[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59017-59018]
[FR Doc No: 2013-23369]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9901-33-OAR]

Meeting of the Mobile Sources Technical Review Subcommittee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Mobile Sources Technical Review
Subcommittee (MSTRS) will meet on October 29, 2013. The MSTRS is a
subcommittee under the Clean Air Act Advisory Committee. This is an
open meeting. The meeting will include discussion of current topics and
presentations about activities being conducted by EPA's Office of
Transportation and Air Quality. The preliminary agenda for the meeting
and any notices about change in venue will be posted on the
Subcommittee's Web site: http://www.epa.gov/air/caaac/mobile_sources.html. MSTRS listserver subscribers will receive notification
when the agenda is available on the Subcommittee Web site. To subscribe
to the MSTRS listserver, send an email to<EMAIL_ADDRESS>
DATES: Tuesday, October 29, 2013 from 9:00 a.m. to 4:30 p.m.
Registration begins at 8:30 a.m.

ADDRESSES: The meeting is currently scheduled to be held at The Madison
Hotel at 1177 15th St. NW., Washington, DC 20005. However, this date
and location are subject to change and interested parties should
monitor the Subcommittee Web site (above) for the latest logistical
information. The hotel is located five blocks from the McPherson Square
Metro Station.

FOR FURTHER INFORMATION CONTACT: For technical information: Elizabeth
Etchells, Designated Federal Officer, Transportation and Climate
Division, Mailcode 6406J, U.S. EPA, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; Ph:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>For logistical and administrative
information: Ms. Cheryl Jackson, U.S. EPA, Transportation and Climate
Division, Mailcode 6406J, U.S. EPA, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460;<PHONE_NUMBER>; email<EMAIL_ADDRESS>    Background on the work of the Subcommittee is available at: http://www.epa.gov/air/caaac/mobile_sources.html. Individuals or
organizations wishing to provide comments to the Subcommittee should
submit them to Ms. Etchells at the address above by October 15, 2013.
The Subcommittee expects that public statements presented at its
meetings will not be repetitive of previously submitted oral or written
statements.

SUPPLEMENTARY INFORMATION: During the meeting, the Subcommittee may
also hear progress reports from some of its workgroups as well as
updates and announcements on activities of general interest to
attendees.
    For Individuals With Disabilities: For information on access or
services for individuals with disabilities, please contact Ms. Etchells
or Ms. Jackson (see above). To request accommodation of a disability,
please contact Ms. Etchells or Ms. Jackson, preferably at least 10 days
prior to the meeting, to give EPA as much time as possible to process
your request.

    Dated: September 18, 2013.
Christopher Grundler,
Director, Office of Transportation and Air Quality.
[FR Doc. 2013-23369 Filed 9-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Proposed Rules]
[Pages 62847-62848]
[FR Doc No: 2016-21938]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2016-8927; Airspace Docket No. 15-ANM-24]
RIN 2120-AA66

Proposed Establishment of Restricted Area R-2603; Fort Carson, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish restricted area R-2603
within the existing Fort Carson, CO, Pinon Canyon Maneuver Site (PCMS),
near Trinidad, CO. The U.S. Army requires additional restricted
airspace because the restricted area ranges at Fort Carson are not
large enough to meet all training requirements. The proposed R-2603
would provide increased ground-to-air, air-to-ground, and air-to-air
battle space to increase training capacity and relieve training
congestion at Fort Carson.

DATES: Comments must be received on or before October 28, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2016-8927 and Airspace Docket No. 15-ANM-24, at the beginning of
your comments. You may also submit comments through the Internet at
http://www.regulations.gov. Comments on environmental and land use
aspects should be directed to: Fort Carson NEPA Program Manager,
Directorate of Public Works, Environmental Division, 1626 Evans Street,
Building 12191, Fort Carson, CO 80913-4362. You may review the public
docket containing the proposal, any comments received, and any final
disposition in person in the Docket Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays. The Docket Office
is on the ground floor of the building at the above address.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, 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
the 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 would establish a restricted area at Fort Carson, CO,
to enhance aviation safety and accommodate essential Army training
requirements.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2016-8927 and Airspace Docket No. 15-ANM-24) and be submitted in
triplicate to the Docket Office at the address listed above. You may
also submit comments through the Internet at www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA

Docket No. FAA-2016-8927 and Airspace Docket No. 15-ANM-24.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at www.regulations.gov.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person at the Docket
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Western
Service Center, Federal Aviation Administration, 1601 Lind Ave. SW.,
Renton, WA 98057.

Background

    To conduct realistic and coordinated large-scale training that
integrate ground and air resources, the U.S. Army must maintain large
maneuver and training areas of varying characteristics and complex
terrain. As the overseas deployment cycle slows, soldiers must now
train more often at home station in order to sustain their combat
skills. As a result, competition among units for training time and
space at Fort Carson, CO, will sharply increase. Fort Carson provides
training for up to ten Army Brigades per year. In addition, Fort Carson
conducts training with Reserve, National Guard, joint services, foreign
military services, special operations forces and other Federal
agencies. The current training areas and ranges at Fort Carson do not
have the capacity to accommodate all current and evolving large-scale,
integrated training requirements. To address this training shortfall,
the Army must take advantage of the larger space and greater training
capacity available at the existing Pinon Canyon Maneuver Site (PCMS),
near Trinidad, CO. The PCMS is a military training site for Fort
Carson, CO. The proposed designation of restricted area R-2603, within
the PCMS, would provide the increased space needed to conduct various
activities including force-on-force maneuver training, lasers and
hazardous ground-to-air, air-to-ground and air-to-air operations.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 73 to establish a
new restricted area, designated R-2603, extending from the surface to
but not including 10,000 feet MSL, within the existing Fort Carson
PCMS. The proposed restricted area would contain various hazardous
activities including, but not limited to: Electronic jamming;
pyrotechnic activities; airborne and ground-based lasers; hazardous
air-to-ground, ground-to-air and air-to-air activities involving fixed-
wing and rotary-wing aircraft; and night-time lights-out flight
maneuvers. Additionally, only ``non-dud'' producing munitions (40
millimeter and below) would be fired in the proposed restricted area.
    R-2603 would be activated for specific times as announced by
issuance of a Notice to Airmen (NOTAM). It is estimated that the area
would be required to support approximately five training cycles per
year with the longest duration of each cycle being approximately four
to five weeks. The area would be activated only when needed to support
operations that pose a hazard to aviation.
    The U.S. Army requested this action to provide additional
restricted airspace to resolve a training capacity shortfall at Fort
Carson, CO.

Regulatory Notices and Analyses

    The FAA has determined that this proposed 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
Department of Transportation (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 will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subjected to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, restricted areas.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

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

Sec.   73.26 Colorado (Amended)

0
2. Sec.  73.26 is amended as follows:
* * * * *

R-2603 Fort Carson, CO [New]

    Boundaries. Beginning at lat. 37[deg]22'30'' N., long.
104[deg]04'47'' W.; to lat. 37[deg]21'15'' N., long. 104[deg]02'35''
W.; to lat. 37[deg]21'10'' N., long. 103[deg]54'41'' W.; to lat.
37[deg]32'46'' N., long. 103[deg]42'46'' W.; to lat. 37[deg]38'33''
N., long. 103[deg]35'11'' W.; to lat. 37[deg]38'32'' N., long.
103[deg]48'43'' W.; to lat. 37[deg]38'10'' N., long. 103[deg]48'47''
W.; to lat. 37[deg]35'57'' N., long. 103[deg]54'40'' W.; to lat.
37[deg]35'59'' N., long. 103[deg]57'50'' W.; to lat. 37[deg]33'21''
N., long. 103[deg]57'55'' W.; to lat. 37[deg]32'27'' N., long.
104[deg]02'15'' W.; to lat. 37[deg]32'27'' N., long. 104[deg]06'32''
W.; thence to the point of beginning.
    Designated altitudes. Surface to but not including 10,000 feet
MSL.
    Time of designation. By NOTAM.
    Controlling agency. FAA, Denver ARTCC.
    Using agency. U.S. Army, Commander, Fort Carson, CO.

    Issued in Washington, DC, on September 6, 2016.
Leslie M. Swann,
Acting Manager, Airspace Policy Group.
[FR Doc. 2016-21938 Filed 9-12-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43748-43749]
[DOCID:fr28jy08-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-436-000]

Midwestern Gas Transmission Company; Notice of Request Under
Blanket Authorization

July 17, 2008.
    Take notice that on July 8, 2008, Midwestern Gas Transmission
Company (Midwestern), 100 West 5th Street, ONEOK Plaza, Tulsa, Oklahoma
74103, filed in Docket No. CP08-436-000, an application pursuant to
sections 157.205, 157.208, and 157.210 of the Commission's Regulations
under the Natural Gas Act (NGA) as amended, to modify facilities at the
Sullivan compressor station located in Sullivan County, Indiana, and
the Paris compressor station located in Edgar County, Illinois, under
Midwestern's blanket certificate issued in Docket No. CP82-414-000,\1\
all as more fully set forth in the application which is on file with
the Commission and open to the public for inspection.
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    \1\ 20 FERC ] 62,411 (1982).
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    Midwestern states that it proposes to construct, own, and operate
two additional bi-directional suction and two additional discharge
pipeline segments, one of each at both the Sullivan (compressor station
2113) and Paris (compressor station 2115) compressor stations.
Midwestern also states that both compressor stations are currently
designed only to allow natural gas volumes to flow northward on
Midwestern's line 2100-1. Midwestern further states that the project
would provide incremental capability to allow up to 150,000 Dth/day of
natural gas to flow southbound and that the proposed facilities would
cost approximately $3,840,492 to construct.
    Any questions concerning this application may be directed to Joseph
W. Miller, Midwestern Gas Transmission Company, 100 West 5th Street,
ONEOK Plaza, Tulsa, Oklahoma 74103, or via telephone at<PHONE_NUMBER>
or via facsimile at<PHONE_NUMBER>.
    This filing is available for review at the Commission or may be
viewed on the Commission's Web site at http://www.ferc.gov, using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number filed to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or, for
TTY, contact<PHONE_NUMBER>. Comments,

protests and interventions may be filed electronically via the Internet
in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site under the ``e-Filing'' link. The
Commission strongly encourages intervenors to file electronically.
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-17159 Filed 7-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 1, 2008 (Volume 73, Number 63)]
[Notices]
[Page 17392-17393]
[DOCID:fr01ap08-89]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57559; File No. SR-NYSEArca-2008-34]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to the
Implementation of Phase Two of the Options Penny Pilot

March 26, 2008.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 25, 2008, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been substantially prepared by the Exchange. NYSE Arca has
designated this proposal as one constituting a stated policy, practice,
or interpretation with respect to the meaning, administration, or
enforcement of an existing rule under section 19(b)(3)(A)(i) of the Act
\3\ and Rule 19b-4(f)(1) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca is proposing to implement the next phase of the Penny
Pilot in options classes (``Pilot Program''), by identifying the
additional issues to be added to the Pilot Program. The text of the
proposed rule change is available on the Exchange's Web site (http://
www.nysearca.com), at NYSE Arca's principal office, and at the
Commission's Public Reference Room.\5\
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    \5\ Exhibit 3 to the filing contains a Regulatory Bulletin that
constitutes the text of the proposed rule change.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NYSE Arca included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On September 27, 2007, the Commission approved the Exchange's
proposal to (i) extend the Pilot Program through March 27, 2009, and
(ii) expand the Pilot Program to include an additional twenty-eight
underlying

issues on March 28, 2008 (``Phase II'').\6\ The Exchange hereby
proposes to implement Phase II of the Pilot Program on March 28, 2008,
by adding twenty-eight additional issues, bringing the total number of
issues included in the Pilot Program to sixty-three. These twenty-eight
new options classes are among the most actively traded, multiply-listed
options classes. A Regulatory Bulletin, attached to the proposed rule
change as Exhibit 3 and disseminated to NYSE Arca's members, identifies
these additional twenty-eight underlying securities. Pursuant to NYSE
Arca Rule 6.72, this Regulatory Bulletin will also be published by the
Exchange on its Web site. The thirty-five classes currently in the
Pilot Program will continue to be quoted as they are today.
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    \6\ See Securities Exchange Act Release No. 56568 (September 27,
2007), 72 FR 56422 (October 3, 2007) (SR-NYSEArca-2007-88).
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
and furthers the objectives of Section 6(b)(5) of the Act,\7\ in that
it is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest.
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    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change has become effective pursuant to section
19(b)(3)(A)(i) of the Act\8\ and Rule 19b-4(f)(1) thereunder,\9\
because it constitutes a stated policy, practice, or interpretation
with respect to the meaning, administration, or enforcement of an
existing rule of the Exchange.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(i).
    \9\ 17 CFR 240.19b-4(f)(1).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\10\
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    \10\ See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2008-34 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2008-34. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the NYSE Arca. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2008-34 and should
be submitted on or before April 22, 2008.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-6656 Filed 3-31-08; 8:45 am]

BILLING CODE 8011-01-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2006 MEMORANDUM SUBJECT: Agency Response to Comments on the 2002 Lindane RED FROM: Mark T. Howard Chemical Review Manager Reregistration Branch 3 TO: Public Docket for Lindane ( FDMS Docket # OPP 2002 0202)

The Agency received a broad range of comments in response to EPA's Notice of Availability for Public Comment on the Lindane Reregistration Eligibility Decision ( 67 FR 59500, September 23, 2002). The Federal Register Notice 60 day public comment period ran from September 23 to November 22, 2002. A total of 229 comments were received from registrants, private citizens, state and local government agencies, non profit environmental and consumer groups, industry interest groups, and commodity based associations. The vast majority of comments came from private citizens through an e mail campaign asking to discontinue the use of lindane, particularly pharmaceutical uses of lindane. The attachments to this memo address new issues raised by the public. Several comments received were redundant from previous comment periods and responses can be found in earlier response to comment documents.

There are four attachments to this document, as follows: Attachment A, a memorandum from the Health Effects Division ( HED), addresses comments on the human health risk assessment; Attachment B, a memorandum from the Environmental Fate and Effects Division ( EFED), addresses comments on the environmental risk assessment; Attachment C, a memorandum from the Office of General Counsel, addresses a data compensation issue; and Attachment D, a document that lists all the names of stakeholder groups who submitted comments.

While the attachments to this document respond to technical questions and comments on the Lindane RED, this memorandum also describes EPA policy on whether the Federal Food, Drug, and Cosmetic Act ( FFDCA) requires the Agency to include in its safety assessment those exposures resulting from the use of lindane in pharmaceutical products in response to the public comments on this issue.

Public Comments. Crompton Corporation argued that pharmaceutical uses should not be considered in the risk assessment. The Consumer Specialty Products Association argued that that EPA does not have the authority under FFDCA & FQPA to regulate any non pesticide, food use 2 ( such as pharmaceutical uses). The Consumers Union argued that FQPA requires that EPA consider pharmaceutical uses. Beyond Pesticides argued that all pharmaceutical uses should be included in the aggregate risk assessment. The American Chemistry Council argued that FQPA does not intend for EPA to incorporate any pharmaceutical use or non pesticidal uses in its aggregate assessments. The Natural Resources Defense Council argued that EPA needs to aggregate pharmaceutical use in its risk assessments.

After carefully considering the comments from the public, FDA, public interest groups, industry groups, and other interested parties, EPA has concluded the following:

In determining the risk to human health, the Agency examines more than just dietary exposures. Section 408 of FFDCA requires EPA to consider potential sources of exposure to a pesticide and related substances in addition to the dietary sources expected to result from a pesticide use subject to the tolerance. In order to determine whether to maintain a pesticide tolerance, EPA must " determine that there is a reasonable certainty of no harm. . . ." Under FFDCA section 505, the Federal Drug Administration reviews human drugs for safety and effectiveness and may approve a drug notwithstanding the possibility that some patients may experience adverse side effects. EPA does not believe that, for purposes of the section 408 dietary risk assessment, it is compelled to treat a pharmaceutical patient the same as a non patient, or to assume that combined exposures to pesticide and pharmaceutical residues that lead to a physiological effect in the patient constitutes " harm" under the meaning of section 408 of the FFDCA.

EPA believes the appropriate way to consider the pharmaceutical use of lindane in its risk assessment would be to examine the impact that the additional non occupational pesticide exposures would have to a pharmaceutical patient exposed to the same compound. Where the additional pesticide exposure has no more than a minimal impact on the pharmaceutical patient, EPA could make a reasonable certainty of no harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA. If the potential impact on the pharmaceutical user as a result of co exposure from pesticide use is more than minimal, then EPA would not be able to conclude that pesticide residues were safe.

However, in the case of lindane, the Agency will be publishing an Addendum to the RED that addresses the continued registration of lindane. Thus, the co exposure approach discussed above is not being presented in this document.

Further information on FDA and how it regulates lindane can be obtained from its website: www. fda. gov; e. g., http:// www. fda. gov/ bbs/ topics/ ANSWERS/ ANS00725. html.

Atttachments Attachment A A  1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 Office of Prevention, Pesticides and Toxic Substances February 28, 2003 MEMORANDUM SUBJECT: Lindane; Chemical No. 009001. HED's Response to Public Comment on HED's Revised Risk Assessment for Lindane Registration Eligibility Document ( RED)

DP Barcode: D287964 Reregistration Case #: 0315 FROM: Becky Daiss Environmental Health Scientist Reregistration Branch 4/ HED ( 7509C)

THROUGH: Susan Hummel Branch Senior Scientist Reregistration Branch 4/ HED ( 7509C)

TO: Mark Howard Reregistration Branch 3 Special Review & Reregistration Division ( 7508C)

This provides the Health Effects Division's ( HED) response to comments from the public on EPA's July 31, 2002 Revised Human Health Risk Assessment for Lindane ( gammahexachlorocyclohexane The following organizations submitted comments on the human health risk assessment; National Resources Defence Council ( NRDC), National Pediculosis Association, Inc. ( NPA), Pesticide Action Network North America ( PANNA), Alaska Community Action on Toxics ( ACAT), Beyond Pesticides, Office of the Attorney General of the State of New York, Crompton Corporation, American Chemistry Council ( ACC), and Consumer Specialties Products Association, Inc ( CSPA). This memorandum addresses only those comments that have not been raised and responded to in previous public comment and response documents. ( B. Daiss, D282320, 4/ 25/ 02, D280623, 1/ 30/ 2002) Attachment A A  2 Comments on the Assessment of Risks from Use of Lindane for Treatment of Lice and Scabies Public Comment: In comments on the blood level analysis used to assess potential risks from lindane used as a scabies treatment, Crompton Corporation disagrees with HED's use of a 10 fold uncertainty factor to account for variability of responses in humans. Crompton states that an uncertainty factor of 10 is not necessary because the comparison of blood levels rather than administered dose takes into account the phamacokinetics portion of the 10 fold intraspecies uncertainty factor and that, therefore, a 3 fold factor is sufficient.

HED Response: HED believes that use of an uncertainty factor of 10 to address intraspecies variation in exposure related effects is reasonable regardless of the route of administration and irrespective of whether potential differences in phamacokinectic uptake and distribution are accounted for.

Public Comment: NRDC, Office of Attorney General of the State of New York, PANNA, ACAT, and NPA commented on HED's failure to perform a Margin of Exposure ( MOE) analysis for use of lindane to treat head lice. Several of these organizations submitted MOE analyses for EPA's consideration.

HED Response: As should have been pointed out in HED's Revised Assessment of Risk from Use of Lindane for Treatment of Lice and Scabies, HED did not conduct an MOE analysis of potential risk from lindane treatment of head lice because we do not believe that there is sufficient data to conduct a reasonable, scientifically sound quantification of MOE's associated with lindane treatment of head lice. Critical data on the dermal absorption associated with the short application interval typical of lice treatment are unavailable. While HED has data on dermal absorption of lindane associated with 24 hour exposure periods ( which were used to assess potential risk from treatment of scabies), we do not have absorption data for the 5 to 15 minute exposure duration associated with head lice treatment. HED does not believe that the 24 hour dermal absorption factors derived from both human and monkey studies is applicable to 5 to 15 minute exposures, nor do we believe is possible to extrapolate to a shorter duration factor with any degree of certainty. A linear extrapolation of dermal absorption from 24 hours to 15 minutes would result in dermal absorption factors well below any of those used in the analyses submitted by commenters. An assumption of positive linear correlation is highly uncertain, however, and has minimal scientific basis. Commenters submitting MOE assessments also tended to assume that the amount of lindane available for absorption from head lice treatment was the same as that for scabies treatment. This is not the case as lindane products used for lice treatment are applied to a much smaller area ( i. e., the scalp) than scabies treatment products, which are applied to the entire body below the neck. There are clearly uncertainties associated with the blood level analysis HED used to assess potential risks from use of lindane to treat lice, as discussed in the analysis. However, HED believes that the significant difference in blood levels associated with acute accidental ingestion which resulted in short term adverse effects versus blood levels associated with label prescribed head lice treatment ( 0.00613 ug/ mL vs 0.32 ug/ mL respectively) Attachment A A  3 indicates that label prescribed use of lindane head lice products does not pose human health risks of concern.

Public Comment: NPA argued that the Agency for Toxic Substances and Drug Registration's ( ATSDR's) NOAEL of 1 mg/ kg/ day for acute oral exposure should have been used by HED in its assessment of risk from lindane treatment of lice and scabies. NPA submitted an MOE analysis of potential risks from lice treatment in which it compared MOEs derived using the ATSDR NOAEL and the NOAEL used by HED in its analysis of risk from scabies treatment.

HED Response: HED used a NOAEL of 6 mg/ kg/ day based on an acute oral toxicity study in rats. The ATSDR NOAEL of 1 mg/ kg/ day is similarly based on a short term oral rat study ( 4 days, 1 dose per day). HED believes that the determination of similar NOAELs by EPA and ATSDR supports the endpoint used in HED's assessment of scabies treatment. Use of a NOAEL of 1 mg/ kg/ day would not significantly increase the very low MOE's derived in HED's assessment of scabies treatment nor would it alter HED's conclusion that our analysis indicates MOE's of concern from both high and low end treatment scenarios for all ages assessed. Regarding NPA's MOE analysis of head lice treatment, as noted in the response to the previous comment, HED does not believe that there is sufficient data to conduct a reasonable, scientifically sound quantification of MOE's associated with lindane treatment of head lice.

Comments on Assessment of Occupational Risk Public Comment: Crompton Corporation argued that EPA should note that the occupational risks associated with treatment of canola seed are acceptable if respiratory protection is required of the seed treaters.

HED Response: HED agrees that use of respirators during treatment of canola seed would result in MOEs that are above the target MOE of 100 for occupational exposure and would therefore not pose risks of concern. Attachment B B  1 PC Code: 009001 DP Code: D287966 MEMORANDUM DATE: March 26, 2003 SUBJECT: Response to Final Comments the RED Lindane TO: Betty Shackleford, Branch Chief Mark T. Howard, Team Leader Special Review and Reregistration Division ( 7508C)

FROM: Nicholas E. Federoff, Wildlife Biologist, Team Leader Faruque Khan, Ph. D., Environmental Scientist José L. Meléndez, Chemist Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C)

THROUGH: Mah T. Shamim, Ph. D., Chief Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C)

EFED has received a number of comments from the registrant as well as other interested groups and individuals regarding the RED chapter. EFED comments are as follows:

Comments # 34 California Regional Water Quality Control Board ( CRWQCB)

The USEPA underestimates discharge during environmentally relevant time frames. The risk assessment should be structured to include concentrations estimated on 1 hour and four hour frames, as well as lifetime exposure risk estimates.

EPA selected results from a statistical distribution for the estimation of lindane drinking water concentrations. The 10th percentile stream dilution factor ( SDF) was recommended to represent acute concentrations likely to be found in drinking waters, while 50th percentile SDF was recommended to represent chronic concentrations. EFED should again indicate that these recommendations are based on statistical distribution curves, for the estimation of acute and Attachment B B  2 chronic time frames. These values are used for the estimation of risk of exposure to humans, according to the Guidelines for Exposure Assessment ( USEPA, 1992a).

The analysis relies on dilution in estimating surface water concentrations of pesticides. However, numerous wastewater treatment plants discharge into otherwise dry streams or into shallow, poorly mixed water bodies composed primarily or their effluent:

EFED's purpose was to estimate concentrations of lindane in possible sources of drinking water. It is doubtful that wastewaters coming directly from treatment facility or plant would be used as a source of drinking waters.

Comments # 43 Crompton Corporation Lindane does not break down into pentachlorohexane, but into pentachlorohexene:

This issue has been addressed previously under DP Barcode D274510. EPA states that lindane is highly persistent, with a half life of 2.6 years in soil, while studies in the field showed shorter half lives of 25, 65, and 107 days:

This issue has been addressed previously under DP Barcode D274510.

Comments # 47 Pesticide Action Network North America ( PANNA), and Alaska Community Action on Toxics ( ACAT)

PANNA and ACAT suggest that The Agency does not have sufficient evidence and/ or data to suggest that mammals will be averse to the consumption of treated seeds and analysis of endocrine disrupting effects of lindane to wildlife.

EFED fully agrees with PANNA and ACAT and has stated such in our DRAFT chapter. We do have data regarding possible aversion in some avian species but none for mammalian species. In addition, we have strongly suggested from available data that lindane may be an endocrine disrupting compound and should fully be tested as such when such policy, directives and procedures become available within The Agency.

Comments # 49 Beyond Pesticides Lindane is highly persistent in soils and is stable in both fresh and salt water.

The issue of the persistence of Lindane in soil and water has been addressed previously in the RED chapter and under DP Barcode D274510. Attachment B B  3 Lindane's use as a lice and scabies treatment and its endocrine disrupting properties must be considered in the assessment of ecological risk. Also, EPA can't assume that mammals will express the same aversion to eating lindane treated seed as birds do.

EFED fully agrees with BEYOND PESTICIDES and has stated such in our DRAFT chapter. We do have data regarding possible aversion in some avian species but none for mammalian species. In addition, we have strongly suggested from available data that lindane may be an endocrine disrupting compound and should be fully tested as such when policy, directives and procedures become available within The Agency. Regarding risks from Lindane's scabies and lice use, EFED did run a " down the drain" model and concluded that risk from any additional concentrations was very minor and would not increase the aquatic risk substantially more than already stated in the RED chapter .

Comments # 54 County Sanitation Districts, of Los Angeles County ( CSDs)

The CSDs indicate that the EFED memorandum relied upon sales rates of lindane pharmaceuticals and theoretical calculations to determine lindane loadings to surface waters, not actual effluent concentrations at a POTW. The EFED reported 0.03 ppb from the Publicly Owned Treatment Works ( POTWs) of Sanitation Districts of Los Angeles County. However, CSDs indicates that theoretical calculations were used while actual POTW effluent values were available to EPA. Data were submitted to the EPA by the Districts, including 474 influent lindane samples, and 743 effluent lindane samples ( from 1990 to 1999). The OPP model does not account for the significant variability in the actual data. While the average effluent lindane concentrations among the wastewater treatment plants varied from 10 to 40 ppt, maximum effluent lindane concentrations up to 340 ppt were recorded.

The application of the 10th stream dilution values to determine acute risks is inappropriate. Acute risk is generally defined as a risk based on short term exposure, not a risk based on having drinking water coming from a lower flow stream.

OPP EFED used sales data of pharmaceutical usages of lindane and actual POTW effluent values of lindane for the year of 2000 to estimate the loadings to surface waters. The estimated concentrations are comparable for both scenarios. EFED was not aware of 743 effluent lindane concentrations collected during 1990 to 1999. However, using the reported maximum effluent lindane concentration of 0.340 µ g/ L ( 340 ppt), the estimated acute concentration 4.5E 03 µ g/ L) and chtonic concentratino ( 3.4 E 04 µ g/ L) are many fold lower than the DWLOC ( Crinking Water Level of Comparison) for acute ( 170 µ g/ L) and chronic ( 14 µ g/ L) concentrations as well as current MCL ( 0.2 µ g/ L) for lindane.

The EPA OPP needs to prepare a parallel document that considers the concentrations of lindane in surface waters that are not sources of drinking waters. Attachment B B  4 In general, the estimated acute and chronic concentrations of drinking water are always more conservative than the surface waters that are not sources of drinking waters. Therefore, the estimates of acute and chronic exposures due to pharmaceutical usages of lindane in non drinking surface water bodies will be lower than the surface water sources of drinking water. EFED believes that further assessment of pharmaceutical usages of lindane in non drinking surface water is not warranted at this time.

REFERENCE: U. S. Environmental Protection Agency. 1992a. Guidelines for Exposure Assessment. Federal Register 57( 104): 22888   22938 Attachment C C  1 MEMORANDUM SUBJECT: Lindane; Chemical No. 009001. OGC's Response to Public Comment on the Lindane Registration Eligibility Document ( RED)

Reregistration Case #: 0315 FROM: Gautam Srinivasan Attorney Advisor Pesticides and Toxic Substances Law Office ( 2333A)

THROUGH: Kevin Lee Assistant General Counsel Pesticides and Toxic Substances Law Office ( 2333A)

TO: Mark Howard Reregistration Branch 3 Special Review & Reregistration Division ( 7508C)

This memorandum responds to a comment submitted by Syngenta Crop Protection, Inc. on the Lindane Registration Eligibility Document.

Comment: Syngenta Crop Protection, Inc. (" Syngenta") objected to the use of an occupational exposure study ( the " Helix Study") conducted by Syngenta to support the registration of the active ingredient thiamethoxam. Syngenta stated that the Helix Study meets the statutory and regulatory criteria for exclusive use protection. Because the Helix Study is an exclusive use study, Syngenta argued it was unlawful for EPA to use the Helix Study to evaluate certain on farm seed treatment uses of lindane. Syngenta asked that EPA remove all references to the Helix Study from the lindane RED and that EPA not reregister any remaining uses of lindane until acceptable occupational exposure data are provided to EPA.

Response: EPA disagrees with Syngenta with regard to use of the Helix Study. EPA is not limited in the data it may consider when making a risk benefit determination in connection with the development of a reregistration eligibility determination for a particular pesticide. EPA has long drawn a distinction between data that must be submitted to satisfy the requirements of 40 CFR part 158, and data that may be reviewed to make a risk benefit determination. EPA has stated that when reviewing the risk benefit criteria, " EPA may consider any relevant data without regard to who submitted the data, for what purpose, or when the data were submitted." 49 FR 30884, 30888 ( Aug. 1, 1984). This includes review of exclusive use data. When, however, EPA reviews individual products to determine whether they have complied with the data requirements of registration or reregistration, EPA will ensure that the registrants of such products submit or cite required studies. Attachment C C  2 The fact that EPA reviews an exclusive use study in making a risk benefit determination in a RED document does not deny the data owner the protections afforded by FIFRA. The economic interests of the data submitter are protected through the registration and reregistration of individual products. It is in connection with those activities that EPA must determine whether an applicant or registrant has submitted or cited data required for the registration or continued registration of the pesticide product.

An applicant for registration or reregistration may not satisfy a 40 CFR part 158 requirement by citing an exclusive use study. EPA explained this in detail in the 1984 FR notice: " The prohibition against unauthorized citation of an exclusive use study applies only to an applicant's right to cite another's study in his application for registration, not to the Agency's review of data to determine whether or not the pesticide should be registered on risk/ benefit grounds. The Agency's review of data for this purpose in no way negates or compromises the rights of the exclusive use data submitter or undermines the intent of Congress in providing such protection. A second applicant who wishes to cite the exclusive use study must obtain the written authorization of the exclusive use data submitter. If permission is denied, the second applicant is not precluded from entering the market, but must first replicate the necessary data or obtain it from another source. Thus, the exclusive use data submitter is assured that no competitor enters the market without either having his permission to cite data submitted to EPA ( which he may condition upon the payment of royalties or compensation) or having generated ( or otherwise acquired) at least the equivalent set of data required for registration." 49 FR at 30888.

Therefore, it was not unlawful for EPA to utilize the Helix Study in making the risk benefit determination captured in the lindane RED. EPA will not remove references to the Helix Study from the lindane RED. Such references do not violate or compromise Syngenta's exclusive use protection. EPA will, however, ensure appropriate protection for any data required for specific product registration or reregistration in connection with product registration and reregistration activities. Attachment D D  1 List of organizations submitting comments on the 2002 Lindane RED ( OPP 2002 0202):

Various Private Citizens California Regional Water Quality Control Board County Sanitation Districts of Los Angeles Technology Sciences Group, Inc.

Consumer Specialty Products Assoc. ( CSPA)

Pesticide Action Network North America ( PANNA)

Consumers Union Beyond Pesticides Syngenta Crop Protection, Inc.

National Pediculosis Association American Chemistry Council Natural Resources Defense Council ( NRDC)

State of New York; Office of the Attorney General