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U.S. Department of Health and Human Services

Animal & Veterinary

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Recently Enacted FDA Amendments Act Has Major Food Safety Components

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No IV

The FDA Amendments Act of 2007 (FDAAA) was signed into law by the President on September 27, 2007 (Public Law 110-085). Among its many provisions, the law reauthorizes and expands user fees for prescription human drugs and for medical devices. These programs are designed to ensure that FDA staff has the additional resources needed to conduct the complex and comprehensive reviews necessary to make new drugs and devices available to consumers. The new law also reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, both of which are designed to encourage more research into, and more development of, treatments for children.

Focus on food safety

Title X of the FDAAA imposes several requirements in the food safety arena. Many of these apply to human and pet food and generally deal with processing and ingredient standards, improved communication during an ongoing recall, and a mechanism for reporting food determined to be threatening to human or animal health.

According to the new law, the impetus behind enactment of the FDAAA was to increase the public’s confidence in the safety of the food supply.

Of major concern has been the increased amount of imported food, which now accounts for 13 percent of the average American diet, including 9.5 percent of red meat, and 78.6 percent of fish and shellfish. Also cited in the legislation is the decrease since 2003 in the number of full-time FDA inspectors.

In order to further enhance the safety of pet food, the new law directs that within 2 years the Secretary of Health and Human Services (HHS) is to promulgate new regulations to establish ingredient standards and definitions, processing standards, and updated standards for labeling to include nutritional and ingredient information.

Early warning system and effective communications

The new law also requires that, within 1 year, an early warning and surveillance system be established in order to identify any adulteration incidents affecting the pet food supply and also to alert the public about any outbreaks of illness associated with pet food. To do this, the law instructs the Secretary of HHS to consider the use of surveillance and monitoring mechanisms already in place to monitor human or animal health (e.g., FoodNet, PulseNet, and FDA’s Food Emergency Response Network).

FDA has already taken several steps to improve communication about a pet food recall, including posting information about the recall on FDA’s Internet Web site in a single location.

Reportable Food Registry

By September 27, 2008, FDA is also directed to establish a “Reportable Food Registry” to which instances of “reportable food” would be submitted by the Agency via an electronic portal, based on reports submitted by food facilities (i.e., manufacturers, processors, packers) that have registered pursuant to Section 415(a) of the Federal Food, Drug, and Cosmetic Act. For purposes of this requirement, “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that use of it will cause serious adverse health consequences or death to humans or animals.

Generally, any reports about such foods are to be submitted to the registry no later than 24 hours after a firm has determined that the food item poses possible serious adverse health effects.

However, the law says that no report would be required if the party with which the adulteration originated detected the adulteration prior to any transfer of it to another person and either corrected the adulteration or destroyed the adulterated product.

Also, the new legislation authorizes persons submitting these reports to include a statement to the effect that the submitter “denies” that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.

The new law delineates several follow-up actions after a report is submitted to the registry, and all responsible parties are instructed to maintain records related to each report for 2 years. In addition, this law gives FDA 9 months to develop regulations and a guidance to industry to implement the food registry. The guidance is to include specific information on how to submit the reports to the registry via the electronic portal and how to provide the required notification to other persons in the supply chain about a suspect feed product that poses a “reasonable probability” of causing serious adverse health consequences.

Aquaculture and seafood inspection; genetically engineered seafood

The new law also authorizes the Secretary of HHS to enhance FDA’s inspection program for aquaculture and seafood, consistent with obligations of the United States under international agreements and U.S. law. In addition, upon the request of any State, the Secretary may enter into partnership agreements to implement inspection programs to Federal standards regarding the importation of aquaculture and seafood products.

Lastly, the Commissioner of Food and Drugs is directed by the new law to consult with the Assistant Administrator of the National Marine Fisheries Service to produce a report on any environmental risks associated with genetically engineered seafood products, including the impact on wild fish stocks.