EPA’s proposed rule on pesticide testing on children is stirring an ethical controversy
Last year, the Environmental Protection Agency recruited for a pesticide study 60 infants and toddlers whose low-income parents were bringing them to Florida public-health clinics and hospitals. The two-year study was observational—no infants were to be intentionally dosed with pesticides—so EPA could determine how the babies absorbed chemicals already present in their households.
Yet, the Children’s Environmental Exposure Research Study, known as CHEERS, was not so innocuous. EPA received $2.1 million from the American Chemistry Council to conduct the tests. According to David Christenson, president of American Federation of Government Employees Local 3607, which represents Region 8 EPA staff and scientists, the agency inventoried the households to discover the types of pesticides the parents were using, such as rat or roach bait; yet, even if those chemicals had been banned, EPA did not remove them. Instead, families who completed the study were to receive a T-shirt, a certificate of appreciation, $970, and a Camcorder, which they were to use to document their children’s behavior during the study. The families could keep the Camcorder.
| STORY UPDATE – 12/15/05 |
EPA union opposes proposed rule
The national American Federation of Government Employees sent a letter on December 7 to the Environmental Protection Agency condemning a proposed rule on pesticide testing on humans `See “Pandora’s box,” December 8-14, 2005`.
The AFGE, which represents 6,500 EPA staff and scientists, also formally submitted their comments to the public docket.
The proposed rule governs the protocol followed by third-party testers, such as pesticide manufacturers, when intentionally testing pesticides on humans, including children and pregnant women, if the data would be submitted to EPA for consideration.
“The proposed rule has so many loopholes and exceptions that, if adopted, it could force EPA’s Bargaining Unit to accept data from third-party human studies that were conducted in an unethical manner,” reads the letter, signed by national president John Gage.
EPA has emphatically denied the proposed rule would allow intentional pesticide testing on humans. Critics including Physicians for Social Responsibility, Public Employees for Environmental Responsibility, and the Organic Consumers Union have been vocal in their opposition to the proposed rule.
The letter says that the burden of proof for reviewing and arguing against the exemptions “will fall to EPA scientists,” many of them AFGE members. To read the letter, go to this AFGE page.
Last April, EPA canceled CHEERS after Democratic senators threatened to uphold the confirmation of administrator-to-be Stephen Johnson, who had served as Assistant Administrator of EPA’s Office of Prevention, Pesticides, and Toxic Substances. But the controversy did not pass; rather, it started an incendiary debate in Congress and within the medical and bioethics fields about human testing, particularly on children and other vulnerable people.
As part of an appropriations bill, Congress in August required EPA to propose a rule governing pesticide testing on children and pregnant women. EPA is lauding its proposed rule, and contends it categorically bans intentional-dosing pesticide tests on these groups. But critics, including EPA scientists, doctors, members of Congress, and government watchdogs, argue the rule is compromised by loopholes and vague language that favor the pesticide industry, which has benefited from policies implemented during the Bush Administration. These exceptions, detractors say, would allow “third parties,” such as pesticide manufacturers, to test their products on children who are orphaned, neglected, or live in foreign countries if the research would provide a “public health benefit.” Nor does the proposed rule cover prisoners and people residing in state mental hospitals and other institutions. `See story, next page.`
EPA denies these loopholes exist; in response to a Baltimore Sun article critical of the proposed rule, Jim Jones, director of EPA’s Office of Pesticide Programs, wrote a letter to the editor, saying “to write that the EPA would single out some children as less deserving of health protection ... is outrageous and only serves as a sensational soundbite that misinforms the public.”
Critics remain unfazed by EPA’s contentions. Dr. Alan Lockwood is a professor of neurology and nuclear medicine at the University of Buffalo and chairman of the environmental and health committee of Physicians for Social Responsibility. “In this case, EPA is proposing a rule not sufficiently protective of human health and the environment,” says Lockwood, who last year published a journal article that showed six pesticide tests conducted on adults by third parties violated scientific and ethical principles. “And what’s worse, they’re creating the illusion the rule contains a prohibition.”
Children and fetuses are especially vulnerable to pesticides, many of which can affect brain and neural development. Scientific studies have shown that women who have been exposed to pesticides during pregnancy tend to have smaller babies. Compared to adults, children “eat more food, drink more water, and breathe more air,” says Lockwood, adding that kids haven’t developed the enzymes necessary to metabolize pesticides.
William Jordan, EPA senior policy adviser in the Office of Pesticide Programs, says the criticisms are unfounded and inaccurate. The rule, he says, would prohibit any intentional pesticide dosing of neglected, abused, or mentally retarded children. If testers cant obtain parental consent, they must obtain approval from Independent Review Boards — often paid by the same companies who are funding the testing — to find someone else, such as a guardian or a state agency, to give consent.
Missing from the proposed rule is a provision covering testing on institutionalized populations, such as prisoners. While Department of Health and Human Services is considering rewriting its regulations for prisoners, EPA is asking for public comment on the issue. However, Jordan allowed that the ethics of testing prisoners is “tricky,” and that U.S. law states that researchers conducting tests on vulnerable populations “need to pay particular attention to informed consent.”
| “In this case, EPA is proposing a rule not sufficiently protective of human health and the environment. And what’s worse, they’re creating the illusion the rule contains a prohibition.”
– Dr. Alan Lockwood
A National Academy of Sciences committee that reviewed the proposed rule condemned human testing of pesticides, but stopped short of recommending that EPA ban all intentional-dosing pesticide tests on all humans, adding they should be allowed only if there is a “compelling scientific need.”
“Shame on them,” says Lockwood, adding that the only way to protect the health of all people is to ban all intentional-dosing pesticide studies. “They left a loophole wide open for industry and the huge influence that pesticide companies have at EPA. The risks are so great by opening that Pandora’s box, that it needs to be an absolute.”
The project’s study director, Anne-Marie Mazza, did not return calls to the Current.
The profits of a $200 billion-a-year industry hinge on the passage of the proposed rule. Pesticide manufacturers use human tests on adults to convince EPA that their products are safe. For example, after Congress passed legislation in 1996 that would reduce concentrations of pesticides in food, the industry embarked on dozens of human experiments intended to show that the thresholds could be higher. “They put money into studies with very small sample sizes that come to bizarre conclusions,” Lockwood says.
|Dr. Alan Lockwood, professor of neurology and nuclear medicine at the University of Buffalo and chairman of the environmental and health committee of Physicians for Social Responsibility.|
George Clarke, a spokesman for Croplife America, which represents 80 pesticide manufacturers, says the proposed rule is protective. “We think everybody benefits by having protections in place. Everybody is in agreement about safety and risk assessments, which is a good thing.”
But within EPA, there is discord about the proposal, although according to Jeff Ruch, executive director of Public Employees for Environmental Responsibility, a service organization representing EPA staff and scientists, “it is fair to say there is a lot of fear of speaking out.”
Christenson of AFGE Local 3607 says the union plans to comment on the proposed rule with “concerns” about its ethics. The union had not issued an official statement at press time.
“The subject of human research is enormously controversial,” Jordan says. “I have lively conversations with colleagues about the right course of action. I hope there is not a fear of speaking out.”
An EPA internal memo obtained by the Current provides talking points for EPA staffers who might be asked about the rule, and reiterates EPA’s position that children and pregnant women won’t be intentionally dosed in pesticide tests. However, the language in the memo is flabby: “EPA’s regulations are designed to strongly discourage and prevent the conduct of human studies that do not meet high ethical and scientific standards.”
Critics have reason to be skeptical about EPA’s proposed rule. In 1998, former EPA Administrator Carol Browner declared a moratorium on considering or relying upon human pesticide experiments. However, in 2003, the Bush Administration reversed the moratorium, “at the urging of pesticide manufacturers,” according to a June 2005 report published by the minority staff on the U.S. House of Representatives Committee on Government Reform.
Before and after the moratorium, pesticide testing on humans has been unregulated, and many experiments have been found to contain significant ethical and scientific defects. In June 2005, Senator Barbara Boxer and U.S. Representative Henry Waxman, both Democrats, released a report, “Human Pesticide Experiments,” that analyzed 22 studies EPA was reviewing as part of its efforts to set exposure standards for pesticides.
| COMMENT ON THE RULE |
There are several ways to submit a comment about the proposed rule. Deadline for comments is December 12, 2005.
You can read the rule in the Adobe Acrobat format (pdf) at the link EPA 40 CFR Part 26.
Identify all comments to EPA with the rule’s docket number: OPP-2003-0132.
• At regulations.gov, follow on-line instructions for submitting comments
• E-mail comments to firstname.lastname@example.org
• Mail comments to Public Information and Records Integrity Branch, Office of Pesticide Programs, EPA, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460-0001
• More information: William Jordan, Mailcode 7501C, Office of Pesticide Programs, at the EPA address listed above. Phone: (703) 305-1049. Fax: (703) 308-4776. E-mail address: email@example.com
According to the Government Reform Committee’s report, some of the experiments “put human subjects at risk of significant harm without any promise of health or environmental benefit.”
One experiment involved MITC, methyl isothiocyanate, a chemical closely related to one that killed thousands in Bhopal, India. It is also a breakdown product of a widely used agricultural pesticide, metam sodium. The experiment was sponsored by the Metam Sodium Task Force, a group of pesticide manufacturers formed to share the costs of “developing defensive data following a spill of metam sodium into the Sacramento River.”
Although the adult test subjects inhaled the chemical and exposed their eyes to it for up to eight hours, no informed-consent reports were provided to the EPA. In 2004, an EPA review of the experiment concluded the study “shows little concern for the safety or welfare of the research subjects.”
Nevertheless, the Committee report says, EPA considered and relied upon the study to complete a revised human-health assessment for metam sodium.
Similar deficiencies are detailed in a November 2004 article by Lockwood, “Human Testing of Pesticides: Ethical and Scientific Considerations,” which appeared in the peer-reviewed journal American Journal of Public Health.
Lockwood reviewed six pesticide-dosing studies conducted by third parties (some paid for by Dow Chemical) and submitted to EPA for consideration during the pesticide-registration process. “All had serious ethical or scientific deficiencies—or both,” Lockwood wrote, “including unacceptable informed-consent procedures, unmanaged financial conflicts of interest, inappropriate test methods ... and distorted results.”
In one experiment, the list of possible side effects and risks didn’t mention weakness, respiratory failure, and death; another test incorrectly implied the chemical might improve intellectual function.
While the report caused a stir within the industry, Lockwood says, “I haven’t heard a peep from the testers.” William Jordan of EPA declined to comment on Lockwood’s findings, but added that “there are requirements of informed consent. Just like there are speeding laws, that doesn’t mean everybody follows them.”
The coziness between politics and the industry can be tracked not only in dollars—since 2000, the pesticide and chemical industries have contributed $26.8 million to political candidates— but policy decisions. The Natural Resources Defense Council has tracked the Bush Administration’s and EPA’s records regarding the pesticide industry, which includes allowing U.S. farmers to continue using methyl bromide, a cancer-causing chemical banned under an international treaty signed by President Reagan in 1987. The U.S. negotiated an exemption from the treaty last year.
Last February, the NRDC sued EPA, alleging that EPA documents show the agency met secretly more than 40 times with Sygenta, the main manufacturer of atrazine, a weed killer that has contaminated water sources across the country. The European Union has banned atrazine, which can damage the reproductive system. The U.S. has not.
EPA’s proposed rule on pesticide testing also smells of industry influence, critics say. Even the National Academy of Sciences committee, which reviewed and commented on the rule, reportedly has ties to the chemical industry. The NRDC reports that committee co-chair Michael Taylor is a former pesticide-industry executive and lawyer and James Bruckner is a consultant for Lockheed-Martin, currently embroiled in a lawsuit in which it contends that tap water contaminated by fuel is harmless, based on a human study it funded.
And EPA itself, by attempting to conduct CHEERS, set the tone for third-party testing, says Ruch of the service organization PEER. “Part of the concern expressed by scientists is that there is a larger agenda driven by pesticide and chemical industries that has to do with persuading EPA to rely on human testing.” •
By Lisa Sorg
He said, she said
Different conclusions drawn from same rule
Section 26 of EPA’s proposed rule is stirring the most controversy. Critics, including the Organic Consumers Association, Physicians for Social Responsibility, and a union and a service organization representing some EPA staff and scientists, contend vague language creates loopholes that would allow pesticide testing on children and pregnant women. EPA counters that these groups are misinterpreting the rule and that under no circumstances would it allow intentional-dosing pesticide testing on these groups.
How the rule is worded: ”If the Independent Review Board determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding ...
“If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children) it may waive the consent requirements, provided an appropriate mechanism ... is substituted.”
What EPA says: The rule echoes long-standing regulations established by the Department of Health and Human Services. A separate section bans all research involving intentional exposure of children if the testers intend to submit their findings to EPA. Thus, the quoted paragraph above applies only to observational studies, i.e., research that does not involve intentional dosing of test participants.
What critics say: An Independent Review Board is often established by the same company paying for the testing. Children who cannot give informed consent, including those who are neglected, abused, or mentally retarded, can be tested on. “Direct benefit” is undefined. It still allows intentional dosing if study results are only for publication and not for submission to EPA.
How the rule is worded: “To what do these regulations apply? It also includes research conducted or supported by EPA outside the U.S., but in appropriate circumstances, the Administrator may waive the applicability of some or all of the requirements of these regulations for research of this type.”
What EPA says: The rule is based on existing Department of Health and Human Services regulations. Other countries have adopted similar, but not identical, rules regarding intentional dosing, and third parties conducting tests in those countries would have to follow those nations’ regulations as long as they were at least as stringent as U.S. law. Nations without testing laws would be required to adhere to U.S. testing law.
What critics say: The vagueness of the term “appropriate circumstances” could allow third parties to conduct intentional-dosing pesticide studies on children or pregnant women in foreign countries.
How the rule is worded: “EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient research is found to be crucial to fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study—an intentional dosing study involving pregnant women or children as subjects—were found to be crucial to the protection of public health.”
What the EPA says: The rule states the EPA won’t consider ethically or scientifically deficient pesticide-testing studies except for “a very narrow situation where the data from that study show we need to take a more stringent regulatory measure to protect public health” and only after seeking the advice of the ethics and science experts on an independent, external Human Studies Review Board.
What critics say: There are no criteria in the rule to determine what constitutes a test that would be crucial to protecting public health. •