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EPA Considers Human Testing of Pesticides; Public Comments Due by August 5, 2003

(Beyond Pesticides, May 19, 2003) The Bush Administration announced on May 7, 2003 that it is considering allowing human studies to support the registration of pesticides, a practice that was banned by the Clinton Administration in a 1998 administrative rule that said human studies would not be used to establish regulatory levels (using "no observable adverse effect levels," or NOAELs) for pesticides. The proposal to allow testing of pesticides on humans is open to public comment until August 5, 2003, a 90-day public comment period.

An Advance Notice of Proposed Rulemaking (ANPR) was published by EPA in the Federal Register (68 FR 24410) on May 7, 2003, soliciting public comment about criteria and standards the agency would use in deciding the extent to which it will rely on certain kinds of human research to support its decision to register pesticides. EPA says, "This notice begins a process to establish rigorous scientific and ethical standards that EPA would apply in its analysis of various types of research involving people exposed to toxicants to identify or quantify their effects." In the AJNPR, EPA says it will particularly focus on "third-party intentional dosing human studies," but recognizes that standards applicable to these studies may also be applicable to other types of studies. "Third party studies: refers to research not conducted or supported by EPA or other federal agencies, and therefore not governed by the Common Rule to ensure that test subjects have adequate protections. The agency is seeking public comments on how to determine the extent to which it will consider or rely on results from particular types of studies involving human subjects, and "how EPA might be able to establish robust standards for the protection of human subjects, in preparation for developing a rule or policy on this issue." The agency's focus in developing a future policy or rule must be protection of the welfare of human research subjects and adherence to the most rigorous ethical and scientific standards. Along with public comments, EPA will also consider advice expected later this year from the National Academy of Sciences.

In a press release on the subject of human testing in November, 2001, the Natural Resources Defense Council said the following:

"Ironically, EPA is changing its policy partly in response to pressure by a German pesticide manufacturer, Bayer, which in August submitted a human study of azinphos methyl, an insecticide derived from World War II nerve gases. Bayer scientists were among those who conducted human experiments in the Nazi concentration camps when the company was a subsidiary of I.G. Farben, the infamous manufacturer of Nazi death camp gas. Bayer submitted the azinphos methyl test in an effort to reduce otherwise applicable safety requirements for the chemical.

In late October, EPA made a tentative decision not to use the Bayer study because it was scientifically unnecessary to consider it, not because of legal and ethical questions it raised. However, there are more than 10 other human pesticide studies awaiting EPA consideration. If EPA ultimately accepts the Bayer study or any of the other human studies before it, the floodgates could open for other human pesticide studies."

From EPA's Advance Notice of Proposed Rulemaking:

In December 2001, EPA asked the advice of the National Academy of Sciences (NAS) on the many difficult scientific and ethical issues raised by this debate, and also stated the Agency's interim approach on third-party intentional dosing human subjects studies. At that time the Agency committed that when it receives the NAS report, ``EPA will engage in an open and participatory process involving federal partners, interested parties and the public during its policy development and/or rulemaking regarding future acceptance, consideration or regulatory reliance on such human studies.'' Since making that commitment, EPA has decided to initiate a rulemaking process by issuing this ANPR.

In early 2002, various parties from the pesticide industry filed a petition with the U.S. Court of Appeals for the District of Columbia for review of EPA's December 2001 press release. These parties argued that the Agency's interim approach constituted a ``rule'' promulgated in violation of the procedural requirements of the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act. The court has denied motions concerning emergency relief and other matters, briefs have been filed, and oral argument of the merits of the case occurred on March 17, 2003.

Under a contract with EPA, the NAS has convened a committee to provide the requested advice. The committee met in December 2002, and again in January and March 2003. The committee's final report is due in December 2003.

Notwithstanding these many recent developments concerning human studies, some things have not changed. EPA remains committed to full compliance with the Common Rule for all research with human subjects conducted or supported by the Agency. This body of research has provided many important insights and has contributed significantly to the protection of human health. The Agency will continue to conduct and support such research, and to consider and rely on its results in Agency actions. EPA also remains committed to scientifically sound assessments of the hazards of environmental agents, taking into consideration available, relevant, and appropriate scientific research.

EPA's Rulemaking Process and Request for Public Comment

EPA intends to undertake notice-and-comment rulemaking on the subject of its consideration of or reliance on research involving human subjects. The Agency will particularly focus on third-party intentional dosing human studies, but recognizes that the principles applicable to third-party studies may also be relevant to studies conducted or supported by the federal government. The first step in this process is this ANPR which calls for comments and suggestions from all interested parties. The next step the Agency would expect to undertake would be to issue a proposed rule for public comment. In developing any proposed rule, EPA will consider the advice in the National Academy of Sciences committee report, along with comments received in response to this ANPR. Comments received on any proposed rule would then be taken into consideration in developing a final rule or policy.

In general, the Agency expects that any rule or policy coming out of this process may do one or more of the following:

o Specify, if and to the extent determined by EPA to be appropriate, whether EPA would accept, consider, or rely on results from particular types of studies involving intentional dosing of human subjects or from human studies with particular characteristics.
o Establish minimum standards relating to the protection of human subjects which would be required to be met in the design and conduct of a study with human subjects, in order for EPA to accept, consider, or rely on the results of the study.
o Establish procedures for ensuring that any minimum standards for the conduct of third-party research with human subjects had been adhered to in the conduct of any such study that EPA intended to accept, consider, or rely on.

Submit your comments, identified by docket ID number OPP-2003-0132, online at http://www.epa.gov/edocket (EPA's preferred method) or mailed to the Public Information and Records Integrity Branch (PIRIB), (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. For additional submission methods and detailed instructions, go to Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: William L. Jordan, Mail code 7501C, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703)305-1049, fax number: (703) 308-4776; e-mail address:
jordan.william@epa.gov.