Food makers need to file reports with regulators when they suspect serious problems with foods ranging from smoked salmon to sheep feed.
Under rules that took effect Sept. 8, the Food and Drug Administration is requiring reports to the Reportable Food Registry within 24 hours anytime there is a reasonable probability that "the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals," according to information from the FDA. The agency may consider "enforcement discretion" until Dec. 8 in cases where responsible parties make reasonable efforts to comply with the law and act to protect public health.
The regulations apply to registered food facilities that make, process, pack, or hold most food regulated by the FDA, but not to foods regulated by the Department of Agriculture through the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act. They also do not apply to dietary supplements or infant formula, which have separate reporting requirements.
Federal, state, and local governmental authorities can also voluntarily file reports with the registry.
Michael R. Taylor, JD, senior adviser to the FDA commissioner, said during a Sept. 8 conference call with news media that the new authority enhances his agency's ability to prevent foodborne illness.
"We also hope that this, too, will build on the partnership that already exists among government agencies (and) the food industry—who have a common interest in swiftly removing from commerce potentially contaminated or harmful products before they get into consumers' hands," Taylor said.
Taylor noted the FDA had performed outreach during development of the reporting system and the guidance for industry.
The new law requires companies to report the results of any internal tests that provide reason to believe the tested products could harm people or animals, Taylor said. It also gives the FDA the authority to require companies to notify their suppliers or customers when a problem is detected.
"This is intended to inform us of contamination problems before people get sick, if that is a possibility," Taylor said.
The reporting requirements were created through provisions of the Food and Drug Administration Amendments Act of 2007, which President George W. Bush signed into law in September 2007.
The act required the secretary of health and human services to establish the registry within one year, but the FDA announced in a May 27, 2008, Federal Register notice that implementation was delayed while the agency developed an electronic reporting portal. FDA officials also announced at that time they were seeking comments on some of the registry provisions.
Congress passed the act with the intent that the registry would track patterns of adulteration in food and help the FDA better use its limited inspection resources.
The reporting burden is shouldered by the "owner, operator, or agent in charge" of a domestic or foreign food manufacturing, processing, packing, or holding facility. Those parties are also responsible for investigating the cause of any adulteration and reporting their findings, according to the FDA.
The law contains reporting exemptions for parties that detect and correct problems before contaminated food leaves their possession.
More information on the law is available at www.fda.gov. Under the "Food" tab, click on "Reportable Food Registry." A link to the FDA guidance for industry is available on the same page.