CHEERS. Dec 21, 2004. U.S. rethinks human studies on pesticides. By Katherine Stapp. Inter Press Service News Agency.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Return to Index on US EPA's CHEERS study in Duval County, Florida

A US EPA "Children's Environmental Exposure Research Study" (CHEERS) was approved to assess children's exposure to pesticides in Duval County, Florida. The proposal is a two-year longitudinal field measurement study of young children's (aged 0 to 3 years) potential exposures to current-use pesticides and selected phthalates, polybrominated diphenyl ethers, and perfluorinated compounds that may be found in residential environments.

Pesticides include the fluorinated Bifenthrin, Fipronil, Lambda-cyhalothrin, and Cyfluthrin I, II, III, IV, total;
Chemicals include: 4-fluoro-3-phenoxybenzoic acid and the perfluorinated PFOS and PFOA.

http://www.ipsnews.net/africa/interna.asp?idnews=26761

December 21, 2004

IPS (Inter Press Service News Agency)

ENVIRONMENT:

U.S. Rethinks Human Studies on Pesticides

By Katherine Stapp

NEW YORK, Dec 21 (IPS) - Human studies involving dangerous pesticides are making a comeback in the United States, despite intense criticism from public interest groups which say that industry-sponsored research is inherently biased and designed to prove that its products are safe.

After a six-year hiatus on accepting data from third-party human studies, the Environmental Protection Agency (EPA) recently announced it would begin vetting ”ethically problematic studies on a case-by-case basis.”

The agency is also seeking to conduct its own research -- with two million dollars in funding from the American Chemical Council, an industry lobby group -- into household pesticide use in Florida State.

Called the Children's Environmental Exposure Research Study, or CHEERS, the study targets children ranging in age from infants to three years old. For taking part, each family is promised 970 dollars, a free video camera and other perks, like a ”study bib.”

Children are especially vulnerable to pesticides because they absorb more of the substances relative to body weight than adults, and have developing organ systems that are less able to break down toxic chemicals.

While the EPA's recruiting pitch states, ”participants are not required to use pesticides or to change any of their regular household routines,” opponents argue that the financial incentive is intrinsically unethical.

”They're enticing low-income people to undergo exposure,” said Jay Feldman, executive director of Beyond Pesticides, a non-profit lobby group. ”The implication is that if you use these chemicals, you will be rewarded.”

The sorts of pesticides that would be studied include those used in cleaning and yard-care products as well as phthalates (chemicals used in plastics) and brominated biphenyl ethers (flame retardants).

Following a barrage of criticism, EPA shelved the CHEERS study pending ”final review” by an expert panel made up of members of the U.S. Science Advisory Board, the federal Science Advisory Panel, and the U.S. Children's Health Protection Advisory Committee, whose report is due early next year. However, half the participants have already been selected, and the agency has refused demands to abandon the research altogether.

”EPA scientists need to fully understand how children are exposed to pesticides and through what media,” the agency said in a statement given to IPS. ”CHEERS was designed to fill these critical data gaps ... ultimately leading to actions that would lower children's exposures to pesticides.”

The study is particularly controversial because children living in households where pesticides are used have been found to suffer higher rates of leukaemia, brain cancer and soft tissue sarcoma. A study by Greenpeace India in April determined that exposure to even small doses of pesticides impairs children's analytical abilities, motor skills and memory.

The EPA says it chose Duvall County, Florida for the CHEERS study because the area has a particularly high concentration of pesticides, and data from a previous study in 2001 was available to assist in planning the research.

But critics note that the three county health clinics from which subjects are drawn serve the poorest and least educated members of the community.

If it goes forward, the study could give a boost to the chemical industry, which has faced increasingly strict regulation of its products.

In 1996, following a congressional directive for extensive study of pesticide hazards by the National Academy of Sciences, the pesticide tolerance factor for children -- officially called the ”no observable effect level” -- was raised to be 10 times higher than for adults.

This forced chemical companies to re-register most pesticides with the EPA and to determine what constitutes ”safe” exposure levels in the general population.

”Industry was not happy with that,” said Dennis McKinney of Public Employees for Environmental Responsibility, a non-profit alliance of local, state and federal scientists, law enforcement officers, land managers and other professionals.

”CHEERS is just part of a broader effort to gather data that will allow them to raise the bar on acceptable pesticide levels,” he added in an interview.

The gold standard of human research ethics is widely considered to be the Declaration of Helsinki, a statement of principles adopted by the World Medical Association in 1964. Among other things, it states that protocols must be approved by committees that are ”independent of the investigator, the sponsor or any other kind of undue influence.”

But a review of six human-dosing studies of pesticides conducted by the chemical industry between 1992 and 1999 -- and which specifically claimed to comply with Helsinki -- found that all the experiments were green lighted by ethics committees that were part of the sponsoring research organisation.

The studies were conducted both in the United States and Europe but all were aimed at influencing EPA regulations.

”All had serious ethical or scientific deficiencies -- or both -- including unacceptable informed consent procedures, unmanaged financial conflicts of interest, inadequate statistical power, inappropriate test methods and endpoints, and distorted results,” concluded Alan Lockwood, a neurology professor at the University of Buffalo whose critique was published in the American Journal of Public Health in November.

For example, three of the studies used consent forms that identified the pesticide only as ”the compound under test,” and failed to specifically list the participant's role and the potential risks.

In a study of chlorpyrifos, manufactured under the trade name Dursban by Dow Chemical, the opening paragraph of the side-effects statement asserted, ”low doses of these agents have been shown to improve performance on numerous tests of mental function.”

It did not mention that studies have linked Dursban -- which is still found in products ranging from flea collars for pets to garden and insect control products -- to neurological and developmental damage in animals and young children.

In December 2003, Dow was fined two million dollars for claiming the chemical had no ”long term (health) effects” and posed ”no evidence of significant risk to the environment.”

And despite the prevailing view that the adverse effects from pesticides can take many years to manifest, Lockwood said that none of the studies included plans for long-term monitoring of subjects, or even any consideration that there might be delayed effects.

Noting that the studies were submitted to the EPA but never published, Lockwood concluded, ”there is little doubt about their real purpose -- the production of data that will be used to affect the pesticide regulatory process.” (END/2004)