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From Health Law Daily, August 15, 2013

Court declines to allow additional FDA delays on implementation of food safety regulations

By Anthony H. Nguyen, JD

An FDA motion for reconsideration on court imposed deadlines for promulgation of food safety rules was granted in part and denied in part (Center for Food Safety v Hamburg, August 13, 2013, Hamilton, P). The FDA had asserted that for two areas of food safety, complexity of regulatory activity prevented the agency for meeting deadlines as set forth in the Food Safety and Modernization Act of 2010. The district court permitted extension for regulations regarding sanitary transport because the opposing party agreed to a revised deadline. The court denied an extension for intentional adulteration regulations noting that Congress had imposed the original deadlines.

Background. During initial declaratory and injunctive relief requests brought by the Center for Food Safety (CFS), the FDA admitted that it failed to comply with deadlines to promulgate final regulations on seven major food safety regulatory areas required by the Food Safety and Modernization Act of 2010 (FSMA) (P.L. 111-353), but cited the complexity of the regulations it was directed to promulgate, in addition to staffing and other issues. It argued that while the regulations were important to health and safety, any regulations promulgated needed to be carefully considered and developed.

The district court at that time disagreed because the FSMA contained specific deadlines and the failure to comply constituted a “failure to act” under the Administrative Procedure Act. The court granted CFS’ request for declaratory and injunctive relief and ordered the two parties to confer and submit a joint statement setting forth proposed deadlines sufficient to form the basis of an injunction. However, CFS and the FDA were unable to reach an agreement and submitted competing proposals. After review, the court issued an order granting CFS injunctive relief with regard to any regulations not yet published, requiring the FDA to publish all proposed regulations by November 30, 2014, and all final regulations no later than June 30, 2015.

Subsequently, the FDA filed a motion seeking reconsideration of the court’s order as to two of the seven areas – intentional adulteration (or intentional contamination), and sanitary transport – or, in the alternative, an order staying the judgment as to those two areas pending a decision by the Solicitor General as to whether to authorize an appeal of the court’s order.

CFS asserted that the FDA’s motion for reconsideration was an attempt to relitigate matters and that the FDA had not presented adequate grounds for staying the court’s judgment.

Areas of concern. The FDA contended that it was unable to complete the proposed rules in the remaining two areas – intentional adulteration and sanitary transport – by the November deadline, because of the complexity of the issues, the amount of work required, and other reasons it previously argued.

The FDA asserted that it could not publish an intentional adulteration proposed rule until the second half of 2015, with the final rule anticipated for the second half of 2017. Additional time was required because the FDA had not previously regulated this area and needed to develop criteria for preventative controls. As to the sanitary transport regulations, the FDA also noted that the earliest date proposed regulations could be published was January 31, 2014.

Rules on reconsideration. A motion for reconsideration may be construed either as a motion to alter or amend judgment pursuant to Federal Rules of Civil Procedure 59(e), or as a motion for relief from judgment pursuant to Federal Rule 60(b). Rule 59(e) also provides that any “motion to alter or amend a judgment shall be filed no later than 28 days after entry of the judgment.” Whereas under Rule 60(b), the court may relieve a party from a final judgment or order for (1) mistake, inadvertence, surprise, or excusable neglect; (2) newly discovered evidence that, with reasonable diligence, could not have been discovered in time to move for a new trial under Rule 59(b); (3) fraud, misrepresentation, or misconduct by an opposing party; (4) a judgment that is (a) void, (b) satisfied, released, or discharged, (c) based on an earlier judgment that has been reversed or vacated, or (d) prospectively no longer equitable; or (5) any other reason that justifies relief.

Extension requests. The court agreed with CFS that the FDA had not met the standard for amending the court’s judgment under either Rule 59(e) or 60(b). Since CFS agreed with the FDA’s request to extend the deadline for publication of the proposed sanitary transport rule to January 31, 2014, the court amended its order to reflect the agreement. The court held that the publication date of the final rule would remain unchanged.

The court, however, declined to allow the FDA an extension for promulgation of the intentional adulteration rule because any dispute on deadlines was between the agency and Congress. The district court was unwilling to grant extension after extension when presented with clear congressional directive under the FSMA that the process of issuing regulations be close-ended.

The case number is C 12-4529 PJH.

Attorneys: George Andreas Kimbrell, Center for Food Safety, for the Center for Food Safety, and the Center for Environmental Health. Gerald Cooper Kell, U.S. Department of Justice, for Margaret A. Hamburg, Commissioner of the U.S. Food and Drug Administration.

Companies: Center for Food Safety; Center for Environmental Health; U.S. Food and Drug Administration

MainStory: TopStory FoodSafetyNews FoodStandardsNews FoodNews CaliforniaNews

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