, during the interval 
required for the Department to analyze the confirmatory samples by gas 
chromotography and mass spectrometry, changes are made in processing 
procedures which are expected to result in no confirmable levels of 
nitrosamines in pumped bacon produced by these new procedures, an 
establishment may submit samples to USDA for analysis upon prior 
notification and arrangements with USDA. If, however, an establishment 
furnishes USDA with laboratory results from testing five consecutive 
lots of pumped bacon produced under the new procedures and the testing 
is performed by the USDA methodology and procedures, those results will 
be utilized in making the determination concerning the product produced 
under the new procedures. Should the results of these tests reveal that 
confirmable levels of nitorosamines are not indicated in any of the five 
consecutive lots, the confirmation analysis by USDA shall be terminated 
and the establishment shall revert to normal monitoring status. In the 
event the test results continue to indicate nitrosamines, however, USDA 
shall proceed in its confirmation analysis on the original samples taken 
for

[[Page 247]]

confirmation. If any one of the original samples collected by USDA for 
confirmation if found to contain confirmable levels of nitrosamines, all 
pumped bacon in the producing establishment and all future production 
will be retained. The Department shall sample and analyze such retained 
pumped bacon for nitrosamines on a lot by lot basis. A production lot 
shall be that pumped bacon produced by the establishment in any single 
shift. Samples from any lot of pumped bacon under retention found to 
contain nitrosamines at a confirmable level shall cause the lot of 
pumped bacon to be disposed of in a manner to assure it will not form 
nitrosamines when cooked. Such disposal may include incorporation of the 
uncooked pumped bacon as an ingredient of another meat food product 
provided it is processed for eating without further preparation in a 
manner to preclude the formation of nitrosamines. Bacon subsequently 
produced shall not be retained because of nitrosamines if the operator 
of the establishment makesadjustments in the processing of the product 
and laboratory results obtained by TEA analysis of samples from five 
consecutive normal sized lots of pumped bacon indicates that the product 
being produced contains no confirmable levels of nitrosamines. These 
tests from five consecutive normal sized lots of pumped bacon shall be 
conducted by the Department: Provided, however, That if the 
establishment furnishes the Department with the results of tests 
conducted under the methodology and procedures used by the Department, 
such test results will be utilized in making the determination 
concerning the nitrosamine content of the product. All tests of pumped 
bacon for nitrosamines under this subparagraph shall be made on pumped 
bacon cooked 340  deg.F. for 3 minutes on each side. In order to 
determine that no confirmable levels of nitrosamines are present in a 
sample tested, the testing must be performed by methodology and 
procedures that would detect the presence of any nitrosamines at 10 PPB.
    (3) Notwithstanding the provisions of paragraph (b)(1) of this 
section, sodium nitrite may be used at:
    (i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500 
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; 
provided that the establishment has a partial quality control program as 
provided in Sec. 318.4(d) that results in compliance with this 
provision, or
    (ii) A predetermined level between 40 and 80 ppm (potassium nitrite 
at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium 
erythorbate (isoascorbate); and additional sucrose or other similar 
fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of 
lactic acid producing bacteria such as Pediococcus acetolactii or other 
bacteria demonstrated to be equally effective in preventing the growth 
of botulinum toxin at a level sufficient for the purpose of preventing 
the growth of botulinum toxin; provided that the establishment has a 
partial quality control program as provided in Sec. 318.4(d) that 
results in compliance with this provision.
    (4) The Department shall collect samples of bacon from plants 
producing under paragraph (b)(3) of this section and analyze them for 
the level of nitrosamines. Samples shall be randomly selected throughout 
the production of a lot. The actual sampling plans and methods of 
analysis that are used will result in approximately the same likelihood 
as under paragraph (b)(2) of this section of having a presumptive 
positive result when the true mean level of nitrosamines in a production 
lot is 10 ppb. In the event of a presumptive positive result, the plant 
shall become subject to the provisions of paragraph (b)(2) of this 
section.
    (5) Immersion cured bacon. Immersion cured bacon may be placed in a 
brine solution containing salt, nitrite and flavoring material or in a 
container with salt, nitrite and flavoring material. Sodium nitrite 
shall not exceed 120 ppm ingoing or an equivalent amount of potassium 
nitrite (148 ppm ingoing) based on the actual or estimated skin-free 
green weight of the bacon bellies.
    (6) Bacon made with dry curing materials. With respect to bacon made 
with dry curing materials, the product shall be cured by applying a 
premeasured

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amount of cure mixture to the bacon belly surfaces, completely covering 
the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an 
equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured 
bacon based on the actual or estimated skin-free green weight of the 
bacon belly.
    (c) Under appropriate declaration as required in parts 316 and 317 
of this subchapter, the following substances may be added to products:
    (1) Common salt, approved sugars (sucrose, cane or beet sugar), 
maple sugar, dextrose, invert sugar, honey, corn syrup solids, (corn 
syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, 
spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium 
nitrite, and other substances specified in the chart in paragraph (c)(4) 
of this section may be added to products under conditions, if any, 
specified in this part or in part 317 of this subchapter.
    (2) Other harmless artificial flavorings may be added to products 
with the approval of the Administrator in specific cases.
    (3) Coloring matter and dyes other than those specified in the chart 
in paragraph (c)(4) of this section may be applied to products, mixed 
with rendered fat, applied to natural and artificial casings, and 
applied to such casings enclosing products, if approved by the 
Administrator in specific cases. When any coloring matter or dye is 
applied to casings, there shall be no penetration of coloring into the 
product.
    (4) The substances specified in the following chart are acceptable 
for use in the preparation of products, provided they are used for the 
purposes indicated, within the limits of the amounts stated and under 
other conditions specified in this part and part 317 of this subchapter. 
In addition to the substances listed in the following chart, part 319 of 
this subchapter specifies other substances that are acceptable in 
preparing specified products.


----------------------------------------------------------------------------------------------------------------
 Class of substance           Substance                 Purpose                Products              Amount
----------------------------------------------------------------------------------------------------------------
Acidifiers..........  Acetic acid.............  To adjust acidity.....  Various 2.............  Sufficient for
                                                                                                 purpose.3
                      Citric acid.............  ......do..............  ......do..............      Do.
                      Glucono delta-lactone...  ......do..............  ......do..............      Do.
                      Lactic acid.............  ......do..............  ......do..............      Do.
                      Phosphoric acid.........  ......do..............  ......do..............      Do.
                      Tartaric acid...........  ......do..............  ......do..............      Do.
Anti-coagulants.....  Citric acid.............  To prevent clotting...  Fresh blood of          0.2 percent with
                                                                         livestock.              or without
                                                                                                 water. When
                                                                                                 Water is used
                                                                                                 to make a
                                                                                                 solution of
                                                                                                 citric acid
                                                                                                 added to blood
                                                                                                 of livestock,
                                                                                                 not more than 2
                                                                                                 parts of water
                                                                                                 to 1 part of
                                                                                                 citric acid
                                                                                                 shall be used.
                      Sodium citrate..........  ......do..............  ......do..............  Not to exceed
                                                                                                 0.5 percent
                                                                                                 based on the
                                                                                                 ingoing weight
                                                                                                 of the product.
                                                                                                 When water is
                                                                                                 used to make a
                                                                                                 solution of
                                                                                                 sodium citrate
                                                                                                 added to blood
                                                                                                 of livestock,
                                                                                                 not more than 2
                                                                                                 parts of water
                                                                                                 to 1 part of
                                                                                                 sodium citrate
                                                                                                 shall be used.
Antifoaming agent...  Methyl polysilicone.....  To retard foaming.....  Soups.................  10 parts per
                                                                        Rendered fats.........   million.
                                                                        Curing pickle.........      Do.
                                                                                                50 parts per
                                                                                                 million.
----------------------------------------------------------------------------------------------------------------


Antioxidants and oxygen   BHA (butylated                To retard rancidity......  Dry sausage..............  0.003 percent based   .006 percent in
 interceptors.             hydroxyanisole).                                                                    on total weight.      combination.
                          BHT (butylated                ......do.................  ......do.................  ......do............
                           hydroxytoluene).
                          Propyl gallate..............  ......do.................  ......do.................  ......do............

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                          TBHQ (tertiary                ......do.................  ......do.................  ......do............  0.006 percent in
                           butylhydroquinone).                                                                                       combination only
                                                                                                                                     with BHA and/or
                                                                                                                                     BHT.
                          BHA (butylated                ......do.................  Rendered animal fat or a   0.01 percent........  0.02 percent in
                           hydroxyanisole).                                         combination of such fat                          combination.
                                                                                    and vegetable fat.
                          BHT (butylated                ......do.................  ......do.................  ......do............
                           hydroxytoluene).
                          Glycine.....................  ......do.................  ......do.................  ......do............