7 USC 450；7 USC 1901-1906；21 USC 451-470、601-695；7 美国联邦法规2.18、2.53。
68 FR 34224，2003年 6 月 6 日，除非另有说明。
抗菌剂。 A substance in or added to an RTE product that has the effect of reducing or eliminating a microorganism, including a pathogen such as L. monocytogenes, or that has the effect of suppressing or limiting growth of L. monocytogenes in the product throughout the shelf life of the product. Examples of antimicrobial agents added to RTE products are potassium lactate and sodium diacetate.
Antimicrobial process. An operation, such as freezing, applied to an RTE product that has the effect of suppressing or limiting the growth of a microorganism, such as L. monocytogenes, in the product throughout the shelf life of the product.
Deli product. A ready-to-eat meat or poultry product that typically is sliced, either in an official establishment or after distribution from an official establishment, and typically is assembled in a sandwich for consumption.
Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, or wiener, such as a product defined in 9 CFR 319.180 and 319.181.
Lethality treatment. A process, including the application of an antimicrobial agent, that eliminates or reduces the number of pathogenic microorganisms on or in a product to make the product safe for human consumption. Examples of lethality treatments are cooking or the application of an antimicrobial agent or process that eliminates or reduces pathogenic microorganisms.
Post-lethality exposed product. Ready-to-eat product that comes into direct contact with a food contact surface after the lethality treatment in a post-lethality processing environment.
Post-lethality processing environment. The area of an establishment into which product is routed after having been subjected to an initial lethality treatment. The product may be exposed to the environment in this area as a result of slicing, peeling, re-bagging, cooling semi-permeable encased product with a brine solution, or other procedures.
Post-lethality treatment. A lethality treatment that is applied or is effective after post-lethality exposure. It is applied to the final product or sealed package of product in order to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.
Prerequisite program. A procedure or set of procedures that is designed to provide basic environmental or operating conditions necessary for the production of safe, wholesome food. It is called “prerequisite” because it is considered by scientific experts to be prerequisite to a HACCP plan.
Ready-to-eat (RTE) product. A meat or poultry product that is in a form that is edible without additional preparation to achieve food safety and may receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. RTE product is not required to bear a safe-handling instruction (as required for non-RTE products by 9 CFR 317.2(l) and 381.125(b)) or other labeling that directs that the product must be cooked or otherwise treated for safety, and can include frozen meat and poultry products.
(a) Listeria monocytogenes can contaminate RTE products that are exposed to the environment after they have undergone a lethality treatment. L. monocytogenes is a hazard that an establishment producing post-lethality exposed RTE products must control through its HACCP plan or prevent in the processing environment through a Sanitation SOP or other prerequisite program. RTE product is adulterated if it contains L. monocytogenes, or if it comes into direct contact with a food contact surface that is contaminated with L. monocytogenes. Establishments must not release into commerce product that contains L. monocytogenes or that has been in contact with a food contact surface contaminated with L. monocytogenes without first reworking the product using a process that is destructive of L. monocytogenes.
(b) In order to maintain the sanitary conditions necessary to meet this requirement, an establishment producing post-lethality exposed RTE product must comply with the requirements included in one of the three following alternatives:
(1) Alternative 1. Use of a post-lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product and an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes. If an establishment chooses this alternative:
(i) The post-lethality treatment must be included in the establishment's HACCP plan. The antimicrobial agent or process used to suppress or limit the growth of the pathogen must be included in either the establishment's HACCP plan or its Sanitation SOP or other prerequisite program.
(ii) The establishment must validate the effectiveness of the post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The establishment must document, either in its HACCP plan or in its Sanitation SOP or other prerequisite program, that the antimicrobial agent or process, as used, is effective in suppressing or limiting growth of L. monocytogenes.
(2) Alternative 2. Use of either a post-lethality treatment (which may be an antimicrobial agent) that reduces or eliminates microorganisms on the product or an antimicrobial agent or process that suppresses or limits growth of L. monocytogenes. If an establishment chooses this alternative:
(i) The post-lethality treatment must be included in the establishment's HACCP plan. The antimicrobial agent or process used to suppress or limit growth of the pathogen must be included in either the establishment's HACCP plan or its Sanitation SOP or other prerequisite program.
(ii) The establishment must validate the effectiveness of a post-lethality treatment incorporated in its HACCP plan in accordance with § 417.4. The establishment must document in its HACCP plan or in its Sanitation SOP or other prerequisite program that the antimicrobial agent or process, as used, is effective in suppressing or limiting growth of L. monocytogenes.
(iii) If an establishment chooses this alternative and chooses to use only an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes, its sanitation program must:
(A)在杀菌后加工环境中对食品接触表面进行测试，以确保表面卫生且不含单核细胞增生李斯特菌或指示生物；
(乙)确定在食品接触表面对指示生物进行阳性测试后，企业将在何种条件下实施保留和测试程序；
（三）说明进行测试的频率；
（四）确定将被抽样的地点的大小和位置；和
(五)包括解释为什么测试频率足以确保维持对单核细胞增生李斯特菌或指示生物的有效控制。
(四)选择此替代方案并使用产品杀菌后处理的企业可能会比选择替代方案 1 更频繁地接受 FSIS 的验证测试。选择此替代方案并使用抗菌剂或工艺抑制或限制单核细胞增生李斯特菌的生长可能会比使用杀灭后处理更频繁地进行 FSIS 验证测试。
( 3 ) 备选方案 3. 仅使用卫生措施。
(一)如果企业选择此替代方案，其卫生计划必须：
(一)在杀菌后加工环境中对食品接触表面进行测试，以确保表面卫生且不含单核细胞增生李斯特菌或指示生物；
(乙)确定在食品接触表面对指示生物进行阳性测试后，企业将在何种条件下实施保留和测试程序；
（三）说明进行测试的频率；
（四）确定将被抽样的地点的大小和位置；和
(五)包括解释为什么测试频率足以确保维持对单核细胞增生李斯特菌或指示生物的有效控制。
(二)生产熟食产品或热狗产品的企业，除了满足本节(b)(3)(i)段的要求外，还必须满足以下要求：
(一)企业必须在杀菌后加工环境中对食品接触表面上的单核细胞增生李斯特氏菌或指示生物进行初步阳性检测后，验证其针对卫生采取的纠正措施是否有效，通过进行后续检测，包括对最有可能成为微生物污染源的食品接触表面区域的特定部位进行有针对性的测试，并在周围的食品接触表面区域进行必要的额外测试，以确保纠正措施的有效性。
(乙)在此后续测试期间，如果企业对指示生物进行第二次阳性测试，则企业必须持有可能因与食品接触表面接触而受到污染的产品批次，直到企业纠正测试结果指示的问题.
（三）为了将根据本节持有的产品投放市场，企业必须使用抽样方法和频率对批次进行单核细胞增生李斯特菌或指示生物的抽样和测试，该抽样方法和频率将提供一定水平的统计置信度，以确保每批没有掺假与单核细胞增生李斯特菌。企业必须记录此测试的结果。或者，企业可以使用对单核细胞增生李斯特菌或指示生物具有破坏性的工艺对保存的产品进行返工。
(三)选择备选方案 3 的企业可能比选择备选方案 1 或 2 的企业更频繁地接受 FSIS 验证测试。选择备选方案 3 并生产熟食肉类或热狗产品的企业可能需要接受更多比不生产此类产品的频繁验证测试。
(三)对于 (b) 段中的所有三个备选方案：
(一)企业可以使用验证测试，包括对单核细胞增生李斯特菌或指示生物（如李斯特菌）的测试，以验证其卫生程序在杀菌后处理环境中的有效性。
( 2 )用于控制单核细胞增生李斯特氏菌的卫生措施和用于抑制或限制病原体生长的抗菌剂或过程的程序可以纳入企业的 HACCP 计划或其卫生 SOP 或其他前提方案中。当这些控制程序被纳入卫生 SOP 或前提方案，而不是作为 HACCP 计划中的 CCP 时，企业必须有文件支持在其危害分析中做出的决定，即单核细胞增生李斯特菌不是合理可能的危害。发生。
( 3 )根据第 416 部分，企业必须在杀菌后处理环境中保持卫生。
( 4 )如果HACCP 计划中包含单核细胞增生李斯特菌控制措施，则企业必须根据§ 417.4验证和验证其 HACCP 计划中包含的单核细胞增生李斯特菌控制措施的有效性。
( 5 )如果卫生 SOP 中包含单核细胞增生李斯特菌控制措施，则必须根据§ 416.14评估措施的有效性。
( 6 )如果解决单核细胞增生李斯特菌的措施在除卫生 SOP 之外的前提方案中得到解决，则企业必须根据9 CFR 417.5将程序和程序产生的结果包含在文件中，要求企业保持。
( 7 )企业必须根据 FSIS 检验人员的要求提供验证结果，以证明其采用的措施（无论是根据其 HACCP 计划还是卫生 SOP 或其他前提方案）的有效性。
(四)[预订的]
( e )通过使用杀灭后处理或抗菌剂或消除或减少、抑制或限制生物体生长的工艺来控制单核细胞增生李斯特菌的企业可以在产品标签上声明这一事实，前提是该企业已验证声明.
[ 68 FR 34224，2003年 6 月 6 日，经80 FR 35188，2015年 6 月 19 日修订]
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