FDA food safety plan in limbo
WASHINGTON – After the Sept. 11 attacks, the Food and Drug Administration developed a comprehensive plan to guard the U.S. food supply against tainted imports, which were seen as a serious security threat. But nearly six years later, the plan has languished because of a lack of official will and tight federal budgets, according to former senior officials involved in formulating the strategy.
That is a painful realization for lawmakers and others who now are struggling to deal with the discovery of chemicals used to make plastics and to treat swimming pool water in pet food ingredients imported from China. The contamination is believed to have killed or sickened hundreds of animals, forcing the recall of more than 100 brands of pet food. Similar ingredients commonly used in food meant for human consumption are imported with little government supervision.
“It was a bitter pill to swallow,” said Benjamin L. England, a former FDA regulatory lawyer who worked on the plan for the agency’s enforcement branch. “I’m disappointed that they are basically sitting on the solution.”
In the immediate aftermath of the 2001 terrorist attacks, the government and an army of experts developed protections against a wide array of threats. But as time passed and no new attacks occurred, the sense of urgency drained away. In the case of foodstuffs, the FDA’s Import Strategic Plan fell victim to budget constraints, competing priorities and government inertia.
“The bottom line is that the United States is being overwhelmed with food imports, and they are not being screened by the FDA,” said William Hubbard, a former FDA associate commissioner for policy and planning.
“A lot of time and effort went into it, and the best minds of the agency were brought in,” he said of the import protection plan. “It wasn’t approved or disapproved. It was basically, ‘We can’t do this because we have no money.’ “
There is, however, a new urgency to deal with the threat: The chemicals implicated in the pet deaths, identified as melamine and cyanuric acid, were found in protein ingredients used in human foods, ranging from bread to veggie burgers. One of the most commonly used of these ingredients is wheat gluten.
This week, the FDA announced that it is expanding testing for contamination of human foods. China, a country with a reputation for lax safety standards, is a major supplier of ingredients used in both pet and human food products marketed by U.S. companies.
Dr. David Acheson, chief medical officer of the FDA’s food-safety center, said the agency was alerting food producers and importers about possible risks involving six protein-concentrate products. It also is testing imports from China.
But, in an interview, Acheson and Domenic Veneziano – who oversees imports for the FDA’s enforcement branch – said they were unsure of the status of the Import Strategic Plan.
“It’s moving through the system. As to quite how far, I’m not sure,” Acheson said. Veneziano said the plan was under review by the Health and Human Services Department.
Under the plan, the agency would have direct access to quality-control information for the entire life cycle of a product, instead of relying on data from foreign manufacturers and shippers.
The FDA regulates drugs, food, cosmetics and other products. The volume of imports under its jurisdiction has roughly doubled since 2002. A little less than 1 percent of shipments are inspected.
By law – strengthened after the Sept. 11 attacks – foreign manufacturers and shippers must alert the FDA that food is headed for the United States. Companies involved in food production and shipping must keep records identifying their suppliers and customers. The FDA has the authority to detain food shipments if there is credible evidence that they pose a serious health threat.
But Carl R. Nielsen, a former head of import operations for the FDA, said that the reporting rules yielded little useful information on the ways food is prepared, packaged, stored and shipped – key elements in managing risks.
Despite problems with safeguarding imports, FDA officials say they are not operating in the dark. For example, Acheson said inspections focused on classes of foods for high-risk groups, such as baby formula.
England and Nielsen said the Import Strategic Plan included several technological improvements, among them a computer-based system that would put intelligence data and other information in the hands of inspectors at points of entry.