During a Wednesday morning conference call, Erwin Miller, chief of the Data Systems Integration Branch for FDA’s Center for Food Safety and Applied Nutrition, said the changes will improve the accuracy of the registration database in the U.S. and overseas.
He said key elements of the amendments to the rule will codify certain provisions in the Food Safety Modernization Act (FSMA), which was enacted in 2011.
The amended regulations, which affect “registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States …,” are scheduled to be published today in the Federal Register.
“These amendments will further enhance FDA’s capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources,” the agency’s notice stated.
Among other things, the changes will require:
email addresses from registrants;
registration renewals every two years on even-numbered years;
assurance that FDA can inspect food facilities according to federal law;
permit electronic records submission by January 2020, and
require unique food facility identifiers by 2020.
Further, the definition of retail food establishments is being revised so some will not be required to file information with FDA as retail food facilities. There is also clarification about the annual monetary value of food product sales to consumers under the rule, Miller said.
He noted that, in some instances, food facility information submitted to FDA has been falsified, so the agency is trying to make it more difficult for unauthorized individuals to register facilities.
In stressing the federal agency’s roles regarding partnership, education and training, Miller said FDA will be issuing guidance on the final rule in the near future.
“FDA is committed to working cooperatively with the food establishments to facilitate an understanding of the rules,” he said.
In a question-and-answer session at the end of the call, one participant asked about the required unique facility identifiers (UFIs) that FDA will provide to make sure companies’ correct information is being registered with the agency. She said that some facility registrations were canceled in the past due to incorrect information.
“What happens is when we get multiple registrations with the same address, we have to vet that out,” Miller replied.
Another participant asked how FDA will verify the information submitted via an online facility registration form, how long it will take, and whether the agency will notify registrants about what type of problem might have caused a delay in registration.
“One of the things that the agency will strive to do is guidance through the process,” Miller said. “This will not be implemented until 2020, which gives us time so that whatever we decide to do will be in the best interests of the industry and will not be a burden to the requirements.”
He suggested facility owner/operators, registered agents and others contact the FDA’s help desk — FDA Unified Registration and Listing Systems, or FURLS — for more information and/or technical assistance.
