Toxic Free NC - Human Testing

If the pesticide industry gets its way, residents of the Raleigh area could find themselves in demand as human guinea pigs for testing of the chemicals.

Pesticide makers — including Bayer CropScience, with offices in Research Triangle Park — are pressing the federal Environmental Protection Agency to reverse a longstanding agency policy rejecting human tests of pesticides. In response, the EPA earlier this year issued a notice of proposed rulemaking on the matter. The comment period closed last month.

Pesticide manufacturers argue that the rule change is necessary to learn what happens when humans are exposed to or ingest the toxic chemicals.

“Human clinical trials with pesticides are conducted to help refine the parameters and limits of risk and to increase the confidence in risk assessment so that risks are not underestimated or overestimated,” according to a statement from Jay Vroom, president of CropLife America, a Washington-based industry advocacy group that represents Bayer as well as other pesticide makers with North Carolina ties, including BASF Corp. in Research Triangle Park and Syngenta Crop Protection in Greensboro.

“The net benefit to society is that safe use of pesticides can be more closely aligned with efficacy using the least amount of product to accomplish the necessary crop protection and pest control.”

But the drive to allow human testing worries environmentalists and public safety advocates. They argue that testing toxic chemicals on humans is unethical because the test subjects bear all the risk while the pesticide companies — which stand to gain from the loosened regulations the changes aim for — reap the benefits.

“This isn’t medicine or food — pesticides don’t have any role in the human body,” says Fawn Pattison, executive director of Toxic Free NC(ARC), a nonprofit pesticide watchdog group headquartered in Raleigh. “There’s no possible benefit to a human subject who would swallow this stuff. It puts human subjects at risk purely for the sake of profit.”

Shadows of History

The disturbing history of human testing has heightened the emotional nature of the current debate.

A catalyst for the proposed policy change was Bayer’s submission to the EPA in August 2001 of a human study of azinphos methyl conducted by a contractor in Scotland in 1998. Azinphos methyl is an insecticide derived from nerve gases developed during World War Two. Bayer scientists were among those who conducted human experiments in Nazi concentration camps. At the time, the company was a subsidiary of IG Farben, which manufactured the poison gas used to kill Nazi prisoners.

More recently, at least one participant from the Scottish azinphos methyl study has come forward to accuse Bayer and its contractor of treating subjects unethically by failing to give them the information needed to give truly informed consent.

Subject Bruce Turnbull last year told the Sunday Herald in Glasgow that he was informed the chemical he ingested was a drug, not a pesticide. He was not told for whom the test was being conducted, or the fact that the substance already had been deemed “highly hazardous” by the World Health Organization. And the subjects — who were paid 700 pounds, or about $1,000, for their participation — were not given follow-up exams to test for the long-term effects of exposure to the chemical.

Turnbull now suffers from health problems that he believes may be related to pesticide ingestion. The EPA acknowledges that the chemical at high exposures can cause nausea, dizziness and confusion, and at very high exposures respiratory paralysis and even death.

However, the agency ultimately determined azinphos methyl’s toxicity based on animal tests. Though it did not reject Bayer’s human test, it said the test did not affect its decision to continue to allow most uses of the chemical, which is commonly sprayed on fruit and vegetable crops, grains and cotton.

Horror over the Nazi regime’s human experimentation led to the establishment of the Nuremberg Code, which says such tests are justified only if they are likely “to yield fruitful results for the good of society, unprovable by other methods or means of study.” The code also holds human testing to be indefensible when its aim is to weaken public health protections.

In the United States, administrations both Republican and Democrat have frowned on the idea of accepting pesticide tests conducted on human subjects. In 1975, when some EPA staff members under President Ford suggested the agency should encourage human tests for certain pesticides, agency Administrator Russell Train told the Washington Post that he was “shocked and appalled” by the proposal and that it should not be dignified with further discussion.

Under the first Bush administration, EPA Administrator Lee Thomas prohibited the agency from considering a proposal to assess the health risks of certain chemicals with human tests done by the Nazis in the 1940s. And in 1998, a scientific advisory panel of doctors, ethicists and scientists brought together by the President Clinton’s EPA concluded that human testing of pesticides can’t be justified “to facilitate the interests of industry or of agriculture.” The Clinton administration subsequently banned the use of human pesticide tests for making regulatory decisions.

But in early 2001, under pressure from the pesticide industry, President Bush’s former EPA Administrator Christine Todd Whitman lifted the ban. In response to public outcry over the move, the agency temporarily reinstated the ban until a National Academy of Sciences panel could study the issue.

CropLife America responded by suing the government over its reversal. This past June, the U.S. Court of Appeals for the District of Columbia overturned the EPA’s temporary moratorium and ordered the agency to reinstate its previous policy of evaluating human test data on a case-by-case basis. That worries opponents of human testing, including the Natural Resources Defense Council (NRDC), which is fighting the change.

“If EPA ultimately accepts the Bayer study or any of the other human studies before it, the floodgates could open for other human pesticide studies,” the NRDC warns in a statement on its Web site.

The EPA now will consider the more than 200 comments it received on the human testing issue before crafting a new proposed rule. According to William Jordan, a senior policy advisor in the EPA’s Office of Pesticide Programs, the agency does not yet have a specific timeline for issuing the rule.

For more information on human testing of pesticides from ARC, go to the organization’s Web site. For information on the issue from CropLife America, click here and then on “Issues” and “Medical Testing.”