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Congressional Report Faults FDA Inaction

Investigators say FDA has not implemented its own food safety plans

June 13, 2008

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Grappling with another high profile food contamination, the U.S. Food and Drug Administration is coming in for more criticism, this time from Congressional investigators.

The General Accountability Office told the House Energy and Commerce Committee Thursday the agency has done little to implement its own revised food safety plan. The charges echo similar complaints from the Center for Science in the Public Interest (CSPI).

Plum, Roma and round tomatoes are filling trash bins behind restaurants and grocery shelves as 167 people have been reported ill from eating salmonella-tainted tomatoes. The outbreak has been documented in at least 17 states so far, according to the Centers for Disease Control, which is still getting reports of people falling ill.

Since FDA's plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan, investigators report. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. But to date, few steps have been taken.

From the information GAO said it has obtained on the Food Protection Plan, however, it is unclear what FDA's overall resource need is for implementing the plan, which could be significant.

For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million.

In addition, GAO said, timelines for implementing the various strategies in the plan are unclear, although a senior level FDA official estimated that the overall plan will take five years to complete. GAO also said it is concerned that the FDA hasn't provided much information about its plan. FDA officials reportedly told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release.

"Concerns about food safety oversight are not new," said Lisa Shames, GAO Director Natural Resources and Environment, in testimony before the subcommittee. "GAO and others have consistently reported on a lack of adequate oversight of food safety by FDA, and have provided many recommendations for better leveraging FDA's limited resources and suggestions for additional authorities that would allow FDA to better fulfill its responsibilities.

"In 1998, we reported that limitations in FDA's authority and its need to more effectively target limited resources could adversely affect its ability to ensure food safety. A decade later, the story remains the same and has only taken on a greater sense of urgency due to changing demographics and consumption patterns."

In fact, Shames noted that FDA has implemented few of the GAO's past recommendations to leverage its resources and improve food safety oversight. Since 2004, GAO said it has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations.

For the remaining recommendations, GAO said the FDA has not fully implemented them, but in some cases has taken some steps. GAO said planned activities in the Food Protection Plan could help address several of the recommendations that FDA has not implemented, but the agency has yet to act.

CSPI's charges

The GAO's findings follow complaints from consumer groups that FDA moves too slowly to effectively ensure the safety of food products.

"Since 2006, CSPI has been urging FDA to require all farms that feed the American public to have written food safety plans, but the FDA has not done that," Klein said. "Instead, the agency and the Bush Administration rely on voluntary, and obviously ineffective, industry programs.

The result is yet another produce outbreak sickening consumers and dealing another setback to another important industry, which includes many growers who have implemented food safety measures, Klein said.

"Consumers can't afford to risk their health by eating tainted produce, and they can't afford the blow to their wallets when FDA tells them to throw out what may actually be safe food because the agency can't figure out the precise source of the contamination," she said.

Some published reports say that Florida and the eastern shore of Virginia have been the target of an ongoing FDA "tomato safety initiative."

FDA says the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. The agency also notes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months.

Klein said trying to track down contamination after the fact isn't getting the job done.

"Without food safety plans, on-farm inspections, and effective traceback systems, all consumers can do is cross their fingers and hope that the food they eat is safe," she said. "Even now, with 145 people in 16 states sick, FDA can't tell consumers whether the contaminated tomatoes were domestically produced or imported. The agency needs to overhaul its food safety system, and it needs to do it now."

Klein said that since 1990, more than 3,000 Americans have gotten sick from tomatoes contaminated in 24 known outbreaks. And she said those numbers don't take into account what must be countless unidentified tomato-related outbreaks.

"How many more consumers have to get sick before FDA gets serious about produce safety?" Klein asked.

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