Comments needed on FDA’s proposed registration requirements


The FDA is proposing a new regulation that amends the current requirements for any business that holds, stores, manufactures, or processes food (termed “food facility”) to register each location with the FDA.

The Tester-Hagan amendment to the federal Food Safety Modernization Act sought to reduce the sfarmers-market-jarscope of this pre-existing requirement by exempting any food business that sells the majority of its food directly to consumers at locations such as roadside stands and farmers markets. The amendment directed FDA to develop a list of other direct-to-consumer venues that would be considered, and the agency has developed a rather comprehensive list.  But the FDA’s proposed rule only exempts farms selling at such direct-to-consumer locations  — leaving many small artisan food producers subject to unnecessary regulation.

In addition, for those businesses that must register, the proposed rule requires electronic registration and a contact email address.  The proposed rule also requires that every food business also register with Dun & Bradstreet’s system to get a universal number, which is then also filed with the FDA. …

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