EPA to permit pesticide testing on humans

Three US legislators are asking the US Environmental Protection Agency (EPA) to withdraw a planned rule to permit pesticide experimentation on humans, including pregnant and nursing mothers and children. The final draft rule was set to be released last week, but a copy was leaked to the legislators by a concerned administration official who requested that the original copy of the plan not be duplicated in its entirety and widely distributed. Sen. Barbara Boxer (D-CA) and Representatives Henry Waxman (D-CA) and Hilda Solis (D-CA) released details of the rule and called on EPA Administrator Stephen Johnson to withdraw it, calling it a "profound moral and ethical breach." "This rule has not been signed by EPA Administrator Stephen Johnson yet. It's within his power to fix this regulation, and we are calling on him to do so," said Boxer. In August 2005, Congress enacted a moratorium on the EPA using human pesticide experiments until strict ethical standards were established. Boxer championed the moratorium in the US Senate; Solis pushed the moratorium through the US House of Representatives. The law creating the moratorium passed overwhelmingly in the House and Senate with strong bipartisan support, which included conservative Republicans, who questioned the ethics of testing toxic chemicals on humans. But the leaked final draft rule would allow manufacturers to conduct testing of pesticides upon pregnant women and children so long as there is no "intent" at the outset of the study to submit the results to the EPA. Additionally, the plan would allow pesticides to be tested upon pregnant women and children in studies intended for submission to the EPA at exposure levels up to the current legal limits– even though the National Academy of Sciences found that in some cases this level of exposure could present acute risks to children. "The regulation is an open invitation to test pesticides on humans, which is the exact opposite of what Congress intended," said Waxman. "The administration predicts that over 30 pesticide experiments will be submitted to EPA each year under the new rule. That's an enormous step in the wrong direction." Peer-reviewed scientific studies across the world have documented that people with high levels of pesticides in their blood are far more likely to develop genetic mutations linked with cancers, birth defects and neurological disorders. In its moratorium legislation, Congress required that the EPA establish a Human Subjects Review Board (HSRB) as recommended by the National Academy of Sciences. The academy urged that this board review research protocols prior to consideration by an Independent Review Board (IRB). The academy expected that the HSRB would have ethical and pesticide expertise that IRBs typically lack. This approach would allow an IRB to block unethical research or require modifications suggested by the HSRB prior to the initiation of a study. But the final draft rule would establish a powerless HSRB that would consider research protocols after an IRB and EPA staff had already approved a study. Under the administration plan, the HSRB would not have any authority to block or require modifications to unethical research. "The administration plan is inconsistent with the law passed by Congress with bipartisan support," said Boxer. "The loopholes which allow continued testing on pregnant women, infants and children are contrary to law and widely accepted ethical guidelines, including the Nuremberg code. The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing." The EPA final draft rule introduces new loopholes that will allow for ethical abuse, the legislators warn. While the plan would require researchers to document their ethical compliance in the United States when the plan applies to them, it waives overseas researchers from having to prove a study was ethically conducted– even when the researcher intends to submit the study to EPA. The rule would subject EPA observational studies to the Common Rule, which states general standards of ethical conduct for research. However, observational studies conducted by the pesticide industry would be bound by no specific ethical requirements. These loopholes were never suggested or even contemplated by Congress, the three legislators say. On Apr. 8, 2005, Administrator Johnson canceled a controversial study that would have allowed pesticide dosing of children. "The Children's Health Environmental Exposure Research Study was designed to fill critical data gaps in our understanding of how children may be exposed to pesticides and chemicals currently used in households," Johnson said. "Information from the study was intended to help EPA better protect children." "As a scientist and a 24-year employee of the EPA, I have a deep passion for the agency's mission to protect human health and the environment," Johnson said at the time. "Continual review and reassessment is a fundamental aspect of scientific progress, and I am committed to ensuring that EPA's research is based on sound science with the highest ethical standards." Erik Olson, an attorney with the Natural Resources Defense Council, says the EPA's latest rule is not justified legally or ethically. "EPA is giving its official blessing for pesticide companies to use pregnant women, infants and children as lab rats in flagrant violation of a new federal law cracking down on this repugnant practice. There is simply no legal or moral justification for the agency to allow human testing of dangerous chemicals. None." Attorney Jeff Ruch, executive director of Public Employees for Environmental Responsibility, says his organization objects to the plan because it allows dosing experiments involving infants and pregnant women using non-pesticide chemicals. "Thus, companies will be free to test agents such as perchlorate on nursing mothers. The proposal only forbids (with loopholes) pesticide dosing studies using children and pregnant women." "When I asked the EPA representative at the stakeholders' meeting about this discrepancy, he admitted it and explained that the agency was only trying to respond to the biggest source of public controversy, that being pesticide experiments," said Ruch. One very large omission in the proposed EPA rule is any prohibition or check against paying poor people amounts that would induce them to sign informed consent papers or falsely certify that they were already exposing themselves to the chemical under study, Ruch said. Ruch says the rule opens the doors to all pre-rule human studies. "The proposal allows EPA to utilize for regulatory purposes any human dosing study conducted before the effective date of the new rule on a case-by-case basis, considering the ethical standards prevalent at the time. Since prior to the rule, EPA recognized no ethical standards at all, this means that all prior human studies can come in through EPA's wide open door." "This is yet another example of the Bush administration choosing to ignore the letter of the law and going its own way," Solis said. "Congress passed legislation to curb the practice of unethical pesticide testing on humans, but with this rule the Bush administration is authorizing systematic testing of pesticides on humans which not only fails to meet its congressional mandate but which will increase the number of unethical studies."