FDA Finally Releases Proposed FSMA Rules

Nearly a year after they were originally anticipated, two of the rules needed for full implementation of the Food Safety Modernization Act have finally been released by the FDA: the produce safety and preventive controls — considered by many to be the most important of the five awaiting release.

Weighing in at more than 1,200 pages, the rules are comprehensive to say the least. Several days after their initial release on January 4, food safety experts and industry analysts were still poring over the document for all their nuances. (Public comments are due to the agency by May 16.)

Initial reaction was generally positive. “We’ve long been advocating and agitating to get these rules out, and an initial review makes it clear that the FDA made a real effort to ensure that the rules are consistent with food safety practices that are current within the industry,” said Tom O’Brien, a lobbyist for the Produce Marketing Association, which will soon announce a webinar to discuss the proposed rules. “They also said that it does not make sense to include finished product testing in the rule, which I think goes to show how much homework they did on produce safety.”

Some of the potential problems with the rules, O’Brien noted, stem from the original legislative language. For example, the so-called “Tester Amendment,” allowing for qualified exemptions, is interpreted in the rule to apply to foreign farms as well as domestic. “That may be controversial and may not have been what the law’s Congressional supporters intended, but it flows from the language of the law.”

The rules were generally what the public had expected, said Michael Doyle, PhD, regent professor of microbiology and director of the Center for Food Safety at the University of Georgia. “The produce rule basically codifies the gaps and focuses on hazard analysis and preventive controls. It’s interesting to me that the preventive controls rule includes importer companies. Who’s going to have the oversight to ensure that these businesses are complying? How many countries will let us have our inspectors there?”

Dr. Doyle was skeptical of exuberant press commentary that suggests that the rules (the final three are anticipated soon) will solve the U.S. food safety problems. “This raises the bar on food safety and should reduce the number of outbreaks and recalls, but it won’t eliminate them. Still, I hope this will give consumers assurance that more is being done to ensure the safety of their food.”

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