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FDA’s Excuses to Court on Food Safety Rule Delays Are Unconvincing


The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011.

As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year.

Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis and critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements. But the deadlines came and went while OIRA sat on the regulations to avoid criticism from Republicans during the 2012 election season.

Last summer, the Center for Food Safety and the Center for Environmental Health sued FDA (and the White House) for failing to meet the deadlines and asked the court, the U.S. District Court for the Northern District of California, to order FDA to promulgate the rules by a date certain.

On Friday, FDA filed a motion to dismiss the lawsuit on the grounds that the regulations are not “unreasonably delayed” under the Administrative Procedure Act. According to the government filing, the delays are reasonable and understandable, given the “enormity and scope of the task” and the complexity of the issues that the regulations must resolve. The government warrants that FDA has devoted “enormous effort and resources to developing the novel and complex regulations” and is making “substantial progress” toward getting the regulations promulgated.

These excuses are, however, entirely beside the point. Despite the enormity of the task, FDA was on track to publish proposed rules more than a year ago. The holdup has been the OIRA review process. It is not the complexity of the issues that is holding up the regulations; it is the fear of criticism by right wing pundits and politicians. The statute does not recognize that as an excuse for failing to implement its prescriptions.

The Food Safety Modernization Act told FDA to promulgate the regulations and to do so by specific deadlines. It does not assign any role at all to OIRA.

The election is now over, and OIRA need not worry, if it ever should have, that the predictable complaints from right wing ideologues will sway the election. It should immediately free up the regulations so that FDA can do the job that Congress assigned to it. Failing that, the court should order FDA to publish its notices of proposed rulemaking forthwith, whether or not OIRA approves.

 This article originally appeared on the Center for Progressive Reform’s blog December 5, 2012.

© Food Safety News
  • MrMcFritters

    I’ve heard three reasons for the delay from smarter and more in-the-know folks than I: (1) politics, (2) that our international trading partners find the idea of extraterritorial application of US law and FDA inspections in other countries to be offensive and a potential trade war trigger, and (3) that figuring out how to create generic HACCP regs, as opposed to process or food specific regs (i.e., seafood, fruit juice) is proving to be something like impossible.  These, of course, are not mutually exclusive.

    My own take is that both the international provisions and the basic structure of the statute are somewhere between impossible and unworkable to implement, especially in this budget environment, and the delay reflects the struggle to sort this out, probably with a dash of politics tossed in.  Under Executive Order 12866 it seems that OIRA is the place to attempt to work such issues out, and I haven’t met anyone knowledgeable about how the sausage is made who is at all shocked by the delay.

  • Ben Mark

    You don’t need for every food facility HACCP. You’ll need GAP’s and they are already out there besides other procedures for the different food industry. FDA doesn’t not traveling to every single food producer in the last corner of the world to check out how they raise food for the rest of the world. The brokers have to show the documentation of sanitary procedures etc. and this is the hang-up. They don’t want to show anything, just bring  the food in and make money.