Most FSMA Proposals to Meet Court's November Deadline, Extensions Needed on Two, FDA Says
The Food and Drug Administration will ask the Northern California U.S. District Court to reconsider its deadlines for two of the seven Food Safety Modernization Act deadlines, according to a July 19 court filing. The district court had ordered FDA to propose all seven rules required by FSMA by Nov. 30, with final versions due by June 2015 (see 13062412). But the FDA says meeting the November deadline for two of the proposed rules -- sanitary transport and intentional adulteration -- will be impossible.
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The past-due FSMA rules subject to the court deadlines include provisions on produce safety, preventative controls, the Foreign Supplier Verification Program, third-party accreditation, intentional adulteration, and sanitary transport. FDA already proposed its produce safety and preventative controls for human food regulations in January (see 13010805 and 13010429, respectively). It says it intends to propose rules on the Foreign Supplier Verification Program, third-party accreditation, and preventative controls for animal food by Nov. 30, in compliance with court deadlines.
But meeting the Nov. 30 deadline for the sanitary transport and intentional adulteration proposed rules will be impossible, FDA said. Although a first draft of the sanitary transport proposal is now ready, the proposed rule still has to go through interagency and Office of Management and Budget Review, and FDA staff working on the rule projects it won’t be ready until Jan. 31, two months past the court deadline. The intentional adulteration proposal is even further behind, the agency said. Because of the complexity of the issues involved, FDA wants to publish an advance notice of proposed rulemaking to get public comments before it even begins to draft its proposal. To be able to consider such input, FDA said it wouldn’t be able to issue a proposed rule until the second half of 2015. That would even come after the court’s deadline for the final rule.
In the alternative, if the Northern California court declines to reconsider, it should at least stay its schedule as it relates to the intentional adulteration and sanitary transport rules to allow FDA to consider whether it should appeal, the agency said. “It would not further Congress’ purpose or the public interest to compel issuance of regulations on a schedule that is not viable,” FDA said.
Email ITTNews@warren-news.com for a copy of the FDA request for reconsideration.