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External Review Draft of the
Interim Guidance for Microarray-Based Assays:
Data Submission, Quality, Analysis, Management and Training Considerations

Prepared for the U.S. Environmental Protection Agency
by members of the Genomics Workgroup,
a group of EPA's Science Policy Council

Science Policy Council
U.S. Environmental Protection Agency
Washington, DC 20460

External Review Draft of the Interim Guidance for Microarray-Based Assays, March 13, 2007 (PDF) (101 pp, 868KB, About PDF)

Advances in the science of genomics will have significant implications for risk assessment policies and regulatory decision making.

In 2002, the Environmental Protection Agency issued the Interim Policy on Genomics. The Interim Policy described genomics as the study of all the genes of a cell or tissue, at the DNA (genotype), mRNA (transcriptome), or protein (proteome) level. While noting that the understanding of genomics is far from established, the Interim Policy stated that such data may be considered in the decision making process, but that these data alone are insufficient as a basis for decisions.

Following the release of the Interim Policy, EPA's Science Policy Council (SPC) created a cross-EPA Genomics Task Force which developed a Genomics White Paper entitled "Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA". That document identified EPA risk assessment practices and regulatory areas likely to be influenced by the generation of genomics data and provided recommendations on additional steps EPA could take to prepare itself to receive and consider such information. One recommendation was to establish a framework for analysis and acceptance criteria for genomics information for scientific and regulatory purposes.

The draft Interim Guidance for Microarray-Based Assays provides that analysis for DNA microarray-based assays, a subset of potential genomics assays. The document outlines recommendations for:

The guidance applies to both human health and ecological DNA microarray data. The draft document was developed to provide information to the regulated community and other interested parties regarding submitting microarray data to the Agency and to provide guidance for reviewers in evaluating such data and/or information. Microarray technology is rapidly changing, such that methodologies for generating such data and ensuring its quality will likely change, however the need to ensure consistency and quality in generating, analyzing and using the data will not. As the state of the science develops, EPA plans to revisit this guidance as necessary.

EPA is releasing the External Review Draft of the Interim Guidance for Microarray-Based Assays to seek public comment prior to external peer review. The contractor-lead external expert peer review will be conducted by letter and closed teleconference in the May 2007 timeframe. EPA will share all comments received by April 30, 2007 with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA when it finalizes the document.

EPA will consider peer review and public comments received in finalizing its Interim Guidance for Microarray-Based Assays.

Public comments on the external review draft may be submitted to the public docket. Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-0212, to www.regulations.gov. Follow the on-line instructions for submitting comments. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov website is an "anonymous access" system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment.

This draft interim guidance, when finalized, will represent EPA's current thinking on this topic. It does not create or confer any rights for or on any person or operate to bind the public. The use of any mandatory language in this document is intended to describe laws of nature, scientific principles, or technical requirements and is not intended to impose any legally enforceable rights or obligations. Alternative approaches may be used if the approach satisfies the requirements of the applicable statutes and regulations. Mention of trade names or commercial products does not constitute endorsement of recommendation for use. This is an external review draft, and is not approved for final publication.

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