Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt9.2.318&rgn=div5
Timestamp: 2020-02-28 19:33:46
Document Index: 681047690

Matched Legal Cases: ['art 318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', '§318', 'art 327', '§318', '§318', 'art 317', '§318', '§303', '§331', 'art 314', 'art 329', '§318', '§303', '§303', '§318', '§310', 'art 319', 'art 319', 'art 319', '§317', '§318', '§381', '§381', 'art 350', '§318', 'art 417', '§301', '§319', '§319', '§950', 'art 51', '§319', '§319', '§319', '§319', 'art 329', '§319', '§319', '§319', '§319', '§319', '§319', '§319', '§319', '§318', '§318', '§319', '§319', 'art 417', '§301', '§301', '§310', '§319']

Title 9 → Chapter III → Subchapter A → Part 318
§318.1 Products and other articles entering official establishments.
§318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.
§318.3 Designation of places of receipt of products and other articles for reinspection.
§318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.
§318.5 Requirements concerning procedures.
§318.6 Requirements concerning ingredients and other articles used in preparation of products.
§318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes.
§318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.
§318.10 [Reserved]
§318.11 [Reserved]
§318.13 Mixtures containing product but not amendable to the Act.
§318.14 Adulteration of product by polluted water; procedure for handling.
§318.15 Tagging chemicals, preservatives, cereals, spices, etc., “U.S. retained.”
§318.16 Pesticide chemicals and other residues in products.
§318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.
§318.18 Handling of certain material for mechanical processing.
§318.19 Compliance procedure for cured pork products.
§318.20 Use of animal drugs.
§318.21 [Reserved]
§318.22 Determination of added water in cooked sausages.
§318.23 Heat-processing and stabilization requirements for uncured meat patties.
§318.24 Product prepared using advanced meat/bone separation machinery; process control.
Subparts B-G [Reserved]
Source: 35 FR 15586, Oct. 3, 1970, unless otherwise noted.
(a) Except as otherwise provided in paragraphs (g) and (h) of this section or §318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with §318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under §318.3, until it has been reinspected by the inspector.
(b) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been (1) previously inspected and passed and is identified as such in accordance with the requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the regulations thereunder, and has not been prepared other than in an establishment inspected under said Act, or (2) has been inspected and passed and is identified as such in accordance with the requirements of a State law.
(c) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this part or part 317 of this subchapter, and a list of ingredients in the article if composed of two or more ingredients: Provided, That in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper.
(d) To ensure the safe use of preparations used in hog scalding water or in the denuding of tripe, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.
(e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.
(g) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in §318.12(a).
(h)(1) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of paragraph 23(a) of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of §303.1(a)(2) of this subchapter.
(2) Meat, meat byproducts, and meat food products bearing official marks showing that they were inspected and passed under State inspection in any State not designated in §331.2 of this subchapter may be received by official establishments for storage and distribution solely in intrastate commerce. The presence of such State inspected products must not create any unsanitary condition or otherwise result in adulteration of any products at the official establishment or interfere with the conduct of inspection under this subchapter. In addition, such State inspected products must be stored separately and apart from the federally inspected products in the official establishment.
(i) The operator of the official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question.
(j) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Administrator to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of this regulation. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified.
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 1984; 64 FR 72174, Dec. 23, 1999]
(a) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a Program employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in this subchapter.
(b) All products, whether fresh, cured, or otherwise prepared, even though previously inspected and passed, shall be reinspected by Program employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of the regulations in this subchapter are complied with.
(c) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The circuit supervisor shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator.1
1Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisors of Program circuits. These sampling plans are developed for individual products by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved, such as liver, oxtails, etc.
(d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the area supervisor.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]
Every official establishment shall designate, with the approval of the circuit supervisor, a dock or place at which products and other articles subject to reinspection under §318.2 shall be received, and such products and articles shall be received only at such dock or place.
(a) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by Program employees unless such preparation is conducted as a custom operation exempted from inspection under §303.1(a)(2) of this subchapter in any official establishment or consists of operations that are exempted from inspection under §303.1(d) of this subchapter and are conducted in a retail store in an establishment subject to inspection only because the State or Territory in which the establishment is located is designated under paragraph 301(c) of the Act. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.
(b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to assure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter. The effectiveness of such measures will be subject to review by the Department.
(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:
(1) A letter to the Administrator from the establishment owner of operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control system requires it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.
(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be responsible for the quality control system.
(3) A list identifying those parts and sections of the Federal meat inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the quality control system will serve to maintain compliance with the applicable regulations.
(4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters or limits which will be used, and the points at which corrective action will occur and the nature of such corrective action—ranging from least to most severe: Provided, That, subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator.
(e) Evaluation and Approval of Total Plant Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system will be approved and plans will be made for implementation under departmental supervision.
(2) In any situation where the system is found by the Administrator to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Administrator, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding.
(3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control system to assure compliance with the requirements of the Act and regulations thereunder. The Secretary shall continue to provide the Federal inspection necessary to carry out his responsibilities under the Act.
(g) Termination of Total Plant Quality Control. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator.
(2) The approval of a total plant quality control system may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:
(i) If adulterated or misbranded meat food product is found by the Administrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. In those instances where there is conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of approval shall remain in effect pending the final determination of the proceeding.
(ii) If the establishment fails to comply with the quality control system or program to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of quality control approval shall remain in effect pending the final determination of the proceeding.
(3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date.
(h)(1) Operating Schedule Under Total Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permission will be granted provided that:
(i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year.
(ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection.
(iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector.
(2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in §318.4(h)(1) have been or will be met.
(3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspection services at the discretion of the circuit supervisor and charged for such services.
(Reporting requirements were approved by the Office of Management and Budget under control number 0583-0015)
[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000; 78 FR 66837, Nov. 7, 2013]
(a)(1) Care shall be taken to assure that product is not adulterated when placed in freezers. If there is doubt as to the soundness of any frozen product, the inspector will require the defrosting and reinspection of a sufficient quantity thereof to determine its actual condition.
(2) Frozen product may be defrosted in water or pickle in a manner and with the use of facilities which are acceptable to the inspector. Before such product is defrosted, a careful examination shall be made to determine its condition. If necessary, this examination shall include defrosting of representative samples by means other than in water or pickle.
(b) Product, such as pork tenderloins, brains, sweetbreads, stew, or chop suey, shall not be packed in hermetically sealed metal or glass containers, unless subsequently heat processed or otherwise treated to preserve the product in a manner approved by the Administrator in specific cases.
(c) Care shall be taken to remove bones and parts of bones from product which is intended for chopping.
(d) Heads for use in the preparation of meat food products shall be split and the bodies of the teeth, the turbinated and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.
(e) Kidneys for use in the preparation of meat food products shall first be freely sectioned and then thoroughly soaked and washed. All detached kidneys, including beef kidneys with detached kidney fat, shall be inspected before being used in or shipped from the official establishment.
(f) Cattle paunches and hog stomachs for use in the preparation of meat food products shall be thoroughly cleaned on all surfaces and parts immediately after being emptied of their contents, which shall follow promptly their removal from the carcasses.
(g) Clotted blood shall be removed from hog hearts before they are shipped from the official establishment or used in the preparation of meat food products.
(h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog bungs, hog middles, and hog stomachs which are to be used as containers of any meat food product shall be presented for inspection, turned with the fat surface exposed.
(i) Portions of casings which show infection with Oesophagostomum or other nodule-producing parasite, and weasands infected with the larvae of Hypoderma lineatum, shall be rejected, except that when the infestation is slight and the nodules and larvae are removed, the casing or weasand may be passed.
(b)(1) The only animal casings that may be used as containers of product are those from sheep, swine, or goats. Casings from cattle may be used as containers of products. However, if casings from cattle are derived from the small intestine, the small intestine must comply with the requirements in 9 CFR 310.22(d). Establishments that use casings derived from the small intestine of cattle as containers for products must demonstrate, through documentation, that the small intestine from which the casing was derived complies with the requirements in 9 CFR 310.22(d).
(7) Blood from livestock prepared in accordance with §310.20 of this subchapter may be used as an ingredient of a meat food product for which a standard is prescribed in part 319 of this subchapter, if permitted by such standard, and may be used in any meat food product for which no such standard is prescribed in part 319 of this subchapter if it is a common and usual ingredient of such product.
(8) Intestines shall not be used as ingredients in any meat food product for which a standard is prescribed in part 319 of this subchapter and shall not be used in other products unless the products are labeled in accordance with §317.8(b)(3) of this subchapter. When small intestine from cattle is used in a meat food product or for edible rendering, it must comply with the requirements in 9 CFR 310.22(d).
(12) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of level permitted in §318.16.
(13) Use of “Mechanically Separated (Kind of Poultry),” as defined in §381.173 of this chapter, in the preparation of meat food products shall accord with §381.174 and all other applicable provisions of this subchapter.
(a) Preservatives and other substances not permitted in domestic product under the regulations in this subchapter may be used in the preparation and packing of product intended for export provided the product (1) accords to the specifications or directions of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; and (3) is labeled on the outside container to show that it is intended for export, and is otherwise labeled as required by this subchapter for such export product.
(b) The preparation and packing of export product as provided for in paragraph (a) of this section shall be done in a manner acceptable to the inspector in charge so that the identity of the export product is maintained conclusively and the preparation of domestic product is adequately protected. The preservatives and other substances not permitted in domestic product shall be stored in a room or compartment separate from areas used to store other supplies and shall be held under Program lock. Use of the preservatives or other substances shall be under the direct supervision of a Program employee.
(c) The packing of all articles under paragraph (a) of this section shall be conducted under the direct supervision of a Program employee.
(d) No article prepared or packed for export under paragraph (a) of this section shall be sold or offered for sale for domestic use or consumption, but unless exported shall be destroyed for food purposes under the direct supervision of a Program employee.
(e) The contents of the container of any article prepared or packed for export under paragraph (a) of this section shall not be removed, in whole or in part, from such container prior to exportation, except under the supervision of a Program employee. If such contents are removed prior to exportation, then the article shall be either repacked, in accordance with the provisions of paragraphs (b) and (c) of this section, or destroyed for food purposes under the direct supervision of a Program employee.
(f) Permission must be obtained from the Administrator before meats packed in borax are shipped from one official establishment to another or to an unofficial establishment for storage, except such meat prepared for the account of Federal agencies.
(g) At all times, the identity of meat to which borax has been added shall be effectively maintained. In no case shall such meat, nor any trimmings or fat derived from such meat, whether unwashed or washed, or otherwise treated, be diverted to domestic use.
(h) Salt used for bulking meat previously packed in borax may not again be used in an edible products department other than in connection with the packing of meat in borax. Only metal equipment should be used for handling such meat. Particularly effective cleansing will be required if wooden equipment such as trucks, washing vats, etc., is used. Boxes from which boraxed meat has been removed may be used for repacking meat in borax, but their use as containers for other meat will be dependent upon the effective removal of all traces of borax.
(i) The following instructions pertain to export cured pork packed in borax for the account of Federal agencies. The meat may be packed in borax in a room in which there is borax-free meat, provided proper care is taken to see that the borax-free meat is not affected by the borax. Under the same condition, meat packed in borax may be received, unpacked, defrosted, soaked, washed, smoked, and repacked in a room where there is other meat. However, meat originally packed in borax shall at all times be subject to the restrictions of meat so packed, even though repacked without borax. After packing or repacking, borax packed meat may be stored in a room with meat not packed in borax, provided a reasonable degree of separation is maintained between the two classes of product.
[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38 FR 29214, Oct. 23, 1973]
Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Program, for examination, as often as may be deemed necessary for the efficient conduct of the inspection.
Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of §318.1.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]
(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.
(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator1 shall be applied to the surface of the rooms and equipment and rinsed with potable water before use.
(c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:
(1) Separate and condemn all product in damaged or extensively rusted containers.
(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:
(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator,1 rinse in potable water, and dry thoroughly; or
1A list of approved disinfectants is available upon request to Scientific Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly.
(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.
(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers.
[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]
When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a “U.S. retained” tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.
(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act.
(b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.
(c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator.
(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards:
(1) Lethality. A 6.5-log10 reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency.
(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log10 multiplication of Clostridium perfringens within the product.
(b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in §301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule.
(c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.
[64 FR 744, Jan. 6, 1999]
Material to be processed into “Mechanically Separated (Species)” shall be so processed within 1 hour from the time it is cut or separated from carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 °F. (4 °C.) or less, or held indefinitely at 0 °F. (−18 °C.) or less. “Mechanically Separated (Species)” shall, directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 °F. (4 °C.) or less or indefinitely at 0 °F. (−18 °C.) or less.
[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]
(1) A product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in §319.104 or the chart in §319.105.
Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations.
Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations.
Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III.
Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit into Group I, Group II, or Group III shall be placed in this Group.
(3) A lot is that product from one production shift.
(4) A production rate is frequency of production, expressed in days per week.
(5) Protein fat free percentage, protein fat free content, PFF percentage, PFF content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.
(b) Normal Compliance Procedures. The Department shall collect samples of cured pork products and analyze them for their PFF content. Analyses shall be conducted in accordance with the “Official Methods of Analysis of the Association of Official Analytical Chemists §§950.46, and 928.08 (Chapter 39).1 The “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is incorporated by reference with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Each analytical result shall be recorded and evaluated to determine whether future sampling of product Groups within an official establishment shall be periodic or daily under the provisions of paragraph (b)(1) of this section, and if the affected lot and subsequent production of like product shall be U.S. retained, or administratively detained, as appropriate, as provided in paragraph (b)(2) of this section.2
1A copy of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is on file with the Director, Office of the Federal Register, and may be purchased from the Association of Official Analytical Chemists, Inc., 2200 Wilson Boulevard, Suite 400, Arlington, Virginia 22201.
2Rules for Rounding:
1. Laboratory results for percent meat protein and fat will be reported to the second decimal place (hundredths).
2. PFF and Sample Values for charting purposes will be calculated from the reported laboratory results to the second decimal place. Rounding of calculations to reach two decimal places will be done by the following rule:
All values of five-thousandths (0.005) or more will be rounded up to the next highest hundredth. All values of less than five-thousandths (0.005) will be dropped.
3. For compliance with the Absolute Minimum PFF requirements, the PFF will be rounded to the first decimal place (tenths). Rounding of calculations to reach one decimal place will be done by the following rule:
All PFF values of five-hundredths (0.05) or more will be rounded up to the next highest tenth. All PFF values of less than five-hundredths (0.05) will be dropped.
4. For product disposition (pass-fail of a minimum PFF standard for retained product) the average PFF calculation will be rounded to the first decimal place. Individual PFF Values will be calculated to the nearest hundredth as in (2) above. The average, however, will be rounded to the nearest tenth as in (3) above.
(1) Criteria to determine sampling frequency of Product Groups. For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows:
(i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirement of §319.104 or §319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.
(ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91.
(iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference.
(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value.
(v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values.
(vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than −1.40 (e.g., −1.39, −1.14, 0, 0.50, etc.) and shall be daily when the Group Value is −1.40 or less (e.g., −1.40, −1.45, −1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is −1.65 or greater (e.g., −1.63, −1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c).
(2) Criteria for U.S. retention or administrative detention of cured pork products for further analysis. Cured prok products shall be U.S. retained, or administratively detained, as appropriate, when prescribed by paragraphs (b)(2) (i) or (ii) of this section as follows:
(i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of §319.104 or §319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be U.S. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there U.S. retained. Any subsequently produced lots of like product and any lots of like product for which production dates cannot be established shall be U.S. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such U.S. retained product shall be in accordance with paragraph (c) of this section.
(ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be U.S. retained shall be as follows:
(A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of §319.104 and §319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.
(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of this section by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section to find the standardized difference.
(C) Use the lesser of 1.65 and the standardized difference as the Sample Value.
(D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be ignored in determining future Product Values.
(E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is −1.65 or less (e.g., −1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be U.S. retained and further evaluated under paragraph (c) of this section. Except for release of individual lot pursuant to paragraph (c)(1), subsequently produced lots of like product shall continue to be U.S. retained until discontinued pursuant to paragraph (c)(2) of this section.
(c) Compliance procedure during product retention. When a product lot is U.S. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section.3
3If the processor does not wish to have the product evaluated in this manner, alternate sampling plans may be used provided such plans have been formulated by the processor and approved by the Administrator prior to evaluation by the three-sample criteria, and provided the analyses specified in such plans are performed at the expense of the processor.
(1) A product lot which is U.S. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met:
(i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by §319.104 or §319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain.
(ii) The lot of the product is relabeled to conform to the provisions of §319.104 or §319.105, under the supervision of a program employee.
(iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of U.S. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section.
(2) The PFF content of three randomly selected samples from each U.S. retained lot shall be used to maintain the Product Value described in paragraph (c)(2)(ii). The manner and effect of such maintenance shall be as follows: (i) Find the average PFF content of the three samples.
(ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of §319.104 or §319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirements.
(iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference.
(iv) Use the lesser of 1.30 and the standardized difference as the Sample Value.
(v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (c)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values.
(vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a U.S. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section. Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew.
(vii) When U.S. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section.
(3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing a product from its Product Group, provided product lots are being U.S. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first U.S. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being U.S. retained, the product shall again be considered with its Group.
(e) Quality control. Cured pork products bearing on their labeling the statement “X% of Weight is Added Ingredients” shall be prepared only under a quality control system or program in accordance with §318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under §318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided in plant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect.
[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, Aug. 25, 1997]
Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein.
[50 FR 32165, Aug. 9, 1985]
(1) Cooked sausage. Cooked sausage is any product described in §319.140 and §§319.180-319.182 of this chapter.
(2) Group 1 Protein-Contributing Ingredients. Ingredients of livestock or poultry origin from muscle tissue which is skeletal or which is found in the edible organs, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing; meat byproducts; mechanically separated (species); and poultry products; except those ingredients processed by hydrolysis, extraction, concentrating or drying.
(3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup 1 protein-contributing ingredients processed by hydrolysis, extraction, concentrating, or drying, or any other ingredient which contributes protein.
(b) The amount of added water in cooked sausage is calculated by:
(1) Determining by laboratory analysis the total percentage of water contained in the cooked sausage; and
(2) Determining by laboratory analysis the total percentage of protein contained in the cooked sausage; and
(3) Calculating the percentage of protein in the cooked sausage contributed by the Group 2 protein-contributing ingredients; and
(4) Subtracting one pecent from the total percentage of protein calculated in (b)(3)); and
(5) Subtracting the remaining percentage of protein calculated in (b)(3) from the total protein content determined in (b)(2); and
(6) Calculating the percentage of indigenous water in the cooked sausage by multiplying the percentage of protein determined in (b)(5) by 4, (This amount is the percentage of water attributable to Group 1 protein-contributing ingredients and one percent of Group 2 protein-contributing ingredients in a cooked sausage.); and
(7) Subtracting the percentage of water calculated in (b)(6) from the total percentage of water determined in (b)(1). (This amount is the percentage of added water in a cooked sausage.)1
1The equation for the narrative description of the calculation for added water is as follows: AW = TW-(TP-(P-1.0))4, Where AW = Added Water, TW-Total Water Determined by Laboratory Analysis, TP = Total Protein Determined by Laboratory Analysis, P = Protein Contributed by Group 2 Protein-Contributing Ingredients, 1.0 = Percent Allowance for Group 2 Protein-Contributing Ingredients, 4 = Moisture-Protein Ratio for Cooked Sausage.
[55 FR 7299, Mar. 1, 1990]
(1) Patty. A shaped and formed, comminuted, flattened cake of meat food product.
(2) Comminuted. A processing term describing the reduction in size of pieces of meat, including chopping, flaking, grinding, or mincing, but not including chunking or sectioning.
(3) Partially-cooked patties. Meat patties that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.
(4) Char-marked patties. Meat patties that have been marked by a heat source and that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.
(b) Heat-processing procedures for fully-cooked patties. (1) Official establishments which manufacture fully-cooked patties shall use one of the following heat-processing procedures:
Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties
Minimum internal temperature at the center of each patty
Minimum holding time after required internal temperature is reached
Or centigrade
151 66.1 .68 41
152 66.7 .54 32
153 67.2 .43 26
154 67.8 .34 20
155 68.3 .27 16
156 68.9 .22 13
157 (and up) 69.4 (and up) .17 10
(2) The official establishment shall measure the holding time and temperature of at least one fully-cooked patty from each production line each hour of production to assure control of the heat process. The temperature measuring device shall be accurate within 1 degree F.
(3) Requirements for handling heating deviations. (i) If for any reason a heating deviation has occurred, the official establishment shall investigate and identify the cause; take steps to assure that the deviation will not recur; and place on file in the official establishment, available to any duly authorized FSIS program employee, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence.
(ii) In addition, in the case of a heating deviation, the official establishment may reprocess the affected product, using one of the methods in paragraph (b)(1) in this section; use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics; or relabel the affected product as a partially-cooked patty product, if it meets the stabilization requirements in paragraph (c) of this section.
(c) Stabilization. (1) Fully cooked, partially cooked, and char-marked meat patties must be produced using processes ensuring no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log10 multiplication of Clostridium perfringens, within the product.
(2) For each meat patty product produced using a stabilization process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in §301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule.
(3) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.
(4) Partially cooked patties must bear the labeling statement “Partially cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement must be adjacent to the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(5) Char-marked patties must bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement shall be adjacent to the product name, at least one-half the size of the largest letter in the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(a) General. Meat, as defined in §301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in §310.22 of this subchapter, using advances in mechanical meat/bone separation machinery (i.e., AMR systems) that, in accordance with this section, recover meat—
(c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances:
(ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g.1
1The excessive iron (ExcFe) measurement for an analyzed sample is equal to the obtained iron (Fe) result expressed in mg/100 g measured and rounded to the nearest 100th or more for that sample, minus the product of three factors: (1) The iron to protein ratio (IPR) factor associated with corresponding hand-deboned product; (2) the obtained protein (P) result (%) for that sample; and (3) a constant factor of 1.10. In formula, this can be written as: ExcFe = mFe − IPR × Protein × 1.10, where ExcFe represents the excess iron, expressed in units of mg/100 g; mFe represents the measured level of iron (Fe, mg/100 g), IPR is the iron to protein ratio for the appropriate hand-deboned product, and “Protein” is the measured level of protein rounded to the nearest 100th and expressed as a percentage of the total weight of the sample. In lieu of data demonstrating otherwise, the values of IPR to be used in the above formula are as follows: For beef products the value of IPR is equal to 0.104, except for any combination of bones that include any beef neckbone product, for which the value of 0.138 is to be used; for pork product, the IPR value is 0.052. Other IPR values can be used provided that the operator of an establishment has verified and documented the ratio of iron content to protein content in the skeletal muscle tissue attached to bones prior to their entering the AMR system, based on analyses of hand-deboned samples, and the documented value is to be substituted for the IPR value (as applicable) in the above formula with respect to product that the establishment mechanically separates from those bones.
(2) If product that may not be labeled or used as “meat” under this section meets the requirements of §319.5 of this subchapter, it may bear the name “Mechanically Separated (Species)” except as follows: