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Policy Watch:
Should pesticides be tested on people?
EPA says yes, and Congress says no.


The US Chemical Industry wants the EPA's go-ahead to use humans as lab rats for pesticide safety testing. Offering people money to be intentionally dosed with poisons could prey on the vulnerability of low-income people.

The US Congress recently blocked an EPA initiative to accept pesticide dosing studies conducted on humans. Early in 2005, the EPA had announced its intention to accept such studies from industry on a “case by case basis” after failing to issue regulations for such studies in keeping with a 2004 court decision.

Chemical companies, including Bayer CropScience, have asked that EPA accept their laboratory studies performed on human test subjects. Bayer and other companies, many of which have research facilities here in North Carolina, seek to decrease safety precautions associated with pesticide regulation by demonstrating "no adverse effects" when humans are intentionally dosed with pesticides. Some ethicists consider all testing of toxics on humans to be unethical; federal and international law state that such testing is unacceptable when its aim is to weaken public health protections, or when test subjects are not fully informed about risks, or about the aim of the study.

Public outcry against such testing came to a head in early 2005 after the EPA revealed its plans to monitor low-income children being exposed to pesticides in their homes through the CHEERS study in Duval County, Florida. Senator Barbara Boxer held up the nomination of the EPA’s new director until the study was cancelled. During a comment period in 2004, EPA received an overwhelming response from the public in opposition to allowing human tests. EPA also received recommendations from the National Academy of Sciences that warn EPA as to the very limited usefulness of intentional dosing studies.

The Issues

• Human test subjects should not be used for non-therapeutic testing of toxic substances such as pesticides.
• Such tests are unethical, because while the test subjects bear all the risk, the benefits go only to pesticide companies, who stand to profit from loosened regulations.
• EPA should impose a permanent moratorium on all human testing of pesticides.
• Clinical studies should never be done on children, infants, or pregnant women, since informed consent is impossible.
• Epidemiological studies, such as accidental poisonings or studies of workers who have been exposed to pesticides through their jobs, are valuable and should be considered as EPA evaluates risks.

Background

Since the passage of the 1996 Food Quality Protection Act (FQPA), pesticide companies have been required to perform extensive safety testing in order to register their products for use. Last year, at the request of chemical companies, the Bush administration asked the US EPA to accept laboratory studies of pesticides performed on humans. Chemical companies feel that the uncertainty factors used when safety testing is done on animals may be too restrictive, and are seeking the right to use human studies with the hopes of loosening pesticide regulations. This is a drastic turnaround from the moratorium on human studies observed during the Reagan, Bush I and Clinton administrations.

EPA sought public comments on how to determine the extent to which it will consider or rely on results from studies involving human subjects, and "how EPA might be able to establish robust standards for the protection of human subjects, in preparation for developing a rule or policy on this issue." While EPA received just a handful of comments in support of accepting human tests (all from the pesticide industry), dozens of public interest organizations and more than 500 citizens (including many of you) asked the EPA not to accept such tests. EPA also received a lengthy study from the National Academy of Sciences expressing serious concern about accepting human tests.

Instead of “robust standards,” EPA decided to dodge the ethical issues by pledging to review human tests submitted by the chemical industry on a case-by-case basis. That’s when Congress stepped in and help up EPA’s budget on the requirement that the agency stop accepting such studies altogether until strict regulations are drafted.

Since the Nuremburg Trials of World War II, human testing has been considered justified only if they are likely "to yield fruitful results for the good of society, unprovable by other methods or means of study." A 1998 panel of the National Academy of Sciences agreed, stating that human testing of pesticides "to facilitate the interests of industry or of agriculture" is unjustifiable. Several pesticide companies have recently submitted human test data to the EPA in hopes of reversing this policy against human tests. These tests do not appear to meet the criteria, since their results could only be increased application of the pesticides tested, and because the same tests could have been carried out on animals. According to Lynn Goldman, former EPA pesticide program director, the only reason such tests are being conducted is to make more money for pesticide companies.

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