EPA Proposed Research Rules Leaked

EPA Proposed Research Rules Leaked

Thu Aug 11, 2005

A storm is gathering as EPA’s proposed rules for human pesticide experiments have been made public by the Public Employees for Environmental Responsibility.

Stephen Johnson who heads the EPA has delivered what, Eric Olson called, a “slap in the face” to Congress.

This is not the first time he has shown bad faith. When his appointment was held up by Senator Barbara Boxer and Senator Bill Nelson.until he suspended the notorious Children’s Environmental Exposure Research Study (CHEERS)–that was designed to expose toddlers to pesticide and record their reactions, Johnson agreed only to invite pesticide producers to submit their own study.

This time, EPA diddled Congress pretending to change its draft only to resubmit the same language to the White House. As Eric Olson, senior attorney for the National Resources Defense Council, said: “It’s clearly a violation of Congress’ direct prohibition on all testing of pregnant women, infants and children.”

The EPA proposed rules would essentially overturn the ethical principles of the Nuremberg Code which prohibit exposing human beings in experiments that test poisonous substances.

The EPA is serving as the mascot for the pesticide industry–leading the charge down the slippery slope to genocide.

If anyone thinks this over reacting, listen to EPA’s linguistic doublespeak: as EPA bureaucrats try to sell the American public on immoral policies that would expose, but not “intentionally dose” pregnant women and children to poisonous substances whose goal is to kill!:

“Our proposal bans the intentional dosing of pregnant women and children with pesticides for toxicity studies, follows the recommendations set by the nation’s highest science review panel, and adheres to the highest ethical standards set for federal agencies.”

The EPA administrators who formulated the statement–“our proposal…..adheres to the highest ethical standards…” and those who cynically named a children’s pesticide exposure experiment –CHEERS– have a cultural affinity to those who formulated the Nazi slogan above the gate to Auschwitz: “Arbeit macht frei” – Work Brings Freedom

We need a law prohibiting all pesticide experiments on human beings–whether by intentional dosing or preventable exposure.

Some fundamental moral principles do not have two sides– human pesticide experiments are unthinkable.

This ignoble policy change in America is being propelled by Crop Life–in particular, Bayer CropScience. See: http://www.cbgnetwork.org/402.html.

Bayer started legal action when Friends of the Earth told them it had legally obtained copies of safety data from the Swedish pesticide regulator KEMI and said it was going to tell the public how they could obtain the information in the same way. The information at the center of the row is of interest to people exposed to pesticides through work, living near sprayed fields, legal representatives and academics researching the environmental and health impacts of pesticide use. In July 2004, Bayer CropScience dropped its suit and promised never to sue FOI. What information about pesticide safety did Bayer fight to suppress?? See: http://www.foe.co.uk/resource/press_releases/gm_pesticide_secrets_to_go_2806 2004.html

See Corporate Watch Re: “Bayer Responsible in Pesticide Deaths of 24 Children in Peru” Families Appeal to Secretary General Kofi Annan to Exclude Bayer from the UN Global Compact Pesticide Action Network Latin America and Red de Accion en Alternativas al uso de Agroqumicos August 30th, 2002

“Following a nine-month investigation, a Peruvian Congressional Subcommittee has issued its final report on the poisoning deaths by the organophosphate pesticide methyl parathion of 24 children in the remote village of Tauccamarca in October 1999. The Subcommittee concluded that there is significant evidence of administrative and criminal responsibility on the part of Ministry of Agriculture, and of criminal responsibility on the part of the agrochemical company Bayer. Headquartered in Germany, Bayer has been a principle Peruvian importer and distributor of both methyl and ethyl parathion. The report recommends that the government and Bayer indemnify the families of the dead children.” See: http://corpwatch.org/article.php?id=3789

Do we want this company to determine the safety of pesticides by exposing human beings to lethal poisons?

Do we want companies such as Bayer CropScience to influence public policies that would undermine the moral standards of human research in a civilized society?

Contact: Vera Hassner Sharav
212-595-8974

THE WASHINGTON POST
EPA Devises Rules on the Use of Data From Pesticide Tests on Humans
By Juliet Eilperin

The Environmental Protection Agency is set to release the first-ever federal standards governing use of data from tests that expose human subjects to toxic pesticides, but lawmakers and some medical experts said the rules fail to adequately protect children and pregnant women.

The proposal — which was obtained yesterday from the advocacy group Public Employees for Environmental Responsibility and will become public within weeks — would limit the instances in which pesticide manufacturers could expose children and pregnant women to toxic chemicals, and would establish an independent board to gauge whether such human experiments meet established ethical standards. But the new rules, which will be subject to public comment before taking effect in about six months, allow some tests on vulnerable subjects and do not apply to studies conducted before the guidelines become law.

Much of the controversy centers on whether it is acceptable to expose children and pregnant women to pesticides under any circumstances. One EPA official, who asked not to be identified because the agency has not published its proposal, said the EPA wanted to let manufacturers keep the option of testing on children such products as mosquito and tick repellents to ascertain their efficacy.

For months, lawmakers have been dueling with Bush administration officials over how drastically they should curb tests that expose humans to toxic chemicals, including an insecticide used in chemical warfare during World War I. Two weeks ago, Congress prohibited the EPA from considering data culled from such experiments until the government enacts stricter national standards.

For years, federal officials allowed manufacturers to conduct human studies on the grounds that they provided a clearer picture of how pesticides could affect the environment and public health. President Bill Clinton imposed a moratorium in 1998 out of concern that such tests harmed volunteers; although President Bush initially backed the moratorium, his administration abandoned it in 2003 to satisfy a court ruling in favor of pesticide makers, which argued that the federal government had not engaged the public fully enough before banning the information. EPA officials now consider data from human experiments on a case-by-case basis when judging whether to approve pesticides.

EPA spokeswoman Eryn Witcher said the new rule is “a landmark regulation that will extend very rigorous protections to the public. . . . Our proposal bans the intentional dosing of pregnant women and children with pesticides for toxicity studies, follows the recommendations set by the nation’s highest science review panel, and adheres to the highest ethical standards set for federal agencies.”

However, Sen. Barbara Boxer (D-Calif.), who led the fight in the Senate to restrict pesticide testing on human volunteers, wrote a letter yesterday to EPA Administrator Stephen L. Johnson saying the proposal “fails to adequately ensure that people, including the most vulnerable among us, are protected from unethical industry tests in which human subjects swallow, inhale, are sprayed with, or are otherwise exposed to toxic pesticides.”

“I am writing to you so that you are personally aware that EPA appears to be heading on a course at variance with the dictates of Congress, as well as religious groups, public health and environmental groups that supported congressional action,” Boxer added. “There is still an opportunity for EPA to change course. However, if you go forward with this approach, I am also putting you on notice that I will use every means available to ensure that EPA complies with congressional direction.”

Witcher said the agency will be able to comment in greater detail once the new rules are finalized, and “there will be ample opportunity for public feedback” before they take effect.

Leo Trasande, assistant director of the Mount Sinai Center for Children’s Health and the Environment, said after reviewing the proposal that the agency is on “a dangerous slippery slope” that could allow pesticide makers to conduct questionable studies as long as they said they were not aimed at gauging their products’ toxicity.

“EPA is again failing in its duty to protect children from pesticides and other toxic exposures,” he said.

CropLife America spokesman George Clarke, whose group represents the country’s biggest pesticide manufacturers, said yesterday he will not comment on the EPA’s plan until it is formally unveiled.

C 2004 The Washington Post Company

http://www.baltimoresun.com/news/health/bal-te.testing11aug11,1,5869652.story?coll=bal-home-headlines

Proposed EPA rules on human testing come under attack
Document aims to protect subjects used in studies
By Andrew Schneider
Sun National Staff

August 11, 2005

WASHINGTON – New rules drafted by the Environmental Protection Agency to protect human subjects of scientific tests came under harsh criticism yesterday from environmental groups, government scientists and members of Congress, who called the proposal misleading, dangerous and industry-friendly.

The 76-page draft, obtained by The Sun, was hurried to completion this month after Congress denounced this summer standards for EPA-related tests and noted health risks and ethical lapses in tests performed by the pesticide industry.

An introduction to the document promises more stringent rules, including tighter controls on human studies, the creation of an independent panel to evaluate the ethics of proposed studies, and protections preventing pregnant women and children from being used as test subjects.

EPA press secretary Eryn Witcher said she could not comment on specific criticism of the proposed rules because they are being reviewed. But she called the proposal “landmark regulation that will extend very rigorous protections.”

The language of the rules falls short of those promises, according to EPA toxicologists, health experts and lawyers at the agency’s headquarters and at its regional offices.

“This is a very important ethical, scientific and clinical issue, and they are going to try to fool the American public about its intent,” said an EPA toxicologist who requested anonymity for fear of retribution. “It’s a magician’s trick.”

Richard Wiles, senior vice president of the Environmental Working Group, which for decades has fought for better pesticide controls, said the rules “will give the pesticide industry essentially all the power.”

The proposed rules are “so full of loopholes that almost any conceivable study would be allowed, and this may lead to an increase in pesticide levels in our food and concomitant damage to health and environment,” said Dr. Alan Lockwood, a neurologist who serves with Physicians for Social Responsibility.

‘Slap in the face’

The proposals were described by an environmentalist as a “slap in the face” to Congress, which had faulted the agency for moving forward on an earlier draft that legislators considered seriously flawed.

“Then EPA goes ahead and submits the same thing to the White House for approval,” said Eric Olson, senior attorney for the National Resources Defense Council, which has worked closely with Congress on human testing issues. “It’s clearly a violation of Congress’ direct prohibition on all testing of pregnant women, infants and children.”

Congress reviewed 22 EPA-related human studies conducted by the pesticide companies and found that test subjects didn’t know what they were being exposed to and, in many cases, had no idea why the testing was being done.

They also found no evidence in many of those cases that the testing followed accepted international ethical standards.

Florida study

Congress’ concern over EPA’s pesticide program was piqued this year when it learned about an agency project that, using $2 million from the chemical industry, would have measured the pesticide consumption of infants in low-income households in Florida.

EPA would have paid the parents every time they sprayed pesticides. Children in the program were to be given teething rings and slices of cheese because researchers knew the youngsters would drop them, then place them in their mouths. In addition, the project was to have given parents about $1,000 and video equipment to monitor and record their children’s activities.

The program was canceled after it surfaced during the confirmation hearings of EPA Administrator Stephen L. Johnson.

Concerns about human testing standards for EPA-related projects forged unusual agreement recently among Democrats and Republicans. Last month, the Senate approved legislation, 60-37, halting the agency’s human testing projects and demanding that it issue detailed rules within 180 days.

‘Flawed approach’

Late yesterday, Sen. Barbara Boxer, a California Democrat, wrote EPA Administrator Johnson, demanding changes, saying the proposal failed to address congressional concerns.

She urged Johnson to “abandon its flawed approach prior to proposing the rule.

“This proposal fails to adequately ensure that people, including the most vulnerable among us, are protected from unethical industry tests in which human subjects swallow, inhale, are sprayed with, or are otherwise exposed to toxic pesticides,” said the senator, who, with members of the House, have been fighting EPA on the issue.

California Rep. Henry Waxman yesterday called the proposal “deeply flawed” and said it “would allow unethical pesticide experiments on humans.

“Some of the industry experiments violate our most basic values, and EPA should stop looking to exploit loopholes and spend its time complying with the important ethical principles that govern human research,” he said.

Review process

The proposal is being evaluated by the White House Office of Management and Budget, which will offer recommendations. Once the EPA makes additional changes, the proposal will be open for public comment, said Witcher, the EPA press secretary.

Once the plan is finalized, the EPA looks forward to “addressing all questions and concerns,” said Witcher, the agency spokeswoman.

Most critics of the proposal say it leaves too much open to interpretation.

“Our concern is once you allow testing on these people who should be most protected, and you say there are only very narrow types of tests that are prohibited, it will be the wild west for testing of these prohibited classes of people,” said Wiles, of the Environmental Working Group.

The National Resources Defense Council’s Olson agrees. The rules would prohibit “toxicity” tests, which determine how human subjects react to increasing levels of pesticides. But they would continue to permit exposure to pesticides in other types of tests.

“They will continue to allow testing on pregnant women, infants and children, including orphans and wards of the state if it’s not considered toxicity testing,” said Olson.

Test results

Critics also say the proposed rules are unclear about whether the EPA can use the results from the 22 tests in question and others that may surface. EPA says it will decide on a case-by-case basis.

But Wiles says that is a dangerous approach.

“Regardless of how great or dedicated the people in EPA may be, each human study comes along with its own army of lobbyists and industry scientists to explain why this is the test that has to be accepted,” he said.

Those inside the agency said they were most concerned by the EPA’s absence of institutional review boards. Most federal agencies rely on the independent panels, with members of varying expertise, to weigh in on ethical policies and answer to the head of the agency. The EPA appoints a single person to fulfill that role.

“You have to have an independent IRB,” Wiles said. “That’s how all medical research is done.”

“It’s all about money,” Wiles added. “Basically the human studies are designed to keep their products on the market, to avoid health restrictions to keep making money from the sale of pesticides. That’s what it’s all about. It allows the use of pesticides that might otherwise be banned.”

Croplife America, the lobbying group and trade organization of the pesticide industry, disagrees.

No profit motive

In an interview with The Sun last month, officials of the group said that human testing had nothing to do with profits and was done only to increase safety.

Several of the EPA scientists interviewed said they weren’t concerned by the industry’s profits, but rather the health consequences of increasing pesticide use. Weakening public health protections from pesticides, they said, will allow higher concentrations of the chemicals in the environment, foods and drinking water.

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