Federal Register
Vol. 75, No. 8
Wednesday, January 13, 2010
Vol. 75, No. 8
Wednesday, January 13, 2010
There are 4 announcements in this issue
1. TOXICS - ND. EPA. An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study
2. TOXICS - ND. EPA. Pesticide Experimental Use Permits; Receipt of Applications; Comment Requests
3. TOXICS - ND. EPA. Notice of Receipt of a Pesticide Petition Filed for Residues of Polymeric Polyhydroxy Acid in or on All Food Commodities
4. TOXICS - ND. EPA. Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations
CODES USED: THE FOLLOWING CODES ARE USED TO IDENTIFY THE TYPE OF ANNOUNCEMENT & ISSUE AREA.
REPORTING FORMAT: ISSUE CODE - TYPE CODE. AGENCY. ANNOUNCEMENT.
ISSUE CODES: AIR - Air; ALL - Cross-Media, ecosystems, Env. Justice; CLIMATE - Climate Change, Global Warming; DRINK - Drinking Water, SDWA, Underground Injection; ENERGY - Energy; GLAKES - Great Lakes; HAZ - Hazardous Waste, RCRA, HSWA, DOT/RSPA, Some Nuclear (NRC); LAND - Land Use, Forests; P2 - Pollution Prevention, Sustainability, Recycling, Pjt. XL; REMED - Remediation, Brownfields, Superfund; TANKS - AST, UST; TOXICS = Toxics, TRI, TSCA, Pesticides, Risks, RTK; TRANSPORT - Transportation; SOLID - Solid Waste, RCRA Subtitle D; WATER - Surface Water, NPS, NPDES, Wetlands; WILDLIFE = Wildlife, Biodiversity, Endangered Species.
TYPE CODES: ANPR - Advance Notice of Proposed Rulemaking; FR - Final Rule; FRD - Direct final rule; FRI - Interim final rule; ICR - Information Collection Request; ND - Notice of data, information, reports, etc. availability; NF - Notice of Fuding Opportunity; NM - Notice of Meeting; NS - Notice of administrative/court settlement; PR - Proposed Rule; ROD - Record of decision.
ANNOUNCEMENT 1
Subject: TOXICS - ND. EPA. An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study
[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1770]
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:
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.
[Notices]
[Page 1770]
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:
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.
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
ANNOUNCEMENT 2
Subject: TOXICS - ND. EPA. Pesticide Experimental Use Permits; Receipt of Applications; Comment Requests
[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1772-1773]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0615; FRL-8433-2]
Pesticide Experimental Use Permits; Receipt of Applications;
Comment Requests
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's receipt of applications 29964-EUP-
I and 29964-EUP-O from Pioneer Hi-Bred International, Inc. requesting
experimental use permits (EUPs) for seed blends of the plant-
incorporated protectants (PIPs) [DAS-59122-7] Bacillus thuringiensis
Cry34Ab1 and Cry35Ab1 proteins and the genetic material (vector PHP
17662) necessary for their production in Event DAS-59122-7 corn and
[TC1507] Bacillus thuringiensis Cry1F protein and the genetic material
(vector PHP8999) necessary for its production in Event TC1507 corn and
[MON810] Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic
material necessary for its production (Vector PV-ZMCT01) in Event
MON810 corn (Organization for Economic Cooperation and Development
(OECD) Unique Identifier MON[Oslash][Oslash]81[Oslash]-6). The Agency
has determined that the permits may be of regional and national
significance. Therefore, in accordance with 40 CFR 172.11(a), the
Agency is soliciting comments on these applications.
DATES: Comments must be received on or before February 12, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0615, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail
address: mendelsohn.mike@epa.gov.
[Notices]
[Page 1772-1773]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0615; FRL-8433-2]
Pesticide Experimental Use Permits; Receipt of Applications;
Comment Requests
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's receipt of applications 29964-EUP-
I and 29964-EUP-O from Pioneer Hi-Bred International, Inc. requesting
experimental use permits (EUPs) for seed blends of the plant-
incorporated protectants (PIPs) [DAS-59122-7] Bacillus thuringiensis
Cry34Ab1 and Cry35Ab1 proteins and the genetic material (vector PHP
17662) necessary for their production in Event DAS-59122-7 corn and
[TC1507] Bacillus thuringiensis Cry1F protein and the genetic material
(vector PHP8999) necessary for its production in Event TC1507 corn and
[MON810] Bacillus thuringiensis Cry1Ab delta-endotoxin and the genetic
material necessary for its production (Vector PV-ZMCT01) in Event
MON810 corn (Organization for Economic Cooperation and Development
(OECD) Unique Identifier MON[Oslash][Oslash]81[Oslash]-6). The Agency
has determined that the permits may be of regional and national
significance. Therefore, in accordance with 40 CFR 172.11(a), the
Agency is soliciting comments on these applications.
DATES: Comments must be received on or before February 12, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0615, by one of the following methods:
Follow the on-line instructions for submitting comments.
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8715; e-mail
address: mendelsohn.mike@epa.gov.
ANNOUNCEMENT 3
Subject: TOXICS - ND. EPA. Notice of Receipt of a Pesticide Petition Filed for Residues of Polymeric Polyhydroxy Acid in or on All Food Commodities
[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1773-1775]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0917; FRL-8805-6]
Notice of Receipt of a Pesticide Petition Filed for Residues of
Polymeric Polyhydroxy Acid in or on All Food Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the Agency's receipt of an initial
filing of a pesticide petition proposing the establishment of a
regulation for residues of the plant growth regulator, polymeric
polyhydroxy acid, in or on all food commodities.
DATES: Comments must be received on or before February 12, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0917 and the pesticide petition number (PP), by
one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Menyon Adams, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 347-8496; e-mail
address: adams.menyon@epa.gov.
[Notices]
[Page 1773-1775]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0917; FRL-8805-6]
Notice of Receipt of a Pesticide Petition Filed for Residues of
Polymeric Polyhydroxy Acid in or on All Food Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the Agency's receipt of an initial
filing of a pesticide petition proposing the establishment of a
regulation for residues of the plant growth regulator, polymeric
polyhydroxy acid, in or on all food commodities.
DATES: Comments must be received on or before February 12, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0917 and the pesticide petition number (PP), by
one of the following methods:
Follow the on-line instructions for submitting comments.
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Menyon Adams, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 347-8496; e-mail
address: adams.menyon@epa.gov.
ANNOUNCEMENT 4
Subject: TOXICS - ND. EPA. Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations
[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1775-1780]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0135; FRL-8804-9]
Notice of Receipt of Requests to Voluntarily Cancel Certain
Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request by registrants to voluntarily cancel
certain pesticide registrations.
DATES: Unless a request is withdrawn by July 12, 2010 or February 12,
2010 for registrations for which the registrant requested a waiver of
the 180-day comment period, orders will be issued canceling these
registrations. The Agency will consider withdrawal requests postmarked
no later than July 12, 2010 or February 12, 2010, whichever is
applicable. Comments must be received on or before July 12, 2010 or
February 12, 2010, for those registrations where the 180-day comment
period has been waived.
ADDRESSES: Submit your comments and your withdrawal request, identified
by docket identification (ID) number EPA-HQ-OPP-2009-0135, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001. Written Withdrawal Request,
Attention: John Jamula, Information Technology and Resources Management
Division (7502P).
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: John Jamula, Information Technology
and Resource Management Division, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6426; e-mail address:
jamula.john@epa.gov.
[Notices]
[Page 1775-1780]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0135; FRL-8804-9]
Notice of Receipt of Requests to Voluntarily Cancel Certain
Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request by registrants to voluntarily cancel
certain pesticide registrations.
DATES: Unless a request is withdrawn by July 12, 2010 or February 12,
2010 for registrations for which the registrant requested a waiver of
the 180-day comment period, orders will be issued canceling these
registrations. The Agency will consider withdrawal requests postmarked
no later than July 12, 2010 or February 12, 2010, whichever is
applicable. Comments must be received on or before July 12, 2010 or
February 12, 2010, for those registrations where the 180-day comment
period has been waived.
ADDRESSES: Submit your comments and your withdrawal request, identified
by docket identification (ID) number EPA-HQ-OPP-2009-0135, by one of
the following methods:
Follow the on-line instructions for submitting comments.
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001. Written Withdrawal Request,
Attention: John Jamula, Information Technology and Resources Management
Division (7502P).
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: John Jamula, Information Technology
and Resource Management Division, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6426; e-mail address:
jamula.john@epa.gov.
