The Food and Drug Administration last week issued several draft guidance documents and one final guidance document relating to rules under the Food Safety Modernization Act (FSMA). The documents cover supplier verification and supply chain controls under the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF) rule.
“IDFA is pleased that FDA has finally issued this much-anticipated guidance on supply chain controls and the FSVP rule,” said John Allan, vice president of regulatory affairs and international standards at IDFA, “but given the volume of content provided, we will need to review these documents carefully to ensure our outstanding questions have been answered and FDA’s expectations for the industry are both reasonable and practical.”
Foreign Supplier Verification Programs
This guidance, presented in a question-and-answer format, attempts to address many questions frequently asked by industry, such as:
- What to do if multiple entities meet the definition of “importer” for a particular food;
- The role of corporate headquarters for supplier verification and handling FSVP for intra-company shipments;
- FSVP requirements for importers who also are receiving facilities under the preventive controls regulations;
- How to comply with the supplier evaluation requirements; and
- The role that third parties can play to assist importers with their supplier verification responsibilities.
Read FDA’s “The Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Draft Guidance for Industry.”
Small Entity Compliance Guide
The Small Entity Compliance Guide is final and effective immediately. It provides an overview of the FSVP regulation and a discussion of the foods covered by the regulation, with a focus on the modified procedures for very small importers or importers of food from certain small foreign suppliers. This regulation applies to importers and foreign suppliers of limited sizes, which the FDA further defines in the guidance.
Read FDA’s “Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide.”
Draft Guidance on Public Health Protection
This guidance addresses the term “same level of public health protection” that is used in both the FSVP regulation and the Produce Safety regulation. The aim is to provide a framework for determining the adequacy of a process, procedure or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food.
Read FDA’s draft guidance on public health protection here.
Supply-Chain Program for Human Food Products
FDA has released a draft Chapter 15 of the Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food, which focuses on supply-chain programs under the PCHF rule. The draft guidance includes recommendations for receiving facilities establishing and implementing supply-chain programs for their suppliers, and is aligned for the most part with the FSVP guidance.
Read FDA’s “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.”
FSVP for Grain Raw Agricultural Commodities
In addition, FDA also issued a guidance announcing the agency’s intention to exercise enforcement discretion, effective immediately, with regard to the application of the FSVP regulation to importers that are solely engaged in the storage of grain raw agricultural commodities (RACs) intended for further distribution or processing, and grain RACs importers that do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing. This rule may apply to dairy companies who use imported grains in their products. This enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the PCHF rules.
Read FDA’s “Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.”
Hazard Analysis and Risk-Based Preventive Controls for Animal Food
FDA has released the first five chapters of its draft guidance intended to assist animal food facilities to comply with the PCAF rule. The chapters cover: (1) food safety plan requirements; (2) recommendations for conducting a hazard analysis; (3) hazards associated with the manufacturing, processing, packing, and holding of animal food; (4) examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and (5) preventive control management components. FDA also announced that forthcoming guidance for the PCAF rule will include an in-depth guidance on supply-chain programs.
Read FDA’s “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Guidance for Industry.”
Comments on the first five chapters of the PCAF guidance are due to FDA by July 23, 2018. IDFA is requesting feedback from members through its regulatory committees and will develop comments to FDA, as needed.
For additional information or to provide comments, contact Allan at firstname.lastname@example.org.
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from Hogan Lovells US LLP, IDFA’s outside legal counsel.