Document ID: EPA-HQ-ORD-2007-0212-0001
Agency: epa
Document Type: Notice
Title: Notice of Availability of the External Review Draft of an Interim Guidance for Microarray-Based Assays, March 14, 2007
Posted Date: 2007-03-14T04:00Z

[Federal Register: March 14, 2007 (Volume 72, Number 49)]
[Notices]               
[Page 11873-11874]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr07-52]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0212; FRL-8287-6]

 
Notice of Availability of the External Review Draft of an Interim 
Guidance for Microarray-Based Assays

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for public comment.

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SUMMARY: The U.S. Environmental Protection Agency is announcing a 45 
day public comment period for the External Review Draft of the 
``Interim Guidance for Microarray-Based Assays: Data Submission, 
Quality, Analysis, Management and Training Considerations.'' EPA is 
releasing this draft document solely for the purpose of seeking 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. All comments received, 
submitted in accordance with this notice, will be shared with the 
external peer review panel for their consideration. Comments received 
after the close of the comment period may be considered by EPA when it 
finalizes the document. This document has not been formally 
disseminated by EPA. This draft interim guidance does not represent and 
should not be construed to represent any EPA policy, viewpoint, or 
determination. Members of the public may obtain the draft interim 
guidance from http://www.regulations.gov; or www.epa.gov/osa/spc/

genomicsguidance.htm; or from Dr. Kathryn Gallagher via the contact 
information below.
    This draft Interim Guidance for Microarray-Based Assays outlines 
recommendations for: (1) What data to submit to the Agency for 
microarray studies, (2) performance approach considerations regarding 
quality assessment parameters, (3) data analysis approaches that should 
be considered; and (4) data management and storage issues for data 
submitted to or used by the Agency. 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 about submitting microarray data to the Agency and 
to provide guidance for EPA staff in evaluating such data and/or 
information.

DATES: All comments received by April 30, 2007 will be shared with the 
external peer review panel for their consideration. Comments received 
beyond that time may be considered by EPA when it finalizes the 
document.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2007-0212, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for 

submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, 
Attention Docket ID No. EPA-HQ-ORD-2007-0212. Deliveries are only 
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. Special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0212. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://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 by statute through http://www.regulations.gov or 

e-mail. The http://www.regulations.gov Web site 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. If you 
send an e-mail comment directly to EPA, without going through 
http://www.regulations.gov, your e-mail address will be automatically captured 

and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses.
    Docket: All documents in the docket are listed in the 
http://www.regulations.gov index. Although listed in the index, some 

information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA 

West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the ORD 
Docket is (202) 566-1752.

[[Page 11874]]

FOR FURTHER INFORMATION CONTACT: Dr. Kathryn Gallagher, Office of the 
Science Advisor, Mail Code 8105-R, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone 
number: (202) 564-1398; fax number: (202) 564-2070, E-mail: 
Gallagher.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION: The mapping of diverse animal, plant, and 
microbial species genomes using molecular technologies has 
significantly affected research across all areas of the life sciences. 
The current understanding of biological systems is rapidly changing in 
ways previously unimagined and novel applications of this technology 
have already been commercialized. These advances in genomics are likely 
to have significant implications for risk assessment policies and 
regulatory decision making. In 2002, EPA issued its Interim Policy on 
Genomics (available at http://www.epa.gov/osa/spc/genomics.htm) that 

communicated the Agency's initial approach to using genomics 
information in risk assessment and decision making. 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 Agency stated that such data may be considered in the 
decision making process, but that these data alone were 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 and charged it 
with examining the broader implications genomics is likely to have on 
EPA programs and policies. The Genomics Task Force developed a Genomics 
White Paper entitled ``Potential Implications of Genomics for 
Regulatory and Risk Assessment Applications at EPA'' (available at 
http://www.epa.gov/osa/genomics.htm). That document identified four 

areas likely to be influenced by the generation of genomics information 
within EPA and the submission of such information to EPA: (1) 
Prioritization of contaminants and contaminated sites; (2) monitoring; 
(3) reporting provisions; and (4) risk assessment. The Task Force 
identified the establishment of a framework for analysis and acceptance 
criteria for genomics information for scientific and regulatory 
purposes as a critical need. The Task Force recommended that the Agency 
charge a workgroup to establish such a framework and in doing so 
consider the performance of assays across genomic platforms (e.g., 
reproducibility, sensitivity, pathway analysis tools) and the criteria 
for accepting genomics data for use in a risk assessment (e.g., assay 
validity, biologically meaningful response).
    In 2004, EPA's Genomics Technical Framework and Training Workgroups 
were formed with the responsibility to ensure that the technical 
framework and training activities build upon the Agency's Interim 
Policy on Genomics while continuing to engage other interested parties. 
Information developed by these workgroups is intended for use by the 
EPA program offices and regions to determine the applicability of 
specific genomics information to the evaluation of risks under various 
statutes.
    To this end, EPA's Genomics Technical Workgroup considered all of 
the ``omics'' technologies and applications and decided that an interim 
guidance document on the use of data generated by DNA microarray 
technology would be most beneficial to the Agency and regulated 
community at this time. Consequently, this document describes data 
submission, quality, analysis, management and training considerations 
for microarray-based assays. It is important to note that 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 will consider all peer review and public comments in finalizing 
its Interim Guidance for Microarray-Based Assays. To obtain additional 
information, visit: http://www.epa.gov/osa/spc/genomicsguidance.htm

    Dated: March 9, 2007.
Elizabeth Lee Hofmann,
Acting Chief Scientist, Office of the Science Advisor.
[FR Doc. E7-4650 Filed 3-13-07; 8:45 am]

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