EPA Science Inventory

Toxicogenomics and the Regulatory Framework

Citation:

GALLAGHER, K., F. M. GOODSAID, D. J. DIX, S. EULING, M. KRAMER, N. MCCARROLL, J. PRESTON, P. SAYRE, B. SEN, D. WOLF, AND W. H. BENSON. Toxicogenomics and the Regulatory Framework. Chapter 14, Darrell R. Boverhof and B. Bhaskar Gollapudi (ed.), Applications of Toxicogenomics in Safety Evaluation and Risk Assessment. John Wiley & Sons Incorporated, New York, NY, , 293-321, (2011).

Description:

Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expected to improve dose-response assessments and the underlying premise for linear versus nonlinear extrapolations. The US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) have seized upon this opportunity to enhance their missions of protecting human health and environmental health by moving in a considered, yet expeditious, manner to position themselves to utilize genomics data in regulatory and risk assessment applications as appropriate. This chapter provides an overview of the initiatives within these two US government agencies to develop frameworks for applying toxicogenomics information in their regulatory and risk assessment activities.

Purpose/Objective:

Describe initiatives within the EPA and the Food and Drug Administration to develop frameworks for applying toxicogenomics information in their regulatory and risk assessment activities.

Record Details:

Record Type: DOCUMENT (BOOK CHAPTER)
Start Date: 08/01/2011
Completion Date: 08/01/2011
Record Last Revised: 02/05/2013
Record Created: 09/19/2011
Record Released: 09/19/2011
OMB Category: Other
Record ID: 238287

Organization:

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RESEARCH AND DEVELOPMENT

NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB

GULF ECOLOGY DIVISION

IMMEDIATE OFFICE