Did EPA Bend to Industry to Develop Pesticide Testing on Children Policy?
The Public Employees for Environmental Responsibility (PEER) claim that pesticide industry lobbyists (Crop Life America, Bayer Crop Life Science) met with the Environmental Protection Agency and the Office of Management and Budget to develop Bush's September 12, 2005 Proposed Rule on Human Pesticide Experiments. This is not, in itself, unusual. Consultations with industry, lobbyists and the public are typically required for external government policies in most western jurisdictions. What is unusual about the August 9th, 2005 meeting, noted by PEER, is that all parties reviewed the current regulatory framework for pesticide testing with the specific aim of finding loopholes that would allow for testing on children.
Quite a change in tune for the EPA. This is a department, afterall, that has traditionally legislated against all pesticide testing on children and pregnant women due to potential nervous system damage and other developmental defects. What PEER find most upsetting about the document they recovered from the August 9th meeting, are text changes to the policy that the lobbyists requested. Phrases such as "Re: kids - never say never" and "Pesticides have benefits. Rule should say so. Testing, too has benefits".
Having worked in policy, I can tell you that writers are typically urged to write policies that are worded generally and do not impede industry. The EPA is market driven, so there is extra pressure for writers to sacrifice a concise document for a policy that states benefits of the product to be regulated. That this policy allows for dosing experiments of non-pesticide toxic compounds on infants and pregnant women, however, should be sparking public outrage. This policy allows for the testing of individual compounds that compose a pesticide on the humans most likely to suffer the long-term negative effects of exposure. It actually is a step closer to the human experiments that took place in 1940s Europe, than it is the human experiments regulated by the Clinton administration. This is a gross departure from past EPA policy. The EPA's Scientific Advisory Panel and OFfice of Inspector General have spoken out against this policy.
But it's a blip in the backpage of the newspaper.
Here are the notes that tip off PEER's rage.
http://www.peer.org/docs/epa/06_26_5_EPA_HumanTesting_meetingnotes.pdf
Sacramento Bee article on the rules.
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.
About the writer: The Bee's Michael Doyle can be reached at (202) 383-0006 or
mdoyle@mcclatchydc.com.
This email address is being protected from spam bots, you need Javascript enabled to view it
Quite a change in tune for the EPA. This is a department, afterall, that has traditionally legislated against all pesticide testing on children and pregnant women due to potential nervous system damage and other developmental defects. What PEER find most upsetting about the document they recovered from the August 9th meeting, are text changes to the policy that the lobbyists requested. Phrases such as "Re: kids - never say never" and "Pesticides have benefits. Rule should say so. Testing, too has benefits".
Having worked in policy, I can tell you that writers are typically urged to write policies that are worded generally and do not impede industry. The EPA is market driven, so there is extra pressure for writers to sacrifice a concise document for a policy that states benefits of the product to be regulated. That this policy allows for dosing experiments of non-pesticide toxic compounds on infants and pregnant women, however, should be sparking public outrage. This policy allows for the testing of individual compounds that compose a pesticide on the humans most likely to suffer the long-term negative effects of exposure. It actually is a step closer to the human experiments that took place in 1940s Europe, than it is the human experiments regulated by the Clinton administration. This is a gross departure from past EPA policy. The EPA's Scientific Advisory Panel and OFfice of Inspector General have spoken out against this policy.
But it's a blip in the backpage of the newspaper.
Here are the notes that tip off PEER's rage.
http://www.peer.org/docs/epa/06_26_5_EPA_HumanTesting_meetingnotes.pdf
Sacramento Bee article on the rules.
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.
About the writer: The Bee's Michael Doyle can be reached at (202) 383-0006 or
mdoyle@mcclatchydc.com.
This email address is being protected from spam bots, you need Javascript enabled to view it
posted by Anthropolochic at 9:03 AM
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