Wednesday, November 19, 2008

Environmental Federal Register, Vol. 73, No. 224, November 19, 2008

Federal Register
Vol. 73, No. 224
Wednesday, November 19, 2008
 
There are 14 announcements in this issue
 
    1. TOXICS - FR. EPA. Ipconazole; Pesticide Tolerances
 
    2. TOXICS - FR. EPA. Polyoxin D Zinc Salt; Exemption from the Requirement of a Tolerance
 
    3. WATER - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Reporting Requirements for BEACH Act Grants (Renewal), EPA ICR Number 2048.03, OMB Control Number 2040-0244
 
    4. AIR, TOXICS - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Inorganic Arsenic Emissions From Glass Manufacturing Plants, EPA ICR Number 1081.09, OMB Control Number 2060-0043
 
    5. AIR - ND. EPA. Clean Air Act Advisory Committee; Notice of Charter Renewal
 
    6. TOXICS - ND. EPA. Notice of Filing of a Pesticide Petition for Residues of
Pesticide Chemicals in or on Various Commodities
 
    7. REMED - NF. EPA. Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding Guidance for State and Tribal Response Programs
 
    8. TOXICS - ND. EPA. Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability
 
    9. TOXICS - ND. EPA. Chromated Arsenicals, Pentachlorophenol, Creosote Reregistration Eligibility Decisions; Notice of Availability
 
  10. AIR - FR. DHHS/FDA. Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
 
  11. WATER, WILDLIFE - ND. DOC/NOAA. Final Framework for the National System of Marine Protected Areas of the United States and Response to Comments
 
  12. HAZ/Nuclear - PR. NRC. Physical Protection of Byproduct Material; Availability of preliminary draft rule language
 
  13. SOLID, P2 - ND/Presidential Documents. Proclamation 8319 of November 14, 2008; America Recycles Day, 2008
 
  14. AGRICULTURE, ENERGY - ND. USDA/APHIS. Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production
        

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 - FR. EPA. Ipconazole; Pesticide Tolerances
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Rules and Regulations]              
[Page 69554-69559]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0226; FRL-8389-1]

Ipconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
ipconazole from seed treatment in or on cotton, peanut, soybean, dry
shelled pea and bean (Subgroup 6C), cereal grains (Group 15) except
rice, and forage, fodder, and straw of cereal grains (Group 16) except
rice. Chemtura Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 19, 2008. Objections and
requests for hearings must be received on or before January 20, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0226. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov
. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tawanda Maignan, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8050; e-mail address: maignan.tawanda@epa.gov.
 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
 


ANNOUNCEMENT 2


Subject: TOXICS - FR. EPA. Polyoxin D Zinc Salt; Exemption from the Requirement of a Tolerance
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Rules and Regulations]              
[Page 69559-69564]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0417; FRL-8389-5]

Polyoxin D Zinc Salt; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the polyoxin D zinc salt (zinc 5-[[2-
amino-5-o-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-3,4-
dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-[beta]-D-
allofuranuronatein) on almonds, cucurbit vegetables, fruiting
vegetables, ginseng, grapes, pistachios, pome fruits, potatoes and
strawberries when applied/used as a biochemical pesticide to control
and suppress fungal diseases. Arysta LifeScience North America
Corporation submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of polyoxin D zinc salt (zinc 5-
[[2-amino-5-o-(aminocarbonyl)-2-deoxy-L-xylonoyl]amino]-1-(5-carboxy-
3,4-dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,5-dideoxy-[beta]-D-
allofuranuronatein).

DATES: This regulation is effective November 19, 2008. Objections and
requests for hearings must be received on or before January 20, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008--0417. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov
. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0031; e-mail
address: pfeifer.chris@epa.gov.
 
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ANNOUNCEMENT 3


Subject: WATER - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Reporting Requirements for BEACH Act Grants (Renewal), EPA ICR Number 2048.03, OMB Control Number 2040-0244
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69633-69634]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0357; FRL-8742-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Reporting Requirements for BEACH
Act Grants (Renewal), EPA ICR Number 2048.03, OMB Control Number 2040-
0244

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before December 19,
2008.

ADDRESSES: Submit your comments, referencing Docket ID number EPA-HQ-
OW-2008-0357, to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail to ow-docket@epa.gov, or by mail to: EPA
Docket Center, Environmental Protection Agency, Water Docket (28221T),
1200 Pennsylvania Ave., NW. Washington, DC 20460 and (2) OMB at: Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Lars Wilcut, Standards and Health
Protection Division, Office of Science and Technology (4305T),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 566-0447; fax number:
(202) 566-0409; e-mail address: wilcut.lars@epa.gov.
 
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ANNOUNCEMENT 4


Subject: AIR, TOXICS - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Inorganic Arsenic Emissions From Glass Manufacturing Plants, EPA ICR Number 1081.09, OMB Control Number 2060-0043
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69634-69635]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0375; FRL-8742-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Inorganic Arsenic
Emissions From Glass Manufacturing Plants, EPA ICR Number 1081.09, OMB
Control Number 2060-0043

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before December 19,
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-OECA-
2008-0375, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to docket.oeca@epa.gov, or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Sounjay Gairola, Office of Enforcement
and Compliance Assurance, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-4003; e-mail address: gairola.sounjay@epa.gov.

 
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ANNOUNCEMENT 5


Subject: AIR - ND. EPA. Clean Air Act Advisory Committee; Notice of Charter Renewal
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69635]

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8741-6]

Clean Air Act Advisory Committee; Notice of Charter Renewal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Charter Renewal.

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    The charter for the Environmental Protection Agency's Clean Air Act
Advisory Committee (CAAAC) will be renewed for an additional two-year
period, as a necessary committee which is in the public interest, in
accordance with the provisions of the Federal Advisory Committee Act
(FACA), 5 U.S.C. App. 2. The purpose of CAAAC is to provide advice and
recommendations to the EPA Administrator on issues associated with
policy and technical issues associated with implementation of the Clean
Air Act.
    It is determined that CAAAC is in the public interest in connection
with the performance of duties imposed on the Agency by law.
    Inquiries may be directed to Pat Childers, CAAAC Designated Federal
Officer, U.S. EPA, Mail Code 6102A, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, or by e-mail childers.pat@epa.gov.
 
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ANNOUNCEMENT 6


Subject: TOXICS - ND. EPA. Notice of Filing of a Pesticide Petition for Residues of
Pesticide Chemicals in or on Various Commodities
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69635-69637]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0561; FRL-8389-6]

Notice of Filing of a Pesticide Petition for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment or modification of regulations for
residues of acetic acid in or on various commodities.

DATES: Comments must be received on or before December 19, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0561 and the pesticide petition number PP
8F7319, 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'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: Cheryl Greene, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703 ) 308-0352; e-mail
address: greene.cheryl@epa.gov.

 
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ANNOUNCEMENT 7


Subject: REMED - NF. EPA. Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding Guidance for State and Tribal Response Programs
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69637-69644]

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8742-3]

Comprehensive Environmental Response, Compensation and Liability
Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding
Guidance for State and Tribal Response Programs

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) will begin to accept
requests, from December 1, 2008 through January 31, 2009, for grants to
supplement State and Tribal Response Programs. This notice provides
guidance on eligibility for funding, use of funding, grant mechanisms
and process for awarding funding, the allocation system for
distribution of funding, and terms and reporting under these grants.
EPA has consulted with state and tribal officials in developing this
guidance.
    The primary goal of this funding is to ensure that state and tribal
response programs include, or are taking reasonable steps to include,
certain elements and a public record. Another goal is to provide
funding for other activities that increase the number of response
actions conducted or overseen by a state or tribal response program.
This funding is not intended to supplant current state or tribal
funding for their response programs. Instead, it is to supplement their
funding to increase their response capacity.
    For fiscal year 2009, EPA will consider funding requests up to a
maximum of $1.5 million per state or tribe. Subject to the availability
of funds, EPA regional personnel will be available to provide technical
assistance to states and tribes as they apply for and carry out these
grants.

DATES: This action is effective as of December 1, 2008. EPA expects to
make non-competitive grant awards to states and tribes which apply
during fiscal year 2009.

ADDRESSES: Mailing addresses for U.S. EPA Regional Offices and U.S. EPA
Headquarters can be located at http://www.epa.gov/brownfields.

FOR FURTHER INFORMATION CONTACT: The U.S. EPA's Office of Solid Waste
and Emergency Response, Office of Brownfields and Land Revitalization,
(202) 566-2777.

 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
 
 
 

ANNOUNCEMENT 8


Subject: TOXICS - ND. EPA. Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69644-69646]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0650; FRL-8386-4]

Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver
Products as Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice makes available for public review and comment a
petition for rulemaking and collateral relief filed by the
International Center for Technology Assessment (ICTA) and others. In
general, the petition requests that the Agency classify nanoscale
silver as a pesticide, require formal pesticide registration of all
products containing nanoscale silver, analyze the potential human
health and environmental risks of nanoscale silver, take regulatory
actions under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) against existing products that contain nanoscale silver, and
take other regulatory actions under FIFRA as appropriate for nanoscale
silver products. The Agency has determined that the petition raises
issues that potentially affect private and public sector stakeholders.
Through this notice, EPA is asking for public comment on the petition.

DATES: Comments must be received on or before January 20, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0650, 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: Nathanael R. Martin, Field and
External Affairs Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6475; fax number: (703) 305-5884; e-
mail address: martin.nathanael@epa.gov.

 
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ANNOUNCEMENT 9


Subject: TOXICS - ND. EPA. Chromated Arsenicals, Pentachlorophenol, Creosote Reregistration Eligibility Decisions; Notice of Availability
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69646-69647]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0416; FRL-8388[dash]4]

Chromated Arsenicals, Pentachlorophenol, Creosote Reregistration
Eligibility Decisions; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (REDs) for the pesticides chromated arsenicals
(e.g., CCA), pentachlorophenol, and creosote, collectively referred to
as ``heavy duty wood preservatives.'' The Agency's risk assessments and
other related documents also are available in the chromated arsenicals,
pentachlorophenol, and creosote Dockets. The term heavy duty wood
preservative is used to differentiate wood preservatives applied using
specialized high pressure treatment cylinders (also called ``retorts'')
from those applied using non-specialized methods (e.g., brush, dip).
The three wood preservatives are used primarily for industrial purposes
such as utility poles, pilings, and railroad ties. EPA has reviewed the
heavy duty wood preservatives through the public participation process
that the Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.

FOR FURTHER INFORMATION CONTACT: For pesticide-specific information
contact the Chemical Review Manger identified in the Table in Unit II.
for the pesticide of interest.
    For general information contact: Lance Wormell, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0523; fax number: (703) 308-6467; e-
mail address: wormell.lance@epa.gov.

 
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ANNOUNCEMENT 10


Subject: AIR - FR. DHHS/FDA. Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Rules and Regulations]              
[Page 69532-69552]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2007-N-0314] (formerly 2007N-0262)
RIN 0910-AF92

Use of Ozone-Depleting Substances; Removal of Essential-Use
Designation (Epinephrine)

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA), after consultation
with the Environmental Protection Agency (EPA), is amending FDA's
regulation on the use of ozone-depleting substances (ODSs) in self-
pressurized containers to remove the essential-use designation for
epinephrine used in oral pressurized metered-dose inhalers (MDIs). The
Clean Air Act requires FDA, in consultation with the EPA, to determine
whether an FDA-regulated product that releases an ODS is an essential
use of the ODS. FDA has concluded that there are no substantial
technical barriers to formulating epinephrine as a product that does
not release ODSs, and therefore epinephrine would no longer be an
essential use of ODSs as of December 31, 2011. Epinephrine MDIs
containing an ODS cannot be marketed after this date.

DATES:  This rule is effective December 31, 2011.

ADDRESSES:  For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT:  Martha Nguyen or Michelle Bernstein,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, rm. 6224, Silver Spring, MD 20993-
0002, 301-796-3601.

 
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ANNOUNCEMENT 11


Subject: WATER, WILDLIFE - ND. DOC/NOAA. Final Framework for the National System of Marine Protected Areas of the United States and Response to Comments
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69608-69613]

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration (NOAA)

Final Framework for the National System of Marine Protected Areas
of the United States and Response to Comments

AGENCY: NOAA, Department of Commerce (DOC).

ACTION: Notice of availability of the final Framework for the National
System of Marine Protected Areas of the United States and response to
comments on Revised Draft Framework.

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SUMMARY: NOAA and the Department of the Interior (DOI) jointly propose
the Framework for the National System of Marine Protected Areas of the
United States (Framework), as required by Executive Order 13158 on
Marine Protected Areas (MPAs). This Framework provides overarching
guidance for collaborative efforts among federal, state, commonwealth,
territorial, tribal and local governments and stakeholders to develop
an effective National System of MPAs (national system) from existing
sites, build coordination and collaborative efforts, and identify
ecosystem-based gaps in the protection of significant natural and
cultural resources for possible future action by the nation's MPA
authorities. The document further provides the guiding principles, key
definitions, goals, and objectives for the National System, based on
the breadth of input received from MPA stakeholders and governmental
partners around the nation over the past several years, and two public
comment periods.

FOR FURTHER INFORMATION CONTACT: Please direct all questions and
requests for additional information concerning the Framework to: Lauren
Wenzel, NOAA, at 301-713-3100, ext. 136 or via e-mail at
Lauren.wenzel@noaa.gov. An electronic copy of the Framework is
available for download at http://www.mpa.gov/.
 
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ANNOUNCEMENT 12


Subject: HAZ/Nuclear - PR. NRC. Physical Protection of Byproduct Material; Availability of preliminary draft rule language
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Proposed Rules]              
[Page 69590-69591]

NUCLEAR REGULATORY COMMISSION

10 CFR Part 37

RIN 3150-AI12
[NRC-2008-0120]

Physical Protection of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Availability of preliminary draft rule language.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is making available
preliminary draft proposed rule language to amend its regulations to
add a new part 37 to Title 10 of the Code of Federal Regulations. This
new Part 37 will contain the security (physical protection)
requirements that are designed to provide reasonable assurance of
preventing the theft or diversion of Category 1 and Category 2
quantities of radioactive material as designated by the International
Atomic Energy Agency (IAEA). The new provisions will address background
checks, fingerprinting, access control, physical security during use,
and physical security during any transport of category 1 and category 2
quantities of material. At this time, the staff is only posting the
preliminary draft language for the physical protection of the material
while it is being transported. These requirements will be contained in
subpart D of the new part 37. Draft preliminary language for other
aspects of the proposed new part 37 will be posted and noticed in the
future. The availability of the preliminary draft rule language is
intended to inform stakeholders of the current status of the NRC's
activities and solicit public comments on the information at this time.
Comments may be provided as indicated under the ADDRESSES heading. The
NRC may post updates periodically under Docket NRC-2008-0120
on the Federal eRulemaking Portal at http://www.regulations.gov that
may be of interest to stakeholders.

DATES: Submit comment by January 5, 2009. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to assure consideration only for comments received on or before
this date.

ADDRESSES: You may submit comments by any one of the following methods.
Please include the number RIN 3150-AI12 in the subject line of your
comments. Comments on rulemakings submitted in writing or in electronic
form will be made available to the
public in their entirety in NRC's Agencywide Documents Access and
Management System (ADAMS) and at http://www.regulations.gov. Personal
information, such as your name, address, telephone number, e-mail
address, etc., will not be removed from your submission.
    Federal e-Rulemaking Portal: Go to http://www.regulations.gov and
search for documents filed under Docket ID [NRC-2008-0120]. Address
questions about NRC dockets to Carol Gallagher 301-415-5905; e-mail
Carol.Gallagher@nrc.gov.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not
receive a reply e-mail confirming that we have received your comments,
contact us directly at 301-415-1677. Comments can also be submitted via
the Federal eRulemaking Portal http://www.regulations.gov.
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
301-415-1677).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
301-415-1101.
    You can access publicly available documents related to this
document using the following methods:
    NRC's Public Document Room (PDR): The public may examine and have
copied for a fee publicly available documents at the NRC's PDR, Public
File Area O-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland 20852-2738.
    NRC's Agencywide Documents Access and Management System (ADAMS):
Publicly available documents created or received at the NRC are
available electronically at the NRC's Electronic Reading Room at http:/
/www.nrc.gov/reading-rm/adams.html
. From this page, the public can gain
entry into ADAMS, which provides text and image files of NRC's public
documents. If you do not have access to ADAMS or if there are problems
in accessing the documents located in ADAMS, contact the NRC's PDR
reference staff at 1-899-397-4209, 301-415-4737, or by e-mail to
pdr.resource@nrc.gov.
    Federal e-Rulemaking Portal: Go to http://www.regulations.gov and
search for documents filed under Docket ID [NRC-2008-0120].

FOR FURTHER INFORMATION CONTACT: Merri Horn, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-
8126, e-mail Merri.Horn@nrc.gov.

 
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ANNOUNCEMENT 13


Subject: SOLID, P2 - ND/Presidential Documents. Proclamation 8319 of November 14, 2008; America Recycles Day, 2008
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Presidential Documents]              
[Page 69519-69520]

                        Presidential Documents

Title 3--
The President

                Proclamation 8319 of November 14, 2008
 
                America Recycles Day, 2008

                By the President of the United States of America

                A Proclamation

                On America Recycles Day, we highlight the importance of
                recycling as a way to safeguard and protect the
                environment and preserve our precious natural
                resources. . .

 
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ANNOUNCEMENT 14


Subject: AGRICULTURE, ENERGY - ND. USDA/APHIS. Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production
 
[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]              
[Page 69602-69604]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0016]

Syngenta Seeds, Inc.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Corn
Genetically Engineered To Produce an Enzyme That Facilitates Ethanol
Production

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Syngenta Seeds, Inc.,
seeking a determination of nonregulated status for corn designated as
transformation event 3272, which has been genetically engineered to
produce a microbial enzyme that facilitates ethanol production. The
petition has been submitted in accordance with our regulations
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
comments on whether this genetically engineered corn is likely to pose
a plant pest risk. We are also making available for public comment an
environmental assessment for the proposed determination of nonregulated
status.

DATES: We will consider all comments we receive on or before January
20, 2009.

ADDRESSES: You may submit comments by either of the following methods:
    Federal eRulemaking Portal: Go to http://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0016
to submit or view comments and
to view supporting and related materials available electronically.
    Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2007-0016, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2007-0016.
    Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Andrea Huberty, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD
20737-1236; (301) 734-0485, e-mail: andrea.f.huberty@aphis.usda.gov. To
obtain copies of the petition or the draft environmental assessment,
contact Ms. Cindy Eck at (301) 734-0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The petition and the draft environmental
assessment are also available on the Internet at http://
www.aphis.usda.gov/brs/aphisdocs/05_28001p.pdf
and http://
www.aphis.usda.gov/brs/aphisdocs/05_28001p_ea.pdf
.

 
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