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Industry to FDA: Go slow on mandating finished-product testing

by Joan Murphy | April 26, 2011

SILVER SPRING, MD — The U.S. Food & Drug Administration should not mandate finished-product testing when it writes new preventive control rules under the federal food safety law, according to Robert Guenther, senior vice president of public policy for the United Fresh Produce Association, based in Washington.

The FDA held a daylong public meeting April 20 to give stakeholders an opportunity to comment on a critical element of the Jan. 4 law: a provision that requires registered facilities to evaluate hazards and identify and implement preventive controls to minimize food-safety risks.

The agency has 18 months to draft a regulation that will require food facilities to follow preventive controls, the focus of the public meeting.

The FDA is also working on a regulation that would set requirements for preventing intentional contamination, which would apply to dairy, produce farms and packing facilities, Don Kraemer, acting deputy director of the Center for Food Safety & Applied Nutrition, said at the morning session.

The FDA is writing a separate regulation for produce safety on farms and packinghouses, and an additional regulation for preventing food-safety mishaps during transportation of food, he said. The transportation regulation applies to transporters and businesses that ship and receive food, Mr. Kraemer explained.

But the focus of the April 20 meeting was the preventive control regulations for facilities.

The produce industry is concerned about looming requirements for finished-product testing. It is one of many tools companies use to verify their processes, but if not properly defined, testing can lead to unreliable information, warned Mr. Guenther.

Another food representative echoed Mr. Guenther’s comments later at the meeting.

John Allan, director of regulatory and international affairs at the American Frozen Food Institute, said, “Industry and FDA efforts should focus on ensuring that preventive measures are properly designated and effective rather than utilizing resources to try to detect the rare positive food sample coming off a production chain.”

After a general morning session, the FDA hosted six breakout sessions to learn the industry’s opinions on critical elements of the rule. Among the hot issues on which the FDA is looking for input are on-farm manufacturing and the definition of small and very small businesses.

While the preventive-control regulations may be one of the more critical to making the new law work, the FDA is tasked with developing 50 regulations, guidance documents and reports required by Congress in three years.

In response, the agency has created the following committees staffed with FDA personnel that are driving the rule’s implementation: Prevention Standards, which includes the product safety regulation and guidance; Inspections and Compliance; Imports: Federal/State Integration; Fees; and Reports & Studies.