SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a revised draft guidance for industry entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” We are issuing the revised draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

In the Federal Register of February 7, 2008 (73 FR 7293), we made available a draft guidance for industry entitled “Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods” (the 2008 draft Listeria guidance). The recommendations in the 2008 draft Listeria guidance were intended to complement the requirements in a regulation entitled “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food,” which had been established in part 110 (21 CFR part 110). The recommendations in the 2008 draft Listeria guidance also were intended to assist processors of refrigerated and frozen RTE foods in meeting the requirements in part 110 with respect to the control of L. monocytogenes. We gave interested parties an opportunity to submit comments by April 7, 2008, for us to consider before beginning work on the final version of the guidance. We received several comments on the 2008 draft Listeria guidance.

Since issuing the 2008 draft Listeria guidance, we conducted rulemaking to amend the current good manufacturing practice (CGMP) requirements in part 110 to modernize them and establish them in new part 117 (21 CFR part 117), subparts A, B, and F (80 FR 55908, September 17, 2015). Part 117 (entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”) also includes new requirements (in subparts A, C, D, E, F, and G) for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to establish and implement hazard analysis and risk-based preventive controls for human food (the human food preventive controls requirements). The new human food preventive controls requirements are part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). We also discussed certain recommendations in the 2008 draft Listeria guidance with our Food Advisory Committee during a meeting held on December 7 and 8, 2015 (80 FR 69229, November 9, 2015 and Ref. 1).

We have revised the 2008 draft Listeria guidance to reflect the comments we received on that draft guidance, the amended CGMP requirements now established in part 117, the new human food preventive controls requirements established in part 117, and the recommendations of our Food Advisory Committee (Ref. 2). The revised draft guidance is intended to explain our current thinking on procedures and practices to help food establishments that are subject to part 117 to: (1) Comply with the CGMP requirements of part 117 ( e.g., for personnel, buildings and facilities, equipment and utensils, and production and process controls) during the production of an RTE food that is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes; and (2) comply with certain human food preventive controls requirements regarding environmental pathogens in such RTE foods.

Part 117 defines “environmental pathogen” to mean a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen (21 CFR 117.3). Within that definition, L. monocytogenes is listed as an example of an environmental pathogen. The hazard analysis required by part 117 must include an evaluation of environmental pathogens whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen (§ 117.130(c)(1)(ii)). If the hazard analysis identifies L. monocytogenes as a hazard requiring a preventive control, the facility must identify one or more preventive controls to provide assurances that L. monocytogenes will be significantly minimized or prevented in the facility's food products and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the FD&C Act (§ 117.135(a)). In addition, the human food preventive controls requirements specify that, as appropriate to the facility, the food, and ( printed page 4805) the nature of the preventive control and its role in the facility's food safety system, the facility must conduct activities that include environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples (§ 117.165(a)(3)). The revised draft guidance includes recommendations for controls to significantly minimize or prevent L. monocytogenes in RTE foods, for sanitation controls to eliminate L. monocytogenes from the food production environment, and for environmental monitoring as verification of sanitation controls.

II. Paperwork Reduction Act of 1995

The revised draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB Control No. 0910-0751.

FDA tentatively concludes that the revised draft guidance also contains proposed information collection provisions that are subject to review by OMB under the PRA but are not included in the information collection approved under OMB Control No. 0910-0751. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice on the proposed collection of information in a future issue of the Federal Register .

III. Electronic Access

Persons with access to the Internet may obtain the revised draft guidance at either http://www.fda.gov/​FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

IV. References

The following references are on display at the Division of Dockets Management (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register , but Web sites are subject to change over time.

1. FDA. 2015. Food Advisory Committee Meeting, Charge and Questions. Topic: Addressing Listeria monocytogenes in Ready-To-Eat Foods, December 7-8, 2015. Available at http://www.fda.gov/​downloads/​AdvisoryCommittees/​CommitteesMeetingMaterials/​FoodAdvisoryCommittee/​UCM472842.pdf.

2. FDA. 2015. Food Advisory Committee (FAC) Recommendations. Topic: Addressing Listeria monocytogenes in Ready-To-Eat Foods, December 7-8, 2015. Available at http://www.fda.gov/​downloads/​AdvisoryCommittees/​CommitteesMeetingMaterials/​FoodAdvisoryCommittee/​UCM476521.pdf.