to be taken which would avoid recontamination of fully-cooked patties by less-than-fully-cooked cooked product during processing. (ii) To prevent indirect contamination of fully-cooked patties: (A) Any work surface, machine, or tool which contacts other product shall be cleaned and sanitized before it contacts unpackaged fully-cooked patties. The sanitizer shall be germicidally equivalent to 50 ppm chlorine. (B) Employees shall wash their hands with soap and water and sanitize their hands whenever they enter the fullycooked patty area or before handling unpackaged, fully-cooked patties. They must also wash and sanitize their hands whenever they become contaminated during operations to avoid contamination of fully-cooked patties. The sanitizer shall be germicidally equivalent to 50 ppm chlorine. (C) All employee outer garments, including aprons, smocks, and gloves shall be identified as restricted for use in the fully-cooked area only. The employee shall change garments at least daily. The garments shall be hung in a designated location before the employee leaves the area. (iii) Fully-cooked patties stored in the same room with other product, shall first be packaged or covered to prevent microbial contamination. (iv) Fully-cooked, partially-cooked, and char-marked patties shall be stored at a chamber temperature of 40 F or below. (c) Requirements for handling heating or cooling deviations. (1) If for any reaon a heating or cooling deviation has iccurred, the official establishment hall investigate and identify the ause; take steps to assure that the deiation will not recur; and place on file In the official establishment, available o any duly authorized representative f the Secretary, a report of the invesigation, the cause of the deviation, nd the steps taken to prevent recurence; and (2) In addition, in the case of a heatng deviation, the official establishhent may (i) reprocess the affected roduct, by a method in paragraph b)(1)(i) in this section, or (ii) use the ffected product as an ingredient in anther product processed to one of the temperature and time combinations in paragraph (b)(1)(i) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics, or (iii) relabel the affected product as a partially-cooked patty product, if it meets the partially-cooked requirements in paragraph (b)(1)(ii) of this section. (3) In addition, in the case of a cooling deviation, contact the Regional Director to determine the disposition of the product. [58 FR 41151, Aug. 2, 1993] $318.24 Compliance procedures for meat derived from advanced meat/ bone separation machinery and recovery systems. (a) The product resulting from the separating process shall not have a calcium content exceeding 0.15 percent or 150 mg/100 gm of product within a tolerance of 0.03 percent or 30 mg, as prescribed in §301.2(rr)(2) of this subchapter. (b) To verify the calcium content in meat derived from advanced meat/bone separation machinery and recovery systems, a compliance program consisting of the following parameters shall be followed by manufacturers of meat defined in §301.2(rr)(2) of this subchapter. (1) An analysis of a sample of at least 1 pound from each lot shall be performed by the operator of the establishment or his or her agent. For purposes of this paragraph, a lot shall consist of the meat derived from advanced meat/bone separation machinery and recovery systems, designated as such by the operator of the establishment or his or her agent, from the product produced from a single species of livestock in no more than one continuous shift of up to 12 hours. Individual results from the chemical analyses shall be compared to the calcium limit, prescribed in paragraph (a) of this section, in order to demonstrate compliance. If compliance is not demonstrated, that is, if any single analytical result is 1 more than 0.18 percent, 2 before product from a production lot that is still at the establishment or one that is subsequently produced can be considered to be in compliance, at least three samples from that production lot shall be taken and analyzed for calcium, either separately, or, at the option of the establishment, as a composite (i.e., combining the three samples for analysis). The average of the results or the composite result must be less than or equal to 0.15 percent. Taking three samples from each subsequently produced lot and analyzing them in order to demonstrate compliance shall continue until five consecutive lots have mean or composite results less than or equal to 0.15 percent. If the statistical evidence indicates that a production lot is not in compliance with the calcium limit, as prescribed in §301.2(rr)(2) of this subchapter, the lot must be labeled as MS(S) and meet all of the requirements for MS(S) in §319.5 of this subchapter. (2) The management of the establishment must maintain records to support the validity of the calcium content (as a measure of bone solids) to assure the process is in control. Such records shall be made available to the inspector or any other duly authorized representative of the Agency upon request. (Recordkeeping requirements were approved by the Office of Management and Budget under control number 0583-0095.) [59 FR 62561, Dec. 6, 1994] The value 0.18 percent was derived by multiplying by 3 the expected analytical standard deviation obtained by FSIS laboratories on the approved chemical procedure for measuring calcium which uses Ethylenediaminetetraacetic acid (EDTA) as provided in the "Official Methods of Analysis of the AOAC International" (formerly the Association of Official Analytical Chemists), 15th Ed. (1990). 2 Individual or an average of results shall be rounded to the nearest 0.01 percent calcium. Subparts B-F [Reserved] Subpart G-Canning and Canned Products 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. E (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. (1) 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. Airtight 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. (1) 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. (0) 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. condition (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 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. $318.301 Containers and closures. (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; 40 |