FDA Sets Court-Ordered 'Targets' for FSMA Rules, But Center for Food Safety Wants Deadlines
The Food and Drug Administration submitted its required timeline for seven Food Safety Modernization Act regulations, including the Foreign Supplier Verification Program, to the Northern California U.S. District Court on June 10. The proposal sets goals for publication, or “target timeframes,” for issuing the FSMA-required proposed and final rules. The court had ordered the timeline after finding FDA violated FSMA deadlines for the regulations, but left it up to FDA and the Center for Food Safety to establish the specifics (see 13042402). The Center for Food Safety opposed FDA’s proposed approach in its own June 10 submission, arguing that the court order required concrete dates.
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The district court in April rejected FDA’s reasoning for its delayed proposal of seven rules required by FSMA. That law set strict deadlines for several FDA rules, but the required regulations are now in some cases approaching two years overdue. The rules include preventative controls (HARPC); registration requirements for farms; produce safety; intentional contamination; food transportation; Foreign Supplier Verification Program; and third-party audits. In the court’s decision, it said the concrete deadlines set by the law mean FDA’s reasons for the delays don’t matter. Given that Congress intended that the process be “closed-ended, rather than open-ended” by imposing the deadlines, the court decided to impose a timeline on the agency for FSMA implementation. It left it up to the parties to decide the exact dates.
In its response, FDA didn’t set strict deadlines for the rules. Instead, it put forward “target timeframes” that would be goals it would try to meet. Given the “numerous factors and variables” that will affect the rulemaking schedule, including the need to get public input on interrelated provisions, limited resources, and the Office of Management and Budget approval process, “it is not feasible to predict with anything approaching certainty when the final FSMA regulations will be ready to be published,” it said. So “FDA developed a schedule of target timeframes that the agency will endeavor to meet in completing its tasks, with the caveat that future developments, such as the need to supplement the administrative record with additional information, or the need to re-open one or more regulations, may render FDA unable to act within all of these timeframes.”
The Center for Food Safety said FDA’s approach would allow the agency to avoid deadlines altogether by establishing new timeframes beyond its targets, at its own discretion. “As such, [FDA’s] proposal utterly fails to comply with the court’s order and FSMA” The “numerous factors and variables” that FDA offers as reasons it can’t set strict deadlines are arguments the court already heard and rejected when it ordered the timeline, the group said. If the agency can’t meet a deadline, it should be required to request more time from the court, instead of making that decision unilaterally, it said. “Permitting FDA to unilaterally extend the timeline as it so chooses, without transparency of court approval, would undermine the purposes of FDA and the court’s order, instead increasing the chances of more undue, unnecessary, and unlawful delay by the agency,” said the Center for Food Safety.”
In addition to rejecting FDA’s proposed schedule, the court should also require quarterly reporting by the agency on its progress in meeting the deadlines, the Center for Food Safety said. And citing a provision that says OMB approval of rules isn’t required for rules where there is a legal deadline to meet, the group asked the court to bar FDA from seeking OMB approval of the FSMA rules if the process would “impact or prevent FDA from meeting the court-ordered deadlines.”
Email ITTNews@warren-news.com for a copy of the June 10 FDA and Center for Food Safety submissions.