The GAO did a performance audit of FDA’s food advisory and recall process from May 2011 to July 2012 and found significant problems.
Oct. 8
FDA misses deadline to start registrations
By Coral Beach, Staff Writer
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 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.
Oct. 29
FDA begins facility registration 21 days late
By Coral Beach, Staff Writer
Operators of food facilities could begin registering (and re-registering) with the Food and Drug Administration as of Oct. 22 — three weeks after the deadline imposed by the Food Safety Modernization Act.
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.
Nov. 12
GAO tells FDA to rethink certification
By Tom Karst, National Editor
The Food and Drug Administration can’t oversee global food imports on its own and should not plan on relying on third-party certifications — letting rules already in place in exporting countries to ensure food safety.
A new report from the U.S. Government Accountability Office calls on the FDA to better oversee food imports by leveraging other countries’ food safety resources.
The FDA could use regulations in other countries to ensure food safety rather than mandate third-party food safety inspections, according to the report.
The GAO said the FDA must establish a voluntary user-fee program for importers that encourages third-party certification. Encouraging importers to pay for the voluntary service will be a challenge, according to the GAO.
David Acheson, former FDA associate commissioner for food protection and partner in Leavitt Partners, Washington, D.C., said establishing an equivalency program for the many different produce items alone would take years to do.
Acheson said he believes the GAO report puts pressure on the FDA to develop a private-sector third-party audit system and accreditation process.
Whether the FDA intends to recognize third-party food safety audits is not yet known, he said.
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