For Immediate Release: Jun 16, 2005
Contact: Kirsten Stade (202) 265-7337


Proposed New Rules Lack Any Ethical Protections for Study Subjects

Washington, DC — In recent Federal Register notices, the U.S. Environmental Protection Agency is proposing that pesticide companies submit human exposure experiments when seeking to market new chemicals or broaden the application of existing ones. EPA is not, however, requiring the industry to observe any ethical safeguards, such as informed consent, no undue risk to participants and exclusion of infants or other vulnerable populations, according to Public Employees for Environmental Responsibility (PEER).

These new policies hang in the balance while Congress debates whether to prohibit the agency from accepting any human pesticide dosing studies. Such a ban has already passed in the House of Representatives and consideration of a similar amendment is imminent in the Senate. Just weeks ago, 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 in order to remove Senate objections to his confirmation.

Nonetheless, the agency is signaling a desire to propel a much broader, industry-driven human experimentation agenda. In its latest notice filed on June 8th, the agency promised that the proposed pesticide rule for toxic agents is “the first of several planned changes.”

In its new proposal, EPA would revamp nearly 20-year old data requirements for pesticides by encouraging the companies to submit human dosing studies “in addition to, or in lieu of” conventional animal studies or background environmental exposure studies, because —

  • The human dosing studies may eliminate the need for pesticide companies to pay for expensive toxicological testing in cases where the human subjects evidence no detectible harm; and
  • Background environmental exposure tests “usually overestimate exposure because they only provide estimates of potential exposure, not measurements of absorbed dose.”

“The issue here is not the march of science but whether standards of basic decency will be applied to experiments conducted for commercial gain,” stated PEER Executive Director Jeff Ruch, whose organization has been relaying ethical concerns raised by EPA’s own scientists. “It is beyond ironic that EPA claims these studies are required to protect human health while turning its back on the health risks posed to the troops of human guinea pigs it is creating.”

At a recent EPA office groundbreaking in Denver, Johnson decried Congressional interference in the CHEERS study. Not only has Johnson personally championed the pesticide industry drive to legitimize widespread human dosing work but he has also refused to require that industry studies conform with informed consent rules or safeguards for infants, pregnant women, fetuses and other vulnerable groups that apply to all medical experiments submitted to regulatory agencies such as FDA or research bodies, such as NIH.

The new rules will likely result in thousands of corporate sponsored human dosing studies each year, in part because EPA states that it “generally is not allowing surrogate data” using other benign chemicals. Instead, the agency “encourages applicants and registrants to generate needed exposure data using the pesticide product for which the registration is sought.” This requirement will mean separate batteries of human dosing for each new chemical or new application in order to build a meaningful database.


View the public comment extension notice in the June 8, 2005, Federal Register at 70 FR 33414 (at page2)

Look at the proposed new pesticide data requirements at 70 FR 12276 (beginning at page 6)
See pages 12292 to 12302 for human testing provisions
And pages 12312 to 12313 for lack of ethical safeguards

Read the PEER comments on lack of safeguards in EPA policy

For background on EPA’s drive to promote human dosing studies