[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 6560-50-P