The rule makes electronic registration mandatory (with the availability of a waiver process) beginning Jan. 4, 2020. The next biennial registration period will be Oct. 1 through Dec. 31, 2016.

FDA Rule Requires Registration of Food Facilities

Erwin C. Miller, chief of the Data Systems Integration Branch in FDA's Center for Food Safety and Applied Nutrition, says the measure supports FDA's ability to respond quickly to food-related emergencies.

The U.S. Food and Drug Administration has finalized another rule to implement the Food Safety Modernization Act, with this one requiring the registration of domestic and foreign facilities that manufacture, process, pack, or hold food for consumption by people or animals in the United States. Facilities will be required to provide a unique facility identifier number by Oct. 1, 2020, as part of the registration process, which will allow FDA to verify the facility-specific address. FDA will issue a guidance document to support compliance with the UFI requirement, Erwin C. Miller, M.S., chief of the Data Systems Integration Branch in FDA's Center for Food Safety and Applied Nutrition, wrote in a blog post last week.

He said the rule's requirements "will be invaluable in providing the FDA with more accurate information about facility locations and information about the activities within facilities—thus aiding investigators in responding to foodborne illness outbreaks or earthquakes, floods, or other disasters. The final rule will also help the agency identify high-risk facilities and ensure that personnel with the proper training are dispatched to conduct an inspection.

"While there is no fee for registration, some in the food industry submitted comments stating that certain aspects of the proposed rule would be too burdensome," Miller added. "In response to these comments, the agency has postponed the requirement for mandatory electronic registrations and the submission of a UFI to 2020 to ensure that facilities have ample time to comply."

The registration rule affects establishments located on farms and "farm-operated businesses" by expanding the definition of a "retail food establishment," which is not required to register as a food facility. Congress, through the act, directed FDA to amend this definition. (Under the final rule, a farm-operated business is a business managed by one or more farms and that conducts manufacturing/processing not on the farm.)

"The registration of food facilities has long been considered a key component of food safety. The September 2001 terrorist attacks highlighted the need to enhance the security of the infrastructure of the United States, including the food supply," Miller explained.

The rule also makes electronic registration mandatory (with a waiver process being available) beginning Jan. 4, 2020. The next biennial registration period will be Oct. 1 through Dec. 31, 2016.

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