Daily News Archive
Industry’s Human Testing Proposals & EPA Guidelines Flawed
HSRB calls the human testing proposals scientifically flawed and unclear in their intent. Specifically, HSRB calls for industry to develop a clearer explanation of how the results will be used. “None of these protocols can be properly evaluated in regard to scientific validity because they lack: (1) a developed rationale documenting the need for new data; (2) a clear and appropriate plan for the handling of the data (including its statistical analysis), and (3) an explanation of the uses to which the data will be put,” the draft report states.
HSRB also criticizes EPA for not providing “compelling justification” for why the new agricultural studies are needed, and is seeking an overhaul of EPA guidelines governing pesticide occupational exposure research.
The study protocols are part of a planned series of 60 studies intended to characterize how farmworkers are exposed to pesticides. When combined with chemical risk data, EPA uses the information to set pesticide safety limits for farmworkers and the public.
EPA's occupational exposure pesticide database has not been revised since updates in the late 1980s and the early 1990s. EPA and industry officials say the aging database warrants new research that could improve exposure estimates and track more recent agricultural techniques. However, environmentalists argue the effort will result in lax pesticide safety limits because the agency could reduce mathematical adjustments included in pesticide risk assessments meant to account for uncertainty in the exposure estimates.
HSRB’s criticisms are having a broader impact on other human pesticide exposure studies with a similar framework. For example, the agency planned to submit occupational antimicrobial exposure research proposals to the HSRB at its next scheduled meeting on Oct. 18-19. But those exposure studies are based on a framework similar to the farmworker studies, which could earn similar criticisms from the board. Because of this concern, EPA is expected to drop the proposals from the October agenda, pending the SAP review.
EPA finalized its rule for human studies in February, 2006, and as part of that, established HSRB to obtain expert peer review of both proposals for new research and completed third party intentional dosing research intended for submission to EPA.
The 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 sets long-anticipated restrictions on human pesticide testing, but falls short of providing adequate protection to human subjects and does little to ensure critical ethical guidelines will be followed.
Sources: Inside Washington Publishers; Pesticides and You, Fall 2005.