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FSMA Approaches Two-Year Anniversary as Components Languish

January 4, 2011 was a landmark day for food safety advocates nationwide. It was the day President Obama signed into law the first major piece of federal legislation concerning food safety since 1938: the 2011 Food Safety Modernization Act.

But as the act’s two-year anniversary approaches, many of its major components are stuck in the approval process, missing deadlines along the way. Critical pillars of the act – rules on fruit and vegetables, imports and outbreak prevention – remain stalled at the White House Office of Management and Budget. Neither OMB nor the U.S. Food and Drug Administration will provide a time frame for when the rules might be released.

Since the act’s signing at the start of 2011, Americans have been hit by 14 multistate foodborne illness outbreaks involving FDA-regulated products, resulting in 1,358 reported illnesses, 423 hospitalizations and 37 deaths. Had the FSMA rules been in place during that time period, some of those outbreaks may have been mitigated or even prevented altogether, said Sandra Eskin, director of the Pew Charitable Trusts Food Safety Campaign.

Granted, some of the rules will still take years to fully implement following their release, and some rules still have due dates as far out as 30 months after the signing of the bill. But for now, food safety advocates such as Eskin continue urging the OMB to finally release overdue FSMA rules for their public commenting period – the next step in the process for several lingering components.

Last Wednesday, Pew delivered a petition to the White House asking for this next step. The letter, addressed to President Obama and carrying 35,000 signatures, highlighted the U.S. Centers for Disease Control’s estimate that 3,000 Americans continue to die from foodborne illness every year.

The sooner the final rules of FSMA are implemented, Eskin said, the sooner the U.S. may see that number decline.

Upon receiving drafted rules from the FDA, OMB is granted 90 days to review them before releasing a draft proposal for public comment. The agency is allowed one 30-day extension if necessary, meaning that even with the extension, a number of FSMA rules should have been submitted to the public comment process around May 1, 2012.

The proposed rules for new produce safety standards were due at OMB on Jan. 4, 2012, one year after the signing of the bill. According to the Federal Register, FDA delivered those rules to OMB on Dec. 9, 2011.

Final rules on outbreak prevention requirements for domestic producers and verification rules for foreign food manufacturers were also due on Jan. 4, 2012. FDA submitted those in November 2011.

The status of those rules have all remained under wraps at OMB for more than a year.

“The bottom line is they are way late. Way late,” Eskin said. “It’s been incredibly frustrating for everyone involved.”

The Obama Administration has recently indicated that the lingering FSMA rules remain a high priority for OMB.

“The Obama Administration is committed to food safety and we have taken key steps including putting out a food safety rule cracking down on salmonella in eggs and expanding E. coli testing for beef,” an OMB spokeswoman wrote to the Huffington Post last month. “We are working as expeditiously as possible to implement the food safety legislation we fought so hard for. When it comes to rules with this degree of importance and complexity, it is critical that we get it right.”

“Publishing the FSMA rules is a priority for the [FDA],” an FDA spokeswoman told Food Safety News last month. “At this time, several key proposed rules are still under review by the Office of Management Budget. While the rule-making process can be complex and demanding, it will eventually provide for a framework that will have an enormous impact in modernizing the food safety system. We have made every effort to engage with all interested stakeholders throughout the process and will continue to do so after the rules are published.”

The agencies have, however, worked to successfully implement a number of FSMA measures that have already made tangible impacts on the safety of the U.S. food supply.

In November, the FDA used new powers granted under the FSMA to suspend the registration of Sunland Inc., a peanut butter processor responsible for a Salmonella outbreak in Trader Joe’s brand peanut butter starting in September. A suspended FDA registration prohibits the manufacturer from selling products anywhere in the U.S.

Had the FSMA been fully enacted by that time, the FDA would have had the power to suspend Sunland before any outbreak occurred at all, Eskin said. Rules still undergoing review include those that would allow the FDA to suspend facilities believed to pose a health threat, and Sunland is now known to have had a series of inspection problems in recent years.

“What the FSMA shows is that when you give the FDA the tools to be effective – like the ability to close a plant – it’s really effective,” Eskin said.

The FDA has also developed a consumer-friendly recall search engine, exercised its ability to detain food products suspected to pose a public threat undertaken its new responsibility of issuing reports to Congress. On its website, the agency has provided first year and second year progress reports as it continues to implement the FSMA rules in stages.

Pew has not received a response to its White House petition. When Eskin reads statements from the OMB and FDA about the complicated process behind implementing the FSMA, she said that they only reinforce that the government should finally submit the proposed rules to the public commenting process.

“You can do the best you can and then propose the rules and all those commentators will respond, question, and tweak what you proposed. That’s the way it works,” Eskin said. “There are very smart people at OMB and FDA, but there’s nothing like the people in the trenches.”

This story has been corrected to reflect that FDA submitted the produce safety rule to OMB in December 2011, not 2012.

© Food Safety News
  • Gail Millard

    Maybe the person to contact would be Mrs. Obama.  kind of brings into question how she feels about food safety with two daughters.