FDA Now Requires Mandatory Reporting For Potentially Dangerous Foods

Posted on September 11, 2009 by Shawn Stevens

The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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Senate Confirms Dr. Margaret Hamburg To Head FDA

Posted on May 20, 2009 by Shawn Stevens

The U.S. Senate has officially confirmed Dr. Margaret Hamburg to lead the Food and Drug Administration (“FDA”). Hamburg, a bioterrorism expert, will be sworn in as the 21st commissioner of the FDA, and only the second woman to hold the post in 100 years of agency history. She was confirmed unanimously.

Hamburg’s first priority will be to help direct the development of a vaccine for the H1N1 flu. Notably, Hamburg has, in turn, promised to place greater emphasis on food safety. In the midst of numerous high-profile food-borne illness outbreaks, Hamburg stated she intends to shift the agency’s focus from chasing outbreaks once they occur to preventing them in the first instance. To accomplish this goal, Hamburg would also like to take advantage of the recent spike in food safety awareness by media, consumers and industry. As she puts it, “the growing consensus among experts and industry is that now is the time to shift to a food safety system that puts prevention first.”

We, of course, wish her the best as we all work, collectively, to enhance food safety.

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Proposed 2010 FDA Budget Has Additional Food Safety Focus

Posted on May 11, 2009 by Shawn Stevens

As the FDA works to protect and promote the public health, it is requesting $3.2 billion as part of it's fiscal year (FY) 2010 budget. The request represents a 19% increase over the current FDA budget. Click on the following link to view a summary of the FDA Proposed Budget.

Notably, the FDA has asked for an additional $259.3 million to fund a new food safety initiative. The goal of the new initiative, “Protecting America’s Food Supply,” is to better prevent intentional and unintentional contamination of foods through risk-based prevention and verification. The initiative, as proposed, would focus on foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain.

In addition, the FDA also proposes to collect a total of $94.4 million in new user fees from the registration of food facilities. It is anticipated that the additional fees will enable the FDA increase routine inspections, while at the same time conducting additional inspection for those facilities that fail to meet the FDA’s safety standards.

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New Report Urges Stand-Alone Food Safety Agency In HHS

Posted on March 26, 2009 by Shawn Stevens

Food safety has long been a battle fought on multiple fronts. Once again, the principle proves true. As we continue to report on the absence of effective food safety laws abroad, our colleagues here at home are working feverishly to improve the effectiveness and efficiency of our own food safety system.

Is it possible, some ask, that all federal food safety responsibilities might be integrated into a single food safety agency? Although not likely in the very short-term, it would seem, at the very least, that the table is being set. As the search continues for new solutions to new food safety challenges, Trust for America's Health, along with the Robert Wood Johnson Foundation, released a report advocating significant changes to our national food safety system. The report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, outlines various weaknesses in the current system, and proposes, among other things, numerous improvements to the food safety functions of the  Department of Health and Human Services (“HHS”). In essence, the report advocates (as a first step) the creation of a new, stand-alone food agency within HHS.

Currently, the Food and Drug Administration (“FDA”), an agency within HHS, has responsibility for regulating the safety of drugs, medical devices and many foods. Although the United States Department of Agriculture, through its Food Safety and Inspection Service (“FSIS”), is responsibile for all meat, poultry and egg products sold in interstate commerce, the FDA regulates the safety of virtually all other foods (Learn how our food is currently regulated). To view the current, rather confusing, organizational structure of the FDA, click on the following link :

 

          

 

To increase efficiency (and decrease confusion), the new report urges Congress to quickly create a stand-alone Food Safety Administration (“FSA”) within HHS. Conceptually, the proposal would effectively split the FDA into two seperate agencies, each operating on the same plane - one devoted to food and the other devoted to drugs and medical devices. While the FSA would be responsible for regulating food safety, the drug and device sections of the FDA would become a separate agency called the “Federal Drug and Device Administration.” According to the report, a stand-alone food agency would fix the following key weaknesses under the current  structure:

  • Inadequate leadership, prioritization, and coordination within FDA: No FDA official whose full-time job is food safety has line authority over all food safety functions. FDA's three major food safety components are managed separately, hampering efforts to effectively prevent disease outbreaks.
  • Inadequate technologies and inspection practices: Current laws and practices are antiquated. Existing laws date back to 1906 and 1938, and policies are disproportionately focused on monitoring food after it has been produced, instead of trying to prevent and detect problems throughout the entire production process. And, there is no system in place to keep inspection practices up-to-date with the constantly modernizing food production technologies and practices.
  • Inadequate staffing and resources: The FDA's Science Board found the agency is chronically underfunded. While the U.S. Government Accountability Office reports the turnover rate in FDA science staff in key areas, including food safety, is twice that of other government agencies.
  • Inadequate inspection of imports (my favorite): Only one percent of imported foods are currently inspected, even though approximately 60 percent of fresh fruits and vegetables and 75 percent of seafood Americans consume is imported.

A stand-alone food safety agency such as the FSA would also, according to the report's authors, result in integrated and accountable senior leadership, integrated public health and science functions, and integrated compliance and enforcement programs. Click here (or on the picture to the right) to view the proposed organizational structure of a new FSA.  Ultimately, according to Risa Lavizzo-Mourey, president and CEO of RWJF, the proposal contained within the report is needed to ensure that "food safety [becomes] a priority on the prevention menu." 

Notably, in addition to the significant proposed changes to the fundamental structure of FDA, the report advocates (as a second step) potential future changes to FSIS and other agencies as well. Although FSIS in the short-term would likey continue to operate within the USDA as a separate agency, the report ultimately recommends that all current federal food safety functions (including FSIS responsibilities) should eventually be integrated into a single food safety agency. Thus, although the proposed immediate changes to the FDA will likely garner the most attention as the report is studied and considered, pointed advocacy for a single food safety administration (for all federal food regulatory functions) will likely follow.

In any event, as part of its vision, the report also recommends that a spot at the table be cleared (assuming a new food safety agency is created) for a single Food Safety Czar. We, of course, will wait for a response from Congress and the Obama Administration before we offer our comments on potential candidates . . .

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FDA To Require Reporting Of Positive Food Product Test Results

Posted on February 12, 2009 by Shawn Stevens

In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.

In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.

Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring.  We, of course, will keep you posted.

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