FDA misses deadline to begin food facility registrations

10/03/2012 12:59:34 PM
Coral Beach

As of Oct. 1 “food facilities” were supposed to begin registering and re-registering with the Food and Drug Administration, but on that day the agency announced it was not yet ready to begin accepting registrations — and officials do not know when it will be ready.

The requirement is part of the Food Safety Modernization Act and applies to all facilities, foreign and domestic, that “manufacture, process, pack, or hold food for human or animal consumption in the United States,” according to the FDA.

The registration period is supposed to be from Oct. 1 through Dec. 31. New facilities must register and facilities that have registrations on file are required to re-register this year and again in every even-numbered year.

But until the FDA finalizes “related guidance documents and implement(s) certain policies and processes” no one will be allowed to register or re-register, said FDA trade press liaison Sebastian Cianci.

Cianci said as of Oct. 1 FDA officials had not yet decided whether the Dec. 31 registration deadline will be extended.

“FDA is considering this issue and will announce its decision in the near future,” Cianci said.

Who must register?

The FDA’s frequently asked questions Web page about the registration process that 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.

Gombas 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.

National Editor Tom Karst contributed to this report.

Comments (2) Leave a comment 

When I read the message on FDA's website it says: Biennial Registration RENEWALS are not being accepted... It does NOT say first time accounts are not accepted. We called FDA yesterday and where told new accounts are just working fine and we could sign up.
What's Mr. Gombas problem to understand clear language or talk to FDA? Is it another misinformation to the industry? It says clear who has to register too: The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003.

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Domestic facilities are required to register whether or not food from the facility enters interstate commerce.

Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

Here is the link the organizations should send to their members if they terested in helping them: www.access.fda.gov/