EPA avoids regulation of chemical experiments on humans

WASHINGTON, DC, February 8, 2005 (ENS): Experiments that intentionally dose human subjects with pesticides and other chemicals will be evaluated and approved by the U.S. Environmental Protection Agency (EPA) in a wide open case-by-case manner, the agency says in a draft notice for publication in the Federal Register.

The EPA is seeking public comment on this case-by-case method of considering experiments that involve human subjects in a notice dated February 2 and signed by Susan Hazen, acting assistant administrator in the Office of Prevention, Pesticides and Toxic Substances.

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

The notice 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 (HHS). Instead, EPA announces that it "indends to publish a proposed rule” at some time in the future.

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.

In the notice, the EPA says its overall goals are, "That human participants in any research required by, conducted for, or considered by EPA are treated ethically; and that all scientifically sound data relevant to EPA decision-making is considered and used appropriately in reaching decisions under our authorities."

But the attorney who heads a national association of natural resources government employees says the agency’s procedure lacks ethical or safety guidelines. “EPA’s stance is appallingly amoral," said Jeff Ruch, executive director of Public Employees for Environmental Responsibility (PEER), which made the notice public on Monday.

“At the request of chemical companies seeking to justify higher exposure limits, EPA will sanction dosing of infants, pregnant women and other vulnerable persons with commercial poisons,” Ruch said.

After a heated public debate about intentional dosing human toxicity studies with pesticides and several attempts at rulemaking, one of which ended in a 2003 court ruling that sent the agency back to the drawing board, the EPA is using this Federal Register notice to outline the case-by-case procedure it is now using to evaluate such studies.

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. The agency says it will continue to accept scientifically valid third party studies unless there is "clear evidence" that the studies were "fundamentally" unethical, that is, "the studies were intended to seriously harm participants or failed to obtain informed consent ..."

The agency said it intends to expand the functions of the EPA Human Subjects Research Review Official (HSRRO). This official has responsibility for assuring that all human subjects research conducted or supported by the EPA complies with the requirements of the Common Rule.

Ruch says by giving the HSRRO this responsibility, the EPA avoids "any requirement of an independent safety or ethical review, as is required for all other government human subject studies."

The agency will not require that companies demonstrate that they have abided by informed consent, appropriate inducement and other basic ethical standards.

Instead, the EPA says it will at some future time, "develop and make public a policy statement that encourages, but does not require," non-federal researchers planning studies involving human participants to support an EPA regulatory decision, to submit a proposed protocol to EPA prior to conducting the research.

Also the EPA intends to publish a "non-binding guidance" explaining that the agency expects compliance with the Common Rule for any future human studies specifically required by the EPA.

The EPA says it intends to reach out to scientific journals encouraging improved reporting of the ethics of published human studies.

The EPA case-by-case process allows wide latitude to scientists and chemical companies. Any "stakeholder" may urge EPA to: "(1) Conclude that this process is inapplicable; (2) consider factors other than those described here; or (3) make an exception to the process as described."

EPA notes that based on individual circumstances it may decide to act differently from the review process described in the Federal Register notice. "Affected parties should not assume that EPA will follow a prescribed method of reviewing a particular human study in each and every instance," the agency writes.

The only requirement the agency says it will adhere to is that in any action involving consideration and review of a third-party, intentional dosing human study, EPA "will explicitly state the basis upon which such a study has been evaluated."

“Since there are no public notice requirements," Ruch said, "the outside world will never learn of ethically dubious corporate experiments."

He warned that many corporate studies will be done in developing countries, inviting "chemical companies to push the outside of the moral envelope.”

Last November the EPA delayed its own controversial Children's Health Environmental Exposure Risk Study (CHEERS) which would measure children's exposure to pesticides in the home, to calm public concern generated by news reports questioning whether the study conforms to ethical standards.

The EPA would pay 60 families nearly $1,000 each for involvement in the two-year study.

Critics such as the Environmental Working Group and PEER say collecting such human testing data unethically encourages study participants to be exposed to toxic substances to allow industry to push for reduced regulatory controls on pesticides and other chemicals.

The EPA is forming a panel to review the study. In a January 24 letter to then EPA Deputy Administrator Stephen Johnson, the Environmental Working Group requests that the makeup of the panel be "fair and balanced."

"By that we mean that there should be no past or present pesticide or chemical industry employees, consultants or contractors on the review panel, and that there must be several individuals with strong public health credentials, including expertise in pediatric environmental health," wrote Environmental Working Group Senior Vice President Richard Wiles.

Johnson, who has defended the CHEERS study, has now been elevated to the position of EPA Acting Administrator, following the departure of former EPA Adminstrator Mike Leavitt January 28 to head the Department of Health and Human Services.

Wiles notes that his organization and others object to the "fundamentally unethical nature" of the CHEERS study design, which proposed to "stand by and simply observe what the study acknowledged to be high pesticide exposures to infants and small children."

The federal register notice, with its wide open non-binding guidelines appears to be the agency's attempt to lay the groundwork for justifying consideration of such human studies.

This draft notice is identical to an earlier draft of the EPA's approach to human testing of chemical exposures. The first draft was withdrawn after PEER publicly released it in late November. Ruch says this latest draft is "identical in effect to the earlier draft" but specifies possible standards that EPA may consider in the future.

Pesticide makers, who support human testing data as more reliable than animal studies in developing accurate exposure limits, have been awaiting a rule for years.