U.S – The U.S. Food and Drug Administration (FDA) has issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA).
This was influenced by the comments and questions it received from stakeholders as it began implementing these rules.
“In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health. As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance,” clarified the FDA
The provisions include rules under Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for both Human Food and Animal Food, Foreign Supplier Verification Program (FSVP), Produce Safety (PSR), and Intentional Adulteration (IA).
In many instances, this guidance builds upon previously announced enforcement policies.
The purpose of the guidance document is to state that at this time and based on the agency’s current understanding of the risks, the FDA does not intend to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.
The applicable requirements are established in FDA’s regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR Part 507); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR Part 117); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L (FSVP)); “Mitigation Strategies to Protect Food Against Intentional Adulteration” (21 CFR Part 121); and “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112).
Section II of the document describes certain enforcement discretion policies that were issued previously and are relevant to the enforcement policies discussed in sections III.B and III.C.
Section III describes new or extended enforcement discretion policies. Section III. A describes the extension of FDA’s enforcement discretion in certain circumstances when a receiving facility that is a contract manufacturer/processor is not in compliance with certain supply-chain program requirements for food manufactured for a brand owner.
Section III.B describes the agency’s intent not to enforce requirements of the Intentional Adulteration regulation for facilities under the preexisting farm-activity related enforcement policy.
It also announces that FDA does not intend to enforce the Intentional Adulteration regulation’s requirement for reanalysis in certain circumstances— for example, when there is a single failure that is addressed through the implementation of corrective action procedures.
Further, Section III.C describes that FDA does not intend to enforce the supplier approval and verification requirements in part 117, part 507, and the FSVP regulation with regard to supplier compliance with requirements that are already associated with an enforcement discretion policy.
The FDA underscored that the contents of the guidance are not in any way binding, unless specifically incorporated into a contract.