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From January 31, 2006                                                                                                        

EPA Finalizes Rule for Human Studies Research
(Beyond Pesticides, January 31, 2006) The Environmental Protection Agency (EPA) finalized the rules that allows for human pesticide testing and the use of resulting data for pesticide registration after receiving over 50,000 comments during a 90-day public comment period see Photo Stories. The final rule, which amends 40 CFR Part 26 Protections for Subjects in Human Research, continues a major controversy over human testing that erupted when the Bush Administration reversed a federal government prohibition on this type of testing.

The rule (70 FR 53838) will ban all third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA, and EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children for all substances EPA regulates. According to EPA officials, the new rules will also establish stringent enforceable ethical safeguards to protect individuals who volunteer to participate in third-party intentional dosing research. Although EPA is assuring the highest levels of safeguards available, what continues to be an ssue with this rule is pesticide “benefits” do not justify the intentional dosing of human subjects even on a voluntary basis. According to Beyond Pesticides, It is unethical to test toxic chemicals on human subjects when there is not documented and fully determined societal benefit. Most toxic pesticide uses can be replaced by less toxic alternative practices and products.

In a news release issued by EPA, Susan Hazen, acting assistant administrator in EPA's Office of Prevention, Pesticides and Toxic Substances said, "These final rules will protect pregnant women and children from unethical human research involving pesticides and other environmental substances." Hazen continued, "Pregnant women and children should never be involved in these types of studies. Now adult volunteers (non-pregnant) will have the highest level of ethical safeguards available if they choose to participate in research studies."

Examples of human research studies include measuring worker exposure levels. Exposing subjects to low doses of a substance to measure how it is absorbed, distributed, metabolized, and excreted. Lastly, although according to EPA, they have not required or encouraged it, occasionally some third parties have conducted and submitted to EPA reports of research involving intentional exposure to human subjects to a substance to identify or measure its toxic effects. The latter studies occur in a controlled laboratory or clinical setting says EPA.

In the final rule, Protections for Subjects in Human Research, EPA says it intends to significantly strengthen and expand the protection for participants in third party research by:

  1. Prohibiting new research involving intentional exposure of pregnant woman or children, intended for submission to EPA under pesticide laws;
  2. Extending the ethical protections in the Federal Policy for the Protection of Human Subjects of Research (the “Common Rule”) to other human research involving intentional exposure of non-pregnant adults, intended for submission to EPA under pesticide laws;
  3. Requiring submission to EPA of protocols and related information to ensure any future studies meet this highest ethical safegrounds; and
  4. Establishing an independent Human Studies Review Board (HSRB) to obtain expert peer review of both proposals for new research and completed third party intentional dosing, research on which EPA may rely under the pesticide laws.

In addition, the final rule also:

  1. Categorically prohibits any EPA-sponsored research involving intentional exposure of pregnant women or children to any environmental substance; and
  2. Adopts regulations of the Department of Health and Human Services to provide additional protections beyond those of the Common Rule to pregnant women and children in EPA observational research where there is only minimal risk and when research which does not involve intentional exposure to any substance.

Although the EPA rule has expanded the Common Rule, EPA has not proposed to adopt subpart C of the Common Rule at this time, which provides additional protections pertaining to biomedical and behavioral research involving prisoners as subjects. EPA is waiting for recommendations (which is expected to consist of significant changes) to come from an advisory committee out of the Department of Health and Human Services (HHS). The agency decided to defer the decision until the possible HHS revisions are settled since EPA neither conducts nor supports research with prisoners, and has not received any third party research with prisoners for many years.

In the new rule adult volunteers (non-pregnant) who choose to participate in this research will have the highest level of ethical safeguards available, according to EPA.

EPA does not evaluate pesticides for their societal benefits in light of alternative approaches, practices and products. EPA does not by practice or rule, under the “unreasonable adverse effects” standard of the federal pesticide registration law (Federal Insecticide, Fungicide and Rodenticide Act - FIFRA), generally evaluate the actual need for a pesticide to determine whether the pest is adequately defined and, if so, whether there is a less toxic approach to pest prevention or management. Therefore, EPA is not equipped to meet the rule’s requirement that human studies are approved “only if risks to subjects . . . are reasonable in relation to anticipated benefits.” This is a threshold issue when discussing the ethics of intentionally dosing human subjects with pesticides.

Within this rule EPA acknowledges it’s mission is to make the best possible regulatory decisions to protect public health and the environment. The Agency does not want to ignore potentially important information that might benefit its assessments and decision-making. According to EPA, the sweeping requirements of this final rule will lay the groundwork and provide an important foundation for the Agency to build upon in future actions that may be determined necessary to provide further protections to public health.

Observational studies that encourage pesticide use with incentives remain unaffected by the rule. Studies such as the highly controversial, and at least temporarily derailed Children’s Environmental Exposure Research Study (CHEERS), would not be outlawed or restricted by the proposed rule.

For more information, see Human Testing Daily News Stories and contact Beyond pesticides. Use the Google search engine on the Beyond Pesticide homepage to find a series of articles on this subject.