May 3, 2012

OMB’s Prudence in Regulatory Review

Editor’s Note:  The article below discusses complex, detailed regulatory proposals with far-reaching and potentially unseen impacts throughout the economy.  Americans should be appreciative of OMB undertaking the painstaking (and apparently thankless) task of carefully reviewing FDA’s regulatory plans to ensure that they advance the public interest consistent with legal authorities.  OMB’s review of FDA regulations, a long-established basic exercise of Presidential authority and responsibility, is a prudent approach to avoiding the unexpected consequences of faulty “slam dunk” analyses.

From: The Washington Post

Food-safety rules in limbo at Office of Management and Budget

By Dina ElBoghdady

More than a year after President Obama signed a landmark food-safety bill, the key provisions are hung up at a unit of the White House that is in charge of reviewing proposed policy changes.

The delay at the Office of Management and Budget baffles consumer advocates and industry groups, which joined forces to lobby for passage of the legislation and press for its funding. The united front by this unusual alliance — and the president’s enthusiastic endorsement of the legislation in the past — makes the hold-up especially puzzling.

In recent letters to the administration, nearly half a dozen groups expressed frustration with the OMB.

“There’s no explanation for the hold-up,” said Erik Olson, director of food programs at the Pew Health Group, which co-wrote one of the letters with the Grocery Manufacturers Association. “Until this new package of safeguards is put into place, all the promise of the new food-safety law will not be met.”

OMB officials say the duration of this review is not unusual given the complexity of the regulations. “The administration is working as expeditiously as possible to implement this legislation we fought so hard for,” said Moira Mack, an OMB spokeswoman.

Obama signed the legislation in January 2011 after a string of food-borne outbreaks shook consumer confidence in the nation’s food supply. On many occasions, he has highlighted food safety as a top priority for his administration, which came in just as an deadly outbreak erupted involving salmonella-contaminated peanuts and peanut butter.

In March 2009, Obama declared that “food safety is something I take seriously, not just as your president but as a parent,” and set up an inter-agency group to advise him on how to revamp food-safety regulations that had not been updated since 1938. The group’s key recommendations were rolled into the new law.

That law empowers the Food and Drug Administration to prevent food-borne illnesses instead of simply reacting to them. Its provisions require produce farmers, food-processing facilities and animal-food plants to adopt strategies that would help them spot and combat food-safety hazards. It also mandates that food imported into this country meet the same safety standards as food produced domestically.

To put these provisions in place, the OMB must approve draft rules, which are then submitted to the public for comment before being finalized. An executive order gives the OMB 90 days to review proposed regulations. The rule on imports was supposed to be finalized by Jan. 4 and the produce proposal was to be submitted for public comment by then. The others are supposed to be finalized by July 4.

It is possible for the OMB to extend its reviews and that often happens. The food-safety rules have remained at the office since late last year.

“People have been working hard to get these rules out for public comment as soon as possible,” said Mike Taylor, the FDA’s deputy commissioner for foods. “These are complex, ground-breaking rules and care is needed.”

In the meantime, the industry is in limbo and consumers are at risk, some groups said.

“The lengthy congressional debate over food safety combined with draft regulations that have missed the statutory deadlines create uncertainty and paralysis,” Bryan Silbermann, chief executive of the Produce Marketing Association, wrote in a letter to Obama last month. “It is much more difficult for companies to invest in additional food safety safeguards without knowing what the FDA rules will be.”

Some experts who are tracking the issue say that the OMB’s Office of Information and Regulatory Affairs — run by legal scholar Cass Sunstein — has raised questions about the FDA’s analysis of the provisions’ costs and benefits.

Rena Steinzor, president of the Center for Progressive Reform, said OIRA routinely second-guesses regulators and delays regulation. But usually the delays come at the behest of industry, she said.

With the food-safety rules, one explanation could be that the proposals have run into private objections from a company or other party that would be affected by them, Steinzor said. But FDA officials said they’ve held hundreds of meetings with affected parties and see no sign of such resistance.

Another possible explanation, Steinzor said, is OIRA’s own caution. “The economists at OIRA, who have their own ideas, may be objecting,” she said. “They are a breed unto themselves. They’re very hostile to the idea of regulation and they always have been, no matter which administration.”



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