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FDA Tweaks Its Guidance on Food Facility Registration

FDA has released a revised guidance document on food facility registration: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition).  The revised guidance adds only one new question and answer to the 34-page guidance:

1.3 Q: [Added November 2014] Under the supplemental notice of proposed rulemaking for preventive controls for human food, FDA has proposed changing the farm definition for registration and other purposes.  Under the proposed change, a farm would no longer be required to register as a food facility solely because it packs or holds raw agricultural commodities grown on a farm under different ownership.  While the rulemaking is still ongoing, what is FDA’s policy regarding farms that also pack or hold raw agricultural commodities grown on a farm under different ownership?

A: FDA does not intend to prioritize enforcing the registration requirement in this circumstance.

This change is intended to reflect a proposed change in the definition of “farm” in FDA’s supplemental proposed rule on Preventive Controls for Human Food.  FDA is proposing that a farm that also packs or holds raw agricultural commodities (RACs) grown on another farm not under the same ownership is still a “farm” exempt from FDA registration.  This change in FDA’s position was urged by several stakeholders in the produce industry.

According to the Federal Register notice announcing the revised guidance, “FDA intends to make further updates to this guidance once certain FSMA rulemakings are final…”  If the supplemental proposed rule on Preventive Controls for Human Food is finalized as proposed, it would change the rules on FDA registration in a number of other ways.  For example, it would expand the definition of what is a “farm” exempt from FDA registration by expanding the activities by farms that would be considered “packing” or “holding” to include activities incidental to the packing of RACs (such as sorting, culling, grading, packaging, and labeling of RACs) and activities incidental to the storage of RACs (such as blending lots of the same RAC, fumigating RACs).  Again, these changes have been sought by stakeholders in the produce industry.

The revised guidance is effective immediately, but FDA accepts comments on guidance documents at any time.

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