G.A.O.: Gaps remain in F.D.A. food safety oversight

by Eric Schroeder
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WASHINGTON — A performance audit conducted by the U.S. Government Accountability Office between January and April shows that while the Food and Drug Administration has begun to take action to address weaknesses in food safety research, gaps remain.

The G.A.O.’s task in conducting the audit was to examine ways in which the F.D.A. may use science to more effectively support its regulatory work and inform the public about food content and safety. As such, the report focused on three things: F.D.A.’s progress in addressing selected recommendations identified by the Science Board; incorporation of scientific and risk analysis into its oversight of the accuracy of food labeling, fresh produce, and the safety of dietary supplements; and a new computer screening tool that may improve its efforts to screen imports using a risk-based approach.

According to the G.A.O.’s findings, a lack of certain scientific information has hampered the F.D.A. in its ability to carry out some food safety responsibilities, including oversight of food labels, fresh produce and dietary supplements.

“For food labels, we found that F.D.A.’s research on their accuracy, consumers’ perceptions of them, and other labeling options was limited,” wrote Lisa Shames, director of Natural Resources and Environment for G.A.O., in a letter accompanying the G.A.O. report. “For fresh produce, we found that gaps in scientific knowledge have limited F.D.A.’s efforts to integrate science and risk analysis into its oversight. Finally, for dietary supplements, we found that F.D.A. lacked information to better identify safety concerns associated with dietary supplements.”

Inadequate labeling a concern

Regarding food labeling, the G.A.O. report identified three areas in which the F.D.A.’s oversight has contributed to inadequate labeling: accuracy of Nutrition Facts Panel information; misleading food labeling; and options for a front-of-package nutrition labeling system.

“F.D.A.’s research to determine the accuracy of nutrient information is limited and outdated and shows varying degrees of compliance,” Ms. Shames wrote. “F.D.A. has not conducted random sampling on food labeling since 1996.”

Ms. Shames noted that while F.D.A. found most of the randomly selected products tested within allowable ranges, compliance rates varied for a few nutrients. While variances may contribute to impaired health, the F.D.A. said it has no plans for future studies, Ms. Shames said.

Misleading food labeling continues to be a problem because the F.D.A. does not have the empirical research on consumer perceptions to support enforcement against misleading food labels, Ms. Shames wrote.

The G.A.O. audit found more collaborative research is needed to help the F.D.A. sort out the options for a front-of-package nutrition labeling system. The G.A.O. has recommended that F.D.A. collaborate with other federal agencies and stakeholders to evaluate options for a “simplified, empirically valid system that conveys overall nutritional quality and that mitigates labels that are misleading to consumers.” In addition, the G.A.O. recommended F.D.A. maintain data on labeling violations and the corrective actions taken in a searchable format, analyze violation data in routine management reports, and track regulatory meetings on labeling violations to assess whether they are an effective use of resources.

More work to be done in produce

A little less than two years after a G.A.O. report found gaps in science were impeding F.D.A.’s ability to make decisions on regulating fresh produce, Ms. Shames said only “limited steps” have been taken to fill some of the science gaps.

“To fill some gaps, F.D.A. conducts laboratory research on fresh produce commodities and their associated pathogens,” she wrote. “For example, at the time of our review, F.D.A. had a study under way to improve its understanding of how one type of Salmonella contaminated tomatoes.”

Other projects under way at the time of the G.A.O. audit included F.D.A.’s work with university researchers on a U.S. Department of Agriculture-funded project that looked at options for reducing the risk of E. coli O157:H7 in leafy greens, and plans to fund about $1 million in extramural research on the safety of fresh produce.

Ms. Shames said the F.D.A. relies heavily on the research of other federal agencies for scientific knowledge, but indicated “it can be difficult to get other agencies to conduct research that meets’ F.D.A.’s needs, such as developing baseline data on contamination in lettuce in different regions and seasons. Such research would aid F.D.A.’s regulatory work but is extremely expensive to conduct. Therefore, gaps in science remain.”

The full report is available at www.gao.gov.

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