An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study, 1770 [2010-486]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES 1770 Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010. Docket Numbers: RP10–147–002. Applicants: Natural Gas Pipeline Company of America. Description: Emergency Motion of Natural Gas Pipeline Company of America LLC for Limited Stay of Requirement to File Cost and Revenue Study. Filed Date: 12/22/2009. Accession Number: 20091222–5279. Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010. Docket Numbers: RP09–614–001. Applicants: Cheniere Creole Trail Pipeline, LP. Description: Request of Cheniere Creole Trail Pipeline LP for Limited Waiver of Order No. 712 Electronic Capacity Release Requirements. Filed Date: 12/23/2009. Accession Number: 20091223–4009. Comment Date: 5 p.m. Eastern Time on Monday, January 4, 2010. Docket Numbers: RP10–19–001. Applicants: Columbia Gas Transmission, LLC. 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Persons unable to file electronically should submit an original and 14 copies of the protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at https://www.ferc.gov, using the ‘‘eLibrary’’ link and is available for review in the Commission’s Public Reference Room in Washington, DC. There is an ‘‘eSubscription’’ link on the Web site that enables subscribers to receive e-mail notification when a VerDate Nov<24>2008 16:51 Jan 12, 2010 Jkt 220001 document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail FERCOnlineSupport@ferc.gov, or call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2010–459 Filed 1–12–10; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9094–9] An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: EPA is announcing the availability of a final report titled, ‘‘An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study’’ (EPA/600/R–09/028F), which was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD). Toxicogenomics is the application of genomic technologies (e.g., transcriptomics, genome sequence analysis) to study effects of environmental chemicals on human health and the environment. Currently, EPA provides no guidance for evaluating and incorporating genomic data into risk assessment. This report describes an approach to evaluate toxicogenomic data for use in risk assessment and a case study for dibutyl phthalate (DBP). A multidisciplinary team of scientists developed the approach and performed the case study. In this approach, the genomic data and the human outcome and/or toxicity data are considered together to determine the relationship between genomic changes and toxicity or health outcomes and inform mechanisms and modes of toxicity. The DBP case study focuses on male reproductive developmental effects and the use of genomic data in qualitative aspects of the risk assessment because of the type of genomic data available for DBP. It is important to note that the case study presented in this report is a separate activity from any of the ongoing IRIS human health assessments for the phthalates. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 The final report includes the development of exploratory methods for analyzing genomic data for application to risk assessment and some preliminary results. In addition, recommendations for risk assessors, research needs, and future directions for generating and applying genomic data in risk assessment are described. The approach and case study may be used as a template for evaluating and analyzing genomic data in future chemical assessments and the methods and research needs may be used by researchers performing genomic studies for use in risk assessment. ADDRESSES: The document will be available electronically through the NCEA Web site at www.epa.gov/ncea. A limited number of paper copies will be available from the EPA’s National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone: 1– 800–490–9198; facsimile: 301–604– 3408; e-mail: nscep@bps-lmit.com. Please provide your name, your mailing address, the title and the EPA number of the requested publication. FOR FURTHER INFORMATION CONTACT: The Information Management Team, National Center for Environmental Assessment (8601P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Telephone: 703–347–8561; fax: 703–347–8691; email: nceadc.comment@epa.gov. Dated: October 27, 2009. Peter W. Preuss, Director, National Center for Environmental Assessment. [FR Doc. 2010–486 Filed 1–12–10; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9102–5] Proposed Consent Decree, Clean Air Act Citizen Suit AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of proposed consent decree; request for public comment. SUMMARY: In accordance with section 113(g) of the Clean Air Act, as amended (‘‘Act’’), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree, to address a lawsuit filed by WildEarth Guardians in the United States District Court for the District of Colorado: WildEarth Guardians v. Jackson, No. 09–cv–01964–MSK–MEH (D. Colo.). Plaintiff filed a deadline suit E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Page 1770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-486]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9094-9]


An Approach to Using Toxicogenomic Data in U.S. EPA Human Health 
Risk Assessments: A Dibutyl Phthalate Case Study

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing the availability of a final report titled, 
``An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk 
Assessments: A Dibutyl Phthalate Case Study'' (EPA/600/R-09/028F), 
which was prepared by the National Center for Environmental Assessment 
(NCEA) within EPA's Office of Research and Development (ORD).
    Toxicogenomics is the application of genomic technologies (e.g., 
transcriptomics, genome sequence analysis) to study effects of 
environmental chemicals on human health and the environment. Currently, 
EPA provides no guidance for evaluating and incorporating genomic data 
into risk assessment. This report describes an approach to evaluate 
toxicogenomic data for use in risk assessment and a case study for 
dibutyl phthalate (DBP). A multidisciplinary team of scientists 
developed the approach and performed the case study. In this approach, 
the genomic data and the human outcome and/or toxicity data are 
considered together to determine the relationship between genomic 
changes and toxicity or health outcomes and inform mechanisms and modes 
of toxicity. The DBP case study focuses on male reproductive 
developmental effects and the use of genomic data in qualitative 
aspects of the risk assessment because of the type of genomic data 
available for DBP. It is important to note that the case study 
presented in this report is a separate activity from any of the ongoing 
IRIS human health assessments for the phthalates.
    The final report includes the development of exploratory methods 
for analyzing genomic data for application to risk assessment and some 
preliminary results. In addition, recommendations for risk assessors, 
research needs, and future directions for generating and applying 
genomic data in risk assessment are described. The approach and case 
study may be used as a template for evaluating and analyzing genomic 
data in future chemical assessments and the methods and research needs 
may be used by researchers performing genomic studies for use in risk 
assessment.

ADDRESSES: The document will be available electronically through the 
NCEA Web site at www.epa.gov/ncea. A limited number of paper copies 
will be available from the EPA's National Service Center for 
Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 
45242; telephone: 1-800-490-9198; facsimile: 301-604-3408; e-mail: 
lmit.com">nscep@bps-lmit.com. Please provide your name, your mailing address, the 
title and the EPA number of the requested publication.

FOR FURTHER INFORMATION CONTACT: The Information Management Team, 
National Center for Environmental Assessment (8601P), U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460. Telephone: 703-347-8561; fax: 703-347-8691; e-
mail: nceadc.comment@epa.gov.

    Dated: October 27, 2009.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 2010-486 Filed 1-12-10; 8:45 am]
BILLING CODE 6560-50-P
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