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CSPI questions process in FDA’s decision not to enforce certain FSMA provisions

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The Center for Science in the Public Interest (CSPI) is exploring whether FDA followed process when it announced on Jan. 4 that it will not enforce certain Food Safety Modernization Act (FSMA) requirements.

When FDA announced the change in January, the agency issued a guidance outlining key areas where it intends to exercise enforcement discretion related to four FSMA rules: the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food; the Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption rule; and the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals rules.

The provisions reflect some of the trickier, and more problematic aspects of the FSMA rules, such as the definition of “farm,” and the written company-to-company food safety assurances required under FSMA.

Other areas identified for enforcement discretion within the guidance include the Foreign Supplier Verification Program (FSVP) requirements for importers of food contact substances, and the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food.

According to Laura MacCleery, CSPI’s director of regulatory affairs, the problem is that FDA did not follow typical procedures. The agency came out with a final guidance announcing the enforcement discretion on aspects of four FSMA-related rules, without first issuing a draft guidance or seeking any public comment, which MacCleery called “troubling.”

“It’s unusual for an agency to do that,” MacCleery said. “Here they didn’t take public input and that is troubling.”

FDA had extended the compliance dates in August 2016 for many of the provisions covered by the enforcement discretion guidance. But FDA Commissioner Scott Gottlieb said in January that the decision to exercise enforcement discretion would reduce burdens on both industry and government and give the agency a chance to chart the “most effective and efficient way forward” in these FSMA areas.

“While this enforcement policy is in place, FDA will consider the most effective and practical approaches to address issues that have been raised since the FSMA rules became final and provide long-term certainty for stakeholders,” the agency said earlier this year. 

But the agency has outlined no timeline for resolving these issues.

CSPI criticized the decision immediately, noting that it would undermine key FSMA rules and ultimately threaten to expose consumers to food hazards, such as Salmonella and E. coli.

“FSMA was intended to cover the entire food chain, from farm to fork, and the Trump administration’s new guidance would create a gap in that safety chain by exempting, at least for now, some of those who harvest, package, and hold food produced on farms,” wrote Peter Lurie, the group’s director and president.

The group now is looking into the possibility of challenging the guidance, possibly based on the unusual approach that FDA took in issuing it.

According to MacCleery, the question is whether FDA is trying to “undo a final rule with a guidance” and whether it is appropriate for the agency to do that, MacCleery said.

“That is a question that we are still trying to answer,” she said.

The lack of time for public comment is also problematic, MacCleery noted.

When the agency issued the guidance, it stated that the change is effective immediately, “because FDA has determined that prior public participation is not feasible or appropriate,” but that is not the typical process that government agencies normally follow, MacCleery said.

CSPI is also studying the FDA decision for enforcement discretion in an effort to determine exactly what impact the change would have on the public health.

“It would have been easier to understand the impact, if we had been given time for public comment,” MacCleery said. 


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