21 CFR Part 117, Subpart G - Supply-Chain Program

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the “small business” definition in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the “small business” definition.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.” This guidance states agency compliance policy regarding certain entities and/or activities related to the “farm” definition, written assurances, food contact substances, and human food by-products for use as animal food.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.” The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The newly available draft chapter is entitled “Chapter Six—Use of Heat Treatments as a Process Control.”

The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The revised draft guidance is intended for any person who is subject to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help such persons comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a 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 L. monocytogenes ) that would significantly minimize L. monocytogenes.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”—Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” This draft guidance explains our current thinking on disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules. This document describes our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of disclosure statements.

The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of September 17, 2015.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities; Draft Guidance for Industry.” The draft guidance, when finalized, will help food establishments determine whether the activities that they perform are within the “farm” definition established in our regulation for Registration of Food Facilities. Determining whether the activities a food establishment performs are within the “farm” definition plays a key role in determining whether its business is exempt from our regulations for Registration of Food Facilities, and from certain requirements in our regulations for “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.”

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food).” This draft guidance explains our current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (the Preventive Controls for Human Food Rule) or under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (the Preventive Controls for Animal Food Rule). This draft guidance also explains our current thinking on how a business would submit Form FDA 3942a attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule. We also are announcing an opportunity for public comment on the proposed collection of information embodied in Forms FDA 3942a and 3942b. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and allow 60 days for public comment in response to the notice.

The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” The final rule published with some editorial and inadvertent errors. This document corrects those errors.

The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” The final rule published with some editorial and inadvertent errors. This document corrects those errors.

The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade “A” milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Final Rules to Establish Requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food.” The public meeting will provide interested persons an opportunity to discuss the final rules for current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food (the preventive controls final rules) and FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act (FSMA) implementation, which involves putting in place the new public health prevention measures and the risk-based industry oversight framework that is at the core of FSMA. The purpose of the public meeting is to brief stakeholders and interested persons on the key components of the preventive controls final rules, respond to questions, and discuss the next phase of FSMA implementation with respect to human and animal food preventive controls requirements.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed revisions to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose significant changes to four of the proposed rules including: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs). The purpose of the public meeting is to solicit oral stakeholder and public comments on the new content of the supplemental proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the supplemental proposed rules.

The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3646), entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and its information collection provisions.

The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” that appeared in the Federal Register of January 16, 2013. We are taking this action to allow interested persons an opportunity to consider the interrelationships between this proposal and the two proposals announced in July 2013 on the Foreign Supplier Verification Program and on Accreditation of Third-Party Auditors/Certification Bodies. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendix in which all references are numbered incorrectly. This document corrects those errors.

The Food and Drug Administration (FDA or “we”) is reopening the comment period for a document entitled “Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013. We are reopening the comment period to update comments and to receive any new information.

The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection related to the proposed rule on “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.

The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related public meetings announced in the January 31, 2013, Federal Register . These public meetings will be held along with the February 28 to March 1, 2013, Washington, DC public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). These proposed rules are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule), which are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.