EPA comment period closes for chemical tests on humans

WASHINGTON, DC, May 9, 2005 (ENS): To win Senate confirmation as administrator of the U.S. Environmental Protection Agency (EPA) last month, then Acting EPA Administrator Stephen Johnson canceled a planned study in which parents were to be paid to expose their infant children to pesticides. But now the agency is finalizing a new policy that permits the same type of human dosing studies by industry.

Today the EPA closes public comment on its policy of accepting the results of experiments that intentionally dose humans with pesticides and other chemicals on a wide open case-by-case basis, without defining what criteria are required of experimenters.

The agency does not define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.

During his Senate confirmation hearing, Johnson disclosed that the EPA has funded or is currently funding than 250 experiments on human subjects, several of which involve chemical testing on children, including:

• Exposing children ages 3 to 12 to the agricultural insecticide chlorpyrifos to test absorption in their systems through “urinary biomarker measurements.”
• Paying 12 “young male volunteers” to inhale methanol vapors at levels described as “a worst case scenario”
• Having asthma sufferers inhale potentially harmful ultrafine carbon particles
  

The study that was canceled was financed jointly by EPA and industry. Called CHEERS (Children’s Environmental Exposure Research Study) it would have paid Florida parents to apply pesticides and other chemicals in the rooms primarily occupied by their infant children.

	"The Bush administration is setting the ethical bar so low that only the most sleazy cannot limbo under it.” - PEER Program Director Rebecca Roose

Since industry is not required to disclose the conditions under which experiments were conducted, it is not clear how EPA will ever learn of “fundamentally unethical” practices, PEER commented.

"It is even more alarming that until the CHEERS controversy surfaced, EPA regional office staff did not know that studies they conduct or support are subject to HHS [Department of Health and Human Services] regulations, PEER wrote.

"It is hard to believe that these are truly the criteria by which EPA judges human subject studies, because they would be clear violations of HHS regulations," wrote PEER.

"EPA should never accept or use data from any human subject study if there is even the slightest evidence of intentional harm, serious or otherwise. EPA should never accept or use data from any human subject study if there is any evidence that adequate informed consent was not obtained. To hold third-party researches to such low standards justifies past unethical behavior, encourages unethical behavior in the future and allows for unnecessary risks for countless human study participants," the employees' organization wrote.

“The Bush administration is setting the ethical bar so low that only the most sleazy cannot limbo under it,” warned PEER Program Director Rebecca Roose. “The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA’s standards for experiments to determine how much commercial poisons harm people.”

In its policy notice in the Federal Register, published February 8, the EPA defers adopting legally binding protections for infants, fetuses, pregnant women, and prisoners that apply to all medical and drug testing overseen by the Department of Health and Human Services. Instead, EPA announces that it "indends to publish a proposed rule" at some time in the future.

The agency says that any research on human subjects conducted or supported by the EPA is subject to the principles of the 1979 Belmont Report, known as the Common Rule. These principles include such basics as informed consent about the research procedure, purposes, risks and anticipated benefits, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.

But third party studies, conducted by groups not supported by federal money, are not subject to the Common Rule. "EPA should establish a system to describe and track all human subject studies, and put this system on its website. It should establish agency-wide training on the requirements of the Common Rule for all staff conducting, granting money for, or reviewing human subject studies," PEER wrote.

PEER said in a media statement today that "the EPA’s refusal to adopt basic safeguards requiring proof of informed consent, independent review, or protections for children is part of a Bush administration drive to liberalize rules on human testing of pesticides and other chemicals. Without actual human experimental data to justify higher chemical exposures for children, industry must abide by the 1996 amendments to the Federal Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for children."

In its policy statement, the EPA says it "may propose to adopt some or all of the HHS regulations that provide additional protections for certain populations of vulnerable subjects." This proposal "may" require a sponsor or investigator to provide the protocol for the human studies to the EPA for prior review and approval.

But the guidelines proposed by the agency are all voluntary and non-binding upon the experimenters, the EPA and the public, the agency states.

Read the PEER comments on lack of safeguards in EPA policy: http://www.peer.org/docs/epa/05_9_5_comments.pdf

See EPA’s “No Safeguards” Human Testing Policy Notice: http://www.peer.org/docs/epa/05_9_5_notice.pdf

Look at other EPA human dosing experiments: http://www.peer.org/docs/epa/05_9_5_humandosing.pdf

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