New rules for testing on humans denounced

Senior EPA staff criticize agency proposal as flawed

July 05, 2005|By Andrew Schneider | Andrew Schneider,SUN STAFF

While Congress pushes for laws to restrict how and when scientists use human test subjects for the Environmental Protection Agency, the agency is seeking to loosen its rule for experiments involving humans.

Senior EPA toxicologists, physicians and lawyers have examined the agency's proposed ethical guidelines and denounced them as dangerous.

"In fact, if implemented in its present form, the rule may greatly weaken existing protections outlined in the EPA Common Rule for the Protection of Human Subjects," said the introduction to a six-page internal EPA memo obtained by The Sun.

EPA scientists occasionally study chemicals' effects on humans but more often contract out to universities and medical centers. The agency also allows industries, including pesticide companies, to submit results of their tests on humans as they seek EPA approval.

The EPA has promised to revise its old standards for human experimentation by next month. The rule would cover human experimentation conducted by the EPA or funded by the agency. It also would cover experiments conducted by industry and submitted to the EPA for review to demonstrate product safety.

The proposed rule falls "far short" of strengthening protections for individuals who participate as test subjects in human research, the memo said. It was addressed to William Jordan, the principal author of the proposed rule and a senior policy adviser in the EPA's Office of Pesticide Programs.

"Because of fundamental flaws in the rule as proposed, protections for children, women, fetuses and certain neonates will not be fully effective," the memo added.

The EPA disagrees. The agency's proposed rule "will be based on scientific and ethical principles and at this time the draft rule is being deliberated internally and no final agency decisions have been made," said Eryn Witcher, EPA press secretary.

"We expect to propose a draft rule by late August that will be open for public review and comment," she said Sunday.

The evaluation of the proposed rule, which was produced by the agency's National Enforcement Investigations Center, was distributed to more than two dozen EPA staff members last Tuesday. They were participating in a Washington-based teleconference held to discuss last-minute concerns before the final rule was signed off on by Stephen L. Johnson, the EPA's new administrator, and his team.

Although none of those involved in the meeting, nor those who authored the evaluation, would agree to be quoted, many expressed concern that the wording of the proposed rule would open the door to ethical abuses.

In May, California Rep. Hilda L. Solis, the ranking Democrat on the Energy and Commerce Subcommittee on Environment and Hazardous Materials, introduced an amendment to prohibit the EPA from conducting its own human experimentation or accepting similar studies from industry.

Last Wednesday, the Senate voted in favor of an amendment by California Sen. Barbara Boxer, a Democrat, to the EPA's funding bill to ban human testing for one year. But at the same time, the Senate passed another amendment by Sen. Conrad Burns, a Montana Republican, to allow the agency to use at least some human testing.

The battle is expected to continue this week when Congress reconvenes from its holiday recess.

A ban on human pesticide testing was established by former EPA Administrator Carol M. Browner in 1998. That changed in October 2001 when, the Los Angeles Times reported, the head of the agency's Office of Prevention, Pesticides and Toxic Substances told a meeting of pesticide manufacturers that the EPA would again consider the results of pesticide experiments on humans.

The head of the pesticides and toxic substances office then was Johnson, now the EPA's chief.

There is no shortage of ethical guidelines for the scientific community on protecting human test subjects. Most were developed in reaction to Nazi human experimentation during World War II. Government and industry ethicists have further refined the rules over the decades.

Seventeen federal agencies, including the EPA, have adopted the "Common Rule," which is the Federal Policy for the Protection of Human Subjects.

The critics of the EPA's proposed rule say it ignores or wrongly interprets the standards of the Common Rule and the more current human testing guidelines by the National Academy of Sciences.

The internal EPA critique raised several areas of concern. It called the rule for research involving intentional exposure "seriously flawed" because it does not preclude "the unethical practice" of encouraging test subjects to continue their behavior even though the researcher knows the action could cause harm.

For example, the critics referred to a controversial and aborted plan by the agency to use chemical industry money to fund a project to measure pesticide consumption by infants living in low-income households in Florida.

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