INTENTIONAL HUMAN DOSING STUDIES FOR EPA REGULATORY PURPOSES: SCIENTIFIC AND ETHICAL ISSUES by National Research Council of the National Academies

Author:National Research Council of the National Academies
Language: eng
Format: epub
Tags: Environment and Environmental Studies : Environmental Health and Safety. Policy for Science and Technology
Publisher: NATIONAL ACADEMY PRESS
Published: 2004-06-10T00:00:00+00:00

Balancing the interests of the various parties affected by EPA’s statutory requirements can lead to the development of regulations that effectively establish legal rights and responsibilities. Parties can correctly insist that the rights and responsibilities that are ultimately established and enforced by EPA through its regulations implement the public policy that Congress has enacted. In our democratic system of government, Congress codifies a particular balance when it writes binding law, and that balance should be observed by administrative agencies until it is changed.

Even in cases where the agency employs elements of discretion in fine-tuning the ultimate regulations, that discretion should be based on the best relevant and available understanding of the information Congress has directed the agency to take into account. In the case of risk assessments and the regulatory decisions that employ them, this information includes the scientific components of the assessment. The more accurate the science-based components of the regulatory systems EPA administers under these statutes, the better informed EPA’s exercise of discretion will be.

In addition to its stated general preference for replacing default assumptions with scientific findings, EPA has expressed a specific preference for supplementing animal data with human data when conducting human risk assessments. EPA has said that it looks to human data whenever possible in completing human risk assessments: “If adequate human studies (confirmed for validity and applicability) exist, these studies are given first priority in the dose-response assessment, and animal toxicity studies are used as supportive evidence” (EPA, 1989). Often, such data can be obtained from epidemiological studies, which do not involve the intentional dosing of research participants, but rather evaluate the effects of exposures that have occurred in an occupational setting or because of the peculiarities of a specific geographical setting.6 Regardless of the origins of such human data, “risk assessments based on human data have the advantage of avoiding the problems inherent in interspecies extrapolation” (EPA, 1993).

6This quotation from the Risk Assessment Guidance refers specifically to epidemiological data.

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