Knowing if you are an entity that has to register with FDA is more important than ever. Much of what you have to do to comply with FSMA is linked to whether or not you have to register with FDA. So the fact that on July 13, FDA finalized a new FSMA registration rule is helpful. The final rule, Amendments to Registration of Food Facilities, updates the food facility registration (FFR) requirements and is intended to improve the utility of the FFR database to further enhance FDA’s capabilities to respond to food-related emergencies and provide FDA with information to better focus and better utilize its limited inspection resources. Since 2003, as a part of the Bioterrorism Act, food facilities that manufacture/process, pack or hold food for consumption in the United States have been required to register with the FDA. Now, this new final rule of FSMA adds additional requirements to that registration to improve the accuracy of the database and reduce fraud. Some of requirements took effect upon enactment of FSMA and are now simply being codified, while others have future effective dates. With the rule, food facility registration must include: The email address of the facility contact person for domestic facilities and of the U.S. agent for foreign food facilities. The type of activity conducted at the facility for each food product category. Assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. By Oct. 1, 2020, a unique facility identifier (UFI) for both domestic and foreign facilities; the final rule does not, however, require the submission of a DUNS number. Note: If FDA is unable to verify the UFI or to verify that the facility-specific address associated with the UFI is the same address associated with the registration, the facility would have the opportunity to fix the information in the registration or contact the UFI provider to resolve a discrepancy. Additional provisions of the final rule are: Food facilities must renew their registrations every two years, between October 1 and December 31 of each even-numbered year. This has, in fact, been in place since FSMA was signed in to law in 2011. By January 4, 2020, all registrations must be submitted electronically. The definition of a retail food establishment is expanded to include more establishments, thus increasing those that are not required to register. The rule now defines retail food establishments as those which sell/distribute food or food products directly to consumers at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; through a community supported agriculture program; any other such direct sales platform as determined by the Secretary. This revises the definition to be consistent with that of FSMA. Measures by which FDA can verify registration information and take steps to keep the FFR up to date by identifying additional circumstances under which FDA will cancel registrations, (such as the facility being out of business, having new owners, having not updated certain registration information, etc.) For both the electronic submission and email provision requirements, food facilities can submit written requests for waivers, with the request explaining why the requirement is not reasonable for the facility. Although the original rule proposed to shorten the timeframe for submitting updates and cancellations from 60 to 30 days, FDA retained the original 60-day requirement in response to numerous comments received on the issue. As such, updates to registration information or cancellation of registration must be submitted within 60 days of any change to any of the required information or the reason for the cancellation. FDA will be holding a webinar on August 3, 2016, on the final rule and plans to issue guidance on the rule. So, at least this new rule has added some clarity. But what we all desperately need from FDA is help, through guidance, of how the agency is looking at manufacturing and processing versus farm activities. This gray area is causing a lot of anguish with industry in relation to “Am I a farm or am I not a farm?” The answer is dependent on what you do and who owns the operation; but even when the grower owns the operation, it gets tricky in relation to the actual activity. My advice to those struggling with this is to pick a lane that you can justify and makes sense based on the regulations. Then wait for further guidance from FDA, and make adjustments as needed. As a final point, I hope that FDA will recognize the need for enforcement discretion when facilities don’t quite have it right because of the lack of clarity from FDA. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
