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Food Safety Modernization Act Could Finally Be Implemented With Election Over

Obama signed the landmark Food Safety Modernization Act (FSMA) into law in January 2011. The act, which was sponsored by Democratic Rep. Betty Sutton of Ohio and passed with modest Republican support, promised the biggest overhaul of the country's food safety regulations in decades.

It was supposed to shift the country's legal regime on food safety away from criminal punishment and toward prevention, largely by instituting four sets of rules about how the food industry, both here and abroad, would have to ensure its products are safe. The four regulations would impose stronger controls on imported foods, mandate comprehensive systems for preventing produce contamination, and require more frequent inspections and rigorous controls of facilities that produce packaged foods and animal feed.

"This law was the first modernization of food safety laws in about 70 years," said Caroline Smith DeWaal, a food safety expert with the Center for Science in the Public Interest. "It impacts 80 percent of the foods that consumers purchase -- essentially all foods except those containing meat or poultry are covered under this act."

Yet, nearly two years after its passage, none of these four major regulations have even been released in provisional form -- despite the fact that FSMA set Jan. 4, 2012 as the deadline for that release. According to some, the delay is the product of politically motivated intransigence in the White House.

The Food and Drug Administration (FDA), which was tasked with writing the FSMA regulations, first submitted a draft of those regulations to the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) for approval in late fall of 2011. The FDA's 10 person policy team worked straight through Thanksgiving and Christmas to address a few early concerns raised by OIRA, on the assumption that they would be able to release the proposed rules by the statutory deadline. But then the deadline passed and OIRA's economists gave no sign that they were going to release the rules. According to FDA spokeswoman Carla Daniels, they still haven't done so.

FSMA will generate more than 1,000 pages of regulations, so it wouldn't have been unreasonable for the economists at OIRA -- which is under the direct control of the White House -- to take several months to review the four big rules before releasing them for public comment. But it's unlikely that the process would take an entire year unless the economists were intentionally moving slowly, according to Leland Beck, a Washington attorney who writes the well-regarded policy blog Federal Regulations Advisor.

"Whether OIRA speeds up or slows down review of FDA’s FSMA regulations is a White House decision," Beck told The Huffington Post.

The Huffington Post's requests for comment from the OMB were not returned. But the broad consensus among Washington insiders who work on food policy is that the administration put pressure on OIRA to slow down the approval of the FSMA rules -- among many other regulations -- for political reasons.

"I think they didn't want to give the Republicans a talking point," DeWaal said. "That the president was over-regulating or something."

Given that Obama and former Republican presidential candidate Mitt Romney sparred over economic regulations extensively in the debates, stalling on the release of expensive regulations may have been politically prudent. Many of the regulations mandated by FSMA will be especially costly to small farmers and businesses that don't have the elaborate food safety control mechanisms of corporations like ConAgra and Kraft. And even conservative estimates put the cost of implementing FSMA, both to the government and to the food industry, in the billions of dollars.

Yet food safety advocates argue that the benefits of the regulations are likely to far outweigh the costs. Almost 50 million Americans contract a foodborne illnesses every year, and about 3,000 of those cases result in death. A 2010 Pew Trusts study on the economic impact of food poisoning put the total cost of foodborne illness at $152 billion a year. Implementing FSMA won't eliminate food poisoning -- but even making the food system 10 percent safer would yield tremendous benefits in terms of costs and overall public health.

"At the end of the day, these health and safety regulations are being run through an economic filter that is really not essential but is in fact delaying important health and safety regulations from taking effect. And we saw the evidence of the dangers of that this summer, when we had four major outbreaks linked to FDA-regulated foods," DeWaal said.

Now that the election is over, most FSMA watchers believe the political pressure opposing the release of new regulations may soften.

William Hubbard, a retired FDA policy official, said he suspected that several Obamacare-related regulations would take precedence, but that the FSMA rules would be released immediately after that, probably early in the new year.

But he emphasized that the release of the rules will not immediately translate into full implementation of the law. Even after the OMB releases the proposed rules, the public will have 60 days to comment. Then the FDA will take at least a year to incorporate the public's suggestions into the so-called "final rules." These need the approval of several other federal agencies -- and then take a year or more to actually become law.

"It's not unreasonable to assume that this huge structure created by Congress to improve our food safety system won't be in effect until 2016, or even 2017," Hubbard said.

That only makes Sandy Eskin, the head of food safety at Pew Trusts, all the more anxious for OIRA to release the proposed rules to the public.

"The administration keeps saying that it's taking a long time to release the rules because they're complicated," she said. "My response is? Of course they're complicated! That's why we have the administrative system in place to allow the public to comment them. That's why you have to release them."

UPDATE: 11/20 10:45 p.m. Several hours after this piece went live, OMB spokeswoman Moira Mack issued the following statement to The Huffington Post on the agency's progress on the approval of regulations tied to FSMA:

“The Obama Administration is committed to food safety and we have taken key steps including putting out a food safety rule cracking down on salmonella in eggs and expanding E. coli testing for beef. We are working as expeditiously as possible to implement the food safety legislation we fought so hard for. When it comes to rules with this degree of importance and complexity, it is critical that we get it right.”

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