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From April 11, 2005

EPA Pulls Study That Encourages Children's Pesticide Exposure
Other Human Pesticide Testing Studies Continue
(Beyond Pesticides, April 11, 2005)
In a defensively worded statement on April 8, 2005, Stephen Johnson, Acting Administrator for the U.S. Environmental Protection Agency (EPA) announced the end of the Children’s Environmental Exposure Research Study (CHEERS) in which parents were paid to use pesticides in the rooms occupied by their infant children under age three.

Mr. Johnson did not admit any ethical problems with the study but concluded without explanation that the study could not “go forward…in an atmosphere absent of gross misrepresentation and controversy.” U.S. Senators Barbara Boxer (D-CA) and Bill Nelson (D-FL) had previously announced that they would hold Johnson’s confirmation as EPA Administrator unless he cancelled CHEERS.

While CHEERS will not go forward with EPA funding, the exact same study can proceed with private sponsors, according to Public Employees for Environmental Responsibility (PEER). In fact, the American Chemistry Council, which represents 135 companies including pesticide manufacturers, had already pledged $2 million toward the study’s $9 million overall cost.

In February, EPA published a draft policy that opens the door for accepting any experiments conducted by pesticide companies and chemical manufacturers using human subjects without establishing safeguards to ensure that the studies are conducted ethically and without harm to the subjects. Under this policy, EPA indefinitely delays ethical rules and, instead, relies on its political appointees to flag immoral or unsafe practices on a “case-by-case” basis.

“The reason Stephen Johnson clung so stubbornly to this creepy CHEERS effort is that it served as the beacon to industry that EPA would welcome similar experiments,” stated PEER Executive Director Jeff Ruch, noting that the pesticide industry wants to use human testing to trump animal studies so as to justify relaxed exposure limits. “Stephen Johnson has become the pesticide industry’s ‘go-to-guy’ at EPA.”

In an August 2003 letter to EPA on human testing with pesticides, Beyond Pesticides said the following:

"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research points out that three basic ethical principles need to be kept in mind when considering using humans as test subjects: respect for persons, beneficence, and justice. Human-based research in order to alter pesticide tolerance levels rmandated by EPA [or generate data to support pesticide product label application rates], and subsequently increase profits for the pesticide companies sponsoring the studies does not qualify as an ethical endeavor. This position is strengthened by the fact that EPA does not generally review efficacy data on pesticides, many of which are not necessary or cost-effective in achieving pest management goals. Since EPA, as a matter of policy, allows the marketplace to define product benefit, the agency has no way of knowing whether pesticide products achieve anything other than sales for the registrants. Ethical scientific studies are those whose results are meant for the betterment of society and the test subjects. In her January 8, 2003 remarks to the Committee on the Use of Third Party Toxicity Research with Human Research Participants, Vera Hassner Sharav, the president of the Alliance for Human Research Protection (AHRP), testified that 'pesticide experiments in human beings are morally unconscionable and scientifically dubious-they fail to meet fundamental standards of permissible research-as they offer no potential therapeutic benefit to the subjects or society.'"

Under the overall human dosing policy advocated by Mr. Johnson, EPA will have no protections for –

· Infants, neonates, pregnant women, and prisoners. By contrast, all medical and drug testing overseen by the Department of Health and Human Services has such safeguards; and

· Ensuring that companies have obtained informed consent or have not paid undue inducements.

As evidenced by EPA's support for CHEERS, the agency lacks any independent safety or ethical review mechanism. After the study had drawn controversy, EPA published on November 23, 2004 a Federal Register notice (69 FR 68143-68144) looking for experts in “ethical standards of research protocols and bioethics” because the agency lacked expertise in those areas. The agency then followed with the "Invitation for Comments on the 'ShortList' Candidates for Children's Environmental Exposure Research Study (CHEERS) Review Panel of the EPA Science Advisory Board (SAB)" which included 29 candidates.

To mask its lack of standards, during his confirmation hearing, Mr. Johnson claimed that the Centers for Disease Control had approved CHEERS. But, according to a January 18, 2005 letter from EPA to Representative Bart Gordon (D-TN), CDC had not reviewed it.

“EPA should adopt the basic safeguards required by common decency before they start using human dosing experiments,” Mr. Ruch added. “Canceling CHEERS does not end the argument about the need for ethical standards in human testing; it merely opens another round in that debate.”

Source: Environmental Media Services