Bush urges FDA recall power, more clout for safety agency

Times Staff Writers

The Bush administration on Tuesday moved to protect the nation against tainted food and dangerous consumer products through government-ordered recalls, tighter safety rules for manufacturers and steeper fines for those who violate them.

In parallel proposals from the White House and the Food and Drug Administration, officials acknowledged flaws in the current screening system. The remedies -- some of which would require congressional action and some that could be implemented by regulations -- would cover imports such as toys contaminated by lead paint, as well as domestically produced foods like the tainted California spinach that last year killed three people and sickened hundreds more.

“While we have strong food and product safety standards, we need to do more to ensure that American families have confidence in what they find on our store shelves,” President Bush said in announcing the plan. “They have the right to expect the food they eat, or the medicines they take, or the toys they buy for their children to be safe.”

The administration’s call comes after years of complaints by consumer groups and congressional Democrats that the government was failing to respond to a stream of problems with products originating in the United States and abroad. Critics in particular cited the lack of new funding for the FDA, the Consumer Product Safety Commission and other regulatory agencies feeling the pinch of tight domestic budgets.


“I welcome the acknowledgment by the administration that we need increased authority and increased power to better protect the American people, but I’m also very concerned by the lack of detail on how we assure this is going to occur,” said Rep. Rosa DeLauro (D-Conn.), who chairs a panel that allocates funding for the FDA and other consumer protection agencies.

Health and Human Services Secretary Mike Leavitt acknowledged that “we haven’t gotten to the point of putting a price tag” on it. He said that would be addressed in the president’s 2009 budget, which is expected to be submitted to Congress in February. A coalition of consumer and industry groups has called for doubling the FDA’s $450-million food safety budget within five years, but the 2009 budget is expected to stop well short of such an expansion.

The White House and FDA proposals point to prevention as the key to avoiding problems and would significantly expand regulation of private business -- a reversal of the administration’s broad preference for less government oversight and more reliance on market forces.

The safety plans call on importers and domestic producers to take on greater responsibility by putting safeguards in place at critical points in the production and distribution chain. The strategy is advocated by consumer groups, which acknowledge that it would be impractical in a global economy to try to inspect every farm and factory.

To encourage importers to become more closely involved in monitoring their overseas suppliers, the plan offers the prospect of expedited clearance at the border for companies that can certify their goods meet certain standards. Categories of imports deemed “high risk” would require mandatory safety plans.

The administration also is seeking new legal authority for the FDA, including the power to issue mandatory recalls. The agency currently must cajole producers into voluntary withdrawals. In addition, the FDA would be able to impose safety plans on domestic and foreign producers. The agency is responsible for about 80% of the food supply -- the exceptions being meat and poultry, which are monitored by the Agriculture Department -- but it is hampered by weak regulatory powers and budget constraints that have led to cutbacks in inspections and in basic food-safety research.

The Consumer Product Safety Commission would see its recall authority strengthened in several ways. For example, it would become illegal for companies to reintroduce a recalled product -- a practice that some unscrupulous firms have resorted to.

However, the plans make only cursory references to so-called trace-back rules -- requirements for meticulous documentation that would enable investigators to follow the individual ingredients of a problem product to their origins.


“If you don’t have trace-back, you have a very difficult time making a mandatory recall system work effectively,” said Sarah A. Klein, a staff lawyer with the Center for Science in the Public Interest, a food-safety watchdog group.

Rules now require companies to document whom they obtained a product from and whom they sold it to. Anything more than that would be burdensome, said Stuart M. Pape, a lawyer representing the food industry.

“It’s very complicated and potentially very expensive,” he said. “Lots of ingredients get commingled along the way. How do you keep track of wheat when a bunch of different farmers grow it and take it to a co-op and it gets put in a silo?”

The plan also calls for fines of up to $10 million for companies that flout rules, and for deployment of more U.S. government inspectors overseas.


Donald L. Mays, product safety director for Consumers Union, said the administration’s plans moved in the right direction -- just not far enough. For example, he said, officials missed an opportunity to impose an outright ban on lead paint in consumer products.

“I wouldn’t say the plan is completely there,” Mays said. “It still favors trade over requirements for testing and inspection to make sure a product is safe before it leaves its country of origin.”