Food Safety:

FDA and USDA Should Strengthen Pesticide Residue Monitoring Programs and Further Disclose Monitoring Limitations

GAO-15-38: Published: Oct 7, 2014. Publicly Released: Nov 6, 2014.

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What GAO Found

The Food and Drug Administration's (FDA) most recent data from 2008 through 2012 show that pesticide residue violation rates in 10 selected fruits and vegetables were low, but FDA's approach to monitoring for violations, which targets commodities it has identified as high risk, has limitations. Among other things, GAO found that FDA tests relatively few targeted (i.e., non-generalizable) samples for pesticide residues. For example, in 2012, FDA tested less than one-tenth of 1 percent of imported shipments. Further, FDA does not disclose in its annual monitoring reports that it does not test for several commonly used pesticides with an Environmental Protection Agency (EPA) established tolerance (the maximum amount of a pesticide residue that is allowed to remain on or in a food)—including glyphosate, the most used agricultural pesticide. Although FDA is not required by law to select particular commodities for sampling or test for specific pesticides, disclosing this limitation would help meet Office of Management and Budget (OMB) best practices for conducting and reporting data collection and help users of the reports interpret the data. Also, FDA does not use statistically valid methods consistent with OMB standards to collect national information on the incidence and level of pesticide residues. FDA officials said that it would be costly to calculate national estimates for the foods it regulates because it would require a large number of samples for a wide array of products, but did not provide documentation on the cost of doing so or an assessment of the trade-offs of doing less targeting and more random sampling. Limitations in FDA's methodology hamper its ability to determine the national incidence and level of pesticide residues in the foods it regulates, one of its stated objectives.

For domestic and imported meat, poultry, and processed egg products, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service's (FSIS) most recent available data from 2000 through 2011 show the agency found a low rate of pesticide residue violations, but its data had limitations. Specifically, for this period, FSIS did not test meat, poultry, and processed egg products for all pesticides with established EPA tolerance levels. Like FDA, FSIS is not required by law to test the foods it samples for specific pesticides, but disclosing this limitation in annual reports would meet OMB reporting best practices. Since 2011, FSIS has increased the number of pesticides it has tested for and samples it has taken and engaged with EPA on changes to FSIS's monitoring program to better provide EPA with data it needs to assess the risks of pesticides.

The most recent data from USDA's Agricultural Marketing Service's (AMS) annual survey of highly consumed commodities, including fruits and vegetables, show that, from 1998 through 2012, pesticide residue detections varied by commodity and were generally well below tolerance levels. EPA and others praise AMS's data collection efforts as providing valuable information on the incidence and level of pesticide residues in foods. In addition, while the sampling methodology used by AMS in the Pesticide Data Program meets many of OMB's best practices for conducting and releasing information to the public concerning a data collection effort, it does not meet several others, such as some principles of probability sampling that are important for ensuring that the data the agency collects are nationally representative. As AMS does not disclose these limitations in its annual monitoring reports, users of the data may misinterpret information in these reports and draw erroneous conclusions based on the data.

Why GAO Did This Study

From 1970 to 2007, hundreds of millions of pounds of pesticides were applied annually to U.S. food crops to protect them from pests. To protect consumers, EPA sets standards—known as tolerances—for pesticide residues on foods. FSIS monitors meat, poultry, and processed egg products to ensure they do not violate EPA's tolerances, and FDA monitors other foods, including fruits and vegetables. AMS gathers annual residue data for highly consumed foods, although not for enforcement purposes.

GAO was asked to review federal oversight of pesticide residues in food. This report examines (1) what FDA data show with respect to pesticide residue violations in the foods that it regulates; (2) what FSIS data show with respect to pesticide residue violations in the foods that it regulates; and (3) what AMS data show with respect to pesticide residue levels in fruits and vegetables. For each agency, GAO examined limitations, if any, in the agencies' monitoring of foods for pesticide residues. GAO analyzed FDA, FSIS, and AMS pesticide residue data, including their reliability, reviewed agency methods for sampling foods for testing, and interviewed agency officials.

What GAO Recommends

GAO recommends that FDA improve its methodology and FDA and USDA disclose limitations in their monitoring and data collection efforts. FDA said it will consider methodological changes and will disclose limitations. USDA agreed with GAO's recommendations.

For more information, contact John Neumann at (202) 512-3841 or neumannj@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: In February 2015, FDA posted a report summarizing the results of its Fiscal Year 2012 Pesticide Monitoring Program. The report identified which pesticides the agency tested for in FY 2012. However, the report did not identify which pesticides with EPA-established tolerances were not tested for, nor did it discuss the potential effect of not testing for those pesticides. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.

    Recommendation: To better inform users of the annual monitoring report about the frequency and scope of pesticide tolerance violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to disclose in the agency's annual pesticide monitoring program report which pesticides with EPA-established tolerances the agency did not test for in its pesticide monitoring program and the potential effect of not testing for those pesticides.

    Agency Affected: Department of Health and Human Services

  2. Status: Open

    Comments: In February 2015, FDA issued a report summarizing the results of its pesticide monitoring program for Fiscal Year 2012. This report followed by about 4 months the issuance of our report, GAO-15-38, in October 2014. The FDA report stated that the sampling methodology used in FY 2012 was not statistically based. However, in light of our recommendation that FDA design and implement a statistically valid sampling methodology, the agency could have used its February 2015 report to announce its plan to develop such a methodology for use in the future, but it did not do so. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.

    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to design and implement a statistically valid sampling methodology that would enable the agency, within existing resources, to gather nationally representative pesticide residue incidence and level data for both domestically produced and imported foods, or justify statistically the use of a nonprobability method that can measure the estimation error. In designing either approach, FDA should consider the extent to which the benefits exceed the costs.

    Agency Affected: Department of Health and Human Services

  3. Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.

    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to report the nationally representative incidence and level data in its annual pesticide monitoring reports, including disclosing the limits of its chosen sampling methodology.

    Agency Affected: Department of Health and Human Services

  4. Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.

    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to use the incidence and level data to assess the effectiveness of FDA's targeted pesticide compliance and enforcement monitoring program, including its use of the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting targeting tool for imported foods, by comparing the rate of violations detected through the program to the overall rate of pesticide residue violations within the domestic and imported food supplies.

    Agency Affected: Department of Health and Human Services

  5. Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.

    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to identify any types of domestic and imported foods that are at high risk for pesticide residue tolerance violations to improve the ability of its targeted pesticide compliance and enforcement monitoring program to consistently identify food likely to have violations.

    Agency Affected: Department of Health and Human Services

  6. Status: Open

    Comments: In March 2015, FSIS issued its Fiscal Year 2015 Residue Sampling Plan for the National Residue Program for Meat, Poultry, and Egg Products. The sampling plan contained information on the pesticides that FSIS would include in its residue testing program. However, the sampling plan did not identify pesticides with EPA-established tolerances that FSIS did not plan to include in its testing program. In December 2015, FSIS issued its Fiscal Year 2014 Residue Sample Results for its national residue program. The agency's report on its results did not identify pesticides with EPA-established tolerances that were not included in its testing program, nor did it report on the potential effect of not testing for those pesticides. In June 2016, FSIS issued its sampling plan for Fiscal Year 2016. The sampling plan contained information on the pesticides that FSIS would include in its residue testing program. However, the sampling plan did not identify pesticides with EPA-established tolerances that FSIS did not plan to include in its testing program. The FSIS sampling results for Fiscal Year 2015 were not available as of December 2016.

    Recommendation: To better inform the public about the frequency and scope of pesticide tolerance violations, the Secretary of Agriculture should direct the FSIS Administrator to disclose in the agency's annual pesticide monitoring program report which pesticides with EPA-established tolerances the agency did not test for in its National Residue Program and the potential effect of not testing for those pesticides.

    Agency Affected: Department of Agriculture

  7. Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. As with earlier reports, this report does not provide sufficient documentation of the survey methods used in the program. In particular, the report does not provide complete information on the sampling methodology the agency used, such as how it identified and selected states, food distribution centers, and commodities for pesticide residue testing. Further, it does not include measures of sampling error for reported estimates.

    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by providing more complete information on the sampling methodology the agency uses, such as how it identifies and selects states, food distribution centers, and commodities for pesticide residue testing, and include measures of sampling error for reported estimates.

    Agency Affected: Department of Agriculture

  8. Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. This report has a new section titled Sampling Limitations. In that section, the agency acknowledges that the total number of distribution centers and terminal markets within the participating states is difficult to establish because existing sites may go out of business or merge and new sites may open during the course of the year. Despite this limitation, the agency concludes that the sites selected in the program are representative of all sites in these states. However, the agency has not provided sufficient documentation in the report to support the claim that its data are representative of conditions across the country for commodities in the U.S. food supply.

    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by reporting on the extent to which its survey covers commodities in the U.S. food supply and any limitations associated with its survey methodology.

    Agency Affected: Department of Agriculture

  9. Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. This report does not describe methods users should employ to analyze the data, including obtaining margins of error for making generalizeable estimates of pesticide residues in commodities.

    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by describing methods users should employ to analyze the data, including obtaining margins of error for making generalizeable estimates of pesticide residues in commodities.

    Agency Affected: Department of Agriculture

 

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