The U.S. Food and Drug Administration (FDA) on March 11 issued new guidance announcing its intent to exercise enforcement discretion for several requirements in the regulations implementing the Food Safety Modernization Act (FSMA).
Per FDA’s policy, the agency does not intend to enforce certain requirements as they currently apply to entities or activities covered within the guidance during the enforcement discretion period.
The new guidance extends or builds upon previously announced enforcement policies, and addresses the following areas:
1. Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds:
The new guidance maintains FDA policy previously issued on March 28, 2019 in which the agency announced its intent to not enforce Produce Safety Rule – 21 CFR 112 – requirements for entities growing, harvesting, packing, or holding almonds, hops, pulse crops, or wine grapes while the agency considers rulemaking to address the unique circumstances of these commodities.
2. Enforcement Policy for Certain Entities Subject to Current Good Manufacturing Practice (CGMP) and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Program (FSVP) Requirements:
FDA’s announcement extends the guidance issued by the agency on January 4, 2018 that outlines enforcement discretion for: 1) facilities that would be considered farms except for certain factors and activities; 2) written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health; 3) the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and 4) FSVP requirements for importers of food contact substances.
3. Enforcement Policy for Supply-Chain Program Requirements Applicable to CoManufacturers of Human Food and Animal Food:
The guidance formally extends FDA’s enforcement discretion guidance that technically expired on Nov. 6, 2019 for certain supplychain program requirements that apply to co-manufacturers of human and/or animal food.
4. Enforcement Policy for Certain Entities and Requirements Under the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) Regulation:
The guidance announces new enforcement discretion policies for FDA’s IA Rule for certain types of facilities and activities. Significantly, FDA’s IA rule exempts from requirements facilities that solely manufacture, process, pack or hold animal feed and pet food. In addition, the final rule exempts facilities, such as grain elevators, that solely store food (e.g., grain) that may be destined for human consumption, except the holding of food in liquid storage tanks. However, the rule also expressly exempts from requirements the storage of mineral oil in liquid storage tanks and its application to raw whole grains or oilseeds.
5. Enforcement Policy for Supplier Approval and Verification Requirements in Part 117 (Human Food), Part 507 (Animal Food), and the FSVP Regulations:
The guidance establishes new enforcement discretion policy for receiving facilities and FSVP importers who are required to verify their supplier’s compliance with the requirements under FDA’s FSMArelated human food, animal food, and produce safety regulations. The policy states that if a supplier is subject to enforcement discretion for compliance with these regulations, then the receiving facility or FSVP importer does not have to verify its supplier’s compliance in areas for which their supplier is under enforcement discretion,
— From the March 18 National Grain and Feed Association (NGFA) Newsletter