According to a report in today’s N.Y. Times, children and pregnant women will no longer be allowed to participate in studies of potentially toxic pesticides.
The new regulations, proposed for adoption Jan. 1, 2006, are a significant step in the right direction for the EPA, which has a long history of “too little – too late” when it comes to watching over our most vulnerable populations, children and pregnant women. Witness the recent “CHEERS” study fiasco: parents were to be paid nearly $1000 over 2 years to expose their children to neurotoxic pesticides from birth to age three. The study was halted before it began only under intense political pressure holding up confirmation of President Bush’s nominee for EPA chief. Hopefully this is the beginning of a new era in federal environmental protections for our most cherished resources, our children.
September 7, 2005
E.P.A. to Bar Data From Pesticide Studies Involving Children and Pregnant Women
By MICHAEL JANOFSKY
WASHINGTON, Sept. 6 – Researchers will no longer be allowed to include children and pregnant women in studies examining the effects of pesticides to help set federal standards, according to the first regulations for human testing of pesticides that the Environmental Protection Agency plans to propose.
The regulations, to be proposed on Wednesday, would also establish an independent oversight panel to ensure that all studies submitted to the agency were conducted ethically and followed internationally accepted protocols for human testing.
Agency officials discussed the new regulations with reporters on Tuesday. They declined to make copies of the proposal available, leading at least one major critic of the agency, Senator Barbara Boxer, Democrat of California, to suggest that a close examination of the regulations might reveal weaknesses identified in an earlier version. Agency officials said those weaknesses were removed from a draft sent to the Office of Management and Budget last month.
In a statement, Senator Boxer said of the proposal: “One thing is clear. It must be changed dramatically from the version E.P.A. forwarded to O.M.B. just a few weeks ago. If not, it will be a direct attack on our most vulnerable citizens.”
The proposed regulations, which would take effect in January after a public comment period, came several months after Congress put restrictions on human pesticide tests as part of an appropriations bill. Congressional concern grew after reports that parents in Florida would be paid to participate in a program, known as Cheers, by allowing their children to be tested to measure household exposure to pesticides.
“This proposed rule contains some of the strongest protections for human subjects ever proposed by the federal government,” Jim Jones, director of pesticide programs for the agency, said Tuesday in a conference call with reporters.
Mr. Jones said the agency was so alarmed by public anger over pesticide testing involving humans that the new protocols would bar the agency from considering any tests that include pregnant women and children.
He also said the proposed regulations would apply to the 22 toxicity tests involving humans that are now before the agency. Two of them included children, though none involved pregnant women, Mr. Jones said.
Environmental groups expressed worry that the agency might blur the lines between past and future tests.
“This is a huge problem if they are going to accept studies already done,” said Erik D. Olson, a senior lawyer with the Natural Resources Defense Council. “Dozens of past unethical studies are now before the E.P.A. If they accept them, the new rules are plainly inadequate.”
The leading trade organization for pesticide manufacturers, CropLife America, defended its testing practices, saying its members have always worked to ensure the safety of participants.
At the same time, the group’s president, Jay Vroom, welcomed the new E.P.A. regulations, saying they “have the potential to establish ethical and scientific safeguards and uniform standards to protect research subjects and improve the risk assessment process.”
Mr. Vroom also said future tests would “only involve healthy adult volunteers and exclude pregnant women.”
In most cases, the tests are conducted by chemical manufacturers and the results submitted to the E.P.A. as part of a chemical’s approval process. But critics in recent years have questioned the effectiveness of a system in which the companies have an enormous financial interest in winning approval.
Mr. Jones said an oversight panel to review tests involving pesticides would include medical ethicists and experts in chemical tests and would exclude anyone with connections to the agency or chemical companies.
Copyright 2005 The New York Times Company