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 at 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.
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Thomas McGarity | December 5, 2012
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 […]
David Hunter | December 4, 2012
The World Bank has started a process that appears likely to weaken its environmental and social safeguard policies. Although the Bank has repeatedly stated there will be no “dilution” of the policies, the Bank’s scoping paper released in October and its ongoing consultations clearly reveal a desire to replace clear standards with discretion and deference […]
Robert Verchick | December 3, 2012
Property lawyers in the United States love the Public Trust Doctrine (PTD). There’s such a rich history. The doctrine, which holds that important resources must be held “in trust” for public use, originated in Roman law. Centuries later it was forced on King John through the Magna Carta. During America’s industrial revolution, our Supreme Court […]
Holly Doremus | November 30, 2012
Cross-posted from Legal Planet. This coming Monday, Dec. 3, the U.S. Supreme Court will hear oral argument in the logging roads case. The case involves two consolidated petitions, Decker v. Northwest Environmental Defense Center and Georgia Pacific v. Northwest Environmental Defense Center , both challenging the same decision of the Ninth Circuit, Northwest Environmental Defense […]
Holly Doremus | November 29, 2012
Cross-posted from Legal Planet. The Washington Post reported this week that scientists think they can resurrect the Pinta Island subspecies of Galapagos tortoise whose last remaining member, “Lonesome George,” died this summer. Scientists at Ecuador’s Galapagos National Park say they have found enough Pinta Island genetic material in tortoise on another nearby island that an […]
Rena Steinzor | November 28, 2012
For a potentially earth-shattering move against one of the most notorious corporate environmental scofflaws in history, the Environmental Protection Agency (EPA) sure hid its light under a bushel this morning. The agency’s scant three-paragraph press release announced simply: “BP Temporarily Suspended from New Contracts with the Federal Government,” adding that “EPA is taking this action […]
| November 28, 2012
Action on climate change should be one of the first things President Obama takes on in his second term. There are countless steps the President might take, but perhaps one of the easiest things for him to do on that front is to instruct the Office of Management and Budget (OMB) to release eight Department […]
Ben Somberg | November 26, 2012
CPR Member Scholar Noah Sachs published an op-ed in the Richmond Times-Dispatch this morning critiquing the Independent Agency Regulatory Analysis Act. That bill would allow the White House to review rules proposed by independent federal agencies. Writes Sachs: Imagine if important government agencies, purposely designed by Congress to be insulated from political pressure, suddenly had […]
Thomas McGarity | November 21, 2012
One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act. Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out […]