F.D.A. asking for more time

by Jay Sjerven
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The Food and Drug Administration, running up against a court-ordered deadline for issuing a proposed rule on intentional adulteration of food, on Oct. 23 filed a motion with the U.S. Ninth District Court of Appeals requesting an emergency stay of injunctions issued by the Ninth District Court requiring the proposed rule be published by Nov. 30. The F.D.A. argued “even prior to the government shutdown, it would not have been feasible within the timeframe allotted by the district court to develop a proposed rule that would advance the implementation of the F.D.A. Food Safety Modernization Act (F.S.M.A.) and permit responsible notice and comment.”

The F.D.A. noted the government shutdown shortened by more than two weeks “the already inadequate period” provided by the district court.

“F.D.A. has devoted, and will continue to devote, extensive resources to the development of the intentional adulteration regulation,” the F.D.A. said. “In the absence of relief from this court, however, the agency will be required to use those resources toward the issuance of a proposed rule for which it lacks an informational foundation.”

The F.D.A.’s Oct. 23 motion was the latest action in a running battle of litigation with the Center for Food Safety, which sought to speed the implementation of the F.S.M.A. and in particular the issuance of proposed and then final rules related to food safety required under the act.

The C.F.S. in August 2012 filed suit in the U.S. Ninth District Court in San Francisco that asserted the F.D.A. unlawfully and unreasonably withheld promulgation of F.S.M.A. rules that Congress had specified should be issued in either proposed or final versions by July 3, 2012, and asked the court to issue an injunction to remedy the delay. The court in April 2013 granted the C.F.S. motion, and on June 21, the court entered an injunction requiring the F.D.A. to publish notices of proposed rulemaking (N.P.R.M.s) for seven rules required under the F.S.M.A. by Nov. 30, 2013, with publication of final rules to follow by June 30, 2015.

The F.D.A. pointed out to date the agency has published N.P.R.M.s with respect to five of the seven rules at issue and that it expects to publish an N.P.R.M.s for one additional rule governing sanitary transport and preventive controls within the next few months. But it asserted it required more time to work on the intentional adulteration rule.

The agency filed a motion with the Ninth District Court on Sept. 13 requesting the court lift its Nov. 30 deadline, but the court on Oct. 21 denied the motion.

The F.D.A. on Oct. 18, a day after agency personnel returned to work after the government shutdown, filed a separate motion with the Ninth District Court of Appeals seeking relief from the district court’s Nov. 30 deadline. It acknowledged at the time of the filing, the district court had not ruled on the F.D.A.’s Sept. 13 motion to lift the deadline. The F.D.A. said it would advise the appeals court when the district court ruled. The district court’s Oct. 21 ruling against the government’s motion led to the agency’s Oct. 23 motion for emergency relief.

The F.D.A.’s Oct. 18 motion presented its argument that the agency required and should be allowed more time to issue a proposed rule on intentional adulteration of food.

“F.D.A. is seeking this emergency stay to prevent the irreparable harm that would follow from compliance with the district court’s Nov. 30 deadline,” the F.D.A. stated. “Compliance with that deadline threatens to waste scarce agency resources and risks results inconsistent with the public interest by requiring F.D.A. to spend the next several weeks completing and publishing a proposal that does not take account of pertinent information.”

The F.D.A. noted, given its limited resources and staff, it prioritized development of the seven rules required under the F.S.M.A. The agency selected four rules to comprise the “first wave” in rulemaking: Preventive Controls for Human Food, Produce Safety Standards, Foreign Supplier Verification Program, and Preventive Controls for Animal Food. It asserted it could not work on all seven of the rules simultaneously. And in the case of the rule on intentional adulteration of food, the F.D.A. said it required more information, especially from industry on how it assesses vulnerability and what measures it currently employs against intentional adulteration.

“The government is seeking this stay so that the agency is not constrained to abandon this approach and issue an underdeveloped proposed rule during the pendency of this appeal,” the F.D.A. motion stated. “By accelerating the rulemaking process without fully considering the consequences, the district court’s order threatens to stymie agency efforts and undermine F.S.M.A.’s purpose. Truncating the process outlined by F.D.A. could lead to an inadequately considered proposal that would hinder rather than expedite the promulgation of an effective final rule.”

The F.D.A. in its Oct. 23 filing requested the appeals court act on its motion within 10 days to allow the agency “to focus its efforts on the creation of a rule that will satisfy Congress’ objectives and withstand judicial scrutiny.”

The F.D.A. also requested in the event the motion is not granted, the appeals court at minimum extend the period of compliance with district court’s order until Dec. 20, to reflect the time lost to the government shutdown.

“A stay of that kind will not obviate the irreparable injury that will result from the district court’s injunction,” the F.D.A. said. “It would merely adjust the deadline wrongly imposed by the district court to reflect the fact that F.D.A. was unable to take any action with regard to the proposed rule for more than two weeks as a result of the lapse in appropriations.”

George Kimbrell, senior attorney for the Center for Food Safety, told Food Business News, “A federal court has repeatedly held that F.D.A. violated the law by failing to comply with Congress’s deadlines for the roll-out of the urgently-needed F.S.M.A. Due to Center for Food Safety’s successful litigation, F.D.A. is again required to finish the F.S.M.A. rules to protect public health and safety and prevent food-borne illness on a close-ended schedule determined by the court.

“Unfortunately, rather than comply with the court’s orders and Congress’s mandates in F.S.M.A., F.D.A. has irresponsibly continued to fight in court, appealing the decision to the Court of Appeals and also, in the interim, filing a specific motion for relief from one of the upcoming deadlines, the Nov 30, 2013, deadline for the publication of the draft intentional adulteration rule,” Mr. Kimbrell said. “C.F.S. is opposing this motion because F.D.A. has been working on this issue by its own admission for 12 years, and more time is not needed. Given that all that is required is a draft rule, the agency will have sufficient time after public comment to revise the rule as needed before it is final. F.D.A.’s recalcitrance is just another instance of the agency putting industry’s bottom line ahead of the public health, and is contrary to law. The court of appeals will rule on the motion to stay in early November.”
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