[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66482]
[FR Doc No: 2023-21018]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4721-DR; Docket ID FEMA-2023-0001]

Oklahoma; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oklahoma (FEMA-4721-DR), dated July 19, 2023,
and related determinations.

DATES: The declaration was issued July 19, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 19, 2023, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Oklahoma resulting from severe storms, straight-line winds, and
tornadoes during the period of June 14 to June 18, 2023, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Oklahoma.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Adam D. Burpee, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Oklahoma have been designated
as adversely affected by this major disaster:

    Beaver, Cimarron, Comanche, Cotton, Craig, Creek, Delaware,
Harper, Jefferson, Love, Major, Mayes, McCurtain, Payne, Pushmataha,
Rogers, Stephens, Tulsa, and Woodward Counties for Public
Assistance.
    All areas within the State of Oklahoma are eligible for
assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-21018 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55235-55237]
[FR Doc No: 2011-22450]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30800; Amdt. No. 3441]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective September 7, 2011. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 7, 2011.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability--All SIAPs are available online free of charge. Visit
http://nfdc.faa.gov to register. Additionally, individual SIAP and
Takeoff Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this

amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on August 19, 2011.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, identified as follows:

* * * EFFECTIVE UPON PUBLICATION

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date            State               City               Airport          FDC No.      FDC Date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
22-Sep-11............  CO               Denver.............  Denver Intl........       1/1391      8/16/11  ILS OR LOC RWY 7, Amdt 2A.
22-Sep-11............  CO               Denver.............  Denver Intl........       1/1393      8/16/11  ILS RWY 26, Amdt 2.
22-Sep-11............  TX               Dallas-Fort Worth..  Dallas/Fort Worth         1/7239      7/28/11  RNAV (RNP) Z RWY 31R, Amdt 1B.
                                                              Intl.
22-Sep-11............  TX               Dallas-Fort Worth..  Dallas/Fort Worth         1/7240      7/28/11  RNAV (RNP) Z RWY 31L, Orig-C.
                                                              Intl.
22-Sep-11............  TX               Dallas-Fort Worth..  Dallas/Fort Worth         1/7241      7/28/11  RNAV (GPS) Y RWY 31L, Orig.
                                                              Intl.
22-Sep-11............  TX               Dallas-Fort Worth..  Dallas/Fort Worth         1/7242      7/28/11  CONVERGING ILS RWY 31R, Amdt 7B.
                                                              Intl.
22-Sep-11............  TX               Eastland...........  Eastland Muni......       1/7445      7/28/11  NDB RWY 35, Amdt 3.
22-Sep-11............  IA               Monticello.........  Monticello Rgnl....       1/7975       8/2/11  RNAV (GPS) RWY 15, Amdt 1.
22-Sep-11............  MA               Lawrence...........  Lawrence Muni......       1/8163       8/8/11  ILS OR LOC Z RWY 5, Orig.
22-Sep-11............  TX               Houston............  Houston-Southwest..       1/8752       8/8/11  LOC/DME RWY 9, Amdt 3A.
22-Sep-11............  WI               Oconto.............  Oconto/J. Douglas         1/8920       8/8/11  GPS RWY 11, Orig.
                                                              Bake Memorial.
22-Sep-11............  WI               Oconto.............  Oconto/J. Douglas         1/8922       8/8/11  GPS RWY 29, Orig-A.
                                                              Bake Memorial.
22-Sep-11............  KS               Harper.............  Harper Muni........       1/9393       8/9/11  VOR OR GPS B, Amdt 1.
22-Sep-11............  IL               Alton/St. Louis....  St Louis Rgnl......       1/9395       8/9/11  VOR A, Amdt 9.
22-Sep-11............  IN               Indianapolis.......  Indianapolis              1/9445       8/8/11  ILS OR LOC RWY 36, Amdt 5.
                                                              Executive.
22-Sep-11............  IN               Indianapolis.......  Indianapolis              1/9446       8/8/11  RNAV (GPS) RWY 36, Orig-A.
                                                              Executive.
22-Sep-11............  IN               Marion.............  Marion Muni........       1/9712       8/9/11  VOR RWY 15, Amdt 10A.
22-Sep-11............  GA               Brunswick..........  Malcolm McKinnon...       1/9942      8/16/11  Takeoff Minimums and Obstacle DP, Amdt 2.
22-Sep-11............  WI               Milwaukee..........  Milwaukee/Lawrence        1/9970       8/9/11  RNAV (GPS) RWY 15L, Orig.
                                                              J Timmerman.
22-Sep-11............  WI               Milwaukee..........  Milwaukee/Lawrence        1/9971       8/9/11  LOC RWY 15L, Amdt 6.
                                                              J Timmerman.
22-Sep-11............  WI               Milwaukee..........  Milwaukee/Lawrence        1/9972       8/9/11  VOR RWY 4L, Amdt 9.
                                                              J Timmerman.
22-Sep-11............  WI               Milwaukee..........  Milwaukee/Lawrence        1/9973       8/9/11  VOR RWY 15L, Amdt 14.
                                                              J Timmerman.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-22450 Filed 9-6-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 241 (Friday, December 14, 2012)]
[Notices]
[Page 74479]
[FR Doc No: 2012-30237]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9006-5]

Environmental Impacts Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 12/03/2012 Through 12/07/2012
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

SUPPLEMENTARY INFORMATION:  As of October 1, 2012, EPA will not accept
paper copies or CDs of EISs for filing purposes; all submissions on or
after October 1, 2012 must be made through e-NEPA. While this system
eliminates the need to submit paper or CD copies to EPA to meet filing
requirements, electronic submission does not change requirements for
distribution of EISs for public review and comment. To begin using e-
NEPA, you must first register with EPA's electronic reporting site--
https://cdx.epa.gov/epa_home.asp.

EIS No. 20120379, Final EIS, BLM, CA, West Chocolate Mountains
Renewable Energy Evaluation Area, Proposed California Desert
Conservation Area Plan Amendment, Imperial County, CA, Review Period
Ends: 01/14/2013, Contact: Sandra McGinnis<PHONE_NUMBER>.
EIS No. 20120380, Draft EIS, BLM, AK, Ring of Fire Resource Management
Plan Amendment, Haines Block Planning Area, Southeast Alaska, Comment
Period Ends: 03/14/2013, Contact: Molly Cobbs<PHONE_NUMBER>.
EIS No. 20120381, Draft Supplement, NRC, TX, GENERIC--License Renewal
of Nuclear Plants Supplement 48 Regarding South Texas Project, Units 1
and 2 (NUREG 1437) Matagorda County, TX, Comment Period Ends: 02/22/
2013, Contact: Tam Tran<PHONE_NUMBER>.
EIS No. 20120382, Draft Supplement, FTA, MN, Central Corridor Light
Rail Transit Project, Construction-Related Potential Impacts on
Business Revenue, St. Paul and Twin Cities Metropolitan Area, MN,
Comment Period Ends: 01/30/2013, Contact: Maya Sarna<PHONE_NUMBER>
EIS No. 20120383, Draft EIS, USACE, CA, Gregory Canyon Landfill,
Application for Permit Authorizing Discharge of Fill in U.S. Waters,
San Diego County, CA, Comment Period Ends: 02/12/2013, Contact: William
H. Miller<PHONE_NUMBER>.
EIS No. 20120384, Final EIS, BLM, NV, Searchlight Wind Energy Project,
NVN-084626 and NVN-086777, Application for Right-of-Way Grant on Public
Land to Develop, Construct, Operate, Maintain and Decommission of a 200
megawatt Wind Energy Facility, USACE Section 404 Permit, Clark County,
NV, Review Period Ends: 01/14/2013, Contact: Gregory Helseth 702-515-
5173
EIS No. 20120385, Final EIS, DOE, WA, Hanford Site Tank Closure and
Waste Management Project, Richland, Benton County, WA, Review Period
Ends: 01/14/2013, Contact: Mary Beth Burandt<PHONE_NUMBER>.
EIS No. 20120386, Final EIS, FTA, MD, Red Line Project, Implementation
of a new East-West Light Rail Transit Alignment, Baltimore County, MD,
Review Period Ends: 01/28/2013, Contact: Daniel Koenig<PHONE_NUMBER>.

Amended Notices

EIS No. 20120334, Draft EIS, USFS, OR, Oregon Dunes NRA Management Area
10(C) Designated Routes Project, Central Coast Ranger District, Oregon
Dunes National Recreation Area, Siuslaw National Forest, Coos, Douglas,
and Lane Counties OR, Comment Period Ends: 01/24/2013, Contact: Angie
Morris<PHONE_NUMBER>. Revision to FR Notice Published 10/26/2012;
Extending Comment from 12/10/2012 to 01/24/2013.

    Dated: December 11, 2012.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2012-30237 Filed 12-13-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 12, 2009 (Volume 74, Number 47)]
[Notices]
[Page 10727]
[DOCID:fr12mr09-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9282-032]

Notice of Application for Transfer of License, and Soliciting
Comments and Motions To Intervene

March 4, 2009.
    In the matter of: Winslow H. MacDonald, Trustee, Heidi B.
Robichaud, Successor Trustee, Milford Elm Street Trust, 37 Wilton
Road, Milford LLC, and 282 Route 101, LLC.

    On February 2, 2009, Winslow H. MacDonald, Trustee, Heidi B.
Robichaud, Successor Trustee, and Milford Elm Street Trust
(collectively, transferors) and 37 Wilton Road, Milford LLC and 282
Route 101 LLC (collectively, transferees) filed an application, for
transfer of license of the Pine Valley Dam Project, located on the
Souhegan River in Hillsborough County, New Hampshire.
    Applicants seek Commission approval to transfer the license for the
Pine Valley Dam from the transferors to the transferees.
    Applicant Contact: Mr. Mark Prolman, Prolman Realty, 100 Elm
Street, Nashua, NH 03060.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 30 days from
the issuance of this notice. Comments and motions to intervene may be
filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii)(2008) and the instructions on the Commission's Web
site under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the eLibrary link of the Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-9282-
032) in the docket number field to access the document. For assistance,
call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-5253 Filed 3-11-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69716-69717]
[FR Doc No: 2011-29003]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC12-19-000.
    Applicants: LSP Energy Limited Partnership, TPF II Southeast
Holdings, LLC.
    Description: LSP Energy Limited Partnership and TPF II Southeast
Holdings, LLC, Joint Application For Approval Under Section 203 of the
Federal Power Act, And Request for Expedited.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5232.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2912-002.
    Applicants: Alliance for Cooperative Energy Services.
    Description: Notice of Non-Material Change in Status of Alliance
for Cooperative Energy Services Power Marketing LLC.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5164.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER10-3058-001; ER10-3059-001; ER10-3065-001; ER10-
3066-001.
    Applicants: Pinelawn Power, LLC.
    Description: J-POWER North America Holdings Co., Ltd.'s
Supplemental Filing of Triennial Market Power Update for the Northeast
Region.
    Filed Date: 10/20/2011.
    Accession Number: 20111020-5152.
    Comment Date: 5 p.m. Eastern Time on Thursday, November 10, 2011.

    Docket Numbers: ER12-305-000.
    Applicants: Orange Grove Energy, L.P.
    Description: Orange Grove Energy, L.P. submits tariff filing per
35.13(a)(2)(iii: Orange Grove Black Start Agreement to be effective 1/
1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5108.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-306-000.
    Applicants: Baltimore Gas and Electric Company, PJM
Interconnection, L.L.C.
    Description: Baltimore Gas and Electric Company submits tariff
filing per 35.13(a)(2)(iii: BGE submits revisions to PJM's Tariff
Attach H-2A-BGE's Trans. Formula Rate to be effective 6/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5125.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-307-000.
    Applicants: Green Mountain Energy Company.
    Description: Request for Limited One-Time Waiver of Tariff
Provision and Expedited Treatment of Green Mountain Energy Company.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5141.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-308-000.
    Applicants: Manzana Wind LLC.
    Description: Manzana Wind LLC submits tariff filing per 35.12:
Market-Based Rate Application to be effective 12/31/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5166.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-309-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: 11-1-11 Attachment X--Queue
Reform to be effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5174.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-310-000.
    Applicants: Ameren Illinois Company, Midwest Independent
Transmission System Operator, Inc.
    Description: Ameren Illinois Company submits tariff filing per
35.13(a)(2)(iii: 11-01-11 AIC Attachment O to be effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5175.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-311-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: Rate Schedule Amendments for ITCC Language
to be effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5180.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-312-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: 11-01-11 Attachment MM and
MM-GRE to be effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5181.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-313-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(i): Hercules Municipal Utility IA and WDT Service
Agreements to be effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5187.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-314-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: TO Amendments for ITCC Language to be
effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5188.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-315-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits tariff filing per 35:
Compliance Filing to Bring Accepted Provision into eTariff to be
effective 1/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5189.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-316-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits tariff filing per
35.13(a)(2)(iii: Revision to MT OATT Schedule 3 Regarding Self-Supply
to be effective 12/31/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5191.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-317-000.

    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: WDAT Amendments for ITCC Language to be
effective 1/1/2012.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5202.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-318-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: E&P Agreement for Westlands Solar Farms to be
effective 11/3/2011.
    Filed Date: 11/02/2011.
    Accession Number: 20111102-5012.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 23, 2011.

    Docket Numbers: ER12-319-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Duke Energy Ohio, Inc. submits notice of cancellation.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5231
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-320-000.
    Applicants: PacifiCorp.
    Description: Notice of Termination of Pacificorp.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5234.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-321-000.
    Applicants: PacifiCorp.
    Description: Notice of Termination of Pacificorp.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5235.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Docket Numbers: ER12-322-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notices of Termination of Hercules WDT Service
Agreement Nos. 9 and 13 of Pacific Gas and Electric Company.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5236.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 22, 2011.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES11-51-000.
    Applicants: PacifiCorp.
    Description: Amendment to Application for Authorization to Issue
and Sell up to $1.5 Billion for Unsecured Short-Term Indebtedness of
Pacificorp.
    Filed Date: 10/28/2011.
    Accession Number: 20111028-5212.
    Comment Date: 5 p.m. Eastern Time on Monday, November 14, 2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 2, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-29003 Filed 11-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 137 (Thursday, July 16, 2020)]
[Notices]
[Pages 43250-43251]
[FR Doc No: 2020-15345]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0183; OMB Control Number 1625-0025]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-Day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0025,
Carriage of Bulk Solids Requiring Special Handling; without change. Our
ICR describes the information we seek to collect from the public.
Review and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
August 17, 2020.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2020-0183]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents. These comments will help OIRA
determine whether to approve the ICR referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2020-0183], and must be received by August 17,
2020.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for

alternate instructions. Documents mentioned in this notice, and all
public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For more about privacy and submissions to OIRA in
response to this document, see the https://www.reginfo.gov, comment-
submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each
ICR. An OMB Notice of Action on each ICR will become available via a
hyperlink in the OMB Control Number: 1625-0025.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (85 FR 23838, April 29, 2020)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Carriage of Bulk Solids Requiring Special Handling--46 CFR
part 148.
    OMB Control Number: 1625-0025.
    Summary: As specified in 46 CFR part 148, the petition for a
Special Permit allows the Coast Guard to determine the manner of safe
carriage for unlisted materials. The information required by Dangerous
Cargo Manifests and Shipping Papers permit vessel crews and emergency
personnel to properly and safely respond to accidents involving
hazardous substances. See 46 CFR 148 Subpart B and Sec. Sec.  148.60
and 148.70.
    Need: The Coast Guard administers and enforces statutes and rules
for the safe transport and stowage of hazardous materials, including
bulk solids.
    Forms: Not applicable.
    Respondents: Owners and operators of vessels that carry certain
bulk solids.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 850
hours to 910 hours a year due to an increase in the estimated annual
number of responses.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: July 10, 2020.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2020-15345 Filed 7-15-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Rules and Regulations]
[Pages 48298-48299]
[FR Doc No: 2013-18699]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0269; Airspace Docket No. 13-ASW-3]

Amendment of Class E Airspace; Commerce, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Commerce, TX.
Additional controlled airspace is necessary to accommodate new Area
Navigation (RNAV) Standard Instrument Approach Procedures at Commerce
Municipal Airport. This action enhances the safety and management of
Instrument Flight Rule (IFR) operations at the airport. Geographic
coordinates are also updated.

DATES: Effective date: 0901 UTC, October 17, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On June 3, 2013, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to amend Class E airspace for the
Commerce, TX, area, creating additional controlled airspace at Commerce
Municipal Airport (78 FR 33019) Docket No. FAA-2013-0269. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9W dated August 8, 2012, and effective September
15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface ensuring controlled airspace exists to contain
aircraft executing new standard instrument approach procedures at
Commerce Municipal Airport, Commerce, TX. Small segments are added from
the 6.3-mile radius of the airport to 9.5 miles north and 9.3 miles
south of the airport for the safety and management of IFR operations.
Geographic coordinates of the airport are also updated to coincide with
the FAA's aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Commerce Municipal Airport,
Commerce, TX.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA

Order 1050.1E, ``Environmental Impacts: Policies and Procedures,''
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW TX E5 Commerce, TX [Amended]

Commerce Municipal Airport, TX
    (Lat. 33[deg]17'34'' N., long. 95[deg]53'47'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Commerce Municipal Airport, and within 2
miles each side of the 183[deg] bearing from the airport extending
from the 6.3-mile radius to 9.3 miles south of the airport, and
within 2 miles each side of the 003[deg] bearing from the airport
extending from the 6.3-mile radius to 9.5 miles north of the
airport.

    Issued in Fort Worth, Texas, on July 25, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-18699 Filed 8-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Page 85217]
[FR Doc No: 2016-28326]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-360-000]

Rio Bravo Solar I, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding
Rio Bravo Solar I, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 7, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: November 17, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-28326 Filed 11-23-16; 8:45 am]
BILLING CODE 6717-01-P


1 May 18, 2005 EPP PURCHASING GUIDES   RESPONSE TO COMMENTS I. BACKGROUND On June 30, 2004, EPA issued a Federal Register ( FR) notice soliciting public comment on four draft EPP Purchasing Guides. The intent of the guides is to help federal government purchasers consider the environmental factors in the EPP equation when making purchases in the following areas:

  Carpets   Cleaning products   Copiers   Meetings and conferences The FR notice also asked for reaction to several questions, including whether the guides' discussions were helpful and whether the approach used in the guides was useful. The comment period was open for 60 days.

EPA received 24 comment in all, including some comments that were submitted late: 11 on the Cleaning Products Guide; 2 on the Copiers Guide; 7 on the Carpets Guide; 1 on the Meetings and Conferences Guide; and 3 general comments applicable to multiple guides.

Comments were submitted by 9 trade associations, 6 companies/ labs, 4 government purchasers, 2 individuals, 2 anonymous, and 1 environmental choice program.

This document summarizes the major comments received on the guides and includes EPA's response to those comments.

II. CLEANERS GUIDE Comment: Several commenters requested that EPA's Design for the Environment ( DfE)

Formulator Initiative and the Unified Green Cleaning Alliance be added to the list of resources in the guide.

Response: EPA concurs and has added these references to the revised draft. 2 Comment: Several commenters submitted minor editorial comments either in written format or within a redlined version of the guide.

Response: EPA has incorporated most of these edits in the revised draft. Others that did not adhere to EPA/ GPO style were not accepted.

Comment: Several commenters expressed concern over the issue of life cycle analysis, main concerns being that is needs to be better defined as it relates to cleaning products, and that it is costly to implement.

Response: As EPA has indicated in the guides, life cycle analysis is one of EPA's five guiding principles for making environmentally preferable purchases. To assist purchasers further, EPA has added a link in the guide for additional information on life cycle analysis.

Comment: Several organizations submitted comments in effect saying that the choice of a particular product or ingredient is affected or influenced by certain situations or circumstances and that the selection process is not always straightforward.

Response: EPA agrees that tradeoff issues are involved in the product selection process. The guides were not intended to be prescriptive, but rather to provide suggestions to help government purchasers consider environmental factors when making purchasing decisions. In the first paragraph of the guides,

EPA acknowledges that multiple factors are important.

Comment: The Consumer Products Specialty Corporation ( CSPA) and the Alkylphenols &

Ethoxylates Research Council ( APERC) submitted similar comments expressing concern that EPA is providing information that is not verified by the referenced organizations.

Response: As noted earlier, EPA's purpose in the guides is to identify a number of environmental factors to consider in purchasing decisions. These considerations come from EPA, other government agencies, industry, and non governmental organizations. The organizations referenced in the guides are credible, reputable organizations that EPA and others have worked with for years. As noted in the introductory paragraph, EPA is not endorsing specific organizations and has not verified all information provided by these organizations. Fact checking and verifying all of the information posted or published by these groups is not realistic from a time or budgetary standpoint. 3 Comment: A couple of organizations commented that the guide should address cleaning as a process, not just focus on products or ingredients.

Response: Ingredients are a relevant consideration; however, the guide does include a number of other attributes besides ingredient characteristics. The focus of the guide is on information related to purchasing decisions. Comprehensive information on cleaning processes and practices is available from a variety of sources ( some of these are already included in the " Contacts and Resources" section of the guide and others have been added).

Comment: ServiceMaster Clean submitted a comment saying that EPA should be careful when using the term " hazardous" to describe cleaning products.

Response: EPA has used this term in the guide to accurately categorize the concentrated forms of some cleaners, as defined by several regulatory programs.

Comment: APERC submitted a comment questioning why EPA has " dismissed the basic principles of risk assessment."

Response: The purpose of the guide is to provide practical information that will assist federal purchasers in making purchasing decisions. The guide is not intended to be a risk assessment document, nor is it meant to substitute for Material Safety Data Sheets or similar documents that provide important information on proper storage, handling, use, and disposal. Many of the recommendations in the guide are based on the fundamental pollution prevention principles of reducing the quantity and hazards of materials used. The pursuit of pollution prevention objectives is not dependent on risk findings.

Comment: Both CSPA and APERC submitted comments arguing that an entire class of compounds   alkylphenol ethoxylates ( APEs)   should not be implicated because of a single ingredient.

APERC also believes that EPA has mistaken nonylphenol with nonylphenol ethoxylates regarding its inference about reproductive effects and endocrine disruption.

Response: The actual risks from these chemicals at typical exposure levels are often uncertain, and in many cases are probably low. Regardless of the expected risk levels, however, reducing the intrinsic hazard of a product is a desirable pollution prevention objective as part of decisions that also take into account other important product attributes. EPA also notes the following information from a National Academy of Sciences report that corroborates the Agency's statement: "... alkylphenol ethoxylates have 4 been shown to induce vitellogenin synthesis, a hallmark of estrogen exposure, and to decrease the rate of testicular growth in male fish in tests that duplicate concentrations found in some effluents." Hormonally Active Agents in the Environment, National Research Council, National Academy of Sciences, 1999.

Comment: The Soap and Detergent Association submitted a comment expressing concern over the guide's implication that cleaning products containing phosphorus or nitrogen are contributing to nutrient loading in water bodies. The organization pointed out that any relevant contributions are negligible.

Response: EPA recognizes the commenter's concern and has amended the revised draft guide accordingly.

Comment: CSPA submitted a comment disputing the statistic in the guide regarding cleaning products' contribution to nonvehicular VOC emissions in California.

Response: Based on review of the data, EPA has deleted this sentence.

Comment: Several organizations submitted comments disputing the statement in the guide regarding reports to Poison Control Centers involving cleaning products.

Response: EPA acknowledges that the statistic referenced in the guide relates to household cleaning products, not commercial, and is therefore not applicable to this guide. EPA has replaced the statistic with one that is more relevant to commercial cleaners.

Comment: ServiceMaster Clean and the Soap and Detergent Association took issue with the guide's suggestion that purchasers use cleaning products that are made from renewable resources, such as biobased materials. The commenters claimed that this decision should be made on a case by case basis and that life cycle studies do not show a clear advantage to using renewable resources.

Response: Use of renewable resources is a commonly accepted environmental principle aimed at conserving natural resources and reducing pollution. EPA emphasizes that the attributes mentioned in the guide are merely considerations, and that different situations may require purchasers to be more focused on particular attributes. EPA points out in the " What Can You Do?" section of the guide that the overall best value when making purchasing decisions takes into account performance, price, availability, regulatory requirements, and environmental impact. EPA further states that purchasers should examine as many relevant product attributes as possible, recognizing that tradeoffs are inevitable. 5 Comment: ServiceMaster Clean indicated that " LD50" testing involves animal testing and that this may be at odds with the ethical policies of some companies.

Response: The lethal and effective dose concentrations indicated in the guide are related to aquatic testing, not mammalian. EPA's inclusion of " low aquatic toxicity" in its list of desirable attributes is again based on the approach of reducing hazards while also taking into account other important product attributes. EPA also reiterates that this is just one attribute that should be examined, with the understanding that tradeoffs are to be expected.

Comment: CSPA indicated that it strongly disagrees with the guide's statement to limit the use of disinfectants.

Response: EPA has clarified this statement in the revised guide by indicating when disinfectant use is most appropriate ( i. e., in areas where people are likely to come in contact with the contaminated surface)

and when it is less useful.

Comment: CSPA also indicated that broad claims such as " environmentally preferable" should not be used and are contrary to the FTC environmental marketing guide.

Response: EPA notes that this is the term used in EO 13101. The purpose of the guide is to assist federal purchasers in determining environmental preferability. Use of the term in an advertising or marketing context is a different issue.

Comment: ServiceMaster Clean expressed concern that the attributes regarding clear labeling and information on use and disposal could mean an additional regulatory burden for companies.

Response: EPA notes that this is not a regulatory requirement. It is simply common sense for consumers to purchase products with clear labels and instructions.

Comment: Coastwide Laboratories suggested adding language regarding the efforts a company has made to minimize the effects of transportation.

Response: EPA believes that many of the " Packaging and Shipping" attributes in the guide, such as having products shipped in bulk and using refillable bottles, already inherently take into account transportation effects. 6 Comment: CSPA believes the Contacts and Resources list in the guide is too focused on environmental groups.

Response: EPA has researched and added other resources to create a more complete list.

III. CARPETS GUIDE Comment: Several commenters submitted minor editorial suggestions to be incorporated into the guide.

Response: EPA has incorporated these edits when applicable.

Comment: The Air Force Center for Environmental Excellence submitted a comment suggesting that EPA remove the reference to using PET carpet in offices and residential areas ( which the guide says are light to moderate wear conditions) because the Air Force classifies offices as heavy to severe wear, and residential as moderate to severe wear, which would preclude them from using PET carpet.

Response: EPA added language to the guide explaining that, in general, carpet made from PET and polypropylene face fiber is not as durable as carpet made from nylon face fiber and that EPA recommends that consumers refer to the " Selecting Carpet and Rugs" page of the Carpet and Rug Institute's ( CRI's)

Web site at < www. carpet rug. com/ index. cfm> when determining which type of carpet to purchase.

Comment: INVISTA submitted a comment indicating that the name " DuPont Carpet Reclamation Program" should be changed to " INVISTA Reclamation Program" to reflect the new corporate identity.

INVISTA also indicated that several carpet companies have products that are certified environmentally preferable under SCS Pilot specification.

Response: EPA has changed the name of the program from Dupont to INVISTA in the guide. In addition, EPA added reference to the SCS carpet specification page and the fact that several carpet manufacturers have received this certification.

Comment: The Vinyl Institute submitted a comment suggesting that the sentence that refers to use of recycled PVC be expanded to apply more broadly to all materials.

Response: EPA has revised the guide to include all materials in its reference about use of recycled materials. 7 Comment: An EPA Region 9 employee submitted a comment noting controversy regarding the use of recycled PVC. The commenter included and article from Healthy Building News. The commenter also believes the guide should specify non PeBDE carpet cushion since PeBDE is/ has been phased out.

Response: While EPA agrees that some controversy may exist regarding the use of PVC in carpet,

the Agency notes that the guide merely acknowledges the availability of recycled PVC in carpet. EPA is in no way saying that PVC should be considered over other recycled materials. Regarding the specification of non PBDE carpet cushion, EPA has added language to this effect in the guide.

Comment: Collins & Aikman ( C& A) submitted a comment suggesting that EPA mention another new product in the " Materials Used in Carpet" section of the guide. The product is a carpet backing made from postconsumer glass and PVB plastic recovered from windshield and safety glass recycling.

Response: EPA has added reference to the new carpet backing product in the guide.

Comment: The Carpet and Rug Institute ( CRI) submitted several comments related to health and environmental issues; life cycle and tradeoff issues; the five guiding principles; and the " What Can You Do?" sections.

Response: EPA has added language addressing several of CRI's comments in the revised guide.

IV. COPIERS GUIDE Comment: The American Plastics Council ( APC) believes that all of the points listed under " Why Green Your Copier?" are already covered by ENERGY STAR and other programs.

Response: EPA acknowledges that several other programs offer guidance for choosing environmentally preferable copiers, but the Agency notes that the purpose of its Copiers Guide is to present existing information in one useful resource to assist federal government purchasers in making purchasing decisions.

Comment: TerraChoice requested that the new criterium CCD 035 for Copiers be added to the guide.

Response: EPA has added reference to Canada's Environmental Choice Program and its photocopier certification in the " Contacts and Resources" section of the guide. 8 Comment: The Electronic Industries Alliance ( EIA) questions the need for the guide, citing the Electronic Product Environmental Assessment Tool ( EPEAT) and other EPA led efforts underway to address EPP for electronics.

Response: EPA agrees that there are several quite useful projects underway to address environmental issues for electronics, but the Agency notes that not all of these efforts specifically target copiers, which is the focus of this guide. In particular, EPA strongly supports the EPEAT process and commends EIA for its involvement in it, but notes that copiers are not currently included in it. In addition,

the EPP guides are meant to pull together relevant information for procurement officials from a number of sources beyond EPA, including other governments, businesses, and nongovernment groups. There are other sources of information for this guide besides the efforts cited in the comment.

Comment: EIA claims that the guide fails to adhere to such principles as use of life cycle environmental impacts.

Response: EPA notes that it is difficult to respond to this comment because it does not provide explanations or examples regarding the statement. However, the Agency notes that life cycle analysis is one of EPA's five guiding principles for making environmentally preferable purchases and is discussed in the guide multiple times. To assist purchasers further, EPA has added a link in the guide for additional information on life cycle analysis.

Comment: EIA states that the " guidelines lack scientific and technical rigor."

Response: EPA did not intend for the Copiers Guide to present specific criteria for purchasing environmentally preferable products. The purpose of the guide is merely to describe the challenges,

successes, and resources associated with copiers, focusing on how to incorporate environmental considerations into purchasing decisions. EPA has outlined overall principles for its EPP Program and EPA clearly identifies its EPP guidelines on its Web site. These guidelines do not require any agency to use any specific documents, such as the Copiers Guide. To further clarify the purpose of the EPP guides, EPA has replaced the term " guidelines" with " considerations" in each of the guides.

Comment: EIA stated that " a number of the suggested characteristics are not easily quantifiable."

Response: EPA has attempted to cite numeric standards when available, but notes that some of the environmental considerations suggested in the guide involve less quantitative actions. While this sometimes 9 complicates the procurement decision, these points are still believed to be worth considering.

Comment : EIA does not support the use of third party testing for product research .

Response: EPA agrees with EIA that procurement officials should use industry developed statements and self certifications, and has added language to that effect to the guide, but also believes that there may be a role for third party testing and thus continues to include it as an example.

Comment: EIA recommends that the scope of the document be limited to stand alone, standard size copiers only, but does not explain the basis for this preference.

Response: Absent more information on the basis for this, EPA will retain the guide's current scope,

which does address multi functional systems as well as stand alone copiers.

Comment: EIA " is concerned that the guideline has added categories that are beyond the scope of environmental characteristics," but also says the guide " fails to account properly for other important factors, including price, performance, service, reliability, etc."

Response: Although the guide focuses on environmental characteristics, in certain places it does refer to other relevant considerations in the purchase decision, such as cost. In fact, the guides include discussion of EPA's five guiding principles, one of which is to " include environmental factors as well as traditional considerations of price and performance as part of the normal purchasing process."

Comment: EIA believes the toner cartridge recommendation in the guide is unclear and may provide an inappropriate preference for some cartridges.

Response: EPA did not intend to give preference to any particular type of environmentally preferable toner cartridge procurement option. To give equal preference to each option, EPA has changed the recommendation in the guide to read " Use returnable, recyclable, or remanufactured toner cartridges."

Comment: APC submitted a comment questioning the styrene and polybrominated biphenyls ( PBBs) and diphenyl ethers ( PBDE) criteria provided in the guide. Specifically, APC asked for this information to be corroborated, including indicating what the criteria are based on..

Response: A proposed rule on PBDEs refers to these chemicals as persistent,

bioaccumulative, and toxic. PBBs are classified as carcinogenic by the NTP and IARC and are also 10 persistent and bioaccumulative. Neurological effects have been seen in workers exposed to styrene and there is suggestive evidence of adverse reproductive effects in exposed workers. Animal studies with styrene have also shown effects in the liver, kidneys, blood, and immune system. The RfC for styrene is 1 mg/ m3.

V. MEETINGS AND CONFERENCES GUIDE Comment: An individual commented that the first sentence of the guide is too jocular considering the serious nature of the guide.

Response: EPA acknowledges the individual's comment and has changed the first sentence of the guide.

Comment: The same individual commented that he does not believe the guide goes far enough in actually requiring hotels and venues to meet minimum standards or to be rated on their environmental preferability.

Response: The guides are merely intended to provide useful information to assist federal purchasers in making environmentally preferable purchasing decisions. Under EO 13101, EPA has no legal or statutory authority to require hotels and other venues to meet minimum standards.

Comment: The American Plastics Council ( APC) believes the guide does not include enough information on products that contain recycled content.

Response: EPA notes that it mentions multiple times in the guide to look for recycled content as a desirable attribute when planning meetings. EPA mentions other factors as well to present a balanced approach to decisionmaking.

Comment: APC also questioned why EPA gives preference for reusable mugs over cups that have recycled content.

Response: EPA did not intend to discount recyclable food/ beverage items as options when planning environmentally preferable meetings. The Agency was merely being consistent with its pollution prevention hierarchy, which encourages source reduction ( including reuse) first, followed by recycling and composting, and, lastly, disposal in combustion facilities and landfills. To clarify its position, EPA has 11 added language to the guide regarding the use of recycled content/ recyclable containers.


                                    AGENDA
                   US ENVIRONMENTAL PROTECTION AGENCY (EPA)
                    FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
                                 OPEN MEETING
                            April 10  -  13, 2012
              FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/
                     OPP Docket Telephone:<PHONE_NUMBER>
                     Docket Number: EPA-HQ-OPP-2012-0040
                      US Environmental Protection Agency
                         Conference Center Lobby Level
                        One Potomac Yard (South Bldg.)
                  2777 S. Crystal Drive, Arlington, VA 22202

         Scientific Issues Associated with Chlorpyrifos Health Effects

   Please note that all times are approximate (see note at end of Agenda).
                                    Day 1
                           Tuesday, April 10, 2012

9:00 A.M. 	Opening of Meeting and Administrative Procedures
            Fred Jenkins, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members
      Kenneth Portier, Ph.D., FIFRA SAP Chair

9:10 A.M. 	Welcome and Opening Remarks
      Steven Bradbury, Ph.D., Director, Office of Pesticide Programs (OPP), EPA
      Karen Whitby, Ph.D., Acting Director, Health Effects Division, OPP, EPA

9:35 A.M. 	Introduction: Scientific Issues Concerning Health Effects of Chlorpyrifos
      Anna Lowit, Ph.D., OPP, EPA

10:00 A.M. 	Adverse Outcome Pathways: Data for Chlorpyrifos at Varying Levels of Biological Organization
      William R. Mundy, Ph.D., Office of Research and Development (ORD), EPA

10:30 A.M. 	Break

10:45 A.M. 	Chlorpyrifos Effects on the Developing Brain Animal Studies: Animal Studies
      Ginger Moser, Ph.D., DABT, Fellow ATS, (ORD), EPA

11:30 A.M. 	Lunch

12:30 P.M. 	Review of Children's Health Epidemiology Cohort Studies
      Carol H. Christensen, Ph.D., MPH, OPP, EPA

2:00 P.M. 	Review of Chlorpyrifos Biomonitoring Research and Interpretive Approaches
      Lieutenant Aaron Niman, US Public Health Service, OPP EPA

2:30 P.M. 	Summary of Chlorpyrifos Health Effects
      Anna Lowit, Ph.D., OPP, EPA

3:00 P.M. 	Break

3:10 P.M. 	Public Comments

5:45 P.M. 	Adjourn

                                    Day 2
                          Wednesday, April 11, 2012

9:00 A.M. 	Opening of Meeting and Administrative Procedures
            Fred Jenkins, Ph.D. Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members
      Kenneth Portier, Ph.D., FIFRA SAP Chair

9:10 A.M. 	Public Comments (Cont'd)

10:30 A.M. 	Break

10:45 A.M. 	Public Comments (Cont'd)

12:00 P.M. 	Lunch

1:00 P.M. 	Charge to the Panel

Question 1.0 Mode of action/adverse outcome pathway:  Acetylcholinesterase (AChE) inhibition
Question 1.0
It is well established that AChE inhibition is the primary mode of action/adverse outcome pathway for OPs, like chlorpyrifos.  Because AChE inhibition is the initiating event for this mode of action/adverse outcome pathway, using AChE inhibition as a regulatory endpoint is protective of downstream cholinergic effects.  Moreover, historically, given the sensitivity of AChE inhibition data for OPs, these data have been considered to be protective of other potential toxicities and/or modes of action for OPs.   In 2008, the Agency performed a comprehensive review of the available AChE data from multiple lifestages.  This review has been supplemented with the newest studies.  Consistent with the recommendations from the 2008 SAP, the Agency believes that AChE data remain the most robust dose response data for deriving points of departure in in vivo experimental toxicology studies with laboratory animals.  Please comment on the Agency's preliminary conclusion that AChE data remain the most robust source of data for deriving points of departure for chlorpyrifos.  Please include a discussion of the strengths and uncertainties of this preliminary conclusion.

2:00 P.M. 	Charge to Panel (Cont'd)

Question 2.0 Mode(s) of action/adverse outcome pathway(s): Plausible pathways leading to potential neurodevelopmental outcomes

Question 2.1.
As discussed in Section 3.2.1, although there are numerous mechanistic studies in the scientific literature, the research on different hypotheses does not provide sufficient data to establish causal linkages among different levels of biological organization to show how effects lead to adversity.  As such, a mode of action or adverse outcome pathway leading to effects on the developing brain cannot be established at this time.  Moreover, although multiple biologically plausible hypotheses are being pursued by researchers, based on the current state of the science, no one pathway has sufficient data to be considered more credible than the others.  Please comment on the Agency's preliminary conclusion that although there are multiple biologically plausible hypotheses being evaluated by research scientists, the mechanistic experimental toxicology data do not yet support a coherent set of key events in a mode of action/adverse outcome pathway.

2:45 P.M. 	Break

3:00 P.M. 	Charge to the Panel (Cont'd)

Question 2.2.
Although a mode of action/adverse outcome pathway has not been established, qualitatively, the growing body of mechanistic studies does demonstrate that chlorpyrifos and/or its oxon are biologically active on a number of processes that affect the developing brain.  Some mechanistic studies provide evidence of possible effects which are similarly sensitive or more sensitive than AChE inhibition (e.g., neurite outgrowth, binding to muscarinic receptors, axonal transport; serotonergic nervous system development).  Some of these comparisons must be considered with caution since the amount of change in the in vitro systems required to elicit an adverse effect in vivo is unknown.  Moreover, extrapolation from in vitro perturbations to in vivo effects has not been established, which introduces additional uncertainties.  Given the doses/concentrations evaluated in the in vitro and in vivo mechanism studies, Please comment on the degree to which these studies suggest that endpoints relevant to evaluating potential neurodevelopmental outcomes may or may not be more sensitive than AChE inhibition.   Please include in your comments a discussion of the strengths and uncertainties.  Please also include in your comments a discussion of the scientific understanding of dose response relationships for biological perturbations and the magnitude, frequency and/or duration of such perturbations that are can lead to adverse effects at higher levels of biological organization to support characterization of the likelihood of adverse outcomes in a human health risk assessment (as articulated in NRC 2007).

4:00 P.M. 	Charge to the Panel (Cont'd)

Question 3.0 Neurodevelopmental data from laboratory animals
Question 3.1
As discussed in Section 3.2.2, the experimental toxicology data in laboratory rodents show neurobehavioral effects following developmental exposure with changes in a number of neurological domains. In 2008, the SAP agreed to this preliminary conclusion, and the nine additional studies available since 2008 add further support.  Please comment on the degree to which these studies show changes in a number of neurological domains and support the qualitative conclusion that chlorpyrifos exposure during gestation and/or early post-natal period may result in long-term adverse effects on the developing nervous system.  What evidence does and does not support this conclusion?  Please also include in your comments a discussion of the strengths and uncertainties.  Please also include in your comments a discussion of the scientific understanding of dose response relationships for biological perturbations and the magnitude, frequency and/or duration of such perturbations that are can lead to adverse effects at higher levels of biological organization to support characterization of the likelihood of adverse outcomes in a human health risk assessment (as articulated in NRC 2007).

4:45 P.M. 	Charge to the Panel (Cont'd)

Question 3.2
The dose response data in the in vivo experimental neurodevelopmental toxicity studies are not amenable to empirical dose response modeling as many studies use only one or two doses, and in some cases the lower dose, but not higher dose level, produced significant effects.   Many studies report effects at a dose of 1 mg/kg/d-- a dose that produces some amount of brain ChE inhibition when given directly to the pups post-natally, but may or may not alter fetal brain ChE activity when given to the dams gestationally.   One study (Braquenier et al., 2010) using lower doses, administered to the dam on GD15-LD14, reported a NOEL of 0.2 mg/kg/d.  Comparing the NOEL of 0.2 mg/kg/d to a repeated dosing AChE inhibition BMDL10 of 0.03 mg/kg/d suggests that AChE inhibition is a sensitive and protective endpoint.
   a.  Please comment on the scientific quality and robustness of the animal neurodevelopmental toxicity studies.

5:30 P.M. 	Adjourn
                                    Day 3
                           Thursday, April 12, 2012

9:00 A.M. 	Opening of Meeting and Administrative Procedures
            Fred Jenkins, Ph.D. Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members
            Kenneth Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

9:10 A.M. 	Charge to Panel (Cont'd)

Question 3.2
   b. Please comment on the degree to which studies that measured AChE inhibition and those that measured neurodevelopmental outcomes can be integrated to evaluate whether  points of departure based on 10% AChE inhibition provide more sensitive endpoints than endpoints measured in the experimental neurodevelopmental studies (as reviewed in Section 3.2.2).  Please include in your comments a consideration of the strengths and uncertainties associated with this assessment.

10:15 A.M. 	Break

10:30 A.M. 	Charge to Panel (Cont'd)

Question 4.0 Epidemiology Regarding Children's Health

Question  4.1.  Section 4.0 and Appendices 5 and 6 provide the Agency's review of the available epidemiology studies from the Columbia Mothers and Newborn study, the Mt. Sinai Child Development study, and the Center for Health Assessment of Mothers and Children of Salinas Valley (CHAMACOS) study. Consistent with the 2008 SAP recommendations, the Agency has considered information offered from each of the three cohort investigations; however EPA acknowledges the primacy of the Columbia cohort data for the purposes of informing risk assessment because researchers measured chlorpyrifos parent compound directly in this study.  Please comment on the sufficiency, clarity, and quality of the Agency's epidemiology review as contained in Section 4.0 and Appendices 5 and 6 of the draft issue paper with respect to identifying the major strengths and limitations of each study.

11:20 A.M. 	Charge to Panel (Cont'd)

Question 4.2.  Similar to the initial conclusions from 2008, the Agency has preliminarily concluded that, qualitatively, chlorpyrifos likely played a role in the neurodevelopmental outcomes reported in the epidemiologic studies, and that information available since 2008, including both new etiologic investigations as well as epidemiologic methods papers, strengthens this conclusion.  Please comment on the Agency's preliminary, qualitative conclusion that chlorpyrifos likely played a role in the neurodevelopmental outcomes observed in the epidemiologic studies.  Please include in your comments a discussion of the strengths and uncertainties associated with this preliminary conclusion.

12:15 P.M. 	Lunch

1:15 P.M. 	Charge to Panel (Cont'd)

Question 4.3.  As discussed in Question 2.0, a mode of action/adverse outcome pathway has not yet been fully elucidated for the potential neurodevelopmental outcomes as a result of prenatal chlorpyrifos exposure.  Although this does not undermine the qualitative interpretation of these studies, and the preliminarily conclusion stated above (Question 4.2), the identification of the dose response for neurodevelopmental effects based on mode of action is not possible. Further, given the urine and cord blood sampling frequency in the study there is a large degree of uncertainty in estimating absolute exposure-response relationships, as opposed to establishing relative exposure groups for evaluating associations.  With respect to dose-response, critical durations of exposure, and windows of susceptibility are unknown.  In 2008, the SAP cautioned against using the Columbia cohort data for deriving a point of departure due, in part, to only measuring biomarkers (3rd trimester maternal, cord blood, meconium) at one point in time, and because they cannot exclude possibility that the effects seen were due to chlorpyrifos in combination with other pesticides.    In 2008, the SAP advised against using data from the epidemiology studies (including the Columbia Mothers and Newborn study which measured chlorpyrifos directly) for deriving a point of departure due to limitations of the exposure assessment in these epidemiology studies for the purpose of risk assessment, e.g., lack of repeated exposure estimates to ascertain more specifically the variability and periodicity of exposure over time (i.e., predominant use of one-time exposure estimate).
   a.  Due to the limitations of exposure assessment performed in the epidemiologic investigations for the purposes of quantitative risk assessment, the Agency has concluded that the epidemiologic data are not sufficient for deriving points of departure for quantitative risk assessment.  The Agency proposes that AChE inhibition data from laboratory animals remain the most appropriate data to use for dose-response modeling and the derivation of points of departure.  Please comment on the scientific evidence that does and does not support this conclusion, as well as the strengths and limitations of the evidence.

2:15 P.M. 	Break

2:30 P.M. 	Charge to Panel (Cont'd)

Question 4.3.
   b. The Agency does, however, believe that the epidemiologic data are useful to informing other key aspects of the chlorpyrifos risk assessment including hazard characterization, exposure characterization, and quantitative uncertainty characterization and analysis.  Please suggest approaches/analyses for potentially using the epidemiology data in different parts of the chlorpyrifos risk assessment including those noted above. (Note: Some of these may also be covered in Question 5.4 below.)

3:30 P.M. 	Charge to Panel (Cont'd)

Question 5.0 Exposure Profile & Biomonitoring Research

Question 5.1:
   a. Section 5 of the draft issue paper presents an overview of the principal chlorpyrifos biomarkers and a comparison of biomonitoring studies that measured urinary TCPy levels in a range of study populations involving both the general population and potentially vulnerable populations, including children, workers, and farm families.
      Please comment on the degree to which the Agency identified the primary chlorpyrifos biomarkers of exposure, appropriately discussed the strengths and limitations of such biomarkers, and how the strengths and limitations affect the interpretation of the chlorpyrifos biomonitoring data.

4:30 P.M. 	Charge to Panel (Cont'd)

   b. Section 5 of the draft issue paper compares biomonitoring findings from the three children's health cohorts with other major observational exposure studies in the United States.  Based on comparison with NHANES 2001-2002, median TCPy levels in the CHAMACOS and Mount Sinai cohorts were slightly higher than in the general population.  It should be noted that the exposures experienced by the CHAMACOS and Mount Sinai cohorts overlapped the start of the residential chlorpyrifos phase-out.  By contrast, median TCPy levels in the Columbia cohort, for which sampling occurred when chlorpyrifos use should have rapidly declined due to the voluntary cancelation, were slightly lower than the levels measured by NHANES in the general population.  Please comment on the adequacy of the Agency's comparison for the purposes of evaluating chlorpyrifos exposure levels in the three children's health cohorts.  Are there any additional biomonitoring studies that should included in the Agency's comparison?

5:30 P.M. 	Adjourn

                                    Day 4
                            Friday, April 13, 2012

9:00 A.M. 	Opening of Meeting and Administrative Procedures
            Fred Jenkins, Ph.D. Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members
            Kenneth Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

9:10 A.M. 	Charge to Panel (Cont'd)

Question 5.2:
In Section 5.0 of the draft issue paper, the Agency summarized the 2008 preliminary findings on the association between urinary TCPy levels and AChE/BuChE inhibition and discussed two recent studies involving manufacturing workers in the US and Egypt.  Please comment on the scientific quality of these studies and their findings. Please include a discussion of their strengths and limitations.  Please comment on the strengths and limitations of the evidence from this research to show an association between TCPy and AChE/BuChE inhibition at exposure levels experienced by occupational populations.

10:00 A.M. 	Charge to Panel (Cont'd)

Question 5.3:
Several approaches ranging from qualitative to the most sophisticated PBPK/PD modeling approach were introduced as potential options for analyzing the chlorpyrifos biomonitoring data.  Please comment on the strengths and limitations of these approaches.  In addition, please suggest, if appropriate, alternative approaches or analyses not identified by the Agency.

10:45 A.M. 	Break

11:00 A.M. 	Charge to Panel (Cont'd)

Question 5.4:
Characterization of chlorpyrifos exposure experienced by women in the Columbia cohort, particularly during the pre-cancellation period, remains an important uncertainty in using these data in quantitative risk assessment.  Exposure levels in the range measured in the cord blood data from the epidemiology studies (pg/g plasma) are probably low enough that is unlikely that the cohort mothers were experiencing AChE inhibition at the time of delivery; however, the biomonitoring data were taken after birth and not necessarily associated in time with an application of chlorpyrifos.  As such, the actual level of such exposure particularly during any critical window(s) of susceptibility is not known, and a better understanding of the range of possible exposures and the degree to which they may or may not have elicited inhibition of AChE, remains a key scientific question.  In light of Panel discussions of Questions 4.3 and 5.3, please suggest approaches and/or analyses which would inform the understanding of the degree to which exposure levels experienced by the Columbia cohort participants may or may not have been below doses which result in 10% inhibition of AChE in the most sensitive lifestage.  Please discuss the strengths and uncertainties associated with such analyses.  Please include in your discussions approaches involving chlorpyrifos and its metabolites and also chlorpyrifos plus other AChE-inhibiting pesticides (propoxur, diazinon) which the cohort participants were exposed too.

11:45: A.M. 	Charge to Panel (Cont'd)

Question 6: Characterizing the range of potential risks.

The 2009 NRC report, Science and Decisions, focused on improving the technical analysis through the development and use of scientific knowledge and information to promote more accurate characterizations of risk, and thus improving the utility of risk assessment for risk-management decisions. The NRC report also pointed out that regulatory risk assessment does not routinely approach public health and environmental problems by arraying a wide range of options for dealing with them.  In the case of chlorpyrifos, in light of the discussions of Questions 1-5, please provide guidance for assessing and presenting the range of plausible responses at given doses, and the effect of the overall uncertainty and variability around that range.

12:30 P.M. 	Adjourn

Please be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the Designated Federal Official for this meeting, Dr. Fred Jenkins, via telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>


				SRC TR-12-033

HPV3 TOXICITY TEST PLAN REVIEW (DRAFT)

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester,
CASRN 22527-63-5

Prepared by:

William L. Richards, Teresa Manyin, and Laura Morlacci

Chemical, Biological and Environmental Center

SRC, Inc.

7502 Round Pond Road

North Syracuse, NY 13212

Contract No. EP-W-09-027

Task FG<IP_ADDRESS>

Submitted to:

OCSPP/OPPT/RAD (7403M)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, D.C. 20460

Debra Milligan, Project Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

March 9, 2012

HPV3 Toxicity Test Plan Review

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester,
CASRN 22527-63-5

The test rule, “Testing of Certain High Production Volume Chemicals;
Third Group of Chemicals” (76 FR 65385, October 21, 2011), requires
the following toxicity testing for propanoic acid, 2-methyl-,
3-(benzoyloxy)-2,2,4-trimethylpentyl ester, CASRN 22527-63-5: C1
(aquatic toxicity), D (mammalian toxicity – acute), E1 (bacterial
reverse mutation test), E2 (chromosomal aberration or micronucleus test)
and F1 (mammalian toxicity – repeated
dose/reproduction/developmental).  Eastman Chemical Company (Eastman)
submitted a test plan on February 20, 2011 to address the endpoints
required by the test rule.  The adequacy of the test plan is evaluated
below.

1.  General Comments:

The test rule classifies propanoic acid, 2-methyl-,
3-(benzoyloxy)-2,2,4-trimethylpentyl ester, CASRN 22527-63-5 as a Class
1 Chemical Substance for which testing must be conducted with material
having a purity of 99% or greater.  However, for toxicity testing,
Eastman proposes the use of a bulk reaction product of the following
purity: 60-65% propanoic acid, 2-methyl-,
3-(benzoyloxy)-2,2,4-trimethylpentyl ester (CASRN 22527-63-5), 20-25%
1,3-pentanediol, 2,2,4-trimethyl-1,3-dibenzoate (CASRN 68052-23-3), and
10-15% 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (CASRN 6846-50-0).
EPA approves Eastman’s plan to conduct aquatic and mammalian toxicity
tests of this mixture (“the bulk reaction product”) based on the
following:

(1) Eastman states that “The manufacture of benzoate ester for
commercial use has been as a bulk reaction and there is no readily
available process to synthesize the chemical substance by direct
reaction to achieve the purity required for Class 1 substances.  Eastman
believes that use of the bulk reaction product which is formulated into
finished products for commercial sale will more accurately represent
exposure and use of the benzoate ester and avoid a costly and
technically uncertain purification procedure.”

(2) In commerce, the bulk reaction product that is formed through an
esterification reaction between benzoic acid (CASRN 65-85-0) and
2,2,4-trimethyl-1,3-pentanediol diisobutyrate (CASRN 6846-50-0) results
in three chemicals (CASRNs 22527-63-5, 68052-23-3, and 6846-50-0).
These chemicals, the diesters of 2,2,4-trimethyl-1,3-pentanediol with
benzoic acid and 2-methylpropanoic acid (isobutyric acid), can be
considered close analogs.

(3) The major constituent of the bulk reaction product is the test rule
substance, propanoic acid, 2-methyl-,
3-(benzoyloxy)-2,2,4-trimethylpentyl ester, CASRN 22527-63-5.

For all toxicity tests, the final study report should include the
analyzed composition of the test substance, including identities and
concentrations of major ingredients and of impurities.

2.  Aquatic Toxicity

 ≥ 4.2 or an Acute Toxicity to Daphnia test using ASTM E 729-96
(Reapproved 2007) if the measured log Kow is < 4.2.

In addition to daphnid testing, the following studies of the bulk
reaction product must be conducted to fulfill testing requirement C1 of
the test rule:  Toxicity to Plants (Algae) using ASTM E 1218-04
(required for all chemicals regardless of log Kow value); and Acute
Toxicity to Fish using ASTM E 729-96 (Reapproved 2007) if the measured
log Kow is < 4.2.  Note that Eastman failed to include these required
tests in the submitted test plan.

3.  Mammalian Toxicity – Acute

EPA approves Eastman’s plan to conduct an Acute Oral Toxicity –
Up-and-Down Procedure test of the bulk reaction product using OECD TG
425 to fulfill testing requirement D.

4.  Bacterial Reverse Mutation Test

EPA approves Eastman’s plan to conduct a Bacterial Reverse Mutation
Test using 40 CFR 799.9510 of the bulk reaction product to fulfill
testing requirement E1.

5.  Chromosomal Aberration/Micronucleus Test

EPA approves Eastman’s plan to conduct an In vitro Mammalian
Chromosomal Aberration Test of the bulk reaction product using 40 CFR
799.9537 to fulfill testing requirement E2.

6.  Mammalian Toxicity – Repeated Dose/Reproduction/Developmental

For the following reasons, EPA does not approve Eastman’s request to
fulfill testing requirement F1 “through the use of data already
available on the three primary metabolites of the test substance:
namely benzoic acid, 2,2,4-trimethyl-1,3-pentanediol (TMPD) and
isobutyrate.”:

(1) For the diesters of 2,2,4-trimethyl-1,3-pentanediol (CASRNs
22527-63-5, 68052-23-3 and  6846-50-0) that are present in the bulk
reaction product that Eastman proposes for testing for the
physical/chemical properties, environmental fate, aquatic toxicity,
acute mammalian toxicity and genotoxicity endpoints, Eastman has not
provided data to show that non-enzymatic or enzymatic hydrolysis of
these esters will occur fast enough to justify testing of only the
presumptive hydrolysis products/metabolites for addressing the mammalian
repeated-dose, reproductive, and developmental toxicity endpoints.
Eastman cites an oral gavage study of diethyleneglycol dibenzoate, which
showed “that the ester linkages are completely hydrolyzed with no
evidence of parent compound in the urine”.  However, the rate and
extent of non-enzymatic or enzymatic hydrolysis of the three diesters
present in Eastman’s bulk reaction product (CASRNs 22527-63-5,
68052-23-3 and 6846-50-0) may be inhibited compared with
diethyleneglycol dibenzoate because of greater steric hindrance by the
branched 2,2,4-trimethylpentyl moiety than by the diethylene glycol
moiety.

(2) Eastman does not present a rationale to show that data from separate
repeated-dose, reproductive, and developmental toxicity studies of
individual hydrolysis products/metabolites of the bulk reaction product
would be adequate to characterize toxicity of the mixture of these
substances expected to occur in vivo.  Although data for the individual
hydrolysis products/metabolites are useful to address the overall
toxicity of the bulk reaction product, the data for these individual
hydrolysis products/metabolites would not address the potential for
interactions (e.g., additivity, synergism or antagonism) among these
degradatation products, mono-ester intermediates, and the residual
diesters of the bulk reaction product.  The likelihood for such
interactions could vary with exposure route since the acidic environment
of the stomach during oral exposure could result in higher rates of
nonenzymatic ester hydrolysis than for exposures by the inhalation or
dermal routes.

Based on the preceding discussion, testing requirement F1 should be
fulfilled by conducting a Combined Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity Screening Test (40 CFR 799.9365) of
the bulk reaction product; OR the Reproduction/Developmental Toxicity
Screening Test (40 CFR 799.9355) AND the Repeated Dose 28-Day Oral
Toxicity Study in Rodents Test (40 CFR 799.9305) of the bulk reaction
product.

Conclusion:  The submitted test plan for toxicity testing is adequate to
satisfy test rule requirements C1, D, E1, E2, and F1 with the exceptions
and stipulations listed above.

Final HPV3 Toxicity Test Plan Review		CASRN 22527-63-5

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