CFSAN Issues Updated Guidance on Food Facility Registration

FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016).

Publication of this draft guidance coincides with the 2016 Food Facility Registration biennial renewal period, which began on October 1, 2016, and will end on December 31, 2016.

This draft guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act.  Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with FDA and renew such registrations biennially in even-numbered years.

The draft guidance seventh edition essentially (i) adds information relating to the Food Facility Registration final rule, issued in July 2016; (ii) clarifies the revised definition of “farm” in the Preventive Controls for Human Food final rule, issued in September 2015; and (iii) addresses questions received from stakeholders since publication of the sixth edition.  The seventh edition is divided into 17 sections (with two to be completed prospectively), as follows:

  1. Who Must Register?
  2. Who Is Exempt from Registration? [Reserved]
  3. Definitions [Reserved]
  4. When Must You Register or Renew Your Registration?
  5. How and Where Do You Register or Renew Your Registration?
  6. What Information Is Required in the Registration?
  7. What Optional Items Are Included in the Registration?
  8. How and When Do You Update Your Facility’s Registration Information?
  9. How and When Do You Cancel Your Facility’s Registration Information?
  10. What Other Registration Requirements Apply?
  11. What Are the Consequences of Failing to Register, Renew, Update, or Cancel Your Registration?
  12. What Does Assignment of a Registration Number Mean?
  13. Is Food Registration Information Available to the Public?
  14. Waiver Request
  15. General Registration Questions
  16. Suspension of Registration
  17. Compliance Dates

This draft guidance, when finalized, will represent the current thinking of FDA on this topic, but will not establish any rights for any person and will not be binding on FDA or the public.  Food facilities may use an alternate approach if it satisfies the requirements of the applicable statute and regulations.

While comments may be submitted to FDA about guidance documents at any time, to be considered in finalizing this draft guidance, comments should be submitted by February 6, 2017.

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