Tuesday, November 25, 2008

Environmental Federal Register, Vol. 73, No. 227, November 24, 2008

Note: This is an update issue for Monday, November 24, 2008. Scroll down for today's issue.
 
Federal Register
Vol. 73, No. 227
Monday, November 24, 2008
 
Note: Most Agencies published their Semiannual Regulatory Agendas this day as part of the national Regulatory Plan and the Unified Agenda. WIMS has published the link to U.S. EPA's Agenda. Access the Federal Register index for links to the agenda for additional Agencies (click here). Also, access the government website for the Regulatory Plan and the Unified Agenda which have been updated with the new Fall update (click here).
 
There are 4 announcements in this issue
 
    1. ALL - PR. EPA. Semiannual Regulatory Agenda; Fall 2008 Regulatory Agenda
 
    2. TOXICS - ND. EPA. Literature Search for 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) Dose-Response Studies for Use in an Upcoming Expert Panel Workshop; Public review period, and request for information
 
    3. TOXICS - NM. DHHS. National Toxicology Program (NTP). NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products and Final Background Review Document: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products; Notice of Transmittal of ICCVAM Test Method
Recommendations to Federal Agencies
 
    4. TRANSPORT - NM. DOT. National Surface Transportation Infrastructure Financing Commission
   
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: ALL - PR. EPA. Semiannual Regulatory Agenda; Fall 2008 Regulatory Agenda
 
[November 24, 2008 (Volume 73, Number 227)]
[Unified Agenda]

Semiannual Regulatory Agenda

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Ch. I

[FRL-8702-9]

[EPA-HQ-OAR-2008-0205

[EPA-HQ-OAR-2008-0206

[EPA-HQ-OW-2008-0226

Fall 2008 Regulatory Agenda

AGENCY: Environmental Protection Agency.

ACTION: Semiannual regulatory flexibility agenda and semiannual
regulatory agenda.

_______________________________________________________________________

SUMMARY: The Environmental Protection Agency (EPA) publishes the
semiannual regulatory agenda online (the e-agenda) at www.reginfo.gov
to update the public about:

<bullet> Regulations and major policies currently under development,

<bullet> Reviews of existing regulations and major policies, and

<bullet> Rules and major policymakings completed or canceled since the
last agenda.

Definitions:

    ``Semiannual regulatory agenda,'' ``E-Agenda,'' and ``online
regulatory agenda,'' all refer to the same comprehensive collection
of information that used to be published in the Federal Register,
but which is now available through an online database but not be
published in the Federal Register.

    ``Regulatory Plan'' refers to the document published in part 2
of the Federal Register that addresses the core of the Agency's
regulatory priorities that will be issued in the coming fiscal
year.

    ``Regulatory Flexibility Agenda'' refers to a document about
regulations with a significant impact on a substantial number of
small entities that will continue to be published in the Federal
Register because of a requirement of the Regulatory Flexibility
Act.

    ``Unified Agenda'' refers to the collection of all agencies'
agendas with an introduction prepared by the Regulatory Information
Service Center.

     ``Monthly Action Initiation List'' (AIL) refers to a list that
EPA posts online each month of the regulations newly approved for
development.

     ``Regulatory agenda preamble'' refers to the document you are
reading now. It appears as part of the Regulatory Flexibility
Agenda and introduces both EPA's regulatory flexibility agenda and
the e-agenda.

FOR FURTHER INFORMATION CONTACT:  If you have questions or comments
about a particular action, please get in touch with the agency contact
listed in each agenda entry. If you have general questions about EPA's
regulatory agenda, regulatory plan, regulatory flexibility agenda, or
EPA's regulatory development process, please contact: Phil Schwartz
(schwartz.philip@epa.gov; 202-564-6564) or Caryn Muellerleile
(muellerleile.caryn@epa.gov; 202-564-2855).

    TO BE PLACED ON AN AGENDA MAILING LIST: If you would like to
receive an e-mail with a link to new regulatory agendas as soon as
they are published, please send an e-mail message to: nscep@bps-
lmit.com and put ``E-Regulatory Agenda: Electronic Copy'' in the
subject line.

     If you would like to receive a monthly e-mail with a link to
our new update, the Action Initiation List, go to http://
www.epa.gov/lawsregs/search/ail.html<greek-i>notification and
complete the five steps listed there.

     If you would like to receive a hard copy of the semiannual
agenda about 2 to 3 months after publication, please send an e-mail
with your name and complete address to: nscep@bps-lmit.com and put
``Regulatory Agenda Hard Copy'' in the subject line, or call 800-
490-9198. There is no charge for a single copy of the agenda.
 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
 


ANNOUNCEMENT 2


Subject: TOXICS - ND. EPA. Literature Search for 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) Dose-Response Studies for Use in an Upcoming Expert Panel Workshop; Public review period, and request for information
 
[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]              
[Page 70999-71000]

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8744-2; Docket ID No. EPA-HQ-ORD-2008-0789]

Literature Search for 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD)
Dose-Response Studies for Use in an Upcoming Expert Panel Workshop

AGENCY: Environmental Protection Agency.

ACTION: Notice; availability of a literature search, public review
period, and request for information.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a
45-day public review and request for additional information on
available peer-reviewed literature for 2,3,7,8-tetrachlorodibenzo-p-
dioxin (TCDD) dose-response for use in human health risk assessment. An
initial literature search was conducted by EPA through an Interagency
Agreement with the Department of Energy's Argonne National Laboratory.
Results of this preliminary search are available via the dioxin Web
site http://www.epa.gov/ncea/dioxin. The public is invited to review
the preliminary literature search results and submit any additional
information, specifically peer-reviewed TCDD dose-response studies, to
EPA that are not already identified in the literature search. Please
submit any information in accordance with the instructions provided
below. It is requested that the full publication be provided to EPA if
possible. Results of this literature search will be used by scientists
from EPA and other scientists from outside of EPA in the conduct of a
scientific expert workshop, open to the public, to be held in
Cincinnati, Ohio, on February 18-20, 2009. This workshop will be
announced in a future Federal Register notice.
    This notice provides: (1) A link to the electronic list of recent
literature search results for TCDD dose-response; and (2) instructions
to the public for submitting additional scientific information
pertinent to TCDD dose-response assessment to EPA that is not already
identified in the literature search.

DATES: The 45-day public comment period begins November 24, 2008, and
ends January 8, 2009.

ADDRESSES: Please submit relevant scientific information, identified by
docket ID number EPA-HQ-ORD-2008-0789, online at http://
www.regulations.gov
(EPA's preferred method); by e-mail to
ord.docket@epa.gov; by mail to the Office of Environmental Information
(OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or by hand
delivery or courier to the EPA Docket Center, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m.
Monday through Friday, excluding legal holidays. Please see
SUPPLEMENTARY INFORMATION below for detailed instructions.

FOR FURTHER INFORMATION CONTACT: For information and help on submitting
scientific information, please contact the OEI Docket by e-mail
(ord.docket@epa.gov), by phone (202-566-1752), or by fax (202-566-
1753). For information and help on accessing the Literature Search for
TCDD Dose-Response and for technical information, please contact Glenn
E. Rice, National Center for Environmental Assessment (Mail Code: MSA-
110), Office of Research and Development, U.S. Environmental Protection
Agency, Cincinnati, Ohio 45268; telephone: 513-569-7813; facsimile:
513-487-2539; or e-mail: rice.glenn@epa.gov.
 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
 
 
 

ANNOUNCEMENT 3


Subject: TOXICS - NM. DHHS. National Toxicology Program (NTP). NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability
of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products and Final Background Review Document: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products; Notice of Transmittal of ICCVAM Test Method
Recommendations to Federal Agencies
 
[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]              
[Page 71003-71004]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Availability
of the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation
Status of Five In Vitro Test Methods Proposed for Assessing Potential
Pyrogenicity of Pharmaceuticals and Other Products and Final Background
Review Document: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products; Notice of Transmittal of ICCVAM Test Method
Recommendations to Federal Agencies

AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH)

ACTION: Availability of the ICCVAM Test Method Evaluation Report and
Final Background Review Document.

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

SUMMARY: NICEATM announces availability of the ICCVAM Test Method
Evaluation Report: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products (NIH Publication 08-6392). The test method evaluation
report (TMER) describes five in vitro pyrogen test methods that can be
used for detecting Gram-negative endotoxin in human parenteral
pharmaceuticals. The report includes ICCVAM's (a) Recommendations on
uses and limitations for each test method, (b) recommendations for
standardized protocols, (c) recommendations for future studies, and (d)
recommendations for the development of performance standards.
    ICCVAM concludes that none of these test methods can be considered
as a complete replacement for the rabbit pyrogen test (RPT) for all
testing situations for the detection of Gram-negative endotoxin.
However, ICCVAM recommends that they can be considered for use on a
case-by-case basis to detect Gram-negative endotoxin in human
parenteral drugs, subject to product-specific validation to demonstrate
equivalence to the RPT, in accordance with applicable U.S. Food and
Drug Administration regulations. When used in this manner, these
methods can reduce the number of animals needed for pyrogenicity
testing. The report also recommends that these
and other in vitro alternative test methods be considered prior to in
vivo pyrogenicity testing, where determined appropriate for a specific
testing situation.
    NICEATM also announces availability of the final ICCVAM Background
Review Document: Validation Status of Five In Vitro Test Methods
Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and
Other Products (NIH Publication 08-6391). The final background review
document (BRD) provides the data and analyses used to assess the
current validation status of these five in vitro test methods.
    The ICCVAM TMER and supporting BRDs have been forwarded to U.S.
Federal agencies for regulatory and other acceptance consideration,
where applicable. Responses received will be posted on the NICEATM-
ICCVAM Web site.

ADDRESSES: Electronic copies of the ICCVAM TMER and final BRD are
available from the NICEATM-ICCVAM Web site at http://
iccvam.niehs.nih.gov
or by contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC
27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
niceatm@niehs.nih.gov Courier address: NICEATM, NIEHS, 79 T.W.
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC
27709.
 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
 
 
 

ANNOUNCEMENT 4


Subject: TRANSPORT - NM. DOT. National Surface Transportation Infrastructure Financing Commission
 
[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]              
[Page 71083-71084]

DEPARTMENT OF TRANSPORTATION

[Docket No. OST-2007-27407]

National Surface Transportation Infrastructure Financing
Commission

AGENCY: Department of Transportation (DOT).

ACTION: Notice of meeting location and time.

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

SUMMARY: This notice lists the location and time of the seventeenth
meeting of the National Surface Transportation Infrastructure Financing
Commission.

FOR FURTHER INFORMATION CONTACT: John V. Wells, Chief Economist, U.S.
Department of Transportation, (202) 366-9224, jack.wells@dot.gov.

SUPPLEMENTARY INFORMATION: By Federal Register Notice dated March 12,
2007, and in accordance with the requirements of the Federal Advisory
Committee Act (``FACA'') (5 U.S.C. App. 2) and the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users
(``SAFETEA-LU'') (Pub. L. 109-59, 119 Stat. 1144), the U.S. Department
of Transportation (the ``Department'') issued a notice of intent to
form the National Surface Transportation Infrastructure Financing
Commission (the ``Financing Commission''). Section 11142(a) of SAFETEA-
LU established the National Surface Transportation Infrastructure
Financing Commission and charged it with analyzing future highway and
transit needs and the finances of the Highway Trust Fund and with
making recommendations regarding alternative approaches to financing
surface transportation infrastructure.

Notice of Meeting Location and Time

    The Commissioners have agreed to hold their seventeenth meeting
from 8:30 a.m. to 4 p.m. on Wednesday, December 10, 2008, at the office
of the Information Technology and Innovation Foundation (ITIF), 1250 I
(``Eye'') Street, NW., Suite 200, Washington, DC 20005. The meeting
will be open to the public.
    If you need accommodations because of a disability or require
additional information to attend the meeting, please contact John V.
Wells, Chief Economist, U.S. Department of Transportation, (202) 366-
9224, jack.wells@dot.gov.
 
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT: