F.D.A. issues first new rules under food safety act

by Jay Sjerven
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WASHINGTON — The Food and Drug Administration on May 4 announced the first two regulations to be issued under the F.D.A. Food Safety Modernization Act (F.S.M.A.), signed into law by President Barack Obama in January. Both rules will take effect July 3.

The first rule strengthens the F.D.A.’s ability to prevent potentially unsafe food from entering commerce by allowing the agency to administratively detain food the agency believes has been produced under unsanitary or unsafe conditions.

Previously, the F.D.A.’s ability to detain food products applied only when the agency had credible evidence that a food product was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.

Beginning in July, the F.D.A. will be able to detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace while the agency determines whether an enforcement action, such as seizure or federal injunction against distribution of the product in commerce, is necessary.

Before this new rule, the F.D.A. often would work with state agencies to embargo a food product under the state’s legal authority until federal enforcement action could be initiated in federal court.

“This authority strengthens significantly the F.D.A.’s ability to keep potentially harmful food from reaching U.S. consumers,” said Mike Taylor, F.D.A. Deputy Commissioner for Foods.

David W.K. Acheson of Leavitt Partners, Washington, said the F.D.A. itself never administratively detained an article of food under its current authority. Dr. Acheson said by “lowering the bar” for use of administrative detention, the F.D.A. is more likely to use the authority in situations similar to those for ordering a Class II recall, i.e. situations where the use of, or exposure to, a violating product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

“The new authority has the potential to have a significant economic impact on the industry if product that is not contaminated is detained,” Dr. Acheson observed. “In their cost analysis, the agency estimated that 48% of detained product is not contaminated, based on a model of the per cent of imported product that is detained and later released. For fresh produce that has a short shelf life, this could have a significant impact.”

Dr. Acheson told Food Business News unlike the U.S. Department of Agriculture, which, for instance, may compensate poultry producers should they be required to cull or destroy their flock to arrest the spread of disease, the F.D.A. has no fund or mechanism to compensate produce growers or food manufacturers for losses in the event a detained food is determined not to be contaminated. This may prove to be a problem that must be addressed going forward.

At the same time, the considered and deliberate use of the expanded administrative detention authority may reduce the extent to which consumer confidence declines during a recall, Dr. Acheson said.

“The 2006 spinach and the 2008 tomato/hot pepper (Salmonella) outbreaks had significant impacts on both the industry and consumer confidence,” he said. “The lower bar for administrative detention may allow the agency to provide more assurance to consumers that product in commerce is safe and limit the long-term decrease in consumer confidence that follows a broad product recall.”

Dr. Acheson said industry’s best defense against having products administratively detained is to have implemented preventive controls and a clearly documented food plan and product tracking system. These would assist food manufacturers to demonstrate their products are not adulterated or misbranded or enable them to clearly define the scope of any problem that may exist.

“It will be important for industry to monitor how the F.D.A. uses this new enforcement tool and provide feedback to ensure that the rule is implemented in a way that both protects public health and ensures that the good actors are not adversely affected by the actions of a few bad actors,”

Dr. Acheson said.

The second rule requires anyone importing food into the United States to inform the F.D.A. if any other country has refused entry to the same product, including food for animals. This new requirement will provide the agency with more information about foods that are being imported, which may improve the F.D.A.’s ability to target foods that may pose a significant risk to public health.

This new reporting requirement will be administered through the F.D.A.’s prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

With prior notice, in the event of a credible threat from a specific product or a specific manufacturer or processor, the F.D.A. will be able to mobilize and assist in the detention and removal of products that may pose a serious health threat.

“The new information on imports can help the F.D.A. make better-informed decisions in managing the potential risks of imported food entering the United States,” Mr. Taylor said. 

Senate acts to raise penalties for violating new food safety law

The U.S. Senate on April 15 passed by unanimous consent the Food Safety Accountability Act, which would raise criminal penalties for any individual or corporation that knowingly endangers lives by contaminating the food supply by distributing misbranded or tainted food products. The Senate bill was sent to the House of Representatives, and the House leadership referred it to the House Committee on Energy and Commerce and the House Committee on the Judiciary for their consideration.

The measure was introduced by Senator Patrick Leahy of Vermont, chairman of the Senate Committee on the Judiciary.

“Food safety received considerable attention last year, and I was pleased that Congress finally passed comprehensive food safety reforms,” Mr. Leahy said. “But our work is not done. On behalf of the hundreds of individuals sickened by recent salmonella outbreaks, I urge the House to quickly pass the Food Safety Accountability Act and join the Senate in continuing to improve our food safety system.”

The legislation would make knowingly distributing tainted or mislabeled food a felony; it currently is a misdemeanor. The legislation would establish fines and give law enforcement the ability to seek prison sentences of up to 10 years for such offenses.

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