(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) Containers of preparations which enter any official establishment for use in hog scalding water or in denuding of tripe shall bear labels showing the chemical names of the preparations. In the case of any preparation containing any of the chemicals which are specifically limited by § 318.7(c)(4) as to amount permitted to be used, the labels on the containers must also show the percentage of each such chemical in the preparation and must provide dilution directions which prescribe the maximum allowable use concentration of the preparations.

(e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.

(f) [Reserved]

(g) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in § 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.

(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

(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.

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 correctiveaction—ranging from least to most severe: Provided, That, subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator.

(d) Partial Quality Control Programs. (1) Any owner or operator of an official establishment preparing meat food products who is required to have a quality control program for a product operation, or part of an operation shall make the written program and data and information generated by the program available to Program employees.

(2)(i) This quality control program shall include, as appropriate for the operation which the program concerns, detailed information on: raw material control, the critical check or control points, the nature and frequency of tests to be made, the charts and records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the limits that will be used and the points at which corrective action will be taken to prevent recurrence of a loss of control, and the nature of the corrective action—ranging from the least to the most severe.

(ii) This quality control program shall ensure that the product, operation, or part of an operation which it concerns is in control and that applicable product or label limits are being met. Process control is to be determined by generally recognized statistical process control procedures.

(e) Evaluation and Approval of Total Plant Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system will be approved and plans will be made for implementation under departmental supervision.

(2) In any situation where the system is found by the Administrator to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Administrator, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding.

(3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control system to assure compliance with the requirements of the Act and regulations thereunder. The Secretary shall continue to provide the Federal inspection necessary to carry out his responsibilities under the Act.

(f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section, may only use, as a part of any labeling, the following logo. Any labeling bearing the logo and any wording of explanation with respect to this logo shall be approved as required by parts 316 and 317 of this subchapter.

(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.

(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.

(a) All ingredients and other articles used in the preparation of any product shall be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated. Official establishments shall furnish inspectors accurate information on all procedures involved in product preparation including product composition and any changes in such procedures essential for inspectional control of the product.

(b)(1) The only animal casings that may be used as containers of product are those from cattle, sheep, swine, or goats.

(2) Casings for products shall be carefully inspected by Program employees. Only those casings which have been carefully washed and thoroughly flushed with clean water immediately before stuffing and are suitable for containers, are clean, and are passed on such inspection shall be used, except that preflushed animal casings packed in salt or salt and glycerine solution or other approved medium may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed before use.

(3) Hog and sheep casings intended for use as containers of product may be treated by soaking in or applying thereto sound, fresh pineapple juice or papain or bromelin or pancreatic extract to permit the enzymes contained in these substances to act on the casings to make them less resistant. The casings shall be handled in a clean and sanitary manner throughout and the treatment shall be followed by washing and flushing the casings with water sufficiently to effectively remove the substance used and terminate the enzymatic action.

(4) On account of the invariable presence of bone splinters, detached spinal cords shall not be used in the preparation of edible product other than for rendering where they constitute a suitable raw material.

(5) Testicles if handled as an edible product may be shipped from the official establishment as such, but they shall not be used as an ingredient of a meat food product.

(6) Tonsils shall be removed and shall not be used as ingredients of meat food products.

(7) Blood from livestock prepared in accordance with § 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.

(9) Poultry products and egg products (other than shell eggs) which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when identified as having been inspected and passed for wholesomeness by the Department under the regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to be sound and otherwise acceptable when presented for use. Poultry products and egg products (other than shell eggs) which have not been so inspected and passed for wholesomeness shall not be used in the preparation of such meat food products.

(10) Dry milk products which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when produced in a plant approved by the Department under the regulations in 7 CFR part 58, and when found to be sound and otherwise acceptable when presented for use. Dry milk products prepared in a plant not so approved shall not be used in the preparation of such meat food products.

(11) [Reserved]

(12) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of level permitted in § 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)(1) No substance may be used in the preparation of any product unless it is approved in paragraph (c)(4) of this section or elsewhere in part 318 or in part 319 of this subchapter, or by the Administrator in specific cases.

(2) Approval of new substances or new uses or new levels of use of approved substances may be granted by the Administrator if:

(i) The substance has been previously approved by the Food and Drug Administration (FDA) for use in meat or meat food products as a food additive, color additive, or as a substance generally recognized as safe and is listed in title 21 of the Code of Federal Regulations, parts 73, 74, 81, 172, 173, 179, 182 or 184.

(ii) Its use is in compliance with applicable FDA requirements; and

(iii) The Administrator has determined that:

(A) The use of the substance will not render the product in which it is used adulterated or misbranded or otherwise not in compliance with the requirements of the Act; and

(B) Its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the stated technical effect as determined in specific cases.

(3) Whenever the Administrator determines that approval of a new substance or new use or new level of use of an approved substance should be granted in accordance with paragraph (a)(2) of this section, the Administrator shall issue a final rule amending the chart of substances in paragraph (c)(4) of this section to include the additional substance or new use of the substance, and any technical effect or change in level of use of the substance.

(4) No product shall bear or contain any substance which would render it adulterated or misbranded, or which is not approved in part 318 or part 319 of this subchapter, or by the Administrator in specific cases.

(b) Requirements for the use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon. Nitrates shall not be used in curing bacon.

(1) Pumped bacon. With respect to bacon injected with curing ingredients and massaged bacon: sodium nitrite shall be used at 120 parts per million (PPM) ingoing or an equivalent amount of potassium nitrite shall be used (148 PPM ingoing); and 550 PPM of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 PPM of sodium ascorbate or sodium erythorbate.

(2) The Department shall collect samples of pumped bacon from producing plants and analyze them for the level of nitrosamines by the Thermal Energy Analyzer (TEA). In the event that a TEA analysis indicates that a confirmable level of nitrosamines might be present, additional samples shall be collected and analyzed by gas chromatography. Presumptive positive results must be confirmed by mass spectrometry before being considered positive. If, during the interval required for the Department to analyze the confirmatory samples by gas chromotography and mass spectrometry, changes are made in processing procedures which are expected to result in no confirmable levels of nitrosamines in pumped bacon produced by these new procedures, an establishment may submit samples to USDA for analysis upon prior notification and arrangements with USDA. If, however, an establishment furnishes USDA with laboratory results from testing five consecutive lots of pumped bacon producedunder the new procedures and the testing is performed by the USDA methodology and procedures, those results will be utilized in making the determination concerning the product produced under the new procedures. Should the results of these tests reveal that confirmable levels of nitorosamines are not indicated in any of the five consecutive lots, the confirmation analysis by USDA shall be terminated and the establishment shall revert to normal monitoring status. In the event the test results continue to indicate nitros-amines, however, USDA shall proceed in its confirmation analysis on the original samples taken for confirmation. If any one of the original samples collected by USDA for confirmation if found to contain confirmable levels of nitrosamines, all pumped bacon in the producing establishment and all future production will be retained. The Department shall sample and analyze such retained pumped bacon for nitrosamines on a lot by lot basis. A production lot shall be that pumped bacon produced by the establishment in any single shift. Samples from any lot of pumped bacon under retention found to contain nitrosamines at a confirmable level shall cause the lot of pumped bacon to be disposed of in a manner to assure it will not form nitrosamines when cooked. Such disposal may include incorporation of the uncooked pumped bacon as an ingredient of another meat food product provided it is processed for eating without further preparation in a manner to preclude the formation of nitrosamines. Bacon subsequently produced shall not be retained because of nitrosamines if the operator of the establishment makesadjustments in the processing of the product and laboratory results obtained by TEA analysis of samples from five consecutive normal sized lots of pumped bacon indicates that the product being produced contains no confirmable levels of nitrosamines. These tests from five consecutive normal sized lots of pumped bacon shall be conducted by the Department: Provided, however, That if the establishment furnishes the Department with the results of tests conducted under the methodology and procedures used by the Department, such test results will be utilized in making the determination concerning the nitrosamine content of the product. All tests of pumped bacon for nitrosamines under this subparagraph shall be made on pumped bacon cooked 340 °F. for 3 minutes on each side. In order to determine that no confirmable levels of nitrosamines are present in a sample tested, the testing must be performed by methodology and procedures that would detect the presence of any nitrosamines at 10 PPB.

(3) Notwithstanding the provisions of paragraph (b)(1) of this section, sodium nitrite may be used at:

(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; provided that the establishment has a partial quality control program as provided in § 318.4(d) that results in compliance with this provision, or

(ii) A predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and additional sucrose or other similar fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the growth of botulinum toxin at a level sufficient for the purpose of preventing the growth of botulinum toxin; provided that the establishment has a partial quality control program as provided in § 318.4(d) that results in compliance with this provision.

(4) The Department shall collect samples of bacon from plants producing under paragraph (b)(3) of this section and analyze them for the level of nitrosamines. Samples shall be randomly selected throughout the production of a lot. The actual sampling plans and methods of analysis that are used will result in approximately the same likelihood as under paragraph (b)(2) of this section of having a presumptive positive result when the true mean level of nitrosamines in a production lot is 10 ppb. In the event of a presumptive positive result, the plant shall become subject to the provisions of paragraph (b)(2) of this section.

(5) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring material. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or estimated skin-free green weight of the bacon bellies.

(6) Bacon made with dry curing materials. With respect to bacon made with dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.

(c) Under appropriate declaration as required in parts 316 and 317 of this subchapter, the following substances may be added to products:

(1) Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids, (corn syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other substances specified in the chart in paragraph (c)(4) of this section may be added to products under conditions, if any, specified in this part or in part 317 of this subchapter.

(2) Other harmless artificial flavorings may be added to products with the approval of the Administrator in specific cases.

(3) Coloring matter and dyes other than those specified in the chart in paragraph (c)(4) of this section may be applied to products, mixed with rendered fat, applied to natural and artificial casings, and applied to such casings enclosing products, if approved by the Administrator in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product.

(4) The substances specified in the following chart are acceptable for use in the preparation of products, provided they are used for the purposes indicated, within the limits of the amounts stated and under other conditions specified in this part and part 317 of this subchapter. In addition to the substances listed in the following chart, part 319 of this subchapter specifies other substances that are acceptable in preparing specified products.

(d) No substance may be used in or on any product if it conceals damage or inferiority or makes the product appear to be better or of greater value than it is. Therefore:

(1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat food products, such as chopped and formed steaks or patties; or in any other meat food products consisting of fresh meat (with or without seasoning), except chorizo sausage, and except other meat food products in which paprika or oleoresin paprika is permitted as an ingredient in a standard of identity or composition in part 319 of this subchapter.

(2) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of sorbic acid may not be used in cooked sausage or any other product; sulfurous acid and salts of sulfurous acid may not be used in or on any product and niacin or nicotinamide may not be used in or on fresh product; except that potassium sorbate, propylparaben (propyl p-hydroxybenzoate), calcium propionate, sodium propionate, benzoic acid, and sodium benzoate may be used in or on any product only as provided in the chart in § 318.7(c)(4) or as approved by the Administrator in specific cases.

(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.

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.

(a) When dog food, or similar uninspected article is manufactured in an edible product department, there shall be sufficient space allotted and adequate equipment provided so that the manufacture of the uninspected article in no way interferes with the handling or preparation of edible products. Where necessary to avoid adulteration of edible products, separate equipment shall be provided for the uninspected article. To assure the maintenance of sanitary conditions in the edible product departments, the operations incident to the manufacture of the uninspected article will be subject to the same sanitary requirements that apply to all operations in edible product departments. The manufacture of the uninspected article shall be limited to those hours during which the establishment operates under inspectional supervision; and there shall be no handling, other than receiving at the official establishment, of any of the product ingredient of the uninspected article, other than during the regular hours of inspection. The materials used in the manufacture of the uninspected article shall not be used so as to interfere with the inspection of edible product or the maintenance of sanitary conditions in the department or render any edible product adulterated. The meat, meat byproducts, and meat food product ingredients of the uninspected article may be admitted into any edible products department of an official establishment only if they are U.S. Inspected and Passed. Products within § 314.11 of this subchapter or parts of carcasses of kinds not permitted under the regulations in this subchapter to be prepared for human food (e.g., lungs or intestines), which are produced at any official establishment, may be brought into the inedible products department of any official establishment for use in uninspected articles under this section. The uninspected article may be stored in, and distributed from, edible product departments: Provided, That adequate facilities are furnished, there is no interference with the maintenance of sanitary conditions, and such article is properly identified.

(b) When dog food or similar uninspected article is manufactured in a part of an official establishment other than an edible product department, the area in which the article is manufactured shall be separated from edible product departments in the manner required for separation between edible product departments and inedible product departments. Sufficient space must be allotted and adequate equipment provided so that the manufacture of the uninspected article does not interfere with the proper functioning of the other operations at the establishment. Except as provided in § 314.11 of this subchapter, nothing in this paragraph shall be construed as permitting any deviation from the requirement that dead animals, condemned products, and similar materials of whatever origin, must be placed in the inedible product rendering equipment, and without undue delay. The manufacture of the uninspected article must be such as not to interfere with the maintenance of general sanitary conditions on the premises, and it shall be subject to inspectional supervision similar to that exercised over other inedible product departments. There shall be no movement of any product from an inedible product department to any edible product department. Trucks, barrels, and other equipment shall be cleaned before being returned to edible product departments from inedible product departments. Unoffensive material prepared outside edible product departments may be stored in, and distributed from, edible product departments only if packaged in clean, properly identified, sealed containers.

(c) Animal food shall be distinguished from articles of human food, so as to avoid distribution of such animal food as human food. To accomplish this, such animal food shall be labeled or otherwise identified in accordance with § 325.11(d) of this subchapter.

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.

(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 Administrator 1 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

(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.

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 and roast beef, including sectioned and formed roasts and chunked and formed roasts, and cooked corned beef shall be prepared by one of the time and temperature combinations in the following table. The stated temperature is the minimum which shall be produced and maintained in all parts of each piece of meat for at least the stated time:

(b) Cooked beef, including sectioned and formed roasts and chunked and formed roasts, and cooked corned beef shall be moist cooked throughout the process or, in the case of roast beef or corned beef to be roasted, cooked as provided in paragraph (c) of this section. The moist cooking may be accomplished by (1) placing the meat in a sealed, moisture impermeable bag, removing the excess air, and cooking, (2) completely immersing the meat, unbagged, in water throughout the entire cooking process, or (3) using a sealed oven or steam injection to raise the relative humidity above 90 percent throughout the cooking process.

(c) Roast beef or corned beef to be roasted shall be cooked by one of the following methods:

(1) Heating roasts of 10 pounds or more in an oven maintained at 250 °F (121 °C) or higher throughout the process;

(2) Heating roasts of any size to a minimum internal temperature of 145 °F (62.8 °C) in an oven maintained at any temperature if the relative humidity of the oven is maintained either by continuously introducing steam for 50 percent of the cooking time or by use of a sealed oven for over 50 percent of the cooking time, or if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour; or

(3) Heating roasts of any size in an oven maintained at any temperature that will satisfy the internal temperature and time requirements of paragraph (a) of this section if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour.

The relative humidity may be achieved by use of steam injection or by sealed ovens capable of producing and maintaining the required relative humidity.

(d)(1) Except as provided in paragraph (d)(2) of this section, establishments producing cooked beef, roast beef, or cooked corned beef shall have sufficient monitoring equipment, including recording devices, to assure that the time (within 1 minute), the temperature (within 1 °F), and relative humidity (within 5 percent) limits of these processes are being met. Data from the recording devices shall be made available to a program employee upon request.

(2) In lieu of recording devices, establishments may propose in the written procedures prescribed in paragraph (f) of this section, an alternative means of providing inspection personnel with evidence that finished product has been prepared in compliance with the humidity requirements of paragraphs (b) and (c) of this section, and the 145 °F (62.8 °C) temperature requirements of paragraph (a) of this section.

(e) Each package of finished product shall be plainly and permanently marked on the immediate container with the date of production either in code or with the calendar date.

(f) In order to assure that cooked beef, roast beef, and cooked corned beef are handled, processed, and stored under sanitary conditions, the establishment shall submit a set of written procedures through the inspector-in-charge for approval by the Regional Director. The written procedures shall include the following information:

(1) The temperature to which raw frozen product is thawed and the time required.

(2) The lot identification procedure for lots of product during processing.

(3) The storage time and temperature combinations which the establishment intends to use before cooking, the cooking time and temperature the establishment intends to use, and the time, if any, the establishment intends to wait after cooking and before cooling.

(4) If a code, instead of the calendar date, is used on the immediate container of the finished product, its meaning shall also be included.

(5) Any other critical control points in the procedures which could affect the safety of the product.

(6) In lieu of recording devices, the alternate means permitted by § 318.17(d)(2) of providing evidence to inspection personnel that the finished product will be prepared in compliance with temperature or humidity requirements.

(7) Any other alternate procedure used that is permitted in this section.

(g) The establishment shall maintain records and reports which document the time, temperature, and humidity at which any cooked beef, roast beef, or cooked corned beef is cooked and cooled at the establishment. Such records shall be kept by the establishment for 6 months or for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such records. Such records shall be made available to the inspector or any duly authorized representative of the Secretary upon request.

(h) The handling and processing of cooked beef, roast beef, and cooked corned beef before, during, and after cooking shall be such as to prevent the finished product from being adulterated. As a minimum, they shall be controled as follows:

(1) The establishment shall notify the inspector-in-charge which processing procedure will be used on each lot, including time and temperature.

(2) In order to assure uniform heat penetration and consequent adequate cooking of each piece of beef, individual pieces of raw product in any one lot shall either not vary in weight by more than 2 pounds or not vary in thickness by more than 2 inches at the thickest part. Alternate methods of assuring uniform heat penetration may be submitted in writing for approval to the Regional Director.

(3) A water-based solution that is used for injecting or immersing the meat shall be refrigerated to 50 °F (10 °C) or lower from the time it contacts the meat, and shall be filtered each time it is recirculated or reused.

(4) A nonmeat ingredient, including the water-based solution in (h)(3) above, which has contacted meat shall be discarded at the end of that day's production unless it is in continuous contact with one batch of product.

(5) Product prepared for cooking shall be entered into the cooking cycle within 2 hours of completion of precooking preparation, or be placed immediately in a cooler at a temperature of 40 °F (4.4 °C) or lower.

(6) The time and temperature requirements shall be met before any product in the lot is removed from the cooking units. Unless otherwise specified in the written procedures approved in accordance with paragraph (f) of this section, the heat source shall not be shut off until these requirements are met.

(7) Other than incidental contact caused by water currents during immersion cooking or cooling, product shall be placed so that it does not touch or overlap other products. This provision does not apply to product that is stirred or agitated to assure uniform heat transfer.

(8) Temperature sensing devices shall be so placed that they monitor product in the coldest part of the cooking unit; and when an oven temperature is required by paragraph (c) of this section, the oven temperature shall also be monitored in the coldest part of the cooking unit.

(9) If a humidity sensing device is required in an oven, it shall be placed so that it measures humidity in either the oven chamber or at the exit vent.

(10) Chilling shall begin within 90 minutes after the cooking cycle is completed.

(i) All product shall be chilled from 120 °F (48.8 °C) to 55 °F (12.7 °C) in no more than 6 hours.

(ii) Chilling shall continue and the product shall not be packed for shipment until it has reached 40 °F (4.4 °C).

(11) Any establishment that has experienced a cooking process deviation during preparation of product may either reprocess the product completely, continue the heating to 145 °F (62.8 °C), or contact the Regional Director for a review of the process schedule for adequacy and, if needed, for a cooking schedule to finish that one batch of product.

(12) An establishment that has experienced a cooling deviation after the product has been cooked shall contact the Regional Director to determine the disposition of that retained product.

(i) Cooked beef, roast beef, and cooked corned beef shall be so handled as to assure that the product is not recontaminated by direct contact with raw product. To prevent direct contamination of the cooked product, establishments shall:

(1) Physically separate areas where raw product is handled from areas where exposed cooked product is handled, using a solid impervious floor to ceiling wall; or

(2) Handle raw and exposed cooked product at different times, with a cleaning of the entire area after the raw material handling is completed and prior to the handling of cooked product in that area; or

(3) Submit a written procedure for approval through the inspector-in-charge to the Circuit Supervisor detailing the steps to be taken which would avoid recontamination of cooked product by raw product during processing.

(j) To prevent indirect contamination of cooked product:

(1) Any work surface, machine, or tool which contacts raw product shall be thoroughly cleaned and sanitized with a solution germicidally equivalent to 50 ppm chlorine before it contacts cooked product;

(2) Employees shall wash their hands and sanitize them with a solution germicidally equivalent to 50 ppm chlorine whenever they enter the heat processed product area or before preparing to handle cooked product, and as frequently as necessary during operations to avoid product contamination; and

(3) Outer garments, including aprons, smocks, and gloves, shall be especially identified as restricted for use incooked product areas only, changed at least daily, and hung in a designated location when the employee leaves the area.

(k) Cooked product shall not be stored in the same room as raw product unless it is first packaged in a sealed, water-tight container or is otherwise protected by a covering that has been approved, upon written request, by the Circuit Supervisor.

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.

(a) Definitions. For the purposes of this section:

(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.

(2) A Product Group or a Group means one of the following:

(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

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.

(a) Definitions—Accredited laboratory— A non-Federal analytical laboratory that has met the requirements for accreditation specified in this section and hence, at an establishment's discretion, may be used in lieu of an FSIS laboratory for analyzing official regulatory samples. Payment for the analysis of official samples is to be made by the establishment using the accredited laboratory.

Accreditation—Determination by FSIS that a laboratory is qualified to analyze official samples of product subject to regulations in this subchapter and part 381 of this chapter for the presence and amount of all four food chemistry analytes (protein, moisture, fat, and salt); or a determination by FSIS that a laboratory is qualified to analyze official samples of product subject to regulations in this subchapter and part 381 of this chapter for the presence and amount of one of several classes of chemical residue, in accordance with the requirements of the Accredited Laboratory Program. Accreditations are granted separately for the food chemistry analysis of official samples and for the analysis of such samples for any one of the several classes of chemical residue. A laboratory may hold more than one accreditation.

AOAC methods—Methods of chemical analysis, Chapter 39, Association of Official Analytical Chemists (AOAC), published in the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990.1 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.

Chemical residue misidentification— see “correct chemical residue identification” definition.

Coefficient of variation (CV)— The standard deviation of a distribution of analytical values multiplied by 100, and divided by the mean of those values.

Comparison Mean—The average, for a sample, of all accredited and FSIS laboratories’ average results, each of which has a large deviation measure of zero, except when only two laboratories perform the analysis, as in the case of split sample analysis by both an accredited laboratory and an FSIS laboratory. In the latter case, the comparison mean is the average of the two laboratories’ results. For food chemistry, a result for a laboratory is the obtained analytical value; for chemical residues, a result is the logarithmic transformation of the obtained analytical value.

Correct chemical residue identification—Correct identification by a laboratory of a chemical residue whose concentration, in a sample, is equal to or greater than the minimum reporting level for that residue, as determined by the median of all positive analytical values obtained by laboratories analyzing the sample. Failure of a laboratory to report the presence such a chemical residue is considered a mis-ident-i-fi-cation. In addition, reporting the presence of a residue at a level equal to or above the minimum reporting level that is not reported by 90 percent or more of all other laboratories analyzing the sample, is considered a misidentification.

CUSUM—A class of statistical procedures for assessing whether or not a process is “in control”. Each CUSUM value is constructed by accumulating incremental values obtained from observed results of the process, and then determined to either exceed or fall within acceptable limits for that process. The initial CUSUM values for each laboratory whose application for accreditation is accepted are set at zero. The four CUSUM procedures are:

(1) Positive systemic laboratory difference CUSUM (CUSUM-P)—monitors how consistently an accredited laboratory gets numerically greater results than the comparison mean;

(2) Negative systematic laboratory difference CUSUM (CUSUM-N)—monitors how consistently an accredited laboratory gets numerically smaller results than the comparison mean;

(3) Variability CUSUM (CUSUM-V)—monitors the average “total discrepancy” (i.e., the combination of the random fluctuations and systematic differences) between an accredited laboratory's results and the comparison mean;

(4) Individual large discrepancy CUSUM (CUSUM-D)—monitors the magnitude and frequency of large differences between the results of an accredited laboratory and the comparison mean.

Individual large deviation—An analytical result from a non-Federal laboratory that differs from the sample comparison mean by more than would be expected assuming normal laboratory variability.

Initial accreditation check sample—A sample prepared and sent by an FSIS laboratory to a non-Federal laboratory to ascertain if the non-Federal laboratory's analytical capability meets the standards for granting accreditation.

Interlaboratory accreditation maintenance check sample—A sample prepared and sent by FSIS to a non-Federal laboratory to assist in determining if acceptable levels of analytical capability are being maintained by the accredited laboratory.

Large deviation measure—A measure that quantifies an unacceptably large difference between a non-Federal laboratory's analytical result and the sample comparison mean.

Minimum proficiency level—The minimum concentration of a residue at which an analytical result will be used to assess a laboratory's quantification capability. This concentration is an estimate of the smallest concentration for which the average coefficient of variation (CV) for reproducibility (i.e., combined within and between laboratory variability) does not exceed 20 percent. (See Table 2)

Minimum reporting level—The number such that if any obtained analytical value equals or exceeds this number, then the residue is reported together with the obtained analytical value.

Official Sample—A sample selected by a Program employee in accordance with FSIS procedures for regulatory use.

Probation— The period commencing with official notification to an accredited laboratory that its check or split sample results no longer satisfy the performance requirements specified in this rule, and ending with official notification that accreditation is either fully restored, suspended, or revoked.

QA (quality assurance) recovery—The ratio of a laboratory's unadjusted analytical value of a check sample residue to the residue level fortified by the FSIS laboratory that prepared the sample, multiplied by 100. (See Table 2.)

QC (quality control) recovery—The ratio of a laboratory's unadjusted analytical value of a quality control standard to the fortification level of the standard, multiplied by 100. (See Table 2.)

Refusal of Accreditation—An action taken when a laboratory which is applying for accreditation is denied the accreditation.

Responsibly connected—Any individual who or entity which is a partner, officer, director, manager, or owner of 10 per centum or more of the voting stock of the applicant or recipient of accreditation or an employee in a managerial or executive capacity or any employee who conducts or supervises the chemical analysis of FSIS official samples.

Revocation of Accreditation—An action taken against a laboratory which removes its right to analyze official samples.

Split sample— An official sample divided into duplicate portions, one portion to be analyzed by an accredited laboratory (for official regulatory purposes) and the other portion by an FSIS laboratory (for comparison purposes).

Standardizing Constant—The number which is the result of a mathematical adjustment to the “standardized value.” Specifically, the number equals the square root of the expected variance of the difference between the accredited or applying laboratory's result and the comparison mean on a sample, taking into consideration the standardizing value, the correlation and number of repeated results by a laboratory on a sample, and the number of laboratories that analyzed the sample.

Standardized Difference—The quotient of the difference between a laboratory's result on a sample and the comparison mean of the sample divided by the standardizing constant.

Standardizing Value—A number representing the performance standard deviation of an individual result (see Tables 1 and 2 and footnotes to the Tables for determining exact procedures for calculation).

Suspension of Accreditation—Action taken against a laboratory which temporarily removes its right to analyze official samples. Suspension of accreditation ends when accreditation is either fully restored or revoked.

Systematic laboratory difference—A comparison of one laboratory's results with the comparison means on samples that shows, on average, a consistent relationship. A laboratory that is reporting, on average, numerically greater results than the comparison mean has a positive systematic laboratory difference and, conversely, numerically smaller results indicate a negative systematic laboratory difference.

Variability— Random fluctuations in a laboratory's processes that cause its analytical results to deviate from a true value.

Variance—The expected average of the squared differences of sample results from an expected sample mean.

(b) Laboratories accredited for analysis of protein, moisture, fat, and salt content of meat and meat products—

(1) Applying for accreditation. Application for accreditation shall be made on designated forms provided by FSIS, or otherwise in writing, by the owner or manager of a non-Federal analytical laboratory and sent to the Accredited Laboratory Program, room 516-A, Annex Building, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street SW., Washington, DC 20250-3700, and shall specify the kinds of accreditation that are wanted by the owner or manager of the laboratory. A laboratory whose accreditation has been refused or revoked may reapply for accreditation after 60 days from the effective date of that action, and must provide written documentation specifying what corrections were made.

(i) At the time that an Application for Accreditation is filed with the Accredited Laboratory Program, FSIS, and annually thereafter upon receipt of the bill issued by FSIS on the anniversary date of each accreditation, the management of a laboratory shall reimburse the program at the rate specified in 9 CFR 391.5 for the cost of each accreditation that is sought for the laboratory or that the laboratory holds.

(ii) Simultaneously with the initial application for accreditation, the management of a laboratory shall forward a check, bank draft, or money order in the amount specified in 9 CFR 391.5 made payable to the U.S. Department of Agriculture along with the completed application for the accreditation(s) sought by the laboratory. Accreditation will not be granted or continued, without further procedure, for failure to pay the accreditation fee(s). The fee(s) paid shall be nonrefundable and shall be credited to the account from which the expenses of the laboratory accreditation program are paid.

(iii) Annually on the anniversary date of each accreditation, FSIS will issue a bill in the amount specified in 9 CFR 391.5.

(iv) Bills are payable upon receipt by check, bank draft, or money order, made payable to the U.S. Department of Agriculture, and become delinquent 30 days from the date of the bill. Accreditation will be terminated without further procedure for having a delinquent account. The fee(s) paid shall be nonrefundable and shall be credited to the account from which the expenses of the Accredited Laboratory Program are paid.

(v) The accreditation of a laboratory that was accredited by FSIS on or before December 13, 1993 and was not on probation and whose accreditation on that date was not in suspension or revocation shall be continued, provided that such laboratory reapply for accreditation in accordance with the provisions of this paragraph (b)(1) by January 12, 1994 (30 days after the effective date of this section), and that the reapplication be accepted by the Agency. The CUSUM values for such laboratory will be reset at zero upon acceptance of its reapplication. The accreditation of a laboratory that is on probation shall be continued, provided that the laboratory reapply for accreditation by February 11, 1994 (60 days after the effective date of this section), that the reapplication be accepted by the Agency, and that the laboratory satisfy the terms of the probation.

(2) Criteria for obtaining accreditation. Non-Federal analytical laboratories may be accredited for the analyses of moisture, protein, fat, and salt content of meat and meat food products. Accreditation will be given only if the applying laboratory successfully satisfies the requirements presented below, for all four analytes. This accreditation authorizes official FSIS acceptance of the analytical test results provided by these laboratories on official samples. To obtain FSIS accreditation for moisture, protein, fat, and salt analyses, a non-Federal analytical laboratory must:

(i) Be supervised by a person holding, as a minimum, a bachelor's degree in either chemistry, food science, food technology, or a related field and having 1 year's experience in food chemistry, or equivalent qualifications, as determined by the Administrator.

(ii) Demonstrate acceptable levels of systematic laboratory difference, variability, and individual large deviations in the analyses of moisture, protein, fat, and salt content using AOC methods. An applying laboratory will successfully demonstrate these capabilities if its moisture, protein, fat, and salt results from a 36 check sample accreditation study each satisfy the criteria presented below.2 If the laboratory's analysis of an analyte (or analytes) from the first set of 36 check samples does not meet the criteria for obtaining accreditation, a second set of 36 check samples will be provided within 30 days following the date of receipt by FSIS of a request from the applying laboratory. The second set of samples shall be analyzed for only the analyte(s) for which unacceptable initial results had been obtained by the laboratory. If the results of the second set of samples do not meet the accreditation criteria, the laboratory may reapply after a 60-day waiting period, commencing from the date of refusal of accreditation by FSIS. At that time, a new application, all fees, and all documentation of corrective action required for accreditation must be submitted.

(A) Systematic laboratory difference: The absolute value of the average standardized difference must not exceed 0.73 minus the product of 0.17 and the standard deviation of the standardized differences.

(B) Variability: The estimated standard deviation of the standardized differences must not exceed 1.15.

(C) Individual large deviations: One hundred times the average of the large deviation measures of the individual samples must be less than 5.0.3

(iii) Allow inspection of the laboratory by FSIS officials prior to the determination of granting accredited status.

(iv) Pay the accreditation fee by the date required.

(3) Criteria for maintaining accreditation. To maintain accreditation for moisture, protein, fat, and salt analyses, a non-Federal analytical laboratory must:

(i) Report analytical results of the moisture, protein, fat, and salt content of official samples, weekly, on designated forms to the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA 30604, or to the address designated by the Quality Systems Branch, FSIS Chemistry Division.

(ii) Maintain laboratory quality control records for the most recent 3 years that samples have been analyzed under this Program.

(iii) Maintain complete records of the receipt, analysis, and disposition of official samples for the most recent 3 years that samples have been analyzed under this Program.

(iv) Maintain a standards book, which is a permanently bound book with sequentially numbered pages, containing all readings and calculations for standardization of solutions, determination of recoveries, and calibration of instruments. All entries are to be dated and signed by the analyst immediately upon completion of the entry and by his/her supervisor within 2 working days. The standards book is to be retained for a period of 3 years after the last entry is made.

(v) Analyze interlaboratory accreditation maintenance check samples and return the results to FSIS within 3 weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS.

(vi) Inform the Accredited Laboratory Program, room 516-A, Annex Building, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, by certified or registered mail, within 30 days, when there is any change in the laboratory's ownership, officers, directors, supervisory personnel, or other responsibly connected individual or entity.

(vii) Permit any duly authorized representative of the Secretary to perform both announced and unannounced on-site laboratory reviews of facilities and records during normal business hours, and to copy any records pertaining to the laboratory's participation in the Accredited Laboratory Program.

(viii) Use official AOAC methods 4 on official and check samples. 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.

(ix) Demonstrate that acceptable limits of systematic laboratory difference, variability, and individual large deviations are being maintained in the analyses of moisture, protein, fat, and salt content. An accredited laboratory will successfully demonstrate the maintenance of these capabilities if its moisture, protein, fat, and salt results from interlaboratory accreditation maintenance check samples and/or split samples satisfy the criteria presented below.5

(A) Systematic laboratory difference:

(1) Positive systematic laboratory difference: The standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-P. This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-P value. The new CUSUM-P value is obtained by adding algebraically, the CUSUM increment to the last previously computed CUSUM-P value. If this computation yields a value smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values are initialized at zero; that is, the CUSUM-P value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not exceed 5.2.

(2) Negative systematic laboratory difference: The standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-N. This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-N value. The new CUSUM-N value is obtained by subtracting, algebraically, the CUSUM increment to the last previously computed CUSUM-N value. If this computation yields a value smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values are initialized at zero; that is, the CUSUM-N value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not exceed 5.2.

(B) Variability: The absolute value of the standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split sample or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-V. This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the larger of −0.4 and the absolute value of the standardized difference minus 0.9. If this computation yields a value larger than 1.6, the increment is set equal to 1.6.

(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-V value. If this computation yields a value less than 0, the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized at zero; that is, the CUSUM-V value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not exceed 4.3.

(C) Large deviations: The large deviation measure of the accredited laboratory's result for each split sample or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-D.6 This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the value of the large deviation measure minus 0.025.

(2) Compute the new CUSUM-D value. The new CUSUM-D value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-D value. If this computation yields a value less that 0, the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized at zero; that is, the CUSUM-D value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not exceed 1.0.

(x) Meet the following requirements if placed on probation pursuant to paragraph (e) of this section:

(A) Send all official samples that have not been analyzed as of the date of written notification of probation to a specified FSIS laboratory by certified mail or private carrier or, as an alternative, to an accredited laboratory approved for food chemistry. Mailing expenses will be paid by FSIS.

(B) Analyze a set of check samples similar to those used for initial accreditation, and submit the analytical results to FSIS within 3 weeks of receipt of the samples.

(C) Satisfy criteria for check samples specified in paragraphs (b)(2)(ii) (A), (B), and (C) of this section.

(xi) Expeditiously report analytical results of official samples to the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA 30604, or to the address designated by the Quality Systems Branch, FSIS Chemistry Division. The Federal inspector at any establishment may assign the analysis of official samples to an FSIS laboratory if, in the inspector's judgment, there are delays in receiving test results on official samples from an accredited laboratory.

(xii) Pay the required accreditation fee when it is due.

(c) Laboratories accredited for analysis of a class of chemical residues in meat and meat food products.

(1) Applying for accreditation. Application for accreditation shall be made on designated forms provided by FSIS, or otherwise in writing, by the owner or manager of the non-Federal analytical laboratory and sent to the Accredited Laboratory Program, room 516-A, Annex Building, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, and shall specify the kinds of accreditation that are wanted by the owner or manager of the laboratory. A laboratory whose accreditation has been refused or revoked may reapply for accreditation after 60 days from the effective date of that action, and must provide written documentation specifying what corrections were made.

(i) At the time that an Application for Accreditation is filed with the Accredited Laboratory Program, FSIS, and annually thereafter upon receipt of the bill issued by FSIS on the anniversary date of each accreditation, the management of a laboratory shall reimburse the program at the rate specified in 9 CFR 391.5 for the cost of each accreditation that is sought for the laboratory or that the laboratory holds.

(ii) Simultaneously with the initial application for accreditation, the management of a laboratory shall forward a check, bank draft, or money order in the amount specified in 9 CFR 391.5 made payable to the U.S. Department of Agriculture along with the completed application for the accreditation(s) sought for the laboratory. Accreditation will not be granted or continued, without further procedure, for failure to pay the accreditation fee(s). The fee(s) paid shall be nonrefundable and shall be credited to the account from which the expenses of the laboratory accreditation program are paid.

(iii) Annually on the anniversary date of each accreditation, FSIS will issue a bill in the amount specified in 9 CFR 391.5.

(iv) Bills are payable upon receipt by check, bank draft, or money order, made payable to the U.S. Department of Agriculture, and become delinquent 30 days from the date of the bill. Accreditation will be terminated without further procedure for having a delinquent account. The fee(s) paid shall be nonrefundable and shall be credited to the account from which the expenses of the Accredited Laboratory Program are paid.

(v) The accreditation of a laboratory that was accredited by FSIS on or before December 13, 1993 and was not on probation and whose accreditation on that date was not in suspension or revocation shall be continued, provided that such laboratory reapply for accreditation in accordance with the provisions of this paragraph (c)(1), by January 12, 1994 (30 days of the effective date of this section), and that the reapplication be accepted by the Agency. The CUSUM values for such laboratory will be reset at zero upon acceptance of its reapplication. The accreditation of a laboratory that is on probation shall be continued, provided that such laboratory reapply for accreditation by February 11, 1994 (60 days of the effective date of this section), that the reapplication be accepted by the Agency, and that the laboratory satisfy the terms of the probation.

(2) Criteria for obtaining accreditation. Non-Federal analytical laboratories may be accredited for the analysis of a class of chemical residues in meat and meat food products. Accreditation will be given only if the applying laboratory successfully satisfies the requirements presented below. This accreditation authorizes official FSIS acceptance of the analytical test results provided by these laboratories on official samples. To obtain FSIS accreditation for the analysis of a class of chemical residues, a non-Federal analytical laboratory must:

(i) Be supervised by a person holding, as a minimum, a bachelor's degree in either chemistry, food science, food technology, or a related field. Further, either the supervisor or the analyst assigned to analyze the sample must have 3 years’ experience determining analytes at or below part per million levels, or equivalent qualifications, as determined by the Administrator.

(ii) Demonstrate acceptable limits of systematic laboratory difference, variability, individual large deviations, recoveries, and proper identification in the analysis of the class of chemical residues for which application was made, using FSIS approved procedures. An applying laboratory will successfully demonstrate these capabilities if its analytical results for each specific chemical residue provided in a check sample accreditation study containing a minimum of 14 samples satisfy the criteria presented in this paragraph (c)(2)(ii).7 In addition, if the laboratory is requesting accreditation for the analysis of chlorinated hydrocarbons, all analytical results for the residue class must collectively satisfy the criteria. [Conformance to criteria (c)(2)(ii) (A), (B), (C), (D), (E), and (F) will only be determined when six or more analytical results with associated comparison means at or above the logarithm of the minimum proficiency level are available.] If the results of the first set of check samples do not meet these criteria for obtaining accreditation, a second set of at least 14 samples will be provided within 30 days following the date of receipt by FSIS of a request from the applying laboratory. If the results of the second set of samples do not meet accreditation criteria, the laboratory may reapply after a 60-day waiting period, commencing from the date of refusal of accreditation by FSIS. At that time, a new application, all fees, and all documentation of corrective action required for accreditation must be submitted.

(A) Systematic laboratory difference: The absolute value of the average standardized difference must not exceed 1.67 (2.00 if there are less than 12 analytical results) minus the product of 0.29 and the standard deviation of the standardized differences.

(B) Variability: The standard deviation of the standardized differences must not exceed a computed limit. This limit is a function of the number of analytical results used in the computation of the standard deviation, and of the amount of variability associated with the results from the participating FSIS laboratories.

(C) Individual large deviations: One hundred times the average of the large deviation measures of the individual analytical results must be less than 5.0.8

(D) QA recovery: The average of the QA recoveries of the individual analytical results must lie within the range given in Table 2 under the column entitled “Percent Expected Recovery.”

(E) QC recovery: All QC recoveries must lie within the range given in Table 2 under “Percent Expected Recovery.” Supporting documentation must be made available to FSIS upon request.

(F) Correct identification: There must be correct identification of all chemical residues in all samples.

(iii) Allow inspection of the laboratory by FSIS officials prior to the determination of granting accredited status.

(iv) Pay the accreditation fee by the date required.

(3) Criteria for maintaining accreditation. To maintain accreditation for analysis of a class of chemical residues, a non-Federal analytical laboratory must:

(i)[Reserved]

(ii) Maintain laboratory quality control records for the most recent 3 years that samples have been analyzed under this Program.

(iii) Maintain complete records of the receipt, analysis, and disposition of official samples for the most recent 3 years that samples have been analyzed under the Program.

(iv) Maintain a standards book, which is a permanently bound book with sequentially numbered pages, containing all readings and calculations for standardization of solutions, determination of recoveries, and calibration of instruments. All entries are to be dated and signed by the analyst immediately upon completion of the entry and by his/her supervisor within 2 working days. The standards book is to be retained for a period of 3 years after the last entry is made.

(v) Analyze interlaboratory accreditation maintenance check samples and return the results to FSIS within 3 weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS.

(vi) Inform the Accredited Laboratory Program, room 516-A, Annex Building, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, by certified or registered mail, within 30 days of any change in the laboratory's ownership, officers, directors, supervisory personnel, or any other responsibly connected individual or entity.

(vii) Permit any duly authorized representative of the Secretary to perform both announced and unannounced on-site laboratory reviews of facilities and records during normal business hours, and to copy any records pertaining to the laboratory's participation in the Accredited Laboratory Program.

(viii) Use analytical procedures designated and approved by FSIS.

(ix) Demonstrate that acceptable limits of systematic laboratory difference, variability, and individual large deviations are being maintained in the analysis of samples, in the chemical residue class for which accreditation was granted. A laboratory will successfully demonstrate the maintenance of these capabilities if its analytical results for each specific chemical residue found in interlaboratory accreditation maintenance check samples and/or split samples satisfy the criteria presented in this paragraph (c)(3)(ix).9,10 In addition, if the laboratory is accredited for the analysis of chlorinated hydrocarbons, all analytical results for the residue class must collectively satisfy the criteria.

(A) Systematic laboratory difference:

(1) Positive systematic laboratory difference: The standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split and/or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-P.11 This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-P value. The new CUSUM-P value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-P value. If this computation yields a value smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values are initialized at zero; that is, the CUSUM-P value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not exceed 4.8.

(2) Negative systematic laboratory difference: The standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split and/or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-N.12 This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-N value. The new CUSUM-N value is obtained by subtracting, algebraically, the CUSUM increment to the last previously computed CUSUM-N value. If this computation yields a value smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values are initialized at zero; that is, the CUSUM-N value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not exceed 4.8.

(B) Variability: The absolute value of the standardized difference between the accredited laboratory's result and that of the FSIS laboratory for each split and/or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-V.13 This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the larger of −0.4 and the absolute value of the standardized difference minus 0.9. If this computation yields a value larger than 1.6, the increment is set equal to 1.6.

(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-V value. If this computation yields a value less than 0, the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized at zero; that is, the CUSUM-V value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not exceed 4.3.

(C) Large Deviations: The large deviation measure of the accredited laboratory's result for each split and/or interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-D.14 This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the large deviation measure minus 0.025.

(2) Compute the new CUSUM-D value. The new CUSUM-D is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-D value. If this computation yields a value less than 0, the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized at zero; that is, the CUSUM-D value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not exceed 1.0.

(x) Meet the following requirements if placed on probation pursuant to paragraph (e) of this section:

(A) Send all official samples that have not been analyzed as of the date of written notification of probation to a specified FSIS laboratory by certified mail or private carrier or, as an alternative, to an accredited laboratory accredited for this specific chemical residue. Mailing expense will be paid by FSIS.

(B) Analyze a set of check samples similar to those used for initial accreditation, and submit analytical results to FSIS within 3 weeks of receipt of the samples.

(C) Satisfy criteria for check samples as specified in paragraphs (c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section.

(xi) Expeditiously report analytical results of official samples to the Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA 30604, or to the address designated by the Quality Systems Branch, FSIS Chemistry Division. The Federal inspector at any establishment may assign the analysis of official samples to an FSIS laboratory if, in the judgment of the inspector, there are delays in receiving test results on official samples from an accredited laboratory.

(xii) Every QC recovery associated with reporting of official samples must be within the appropriate range given in Table 2 under “Percent Expected Recovery.” Supporting documentation must be made available to FSIS upon request.

(xiii) Demonstrate that acceptable levels of systematic laboratory difference, variability, individual large deviations, recoveries, and proper identification are being maintained in the analysis of interlaboratory accreditation maintenance check samples, in the chemical residue class for which accreditation was granted. A laboratory will successfully demonstrate the maintenance of these capabilities if its analytical results for each specific chemical residue found in interlaboratory accreditation maintenance check samples satisfy the criteria presented below. In addition, if the laboratory is accredited for the analysis of chlorinated hydrocarbons, all analytical results for the residue class must collectively satisfy the criteria.

(A) Systematic laboratory difference—(1) Positive systematic laboratory difference: The standardized difference between the accredited laboratory's result and the comparison mean for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-P.15 This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-P value. The new CUSUM-P value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-P value. If this computation yields a value smaller than 0, the new CUSUM-P value is set equal to 0. [CUSUM-P values are initialized at zero; that is, the CUSUM-P value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not exceed 4.8.

(2) Negative systematic laboratory difference: The standardized difference between the accredited laboratory's result and the comparison mean for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-N.16 This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to:

(ii) Compute the new CUSUM-N value. The new CUSUM-N value is obtained by subtracting, algebraically, the CUSUM increment to the last previously computed CUSUM-N value. If this computation yields a value smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values are initialized at zero; that is, the CUSUM-N value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new CUSUM-N value. The new CUSUM-N value must not exceed 4.8.

(B) Variability: The absolute value of the standardized difference between the accredited laboratory's result and the comparison mean for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-V.17 This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the larger of −0.4 or the absolute value of the standardized difference minus 0.9. If this computation yields a value larger than 1.6, the increment is set equal to 1.6.

(2) Compute the new CUSUM-V value. The new CUSUM-V value is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-V value. If this computation yields a value less than 0, the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized at zero; that is, the CUSUM-V value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not exceed 4.3.

(C) Large deviations: The large deviation measure of the accredited laboratory's result for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-D.18 This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM increment is set equal to the value of the large deviation measure minus 0.025.

(2) Compute the new CUSUM-D value. The new CUSUM-D is obtained by adding, algebraically, the CUSUM increment to the last previously computed CUSUM-D value. If this computation yields a value less than 0, the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized at zero; that is, the CUSUM-D value associated with the first sample is set equal to the CUSUM increment for that sample.]

(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not exceed 1.0.

(D) Each QC Recovery is within the range given in Table 2 under “Percent Expected Recovery”. Supporting documentation must be made available to FSIS upon request.

(E) Not more than 1 residue misidentification in any 2 consecutive check samples.

(F) Not more than 2 residue misidentifications in any 8 consecutive check samples.

(xiv) Pay the accreditation fee when it is due.

(d) Refusal of accreditation. Upon a determination by the Administrator, a laboratory shall be refused accreditation for the following reasons:

(1) A laboratory shall be refused accreditation for moisture, protein, fat, and salt analysis for failure to meet the requirements of paragraph (b)(1) or (b)(2) of this section.

(2) A laboratory shall be refused accreditation for chemical residue analysis for failure to meet the requirements of paragraph (c)(1) or (c)(2) of this section.

(3) A laboratory shall be refused subsequent accreditation for failure to return to an FSIS laboratory, by certified mail or private carrier, all official samples which have not been analyzed as of the notification of a loss of accreditation.

(4) A laboratory shall be refused accreditation if the applicant or any individual or entity responsibly connected with the applicant has been convicted of or is under indictment or if charges on an information have been brought against the applicant or responsibly connected individual or entity in any Federal or State court concerning the following violations of law:

(i) Any felony.

(ii) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.

(iii) Any misdemeanor based upon a false statement to any governmental agency.

(iv) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.

(e) Probation of accreditation. Upon a determination by the Administrator, a laboratory shall be placed on probation for the following reasons:

(1) If the laboratory fails to complete more than one interlaboratory accreditation maintenance check sample analysis within 12 consecutive months as required by paragraphs (b)(3)(v) and (c)(3)(v) of this section.

(2) If the laboratory fails to meet any of the criteria set forth in paragraphs (b)(3)(v) and ((b)(3)(ix) and (c)(3)(v) and (c)(3)(ix) of this section.

(f) Suspension of accreditation. The accreditation of a laboratory shall be suspended if the laboratory or any individual or entity responsibly connected with the laboratory is indicted or if charges on an information have been brought against the laboratory or responsibly connected individual or entity in any Federal or State court concerning any of the following violations of law:

(1) Any felony.

(2) Any misdemeanor based upon acquiring, handling or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.

(3) Any misdemeanor based upon a false statement to any governmental agency.

(4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.

(g) Revocation of accreditation. The accreditation of a laboratory shall be revoked for the following reasons:

(1) An accredited laboratory which is accredited to perform analysis under paragraph (b) of this section shall have its accreditation revoked for failure to meet any of the requirements of paragraph (b)(3) of this section except for the following circumstances. If the accredited laboratory fails to meet the criteria for reporting the analytical results on interlaboratory accreditation maintenance check samples as set forth in paragraph (b)(3)(v) of this section or if, at any time, the CUSUM results from the analysis of such interlaboratory accreditation maintenance check samples and/or split samples have not satisfied the criteria specified in paragraph (b)(3)(ix) of this section and there have been, during the previous 12 months, no other occasions on which such CUSUM results have not satisfied such criteria, the laboratory shall be placed on probation; but if there have been such other occasions during those 12 months, the laboratory's accreditation will be revoked.

(2) An accredited laboratory which is accredited to perform analysis for a class of chemical residues under paragraph (c) of this section shall have the accreditation to perform this analysis revoked if it fails to meet any of the requirements in paragraph (c)(3) of this section except for the following circumstances. If the accredited laboratory fails to meet any of the criteria set forth in paragraphs (c)(3)(v), (c)(3)(ix), and (c)(3)(xiii) of this section and it has not so failed during the 12 months preceding its failure to meet the criteria, it shall be placed on probation, but if it has so failed at any time during those 12 months, its accreditation will be revoked.

(3) An accredited laboratory shall have its accreditation revoked if the Administrator determines that the laboratory or any responsibly connected individual or any agent or employee has:

(i) Altered any official sample or analytical finding, or,

(ii) Substituted any analytical result from any other laboratory for its own.

(4) An accredited laboratory shall have its accreditation revoked if the laboratory or any individual or entity responsibly connected with the laboratory is convicted in a Federal or State court of any of the following violations of law:

(i) Any felony.

(ii) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.

(iii) Any misdemeanor based upon a false statement to any governmental agency.

(iv) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.

(h) Notification and hearings. Accreditation of any laboratory shall be refused, suspended, or revoked under the conditions previously described herein. The owner or operator of the laboratory shall be sent written notice of the refusal, suspension, or revocation of accreditation by the Administrator. In such cases, the laboratory owner or operator will be provided an opportunity to present, within 30 days of the date of the notification, a statement challenging the merits or validity of such action and to request an oral hearing with respect to the denial, suspension, or revocation decision. An oral hearing shall be granted if there is any dispute of material fact joined in such responsive statement. The proceeding shall thereafter be conducted in accordance with the applicable rules of practice which shall be adopted for the proceeding. Any such refusal, suspension, or revocation shall be effective upon the receipt by the laboratory of the notification and shall continue in effect until final determination of the matter by the Administrator.

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

(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

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

(1) 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.

(2) Heat-processed. Treatment by a heat source, including, but not limited to, frying, broiling, baking, or roasting, which results in a fully-cooked, partially-cooked, or char-marked product.

(3) Patty. A shaped and formed, comminuted, flattened cake of meat food product.

(b) Processing procedures for heat-processed patties. Fully-cooked, partially-cooked, or char-marked patties shall be processed as follows:

(1) Heat processing. (i) Official establishments which manufacture fully-cooked patties shall utilize one of the heat-processing procedures in Table A of this paragraph:

(ii) Official establishments which manufacture partially-cooked patties shall raise the internal temperature at the center of each patty to a minimum internal temperature of 140 °F. and then cool it to a maximum internal temperature of 40 °F within 2 hours.

(iii) Official establishments which manufacture char-marked patties (if marked by a heat source) may raise the temperature at the center of each patty, but not above 70 °F, when the char-marks are applied to the patty. The process of char-marking the patty and cooling the patty to a maximum internal temperature of 40 °F shall be completed within 2 hours or less.

(iv) The official establishment shall measure the holding time and temperature of at least one heat-processed 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 °F.

(2) Cooling. (i) Fully-cooked patties shall be cooled to an internal temperature of 40 °F or below within 2 hours after heat-processing.

(ii) Cooling requirements for partially-cooked and char-marked patties are combined with those for heat-processing and are contained in paragraph (b)(1)(ii) and (iii) of this section.

(iii) The internal temperature measuring device shall be accurate within 1 °F.

(3) Cooking instruction label requirement. (i) Partially-cooked patties shall bear the labeling statement “Partially-cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 °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.

(ii) Char-marked patties. Product shall bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 °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.

(4) Sanitary handling and storage practices. Fully-cooked patties shall be handled in accordance with the following provisions so as to assure that the patties are not recontaminated.

(i) To prevent direct contamination of fully-cooked patties, official establishments shall:

(A) Physically separate areas where unpackaged, fully-cooked patties are handled from areas where less-than-fully-cooked products are handled using a solid impervious floor to ceiling wall; or

(B) Handle unpackaged, fully-cooked patties and less-than-fully-cooked product at different times, and cleaning the entire area after handling other products before handling unpackaged, fully-cooked patties; or

(C) Submit a written procedure through the inspector-in-charge to the Regional Director detailing the steps to be taken which would avoid recontamination of fully-cooked patties by less-than-fully-cooked cooked product during processing.

(ii) To prevent indirect contamination of fully-cooked patties:

(A) Any work surface, machine, or tool which contacts other product shall be cleaned and sanitized before it contacts unpackaged fully-cooked patties. The sanitizer shall be germicidally equivalent to 50 ppm chlorine.

(B) Employees shall wash their hands with soap and water and sanitize their hands whenever they enter the fully-cooked patty area or before handling unpackaged, fully-cooked patties. They must also wash and sanitize their hands whenever they become contaminated during operations to avoid contamination of fully-cooked patties. The sanitizer shall be germicidally equivalent to 50 ppm chlorine.

(C) All employee outer garments, including aprons, smocks, and gloves shall be identified as restricted for use in the fully-cooked area only. The employee shall change garments at least daily. The garments shall be hung in a designated location before the employee leaves the area.

(iii) Fully-cooked patties stored in the same room with other product, shall first be packaged or covered to prevent microbial contamination.

(iv) Fully-cooked, partially-cooked, and char-marked patties shall be stored at a chamber temperature of 40 °F or below.

(c) Requirements for handling heating or cooling deviations. (1) If for any reason a heating or cooling 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 representative of the Secretary, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence; and

(2) In addition, in the case of a heating deviation, the official establishment may (i) reprocess the affected product, by a method in paragraph (b)(1)(i) in this section, or (ii) use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1)(i) 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 (iii) relabel the affected product as a partially-cooked patty product, if it meets the partially-cooked requirements in paragraph (b)(1)(ii) of this section.

(3) In addition, in the case of a cooling deviation, contact the Regional Director to determine the disposition of the product.

(a) The product resulting from the separating process shall not have a calcium content exceeding 0.15 percent or 150 mg/100 gm of product within a tolerance of 0.03 percent or 30 mg, as prescribed in § 301.2(rr)(2) of this subchapter.

(b) To verify the calcium content in meat derived from advanced meat/bone separation machinery and recovery systems, a compliance program consisting of the following parameters shall be followed by manufacturers of meat defined in § 301.2(rr)(2) of this subchapter.

(1) An analysis of a sample of at least 1 pound from each lot shall be performed by the operator of the establishment or his or her agent. For purposes of this paragraph, a lot shall consist of the meat derived from advanced meat/bone separation machinery and recovery systems, designated as such by the operator of the establishment or his or her agent, from the product produced from a single species of livestock in no more than one continuous shift of up to 12 hours. Individual results from the chemical analyses shall be compared to the calcium limit, prescribed in paragraph (a) of this section, in order to demonstrate compliance. If compliance is not demonstrated, that is, if any single analytical result is more than 0.18 percent,1 2 before product from a production lot that is still at the establishment or one that is subsequently produced can be considered to be in compliance, at least three samples from that production lot shall be taken and analyzed for calcium, either separately, or, at the option of the establishment, as a composite (i.e., combining the three samples for analysis). The average of the results or the composite result must be less than or equal to 0.15 percent. Taking three samples from each subsequently produced lot and analyzing them in order to demonstrate compliance shall continue until five consecutive lots have mean or composite results less than or equal to 0.15 percent. If the statistical evidence indicates that a production lot is not in compliance with the calcium limit, as prescribed in § 301.2(rr)(2) of this subchapter, the lot must be labeled as MS(S) and meet all of the requirements for MS(S) in § 319.5 of this subchapter.

(2) The management of the establishment must maintain records to support the validity of the calcium content (as a measure of bone solids) to assure the process is in control. Such records shall be made available to the inspector or any other duly authorized representative of the Agency upon request. (Recordkeeping requirements were approved by the Office of Management and Budget under control number 0583-0095.)

(a) Abnormal container. A container with any sign of swelling or product leakage or any evidence that the contents of the unopened container may be spoiled.

(b) Acidified low acid product. A canned product which has been formulated or treated so that every component of the finished product has a pH of 4.6 or lower within 24 hours after the completion of the thermal process unless data are available from the establishment's processing authority demonstrating that a longer time period is safe.

(c) Bleeders. Small orifices on a retort through which steam, other gasses, and condensate are emitted from the retort throughout the entire thermal process.

(d) Canned product. A meat food product with a water activity above 0.85 which receives a thermal process either before or after being packed in a hermetically sealed container. Unless otherwise specified, the term “product” as used in this subpart G shall mean “canned product.”

(e) Closure technician. The individual(s) identified by the establishment as being trained to perform specific container integrity examinations as required by this subpart and designated by the establishment to perform such examinations.

(f) Code lot. All production of a particular product in a specific size container marked with a specific container code.

(g) Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heating medium into a closed retort and the start of process timing.

(h) Critical factor. Any characteristic, condition or aspect of a product, container, or procedure that affects the adequacy of the process schedule. Critical factors are established by processing authorities.

(i) Headspace. That portion of a container not occupied by the product.

(1) Gross headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (i.e., the flange of an unsealed can, the top of the double seam on a sealed can, or the top edge of an unsealed jar).

(2) Net headspace. The vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the inside surface of the lid.

(j) Hermetically sealed containers. Air-tight containers which are designed and intended to protect the contents against the entry of microorganisms during and after thermal processing.

(1) Rigid container. A container, the shape or contour of which, when filled and sealed, is neither affected by the enclosed product nor deformed by external mechanical pressure of up to 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(2) Semirigid container. A container, the shape or contour of which, when filled and sealed, is not significantly affected by the enclosed product under normal atmospheric temperature and pressure, but can be deformed by external mechanical pressure of less than 10 pounds per square inch gauge (0.7 kg/cm2) (i.e., normal firm finger pressure).

(3) Flexible container. A container, the shape or contour of which, when filled and sealed, is significantly affected by the enclosed product.

(k) Incubation tests. Tests in which the thermally processed product is kept at a specific temperature for a specified period of time in order to determine if outgrowth of microorganisms occurs.

(l) Initial temperature. The temperature, determined at the initiation of a thermal process cycle, of the contents of the coldest container to be processed.

(m) Low acid product. A canned product in which any component has a pH value above 4.6.

(n) Process schedule. The thermal process and any specified critical factors for a given canned product required to achieve shelf stability.

(o) Process temperature. The minimum temperature(s) of the heating medium to be maintained as specified in the process schedule.

(p) Process time. The intended time(s) a container is to be exposed to the heating medium while the heating medium is at or above the process temperature(s).

(q) Processing authority. The person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions as indicated in this subpart.

(r) Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program (see § 301.2(f)).

(s) Retort. A pressure vessel designed for thermal processing of product packed in hermetically sealed containers.

(t) Seals. Those parts of a semirigid container and lid or of a flexible container that are fused together in order to hermetically close the container.

(u) Shelf stability. The condition achieved by application of heat, sufficient, alone or in combination with other ingredients and/or treatments, to render the product free of microorganisms capable of growing in the product at nonrefrigerated conditions (over 50 °F or 10 °C) at which the product is intended to be held during distribution and storage. Shelf stability and shelf stable are synonymous with commercial sterility and commercially sterile, respectively.

(v) Thermal process. The heat treatment necessary to achieve shelf stability as determined by the establishment's processing authority. It is quantified in terms of:

(1) Time(s) and temperature(s); or

(2) Minimum product temperature.

(w) Venting. The removal of air from a retort before the start of process timing.

(x) Water activity. The ratio of the water vapor pressure of the product to the vapor pressure of pure water at the same temperature.

(a) Examination and cleaning of empty containers. (1) Empty containers, closures, and flexible pouch roll stock shall be evaluated by the establishment to ensure that they are clean and free of structural defects and damage that may affect product or container integrity. Such an examination should be based upon a statistical sampling plan.

(2) All empty containers, closures, and flexible pouch roll stock shall be stored, handled, and conveyed in such a manner that will prevent soiling and damage that could affect the hermetic condition of the sealed container.

(3) Just before filling, rigid containers shall be cleaned to prevent incorporation of foreign matter into the finished product. Closures, semirigid containers, preformed flexible pouches, and flexible pouch roll stock contained in original wrappings do not need to be cleaned before use.

(b) Closure examinations for rigid containers (cans)—(1) Visual examinations. A closure technician shall visually examine the double seams formed by each closing machine head. When seam defects (e.g., cutovers, sharpness, knocked down flanges, false seams, droops) are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken. In addition to the double seams, the entire container shall be examined for product leakage or obvious defects. A visual examination shall be performed on at least one container from each closing machine head, and the observations, along with any corrective actions, shall be recorded. Visual examinations shall be conducted with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician at the beginning of production, immediately following every jam in the closing machine and after closing machine adjustment (including adjustment for changes in container size).

(2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing head shall be examined on the packer's end during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have container specification guidelines for double seam integrity on file and available for review by Program employees. A teardown examination of the can maker's end shall beperformed on at least one container selected from each closing machine during each examination period except when teardown examinations are made on incoming empty containers or when, in the case of self-manufactured containers, the containers are made in the vicinity of the establishment and the container plant records are made available to Program employees. Additional teardown examinations on the packer's end should be made at the beginning of production, immediately following every jam in a closing machine and after closing machine adjustment (including adjustment for a change in container size). The following procedures shall be used in teardown examinations of double seams:

(i) One of the following two methods shall be employed for dimensional measurements of the double seam.

(a) Micrometer measurement. For cylindrical containers, measure the following dimensions (Figure 1) at three points approximately 120 degrees apart on the double seam excluding and at least one-half inch from the side seam juncture:

(1) Double seam length—W;

(2) Double seam thickness—S;

(3) Body hook length—BH; and

(4) Cover hook length—CH.

(b) Seamscope or seam projector. Required measurements of the seam include thickness, body hook, and overlap. Seam thickness shall be obtained by micrometer. For cylindrical containers, at least two locations, excluding the side seam juncture, shall be used to obtain the required measurements.

(ii) Seam tightness. Regardless of the dimensional measurement method used to measure seam dimensions, at a minimum, the seam(s) examined shall be stripped to assess the degree of wrinkling.

(iii) Side seam juncture rating. Regardless of the dimensional measurement method used to measure seam dimensions, the cover hook shall be stripped to examine the cover hook droop at the juncture for containers having side seams.

(iv) Examination of noncylindrical containers. Examination of noncylindrical containers (e.g., square, rectangular, “D”-shaped, and irregularly-shaped) shall be conducted as described in paragraphs (b)(2) (i), (ii), and (iii) of this section except that the required dimensional measurements shall be made on the double seam at the points listed in the establishment's container specification guidelines.

(c) Closure examinations for glass containers—(1) Visual examinations. A closure technician shall visually assess the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine shall be taken and recorded. In addition to the closures, the entire container shall be examined for defects. Visual examinations shall be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Additional visual examinations shall be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).

(2) Closure examinations and tests. Depending upon the container and closure, tests shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made either before or after thermal processing and at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing machine shall be examined during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have specification guidelines for closure integrity on file and available for review by Program employees. Additional closure examinations should be made at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size).

(d) Closure examinations for semirigid and flexible containers—(1) Heat seals—(i) Visual examinations. A closure technician shall visually examine the seals formed by each sealing machine. When sealing defects are observed, necessary corrective actions, such as adjusting or repairing the sealing machine, shall be taken and recorded. In addition to examining the heat seals, the entire container shall be examined for product leakage or obvious defects. Visual examinations shall be performed before and after the thermal processing operation and with sufficient frequency to ensure proper closure. These examinations should be conducted at least in accordance with a statistical sampling plan. All defects noted and corrective actions taken shall be promptly recorded.

(ii) Physical tests. Tests determined by the establishment as necessary to assess container integrity shall be conducted by the closure technician at a frequency sufficient to ensure proper closure. These tests shall be performed after the thermal processing operation and should be made at least every 2 hours of continuous production. The establishment's acceptance guidelines for each test procedure shall be on file and available for review by Program employees. Test results along with any necessary corrective actions, such as adjusting or repairing the sealing machine, shall be recorded.

(2) Double seams on semirigid or flexible containers shall be examined and the results recorded as provided in paragraph (b) of this section. Any additional measurements specified by the container manufacturer shall also be made and recorded.

(e) Container coding. Each container shall be marked with a permanent, legible, identifying code mark. The mark shall, at a minimum, identify in code the product (unless the product name lithographed or printed elsewhere on the container) and the day and year the product was packed.

(f) Handling of containers after closure. (1) Containers and closures shall be protected from damage which may cause defects that are likely to affect the hermetic condition of the containers. The accumulation of stationary containers on moving conveyors should be minimized to avoid damage to the containers.

(2) The maximum time lapse between closing and initiation of thermal processing shall be 2 hours. However, the Administrator may specify a shorter period of time when considered necessary to ensure product safety and stability. A longer period of time between closing and the initiation of thermal processing may be permitted by the Administrator.

(a) Process schedules. Prior to the processing of canned product for distribution in commerce, an establishment shall have a process schedule (as defined in § 318.300(n) of this subpart) for each canned meat product to be packed by the establishment.

(b) Source of process schedules. (1) Process schedules used by an establishment shall be developed or determined by a processing authority.

(2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements shall be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority shall amend the process schedule accordingly.

(3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, shall be made available by the establishment to the Program employee upon request.

(c) Submittal of process information. (1) Prior to the processing of canned product for distribution in commerce, the establishment shall provide the inspector at the establishment with a list of the process schedules (including alternate schedules) along with any additional applicable information, such as the retort come-up operating procedures and critical factors.

(2) Letters or other written communications from a processing authority recommending all process schedules shall be maintained on file by the establishment. Upon request by Program employees, the establishment shall make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment shall provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to establish the process schedule. Once submitted, the process schedules and associated critical factors and the procedures for measuring (including the frequency), controlling, and recording of critical factors shall not be changed without the prior written submittal of the revised procedures (including supporting documentation) to the inspector at the establishment.

Critical factors specified in the process schedule shall be measured, controlled and recorded by the establishment to ensure that these factors remain within the limits used to establish the process schedule. Examples of factors that are often critical to process schedule adequacy may include:

(a) General. (1) Maximum fill-in weight or drained weight;

(2) Arrangement of pieces in the container;

(3) Container orientation during thermal processing;

(4) Product formulation;

(5) Particle size;

(6) Maximum thickness for flexible, and to some extent semirigid containers during thermal processing;

(7) Maximum pH;

(8) Percent salt;

(9) Ingoing (or formulated) nitrite level (ppm);

(10) Maximum water activity; and

(11) Product consistency or viscosity.

(b) Continuous rotary and batch agitating retorts. (1) Minimum headspace; and

(2) Retort reel speed.

(c) Hydrostatic retorts. (1) Chain or conveyor speed.

(d) Steam/air retorts. (1) Steam/air ratio; and

(2) Heating medium flow rate.

(a) Posting of processes. Process schedules (or operating process schedules) for daily production, including minimum initial temperatures and operating procedures for thermal processing equipment, shall be posted in a conspicuous place near the thermal processing equipment. Alternatively, such information shall be available to the thermal processing system operator and the inspector.

(b) Process indicators and retort traffic control. A system for product traffic control shall be established to prevent product from bypassing the thermal processing operation. Each basket, crate or similar vehicle containing unprocessed product, or at least one visible container in each vehicle, shall be plainly and conspicuously marked with a heat sensitive indicator that will visually indicate whether such unit has been thermally processed. Exposed heat sensitive indicators attached to container vehicles shall be removed before such vehicles are refilled with unprocessed product. Container loading systems for crateless retorts shall be designed to prevent unprocessed product from bypassing the thermal processing operation.

(c) Initial temperature. The initial temperature of the contents of the coldest container to be processed shall be determined and recorded by the establishment at the time the processing cycle begins to assure that the temperature of the contents of every container to be processed is not lower than the minimum initial temperature specified in the process schedule. Thermal processing systems which subject the filled and sealed containers to water at any time before process timing begins shall be operated to assure that such water will not lower the temperature of the product below the minimum initial temperature specified in the process schedule.

(d) Timing devices. Devices used to time applicable thermal processing operation functions or events, such as process schedule time, come-up time and retort venting, shall be accurate to assure that all such functions or events are achieved. Pocket watches and wrist watches are not considered acceptable timing devices. Analog and digital clocks are considered acceptable. If such clocks do not display seconds, all required timed functions or events shall have at least a 1-minute safety factor over the specified thermal processing operation times. Temperature/time recording devices shall correspond within 15 minutes to the time of the day recorded on written records required by § 318.306.

(e) Measurement of pH. Unless other methods are approved by the Administrator, potentiometric methods using electronic instruments (pH meters) shall be used for making pH determinations when a maximum pH value is specified as a critical factor in a process schedule.

(a) Instruments and controls common to different thermal processing systems—(1) Indicating temperature devices. Each retort shall be equipped with at least one indicating temperature device that measures the actual temperature within the retort. The indicating temperature device, not the temperature/time recording device, shall be used as the reference instrument for indicating the process temperature.

(i) Mercury-in-glass thermometers. A mercury-in-glass thermometer shall have divisions that are readable to 1F °(or 0.5C°) and whose scale contains not more than 17F°/inch (or 4.0C°/cm) of graduated scale. Each mercury-in-glass thermometer shall be tested for accuracy against a known accurate standard upon installation and at least once a year to ensure its accuracy. Records that specify the date, standard used, test method, and the person or testing authority performing the test shall be maintained on file by the establishment and made available to Program employees. A mercury-in-glass thermometer that has a divided mercury column or that cannot be adjusted to the standard shall be repaired and tested for accuracy before further use, or replaced.

(ii) Other devices. In lieu of mercury-in-glass thermometers, the Administrator, upon request, will consider other indicating temperature devices, such as resistance temperature detectors. Any such device that is approved shall, upon installation and at least once a year thereafter, be tested for accuracy against a known accurate standard. Records that specify the date, standard used, test method, and the person or testing authority performing the test shall be maintained on file by the establishment and made available to Program employees. Any such device which cannot be adjusted to the standard shall be replaced, or repaired and tested for accuracy before further use.

(2) Temperature/time recording devices. Each thermal processing system shall be equipped with at least one temperature/time recording device to provide a permanent record of temperatures within the thermal processing system. This recording device may be combined with the steam controller and may be a recording/controlling instrument. When compared to the known accurate indicating temperature device, the recording accuracy shall be equal to or better than 1F °(or 0.5C°) at the process temperature. The temperature recording chart should be adjusted to agree with, but shall never be higher than, the known accurate indicating temperature device. A means of preventing unauthorized changes in the adjustment shall be provided. For example, a lock or a notice from management posted at or near the recording device warning that only authorized persons are permitted to make adjustments, are satisfactory means for preventing unauthorized changes. Air-operated temperature controllers shall have adequate filter systems to ensure a supply of clean, dry air. The recorder timing mechanism shall be accurate.

(i) Chart-type devices. Devices using charts shall be used only with the correct chart. Each chart shall have a working scale of not more than 55F°/inch (or 12C°/cm) within a range of 20F °(or 11C°) of the process temperature. Chart graduations shall not exceed 2F degrees (or 1C degree) within a range of 10F degrees (or 5C degrees) of the process temperature. Multipoint plotting chart-type devices shall print temperature readings at intervals that will assure that the parameters of the process time and process temperature have been met. The frequency of recording should not exceed 1-minute intervals.

(ii) Other devices. In lieu of chart-type devices, the Administrator will consider for approval other recording devices upon request.

(3) Steam controllers. Each retort shall be equipped with an automatic steam controller to maintain the retort temperature. This may be a recording/controlling instrument when combined with a temperature/time recording device.

(4) Air valves. All air lines connected to retorts designed for pressure processing in steam shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of air into the retort during the process cycle.

(5) Water valves. All retort water lines that are intended to be closed during a process cycle shall be equipped with a globe valve or other equivalent-type valve or piping arrangement that will prevent leakage of water into the retort during the process cycle.

(b) Pressure processing in steam—(1) Batch still retorts. (i) The basic requirements and recommendations for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, bulb sheaths or probes of indicating temperature devices and probes of temperature/time recording devices shall be installed either within the retort shell or in external wells attached to the retort. External wells shall be connected to the retort through at least a 3/4 inch (1.9 cm) diameter opening and equipped with a 1/16 inch (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulb or probe. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described under paragraph (a)(3) of this section.

(iii) Steam inlet. The steam inlet to each retort shall be large enough to provide steam for proper operation of the retort, and shall enter at a point to facilitate air removal during venting.

(iv) Crate supports. Vertical still retorts with bottom steam entry shall employ bottom retort crate supports. Baffle plates shall not be used in the bottom of retorts.

(v) Steam spreader. Perforated steam spreaders, if used, shall be maintained to ensure they are not blocked or otherwise inoperative. Horizontal still retorts shall be equipped with perforated steam spreaders that extend the full length of the retort unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority. Such information shall be maintained on file by the establishment and made available to Program employees for review.

(vi) Bleeders and condensate removal. Bleeders, except those for external wells of temperature devices, shall have 1/8 inch (or 3 mm) or larger openings and shall be wide open during the entire process, including the come-up time. For horizontal still retorts, bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost locations of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top. Bleeders may be installed at positions other than those specified above, as long as the establishment has heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the bleeders accomplish removal of air and circulate the steam within the retort. This information shall be maintained on file by the establishment and made available to Program employees for review. All bleeders shall be arranged in away that enables the retort operator to observe that they are functioning properly. Vertical retorts shall have at least one bleeder opening located in the portion of the retort opposite the steam inlet. All bleeders shall be arranged so that the retort operator can observe that they are functioning properly. In retorts having a steam inlet above the level of the lowest container, a bleeder shall be installed in the bottom of the retort to remove condensate. The condensate bleeder shall be so arranged that the retort operator can observe that it is functioning properly. The condensate bleeder shall be checked with sufficient frequency to ensure adequate removal of condensate. Visual checks should be performed at intervals of not more than 15 minutes and the results recorded. Intermittent condensate removal systems shall be equipped with an automatic alarm system that will serve as a continuous monitor of condensate bleeder functioning. The automatic alarm system shall be tested at the beginning of each shift for proper functioning and the results recorded. If the alarm system is not functioning properly, it must be repaired before the retort is used.

(vii) Stacking equipment—(a) Equipment for holding or stacking containers in retorts. Crates, trays, gondolas, carts, and other vehicles for holding or stacking product containers in the retort shall be so constructed to ensure steam circulation during the venting, come-up, and process times. The bottom of each vehicle shall have perforations at least 1 inch (2.5 cm) in diameter on 2 inch (or 5 cm) centers or the equivalent unless the adequacy of another arrangement is documented by heat distribution data or other documentation from a processing authority and such information is maintained on file by the establishment and made available to Program employees for review.

(b) Divider plates. Whenever one or more divider plates are used between any two layers of containers or placed on the bottom of a retort vehicle, the establishment shall have on file documentation that the venting procedure allows the air to be removed from the retort before timing of the thermal process is started. Such documentation shall be in the form of heat distribution data or documentation from a processing authority. This information shall be made available to Program employees for review.

(viii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have on file documentation that the mufflers do not impede the removal of air from the retort. Such documentation shall consist of either heat distribution data or documentation from the muffler manufacturer or from a processing authority. This information shall be made available to Program employees for review.

(ix) Vents—(a) Vents shall be located in that portion of the retort opposite the steam inlet and shall be designed, installed, and operated in such a way that air is removed from the retort before timing of the thermal process is started. Vents shall be controlled by a gate, plug cock, or other full-flow valve which shall be fully opened to permit rapid removal of air from retorts during the venting period.

(b) Vents shall not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross-sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be connected to a closed drain without an atmospheric break in the line. A manifold header connecting vents or manifolds from several still retorts shall lead to the atmosphere. The manifold header shall not be controlled by a valve and shall be of a size such that the cross-sectional area is at least equal to the total cross-sectional area of all connecting retort manifold pipes from the maximum number of retorts to be vented simultaneously.

(c) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information shall be maintained on file by the establishment and made available to Program employees for review.

(d) For crateless retort installations, the establishment shall have heat distribution data or other documentation from the equipment manufacturer or from a processing authority that demonstrates that the venting procedure used accomplishes the removal of air and condensate. This information shall be maintained on file by the establishment and made available to Program employees for review.

(e) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows:

(1) Venting horizontal retorts.

(i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.

At least the following processing and production information shall be recorded by the establishment: date of production; product name and style; container code; container size and type; and the process schedule, including the minimum initial temperature. Measurements made to satisfy the requirements of § 318.303 regarding the control of critical factors shall be recorded. In addition, where applicable, the following information and data shall also be recorded:

(a) Processing in steam—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or the number of retort crates per retort load, product initial temperature, time steam on, the time and temperature vent closed, the start of process timing, time steam off, and the actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required for batch, still steam retorts in paragraph (a)(1) of this section, record the functioning of the condensate bleeder(s) and the retort or reel speed.

(3) Continuous rotary retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent closed, time process temperature reached, the time the first can enters and the time the last can exits the retort. The retort or reel speed shall be determined and recorded at intervals not to exceed 4 hours. Readings of the indicating temperature device(s) and temperature recorder(s) shall be made and recorded at the time the first container enters the retort and thereafter with sufficient frequency to ensure compliance with the process schedule. These observations should be made and recorded at intervals not exceeding 30 minutes of continuous retort operation. Functioning of the condensate bleeder(s) shall be observed and recorded at the time the first container enters the retort and thereafter as specified in § 318.305(b)(3)(v).

(4) Hydrostatic retorts. Record the retort system number, the approximate total number of containers retorted, product initial temperature, time steam on, the time and temperature vent(s) closed, time process temperature reached, time first containers enter the retort, time last containers exit the retort, and, if specified in the process schedule, measurements of temperatures in the hydrostatic water legs. Readings of the temperature indicating device, which is located in the steam/water interface, and the temperature recording device shall be observed and the temperatures recorded at the time the first containers enter the steam dome. Thereafter, these instruments shall be read and the temperatures recorded with sufficient frequency to ensure compliance with the temperature specified in the process schedule and should be made at least every hour of continuous retort operation. Container conveyor speed, and for agitating hydrostatic retorts, the rotative chain speed, shall be determined and recorded at intervals of sufficient frequency to ensure compliance with the process schedule and should be performed at least every 4 hours.

(b) Processing in water—(1) Batch still retorts. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, the start of process timing, water level, water recirculation rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(2) Batch agitating retorts. In addition to recording the information required in paragraph (b)(1) of this section, record the retort or reel speed.

(c) Processing in steam/air mixtures. For each retort batch, record the retort number or other designation, the approximate number of containers or number of retort crates per retort load, product initial temperature, time steam on, venting procedure, if applicable, the start of process timing, maintenance of circulation of the steam/air mixture, air flow rate or forced recirculation flow rate (if critical), overriding pressure maintained, time steam off, and actual processing time. The indicating temperature device and the temperature recorder shall be read at the same time at least once during process timing and the observed temperatures recorded.

(d) Atmospheric cookers—(1) Batch-type systems. For each cooker batch, record the cooker number or other designation and the approximate number of containers. In addition, record all critical factors of the process schedule such as cooker temperature, initial temperature, the time the thermal process cycle begins and ends, hold time, and the final internal product temperature.

(2) Continuous-type systems. Record the cooker number or other designation, the time the first containers enter and the last containers exit a cooker, and the approximate total number of containers processed. In addition, record all critical factors of the process schedule such as the initial temperature, cooker speed, and final internal product temperature.

(a) Whenever the actual process is less than the process schedule or when any critical factor does not comply with the requirements for that factor as specified in the process schedule, it shall be considered a deviation in processing.

(b) Deviations in processing (or process deviations) shall be handled under quality control as provided in paragraph (c) of this section or shall be handled in accordance with paragraph (d) of this section.

(c) Any partial quality control program or any portion of a total quality control system for handling process deviations shall be prepared in accordance with § 318.4.

(d) Handling process deviations without an approved quality control program. (1) Deviations identified in-process. If a deviation is noted at any time before the completion of the intended process schedule, the establishment shall:

(i) Immediately reprocess the product using the full process schedule; or

(ii) Use an appropriate alternate process schedule provided such a process schedule has been established in accordance with § 318.302 (a) and (b) and is filed with the inspector in accordance with § 318.302(c); or

(iii) Hold the product involved and have the deviation evaluated by a processing authority to assess the safety and stability of the product. Upon completion of the evaluation, the establishment shall provide the inspector the following:

(a) A complete description of the deviation along with all necessary supporting documentation;

(b) A copy of the evaluation report; and

(c) A description of any product disposition actions, either taken or proposed.

(iv) Product handled in accordance with paragraph (d)(1)(iii) of this section shall not be shipped from the establishment until the Program has reviewed all of the information submitted and approved the product disposition actions.

(v) If an alternate process schedule is used that is not on file with the inspector or if an alternate process schedule is immediately calculated and used, the product shall be set aside for further evaluation in accordance with paragraphs (d)(1)(iii) and (iv) of this section.

(vi) When a deviation occurs in a continuous rotary retort, the product shall be handled in accordance with paragraphs (d)(1)(iii) and (iv) of this section or in accordance with the following procedures:

(a) Emergency stops.

(1) When retort jams or breakdowns occur during the processing operations, all containers shall be given an emergency still process (developed per § 318.302(b)) before the retort is cooled or the retort shall be cooled promptly and all containers removed and either reprocessed, repacked and reprocessed, or destroyed. Regardless of the procedure used, containers in the retort intake valve and in transfer valves between retort shells at the time of a jam or breakdown shall be removed and either reprocessed, repacked and reprocessed and or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 301.2(ttt) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) The time the retort reel stopped and the time the retort is used for an emergency still retort process shall be noted on the temperature/time recording device and entered on the other production records required in § 318.306.

(b) Temperature drops. When the retort temperature drops below the temperature specified in the process schedule, the reel shall be stopped and the following actions shall be taken:

(1) For temperature drops of less than 10 ° F (or 5.5 ° C) either, (i) all containers in the retort shall be given an emergency still process (developed per § 318.302(b)) before the reel is restarted; (ii) container entry to the retort shall be prevented and an emergency agitating process (developed per § 318.302(b)) shall be used before container entry to the retort is restarted; or (iii) container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 318.2(ee) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) For temperature drops of 10 ° F (or 5.5 ° C) or more, all containers in the retort shall be given an emergency still process (developed per § 318.302(b)). The time the reel was stopped and the time the retort was used for a still retort process shall be marked on the temperature/time recording device by the establishment and entered on the other production records required in § 318.306. Alternatively, container entry to the retort shall be prevented and the reel restarted to empty the retort. The discharged containers shall be either reprocessed, repacked and reprocessed, or destroyed. Product to be destroyed shall be handled as “U.S. Inspected and Condemned”, as defined in § 301.2(ee) of this subchapter, and disposed of in accordance with part 314 of this subchapter.

(2) Deviations identified through record review. Whenever a deviation is noted during review of the processing and production records required by § 318.307 (a) and (b), the establishment shall hold the product involved and the deviation shall be handled in accordance with paragraphs (d)(1) (iii) and (iv) of this section.

(e) Process deviation file. The establishment shall maintain full records regarding the handling of each deviation. Such records shall include, at a minimum, the appropriate processing and production records, a full description of the corrective actions taken, the evaluation procedures and results, and the disposition of the affected product. Such records shall be maintained in a separate file or in a log that contains the appropriate information. The file or log shall be retained in accordance with § 318.307(e) and shall be made available to Program employees upon request.

(a) Finished product inspections shall be handled under quality control as provided in paragraph (b) or paragraph (c) of this section or shall be handled in accordance with paragraph (d) of this section.

(b) Any partial quality control program for finished product inspection shall be prepared in accordance with § 318.4 of this part.

(c) That portion of a total quality control system for finished product inspection shall be prepared in accordance with § 318.4 of this part.

(d) Handling finished product inspections without an approved quality control program.

(1) Incubation of shelf stable canned product—(i) Incubator. The establishment shall provide incubation facilities which include an accurate temperature/time recording device, an indicating temperature device, a means for the circulation of the air inside the incubator to prevent temperature variations, and a means to prevent unauthorized entry into the facility. The Program is responsible for the security of the incubator.

(ii) Incubation temperature. The incubation temperature shall be maintained at 95±5 °F (35±2.8 °C). If the incubation temperature falls below 90 °F (or 32 °C) or exceeds 100 °F (or 38 °C) but does not reach 103 °F (or 39.5 °C), the incubation temperature shall be adjusted within the required range and the incubation time extended for the time the sample containers were held at the deviant temperature. If the incubation temperature is at or above 103 °F (or 39.5 °C) for more than 2 hours, the incubation test(s) shall be terminated, the temperature lowered to within the required range, and new sample containers incubated for the required time.

(iii) Product requiring incubation. Shelf stable product requiring incubation includes:

(a) Low acid products as defined in § 318.300(m); and

(b) Acidified low acid products as defined in § 318.300(b).

(iv) Incubation samples. (a) From each load of product processed in a batch-type thermal processing system (still or agitation), the establishment shall select at least one container for incubation.

(b) For continuous rotary retorts, hydrostatic retorts, or other continuous-type thermal processing systems, the establishment shall select at least one container per 1,000 for incubation.

(c) Only normal-appearing containers shall be selected for incubation.

(v) Incubation time. Canned product requiring incubation shall be incubated for not less than 10 days (240 hours) under the conditions specified in paragraph (d)(1)(ii) of this section.

(vi) Incubation checks and record maintenance. Designated establishment employees shall visually check all containers under incubation each working day and the inspector shall be notified when abnormal containers are detected. All abnormal containers should be allowed to cool before a final decision on their condition is made. For each incubation test the establishment shall record at least the product name, container size, container code, number of containers incubated, in and out dates, and incubation results. The establishment shall retain such records, along with copies of the temperature/time recording charts, in accordance with § 318.307(e).

(vii) Abnormal containers. The finding of abnormal containers (as defined in § 318.300(a)) among incubation samples is cause to officially retain at least the code lot involved.

(viii) Shipping. No product shall be shipped from the establishment before the end of the required incubation period except as provided in this paragraph or paragraph (b) or (c) of this section. An establishment wishing to ship product prior to the completion of the required incubation period shall submit a written proposal to the area supervisor. Such a proposal shall include provisions that will assure that shipped product will not reach the retail level of distribution before sample incubation is completed and that product can be returned promptly to the establishment should such action be deemed necessary by the incubation test results. Upon receipt of written approval from the area supervisor, product may be routinely shipped provided the establishment continues to comply with all requirements of this subpart.

(2) Container condition—(i) Normal containers. Only normal-appearing containers shall be shipped from an establishment as determined by an appropriate sampling plan or other means acceptable to Program employees.

(ii) Abnormal containers. When abnormal containers are detected by any means other than incubation, the establishment shall inform the inspector, and the affected code lot(s) shall not be shipped until the Program has determined that the product is safe and stable. Such a determination will take into account the cause and level of abnormals in the affected lot(s) as well as any product disposition actions either taken or proposed by the establishment.

All operators of thermal processing systems specified in § 318.305 and container closure technicians shall be under the direct supervision of a person who has successfully completed a school of instruction that is generally recognized as adequate for properly training supervisors of canning operations.

Establishments shall prepare and maintain a current procedure for the recall of all canned product covered by this subpart. Upon request, the recall procedure shall be made available to Program employees for review.