May 18, 2012

FDA Aide Joins Industry to Push Stalled Food Regulations

From: Bloomberg

By Andrew Zajac

Food companies, consumer groups and even a senior administration official are pressuring the White House to announce new food safety regulations that were mandated by law to be released more than four months ago.

Food companies such as General Mills Inc. and consumer groups are joining forces to lobby President Barack Obama’s administration to implement provisions of the Food Safety Modernization Act, which would increase oversight of the U.S. food chain.

“I can’t remember an issue where my members were so insistent that government get off its butt and issue regulations,” said Bryan Silbermann, president and CEO of the Newark, Delaware-based Produce Marketing Association. His group, which includes Wal-Mart Stores Inc., (WMT) (WMT) the largest food retailer in North America, and Sysco Corp., the largest distributor of food to restaurants in North America, wrote a letter to Obama on April 5 urging him to release the draft rules.

The delay is due to “political issues in an election year,” Silbermann said in an interview. “People are dithering.”

A U.S. Food and Drug Administration official, concerned that the regulations were stalled in a review by the White House Office of Management and Budget, has worked behind the scenes to step up pressure on regulators to release the rules, according to two food safety advocates.

“The official told me that process has slowed down and that the people who had a stake in making things happen should make their voices heard,” said William Marler, a Seattle-based food safety lawyer who backs a greater role for the FDA.

Pressure Encouraged

Marler has blogged about the delay and Food Safety News, a news service associated with his law firm, has published stories on the regulatory holdup.

Nancy Donley, of STOP Foodborne Illness, a Chicago-based nonprofit food safety advocacy group, said that her organization was contacted by the FDA official and urged to keep up its campaign. “He has thanked us every time we’ve spoken out and has encouraged us to keep the pressure on,” she said in a telephone interview. Both Marler and Donley declined to identify the FDA official publicly.

The FDA’s legal power over domestically-grown fruits and vegetables and imported food will be expanded under the law, which Obama signed in January 2011. The agency will also get the power to order recalls of contaminated food. The Congressional Budget Office estimates that carrying out the law will cost $1.4 billion through 2015.

3,000 Deaths

The Centers for Disease Control estimates that about 3,000 Americans die each year from food contamination. Food-borne pathogens sicken some 48 million people a year in the U.S. and result in 128,000 hospitalizations, according to the CDC.

The rules under OMB review are especially important because they are just the foundation for wider regulations authorized by the law, said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, Washington nonprofit health advocacy group.

“The delay at this point signifies a much longer implementation time,” DeWaal said.

The FDA says it welcomes the debate.

“People representing both consumers and industry care deeply about these food safety rules and they are not shy about telling FDA or others in the administration they want them released,” Michael Taylor, FDA’s deputy commissioner for foods, said in an e-mailed statement. “I respect their right to express their views to me and to others.”

Taylor said the proposed rules are in “the late stages of clearance and we expect them soon.” Release of the rules will be followed by a public comment period that could lead to changes in the regulations. Taylor declined to address whether he or any other FDA official encouraged a pressure campaign on the White House.

Prevention First

Under the new law, the FDA would shift its focus from responding to food contamination outbreaks to preventing the adulteration of items in the food chain at the source. The agency also intends to hire more field inspectors to examine high-risk items such as leafy greens, fruit and imported food.

The FDA submitted food safety rules to Cass Sunstein, the administration’s top regulator, in November and December of 2011. Sunstein is administrator of the Office of Information and Regulatory Affairs. The agency, part of OMB, is responsible for analyzing whether U.S. regulations are worth their cost and making sure they strike a balance between public safety and economic growth.

The FDA official complained “about Sunstein ‘sitting on the regs,’” according to Marler. “I think he’s really frustrated with OMB,” he said.

Important, Complex

OMB says it is not unusual for a review of major public health regulations to extend past deadlines.

“The Administration is working as expeditiously as possible to implement this legislation we fought so hard for,”said Moira Mack, an OMB spokeswoman. “When it comes to rules with this degree of importance and complexity, it is critical that we get it right.”

John Bode, a Washington lawyer who represents food producers, said it’s unlikely that wrangling over cost is holding up the rules.

“In my experience in rulemaking, I’ve just not seen a cost-benefit analysis cause an extended delay in a proposed rule,” Bode said.

Groups writing letters to administration officials in support of release of the rules include the Consumers Union, the Grocery Manufacturers Association, the Pew Charitable Trusts and the Global Food Safety Initiative, a project of the Consumer Goods Forum.

General Mills, Blue Diamond

“We ask you to support the prompt release of the major proposed FSMA rules currently under review at OMB,” said a March 27 letter to Health and Human Services Secretary Kathleen Sebelius signed jointly by Rebecca Rimel, president and CEO of the Pew trusts, and Pamela Bailey, president of the grocery manufacturers’ group.

The Pew trusts, headquartered in Philadelphia, underwrite food safety programs, and the Washington-based GMA represents more than 300 businesses in the consumer packaged goods industry, including Blue Diamond Growers, Campbell Soup Co. (CBP) (CBP), and General Mills.

“General Mills is and has been strongly supportive of the FDA Food Safety Modernization Act, and we look forward to the implementation of the Act after it has completed its regulatory review,” Maerenn Jepsen, a spokeswoman for the Minneapolis-based company, said in an e-mailed statement. “We believe it’s good for Sysco and the industry to play by a consistent set of rules,” said Charley Wilson, a spokesman for the Houston-based company.

Four Areas

Draft rules submitted by FDA to OMB cover four areas: a requirement that imported food meet the same safety standards as domestic produce; new safety standards for food production facilities; a set of guidelines for animal feed makers; and new requirements for growing and processing fruits and vegetables.

Under the food safety law, the FDA was required to publish a proposed rule for produce — a major expansion of the FDA’s regulatory power — by Jan. 4, the first anniversary of Obama’s signing of the law. Instead, that rule and the other guidelines have remained under study in Sunstein’s office.

Silbermann likens the Obama administration’s hesitation on food safety regulations to the president’s self-professed evolution to support gay marriage.

“He didn’t want to touch it, but when forced to, he supported it,” Silbermann said. “I’d like to think that the same thing will happen with food safety regulations.”

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