The first step for most farms trying to navigate the Food Safety Modernization Act (FSMA) is to determine whether or not a specific rule applies to their farm operation. When it comes to the Preventive Controls for Human Food (“Preventive Controls”) rule, farmers now have some additional clarity on whether or not they are exempt. The Food and Drug Administration (FDA) recently released the final guidance document, “Questions and Answers Regarding Food Facility Registration” (“Food Facility Registration”), which explains who must register with the FDA under the rule. If a farm business does not have to register with the FDA, then it is exempt from the Preventive Controls rule.

While farms are exempt from the Preventive Controls rule, some of the activities a farm business might partake in could fall under the rule, so understanding the details is important. Read NSAC’s Who is Subject to FDA’s New FSMA Food Facilities Rule? – Part 1 for more information about what activities are and are not exempt from registration under the Preventive Controls rule.

The National Sustainable Agriculture Coalition (NSAC) submitted formal comments on both Preventive Controls final rule and the draft guidance on the “farm definition” in an effort to ensure that these rules worked well for farmers, food producers and processors, and consumers alike. In submitting our comments on the Food Facility Registration guidance, we utilized analyses conducted for prior comments, as well as feedback from our member organizations. NSAC was pleased to find that many of our recommendations were incorporated into the final guidance, though we believe there are still challenges of clarity that remain to be addressed.

Incorporated NSAC Recommendations

The Food Facility Registration final guidance includes NSAC’s recommendations to:

• Define “farm mixed-type facility” the first time it is used in the document, providing an additional reference for farms who are trying to determine whether or not they are required to register. Farms that are mixed-type facilities are required to register with FDA.
• Define “retail food establishment” the first time it is used in the document. A farm’s activities may be exempt because they fall under the “retail food establishment” definition.
• Add language stating farms do not have to register with the FDA if they are placing labels directly on raw agricultural commodities (RACs), or boxes containing RACs.
• Add language clarifying what facilities are exclusively regulated by the USDA and are therefore exempt from registration.

There were several question and answer examples to which NSAC requested modifications, however, that are not included in the Food Facility Registration final guidance. One particularly confusing example, for example, fails to explain that a packing facility cannot use the farm exemption if no owner is a farmer.

FDA also took into consideration our recommendation to reword language about the role of an owner of a shared use facility. The draft Food Facility Registration guidance document inaccurately stated that an owner of a shared use facility is required to either confirm that each food-producing business is registered with FDA or register the entire facility. The language in the draft guidance also caused confusion because it inferred the owner could force all food business tenants, regardless of their exemption status, to register. The final Food Facility Registration guidance document did not directly address this issue, but FDA has addressed it in a new Supplemental Questions and Answers Regarding Food Facility Registration: Draft Guidance for Industry (“supplemental draft guidance”). NSAC will be analyzing and commenting on the supplemental draft guidance in the coming days. Comments on the supplemental draft guidance are being accepted until October 19, 2018.

Need for Further Clarity Remains

While the final Food Facility Registration guidance provides important clarifications for farmers trying to navigate FSMA rules, there are still a few question and answer examples in it that remain unclear. Unfortunately, FDA did not adopt our requests for other changes that would have addressed some of these; for example, creating an additional guidance document and adding language to make some of the confusing aspects of the farm definition clear. Specifically, NSAC requested clarity on the “ownership” and “one general physical location” requirements of the farm definition. That said, FDA does plan to issue a new rule regarding the farm definition in the next year.

Recently, FDA decided to use discretion when enforcing the Preventive Controls rule for certain types of secondary activities farms. NSAC recommended the final Food Facility Registration guidance document include language confirming FDA will use discretion when it comes to enforcing the Preventive Controls rule for farm businesses that are very close to meeting the secondary farm activities definition; but the final guidance fails to include this clarification.

Some farm businesses that already registered with the FDA based on misinformation or insufficient information are now trying to navigate how to cancel this registration. Additionally, some farmers have been asked to provide a written justification with their cancelation requests. NSAC recommended that FDA issue a statement to make it clear no written justification is required to cancel a registration; the final guidance document does not include this request. FDA also neglected to add additional language that NSAC requested instructing farm businesses falling under a revised farm definition on how to cancel their registration.

Disappointingly, there is also no additional guidance for receiving facilities about the verification requirements for their suppliers. Without this important clarification some receiving facilities might require exempt farms to comply with onsite audits, which were specifically prohibited by FSMA. Also, without this additional guidance, receiving facilities might require nonexempt farms to comply with duplicative requirements.

The final guidance document is a strong step toward providing clear information on the Preventive Control rule registration requirement, but additional guidance and clarity is still necessary in order for all farm businesses to understand when they must comply with the rule and when they are exempt.