Bush’s EPA nominee advocates human guinea-pig experiments

Bush has fingered Stephen L. Johnson as new head of the Environmental Protection Agency, replacing Mike Leavitt, who has been nominated for Secretary of Health. As the EPA’s assistant administrator for toxic substances, Johnson has taken some controversial positions. Writes Gene C. Gerard in a commentary for Intervention magazine:

During President Clinton’s administration, the E.P.A. would not
consider the results of controversial trials that tested pesticides on
people. But after Mr. Bush was elected, Johnson changed E.P.A. policy
to resume consideration. However, a panel of scientists and ethicists
convened by the E.P.A. in 1998 determined that these types of trials
were unethical and scientifically unsuitable to estimate the safety of

In 2001, the trials considered by the E.P.A. gave paid subjects doses
of pesticides 100 to 300 times greater than levels that E.P.A.
officials considered safe for the general public. The E.P.A. evaluated
three studies that year from Dow Chemicals, Bayer Corporation, and the
Gowan Company. The Bayer and Gowan studies were conducted in
third-world countries, where volunteers were more readily available,
while Dow conducted their study in Nebraska….

It’s wasn’t surprising then that in October of last year, Johnson
strongly supported a study in which infants will be monitored for
health impacts as they undergo exposure to known toxic chemicals for a
two year period. The Children’s Environmental Exposure Research Study,
dubiously known as CHEERS, will analyze how chemicals can be ingested,
inhaled, or absorbed by children ranging from infants to three year
olds. The study will analyze 60 infants and toddlers in Duval County,
Florida who are routinely exposed to pesticides in their homes. Yet the
E.P.A. acknowledges that pesticide exposure is a documented risk factor
for some types of childhood cancer and the early onset of asthma.

Other aspects of CHEERS are equally troublesome. The participants will
be selected from six health clinics and three hospitals in Duval
County. The E.P.A. study proposal noted that “Although all Duval County
citizens are eligible to use the [health care] centers, they primarily
serve individuals with lower incomes. In the year 2000, 75 percent of
the users of the clinics for pregnancy issues were at or below the
poverty level.” The proposal also cited that “The percentage of births
to individuals classified as black in the U.S. Census is higher at
these three hospitals than for the County as a whole.”

The E.P.A. is targeting the poor and African-Americans for the study,
presumably in the hope that they will be less informed about the
dangers of exposing their children to pesticides, and will therefore
continue to expose them over the two year period. The study actually
mandates that participants not be provided information about the proper
ways to apply or store pesticides around the home. And the parents
cannot be informed of the risks of prolonged or excessive exposure to
pesticides. Additionally, the study does not provide steps to intervene
if the children show signs of developmental delay or register high
levels of exposure to pesticides in the periodic testing.

Parents receive $970 for participating in the study, but only if they
continue over the two year period. This is a powerful inducement for
these impoverished parents to keep exposing their children to
pesticides…. Additionally, it was disclosed that the American Chemistry
Council gave $2.1 million to the E.P.A. to fund CHEERS. The council is
comprised of many pesticide manufacturers.

The website for the CHEERS program denies that participants will be asked to expose their children to pesticides—probably in response to the criticisms that have been raised. But Gerard writes that the payment "is a powerful inducement for these impoverished parents to keep exposing their children to pesticides."

  1. source

    HI. This is beyond awful. I’d like to send in on to folks in toxicology who probably wouldn’t consider the info seriously if signed only "bill". Is the article from somewhere. IF not, is there an article "from somewhere" I could forward on?

    Scientists are a skeptical lot, particularly when "science" is being criticized. However, I know many would be apalled and should be informed. It helps to have folks in the field socially aware.

    1. Please pay attention
      I appreciate your concern, but there are two links in my post–to the original story in Intervention magazine, and to the EPA’s own page on the CHEERS program. That should be everything you need.

  2. A disturbing update
    From TruthOut:

    EPA on Threshold of Brave New World of Human Testing
    Public Employees for Environmental Responsibility

    Monday 09 May 2005

    EPA Invites Industry to Mimic Practices of Discontinued CHEERS Study.

    Washington, DC – In the wake of the recent cancellation of the CHEERS study in which parents were to be paid to expose their infant children to pesticides, the U.S. Environmental Protection Agency is finalizing a new policy that encourages the same type of human dosing studies by industry. Today EPA closes public comment on its “no safeguards” policy of accepting all human subject experiments submitted by industry, according to a filing today by Public Employees for Environmental Responsibility (PEER).

    Under its new policy, EPA would accept all human chemical dosing studies “unless there is clear evidence that the conduct of these studies was fundamentally unethical… or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted.” Since industry is not required to disclose the conditions under which experiments were conducted, it is not clear how EPA will ever learn of “fundamentally unethical” practices. Moreover, EPA is unwilling to define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.

    “The Bush Administration is setting the ethical bar so low that only the most sleazy cannot limbo under it,” stated PEER Program Director Rebecca Roose. “The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA’s standards for experiments to determine how much commercial poisons harm people.”

    EPA’s refusal to adopt basic safeguards requiring proof of informed consent, independent review or protections for children is part of a Bush Administration drive to liberalize rules on human testing of pesticides and other chemicals. Without actual human experimental data to justify higher chemical exposures for children, industry must abide by the 1996 amendments to the Federal Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for children.

    At the same time it is encouraging industry to expose human subjects, EPA itself is conducting similar experiments that serve to provide a template for industry. Last month to avoid a hold on his confirmation, EPA Administrator Stephen Johnson reluctantly cancelled a controversial study financed jointly by EPA and industry called CHEERS (Children’s Environmental Exposure Research Study) that would have paid Florida parents to apply pesticides and other chemicals in the rooms primarily occupied by their infant children. During his confirmation, Johnson disclosed that EPA is also conducting more than 250 other human experiments, several of which involve chemical testing on children, including

    * Exposing children (ages 3 to 12) to a powerful agricultural insecticide (chlorpyrifos) to test absorption in their systems through “urinary biomarker measurements”;

    * Paying “young male volunteers” to inhale methanol vapors at levels described as “a worst case scenario”; and

    * Having asthma sufferers inhale potentially harmful ultrafine carbon particles.

    “The need for safeguards is particularly acute because EPA is giving industry an economic incentive to push the edge of the ethical envelope,” Roose added. “It is distressing that a federal agency is using tax dollars to write a primer for commercial exploitation of human subjects.”