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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization Act May 2018

Final

Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization Act

Docket Number:
FDA-2018-D-1378
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine

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”.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28).  This guidance document is intended to assist small entities in complying with the final rule entitled “The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules” (81 FR 52284). The rule is binding and has the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Guidance

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Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1378.