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KEYCODE BAYER #246

Public Employees for Environmental Responsibility
News Release, May 30, 2006

PESTICIDE INDUSTRY PLOTTED BUSH HUMAN TESTING POLICY

Meeting with OMB Staff Laid Out Exemptions for Experiments on Children

One month before the Bush administration proposed rules authorizing experiments on humans with pesticides and other chemicals, its key operatives met with pesticide industry lobbyists to map out its provisions, according to meeting notes posted today by Public Employees for Environmental Responsibility (PEER). The industry requests for exemptions allowing some chemical testing on children and other provisions were incorporated into the human testing rule ultimately adopted this January 26th.

At the August 9, 2005 meeting held inside the President’s Office of Management and Budget, representatives of the pesticide trade association, Crop Life America, as well as Bayer Crop Life Science met with OMB and U.S. Environmental Protection Agency officials. Also attending was a former top EPA official, James Aidala, who now acts a lobbyist at a law firm representing chemical companies.

The meeting notes detail industry concerns about the text of a proposed rule that the Bush administration first unveiled a month later on September 12th. For example, the Crop Life America attendees urged:

• “Re kids—never say never” (emphasis in original);
• “Pesticides have benefits. Rule should say so. Testing, too, has benefits”; and
• “We want a rule quickly—(therefore) narrow (is) better. Don’t like being singled out but, speed is most imp.”

“These meeting notes make it clear that the pesticide industry’s top objective is access to children for experiments. After reading these ghoulish notes one has the urge to take a shower,” commented PEER Executive Director Jeff Ruch, whose organization works with EPA scientists who have been prevented from voicing ethical and scientific concerns about human subject testing. “For an administration which trumpets its concern for the ‘value and dignity of life,’ it is disconcerting that no ethicists, children advocates or scientists were invited to this meeting to counterbalance the pesticide pushers.”

The upcoming August 3rd deadline for EPA final approval for a controversial class of pesticides derived from nerve agents called organophosphates appeared to be a top industry priority. Jim Aidala, the industry lobbyist, stated, “Won’t be able to meet the FQPA (Food Quality Protection Act) deadline. Wouldn’t anyway. Just do the rule first, then proceed ASAP.”

Aidala also suggested how the rules could make subtle exceptions for chemicals testing on children:

• “Distinguish testing kids from using data on kids who were tested”; and
• “Some workers may legally be children, albeit old enough for DOL” (Department of Labor coverage).

The human testing rule adopted by EPA earlier this year contains the loopholes advocated at the OMB meeting for exposing children to pesticides, such as testing on workers and exposures unconnected with the approval process for new pesticides or new uses for existing agents. In addition, the rule broadly allows dosing experiments on infants and pregnant women using non-pesticide chemicals.

“Unfortunately, using human beings as guinea pigs to test the toxic strength of commercial poisons has become a central regulatory strategy under the Bush administration,” Ruch added.

Meeting Record Regarding: Protections for Test Subjects in Human Research
Date: 8/ 9/2005

Jim Aidala, Bergeson & Campbell
Ray McAllister, Pat Donnelly, Crop Life America
Jean Reimers, Bayer Crop Science
Angela Hofmann, Charlotte Bertrand, Bruce Rodar, EPA
Keith Belton, John M. Carley, Art Fraas, OMB/OIRA

See the Crop Life-OMB meeting notes

Political pressure on EPA scientists to approve organophosphate pesticides

Sacramento Bee, January 24, 2006

New pesticide research rules face heavy fire

EPA calls them tough and fair; critics want human testing out.

WASHINGTON - The Bush administration would allow some limited pesticide testing on children and pregnant women under controversial rules set to be made final as early as this week.

After fielding some 50,000 public comments on its earlier human-testing proposals, the Environmental Protection Agency is setting out final rules that officials call tough and fair. But California Democrats and environmentalists are raising an outcry, and courts could remain busy sorting it all out.
The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Sen. Barbara Boxer, D-Calif., said Monday.

The new rules would prohibit regulators from using so-called "intentional exposure" research that involved children or pregnant women. But under what regulators described as "narrowly defined circumstances," such research could still be used - if the researcher hadn't originally intended to submit the results to the EPA.

The new rules require researchers to document their compliance with ethical guidelines, but exempt certain overseas tests. Testing on adults could proceed, following review by a new Human Studies Review Board that could "comment on" but not stop a proposed experiment.

"EPA does not want to ignore potentially important information," the agency says in its final rule. "At the same time, the agency's conduct should encourage high ethical standards in research with human subjects."

On Monday, Boxer and several California colleagues were one step ahead of the EPA, which hadn't yet formally released the final rules protecting human subjects. But a leaked draft of the new rules, spanning some 100 pages, spells out both the new regulations and how they will be presented to the public.
"Message: the ethics and scientific value of human studies are topics of high public interest, and the agency has been deliberating its position," the EPA's written "communications plan" states. EPA officials could not be reached for comment Monday.

The issue is particularly important in California, where farmers and others applied 644 million pounds of pesticides in 2003. It's also closely watched by church and environmental groups, which raise red flags over human testing, as well as by manufacturers, which can rely on testing to secure necessary approval permits.

"Humans process some substances differently from animals," the EPA notes in its final rule, scheduled for publication in the Federal Register. "Studies of this kind can provide essential support for safety monitoring programs. Animal data alone can sometimes provide an incomplete or misleading picture of a substance's safety or risk."

The 50,000 comments received by the EPA since September showcase the level of public interest, although regulators noted that 99 percent of the comments were part of an e-mail or organized letter-writing campaign.

The American Mosquito Control Association, among others, previously advised lawmakers that human testing is necessary in order to develop new and safer chemical alternatives. Otherwise, the mosquito control group warned, diseases like the West Nile virus could spread more readily.

"Let's look at things as they really are in the world around us," Sen. Conrad Burns, R-Mont., said during debate last year. " ... We do not do anything in this environment around us where there are no chemicals."

Burns failed and Boxer prevailed, as the Senate in June imposed a moratorium on the EPA's use of human pesticide testing; the House had adopted a similar moratorium authored by California Rep. Hilda Solis, D-El Monte. The moratorium came following reports of some studies involving the intentional swallowing of pesticides.

The moratorium is in place until the final rule takes effect, which is 60 days after publication. But if environmentalists conclude that "loopholes" will result in laws being broken, further lawsuits would likely follow.