Court Extends Deadline for FSMA Rules

The Center for Food Safety’s tug-of-war with the U.S. Food and Drug Administration over the agency’s delayed food safety rules continued last week as a judge ruled that FDA had more time to come up with a schedule for releasing the outstanding rules.

In a ruling yesterday, Judge Phyllis Hamilton of the Oakland U.S. District Court said FDA and CFS now have until June 10 to agree on a schedule for releasing the yet-unpublished food safety rules, mandated by the Food Safety Modernization Act of 2011.

CFS filed suit against FDA Commissioner Margaret Hamburg in August of 2012 after the FDA missed a series of deadlines for publishing the regulations mandated by FSMA, which is intended to update the U.S. food safety system by transforming it from a reactive one to a preventive one.

After numerous deadlines went by without the release of the mandated rules, CFS went to court to try to force FDA to adhere to these time constraints.

In a decision this April, Judge Hamilton ruled that FDA must come up with a new schedule for issuing the proposed rules by May 20.

But when FDA sent its updated schedule to the non-profit food watchdog May 15, the group was not happy with the timeline. Since the two parties did not have enough time to discuss these problems before the new timeline was due five days later, they filed a Joint Stipulation for Extension of Time, which Judge Hamilton granted on May 17.

According to the order, CFS and the federal food regulatory agency now have until June 10 to agree upon a timeframe for releasing the rules that’s acceptable to both parties.

Since CFS filed its complaint last year, FDA has released some of the key FSMA-mandated rules it failed to publish on time, including preventive controls for human food and standards for produce safety, both released in early January.

Other rules continue to languish at the White House Office of Management and Budget’s Office of Internal and Regulatory Affairs, which must approve the rules before they are published. FDA attributes some of the delay in its release of the FSMA rules to the hang-ups that come with this part of the process.

Among those rules that have yet to be released are the foreign supplier verification program – set to overhaul import safety, an establishment of regulations to ensure the safe transport of food products and a rule ensuring neutrality of third-party audits.

do you require records from your suppliers?

do you require records from your suppliers?.

do you require records from your suppliers?

[04/28/08] 
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Public Involvement in Food Safety Modernization Act

The public should not hesitate to be more involved in the food safety policymaking process, Dr. Elisabeth Hagen and Michael Taylor, the nation’s two leading food safety officials, told an audience at the Food Safety Summit in Baltimore late last week.

Dr. Hagen is Under Secretary for Food Safety at the U.S. Department of Agriculture and Taylor is Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration. Both Hagen and Taylor encouraged stakeholders of all kinds to get involved and comment on regulations.

“Never underestimate how important your voices are,” said Dr. Hagen, when asked about the lengthy process required to move forward on food safety policies.

That process now regularly includes a months-long review by the White House Office of Management and Budget, which is where the most critical Food Safety Modernization Act Rules were recently stuck for more than a year, a move that frustrated industry stakeholders and public health advocates. A handful of food safety rules, including the foreign supplier verification program set to overhaul import safety, which was required by FSMA, and a rule that would require mechanically tenderized meat products be labelled, have now also been in limbo at OMB for many months.

“If you want to know why something is still sitting [at OMB], I suggest that you ask [OMB],” said Hagen, during a food safety town hall, attended by several hundred food industry professionals and health officials. Hagen reminded the audience that while she and Taylor lead food safety initiatives at the agencies, they “don’t control the entire process” and it helps to hear feedback on what the public wants.

Both officials said the OMB review process was necessary, but admitted that the delays can be frustrating.

“It’s a necessary part of the process. OMB is there for a reason,” said Dr. Hagen, who said there was a lot of constructive “back and forth” that happens between the agency and the OMB’s Office of Information and Regulatory Affairs, which oversees the reviews. “Sometimes we need to be able to step back and look at the questions that might be raised, that we might not be considering.”

“But it can be frustrating, because it’s hard to get anything done in Washington, DC,” she said. “When we make something a priority and we say, this is important, we think it’s going to protect consumers, we want it to happen right away, but there are checks and balances, I think, in any system we work in and we can’t just push things through because we think that they’re supposed to happen.”

What about that rule to label mechanically tenderized meats, specifically? “We look forward to getting that rule out as soon as possible,” said Hagen.

“There is frustration,” admitted Taylor, explaining that he has a long perspective on the process because has been involved with federal rulemaking, on and off, for more than three decades.

“There’s just no question that OMB has an important role to play. It works under executive order…. but it’s a fact of life that there is an accumulation of analytical requirements and box-checking requirements for rulemaking that have made it far more cumbersome and time-consuming than it has been historically. What that means is that the process is heavy, it’s weighty.”

“What that means to me, and I’ll be frank about this, is that we need to all work as part of this process, and that has a public dimension to it. You shouldn’t hesitate to engage in this. I think the government needs to know that there’s strong public support to get stuff done,” Taylor told the audience. “We need to all keep working hard, be unrelenting, and let that frustration be motivating rather than debilitating. That’s the spirit we’re pushing forward with at FDA.”

Taylor said the public should expect the foreign supplier verification rule, which is being anxiously anticipated by the food industry and especially by importers, to be released “soon.”

“We’re right at the last stages of the administration’s review we’re hoping for clearance very soon,” he said. “We’ve given people plenty to chew on already and there will plenty more to come soon. Don’t plan any long vacations this summer.”

New deadline ordered for FDA food safety reforms

New deadline ordered for FDA food safety reforms.

New deadline ordered for FDA food safety reforms

A federal judge is siding with two California advocacy groups in ruling that the Food and Drug Administration must set a new timetable to implement delayed food safety reforms.

U.S. District Judge Phyllis Hamilton in Oakland, Calif., handed down the decision Monday.

The case stems from the Food Safety and Modernization Act passed by Congress in 2011. The act created a sweeping set of rules that will allow the FDA to order recalls and make it easier to trace contaminated food.

Congress mandated the FDA enact the new rules within 18 months.

Two nonprofits, the Center for Food Safety and Center for Environmental Health, alleged the agency failed to meet the deadlines and sued in 2012.

FDA spokeswoman Shelly Burgess said she could not comment on pending litigation.

Getting to the CORE of Foodborne Illness

Kathleen Gensheimer, M.D., MPH, Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese. Any of these products might show up on your weekly grocery list. Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months after it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE)evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products.

The highlights of CORE’s work are outlined in a new report entitled“FDA’s CORE: A Food Safety Network 2011-2012.” 

Read the entire blog at FDA Voice.

 

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