US LAWS, STATUTES & CODES ON-LINE

(ii) Time and temperature shall be monitored by a calibrated recording instrument that meets the requirements of paragraph (d) of this section, except for paragraph (c)(1)(iv).

(iii) The time to raise product temperature from 60 °F. to 120 °F shall not exceed 2 hours unless the product is cured or fermented.

(iv) Time, in combination with temperatures of 138 °F to 143 °F, need not be monitored if the product's minimum thickness exceeds 2 inches (5.1 cm) and refrigeration of the product does not begin within 5 minutes of attaining 138 °F (58.9 °C).

(v) The establishment shall use procedures which insure the proper heating of all parts of the product. It is important that each piece of sausage, each ham, and other product treated by heating in water be kept entirely submerged throughout the heating period; and that the largest pieces in a lot, the innermost links of bunched sausage or other massed articles, and pieces placed in the coolest part of a heating cabinet or compartment or vat be included in the temperature tests.

(2) Refrigerating. At any stage of preparation and after preparatory chilling to a temperature of not above 40 °F. or preparatory freezing, all parts of the muscle tissue of pork or product containing such tissue shall be subjected continuously to a temperature not higher than one of those specified in table 1, the duration of such refrigeration at the specified temperature being dependent on the thickness of the meat or inside dimensions of the container.

(i) Group 1 comprises product in separate pieces not exceeding 6 inches in thickness, or arranged on separate racks with the layers not exceeding 6 inches in depth, or stored in crates or boxes not exceeding 6 inches in depth, or stored as solidly frozen blocks not exceeding 6 inches in thickness.

(ii) Group 2 comprises product in pieces, layers, or within containers, the thickness of which exceeds 6 inches but not 27 inches, and product in containers including tierces, barrels, kegs, and cartons having a thickness not exceeding 27 inches.

(iii) The product undergoing such refrigeration or the containers thereof shall be so spaced while in the freezer as will insure a free circulation of air between the pieces of meat, layers, blocks, boxes, barrels, and tierces in order that the temperature of the meat throughout will be promptly reduced to not higher than 5 °F., −10 °F., or −20 °F., as the case may be.

(iv) In lieu of the methods prescribed in Table 1, the treatment may consist of commercial freeze drying or controlled freezing, at the center of the meat pieces, in accordance with the times and temperatures specified in Table 2.

(v) During the period of refrigeration the product shall be kept separate from other products and in the custody of the Program in rooms or compartments equipped and made secure with an official Program lock or seal. The rooms or compartments containing product undergoing freezing shall be equipped with accurate thermometers placed at or above the highest level at which the product undergoing treatment is stored and away from refrigerating coils. After completion of the prescribed freezing of pork to be used in the preparation of product covered by paragraph (b) of this section the pork shall be kept under close supervision of an inspector until it is prepared in finished form as one of the products enumerated in paragraph (b) of this section or until it is transferred under Program control to another official establishment for preparation in such finished form.

(vi) Pork which has been refrigerated as specified in this subparagraph may be transferred in sealed railroad cars, sealed motortrucks, sealed trailers, or sealed closed containers to another official establishment at the same or another location, for use in the preparation of product covered by paragraph (b) of this section. Such vehicles and containers shall be sealed and transported between official establishments in accordance with §325.7 of this subchapter.

(3) Curing—(i) Sausage. The sausage may be stuffed in animal casings, hydrocellulose casings, or cloth bags. During any stage of treating the sausage for the destruction of live trichinae, except as provided in Method 5, these coverings shall not be coated with paraffin or like substance, nor shall any sausage be washed during any prescribed period of drying. In the preparation of sausage, one of the following methods may be used:

Method No. 1. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 31/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, sausage having a diameter not exceeding 31/2 inches, measured at the time of stuffing, shall be held in a drying room not less than 20 days at a temperature not lower than 45 °F., except that in sausage of the variety known as pepperoni, if in casings not exceeding 13/8 inches in diameter measured at the time of stuffing, the period of drying may be reduced to 15 days. In no case, however, shall the sausage be released from the drying room in less than 25 days from the time the curing materials are added, except that sausage of the variety known as pepperoni, if in casings not exceeding the size specified, may be released at the expiration of 20 days from the time the curing materials are added. Sausage in casings exceeding 31/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing, shall be held in a drying room not less than 35 days at a temperature not lower than 45 °F., and in no case shall the sausage be released from the drying room in less than 40 days from the time the curing materials are added to the meat.

(B) Reduction in Drying Room Time. During the holding period, the sausage may be smoked or fermented. If the temperature is increased to 70 °F. (21.1 °C) or higher, while the sausage is being held after adding curing materials but before the drying period, the subsequent drying room times prescribed for this method may be reduced according to the schedule in Table 3B. No interpolation of values is permissible.

(C) Reduced Salt Content—Drying Room Times. Salt content of less than 3.33 pounds for each hundredweight of sausage formulation, excluding dry ingredients, (such as salts, sugars, and spices), may be permitted provided the drying time is increased according to the schedule contained in Table 4.

Trichina Treatment of Sausage by Method No. 6;

Method No. 7, Dry Sausages. (A) General Requirements. The establishment shall use meat particles reduced in size to no more than 1/4 inch in diameter. The establishment shall add a curing mixture containing no less than 2.7 pounds of salt per hundred pounds of meat and mix it uniformly throughout the product. The establishment shall hold, heat, and dry the product according to paragraph (B) or (C) below.

(B) Holding, Heating, and Drying Treatment, Large Sausages. Except as permitted in (C) below, the establishment shall subject sausages in casings not exceeding 105 mm in diameter, at the time of stuffing, to all of the following minimum chamber temperatures and time periods.

Following the preceding treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °C) for not less than 7 days.

(C) Heating and Drying Treatment, Small Sausages. Alternatively, the establishment may subject sausages in casings not exceeding 55 mm in diameter, at the time of stuffing, to all of the following minimum chamber temperatures and time periods.

Following the preceding heat treatment, the establishment shall dry the sausages at a temperature not lower than 50 °F (10 °C) for not less than 4 days.

(ii) Capocollo (capicola, capacola). Boneless pork butts for capocollo shall be cured in a dry-curing mixture containing not less than 41/2 pounds of salt per hundredweight of meat for a period of not less than 25 days at a temperature not lower than 36 °F. If the curing materials are applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be smoked for a period of not less than 30 hours at a temperature not lower than 80 °F., and shall finally be held in a drying room not less than 20 days at a temperature not lower than 45 °F.

(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-curing mixture containing not less than 41/2 pounds of salt per hundredweight of meat for a period of not less than 18 days at a temperature not lower than 36 °F. If the curing mixture is applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be held in a drying room not less than 35 days at a temperature not lower than 45 °F.

(iv) Hams and pork shoulder picnics. In the curing of hams and pork shoulder picnics, one of the methods below shall be used. For calculating days per pound, the establishment shall use the weight of the heaviest ham or picnic in the lot.

Method No. 1. The hams and pork shoulder picnics shall be cured by a dry-salt curing process not less than 40 days at a temperature no lower than 36 °F. The products shall be laid down in salt, not less than 4 pounds to each hundredweight of product, the salt being applied in a thorough manner to the lean meat of each item. When placed in cure, the products may be pumped with pickle if desired. At least once during the curing process, the products shall be overhauled (turned over for the application of additional cure) and additional salt applied, if necessary, so that the lean meat of each item is thoroughly covered. After removal from cure, the products may be soaked in water at a temperature not higher than 70 °F for not more than 15 hours, during which time the water may be changed once, but they shall not be subjected to any other treatment designed to remove salt from the meat except that superficial washing may be allowed. The products shall finally be dried or smoked at a time and temperature not less than a combination prescribed in Table 5 of Method No. 3.

Drying Times and Temperatures for Trichina Inactivation in Hams and Shoulders

Method No. 4. (A) Cure: Establishments shall cure hams and shoulders by using a cure mixture containing not less than 71.5 percent salt by weight to cover all exposed muscle tissue and to pack the hock region. Establishments may substitute potassium chloride (KCl) for up to half of the required salt on an equal weight basis.

(v) Boneless pork loins and loin ends. In lieu of heating or refrigerating to destroy possible live trichinae in boneless loins, the loins may be cured for a period of not less than 25 days at a temperature not lower than 36 °F. by the use of one of the following methods:

Method No. 1. Application of a dry-salt curing mixture containing not less than 5 pounds of salt to each hundredweight of meats.

(4) The Administrator shall consider additional processing methods upon petition by manufacturers, and shall approve any such method upon his/her determination that it can be properly monitored by an inspector and that the safety of such methods is adequately documented by data which has been developed by following an experimental protocol previously reviewed and accepted by the Department.

(d) General instructions: When necessary to comply with the requirements of this section, the smokehouses, drying rooms, and other compartments used in the treatment of pork to destroy possible live trichinae shall be suitably equipped, by the operator of the official establishment, with accurate automatic recording thermometers. Circuit supervisors are authorized to approve for use in sausage smokehouses, drying rooms, and other compartments, such automatic recording thermometers as are found to give satisfactory service and to disapprove and require discontinuance of use, for purposes of the regulations in this subchapter, any thermometers (including any automatic recording thermometers) of the establishment that are found to be inaccurate or unreliable.

(e) The requirements for using the pooled sample digestion technique to analyze pork for the presence of trichina cysts are:

(1) The establishment shall submit for the approval of the Regional Director its proposed procedure for identifying and pooling carcasses, collecting and pooling samples, testing samples (including the name and address of the laboratory), communicating test results, retesting individual carcasses, and maintaining positive identification and clear separation of pork found to be trichina-free from untested pork or trichina-positive pork.

(2) The establishment shall use the services of a laboratory approved by the Administrator for all required testing. Such approval shall be based on adequacy of facilities, reagents, and equipment, and on demonstration of continuing competency and reliability in performing the pooled sample digestion technique for trichinae.

(3) The establishment shall sample no less than 5 grams of diaphragm muscle or tongue tissue from each carcass or no less than 10 grams of other muscle tissue. Samples may be pooled but a pool shall not consist of more than 100 grams of sample. Sampling and sample preparation are subject to inspection supervision.

(4) Pork or products made from tested pork shall not be released as trichina free from the official establishment without treatment until the inspector in charge receives a laboratory report that the tested pork is free of trichina cysts.

(f) Approval of other tests for trichinosis in pork. The Administrator shall consider any additional analytical method for trichinosis upon petition by a manufacturer, and may approve that method upon the determination that it will detect at least 98 percent of swine bearing cysts present at a tissue density equal to or less than one cyst per gram of muscle from the diaphragm pillars at a 95 percent confidence level. Any such petitions shall be supported by any data and other information that the Administrator finds necessary. Notice of any approval shall be given in the Federal Register, and the approved method will be incorporated into this section.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 31517; Nov. 15, 1973; 39 FR 40580, Nov. 19, 1974; 50 FR 5229, Feb. 7, 1985; 50 FR 48075, Nov. 21, 1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, June 22, 1992; 57 FR 33633, July 30, 1992; 57 FR 56440, Nov. 30, 1992]

(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.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53 FR 24679, June 30, 1988]

Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of §318.1.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]

(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.

(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator¹ shall be applied to the surface of the rooms and equipment and rinsed with potable water before use.

(c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:

(1) Separate and condemn all product in damaged or extensively rusted containers.

(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:

(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator,¹ rinse in potable water, and dry thoroughly; or

(ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly.

(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.

(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]

When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a “U.S. retained” tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.

(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act.

(b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.

(c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator.

(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards:

(1) Lethality. A 6.5-log₁₀ reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency.

(2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log₁₀ multiplication of Clostridium perfringens within the product.

(b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in §301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule.

(c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.

[64 FR 744, Jan. 6, 1999]

Material to be processed into “Mechanically Separated (Species)” shall be so processed within 1 hour from the time it is cut or separated from carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 °F. (4 °C.) or less, or held indefinitely at 0 °F. (−18 °C.) or less. “Mechanically Separated (Species)” shall, directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 °F. (4 °C.) or less or indefinitely at 0 °F. (−18 °C.) or less.

[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]

(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:

Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations.

(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

(1) Criteria to determine sampling frequency of Product Groups. For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows:

(i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirement of §319.104 or §319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91.

(iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference.

(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value.

(v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values.

(vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than −1.40 (e.g., −1.39, −1.14, 0, 0.50, etc.) and shall be daily when the Group Value is −1.40 or less (e.g., −1.40, −1.45, −1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is −1.65 or greater (e.g., −1.63, −1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c).

(2) Criteria for U.S. retention or administrative detention of cured pork products for further analysis. Cured prok products shall be U.S. retained, or administratively detained, as appropriate, when prescribed by paragraphs (b)(2) (i) or (ii) of this section as follows:

(i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of §319.104 or §319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be U.S. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there U.S. retained. Any subsequently produced lots of like product and any lots of like product for which production dates cannot be established shall be U.S. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such U.S. retained product shall be in accordance with paragraph (c) of this section.

(ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be U.S. retained shall be as follows:

(A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of §319.104 and §319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(B) Divide the difference determined in paragraph (b)(2)(ii)(A) of this section by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section to find the standardized difference.

(C) Use the lesser of 1.65 and the standardized difference as the Sample Value.

(D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be ignored in determining future Product Values.

(E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is −1.65 or less (e.g., −1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be U.S. retained and further evaluated under paragraph (c) of this section. Except for release of individual lot pursuant to paragraph (c)(1), subsequently produced lots of like product shall continue to be U.S. retained until discontinued pursuant to paragraph (c)(2) of this section.

(c) Compliance procedure during product retention. When a product lot is U.S. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section.³

(1) A product lot which is U.S. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met:

(i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by §319.104 or §319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain.

(ii) The lot of the product is relabeled to conform to the provisions of §319.104 or §319.105, under the supervision of a program employee.

(iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of U.S. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section.

(2) The PFF content of three randomly selected samples from each U.S. retained lot shall be used to maintain the Product Value described in paragraph (c)(2)(ii). The manner and effect of such maintenance shall be as follows: (i) Find the average PFF content of the three samples.

(ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of §319.104 or §319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirements.

(iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference.

(iv) Use the lesser of 1.30 and the standardized difference as the Sample Value.

(v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (c)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values.

(vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a U.S. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section. Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew.

(vii) When U.S. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section.

(3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing a product from its Product Group, provided product lots are being U.S. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first U.S. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being U.S. retained, the product shall again be considered with its Group.

(d) Adulterated and misbranded products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)).

(e) Quality control. Cured pork products bearing on their labeling the statement “X% of Weight is Added Ingredients” shall be prepared only under a quality control system or program in accordance with §318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under §318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided in plant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect.

[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, Aug. 25, 1997]

Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein.

[50 FR 32165, Aug. 9, 1985]

(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 misidentification. 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, Food Safety and Inspection Service, U.S. Department of Agriculture, 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 Assistant Administrator, Office of Public Health and Science.

(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, Food Safety and Inspection Service, U.S. Department of Agriculture, 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 methods⁴ 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:

2.0, if the standardized difference is greater than 1.6,

(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 COSUM-P value is set equal to 0. [COSUM-P values are initialized at zero; that is, the COSUM-P value associated with the first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new COSUM-P value. The new COSUM-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 COSUM-N. This value is computed and evaluated as follows:

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

2.0, if the standardized difference is greater than 1.6,

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

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

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

(3) Evaluate the new COSUM-D value. The new COSUM-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 Assistant Administrator, Office of Public Health and Science. 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, Food Safety and Inspection Service, U.S. Department of Agriculture, 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, Food Safety and Inspection Service, U.S. Department of Agriculture, 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 COSUM-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:

2.0, if the standardized difference is greater than 2.5,

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

(iii) Evaluate the new COSUM-P value. The new COSUM-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 COSUM-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:

2.0, if the standardized difference is greater than 1.5,

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

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

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

(3) Evaluate the new COSUM-D value. The new COSUM-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 Assistant Administrator, Office of Public Health and Science. 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 COSUM-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:

2.0, if the standardized difference is greater than 2.5,

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

(iii) Evaluate the new COSUM-P value. The new COSUM-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 COSUM-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:

2.0, if the standardized difference is greater than 1.5,

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

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

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

(3) Evaluate the new COSUM-D value. The new COSUM-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.

[52 FR 2185, Jan. 20, 1987, as amended at 58 FR 65260, 65262–65264, Dec. 13, 1993; 59 FR 33642, June 30, 1994; 59 FR 66448, Dec. 27, 1994; 60 FR 10305, Feb. 24, 1995; 69 FR 254, Jan. 5, 2004]

(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

[55 FR 7299, Mar. 1, 1990]

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

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

(2) Comminuted. A processing term describing the reduction in size of pieces of meat, including chopping, flaking, grinding, or mincing, but not including chunking or sectioning.

(3) Partially-cooked patties. Meat patties that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.

(4) Char-marked patties. Meat patties that have been marked by a heat source and that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section.

(b) Heat-processing procedures for fully-cooked patties. (1) Official establishments which manufacture fully-cooked patties shall use one of the following heat-processing procedures:

(2) The official establishment shall measure the holding time and temperature of at least one fully-cooked patty from each production line each hour of production to assure control of the heat process. The temperature measuring device shall be accurate within 1 degree F.

(3) Requirements for handling heating deviations. (i) If for any reason a heating deviation has occurred, the official establishment shall investigate and identify the cause; take steps to assure that the deviation will not recur; and place on file in the official establishment, available to any duly authorized FSIS program employee, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence.

(ii) In addition, in the case of a heating deviation, the official establishment may reprocess the affected product, using one of the methods in paragraph (b)(1) in this section; use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics; or relabel the affected product as a partially-cooked patty product, if it meets the stabilization requirements in paragraph (c) of this section.

(c) Stabilization. (1) Fully cooked, partially cooked, and char-marked meat patties must be produced using processes ensuring no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log₁₀ multiplication of Clostridium perfringens, within the product.

(2) For each meat patty product produced using a stabilization process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in §301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule.

(3) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant.

(4) Partially cooked patties must bear the labeling statement “Partially cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement must be adjacent to the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(5) Char-marked patties must bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement shall be adjacent to the product name, at least one-half the size of the largest letter in the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

[64 FR 744, Jan. 6, 1999]

(a) General. Meat, as defined in §301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in §310.22 of this subchapter, using advances in mechanical meat/bone separation machinery (i.e., AMR systems) that, in accordance with this section, recover meat—

(1) Without significant incorporation of bone solids or bone marrow as measured by the presence of calcium and iron in excess of the requirements in this section, and

(2) Without the presence of any brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG).

(b) Process control. As a prerequisite to labeling or using product as meat derived by the mechanical separation of skeletal muscle tissue from livestock bones, the operator of an establishment must develop, implement, and maintain procedures that ensure that the establishment's production process is in control.

(1) The production process is not in control if the skulls entering the AMR system contain any brain or trigeminal ganglia tissue, if the vertebral column bones entering the AMR system contain any spinal cord, if the recovered product fails otherwise under any provision of paragraph (c)(1), if the product is not properly labeled under the provisions of paragraph (c)(2), or if the spent bone materials are not properly handled under the provisions of paragraph (c)(3) of this section.

(2) The establishment must document its production process controls in writing. The program must be designed to ensure the on-going effectiveness of the process controls. If the establishment processes cattle, the program must be in its HACCP plan, its Sanitation SOP, or other prerequisite program. The program shall describe the on-going verification activities that will be performed, including the observation of the bones entering the AMR system for brain, trigeminal ganglia, and spinal cord; the testing of the product exiting the AMR system for bone solids, bone marrow, spinal cord, and DRG as prescribed in paragraph (c)(1) of this section; the use of the product and spent bone materials exiting the AMR system; and the frequency with which these activities will be performed.

(3) The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process.

(4) The establishment shall make available to inspection program personnel the documentation described in paragraphs (b)(2) and (b)(3) of this section and any other data generated using these procedures.

(c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances:

(i) Bone solids. The product's calcium content, measured by individual samples and rounded to the nearest 10th, is more than 130.0 mg per 100 g.

(ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g.¹

(iii) Brain or trigeminal ganglia. Skulls that enter the AMR system have tissues of brain or trigeminal ganglia.

(iv) Spinal cord. Vertebral column bones that enter the AMR system have tissues of spinal cord, or the product that exits the AMR system contains spinal cord.

(v) DRG. The product that exits the AMR system contains DRG.

(2) If product that may not be labeled or used as “meat” under this section meets the requirements of §319.5 of this subchapter, it may bear the name “Mechanically Separated (Species)” except as follows:

(i) If skulls or vertebral column bones of cattle younger than 30 months of age that enter the AMR system have tissues of brain, trigeminal ganglia, or spinal cord, the product that exits the AMR system shall not be used as an ingredient of a meat food product.

(ii) If product that exits the AMR system contains spinal cord or DRG from bones of cattle younger than 30 months of age, it shall not be used as an ingredient of a meat food product.

(iii) If product derived from any bones of cattle of any age does not comply with (c)(1)(i) or (ii), it may bear a common or usual name that is not false or misleading, except that the product may not bear the name “Mechanically Separated (Beef).”

(3) Spent skulls or vertebral column bone materials from cattle younger than 30 months of age that exit the AMR system shall not be used as an ingredient of a meat food product.

[69 FR 1884, Jan. 12, 2004]

Source:  51 FR 45619, Dec. 19, 1986, unless otherwise noted.

§ 318.300   Definitions.

(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 be performed 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.

Maximum and minimum values for each dimensional measurement shall be recorded by the closure technician.

(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. Temperature-indicating devices, such as resistance temperature detectors, used in lieu of mercury-in-glass thermometers, shall meet known, accurate standards for such devices when tested for accuracy. The records of such testing shall be available to FSIS program employees.

(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. Temperature/time recording devices or procedures used in lieu of chart-type devices must meet known accurate standards for such devices or procedures when tested for accuracy. Such a device must be accurate enough for ensuring that process time and temperature parameters have been met.

(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 a way 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.

Specifications (Figure 1): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other full-flow valve and discharging to atmosphere. The end vents shall not be more than 21/2 feet (or 75 cm) from ends of retort. Venting method (Figure 1): Vent valves shall be wide open for at least 5 minutes and to at least 225°F (or 107°C), or at least 7 minutes and to at least 220°F (or 104.5°C).

(ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.

Specifications (Figure 2): One, 1-inch (2.5 cm) vent for every 5 feet (1.5 m) of retort length; vents not over 21/2 feet (or 75 cm) from ends of retort; size of manifold for retorts less than 15 feet (4.6 m) in length, 21/2 inches (6.4 cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 cm).

(iii) Venting through water spreaders.

Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 21/2 inches (6.4 cm).

(iv) Venting through a single 21/2 inch (6.4 cm) top vent for retorts not exceeding 15 feet (4.6 m) in length.

Specifications (Figure 4): A 21/2 inch (6.4 cm) vent equipped with a 21/2 inch (6.4 cm) gate, plug cock, or other full-flow valve and located within 2 feet (61 cm) of the center of the retort.

(2) Venting vertical retorts.

(i) Venting through a 11/2 inch (3.8 cm) overflow.

Specifications (Figure 5): A 11/2 inch (3.8 cm) overflow pipe equipped with a 11/2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11/2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header.

(ii) Venting through a single 1 inch (2.5 cm) side or top vent.

Specifications (Figure 6 or 7): A 1 inch (2.5 cm) vent in lid or top side, equipped with a gate, plug cock, or other full-flow valve and discharging directly into the atmosphere or to a manifold header.

(2) Batch agitating retorts. (i) The basic requirements 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 (1.6 mm) or larger bleeder opening so located as to provide a constant flow of steam past the length of the bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in 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(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 1/8 inch (or 3 mm) or larger and shall be wide open during the entire process including the come-up time. Bleeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers, at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (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 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 a way that enables the retort operator to observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who developed the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the retort to remove condensate during retort operation. 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.

(vi) Retort or reel speed timing. The retort or reel speed shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(vii) Bleeder and vent mufflers. If mufflers are used on bleeders or vent systems, the establishment shall have 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 maintained on file by the establishment and made available to Program employees for review.

(3) Continuous rotary retorts. (i) The basic requirements 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 bulbs or probes. The bleeder for external wells shall emit steam continuously during the entire thermal processing period.

(ii) Steam controllers are required as described in 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(s) to facilitate air removal during venting.

(iv) Bleeders. Bleeders, except those for external wells of temperature devices, shall be 1/8 inch (3.2 mm) or larger and shall be wide open during the entire process, including the come-up time. B!eeders shall be located within approximately 1 foot (or 30 cm) of the outermost location of containers at each end along the top of the retort. Additional bleeders shall be located not more than 8 feet (2.4 m) apart along the top of the retort. 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 a processing authority 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 so that the retort operator can observe that they are functioning properly.

(v) Venting and condensate removal. The air in the retort shall be removed before processing is started. Heat distribution data or other documentation from the manufacturer or from the processing authority who deve!oped the venting procedure shall be kept on file by the establishment and made available to Program employees for review. At the time the steam is turned on, the drain shall be opened to remove steam condensate from the retort. A bleeder shall be installed in the bottom of the shell to remove condensate during the retort operation. 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.

(vi) Retort speed timing. The rotational speed of the retort shall be specified in the process schedule. The speed shall be adjusted as specified, and recorded by the establishment when the retort is started, and checked and recorded at intervals not to exceed 4 hours to ensure that the correct retort speed is maintained. Alternatively, a recording tachometer may be used to provide a continuous record of the speed. If a recording tachometer is used, the speed shall be manually checked against an accurate stopwatch at least once per shift and the results recorded. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

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

(4) Hydrostatic retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a) (1) and (2) of this section. Additionally, indicating temperature devices shall be located in the steam dome near the steam/water interface. Where the process schedule specifies maintenance of particular water temperatures in the hydrostatic water legs, at least one indicating temperature device shall be located in each hydrostatic water leg so that it can accurately measure water temperature and be easily read. The temperature/time recorder probe shall be installed either within the steam dome or in a well attached to the dome. Each probe shall have a 1/16 inch (1.6 mm) or larger bleeder opening which emits steam continuously during the processing period. Additional temperature/time recorder probes shall be installed in the hydrostatic water legs if the process schedule specifies maintenance of particular temperatures in these water legs.

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

(iii) Steam inlet. The steam inlets shall be large enough to provide steam for proper operation of the retort.

(iv) Bleeders. Bleeder openings 1/4 inch (or 6 mm) or larger shall be located in the steam chamber(s) opposite the point of steam entry. Bleeders shall be wide open and shall emit steam continuously during the entire process, including the come-up time. All bleeders shall be arranged in such a way that the operator can observe that they are functioning properly.

(v) Venting. Before the start of processing operations, the retort steam chamber(s) shall be vented to ensure removal of air. Heat distribution data or other documentation from the manufacturer or from a processing authority demonstrating that the air is removed from the retort prior to processing shall be kept on file at the establishment and made available to Program employees for review.

(vi) Conveyor speed. The conveyor speed shall be calculated to obtain the required process time and recorded by the establishment when the retort is started. The speed shall be checked and recorded at intervals not to exceed 4 hours to ensure that the correct conveyor speed is maintained. A recording device may be used to provide a continuous record of the conveyor speed. When a recording device is used, the speed shall be manually checked against an accurate stopwatch at least once per shift by the establishment. A means of preventing unauthorized speed changes of the conveyor shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

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

(c) Pressure processing in water—(1) Batch still retorts. (i) The basic requirements for indicating temperature devices and temperature/time recording devices are described in paragraphs (a)(1) and (2) of this section. Additionally, bulbs or probes of indicating temperature devices shall be located in such a position that they are beneath the surface of the water throughout the process. On horizontal retorts, the indicating temperature device bulb or probe shall be inserted directly into the retort shell. In both vertical and horizontal retorts, the indicating temperature device bulb or probe shall extend directly into the water a minimum of 2 inches (or 5 cm) without a separable well or sleeve. In vertical retorts equipped with a recorder/controller, the controller probe shall be located at the bottom of the retort below the lowest crate rest in such a position that the steam does not strike it directly. In horizontal retorts so equipped, the controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for direct steam impingement on the controller probe. Air-operated temperature controllers shall have filter systems to ensure a supply of clean, dry air.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority demonstrating uniform heat distribution within the retort shall be kept on file at the establishment and made available to Program employees for review.

(v) Crate supports. A bottom crate support shall be used in vertical retorts. Baffle plates shall not be used in the bottom of the retort.

(vi) Stacking equipment. For filled flexible containers and, where applicable, semirigid containers, stacking equipment shall be designed to ensure that the thickness of the filled containers does not exceed that specified in the process schedule and that the containers do not become displaced and overlap or rest on one another during the thermal process.

(vii) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(viii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). For retorts requiring complete immersion of containers, water shall cover the top layer of containers during the entire come-up time and thermal processing periods and should cover the top layer of containers during cooling. For retorts using cascading water or water sprays, the water level shall be maintained within the range specified by the retort manufacturer or processing authority during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the water level at intervals to ensure it meets the specified processing parameters.

(ix) Air supply and controls. In both horizontal and vertical still retorts, a means shall be provided for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(x) Water recirculation. When a water recirculation system is used for heat distribution, the water shall be drawn from the bottom of the retort through a suction manifold and discharged through a spreader that extends the length or circumference of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running, and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution or other documentation from a processing authority and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used, provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(2) Batch agitating 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, the indicating temperature device bulb or probe shall extend directly into the water without a separable well or sleeve. The recorder/controller probe shall be located between the water surface and the horizontal plane passing through the center of the retort so that there is no opportunity for steam to directly strike the controller bulb or probe.

(ii) Pressure recording device. Each retort shall be equipped with a pressure recording device which may be combined with a pressure controller.

(iii) Steam controllers are required as described in paragraph (a)(3) of this section.

(iv) Heat distribution. Heat distribution data or other documentation from the equipment manufacturer or a processing authority shall be kept on file by the establishment and made available to Program employees for review.

(v) Stacking equipment. All devices used for holding product containers (e.g., crates, trays, divider plates) shall be so constructed to allow the water to circulate around the containers during the come-up and thermal process periods.

(vi) Drain valve. A nonclogging, water-tight drain valve shall be used. Screens shall be installed over all drain openings.

(vii) Water level. There shall be a means of determining the water level in the retort during operation (i.e., by using a gauge, electronic sensor, or sight glass indicator). Water shall completely cover all containers during the entire come-up, thermal processing, and cooling periods. A means to ensure that water circulation continues as specified throughout the come-up, thermal processing, and cooling periods shall be provided. The retort operator shall check and record the adequacy of the water level with sufficient frequency to ensure it meets the specified processing parameters.

(viii) Air supply and controls. Retorts shall be provided with a means for introducing compressed air or steam at the pressure required to maintain container integrity. Compressed air and steam entry shall be controlled by an automatic pressure control unit. A nonreturn valve shall be provided in the air supply line to prevent water from entering the system. Overriding air or steam pressure shall be maintained continuously during the come-up, thermal processing, and cooling periods. If air is used to promote circulation, it shall be introduced into the steam line at a point between the retort and the steam control valve at the bottom of the retort. The adequacy of the air circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review.

(ix) Retort or reel speed timing. The retort or reel speed timing shall be checked before process timing begins and, if needed, adjusted as specified in the process schedule. In addition, the rotational speed shall be determined and recorded at least once during process timing of each retort load processed. Alternatively, a recording tachometer can be used to provide a continuous record of the speed. The accuracy of the recording tachometer shall be determined and recorded at least once per shift by the establishment by checking the retort or reel speed using an accurate stopwatch. A means of preventing unauthorized speed changes on retorts shall be provided. For example, a lock or a notice from management posted at or near the speed adjustment device warning that only authorized persons are permitted to make adjustments are satisfactory means of preventing unauthorized changes.

(x) Water recirculation. If a water recirculation system is used for heat distribution, it shall be installed in such a manner that water will be drawn from the bottom of the retort through a suction manifold and discharged through a spreader which extends the length of the top of the retort. The holes in the water spreader shall be uniformly distributed. The suction outlets shall be protected with screens to keep debris from entering the recirculation system. The pump shall be equipped with a pilot light or a similar device to warn the operator when it is not running and with a bleeder to remove air when starting operations. Alternatively, a flow-meter alarm system can be used to ensure proper water circulation. The adequacy of water circulation for maintaining uniform heat distribution within the retort shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. Alternative methods for recirculation of water in the retort may be used provided there is documentation in the form of heat distribution data or other documentation from a processing authority maintained on file by the establishment and made available to Program employees for review.

(xi) Cooling water entry. In retorts for processing product packed in glass jars, the incoming cooling water should not directly strike the jars, in order to minimize glass breakage by thermal shock.

(d) Pressure processing with steam/air mixtures in batch retorts. (1) The basic requirements 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 for indicating temperature devices and temperature/time recording devices or controller probes shall be inserted directly into the retort shell in such a position that steam does not strike them directly.

(2) Steam controllers are required as described in paragraph (a)(3) of this section.

(3) Recording pressure controller. A recording pressure controller shall be used to control the air inlet and the steam/air mixture outlet.

(4) Circulation of steam/air mixtures. A means shall be provided for the circulation of the steam/air mixture to prevent formation of low-temperature pockets. The efficiency of the circulation system shall be documented by heat distribution data or other documentation from a processing authority, and such data shall be maintained on file by the establishment and made available to Program employees for review. The circulation system shall be checked to ensure its proper functioning and shall be equipped with a pilot light or a similar device to warn the operator when it is not functioning. Because of the variety of existing designs, reference shall be made to the equipment manufacturer for details of installation, operation, and control.

(e) Atmospheric cookers—(1) Temperature/time recording device. Each atmospheric cooker (e.g., hot water bath) shall be equipped with at least one temperature/time recording device in accordance with the basic requirements described in paragraph (a)(2) of this section.

(2) Heat distribution. Each atmospheric cooker shall be equipped and operated to ensure uniform heat distribution throughout the processing system during the thermal process. Heat distribution data or other documentation from the manufacturer or a processing authority demonstrating uniform heat distribution within the cooker shall be kept on file by the establishment and made available to Program employees for review.

(f) Other systems. All other systems not specifically delineated in this section and used for the thermal processing of canned product shall be adequate to produce shelf-stable products consistently and uniformly.

(g) Equipment maintenance. (1) Upon installation, all instrumentation and controls shall be checked by the establishment for proper functioning and accuracy and, thereafter, at any time their functioning or accuracy is suspect.

(2) At least once a year each thermal processing system shall be examined by an individual not directly involved in daily operations to ensure the proper functioning of the system as well as all auxiliary equipment and instrumentation. In addition, each thermal processing system should be examined before the resumption of operation following an extended shutdown.

(3) Air and water valves that are intended to be closed during thermal processing shall be checked by the establishment for leaks. Defective valves shall be repaired or replaced as needed.

(4) Vent and bleeder mufflers shall be checked and maintained or replaced by the establishment to prevent any reduction in vent or bleeder efficiency.

(5) When water spreaders are used for venting, a maintenance schedule shall be developed and implemented to assure that the holes are maintained at their original size.

(6) Records shall be kept on all maintenance items that could affect the adequacy of the thermal process. Records shall include the date and type of maintenance performed and the person conducting the maintenance.

(h) Container cooling and cooling water. (1) Potable water shall be used for cooling except as provided for in paragraphs (h) (2) and (3) of this section.

(2) Cooling canal water shall be chlorinated or treated with a chemical approved by the Administrator as having a bactericidal effect equivalent to chlorination. There shall be a measurable residual of the sanitizer in the water at the discharge point of the canal. Cooling canals shall be cleaned and replenished with potable water to prevent the buildup of organic matter and other materials.

(3) Container cooling waters that are recycled or reused shall be handled in systems that are so designed, operated, and maintained so there is no buildup of microorganisms, organic matter, and other materials in the systems and in the waters. System equipment, such as pipelines, holding tanks and cooling towers, shall be constructed and installed so that they can be cleaned and inspected. In addition, the establishment shall maintain, and make available to Program employees for review, information on at least the following:

(i) System design and construction;

(ii) System operation including the rates of renewal with fresh, potable water and the means for treating the water so that there is a measurable residual of an acceptable sanitizer, per paragraph (h)(2) of this section, in the water at the point where the water exits the container cooling vessel;

(iii) System maintenance including procedures for the periodic cleaning and sanitizing of the entire system; and

(iv) Water quality standards, such as microbiological, chemical and physical, monitoring procedures including the frequency and site(s) of sampling, and the corrective actions taken when water quality standards are not met.

(i) Post-process handling of containers Containers shall be handled in a manner that will prevent damage to the hermetic seal area. All worn and frayed belting, can retarders, cushions, and the like shall be replaced with nonporous materials. To minimize container abrasions, particularly in the seal area, containers should not remain stationary on moving conveyors. All post-process container handling equipment should be kept clean so there is no buildup of microorganisms on surfaces in contact with the containers.

[51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]

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) Process records. Charts from temperature/time recording devices shall be identified by production date, container code, processing vessel number or other designation, and other data as necessary to enable correlation with the records required in §318.306. Each entry on a record shall be made at the time the specific event occurs, and the recording individual shall sign or initial each record form. No later than 1 working day after the actual process, the establishment shall review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, shall be signed or initialed and dated by the person conducting the review. All processing and production records required in this subpart shall be made available to Program employees for review.

(b) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems shall be designed and operated in a manner that will ensure compliance with the applicable requirements of §318.306.

(c) Container closure records. Written records of all container closure examinations shall specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records shall be signed or initialed by the container closure technician and shall be reviewed and signed by the establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart shall be made available to Program employees for review.

(d) Distribution of product. Records shall be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended use.

(e) Retention of records. Copies of all processing and production records required in §318.306 shall be retained for no less than 1 year at the establishment, and for an additional 2 years at the establishment or other location from which the records can be made available to Program employees within 3 working days.

[51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000]

(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) must be handled according to:

(1)(i) A HACCP plan for canned product that addresses hazards associated with microbial contamination, or,

(ii) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(iii) Paragraph (d) of this section.

(c) [Reserved]

(d) Procedures for handling process deviations where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.

(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.

[51 FR 45619, Dec. 19, 1986, as amended at 53 FR 49848, Dec. 12, 1988; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, Sept. 5, 2000]

(a) Finished product inspections must be handled according to:

(1) A HACCP plan for canned product that addresses hazards associated with microbiological contamination;

(2) An FSIS-approved total quality control system;

(3) Alternative documented procedures that will ensure that only safe and stable product is shipped in commerce; or

(4) Paragraph (d) of this section.

(b)–(c) [Reserved]

(d) Procedures for handling finished product inspections where the HACCP plan for thermally processed/commercially sterile product does not address food safety hazards associated with microbial contamination, where there is no approved total quality control system, or where the establishment has no alternative documented procedures for handling process deviations.

(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.

[51 FR 45619, Dec. 19, 1986, as amended at 57 FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, Sept. 5, 2000]

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.

[51 FR 45619, Dec. 19, 1986]

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.

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