2. Implementing FSMA stalls out

12/28/2012 12:43:00 PM
Fred Wilkinson

Year in Produce 2012The landmark Food Safety Modernization Act became law, but questions concerning fees coupled with parallel efforts of the Produce Traceability Initiative left many taking a “wait and see” approach to implementation.

Feb. 20
Roadblocks stall FDA food safety rules
By Scott Christie, Special to The Packer

GRAND RAPIDS, Mich. — Now more than a year old, the Food Safety Modernization Act brought a focus on preventing foodborne illness outbreaks and recalls.

Some of the provisions in the act became effective immediately, including giving the Food and Drug Administration mandatory recall authority, and increased inspections and records access, said Steve Kluting, partner and co-chairman of the Food Law Group of Varnum Law Firm.
Food Law Group offered a seminar on the FSMA Feb. 15 to growers and processors in the Grand Rapids area.

Kluting said the FDA’s produce safety rules and guidances are completed and are expected soon. The agency has reportedly submitted documents to the White House Office of Management and Budget.

Aug. 6
GAO report urges FDA to clarify recall protocol
By Tom Karst, National Editor

When it comes to the Food and Drug Administration’s new power to force a food recall, the agency isn’t saying how and when it plans to use that authority — or if it will even share that information with the food industry.

According to a report from the Government Accountability Office, the FDA believes the Food Safety Modernization Act doesn’t even require the agency to release information on what would trigger a mandatory recall or how it would be handled.

The GAO report recommends that the FDA issue regulations or industry guidance to clarify the new recall process. The Food Safety Modernization Act gives the FDA the power to recall food and medical products. Before, and used only in rare cases, the FDA could shut a company down for food safety violations but not force a product recall.

Oct. 1
FDA officials say agency ‘embraces change’
By Coral Beach, Staff Writer

Many are frustrated that the produce rule from the Food and Drug Administration has been stuck in the Office of Management and Budget for months, but the agency has taken other action related to requirements in the Food Safety Modernization Act.

The agency published eight new guidance documents and three rules in the Federal Register in the past year and a half.

The FSMA includes 90 so-called deliverables in the form of rules, notices, reports to Congress and other actions.

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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