PART 430—REQUIREMENTS FOR SPECIFIC CLASSES OF PRODUCT Authority: 7 U.S.C. 450; 7 U.S.C. 1901-1906; 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53. Source: 68 FR 34224, June 6, 2003, unless otherwise noted. § 430.1 Definitions. Antimicrobial agent. L. monocytogenes, L. monocytogenes Antimicrobial process. L. monocytogenes, Deli product. Hotdog product. Lethality treatment. Post-lethality exposed product. Post-lethality processing environment. Post-lethality treatment. Prerequisite program. Ready-to-eat (RTE) product. § 430.4 Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products. (a) Listeria monocytogenes L. monocytogenes L. monocytogenes, L. monocytogenes. L. monocytogenes L. monocytogenes 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. and L. monocytogenes. (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. or L. monocytogenes. (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, (A) Provide for testing of food contact surfaces in the post-lethality processing environment to ensure that the surfaces are sanitary and free of L. monocytogenes (B) Identify the conditions under which the establishment will implement hold-and-test procedures following a positive test of a food-contact surface for an indicator organism; (C) State the frequency with which testing will be done; (D) Identify the size and location of the sites that will be sampled; and (E) Include an explanation of why the testing frequency is sufficient to ensure that effective control of L. monocytogenes (iv) An establishment that chooses this alternative and uses a post-lethality treatment of product will likely be subject to more frequent verification testing by FSIS than if it had chosen Alternative 1. An establishment that chooses this alternative and uses an antimicrobial agent or process that suppresses or limits the growth of L. monocytogenes (3) Alternative 3. (i) If an establishment chooses this alternative, its sanitation program must: (A) Provide for testing of food contact surfaces in the post-lethality processing environment to ensure that the surfaces are sanitary and free of L. monocytogenes (B) Identify the conditions under which the establishment will implement hold-and-test procedures following a positive test of a food-contact surface for an indicator organism; (C) State the frequency with which testing will be done; (D) Identify the size and location of the sites that will be sampled; and (E) Include an explanation of why the testing frequency is sufficient to ensure that effective control of L. monocytogenes (ii) An establishment producing a deli product or a hotdog product, in addition to meeting the requirements of paragraph (b)(3)(i) of this section, must meet the following requirements: (A) The establishment must verify that the corrective actions that it takes with respect to sanitation after an initial positive test for L. monocytogenes (B) During this follow-up testing, if the establishment obtains a second positive test for an indicator organism, the establishment must hold lots of product that may have become contaminated by contact with the food contact surface until the establishment corrects the problem indicated by the test result. (C) In order to release into commerce product held under this section, the establishment must sample and test the lots for L. monocytogenes L. monocytogenes. L. monocytogenes (iii) An establishment that chooses Alternative 3 is likely to be subject to more frequent verification testing by FSIS than an establishment that has chosen Alternative 1 or 2. An establishment that chooses Alternative 3 and that produces deli meat or hotdog products is likely to be subject to more frequent verification testing than one that does not produce such products. (c) For all three alternatives in paragraph (b): (1) Establishments may use verification testing that includes tests for L. monocytogenes Listeria (2) Sanitation measures for controlling L. monocytogenes L. monocytogenes (3) The establishment must maintain sanitation in the post-lethality processing environment in accordance with part 416. (4) If L. monocytogenes L. monocytogenes (5) If L. monocytogenes (6) If the measures for addressing L. monocytogenes (7) The establishment must make the verification results that demonstrate the effectiveness of the measures it employs, whether under its HACCP plan or its Sanitation SOP or other prerequisite program, available upon request to FSIS inspection personnel. (d) [Reserved] (e) An establishment that controls L. monocytogenes [68 FR 34224, June 6, 2003, as amended at 80 FR 35188, June 19, 2015]