US food safety plan calls for FDA recall power

Nov 6, 2007 (CIDRAP News) – A new food protection plan released by the Bush administration today proposes giving the Food and Drug Adminstration (FDA) the power to require companies to recall unsafe foods, among a number of other steps.

The food protection plan was released along with an overall Import Safety Plan, both prompted by a series of tainted imports in recent months, including chemically contaminated pet food, toys with lead paint, and seafood containing traces of unauthorized drugs.

The FDA can force a prescription drug off the market by withdrawing its approval, but it currently cannot compel a company to recall a hazardous food, a fact that consumer groups have often decried. The agency has maintained that companies in the vast majority of cases recall such products voluntarily. But today officials acknowledged that the mandatory recall authority would sometimes be useful.

"The mandatory recall authority that we're requesting here would be used in situations where manufacturers don't want to make a voluntary recall," said Dr. David Acheson, the FDA's assistant commissioner for food safety, at an afternoon teleconference. "We've had situations where it hasn't worked, where there have been delays or refusal. This allows us to plug that hole."

"A key feature of both our Import Safety Plan and our Food Protection Plan is a recommendation that the FDA be granted new authority to recall the unsafe food products," President Bush said in a statement today. "With this authority, the FDA will be in a better position to act quickly if any problem occurs."

Providing the FDA with food recall authority will require congressional action, according to an Associated Press report today.

The new Food Safety Plan deals with both imported and domestic food products and embodies a comprehensive approach involving "prevention, intervention, and response," administration officials said.

"The idea is to take a comprehensive approach to food safety to look at the total life cycle of the food, from the time it's in the ground until it's in the consumer's mouth," said Tevi Troy, deputy secretary of the Department of Health and Human Services (HHS), at the news conference.

"The idea is to build safety into products every step of the way," Troy said.

In an FDA news release, FDA Commissioner Andrew von Eschenbach, MD, said, "Although our agency clearly needs to maintain and enhance its response capacity, the primary goal is to prevent contaminated food from ever reaching the consumer."

The overall Import Safety Plan was prepared by a cabinet-level task force set up in July. HHS Secretary Mike Leavitt, in a letter that accompanied the 86-page plan, said it is based on feedback from stakeholders after the working group's initial findings were released on Sep 10. A public meeting was held in Washington, DC, Oct 1 to solicit comments.

"The public and private sectors have a shared interest in import safety, and substantive improvement will require the careful collaboration of the entire importing community," Leavitt wrote in the letter.

The final plan includes 14 broad recommendations and 50 action steps. Some are short-term goals, while others address long-term implementation.

In addition to the proposal for FDA recall authority, some of the short-term measures include:

  • Providing for safety and security certification for foreign producers, based on the product's risk level and intended use, similar to how the US Department of Agriculture certifies countries that export meat, poultry, and egg products. Certification would be mandatory for high-risk products.
  • Amending federal laws to allow authorities to seize the assets of companies that violate food safety acts
  • Raising civil penalties for companies that violate the Consumer Product Safety Act
  • Denying entry to foreign firms that don't allow the FDA to verify if they are complying with US safety standards
  • Developing uniform interdepartmental procedures for clearing shipments into the United States
  • Implementing rapid response systems for import safety incidents
  • Strengthening the protection of intellectual property rights to discourage trade in counterfeit products that may be harmful to consumers

Among the longer-term measures, the action plan includes the following:

  • Developing and promoting good importer practices
  • Instituting incentives for foreign producers to voluntarily certify their products
  • Creating a single-window interface for governmental and private exchange of import data
  • Expanding laboratory capacity and developing methods to more quickly identify contaminants
  • Expediting recalls through advanced use of technology, such as integrated circuit or radiofrequency tracking systems

Leavitt, in his letter that accompanied the plan, recommended the working group meet again in 30 days to review progress on the short-term goals spelled out in the document.

Editor's note: CIDRAP News will cover the FDA Food Safety Plan in more detail in a later story.

See also:

Nov 6 FDA news release about the food safety plan
http://www.hhs.gov/news/press/2007pres/11/20071106a.html

FDA's Food Protection Plan
http://www.fda.gov/Food/GuidanceRegulation/FoodProtectionPlan2007/default.htm

Nov 6 White House fact sheet about the Import Safety Plan
http://georgewbush-whitehouse.archives.gov/news/releases/2007/11/20071106-7.html

Action Plan for Import Safety (full text)
http://archive.hhs.gov/importsafety/report/actionplan.pdf

Statement by President Bush
http://georgewbush-whitehouse.archives.gov/news/releases/2007/11/20071106-8.html

Sep 12 CIDRAP News story "US import safety panel calls for risk-based monitoring"

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