EPA Begins Promised Process for Evaluatinv Use of Human Data

Lisa M. Campbell
Bergeson & Campbell, P.C.
Washington, D.C.

In early September, the United States Environmental Protection Agency (EPA) signed its long awaited contract with the National Academy of Sciences (NAS), pursuant to which NAS will review EPA's use of human studies. This is an important milestone in the several year old debate on the use of human data to assess pesticide products, and the resolution of the issues that NAS is reviewing under the contract will have long lasting and far reaching impact on pesticide products and industry generally.

The debate over EPA's use of human data to assess pesticide products has been the subject of much attention, and several reversals of EPA policy, for a number of years, beginning with the Environmental Working Group's (EWG) release in 1998 of a report detailing its opposition to human studies of pesticide products, entitled The English Patient. EPA at that time adopted an interim policy stating that EPA would not use these studies while it conducted an evaluation of its policy. EPA then convened a Joint Subcommittee of its Scientific Advisory Panel (SAP) and its Science Advisory Board (SAB) to review the issue. This Subcommittee met in December 1998 and issued a report in September 2000 in which the majority of members recommended the continued use of human data under defined circumstances. In October 2001, EPA indicated that it would rescind its interim policy and begin again considering human data.

Just a few months later, however, on Dec. 14, 2001, a press release announcing that EPA "will not consider or rely on any such human studies in its regulatory decision making, whether previously or newly submitted" until NAS had considered issues concerning the use of these studies and "a policy is in place." This decision was not well-received by many in industry, and earlier this year, CropLife Association and others sued EPA for violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Administrative Procedure Act, and other authorities in response to EPA's unilateral decision to suspend reliance on human data for purposes of supporting FIFRA pesticide registrations. This court challenge is ongoing, and it is difficult to predict when a decision will be issued.

The now agreed to NAS review is thus the first step in EPA's current reevaluation of its policy. It has been the subject of much discussion since EPA's Dec. 14, 2001, decision to suspend for the indefinite future reliance upon human studies in its regulatory decision-making. Under the terms of the Agreement's "Statement of Work," NAS will establish a Federal Advisory Committee Act (FACA) panel of 15 people to consider and obtain public input on certain issues, including:

• A description of the current legal (statutory or regulatory) requirements governing the conduct of third-party research with human subjects and consideration by a federal agency of the results of such research;
• A description of the current policies and practices of other federal agencies regarding acceptance, consideration, and reliance on third-party research with human subjects, and a description of any requirements and enforcement practices of such agencies relating to the ethical conduct of such research;
• The types of third-party human research, if any, that EPA should always refuse to accept, consider, or rely on;
• The minimum standards relating to the protection of human subjects which should be met in the design and conduct of a study with human subjects, in order for EPA to accept, consider, and rely on the results of the study in regulatory decision-making;
• The minimum scientific standard relating to the reliability and relevance of the results that should be met for a human study, for EPA to accept, consider, and use the results of the study in regulatory decision-making; and
• The ways in which minimum standards for the conduct of third-party research with human subjects should be imposed, implemented, and enforced.

The contract is for an 18-month period. The final report is due to EPA within 16 months of September 2002, or by December 2003. The FACA process is sure to result in significant debate, and the report issued will be the foundation for EPA's development of a proposed policy that itself likely will be released for public comment. The effect of the industry lawsuit on the resolution of this issue remains to be seen; a court ruling favorable to industry could well change EPA's course with regard to the consideration of human data while the NAS process is ongoing.