FDA Enforcement Discretion
Wednesday, February 7, 2018
In early January the FDA published Guidance for the Industry to state the intent of the FDA not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. This is also referred to as Enforcement Discretion. This announcement applies to registered facilities that are only packing or holding RACs and perform activities that are performed on farms, even if as a company they don’t meet the farm definition due to ownership requirements. This is in part due to the Georgia Fruit and Vegetable Growers Association as well as other leading produce trade organizations raising complex questions about relevant factors, such as farm-related activities and farm ownership, that impact the determination of whether an entity is a “farm” as well as other issues. This consistent conversation emphasized the need for additional regulatory guidance and/or changes to the regulations to provide practicality, clarity and certainty to the regulated industry. The announcement was posted in the Federal Register but FDA has created an easy to read Fact Sheet that is a good starting point.
To put this into a little more context, in August 2016 FDA extended the compliance date for facilities that fell under the Preventive Controls Rule for Human Foods “solely engaged in” packing or holding RACs so that it aligned with the compliance dates for the Produce Safety Rule. This was done to give FDA time to resolve issues associated with having similar activities regulated under the different rules and provisions found in the Produce Safety Rule, Current Good Manufacturing Practices in the Preventive Controls for Human Foods Rule, and the Foreign Supplier Verification Programs Rule. However, FDA is still working to resolve the issue through rulemaking, which takes a lot of time. (Bonus, FDA announced they will not inspect farms until spring of 2019 without cause.)
Specifically, this FDA compliance policy guidance announced FDA “enforcement discretion” regarding:
Definition of Secondary Activities Farm
· Facilities that would qualify as secondary activities farms except for the ownership of the facility (e.g., certain produce packinghouses and warehouses);
Farm & Secondary Activity Farm Activities
· Facilities that would qualify as farms if they did not color RACs;
· Facilities that would qualify as secondary activities farms except that they pack, package, label, and/or hold processed food that consists only of RACs that have been dried/dehydrated to create a distinct commodity (e.g., dried beans);
Written assurances under the “customer provisions”
Certain human food by-products for use as animal food
It is strongly recommended that GFVGA member companies review this policy guidance in its entirety to determine its applicability to their business specific situation. It is recommended all operations should also consider consulting legal counsel before implementing and procedures, policies or practices to determine your legal rights and responsibilities and to determine compliance to the Federal Food Drug and Cosmetic Act as well as applicable local, county and state laws.
United Fresh hosted a webinar that’s now posted on YouTube entitled, “Farm vs. Facility Update Webinar”, sponsored by Ecolab. A playback recording of this webinar is available here: https://youtu.be/wADqKdHQtp4. Specifically, the focus of the webinar was the recent enforcement discretion guidance, and the FDA draft guidance on facility registration (question O4 is quite relevant)!