Food security plan has stalled
After Sept. 11, 2001, the Food and Drug Administration developed a comprehensive plan to guard the nation’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 pains lawmakers and others as they deal with the discovery of chemicals used to make plastics and 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 common in humans’ food 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.”
Many members of Congress are now demanding action. But a blueprint for dealing with the security concern already has been drafted.
After the 2001 terrorist attacks, the government and experts developed protections against an array of threats. But as time passed without new attacks, the sense of urgency drained away. In the case of foodstuff, 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. This is all good stuff, and it should be done, but we don’t have money.’ ”
There is, however, a new urgency. 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 common of these ingredients is wheat gluten.
FDA investigators suspect the interaction of melamine (used to make plastics more pliable) and cyanuric acid (used to sanitize pool water) might have caused fatal kidney problems in pets. A possible reason for adding the chemicals is that in certain tests, they can make food ingredients appear protein-rich.
This week, the FDA announced that it was expanding testing for contamination of human foods, though none has been detected. China, a country with a reputation for lax safety standards, is a major supplier of ingredients in pet and human foods marketed by U.S. companies.
The FDA, still under a cloud from the Vioxx drug safety controversy, faces the possibility of a more damaging controversy over the food supply. The agency approved Vioxx for sale as a prescription painkiller and only later discovered it posed the risk of heart attacks and other health problems.
Dr. David Acheson, chief medical officer of the agency’s food safety center, said the FDA was alerting food producers and importers about possible risks involving six protein concentrate products. It is also testing imports from China.
“We are trying to get ahead of the curve,” he said.
Somewhere in the system
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.
A detailed briefing on the plan was presented to the agency’s top managers at a 2003 retreat in Virginia, Hubbard said. A 2004 FDA budget document declared that the plan would “reinvent the import process.”
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 that account for about 25% of U.S. consumer spending. The volume of imports under its jurisdiction has roughly doubled since 2002. About 1% of shipments are actually inspected.
Under current law -- strengthened after Sept. 11 -- foreign manufacturers and shippers must register with the FDA and provide basic information, including emergency contacts and the categories of food handled. They also are required to alert the FDA when food is headed for the United States. Companies involved in food production and shipping must keep records documenting who their suppliers and customers are.
The FDA has the authority to detain food shipments if credible evidence suggests they would pose a serious health threat to people or animals.
But Carl R. Nielsen, a former head of import operations for the FDA’s enforcement branch, said the current reporting rules yield little useful information on how food is prepared, packaged, stored and shipped -- key elements in managing risks.
“Registration and prior notice, even though they can be of some value, are not the final solution at all,” said Nielsen, a 28-year veteran of the agency. “One of the holes is that those [requirements] are not linked to the conditions of manufacture.” Nielsen and England are partners in FDAImports.com, a consulting firm for importers that seek to comply with U.S. government requirements.
What’s being done now
Despite the problems with safeguarding imports, FDA officials say, they are not operating in the dark. For example, Acheson said, inspections focus on classes of foods considered high risks, such as baby formula.
England and Nielsen said the Import Strategic Plan included several technological improvements, among them a computer system to put intelligence and other information in the hands of inspectors at points of entry.
That part of the plan may be tested soon in Los Angeles, Veneziano said.
Another element of the plan would have worked like the “trusted traveler” programs used in aviation security. Foreign manufacturers that worked closely with major U.S. firms and followed the same food safety standards would be able to move their products through the pipeline more quickly. That would allow the FDA to concentrate its limited staff on greater threats, England said.
A third element would have shifted some FDA inspectors from domestic industry to import duty. Part of the idea was to see whether states could take more responsibility for monitoring domestic producers.
It’s unclear how much the plan would have cost to carry out. “It would have been millions, and they only had a couple of hundred thousand,” England said.
A coalition of industry and consumer groups lobbying for major increases in the FDA budget estimates that the overall food program -- with an annual allocation of about $440 million now -- needs an additional $125 million a year for the next five years.
“The budget has been steadily cut at the FDA, and therefore, the vulnerability is steadily going up,” said Hubbard, who is among those campaigning for more money for food safety programs.
ricardo.alonso-zaldivar @latimes.com
