The FDA has released a Small Entity Compliance Guide for FSMA which provides clarification on compliance dates and information on extensions.
On August 24, 2016, FDA published in the Federal Register a final rule that extended the dates for compliance with certain provisions in four final rules:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117);
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507);
- Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption (21 CFR Part 112); and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1, Subpart L).
FDA extended the compliance dates of these four rules to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. The final rule became effective on August 24, 2016.
On January 5, 2018, FDA issued a guidance document entitled: “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry”. This guidance document states the intent of FDA not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.
The January 2018 guidance document covers essentially all of the regulatory provisions addressed in the August 2016 final rule:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117);
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507);
- Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption (21 CFR Part 112); and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1, Subpart L).
Entities seeking additional detail on FDA’s policy regarding its intent not to enforce the regulatory provisions discussed in the August 2016 final rule should consult the January 2018 final guidance entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry” on the Food Safety Modernization Act on fda.gov.
Read the full announcement here.
Download full Compliance Guide
