July 3, 2012

FSMA Rules Remain Under OMB Review

Editor’s Note:  OMB’s careful review of the draft FDA regulations, despite limited staff, is deserving of praise and is important to the long term safety of the food supply.

From: Food Safety News

More Deadlines Missed as FSMA Rules Remain Stalled at OMB

Key food safety rules have now been under administration review for 6 months

by Helena Bottemiller

Food safety advocates remain frustrated and confused as central Food Safety Modernization Act rules have failed to advance more than six months after they were sent to the White House Office of Management and Budget.

Under FSMA, which President Obama signed in January 2011, the U.S. Food and Drug Administration was directed to churn out a final rule for a foreign supplier verification program and a proposed produce safety rule (for “high risk” produce) by January. As of this week, the foreign supplier verification program was supposed to be established and one of the law’s most important elements, the preventative controls requirement, was supposed to take effect.

But these three rules–and another regarding animal feed–are all going to miss their deadlines because they are still under review at OMB’s Office of Information and Regulatory Affairs, where, many speculate, some unknown combination of technical issues and politics is holding them hostage. It is normal for major regulations to head to OIRA, where they undergo a cost-benefit analysis, but it is not normal for non-controversial rules, like FSMA, to linger for longer than three months. (Under a 1993 executive order issued by President Clinton, OIRA has 90 days to review a draft regulation, 120 days with an extension. The FSMA rules were submitted in Dec. 2011).

For the past several months, food manufacturers, consumer advocates, victims of foodborne illness, and the produce industry have all called for the rules to be released, to no avail.

After years of fighting for the landmark law, which aimed to shift the food safety system from reactive to preventative, advocates are concerned that it’s being implemented too slowly. For food growers, packers, and processors, the hold up amounts to more regulatory uncertainty.

“We just don’t understand why this administration, which supported the bill and even threatened to veto an ag appropriations bill, wouldn’t let these proposals move forward,” said Sandra Eskin, director of the Pew Health Group Food Safety Campaign.

Eskin said she was well aware of the election year speculation–that perhaps nothing will move forward until after the presidential election–but said she thought the provisions should be a no-brainer for the administration.

“Ensuring the safety of the food supply is an essential function of government,” said Eskin, noting that polling data has shown that voters across parties agree. “This is a smart thing to do. It’s not regulatory, it’s public health protection.”

In lieu of any major rulemaking action, the discussion has turned to how FDA might enforce key provisions of the new law before rules are drafted, commented on, negotiated, and finalized.

The Grocery Manufacturers Association wrote to the FDA in early May asking that the agency clarify whether it would enforce the preventive controls part of the law, which would require most food processors to create and put in place preventive food safety plans, on the 18 month deadline (this week) or wait until the rulemaking process yielded a final rule to enforce. The group also wanted to know what the agency was planning to do about the foreign supplier verification program.

“I am writing on an issue of significant importance to the food industry,” wrote Leon Bruner, GMA’s senior vice president for scientific and regulatory affairs. Bruner noted that Taylor had said that “FDA would not enforce the new, substantive requirements in the new Preventative Controls and FSVP provisions until the Agency had issued final regulations implementing those sections of the law, and allowed time for companies to come into compliance with those regulations.”

Bruner asked for confirmation, in writing, that that was the case, adding that “GMA strongly endorses this approach.”

“There is great uncertainty within the food industry, consumer advocates, the media and the public regarding this issue,” wrote Bruner.

He urged FDA to publish a written position on the issue, as Micheal Landa, FDA’s director of the Center for Food Safety and Applied Nutrition, had suggested during a recent Food and Drug Law Institute meeting.

The Snack Food Association also sent a letter in late May on behalf of several food industry groups–including the American Frozen Food Institute, the American Bakers Association, and the National Fisheries Institute–urging FDA to issue a guidance “as soon as possible” with a timeline on enforcement.

The letter stated that the groups believe it “makes perfect sense” to delay enforcement on the new requirements until the final rules are issued, but said that it was essential that the agency put its “enforcement posture” in writing.

The letter added that the delay and uncertainty was causing increasing anxiety and concern within the food industry: “Although our industry supported passage of this legislation, it was with the understanding that there would be an orderly transition from the old system to the new one.”

Michael Taylor, Deputy Commissioner for Foods at FDA replied to both letters on June 18, confirming that it is the agency’s intention to not enforce either provision until there’s a final rule on the books.

“FDA is committed to full and timely implementation of FSMA and will be issuing proposed rules to implement sections 103 and 301,” wrote Taylor. “Those rules, when final, will contain provisions that clarify industry’s responsibilities and will foster compliance with FSMA’s new requirements in an orderly and effective manner. FDA will expect to enforce compliance with these new FSMA requirements in timeframes that will be described in the [final] rules.”

But section 103 of the law, which covers preventive controls, seems to suggest that whether or not the rules are finalized, food facilities have to identify hazards and put preventive controls in place by this week.

One of GMA’s online FSMA documents, prepared by law firm Hogan Lovells, flags the issue: “Note that under the statute, these requirements are effective after 18 months even if FDA has not yet issued regulations.”

The Center for Science in the Public Interest wrote FDA last week urging the agency to enforce Section 103 regardless of rulemaking holdup, saying the group was “deeply disappointed” that the agency had decided to delay enforcement.

“Section 103 requires food facilities to conduct a hazard analysis and implement preventive controls that will reduce the number of illnesses caused by foodborne hazards. Congress wrote the section to be self-executing, meaning its provisions are effective without the need of an intervening action by the agency to implement them,” wrote Caroline Smith DeWaal, CSPI’s director of food safety and David Plunkett, a senior staff attorney at CSPI in their letter.

The letters are available online:
Snack Food Association to FDA

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