Jan. 1, 2009 CODE OF FEDERAL REGULATIONS 9 Part 200 to End Revised as of January 1, 2009 Animals and Animal Products Containing a codification of documents of general applicability and future effect As of January 1, 2009 With Ancillaries

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 Table of Contents Page Explanation v Title 9: Chapter II—Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agriculture 3 Chapter III—Food Safety and Inspection Service, Department of Agriculture 79 Finding Aids: Table of CFR Titles and Chapters 713 Alphabetical List of Agencies Appearing in the CFR 733 List of CFR Sections Affected 743

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(a) The incorporation will substantially reduce the volume of material published in the Federal Register.

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(c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51.

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 202-741-6010.

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January 1, 2009.

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, 2009.

For this volume, Bonnie Fritts was Chief Editor. The Code of Federal Regulations publication program is under the direction of Michael L. White, assisted by Ann Worley.

 <LRH>9 CFR Ch. II (1-1-09 Edition)</LRH> <RRH>Grain Inspection, Packers and Stockyards Administration, USDA</RRH> <CFRTITLE> <TITLEHD> <PRTPAGE P="1"/> <HD SOURCE="HED">Title 9—Animals and Animal Products</HD> <P>(This book contains part 200 to end)</P> </TITLEHD> <CFRTOC> <EDNOTE> <HD SOURCE="HED">Editorial Note:</HD> <P>Other regulations issued by the Department of Agriculture appear in title 7, title 36, chapter II, and title 41, chapter 4.</P> </EDNOTE> <PTHD>Part</PTHD> <CHAPTI> <SUBJECT> <E T="04">chapter ii</E>—Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agriculture</SUBJECT> <PG>201</PG> </CHAPTI> <CHAPTI> <SUBJECT> <E T="04">chapter iii</E>—Food Safety and Inspection Service, Department of Agriculture</SUBJECT> <PG>301</PG> </CHAPTI> </CFRTOC> </CFRTITLE> <CHAPTER> <TOC> <TOCHD> <PRTPAGE P="3"/> <HD SOURCE="HED">CHAPTER II—GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION (PACKERS AND STOCKYARDS PROGRAMS), DEPARTMENT OF AGRICULTURE</HD> </TOCHD> <PTHD>Part</PTHD> <PGHD>Page</PGHD> <CHAPTI> <PT>200</PT> <RESERVED>[Reserved]</RESERVED> <PT>201</PT> <SUBJECT>Regulations under the Packers and Stockyards Act</SUBJECT> <PG>5</PG> <PT>202</PT> <SUBJECT>Rules of practice governing proceedings under the Packers and Stockyards Act</SUBJECT> <PG>30</PG> <PT>203</PT> <SUBJECT>Statements of general policy under the Packers and Stockyards Act</SUBJECT> <PG>49</PG> <PT>204</PT> <SUBJECT>Organization and functions</SUBJECT> <PG>60</PG> <PT>205</PT> <SUBJECT>Clear title—protection for purchasers of farm products</SUBJECT> <PG>64</PG> <PT>206</PT> <SUBJECT>Swine contract library</SUBJECT> <PG>74</PG> </CHAPTI> </TOC> <PART> <PRTPAGE P="5"/> <RESERVED>PART 200 [RESERVED]</RESERVED> </PART> <PART> <EAR>Pt. 201</EAR> <HD SOURCE="HED">PART 201—REGULATIONS UNDER THE PACKERS AND STOCKYARDS ACT</HD> <CONTENTS> <SUBJGRP> <HD SOURCE="HED">Definitions</HD> <SECHD>Sec.</SECHD> <SECTNO>201.1</SECTNO> <SUBJECT>Meaning of words.</SUBJECT> <SECTNO>201.2</SECTNO> <SUBJECT>Terms defined.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Administration</HD> <SECTNO>201.3</SECTNO> <SUBJECT>Authority.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Applicability of Industry Rules</HD> <SECTNO>201.4</SECTNO> <SUBJECT>Bylaws, rules and regulations, and requirements of exchanges, associations, or other organizations; applicability, establishment.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Registration</HD> <SECTNO>201.10</SECTNO> <SUBJECT>Requirements and procedures.</SUBJECT> <SECTNO>201.11</SECTNO> <SUBJECT>Suspended registrants; officers, agents, and employees.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Schedules of Rates and Charges</HD> <SECTNO>201.17</SECTNO> <SUBJECT>Requirements for filing tariffs.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">General Bonding Provisions</HD> <SECTNO>201.27</SECTNO> <SUBJECT>Underwriter; equivalent in lieu of bonds; standard forms.</SUBJECT> <SECTNO>201.28</SECTNO> <SUBJECT>Duplicates of bonds or equivalents to be filed with Regional Supervisors.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Market Agency, Dealer and Packer Bonds</HD> <SECTNO>201.29</SECTNO> <SUBJECT>Market agencies, packers and dealers required to file and maintain bonds.</SUBJECT> <SECTNO>201.30</SECTNO> <SUBJECT>Amount of market agency, dealer and packer bonds.</SUBJECT> <SECTNO>201.31</SECTNO> <SUBJECT>Conditions in market agency, dealer and packer bonds.</SUBJECT> <SECTNO>201.32</SECTNO> <SUBJECT>Trustee in market agency, dealer and packer bonds.</SUBJECT> <SECTNO>201.33</SECTNO> <SUBJECT>Persons damaged may maintain suit; filing and notification of claims; time limitations; legal expenses.</SUBJECT> <SECTNO>201.34</SECTNO> <SUBJECT>Termination of market agency, dealer and packer bonds.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Proceeds of Sale</HD> <SECTNO>201.39</SECTNO> <SUBJECT>Payment to be made to consignor or shipper by market agencies; exceptions.</SUBJECT> <SECTNO>201.42</SECTNO> <SUBJECT>Custodial accounts for trust funds.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Accounts and Records</HD> <SECTNO>201.43</SECTNO> <SUBJECT>Payment and accounting for livestock and live poultry.</SUBJECT> <SECTNO>201.44</SECTNO> <SUBJECT>Market agencies to render prompt accounting for purchases on order.</SUBJECT> <SECTNO>201.45</SECTNO> <SUBJECT>Market agencies to make records available for inspection by owners, consignors, and purchasers.</SUBJECT> <SECTNO>201.49</SECTNO> <SUBJECT>Requirements regarding scale tickets evidencing weighing of livestock, live poultry, and feed.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Trade Practices</HD> <SECTNO>201.53</SECTNO> <SUBJECT>Persons subject to the Act not to circulate misleading reports about market conditions or prices.</SUBJECT> <SECTNO>201.55</SECTNO> <SUBJECT>Purchases, sales, acquisitions, payments and settlements to be made on actual weights.</SUBJECT> <SECTNO>201.56</SECTNO> <SUBJECT>Market agencies selling on commission; purchases from consignment.</SUBJECT> <SECTNO>201.61</SECTNO> <SUBJECT>Market agencies selling or purchasing livestock on commission; relationships with dealers.</SUBJECT> <SECTNO>201.67</SECTNO> <SUBJECT>Packers not to own or finance selling agencies.</SUBJECT> <SECTNO>201.69</SECTNO> <SUBJECT>Furnishing information to competitor buyers.</SUBJECT> <SECTNO>201.70</SECTNO> <SUBJECT>Restriction or limitation of competition between packers and dealers prohibited.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Services</HD> <SECTNO>201.71</SECTNO> <SUBJECT>Scales; accurate weights, repairs, adjustments or replacements after inspection.</SUBJECT> <SECTNO>201.72</SECTNO> <SUBJECT>Scales; testing of.</SUBJECT> <SECTNO>201.73</SECTNO> <SUBJECT>Scale operators to be qualified.</SUBJECT> <SECTNO>201.73-1</SECTNO> <SUBJECT>Instructions for weighing livestock.</SUBJECT> <SECTNO>201.76</SECTNO> <SUBJECT>Reweighing.</SUBJECT> <SECTNO>201.81</SECTNO> <SUBJECT>Suspended registrants.</SUBJECT> <SECTNO>201.82</SECTNO> <SUBJECT>Care and promptness in weighing and handling livestock and live poultry.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Inspection of Brands</HD> <SECTNO>201.86</SECTNO> <SUBJECT>Brand inspection: Application for authorization, registration and filing of schedules, reciprocal arrangements, and maintenance of identity of consignments.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">General</HD> <SECTNO>201.94</SECTNO> <SUBJECT>Information as to business; furnishing of by packers, swine contractors, live poultry dealers, stockyard owners, market agencies, and dealers.</SUBJECT> <SECTNO>201.95</SECTNO> <SUBJECT>Inspection of business records and facilities.</SUBJECT> <SECTNO>201.96</SECTNO> <SUBJECT>Unauthorized disclosure of business information prohibited.</SUBJECT> <SECTNO>201.97</SECTNO> <SUBJECT>Annual reports.</SUBJECT> <SECTNO>201.98</SECTNO> <SUBJECT>Packers and dealers not to charge, demand, or collect commission, yardage, or other service charges.</SUBJECT> <SECTNO>201.99</SECTNO> <SUBJECT>Purchase of livestock by packers on a carcass grade, carcass weight, or carcass grade and weight basis.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Poultry—Packers and Live Poultry Dealers</HD> <SECTNO>201.100</SECTNO> <SUBJECT>Records to be furnished poultry growers and sellers.</SUBJECT> <SECTNO>201.108-1</SECTNO> <SUBJECT>Instructions for weighing live poultry.<PRTPAGE P="6"/> </SUBJECT> <SECTNO>201.200</SECTNO> <SUBJECT>Sale of livestock to a packer on credit.</SUBJECT> </SUBJGRP> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 U.S.C. 182, 222, and 228, and 7 CFR 2.22 and 2.81.</P> </AUTH> <SUBJGRP> <HD SOURCE="HED">Definitions</HD> <SECTION> <SECTNO>§ 201.1</SECTNO> <SUBJECT>Meaning of words.</SUBJECT> <P>Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.</P> <CITA>[19 FR 4524, July 22, 1954]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.2</SECTNO> <SUBJECT>Terms defined.</SUBJECT> <P>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:</P> <P>(a) <E T="03">Act</E> means the Packers and Stockyards Act, 1921, as amended and supplemented (7 U.S.C. 181 et seq.).</P> <P>(b) <E T="03">Department</E> means the United States Department of Agriculture.</P> <P>(c) <E T="03">Secretary</E> means the Secretary of Agriculture of the United States, or any officer or employee of the Department authorized to act for the Secretary.</P> <P>(d) <E T="03">Administration</E> or <E T="03">agency</E> means the Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs).</P> <P>(e) <E T="03">Administrator</E> or <E T="03">agency head</E> means the Administrator of the Administration or any person authorized to act for the Administrator.</P> <P>(f) <E T="03">Regional Supervisor</E> 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.</P> <P>(g) <E T="03">Person</E> means individuals, partnerships, corporations, and associations.</P> <P>(h) <E T="03">Registrant</E> means any person registered pursuant to the provisions of the Act and the regulations in this part.</P> <P>(i) <E T="03">Stockyard</E> 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.</P> <P>(j) <E T="03">Schedule</E> means a tariff of rates and charges filed by stockyard owners and market agencies.</P> <P>(k) <E T="03">Custom Feedlot</E> 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.</P> <CITA>[46 FR 50510, Oct. 14, 1981]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Administration</HD> <SECTION> <SECTNO>§ 201.3</SECTNO> <SUBJECT>Authority.</SUBJECT> <P>The Administrator shall perform such duties as the Secretary may require in enforcing the provisions of the act and the regulations in this part.</P> <CITA>[19 FR 4524, July 22, 1954]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Applicability of Industry Rules</HD> <SECTION> <SECTNO>§ 201.4</SECTNO> <SUBJECT>Bylaws, rules and regulations, and requirements of exchanges, associations, or other organizations; applicability, establishment.</SUBJECT> <P>(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.</P> <P>(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, <PRTPAGE P="7"/>or practices relating to, the responsibilities, duties, or obligations of such market agencies to their consignors.</P> <SECAUTH>(7 U.S.C. 181 et seq.)</SECAUTH> <CITA>[19 FR 4524, July 22, 1954, as amended at 44 FR 45361, Aug. 2, 1979]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Registration</HD> <SECTION> <SECTNO>§ 201.10</SECTNO> <SUBJECT>Requirements and procedures.</SUBJECT> <P>(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 §§ 201.27 through 201.34.</P> <P>(b) Each application for registration shall be filed with the regional supervisor for the region in which the applicant proposes to operate. If the Administrator has reason to believe that the applicant is unfit to engage in the activity for which application has been made, a proceeding shall be promptly instituted in which the applicant will be afforded opportunity for full hearing in accordance with the rules of practice governing such proceedings, for the purpose of showing cause why the application for registration should not be denied. In the event it is determined that the application should be denied, the applicant shall not be precluded, as soon as conditions warrant, from again applying for registration.</P> <P>(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.</P> <P>(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 §§ 201.27 through 201.34.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a, 222 and 228)</SECAUTH> <CITA>[49 FR 33003, Aug. 20, 1984, as amended at 54 FR 37094, Sept. 7, 1989; 56 FR 2127, Jan. 22, 1991; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.11</SECTNO> <SUBJECT>Suspended registrants; officers, agents, and employees.</SUBJECT> <P>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.</P> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a and 228)</SECAUTH> <CITA>[49 FR 33003, Aug. 20, 1984]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Schedules of Rates and Charges</HD> <SECTION> <SECTNO>§ 201.17</SECTNO> <SUBJECT>Requirements for filing tariffs.</SUBJECT> <P>(a) <E T="03">Schedules of rate changes for stockyard services.</E> Each stockyard owner and market agency operating at a posted stockyard shall file with the regional supervisor for the region in which they operate a signed copy of all schedules of rates and charges, supplements and amendments thereto. The schedules, supplements and amendments must be conspicuously posted for public inspection at the stockyard, and filed with the regional supervisor, at least 10 days before their effective dates, except as provided in paragraphs (b) and (c) of this section. Each schedule, supplement and amendment shall set forth its effective date, a description of the stockyard services rendered, the stockyard at which it applies, the name and address of the stockyard owner or market agency, the kind of livestock covered by it, and any rules or regulations which affect any rate or charge contained therein. Each schedule of rates and charges filed shall be designated by successive numbers. Each supplement and amendment to such schedule shall be numbered and <PRTPAGE P="8"/>shall designate the number of the schedule which it supplements or amends.</P> <P>(b) <E T="03">Feed charges.</E> When the schedule in effect provides for feed charges to be based on an average cost plus a specified margin, the 10-day filing and notice provision contained in section 306(c) of the Act is waived. A schedule of the current feed charges based on average feed cost and showing the effective date shall be conspicuously posted at the stockyard at all times. Changes in feed charges may become effective 2 days after the change is posted at the stockyard.</P> <P>(c) <E T="03">Professional veterinary services.</E> 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.</P> <P>(d) <E T="03">Joint schedules.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a, 222 and 228)</SECAUTH> <CITA>[49 FR 33003, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">General Bonding Provisions</HD> <SECTION> <SECTNO>§ 201.27</SECTNO> <SUBJECT>Underwriter; equivalent in lieu of bonds; standard forms.</SUBJECT> <P>(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.</P> <P>(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:</P> <P>(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 § 201.32, or</P> <P>(2) A trust agreement governing funds which may be drawn by a trustee as provided in § 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.</P> <P>(c) The provisions of §§ 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.</P> <P>(d) Bonds, trust fund agreements, letters of credit and trust agreements shall be filed on forms approved by the Administrator.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[56 FR 2128, Jan. 22, 1991, as amended at 61 FR 36279, July 10, 1996; 62 FR 11759, Mar. 13, 1997; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.28</SECTNO> <SUBJECT>Duplicates of bonds or equivalents to be filed with Regional Supervisors.</SUBJECT> <P>Fully executed duplicates of bonds, trust fund agreements, and trust agreements maintained under the regulations in this part, and fully executed duplicates of all endorsements, amendments, riders, indemnity agreements, and other attachments thereto, and photographically reproduced copies of any letter of credit or amendment thereto, shall be filed with the Regional Supervisor for the region in which the registrant, packer, or person applying for registration resides, or in the case of a corporation, where the corporation has its home office: <E T="03">Provided,</E> that if such registrant, packer, <PRTPAGE P="9"/>or person does not engage in business in such area, the foregoing documents shall be filed with the Regional Supervisor for the region in which the place of business of the registrant or packer or person is located.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[56 FR 2128, Jan. 22, 1991, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Market Agency, Dealer and Packer Bonds</HD> <SECTION> <SECTNO>§ 201.29</SECTNO> <SUBJECT>Market agencies, packers and dealers required to file and maintain bonds.</SUBJECT> <P>(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 § 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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <SECAUTH>(7 U.S.C. 204, 228(a))</SECAUTH> <CITA>[48 FR 8806, Mar. 2, 1983]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.30</SECTNO> <SUBJECT>Amount of market agency, dealer and packer bonds.</SUBJECT> <P>(a) <E T="03">Market agency selling livestock on commission.</E> To compute the required amount of bond coverage, divide the dollar value of livestock sold during the preceding business year, or the substantial part of that business year, in which the market agency did business, by the actual number of days on which livestock was sold. The divisor (the number of days on which livestock was sold) shall not exceed 130. The amount of bond coverage must be the next multiple of $5,000 above the amount so determined. When the computation exceeds $50,000, the amount of bond coverage need not exceed $50,000 plus 10 percent of the excess over $50,000, raised to the next $5,000 multiple. In no case shall the amount of bond coverage for a market agency selling on commission be less than $10,000 or such higher amount as required to comply with any State law.</P> <P>(b) <E T="03">Market agency buying on commission or dealer.</E> The amount of bond coverage must be based on the average amount of livestock purchased by the dealer or market agency during a period equivalent to 2 business days. To compute the required amount of bond coverage, divide the total dollar value of livestock purchased during the preceding business year, or substantial part of that business year, in which the dealer or market agency or both did business, by one-half the number of days on which business was conducted. <PRTPAGE P="10"/>The number of days in any business year, for purposes of this regulation, shall not exceed 260. Therefore, the divisor (one-half the number of days on which business was conducted) shall not exceed 130. The amount of the bond coverage must be the next multiple of $5,000 above the amount so determined. When the computation exceeds $75,000, the amount of bond coverage need not exceed $75,000 plus 10 percent of the excess over $75,000, raised to the next $5,000 multiple. In no case shall the amount of bond coverage be less than $10,000 or such higher amount as required to comply with any State law.</P> <P>(c) <E T="03">Market agency acting as clearing agency.</E> 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.</P> <P>(d) <E T="03">Packer.</E> 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.</P> <P>(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.</P> <P>(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.</P> <SECAUTH>(7 U.S.C. 204, 228(a))</SECAUTH> <CITA>[48 FR 8806, Mar. 2, 1983]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.31</SECTNO> <SUBJECT>Conditions in market agency, dealer and packer bonds.</SUBJECT> <P>Each market agency, dealer and packer bond shall contain conditions applicable to the activity or activities <PRTPAGE P="11"/>in which the person or persons named as principal or clearees in the bond propose to engage, which conditions shall be as follows or in terms to provide equivalent protection:</P> <P>(a) <E T="03">Condition Clause No. 1: When the principal sells livestock for the accounts of others.</E> 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.</P> <P>(b) <E T="03">Condition Clause No. 2: When the principal buys livestock for his own account or for the accounts of others.</E> 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.</P> <P>(c) <E T="03">Condition Clause No. 3: When the principal clears other registrants buying livestock and thus is responsible for the obligations of such other registrants.</E> 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.</P> <P>(d) <E T="03">Condition Clause No. 4: When the principal buys livestock for his own account as a packer.</E> 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.</P> <CITA>[47 FR 32695, July 29, 1982]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.32</SECTNO> <SUBJECT>Trustee in market agency, dealer and packer bonds.</SUBJECT> <P>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.</P> <CITA>[41 FR 53774, Dec. 9, 1976]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.33</SECTNO> <SUBJECT>Persons damaged may maintain suit; filing and notification of claims; time limitations; legal expenses.</SUBJECT> <P>Each bond and each bond equivalent filed pursuant to the regulations in this part shall contain provisions that:</P> <P>(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;</P> <P>(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;</P> <P>(c) The Administrator is authorized to designate a trustee pursuant to § 201.32;</P> <P>(d) The surety on the bond, or the trustee on the bond equivalent, as the case may be, shall not be liable to pay any claim if it is not filed in writing within 60 days from the date of the transaction on which the claim is based or if suit thereon is commenced less than 120 days or more than 547 days from the date of the transaction on which the claim is based;<PRTPAGE P="12"/> </P> <P>(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.</P> <CITA>[56 FR 2128, Jan. 22, 1991]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.34</SECTNO> <SUBJECT>Termination of market agency, dealer and packer bonds.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[47 FR 32695, July 29, 1982, as amended at 54 FR 26349, June 23, 1989; 61 FR 36279, July 10, 1996; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Proceeds of Sale</HD> <SECTION> <SECTNO>§ 201.39</SECTNO> <SUBJECT>Payment to be made to consignor or shipper by market agencies; exceptions.</SUBJECT> <P>(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: <E T="03">Provided,</E> 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.</P> <P>(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 <PRTPAGE P="13"/>within a reasonable period of time, not to exceed 60 days after sale.</P> <SECAUTH>(7 U.S.C. 181 et seq.)</SECAUTH> <CITA>[19 FR 4528, July 22, 1954, as amended at 28 FR 7218, July 13, 1963; 44 FR 45361, Aug. 2, 1979]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.42</SECTNO> <SUBJECT>Custodial accounts for trust funds.</SUBJECT> <P>(a) <E T="03">Payments for livestock are trust funds.</E> 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.</P> <P>(b) <E T="03">Custodial accounts for shippers' proceeds.</E> 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.</P> <P>(c) <E T="03">Deposits in custodial accounts.</E> 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.</P> <P>(d) <E T="03">Withdrawals from custodial accounts.</E> 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.</P> <P>(e) <E T="03">Accounts and records.</E> 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.</P> <P>(f) <E T="03">Insured banks.</E> Such custodial accounts for shippers' proceeds must be established and maintained in banks whose deposits are insured by the Federal Deposit Insurance Corporation.</P> <P>(g) <E T="03">Certificates of deposit and/or savings accounts.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[47 FR 32696, July 29, 1982, as amended at 54 FR 26349, June 23, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Accounts and Records</HD> <SECTION> <SECTNO>§ 201.43</SECTNO> <SUBJECT>Payment and accounting for livestock and live poultry.</SUBJECT> <P>(a) <E T="03">Market agencies to make prompt accounting and transmittal of net proceeds.</E> 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 <PRTPAGE P="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.</P> <P>(b) <E T="03">Prompt payment for livestock and live poultry—terms and conditions.</E> (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 § 201.200).</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(c) <E T="03">Purchaser to promptly reimburse agents.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 6083, Feb. 17, 1984, as amended at 49 FR 8235, Mar. 6, 1984; 54 FR 16355, Apr. 24, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.44</SECTNO> <SUBJECT>Market agencies to render prompt accounting for purchases on order.</SUBJECT> <P>Each market agency shall, promptly following the purchase of livestock on <PRTPAGE P="15"/>a commission or agency basis, transmit or deliver to the person for whose account such purchase was made, or the duly authorized agent, a true written account of the purchase showing the number, weight, and price of each kind of animal purchased, the names of the persons from whom purchased, the date of purchase, the commission and other lawful charges, and such other facts as may be necessary to complete the account and show fully the true nature of the transaction.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 181 et seq.)</SECAUTH> <CITA>[44 FR 45360, Aug. 2, 1979, as amended at 54 FR 26349, June 23, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.45</SECTNO> <SUBJECT>Market agencies to make records available for inspection by owners, consignors, and purchasers.</SUBJECT> <P>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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 181 et seq.; Pub. L. 96-511, 94 Stat. 2812 (44 U.S.C. 3501 et seq.))</SECAUTH> <CITA>[19 FR 4528, July 22, 1954, as amended at 44 FR 45361, Aug. 2, 1979; 47 FR 746, Jan. 7, 1982; 54 FR 26349, June 23, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.49</SECTNO> <SUBJECT>Requirements regarding scale tickets evidencing weighing of livestock, live poultry, and feed.</SUBJECT> <P>(a) <E T="03">Livestock.</E> 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:</P> <P>(1) The names and location of the agency performing the weighing service,</P> <P>(2) The date of the weighing;</P> <P>(3) The name of the buyer and seller or consignor, or a designation by which they may be readily identified;</P> <P>(4) The number of head;</P> <P>(5) Kind of livestock;</P> <P>(6) Actual weight of each draft of livestock; and</P> <P>(7) The name, initials, or number of the person who weighed the livestock, or if required by State law, the signature of the weigher.</P> <P>(b) <E T="03">Poultry.</E> 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:</P> <P>(1) The name of the agency performing the weighing service;</P> <P>(2) The name of the live poultry dealer;</P> <P>(3) The name and address of the grower, purchaser, or seller;</P> <P>(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;</P> <P>(5) The location of the scale;</P> <P>(6) The gross weight, tare weight, and net weight;</P> <P>(7) The date and time gross weight and tare weight are determined;</P> <P>(8) The number of poultry weighed;</P> <P>(9) The weather conditions;</P> <P>(10) Whether the driver was on or off the truck at the time of weighing; and</P> <P>(11) The license number of the truck or the truck number; <E T="03">provided,</E> that when live poultry is weighed on a scale other than a vehicle scale, the scale ticket need not show the information specified in paragraphs (b)(9)-(11) of this section. Scale tickets issued under <PRTPAGE P="16"/>this paragraph shall be at least in duplicate form and shall be serially numbered and used in numerical sequence. One copy shall be furnished to the grower, purchaser, or seller, and one copy shall be furnished to or retained by the live poultry dealer.</P> <P>(c) <E T="03">Feed.</E> (1) Whenever feed is weighed by or on behalf of a stockyard owner, market agency, dealer, packer, or live poultry dealer where the weight of feed is a factor in determining payment or settlement to a livestock grower or poultry grower, a scale ticket shall be issued which shall show:</P> <P>(i) The name of the agency performing the weighing service or the name and location of the firm responsible for supplying the feed;</P> <P>(ii) The name and address of the livestock grower or poultry grower;</P> <P>(iii) The name or initials or number of the person who weighed the feed, or if required by State law, the signature of the weigher;</P> <P>(iv) The location of the scale;</P> <P>(v) The gross weight, tare weight, and net weight of each lot assigned to an individual grower, if applicable;</P> <P>(vi) The date and time gross weight and tare weight, if gross and tare weights are applicable, are determined;</P> <P>(vii) The identification of each lot assigned to an individual grower by vehicle or trailer compartment number and seal numbers, if applicable;</P> <P>(viii) Whether the driver was on or off the truck at the time of weighing, if applicable; and</P> <P>(ix) The license number or other identification numbers on the truck and trailer, if weighed together, or trailer if only the trailer is weighed, if applicable.</P> <P>(2) Scale tickets issued under this paragraph shall be at least in duplicate form and shall be serially numbered and used in numerical sequence. One copy shall be retained by the person subject to the P&S Act, and a second copy shall be furnished to the livestock grower or poultry grower.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[61 FR 36281, July 10, 1996, as amended at 65 FR 17762, Apr. 5, 2000]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Trade Practices</HD> <SECTION> <SECTNO>§ 201.53</SECTNO> <SUBJECT>Persons subject to the Act not to circulate misleading reports about market conditions or prices.</SUBJECT> <P>No packer, swine contractor, 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.</P> <CITA>[73 FR 62440, Oct. 21, 2008]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.55</SECTNO> <SUBJECT>Purchases, sales, acquisitions, payments and settlements to be made on actual weights.</SUBJECT> <P>(a) Except as provided in paragraph (b) of this section, whenever livestock or live poultry is bought, sold, acquired, paid, or settled on a weight basis, or whenever the weight of feed is a factor in determining payment or settlement to a livestock grower or poultry grower by a stockyard owner, market agency, dealer, packer, or live poultry dealer when livestock or poultry is produced under a growing arrangement, payment or settlement shall be on the basis of the actual weight of the livestock, live poultry, and/or feed shown on the scale ticket. If the actual weight used is not obtained on the date and at the place of transfer of possession, this information shall be disclosed with the date and location of the weighing on the accountings, bills, or statements issued. Any adjustment to the actual weight shall be fully and accurately explained on the accountings, bills, or statements issued, and records shall be maintained to support such adjustment.</P> <P>(b) Whenever the weight of feed is a factor in determining payment or settlement to such livestock grower or poultry grower when the livestock or poultry is produced under a livestock or poultry growing arrangement, any feed that is picked up from or returned by a livestock grower or poultry grower must be weighed or its weight must be reasonably determined. When feed is picked up or returned and not weighed, the stockyard owner, market agency, dealer, packer, or live poultry dealer must document that the method used reasonably determines weight and is <PRTPAGE P="17"/>mutually acceptable to it and the livestock grower or poultry grower. The stockyard owner, market agency, dealer, packer, or live poultry dealer must document and account for the picked up or returned feed weight.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[65 FR 17762, Apr. 5, 2000]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.56</SECTNO> <SUBJECT>Market agencies selling on commission; purchases from consignment.</SUBJECT> <P>(a) <E T="03">Livestock to be sold openly at highest available bid.</E> 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.</P> <P>(b) <E T="03">Purchases from consignment.</E> 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.</P> <P>(c) <E T="03">Key employees not to purchase livestock out of consignments.</E> 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.</P> <P>(d) <E T="03">Purchase from consignments; disclosure required.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 6084, Feb. 17, 1984, as amended at 49 FR 13003, Apr. 2, 1984; 58 FR 52886, Oct. 13, 1993; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.61</SECTNO> <SUBJECT>Market agencies selling or purchasing livestock on commission; relationships with dealers.</SUBJECT> <P>(a) <E T="03">Market agencies selling on commission.</E> No market agency selling consigned livestock shall enter into any agreement, relationship or association with dealers or other buyers which has a tendency to lessen the loyalty of the market agency to its consignors or impair the quality of the market agency's selling services. No market agency selling livestock on commission shall provide clearing services for any independent dealer who purchases livestock from consignment to such market agency without disclosing, on the account of sale to the consignor, the name of the buyer and the nature of the financial relationship between the buyer and the market agency.</P> <P>(b) <E T="03">Market agencies buying on commission.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 6085, Feb. 17, 1984, as amended at 60 FR 42779, Aug. 17, 1995; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.67</SECTNO> <SUBJECT>Packers not to own or finance selling agencies.</SUBJECT> <P>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 <PRTPAGE P="18"/>livestock on a commission basis, nor shall such a market agency permit a packer to have an ownership interest in, finance, or participate in the management or operation of such market agency.</P> <SECAUTH>(7 U.S.C. 228, 228b, 222, 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 32844, Aug. 17, 1984]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.69</SECTNO> <SUBJECT>Furnishing information to competitor buyers.</SUBJECT> <P>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.</P> <CITA>[19 FR 4531, July 22, 1954, as amended at 24 FR 3183, Apr. 24, 1959]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.70</SECTNO> <SUBJECT>Restriction or limitation of competition between packers and dealers prohibited.</SUBJECT> <P>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.</P> <CITA>[24 FR 3183, Apr. 24, 1959]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Services</HD> <SECTION> <SECTNO>§ 201.71</SECTNO> <SUBJECT>Scales; accurate weights, repairs, adjustments or replacements after inspection.</SUBJECT> <P>(a) All scales used by stockyard owners, market agencies, dealers, packers, and live poultry dealers to weigh livestock, livestock carcasses, live poultry, or feed for the purposes of purchase, sale, acquisition, payment, or settlement shall be installed, maintained, and operated to ensure accurate weights. Such scales shall meet applicable requirements contained in the General Code, Scale Code, and Weights Code of the 1996 edition of National Institute of Standards and Technology (NIST) Handbook 44, “Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices,” which is hereby incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register on January 11, 1989, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. These materials are incorporated as they exist on the date of approval and a notice of any change in these materials will be published in the <E T="04">Federal Register.</E> This handbook is for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E> </P> <P>(b) All scales used by stockyard owners, market agencies, dealers, packers, and live poultry dealers to weigh livestock, livestock carcasses, live poultry, or feed for the purpose of purchase, sale, acquisition, payment, or settlement of livestock or live poultry, and all scales used for the purchase, sale, acquisition, payment, or settlement of livestock on a carcass weight basis shall be equipped with a printing device which shall record weight values on a scale ticket or other document.</P> <P>(c) All vehicle scales used to weigh livestock, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock or live poultry shall be of sufficient length and capacity to weigh the entire vehicle as a unit: Provided, That a trailer may be uncoupled from the tractor and weighed as a single unit.</P> <P>(d) No scale shall be operated or used by any stockyard owner, market agency, dealer, packer, or live poultry dealer to weigh livestock, livestock carcasses, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock, <PRTPAGE P="19"/>livestock carcasses or live poultry unless it has been found upon test and inspection, as specified in § 201.72, to be in a condition to give accurate weight. If a scale is inspected or tested and found to be in a condition to give incorrect or inaccurate weights or if any repairs, adjustments or replacements are made to a scale, it shall not be used until it has been inspected and tested and determined to meet all accuracy requirements specified in the regulations in this section.</P> <CITA>[65 FR 17763, Apr. 5, 2000, as amended at 69 FR 18803, Apr. 9, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.72</SECTNO> <SUBJECT>Scales; testing of.</SUBJECT> <P>(a) Each stockyard owner, market agency, dealer, packer, or live poultry dealer who weighs livestock, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock or live poultry, or who weighs livestock carcasses for the purpose of purchase on a carcass weight basis, or who furnishes scales for such purposes, shall cause such scales to be tested by competent persons in accordance with the regulations in this part at least twice during each calendar year at intervals of approximately 6 months. More frequent testing will be required in cases where the scale does not maintain accuracy between tests.</P> <P>(b) Each stockyard owner, market agency, dealer, packer, or live poultry dealer who weighs livestock, livestock carcasses, live poultry, or feed for purposes of purchase, sale, acquisition, payment, or settlement of livestock, livestock carcasses or live poultry shall furnish reports of such tests and inspections on forms prescribed by the Administrator. The stockyard owner, market agency, dealer, packer or live poultry dealer shall retain one copy of the test and inspection report and shall file one copy with the P&S regional office for the region in which the scale is located.</P> <P>(c) When scales used for weighing livestock, livestock carcasses, live poultry, or feed are tested and inspected by an agency of a State or municipality or other governmental subdivision, the forms ordinarily used by such agency for reporting test and inspection of scales shall be accepted in lieu of the forms prescribed for this purpose by the Administrator if such forms contain substantially the same information.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[65 FR 17763, Apr. 5, 2000]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.73</SECTNO> <SUBJECT>Scale operators to be qualified.</SUBJECT> <P>Stockyard owners, market agencies, dealers, packers, and live poultry dealers shall employ qualified persons to operate scales for weighing livestock, livestock carcasses, live poultry, or feed for the purposes of purchase, sale, acquisition, payment, or settlement of livestock, livestock carcasses, or live poultry, and they shall require such employees to operate the scales in accordance with the regulations in this part.</P> <CITA>[65 FR 17763, Apr. 5, 2000]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.73-1</SECTNO> <SUBJECT>Instructions for weighing livestock.</SUBJECT> <P>Stockyard operators, market agencies, dealers, and packers who operate scales on which livestock is weighed in purchase or sales transactions are responsible for the accurate weighing of such livestock. They shall supply copies of the instructions in this section to all persons who perform weighing operations for them and direct such person to familiarize themselves with the instructions and to comply with them at all times. This section shall also apply to any additional weighers who are employed at any time. Weighers must acknowledge their receipt of these instructions and agree to comply with them, by signing in duplicate, P&SA Form 215 provided by the Packers and Stockyards Programs. One copy of the form is to be filed with a regional office of the Packers and Stockyards Programs and the other retained by the agency employing the weighers.</P> <P>(a) <E T="03">Balancing the empty scale.</E> (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, <PRTPAGE P="20"/>whichever is completed first. In addition, the zero balance of the scale shall be verified whenever a weigher resumes weighing duties after an absence from the scale and also whenever a load exceeding half the scale capacity or 10,000 pounds (whichever is less) has been weighed and is followed by a load of less than 1,000 pounds, verification to occur before the weighing of the load of less than 1,000 pounds.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(b) <E T="03">Weighing the load.</E> (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.</P> <P>(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 <FR>1/4</FR> (0.25) inch of the zero mark.</P> <P>(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.</P> <P>(iii) On a dial scale, the weight is indicated automatically when the indicator moves around the dial face and comes to rest.</P> <P>(iv) On an electronic digital scale, the weight of a draft is indicated automatically when the weight value indicated stabilized.</P> <P>(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.</P> <P>(c) <E T="03">Recording the weight.</E> (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 <PRTPAGE P="21"/>certain that the printed weight record agrees with the weight value visually indicated when correct load balance is obtained. He shall also assure himself that the printed weight value is distinct and legible.</P> <P>(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.</P> <P>(d) <E T="03">Scale tickets.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(e) <E T="03">Weigher's responsibilities.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(4) Livestock owners, buyers, or others having legitimate interest in a livestock draft must be permitted to observe the balancing, weighing, and recording procedures, and a weigher shall not deny them that right or withhold from them any information pertaining to the weight of that draft. He shall check the zero balance of the scale or reweigh a draft of livestock when requested by such parties.</P> <P>(f) <E T="03">Sensitivity control.</E> (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.</P> <P>(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 <FR>1/4</FR> inch (0.25) or the width of the central target area, whichever is greater.</P> <P>(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 <PRTPAGE P="22"/>weighbeam to come to rest at the bottom of the trig loop.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(g) <E T="03">General precautions.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(6) Count-off men, gate men, or others assigned to open or close scale gates or to drive livestock on or off the scale, shall perform those functions as directed by the weigher's signals or spoken instructions. They shall prevent persons or animals off the scale from being in contact with any part of the scale platform, stock rack, or gates while the scale is being balanced or used for weighing. They shall not open gates or remove livestock from the scale until directed by the weigher.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 222 and 228 and 15 U.S.C. 46)</SECAUTH> <CITA>[39 FR 40277, Nov. 15, 1974, as amended at 49 FR 39516, Oct. 9, 1984; 61 FR 36282, July 10, 1996; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.76</SECTNO> <SUBJECT>Reweighing.</SUBJECT> <P>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.</P> <CITA>[54 FR 16356, Apr. 24, 1989]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.81</SECTNO> <SUBJECT>Suspended registrants.</SUBJECT> <P>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: <E T="03">Provided,</E> That the provisions of this section shall not be construed to prohibit the employment of <PRTPAGE P="23"/>any person who has been suspended as a registrant until such time as the person demonstrates solvency or obtains the bond required under the Act and regulations. No such person shall be employed, however, until after the expiration of any specified period of suspension contained in the order of suspension.</P> <SECAUTH>(7 U.S.C. 222 and 228 and 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 37374, Sept. 24, 1984]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.82</SECTNO> <SUBJECT>Care and promptness in weighing and handling livestock and live poultry.</SUBJECT> <P>(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.</P> <P>(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.</P> <CITA>[54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, 1989]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Inspection of Brands</HD> <SECTION> <SECTNO>§ 201.86</SECTNO> <SUBJECT>Brand inspection: Application for authorization, registration and filing of schedules, reciprocal arrangements, and maintenance of identity of consignments.</SUBJECT> <P>(a) <E T="03">Application for authorization.</E> 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.</P> <P>(b) <E T="03">Registration and filing of schedules.</E> 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 § 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 § 201.17.</P> <P>(c) <E T="03">Reciprocal arrangements.</E> Any authorized agency or association may make arrangements with an association or associations in the same or in another State, where branding or marking livestock prevails by custom or statute, to perform inspection service at stockyards on such terms and conditions as may be approved by the Administrator: <E T="03">Provided,</E> That such arrangements will tend to further the purpose of the Act and will not result in duplication of charges or services.</P> <P>(d) <E T="03">Maintenance of identity of consignments.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a, 222 and 228)</SECAUTH> <CITA>[49 FR 33005, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <PRTPAGE P="24"/> <HD SOURCE="HED">General</HD> <SECTION> <SECTNO>§ 201.94</SECTNO> <SUBJECT>Information as to business; furnishing of by packers, swine contractors, live poultry dealers, stockyard owners, market agencies, and dealers.</SUBJECT> <P>Each packer, swine contractor, 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, swine contractor, 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.</P> <CITA>[73 FR 62440, Oct. 21, 2008]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.95</SECTNO> <SUBJECT>Inspection of business records and facilities.</SUBJECT> <P>Each stockyard owner, market agency, dealer, packer, swine contractor, 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, swine contractor, or live poultry dealer for such examination of records and inspection of facilities.</P> <CITA>[73 FR 62440, Oct. 21, 2008]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.96</SECTNO> <SUBJECT>Unauthorized disclosure of business information prohibited.</SUBJECT> <P>No agent or employee of the United States shall, without the consent of the stockyard owner, market agency, dealer, packer, swine contractor, 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, swine contractor, or live poultry dealer, or through any information given by the stockyard owner, market agency, dealer, packer, swine contractor, 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.</P> <CITA>[73 FR 62440, Oct. 21, 2008]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.97</SECTNO> <SUBJECT>Annual reports.</SUBJECT> <P>Every packer, live poultry dealer, stockyard owner, market agency, and dealer (except a packer buyer registered to purchase livestock for slaughter only) shall file annually with the Administration a report on prescribed forms not later than April 15 following the calendar year end or, if the records are kept on a fiscal year basis, not later than 90 days after the close of his fiscal year. The Administrator on good cause shown, or on his own motion, may grant a reasonable extension of the filing date or may waive the filing of such reports in particular cases.</P> <APPRO>(Approved by the Office of Management and Budget under Control Number 0580-0015)</APPRO> <CITA>[54 FR 16356, Apr. 24, 1989, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.98</SECTNO> <SUBJECT>Packers and dealers not to charge, demand, or collect commission, yardage, or other service charges.</SUBJECT> <P>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.</P> <CITA>[61 FR 36282, July 10, 1996]</CITA> </SECTION> <SECTION> <PRTPAGE P="25"/> <SECTNO>§ 201.99</SECTNO> <SUBJECT>Purchase of livestock by packers on a carcass grade, carcass weight, or carcass grade and weight basis.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(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)</SECAUTH> <CITA>[33 FR 2762, Feb. 9, 1968, as amended at 33 FR 5401, Apr. 5, 1968; 49 FR 37375, Sept. 24, 1984; 54 FR 37094, Sept. 7, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Poultry—Packers and Live Poultry Dealers</HD> <SECTION> <SECTNO>§ 201.100</SECTNO> <SUBJECT>Records to be furnished poultry growers and sellers.</SUBJECT> <P>(a) <E T="03">Contracts; contents.</E> 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:</P> <P>(1) The duration of the contract and conditions for the termination of the contract by each of the parties; and</P> <P>(2) All terms relating to the payment to be made to the poultry grower, including among others, where applicable, the following:</P> <P>(i) The party liable for condemnations, including those resulting from plant errors;</P> <P>(ii) The method for figuring feed conversion ratios;</P> <P>(iii) The formula or method used to convert condemnations to live weight;</P> <P>(iv) The per unit charges for feed and other inputs furnished by each party; and</P> <P>(v) The factors to be used when grouping or ranking poultry growers.</P> <P>(b) <E T="03">Settlement sheets; contents; supporting documents.</E> 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 <PRTPAGE P="26"/>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.</P> <P>(c) <E T="03">Condemnation and grading certificates.</E> 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.</P> <P>(d) <E T="03">Grouping or ranking sheets.</E> 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.</P> <P>(e) <E T="03">Live poultry purchases.</E> 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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, 1989, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.108-1</SECTNO> <SUBJECT>Instructions for weighing live poultry.</SUBJECT> <P>Live poultry dealers who operate scales on which live poultry is weighed for purposes of purchase, sale, acquisition, or settlement are responsible for the accurate weighing of such poultry. They shall supply copies of the instructions in this section to all persons who perform weighing operations for them and direct such persons to familiarize themselves with the instructions and to comply with them at all times. This section shall also apply to any additional weighers who are employed at any time. Weighers must acknowledge their receipt of these instructions and agree to comply with them by signing in duplicate, a form provided by the Packers and Stockyards Programs, Grain Inspection, Packers and Stockyards Administration. One copy of this form is to be filed with a regional office of the Packers and Stockyards Programs, Grain Inspection, Packers and Stockyards Administration and the other copy retained by the Agency employing the weighers. The following instructions shall be applicable to the weighing of live poultry on all scales, except that paragraph (c)(1) of this section is only applicable to the weighing of live poultry on vehicle scales.</P> <P>(a) <E T="03">Balancing the empty scale.</E> (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.</P> <P>(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.<PRTPAGE P="27"/> </P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(b) <E T="03">Sensitivity control.</E> (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.</P> <P>(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 (<FR>1/4</FR>) inch (0.25) or the width of the central target area, whichever is greater.</P> <P>(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.</P> <P>(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.</P> <P>(5) Friction at weighbeam bearings may reduce the sensitiveness of the scale, cause sluggish weighbeam action and affect weighing accuracy. A weigher must inspect the weighbeam assembly daily to make certain that there is clearance between the weighbeam and the pivot bearings.</P> <P>(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.</P> <P>(c) <E T="03">Weighing the load.</E> (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.<PRTPAGE P="28"/> </P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(iv) On an electronic digital scale the weight of a vehicle is indicated automatically when the weight value indicated is stable.</P> <P>(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.</P> <P>(d) <E T="03">Recording the weight.</E> (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.</P> <P>(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.</P> <P>(e) <E T="03">Weigher's responsibilities.</E> (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.</P> <P>(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.</P> <P>(3) Accurate weighing and weight recording require that a weigher shall not permit operations to be hurried to the extent that inaccurate weights or incorrect weight records may result. The gross, tare and net weights must be determined accurately to the nearest minimum graduation. Manual operations connected with balancing, weighing, and recording shall be performed with the care necessary to prevent damage to the accurately machined and adjusted parts of weighbeams, poises, and printing devices. Rough handling of these parts shall be avoided.</P> <P>(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.</P> <P>(f) <E T="03">General precautions.</E> (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 <PRTPAGE P="29"/>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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[37 FR 4955, Mar. 8, 1972, as amended at 61 FR 36282, July 10, 1996; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 201.200</SECTNO> <SUBJECT>Sale of livestock to a packer on credit.</SUBJECT> <P>(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: </P> <EXTRACT> <P>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 </P> <FP>Covers a single sale.</FP> <FP SOURCE="FP-1">Provides that it will remain in effect until (date).</FP> <FP SOURCE="FP-1">Provides that it will remain in effect until canceled in writing by either party.</FP> <FP>(Omit the provisions not applicable.)</FP> <FP SOURCE="FP-DASH">Date</FP> <FP SOURCE="FP-DASH">Signature</FP> </EXTRACT> <P>(2) Such packer retains such acknowledgment, together with all other documents, if any, setting forth the terms of such credit sales on which the purchaser and seller have agreed, and such dealer or market agency retains a copy thereof, in his records for such time as is required by any law, or by written notice served on such person by the Administrator, but not less than two calendar years from the date of expiration of the written agreement referred to in such acknowledgment; and</P> <P>(3) Such seller receives a copy of such acknowledgment.</P> <P>(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 § 201.43(b)(1).)</P> <P>(c) The provisions of this section shall not be construed to permit any <PRTPAGE P="30"/>transaction prohibited by § 201.61(a) relating to financing by market agencies selling on a commission basis.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(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)</SECAUTH> <CITA>[42 FR 49929, Sept. 8, 1977, as amended at 49 FR 39516, Oct. 9, 1984; 54 FR 37094, Sept. 7, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </SUBJGRP> </PART> <PART> <EAR>Pt. 202</EAR> <HD SOURCE="HED">PART 202—RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE PACKERS AND STOCKYARDS ACT</HD> <CONTENTS> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to Rate Proceedings</HD> <SECHD>Sec.</SECHD> <SECTNO>202.1</SECTNO> <SUBJECT>Applicability of other rules.</SUBJECT> <SECTNO>202.2</SECTNO> <SUBJECT>Definitions.</SUBJECT> <SECTNO>202.3</SECTNO> <SUBJECT>Institution of proceedings.</SUBJECT> <SECTNO>202.4</SECTNO> <SUBJECT>Answer and reply.</SUBJECT> <SECTNO>202.5</SECTNO> <SUBJECT>Hearing.</SUBJECT> <SECTNO>202.6</SECTNO> <SUBJECT>Taking no position on the merits.</SUBJECT> <SECTNO>202.7</SECTNO> <SUBJECT>Modification or vacation of final order.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to Reparation Proceedings</HD> <SECTNO>202.101</SECTNO> <SUBJECT>Rule 1: Meaning of words.</SUBJECT> <SECTNO>202.102</SECTNO> <SUBJECT>Rule 2: Definitions.</SUBJECT> <SECTNO>202.103</SECTNO> <SUBJECT>Rule 3: Beginning a reparation proceeding.</SUBJECT> <SECTNO>202.104</SECTNO> <SUBJECT>Rule 4: Agency action.</SUBJECT> <SECTNO>202.105</SECTNO> <SUBJECT>Rule 5: Filing; time for filing; service.</SUBJECT> <SECTNO>202.106</SECTNO> <SUBJECT>Rule 6: Answer.</SUBJECT> <SECTNO>202.107</SECTNO> <SUBJECT>Rule 7: Reply.</SUBJECT> <SECTNO>202.108</SECTNO> <SUBJECT>Rule 8: Docketing of proceeding.</SUBJECT> <SECTNO>202.109</SECTNO> <SUBJECT>Rule 9: Depositions.</SUBJECT> <SECTNO>202.110</SECTNO> <SUBJECT>Rule 10: Prehearing conference.</SUBJECT> <SECTNO>202.111</SECTNO> <SUBJECT>Rule 11: Hearing, oral or written.</SUBJECT> <SECTNO>202.112</SECTNO> <SUBJECT>Rule 12: Oral hearing.</SUBJECT> <SECTNO>202.113</SECTNO> <SUBJECT>Rule 13: Written hearing.</SUBJECT> <SECTNO>202.114</SECTNO> <SUBJECT>Rule 14: Post-hearing procedure.</SUBJECT> <SECTNO>202.115</SECTNO> <SUBJECT>Rule 15: Submission for final consideration.</SUBJECT> <SECTNO>202.116</SECTNO> <SUBJECT>Rule 16: Issuance of order.</SUBJECT> <SECTNO>202.117</SECTNO> <SUBJECT>Rule 17: Petition to reopen a hearing; to rehear or reargue a proceeding; to reconsider an order; or to set aside a default order.</SUBJECT> <SECTNO>202.118</SECTNO> <SUBJECT>Rule 18: Presiding officer.</SUBJECT> <SECTNO>202.119</SECTNO> <SUBJECT>Rule 19: Fees of witnesses.</SUBJECT> <SECTNO>202.120</SECTNO> <SUBJECT>Rule 20: Official notice.</SUBJECT> <SECTNO>202.121</SECTNO> <SUBJECT>Rule 21: Intervention.</SUBJECT> <SECTNO>202.122</SECTNO> <SUBJECT>Rule 22: Ex parte communications.</SUBJECT> <SECTNO>202.123</SECTNO> <SUBJECT>Rule 23: Action by Secretary.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to All Other Proceedings</HD> <SECTNO>202.200</SECTNO> <SUBJECT>Scope and applicability of rules of practice.</SUBJECT> <SECTNO>202.210</SECTNO> <SUBJECT>Stipulations.</SUBJECT> </SUBJGRP> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 U.S.C. 228(a); 7 CFR 2.22 and 2.81.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>43 FR 30510, July 14, 1978, unless otherwise noted.</P> </SOURCE> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to Rate Proceedings</HD> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>Sections 202.1 through 202.7 appear at 53 FR 51236, Dec. 21, 1988, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 202.1</SECTNO> <SUBJECT>Applicability of other rules.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.2</SECTNO> <SUBJECT>Definitions.</SUBJECT> <P>As used in these rules:</P> <P>(a) <E T="03">Rate proceeding</E> 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</P> <P>(b) <E T="03">Administrator</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 202.3</SECTNO> <SUBJECT>Institution of proceedings.</SUBJECT> <P>(a) <E T="03">Informal complaint.</E> 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 <PRTPAGE P="31"/>any such rate or charge, may file an informal complaint with the Administrator.</P> <P>(b) <E T="03">Investigation.</E> 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.</P> <P>(c) <E T="03">Status of person filing.</E> 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.</P> <P>(d) <E T="03">Formal complaint.</E> 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 <E T="04">Federal Register,</E> together with notice of the time by which, and the place where, any interested person may file a written request to be heard.</P> </SECTION> <SECTION> <SECTNO>§ 202.4</SECTNO> <SUBJECT>Answer and reply.</SUBJECT> <P>Respondent is not required to file an answer. If an answer is filed, complainant is not required to file a reply.</P> </SECTION> <SECTION> <SECTNO>§ 202.5</SECTNO> <SUBJECT>Hearing.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.6</SECTNO> <SUBJECT>Taking no position on the merits.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.7</SECTNO> <SUBJECT>Modification or vacation of final order.</SUBJECT> <P>(a) <E T="03">Informal petition.</E> 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.</P> <P>(b) <E T="03">Formal motion.</E> 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.</P> <P>(c) <E T="03">Publication.</E> 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 <E T="04">Federal Register,</E> together with notice of the place, and the time by which, any interested person may file a written request to be heard.</P> <P>(d) <E T="03">Proceedings.</E> Proceedings upon such a formal motion will be as otherwise provided for a formal complaint.</P> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to Reparation Proceedings</HD> <SECTION> <SECTNO>§ 202.101</SECTNO> <SUBJECT>Rule 1: Meaning of words.</SUBJECT> <P>In these rules, words in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.</P> </SECTION> <SECTION> <SECTNO>§ 202.102</SECTNO> <SUBJECT>Rule 2: Definitions.</SUBJECT> <P>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:<PRTPAGE P="32"/> </P> <P> <E T="03">Act</E> means the Packers and Stockyards Act, 1921, and legislation supplementary thereto and amendatory thereof, 7 U.S.C. 181 et seq.;</P> <P> <E T="03">Agency</E> 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;</P> <P> <E T="03">Agency Head</E> 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;</P> <P> <E T="03">Complainant</E> 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;</P> <P> <E T="03">Department</E> means the United States Department of Agriculture;</P> <P> <E T="03">Docketing</E> of a reparation proceeding means transmittal of papers to the Hearing Clerk and assignment of a docket number as provided in Rule 8, § 202.108, of these rules;</P> <P> <E T="03">Hearing</E> 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;</P> <P> <E T="03">Hearing Clerk</E> means the Hearing Clerk of the Department (see 7 CFR 2.25(a)(3));</P> <P> <E T="03">Judicial Officer</E> 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);</P> <P> <E T="03">Mail</E> 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.</P> <P> <E T="03">Presiding Officer</E> 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;</P> <P> <E T="03">Re-mail</E> 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.</P> <P> <E T="03">Reparation proceeding</E> or <E T="03">Proceeding</E> 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;</P> <P> <E T="03">Report</E> 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.</P> <P> <E T="03">Respondent</E> means the party against whom a complaint is filed and reparation is claimed, in a reparation proceeding;</P> <P> <E T="03">Secretary</E> 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;</P> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.103</SECTNO> <SUBJECT>Rule 3: Beginning a reparation proceeding.</SUBJECT> <P>(a) <E T="03">Filing.</E> 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.</P> <P>(b) <E T="03">Form.</E> The complaint must be in writing, state the facts of the matter complained of, identify each person complained against (respondent), and identify each person who complains against such respondent and claims reparation from such respondent. It may be on a printed form supplied by the Agency, or may be a formal document, or may be a letter, mailgram, or telegram. It may be typewritten or handwritten. If it is not on a printed form supplied by the Agency, the Agency Head may, prior to docketing of the <PRTPAGE P="33"/>proceeding, recommend to the complainant that an amended complaint be filed on such a printed form.</P> <P>(c) <E T="03">Contents and attachments.</E> So far as practicable, the complaint should include the following items as applicable:</P> <P>(1) Date and place where the alleged violation occurred;</P> <P>(2) Quantity and quality of the livestock involved;</P> <P>(3) Whether a sale is involved and, if so, the date, sale price, and amount actually paid and received;</P> <P>(4) Whether a consignment is involved and, if so the date, reported proceeds, gross, net;</P> <P>(5) Amount of reparation claimed, and method of computation;</P> <P>(6) Name and address of each partner or member, if a partnership or joint venture is involved;</P> <P>(7) Name and address of each person involved, including any agent representing the complainant or the respondent in the transaction involved;</P> <P>(8) Other material facts, including terms of contract; and</P> <P>(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.</P> <P>(d) <E T="03">Where to file.</E> 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.</P> <P>(e) <E T="03">Time for filing.</E> 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.</P> <P>(f) <E T="03">Amendment.</E> 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:</P> <P>(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;</P> <P>(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</P> <P>(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), § 202.104(b). If any such amendment is filed after such service, it shall be served on the respondent in any case.</P> <P>(g) <E T="03">Withdrawal.</E> 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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 60 FR 8465, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.104</SECTNO> <SUBJECT>Rule 4: Agency action.</SUBJECT> <P>(a) <E T="03">Informal disposition.</E> If there appears to be any reasonable ground for doing so, the Agency Head shall investigate the matter complained of. If the <PRTPAGE P="34"/>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.</P> <P>(b) <E T="03">Service of complaint.</E> 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.</P> <P>(c) <E T="03">Service of report of investigation.</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 202.105</SECTNO> <SUBJECT>Rule 5: Filing; time for filing; service.</SUBJECT> <P>(a) <E T="03">Filing; number of copies.</E> 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, <E T="03">Provided,</E> 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.</P> <P>(b) <E T="03">Effective date of filing.</E> 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.</P> <P>(c) <E T="03">Additional time for filing.</E> 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.</P> <P>(d) <E T="03">Computation of time.</E> Saturdays, Sundays, and Federal holidays shall be included in computing the time allowed for the filing of any document or paper: <E T="03">Provided,</E> That, when such time expires on a Saturday, Sunday, or Federal holiday, such time shall be extended to include the next following business day.</P> <P>(e) <E T="03">Who shall make service.</E> Copies of all documents or papers required or authorized by the rules in this part to be filed with the Agency shall be served on the parties by the Agency, and copies of all documents or papers required or authorized by the rules in this part to be filed with the Hearing Clerk shall be served on the parties by the Hearing Clerk, unless any such document or paper is served by some other employee <PRTPAGE P="35"/>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.</P> <P>(f) <E T="03">Service on party.</E> (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, <E T="03">provided that,</E> 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.</P> <P>(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 § 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.</P> <P>(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:</P> <P>(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</P> <P>(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.</P> <P>(g) <E T="03">Service on another.</E> 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:</P> <P>(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;</P> <P>(2) Delivery other than by mail to any responsible individual at, or leaving in a conspicuous place at, any such location; or</P> <P>(3) Delivery to such party if an individual, to an officer or director of such party if a partnership, at any location.</P> <P>(h) <E T="03">Proof of service.</E> Any of the following, in the possession of the Department, showing such service, shall be deemed to be accurate:</P> <P>(1) A certified or registered mail receipt returned by the postal service with a signature;</P> <P>(2) An official record of the postal service;</P> <P>(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;</P> <P>(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, <E T="03">Provided</E> 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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41183, Oct. 10, 1990; 60 FR 8465, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.106</SECTNO> <SUBJECT>Rule 6: Answer.</SUBJECT> <P>(a) <E T="03">Filing and service.</E> Within 20 days after service on a respondent, of a complaint or amendment of a complaint, <PRTPAGE P="36"/>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.</P> <P>(b) <E T="03">Required contents.</E> 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.</P> <P>(c) <E T="03">Setoff, counterclaim or cross-claim.</E> 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: <E T="03">Provided,</E> 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.</P> <P>(d) <E T="03">Failure to file.</E> 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), § 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.</P> </SECTION> <SECTION> <SECTNO>§ 202.107</SECTNO> <SUBJECT>Rule 7: Reply.</SUBJECT> <P>(a) <E T="03">Filing and service.</E> 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.</P> <P>(b) <E T="03">Contents.</E> 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.</P> <P>(c) <E T="03">Failure to file.</E> If no reply is filed, the allegations of the answer shall be regarded as denied.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.108</SECTNO> <SUBJECT>Rule 8: Docketing of proceeding.</SUBJECT> <P>Promptly following receipt of the answer, or the reply (if the answer asserts a counterclaim or a setoff), or following the expiration of the period of time prescribed above for the filing of the answer or of the reply, the agency head shall transmit all of the papers which have been filed in the proceeding (including the investigation report if any has been served on the parties) to <PRTPAGE P="37"/>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.109</SECTNO> <SUBJECT>Rule 9: Depositions.</SUBJECT> <P>(a) <E T="03">Application.</E> 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.</P> <P>(b) <E T="03">Response; service.</E> 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.</P> <P>(c) <E T="03">Written questions (interrogatories).</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(d) <E T="03">Order.</E> (1) The presiding officer, if satisfied that good cause for taking the deposition is present, may order the taking of the deposition.</P> <P>(2) The order shall be served on the parties and shall include:</P> <P>(i) The name and address of the officer before whom the deposition is to be made;</P> <P>(ii) The name of the deponent;</P> <P>(iii) Whether the deposition will be oral or on written questions;</P> <P>(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</P> <P>(v) The time, which shall not be less than 20 days after the issuance of the order, and place.</P> <P>(3) The officer, time, place, and manner of the deposition as stated in the presiding officer's order need not be the same as the officer, time, place, and manner suggested in the application.</P> <P>(4) The deposition shall be conducted in the manner (telephone, audio-visual <PRTPAGE P="38"/>telecommunication, or personal attendance of those who are to participate in the deposition) agreed to by the parties.</P> <P>(5) If the parties cannot agree on the manner in which the deposition is to be conducted:</P> <P>(i) The deposition shall be conducted by telephone unless the presiding officer determines that conducting the deposition by audio-visual telecommunication:</P> <P>(A) Is necessary to prevent prejudice to a party;</P> <P>(B) Is necessary because of a disability of any individual expected to participate in the deposition; or</P> <P>(C) Would cost less than conducting the deposition by telephone.</P> <P>(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:</P> <P>(A) Is necessary to prevent prejudice to a party;</P> <P>(B) Is necessary because of a disability of any individual expected to participate in the deposition; or</P> <P>(C) Would cost less than conducting the deposition by telephone or audio-visual telecommunication.</P> <P>(e) <E T="03">Qualifications of officer.</E> 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.</P> <P>(f) <E T="03">Procedure on examination.</E> 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.</P> <P>(g) <E T="03">Certification and filing by officer.</E> 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.</P> <P>(h) <E T="03">Service; correction.</E> 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.</P> <P>(i) <E T="03">Use.</E> If a written hearing is held, a transcript or recording, of a deposition ordered and taken in accord with this section, may be made a part of the record as evidence by any party, by written motion filed with such party's evidence. If an oral hearing is held, except as otherwise provided in these rules, such a transcript or recording may be made a part of the record as evidence, on written motion filed by <PRTPAGE P="39"/>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:</P> <P>(1) That the witness is dead;</P> <P>(2) That the witness is unable to attend or testify for any good reason including age, sickness, infirmity, or imprisonment;</P> <P>(3) That the party offering the transcript or recording has tried without success to procure the attendance of the witness by subpoena; or</P> <P>(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.</P> <FP>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.</FP> <P>(j) <E T="03">Expenses.</E> 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.</P> <P>(k) <E T="03">Subpoenas.</E> No subpoena can issue, to compel attendance, testimony, or production of documentary evidence, at an examination under this rule 9.</P> <P>(l) <E T="03">Agreement of parties.</E> 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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990; 60 FR 8465, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.110</SECTNO> <SUBJECT>Rule 10: Prehearing conference.</SUBJECT> <P>(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:</P> <P>(1) The simplification of issues;</P> <P>(2) The necessity of amendments to pleadings;</P> <P>(3) The possibility of obtaining stipulations of fact and of the authenticity, accuracy, and admissibility of documents, which will avoid unnecessary proof;</P> <P>(4) The limitation of the number of expert or other witnesses;</P> <P>(5) The negotiation, compromise, or settlement of issues;</P> <P>(6) The exchange of copies of proposed exhibits;</P> <P>(7) The identification of documents or matters of which official notice may be requested;</P> <P>(8) A schedule to be followed by the parties for completion of the actions decided at the conference; or</P> <P>(9) Such other matters as may expedite and aid in the disposition of the proceeding.</P> <FP>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.</FP> <P>(b) <E T="03">Manner of the prehearing conference.</E> (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:</P> <P>(i) Is necessary to prevent prejudice to a party;</P> <P>(ii) Is necessary because of a disability of any individual expected to participate in the prehearing conference; or</P> <P>(iii) Would cost less than conducting the prehearing conference by telephone or correspondence. If the presiding officer determines that a prehearing conference conducted by audio-visual telecommunication would measurably increase the United States Department of Agriculture's cost of conducting the prehearing conference, the prehearing conference shall be conducted by personal attendance of any individual who is expected to participate in the prehearing conference, by telephone, or by correspondence.<PRTPAGE P="40"/> </P> <P>(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:</P> <P>(i) Is necessary to prevent prejudice to a party;</P> <P>(ii) Is necessary because of a disability of any individual expected to participate in the prehearing conference; or</P> <P>(iii) Would cost less than conducting the prehearing conference by audio-visual telecommunication.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 60 FR 8466, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.111</SECTNO> <SUBJECT>Rule 11: Hearing, oral or written.</SUBJECT> <P>(a) <E T="03">When held.</E> A hearing, oral or written, shall be held unless:</P> <P>(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;</P> <P>(2) Each respondent admits liability to the complainant in the full amount claimed by the complainant as reparation;</P> <P>(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</P> <P>(4) Before a hearing has been completed the parties settle their dispute or the complainant withdraws the complaint.</P> <P>(b) <E T="03">Whether oral or written.</E> The hearing provided for in paragraph (a) of this section shall be oral if:</P> <P>(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</P> <P>(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</P> <P>(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.</P> <P>(c) <E T="03">Withdrawal of request.</E> 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.</P> <P>(d) <E T="03">Presiding Officer's recommendation.</E> 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.</P> <P>(e) <E T="03">Representation.</E> 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.</P> <CITA>[51 FR 42083, Nov. 21, 1986, as amended at 55 FR 41184, Oct. 10, 1990]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.112</SECTNO> <SUBJECT>Rule 12: Oral hearing.</SUBJECT> <P>(a) <E T="03">Time, place, and manner.</E> (1) If and when the proceeding has reached the stage where an oral hearing is to be held, the presiding officer shall set a time, place, and manner for oral hearing. The time shall be set based upon careful consideration to the convenience of the parties. The place shall be set in accordance with paragraph (a)(2) of this section and careful consideration to the convenience of the parties. <PRTPAGE P="41"/>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.</P> <P>(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.</P> <P>(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:</P> <P>(i) Is necessary to prevent prejudice to a party;</P> <P>(ii) Is necessary because of a disability of any individual expected to participate in the hearing; or</P> <P>(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.</P> <P>(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:</P> <P>(i) Would provide a full and fair evidentiary hearing;</P> <P>(ii) Would not prejudice any party; and</P> <P>(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.</P> <P>(b) <E T="03">Notice.</E> (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.</P> <P>(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.</P> <P>(3) Within 10 days after the presiding officer issues a notice stating the manner in which the hearing is to be conducted, any party may move that the presiding officer reconsider the manner in which the hearing is to be conducted. Any motion for reconsideration must be accompanied by a memorandum in support of the motion stating the basis for the motion and the circumstances that require the hearing to be conducted other than in accordance with the presiding officer's notice.</P> <P>(c) <E T="03">Failure to appear.</E> 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 <PRTPAGE P="42"/>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.</P> <P>(d) <E T="03">Order of proceeding.</E> Complainant shall proceed first, if present at the commencement of the oral hearing.</P> <P>(e) <E T="03">Written statements of direct testimony.</E> (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.</P> <P>(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.</P> <P>(f) <E T="03">Evidence</E>—(1) <E T="03">In general.</E> 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.</P> <P>(2) <E T="03">Objections.</E> 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.</P> <P>(3) <E T="03">Offer of proof.</E> 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.</P> <P>(4) <E T="03">Depositions and affidavits.</E> Except as is otherwise provided in these rules, admission of the deposition of any witness shall be subject to the provisions of rule 9, § 202.109, and affidavits, and statements under penalty of perjury as provided in 28 U.S.C. 1746, Pub. L. 94-550, may be admitted only if the evidence is otherwise admissible and no party objects.</P> <P>(5) <E T="03">Department records.</E> 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 <PRTPAGE P="43"/>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.</P> <P>(6) <E T="03">Exhibits.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(g) <E T="03">Subpoenas</E>—(1) <E T="03">Issuance.</E> 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.</P> <P>(2) <E T="03">Service; proof of service.</E> 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.</P> <P>(h) <E T="03">Oral argument.</E> 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.</P> <P>(i) <E T="03">Transcript or recording.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(j) <E T="03">Filing, and presiding officer's certificate, of the transcript or recording.</E> As soon as practicable after the close of the oral hearing, the reporter shall transmit to the presiding officer the original transcript or recording of the testimony, and as many copies of the transcript or recording as may be required by paragraph (j) of this section for the area offices of the Agency and as may be required for the Washington office of the Agency. At the same time <PRTPAGE P="44"/>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 originally transcribed or recorded) at the appropriate places any words necessary to make the text conform to the correct meaning, as certified by the presiding officer. The presiding officer shall send the copies of the transcript or recording to the hearing clerk who shall send them to the Agency.</P> <P>(k) <E T="03">Keeping of copies of the transcript or recording.</E> 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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990; 60 FR 8466, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.113</SECTNO> <SUBJECT>Rule 13: Written hearing.</SUBJECT> <P>(a) <E T="03">Evidence.</E> 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, § 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.</P> <P>(b) <E T="03">Verification.</E> 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.</P> <P>(c) <E T="03">Complainant's evidence.</E> The complainant shall be served with notice of an opportunity to file evidence. Within 20 days after such service, the complainant may file evidence. What the complainant files in response to that notice shall be served promptly on the respondent.<PRTPAGE P="45"/> </P> <P>(d) <E T="03">Respondent's evidence.</E> 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.</P> <P>(e) <E T="03">Complainant's rebuttal.</E> 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.</P> <P>(f) <E T="03">Failure to file.</E> Failure to file any evidence authorized under this section, within the time prescribed, shall constitute a waiver of the right to file such evidence.</P> <P>(g) <E T="03">Extension of time for depositions.</E> If any party timely files an application for an order for the taking of testimony by deposition pursuant to rule 9, § 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.</P> <P>(h) <E T="03">Investigation report.</E> 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, § 202.104.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.114</SECTNO> <SUBJECT>Rule 14: Post-hearing procedure.</SUBJECT> <P>(a) <E T="03">Oral hearing.</E> 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.</P> <P>(b) <E T="03">Written hearing.</E> 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.</P> <P>(c) <E T="03">Service; delay in preparation of report.</E> 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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 55 FR 41184, Oct. 10, 1990]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.115</SECTNO> <SUBJECT>Rule 15: Submission for final consideration.</SUBJECT> <P>(a) <E T="03">Report.</E> 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.</P> <P>(b) <E T="03">Record.</E> 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.</P> <P>(c) <E T="03">Submission to judicial officer.</E> Unless the hearing clerk reasonably believes that the record is not complete and in proper order, the record and the report shall be submitted to the judicial officer for decision.<PRTPAGE P="46"/> </P> <P>(d) <E T="03">Oral argument.</E> There shall be no right to oral argument other than that provided in rule 12(h), § 202.112(h).</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 60 FR 8467, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.116</SECTNO> <SUBJECT>Rule 16: Issuance of order.</SUBJECT> <P>(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.</P> <P>(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, § 202.117.</P> </SECTION> <SECTION> <SECTNO>§ 202.117</SECTNO> <SUBJECT>Rule 17: Petition to reopen a hearing; to rehear or reargue a proceeding; to reconsider an order; or to set aside a default order.</SUBJECT> <P>(a) <E T="03">Filing of petition</E>—(1) <E T="03">To reopen a hearing.</E> 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.</P> <P>(2) <E T="03">To rehear or reargue a proceeding or reconsider an order.</E> 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.</P> <P>(3) <E T="03">To set aside a default order.</E> 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.</P> <P>(b) <E T="03">Brief or memorandum of law.</E> 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.</P> <P>(c) <E T="03">Procedure.</E> 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.</P> <P>(d) <E T="03">Service; answer.</E> No such petition shall be granted unless it, with the brief or memorandum of law in support of it, if any, is first served on each party to the proceeding other than the one filing it. Each such other party, within 20 days after such service on such party, may file an answer to such petition. If any such party wishes to file a brief or memorandum of law in support of such an answer, it must be filed with such answer. Any such answer, with the brief or memorandum of law in support of it, if any, shall be served on each party to the proceeding other than the one filing it. Any such petition may be denied without such service.<PRTPAGE P="47"/> </P> <P>(e) <E T="03">Submission for decision; service of order.</E> 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.</P> <P>(f) <E T="03">Practice upon decision.</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 202.118</SECTNO> <SUBJECT>Rule 18: Presiding officer.</SUBJECT> <P>(a) <E T="03">Powers.</E> Subject to review as provided elsewhere in these rules, the presiding officer assigned to any proceeding shall have power to:</P> <P>(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;</P> <P>(2) Administer oaths and affirmations;</P> <P>(3) Issue subpoenas requiring the attendance and testimony of witnesses and the production of documentary evidence at an oral hearing;</P> <P>(4) Summon and examine witnesses and receive evidence at an oral hearing;</P> <P>(5) Take or order the taking of depositions;</P> <P>(6) Admit or exclude evidence;</P> <P>(7) Hear oral argument on facts or law;</P> <P>(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;</P> <P>(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;</P> <P>(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;</P> <P>(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</P> <P>(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.</P> <P>(b) <E T="03">Motions and requests.</E> 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, <E T="03">Provided,</E> 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.</P> <P>(c) <E T="03">Reassignment.</E> 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.</P> <P>(d) <E T="03">Disqualification.</E> 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.</P> <P>(e) <E T="03">Procedure on petition for disqualification.</E> Any party may file a petition <PRTPAGE P="48"/>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.</P> <CITA>[43 FR 30510, July 14, 1978, as amended at 60 FR 8467, Feb. 14, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 202.119</SECTNO> <SUBJECT>Rule 19: Fees of witnesses.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.120</SECTNO> <SUBJECT>Rule 20: Official notice.</SUBJECT> <P>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: <E T="03">Provided,</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 202.121</SECTNO> <SUBJECT>Rule 21: Intervention.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 202.122</SECTNO> <SUBJECT>Rule 22: Ex parte communications.</SUBJECT> <P>(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: <E T="03">Provided,</E> That procedural matters shall not be included within this limitation; and <E T="03">Provided further,</E> 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.</P> <P>(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.</P> <P>(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:</P> <P>(1) Such communication if written, or a memorandum stating the substance of such communication if oral; and</P> <P>(2) A copy of any written response or a memorandum stating the substance of any oral response thereto.</P> <P>(d) Copies of all such items placed or included in the record, as provided in this section, shall be served on all parties.</P> <P>(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 <PRTPAGE P="49"/>not given, but it shall not include a request for a status report on any matter or the proceeding.</P> </SECTION> <SECTION> <SECTNO>§ 202.123</SECTNO> <SUBJECT>Rule 23: Action by Secretary.</SUBJECT> <P>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.</P> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Rules of Practice Applicable to All Other Proceedings</HD> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>Sections 202.200 and 202.210 were added at 72 FR 19109, Apr. 17, 2007, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 202.200</SECTNO> <SUBJECT>Scope and applicability of rules of practice.</SUBJECT> <P>The Uniform Rules of Practice for the Department of Agriculture promulgated in Subpart H of Part 1, Subtitle A, Title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the Packers and Stockyards Act, as amended (7 U.S.C. 181 <E T="03">et seq.</E>). In addition, the Supplemental Rules of Practice set forth in this part shall be applicable to such proceedings.</P> </SECTION> <SECTION> <SECTNO>§ 202.210</SECTNO> <SUBJECT>Stipulations.</SUBJECT> <P>(a) The Administrator may enter into a stipulation with any person operating subject to the Packers and Stockyards Act, as amended (P&S Act), prior to issuing a complaint that seeks a civil penalty against that person.</P> <P>(1) The Administrator will give the person notice of an alleged violation of the P&S Act or regulations and provide an opportunity for a hearing;</P> <P>(2) The person has the option to expressly waive the opportunity for a hearing and agree to pay a specified civil penalty within a designated time;</P> <P>(3) The Administrator will agree to settle the matter by accepting payment of the specified civil penalty within a designated time;</P> <P>(4) If the person does not agree to the stipulation, or does not pay the penalty within the specified time, the Administrator may issue an administrative complaint citing the alleged violation; and</P> <P>(5) The civil penalty that the Administrator proposed in a stipulation agreement has no bearing on the civil penalty amount that may be sought in a formal administrative proceeding against the same person for the same alleged violation.</P> <P>(b) [Reserved]</P> </SECTION> </SUBJGRP> </PART> <PART> <EAR>Pt. 203</EAR> <HD SOURCE="HED">PART 203—STATEMENTS OF GENERAL POLICY UNDER THE PACKERS AND STOCKYARDS ACT</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>203.1</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.2</SECTNO> <SUBJECT>Statement of general policy with respect to the giving by meat packers of meat and other gifts to Government employees.</SUBJECT> <SECTNO>203.3</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.4</SECTNO> <SUBJECT>Statement with respect to the disposition of records by packers, live poultry dealers, stockyard owners, market agencies and dealers.</SUBJECT> <SECTNO>203.5</SECTNO> <SUBJECT>Statement with respect to market agencies paying the expenses of livestock buyers.</SUBJECT> <SECTNO>203.6</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.7</SECTNO> <SUBJECT>Statement with respect to meat packer sales and purchase contracts.</SUBJECT> <SECTNO>203.8-203.9</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.10</SECTNO> <SUBJECT>Statement with respect to insolvency; definition of current assets and current liabilities.</SUBJECT> <SECTNO>203.11</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.12</SECTNO> <SUBJECT>Statement with respect to providing services and facilities at stockyards on a reasonable and nondiscriminatory basis.</SUBJECT> <SECTNO>203.13</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>203.14</SECTNO> <SUBJECT>Statement with respect to advertising allowances and other merchandising payments and services.</SUBJECT> <SECTNO>203.15</SECTNO> <SUBJECT>Trust benefits under sections 206 and 207 of the Act.</SUBJECT> <SECTNO>203.16</SECTNO> <SUBJECT>Mailing of checks in payment for livestock purchased for slaughter, for cash and not on credit.</SUBJECT> <SECTNO>203.17</SECTNO> <SUBJECT>Statement of general policy with respect to rates and charges at posted stockyards.</SUBJECT> <SECTNO>203.18</SECTNO> <SUBJECT>Statement with respect to packers engaging in the business of custom feeding livestock.</SUBJECT> <SECTNO>203.19</SECTNO> <SUBJECT>Statement with respect to packers engaging in the business of livestock dealers or buying agencies.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 CFR 2.22 and 2.81.</P> </AUTH> <SECTION> <PRTPAGE P="50"/> <SECTNO>§ 203.1</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.2</SECTNO> <SUBJECT>Statement of general policy with respect to the giving by meat packers of meat and other gifts to Government employees.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(c) Upon the basis of paragraphs (a) and (b) of this section, it is the view of the Department that it is an unfair and deceptive practice in violation of section 202(a) of the Packers and Stockyards Act (7 U.S.C. 192(a)) for any person subject to the provisions of Title II of said Act to give or offer to give meat, money, or anything of value to any Government employee who performs inspection, grading, reporting, or regulatory duties directly relating to the purchase or sale of livestock or the preparation or distribution of meats, meat food products, livestock products in unmanufactured form, poultry or poultry products.</P> <SECAUTH>(Sec. 407, 42 Stat. 169; 7 U.S.C. 228; 9 CFR 201.3)</SECAUTH> <CITA>[26 FR 710, Jan. 25, 1961; 29 FR 4081, Mar. 28, 1964]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.3</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.4</SECTNO> <SUBJECT>Statement with respect to the disposition of records by packers, live poultry dealers, stockyard owners, market agencies and dealers.</SUBJECT> <P>(a) <E T="03">Records to be kept.</E> 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.</P> <P>(b) <E T="03">Records may be disposed of after two years except as otherwise provided.</E> 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; <E T="03">Provided,</E> 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 <PRTPAGE P="51"/>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 <E T="03">Provided further,</E> That microfilm copies of records may be substituted for and retained in lieu of the actual records.</P> <P>(c) <E T="03">Retention for longer periods may be required.</E> 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.</P> <P>(d) <E T="03">Unauthorized disposal of records.</E> 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 <E T="03">et seq.</E>).</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 6085, Feb. 17, 1984, as amended at 54 FR 16357, Apr. 24, 1989; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.5</SECTNO> <SUBJECT>Statement with respect to market agencies paying the expenses of livestock buyers.</SUBJECT> <P>It has become a practice in certain areas of the country for market agencies, engaged in the business of selling consigned livestock on a commission basis, to pay certain of the business or personal expenses incurred by buyers attending livestock sales conducted by such market agencies, such as, expenses for meals, lodging, travel, entertainment and long distance telephone calls. Investigation by the Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), discloses that this practice tends to become a method of competition between similarly engaged market agencies and results in undue and unreasonable cost burdens on such market agencies and the livestock producers who sell their livestock through such market agencies.</P> <P>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.</P> <SECAUTH>(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)</SECAUTH> <CITA>[29 FR 311, Jan. 14, 1964; 29 FR 3304, Mar. 12, 1964, as amended at 32 FR 7700, May 26, 1967]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.6</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.7</SECTNO> <SUBJECT>Statement with respect to meat packer sales and purchase contracts.</SUBJECT> <P>(a) The Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs) receives <PRTPAGE P="52"/>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.</P> <P>(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:</P> <P>(1) <E T="03">Terms of shipment and time of arrival.</E> 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.</P> <P>(2) <E T="03">Quality and condition.</E> (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.</P> <P>(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.</P> <P>(iii) All terms of a transaction should be made clear in the contract, whether written or verbal. If there is any chance of misunderstanding, a written confirmation should be exchanged between the parties. In any case where a contract dispute cannot be settled between the parties and either party intends to file a complaint, such complaint should be brought to the attention of the nearest Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs) area office as soon as possible. However, a concerted effort on the part of both buyer and seller to negotiate clear and complete contracts will greatly reduce misunderstandings which can result in the filing of complaints with the Administration.</P> <P>(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.</P> <SECAUTH>(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)</SECAUTH> <CITA>[30 FR 14966, Dec. 3, 1965, as amended at 32 FR 7701, May 26, 1967]</CITA> </SECTION> <SECTION> <SECTNO>§§ 203.8-203.9</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.10</SECTNO> <SUBJECT>Statement with respect to insolvency; definition of current assets and current liabilities.</SUBJECT> <P>(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. <E T="03">Bowman v. United States Department of Agriculture,</E> 363 F. 2d 81 (5th Cir. 1966).</P> <P>(b) For the purposes of the administration of the Packers and Stockyards Act, 1921, the following terms shall be construed, respectively, to mean:</P> <P>(1) <E T="03">Current assets</E> means cash and other assets or resources commonly <PRTPAGE P="53"/>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.</P> <P>(2) <E T="03">Current liabilities</E> 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.</P> <P>(c) The term current assets generally includes: (1) Cash in bank or on hand; (2) sums due a market agency from a custodial account for shippers' proceeds; (3) accounts receivable, if collectable; (4) notes receivable and portions of long-term notes receivable within one year from date of balance sheet, if collectable; (5) inventories of livestock acquired for purposes of resale or for purposes of market support; (6) feed inventories and other inventories which are intended to be sold or consumed in the normal operating cycle of the business; (7) accounts due from employees, if collectable; (8) accounts due from officers of a corporation, if collectable; (9) accounts due from affiliates and subsidiaries of corporations if the financial position of such subsidiaries and affiliates justifies such classification; (10) marketable securities representing cash available for current operations and not otherwise pledged as security; (11) accrued interest receivable; and (12) prepaid expenses.</P> <P>(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.</P> <P>(e) The term current liabilities generally includes: (1) Bank overdrafts (per books); (2) amounts due a custodial account for shippers' proceeds; (3) accounts payable within one year from date of balance sheet; (4) notes payable or portions thereof due and payable within one year from date of balance sheet; (5) accruals such as taxes, wages, social security, unemployment compensation, etc., due and payable as of the date of the balance sheet; and (6) all other liabilities whose regular and ordinary liquidation is expected to occur within one year.</P> <SECAUTH>(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)</SECAUTH> <CITA>[32 FR 6901, May 5, 1967]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.11</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.12</SECTNO> <SUBJECT>Statement with respect to providing services and facilities at stockyards on a reasonable and nondiscriminatory basis.</SUBJECT> <P>(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 * * *.”</P> <P>(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 * * *.”</P> <P>(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 * * *.”</P> <P>(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 <PRTPAGE P="54"/>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.”</P> <P>(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.”</P> <P>(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.</P> <P>(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.</P> <SECAUTH>(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)</SECAUTH> <CITA>[33 FR 17621, Nov. 26, 1968]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.13</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 203.14</SECTNO> <SUBJECT>Statement with respect to advertising allowances and other merchandising payments and services.</SUBJECT> <EXTRACT> <HD SOURCE="HD3">The Guidelines</HD> <P>1. <E T="03">Who is a customer?</E> (a) A <E T="03">customer</E> is a person who buys for resale directly from the packer, or through the packer's agent or broker; and in addition, a customer is any buyer of the packer's product for resale who purchases from or through a wholesaler or other intermediate reseller. </P> <NOTE> <HD SOURCE="HED">(Note:</HD> <P>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.)</P> </NOTE> <P>(b) <E T="03">Competing customers</E> 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.</P> </EXTRACT> <EXAMPLE> <HD SOURCE="HED">Example:</HD> <P>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.</P> </EXAMPLE> <EXTRACT> <P>2. <E T="03">Definition of services. Services</E> 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.</P> <P>3. <E T="03">Need for a plan.</E> 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:</P> <P>(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, <PRTPAGE P="55"/>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.</P> </EXTRACT> <EXAMPLE> <HD SOURCE="HED">Example 1:</HD> <P>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.</P> </EXAMPLE> <EXAMPLE> <HD SOURCE="HED">Example 2:</HD> <P>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.</P> </EXAMPLE> <EXAMPLE> <HD SOURCE="HED">Example 3:</HD> <P>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.</P> </EXAMPLE> <EXTRACT> <P>(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.</P> <P>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:</P> <P>(1) The packer may enter into contracts with its wholesaler, distributors or other third parties which conform to the requirements of item 5, infra.</P> <P>(2) The packer may place appropriate announcements on product containers or inside thereof with conspicuous notice of such enclosure on the outside.</P> <P>(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.</P> </EXTRACT> <EXAMPLE> <HD SOURCE="HED">Example 1:</HD> <P>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.</P> </EXAMPLE> <EXAMPLE> <HD SOURCE="HED">Example 2:</HD> <P>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.</P> </EXAMPLE> <EXAMPLE> <HD SOURCE="HED">Example 3:</HD> <P>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.</P> <P>(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.)</P> </EXAMPLE> <EXTRACT> <P>(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 <PRTPAGE P="56"/>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.</P> <P>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.</P> </EXTRACT> <EXAMPLE> <HD SOURCE="HED">Example 1:</HD> <P>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.</P> </EXAMPLE> <EXAMPLE> <HD SOURCE="HED">Example 2:</HD> <P>A packer offers a plan for cooperative advertising on radio, television, or in newspapers of general circulation.<SU>1</SU> <FTREF/> 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.</P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> </EXAMPLE> <EXTRACT> <P>(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.</P> <P>(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.<SU>2</SU> <FTREF/> </P> <FTNT> <P> <SU>2</SU> 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.</P> </FTNT> <P>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.</P> <P>(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.)</P> <P>4. <E T="03">Competing customers.</E> 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.</P> <P>5. <E T="03">Wholesaler or third party performance of packer's obligations.</E> A packer may, in good faith, enter into written agreements with <PRTPAGE P="57"/>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:</P> <P>(1) Give notice to the packer's customers in conformity with the standards set forth in items 3(b) and (d), supra;</P> <P>(2) Check customer performance in conformity with the standards set forth in item 3(e), supra;</P> <P>(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</P> <P>(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.</P> <P>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.</P> <P>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.</P> <P>6. <E T="03">Customer's liability.</E> A customer, subject to the Packers and Stockyards Act, who knows, or should know, that it is receiving payments or services which are not available on proportionally equal terms to its competitors engaged in the resale of the same packer's products may be in violation of the provisions of the Act. Also, customers (subject to the Packers and Stockyards Act) that make unauthorized deductions from purchase invoices for alleged advertising or other promotional allowances may be proceeded against under the provisions of the Act.</P> </EXTRACT> <EXAMPLE> <HD SOURCE="HED">Example:</HD> <P>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.</P> </EXAMPLE> <EXTRACT> <P>7. <E T="03">Meeting competition.</E> 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.”</P> <P>8. <E T="03">Cost justification.</E> 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.</P> </EXTRACT> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[58 FR 52886, Oct. 13, 1993; 58 FR 58902, Nov. 4, 1993, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.15</SECTNO> <SUBJECT>Trust benefits under sections 206 and 207 of the Act.</SUBJECT> <P>(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 <PRTPAGE P="58"/>live poultry dealer within the prescribed time by letter, mailgram, or telegram stating:</P> <P>(1) Notification to preserve trust benefits:</P> <P>(2) Identification of packer or live poultry dealer;</P> <P>(3) Identification of seller or poultry grower;</P> <P>(4) Date of the transaction;</P> <P>(5) Date of seller's or poultry grower's receipt of notice that payment instrument has been dishonored (if applicable); and</P> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <CITA>[54 FR 16357, Apr. 24, 1989, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.16</SECTNO> <SUBJECT>Mailing of checks in payment for livestock purchased for slaughter, for cash and not on credit.</SUBJECT> <P>(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: </P> <EXTRACT> <P>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.</P> <P>I hereby direct (name of packer, market agency, or dealer) to make payment for livestock purchased from me, by mailing a check for the full amount of the purchase price before the close of the next business day following the purchase of livestock and transfer of possession thereof or, in the case of a purchase on a “carcass” or “grade and yield” basis, not later than the close of the first business day following determination of the purchase price.</P> <P>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.</P> </EXTRACT> <FP>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.</FP> <P>(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).</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(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)</SECAUTH> <CITA>[42 FR 49929, Sept. 28, 1977, as amended at 49 FR 39516, Oct. 9, 1984; 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.17</SECTNO> <SUBJECT>Statement of general policy with respect to rates and charges at posted stockyards.</SUBJECT> <P>(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 <PRTPAGE P="59"/>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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a, 222 and 228)</SECAUTH> <CITA>[49 FR 33004, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.18</SECTNO> <SUBJECT>Statement with respect to packers engaging in the business of custom feeding livestock.</SUBJECT> <P>(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.</P> <P>(b) Packers contemplating entering into such arrangements with custom feedlots are encouraged to consult with the Administration prior to the commencement of such activities. Custom feedlots are not only places of production, but are also important marketing centers, and in connection with the operation of a custom feedlot, it is customary for the feedlot operator to assume responsibility for marketing fed livestock for the accounts of feedlot customers. When a custom feedlot is owned or operated by a packer, and when such packer purchases fed livestock from the feedlot, this method of operation potentially gives rise to a conflict of interest. In such situations, the packer's interest in the fed livestock as a buyer is in conflict with its obligations to feedlot customers to market their livestock to the customer's best advantage. Under these circumstances, the packer should take appropriate measures to eliminate any conflict of interest. At a minimum, such measures should insure:</P> <P>(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;</P> <P>(2) That all feedlot customers are treated equally by the packer/custom feedlot in connection with the marketing of fed livestock; and</P> <P>(3) That marketing decisions rest solely with the feedlot customer unless otherwise expressly agreed.</P> <P>(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.</P> <P>(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, <PRTPAGE P="60"/>and, where warranted, appropriate action will be taken.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 203, 204, 207, 217a, 222 and 228)</SECAUTH> <CITA>[49 FR 33004, Aug. 20, 1984, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> <SECTION> <SECTNO>§ 203.19</SECTNO> <SUBJECT>Statement with respect to packers engaging in the business of livestock dealers or buying agencies.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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:</P> <P>(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.</P> <P>(d) In the event a packer/dealer or a packer/buying agency arrangement appears to give rise to a violation of the Act, an investigation will be made on a case-by-case basis and, where warranted, appropriate action will be taken.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0015)</APPRO> <SECAUTH>(7 U.S.C. 228, 228b, 222, 15 U.S.C. 46)</SECAUTH> <CITA>[49 FR 32845, Aug. 17, 1984; 54 FR 26349, June 23, 1989, as amended at 68 FR 75388, Dec. 31, 2003]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 204</EAR> <HD SOURCE="HED">PART 204—ORGANIZATION AND FUNCTIONS</HD> <CONTENTS> <SUBJGRP> <HD SOURCE="HED">Public Information</HD> <SECHD>Sec.</SECHD> <SECTNO>204.1</SECTNO> <SUBJECT>Introduction.</SUBJECT> <SECTNO>204.2</SECTNO> <SUBJECT>Organization.</SUBJECT> <SECTNO>204.3</SECTNO> <SUBJECT>Delegation of authority.</SUBJECT> <SECTNO>204.4</SECTNO> <SUBJECT>Public inspection and copying.</SUBJECT> <SECTNO>204.5</SECTNO> <SUBJECT>Indexes.</SUBJECT> <SECTNO>204.6</SECTNO> <SUBJECT>Requests for records.</SUBJECT> <SECTNO>204.7</SECTNO> <SUBJECT>Appeals.</SUBJECT> </SUBJGRP> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>5 U.S.C. 552.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>49 FR 46528, Nov. 27, 1984, unless otherwise noted.</P> </SOURCE> <SUBJGRP> <HD SOURCE="HED">Public Information</HD> <SECTION> <SECTNO>§ 204.1</SECTNO> <SUBJECT>Introduction.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 204.2</SECTNO> <SUBJECT>Organization.</SUBJECT> <P>(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 <PRTPAGE P="61"/>Poultry Division and the Livestock Marketing Division.</P> <P>(b) <E T="03">Office of the Administrator.</E> 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 <E T="03">et seq.</E>), 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.</P> <P>(1) <E T="03">Administrator.</E> 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.</P> <P>(2) <E T="03">Deputy Administrator.</E> 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).</P> <P>(3) <E T="03">Assistant to the Administrator.</E> 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).</P> <P>(4) <E T="03">Director, Industry Analysis Staff.</E> The Director of the Industry Analysis Staff participates with the Administrator and Deputy Administrator in the development and analysis of policies and programs and directs economic studies of structure and performance of the livestock, meat, and poultry marketing, processing, and wholesaling industries. The results of these studies are used to provide economic advice to the Administrator in developing overall policy on antitrust matters and effects of practices or impediments in the marketing system. The Director works closely with the Directors of the Packer and Poultry and the Livestock Marketing Divisions in connection with investigations to provide economic advice and expert testimony in trials and administrative hearings. The Director also coordinates activities and works closely with the Federal Trade Commission and Justice Department in studying the effects of mergers and antitrust matters in the livestock, meat packing and poultry industries.</P> <P>(c) <E T="03">Packer and Poultry Division.</E> 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.</P> <P>(d) <E T="03">Livestock Marketing Division.</E> This Division enforces those provisions of <PRTPAGE P="62"/>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.</P> <P>(e) <E T="03">Field Services.</E> (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.</P> <P>(2) The addresses and the States covered by these offices, which are under regional supervisors, are as follows: </P> <EXTRACT> <FP SOURCE="FP-1">Atlanta—Room 338, 1720 Peachtree Street, NW., Atlanta, Georgia 30309 (Alabama, Florida, Georgia, South Carolina)</FP> <FP SOURCE="FP-1">Bedford—Turnpike Road, Box 101E, Bedford, Virginia 25423 (District of Columbia, Delaware, Maryland, North Carolina, Virginia, West Virginia)</FP> <FP SOURCE="FP-1">Denver—208 Livestock Exchange Building, Denver, Colorado 80216 (Colorado, Montana, New Mexico, Utah, Wyoming)</FP> <FP SOURCE="FP-1">Fort Worth—Room 8A36, Federal Building, 819 Taylor Street, Fort Worth, Texas 76102 (Oklahoma, Texas)</FP> <FP SOURCE="FP-1">Indianapolis—Room 434 Federal Building and U.S. Courthouse, 46 E. Ohio Street, Indianapolis, Indiana 46204 (Illinois, Indiana, Kentucky, Michigan, Ohio)</FP> <FP SOURCE="FP-1">Kansas City—828 Livestock Exchange Building, Kansas City, Missouri 64102 (Kansas, Missouri)</FP> <FP SOURCE="FP-1">Lawndale—15000 Aviation Boulevard, Room 2W6, P.O. Box 6102, Lawndale, California 90261 (Arizona, California, Hawaii, Nevada)</FP> <FP SOURCE="FP-1">Memphis—Room 459, Federal Building, 167 Main Street, Memphis, Tennessee 38103 (Arkansas, Louisiana, Mississippi, Tennessee)</FP> <FP SOURCE="FP-1">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)</FP> <FP SOURCE="FP-1">Omaha—909 Livestock Exchange Building, Omaha, Nebraska 68107 (Iowa, Nebraska)</FP> <FP SOURCE="FP-1">Portland—9370 S.W. Greenburg Road, Suite E, Portland, Oregon 97223 (Alaska, Idaho, Oregon, Washington)</FP> <FP SOURCE="FP-1">South St. Paul—208 Post Office Building, Box 8, South St. Paul, Minnesota 55075 (Minnesota, North Dakota, South Dakota, Wisconsin)</FP> </EXTRACT> </SECTION> <SECTION> <SECTNO>§ 204.3</SECTNO> <SUBJECT>Delegation of authority.</SUBJECT> <P>(a) <E T="03">Deputy Administrator.</E> 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).</P> <P>(b) <E T="03">Division Directors.</E> 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 <PRTPAGE P="63"/>with the respective functions assigned to each of said organizational units in § 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.</P> <P>(c) <E T="03">Regional Supervisors.</E> (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 § 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 § 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.</P> <P>(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.</P> <P>(d) <E T="03">Investigative employees.</E> 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 <E T="03">et seq.</E>), or the enforcement of the Truth-in-Lending Act (15 U.S.C. 1601-1665), with respect to any activities subject to the Packers and Stockyards Act, are hereby individually delegated authority under the Act of January 31, 1925, 43 Stat. 803, 7 U.S.C. 2217, to administer to or take from any person an oath, affirmation, or affidavit whenever such oath, affirmation, or affidavit is for use in any prosecution or proceeding under or in the enforcement of the aforementioned Acts. This authority may not be redelegated and will automatically expire upon the termination of the employment of such employees with the Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs).</P> <P>(e) <E T="03">Concurrent authority.</E> 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.</P> <P>(f) <E T="03">Prior delegations.</E> 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.</P> <P>(g) <E T="03">Reservations of authority.</E> It is hereby reserved to the Administrator and Deputy Administrator authority with respect to proposed rulemaking and final action for the issuance of regulations (§ 201.1 of this chapter <E T="03">et seq.</E>), rules of practice governing proceedings (§ 202.1 of this chapter <E T="03">et seq.</E>), and statements of general policy (§ 203.1 of this chapter <E T="03">et seq.</E>), 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, § 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 <PRTPAGE P="64"/>made or obtained in connection with the administration of the Packers and Stockyards Act which are considered exempt from disclosure under § 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.</P> </SECTION> <SECTION> <SECTNO>§ 204.4</SECTNO> <SUBJECT>Public inspection and copying.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 204.5</SECTNO> <SUBJECT>Indexes.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 204.6</SECTNO> <SUBJECT>Requests for records.</SUBJECT> <P>(a) Requests for records under 5 U.S.C. 552(a)(3) shall be made in accordance with 7 CFR 1.3(a). Authority to make determinations regarding initial requests in accordance with 7 CFR 1.4(c) is delegated to the Freedom of Information Act Officer of the Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs). Requests should be submitted to the FOIA Officer at the following address: Freedom of Information Act Officer (FOIA Request), Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), United States Department of Agriculture, Washington, DC 20250.</P> <P>(b) The request shall identify each record with reasonable specificity as prescribed in 7 CFR 1.3.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 204.7</SECTNO> <SUBJECT>Appeals.</SUBJECT> <P>Any person whose request under § 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.</P> </SECTION> </SUBJGRP> </PART> <PART> <EAR>Pt. 205</EAR> <HD SOURCE="HED">PART 205—CLEAR TITLE—PROTECTION FOR PURCHASERS OF FARM PRODUCTS</HD> <CONTENTS> <SUBJGRP> <HD SOURCE="HED">Definitions</HD> <SECHD>Sec.</SECHD> <SECTNO>205.1</SECTNO> <SUBJECT>Definitions.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Regulations</HD> <SECTNO>205.101</SECTNO> <SUBJECT>Certification—request and processing.</SUBJECT> <SECTNO>205.102</SECTNO> <SUBJECT>Name of person subjecting a farm product to a security interest, on EFS and master list—format.</SUBJECT> <SECTNO>205.103</SECTNO> <SUBJECT>EFS—minimum information.</SUBJECT> <SECTNO>205.104</SECTNO> <SUBJECT>Registration of buyer, commission merchant, or selling agent—minimum information.</SUBJECT> <SECTNO>205.105</SECTNO> <SUBJECT>Master list and portion thereof distributed to registrants—format.</SUBJECT> <SECTNO>205.106</SECTNO> <SUBJECT>Farm products.</SUBJECT> <SECTNO>205.107</SECTNO> <SUBJECT>Crop year.</SUBJECT> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Interpretive Opinions</HD> <SECTNO>205.201</SECTNO> <SUBJECT>System operator.</SUBJECT> <SECTNO>205.202</SECTNO> <SUBJECT>“Effective financing statement” or EFS.<PRTPAGE P="65"/> </SUBJECT> <SECTNO>205.203</SECTNO> <SUBJECT>Place of filing EFS.</SUBJECT> <SECTNO>205.204</SECTNO> <SUBJECT>Filing “notice” of EFS.</SUBJECT> <SECTNO>205.205</SECTNO> <SUBJECT>Fees.</SUBJECT> <SECTNO>205.206</SECTNO> <SUBJECT>Farm products.</SUBJECT> <SECTNO>205.207</SECTNO> <SUBJECT>“Amount” and “County or parish”.</SUBJECT> <SECTNO>205.208</SECTNO> <SUBJECT>Distribution of portions of master list—registration—information to non-registrants on request.</SUBJECT> <SECTNO>205.209</SECTNO> <SUBJECT>Amendment or continuation of EFS.</SUBJECT> <SECTNO>205.210</SECTNO> <SUBJECT>Effect of EFS outside State in which filed.</SUBJECT> <SECTNO>205.211</SECTNO> <SUBJECT>Applicability of court decisions under the UCC.</SUBJECT> <SECTNO>205.212</SECTNO> <SUBJECT>“Buyer in ordinary course of business” and “security interest.”</SUBJECT> <SECTNO>205.213</SECTNO> <SUBJECT>Obligations subject—“person indebted”—“debtor.”</SUBJECT> <SECTNO>205.214</SECTNO> <SUBJECT>Litigation as to whether a system is operating in compliance with the Section.</SUBJECT> </SUBJGRP> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 U.S.C. 1631; 7 CFR 2.22 and 2.81.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>51 FR 29451, Aug. 18, 1986, unless otherwise noted.</P> </SOURCE> <SUBJGRP> <HD SOURCE="HED">Definitions</HD> <SECTION> <SECTNO>§ 205.1</SECTNO> <SUBJECT>Definitions.</SUBJECT> <P>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:</P> <P> <E T="03">Approved Unique Identifier</E> means a combination of numbers selected by the Secretary of State using a selection system or method approved by the Secretary of Agriculture.</P> <P> <E T="03">EFS</E> means <E T="03">effective financing statement</E> as defined in subsection (c)(4);</P> <P> <E T="03">Master list</E> means the accumulation of data in paper, electronic, or other form, described in subsection (c)(2)(C);</P> <P> <E T="03">Portion</E> means portion of the master list distributed to registrants under subsection (c)(2)(E);</P> <P> <E T="03">Registrant</E> 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);</P> <P> <E T="03">The Secretary</E> means the Secretary of Agriculture of the United States;</P> <P> <E T="03">The Section</E> means section 1324 of the above-cited Act, and “subsection” means a subsection of that Section;</P> <P> <E T="03">System</E> means <E T="03">central filing system</E> as defined in subsection (c)(2);</P> <P> <E T="03">System operator</E> means Secretary of State or other person designated by a State to operate a system;</P> <P> <E T="03">UCC</E> or <E T="03">Uniform Commercial Code</E> 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.</P> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56342, Sept. 27, 2006; 72 FR 25948, May 8, 2007]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Regulations</HD> <SECTION> <SECTNO>§ 205.101</SECTNO> <SUBJECT>Certification—request and processing.</SUBJECT> <P>(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.</P> <P>(b) The request must:</P> <P>(1) Include an introductory explanation of how the system will operate;</P> <P>(2) Identify the information which will be required to be supplied on an EFS;</P> <P>(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;</P> <P>(4) Explain the method for recording the date and hour of filing of an EFS, amendment thereto, or continuation thereof;</P> <P>(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);<PRTPAGE P="66"/> </P> <P>(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);</P> <P>(7) Show how frequently portions of the master list will be distributed regularly to registrants;</P> <P>(8) Show the farm products according to which the master list will be organized;</P> <P>(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;</P> <P>(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;</P> <P>(11) If a unique identifier will be used in the system, explain how the unique identifier will be selected and how it will be used by the system, including, but not limited to, how lists will be organized, and how searches may be performed, using the unique identifier.</P> <P>(12) Include copies of:</P> <P>(i) All State legislation or other legal authority under which the system is created and operated, and the system operator is designated;</P> <P>(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</P> <P>(iii) All printed and electronic forms required to be used in connection with the system.</P> <P>(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 Packers and Stockyards Program, Grain Inspection, Packers and Stockyards Administration (GIPSA), USDA, Washington, DC 20250.</P> <P>(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.</P> <P>(e) To make changes to an existing certified central filing system, including changes necessitated or made possible by amendments to the Section, 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 Section. The request must contain relevant new information consistent with the requirements specified elsewhere in this section.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996; 71 FR 56342, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.102</SECTNO> <SUBJECT>Name of person subjecting a farm product to a security interest, on EFS and master list—format.</SUBJECT> <P>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:</P> <P>(a) In the case of a natural person, the surname (last name or family name) must appear first;</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56342, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.103</SECTNO> <SUBJECT>EFS—minimum information.</SUBJECT> <P>(a) The minimum information necessary on an EFS is as follows:</P> <P>(1) Crop year <E T="03">unless</E> every crop of the farm product in question, for the duration of the EFS, is to be subject to the particular security interest;</P> <P>(2) Farm product name (see §§ 205.106, 205.206);</P> <P>(3) Each county or parish in the same State where the farm product is produced or located;<PRTPAGE P="67"/> </P> <P>(4) Name and address of each person subjecting the farm product to the security interest, whether or not a debtor (see § 205.102);</P> <P>(5) Social security number or other approved unique identifier or, if other than a natural person, IRS taxpayer identification number or other approved unique identifier of each such person;</P> <P>(6) Further details of the farm product subject to the security interest <E T="03">if needed</E> to distinguish it from other such product owned by the same person or persons but not subject to the particular security interest (see § 205.207); and</P> <P>(7) Secured party name and address.</P> <P>(b) A requirement of additional information on an EFS is discretionary with the State.</P> <P>(c) Whether to permit one EFS to reflect multiple products, or products in multiple counties, is discretionary with the State.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56342, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.104</SECTNO> <SUBJECT>Registration of buyer, commission merchant, or selling agent—minimum information.</SUBJECT> <P>(a) The minimum information necessary on a registration of a buyer, commission merchant, or selling agent is as follows:</P> <P>(1) Buyer, commission merchant, or selling agent name and address;</P> <P>(2) Farm product or products (see §§ 205.106, 205.206) in which registrant is interested; and</P> <P>(3) If registrant is interested only in such product or products produced or located in a certain county or parish, or certain counties or parishes, in the same State, the name of each such county or parish.</P> <P>(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.</P> <P>(c) A requirement of additional information on a registration form is discretionary with the State.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56342, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.105</SECTNO> <SUBJECT>Master list and portion thereof distributed to registrants—format.</SUBJECT> <P>(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 or located 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 § 205.102), in numerical order by social security number or approved unique identifier (or, if other than a natural person, IRS taxpayer identification number or approved unique identifier) of each such person, or in both alphabetical and numerical orders, as requested by the registrant.</P> <P>(b) Section (c)(2)(E) requires the portion to be distributed in “written or printed form.” This means recording on paper by any technology in a form that can be read by humans without special equipment. The system may, however, honor requests from registrants to substitute recordings on any medium by any technology including, but not limited to, electronic recording on tapes or discs in machine-readable form, and on photographic recording on microfiche. It also includes, if requested by registrants, electronic transmissions whereby registrants can print their own paper copies.</P> <P>(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 <PRTPAGE P="68"/>any one crop year in no more than three distributions.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996; 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.106</SECTNO> <SUBJECT>Farm products.</SUBJECT> <P>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)(C)(iv), must be specific commodities, species of livestock, and specific products of crops or livestock. The Section does not permit miscellaneous categories.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.107</SECTNO> <SUBJECT>Crop year.</SUBJECT> <P>(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:</P> <P>(1) For a crop grown in soil, the calendar year in which it is harvested or to be harvested;</P> <P>(2) For animals, the calendar year in which they are born or acquired;</P> <P>(3) For poultry or eggs, the calendar year in which they are sold or to be sold.</P> <P>(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)(E) makes the EFS effective.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> </SUBJGRP> <SUBJGRP> <HD SOURCE="HED">Interpretive opinions</HD> <SECTION> <SECTNO>§ 205.201</SECTNO> <SUBJECT>System operator.</SUBJECT> <P>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.”</P> </SECTION> <SECTION> <SECTNO>§ 205.202</SECTNO> <SUBJECT>“Effective financing statement” or EFS.</SUBJECT> <P>(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.”</P> <P>(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, authorized, or otherwise authenticated by the debtor and be filed by the secured party.</P> <P>(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 § 205.101.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996; 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <PRTPAGE P="69"/> <SECTNO>§ 205.203</SECTNO> <SUBJECT>Place of filing EFS.</SUBJECT> <P>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)(C). 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 <E T="03">or notice of such financing statements.”</E> (emphasis added)</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.204</SECTNO> <SUBJECT>Filing “notice” of EFS.</SUBJECT> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.205</SECTNO> <SUBJECT>Fees.</SUBJECT> <P>The Section provides at subsection (c)(4)(G) 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)(G) 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.</P> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.206</SECTNO> <SUBJECT>Farm products.</SUBJECT> <P>(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)(C)(iv). The following is a list of such farm products. </P> <EXTRACT> <FP SOURCE="FP-1">Rice, rye, wheat, other food grains (system must specify by name)</FP> <FP SOURCE="FP-1">Barley, corn, hay, oats, sorghum grain, other feed crops (system must specify by name)</FP> <FP SOURCE="FP-1">Cotton</FP> <FP SOURCE="FP-1">Tobacco</FP> <FP SOURCE="FP-1">Flaxseed, peanuts, soybeans, sunflower seeds, other oil crops (system must specify by name)</FP> <FP SOURCE="FP-1">Dry beans, dry peas, potatoes, sweet potatoes, taro, other vegetables (system must specify by name)</FP> <FP SOURCE="FP-1">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)</FP> <FP SOURCE="FP-1">Melons (system must specify by name)</FP> <FP SOURCE="FP-1">Grapefruit, lemons, limes, oranges, tangelos, tangerines, other citrus fruits (system must specify by name)</FP> <FP SOURCE="FP-1">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)</FP> <FP SOURCE="FP-1">Berries (system must specify by name)</FP> <FP SOURCE="FP-1">Tree nuts (system must specify by name)</FP> <FP SOURCE="FP-1">Bees wax, honey, maple syrup, sugar beets, sugar cane, other sugar crops (system must specify by name)</FP> <FP SOURCE="FP-1">Grass seeds, legume seeds, other seed crops (system must specify by name)</FP> <FP SOURCE="FP-1">Hops, mint, popcorn, other miscellaneous crops (system must specify by name)</FP> <FP SOURCE="FP-1">Greenhouse & nursery products produced on farms (system must specify by name)</FP> <FP SOURCE="FP-1">Mushrooms, trees, other forest products (system must specify by name)<PRTPAGE P="70"/> </FP> <FP SOURCE="FP-1">Chickens, ducks, eggs, geese, turkeys, other poultry or poultry products (system must specify by name)</FP> <FP SOURCE="FP-1">Cattle & calves, goats, horses, hogs, mules, sheep & lambs, other livestock (system must specify by name)</FP> <FP SOURCE="FP-1">Milk, other dairy products produced on farms (system must specify by name)</FP> <FP SOURCE="FP-1">Wool, mohair, other miscellaneous livestock products produced on farms (system must specify by name)</FP> <FP SOURCE="FP-1">Fish, shellfish</FP> <FP SOURCE="FP-1">Other farm products (system must specify by name).</FP> </EXTRACT> <P>(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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.207</SECTNO> <SUBJECT>“Amount” and “County or parish”.</SUBJECT> <P>(a) The “amount” of farm products and “county or parish,” on an EFS and on the master list under subsection (c)(4)(C)(iv) and (2)(C)(iii), need not be shown on every EFS and master list entry.</P> <P>(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.</P> <P>(c) Any EFS and master list entry will identify each county or parish in the same State where the product is produced or located. 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.</P> <P>(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.</P> <P>(e) The additional information about amount 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, would vary from case to case.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.208</SECTNO> <SUBJECT>Distribution of portions of master list—registration—information to non-registrants on request.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="71"/>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.”</P> <P>(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.</P> <P>(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 <E T="03">as to those portions</E> 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.</P> <P>(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.</P> <P>(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.</P> <P>(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 <E T="03">furnishing</E> information orally, it does not contain any provision as to how queries are to be <E T="03">received,</E> that is, orally, in writing, or otherwise.</P> <P>(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.</P> <P>(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.</P> <P>(k) Written confirmation is required, by subsection (c)(2)(F), to be given to any non-registered buyer, commission merchant, or selling agent.</P> <P>(l) Such a written confirmation pursuant to subsection (c)(2)(F) does not alter the liability of the non-registrant <PRTPAGE P="72"/>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.</P> <P>(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.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.209</SECTNO> <SUBJECT>Amendment or continuation of EFS.</SUBJECT> <P>(a) The “material change,” required by subsection (c)(4)(D) 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.</P> <P>(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 § 205.208(f).</P> <P>(c) The amendment must be filed in the same manner as the original filing. Note the requirement of subsection (c)(4)(D). 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, authorized, or otherwise authenticated by the debtor, and be filed by the secured party.</P> <P>(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 be signed, authorized, or otherwise authenticated by the debtor.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 61 FR 54728, Oct. 22, 1996; 63 FR 66721, Dec. 3, 1998; 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.210</SECTNO> <SUBJECT>Effect of EFS outside State in which filed.</SUBJECT> <P>(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.</P> <P>(b) The Section provides only for filing an EFS, covering a given product, in the system for the State in which it is produced or located. Upon such filing in such system, subsections (e)(2) and (g)(2)(C) make buyers, commission merchants and selling agents <E T="03">not registered</E> with that system subject to the security interest in that product whether or not they know about it, <E T="03">even if they are outside that State.</E> Subsections (e)(3) and (g)(2)(D) make persons <E T="03">registered</E> with that system subject if they receive written notice of it <E T="03">even if they are outside that State.</E> All of these provisions apply only where an EFS is filed in the system for the State in which the product is produced or located. They do not apply to a filing in another system.<PRTPAGE P="73"/> </P> <P>(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.”</P> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.211</SECTNO> <SUBJECT>Applicability of court decisions under the UCC.</SUBJECT> <P>(a) Court decisions under the Uniform Commercial Code (UCC), about the scope of the “farm products” exception in Section 9-307(1) thereof, and interpreting the terms therein, particularly “person engaged in farming operations” which is not defined in the Section, are applicable to an extent in interpreting the Section. The basis of this is the legislative intent of the Section to pre-empt State laws reflecting that “farm products” exception, as shown in the House Committee Report on Pub. L. 99-198, No. 99-271, Part 1, September 13, 1985, at pages 108 <E T="03">et seq.</E> </P> <P>(b) That UCC Section 9-307(1) reads as follows: </P> <EXTRACT> <P>(1) A buyer in ordinary course of business (subsection (9) of Section 1-201) <E T="03">other than a person buying farm products from a person engaged in farming operations</E> 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)</P> </EXTRACT> </SECTION> <SECTION> <SECTNO>§ 205.212</SECTNO> <SUBJECT>“Buyer in ordinary course of business” and “security interest.”</SUBJECT> <P>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:</P> <P>(a) The legislative intent discussed above in § 205.211, to pre-empt State laws reflecting the “farm products” exception; and</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 205.213</SECTNO> <SUBJECT>Obligations subject—“person indebted”—“debtor.”</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="74"/>Section, and it must be possible to distinguish the entries to which these provisions apply from the other entries.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0016)</APPRO> <CITA>[51 FR 29451, Aug. 18, 1986, as amended at 71 FR 56343, Sept. 27, 2006]</CITA> </SECTION> <SECTION> <SECTNO>§ 205.214</SECTNO> <SUBJECT>Litigation as to whether a system is operating in compliance with the Section.</SUBJECT> <P>(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.</P> <P>(b) The issue whether a system, after certification, is operating in compliance, thus whether it is a “central filing system” as defined, could be litigated and ruled on in a case involving only private parties, such as a lender and a buyer of a farm product. The only immediate effect of a finding in such a case, that a system is not a “central filing system” as defined, would be that the rights of the secured party in the case would be as if the State had no system. However, others would be in doubt as to whether they could safely rely on the same system.</P> </SECTION> </SUBJGRP> </PART> <PART> <EAR>Pt. 206</EAR> <HD SOURCE="HED">PART 206—SWINE CONTRACT LIBRARY</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>206.1</SECTNO> <SUBJECT>Definitions.</SUBJECT> <SECTNO>206.2</SECTNO> <SUBJECT>Swine contract library.</SUBJECT> <SECTNO>206.3</SECTNO> <SUBJECT>Monthly report.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>Sec. 941, Pub. L. 106-78, 113 Stat. 1135; 7 CFR 2.22 and 2.81.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>68 FR 47826, Aug. 11, 2003, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 206.1</SECTNO> <SUBJECT>Definitions.</SUBJECT> <P>The definitions in this section apply to the regulations in this part. The definitions in this section do not apply to other regulations issued under the Packers and Stockyards Act (P&S Act) or to the P&S Act as a whole.</P> <P> <E T="03">Accrual account.</E> (Synonymous with “ledger,” as defined in this section.) An account held by a packer on behalf of a producer that accrues a running positive or negative balance as a result of a pricing determination included in a contract that establishes a minimum and/or maximum level of base price paid. Credits and/or debits for amounts beyond these minimum and/or maximum levels are entered into the account. Further, the contract specifies how the balance in the account affects producer and packer rights and obligations under the contract.</P> <P> <E T="03">Base price.</E> The price paid for swine before the application of any premiums or discounts, expressed in dollars per unit.</P> <P> <E T="03">Contract.</E> Any agreement, whether written or verbal, between a packer and a producer for the purchase of swine for slaughter, except a negotiated purchase (as defined in this section).</P> <P> <E T="03">Contract type.</E> The classification of contracts or risk management agreements for the purchase of swine committed to a packer, by the determination of the base price and the presence or absence of an accrual account or ledger (as defined in this section). The contract type categories are:</P> <P>(1) Swine or pork market formula purchases with a ledger,</P> <P>(2) Swine or pork market formula purchases without a ledger,</P> <P>(3) Other market formula purchases with a ledger,</P> <P>(4) Other market formula purchases without a ledger,</P> <P>(5) Other purchase arrangements with a ledger, and</P> <P>(6) Other purchase arrangements without a ledger.</P> <P> <E T="03">Formula price.</E> A price determined by a mathematical formula under which the price established for a specified market serves as the basis for the formula.</P> <P> <E T="03">Ledger.</E> (Synonymous with “accrual account,” as defined in this section.) An account held by a packer on behalf of a producer that accrues a running positive or negative balance as a result of a pricing determination included in a contract that establishes a minimum and/or maximum level of base price paid. Credits and/or debits for amounts beyond these minimum and/or maximum levels are entered into the account. Further, the contract specifies how the balance in the account affects <PRTPAGE P="75"/>producer and packer rights and obligations under the contract.</P> <P> <E T="03">Negotiated purchase.</E> A purchase, commonly known as a “cash” or “spot market” purchase, of swine by a packer from a producer under which:</P> <P>(1) The buyer-seller interaction that results in the transaction and the agreement on actual base price occur on the same day; and</P> <P>(2) The swine are scheduled for delivery to the packer not later than 14 days after the date on which the swine are committed to the packer.</P> <P> <E T="03">Noncarcass merit premium or discount.</E> An increase or decrease in the price for the purchase of swine made available by an individual packer or packing plant, based on any factor other than the characteristics of the carcass, if the actual amount of the premium or discount is known before the purchase and delivery of the swine.</P> <P> <E T="03">Other market formula purchase.</E> A purchase of swine by a packer in which the pricing determination is a formula price based on any market other than the markets for swine, pork, or a pork product. The pricing determination includes, but is not limited to:</P> <P>(1) A price formula based on one or more futures or options contracts;</P> <P>(2) A price formula based on one or more feedstuff markets, such as the market for corn or soybeans; or</P> <P>(3) A base price determination using more than one market as its base where at least one of those markets would be defined as an “other market formula purchase.”</P> <P> <E T="03">Other purchase arrangement.</E> A purchase of swine by a packer that is not a negotiated purchase, swine or pork market formula purchase, or other market formula purchase, and does not involve packer-owned swine.</P> <P> <E T="03">Packer.</E> Any person engaged in the business of buying swine in commerce for purposes of slaughter, of manufacturing or preparing meats or meat food products from swine for sale or shipment in commerce, or of marketing meats or meat food products from swine in an unmanufactured form acting as a wholesale broker, dealer, or distributor in commerce. The regulations in this part only apply to a packer purchasing at least 100,000 swine per year and slaughtering swine at a federally inspected swine processing plant that meets either of the following conditions:</P> <P>(1) A swine processing plant that slaughtered an average of at least 100,000 swine per year during the immediately preceding 5 calendar years, with the average based on those periods in which the plant slaughtered swine; or</P> <P>(2) Any swine processing plant that did not slaughter swine during the immediately preceding 5 calendar years that has the capacity to slaughter at least 100,000 swine per year, based on plant capacity information.</P> <P> <E T="03">Producer.</E> Any person engaged, either directly or through an intermediary, in the business of selling swine to a packer for slaughter (including the sale of swine from a packer to another packer).</P> <P> <E T="03">Swine.</E> A porcine animal raised to be a feeder pig, raised for seedstock, or raised for slaughter.</P> <P> <E T="03">Swine or pork market formula purchase.</E> A purchase of swine by a packer in which the pricing determination is a formula price based on a market for swine, pork, or a pork product, other than a futures contract or option contract for swine, pork, or a pork product.</P> </SECTION> <SECTION> <SECTNO>§ 206.2</SECTNO> <SUBJECT>Swine contract library.</SUBJECT> <P>(a) <E T="03">Do I need to provide swine contract information?</E> Each packer, as defined in § 206.1, must provide information for each swine processing plant that it operates or at which it has swine slaughtered that has the slaughtering capacity specified in the definition of packer in § 206.1.</P> <P>(b) <E T="03">What existing or available contracts do I need to provide and when are they due?</E> Each packer must send, to the Grain Inspection, Packers and Stockyards Administration (GIPSA), an example of each contract it currently has with a producer or producers or that is currently available at each plant that it operates or at which it has swine slaughtered that meets the definition of packer in § 206.1. This initial submission of example contracts is due to GIPSA on the first business day of the month following the determination <PRTPAGE P="76"/>that the plant has the slaughtering capacity specified in the definition of packer in § 206.1.</P> <P>(c) <E T="03">What available contracts do I need to provide and when are they due?</E> After the initial submission, each packer must send GIPSA an example of each new contract it makes available to a producer or producers within one business day of the contract being made available at each plant that it operates or at which it has swine slaughtered that meets the definition of packer in § 206.1.</P> <P>(d) <E T="03">What criteria do I use to select example contracts?</E> For purposes of distinguishing among contracts to determine which contracts may be represented by a single example, contracts will be considered to be the same if they are identical with respect to all of the following four example-contract criteria:</P> <P>(1) Base price or determination of base price;</P> <P>(2) Application of a ledger or accrual account (including the terms and conditions of the ledger or accrual account provision);</P> <P>(3) Carcass merit premium and discount schedules (including the determination of the lean percent or other merits of the carcass that are used to determine the amount of the premiums and discounts and how those premiums and discounts are applied); and</P> <P>(4) Use and amount of noncarcass merit premiums and discounts.</P> <P>(e) <E T="03">Where and how do I send my contracts?</E> Each packer may submit the example contracts and notifications required by this section by either of the following two methods:</P> <P>(1) <E T="03">Electronic report.</E> Example contracts and notifications required by this section may be submitted by electronic means. Electronic submission may be by any form of electronic transmission that has been determined to be acceptable to the Administrator. To obtain current options for acceptable methods to submit example contracts electronically, contact GIPSA through the Internet on the GIPSA Web site (<E T="03">http://www.usda.gov/gipsa/</E>) or at USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309.</P> <P>(2) <E T="03">Printed report.</E> Each packer that chooses to submit printed example contracts and notifications must deliver the printed contracts and notifications to USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309.</P> <P>(f) <E T="03">What information from the swine contract library will be made available to the public?</E> GIPSA will summarize the information it has received on contract terms, including, but not limited to, base price determination and the schedules of premiums or discounts. GIPSA will make the information available by region and contract type as defined in § 206.1, for public release one month after the initial submission of contracts. Geographic regions will be defined in such a manner to provide as much information as possible while maintaining confidentiality in accordance with section 251 of the Agricultural Marketing Act (7 U.S.C. 1636).</P> <P>(g) <E T="03">How can I review information from the swine contract library?</E> The information will be available on the Internet on the GIPSA Web site (<E T="03">http://www.usda.gov/gipsa/</E>) and at USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309. The information will be updated as GIPSA receives information from packers.</P> <P>(h) <E T="03">What do I need to do when a previously submitted example contract is no longer a valid example due to contract changes, expiration, or withdrawal?</E> Each packer must submit a new example contract when contract changes result in changes to any of the four example-contract criteria specified in paragraph (d) of this section and notify GIPSA if the new example contract replaces the previously submitted example contract. Each packer must notify GIPSA when an example contract no longer represents any existing or available contract (expired or withdrawn). Each packer must submit these example contracts and notifications within one business day of the change, expiration, or withdrawal.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0021)</APPRO> </SECTION> <SECTION> <SECTNO>§ 206.3</SECTNO> <SUBJECT>Monthly report.</SUBJECT> <P>(a) <E T="03">Do I need to provide monthly reports?</E> Each packer, as defined in § 206.1, must provide information for each swine processing plant that it operates or at which it has swine slaughtered that has the slaughtering capacity specified in the definition of packer.<PRTPAGE P="77"/> </P> <P>(b) <E T="03">When is the monthly report due?</E> Each packer must send a separate monthly report for each plant that has the slaughtering capacity specified in the definition of packer in § 206.1. Each packer must deliver the report to the GIPSA Regional Office in Des Moines, IA, by the close of business on the 15th of each month, beginning at least 45 days after the initial submission of example contracts. The GIPSA Regional Office closes at 4:30 p.m. Central Time. If the 15th day of a month falls on a Saturday, Sunday, or federal holiday, the monthly report is due no later than the close of the next business day following the 15th.</P> <P>(c) <E T="03">What information do I need to provide in the monthly report?</E> The monthly report that each packer files must be reported on Form P&SP-341, which will be available on the Internet on the GIPSA Web site (<E T="03">http://www.usda.gov/gipsa/</E>) and at USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309. In the monthly report, each packer must provide the following information:</P> <P>(1) <E T="03">Number of swine to be delivered under existing contracts.</E> Existing contracts are contracts the packer currently is using for the purchase of swine for slaughter at each plant. Each packer must provide monthly estimates of the number of swine committed to be delivered under all of its existing contracts (even if those contracts are not currently available for renewal or to additional producers) in each contract type as defined in § 206.1.</P> <P>(2) <E T="03">Available contracts.</E> Available contracts are the contracts the packer is currently making available to producers, or is making available for renewal to currently contracted producers, for the purchase of swine for slaughter at each plant. On the monthly report, a packer will indicate each contract type, as defined in § 206.1, that the packer is currently making available.</P> <P>(3) <E T="03">Estimates of committed swine.</E> Each packer must provide an estimate of the total number of swine committed under existing contracts for delivery to each plant for slaughter within each of the following 12 calendar months beginning with the 1st of the month immediately following the due date of the report. The estimate of total swine committed will be reported by contract type as defined in § 206.1.</P> <P>(4) <E T="03">Expansion clauses.</E> Any conditions or circumstances specified by clauses in any existing contracts that could result in an increase in the estimates specified in paragraph (c)(3) of this section. Each packer will identify the expansion clauses in the monthly report by listing a code for the following conditions:</P> <P>(i) Clauses that allow for a range of the number of swine to be delivered;</P> <P>(ii) Clauses that require a greater number of swine to be delivered as the contract continues;</P> <P>(iii) Other clauses that provide for expansion in the numbers of swine to be delivered.</P> <P>(5) <E T="03">Maximum estimates of swine.</E> The packer's estimate of the maximum total number of swine that potentially could be delivered to each plant within each of the following 12 calendar months, if any or all of the types of expansion clauses identified in accordance with the requirement in paragraph (c)(4) of this section are executed. The estimate of maximum potential deliveries must be reported for all existing contracts by contract type as defined in § 206.1.</P> <P>(d) <E T="03">What if a contract does not specify the number of swine committed?</E> To meet the requirements of paragraphs (c)(3) and (c)(5) of this section, the packer must estimate expected and potential deliveries based on the best information available to the packer. Such information might include, for example, the producer's current and projected swine inventories and planned production.</P> <P>(e) <E T="03">When do I change previously reported estimates?</E> Regardless of any estimates for a given future month that may have been previously reported, current estimates of deliveries reported as required by paragraphs (c)(3) and (c)(5) of this section must be based on the most accurate information available at the time each report is prepared.</P> <P>(f) <E T="03">Where and how do I send my monthly report?</E> Each packer may submit monthly reports required by this section by either of the following two methods:<PRTPAGE P="78"/> </P> <P>(1) <E T="03">Electronic report.</E> Information reported under this section may be reported by electronic means, to the maximum extent practicable. Electronic submission may be by any form of electronic transmission that has been determined to be acceptable to the Administrator. To obtain current options for acceptable methods to submit information electronically, contact GIPSA through the Internet on the GIPSA Web site (<E T="03">http://www.usda.gov/gipsa/</E>) or at USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309.</P> <P>(2) <E T="03">Printed report.</E> Each packer may deliver its printed monthly report to USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309.</P> <P>(g) <E T="03">What information from monthly reports will be made available to the public and when and how will the information be made available to the public?</E>—(1) <E T="03">Availability.</E> GIPSA will provide a monthly report of estimated deliveries by contract types as reported by packers in accordance with this section, for public release on the 1st business day of each month. The monthly reports will be available on the Internet on the GIPSA Web site (<E T="03">http://www.usda.gov/gipsa/</E>) and at USDA GIPSA, Suite 317, 210 Walnut Street, Des Moines, IA 50309, during normal business hours of 7 a.m. to 4:30 p.m. Central Time, Monday through Friday.</P> <P>(2) <E T="03">Regions.</E> Information in the report will be aggregated and reported by geographic regions. Geographic regions will be defined in such a manner to provide as much information as possible while maintaining confidentiality in accordance with section 251 of the Agricultural Marketing Act (7 U.S.C. 1636) and may be modified from time to time.</P> <P>(3) <E T="03">Reported information.</E> The monthly report will provide the following information:</P> <P>(i) The existing contract types for each geographic region.</P> <P>(ii) The contract types currently being made available to additional producers or available for renewal to currently contracted producers in each geographic region.</P> <P>(iii) The sum of packers' reported estimates of the total number of swine committed by contract for delivery during the next 6 and 12 months beginning with the month the report is published. The report will indicate the number of swine committed by geographic reporting region and by contract type.</P> <P>(iv) The types of conditions or circumstances as reported by packers that could result in expansion in the numbers of swine to be delivered under the terms of expansion clauses in the contracts at any time during the following 12 calendar months.</P> <P>(v) The sum of packers' reported estimates of the maximum total number of swine that potentially could be delivered during each of the next 6 and 12 months if all expansion clauses in current contracts are executed. The report will indicate the sum of estimated maximum potential deliveries by geographic reporting region and by contract type.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0580-0021)</APPRO> </SECTION> </PART> </CHAPTER> <CHAPTER> <LRH>9 CFR Ch. III (1-1-09 Edition)</LRH> <RRH>Food Safety and Inspection Service, USDA</RRH> <TOC> <TOCHD> <PRTPAGE P="79"/> <HD SOURCE="HED">CHAPTER III—FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE</HD> </TOCHD> <EDNOTE> <HD SOURCE="HED">Editorial Note:</HD> <P>Nomenclature changes to chapter III appear at 69 FR 18803, Apr. 9 2004.</P> </EDNOTE> <SUBCHAP> <HD SOURCE="HED">SUBCHAPTER A—AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION</HD> </SUBCHAP> <PTHD>Part</PTHD> <PGHD>Page</PGHD> <CHAPTI> <PT>300</PT> <SUBJECT>Agency mission and organization</SUBJECT> <PG>83</PG> </CHAPTI> <CHAPTI> <PT>301</PT> <SUBJECT>Terminology; Adulteration and misbranding standards</SUBJECT> <PG>86</PG> <PT>302</PT> <SUBJECT>Application of inspection and other requirements</SUBJECT> <PG>91</PG> <PT>303</PT> <SUBJECT>Exemptions</SUBJECT> <PG>92</PG> <PT>304</PT> <SUBJECT>Application for inspection; grant of inspection</SUBJECT> <PG>100</PG> <PT>305</PT> <SUBJECT>Official numbers; inauguration of inspection; withdrawal of inspection; reports of violation</SUBJECT> <PG>101</PG> <PT>306</PT> <SUBJECT>Assignment and authorities of program employees</SUBJECT> <PG>102</PG> <PT>307</PT> <SUBJECT>Facilities for inspection</SUBJECT> <PG>103</PG> <PT>308</PT> <RESERVED>[Reserved]</RESERVED> <PT>309</PT> <SUBJECT>Ante-mortem inspection</SUBJECT> <PG>108</PG> <PT>310</PT> <SUBJECT>Post-mortem inspection</SUBJECT> <PG>116</PG> <PT>311</PT> <SUBJECT>Disposal of diseased or otherwise adulterated carcasses and parts</SUBJECT> <PG>134</PG> <PT>312</PT> <SUBJECT>Official marks, devices and certificates</SUBJECT> <PG>143</PG> <PT>313</PT> <SUBJECT>Humane slaughter of livestock</SUBJECT> <PG>148</PG> <PT>314</PT> <SUBJECT>Handling and disposal of condemned or other inedible products at official establishments</SUBJECT> <PG>154</PG> <PT>315</PT> <SUBJECT>Rendering or other disposal of carcasses and parts passed for cooking</SUBJECT> <PG>157</PG> <PT>316</PT> <SUBJECT>Marking products and their containers</SUBJECT> <PG>158</PG> <PT>317</PT> <SUBJECT>Labeling, marking devices, and containers</SUBJECT> <PG>163</PG> <PT>318</PT> <SUBJECT>Entry into official establishments; reinspection and preparation of products</SUBJECT> <PG>238</PG> <PT>319</PT> <SUBJECT>Definitions and standards of identity or composition</SUBJECT> <PG>291</PG> <PT>320</PT> <SUBJECT>Records, registration, and reports</SUBJECT> <PG>311</PG> <PT>321</PT> <SUBJECT>Cooperation with States and territories</SUBJECT> <PG>313</PG> <PT>322</PT> <SUBJECT>Exports</SUBJECT> <PG>314<PRTPAGE P="80"/> </PG> <PT>325</PT> <SUBJECT>Transportation</SUBJECT> <PG>316</PG> <PT>327</PT> <SUBJECT>Imported products</SUBJECT> <PG>327</PG> <PT>329</PT> <SUBJECT>Detention; seizure and condemnation; criminal offenses</SUBJECT> <PG>345</PG> <PT>331</PT> <SUBJECT>Special provisions for designated States and Territories; and for designation of establishments which endanger public health and for such designated establishments</SUBJECT> <PG>347</PG> <PT>335</PT> <SUBJECT>Rules of practice governing proceedings under the Federal Meat Inspection Act</SUBJECT> <PG>352</PG> <PT>350</PT> <SUBJECT>Special services relating to meat and other products</SUBJECT> <PG>353</PG> <PT>351</PT> <SUBJECT>Certification of technical animal fats for export</SUBJECT> <PG>356</PG> <PT>352</PT> <SUBJECT>Exotic animals and horses; voluntary inspection</SUBJECT> <PG>362</PG> <PT>354</PT> <SUBJECT>Voluntary inspection of rabbits and edible products thereof</SUBJECT> <PG>370</PG> <PT>355</PT> <SUBJECT>Certified products for dogs, cats, and other carnivora; inspection, certification, and identification as to class, quality, quantity, and condition</SUBJECT> <PG>395</PG> <PT>362</PT> <SUBJECT>Voluntary poultry inspection regulations</SUBJECT> <PG>406</PG> <PT>381</PT> <SUBJECT>Poultry products inspection regulations</SUBJECT> <PG>410</PG> </CHAPTI> <SUBCHAP> <RESERVED>SUBCHAPTERS B-C [RESERVED]</RESERVED> </SUBCHAP> <SUBCHAP> <HD SOURCE="HED">SUBCHAPTER D—FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS</HD> </SUBCHAP> <CHAPTI> <PT>390</PT> <SUBJECT>Freedom of information and public information</SUBJECT> <PG>596</PG> <PT>391</PT> <SUBJECT>Fees and charges for inspection services and laboratory accreditation</SUBJECT> <PG>598</PG> </CHAPTI> <SUBCHAP> <HD SOURCE="HED">SUBCHAPTER E—REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT</HD> </SUBCHAP> <CHAPTI> <PT>416</PT> <SUBJECT>Sanitation</SUBJECT> <PG>600</PG> <PT>417</PT> <SUBJECT>Hazard Analysis and Critical Control Point (HACCP) Systems</SUBJECT> <PG>604</PG> <PT>424</PT> <SUBJECT>Preparation and Processing Operations</SUBJECT> <PG>608</PG> <PT>430</PT> <SUBJECT>Requirements for specific classes of product</SUBJECT> <PG>634</PG> <PT>439</PT> <SUBJECT>Accreditation of non-Federal chemistry laboratories</SUBJECT> <PG>637</PG> <PT>441</PT> <SUBJECT>Consumer Protection Standards: Raw Products</SUBJECT> <PG>646</PG> <PT>442</PT> <SUBJECT>Quantity of contents labeling and procedures and requirements for accurate weights</SUBJECT> <PG>648<PRTPAGE P="81"/> </PG> <PT>500</PT> <SUBJECT>Rules of Practice</SUBJECT> <PG>650</PG> </CHAPTI> <SUBCHAP> <HD SOURCE="HED">SUBCHAPTER I—EGG PRODUCTS INSPECTION</HD> </SUBCHAP> <CHAPTI> <PT>590</PT> <SUBJECT>Inspection of eggs and egg products (Egg Products Inspection Act)</SUBJECT> <PG>653</PG> <PT>592</PT> <SUBJECT>Voluntary inspection of egg products</SUBJECT> <PG>699</PG> </CHAPTI> </TOC> <SUBCHAP TYPE="N"> <PRTPAGE P="83"/> <HD SOURCE="HED">SUBCHAPTER A—AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION</HD> <PART> <EAR>Pt. 300</EAR> <HD SOURCE="HED">PART 300—AGENCY MISSION AND ORGANIZATION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>300.1</SECTNO> <SUBJECT>Purpose.</SUBJECT> <SECTNO>300.2</SECTNO> <SUBJECT>FSIS responsibilities.</SUBJECT> <SECTNO>300.3</SECTNO> <SUBJECT>FSIS organization.</SUBJECT> <SECTNO>300.4</SECTNO> <SUBJECT>Organizational terminology; personnel.</SUBJECT> <SECTNO>300.6</SECTNO> <SUBJECT>Access to establishments and other places of business.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>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.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>63 FR 72354, Dec. 31, 1998, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 300.1</SECTNO> <SUBJECT>Purpose.</SUBJECT> <P>This part describes the duties and organization of the Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA). It also includes rules on the access of government employees to regulated places of business.</P> <CITA>[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 300.2</SECTNO> <SUBJECT>FSIS responsibilities.</SUBJECT> <P>(a) <E T="03">Delegations of authority.</E> The Secretary of Agriculture and Under Secretary for Food Safety have delegated to the Administrator of the Food Safety and Inspection Service the responsibility for exercising the functions of the Secretary of Agriculture under various statutes (see 7 CFR 2.7, 2.18, and 2.53).</P> <P>(b) <E T="03">Implementing regulations.</E> 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:</P> <P>(1) The Federal Meat Inspection Act, as amended (FMIA) (21 U.S.C. 601 <E T="03">et seq.</E>), except provisions pertaining to the inspection and certification of the condition of animals for export, and related legislation;</P> <P>(2) The Poultry Products Inspection Act, as amended (PPIA) (21 U.S.C. 451 <E T="03">et seq.</E>);</P> <P>(3) The Egg Products Inspection Act, as amended (EPIA) (21 U.S.C. 1031 <E T="03">et seq.</E>), except for the shell egg surveillance program, voluntary laboratory analyses of egg products, and the voluntary grading program;</P> <P>(4) The Humane Slaughter Act (7 U.S.C. 1901-1906);</P> <P>(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;</P> <P>(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</P> <P>(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.</P> <CITA>[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 300.3</SECTNO> <SUBJECT>FSIS organization.</SUBJECT> <P>(a) <E T="03">General.</E> The organization of FSIS reflects the agency's primary regulatory responsibilities: implementation of the FMIA, the PPIA, and the EPIA. FSIS implements the inspection provisions of the FMIA, the PPIA, and the EPIA through its field structure.</P> <P>(b) <E T="03">Headquarters.</E> FSIS has eight principal components or offices, each of which is under the direction of a Deputy Administrator. The Deputy Administrators, along with their staffs, and the Administrator, along with the Office of the Administrator and three <PRTPAGE P="84"/>staff offices that report to the Administrator, are located at U.S. Department of Agriculture headquarters in Washington, DC.</P> <P>(1) <E T="03">Program Offices.</E> FSIS's headquarters offices are the Office of Public Health and Science, which provides scientific analysis, advice, data, and recommendations on matters involving public health and science; the Office of Management, which provides centralized administrative and support services; the Office of Policy and Program Development, which develops and articulates the Agency's policies regarding food safety and other consumer protections; the Office of Field Operations, which manages regulatory oversight and inspection (see paragraph (c) of this section); the Office of Food Security and Emergency Preparedness, which works to prevent or, if necessary, coordinate a response to an intentional attack on the food supply; the Office of Program Evaluation, Enforcement, and Review, which acts to ensure that Agency programs are functioning in an efficient and effective manner; the Office of Public Affairs, Education, and Outreach, which is responsible for facilitating communications between FSIS and Congress, the Agency's constituents, and the media; and the Office of International Affairs, which is responsible for recommending and developing international policy activities.</P> <P>(2) [Reserved]</P> <P>(c) <E T="03">Field.</E> FSIS's field structure consists of eighteen district offices and a technical center.</P> <P>(1) <E T="03">District offices.</E> 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.</P> <P>The locations of the district offices and the districts' geographic boundaries are as follows:</P> <GPOTABLE CDEF="s50,r150" COLS="2" OPTS="L2,p7,7/8,g1,t1,i1"> <ROW> <ENT I="01"> <E T="03">Alameda, CA</E> </ENT> <ENT>California.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Boulder, CO</E> <LI O="xl"> <E T="03">Salem, OR (satellite office)</E> </LI> </ENT> <ENT>Arizona, Colorado, Nevada, New Mexico, Utah, Alaska, American Samoa, Guam, Hawaii, Idaho, Northern Mariana Islands, Oregon, and Washington.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Minneapolis, MN</E> </ENT> <ENT>Minnesota, Montana, North Dakota, South Dakota, and Wyoming.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Des Moines, IA</E> </ENT> <ENT>Iowa and Nebraska.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Lawrence, KS</E> </ENT> <ENT>Kansas and Missouri.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Springdale, AR</E> </ENT> <ENT>Arkansas, Louisiana, and Oklahoma.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Dallas, TX</E> </ENT> <ENT>Texas.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Madison, WI</E> </ENT> <ENT>Michigan and Wisconsin.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Chicago, IL</E> <LI O="xl"> <E T="03">Pickering, OH, (satellite office)</E> </LI> </ENT> <ENT>Illinois, Ohio, and Indiana.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Philadelphia, PA</E> </ENT> <ENT>Pennsylvania and New Jersey.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Albany, NY</E> </ENT> <ENT>Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Beltsville, MD</E> </ENT> <ENT>Delaware, District of Columbia, Maryland, Virginia, and West Virginia.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Raleigh, NC</E> </ENT> <ENT>North Carolina, South Carolina, and Kentucky.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Atlanta, GA</E> </ENT> <ENT>Florida, Georgia, Puerto Rico, and the Virgin Islands.</ENT> </ROW> <ROW> <ENT I="01"> <E T="03">Jackson, MS</E> </ENT> <ENT>Alabama, Mississippi, and Tennessee.</ENT> </ROW> </GPOTABLE> <P>(2) <E T="03">Technical Service Center.</E> The Technical Service Center, which is located in Omaha, Nebraska, provides technical guidance, review, and training on the interpretation and application of regulatory requirements.</P> <CITA>[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 300.4</SECTNO> <SUBJECT>Organizational terminology; personnel.</SUBJECT> <P>(a) Unless otherwise specifically provided or required in the context of a particular part of the regulations:<PRTPAGE P="85"/> </P> <P> <E T="03">Administrator</E> means the Administrator of the Food Safety and Inspection Service or any other officer or employee of the Department to whom authority has been or may in the future be delegated to act in his or her stead.</P> <P> <E T="03">Circuit Supervisor</E> means the official of the Inspection Service who is assigned responsibility for supervising the conduct of inspection at a specific group of official establishments.</P> <P> <E T="03">Inspection program, inspection service,</E> or <E T="03">program</E> means the organizational unit within the Department with responsibility for carrying out the FMIA, the PPIA, and the EPIA.</P> <P> <E T="03">Inspection program employee, inspection service employee,</E> or <E T="03">program employee</E> means an inspector or other government employee who is authorized to conduct any inspection or perform any other duty in connection with the inspection program, inspection service, or program.</P> <P> <E T="03">Inspection service supervisor</E> or <E T="03">Inspection program supervisor</E> means an inspection program or service employee or program employee who is delegated authority to exercise supervision over one or more phases of the inspection program.</P> <P> <E T="03">Inspector</E> means an inspector of the inspection program, inspection service, and program. (“Inspector” includes an employee or official of the Federal government or the government of a State or territory or the District of Columbia who is authorized by the Administrator to inspect meat and meat products or poultry and poultry products under the authority of the FMIA or the PPIA, respectively, under an agreement entered into between the Administrator and the appropriate State or other agency.)</P> <P> <E T="03">Inspector in charge</E> or <E T="03">IIC</E> means an inspection program employee, inspection service employee, or program employee who has primary responsibility for inspection program functions at a particular official establishment.</P> <P> <E T="03">Secretary</E> means the Secretary of Agriculture of the United States or his or her delegate.</P> <P>(b) FSIS has replaced the regional office and import field office structure referenced in some parts of subchapter A of this chapter. Authority previously delegated to Regional Directors now is delegated to district managers; authority previously delegated to area supervisors and import supervisors now is delegated to inspection program supervisors in the successor district offices.</P> <CITA>[69 FR 253, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 300.6</SECTNO> <SUBJECT>Access to establishments and other places of business.</SUBJECT> <P>(a) <E T="03">General.</E> Upon presentation of credentials—</P> <P>(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</P> <P>(2) Persons subject to provisions of the EPIA must afford representatives of the Secretary access as specified in part 590 of this chapter.</P> <P>(b) <E T="03">Meat and poultry establishments and related industries.</E> (1) At all times, by day or night, whether the establishment is being operated or not, inspection program employees must have access to the premises and to every part of an establishment that slaughters livestock or otherwise prepares meat products or slaughters poultry or otherwise processes poultry products that are subject to inspection for the purpose of conducting an inspection or performing any other inspection program duty. The numbered official badge of an inspection program employee is sufficient identification to entitle him or her to admittance to all parts of such an establishment and its premises.</P> <P>(2) At all ordinary business hours, upon presentation of credentials by a representative of the Secretary, any person (including any firm or corporation or other business unit) subject to recordkeeping requirements under section 202 of the FMIA or section 11(b) of the PPIA must permit such representative to enter his or her place of business to examine the facilities and inventory and to examine and copy the records specified in § 320.1 and § 381.175, respectively, of this chapter and, upon payment of the fair market value <PRTPAGE P="86"/>therefor, take reasonable samples of the inventory.</P> <CITA>[63 FR 72354, Dec. 31, 1998, as amended at 69 FR 254, Jan. 5, 2004]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 301</EAR> <HD SOURCE="HED">PART 301—TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>301.1</SECTNO> <SUBJECT>General.</SUBJECT> <SECTNO>301.2</SECTNO> <SUBJECT>Definitions.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 U.S.C. 138-138i, 450, 1901-1906; 7 CFR 2.7, 2.18, 2.53.</P> </AUTH> <SECTION> <SECTNO>§ 301.1</SECTNO> <SUBJECT>General.</SUBJECT> <P>For purposes of this chapter and unless otherwise specifically provided by regulation or required in the context of particular regulations:</P> <P>(a) Terms have the meanings set forth in this part;</P> <P>(b) The singular form also imports the plural, and the masculine form also imports the feminine and vice versa.</P> <CITA>[69 FR 254, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 301.2</SECTNO> <SUBJECT>Definitions.</SUBJECT> <P>As used in this subchapter, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:</P> <P> <E T="03">The Act.</E> 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 <E T="03">et seq.</E>).</P> <P> <E T="03">Adulterated.</E> This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:</P> <P>(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;</P> <P>(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:</P> <P>(A) A pesticide chemical in or on a raw agricultural commodity;</P> <P>(B) A food additive; or</P> <P>(C) A color additive which may, in the judgment of the Administrator, make such article unfit for human food;</P> <P>(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;</P> <P>(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;</P> <P>(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: <E T="03">Provided,</E> 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;</P> <P>(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;</P> <P>(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;</P> <P>(5) If it is, in whole or in part, the product of an animal which has died otherwise than by slaughter;</P> <P>(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;</P> <P>(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;</P> <P>(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 <PRTPAGE P="87"/>increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or,</P> <P>(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.</P> <P> <E T="03">Anesthesia.</E> Loss of sensation or feeling.</P> <P> <E T="03">Animal food.</E> 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:</P> <P>(1) Processed dry animal food or</P> <P>(2) Livestock or poultry feeds manufactured from processed livestock byproducts (such as meatmeal tankage, meat and bonemeal, bloodmeal, and feed grade animal fat).</P> <P> <E T="03">Animal food manufacturer.</E> Any person engaged in the business of manufacturing or processing animal food.</P> <P> <E T="03">Artificial coloring.</E> 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.</P> <P> <E T="03">Artificial flavoring.</E> A flavoring containing any sapid or aromatic constituent, which constituent was manufactured by a process of synthesis or other similar artifice.</P> <P> <E T="03">Biological residue.</E> 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.</P> <P> <E T="03">Capable of use as human food.</E> 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 §§ 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.</P> <P> <E T="03">Captive bolt.</E> A stunning instrument which when activated drives a bolt out of a barrel for a limited distance.</P> <P> <E T="03">Carbon dioxide.</E> A gaseous form of the chemical formula CO<E T="52">2</E>.</P> <P> <E T="03">Carbon dioxide concentration.</E> Ratio of carbon dioxide gas and atmospheric air.</P> <P> <E T="03">Carcass.</E> All parts, including viscera, of any slaughtered livestock.</P> <P> <E T="03">Chemical preservative.</E> 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.</P> <P>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.</P> <P> <E T="03">Commerce.</E> 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.</P> <P> <E T="03">Consciousness.</E> Responsiveness of the brain to the impressions made by the senses.</P> <P> <E T="03">Cutting up.</E> 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.</P> <P> <E T="03">Dead livestock.</E> The body (cadaver) of livestock which has died otherwise than by slaughter.</P> <P> <E T="03">Dying, diseased, or disabled livestock.</E> Livestock which has or displays symptoms of having any of the following:</P> <P>(1) Central nervous system disorder;</P> <P>(2) Abnormal temperature (high or low);</P> <P>(3) Difficult breathing;</P> <P>(4) Abnormal swellings;</P> <P>(5) Lack of muscular coordination;</P> <P>(6) Inability to walk normally or stand;</P> <P>(7) Any of the conditions for which livestock is required to be condemned <PRTPAGE P="88"/>on ante-mortem inspection in accordance with the regulations in part 309 of this subchapter.</P> <P> <E T="03">Edible.</E> Intended for use as human food.</P> <P> <E T="03">Experimental animal.</E> 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.</P> <P> <E T="03">Exposure time.</E> The period of time an animal is exposed to an anesthesia-producing carbon dioxide concentration.</P> <P> <E T="03">Federal Food, Drug, and Cosmetic Act.</E> The Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.</P> <P> <E T="03">Firm.</E> Any partnership, association, or other unincorporated business organization.</P> <P> <E T="03">Further processing.</E> Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments.</P> <P> <E T="03">Immediate container.</E> The receptacle or other covering in which any product is directly contained or wholly or partially enclosed.</P> <P> <E T="03">Inedible.</E> Adulterated, uninspected, or not intended for use as human food.</P> <P> <E T="03">Inhumane slaughter or handling in connection with slaughter.</E> 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.</P> <P> <E T="03">“Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof).</E> 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.</P> <P> <E T="03">Label.</E> A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.</P> <P> <E T="03">Labeling.</E> All labels and other written, printed, or graphic matter:</P> <P>(1) Upon any article or any of its containers or wrappers, or</P> <P>(2) Accompanying such article.</P> <P> <E T="03">Livestock.</E> Cattle, sheep, swine, goat, horse, mule, or other equine.</P> <P> <E T="03">Meat.</E> (1) The part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing. As applied to products of equines, this term has a comparable meaning.</P> <P>(i) Meat does not include the muscle found in the lips, snout, or ears.</P> <P>(ii) Meat may not include significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).</P> <P>(2) [Reserved]</P> <P> <E T="03">Meat broker.</E> 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.</P> <P> <E T="03">Meat byproduct.</E> 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.</P> <P> <E T="03">Meat food product.</E> 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 <PRTPAGE P="89"/>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.</P> <P> <E T="03">Misbranded.</E> This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:</P> <P>(1) If its labeling is false or misleading in any particular;</P> <P>(2) If it is offered for sale under the name of another food;</P> <P>(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;</P> <P>(4) If its container is so made, formed, or filled as to be misleading;</P> <P>(5) If in a package or other container unless it bears a label showing:</P> <P>(i) The name and place of business of the manufacturer, packer, or distributor; and</P> <P>(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;</P> <P>(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;</P> <P>(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:</P> <P>(i) It conforms to such definition and standard, and</P> <P>(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;</P> <P>(8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;</P> <P>(9) If it is not subject to the provisions of paragraph (vv)(7)(ii) of this section unless its label bears:</P> <P>(i) The common or usual name of the food, if any there be, and</P> <P>(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;</P> <P>(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.</P> <P>(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</P> <P>(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.</P> <P> <E T="03">Nonfood compound.</E> Any substance proposed for use in official establishments, the intended use of which will <PRTPAGE P="90"/>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.</P> <P> <E T="03">Official certificate.</E> Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act.</P> <P> <E T="03">Official device.</E> Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark.</P> <P> <E T="03">Official establishment.</E> 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.</P> <P> <E T="03">Official import inspection establishment.</E> 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 § 327.6 of this subchapter.</P> <P> <E T="03">Official inspection legend.</E> Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act.</P> <P> <E T="03">Official mark.</E> 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.</P> <P> <E T="03">Packaging material.</E> Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for meat products.</P> <P> <E T="03">Person.</E> Any individual, firm, or corporation.</P> <P> <E T="03">Pesticide chemical, food additive, color additive, raw agricultural commodity.</E> 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.</P> <P> <E T="03">Prepared.</E> Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.</P> <P> <E T="03">Process authority.</E> 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.</P> <P> <E T="03">Process schedule.</E> 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.</P> <P> <E T="03">Product.</E> Any carcass, meat, meat byproduct, or meat food product, capable of use as human food.</P> <P> <E T="03">Renderer.</E> 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.</P> <P> <E T="03">Shipping container.</E> 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.</P> <P> <E T="03">State.</E> Any State of the United States or the Commonwealth of Puerto Rico.</P> <P> <E T="03">Supervision.</E> 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.</P> <P> <E T="03">Surgical anesthesia.</E> A state of unconsciousness measured in conformity with accepted surgical practices.</P> <P> <E T="03">Territory.</E> Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.</P> <P> <E T="03">U.S. Condemned.</E> 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.</P> <P> <E T="03">U.S. Inspected and Condemned (or any authorized abbreviation thereof).</E> 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 <PRTPAGE P="91"/>under the regulations in this subchapter.</P> <P> <E T="03">U.S. Passed for Cooking.</E> 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.</P> <P> <E T="03">U.S. Passed for Refrigeration.</E> 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.</P> <P> <E T="03">U.S. Retained.</E> 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.</P> <P> <E T="03">U.S. Suspect.</E> 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.</P> <P> <E T="03">United States.</E> The States, the District of Columbia, and the Territories of the United States.</P> <CITA>[35 FR 15554, Oct. 3, 1970]</CITA> <EDNOTE> <HD SOURCE="HED">Editorial Note:</HD> <P>For <E T="04">Federal Register</E> citations affecting § 301.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.</P> </EDNOTE> </SECTION> </PART> <PART> <EAR>Pt. 302</EAR> <HD SOURCE="HED">PART 302—APPLICATION OF INSPECTION AND OTHER REQUIREMENTS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>302.1</SECTNO> <SUBJECT>Establishments requiring inspection.</SUBJECT> <SECTNO>302.2</SECTNO> <SUBJECT>Application of requirements in designated States or Territories; and to designated plants endangering public health.</SUBJECT> <SECTNO>302.3</SECTNO> <SUBJECT>Livestock and products entering official establishments.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SECTION> <SECTNO>§ 302.1</SECTNO> <SUBJECT>Establishments requiring inspection.</SUBJECT> <P>(a) Inspection under the regulations in this subchapter is required at:</P> <P>(1) Every establishment, except as provided in § 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;</P> <P>(2) Every establishment, except as provided in § 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</P> <P>(3) Every establishment, except as provided in § 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.</P> <CITA>[35 FR 15556, Oct. 3, 1970, as amended at 36 FR 12002, June 24, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 302.2</SECTNO> <SUBJECT>Application of requirements in designated States or Territories; and to designated plants endangering public health.</SUBJECT> <P>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.</P> <CITA>[35 FR 15556, Oct. 3, 1970, as amended at 51 FR 29909, Aug. 21, 1986]</CITA> </SECTION> <SECTION> <SECTNO>§ 302.3</SECTNO> <SUBJECT>Livestock and products entering official establishments.</SUBJECT> <P>All livestock and all products entering any official establishment and all products prepared, in whole or in part, therein, shall be inspected, handled, <PRTPAGE P="92"/>stored, prepared, packaged, marked, and labeled as required by the regulations in this subchapter.</P> <CITA>[35 FR 15556, Oct. 3, 1970]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 303</EAR> <HD SOURCE="HED">PART 303—EXEMPTIONS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>303.1</SECTNO> <SUBJECT>Exemptions.</SUBJECT> <SECTNO>303.2</SECTNO> <SUBJECT>Experimentation: Intensity of inspection coverage.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SECTION> <SECTNO>§ 303.1</SECTNO> <SUBJECT>Exemptions.</SUBJECT> <P>(a) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to:</P> <P>(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;</P> <P>(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: <E T="03">Provided,</E> That the following requirements are met by such custom operator;</P> <P>(i) Establishments that conduct custom operations must be maintained and operated in accordance with the provisions of §§ 416.1 through 416.6, except for: § 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.</P> <P>(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;</P> <P>(iii) The custom prepared products are plainly marked “Not for Sale” as provided in § 316.16 of this subchapter, immediately after being prepared and are kept so identified until delivered to the owner; and</P> <P>(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.</P> <P>(b)(1) The exempted custom prepared products shall be prepared and handled in accordance with the provisions of §§ 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: <E T="03">Provided,</E> That the provisions of §§ 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 § 318.6(b)(9) and (10), shall not apply to the preparation and handling of such exempted products.</P> <P>(2) The exempted custom prepared products shall comply with the requirements of §§ 316.16 and 317.16 of this subchapter.</P> <P>(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.<PRTPAGE P="93"/> </P> <P>(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 § 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.</P> <P>(c) It has been determined that it is impracticable to provide inspection of the preparation of products at establishments in any unorganized Territory at which livestock are slaughtered or their products are prepared for distribution solely within such jurisdiction and that exempting such establishments from requirements of the Act for such inspections under the conditions stated in this section will otherwise facilitate enforcement of the Act. Therefore, such inspection requirements of the Act and of the regulations in this subchapter shall not apply at such establishments if they are operated in accordance with the regulations in part 416, §§ 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.</P> <P>(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.</P> <P>(2) For purposes of paragraph (d)(1) of this section:</P> <P>(i) Operations of types traditionally and usually conducted at retail stores and restaurants are the following:</P> <P>(<E T="03">a</E>) Cutting up, slicing, and trimming carcasses, halves, quarters, or wholesale cuts into retail cuts such as steaks, chops, and roasts, and freezing such cuts;</P> <P>(<E T="03">b</E>) Grinding and freezing products made from meat;</P> <P>(<E T="03">c</E>) Curing, cooking, smoking, rendering or refining of livestock fat, or other preparation of products, except slaughtering or the retort processing of canned products;</P> <P>(<E T="03">d</E>) Breaking bulk shipments of products;</P> <P>(<E T="03">e</E>) Wrapping or rewrapping products.</P> <P>(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:</P> <GPOTABLE CDEF="s50,9" COLS="2" OPTS="L2"> <BOXHD> <CHED H="1"/> <CHED H="1">One-half carcass pounds</CHED> </BOXHD> <ROW> <ENT I="01">Cattle</ENT> <ENT>300</ENT> </ROW> <ROW> <ENT I="01">Calves</ENT> <ENT>37.5</ENT> </ROW> <ROW> <ENT I="01">Sheep</ENT> <ENT>27.5</ENT> </ROW> <ROW> <ENT I="01">Swine</ENT> <ENT>100</ENT> </ROW> <ROW> <ENT I="01">Goats</ENT> <ENT>25</ENT> </ROW> </GPOTABLE> <P>(iii) A retail store is any place of business where:</P> <P>(<E T="03">a</E>) The sales of product are made to consumers only;</P> <P>(<E T="03">b</E>) 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 <E T="04">Federal Register.</E> <SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <PRTPAGE P="94"/> <P>(<E T="03">c</E>) 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;</P> <P>(<E T="03">d</E>) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section;</P> <P>(<E T="03">e</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</P> <P>(<E T="03">f</E>) 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) (<E T="03">a</E>), (<E T="03">b</E>), (<E T="03">d</E>), and (<E T="03">e</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).)</P> <P>(iv) <E T="03">Restaurants.</E> (<E T="03">a</E>) A restaurant is any establishment where:</P> <P>(<E T="03">1</E>) Product is prepared only for sale or service in meals or as entrees directly to individual consumers at such establishments;</P> <P>(<E T="03">2</E>) 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;</P> <P>(<E T="03">3</E>) No sale of product is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and</P> <P>(<E T="03">4</E>) The preparation of product is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.</P> <P>(<E T="03">b</E>) 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.</P> <P>(<E T="03">c</E>) 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: <E T="03">Provided,</E> That the requirements of §§ 320.1 through 320.4 of this subchapter apply to such facility. <E T="03">Provided further,</E> 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.</P> <P>(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.</P> <P>(vi) Consumer: Any household consumer, hotel, restaurant, or similar institution as determined by the Administrator in specific cases.</P> <P>(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 <PRTPAGE P="95"/>that does not have or is not exercising adequate authority with respect to recordkeeping requirements) has been operated in violation of the conditions prescribed in this section for exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail store and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator still has reason to believe that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail store would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of total monthly purchases and of total monthly sales of meat, meat byproducts, and meat food products, in terms of dollar values of the products involved. Such records shall separately show total sales to household consumers and total sales to other consumers and shall be maintained for the period prescribed in § 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.</P> <P>(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.</P> <P>(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the provisions of Chapters 2 through 8, except sections 2-102(a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-203, and 6-105, part IV, of the Food and Drug Administration's Food Service Sanitation Manual (1976 Recommendations), DHEW Publication No. (FDA) 78-2081, which is incorporated by reference, shall apply to the facilities and operations of businesses claiming this exemption. (These materials are incorporated as they exist on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E> </P> <P>(3) Facilities and operations of businesses claiming this exemption shall also conform to the following requirements:</P> <P>(i) <E T="03">Manual cleaning and sanitizing.</E> (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.<PRTPAGE P="96"/> </P> <P>(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.</P> <P>(C) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil.</P> <P>(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:</P> <P>(<E T="03">1</E>) Sinks shall be cleaned prior to use.</P> <P>(<E T="03">2</E>) Equipment and utensils shall be thoroughly washed in the first compartment with a hot detergent solution that is kept clean.</P> <P>(<E T="03">3</E>) Equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment.</P> <P>(<E T="03">4</E>) Equipment and utensils shall be sanitized in the third compartment according to one of the methods prescribed in paragraph (e)(3)(i)(E) (<E T="03">1</E>) through (<E T="03">4</E>) of this section.</P> <P>(E) The food-contact surfaces of all equipment and utensils shall be sanitized by:</P> <P>(<E T="03">1</E>) Immersion for at least <FR>1/2</FR> minute in clean, hot water at a temperature of at least 170 °F; or</P> <P>(<E T="03">2</E>) 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 °F; or</P> <P>(<E T="03">3</E>) 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 °F; or</P> <P>(<E T="03">4</E>) 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 °F for 1 minute; or</P> <P>(<E T="03">5</E>) 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</P> <P>(<E T="03">6</E>) 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)(<E T="03">4</E>) of this section in the case of equipment too large to sanitize by immersion.</P> <P>(F) When hot water is used for sanitizing, the following facilities shall be provided and used:</P> <P>(<E T="03">1</E>) 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 °F; and</P> <P>(<E T="03">2</E>) A numerically scaled indicating thermometer, accurate to ±3 °F, convenient to the sink for frequent checks of water temperature; and</P> <P>(<E T="03">3</E>) Dish baskets of such size and design to permit complete immersion of the tableware, kitchenware, and equipment in the hot water.</P> <P>(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.</P> <P>(ii) <E T="03">Mechanical cleaning and sanitizing.</E> (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.</P> <P>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.</P> <P>(B) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than 15 nor <PRTPAGE P="97"/>more than 25 pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A <FR>1/4</FR>-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.</P> <P>(C) Machine or water line mounted numerically scaled indicating thermometers, accurate to ±3 °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.</P> <P>(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.</P> <P>(E) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of easily movable dishtables for the storage of clean utensils following sanitization.</P> <P>(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.</P> <P>(G) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washers) using chemicals for sanitization may be used: <E T="03">Provided, That,</E> </P> <P>(<E T="03">1</E>) The temperature of the wash water shall not be less than 120 °F.</P> <P>(<E T="03">2</E>) The wash water shall be kept clean.</P> <P>(<E T="03">3</E>) Chemicals added for sanitization purposes shall be automatically dispensed.</P> <P>(<E T="03">4</E>) Utensils and equipment shall be exposed to the final chemical sanitizing rinse in accordance with manufacturers' specifications for time and concentration.</P> <P>(<E T="03">5</E>) The chemical sanitizing rinse water temperature shall be not less than 75 °F nor less than the temperature specified by the machine's manufacturer.</P> <P>(<E T="03">6</E>) Chemical sanitizers used shall meet the requirements of 21 CFR 178.1010.</P> <P>(<E T="03">7</E>) A test kit or other device that accurately measures the parts per million concentration of the solution shall be available and used.</P> <P>(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: </P> <P>(<E T="03">1</E>) Single-tank, stationary-rack, dual-temperature machine: </P> <LDRWK> <FL-2>Wash temperature </FL-2> <LDRFIG>150 °F</LDRFIG> <FL-2>Final rinse temperature </FL-2> <LDRFIG>180 °F</LDRFIG> </LDRWK> <P>(<E T="03">2</E>) Single-tank, stationary-rack, single-temperature machine: </P> <LDRWK> <FL-2>Wash temperature </FL-2> <LDRFIG>165 °F</LDRFIG> <FL-2>Final rinse temperature </FL-2> <LDRFIG>165 °F</LDRFIG> </LDRWK> <P>(<E T="03">3</E>) Single-tank, conveyor machine: </P> <LDRWK> <FL-2>Wash temperature </FL-2> <LDRFIG>160 °F</LDRFIG> <FL-2>Final rinse temperature </FL-2> <LDRFIG>180 °F</LDRFIG> </LDRWK> <P>(<E T="03">4</E>) Multitank, conveyor machine: </P> <LDRWK> <FL-2>Wash temperature </FL-2> <LDRFIG>150 °F</LDRFIG> <FL-2>Pumped rinse temperature </FL-2> <LDRFIG>160 °F</LDRFIG> <FL-2>Final rinse temperature </FL-2> <LDRFIG>180 °F</LDRFIG> </LDRWK> <P>(<E T="03">5</E>) Single-tank, pot, pan, and utensil washer (either stationary or moving-rack):</P> <LDRWK> <FL-2>Wash temperature </FL-2> <LDRFIG>140 °F</LDRFIG> <FL-2>Final rinse temperature </FL-2> <LDRFIG>180 °F</LDRFIG> </LDRWK> <P>(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.</P> <P>(iii) <E T="03">Steam.</E> Steam used in contact with food or food-contact surfaces shall be free from any materials or additives <PRTPAGE P="98"/>other than those specified in 21 CFR 173.310.</P> <P>(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.”</P> <P>(5) The Administrator may withdraw or modify the exemption set forth in § 303.1(e)(1) for a particular establishment when he or she determines that such action is necessary to ensure food safety and public health. Before such action is taken, the owner or operator of the particular establishment shall be notified, in writing, of the reasons for the proposed action and shall be given an opportunity to respond, in writing, to the Administrator within 20 days after notification of the proposed action. The written notification shall be served on the owner or operator of the establishment in the manner prescribed in section 1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). In those instances where there is conflict of any material fact, the owner or operator of the establishment, upon request, shall be afforded an opportunity for a hearing with respect to the disputed fact, in accordance with rules of practice which shall be adopted for the proceeding. However, such withdrawal or modification shall become effective pending final determination in the proceeding when the Administrator determines that an imminent threat to food safety or public health exists, and that such action is, therefore, necessary to protect the public health, interest or safety. Such withdrawal or modification shall be effective upon oral or written notification, whichever is earlier, to the owner or operator of the particular establishment as promptly as circumstances permit. In the event of oral notification, written confirmation shall be given to the owner or operator of the establishment as promptly as circumstances permit. This withdrawal or modification shall continue in effect ending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.</P> <P>(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 § 318.10 of this subchapter.</P> <P>(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.</P> <P>(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: <E T="03">Provided,</E> That such waivers of the provisions of such regulations are not in <PRTPAGE P="99"/>conflict with the purposes or provisions of the Act.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0583-0015)</APPRO> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 303.2</SECTNO> <SUBJECT>Experimentation: Intensity of inspection coverage.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:</P> <P>(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,</P> <P>(ii) The competence of the person conducting operations at such establishment, as indicated by:</P> <P>(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,</P> <P>(B) Demonstrated ability to apply such knowledge in a timely and consistent manner, and</P> <P>(C) Commitment to correcting deficiencies noted by Program employees and otherwise assuring compliance with applicable regulatory requirements, and</P> <P>(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.</P> <P>(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:</P> <P>(i) The complexity of the processing operation(s) conducted at such establishment,</P> <P>(ii) The frequency with which each such operation is conducted at such establishment,</P> <P>(iii) The volume of product resulting from each such operation at such establishment,</P> <P>(iv) Whether and to what extent slaughter operations also are conducted at such establishment,</P> <P>(v) What, if any, food products not regulated under this Act or the Poultry Products Inspection Act also are prepared at such establishment, and</P> <P>(vi) The size of such establishment.</P> <P>(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 <PRTPAGE P="100"/>being tested if and only if the evaluation of the performance of such establishment described in paragraph (b)(1) indicates that there are:</P> <P>(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</P> <P>(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.</P> <P>(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:</P> <P>(A) The evaluation of the characteristics of such establishment described in paragraph (b)(2) of this section,<SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <P>(B) The significance of potential public health consequences of noncompliance, and</P> <P>(C) The availability of Program employees.</P> <P>(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 § 303.1(g) of this subchapter.</P> <CITA>[52 FR 10032, Mar. 30, 1987 and 52 FR 48091, Dec. 18, 1987]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 304</EAR> <HD SOURCE="HED">PART 304—APPLICATION FOR INSPECTION; GRANT OF INSPECTION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>304.1</SECTNO> <SUBJECT>Application for inspection.</SUBJECT> <SECTNO>304.2</SECTNO> <SUBJECT>Information to be furnished; grant or refusal of inspection.</SUBJECT> <SECTNO>304.3</SECTNO> <SUBJECT>Conditions for receiving inspection.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.18, 2.53.</P> </AUTH> <SECTION> <SECTNO>§ 304.1</SECTNO> <SUBJECT>Application for inspection.</SUBJECT> <P>(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.</P> <P>(b) Every application under this section shall be made on an official form furnished by the Program, available from any Regional Director identified in § 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.</P> <P>(c) In cases of change of ownership or location, a new application shall be made.</P> <CITA>[40 FR 2575, Jan. 14, 1975, as amended at 53 FR 49848, Dec. 12, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 304.2</SECTNO> <SUBJECT>Information to be furnished; grant or refusal of inspection.</SUBJECT> <P>(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.</P> <P>(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, §§ 416.1 through 416.6 of this chapter or that the applicant has not received approval of labeling and containers to be used at the establishment as required by the regulations in parts 316 and 317. Any application for <PRTPAGE P="101"/>inspection may be refused in accordance with the rules of practice in part 500 of this chapter.</P> <P>(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).</P> <P>(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.</P> <FP>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.</FP> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 304.3</SECTNO> <SUBJECT>Conditions for receiving inspection.</SUBJECT> <P>(a) Before being granted Federal inspection, an establishment shall have developed written sanitation Standard Operating Procedures, as required by part 416 of this chapter.</P> <P>(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, as required by §§ 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.</P> <P>(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 § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP plan, in accordance with § 417.4 of this chapter.</P> <CITA>[61 FR 38864, July 25, 1996]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 305</EAR> <HD SOURCE="HED">PART 305—OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL OF INSPECTION; REPORTS OF VIOLATION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>305.1</SECTNO> <SUBJECT>Official numbers; subsidiaries and tenants.</SUBJECT> <SECTNO>305.2</SECTNO> <SUBJECT>Separation of official establishments.</SUBJECT> <SECTNO>305.3</SECTNO> <SUBJECT>Sanitation and adequate facilities.</SUBJECT> <SECTNO>305.4</SECTNO> <SUBJECT>Inauguration of inspection.</SUBJECT> <SECTNO>305.6</SECTNO> <SUBJECT>Reports of violations.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15559, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 305.1</SECTNO> <SUBJECT>Official numbers; subsidiaries and tenants.</SUBJECT> <P>(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.<PRTPAGE P="102"/> </P> <P>(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.</P> <P>(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.</P> <CITA>[35 FR 15559, Oct. 3, 1970, as amended at 40 FR 2576, Jan. 14, 1975]</CITA> </SECTION> <SECTION> <SECTNO>§ 305.2</SECTNO> <SUBJECT>Separation of official establishments.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 305.3</SECTNO> <SUBJECT>Sanitation and adequate facilities.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 305.4</SECTNO> <SUBJECT>Inauguration of inspection.</SUBJECT> <P>When inspection is granted, the circuit supervisor shall, at or prior to the inauguration of inspection, inform the operator of the establishment of the requirements of the regulations in this subchapter. If the establishment, at the time inspection is inaugurated, contains any product which has not theretofore been inspected, passed, and marked in compliance with the regulations in this subchapter, the identity of the same shall be maintained, and it shall not be distributed in commerce, or otherwise subject to the requirements of such regulations, or dealt with as inspected and passed under the regulations. The establishment shall adopt and enforce all necessary measures and shall comply with all such directions as the circuit supervisor may prescribe, for carrying out the purposes of this section.</P> </SECTION> <SECTION> <SECTNO>§ 305.6</SECTNO> <SUBJECT>Reports of violations.</SUBJECT> <P>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.</P> </SECTION> </PART> <PART> <EAR>Pt. 306</EAR> <HD SOURCE="HED">PART 306—ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>306.1</SECTNO> <SUBJECT>Designation of circuit supervisor and assistants.</SUBJECT> <SECTNO>306.2</SECTNO> <SUBJECT>Program employees to have access to establishments.</SUBJECT> <SECTNO>306.3</SECTNO> <SUBJECT>Badge as identification of inspectors.</SUBJECT> <SECTNO>306.4</SECTNO> <SUBJECT>Assignment of Program employees where members of family employed; soliciting employment; procuring product from official establishments.</SUBJECT> <SECTNO>306.5</SECTNO> <SUBJECT>Appeals.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15559, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <PRTPAGE P="103"/> <SECTNO>§ 306.1</SECTNO> <SUBJECT>Designation of circuit supervisor and assistants.</SUBJECT> <P>[See §§ 300.3 and 300.4 of this chapter regarding FSIS' organization and inspection program supervisors.]</P> <CITA>[69 FR 254, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 306.2</SECTNO> <SUBJECT>Program employees to have access to establishments.</SUBJECT> <P>[See § 300.6 of this chapter regarding access to establishments and other places of business.]</P> <CITA>[69 FR 254, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 306.3</SECTNO> <SUBJECT>Badge as identification of inspectors.</SUBJECT> <P>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.</P> <CITA>[35 FR 15559, Oct. 3, 1970, as amended at 69 FR 254, Jan. 5, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 306.4</SECTNO> <SUBJECT>Assignment of Program employees where members of family employed; soliciting employment; procuring product from official establishments.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 306.5</SECTNO> <SUBJECT>Appeals.</SUBJECT> <P>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.</P> <CITA>[48 FR 11418, Mar. 18, 1983, as amended at 60 FR 67454, Dec. 29, 1995]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 307</EAR> <HD SOURCE="HED">PART 307—FACILITIES FOR INSPECTION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>307.1</SECTNO> <SUBJECT>Facilities for Program employees.</SUBJECT> <SECTNO>307.2</SECTNO> <SUBJECT>Other facilities and conditions to be provided by the establishment.</SUBJECT> <SECTNO>307.3</SECTNO> <SUBJECT>Inspectors to furnish and maintain implements in a sanitary condition.</SUBJECT> <SECTNO>307.4</SECTNO> <SUBJECT>Schedule of operations.</SUBJECT> <SECTNO>307.5</SECTNO> <SUBJECT>Overtime and holiday inspection service.</SUBJECT> <SECTNO>307.6</SECTNO> <SUBJECT>Basis of billing for overtime and holiday services.</SUBJECT> <SECTNO>307.7</SECTNO> <SUBJECT>Safety requirements for electrical stimulating (EST) equipment.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 U.S.C. 394, 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15560, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 307.1</SECTNO> <SUBJECT>Facilities for Program employees.</SUBJECT> <P>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 <PRTPAGE P="104"/>change clothing if such clothes changing facilities are deemed necessary by the circuit supervisor. At the discretion of the Administrator, small plants requiring the services of less than one full time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Laundry service for inspectors' outer work clothing shall be provided by each establishment.</P> </SECTION> <SECTION> <SECTNO>§ 307.2</SECTNO> <SUBJECT>Other facilities and conditions to be provided by the establishment.</SUBJECT> <P>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:</P> <P>(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);</P> <P>(b) Sufficient light to be adequate for proper conduct of inspection;</P> <P>(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;</P> <P>(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;</P> <P>(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;</P> <P>(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;</P> <P>(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);</P> <P>(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” <PRTPAGE P="105"/>in letters not less than 2 inches high; rooms or compartments for these purposes shall be secure and susceptible of being kept clean, including a sanitary disposal of the floor liquids; establishment employees shall not enter any retention rooms or compartments or open any retention receptacles unless authorized by Program employees);</P> <P>(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);</P> <P>(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 § 318.3 of this subchapter.</P> <P>(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);</P> <P>(l) Sanitary facilities and accommodations as prescribed by § 416.2(c), (d), (e), (f), and (h) of this chapter.</P> <P>(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 § 310.1(b) of this subchapter are required:</P> <P>(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.</P> <P>(2) A minimum of 50 foot candles of shadow-free lighting at the inspection surfaces of the head, viscera, and carcass.</P> <P>(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.</P> <P>(4) For mechanized operations, a line control switch located adjacent to each inspection station.</P> <P>(5) Facilities to position tally sheets or other recording devices, such as digital counters, and facilities to contain condemned brands.</P> <P>(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 × 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.</P> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 307.3</SECTNO> <SUBJECT>Inspectors to furnish and maintain implements in a sanitary condition.</SUBJECT> <P>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 § 416.3(a) of this chapter.</P> <CITA>[64 FR 56415, Oct. 20, 1999]</CITA> </SECTION> <SECTION> <SECTNO>§ 307.4</SECTNO> <SUBJECT>Schedule of operations.</SUBJECT> <P>(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.</P> <P>(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, <PRTPAGE P="106"/>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<FR>1/2</FR> hours after the beginning of scheduled operations.</P> <P>(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 § 307.5: <E T="03">Provided,</E> 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 § 318.4(h) of this subchapter.</P> <P>(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.</P> <P>(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: <E T="03">Provided,</E> 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.</P> <P>(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: <E T="03">Provided,</E> That an inspector may be recalled to his assignment after completion of his daily tour of duty under the provisions of § 307.6(b).</P> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 307.5</SECTNO> <SUBJECT>Overtime and holiday inspection service.</SUBJECT> <P>(a) The management of an official establishment, an importer, or an exporter shall reimburse the Program, at the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday as specified in paragraph (b) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.</P> <P>(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.</P> <CITA>[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]</CITA> </SECTION> <SECTION> <PRTPAGE P="107"/> <SECTNO>§ 307.6</SECTNO> <SUBJECT>Basis of billing for overtime and holiday services.</SUBJECT> <P>(a) Each recipient of overtime or holiday inspection service, or both, shall be billed as provided for in § 307.5(a) and at the rates specified in § 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.</P> <P>(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.</P> <P>(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.</P> <CITA>[40 FR 45800, Oct. 3, 1975, as amended at 54 FR 6389, Feb. 10, 1989]</CITA> </SECTION> <SECTION> <SECTNO>§ 307.7</SECTNO> <SUBJECT>Safety requirements for electrical stimulating (EST) equipment.</SUBJECT> <P>(a) <E T="03">General.</E> 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.</P> <P>(b) <E T="03">Safety requirements</E>—(1) <E T="03">Circuits, grounding.</E> 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.</P> <P>(2) <E T="03">Enclosure.</E> 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.</P> <P>(3) <E T="03">Mandatory Warning Devices and Signals.</E> The following warning devices or signals shall be installed at each opening to the stimulating area through which a person would normally enter:</P> <P>(i) A red light that flashes distinctly during the operating cycle of the stimulating equipment.</P> <P>(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.</P> <P>(iii) An emergency stop button.</P> <P>(4) <E T="03">Optional Warning Device—Horn or Bell.</E> 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.</P> <P>(c) Operation—</P> <P>(1) <E T="03">Training.</E> Only persons who have received safety instruction by the equipment manufacturer or designee may operate electrical stimulating equipment.</P> <P>(2) <E T="03">Cleaning and Maintenance.</E> To prevent an electrical shock to personnel, <PRTPAGE P="108"/>the electricity supplied to the stimulating surfaces shall be locked-off when cleaning, mechanical inspection, maintenance or testing are performed.</P> <P>(3) <E T="03">Water.</E> To prevent an electrical shock, personnel shall not spray streams of water on energized carcasses or on energized stimulating surfaces.</P> <P>(d) Special provisions for manually operated equipment.</P> <P>(1) Stimulating probes or clamps shall be stored in a sanitary container which is insulated with a material approved by the Administrator.<SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <P>(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.</P> <CITA>[53 FR 46432, Nov. 17, 1988, as amended at 64 FR 56415, Oct. 20, 1999]</CITA> </SECTION> </PART> <PART> <RESERVED>PART 308 [RESERVED]</RESERVED> </PART> <PART> <EAR>Pt. 309</EAR> <HD SOURCE="HED">PART 309—ANTE-MORTEM INSPECTION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>309.1</SECTNO> <SUBJECT>Ante-mortem inspection in pens of official establishments.</SUBJECT> <SECTNO>309.2</SECTNO> <SUBJECT>Livestock suspected of being diseased or affected with certain conditions; identifying suspects; disposition on post-mortem inspection or otherwise.</SUBJECT> <SECTNO>309.3</SECTNO> <SUBJECT>Dead, dying, disabled, or diseased and similar livestock.</SUBJECT> <SECTNO>309.4</SECTNO> <SUBJECT>Livestock showing symptoms of certain metabolic, toxic, nervous, or circulatory disturbances, nutritional imbalances, or infectious or parasitic diseases.</SUBJECT> <SECTNO>309.5</SECTNO> <SUBJECT>Swine; disposal because of hog cholera.</SUBJECT> <SECTNO>309.6</SECTNO> <SUBJECT>Epithelioma of the eye.</SUBJECT> <SECTNO>309.7</SECTNO> <SUBJECT>Livestock affected with anthrax; cleaning and disinfection of infected livestock pens and driveways.</SUBJECT> <SECTNO>309.8</SECTNO> <SUBJECT>Cattle affected with anasarca and generalized edema.</SUBJECT> <SECTNO>309.9</SECTNO> <SUBJECT>Swine erysipelas.</SUBJECT> <SECTNO>309.10</SECTNO> <SUBJECT>Onset of parturition.</SUBJECT> <SECTNO>309.11</SECTNO> <SUBJECT>Vaccine livestock.</SUBJECT> <SECTNO>309.12</SECTNO> <SUBJECT>Emergency slaughter; inspection prior to.</SUBJECT> <SECTNO>309.13</SECTNO> <SUBJECT>Disposition of condemned livestock.</SUBJECT> <SECTNO>309.14</SECTNO> <SUBJECT>Brucellosis-reactor goats.</SUBJECT> <SECTNO>309.15</SECTNO> <SUBJECT>Vesicular diseases.</SUBJECT> <SECTNO>309.16</SECTNO> <SUBJECT>Livestock suspected of having biological residues.</SUBJECT> <SECTNO>309.17</SECTNO> <SUBJECT>Livestock used for research.</SUBJECT> <SECTNO>309.18</SECTNO> <SUBJECT>Official marks and devices for purposes of ante-mortem inspection.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.18, 2.53.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15563, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 309.1</SECTNO> <SUBJECT>Ante-mortem inspection in pens of official establishments.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 309.2</SECTNO> <SUBJECT>Livestock suspected of being diseased or affected with certain conditions; identifying suspects; disposition on post-mortem inspection or otherwise.</SUBJECT> <P>(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 <PRTPAGE P="109"/>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.</P> <P>(b) All seriously crippled animals and non-ambulatory disabled livestock shall be identified as U.S. Suspects and disposed of as provided in § 311.1 of this subchapter unless they are required to be classed as condemned under § 309.3. Non-ambulatory disabled livestock are livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.</P> <P>(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 § 311.10 of this subchapter.</P> <P>(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 § 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.</P> <P>(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 § 309.6 shall be identified as a U.S. Suspect and disposed of as provided in § 311.12 of this subchapter.</P> <P>(f) Cattle found on ante-mortem inspection to be affected with anasarca to a lesser extent than as described in § 309.8 shall be identified as U.S. Suspects and disposed of as provided in § 311.8 of this subchapter or paragraph (g) of this section.</P> <P>(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 § 311.8 of this subchapter or condemned and disposed of as provided in § 309.8, whichever is appropriate.</P> <P>(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 § 311.5 of this subchapter or paragraph (i) of this section.</P> <P>(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 § 311.5 of this subchapter, or condemned and disposed of as provided in § 309.13, whichever is appropriate.</P> <P>(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 § 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.</P> <P>(k) Livestock which are offered for ante-mortem inspection under this <PRTPAGE P="110"/>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.</P> <P>(l) Livestock previously condemned for listeriosis, if released for slaughter under § 309.13(b) shall be identified as a U.S. Suspect in accordance with § 309.13(c).</P> <P>(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 § 309.18. No such device shall be removed except by a Program employee.</P> <P>(n) Each animal identified as a U.S. Suspect on ante-mortem inspection shall be set apart and shall be slaughtered separately from other livestock at that establishment unless disposed of as otherwise provided in this part.</P> <P>(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> <P>(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.</P> <CITA>[35 FR 15563, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 FR 36000, Oct. 17, 1974; 69 FR 1873, Jan. 12, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.3</SECTNO> <SUBJECT>Dead, dying, disabled, or diseased and similar livestock.</SUBJECT> <P>(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 § 309.13.</P> <P>(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 § 309.13.</P> <P>(c) Any swine having a temperature of 106 °F. or higher and any cattle, sheep, goats, horses, mules, or other equines having a temperature of 105 °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 °F. or higher in the case of swine, or 105 °F. or higher in the case of other livestock, it shall be condemned and disposed of in accordance with § 309.13.</P> <P>(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 <PRTPAGE P="111"/>slaughter for human food, shall be identified “U.S. Condemned” and disposed of in accordance with § 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.</P> <P>(e) Non-ambulatory disabled cattle that are offered for slaughter must be condemned and disposed of in accordance with § 309.13. FSIS inspection personnel will determine the disposition of cattle that become non-ambulatory after they have passed ante-mortem inspection on a case-by-case basis.</P> <CITA>[35 FR 15563, Oct. 3, 1970, as amended at 69 FR 1873, Jan. 12, 2004; 72 FR 38729, July 13, 2007]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.4</SECTNO> <SUBJECT>Livestock showing symptoms of certain metabolic, toxic, nervous, or circulatory disturbances, nutritional imbalances, or infectious or parasitic diseases.</SUBJECT> <P>(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 § 309.13.</P> <P>(b) If any equine is suspected on ante-mortem inspection of being infected with glanders or dourine, the nearest Veterinary Services unit of the Animal and Plant Health Inspection Service shall be so informed by a Program employee. Tests shall be performed by said unit to determine whether the animal is, in fact, infected with such disease. If it is found on such tests to be infected, the animal shall be disposed of in accordance with paragraph (a) of this section. Otherwise, the animal shall be identified as a U.S. Suspect and disposed of as provided in § 311.10 of this subchapter.</P> <CITA>[35 FR 15563, Oct. 3, 1970 as amended at 38 FR 29214, Oct. 23, 1973]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.5</SECTNO> <SUBJECT>Swine; disposal because of hog cholera.</SUBJECT> <P>(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 § 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.</P> <P>(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.</P> <CITA>[40 FR 27225, June 27, 1975]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.6</SECTNO> <SUBJECT>Epithelioma of the eye.</SUBJECT> <P>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 § 309.13.</P> </SECTION> <SECTION> <SECTNO>§ 309.7</SECTNO> <SUBJECT>Livestock affected with anthrax; cleaning and disinfection of infected livestock pens and driveways.</SUBJECT> <P>(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 § 309.13.</P> <P>(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.</P> <P>(c) Apparently healthy livestock (other than hogs) from a lot in which <PRTPAGE P="112"/>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.</P> <P>(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.</P> <P>(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 § 310.9(e)(1) of this subchapter, or other disinfectant that may be approved in specific cases by the Administrator specifically for this purpose.</P> </SECTION> <SECTION> <SECTNO>§ 309.8</SECTNO> <SUBJECT>Cattle affected with anasarca and generalized edema.</SUBJECT> <P>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 § 309.13.</P> </SECTION> <SECTION> <SECTNO>§ 309.9</SECTNO> <SUBJECT>Swine erysipelas.</SUBJECT> <P>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 § 309.13.</P> </SECTION> <SECTION> <SECTNO>§ 309.10</SECTNO> <SUBJECT>Onset of parturition.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 309.11</SECTNO> <SUBJECT>Vaccine livestock.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 309.12</SECTNO> <SUBJECT>Emergency slaughter; inspection prior to.</SUBJECT> <P>In all cases of emergency slaughter, except as provided in § 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.</P> </SECTION> <SECTION> <SECTNO>§ 309.13</SECTNO> <SUBJECT>Disposition of condemned livestock.</SUBJECT> <P>(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, <PRTPAGE P="113"/>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.</P> <P>(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. Veal calves that are unable to rise from a recumbent position and walk because they are tired or cold may also be set apart and held as provided in this paragraph. 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.</P> <P>(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.</P> <P>(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.</P> <CITA>[35 FR 15563, Oct. 3, 1970, as amended at 72 FR 38729, July 13, 2007]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.14</SECTNO> <SUBJECT>Brucellosis-reactor goats.</SUBJECT> <P>Goats which have reacted to a test for brucellosis shall not be slaughtered in an official establishment.</P> </SECTION> <SECTION> <SECTNO>§ 309.15</SECTNO> <SUBJECT>Vesicular diseases.</SUBJECT> <P>(a) Immediate notification shall be given by the inspector to the local, State, and Federal livestock sanitary officials having jurisdiction when any livestock is found to be affected with a vesicular disease.</P> <P>(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 § 309.13.</P> </SECTION> <SECTION> <SECTNO>§ 309.16</SECTNO> <SUBJECT>Livestock suspected of having biological residues.</SUBJECT> <P>(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.</P> <P>(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 § 314.1 or § 314.3 of this chapter.</P> <P>(c) [Reserved]</P> <P>(d) Calves shall not be presented for ante-mortem inspection in an official establishment except under the provisions of this paragraph.<PRTPAGE P="114"/> </P> <P>(1) <E T="03">Definitions.</E> For purposes of this paragraph, the following definitions shall apply:</P> <P>(i) <E T="03">Calf.</E> A calf up to 3 weeks of age or up to 150 pounds.</P> <P>(ii) <E T="03">Certified calf.</E> 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.</P> <P>(iii) <E T="03">Healthy calf.</E> A calf that an inspector determines shows no visual signs of disease or treatment of disease at ante-mortem inspection.</P> <P>(iv) <E T="03">Producer.</E> The owner of the calf at the time of its birth.</P> <P>(v) <E T="03">Sick calf.</E> A calf that an inspector on ante-mortem inspection determines has either signs of treatment or signs of disease.</P> <P>(vi) <E T="03">Veterinary medical officer.</E> An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.</P> <P>(2) <E T="03">General requirements.</E> (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.</P> <P>(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.</P> <P>(3) <E T="03">Certified group.</E> (i) For a calf to be considered certified, the producer and all other subsequent custodians of the calf must certify in writing that while the calf was in his or her custody, the calf was not treated with animal drugs or was treated with one or more drugs in accordance with FDA approved label directions and was withheld from slaughter for the period(s) of time specified by those label directions. All prior certifications must be presented with the animal at the time of slaughter. The certifications shall contain a list of the calves with accompanying identification numbers, as required by paragraph (d)(3)(ii) of this section, followed by the following language: </P> <EXTRACT> <P>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). </P> <FP SOURCE="FP-DASH">Executed on</FP> <FP>(date of certification)</FP> <FP SOURCE="FP-DASH"/> <FP>(signature of certifier)</FP> <FP SOURCE="FP-DASH"/> <FP>(typed or printed name and address of certifier)</FP> <FP SOURCE="FP-DASH"/> <FP>(business of certifier)</FP> </EXTRACT> <P>(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.</P> <P>(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 § 310.21 (c) and (d).</P> <P>(iv) The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c) and (d).</P> <P>(4) <E T="03">Noncertified group.</E> 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 § 310.21(c). The inspector shall handle <PRTPAGE P="115"/>the remaining carcasses of healthy animals in accordance with § 310.21(c).</P> <P>(5) <E T="03">Calves from producers with previous residue condemnation.</E> 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 § 310.21(e). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(e).</P> <P>(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 § 310.23(a) of this subchapter.</P> <APPRO>(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0053)</APPRO> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 309.17</SECTNO> <SUBJECT>Livestock used for research.</SUBJECT> <P>(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:</P> <P>(1) The operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Program, or the Veterinary Services unit of the Animal and Plant Health Inspection Service of the Department of Agriculture or to the Environmental Protection Agency or to the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such livestock being adulterated, and a Program employee has approved such slaughter;</P> <P>(2) Written approval by the Deputy Administrator, Meat and Poultry Inspection Field Operations is furnished the area supervisor prior to the time of slaughter;</P> <P>(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;</P> <P>(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;</P> <P>(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 § 362.17 of the regulations issued under said Act (7 CFR 362.17), and used in accordance with the labeling approved under said regulations.</P> <P>(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.</P> <P>(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 <PRTPAGE P="116"/>prepared at the official establishment are free from adulteration.</P> </SECTION> <SECTION> <SECTNO>§ 309.18</SECTNO> <SUBJECT>Official marks and devices for purposes of ante-mortem inspection.</SUBJECT> <P>(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 § 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.</P> <P>(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.</P> <P>(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.”</P> <P>(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.</P> </SECTION> </PART> <PART> <EAR>Pt. 310</EAR> <HD SOURCE="HED">PART 310—POST-MORTEM INSPECTION</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>310.1</SECTNO> <SUBJECT>Extent and time of post-mortem inspection; post-mortem inspection staffing standards.</SUBJECT> <SECTNO>310.2</SECTNO> <SUBJECT>Identification of carcass with certain severed parts thereof and with animal from which derived.</SUBJECT> <SECTNO>310.3</SECTNO> <SUBJECT>Carcasses and parts in certain instances to be retained.</SUBJECT> <SECTNO>310.4</SECTNO> <SUBJECT>Identification of carcasses and parts; tagging.</SUBJECT> <SECTNO>310.5</SECTNO> <SUBJECT>Condemned carcasses and parts to be so marked; tanking; separation.</SUBJECT> <SECTNO>310.6</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; marking.</SUBJECT> <SECTNO>310.7</SECTNO> <SUBJECT>Removal of spermatic cords, pizzles and preputial diverticuli.</SUBJECT> <SECTNO>310.8</SECTNO> <SUBJECT>Passing and marking of carcasses and parts.</SUBJECT> <SECTNO>310.9</SECTNO> <SUBJECT>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.</SUBJECT> <SECTNO>310.10</SECTNO> <SUBJECT>Carcasses with skin or hide on; cleaning before evisceration; removal of larvae of Hypodermae, external parasites and other pathological skin conditions.</SUBJECT> <SECTNO>310.11</SECTNO> <SUBJECT>Cleaning of hog carcasses before incising.</SUBJECT> <SECTNO>310.12</SECTNO> <SUBJECT>Sternum to be split; abdominal and thoracic viscera to be removed.</SUBJECT> <SECTNO>310.13</SECTNO> <SUBJECT>Inflating carcasses or parts thereof; transferring caul or other fat.</SUBJECT> <SECTNO>310.14</SECTNO> <SUBJECT>Handling of bruised parts.</SUBJECT> <SECTNO>310.15</SECTNO> <SUBJECT>Disposition of thyroid glands and laryngeal muscle tissue.</SUBJECT> <SECTNO>310.16</SECTNO> <SUBJECT>Disposition of lungs.</SUBJECT> <SECTNO>310.17</SECTNO> <SUBJECT>Inspection of mammary glands.</SUBJECT> <SECTNO>310.18</SECTNO> <SUBJECT>Contamination of carcasses, organs, or other parts.</SUBJECT> <SECTNO>310.19</SECTNO> <SUBJECT>Inspection of kidneys.</SUBJECT> <SECTNO>310.20</SECTNO> <SUBJECT>Saving of blood from livestock as an edible product.</SUBJECT> <SECTNO>310.21</SECTNO> <SUBJECT>Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts.</SUBJECT> <SECTNO>310.22</SECTNO> <SUBJECT>Specified risk materials from cattle and their handling and disposition.</SUBJECT> <SECTNO>310.23</SECTNO> <SUBJECT>Identification of carcasses and parts of swine.</SUBJECT> <SECTNO>310.24</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>310.25</SECTNO> <SUBJECT>Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.18, 2.53.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15567, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 310.1</SECTNO> <SUBJECT>Extent and time of post-mortem inspection; post-mortem inspection staffing standards.</SUBJECT> <P>(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.</P> <P>(b)(1) The staffing standards on the basis of the number of carcasses to be inspected per hour are outlined in the <PRTPAGE P="117"/>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.</P> <P>(2) <E T="03">Cattle inspection.</E> 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. <SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <P>(i) Inspection Using the Viscera Truck.</P> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Steers and Heifers</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 27</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">28 to 56</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">57 to 84</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">85 to 86</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">87 to 143</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> </GPOTABLE> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Cows and Bulls</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 27</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">28 to 55</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">56 to 77</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">78 to 81</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">82 to 134</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> </GPOTABLE> <P>(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 <E T="03">lowest</E> whole number.<PRTPAGE P="118"/> </P> <GPOTABLE CDEF="3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3,3" COLS="27" OPTS="L2,p5,5/6"> <TTITLE>One-Inspector Cattle Kill—Viscera Truck</TTITLE> <TDESC>[Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]</TDESC> <BOXHD> <CHED H="1">1 <LI>Number of feet between points</LI> </CHED> <CHED H="1">2 <LI>Head rack and high rail</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">3 <LI>Viscera and low rail</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">4 <LI>Low rail and head rack</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">5 <LI>Head rack and carcass <SU>2</SU> </LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">6 <LI>Carcass <SU>2</SU> and washbasin</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">7 <LI>Tags—brands and low rail</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">8 <LI>Viscera and washbasin</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">9 <LI>Viscera and high rail</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">10 <LI>Low rail and high rail</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">11 <LI>Head rack and closest washbasin</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">12 <LI>Washbasin and high rail <SU>1</SU> </LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">13 <LI>Head rack and washbasin <SU>1</SU> </LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> <CHED H="1">14 <LI>Viscera and tags—brands</LI> </CHED> <CHED H="2">Strs. Hfrs.</CHED> <CHED H="2">Cows Bulls</CHED> </BOXHD> <ROW> <ENT I="01">1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> </ROW> <ROW> <ENT I="01">3</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> </ROW> <ROW> <ENT I="01">5</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> </ROW> <ROW> <ENT I="01">7</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> </ROW> <ROW> <ENT I="01">9</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> </ROW> <ROW> <ENT I="01">11</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> </ROW> <ROW> <ENT I="01">13</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> </ROW> <ROW> <ENT I="01">15</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.9</ENT> </ROW> <ROW> <ENT I="01">17</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> </ROW> <ROW> <ENT I="01">19</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.5</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> </ROW> <ROW> <ENT I="01">21</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.8</ENT> <ENT>0.9</ENT> <ENT>0.8</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>1.1</ENT> <ENT>1.3</ENT> </ROW> <ROW> <ENT I="01">23</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>0.9</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.2</ENT> <ENT>1.4</ENT> </ROW> <ROW> <ENT I="01">25</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> <ENT>1.0</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.3</ENT> <ENT>1.5</ENT> </ROW> <ROW> <ENT I="01">27</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>1.1</ENT> <ENT>1.2</ENT> <ENT>1.1</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.4</ENT> <ENT>1.7</ENT> </ROW> <ROW> <ENT I="01">29</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.8</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>1.2</ENT> <ENT>1.3</ENT> <ENT>1.2</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>1.5</ENT> <ENT>1.8</ENT> </ROW> <ROW> <ENT I="01">31</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>0.8</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.6</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>1.4</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.6</ENT> <ENT>1.9</ENT> </ROW> <ROW> <ENT I="01">33</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.9</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>1.3</ENT> <ENT>1.4</ENT> <ENT>1.4</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.7</ENT> <ENT>2.1</ENT> </ROW> <ROW> <ENT I="01">35</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.0</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>1.4</ENT> <ENT>1.5</ENT> <ENT>1.5</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.4</ENT> <ENT>1.8</ENT> <ENT>2.2</ENT> </ROW> <ROW> <ENT I="01">37</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.0</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.6</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>1.5</ENT> <ENT>1.6</ENT> <ENT>1.6</ENT> <ENT>.0.8</ENT> <ENT>0.8</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.9</ENT> <ENT>2.3</ENT> </ROW> <ROW> <ENT I="01">39</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>1.1</ENT> <ENT>0.8</ENT> <ENT>0.9</ENT> <ENT>0.8</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>0.9</ENT> <ENT>1.6</ENT> <ENT>1.7</ENT> <ENT>1.7</ENT> <ENT>0.9</ENT> <ENT>0.9</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>2.0</ENT> <ENT>2.4</ENT> </ROW> <ROW> <ENT I="01">41</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>1.1</ENT> <ENT>0.9</ENT> <ENT>0.9</ENT> <ENT>0.9</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.7</ENT> <ENT>0.9</ENT> <ENT>0.9</ENT> <ENT>1.7</ENT> <ENT>1.7</ENT> <ENT>1.8</ENT> <ENT>0.9</ENT> <ENT>0.9</ENT> <ENT>0</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>2.1</ENT> <ENT>2.6</ENT> </ROW> <ROW> <ENT I="01">43</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.2</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>0.9</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.7</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>1.8</ENT> <ENT>1.8</ENT> <ENT>1.9</ENT> <ENT>1.0</ENT> <ENT>1.0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.5</ENT> <ENT>2.2</ENT> <ENT>2.7</ENT> </ROW> <ROW> <ENT I="01">45</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.2</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>0.9</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.8</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>1.8</ENT> <ENT>1.9</ENT> <ENT>2.0</ENT> <ENT>1.0</ENT> <ENT>1.0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>2.3</ENT> <ENT>2.8</ENT> </ROW> <ROW> <ENT I="01">47</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.3</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> <ENT>1.0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.8</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> <ENT>1.9</ENT> <ENT>2.0</ENT> <ENT>2.1</ENT> <ENT>1.1</ENT> <ENT>1.1</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>0.6</ENT> <ENT>2.4</ENT> <ENT>2.9</ENT> </ROW> <ROW> <ENT I="01">49</ENT> <ENT>0.4</ENT> <ENT>0.4</ENT> <ENT>1.4</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> <ENT>1.0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.8</ENT> <ENT>1.0</ENT> <ENT>1.1</ENT> <ENT>2.0</ENT> <ENT>2.1</ENT> <ENT>2.2</ENT> <ENT>1.1</ENT> <ENT>1.1</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.6</ENT> <ENT>2.5</ENT> <ENT>3.1</ENT> </ROW> <ROW> <ENT I="01">51</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.4</ENT> <ENT>1.1</ENT> <ENT>1.2</ENT> <ENT>1.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.9</ENT> <ENT>1.1</ENT> <ENT>1.2</ENT> <ENT>2.1</ENT> <ENT>2.2</ENT> <ENT>2.2</ENT> <ENT>1.2</ENT> <ENT>1.2</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>2.6</ENT> <ENT>3.2</ENT> </ROW> <ROW> <ENT I="01">53</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.5</ENT> <ENT>1.1</ENT> <ENT>1.2</ENT> <ENT>1.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.9</ENT> <ENT>1.1</ENT> <ENT>1.2</ENT> <ENT>2.2</ENT> <ENT>2.3</ENT> <ENT>2.3</ENT> <ENT>1.2</ENT> <ENT>1.2</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>0.7</ENT> <ENT>2.7</ENT> <ENT>3.3</ENT> </ROW> <ROW> <ENT I="01">55</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.5</ENT> <ENT>1.2</ENT> <ENT>1.2</ENT> <ENT>1.2</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>1.0</ENT> <ENT>1.2</ENT> <ENT>1.2</ENT> <ENT>2.3</ENT> <ENT>2.3</ENT> <ENT>2.4</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>2.8</ENT> <ENT>3.4</ENT> </ROW> <ROW> <ENT I="01">57</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.6</ENT> <ENT>1.2</ENT> <ENT>1.3</ENT> <ENT>1.2</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>1.0</ENT> <ENT>1.2</ENT> <ENT>1.3</ENT> <ENT>2.3</ENT> <ENT>2.4</ENT> <ENT>2.5</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>2.9</ENT> <ENT>3.5</ENT> </ROW> <ROW> <ENT I="01">59</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>1.6</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>1.0</ENT> <ENT>1.3</ENT> <ENT>1.3</ENT> <ENT>2.4</ENT> <ENT>2.5</ENT> <ENT>2.6</ENT> <ENT>1.4</ENT> <ENT>1.4</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>0.8</ENT> <ENT>3.0</ENT> <ENT>3.6</ENT> </ROW> <TNOTE> <SU>1</SU> The washbasin referred to here is the one the inspector uses while enroute from the head rack to high rail inspection.</TNOTE> <TNOTE> <SU>2</SU> This refers to the carcass in the bleeding area.</TNOTE> </GPOTABLE> <PRTPAGE P="119"/> <P>(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 <E T="03">lowest</E> whole number.<PRTPAGE P="120"/> </P> <GPOTABLE CDEF="6,6,6,6,6,6,6,6,6,6,6,6,6,6,6,6,6" COLS="17" OPTS="L2"> <TTITLE>Two-Inspector Cattle Kill—Viscera Truck</TTITLE> <TDESC>[Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths of cattle per hour)]</TDESC> <BOXHD> <CHED H="1">Heads and low rail inspection</CHED> <CHED H="2">1</CHED> <CHED H="3">Number of feet between points</CHED> <CHED H="2">2</CHED> <CHED H="3">Head rack and washbasin</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">3</CHED> <CHED H="3">Head rack and carcasses <SU>2</SU> </CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">4</CHED> <CHED H="3">Washbasin and low rail</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">5</CHED> <CHED H="3">Head rack and low rail</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="1">Viscera and high rail inspection</CHED> <CHED H="2">6</CHED> <CHED H="3">Viscera and brands tags (washbasin)</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">7</CHED> <CHED H="3">Viscera and high rail</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">8</CHED> <CHED H="3">High rail and washbasin</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> <CHED H="2">9 <SU>1</SU> </CHED> <CHED H="3">Viscera and washbasin</CHED> <CHED H="4">Strs. Hfrs.</CHED> <CHED H="4">Cows Bulls</CHED> </BOXHD> <ROW> <ENT I="01">1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> </ROW> <ROW> <ENT I="01">3</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> </ROW> <ROW> <ENT I="01">5</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.8</ENT> <ENT>0.7</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.5</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> </ROW> <ROW> <ENT I="01">7</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>0.1</ENT> <ENT>1.5</ENT> <ENT>1.4</ENT> <ENT>0.7</ENT> <ENT>0.9</ENT> <ENT>1.0</ENT> <ENT>0.9</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> </ROW> <ROW> <ENT I="01">9</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>2.2</ENT> <ENT>2.0</ENT> <ENT>1.1</ENT> <ENT>1.3</ENT> <ENT>1.5</ENT> <ENT>1.3</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> </ROW> <ROW> <ENT I="01">11</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> <ENT>0.1</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>2.8</ENT> <ENT>2.7</ENT> <ENT>1.4</ENT> <ENT>1.7</ENT> <ENT>1.9</ENT> <ENT>1.8</ENT> <ENT>0.5</ENT> <ENT>0.6</ENT> <ENT>0.4</ENT> <ENT>0.6</ENT> </ROW> <ROW> <ENT I="01">13</ENT> <ENT>0.2</ENT> <ENT>0.4</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>0.2</ENT> <ENT>3.5</ENT> <ENT>3.3</ENT> <ENT>1.7</ENT> <ENT>2.1</ENT> <ENT>2.4</ENT> <ENT>2.2</ENT> <ENT>0.6</ENT> <ENT>0.7</ENT> <ENT>0.5</ENT> <ENT>0.8</ENT> </ROW> <ROW> <ENT I="01">15</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>0.1</ENT> <ENT>0.3</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> <ENT>4.1</ENT> <ENT>3.9</ENT> <ENT>2.0</ENT> <ENT>2.5</ENT> <ENT>2.9</ENT> <ENT>2.6</ENT> <ENT>0.7</ENT> <ENT>0.9</ENT> <ENT>0.6</ENT> <ENT>0.9</ENT> </ROW> <ROW> <ENT I="01">17</ENT> <ENT>0.3</ENT> <ENT>0.5</ENT> <ENT>0.1</ENT> <ENT>0.4</ENT> <ENT>0.2</ENT> <ENT>0.3</ENT> <ENT>4.8</ENT> <ENT>4.5</ENT> <ENT>2.4</ENT> <ENT>2.9</ENT> <ENT>3.3</ENT> <ENT>3.0</ENT> <ENT>0.8</ENT> <ENT>1.0</ENT> <ENT>0.7</ENT> <ENT>1.0</ENT> </ROW> <ROW> <ENT I="01">19</ENT> <ENT>0.3</ENT> <ENT>0.6</ENT> <ENT>0.2</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>5.4</ENT> <ENT>5.1</ENT> <ENT>2.7</ENT> <ENT>3.3</ENT> <ENT>3.7</ENT> <ENT>3.4</ENT> <ENT>0.9</ENT> <ENT>1.2</ENT> <ENT>0.7</ENT> <ENT>1.2</ENT> </ROW> <ROW> <ENT I="01">21</ENT> <ENT>0.3</ENT> <ENT>0.6</ENT> <ENT>0.2</ENT> <ENT>0.4</ENT> <ENT>0.3</ENT> <ENT>0.4</ENT> <ENT>6.0</ENT> <ENT>5.7</ENT> <ENT>3.0</ENT> <ENT>3.7</ENT> <ENT>4.2</ENT> <ENT>3.7</ENT> <ENT>1.0</ENT> <ENT>1.3</ENT> <ENT>0.8</ENT> <ENT>1.3</ENT> </ROW> <ROW> <ENT I="01">23</ENT> <ENT>0.4</ENT> <ENT>0.7</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.3</ENT> <ENT>0.5</ENT> <ENT>6.6</ENT> <ENT>6.3</ENT> <ENT>3.3</ENT> <ENT>4.0</ENT> <ENT>4.6</ENT> <ENT>4.1</ENT> <ENT>1.2</ENT> <ENT>1.4</ENT> <ENT>0.9</ENT> <ENT>1.4</ENT> </ROW> <ROW> <ENT I="01">25</ENT> <ENT>0.4</ENT> <ENT>0.7</ENT> <ENT>0.2</ENT> <ENT>0.5</ENT> <ENT>0.3</ENT> <ENT>0.5</ENT> <ENT>7.2</ENT> <ENT>6.8</ENT> <ENT>3.6</ENT> <ENT>4.4</ENT> <ENT>5.0</ENT> <ENT>4.5</ENT> <ENT>1.3</ENT> <ENT>1.6</ENT> <ENT>1.0</ENT> <ENT>1.6</ENT> </ROW> <ROW> <ENT I="01">27</ENT> <ENT>0.4</ENT> <ENT>0.8</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.4</ENT> <ENT>0.5</ENT> <ENT>7.8</ENT> <ENT>7.4</ENT> <ENT>3.9</ENT> <ENT>4.7</ENT> <ENT>5.4</ENT> <ENT>4.9</ENT> <ENT>1.4</ENT> <ENT>1.7</ENT> <ENT>1.0</ENT> <ENT>1.7</ENT> </ROW> <ROW> <ENT I="01">29</ENT> <ENT>0.5</ENT> <ENT>0.9</ENT> <ENT>0.2</ENT> <ENT>0.6</ENT> <ENT>0.4</ENT> <ENT>0.6</ENT> <ENT>8.3</ENT> <ENT>7.9</ENT> <ENT>4.2</ENT> <ENT>5.1</ENT> <ENT>5.8</ENT> <ENT>5.2</ENT> <ENT>1.5</ENT> <ENT>1.8</ENT> <ENT>1.1</ENT> <ENT>1.8</ENT> </ROW> <ROW> <ENT I="01">31</ENT> <ENT>0.5</ENT> <ENT>0.9</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.4</ENT> <ENT>0.6</ENT> <ENT>8.9</ENT> <ENT>8.5</ENT> <ENT>4.5</ENT> <ENT>5.4</ENT> <ENT>6.2</ENT> <ENT>5.6</ENT> <ENT>1.6</ENT> <ENT>2.0</ENT> <ENT>1.2</ENT> <ENT>2.0</ENT> </ROW> <ROW> <ENT I="01">33</ENT> <ENT>0.5</ENT> <ENT>1.0</ENT> <ENT>0.2</ENT> <ENT>0.7</ENT> <ENT>0.4</ENT> <ENT>0.7</ENT> <ENT>9.4</ENT> <ENT>9.0</ENT> <ENT>4.8</ENT> <ENT>5.8</ENT> <ENT>6.5</ENT> <ENT>5.9</ENT> <ENT>1.7</ENT> <ENT>2.1</ENT> <ENT>1.3</ENT> <ENT>2.1</ENT> </ROW> <ROW> <ENT I="01">35</ENT> <ENT>0.6</ENT> <ENT>1.1</ENT> <ENT>0.3</ENT> <ENT>0.8</ENT> <ENT>0.5</ENT> <ENT>0.7</ENT> <ENT>10.0</ENT> <ENT>9.5</ENT> <ENT>5.0</ENT> <ENT>6.1</ENT> <ENT>6.9</ENT> <ENT>6.3</ENT> <ENT>1.8</ENT> <ENT>2.2</ENT> <ENT>1.3</ENT> <ENT>2.3</ENT> </ROW> <ROW> <ENT I="01">37</ENT> <ENT>0.6</ENT> <ENT>1.1</ENT> <ENT>0.3</ENT> <ENT>0.8</ENT> <ENT>0.5</ENT> <ENT>0.7</ENT> <ENT>10.5</ENT> <ENT>10.0</ENT> <ENT>5.3</ENT> <ENT>6.4</ENT> <ENT>7.3</ENT> <ENT>6.6</ENT> <ENT>1.9</ENT> <ENT>2.4</ENT> <ENT>1.4</ENT> <ENT>2.4</ENT> </ROW> <ROW> <ENT I="01">39</ENT> <ENT>0.6</ENT> <ENT>1.2</ENT> <ENT>0.3</ENT> <ENT>0.9</ENT> <ENT>0.5</ENT> <ENT>0.8</ENT> <ENT>11.0</ENT> <ENT>10.5</ENT> <ENT>5.6</ENT> <ENT>6.8</ENT> <ENT>7.6</ENT> <ENT>6.9</ENT> <ENT>2.0</ENT> <ENT>2.5</ENT> <ENT>1.5</ENT> <ENT>2.5</ENT> </ROW> <ROW> <ENT I="01">41</ENT> <ENT>0.7</ENT> <ENT>1.2</ENT> <ENT>0.3</ENT> <ENT>0.9</ENT> <ENT>0.6</ENT> <ENT>0.8</ENT> <ENT>11.5</ENT> <ENT>11.0</ENT> <ENT>5.9</ENT> <ENT>7.1</ENT> <ENT>8.0</ENT> <ENT>7.2</ENT> <ENT>2.1</ENT> <ENT>2.6</ENT> <ENT>1.5</ENT> <ENT>2.6</ENT> </ROW> <ROW> <ENT I="01">43</ENT> <ENT>0.7</ENT> <ENT>1.3</ENT> <ENT>0.3</ENT> <ENT>0.9</ENT> <ENT>0.6</ENT> <ENT>0.9</ENT> <ENT>12.0</ENT> <ENT>11.4</ENT> <ENT>6.1</ENT> <ENT>7.4</ENT> <ENT>8.3</ENT> <ENT>7.6</ENT> <ENT>2.2</ENT> <ENT>2.8</ENT> <ENT>1.6</ENT> <ENT>2.8</ENT> </ROW> <ROW> <ENT I="01">45</ENT> <ENT>0.7</ENT> <ENT>1.4</ENT> <ENT>0.3</ENT> <ENT>1.0</ENT> <ENT>0.6</ENT> <ENT>0.9</ENT> <ENT>12.5</ENT> <ENT>11.9</ENT> <ENT>6.4</ENT> <ENT>7.7</ENT> <ENT>8.7</ENT> <ENT>7.9</ENT> <ENT>2.4</ENT> <ENT>2.9</ENT> <ENT>1.7</ENT> <ENT>2.9</ENT> </ROW> <ROW> <ENT I="01">47</ENT> <ENT>0.8</ENT> <ENT>1.4</ENT> <ENT>0.3</ENT> <ENT>1.0</ENT> <ENT>0.6</ENT> <ENT>1.0</ENT> <ENT>13.0</ENT> <ENT>12.4</ENT> <ENT>6.7</ENT> <ENT>8.0</ENT> <ENT>9.0</ENT> <ENT>8.2</ENT> <ENT>2.5</ENT> <ENT>3.0</ENT> <ENT>1.8</ENT> <ENT>3.0</ENT> </ROW> <ROW> <ENT I="01">49</ENT> <ENT>0.8</ENT> <ENT>1.5</ENT> <ENT>0.3</ENT> <ENT>1.1</ENT> <ENT>0.7</ENT> <ENT>1.0</ENT> <ENT>13.4</ENT> <ENT>12.8</ENT> <ENT>6.9</ENT> <ENT>8.3</ENT> <ENT>9.4</ENT> <ENT>8.5</ENT> <ENT>2.6</ENT> <ENT>3.2</ENT> <ENT>1.8</ENT> <ENT>3.1</ENT> </ROW> <ROW> <ENT I="01">51</ENT> <ENT>0.8</ENT> <ENT>1.6</ENT> <ENT>0.3</ENT> <ENT>1.1</ENT> <ENT>0.7</ENT> <ENT>1.0</ENT> <ENT>13.9</ENT> <ENT>13.3</ENT> <ENT>7.2</ENT> <ENT>8.6</ENT> <ENT>9.7</ENT> <ENT>8.8</ENT> <ENT>2.7</ENT> <ENT>3.3</ENT> <ENT>1.9</ENT> <ENT>3.3</ENT> </ROW> <ROW> <ENT I="01">53</ENT> <ENT>0.9</ENT> <ENT>1.6</ENT> <ENT>0.4</ENT> <ENT>1.2</ENT> <ENT>0.7</ENT> <ENT>1.1</ENT> <ENT>14.4</ENT> <ENT>13.7</ENT> <ENT>7.4</ENT> <ENT>8.9</ENT> <ENT>10.0</ENT> <ENT>9.1</ENT> <ENT>2.8</ENT> <ENT>3.4</ENT> <ENT>2.0</ENT> <ENT>3.4</ENT> </ROW> <ROW> <ENT I="01">55</ENT> <ENT>0.9</ENT> <ENT>1.7</ENT> <ENT>0.4</ENT> <ENT>1.2</ENT> <ENT>0.7</ENT> <ENT>1.1</ENT> <ENT>14.8</ENT> <ENT>14.1</ENT> <ENT>7.7</ENT> <ENT>9.2</ENT> <ENT>10.3</ENT> <ENT>9.4</ENT> <ENT>2.9</ENT> <ENT>3.5</ENT> <ENT>2.0</ENT> <ENT>3.5</ENT> </ROW> <ROW> <ENT I="01">57</ENT> <ENT>0.9</ENT> <ENT>1.7</ENT> <ENT>0.4</ENT> <ENT>1.3</ENT> <ENT>0.8</ENT> <ENT>1.2</ENT> <ENT>15.2</ENT> <ENT>14.6</ENT> <ENT>7.9</ENT> <ENT>9.5</ENT> <ENT>10.6</ENT> <ENT>9.7</ENT> <ENT>3.0</ENT> <ENT>3.7</ENT> <ENT>2.1</ENT> <ENT>3.6</ENT> </ROW> <ROW> <ENT I="01">59</ENT> <ENT>0.9</ENT> <ENT>1.8</ENT> <ENT>0.4</ENT> <ENT>1.3</ENT> <ENT>0.8</ENT> <ENT>1.2</ENT> <ENT>15.7</ENT> <ENT>15.0</ENT> <ENT>8.2</ENT> <ENT>9.7</ENT> <ENT>10.9</ENT> <ENT>9.9</ENT> <ENT>3.1</ENT> <ENT>3.8</ENT> <ENT>2.2</ENT> <ENT>3.8</ENT> </ROW> <TNOTE> <SU>1</SU> This column to be used only if brands and tags are not located at the washbasin.</TNOTE> <TNOTE> <SU>2</SU> This refers to the carcasses in the bleeding area.</TNOTE> </GPOTABLE> <PRTPAGE P="121"/> <P>(ii) Inspection Using Viscera Table, Tongue-In Presentation of Heads.</P> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Steers and Heifers</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 32</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">33 to 58</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">59 to 84</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">85 to 86</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">87 to 143</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">144 to 171</ENT> <ENT>3</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">172 to 198</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">199 to 226</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">227 to 253</ENT> <ENT>4</ENT> <ENT>3</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">254 to 280</ENT> <ENT>4</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">281 to 306</ENT> <ENT>5</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">307 to 333</ENT> <ENT>5</ENT> <ENT>5</ENT> <ENT>2</ENT> </ROW> </GPOTABLE> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Cows and Bulls</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 29</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">30 to 56</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">57 to 77</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">78 to 81</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">82 to 134</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">135 to 159</ENT> <ENT>2</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">160 to 187</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">188 to 213</ENT> <ENT>3</ENT> <ENT>4</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">214 to 234</ENT> <ENT>3</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">235 to 264</ENT> <ENT>4</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">265 to 289</ENT> <ENT>5</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">290 to 314</ENT> <ENT>5</ENT> <ENT>5</ENT> <ENT>2</ENT> </ROW> </GPOTABLE> <P>(iii) Inspection Using Viscera Table, Tongue-Out Presentation of Heads.</P> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Steers and Heifers</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 32</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">33 to 58</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">59 to 86</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">87 to 103</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">104 to 156</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">157 to 186</ENT> <ENT>2</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">187 to 216</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">217 to 246</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">247 to 275</ENT> <ENT>3</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">276 to 304</ENT> <ENT>4</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">305 to 333</ENT> <ENT>4</ENT> <ENT>5</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">334 to 362</ENT> <ENT>5</ENT> <ENT>5</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">363 to 390</ENT> <ENT>5</ENT> <ENT>6</ENT> <ENT>2</ENT> </ROW> </GPOTABLE> <GPOTABLE CDEF="s50,4,4,4" COLS="4" OPTS="L2"> <TTITLE>Cows and Bulls</TTITLE> <BOXHD> <CHED H="1">Maximum slaughter rates (head per hour)</CHED> <CHED H="1">Number of inspectors by stations</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> </BOXHD> <ROW> <ENT I="01">1 to 29</ENT> <ENT>a</ENT> <ENT>a</ENT> <ENT>a</ENT> </ROW> <ROW> <ENT I="01">30 to 56</ENT> <ENT>b</ENT> <ENT>b</ENT> <ENT>b</ENT> </ROW> <ROW> <ENT I="01">57 to 79</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">80 to 98</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">99 to 147</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">148 to 174</ENT> <ENT>2</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">175 to 205</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">206 to 233</ENT> <ENT>3</ENT> <ENT>4</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">234 to 256</ENT> <ENT>3</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">257 to 288</ENT> <ENT>4</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">289 to 316</ENT> <ENT>5</ENT> <ENT>4</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">317 to 343</ENT> <ENT>5</ENT> <ENT>5</ENT> <ENT>2</ENT> </ROW> </GPOTABLE> <P>(3) <E T="03">Swine Inspection.</E> 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 § 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 § 307.2(m)(6).</P> <GPOTABLE CDEF="s30,6,6,6,6" COLS="5" OPTS="L2,i1"> <TTITLE>Table 1—One Inspector—Staffing Standards for Swine</TTITLE> <BOXHD> <CHED H="1">Distance walked <SU>1</SU> in feet is—</CHED> <CHED H="1">Maximum inspection rates (head per hour)</CHED> <CHED H="2">Market hogs (heads attached or detached)</CHED> <CHED H="3">Without mirror</CHED> <CHED H="3">With mirror</CHED> <CHED H="2">Sows and boars (heads detached)</CHED> <CHED H="3">Without mirror</CHED> <CHED H="3">With mirror</CHED> </BOXHD> <ROW> <ENT I="01">0 to 5</ENT> <ENT>140</ENT> <ENT>150</ENT> <ENT>131</ENT> <ENT>143</ENT> </ROW> <ROW> <ENT I="01">6 to 10</ENT> <ENT>134</ENT> <ENT>144</ENT> <ENT>126</ENT> <ENT>137</ENT> </ROW> <ROW> <ENT I="01">11 to 15</ENT> <ENT>129</ENT> <ENT>137</ENT> <ENT>122</ENT> <ENT>132</ENT> </ROW> <ROW> <ENT I="01">16 to 20</ENT> <ENT>124</ENT> <ENT>132</ENT> <ENT>117</ENT> <ENT>127</ENT> </ROW> <ROW> <ENT I="01">21 to 35</ENT> <ENT>120</ENT> <ENT>127</ENT> <ENT>113</ENT> <ENT>122</ENT> </ROW> <ROW> <ENT I="01">26 to 30</ENT> <ENT>116</ENT> <ENT>122</ENT> <ENT>110</ENT> <ENT>118</ENT> </ROW> <ROW> <ENT I="01">31 to 35</ENT> <ENT>112</ENT> <ENT>118</ENT> <ENT>106</ENT> <ENT>114</ENT> </ROW> <ROW> <ENT I="01">36 to 40</ENT> <ENT>108</ENT> <ENT>114</ENT> <ENT>103</ENT> <ENT>110</ENT> </ROW> <ROW> <ENT I="01">41 to 45</ENT> <ENT>105</ENT> <ENT>110</ENT> <ENT>100</ENT> <ENT>106</ENT> </ROW> <ROW> <ENT I="01">46 to 50</ENT> <ENT>101</ENT> <ENT>107</ENT> <ENT>97</ENT> <ENT>103</ENT> </ROW> <ROW> <ENT I="01">51 to 55</ENT> <ENT>98</ENT> <ENT>103</ENT> <ENT>94</ENT> <ENT>100</ENT> </ROW> <ROW> <ENT I="01">56 to 60</ENT> <ENT>96</ENT> <ENT>100</ENT> <ENT>91</ENT> <ENT>97</ENT> </ROW> <ROW> <ENT I="01">61 to 65</ENT> <ENT>93</ENT> <ENT>97</ENT> <ENT>89</ENT> <ENT>94</ENT> </ROW> <ROW> <ENT I="01">66 to 70</ENT> <ENT>90</ENT> <ENT>95</ENT> <ENT>87</ENT> <ENT>92</ENT> </ROW> <ROW> <PRTPAGE P="122"/> <ENT I="01">71 to 75</ENT> <ENT>88</ENT> <ENT>92</ENT> <ENT>85</ENT> <ENT>89</ENT> </ROW> <ROW> <ENT I="01">76 to 80</ENT> <ENT>86</ENT> <ENT>89</ENT> <ENT>82</ENT> <ENT>87</ENT> </ROW> <ROW> <ENT I="01">81 to 85</ENT> <ENT>84</ENT> <ENT>87</ENT> <ENT>80</ENT> <ENT>85</ENT> </ROW> <ROW> <ENT I="01">86 to 90</ENT> <ENT>82</ENT> <ENT>85</ENT> <ENT>79</ENT> <ENT>83</ENT> </ROW> <ROW> <ENT I="01">91 to 95</ENT> <ENT>80</ENT> <ENT>83</ENT> <ENT>77</ENT> <ENT>81</ENT> </ROW> <ROW> <ENT I="01">96 to 100</ENT> <ENT>78</ENT> <ENT>81</ENT> <ENT>75</ENT> <ENT>79</ENT> </ROW> <TNOTE> <SU>1</SU> 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).</TNOTE> </GPOTABLE> <GPOTABLE CDEF="s30,8,8,8" COLS="4" OPTS="L2,i1"> <TTITLE>Table 2—Two Inspectors—Staffing Standards for Market Hogs</TTITLE> <BOXHD> <CHED H="1">Distance walked <SU>1</SU> in feet by inspector B is—</CHED> <CHED H="1">Maximum inspection rates (head per hour with heads attached or detached)</CHED> <CHED H="2">Line configuration</CHED> <CHED H="3">Carcass,<SU>2</SU> head viscera <SU>3</SU> </CHED> <CHED H="3">Viscera,<SU>2</SU> head carcass <SU>3</SU> </CHED> <CHED H="3">Head,<SU>2</SU> viscera carcass <SU>3</SU> </CHED> </BOXHD> <ROW EXPSTB="03" RUL="s"> <ENT I="21">Without Mirror</ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">0 to 5</ENT> <ENT>151-253</ENT> <ENT>151-271</ENT> <ENT>151-296</ENT> </ROW> <ROW> <ENT I="01">6 to 10</ENT> <ENT>151-239</ENT> <ENT>151-255</ENT> <ENT>151-277</ENT> </ROW> <ROW> <ENT I="01">11 to 15</ENT> <ENT>151-226</ENT> <ENT>151-240</ENT> <ENT>151-260</ENT> </ROW> <ROW> <ENT I="01">16 to 20</ENT> <ENT>151-214</ENT> <ENT>151-227</ENT> <ENT>151-244</ENT> </ROW> <ROW RUL="s"> <ENT I="01">21 to 25</ENT> <ENT>151-204</ENT> <ENT>151-215</ENT> <ENT>151-231</ENT> </ROW> <ROW EXPSTB="03" RUL="s"> <ENT I="21">With Mirror</ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">0 to 5</ENT> <ENT>151-253</ENT> <ENT>151-303</ENT> <ENT>151-318</ENT> </ROW> <ROW> <ENT I="01">6 to 10</ENT> <ENT>151-239</ENT> <ENT>151-283</ENT> <ENT>151-304</ENT> </ROW> <ROW> <ENT I="01">11 to 15</ENT> <ENT>151-226</ENT> <ENT>151-265</ENT> <ENT>151-289</ENT> </ROW> <ROW> <ENT I="01">16 to 20</ENT> <ENT>151-214</ENT> <ENT>151-249</ENT> <ENT>151-270</ENT> </ROW> <ROW> <ENT I="01">21 to 25</ENT> <ENT>151-204</ENT> <ENT>151-235</ENT> <ENT>151-254</ENT> </ROW> <TNOTE> <SU>1</SU> 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).</TNOTE> <TNOTE> <SU>2</SU> Inspector A.</TNOTE> <TNOTE> <SU>3</SU> Inspector B.</TNOTE> </GPOTABLE> <NOTE> <HD SOURCE="HED">Note:</HD> <P>In multiple-inspector plants, the inspectors must rotate between all inspection positions <E T="03">during each shift</E> to equalize the workload.</P> </NOTE> <GPOTABLE CDEF="s20,7,7,7,7" COLS="5" OPTS="L2,i1"> <TTITLE>Table 3—Two Inspectors—Staffing Standards for Sows and Boars</TTITLE> <BOXHD> <CHED H="1">Distance walked <SU>1</SU> in feet by inspector B is—</CHED> <CHED H="1">Maximum inspection rates (head per hour)</CHED> <CHED H="2">Line Configuration</CHED> <CHED H="3">Carcass,<SU>2</SU> head viscera,<SU>3</SU> heads detached</CHED> <CHED H="3">Viscera,<SU>2</SU> head carcass,<SU>3</SU> heads detached</CHED> <CHED H="3">Head,<SU>2</SU> viscera carcass,<SU>3</SU> heads detached</CHED> <CHED H="3">Head,<SU>2</SU> viscera carcass,<SU>3</SU> heads attached</CHED> </BOXHD> <ROW EXPSTB="04" RUL=""> <ENT I="21">Without Mirror</ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">0 to 5</ENT> <ENT>144-248</ENT> <ENT>144-254</ENT> <ENT>144-267</ENT> <ENT>144-267</ENT> </ROW> <ROW> <ENT I="01">6 to 10</ENT> <ENT>144-235</ENT> <ENT>144-240</ENT> <ENT>144-253</ENT> <ENT>144-253</ENT> </ROW> <ROW> <ENT I="01">11 to 15</ENT> <ENT>144-222</ENT> <ENT>144-227</ENT> <ENT>144-239</ENT> <ENT>144-239</ENT> </ROW> <ROW> <ENT I="01">16 to 20</ENT> <ENT>144-211</ENT> <ENT>144-215</ENT> <ENT>144-226</ENT> <ENT>144-226</ENT> </ROW> <ROW> <ENT I="01">21 to 25</ENT> <ENT>144-201</ENT> <ENT>144-205</ENT> <ENT>144-214</ENT> <ENT>144-214 </ENT> </ROW> <ROW EXPSTB="04" RUL="s"> <ENT I="21">With Mirror</ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">0 to 5</ENT> <ENT>144-248</ENT> <ENT>144-292</ENT> <ENT>144-305</ENT> <ENT>144-292</ENT> </ROW> <ROW> <ENT I="01">6 to 10</ENT> <ENT>144-235</ENT> <ENT>144-273</ENT> <ENT>144-291</ENT> <ENT>144-280</ENT> </ROW> <ROW> <ENT I="01">11 to 15</ENT> <ENT>144-222</ENT> <ENT>144-256</ENT> <ENT>144-272</ENT> <ENT>144-268</ENT> </ROW> <ROW> <ENT I="01">16 to 20</ENT> <ENT>144-211</ENT> <ENT>144-241</ENT> <ENT>144-255</ENT> <ENT>144-255</ENT> </ROW> <ROW> <ENT I="01">21 to 25</ENT> <ENT>144-201</ENT> <ENT>144-228</ENT> <ENT>144-240</ENT> <ENT>144-240</ENT> </ROW> <TNOTE> <SU>1</SU> 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).</TNOTE> <TNOTE> <SU>2</SU> Inspector A.</TNOTE> <TNOTE> <SU>3</SU> Inspector B.</TNOTE> </GPOTABLE> <NOTE> <HD SOURCE="HED">Note:</HD> <P>In multiple-inspector plants, the inspectors must rotate between all inspection positions <E T="03">during each shift</E> to equalize the workload.</P> </NOTE> <GPOTABLE CDEF="s20,6,6,6,6" COLS="5" OPTS="L2,i1"> <TTITLE>Table 4—Three Inspectors or More—Staffing Standards for Swine</TTITLE> <BOXHD> <CHED H="1">Maximum inspection rates (head per hour with heads attached)</CHED> <CHED H="1">Number of inspectors by station</CHED> <CHED H="2">Head</CHED> <CHED H="2">Viscera</CHED> <CHED H="2">Carcass</CHED> <CHED H="2">Total</CHED> </BOXHD> <ROW> <ENT I="11">Market hogs:</ENT> </ROW> <ROW> <ENT I="02">319 to 506</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>3</ENT> </ROW> <ROW> <ENT I="02">507 to 540</ENT> <ENT>1</ENT> <ENT>2</ENT> <ENT>1</ENT> <ENT>4</ENT> </ROW> <ROW> <ENT I="02">541 to 859</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> <ENT>5</ENT> </ROW> <ROW> <ENT I="02">860 to 1,022</ENT> <ENT>2</ENT> <ENT>3</ENT> <ENT>1</ENT> <ENT>6</ENT> </ROW> <ROW> <ENT I="02">1,023 to 1,106</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> <ENT>7</ENT> </ROW> <ROW> <ENT I="11">Sows and boars:</ENT> </ROW> <ROW> <ENT I="02">306 to 439</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>3</ENT> </ROW> <ROW> <ENT I="02">306 to 462 <SU>1</SU> </ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>3</ENT> </ROW> <ROW> <ENT I="02">440 to 475</ENT> <ENT>2</ENT> <ENT>1</ENT> <ENT>1</ENT> <ENT>4</ENT> </ROW> <ROW> <ENT I="02">476 to 752</ENT> <ENT>2</ENT> <ENT>2</ENT> <ENT>1</ENT> <ENT>5</ENT> </ROW> <ROW> <ENT I="02">753 to 895</ENT> <ENT>3</ENT> <ENT>2</ENT> <ENT>1</ENT> <ENT>6</ENT> </ROW> <ROW> <ENT I="02">896 to 964</ENT> <ENT>3</ENT> <ENT>3</ENT> <ENT>1</ENT> <ENT>7</ENT> </ROW> <TNOTE> <SU>1</SU> This rate applies if the heads of sows and boars are <E T="03">detached</E> from the carcasses at the time of inspection.</TNOTE> </GPOTABLE> <NOTE> <HD SOURCE="HED">Note:</HD> <P>In multiple-inspector plants, the inspectors must rotate between all inspection positions <E T="03">during each shift</E> to equalize the workload.</P> </NOTE> <CITA>[35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19903, May 13, 1985]</CITA> </SECTION> <SECTION> <PRTPAGE P="123"/> <SECTNO>§ 310.2</SECTNO> <SUBJECT>Identification of carcass with certain severed parts thereof and with animal from which derived.</SUBJECT> <P>(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.</P> <P>(b) The official State-Federal Department backtag on any carcass shall:</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(5) Disposition and use of identifying devices.</P> <P>(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.</P> <P>(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.</P> <P>(6) Plastic bags used by the establishment for collecting identifying devices will be furnished by the Department.</P> <CITA>[35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.3</SECTNO> <SUBJECT>Carcasses and parts in certain instances to be retained.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.4</SECTNO> <SUBJECT>Identification of carcasses and parts; tagging.</SUBJECT> <P>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 <PRTPAGE P="124"/>“U.S. Retained” tags as soon as practicable and before final inspection. These tags shall not be removed except by a Program employee.</P> </SECTION> <SECTION> <SECTNO>§ 310.5</SECTNO> <SUBJECT>Condemned carcasses and parts to be so marked; tanking; separation.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.6</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; marking.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.7</SECTNO> <SUBJECT>Removal of spermatic cords, pizzles and preputial diverticuli.</SUBJECT> <P>Spermatic cords and pizzles shall be removed from all carcasses. Preputial diverticuli shall be removed from hog carcasses.</P> </SECTION> <SECTION> <SECTNO>§ 310.8</SECTNO> <SUBJECT>Passing and marking of carcasses and parts.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.9</SECTNO> <SUBJECT>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.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="125"/>disinfectants or other disinfectant <SU>1</SU> <FTREF/> approved specifically for this purpose by the Administrator:</P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <P>(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<FR>1/2</FR> pounds of sodium hydroxide or lye in 5<FR>1/2</FR> 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.)</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.)</P> <CITA>[35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.10</SECTNO> <SUBJECT>Carcasses with skin or hide on; cleaning before evisceration; removal of larvae of Hypodermae, external parasites and other pathological skin conditions.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <PRTPAGE P="126"/> <SECTNO>§ 310.11</SECTNO> <SUBJECT>Cleaning of hog carcasses before incising.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.12</SECTNO> <SUBJECT>Sternum to be split; abdominal and thoracic viscera to be removed.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.13</SECTNO> <SUBJECT>Inflating carcasses or parts thereof; transferring caul or other fat.</SUBJECT> <P>(a)(1) Establishments shall not inflate carcasses or parts of carcasses with air, except as set forth in paragraph (a)(2) of this section.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(iv) Uses for which approval is granted are:</P> <P>(A) Compressed air injection of cattle feet to facilitate removal of hair from feet intended for human consumption;</P> <P>(B) Compressed air injection under the skin of cattle heads to facilitate head skinning;</P> <P>(C) Compressed air injection into the skull of all livestock except cattle in conjunction with a captive bolt stunner to hold the animal still for dressing operations; or</P> <P>(D) Compressed air injected into the abdominal cavity of swine to facilitate the skinning operation and to minimize the loss of body fat.</P> <FP>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 °F. for at least 10 seconds immediately prior to each injection.</FP> <P>(b) Transferring the caul or other fat from a fat to a lean carcass is prohibited.</P> <APPRO>(Approved by the Office of Management and Budget under control number 0583-0015)</APPRO> <CITA>[54 FR 36756, Sept. 5, 1989, as amended at 55 FR 29565, July 20, 1990; 69 FR 1891, Jan. 12, 2004]</CITA> </SECTION> <SECTION> <PRTPAGE P="127"/> <SECTNO>§ 310.14</SECTNO> <SUBJECT>Handling of bruised parts.</SUBJECT> <P>When only a portion of a carcass is to be condemned on account of slight bruises, either the bruised portion shall be removed immediately and disposed of in accordance with part 314 of this subchapter, or the carcass shall be promptly placed in a retaining room and kept until chilled and the bruised portion shall then be removed and disposed of as provided in part 314 of this subchapter.</P> </SECTION> <SECTION> <SECTNO>§ 310.15</SECTNO> <SUBJECT>Disposition of thyroid glands and laryngeal muscle tissue.</SUBJECT> <P>(a) Livestock thyroid glands and laryngeal muscle tissue shall not be used for human food.</P> <P>(b) Livestock thyroid glands and laryngeal muscle tissue may be distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with § 314.9 or § 325.19(c) of this subchapter, if they are labeled in accordance with § 316.13(f) of this subchapter. Otherwise, they shall be disposed of at the official establishment in accordance with § 314.1 or § 314.3 of this subchapter.</P> <CITA>[53 FR 45890, Nov. 15, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.16</SECTNO> <SUBJECT>Disposition of lungs.</SUBJECT> <P>(a) Livestock lungs shall not be saved for use as human food.</P> <P>(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 §§ 314.1 and 314.3 of this subchapter.</P> <P>(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 § 318.12 of this subchapter, or they may be distributed from the establishment in commerce, or otherwise, in accordance with the conditions prescribed in § 325.8 of this subchapter for nonhuman food purposes or they may be so distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with §§ 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 §§ 314.1 and 314.3 of this subchapter.</P> <CITA>[36 FR 11639, June 17, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.17</SECTNO> <SUBJECT>Inspection of mammary glands.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(c) Lactating mammary glands of cattle, sheep, swine, and goats shall not be saved for edible purposes.</P> <P>(d) The udders from cows officially designated as “Brucellosis reactors” or as “Mastitis elimination cows” shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 310.18</SECTNO> <SUBJECT>Contamination of carcasses, organs, or other parts.</SUBJECT> <P>(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.</P> <P>(b) Brains, cheek meat, and head trimmings from animals stunned by <PRTPAGE P="128"/>lead, sponge iron, or frangible bullets shall not be saved for use as human food but shall be handled as described in § 314.1 or § 314.3 of this subchapter.</P> </SECTION> <SECTION> <SECTNO>§ 310.19</SECTNO> <SUBJECT>Inspection of kidneys.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 310.20</SECTNO> <SUBJECT>Saving of blood from livestock as an edible product.</SUBJECT> <P>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.</P> <CITA>[64 FR 72174, Dec. 23, 1999]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.21</SECTNO> <SUBJECT>Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts.</SUBJECT> <P>(a) Calf carcasses from animals suspected of containing biological residues under § 309.16(d) of this subchapter shall, on post-mortem inspection, be handled in accordance with the provisions of this section.</P> <P>(b) For purposes of this section, the following definitions shall apply:</P> <P>(1) <E T="03">Calf.</E> A calf up to 3 weeks of age or up to 150 pounds.</P> <P>(2) <E T="03">Certified calf.</E> 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.</P> <P>(3) <E T="03">Healthy carcass.</E> A carcass that an inspector determines shows no lesions of disease or signs of disease treatment at post-mortem inspection</P> <P>(4) <E T="03">Producer.</E> The owner of the calf at the time of its birth.</P> <P>(5) <E T="03">Sick calf carcass.</E> 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.</P> <P>(6) <E T="03">Sign of treatment.</E> 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.</P> <P>(7) <E T="03">Veterinary medical officer.</E> An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.</P> <P>(c) <E T="03">Selection of carcasses for testing.</E> The inspector shall perform a swab bioassay test <SU>1</SU> <FTREF/> on:</P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <P>(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.</P> <P>(2) Any carcass which he/she finds has either lesions of disease which is not condemned because of these lesions or a sign of treatment of disease at the time of post-mortem inspection,</P> <P>(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</P> <P>(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:<PRTPAGE P="129"/> </P> <GPOTABLE CDEF="s25,9,9" COLS="3" OPTS="L2,i1"> <BOXHD> <CHED H="1">Testing level</CHED> <CHED H="1">Sampling Rate (percent of estimated day's slaughter)</CHED> <CHED H="2">Certified</CHED> <CHED H="2">Noncertified</CHED> </BOXHD> <ROW> <ENT I="01">A</ENT> <ENT>100</ENT> <ENT>100</ENT> </ROW> <ROW> <ENT I="01">B</ENT> <ENT>50</ENT> <ENT>50</ENT> </ROW> <ROW> <ENT I="01">C</ENT> <ENT>20</ENT> <ENT>30</ENT> </ROW> <ROW> <ENT I="01">(Start) D</ENT> <ENT>5</ENT> <ENT>10</ENT> </ROW> <ROW> <ENT I="01">E</ENT> <ENT>2</ENT> <ENT>5</ENT> </ROW> <ROW> <ENT I="01">F</ENT> <ENT>1</ENT> <ENT>2</ENT> </ROW> </GPOTABLE> <P>(d) <E T="03">Testing of carcasses:</E> </P> <P>(1) The inspector shall test all carcasses as prescribed in paragraph (c) of this section.</P> <P>(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.</P> <P>(3) Test results shall be determined by the veterinary medical officer.</P> <P>(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.</P> <P>(5) All carcasses and parts thereof from calves selected for testing shall be retained until all test results are complete.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(e) <E T="03">Calves from producers with a previous residue condemnation.</E> 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.</P> <P>(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.</P> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.22</SECTNO> <SUBJECT>Specified risk materials from cattle and their handling and disposition.</SUBJECT> <P>(a) The following materials from cattle are specified risk materials, except when they are from cattle from a country that can demonstrate that its bovine spongiform encephalopathy (BSE) risk status can reasonable be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States:</P> <P>(1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of <PRTPAGE P="130"/>the sacrum), and dorsal root ganglia from cattle 30 months of age and older and</P> <P>(2) The distal ileum of the small intestine and the tonsils from all cattle.</P> <P>(b) Specified risk materials are inedible and prohibited for use as human food.</P> <P>(c) Specified risk materials must be removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with § 314.1 or § 314.3 of this subchapter. The spinal cord from cattle 30 months of age and older must be removed from the carcass at the establishment where the animal was slaughtered.</P> <P>(d) <E T="03">Requirements for use of the small intestine for human food.</E> (1) The small intestine from all cattle may be used for human food if:</P> <P>(i) It is derived from cattle that were inspected and passed in an official establishment in the United States or in a certified foreign establishment in a country listed in 9 CFR 327.2(b) as eligible to export meat and meat products to the United States and it is otherwise eligible for importation under 9 CFR 327.1(b), and</P> <P>(ii) The distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine as measured from the ceco-colic junction and progressing proximally towards the jejunum or by a procedure that the establishment demonstrates is effective in ensuring complete removal of the distal ileum.</P> <P>(iii) If the conditions in paragraphs (d)(1)(i) or (ii) of this section are not met, the entire small intestine must be removed from the carcass, segregated from edible materials, and disposed of in accordance with §§ 314.1 or 314.3 of this subchapter.</P> <P>(2) The requirements in paragraph (d)(1) of this section do not apply to materials from cattle from countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States.</P> <P>(e) <E T="03">Procedures for the removal, segregation, and disposition of specified risk materials.</E> (1) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials. These procedures must address potential contamination of edible materials with specified risk materials before, during, and after entry into the establishment. Establishments must incorporate their procedures for the removal, segregation, and disposition of specified risk materials into their HACCP plans or Sanitation SOPs or other prerequisite programs.</P> <P>(2) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must take appropriate corrective action when either the establishment or FSIS determines that the establishment's procedures for the removal, segregation, and disposition of specified risk materials, or the implementation or maintenance of these procedures, have failed to ensure that specified risk materials are adequately and effectively removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with paragraph (c) of this section.</P> <P>(3) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures as necessary whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.</P> <P>(4) <E T="03">Recordkeeping requirements.</E> (i) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must maintain daily records sufficient to document the implementation and monitoring of the procedures for the removal, segregation, and disposition of the materials listed in paragraph (a) of this section, and any corrective actions taken.<PRTPAGE P="131"/> </P> <P>(ii) Records required by this section may be maintained on computers provided that the establishment implements appropriate controls to ensure the integrity of the electronic data.</P> <P>(iii) Records required by this section must be retained for at least one year and must be accessible to FSIS. All such records must be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.</P> <P>(f) <E T="03">Sanitation of equipment used to cut through specified risk materials.</E> (1) If an establishment that slaughters cattle, or that processes the carcasses or parts from cattle, does not segregate the carcasses and parts from cattle 30 months of age and older from the carcasses and parts from cattle younger than 30 months during processing operations it must:</P> <P>(i) Use dedicated equipment to cut through specified risk materials; or</P> <P>(ii) Clean and sanitize equipment used to cut through specified risk materials before the equipment is used on carcasses or parts from cattle younger than 30 months of age.</P> <P>(2) If an establishments that slaughters cattle, or that process the carcasses or parts from cattle, segregates the carcasses and parts of cattle 30 months of age and older from cattle younger than 30 months of age during processing operations, and processes the carcasses or parts from the cattle younger than 30 months first, it may use routine operational sanitation procedures on equipment used to cut through specified risk materials.</P> <P>(g) Slaughter establishments may ship beef carcasses or parts that contain vertebral columns from cattle 30 months of age and older to another federally-inspected establishment for further processing if the establishment shipping these materials:</P> <P>(1) Maintains control of the carcasses or parts while they are in transit or ensures that the carcasses or parts move under FSIS control;</P> <P>(2) Ensures that the carcasses or parts are accompanied by documentation that clearly states that the carcasses or parts contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter;</P> <P>(3) Maintains records that identify the official establishment that received the carcasses or parts;</P> <P>(4) Maintains records that verify that the official establishment that received the carcasses or parts removed the portions of the vertebral column designated as specified risk materials in paragraph (a)(1) of this section and disposed of them in accordance with § 314.1 or § 314.3 of this subchapter.</P> <P>(h) The materials listed in paragraph (a)(1) of this section will be deemed to be from cattle 30 months of age and older unless the establishment can demonstrate through documentation that the materials are from an animal that was younger than 30 months of age at the time of slaughter.</P> <CITA>[72 FR 38729, July 13, 2007]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.23</SECTNO> <SUBJECT>Identification of carcasses and parts of swine.</SUBJECT> <P>(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.</P> <P>(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.</P> <CITA>[53 FR 40387, Oct. 14, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 310.24</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 310.25</SECTNO> <SUBJECT>Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards.</SUBJECT> <P>(a) Criteria for verifying process control; <E T="03">E. coli</E> testing. (1) Each official establishment that slaughters livestock must test for <E T="03">Escherichia coli</E> Biotype 1 (<E T="03">E.coli</E>) 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:<PRTPAGE P="132"/> </P> <P>(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;</P> <P>(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and</P> <P>(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.</P> <P>(2) Sampling requirements.</P> <P>(i) <E T="03">Written procedures.</E> 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.</P> <P>(ii) <E T="03">Sample collection.</E> 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;</P> <P>(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.</P> <P>(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.</P> <P>(C) For swine carcasses, establishments must sponge or excise tissue from the ham, belly and jowl areas.</P> <P>(iii) <E T="03">Sampling frequency.</E> 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:</P> <P>(A) Cattle, sheep, goats, horses, mules, and other equines: 1 test per 300 carcasses, but, a minimum of one sample during each week of operation.</P> <P>Swine: 1 test per 1,000 carcasses, but a minimum of one sample during each week of operation.</P> <P>(iv) <E T="03">Sampling frequency alternatives.</E> An establishment operating under a validated HACCP plan in accordance with § 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,</P> <P>(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,</P> <P>(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.</P> <P>(v) <E T="03">Sampling in very low volume establishments.</E> (A) Very low volume establishments annually slaughter no more than 6,000 cattle, 6,000 sheep, 6,000 goats, 6,000 horses, mules or other equines, 20,000 swine, or a combination of livestock not exceeding 6,000 cattle and 20,000 total of all livestock. Very low volume establishments that collect samples by sponging shall collect at least one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever comes first. Very low volume establishments collecting samples by excising tissue from carcasses shall collect one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until one series of 13 tests meets the criteria set forth in paragraph (a)(5)(i) of this section.</P> <P>(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.<PRTPAGE P="133"/> </P> <P>(3) <E T="03">Analysis of samples.</E> Laboratories may use any quantitative method for analysis of <E T="03">E. coli</E> that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) <SU>2</SU> <FTREF/> 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.</P> <FTNT> <P> <SU>2</SU> 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.</P> </FTNT> <P>(4) <E T="03">Recording of test results.</E> The establishment shall maintain accurate records of all test results, in terms of CFU/cm<SU>2</SU> 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.</P> <P>(5) <E T="03">Criteria for evaluation of test results.</E> (i) An establishment excising samples from carcasses is operating within the criteria when the most recent <E T="03">E. coli</E> 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:</P> <GPOTABLE CDEF="s50,r50,r50,10,10" COLS="5" OPTS="L2(,0,),i1"> <TTITLE>Table 1—Evaluation of E. Coli Test Results</TTITLE> <BOXHD> <CHED H="1">Type of livestock</CHED> <CHED H="1">Lower limit of marginal range<LI>(m)</LI> </CHED> <CHED H="1">Upper limit of marginal range<LI>(M)</LI> </CHED> <CHED H="1">Number of sample tested<LI>(n)</LI> </CHED> <CHED H="1">Maximum number permitted in marginal range<LI>(c)</LI> </CHED> </BOXHD> <ROW> <ENT I="01">Cattle</ENT> <ENT>Negative <E T="51">a</E> </ENT> <ENT>100 CFU/cm <SU>2</SU> </ENT> <ENT>13</ENT> <ENT>3</ENT> </ROW> <ROW> <ENT I="01">Swine</ENT> <ENT>10 CFU/cm <SU>2</SU> </ENT> <ENT>10,000 CFU/cm <SU>2</SU> </ENT> <ENT>13</ENT> <ENT>3</ENT> </ROW> <TNOTE> <E T="51">a</E> 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<SU>2</SU> carcass surface area.</TNOTE> </GPOTABLE> <P>(ii) Establishments sponging carcasses shall evaluate <E T="03">E. coli</E> test results using statistical process control techniques.</P> <P>(6) <E T="03">Failure to meet criteria.</E> Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.</P> <P>(7) <E T="03">Failure to test and record.</E> 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.</P> <P>(b) Pathogen reduction performance standard; <E T="03">Salmonella</E>—(1) <E T="03">Raw meat product performance standards for Salmonella.</E> An establishment's raw meat products, when sampled and tested by FSIS for <E T="03">Salmonella,</E> as set forth in this section, may not test positive for <E T="03">Salmonella</E> at a rate exceeding the applicable national pathogen reduction performance standard, as provided in Table 2:<PRTPAGE P="134"/> </P> <GPOTABLE CDEF="s100,10,10,10" COLS="4" OPTS="L2,i1"> <TTITLE>Table 2—Salmonella Performance Standards</TTITLE> <BOXHD> <CHED H="1">Class of product</CHED> <CHED H="1">Performance Standard (percent positive for <E T="03">Salmonella</E>)<E T="51">a</E> </CHED> <CHED H="1">Number of samples tested <LI>(n)</LI> </CHED> <CHED H="1">Maximum number of positives to achieve Standard <LI>(c)</LI> </CHED> </BOXHD> <ROW> <ENT I="01">Steers/heifers</ENT> <ENT>1.0%</ENT> <ENT>82</ENT> <ENT>1</ENT> </ROW> <ROW> <ENT I="01">Cows/bulls</ENT> <ENT>2.7%</ENT> <ENT>58</ENT> <ENT>2</ENT> </ROW> <ROW> <ENT I="01">Ground beef</ENT> <ENT>7.5%</ENT> <ENT>53</ENT> <ENT>5</ENT> </ROW> <ROW> <ENT I="01">Hogs</ENT> <ENT>8.7%</ENT> <ENT>55</ENT> <ENT>6</ENT> </ROW> <ROW> <ENT I="01">Fresh pork sausages</ENT> <ENT> <E T="51">b</E> N.A.</ENT> <ENT>N.A.</ENT> <ENT>N.A.</ENT> </ROW> <TNOTE> <E T="51">a</E> Performance Standards are FSIS's calculation of the national prevalence of <E T="03">Salmonella</E> 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 <E T="03">Salmonella</E> on raw products are available in the FSIS Docket Room.</TNOTE> <TNOTE> <E T="51">b</E> Not available; values for fresh pork sausage will be added upon completion data collection programs for those products.</TNOTE> </GPOTABLE> <P>(2) <E T="03">Enforcement.</E> FSIS will sample and test raw meat products in an individual establishment on an unannounced basis to determine prevalence of <E T="03">Salmonella</E> 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.<SU>3</SU> <FTREF/> </P> <FTNT> <P> <SU>3</SU> A copy of FSIS's “Sample Collection Guidelines and Procedure for Isolation and Identification of <E T="03">Salmonella</E> from Meat and Poultry Products” is available for inspection in the FSIS Docket Room.</P> </FTNT> <P>(3) <E T="03">Noncompliance and establishment response.</E> When FSIS determines that an establishment has not met the performance standard:</P> <P>(i) The establishment shall take immediate action to meet the standard.</P> <P>(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.</P> <P>(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.</P> <CITA>[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]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 311</EAR> <HD SOURCE="HED">PART 311—DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES AND PARTS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>311.1</SECTNO> <SUBJECT>Disposal of diseased or otherwise adulterated carcasses and parts; general.</SUBJECT> <SECTNO>311.2</SECTNO> <SUBJECT>Tuberculosis.</SUBJECT> <SECTNO>311.3</SECTNO> <SUBJECT>Hog cholera.</SUBJECT> <SECTNO>311.5</SECTNO> <SUBJECT>Swine erysipelas.</SUBJECT> <SECTNO>311.6</SECTNO> <SUBJECT>Diamond-skin disease.</SUBJECT> <SECTNO>311.7</SECTNO> <SUBJECT>Arthritis.</SUBJECT> <SECTNO>311.8</SECTNO> <SUBJECT>Cattle carcasses affected with anasarca or generalized edema.</SUBJECT> <SECTNO>311.9</SECTNO> <SUBJECT>Actinomycosis and actinobacillosis.</SUBJECT> <SECTNO>311.10</SECTNO> <SUBJECT>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.</SUBJECT> <SECTNO>311.11</SECTNO> <SUBJECT>Neoplasms.<PRTPAGE P="135"/> </SUBJECT> <SECTNO>311.12</SECTNO> <SUBJECT>Epithelioma of the eye.</SUBJECT> <SECTNO>311.13</SECTNO> <SUBJECT>Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.</SUBJECT> <SECTNO>311.14</SECTNO> <SUBJECT>Abrasions, bruises, abscesses, pus, etc.</SUBJECT> <SECTNO>311.15</SECTNO> <SUBJECT>Brucellosis.</SUBJECT> <SECTNO>311.16</SECTNO> <SUBJECT>Carcasses so infected that consumption of the meat may cause food poisoning.</SUBJECT> <SECTNO>311.17</SECTNO> <SUBJECT>Necrobacillosis, pyemia, and septicemia.</SUBJECT> <SECTNO>311.18</SECTNO> <SUBJECT>Caseous lymphadenitis.</SUBJECT> <SECTNO>311.19</SECTNO> <SUBJECT>Icterus.</SUBJECT> <SECTNO>311.20</SECTNO> <SUBJECT>Sexual odor of swine.</SUBJECT> <SECTNO>311.21</SECTNO> <SUBJECT>Mange or scab.</SUBJECT> <SECTNO>311.22</SECTNO> <SUBJECT>Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.</SUBJECT> <SECTNO>311.23</SECTNO> <SUBJECT>Tapeworm cysts (cysticercus bovis) in cattle.</SUBJECT> <SECTNO>311.24</SECTNO> <SUBJECT>Hogs affected with tapeworm cysts.</SUBJECT> <SECTNO>311.25</SECTNO> <SUBJECT>Parasites not transmissible to man; tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms.</SUBJECT> <SECTNO>311.26</SECTNO> <SUBJECT>Emaciation.</SUBJECT> <SECTNO>311.27</SECTNO> <SUBJECT>Injured animals slaughtered at unusual hours.</SUBJECT> <SECTNO>311.28</SECTNO> <SUBJECT>Carcasses of young calves, pigs, kids, lambs, and foals.</SUBJECT> <SECTNO>311.29</SECTNO> <SUBJECT>Unborn and stillborn animals.</SUBJECT> <SECTNO>311.30</SECTNO> <SUBJECT>Livestock suffocated and hogs scalded alive.</SUBJECT> <SECTNO>311.31</SECTNO> <SUBJECT>Livers affected with carotenosis; livers designated as “telangiectatic,” “sawdust,” or “spotted.”</SUBJECT> <SECTNO>311.32</SECTNO> <SUBJECT>Vesicular diseases.</SUBJECT> <SECTNO>311.33</SECTNO> <SUBJECT>Listeriosis.</SUBJECT> <SECTNO>311.34</SECTNO> <SUBJECT>Anemia.</SUBJECT> <SECTNO>311.35</SECTNO> <SUBJECT>Muscular inflammation, degeneration, or infiltration.</SUBJECT> <SECTNO>311.36</SECTNO> <SUBJECT>Coccidioidal granuloma.</SUBJECT> <SECTNO>311.37</SECTNO> <SUBJECT>Odors, foreign and urine.</SUBJECT> <SECTNO>311.38</SECTNO> <SUBJECT>Meat and meat byproducts from livestock which have been exposed to radiation.</SUBJECT> <SECTNO>311.39</SECTNO> <SUBJECT>Biological residues.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15569, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 311.1</SECTNO> <SUBJECT>Disposal of diseased or otherwise adulterated carcasses and parts; general.</SUBJECT> <P>(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: <E T="03">Provided,</E> 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: <E T="03">Provided,</E> That when so moved the products are shipped in containers sealed in accordance with § 318.10(c) of this subchapter or in a sealed means of conveyance as provided in § 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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.2</SECTNO> <SUBJECT>Tuberculosis.</SUBJECT> <P>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.</P> <P>(a) <E T="03">Carcasses condemned.</E> The entire carcass of swine, cattle, sheep, goats, and equines shall be condemned if any of the following conditions occur:</P> <P>(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);<PRTPAGE P="136"/> </P> <P>(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;</P> <P>(3) When there is an associated cachexia;</P> <P>(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);</P> <P>(5) When the lesions are extensive in tissues of either the thoracic or the abdominal cavity;</P> <P>(6) When the lesions are multiple, acute, and actively progressive; or</P> <P>(7) When the character or extent of the lesions otherwise is not indicative of a localized condition.</P> <P>(b) <E T="03">Organs or other parts condemned.</E> An organ or other part of a swine, cattle, sheep, goat, or equine carcass affected by localized tuberculosis shall be condemned when it contains lesions of tuberculosis or when the corresponding lymph node contains lesions of tuberculosis.</P> <P>(c) <E T="03">Carcasses of cattle passed without restriction for human food.</E> 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 <SU>1</SU> <FTREF/> is found free of tuberculosis lesions during postmortem inspection.</P> <FTNT> <P> <SU>1</SU> Such testing is conducted in the tuberculosis eradication program of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture.</P> </FTNT> <P>(d) <E T="03">Portions of carcasses and carcasses of cattle passed for cooking.</E> (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.</P> <P>(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.</P> <P>(e) <E T="03">Portions of carcasses and carcasses of swine passed without restriction for human food.</E> 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.</P> <P>(f) <E T="03">Portions of carcasses of swine passed for cooking.</E> 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.</P> <P>(g) <E T="03">Carcasses of sheep, goats, and equines passed without restriction for human food.</E> 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.</P> <P>(h) <E T="03">Portions of carcasses of sheep, goats, and equines passed for cooking.</E> 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 <PRTPAGE P="137"/>affected organ or other part is condemned.</P> <CITA>[37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, 1973]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.3</SECTNO> <SUBJECT>Hog cholera.</SUBJECT> <P>(a) The carcasses of all hogs affected with hog cholera shall be condemned.</P> <P>(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.</P> <P>(c) When lesions resembling those of hog cholera occur in kidneys and lymph nodes of carcasses of hogs which appeared normal on ante-mortem inspection, further inspection of such carcasses shall be made for corroborative lesions. If on such further inspection, characteristic lesions of hog cholera are found in some organ or tissue in addition to those in the kidneys or in the lymph nodes or in both, then all lesions shall be regarded as those of hog cholera and the carcass shall be condemned. Immediate notification shall be given by the inspector to the official in the Veterinary Services unit of the Animal and Plant Health Inspection Service who has responsibility for control of swine diseases in the State where the swine are located.</P> <CITA>[35 FR 15569, Oct. 3, 1970, as amended at 40 FR 27225, June 27, 1975]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.5</SECTNO> <SUBJECT>Swine erysipelas.</SUBJECT> <P>Carcasses affected with swine erysipelas which is acute or generalized, or which show systemic change, shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.6</SECTNO> <SUBJECT>Diamond-skin disease.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.7</SECTNO> <SUBJECT>Arthritis.</SUBJECT> <P>(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.</P> <P>(b) Carcasses affected with arthritis shall be condemned when there is evidence of systemic involvement.</P> </SECTION> <SECTION> <SECTNO>§ 311.8</SECTNO> <SUBJECT>Cattle carcasses affected with anasarca or generalized edema.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.9</SECTNO> <SUBJECT>Actinomycosis and actinobacillosis.</SUBJECT> <P>(a) The definition of generalization as outlined for tuberculosis in § 311.2(a) shall apply for actinomycosis and actinobacillosis, and carcasses of livestock with generalized lesions of either such disease shall be condemned.</P> <P>(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.</P> <P>(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 <PRTPAGE P="138"/>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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.10</SECTNO> <SUBJECT>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.</SUBJECT> <P>(a) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned:</P> <P>(1) Anthrax.</P> <P>(2) Blackleg.</P> <P>(3) Unhealed vaccine lesions (vaccinia).</P> <P>(4) Strangles.</P> <P>(5) Purpura hemorrhagica.</P> <P>(6) Azoturia.</P> <P>(7) Infectious equine encephalomye-litis.</P> <P>(8) Toxic encephalomyelitis (forage poisoning).</P> <P>(9) Infectious anemia (swamp fever).</P> <P>(10) Dourine.</P> <P>(11) Acute influenza.</P> <P>(12) Generalized osteoporosis.</P> <P>(13) Glanders (farcy).</P> <P>(14) Acute inflammatory lameness.</P> <P>(15) Extensive fistula.</P> <P>(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:</P> <P>(1) Anaplasmosis.</P> <P>(2) Bacillary hemoglobinuria in cattle.</P> <P>(3) Babesiosis (piroplasmosis).</P> <P>(4) Bluetongue.</P> <P>(5) Hemorrhagic septicemia.</P> <P>(6) Icterohematuria in sheep.</P> <P>(7) Infectious bovine rhinotracheitis.</P> <P>(8) Leptospirosis.</P> <P>(9) Malignant epizootic catarrh.</P> <CITA>[35 FR 15569, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.11</SECTNO> <SUBJECT>Neoplasms.</SUBJECT> <P>(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.</P> <P>(b) Carcasses affected with malignant lymphoma shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.12</SECTNO> <SUBJECT>Epithelioma of the eye.</SUBJECT> <P>(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:</P> <P>(1) The affection has involved the osseous structures of the head with extensive infection, suppuration, and necrosis;</P> <P>(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</P> <P>(3) The affection, regardless of extent, is associated with cachexia or evidence of absorption or secondary changes.</P> <P>(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.</P> </SECTION> <SECTION> <PRTPAGE P="139"/> <SECTNO>§ 311.13</SECTNO> <SUBJECT>Pigmentary conditions; melanosis, xanthosis, ochronosis, etc.</SUBJECT> <P>(a) Except as provided in § 311.19, carcasses of livestock showing generalized pigmentary deposits shall be condemned.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.14</SECTNO> <SUBJECT>Abrasions, bruises, abscesses, pus, etc.</SUBJECT> <P>All slight, well-limited abrasions on the tongue and inner surface of the lips and mouth, when without lymph node involvement, shall be carefully excised, leaving only sound, normal tissue, which may be passed for human food. Any organ or other part of a carcass which is badly bruised or which is affected by an abscess, or a suppurating sore shall be condemned; and when the lesions are of such character or extent as to affect the whole carcass, the whole carcass shall be condemned. Portions of carcasses which are contaminated by pus or other diseased material shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.15</SECTNO> <SUBJECT>Brucellosis.</SUBJECT> <P>Carcasses affected with localized lesions of brucellosis may be passed for human food after the affected parts are removed and condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.16</SECTNO> <SUBJECT>Carcasses so infected that consumption of the meat may cause food poisoning.</SUBJECT> <P>(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:</P> <P>(1) Acute inflammation of the lungs, pleura, pericardium, peritoneum, or meninges.</P> <P>(2) Septicemia or pyemia, whether puerperal, traumatic, or without any evident cause.</P> <P>(3) Gangrenous or severe hemorrhagic enteritis or gastritis.</P> <P>(4) Acute diffuse metritis or mammitis.</P> <P>(5) Phlebitis of the umbilical veins.</P> <P>(6) Septic or purulent traumatic pericarditis.</P> <P>(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.</P> <P>(8) Salmonellosis.</P> <P>(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 °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.</P> </SECTION> <SECTION> <SECTNO>§ 311.17</SECTNO> <SUBJECT>Necrobacillosis, pyemia, and septicemia.</SUBJECT> <P>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 § 311.16.</P> </SECTION> <SECTION> <SECTNO>§ 311.18</SECTNO> <SUBJECT>Caseous lymphadenitis.</SUBJECT> <P>(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.</P> <P>(b) A thin carcass showing well-marked lesions in the viscera with only <PRTPAGE P="140"/>slight lesions elsewhere or showing well-marked lesions in the skeletal lymph nodes with only slight lesions elsewhere may be passed for cooking.</P> <P>(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.</P> <P>(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.</P> <P>(e) A well-nourished carcass showing well-marked lesions in the viscera and the skeletal lymph nodes may be passed for cooking; but where the lesions in a well-nourished carcass are both numerous and extensive, it shall be condemned.</P> <P>(f) All affected organs and nodes of carcasses passed for human food without restriction or passed for cooking shall be removed and condemned.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.19</SECTNO> <SUBJECT>Icterus.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.20</SECTNO> <SUBJECT>Sexual odor of swine.</SUBJECT> <P>(a) Carcasses of swine which give off a pronounced sexual odor shall be condemned.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.21</SECTNO> <SUBJECT>Mange or scab.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.22</SECTNO> <SUBJECT>Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.23</SECTNO> <SUBJECT>Tapeworm cysts (cysticercus bovis) in cattle.</SUBJECT> <P>(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:</P> <P>(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.</P> <P>(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: <E T="03">Provided,</E> 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 °F. continuously for a period of not less than 10 days, or in <PRTPAGE P="141"/>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 °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 °F. under positive control of a Program Inspector.</P> <P>(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.</P> <CITA>[36 FR 4591, Mar. 10, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.24</SECTNO> <SUBJECT>Hogs affected with tapeworm cysts.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.25</SECTNO> <SUBJECT>Parasites not transmissible to man; tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms.</SUBJECT> <P>(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.</P> <P>(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: <E T="03">Provided, however,</E> 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 °F. After removal and condemnation of all affected portions.</P> <P>(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).</P> <P>(d) Organs or other parts of carcasses infested with hydatid cysts (echinococus) shall be condemned.</P> <P>(e) Livers infested with flukes or fringed tapeworms shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.26</SECTNO> <SUBJECT>Emaciation.</SUBJECT> <P>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.</P> <CITA>[35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.27</SECTNO> <SUBJECT>Injured animals slaughtered at unusual hours.</SUBJECT> <P>When it is necessary for humane reasons to slaughter an injured animal at night or on Sunday or a holiday when <PRTPAGE P="142"/>the inspector cannot be obtained, the carcass and all parts of all livestock except for cattle shall be kept for inspection, with the head and all viscera except the stomach, bladder, and intestines held by the natural attachments. If all parts are not so kept for inspection, the carcass shall be condemned. If, on inspection of a carcass slaughtered in the absence of an inspector, any lesion or other evidence is found indicating that the animal was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante-mortem inspection, or if there is lacking evidence of the condition which rendered emergency slaughter necessary, the carcass shall be condemned. The parts and carcasses of cattle slaughtered in the absence of an inspector shall not be used for human food.</P> <CITA>[35 FR 15569, Oct. 3, 1970, as amended at 69 FR 1874, Jan. 12, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 311.28</SECTNO> <SUBJECT>Carcasses of young calves, pigs, kids, lambs, and foals.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.29</SECTNO> <SUBJECT>Unborn and stillborn animals.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.30</SECTNO> <SUBJECT>Livestock suffocated and hogs scalded alive.</SUBJECT> <P>All livestock which have been suffocated in any way and hogs which have entered the scalding vat alive shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.31</SECTNO> <SUBJECT>Livers affected with carotenosis; livers designated as “telangiectatic,” “sawdust,” or “spotted.”</SUBJECT> <P>(a) Livers affected with carotenosis shall be condemned.</P> <P>(b) Cattle livers and calf livers showing the conditions sometimes designated as “telangiectatic,” “sawdust,” or “spotted” shall be disposed of as follows:</P> <P>(1) When any or all of the conditions are slight in the organ, the whole organ shall be passed for human food without restriction.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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 § 314.10 of this subchapter.</P> </SECTION> <SECTION> <SECTNO>§ 311.32</SECTNO> <SUBJECT>Vesicular diseases.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <PRTPAGE P="143"/> <SECTNO>§ 311.33</SECTNO> <SUBJECT>Listeriosis.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.34</SECTNO> <SUBJECT>Anemia.</SUBJECT> <P>Carcasses of livestock too anemic to produce wholesome meat shall be condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.35</SECTNO> <SUBJECT>Muscular inflammation, degeneration, or infiltration.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.36</SECTNO> <SUBJECT>Coccidioidal granuloma.</SUBJECT> <P>(a) Carcasses which are affected with generalized coccidioidal granuloma or which show systemic changes because of such disease shall be condemned.</P> <P>(b) Carcasses affected with localized lesions of this disease may be passed for human food after the affected parts are removed and condemned.</P> </SECTION> <SECTION> <SECTNO>§ 311.37</SECTNO> <SUBJECT>Odors, foreign and urine.</SUBJECT> <P>(a) Carcasses which give off a pronounced odor of medicinal, chemical, or other foreign substance shall be condemned.</P> <P>(b) Carcasses which give off a pronounced urine odor shall be condemned.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 311.38</SECTNO> <SUBJECT>Meat and meat byproducts from livestock which have been exposed to radiation.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 311.39</SECTNO> <SUBJECT>Biological residues.</SUBJECT> <P>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.</P> </SECTION> </PART> <PART> <EAR>Pt. 312</EAR> <HD SOURCE="HED">PART 312—OFFICIAL MARKS, DEVICES AND CERTIFICATES</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>312.1</SECTNO> <SUBJECT>General.</SUBJECT> <SECTNO>312.2</SECTNO> <SUBJECT>Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats.</SUBJECT> <SECTNO>312.3</SECTNO> <SUBJECT>Official marks and devices to identify inspected and passed equine products.</SUBJECT> <SECTNO>312.4</SECTNO> <SUBJECT>Official ante-mortem inspection marks and devices.</SUBJECT> <SECTNO>312.5</SECTNO> <SUBJECT>Official seals for transportation of products.</SUBJECT> <SECTNO>312.6</SECTNO> <SUBJECT>Official marks and devices in connection with post-mortem inspection and identification of adulterated products and insanitary equipment and facilities.</SUBJECT> <SECTNO>312.7</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>312.8</SECTNO> <SUBJECT>Official export inspection marks, devices, and certificates.</SUBJECT> <SECTNO>312.9</SECTNO> <SUBJECT>Official detention marks and devices.</SUBJECT> <SECTNO>312.10</SECTNO> <SUBJECT>Official mark for maintaining the identity and integrity of samples.</SUBJECT> </CONTENTS> <AUTH> <PRTPAGE P="144"/> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15573, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 312.1</SECTNO> <SUBJECT>General.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 312.2</SECTNO> <SUBJECT>Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats.</SUBJECT> <P>(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: <SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <GPH DEEP="62" SPAN="1"> <GID>EC11SE91.000</GID> </GPH> <P>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.</P> <GPH DEEP="94" SPAN="1"> <GID>EC11SE91.001</GID> </GPH> <P>For application to calf and goat carcasses and on the larger varieties of sausage and meat food products in animal casings.</P> <GPH DEEP="136" SPAN="1"> <GID>EC11SE91.002</GID> </GPH> <P>For application to beef and hog carcasses primal parts and cuts therefrom, beef livers, beef tongues, beef hearts, and smoked meats not in casings.</P> <GPH DEEP="163" SPAN="1"> <GID>EC11SE91.003</GID> </GPH> <P>For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.</P> <P>(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 <SU>1</SU> 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:</P> <GPH DEEP="131" SPAN="1"> <PRTPAGE P="145"/> <GID>EC11SE91.004</GID> </GPH> <P>(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.</P> <P>(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.</P> <P>(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.</P> <CITA>[35 FR 15573, Oct. 3, 1970; 36 FR 12002, June 24, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 312.3</SECTNO> <SUBJECT>Official marks and devices to identify inspected and passed equine products.</SUBJECT> <P>(a) The official inspection legend required by § 316.12 or § 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: <SU>1</SU> </P> <GPH DEEP="151" SPAN="1"> <GID>EC11SE91.005</GID> </GPH> <GPH DEEP="151" SPAN="1"> <GID>EC11SE91.055</GID> </GPH> <P>(b) The official inspection legend required by § 316.12 or § 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:<SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> 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.</P> </FTNT> <GPH DEEP="148" SPAN="1"> <PRTPAGE P="146"/> <GID>EC11SE91.006</GID> </GPH> <GPH DEEP="148" SPAN="1"> <GID>EC11SE91.007</GID> </GPH> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 312.4</SECTNO> <SUBJECT>Official ante-mortem inspection marks and devices.</SUBJECT> <P>The official marks and devices used in connection with ante-mortem inspection are those prescribed in § 309.18 of this subchapter.</P> </SECTION> <SECTION> <SECTNO>§ 312.5</SECTNO> <SUBJECT>Official seals for transportation of products.</SUBJECT> <P>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 <SU>2</SU> <FTREF/> 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).</P> <FTNT> <P> <SU>2</SU> The number “2135202” is given as an example only. The serial number of the specific seal will be shown in lieu thereof.</P> </FTNT> <GPH DEEP="71" SPAN="2"> <GID>EC11SE91.008</GID> </GPH> <CITA>[35 FR 15573, Oct. 3, 1970, as amended at 39 FR 36000, Oct. 7, 1974; 51 FR 37707, Oct. 24, 1986]</CITA> </SECTION> <SECTION> <PRTPAGE P="147"/> <SECTNO>§ 312.6</SECTNO> <SUBJECT>Official marks and devices in connection with post-mortem inspection and identification of adulterated products and insanitary equipment and facilities.</SUBJECT> <P>(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:</P> <P>(1) The tag (Form MP-427) which is used to retain carcasses and parts of carcasses in the slaughter department; it is black and white, and bears the legend “U.S. Retained.”</P> <P>(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.”</P> <P>(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.”</P> <P>(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:</P> <GPH DEEP="53" SPAN="1"> <GID>EC11SE91.009</GID> </GPH> <P>(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:</P> <GPH DEEP="59" SPAN="1"> <GID>EC11SE91.010</GID> </GPH> <P>(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.</P> <CITA>[35 FR 15573, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 FR 36000; Oct. 7, 1974; 43 FR 29268, July 7, 1978; 64 FR 36415, Oct. 20, 1999; 65 FR 2284, Jan. 14, 2000]</CITA> </SECTION> <SECTION> <SECTNO>§ 312.7</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 312.8</SECTNO> <SUBJECT>Official export inspection marks, devices, and certificates.</SUBJECT> <P>(a) The official export meat inspection mark required by part 322 of this subchapter shall be in the following form as hereinafter specified: <SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> The number “529893” is given as an example only. The number of the official export certificate will be shown in lieu thereof.</P> </FTNT> <GPH DEEP="124" SPAN="1"> <GID>EC11SE91.012</GID> </GPH> <FP>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.</FP> <P>(b) The official export certificate required by part 322 of this subchapter is a paper certificate form for signature by a Program employee, bearing a letterhead and the seal of the United States Department of Agriculture, with a certification that meat or meat food products described on the form is from animals that received ante-mortem and post-mortem inspection and were found sound and healthy and that it has been inspected and passed as provided by law and the regulations of the Department of Agriculture and is sound and wholesome. The certificate also bears a serial number such as “No. 184432.”</P> <CITA>[35 FR 15573, Oct. 3, 1970, as amended at 42 FR 11825, Mar. 1, 1977; 47 FR 29823, July 9, 1982]</CITA> </SECTION> <SECTION> <PRTPAGE P="148"/> <SECTNO>§ 312.9</SECTNO> <SUBJECT>Official detention marks and devices.</SUBJECT> <P>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 § 329.2 of this subchapter.</P> <CITA>[55 FR 47842, Nov. 16, 1990]</CITA> </SECTION> <SECTION> <SECTNO>§ 312.10</SECTNO> <SUBJECT>Official mark for maintaining the identity and integrity of samples.</SUBJECT> <P>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.</P> <GPH DEEP="88" SPAN="1"> <GID>EC11SE91.011</GID> </GPH> <CITA>[52 FR 41958, Nov. 2, 1987]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 313</EAR> <HD SOURCE="HED">PART 313—HUMANE SLAUGHTER OF LIVESTOCK</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>313.1</SECTNO> <SUBJECT>Livestock pens, driveways and ramps.</SUBJECT> <SECTNO>313.2</SECTNO> <SUBJECT>Handling of livestock.</SUBJECT> <SECTNO>313.5</SECTNO> <SUBJECT>Chemical; carbon dioxide</SUBJECT> <SECTNO>313.15</SECTNO> <SUBJECT>Mechanical; captive bolt.</SUBJECT> <SECTNO>313.16</SECTNO> <SUBJECT>Mechanical; gunshot.</SUBJECT> <SECTNO>313.30</SECTNO> <SUBJECT>Electrical; stunning or slaughtering with electric current.</SUBJECT> <SECTNO>313.50</SECTNO> <SUBJECT>Tagging of equipment, alleyways, pens or compartments to prevent inhumane slaughter or handling in connection with slaughter.</SUBJECT> <SECTNO>313.90</SECTNO> <SUBJECT>[Reserved]</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>44 FR 68813, Nov. 30, 1979, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 313.1</SECTNO> <SUBJECT>Livestock pens, driveways and ramps.</SUBJECT> <P>(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.</P> <P>(b) Floors of livestock pens, ramps, and driveways shall be constructed and maintained so as to provide good footing for livestock. Slip resistant or waffled floor surfaces, cleated ramps and the use of sand, as appropriate, during winter months are examples of acceptable construction and maintenance.</P> <P>(c) U.S. Suspects (as defined in § 301.2(xxx)) and dying, diseased, and disabled livestock (as defined in § 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.</P> <P>(d) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized.</P> <CITA>[44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 313.2</SECTNO> <SUBJECT>Handling of livestock.</SUBJECT> <P>(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.</P> <P>(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 <PRTPAGE P="149"/>current shall be reduced by a transformer to the lowest effective voltage not to exceed 50 volts AC.</P> <P>(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.</P> <P>(d) Disabled livestock and other animals unable to move.</P> <P>(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 § 313.1(c).</P> <P>(2) The dragging of disabled animals and other animals unable to move, while conscious, is prohibited. Stunned animals may, however, be dragged.</P> <P>(3) Disabled animals and other animals unable to move may be moved, while conscious, on equipment suitable for such purposes; e.g., stone boats.</P> <P>(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.</P> <P>(f) Stunning methods approved in § 313.30 shall be effectively applied to animals prior to their being shackled, hoisted, thrown, cast, or cut.</P> </SECTION> <SECTION> <SECTNO>§ 313.5</SECTNO> <SUBJECT>Chemical; carbon dioxide.</SUBJECT> <P>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.</P> <P>(a) <E T="03">Administration of gas, required effect; handling.</E> (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.</P> <P>(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.</P> <P>(3) On emerging from the carbon dioxide tunnel, the animals shall be in a state of surgical anesthesia and shall remain in this condition throughout shackling, sticking, and bleeding, except for swine in which death has been induced by the administration of carbon dioxide. Asphyxia or death from any cause shall not be produced in animals before bleeding, except for swine in which death has been induced by the administration of carbon dioxide.</P> <P>(b) <E T="03">Facilities and procedures</E>—(1) <E T="03">General requirements for gas chambers and auxiliary equipment; operator.</E> (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 <PRTPAGE P="150"/>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.</P> <P>(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.</P> <P>(2) <E T="03">Special requirements for gas chamber and auxiliary equipment.</E> 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.</P> <P>(3) <E T="03">Gas.</E> Maintenance of a uniform carbon dioxide concentration and distribution in the anesthesia chamber is a vital aspect of producing surgical anesthesia. This may be assured by reasonably accurate instruments which sample and analyze carbon dioxide gas concentration within the chamber throughout anesthetizing operations. Gas concentration shall be maintained uniform so that the degree of anesthesia in exposed animals will be constant. Carbon dioxide gas supplied to anesthesia chambers may be from controlled reduction of solid carbon dioxide or from a controlled liquid source. In either case the carbon dioxide shall be supplied at a rate sufficient to anesthetize adequately and uniformly the number of animals passing through the chamber. Sampling of gas for analysis shall be made from a representative place or places within the chamber and on a continuing basis. Gas concentrations and exposure time shall be graphically recorded throughout each day's operation. Neither carbon dioxide nor atmospheric air used in the anesthesia chambers shall contain noxious or irritating gases. Each day before equipment is used for anesthetizing animals, proper care shall be taken to mix adequately the gas and air within the chamber. All gas producing and control equipment shall be maintained in good repair and all indicators, instruments, and measuring devices must be available for inspection by Program inspectors during anesthetizing operations and at other times. An exhaust system must be provided so that, in case of equipment failure, non-uniform carbon dioxide concentrations in the gas tunnel or contamination of the ambient air of the establishment will be prevented.</P> <CITA>[44 FR 68813, Nov. 30, 1979, as amended at 59 FR 21640, Apr. 26, 1994]</CITA> </SECTION> <SECTION> <SECTNO>§ 313.15</SECTNO> <SUBJECT>Mechanical; captive bolt.</SUBJECT> <P>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.</P> <P>(a) <E T="03">Application of stunners, required effect; handling.</E> (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.</P> <P>(2) The driving of the animals to the stunning area shall be done with a minimum of excitement and discomfort to <PRTPAGE P="151"/>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.</P> <P>(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.</P> <P>(b) <E T="03">Facilities and procedures</E>—(1) <E T="03">General requirements for stunning facilities; operator.</E> (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.</P> <P>(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.</P> <P>(iii) The stunning area shall be so designed and constructed as to limit the free movements of animals sufficiently to allow the operator to locate the stunning blow with a high degree of accuracy. All chutes, alleys, gates and restraining mechanisms between and including holding pens and stunning areas shall be free from pain-producing features such as exposed bolt ends, loose boards, splintered or broken planking, and protruding sharp metal of any kind. There shall be no unnecessary holes or other openings where feet or legs of animals may be injured. Overhead drop gates shall be suitably covered on the bottom edge to prevent injury on contact with animals. Roughened or cleated cement shall be used as flooring in chutes leading to stunning areas to reduce falls of animals. Chutes, alleys, and stunning areas shall be so designed that they will comfortably accommodate the kinds of animals to be stunned.</P> <P>(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.</P> <P>(2) <E T="03">Special requirements and prohibitions.</E> (i) Choice of instrument and force required to produce immediate unconsciousness varies, depending on kind, breed, size, age, and sex of the animal. Young swine, lambs, and calves usually require less stunning force than mature animals of the same kind. Bulls, rams, and boars usually require skull penetration to produce immediate unconsciousness. Charges suitable for smaller kinds of livestock such as swine or for young animals are not acceptably interchanged for use on larger kinds or older livestock, respectively.</P> <P>(ii) Captive bolt stunners that deliberately inject compressed air into the <PRTPAGE P="152"/>cranium at the end of the penetration cycle shall not be used to stun cattle.</P> <CITA>[44 FR 68813, Nov. 30, 1979, as amended at 69 FR 1891, Jan. 12, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§ 313.16</SECTNO> <SUBJECT>Mechanical; gunshot.</SUBJECT> <P>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.</P> <P>(a) <E T="03">Utilization of firearms, required effect; handling.</E> (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.</P> <P>(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.</P> <P>(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.</P> <P>(b) <E T="03">Facilities and procedure</E>—(1) <E T="03">General requirements for shooting facilities; operator.</E> (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.</P> <P>(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.</P> <P>(iii) The provisions contained in § 313.15(b)(1)(iii) with respect to the stunning area also apply to the shooting area.</P> <P>(iv) The shooting operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately direct the projectile to produce immediate unconsciousness. He must use the correct caliber firearm, powder charge and type of ammunition to produce the desired results.</P> <P>(2) <E T="03">Special requirements.</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 313.30</SECTNO> <SUBJECT>Electrical; stunning or slaughtering with electric current.</SUBJECT> <P>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.<PRTPAGE P="153"/> </P> <P>(a) <E T="03">Administration of electric current, required effect; handling.</E> (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.</P> <P>(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.</P> <P>(3) The quality and location of the electrical shock shall be such as to produce immediate insensibility to pain in the exposed animal.</P> <P>(4) The stunned animal shall remain in a state of surgical anesthesia through shackling, sticking, and bleeding.</P> <P>(b) <E T="03">Facilities and procedures; operator</E>—(1) <E T="03">General requirements for operator.</E> It is necessary that the operator of electric current application equipment be skilled, attentive, and aware of his or her responsibility.</P> <P>(2) <E T="03">Special requirements for electric current application equipment.</E> 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.</P> <P>(3) <E T="03">Electric current.</E> Each animal shall be given a sufficient application of electric current to ensure surgical anesthesia throughout the bleeding operation. Suitable timing, voltage and current control devices shall be used to ensure that each animal receives the necessary electrical charge to produce immediate unconsciousness. The current shall be applied so as to avoid the production of hemorrhages or other tissue changes which could interfere with inspection procedures.</P> <CITA>[44 FR 68813, Nov. 30, 1979, as amended at 50 FR 25202, June 18, 1985]</CITA> </SECTION> <SECTION> <SECTNO>§ 313.50</SECTNO> <SUBJECT>Tagging of equipment, alleyways, pens, or compartments to prevent inhumane slaughter or handling in connection with slaughter.</SUBJECT> <P>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.</P> <P>(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 <PRTPAGE P="154"/>be dressed, processed, or prepared under inspection.</P> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 313.90</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> </PART> <PART> <EAR>Pt. 314</EAR> <HD SOURCE="HED">PART 314—HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE PRODUCTS AT OFFICIAL ESTABLISHMENTS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>314.1</SECTNO> <SUBJECT>Disposition of condemned products at official establishments having tanking facilities; sealing of tanks.</SUBJECT> <SECTNO>314.2</SECTNO> <SUBJECT>Tanking and other facilities for inedible products to be separate from edible product facilities.</SUBJECT> <SECTNO>314.3</SECTNO> <SUBJECT>Disposition of condemned products at official establishments having no tanking facilities.</SUBJECT> <SECTNO>314.4</SECTNO> <SUBJECT>Suppression of odors in preparing inedible products.</SUBJECT> <SECTNO>314.5</SECTNO> <SUBJECT>Inedible rendered fats prepared at official establishments.</SUBJECT> <SECTNO>314.6</SECTNO> <SUBJECT>Inedible fats from outside official establishments.</SUBJECT> <SECTNO>314.7</SECTNO> <SUBJECT>Carcasses of livestock condemned on ante-mortem inspection not to pass through edible product areas.</SUBJECT> <SECTNO>314.8</SECTNO> <SUBJECT>Dead animal carcasses.</SUBJECT> <SECTNO>314.9</SECTNO> <SUBJECT>Specimens for educational, research, and other nonfood purposes; permits for, required.</SUBJECT> <SECTNO>314.10</SECTNO> <SUBJECT>Livers condemned because of parasitic infestation and for other causes; conditions for disposal for purposes other than human food.</SUBJECT> <SECTNO>314.11</SECTNO> <SUBJECT>Handling of certain condemned products for purposes other than human food.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15575, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 314.1</SECTNO> <SUBJECT>Disposition of condemned products at official establishments having tanking facilities; sealing of tanks.</SUBJECT> <P>(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:</P> <P>(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.</P> <P>(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 § 314.3 before leaving such establishment.<PRTPAGE P="155"/> </P> <P>(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.</P> <P>(c) Carcasses of animals condemned under § 309.3 of this subchapter may be disposed of as provided in § 314.3, in lieu of tanking, with the approval of the inspector.</P> </SECTION> <SECTION> <SECTNO>§ 314.2</SECTNO> <SUBJECT>Tanking and other facilities for inedible products to be separate from edible product facilities.</SUBJECT> <P>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.</P> <CITA>[64 FR 56416, Oct. 20, 1999]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.3</SECTNO> <SUBJECT>Disposition of condemned products at official establishments having no tanking facilities.</SUBJECT> <P>(a) Carcasses, parts of carcasses, and other products condemned at an official establishment which has no facilities for tanking shall, except as provided in paragraph (b) of this section or elsewhere in this part, be destroyed in the presence of an inspector by incineration, or denatured with crude carbolic acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella or any other proprietary material approved by the Administrator in specific cases. When such product is to be denatured, it shall be freely slashed before the denaturing agent is applied, except that, in the case of dead animals that have not been dressed, the denaturant may be applied by injection. The denaturant must be deposited in all portions of the carcass or product to the extent necessary to preclude its use for food purposes.</P> <P>(b) All carcasses and parts condemned on account of anthrax, as identified in § 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.</P> </SECTION> <SECTION> <SECTNO>§ 314.4</SECTNO> <SUBJECT>Suppression of odors in preparing inedible products.</SUBJECT> <P>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.</P> <CITA>[64 FR 56416, Oct. 20, 1999]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.5</SECTNO> <SUBJECT>Inedible rendered fats prepared at official establishments.</SUBJECT> <P>Except as provided in § 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 § 325.11(c) of this subchapter.</P> <CITA>[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.6</SECTNO> <SUBJECT>Inedible fats from outside official establishments.</SUBJECT> <P>Except as provided in § 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 <PRTPAGE P="156"/>tank room provided for inedible products, and then only when they have been denatured in accordance with § 314.5 and are marked in accordance with § 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.</P> <CITA>[35 FR 15575, Oct. 3, 1970, as amended at 53 FR 24679, June 30, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.7</SECTNO> <SUBJECT>Carcasses of livestock condemned on ante-mortem inspection not to pass through edible product areas.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 314.8</SECTNO> <SUBJECT>Dead animal carcasses.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 314.9</SECTNO> <SUBJECT>Specimens for educational, research, and other nonfood purposes; permits for, required.</SUBJECT> <P>(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: <E T="03">Provided,</E> 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.</P> <P>(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.</P> <CITA>[35 FR 15575, Oct. 3, 1970, as amended at 38 FR 18665, July 13, 1973; 39 FR 36000, Oct. 7, 1974]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.10</SECTNO> <SUBJECT>Livers condemned because of parasitic infestation and for other causes; conditions for disposal for purposes other than human food.</SUBJECT> <P>(a) Livers condemned on account of hydatid cysts shall be disposed of by tanking pursuant to the provisions of § 314.1 of this subchapter if condemned at official establishments having facilities for tanking; otherwise they shall be destroyed pursuant to the provisions of § 314.3 of this subchapter.</P> <P>(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 § 325.13(a)(1) or (2) or (5), and in accordance with § 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 <PRTPAGE P="157"/>the movement of such articles, for purposes other than use as human food.</P> <P>(c) Livers condemned because of conditions described in paragraph (b) of this section shall be in containers plainly marked “inedible”.</P> <CITA>[41 FR 23701, June 11, 1976]</CITA> </SECTION> <SECTION> <SECTNO>§ 314.11</SECTNO> <SUBJECT>Handling of certain condemned products for purposes other than human food.</SUBJECT> <P>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 § 325.13(a)(2) of this subchapter. The slashing, identification and packing of the product shall be accomplished in an inedible product area under the supervision of an inspector. Facilities must be adequate so that the carcasses or parts saved under these provisions are not contaminated with pus, manure, septic, or toxic materials, or similar substances. The operation must not result in unsanitary conditions within the establishment.</P> <CITA>[35 FR 15575, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 36 FR 11903, June 23, 1971]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 315</EAR> <HD SOURCE="HED">PART 315—RENDERING OR OTHER DISPOSAL OF CARCASSES AND PARTS PASSED FOR COOKING</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>315.1</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; rendering into lard or tallow.</SUBJECT> <SECTNO>315.2</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; utilization for food purposes after cooking.</SUBJECT> <SECTNO>315.3</SECTNO> <SUBJECT>Disposal of products passed for cooking if not handled according to this part.</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SECTION> <SECTNO>§ 315.1</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; rendering into lard or tallow.</SUBJECT> <P>Carcasses and parts passed for cooking may be rendered into lard in accordance with § 319.702 of this subchapter or rendered into tallow, provided such rendering is done in the following manner:</P> <P>(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 °F. for a period of not less than 30 minutes.</P> <P>(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.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 25420, June 13, 1978]</CITA> </SECTION> <SECTION> <SECTNO>§ 315.2</SECTNO> <SUBJECT>Carcasses and parts passed for cooking; utilization for food purposes after cooking.</SUBJECT> <P>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 °F. for a <PRTPAGE P="158"/>period of not less than 30 minutes either before being used in or during the preparation of the finished product.</P> <CITA>[37 FR 2661, Feb. 4, 1972]</CITA> </SECTION> <SECTION> <SECTNO>§ 315.3</SECTNO> <SUBJECT>Disposal of products passed for cooking if not handled according to this part.</SUBJECT> <P>Products passed for cooking if not handled and processed in accordance with the provisions of this part, shall be disposed of in accordance with § 314.1 or § 314.3 of this subchapter.</P> <CITA>[35 FR 15577, Oct. 3, 1970. Redesignated at 37 FR 2661, Feb. 4, 1972]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 316</EAR> <HD SOURCE="HED">PART 316—MARKING PRODUCTS AND THEIR CONTAINERS</HD> <CONTENTS> <SECHD>Sec.</SECHD> <SECTNO>316.1</SECTNO> <SUBJECT>Authorization required to make devices bearing official marks.</SUBJECT> <SECTNO>316.2</SECTNO> <SUBJECT>Approval required for official marks.</SUBJECT> <SECTNO>316.3</SECTNO> <SUBJECT>Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required.</SUBJECT> <SECTNO>316.4</SECTNO> <SUBJECT>Marking devices; to be furnished by official establishments; control of.</SUBJECT> <SECTNO>316.5</SECTNO> <SUBJECT>Branding ink; to be furnished by official establishments; approval by Program; color.</SUBJECT> <SECTNO>316.6</SECTNO> <SUBJECT>Products not to be removed from official establishments unless marked in accordance with the regulations.</SUBJECT> <SECTNO>316.7</SECTNO> <SUBJECT>Marking devices not to be false or misleading; style and size of lettering; approval required.</SUBJECT> <SECTNO>316.8</SECTNO> <SUBJECT>Unmarked inspected products; moved between official establishments; moved in commerce.</SUBJECT> <SECTNO>316.9</SECTNO> <SUBJECT>Products to be marked with official marks.</SUBJECT> <SECTNO>316.10</SECTNO> <SUBJECT>Marking of meat food products with official inspection legend and ingredient statement.</SUBJECT> <SECTNO>316.11</SECTNO> <SUBJECT>Special markings for certain meat food products.</SUBJECT> <SECTNO>316.12</SECTNO> <SUBJECT>Marking of equine carcasses and parts thereof.</SUBJECT> <SECTNO>316.13</SECTNO> <SUBJECT>Marking of outside containers.</SUBJECT> <SECTNO>316.14</SECTNO> <SUBJECT>Marking tank cars and tank trucks used in transportation of edible products.</SUBJECT> <SECTNO>316.15</SECTNO> <SUBJECT>Marking outside containers of inedible grease, etc.</SUBJECT> <SECTNO>316.16</SECTNO> <SUBJECT>Custom prepared products to be marked “Not for Sale.”</SUBJECT> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.17, 2.55.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15577, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 316.1</SECTNO> <SUBJECT>Authorization required to make devices bearing official marks.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 316.2</SECTNO> <SUBJECT>Approval required for official marks.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 316.3</SECTNO> <SUBJECT>Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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:</P> <P>(1) Such preparation is performed at an official establishment; or</P> <P>(2) Such preparation is conducted under State or other governmental inspection and the prepared product is marked to show that fact; or</P> <P>(3) The official marks are removed, defaced, or otherwise destroyed before or during such preparation; or</P> <P>(4) The preparation of the product consists solely of cutting up operations at any establishment exempted from <PRTPAGE P="159"/>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.</P> </SECTION> <SECTION> <SECTNO>§ 316.4</SECTNO> <SUBJECT>Marking devices; to be furnished by official establishments; control of.</SUBJECT> <P>(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.</P> <P>(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.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 46 FR 38072, July 24, 1981]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.5</SECTNO> <SUBJECT>Branding ink; to be furnished by official establishments; approval by Program; color.</SUBJECT> <P>(a) The operator of each official establishment shall furnish all ink for marking products with the official marks at such establishment. Such ink must be made with harmless ingredients that are approved for the purpose by the Administrator. Samples of inks shall be submitted to the Program laboratory from time to time as may be deemed necessary by the inspector in charge.</P> <P>(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.</P> <P>(c) Green ink shall not be used to apply marks to carcasses of cattle, sheep, swine, or goats or fresh meat cuts derived therefrom.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 9088, Apr. 10, 1973]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.6</SECTNO> <SUBJECT>Products not to be removed from official establishments unless marked in accordance with the regulations.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 316.7</SECTNO> <SUBJECT>Marking devices not to be false or misleading; style and size of lettering; approval required.</SUBJECT> <P>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 § 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.</P> </SECTION> <SECTION> <PRTPAGE P="160"/> <SECTNO>§ 316.8</SECTNO> <SUBJECT>Unmarked inspected products; moved between official establishments; moved in commerce.</SUBJECT> <P>(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.</P> <P>(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: <E T="03">Provided,</E> 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: <E T="03">And provided further,</E> That unmarked product shall not be brought into an official establishment in an open container.</P> </SECTION> <SECTION> <SECTNO>§ 316.9</SECTNO> <SUBJECT>Products to be marked with official marks.</SUBJECT> <P>(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.</P> <P>(b) Except as provided otherwise in § 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.</P> <P>(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.</P> <P>(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 § 316.8.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 36 FR 23720, Dec. 14, 1971]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.10</SECTNO> <SUBJECT>Marking of meat food products with official inspection legend and ingredient statement.</SUBJECT> <P>(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.</P> <P>(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 <PRTPAGE P="161"/>capacity of 5 kilograms (11.025 lbs.) or less and containing a single kind of product: <E T="03">Provided,</E> 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.</P> <P>(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.</P> <P>(d) All cured products shall be marked with the list of ingredients in accordance with part 317 of this subchapter.</P> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.11</SECTNO> <SUBJECT>Special markings for certain meat food products.</SUBJECT> <P>(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: <E T="03">Provided,</E> That the following need not be so marked if they bear on each link or piece the name of the product in accordance with § 317.2 of this subchapter: Such products as coppa, capocollo, lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts of meat which are prepared without added substance other than curing materials or condiments; meat rolls, bockwurst, and similar products which do not contain cereal or vegetables; headcheese, souse, sulze, scrapple, blood pudding, and liver pudding; and other products such as loaves, chili con carne, and meat and cheese products when prepared with sufficient cheese to give definite characteristics to the finished products: <E T="03">And provided further,</E> 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.</P> <P>(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.</P> <P>(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.”</P> <P>(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.”</P> <P>(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.</P> <P>(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.<PRTPAGE P="162"/> </P> <P>(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.</P> <P>(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.”</P> <P>(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 § 317.8(b)(28) of this subchapter).</P> </SECTION> <SECTION> <SECTNO>§ 316.12</SECTNO> <SUBJECT>Marking of equine carcasses and parts thereof.</SUBJECT> <P>(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 § 312.3 of this subchapter and with other information prescribed for marking products in this part.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 316.13</SECTNO> <SUBJECT>Marking of outside containers.</SUBJECT> <P>(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.</P> <P>(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<FR>1/2</FR>-inch rubber brand in the form prescribed in part 312 of this subchapter: <E T="03">Provided,</E> 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: <E T="03">Provided further,</E> 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.</P> <P>(c) The outside containers of products for export shall be marked in compliance with part 322 of this subchapter as well as this part.</P> <P>(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.</P> <P>(e) The outside containers of any product which has been inspected and passed for cooking, pork which has been refrigerated as provided in § 318.10(c) of this subchapter, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in § 325.7(b) of this subchapter.</P> <P>(f) The outside containers of glands and organs which are not used for human food purposes, such as those described in § 325.19 of this subchapter, <PRTPAGE P="163"/>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.</P> <P>(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 § 317.3 of this subchapter: <E T="03">Provided,</E> 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.</P> <P>(h) The outside containers of livers prepared as described in § 314.10(b), shall be marked as prescribed in § 314.10(c) of this subchapter.</P> <P>(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.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.14</SECTNO> <SUBJECT>Marking tank cars and tank trucks used in transportation of edible products.</SUBJECT> <P>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 § 317.2 of this subchapter, the official inspection legend containing the number of the official establishment and the words “date of loading,” followed by a suitable space in which the date the tank car or tank truck is loaded shall be inserted. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label.</P> <CITA>[53 FR 28634, July 29, 1988]</CITA> </SECTION> <SECTION> <SECTNO>§ 316.15</SECTNO> <SUBJECT>Marking outside containers of inedible grease, etc.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 316.16</SECTNO> <SUBJECT>Custom prepared products to be marked “Not for Sale.”</SUBJECT> <P>Carcasses and parts therefrom that are prepared on a custom basis under § 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 § 317.16 of this subchapter. Ink used for marking such products must comply with the requirements of § 316.5.</P> <CITA>[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973]</CITA> </SECTION> </PART> <PART> <EAR>Pt. 317</EAR> <HD SOURCE="HED">PART 317—LABELING, MARKING DEVICES, AND CONTAINERS</HD> <CONTENTS> <SUBPART> <HD SOURCE="HED">Subpart A—General</HD> <SECHD>Sec.</SECHD> <SECTNO>317.1</SECTNO> <SUBJECT>Labels required; supervision by Program employee.</SUBJECT> <SECTNO>317.2</SECTNO> <SUBJECT>Labels: definition; required features.<PRTPAGE P="164"/> </SUBJECT> <SECTNO>317.3</SECTNO> <SUBJECT>Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception.</SUBJECT> <SECTNO>317.4</SECTNO> <SUBJECT>Labeling approval.</SUBJECT> <SECTNO>317.5</SECTNO> <SUBJECT>Generically approved labeling.</SUBJECT> <SECTNO>317.6</SECTNO> <SUBJECT>Approved labels to be used only on products to which they are applicable.</SUBJECT> <SECTNO>317.7</SECTNO> <SUBJECT>Products for foreign commerce; printing labels in foreign language permissible; other deviations.</SUBJECT> <SECTNO>317.8</SECTNO> <SUBJECT>False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.</SUBJECT> <SECTNO>317.9</SECTNO> <SUBJECT>Labeling of equine products.</SUBJECT> <SECTNO>317.10</SECTNO> <SUBJECT>Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.</SUBJECT> <SECTNO>317.11</SECTNO> <SUBJECT>Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.</SUBJECT> <SECTNO>317.12</SECTNO> <SUBJECT>Relabeling products; requirements.</SUBJECT> <SECTNO>317.13</SECTNO> <SUBJECT>Storage and distribution of labels and containers bearing official marks.</SUBJECT> <SECTNO>317.14-317.15</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.16</SECTNO> <SUBJECT>Labeling and containers of custom prepared products.</SUBJECT> <SECTNO>317.17</SECTNO> <SUBJECT>Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.</SUBJECT> <SECTNO>317.18-317.23</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.24</SECTNO> <SUBJECT>Packaging materials.</SUBJECT> </SUBPART> <SUBPART> <HD SOURCE="HED">Subpart B—Nutrition Labeling</HD> <SECTNO>317.300</SECTNO> <SUBJECT>Nutrition labeling of meat or meat food products.</SUBJECT> <SECTNO>317.301</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.302</SECTNO> <SUBJECT>Location of nutrition information.</SUBJECT> <SECTNO>317.303-317.307</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.308</SECTNO> <SUBJECT>Labeling of meat or meat food products with number of servings.</SUBJECT> <SECTNO>317.309</SECTNO> <SUBJECT>Nutrition label content.</SUBJECT> <SECTNO>317.310-317.311</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.312</SECTNO> <SUBJECT>Reference amounts customarily consumed per eating occasion.</SUBJECT> <SECTNO>317.313</SECTNO> <SUBJECT>Nutrient content claims; general principles.</SUBJECT> <SECTNO>317.314-317.342</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.343</SECTNO> <SUBJECT>Significant participation for voluntary nutrition labeling.</SUBJECT> <SECTNO>317.344</SECTNO> <SUBJECT>Identification of major cuts of meat products.</SUBJECT> <SECTNO>317.345</SECTNO> <SUBJECT>Guidelines for voluntary nutrition labeling of single-ingredient, raw products.</SUBJECT> <SECTNO>317.346-317.353</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.354</SECTNO> <SUBJECT>Nutrient content claims for “good source,” “high,” and “more”.</SUBJECT> <SECTNO>317.355</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.356</SECTNO> <SUBJECT>Nutrient content claims for “light” or “lite”.</SUBJECT> <SECTNO>317.357-317.359</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.360</SECTNO> <SUBJECT>Nutrient content claims for calorie content.</SUBJECT> <SECTNO>317.361</SECTNO> <SUBJECT>Nutrient content claims for the sodium content.</SUBJECT> <SECTNO>317.362</SECTNO> <SUBJECT>Nutrient content claims for fat, fatty acids, and cholesterol content.</SUBJECT> <SECTNO>317.363</SECTNO> <SUBJECT>Nutrient content claims for “healthy”.</SUBJECT> <SECTNO>317.364-317.368</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.369</SECTNO> <SUBJECT>Labeling applications for nutrient content claims.</SUBJECT> <SECTNO>317.370-317.379</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.380</SECTNO> <SUBJECT>Label statements relating to usefulness in reducing or maintaining body weight.</SUBJECT> <SECTNO>317.381-317.399</SECTNO> <SUBJECT>[Reserved]</SUBJECT> <SECTNO>317.400</SECTNO> <SUBJECT>Exemption from nutrition labeling.</SUBJECT> </SUBPART> </CONTENTS> <AUTH> <HD SOURCE="HED">Authority:</HD> <P>21 U.S.C. 601-695; 7 CFR 2.18, 2.53.</P> </AUTH> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>35 FR 15580, Oct. 3, 1970, unless otherwise noted.</P> </SOURCE> <SUBPART> <HD SOURCE="HED">Subpart A—General</HD> <SECTION> <SECTNO>§ 317.1</SECTNO> <SUBJECT>Labels required; supervision by Program employee.</SUBJECT> <P>(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 § 317.2 except that the following do not have to bear such a label.</P> <P>(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 § 317.2;</P> <P>(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;</P> <P>(3) Animal and transparent artificial casings bearing only the markings required by part 316 of this subchapter;</P> <P>(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;<PRTPAGE P="165"/> </P> <P>(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 § 317.2;</P> <P>(6) Containers of products passed for cooking or refrigeration and moved from an official establishment under § 311.1 of this subchapter.</P> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 317.2</SECTNO> <SUBJECT>Labels: definition; required features.</SUBJECT> <P>(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.</P> <P>(b) Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this part. Except as provided in § 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: <E T="03">Provided, however,</E> 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.</P> <P>(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:</P> <P>(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;</P> <P>(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;</P> <P>(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;</P> <P>(4) An accurate statement of the net quantity of contents, as prescribed in paragraph (h) of this section;</P> <P>(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;</P> <P>(6) Any other information required by the regulations in this part or part 319 of this subchapter.</P> <P>(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 <PRTPAGE P="166"/>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:</P> <P>(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.</P> <P>(2) In the case of a cylindrical or nearly cylindrical container:</P> <P>(i) An area that is 40 percent of the product of the height of the container times the circumference of the container, or</P> <P>(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: <E T="03">Provided, however,</E> 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.</P> <P>(3) In the case of a container of any other shape, 40 percent of the total surface of the container.</P> <P>(e) Any descriptive designation used as a product name for a product which has no common or usual name shall clearly and completely identify the product. Product which has been prepared by salting, smoking, drying, cooking, chopping, or otherwise shall be so described on the label unless the name of the product implies, or the manner of packaging shows that the product was subjected to such preparation. The unqualified terms “meat,” “meat byproduct,” “meat food product,” and terms common to the meat industry but not common to consumers such as “picnic,” “butt,” “cala,” “square,” “loaf,” “spread,” “delight,” “roll,” “plate,” “luncheon,” and “daisy” shall not be used as names of a product unless accompanied with terms descriptive of the product or with a list of ingredients, as deemed necessary in any specific case by the Administrator in order to assure that the label will not be false or misleading.</P> <P>(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.</P> <P>(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner:</P> <P>(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.</P> <P>(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.</P> <P>(ii) The term “corn syrup” may be used to designate either corn syrup or corn syrup solids.</P> <P>(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 <PRTPAGE P="167"/>herein means fat derived from inspected and passed cattle, sheep, swine, or goats.</P> <P>(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.</P> <P>(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: <E T="03">Provided,</E> That the word “and” in lieu of a comma shall be shown between the declaration of such meat ingredients in the statement of ingredients.</P> <P>(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: <E T="03">Provided,</E> That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as “Contains _____ percent of _____ ,” “Less than _____percent of _____ .” The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may also be utilized when an ingredients statement contains a listing of ingredients by individual components. Each component listing may utilize the required quantifying statement at the end of each component ingredients listing.</P> <P>(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 § 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.</P> <P>(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: <E T="03">Provided,</E> 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.</P> <P>(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.</P> <P>(4) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter.</P> <P>(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.</P> <P>(2) The name and place of business of the manufacturer, packer, or distributor may be shown:</P> <P>(i) On the principal display panel, or</P> <P>(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</P> <P>(iii) On the front riser panel of frozen food cartons, or</P> <P>(iv) On the information panel.</P> <P>(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 <PRTPAGE P="168"/>type in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph.</P> <P>(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 § 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.</P> <P>(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: <E T="03">Provided,</E> 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.</P> <P>(4) Except as provided in § 317.7, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semisolid viscous or a mixture of solid and liquid. For example, a declaration of <FR>3/4</FR>-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<FR>1/2</FR> pounds avoirdupois weight shall be expressed as “Net Wt. 24 oz. (1 lb. 8 oz.),” “Net Wt. 24 oz. (1<FR>1/2</FR> lb.),” or “Net Wt. 24 oz. (1.5 lbs.).”</P> <P>(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 <FR>1/2</FR> ounce net weight. Pargraph (h)(12) of this section permits certain exceptions from the provision of this paragraph for multi-unit packages.</P> <P>(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:</P> <P>(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;</P> <P>(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;</P> <P>(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;</P> <P>(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.</P> <P>(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.<PRTPAGE P="169"/> </P> <P>(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.</P> <P>(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.</P> <P>(9) The following exemptions from the requirements contained in this paragraph (h) are hereby established:</P> <P>(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 § 317.19 need not bear a net weight statement when shipped from an official establishment, provided that a net weight shipping statement which meets the requirements of paragraph (h)(2) of this section is applied to their shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size, dual declaration, and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement on random weight consumer size packages for retail sale shall be exempt from the type size, dual declaration, and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.</P> <P>(ii) Individually wrapped and labeled packages of less than <FR>1/2</FR> 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;</P> <P>(iii) Individually wrapped and labeled packages of less than <FR>1/2</FR> 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.</P> <P>(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.</P> <P>(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.</P> <P>(10) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and <PRTPAGE P="170"/>in the same size type as is used for such representation, a statement of the net quantity of each such serving.</P> <P>(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.</P> <P>(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.</P> <P>(i) The official establishment number of the official establishment in which the product was processed under inspection shall be placed as follows:</P> <P>(1) Within the official inspection legend in the form required by part 312 of this subchapter; or</P> <P>(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</P> <P>(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</P> <P>(4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix “EST”.</P> <P>(j) Labels of any product within any of the following paragraphs shall show the information required by such paragraph for such product:</P> <P>(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.</P> <P>(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).</P> <P>(3) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of a meat food product, as permitted in part 318 of this subchapter, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as may be applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring so added as an ingredient in the formula of the meat food product.</P> <P>(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.”<PRTPAGE P="171"/> </P> <P>(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.”</P> <P>(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.”</P> <P>(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.”</P> <P>(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.</P> <P>(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.</P> <P>(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.”</P> <P>(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.</P> <P>(12) Containers of other product packed in, bearing, or containing any chemical preservative shall bear a label stating that fact.</P> <P>(13)(i) On the label of any “Mechanically Separated (Species)” described in § 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.</P> <P>(ii) When any “Mechanically Separated (Species)” described in § 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: <E T="03">Provided,</E> That, calcium content need not be stated where (<E T="03">a</E>) 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 <PRTPAGE P="172"/>contained only hand deboned ingredients or (<E T="03">b</E>) 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.</P> <P>(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.</P> <P>(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 § 318.17, or that have not undergone other processing that would render them ready-to-eat; and all comminuted meat patties not heat processed in a manner that conforms to the time and temperature combinations in the Table for Permitted Heat-Processing Temperature/Time Combinations For Fully-Cooked Patties in § 318.23, except as exempted under paragraph (l)(4) of this section.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(3) Meat and meat products, specified in this paragraph (l), shall bear the labeling statements:</P> <P>(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.);</P> <P>(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.);</P> <P>(iii) Cook thoroughly. (A graphic illustration of a skillet shall be displayed next to the statement.); and</P> <P>(iv) Keep hot foods hot. Refrigerate leftovers immediately or discard. (A graphic illustration of a thermometer <PRTPAGE P="173"/>shall be displayed next to the statement.)</P> <P>(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.</P> <P>(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:</P> <P>(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.</P> <P>(ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel.</P> <P>(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.</P> <P>(2) (i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel.</P> <P>(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.</P> <CITA>[35 FR 15580, Oct. 3, 1970]</CITA> <EDNOTE> <HD SOURCE="HED">Editorial Note:</HD> <P>For <E T="04">Federal Register</E> citations affecting § 317.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.</P> </EDNOTE> </SECTION> <SECTION> <SECTNO>§ 317.3</SECTNO> <SUBJECT>Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception.</SUBJECT> <P>(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.</P> <P>(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 § 312.2(b), § 312.3(a) (only the legend appropriate for horse meat food products) or § 312.3(b) (only the legend appropriate for other (nonhorse) equine meat food products), or any abbreviations, copy or representation thereof.</P> <P>(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 § 312.2(a), § 312.3(a) (only the legend appropriate for horse carcasses and parts of horse carcasses), § 312.3(b) (only the legend appropriate for other equine (nonhorse) carcasses and parts of other (nonhorse) equine carcasses) or § 312.7(a).<PRTPAGE P="174"/> </P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(4) In order that all such brands or other marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such brand or other marking device which does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such brand or other marking device with a permanent identifying number.</P> <APPRO>(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0015)</APPRO> <CITA>[35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.4</SECTNO> <SUBJECT>Labeling approval.</SUBJECT> <P>(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 § 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.</P> <P>(b) The Food Labeling Division shall permit submission for approval of only sketch labeling, as defined in § 317.4(d), for all products, except as provided in § 317.5(b) (2)-(9) and except for temporary use of final labeling as prescribed in paragraph (f) of this section.</P> <P>(c) All labeling required to be submitted for approval as set forth in § 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.</P> <P>(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 § 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.</P> <P>(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 § 317.4(a), except that <PRTPAGE P="175"/>such devices which contain no reference to product and bear no misleading feature shall be used without submission for approval as prescribed in § 317.5(b)(7).</P> <P>(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:</P> <P>(i) The proposed labeling would not misrepresent the product;</P> <P>(ii) The use of the labeling would not present any potential health, safety, or dietary problems to the consumer;</P> <P>(iii) Denial of the request would create undue economic hardship; and</P> <P>(iv) An unfair competitive advantage would not result from the granting of the temporary approval.</P> <P>(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.</P> <P>(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.</P> <CITA>[60 FR 67454, Dec. 29, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.5</SECTNO> <SUBJECT>Generically approved labeling.</SUBJECT> <P>(a)(1) An official establishment or an establishment certified under a foreign inspection system, in accordance with part 327 of this subchapter, is authorized to use generically approved labeling, as defined in paragraph (b) of this section, without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington or the field, provided the labeling is in accordance with this section and shows all mandatory features in a prominent manner as required in § 317.2, and is not otherwise false or misleading in any particular.</P> <P>(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 § 317.4, to determine compliance with labeling requirements. Any finding of false or misleading labeling shall institute the proceedings prescribed in § 335.12.</P> <P>(b) Generically approved labeling is labeling which complies with the following:</P> <P>(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 (except as provided by paragraph (b)(9)(xxv) of this section), or guarantees, or which is not a domestic product labeled in a foreign language;</P> <P>(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 (except as provided by paragraph (b)(9)(xxv) of this section), or guarantees, or which is not a domestic product labeled with a foreign language;</P> <P>(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;</P> <P>(4) Labeling for shipping containers which contain fully labeled immediate containers, provided such labeling complies with § 316.13;</P> <P>(5) Labeling for products not intended for human food, provided they comply with part 325 of this subchapter;</P> <P>(6) Meat inspection legends, which comply with parts 312 and 316 of this subchapter;</P> <P>(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 <PRTPAGE P="176"/>of products, provided such devices contain no reference to product and bear no misleading feature;</P> <P>(8) Labeling for consumer test products not intended for sale; and</P> <P>(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:</P> <P>(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;</P> <P>(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.”;</P> <P>(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);</P> <P>(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);</P> <P>(v) A change in the language or the arrangement of directions pertaining to the opening of containers or the serving of the product;</P> <P>(vi) The addition, deletion, or amendment of a dated or undated coupon, a cents-off statement, cooking instructions, packer product code information, or UPC product code information;</P> <P>(vii) Any change in the name or address of the packer, manufacturer or distributor that appears in the signature line;</P> <P>(viii) Any change in the net weight, provided the size of the net weight statement complies with § 317.2;</P> <P>(ix) The addition, deletion, or amendment of recipe suggestions for the product;</P> <P>(x) Any change in punctuation;</P> <P>(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;</P> <P>(xii) The addition or deletion of open dating information;</P> <P>(xiii) A change in the type of packaging material on which the label is printed;</P> <P>(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;</P> <P>(xv) The deletion of the word “new” on new product labeling;</P> <P>(xvi) The addition, deletion, or amendment of special handling statements, provided that the change is consistent with § 317.2(k);</P> <P>(xvii) The addition of safe handling instructions as required by § 317.2(l);</P> <P>(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;</P> <P>(xix) Changes in the color of the labeling, provided that sufficient contrast and legibility remain;</P> <P>(xx) A change in the product vignette, provided that the change does not affect mandatory labeling information or misrepresent the content of the package;</P> <P>(xxi) A change in the establishment number by a corporation or parent company for an establishment under its ownership;</P> <P>(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;<PRTPAGE P="177"/> </P> <P>(xxiii) Deletion of any claim, and the deletion of non-mandatory features or non-mandatory information; and</P> <P>(xxiv) The addition or deletion of a direct translation of the English language into a foreign language for products marked “for export only.”</P> <P>(xxv) A country of origin statement on any product label described in § 317.8(b)(40) that complies with the requirements in that paragraph.</P> <CITA>[60 FR 67455, Dec. 29, 1995, as amended at 73 FR 50703, Aug. 28, 2008]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.6</SECTNO> <SUBJECT>Approved labels to be used only on products to which they are applicable.</SUBJECT> <P>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 § 317.3: <E T="03">Provided,</E> 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.</P> </SECTION> <SECTION> <SECTNO>§ 317.7</SECTNO> <SUBJECT>Products for foreign commerce; printing labels in foreign language permissible; other deviations.</SUBJECT> <P>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: <E T="03">Provided,</E> </P> <P>(a) That the proposed labeling accords to the specifications of the foreign purchaser,</P> <P>(b) That it is not in conflict with the laws of the country to which the product is intended for export, and</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 317.8</SECTNO> <SUBJECT>False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.</SUBJECT> <P>(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.</P> <P>(b) The labels and containers of product shall comply with the following provisions, as applicable:</P> <P>(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: <E T="03">Provided,</E> 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 <PRTPAGE P="178"/>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.</P> <P>(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: <E T="03">Provided,</E> 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: <E T="03">Provided further,</E> 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: <E T="03">And Provided further,</E> That the provisions of this paragraph shall not apply to products prepared in accordance with § 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.”</P> <P>(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.</P> <P>(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.</P> <P>(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: <E T="03">Provided,</E> That the transparent or semitransparent portion of the principal display panel is free of color tinting and red designs: <E T="03">And provided further,</E> 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.</P> <P>(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:</P> <P>(<E T="03">a</E>) 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<FR>1/2</FR> 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.</P> <P>(<E T="03">b</E>) 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<FR>1/2</FR> inches wide.</P> <P>(6) The word “fresh” shall not be used on labels to designate product <PRTPAGE P="179"/>which contains any sodium nitrate, sodium nitrite, potassium nitrate, or potassium nitrite, or which has been salted for preservation.</P> <P>(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.</P> <P>(ii) Any ingredient not designated in § 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.</P> <P>(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.</P> <P>(9) Product (other than canned product) labeled with the term “loaf” as part of its name:</P> <P>(i) If distributed from the official establishment in consumer size containers may be in any shape;</P> <P>(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;</P> <P>(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.</P> <P>(10) The term “baked” shall apply only to product which has been cooked by the direct action of dry heat and for a sufficient time to permit the product to assume the characteristics of a baked article, such as the formation of a brown crust on the surface, rendering out of surface fat, and the caramelization of the sugar if applied. Baked loaves shall be heated to a temperature of at least 160 °F. and baked pork cuts shall be heated to an internal temperature of at least 170 °F.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.”</P> <P>(16) [Reserved]</P> <P>(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 <PRTPAGE P="180"/>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.</P> <P>(18) “Leaf lard” is lard prepared from fresh leaf fat.</P> <P>(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.</P> <P>(20) Oil, stearin, or stock obtained from beef or mutton fats rendered at a temperature above 170 °F. shall not be designated as “oleo oil,” “oleo stearin,” or “oleo stock,” respectively.</P> <P>(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.</P> <P>(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.</P> <P>(23) When monoglycerides, diglycerides, and/or polyglycerol esters of fatty acids are added to rendered animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and contiguous to the name of the product a statement such as “With Monoglycerides and Diglycerides Added,” or “With Diglycerides and Monoglycerides,” or “With Polyglycerol Esters of Fatty Acids” as the case may be.</P> <P>(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. <SU>1</SU> <FTREF/> </P> <FTNT> <P> <SU>1</SU> “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.</P> <P>(b) No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless—</P> <P>(1) Such oleomargarine or margarine is packaged,</P> <P>(2) The net weight of the contents of any package sold in a retail establishment is one pound or less,</P> <P>(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</P> <P>(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.</P> <P>The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this Act.</P> <P>(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.</P> <P>(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) <PRTPAGE/>and (f) of section 343 of this title) if it complies with the requirements of subsection (b) of this section.</P> <P>(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).</P> </FTNT> <PRTPAGE P="181"/> <P>(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.</P> <P>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.</P> <P>(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.”</P> <P>(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.</P> <P>(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.”</P> <P>(29) Meat of goats shall be identified as goat meat or chevon.</P> <P>(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 § 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.</P> <P>(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.</P> <P>(32) A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:</P> <P>(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.</P> <P>(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 § 317.4.</P> <P>(33) [Reserved]</P> <P>(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.<PRTPAGE P="182"/> </P> <P>(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.</P> <P>(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).</P> <P>(37) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with part 320 of this chapter.</P> <P>(38) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement.</P> <P>(39) When transglutaminase enzyme is used to bind pieces of meat to form a cut of meat, or to reform a piece of meat from a multiple cuts, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Beef Tenderloin” or “Reformed and Shaped Beef Tenderloin.”</P> <P>(40) A country of origin statement on the label of any meat “covered commodity” as defined in 7 CFR Part 65, Subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400.</P> <CITA>[35 FR 15580, Oct. 3, 1970]</CITA> <EDNOTE> <HD SOURCE="HED">Editorial Note:</HD> <P>For <E T="04">Federal Register</E> citations affecting § 317.8, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.</P> </EDNOTE> </SECTION> <SECTION> <SECTNO>§ 317.9</SECTNO> <SUBJECT>Labeling of equine products.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 317.10</SECTNO> <SUBJECT>Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.</SUBJECT> <P>(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.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 317.11</SECTNO> <SUBJECT>Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.</SUBJECT> <P>(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.</P> <P>(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 <PRTPAGE P="183"/>such filling is done under the supervision of a Program employee.</P> <P>(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.</P> </SECTION> <SECTION> <SECTNO>§ 317.12</SECTNO> <SUBJECT>Relabeling products; requirements.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§ 317.13</SECTNO> <SUBJECT>Storage and distribution of labels and containers bearing official marks.</SUBJECT> <P>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.</P> </SECTION> <SECTION> <SECTNO>§§ 317.14-317.15</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 317.16</SECTNO> <SUBJECT>Labeling and containers of custom prepared products.</SUBJECT> <P>Products that are custom prepared under § 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.</P> <CITA>[37 FR 4071, Feb. 26, 1972]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.17</SECTNO> <SUBJECT>Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.</SUBJECT> <P>(a) With respect to sections 1(n) (7), (9), and (12) of the Act and § 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 § 317.2.</P> <P>(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 § 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.</P> <P>(c)(1) Products described in paragraph (b) of this section or § 319.2 of <PRTPAGE P="184"/>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.</P> <P>(2) Products described in paragraph (b) of this section and § 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 °F. At All Times” unless they have been thermally processed to F<E T="52">o</E> 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.</P> <P>(3) Products described in paragraph (b) of this section and § 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.</P> <CITA>[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]</CITA> </SECTION> <SECTION> <SECTNO>§§ 317.18-317.23</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 317.24</SECTNO> <SUBJECT>Packaging materials.</SUBJECT> <P>(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).</P> <P>(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. 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.</P> <P>(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.</P> <P>(d) The Department will monitor the use of packaging material in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information tm designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information <PRTPAGE P="185"/>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.</P> <P>(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health.</P> <P>(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.</P> <P>(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.</P> <CITA>[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]</CITA> </SECTION> </SUBPART> <SUBPART> <HD SOURCE="HED">Subpart B—Nutrition Labeling</HD> <SOURCE> <HD SOURCE="HED">Source:</HD> <P>58 FR 664, Jan. 6, 1993, unless otherwise noted.</P> </SOURCE> <SECTION> <SECTNO>§ 317.300</SECTNO> <SUBJECT>Nutrition labeling of meat or meat food products.</SUBJECT> <P>(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 § 317.309; except as exempted under § 317.400 of this subpart.</P> <P>(b) Nutrition labeling may be provided for single-ingredient, raw meat or meat food products in accordance with the requirements of §§ 317.309 and 317.345. Significant participation in voluntary nutrition labeling shall be measured by the Agency in accordance with §§ 317.343 and 317.344 of this subpart.</P> <CITA>[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.301</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 317.302</SECTNO> <SUBJECT>Location of nutrition information.</SUBJECT> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="186"/>the principal display panel may be considered.</P> <CITA>[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§§ 317.303-317.307</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 317.308</SECTNO> <SUBJECT>Labeling of meat or meat food products with number of servings.</SUBJECT> <P>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 § 317.2(h)(10).</P> <CITA>[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.309</SECTNO> <SUBJECT>Nutrition label content.</SUBJECT> <P>(a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section.</P> <P>(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.</P> <P>(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 § 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 § 317.312(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims.</P> <P>(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 § 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.</P> <P>(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:</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="187"/>than 200 percent of the Reference Amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings.</P> <P>(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 § 317.312(c).</P> <P>(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.</P> <P>(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., <FR>1/8</FR> quiche, <FR>1/4</FR> 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 § 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 § 317.312(c). In expressing the fractional slice, manufacturers shall use <FR>1/2</FR>, <FR>1/3</FR>, <FR>1/4</FR>, <FR>1/5</FR>, <FR>1/6</FR>, or smaller fractions that can be generated by further division by 2 or 3.</P> <P>(6) For nondiscrete bulk products (e.g., whole roast beef, marinated beef tenderloin, large can of chili), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., roast beef and gravy), the serving size shall be the amount in household measure that most closely approximates the Reference Amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product determined in § 317.312(c).</P> <P>(7) For labeling purposes, the term “common household measure” or “common household unit” means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., <FR>1/4</FR> 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:</P> <P>(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate. Cups shall be expressed in <FR>1/4</FR>- or <FR>1/3</FR>-cup increments, tablespoons in whole number of tablespoons for quantities less than <FR>1/4</FR> cup but greater than or equal to 2 tablespoons (tbsp), 1, 1<FR>1/3</FR>, 1<FR>1/2</FR>, or 1 <FR>2/3</FR> 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 <FR>1/4</FR>-tsp increments for quantities less than 1 tsp.</P> <P>(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.</P> <P>(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).</P> <P>(iv) A description of the individual container or package shall be used for single-serving containers and for individually packaged products within multi-serving containers (e.g., can, <PRTPAGE P="188"/>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).</P> <P>(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.</P> <P>(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.</P> <P>(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).</P> <P>(viii) When a serving size, determined from the Reference Amount in § 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.</P> <P>(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.</P> <P>(9) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(8) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams), except for single-serving containers.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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).<PRTPAGE P="189"/> </P> <P>(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).</P> <P>(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)).</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(12) The serving size for meal-type products and main-dish products as defined in § 317.313(l) and § 317.313(m) in single-serving containers will be the entire edible content of the package. Serving size for meal-type products and main-dish products in multi-serve containers will be based on the reference amount applicable to the product in § 317.312(b) if the product is listed in § 317.312(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 317.312(b) will be based on the reference amount according to § 317.312(c), (d), and (e).</P> <P>(13) Another column of figures may be used to declare the nutrient and food component information in the same format as required by § 317.309(e),</P> <P>(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as packaged or purchased.</P> <P>(ii) Per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit.</P> <P>(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.</P> <P>(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)): <E T="03">Provided,</E> 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.</P> <P>(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 <PRTPAGE P="190"/>(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.</P> <P>(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.</P> <P>(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.</P> <P>(A) Using specific Atwater factors (i.e., the Atwater method) given in Table 13, page 25, “Energy Value of Foods—Basis and Derivation,” by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February 1973), which is incorporated by reference. Table 13 of the “Energy Value of Foods—Basis and Derivation,” Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E> 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;</P> <P>(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.);</P> <P>(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</P> <P>(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.</P> <P>(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.</P> <P>(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-<PRTPAGE P="191"/>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.</P> <P>(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 (<FR>1/2</FR>)-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.</P> <P>(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 (<FR>1/2</FR>)-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.</P> <P>(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 (<FR>1/2</FR>)-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.</P> <P>(B) [Reserved]</P> <P>(ii) “Polyunsaturated fat” or “Polyunsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat per serving defined as <E T="03">cis,cis</E>-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 § 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 (<FR>1/2</FR>)-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.</P> <P>(iii) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat per serving defined as <E T="03">cis</E>-monounsaturated fatty acids may be declared voluntarily, except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 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 (<FR>1/2</FR>)-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.</P> <P>(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.”</P> <P>(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.<PRTPAGE P="192"/> </P> <P>(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.</P> <P>(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.)</P> <P>(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.</P> <P>(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.</P> <P>(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.</P> <P>(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.</P> <P>(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 <PRTPAGE P="193"/>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.</P> <P>(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.</P> <P>(7) “Protein”: A statement of the number of grams of protein per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in products represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a product represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as percent of Daily Value. When the protein quality in a product as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a product represented or purported to be for infants, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by appropriate methods of analysis in accordance with § 317.309(h), except when the procedure for a specific food requires another factor.</P> <P>(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.</P> <P>(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 <PRTPAGE P="194"/>equal to the actual amount of protein (grams) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8 in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990, which is incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” as published by the Food and Agriculture Organization of the United Nations/World Health Organization, is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E> 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.</P> <P>(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.</P> <P>(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.</P> <P>(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d) through (g) of this section, products represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For products represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on products represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other products shall use the RDI for adults and children 4 or more years of age.</P> <P>(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:</P> <P>(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<PRTPAGE P="195"/> </P> <P>(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.</P> <P>(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.</P> <P>(iv) The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition: </P> <FP SOURCE="FP-1">Vitamin A, 5,000 International Units</FP> <FP SOURCE="FP-1">Vitamin C, 60 milligrams</FP> <FP SOURCE="FP-1">Calcium, 1.0 gram</FP> <FP SOURCE="FP-1">Iron, 18 milligrams</FP> <FP SOURCE="FP-1">Vitamin D, 400 International Units</FP> <FP SOURCE="FP-1">Vitamin E, 30 International Units</FP> <FP SOURCE="FP-1">Thiamin, 1.5 milligrams</FP> <FP SOURCE="FP-1">Riboflavin, 1.7 milligrams</FP> <FP SOURCE="FP-1">Niacin, 20 milligrams</FP> <FP SOURCE="FP-1">Vitamin B<E T="52">6</E>, 2.0 milligrams</FP> <FP SOURCE="FP-1">Folate, 0.4 milligram</FP> <FP SOURCE="FP-1">Vitamin B<E T="52">12</E>, 6 micrograms</FP> <FP SOURCE="FP-1">Biotin, 0.3 milligram</FP> <FP SOURCE="FP-1">Pantothenic acid, 10 milligrams</FP> <FP SOURCE="FP-1">Phosphorus, 1.0 gram</FP> <FP SOURCE="FP-1">Iodine, 150 micrograms</FP> <FP SOURCE="FP-1">Magnesium, 400 milligrams</FP> <FP SOURCE="FP-1">Zinc, 15 milligrams</FP> <FP SOURCE="FP-1">Copper, 2.0 milligrams</FP> <P>(v) The following synonyms may be added in parenthesis immediately following the name of the nutrient or dietary component: </P> <FP SOURCE="FP-1">Vitamin C—Ascorbic acid</FP> <FP SOURCE="FP-1">Thiamin—Vitamin B<E T="52">1</E> </FP> <FP SOURCE="FP-1">Riboflavin—Vitamin B<E T="52">2</E> </FP> <FP SOURCE="FP-1">Folate—Folacin</FP> <FP SOURCE="FP-1">Calories—Energy</FP> <P>(vi) A statement of the percent of vitamin A that is present as <E T="03">beta</E>-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent of Daily Value of vitamin A in the product (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as <E T="03">beta</E>-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.</P> <P>(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:</P> <GPOTABLE CDEF="s50,r50,5" COLS="3" OPTS="L2,i1"> <BOXHD> <CHED H="1">Food component</CHED> <CHED H="1">Unit of measurement</CHED> <CHED H="1">DRV</CHED> </BOXHD> <ROW> <ENT I="01">Fat</ENT> <ENT>grams (g)</ENT> <ENT>65</ENT> </ROW> <ROW> <ENT I="01">Saturated fatty acids</ENT> <ENT>do</ENT> <ENT>20</ENT> </ROW> <ROW> <ENT I="01">Cholesterol</ENT> <ENT>milligrams (mg)</ENT> <ENT>300</ENT> </ROW> <ROW> <ENT I="01">Total carbohydrate</ENT> <ENT>grams (g)</ENT> <ENT>300</ENT> </ROW> <ROW> <ENT I="01">Fiber</ENT> <ENT>do</ENT> <ENT>25</ENT> </ROW> <ROW> <ENT I="01">Sodium</ENT> <ENT>milligrams (mg)</ENT> <ENT>2,400</ENT> </ROW> <ROW> <ENT I="01">Potassium</ENT> <ENT>do</ENT> <ENT>3,500</ENT> </ROW> <ROW> <ENT I="01">Protein</ENT> <ENT>grams (g)</ENT> <ENT>50</ENT> </ROW> </GPOTABLE> <P>(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 § 317.400(c), and on products in packages <PRTPAGE P="196"/>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.</P> <P>(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.</P> <P>(ii) All information within the nutrition label shall utilize:</P> <P>(A) A single easy-to-read type style,</P> <P>(B) Upper and lower case letters,</P> <P>(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</P> <P>(D) Letters should never touch.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(3) Information on serving size shall immediately follow the heading. Such information shall include:</P> <P>(i) “Serving Size”: A statement of the serving size as specified in paragraph (b)(9) of this section.</P> <P>(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.</P> <P>(4) A subheading “Amount Per Serving” shall be separated from serving size information by a bar.</P> <P>(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).</P> <P>(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.”</P> <P>(7) Except as provided for in paragraph (g) of this section, and except as permitted by § 317.400(d)(2), nutrient information for both mandatory and any voluntary nutrients listed in paragraph <PRTPAGE P="197"/>(c) of this section that are to be declared in the nutrition label, except vitamins and minerals, shall be declared as follows:</P> <P>(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.</P> <P>(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., %).</P> <P>(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.”</P> <P>(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.</P> <P>(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.</P> <GPOTABLE CDEF="s30,r30,r30,r30" COLS="4" OPTS="L2"> <BOXHD> <CHED H="1"/> <CHED H="1">Calories:</CHED> <CHED H="1">2,000</CHED> <CHED H="1">2,500</CHED> </BOXHD> <ROW> <ENT I="01">Total fat</ENT> <ENT>Less than</ENT> <ENT>65 g</ENT> <ENT>80 g</ENT> </ROW> <ROW> <ENT I="01">Saturated fat</ENT> <ENT>Less than</ENT> <ENT>20 g</ENT> <ENT>25 g</ENT> </ROW> <ROW> <ENT I="01">Cholesterol</ENT> <ENT>Less than</ENT> <ENT>300 mg</ENT> <ENT>300 mg</ENT> </ROW> <ROW> <ENT I="01">Sodium</ENT> <ENT>Less than</ENT> <ENT>2,400 mg</ENT> <ENT>2,400 mg</ENT> </ROW> <ROW> <ENT I="01">Total carbohydrate</ENT> <ENT/> <ENT>300 g</ENT> <ENT>375 g</ENT> </ROW> <ROW> <ENT I="01">Dietary fiber</ENT> <ENT/> <ENT>25 g</ENT> <ENT>30 g</ENT> </ROW> </GPOTABLE> <P>(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.”</P> <P>(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.</P> <P>(iv) The abbreviations established in paragraph (g)(2) of this section may be used within the footnote.</P> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="198"/>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.</P> <P>(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.</P> <P>(12) The following sample label illustrates the provisions of paragraph (d) of this section:</P> <GPH DEEP="457" SPAN="2"> <PRTPAGE P="199"/> <GID>EC11SE91.013</GID> </GPH> <P>(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.</P> <P>(ii) Aggregate displays shall comply with format requirements of paragraph <PRTPAGE P="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.</P> <P>(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.</P> <P>(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:</P> <P>(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 § 317.312(b) shall be to the left of the numeric columns.</P> <P>(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.</P> <P>(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 § 317.312(b).</P> <P>(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 § 317.312(b) or as a footnote.</P> <P>(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.</P> <P>(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., <FR>1/2</FR> cup skim milk contributes an additional 40 calories, 65 mg sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).</P> <P>(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.<PRTPAGE P="201"/> </P> <P>(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.</P> <P>(5) The following sample label illustrates the provisions of paragraph (e) of this section:</P> <GPH DEEP="481" SPAN="2"> <PRTPAGE P="202"/> <GID>EC11SE91.014</GID> </GPH> <P>(f)(1) Nutrition information may be presented in a simplified format as set forth herein when any required nutrients, other than the core nutrients <PRTPAGE P="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.</P> <P>(2) The simplified format shall include information on the following nutrients:</P> <P>(i) Total calories, total fat, total carbohydrate, sodium, and protein;</P> <P>(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</P> <P>(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added in fortified or fabricated foods.</P> <P>(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.</P> <P>(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).”</P> <P>(5) Except as provided for in paragraph (g) of this section and in § 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.”</P> <P>(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 § 317.302(a) by one or more of the following means:</P> <P>(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.</P> <P>(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.”</P> <P>(2) Using any of the following abbreviations: </P> <FP SOURCE="FP-1">Serving size—Serv size</FP> <FP SOURCE="FP-1">Servings per container—Servings</FP> <FP SOURCE="FP-1">Calories from fat—Fat cal</FP> <FP SOURCE="FP-1">Calories from saturated fat—Sat fat cal</FP> <FP SOURCE="FP-1">Saturated fat—Sat fat</FP> <FP SOURCE="FP-1">Monounsaturated fat—Monounsat fat</FP> <FP SOURCE="FP-1">Polyunsaturated fat—Polyunsat fat</FP> <FP SOURCE="FP-1">Cholesterol—Cholest</FP> <FP SOURCE="FP-1">Total carbohydrate—Total carb</FP> <FP SOURCE="FP-1">Dietary fiber—Fiber</FP> <FP SOURCE="FP-1">Soluble fiber—Sol fiber</FP> <FP SOURCE="FP-1">Insoluble fiber—Insol fiber</FP> <FP SOURCE="FP-1">Sugar alcohol—Sugar alc</FP> <FP SOURCE="FP-1">Other carbohydrate—Other carb</FP> <P>(3) Omitting the footnote required in paragraph (d)(9) of this section and <PRTPAGE P="204"/>placing another asterisk at the bottom of the label followed by the statement “Percent Daily Values are based on a 2,000 calorie diet” and, if the term “Daily Value” is not spelled out in the heading, a statement that “DV” represents “Daily Value.”</P> <P>(4) Presenting the required nutrition information on any other label panel.</P> <P>(h) Compliance with this section shall be determined as follows:</P> <P>(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.</P> <P>(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 § 317.309(c), or, if no USDA, AOAC, or specified method is available and appropriate, by other reliable and appropriate analytical procedures as so determined by the Agency. The “Official Methods of Analysis” is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: <E T="03">http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.</E> </P> <P>(3) Two classes of nutrients are defined for purposes of compliance:</P> <P>(i) Class I. Added nutrients in fortified or fabricated foods; and</P> <P>(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.</P> <P>(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:</P> <P>(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.</P> <P>(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; <E T="03">Provided,</E> 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.</P> <P>(5) A product with a label declaration of calories, sugars, total fat, saturated <PRTPAGE P="205"/>fat, cholesterol, or sodium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label; <E T="03">Provided,</E> 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.</P> <P>(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.</P> <P>(7) Compliance will be based on the metric measure specified in the label statement of serving size.</P> <P>(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.</P> <P>(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.</P> <APPRO>(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088)</APPRO> <CITA>[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004]</CITA> </SECTION> <SECTION> <SECTNO>§§ 317.310-317.311</SECTNO> <RESERVED>[Reserved]</RESERVED> </SECTION> <SECTION> <SECTNO>§ 317.312</SECTNO> <SUBJECT>Reference amounts customarily consumed per eating occasion.</SUBJECT> <P>(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:</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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:</P> <P>(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;</P> <P>(ii) Serving sizes recommended in comments;</P> <P>(iii) Serving sizes used by manufacturers and grocers; and</P> <P>(iv) Serving sizes used by other countries.<PRTPAGE P="206"/> </P> <P>(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.</P> <P>(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).</P> <P>(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.</P> <P>(9) FSIS sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform Reference Amount.</P> <P>(b) The following Product Categories and Reference Amounts shall be used as the basis for determining serving sizes for specific products:</P> <GPOTABLE CDEF="s25,9" COLS="2" OPTS="L2,i1"> <TTITLE>Table 1—Reference Amounts Customarily Consumed per Eating Occasion—Infant and Toddler Foods <SU>1,2,3</SU> </TTITLE> <BOXHD> <CHED H="1">Product category</CHED> <CHED H="1">Reference amount</CHED> </BOXHD> <ROW> <ENT I="11">Infant & Toddler Foods:</ENT> </ROW> <ROW> <ENT I="02">Dinner Dry Mix</ENT> <ENT>15 g</ENT> </ROW> <ROW> <ENT I="02">Dinner, ready-to-serve, strained type</ENT> <ENT>60 g</ENT> </ROW> <ROW> <ENT I="02">Dinner, soups, ready-to-serve junior type</ENT> <ENT>110 g</ENT> </ROW> <ROW> <ENT I="02">Dinner, stew or soup ready-to-serve toddlers</ENT> <ENT>170 g</ENT> </ROW> <ROW> <ENT I="02">Plain meats and meat sticks, ready-to-serve</ENT> <ENT>55 g</ENT> </ROW> <TNOTE> <SU>1</SU> 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.</TNOTE> <TNOTE> <SU>2</SU> 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.</TNOTE> <TNOTE> <SU>3</SU> 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.</TNOTE> </GPOTABLE> <GPOTABLE CDEF="s100,xls48,xs48" COLS="3" OPTS="L2,i1"> <TTITLE>Table 2—Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply <SU>1,2,3,4,5</SU> </TTITLE> <BOXHD> <CHED H="1">Product category</CHED> <CHED H="1">Reference amount</CHED> <CHED H="2">Ready-to-serve</CHED> <CHED H="1">Reference amount</CHED> <CHED H="2">Ready-to-cook</CHED> </BOXHD> <ROW> <ENT I="01">Egg mixtures, (western style omelet, souffle, egg foo young </ENT> <ENT>110 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Lard, margarine, shortening</ENT> <ENT>1 tbsp</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Salad and potato toppers; e.g., bacon bits</ENT> <ENT>7 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds)</ENT> <ENT>15 g</ENT> <ENT>54 g=bacon. 30 g = breakfast strips.</ENT> </ROW> <ROW> <ENT I="01">Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio of less than 2:1; e.g., pepperoni</ENT> <ENT>30 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Snacks; e.g., meat snack food sticks</ENT> <ENT>30 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Luncheon meat, bologna, 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</ENT> <ENT>55 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet</ENT> <ENT>55 g</ENT> <ENT>n/a. 75 g=uncooked sausage.</ENT> </ROW> <ROW> <ENT I="01">Entrees without sauce, cuts of 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</ENT> <ENT>85 g</ENT> <ENT>114 g.</ENT> </ROW> <ROW> <ENT I="01">Canned meats, canned beef, canned pork. <SU>4</SU> </ENT> <ENT>55 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Entrees with sauce, barbecued meats in sauce</ENT> <ENT>140 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Mixed dishes NOT measurable with a cup; <SU>5</SU> e.g., burrito, egg roll, enchilada, pizza, 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</ENT> <ENT>140 g (plus 55 g for products with sauce toppings)</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Mixed dishes measurable with 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</ENT> <ENT>1 cup</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Salads—pasta or potato, potato salad with bacon, macaroni and meat salad</ENT> <ENT>140 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Salads—all other meat, salads, ham salad</ENT> <ENT>100 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Soups—all varieties</ENT> <ENT>245 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <PRTPAGE P="207"/> <ENT I="01">Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with meatballs</ENT> <ENT>125 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Minor main entree sauce; e.g., pizza sauce with meat, gravy</ENT> <ENT> <FR>1/4</FR> cup</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="01">Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat.</ENT> <ENT/> <ENT/> </ROW> <ROW> <ENT I="11">As reconstituted:</ENT> </ROW> <ROW> <ENT I="12">Amount to make one Reference Amount of the final dish; e.g.,</ENT> </ROW> <ROW> <ENT I="03">Gravy</ENT> <ENT> <FR>1/4</FR> cup</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="03">Major main entree type sauce</ENT> <ENT>125 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="03">Soup</ENT> <ENT>245 g</ENT> <ENT>n/a.</ENT> </ROW> <ROW> <ENT I="03">Entree measurable with a cup</ENT> <ENT>1 cup</ENT> <ENT>n/a.</ENT> </ROW> <TNOTE> <SU>1</SU> 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.</TNOTE> <TNOTE> <SU>2</SU> 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.</TNOTE> <TNOTE> <SU>3</SU> Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount.</TNOTE> <TNOTE> <SU>4</SU> 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.</TNOTE> <TNOTE> <SU>5</SU> Pizza sauce is part of the pizza and is not considered to be sauce topping.</TNOTE> </GPOTABLE> <P>(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:</P> <P>(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.</P> <P>(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.</P> <P>(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).</P> <P>(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:</P> <P>(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.</P> <P>(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.</P> <P>(e) The Reference Amount for an imitation or substitute product or altered product as defined in § 317.313(d), such as a “low calorie” version, shall be the <PRTPAGE P="208"/>same as for the product for which it is offered as a substitute.</P> <P>(f) The Reference Amounts set forth in paragraphs (b) through (e) of this section shall be used in determining whether a product meets the criteria for nutritional claims. If the serving size declared on the product label differs from the Reference Amount, and the product meets the criteria for the claim only on the basis of the Reference Amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the Reference Amount as it appears in paragraph (b) of this section followed, in parentheses, by the amount in common household measure if the Reference Amount is expressed in measures other than common household measures.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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: </P> <EXTRACT> <FP SOURCE="FP-DASH"/> <FP>(Date)</FP> <P>The undersigned, ______ submits this labeling application pursuant to 9 CFR 317.312 with respect to Reference Amount and/or Product Category.</P> <P>Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:</P> <P>(i) A statement of the objective of the labeling application;</P> <P>(ii) A description of the product;</P> <P>(iii) A complete sample product label including nutrition label, using the format established by regulation;</P> <P>(iv) A description of the form in which the product will be marketed;</P> <P>(v) The intended dietary uses of the product with the major use identified (e.g., ham as a luncheon meat);</P> <P>(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;<PRTPAGE P="209"/> </P> <P>(vii) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);</P> <P>(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);</P> <P>(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.</P> <P>(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.</P> <P>(A) In expressing the Reference Amount in grams, the following general rules shall be followed:</P> <P>(<E T="03">1</E>) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment.</P> <P>(<E T="03">2</E>) For quantities less than 10 grams, exact gram weights shall be used.</P> <P>(B) [Reserved]</P> <P>(xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information:</P> <P>(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.</P> <P>(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.</P> <P>(xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed.</P> <P>(A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.</P> <P>(B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.</P> <P>(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.</P> <P>(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.</P> <P>(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. </P> <FP>Yours very truly,</FP> <FP SOURCE="FP-DASH">Applicant</FP> <FP SOURCE="FP-DASH">By</FP> <FP>(Indicate authority)</FP> </EXTRACT> <P>(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.</P> <P>(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.</P> <P>(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 <PRTPAGE P="210"/>the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.</P> <P>(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.</P> <P>(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.</P> <P>(11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the <E T="04">Federal Register</E> 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.</P> <P>(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.</P> <P>(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.</P> <P>(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.</P> <P>(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 <E T="04">Federal Register</E> a final rule amending the regulations to authorize the <PRTPAGE P="211"/>use of the Reference Amount and/or Product Category.</P> <APPRO>(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088)</APPRO> <CITA>[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]</CITA> </SECTION> <SECTION> <SECTNO>§ 317.313</SECTNO> <SUBJECT>Nutrient content claims; general principles.</SUBJECT> <P>(a) This section applies to meat or meat food products that are intended for human consumption and that are offered for sale.</P> <P>(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 § 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.</P> <P>(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.”</P> <P>(2) An implied nutrient content claim is any claim that:</P> <P>(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</P> <P>(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”).</P> <P>(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.</P> <P>(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”).</P> <P>(c) Information that is required or permitted by § 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.</P> <P>(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.”</P> <P>(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”).</P> <P>(2) This disclaimer shall be in easily legible print or type and in a size no less than that required by § 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 <FR>1/16</FR>-inch minimum height, except as permitted by § 317.400(d)(2).</P> <P>(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”).</P> <P>(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, <PRTPAGE P="212"/>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”).</P> <P>(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.</P> <P>(g) Labeling information required in §§ 317.313, 317.354, 317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not otherwise specified, is required to be in letters and/or numbers no less than <FR>1/16</FR> inch in height, except as permitted by § 317.400(d)(2).</P> <P>(h) [Reserved]</P> <P>(i) Except as provided in § 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:</P> <P>(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;”</P> <P>(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 § 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 <FR>1/16</FR>-inch minimum height, except as permitted by § 317.400(d)(2);</P> <P>(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.</P> <P>(4) “Percent fat free” claims are not authorized by this paragraph. Such claims shall comply with § 317.362(b)(6).</P> <P>(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.</P> <P>(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).</P> <P>(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.</P> <P>(B) For “light,” “reduced,” and “added” claims, the reference product shall be a similar product, and</P> <P>(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.</P> <P>(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 <PRTPAGE P="213"/>substantial period of time in the same geographic area by the same business entity or by one entitled to use its trade name, provided the name of the competitor is not used on the labeling of the product. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting labeling is internally consistent (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information, and the declaration of the percentage of nutrient by which the product has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim.</P> <P>(2) For products bearing relative claims:</P> <P>(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 “<FR>1/3</FR> fewer calories than ‘reference product’ ”); and</P> <P>(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