Results in Brief

discuss pesticide regulation issues with government officials and
representatives of other groups.

GAO found a high degree of uniformity among OECD nations, including the United States, with regard to the kinds of test data that are required to register food-use pesticides. However, similar data requirements do not necessarily mean that countries receive the same information about a pesticide product or evaluate it in a similar manner. Important differences were found in data evaluation procedures, the transparency of the decision-making process, and the organization and staffing of agencies that regulate pesticides in the various OECD nations. For several evaluation procedures, such as those dealing with carcinogens, there is a divergence of scientific opinion concerning what approach is most appropriate. With regard to the level of technical resources and expertise available to conduct in-depth assessments of experimental test data, GAO found limitations in at least two of the OECD countries that were visited. Furthermore, the overall lack of written documentation in several OECD countries made it difficult to understand both their registration processes and their rationales for decisions concerning pesticides.

GAO found strong support for harmonization of pesticide regulations among the countries visited. The recent EEC initiative to harmonize the pesticide registration process will result in greater uniformity of test requirements and review procedures for member states. In addition, other efforts underway through the OECD and other organizations should strengthen cooperation among countries and improve information sharing about pesticide regulations. However, much work remains before regulatory differences among nations will be fully resolved.

Principal Findings

Data Registration
Requirements

In reviewing the pesticide registration data requirements of 18 OECD nations and the EEC, GAO found a high level of agreement with U.S. requirements on the battery of toxicology tests used to assess human health effects of food-use pesticides. GAO found somewhat less agreement with regard to the tests that measure the impact of a pesticide on the environment and wildlife; these tests are less easy to standardize due to climatic and geological differences that are present across countries.

Executive Summary

Countries also differ in the extent to which they have established formal test protocols. EPA, for example, has developed detailed guidelines that specify how tests should be conducted in the United States. Several OECD countries have not developed such guidelines but have indicated a willingness to accept test data generated according to the guidelines of OECD, EPA, or other international organizations. The EEC has also recently made considerable progress in developing specific guidance and procedures to structure the pesticide registration process in its member states.

Organizational Structures

The capability of a pesticide registration system to properly evaluate a
chemical compound cannot be ascertained solely from its stated data
requirements. In the course of conducting case studies in five selected
OECD nations, GAO found important differences in the level of technical
resources devoted to evaluating test data, as well as in the way each
country structured the evaluation process. Greece, for example, had one
full-time toxicologist and two other toxicologists serving in an advisory
capacity. In contrast, EPA has found it necessary to build an organization of
approximately 300 full-time staff representing different scientific
disciplines devoted to evaluating registration petitions. Such differences in
what countries require to execute their mission raise questions about the
relative capabilities of nations to conduct scientifically sound reviews.

Evaluation Procedures

GAO found several differences in the data evaluation procedures used by OECD nations. For example, the United States uses what is termed a quantitative risk assessment model to estimate cancer risk, whereas OECD nations apply a threshold model. The best method of assessing cancer risks posed by pesticides is the subject of considerable debate, both in the United States and abroad, and work is being initiated to address differences in approach and methodology. In addition, unlike EPA, most OECD nations review data on product efficacy. This approach can promote safety by limiting the quantity of pesticides used. The United States, in contrast, places greater emphasis on market forces to minimize pesticide use, assuming that users will apply the minimum amount necessary of a pesticide. Further, the decision-making process leading to pesticide registration is often not made public in many OECD nations, thereby making it difficult to ascertain what other similarities and differences in evalution methods may exist.

Enforcement and
Monitoring of Standards

Matters for
Congressional
Consideration

Agency Comments

GAO found that OECD nations' residue enforcement efforts generally focus on the testing of imported foods; less emphasis is given to exported products and domestically grown and consumed foodstuffs. The extent of monitoring efforts, however, varies among OECD countries. In some countries, testing has only recently been implemented, and in others available resources do not provide for comprehensive coverage of imports. Other countries have monitoring systems in place that routinely test food shipments.

GAO also found flexibility in the residue standards that OECD nations accept. For example, if a residue for which no national standard exists is detected on a food sample, OECD countries frequently consider Codex Alimentarius standards-a practice not followed by the United States.

GAO found several fundamental differences across OECD nations' pesticide regulatory systems. Although at this time disparities across these nations appear to be too great to warrant taking what may be the final step in broader harmonization-recognition and acceptance of other nations' registration decisions-the Congress may wish to encourage EPA to conduct further work to clarify the extent and nature of these differences. The Congress may also wish to encourage EPA to expand its involvement in efforts to reach agreement on aspects of pesticide regulatory standards, as a way of furthering harmonization.

Officials from the Department of Agriculture (USDA), EPA, and the Food and
Drug Administration (FDA) reviewed a draft of this report and provided
informal comments. Because of the nature of the report, the majority of
the comments were made by EPA representatives. EPA officials believed
that the report was essentially correct with respect to the technical and
scientific matters discussed. They did make several technical
observations, however, and these have been incorporated in the text
where appropriate.