The registration period was supposed to begin Oct. 1 and run through Dec. 31, but FDA officials were not ready. On Oct. 1, officials said they were still working on guidance documents related to the registration and re-registration process.
The agency posted one of those revised guidance documents, “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” Oct. 19. The revised categories include all fresh, fresh-cut and raw fruits and vegetables, as well as “other” unspecified fruit and vegetable products.
The FSMA requires new facilities to register now and in every even-numbered year. Facilities that have registrations on file are required to re-register this year and again in every even-numbered year going forward. Operators can register by mail or fax, but FDA encourages online registration at: http://tinyurl.com/register-facilities-here.
FDA trade press liaison Sebastian Cianci said on Oct. 2 that FDA officials had not yet decided whether the Dec. 31 registration deadline will be extended because the registration system wasn’t operational on time.
The agency did not address the Dec. 31 deadline in an Oct. 19 new release announcing the registration system would be up and running Oct. 22.
“The Food Safety Modernization Act improves the registration process by ensuring, among other things, that the FDA has accurate contact information for each facility,” states the Oct. 19 release. “The new registration form also includes new categories of foods. These new categories will help FDA rapidly communicate with the right facilities in the event of an emergency.”
Agency officials said in the release that food facilities have long been required to register with the agency. There is no registration fee.
Who must register?
The FDA’s frequently asked questions Web page about the registration process states: “At this time, the same types of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations.”
However, the FDA information includes a reminder that the Food Safety Modernization Act requires the agency to conduct a rulemaking to “clarify the activities that are included as part of the definition of the term ‘facility’…”
That clarification has some in the fresh produce industry wondering who will be required to register.
Dave Gombas, senior vice president for food safety for the Washington D.C.-based United Fresh Produce Association, said recently more detail is needed from FDA.
“My sense is that there is still confusion as to who has to register, particularly in the produce world,” Gombas said. While everyone knows that a fresh-cut processor must register, he said there are gray areas about on-farm and commercial packinghouses. “There is still some confusion about who is exempt and who is not exempt,” he said.
The FDA’s online information states the clarification rule will be proposed as part of the rulemaking for the preventive controls regulation, as provided by the Food Safety Modernization Act.