Recurring outbreaks of food-borne illness from contaminated produce are “unacceptable” in today’s society, the government says. But when it comes to preventing new occurrences, the Food and Drug Administration hasn’t done much of the basic research that would let it write regulations to fix the problem.
Six years after the FDA first issued general guidance to the produce industry on how it might prevent contamination from microbes such as E. coli 0157:H7, experts say federal regulators still can’t answer key questions.
For example, does water used for irrigating crops have to be clean enough for people to drink? And since cow manure is a common source of E. coli, how far from a cow pasture does a spinach patch have to be? Across the road? A quarter-mile away? A mile?
“There are no specific criteria for producers to follow, no specific criteria that can be enforced,” said Michael R. Taylor, who as head of the Agriculture Department’s Food Safety and Inspection Service in 1995 launched a testing program for E. coli that led to major sanitary improvements at meatpacking plants.
Without such specifics, FDA talk of regulations to protect consumers from more outbreaks like the recent ones involving fresh spinach and Taco Bell restaurants may be little more than bureaucratic saber-rattling.
Scientific research is needed for such esoteric matters as the proper distance between a cow pasture and a spinach patch because federal regulations carry the weight of law. Growers, packers and shippers must spend money to comply with government rules. And consumers wouldn’t be helped much if new requirements were based on flawed assumptions.
“The idea of sending inspectors out right away is fairly useless, because without the basic science to set workable standards, you can’t know what will work,” said William Hubbard, a former FDA associate commissioner for policy, planning and legislation.
One reason for the lack of data from the FDA seems to be that its funding has not kept up with increased responsibilities and the rising cost of maintaining its professional staff.
“They haven’t had the resources to develop the standards,” said Hubbard, who is involved with a coalition of business and consumer groups seeking a substantial increase in FDA funding.
In a business-friendly administration, many new regulatory efforts advance slowly, if at all. But the FDA’s predicament is more acute because an agencywide budget squeeze is putting disproportionate pressure on its foods program.
“We’ve got some of the knowledge, and industry can start acting on what they know, but in order for the FDA to provide leadership, they really need to invest in research,” said Taylor, who also previously served as an FDA deputy commissioner and is now an assistant professor at the University of Maryland School of Medicine.
An internal budget analysis prepared this summer, titled “FDA Financial Realities,” concluded that the FDA’s food program budget would need $176 million more in 2007 to provide roughly the same level of service as it did in 2003.
In dollar terms, funding allocated by Congress increased somewhat, from $407 million in 2003 to $450 million for 2007. But the analysis found that the agency’s personnel costs had risen at a much faster rate, creating a squeeze that is leading to layoffs at headquarters and in the field. Most of the FDA’s expenses are for professional staff, such as scientists and doctors, who command salaries that are competitive with those in private industry.
The squeeze on the foods program is markedly worse than for the agency as a whole, the analysis concluded.
FDA officials said they could not provide any figures on how much the agency spent on food safety research.
Most federal food safety research is done through the Department of Agriculture, which shares jurisdiction with the FDA, Taylor and other experts said. The USDA is responsible for meat, poultry and processed eggs; the FDA oversees all other foods, including fresh produce.
The Agriculture Research Service has an annual budget of $85 million for food safety research. But most of that money is spent on projects involving meat products -- the USDA’s chief responsibility -- though produce outbreaks are on the rise.
The research service currently has only one project underway that deals directly with leafy greens such as spinach and lettuce. In October, the service launched a $3-million, four-year water-quality study.
FDA officials say they can’t just go to the White House and demand more money for food safety research.
“FDA isn’t in a position to ask for resources,” said Dr. David Acheson, chief medical officer for the foods division and the agency’s point man in the recent outbreaks. “What FDA does is make optimal use of the resources it gets.”
Because it may not be able to draft new regulations anytime soon, the FDA is hoping state authorities will take the lead. It also plans to use the federal bully pulpit to try to get growers to take stronger preventive measures on their own. The industry is working on voluntary standards it plans to release early next year.
The FDA expects to hold a major public meeting early in the year, probably in California, to solicit the latest scientific advice, Acheson said.
“The idea is that somehow all the stakeholders will get together and in the absence of science and data arrive at some kind of reasonable consensus,” said Trevor Suslow, an agricultural extension agent at UC Davis. “It won’t happen if they wait for the science. They have to pick a starting point and go forward.”
Consumer groups are concerned that the lack of scientific research will lead to more delays in produce safety rules. “I don’t want to see this tied up for another couple of years while they investigate all the science,” said Caroline Smith DeWaal, the director of food safety for the Center for Science in the Public Interest.
The incoming Democratic chairwoman of the House committee that oversees FDA funding said she was baffled that the agency had not asked congressional budget writers for more money for food safety. Rep. Rosa DeLauro (D-Conn.), said she planned to make food safety the topic of her first hearing next year.
“We have to find out where we are falling down here,” said DeLauro. “Is it resources, is it management, is it a combination of the two?
“We have to be able to prevent these outbreaks,” she added, “and not just have a good response when they occur.”