FDA produce safety rules now in the hands of the OMB

02/16/2012 07:09:00 PM
Scott Christie

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.

For now, it is out of FDA’s hands, Kluting said, although he thinks the OMB could pass the information along any day now.

“While the deadline has passed and we didn’t get anything, they have written many, if not all, of these regulations,” Kluting said.

“FDA thinks, and rightfully so, or expects, that its work has been done and is waiting for issuance or approval from OMB.”

Included in those documents are the proposed rules for the Produce Safety Standards, which are to have a comment period and a final rule one year from its orginal release, Kluting said.

“I think the comment period might be narrowed, but it will still provide time for meaningful comment,” he said.

The industry also is waiting on Foreign Supplier Verification requirements, the Voluntary Qualified Importer Program and Protection Against Intentional Adulteration, as well as a list of high-risk products that will use data from the Reportable Food Registry, Kluting said. Items on that list will have to create a consumer-friendly report that stores will have to display identifying reportable foods, but the guidelines for how and where that report will be presented to consumers also is waiting on OMB approval.Kluting encouraged growers and processors to prepare for upcoming FSMA deadlines even though the final rules are not approved.

Requirements such as a Foreign Supplier Verification program and a Hazard Analysis and Critical Control Points program could leave companies on the hook if they don’t have one in place by the deadline, even without published guidance documents.

“I would encourage folks to evaluate the implications of FSMA on your existing regulatory compliance programs,” he said.

“The inspection mandate was effective as of Jan. 11, so you have a much higher probability of inspection than before FSMA.”


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