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How OMB Changed FSMA’s Import Rule

In October, the U.S. Food and Drug Administration posted the latest batch of Office of Management and Budget revisions on proposed Food Safety and Modernization Act (FSMA) rules. Consumer advocates were not pleased with what they saw.

The biggest changes OMB’s Office of Information and Regulatory Affairs (OIRA) made were with regard to the proposed rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

The post revealed that, in the original draft of the rule, FDA had planned to require on-site audits for all foreign suppliers of food subject to a “designated food safety regulation.”

OIRA offered two options instead. The first would require on-site audits for the most serious hazards while importers get to choose how to verify others. The second would allow the importer to choose the verification method for everything.

“They introduced options that FDA wasn’t considering, that are too weak,” Michael Patoka, a policy analyst for the Center for Progressive Reform, told Food Safety News. “The agency clearly thought on-site audits should be mandatory in almost every case.”

Other concerns have been raised about the exemptions OIRA added to the rule, in particular the ones offered to “very small importers” and “very small foreign suppliers,” which would only require written assurance of compliance rather than hazard-analysis and verification. FDA estimates that 59 percent of processed food suppliers and 93 percent of raw produce suppliers would fall under this category.

Patoka said that OIRA’s changes “produce pretty gaping holes in the rules coverage and expose Americans to a greater risk of foodborne illness from imported foods.”

CPR and other advocate groups argue that OIRA undermines the expertise of the FDA, overestimating costs and underestimating benefits.

“OIRA’s role is really supposed to be ensuring the agency analyzes the rule’s economic impact properly,” Patoka said. “What we’ve seen in this case, and in many others, is OIRA actually changes the substance of rules in very real ways – making these changes undermine the potential of these rules to really have a big impact on food safety.”

In Patoka’s view, the changes were made “to mollify the food industry that these programs will not be that much of a change for them. It seems to be a way to appease the corporations to make the rules appear less burdensome.”

In response to a request for comment on such concerns, an OMB spokesperson said that, “Changes made by an agency to a rule while it is under review at OIRA may happen in response to comments or information from a wide range of stakeholders – including the public and agencies across the U.S. government (including the agency that drafted the rule).”

At this point, the consumer advocates hope FDA goes for Option 1 on the FSVP rule. “It’s closer to what they originally intended, and I just think it would be a disaster for them if they went to Option 2,” Patoka said.

“We hope OIRA lets them make that decision,” he added, referring to OIRA’s second pass at the rules once they’re in their final state.

Currently, the public comment period for the FSVP and Third Party Accreditation rules is scheduled to end Nov. 26, but the FDA will soon announce a 60-day extension.

© Food Safety News
  • TP

    On site inspections are the only way to validate food safety.
    And on site unannounced inspections of facilities/fields.
    Documentation is necessary but it is not the total program to food safety.
    “a picture is worth a thousand words”

    • Gene

      I agree, but it seems to me there is also an issue of overlapping regulatory agencies colliding and conflicting with each other that suggests that big government may be the real culprit here