U.S. EPA Sued Over New Human Pesticide Testing Rule

SAN FRANCISCO, California, February 27, 2006 (ENS) - A new U.S. Environmental Protection Agency rule will turn more Americans into "lab rats for industry pesticide tests" according to lawsuits filed Thursday by a coalition of health and environmental advocates, farmworkers and doctors.

The lawsuits were filed simultaneously in the Second Circuit Court of Appeals in New York City and the Ninth Circuit Court of Appeals in San Francisco.

The groups filing lawsuits include Pesticide Action Network North America, Pineros y Campesinos Unidos del Noroeste (Northwest Treeplanters and Farmworkers United), San Francisco Bay Area Physicians for Social Responsibility, and the Natural Resources Defense Council (NRDC). They are represented by attorneys with Earthjustice and NRDC.

The groups contend that the agency’s human testing rule violates a law passed by Congress in 2005 mandating strict ethical and scientific protections for pesticide testing on humans.

"EPA’s rule allows pesticide companies to use intentional tests on humans to justify weaker restrictions on pesticides," said Dr. Margaret Reeves, a senior staff scientist with Pesticide Action Network.

On January 26, the EPA announced new rules that bann all third-party intentional dosing research on pesticides involving children and pregnant women, and EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children for all substances EPA regulates.

This final new rule also establishes what the EPA calls "stringent enforceable ethical safeguards to protect individuals who volunteer to participate in third-party intentional dosing research."

"These final rules will protect pregnant women and children from unethical human research involving pesticides and other environmental substances," said Susan Hazen, acting assistant administrator in EPA's Office of Prevention, Pesticides and Toxic Substances. "Pregnant women and children should never be involved in these types of studies. Now adult volunteers (non-pregnant) will have the highest level of ethical safeguards available if they choose to participate in research studies."

An air-curtain orchard pesticide sprayer driven by technician Andrew Doklovic, who wears protective equipment to minimize his exposure to the chemical. The multiple crossflow fans used to disperse pesticide to apple trees can reduce spray drift by half. (Photo Keith Weller courtesy USDA)

The rule also fails to ensure that pesticide testing on human subjects meets the strictest scientific and ethical standards recommended by a 2004 National Academy of Sciences report and outlined in the Nuremberg Code after World War II.

"The EPA’s rule puts pesticide companies’ profits ahead of human health and scientific integrity," said Dr. Robert Gould, a pathologist and president of San Francisco Bay Area Physicians for Social Responsibility. "Pesticide companies should not be allowed to take advantage of vulnerable populations by enticing people to serve as human laboratory rats."

The chemical industry concedes that its goal is to weaken safety standards by circumventing the margin of safety the EPA uses to estimate a safe human exposure level based on animal studies.

As a result of the agency’s illegal rule, the plaintiff groups contend, the EPA will rely on unethical and unscientific human pesticide tests to weaken regulatory standards.

There have been serious ethical and scientific problems with such tests in the past. For example, a company told participants in one test they were eating vitamins, not toxic pesticides. In other tests, companies have not provided any long-term followup to protect participants’ health.

The Clinton administration banned the EPA from relying on the results of such tests because of their questionable scientific and ethical integrity. The Bush administration at first ratified the Clinton-era moratorium, but then lifted the ban.

Congress reimposed the ban in 2005, pending finalization of stricter rules.

For any new, intentional dosing studies with pesticides, the final rule requires researchers to comply with the requirements of the Common Rule, which outlines current ethical standards for research conducted or supported by the federal government.

Researchers must also submit detailed study protocols to the EPA prior to initiation so that the agency can review to ensure the study meets the new ethical protections and is scientifically sound; and once the study is conducted, provide detailed information to the EPA describing how the study met the necessary ethical protections.

These provisions are not satisfactory to the plaintiff groups. Erik Olson, a senior attorney with the Natural Resources Defense Council, said, "The industry’s human pesticide tests are unscientific and unethical. Their record of abuse is appalling, yet the EPA disregards Congress’ order to crack down on this abhorrent practice."

In order to reach decisions on whether to rely or reject a human study, the EPA is establishing a Human Studies Review Board to provide independent advice and recommendations to the agency on issues related to the scientific and ethical review of research involving human subjects.

The Board will review completed human research relevant to pending pesticide reregistration, tolerance reassessment, and new registration decisions in accordance with the provisions in the final rule. "Only after a external rigorous review, including opportunities for public involvement, will EPA reach decisions on whether to rely or not rely on a human study," the agency said January 26.

U.S. Department of Agriculture technician Betsy Anderson, wearing a special protective mask and gloves, sprays a pesticide on geranium plants. (Photo by Peggy Greb courtesy USDA)

Historically, the EPA has received approximately 33 intentional dosing studies of all types each year. These include studies measuring worker exposure, the efficacy of insect repellents, other studies designed to help assess exposure, and intentional dosing systemic toxicity studies.

Of these 33 studies, four a year on average involved intentional exposure of human subjects to measure what the EPA calls "minor, reversible systemic toxic effects." Systemic effects occur to organs within the body, such as effects on the nervous system which might cause, for example, tremors.

"We expect the number of systemic toxicity studies to drop to as few as 0 or 1 per year," the agency said.

But the plaintiff groups say no intentional pesticide dosing studies should be conducted in the United States. "Unethical testing of pesticides on humans is wrong and has to be stopped," said Jan Hasselman, an attorney with Earthjustice representing the groups in the lawsuit. "EPA’s rule ignores Congress and allows unethical human tests to be used to weaken pesticide regulations."

Intended to kill insect pests that attack agricultural products, many pesticides are known to be harmful to humans adn the environment. The Stockholm Convention on Persistant Organic Pollutants lists 12 chemicals that must be reduced or eliminated worldwide. Nine of those substances are pesticides - aldrin, toxaphene, DDT, chlordane, dieldrin, endrin, HCB, heptachlor, and mirex.