November 21, 2012

Obama Administration: Food Safety Rules Coming ASAP

From: Food Safety News

By James Andrews

The White House Office of Management and Budget (OMB) is still working “expeditiously” to implement major portions of the Food Safety Modernization Act, legislation that has largely sat in budgetary limbo since President Obama signed it into law on January 4, 2011 – nearly two years ago.

“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,” an OMB spokeswoman wrote to the Huffington Post on Tuesday. ”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.”

That comment came in an official response to an article by Joe Satran published earlier Tuesday on the Huffington Post which suggested that the new laws might finally see the light of day with the presidential election over.

But the January 2012 deadline for full implementation is fast approaching its one-year anniversary. According to policy experts interviewed by Satran, many suspect that election season political motivations played into the delay.

Last winter, a 10-person team of U.S. Food and Drug Administration policy officials worked with the OMB’s Office of Information and Regulatory Affairs to clear up some concerns with the legislation before the impending deadline. But that deadline came and went without any laws moving on to the next step.

Policy experts tell Satran that the rules should have been released for public comment after several months, but should not have taken more than a year. The OMB, however, may slow down its review based on White House pressure. Given Obama’s struggle to not be pinned as an “over-regulator” during election season, it might have been the politically safe move to stall on new food safety rules that may add costs to industry, especially small businesses.

“And even conservative estimates put the cost of implementing FSMA, both to the government and to the food industry, in the billions of dollars,” Satran writes. “Yet food safety advocates argue that the benefits of the regulations are likely to far outweigh the costs.”

The five major pillars of the FSMA will help pivot the nation’s food system from taking a more reactive to a more preventative approach to food safety. If they reduce foodborne illness rates by even a fraction, they have the potential to save Americans billions of dollars in healthcare costs every year.

Those five pillars — all still awaiting implementation — consist of the following:

– Preventive controls: FDA will require science-based preventive controls throughout the food system. This includes requiring food facilities to write preventive control plans, establishing minimum standards for safe production of fruits and vegetables and introducing regulation to help prevent intentional adulteration of food at vulnerable points in the food chain.

– Inspection and compliance: FDA has new authority to conduct inspections. FDA will inspect all high-risk domestic facilities every three years, have access to facility records and will establish a laboratory accreditation process for third-party testing laboratories.

– Response to violations: FDA will now have the authority to order food recalls – as opposed to recommending voluntary recalls as it does now – in cases of contamination. Farms will also be required to track their product and develop plans for how to issue recalls, though small farms that sell the majority of their product locally (within 275 miles) and sell less than $500,000 a year in product are exempt.

– Oversight of imports: Food importers must now verify that their facilities and preventive controls meet U.S. standards. FDA can now deny food from foreign facilities entry to the U.S. if the facility does not allow access to inspectors.

– Collaborative partnerships: Health agencies, both foreign and domestic, will work collaboratively to improve public health goals. FSMA provides FDA with a grant to develop state and local health agencies’ ability to improve food safety at a localized level. FDA will also develop a plan to help improve foreign industries’ ability to meet U.S. food safety requirements.

Whenever the OMB does release its proposal for the rules, the public will have 60 days to comment, and then it may take another year for FDA to release its finalized rules. After that, it may take another year for other federal agencies to approve those rules. Realistically, the FSMA rules may take until 2016 – or later – to become law.

In a statement to Food Safety News regarding the FSMA’s delayed implementation, an FDA spokeswoman had this to say:

“Publishing the FSMA rules is a priority for the agency. At this time, several key proposed rules are still under review by the Office of Management Budget. While the rule-making process can be complex and demanding, it will eventually provide for a framework that will have an enormous impact in modernizing the food safety system. We have made every effort to engage with all interested stakeholders throughout the process and will continue to do so after the rules are published.”

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