******** URGENT ACTION REQUEST********

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REQUESTED ACTION: Please contact Senator Diane Feinstein (559-485-7430 DC office and 202-224-3841district office) and Congressman Jerry Lewis (909-862-6030 DC office and 202-225-5861district office) immediately, regarding their conference committee meetings on the Interior appropriations bill. Specifically, urge them to support the Burns Amendment and to oppose the Boxer Amendment to the FY06 Interior appropriations bill, regarding EPA’s use of pesticide registration data which is based on studies of human volunteers. If you are an association with members in agriculture, please ask your members to help.

ISSUE: Senator Barbara Boxer (D-CA) has offered an amendment to the FY06 Interior appropriations bill that would prevent the EPA from using resources to consider or accept data which is based on ethically-run studies of human volunteers, to determine the safety of pesticides and establish use limitations and conditions. Senator Conrad Burns (R-MT) has offered an alternative amendment which would allow the EPA to use said data under reasonable, scientifically necessary and ethically acceptable conditions. Both amendments have been approved by the Senate, and, now will be considered and the differences resolved by a conference committee, in the next few days. California Senator Dianne Feinstein and Congressman Jerry Lewis are two of the conferees.

IMPACT: American Agriculture strongly supports EPA's consideration of ethically-derived human test data to ensure appropriate margins of safety for pesticide use. Unfortunately, the potential impact of the Boxer prohibition threatens the use and availability of a number of soil fumigants and other pesticides and the conditions under which they may be used. The registration and use of pesticides and a number of other products depends heavily on EPA’s consideration of ethically-derived human test data, to establish safety margins on everything from food consumption/residue tolerances to skin absorption/irritation. This includes pesticides used to protect crops such as cotton, peanuts, fruits, nuts, vegetables, nursery trees and plants, corn, wheat, citrus and alfalfa.

The following pages provide increasingly detailed information on this issue, if you need it. Also, you may call me if you have any questions: 831-637-0195, ext 3020. Thank you.

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The Boxer amendment must be dropped in conference. If EPA is prohibited from considering valid scientific and ethically-derived human test data in its pesticide risk assessments, growers may no longer have access to some essential pesticides. Without these ethically-derived, valid, scientific human test data, EPA will be forced to use overly conservative and exaggerated default assumptions, which could lead to the significant modifications in the use and application of several pesticides used to protect crops such as cotton, peanuts, fruits and vegetables, corn, wheat, citrus and alfalfa.

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The Boxer/Solis language which prohibits EPA from considering human data jeopardizes public health protections, because it would prevent the agency from considering a variety of important studies including the following:

Industry supports human studies conducted in accordance with high ethical standards such as would be required by the Burns Amendment.

The Federal Insecticide Fungicide and Rodenticide Act (FIFRA) requires some studies to be conducted with human subjects such as those needed to measure the potential exposure to pesticide users or workers re-entering treated areas or to evaluate the efficacy of mosquito and other insect repellents. Other studies are conducted to provide information that cannot be obtained from animal studies, such as whether exposure to a chemical causes individuals to feel the presence of the chemical in the eye or nose.

The use of human test data in EPA regulatory decisions has been thoroughly examined by the National Academies of Science in its 2004 report Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. The report concluded the following:

Background: EPA is in the process of developing a rule that will outline the ethical requirements that must be met in order for human data to be considered in pesticide risk assessments and codify many of the 2004 National Academies of Science (NAS) recommendations on the use of human data in pesticide regulatory decisions. In its report, Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, NAS concluded that human test data should be considered in EPA regulatory decisions only if all the following conditions are met:

1. The study is necessary, scientifically valid and addresses an important regulatory question that cannot be answered with animal studies or nondosing human studies;
2. The societal benefits of the study outweigh any anticipated risks to participants;
3. There is reasonable certainty that participants will not experience any adverse effects; and
4. All recognized ethical standards and procedures are followed, including equitable selection and recruitment of participants, informed consent, and independent review of the scientific and ethical merits of the study by an Institutional Review Board (IRB).

The NAS study also recommended that EPA establish a high-level advisory board to conduct its own review of human dosing studies prior to and after the conduct of the study to ensure that the study is scientifically and ethically valid for EPA regulatory purposes.

EPA is currently reviewing human test data on a case-by-case basis, considering each study’s adherence to ethical standards, such a those laid out in the NAS report, as well as the study’s adherence to the Federal Policy for the Protection of Human Subjects (Common Rule) and other ethical standards.

The House and Senate Interior appropriations bills both contain conflicting language relating to the use of human test data in pesticide risk assessments. The House bill contains report language commending EPA for clarifying its policy on the use of human data and for its efforts to complete a rulemaking on this issue, as well as legislative language prohibiting EPA from considering valid scientific data derived from human tests. The Senate bill contains this same prohibition, as well as language directing EPA to review and report to Congress within 60 days on all scientific data on third-party intentional human dosing studies to ensure that they meet the criteria laid out in the NAS report.

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