November 3

US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post

Pesticides are chemicals designed to kill or repel insects, plant diseases, weeds, rodents and germs. Among the medical atrocities committed by Nazi doctors were experiments that deliberately exposed human beings to germs and pesticides. Pesticides have absolutely no therapeutic medical use and human beings exposed to them will never derive a benefit from such exposure. EPA’s website acknowledges the long-term serious risks of pesticide exposure: such as neurological and developmental disorders and birth defects:

Human exposure to poisonous chemicals is always undesirable because of the inherent toxicity. Therefore, US government policy prohibited human pesticide experiments, much less the exposure of children to pesticides, or any harmful substances that offer no potential benefit for the children enrolled. But under pressure from Bayer CropLife and the chemical / pharmaceutical giants who had conducted small human pesticide experiments, an advisory panel served industry’s interests, and voted YES to lift the prohibition against pesticide experiments in humans. (See below)

The EPA has taken an even more radical step down the slippery slope than industry. The EPA has undertaken to conduct a pesticide exposure experiment on children instead of rats – something industry dared not do. The EPA has given the experiment a deceptive acronym–CHEERS–and accepted $2 million from the American Chemical Council – which represents 135 manufacturers. Furthermore, the EPA is offering poor families $970 to persuade them to sacrifice their children’s best interest, and expose them to poisonous chemicals. So much for the government promoting familly values!

This pesticide exposure experiment will repeat the agency’s preious experimental crime: EPA’s radiation experiments on poor human beings – including children. See: ACHRE Report

Just as the agency and those who conducted the radiation exposure experiments, defended them, the children’s pesticide exposure experiment is promoted by the Chemical Council and the EPA who speak in forked tongues. Carol Henry, V-P for science and research at the Council told the Post that her industry “wanted to promote a better understanding of the risks associated with chemical exposure.” Linda S. Sheldon, from EPA’s Office of Research and Development who is administrating the experiment, stated: “We are developing the scientific building blocks that will allow us to protect children.”

How can anyone claim they are protecting children by exposing them to harmful substances?

Pesticide experiments and radiation experiments are hazardous, and wholy non-therapeutic. They violate fundamental ethical standards, beginning with the Hippocratic Oath: “First, do no harm”; the Nuremberg Code; and all subsequent codes of medical ethics, including the Declaration of Helsinki; and the Common Rule (Federal Code of Regulations: 45 CFR 46; 21 CFR 50) which the EPA signed in 1991.

Why is industry interested in conducting small human pesticide experiments?

Since 1972, the assessment of pesticide safety is tested in animals–safety is determined by the “no observable effect level” (NOEL) baseline. A 10-fold margin of safety below NOEL is then calculated as safe for humans. However, a series of scientific reports in the 1990s raised serious concern about the safety of children who are increasingly being exposed to pesticides and its hazardous effects, as their use has increased. Children’s environment is especially saturated with organophosphates – and these pose a serious risks for children’s immune system, their developing brain and central nervous system. Indeed, in 1995, the EPA reviewed the scientific reports and confirmed the toxicity of organophosphates and validated the concern for children’s safety.

In 1996, when it became clear that the risk for children is greater than for adults, Congress enacted the Food Quality Protection Act (FQPA) requiring that pesticides that children are exposed to–such as organophosphates–be further reduced by 10-fold. Recently, the US government is betraying a public trust by radically changing public policy to accommodate the chemical / pharmaceutical industry. The industry wants to remove the safety margin for children required under FQPA.

Inasmuch as the serious harmful effects of pesticides are not immediately detectable, industry is anxious to conduct a pesticide experiment using a small number of children to avoid detection of hazardous effects. Finding no hazardous effects, they will claim that pesticides are safe for children. This strategy is both morally unconscionable and scientifically invalid.

Dr. Herbert Needleman,* Professor of Psychiatry and Pediatrics at University of Pittsburgh School of Medicine, who served on EPA’s Scientific Advisory Committee in 1998, provided strong documentation–by using well known statistical methods–to demonstrate why “no limited human study will provide information about safe levels of intake of pesticides by humans, especially children.” To detect a small adverse effect requires at least 2500 test subjects in each comparison group. Thus, a sample of 60 children is inadequate to provide any scientifically valid information. For that reason, EPA’s proposed experiment is disqualified as a legitimate scientific study. Lacking scientific legitimacy, the sturdy is automatically unethical – it must not be conducted.

See: H. Needleman and HR Riegert. Minority Report in “Comments on the Use of Data from the Testing of Human Subjects A Report by the Science Advisory Board and the FIFRA Science Advisory Panel” EPA SAB-EC-00 017 September 2002

See also:

Instead of protecting the environment and its inhabitants, the EPA is about to conduct an unethical, scientifically useless experiment – and the hazards will not be disclosed to parents. The Washington Post reports: “EPA researchers will not tell participants that using pesticides always entails some risk, and not using pesticides will reduce that risk to zero.”

Failure to disclose the risks is a clear cut violation of informed consent – as mandated by every national and international code of ethics. The Common Rule prohibits the conduct of research involving human beings without full disclosure of the risks before they can provide their informed consent. EPA’s demonstration of bad faith is evidence that those involved in the experiment know that if they disclose the truth, even parents who are strapped for money, are likely to decline the offer. This government agency seems to be competing with industry in engaging in corrupt practices.

According to the Post, there are dissenting voices among EPA scientists who are disturbed by the experiment. One EPA pesticide scientist who was willing to be identified, Troy Pierce, expressed his dismay: “This does sound like it goes against everything we recommend at EPA concerning use of [pesticides] related to children. Paying families in Florida to have their homes routinely treated with pesticides is very sad when we at EPA know that [pesticide management] should always be used to protect children.”

By contrast, university-based bioethicists who serve on numerous advisory boards, are marching along like lap-dogs of industry and government: bioethicists are sealing the fate of poor children who will suffer the consequences of being exposed to poisonous substances. In 2003, a committee of scientists and bioethicists convened by The National Academies of Science, voted to overturn a long-standing public policy prohibiting human pesticide experiments. See Committee Report: Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues

Committee Co-Chairs: James F. Childress (IOM), Michael R. Taylor; Members: James V. Bruckner, Alicia Carriquiry, John Doull, Henry T. (Hank) Greely, Siob án D. Harlow, Lester B. Lave, (IOM), Bernard Lo (IOM), Thomas A. Louis, Gilbert S. Omenn, (IOM), Joseph V. Rodricks, Christopher H. Schroeder, Robert Temple, and David Korn, (IOM) liason to the committee.

Members of such panels migrate from one advisory panel to another. They do not represent the moral values of the community, nor do they represent the interest of the individuals and groups who will be affected by their recommendations. Advisory committees are convened for the purpose of lending legitimacy to policy shifts that contradict existing, publicly approved policies. These panels function as a backdoor legislative body without public accountability.

Bioehticists who put their “ethical” stamp of approval on experiments that subject children to poisonous substances, should be disqualified as moral arbiters about anything. Bioethicist Alta Charo is quoted stating EPA’s approach is “reasonable.” Her only expressed reservation is whether the financial incentive to families–$970 dollars – is too high. No concern was expressed about exposing poor children to poisonsous substances.

The Alliance for Human Research Protection calls upon people with a conscience to support our effort on behalf of vulnerable children. Poor children who have no advocates in high places. We must stop an unconscionable assault on America’s children by the chemical industry and government agencies.

* Dr. Needleman has joined the AHRP board of directors.

Contact: Vera Hassner Sharav

Study of Pesticides and Children Stirs Protests
By Juliet Eilperin

October 30, 2004 A-2

An Environmental Protection Agency proposal to study young children’s exposure to pesticides has sparked a flurry of internal agency protests, with several career officials questioning whether the survey will harm vulnerable infants and toddlers.

The EPA announced this month that it was launching a two-year investigation, partially funded by the American Chemical Council, of how 60 children in Duval County, Fla., absorb pesticides and other household chemicals. The chemical industry funding initially prompted some environmentalists to question whether the study would be biased, and some rank-and-file agency scientists are now questioning whether the plan will exploit financially strapped families.

In exchange for participating for two years in the Children’s Environmental Exposure Research Study, which involves infants and children up to age 3, the EPA will give each family using pesticides in their home $970, some children’s clothing and a camcorder that parents can keep.

EPA officials in states such as Georgia and Colorado fired off e-mail messages to each other this week suggesting the study lacked safeguards to ensure that low-income families would not be swayed into exposing their children to hazardous chemicals in exchange for money and high-tech gadgetry. Pesticide exposure has been linked to neurological problems, lung damage and birth defects.

Suzanne Wuerthele, the EPA’s regional toxicologist in Denver, wrote her colleagues on Wednesday that after reviewing the project’s design, she feared poor families would not understand the dangers associated with pesticide exposure.

“It is important that EPA behaves ethically, consistently, and in a way that engenders public health. Unless these issues are resolved, it is likely that all three goals will be compromised, and the agency’s reputation will suffer,” she wrote in an e-mail obtained by The Washington Post. “EPA researchers will not tell participants that using pesticides always entails some risk, and not using pesticides will reduce that risk to zero.”

Troy Pierce, a life scientist in the EPA’s Atlanta-based pesticides section, wrote in a separate e-mail: “This does sound like it goes against everything we recommend at EPA concerning use of [pesticides] related to children. Paying families in Florida to have their homes routinely treated with pesticides is very sad when we at EPA know that [pesticide management] should always be used to protect children.”

Linda S. Sheldon, acting administrator for the human exposure and atmospheric sciences division of the EPA’s Office of Research and Development, said the agency would educate families participating in the study and inform them if their children’s urine showed risky levels of pesticides. She said it was crucial for the agency to study small children because so little is known about how their bodies absorb harmful chemicals.

“We are developing the scientific building blocks that will allow us to protect children,” Sheldon said, adding that the study design was reviewed by five independent panels of academics, officials of the Centers for Disease Control and Prevention, and representatives of the Duval County Health Department.

Families can remain in the study even if they stop using pesticides, Sheldon said, as long as they were using them before the experiment started. It was unlikely that any family would volunteer for the study out of financial need, she added, because researchers will require parents to invest time in monitoring their children’s activities and diet.

“Nobody can go into this study just for that amount of money,” Sheldon said.

R. Alta Charo, a professor of bioethics at the University of Wisconsin at Madison’s law and medical schools who co-authored a National Academy of Sciences report last year on the use of pesticides for research, said EPA officials were struggling with how to balance the need to protect the individual child’s interests against the goal of pursuing a broader scientific agenda. While she said the agency’s approach was reasonable, Charo said it did raise ethical questions.

“Where is the line between enticement and a godfather offer” that impoverished families would find hard to refuse, Charo said. “That is really troubling. We make these decisions over and over in public policy. This is one of those moments.”

Several EPA officials, all of whom asked not to be identified for fear of retaliation, also questioned why the agency removed the study design and its recruitment flier from the EPA’s Web site once some scientists started to complain about the project. Sheldon said the agency is rewriting how it portrays the research.

“We removed it so we could modify it, so it would make more sense,” she said.

© 2004 The Washington Post Company

Chemical Industry Funds Aid EPA Study
Effect of Substances on Children Probed

By Juliet Eilperin
Washington Post Staff Writer
Tuesday, October 26, 2004; Page A23

The Environmental Protection Agency has agreed to accept $2 million from the American Chemistry Council to help fund a study exploring the impact of pesticides and household chemicals on young children, prompting an outcry from environmentalists.

The Children’s Environmental Exposure Research Study — known by its acronym CHEERS — does not mark the first time the agency has accepted chemical industry money to conduct research; the Clinton administration signed similar agreements. But it represents the most money the chemical trade group has given the EPA. The chemical industry council represents about 135 manufacturers and spends $20 million a year on research.

Paul Gilman, who serves as science adviser and assistant administrator for the EPA’s office of research and development, said the money will help the agency conduct “groundbreaking work” on how chemicals are absorbed by infants and children as old as 3.

“We will seek their opinions, but we’re in control of the project,” Gilman said. “We’re comfortable with the fact that it’s our study design.”

Environmental Working Group President Kenneth A. Cook questioned why an agency with a $572 million research budget needed to accept industry contributions to conduct scientific research.

“It simply is not credible that a $7.8 billion agency that employs almost 18,000 people has to go to the chemical industry to get $2 million for a crucial study to see if chemicals hurt kids,” he said. “This is a government function; we should be investing government funds to be absolutely sure it’s independent.”

The study will survey 60 children over the next two years in Duval County, Fla., and collect information on their exposure to pesticides and household chemicals, such as flame retardants and perfluorinated chemicals, a family of substances in products such as Teflon and Scotchgard. Some of these chemicals have come under scrutiny for possible links to health problems.

Carol Henry, vice president for science and research at the American Chemistry Council, said her industry wanted to promote a better understanding of the risks associated with chemical exposure. Teaming up with a preexisting federal study gives her group financial leverage, she said.

“Exposure has been ignored for many, many years. It’s the wasteland of risk assessment,” Henry said. “We’d like the regulatory framework to be based on a very firm scientific foundation.”

Henry said her association had set up a board of academics and industry officials to be “a resource to investigators” on an occasional basis, but added her group would not get advance notice of the results and the government would retain control over its findings. “We’ll give them our guidance, but they don’t have to take it,” she said. The EPA’s Gilman said it was reasonable to accept industry money in light of the gravity of the situation. Researchers still don’t know how these compounds “are getting into our blood,” he said, adding that young children are rarely studied, making the survey especially valuable.

In late September, Linda Sheldon, acting director for the EPA’s human exposure and atmospheric sciences division, said the agency has “very little information about how children may be exposed to chemicals in household products, whether it’s through the air they breathe, food they eat or the surfaces they touch.”

Gilman said the chemical manufacturers imposed no conditions to their contribution: “They said, ‘Who do we make the check out to?’ It’s $2 million in additional support with no strings attached.”

But Cook said he remained concerned industry officials could still influence a study that could lay the groundwork for future regulation. “To have industry sponsoring the government to do it, to us, doesn’t seem like a good idea, to say the least,” Cook said.

© 2004 The Washington Post Company

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