FDA Food Safety Modernization Act
04-12-2010
By Brian Giannini
Now that healthcare reform has been signed into law one of the next big bills that will hit the President’s desk is the FDA Food Safety Modernization Act. According to Sen. Tom Harkin (D-IA), if all goes well, S.510 should be “on the President’s desk by May.”
Several ingredient recalls over the past two years, including peanut butter paste, pistachios, and now HVP (hydrolyzed vegetable protein), that involved hundreds of products have put pressure on the FDA to make changes that would prevent these recalls from happening in the first place. The HVP recall, for example, was caused by Salmonella bacteria which can sometimes cause fatal infections in young children, elderly people and anyone with a weakened immune system. Symptoms in healthy people might include fever, diarrhea, nausea, vomiting and abdominal pain.
The Center for Science in the Public Interest has said that the HVP recall is “yet more proof that the Food and Drug Administration needs more authority, more inspectors and more resources to ensure that our food supply is safe.”
The Center added, “Most Americans would be stunned to learn that FDA doesn’t even have the authority to make recalls like these mandatory.”
A bill passed in July by the House with overwhelming bipartisan support would go a long way toward beefing up the agency’s ability to intervene in such cases, said Erik Olson, director of food and consumer product safety at The Pew Charitable Trusts.
“The existing law is basically a reactive law,” Olson said. “If you find contamination problems, the FDA reacts and goes out and tries to find the problem and asks for a voluntary recall.”
The FDA Food Safety Modernization Act, now awaiting action in the Senate, “would change the whole system, modernize it to say we’re going to try to prevent the contamination before it occurs.”
The new law would give FDA the authority to order a food recall if the firm responsible for manufacturing or distributing the dangerous product fails or refuses to recall it in a timely manner after being made aware of the potentially serious health risk it presents to the public.
The agency will first issue a “prehearing order to cease distribution and give notice” which basically tells a “responsible party” that it should cease all distribution, notify its customers to stop all distribution, and recall the hazardous product. But, before the agency can order a “responsible party” to conduct a food recall, it must first give the firm an opportunity to make its case at an informal administrative hearing within two days. Following the hearing, if FDA continues to believe that a recall is necessary, it can amend the original order to require the firm to immediately initiate a recall.
Failing to follow the FDA recall order would be illegal.
The House bill would also provide for substantial civil penalties for “any person who does not comply with a recall order,” with one set of penalties applicable to any violation and a second higher set of penalties applicable to knowing violations. Civil penalties would be capped and enforcement powers, including recall and suspension of registration, would only be exercised by senior agency leaders.
Now is the time to review your current recall plan and make updates in anticipation of the FDA obtaining this new authority to mandate recalls. You must be able to act quickly and seamlessly through the recall processes. You cannot afford to give FDA the impression that you have a poor recall plan or that you don’t have the resources identified ahead of time to execute a recall in a timely manner. One good way to guarantee that you are ready to handle the worst case scenario is to conduct regular mock recall exercises and identify outside resources that can fill any gaps you find in your planning and preparation.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.
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MYTH: This bill will make it illegal to grow vegetables in a back-yard garden.
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