[Federal Register Volume 76, Number 123 (Monday, June 27, 2011)]
[Notices]
[Page 37360]
[FR Doc No: 2011-16028]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1975-DR; Docket ID FEMA-2011-0001]

Arkansas; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Arkansas (FEMA-1975-DR), dated May 2, 2011, and related
determinations.

DATES: Effective Date: June 6, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, 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 the incident
period for this declared disaster is now April 14, 2011, through and
including June 3, 2011.

    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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-16028 Filed 6-24-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20390-20392]
[FR Doc No: 2011-8621]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64197; File No. SR-CBOE-2011-034]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated: Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Extension of Waiver of Transaction Fee for
Public Customer Orders in SPY Options Executed in Open Outcry or in the
Automated Improvement Mechanism

April 6, 2011.
    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 31, 2011, Chicago Board Options Exchange, Incorporated
(``CBOE'' or the ``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 prepared by CBOE. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Chicago Board Options Exchange, Incorporated (``CBOE'' or
``Exchange'')

proposes to amend its Fees Schedule to extend through June 30, 2011, a
waiver of the transaction fee for public customer orders in options on
Standard & Poor's Depositary Receipts that are executed in open outcry
or in the Automated Improvement Mechanism. The text of the proposed
rule change is available on the Exchange's Web site (http://www.cboe.org/legal), at the Exchange's Office of the Secretary and at
the Commission.

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

    In its filing with the Commission, CBOE 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. CBOE 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, Proposed Rule Change

(a) Purpose
    The Exchange currently waives the $.18 per contract transaction fee
for public customer (``C'' origin code) orders in options on Standard &
Poor's Depositary Receipts (``SPY options'') that are executed in open
outcry or in the Automated Improvement Mechanism (``AIM'').\3\ This fee
waiver is due to expire on March 31, 2011. The Exchange proposes to
extend the fee waiver through June 30, 2011.\4\ The proposed fee waiver
is intended to attract more customer volume on the Exchange in this
product.
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    \3\ See Securities Exchange Act Release No. 34-62902 (September
14, 2010), 75 FR 57313 (September 20, 2010), Securities Exchange Act
Release No. 34-63422 (December 3, 2010), 75 FR 76770 (December 9,
2010) and CBOE Fees Schedule, footnote 8. AIM is an electronic
auction system that exposes certain orders electronically in an
auction to provide such orders with the opportunity to receive an
execution at an improved price. AIM is governed by CBOE Rule 6.74A.
    \4\ The Exchange notes that transaction fees are also currently
waived for customer orders of 99 contracts or less in ETF (including
SPY options), ETN and HOLDRs options. See CBOE Fees Schedule,
footnote 9.
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(b) Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Securities Exchange Act of 1934 (``Act''),\5\ in
general, and furthers the objectives of Section 6(b)(4) \6\ of the Act
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among CBOE
Trading Permit Holders and other persons using its facilities. The
Exchange believes the proposed extension of the fee waiver is equitable
because the fee waiver would apply uniformly to all public customers
trading SPY options. The Exchange believes the proposed extension of
the fee waiver is reasonable because it would continue to provide cost
savings during the extended waiver period for public customers trading
SPY options. Further, the Exchange believes the proposed fee waiver is
consistent with other fees assessed by the Exchange. Specifically, the
Exchange assesses manually executed broker-dealer orders a different
rate ($.25 per contract) as compared to electronically executed broker-
dealer orders ($.45 per contract).\7\ Other exchange fee schedules also
distinguish between electronically and non-electronically executed
orders.\8\
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
    \7\ See CBOE Fees Schedule, Section 1.
    \8\ NASDAQ OMX PHLX, Inc. categorizes its equity options
transaction fees for Specialists, ROTs, SQTs, RSQTs and Broker-
Dealers as either electronic or non-electronic. See NASDAQ OMX PHLX
Fees Schedule, Equity Options Fees. NYSE Amex, Inc. categorizes its
options transaction fees for Non-NYSE Amex Options Market Makers,
Broker-Dealers, Professional Customers, Non BD Customers and Firms
as either electronic or manual. See NYSE Amex Options Fees Schedule,
Trade Related Charges. NYSE Arca, Inc. categorizes its options
transaction fees for Customers, Firms and Broker-Dealers as either
electronic or manual. See NYSE Arca Options Fees Schedule, Trade
Related Charges.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of 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 foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and subparagraph (f)(2) of Rule 19b-4 \10\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend 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.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
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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-CBOE-2011-034 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549.

All submissions should refer to File Number SR-CBOE-2011-034. 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 Web site viewing and
printing 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 such filing also will be available for
inspection and copying at the principal office of CBOE. 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-CBOE-2011-034 and should be submitted on or before May 3,
2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8621 Filed 4-11-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Rules and Regulations]
[Pages 46417-46420]
[FR Doc No: 2017-21111]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2016-0620; FRL-9968-74-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
State of Utah; Revisions to Ozone Offset Requirements in Davis and Salt
Lake Counties

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve State Implementation Plan (SIP) revisions submitted
by the State of Utah on August 20, 2013, and on June 29, 2017. The
submittals revise the portions of the Utah Administrative Code (UAC)
that pertain to ozone offset requirements in Davis and Salt Lake
Counties for major sources. This action is being taken under section
110 of the Clean Air Act (CAA) (Act).

DATES: This final rule is effective on November 6, 2017.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification Number EPA-R08-OAR-2016-0620. All documents in
the docket are listed on the http://www.regulations.gov index. Although
listed in the index, some information may not be publicly available,
e.g., Confidential Business Information or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129. The EPA requests that you contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section to
view the hard copy of the docket. You may view the hard copy of the
docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal
holidays.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 20, 2013, with supporting administrative documentation
submitted on September 12, 2013, Utah sent the EPA revisions to their
nonattainment permitting regulations, specifically to address EPA
identified deficiencies in those regulations that may also affect the
EPA's ability to approve Utah's fine particulate matter
(PM2.5) SIP. These revisions addressed R307-403-1 (Purpose
and Definitions), R307-403-2 (Applicability), R307-403-11 (Actual
Plant-wide Applicability Limits (PALs)), and R307-420 (Ozone Offset
Requirements in Davis and Salt Lake Counties). On June 2, 2016, the EPA
entered into a consent decree with the Center for Biological Diversity,
Center for Environmental Health, and Neighbors for Clean Air regarding
a failure to act, pursuant to CAA sections 110(k)(2)-(4), on certain
complete SIP submissions from states intended to address specific
requirements related to the 2006 p.m.2.5 NAAQS for certain
nonattainment areas, including the submittal from the Governor of Utah
dated August 20, 2013.
    On February 3, 2017, the EPA published a final rulemaking (82 FR
9138) to conditionally approve the revisions in Utah's August 20, 2013
submittal, except for the revisions to R307-420. The submittal did not
contain the appropriate supporting documentation required for the EPA
to take action on R307-420. As a result, the EPA requested an extension
for taking action on R307-420, and on December 20, 2016, the EPA was
granted an extension which moved the deadline for taking final action
on R307-420 from January 3, 2017, to September 29, 2017 (See docket).
Utah submitted on June 29, 2017, an additional SIP revision that
addresses the lack of appropriate supporting documentation for R307-
420.

II. Response to Comments

    No comments were received on our July 14, 2017 notice of proposed
rulemaking (82 FR 32517).

III. Final Action

    The EPA is taking final action to approve Utah's revisions to R307-
420 and R307-403-6, as submitted on August 20, 2013, and June 29, 2017.
R307-420 maintains the offset provisions of the nonattainment area new
source review (NNSR) permitting program in Salt Lake and Davis Counties
after the area is re-designated to attainment for ozone. R307-420 also
establishes more stringent offset requirements for nitrogen oxides that
may be triggered as a contingency measure under Utah's ozone
maintenance plan. R307-420 was also modified to include the definitions
and applicability provisions of R307-403 (Permits: New and Modified
Sources in Nonattainment Areas and Maintenance Areas) to ensure that
the definitions and applicability provisions in R307-420 are consistent
with related permitting rules in R307-403. The EPA is taking final
action to approve these revisions.
    On August 20, 2013, Utah submitted revisions to the definitions in
the NNSR program that addressed certain deficiencies in the program.
Utah also submitted revisions to the corresponding definitions in R307-
420. As explained in our proposed rulemaking published on July 14, 2017
(82 FR 32517), since the EPA had not received the 1999 rulemaking that
created R307-420 as a SIP submittal, we were unable to take action on
the revisions to R307-420 in our February 3, 2017 (82 FR 9138) final
rulemaking for Utah's revisions to Nonattainment Permitting
Regulations.
    Utah's June 29, 2017 submittal addressed this issue by submitting
the 1999 rule revisions that created R307-420 and modified R307-403-6.
As these rule revisions preserve the ozone maintenance plan
requirements for offsets and contingency measures in Salt Lake and
Davis Counties while improving the clarity of those requirements, we
proposed to approve the 1999 rule revisions on July 14, 2017 (82 FR
32517). We also proposed to approve the remaining portion of the August
20, 2013 submittal.
    The EPA is taking final action to approve the subsequent revisions
to R307-420, submitted on August 20, 2013, that Utah promulgated to
ensure that the definitions and applicability provisions in R307-420
are consistent with related permitting rules in R307-403. For the
reasons explained in our July 14, 2017 notice of proposed rulemaking,
the definitions and applicability provisions in R307-403 are consistent
with requirements for NNSR programs found in 40 CFR 51.165. While R307-
420 is part of the ozone maintenance plan for Salt Lake and Davis
Counties and not part of the NNSR program, and therefore, not directly
subject to the requirements in 40 CFR 51.165, we view the corresponding
revisions to the definitions and applicability provisions as
strengthening the maintenance plan. Specifically, the EPA is approving
the

following revisions to Utah's nonattainment permitting regulations:

 Table 1--Revised Sections as Public Noticed in the Utah State Bulletin
                            on March 1, 1999
                      (Submitted on June 29, 2017)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Adds Section R307-420-1 (Purpose).
Adds Section R307-420-2 (Definitions).
Adds Section R307-420-3 (Applicability).
Adds Section R307-420-4 (General Requirements).
Adds Section R307-420-5 (Contingency Measure: Offsets for Oxides of
 Nitrogen).
Revises Section R307-403-6 (Offsets: Ozone Nonattainment Areas and Davis
 and Salt Lake Counties).
1. Removes the phrase: ``and Davis and Salt Lake Counties'' from title.
2. Adds the phrase: ``In any ozone nonattainment area''.
3. Adds the phrase ``42 U.S.C. 7511a''.
4. Removes the language:
``As outlined in Section 182 of the federal Clean Air Act, for moderate
 areas, the emission offset ratio must be at least 1.15.1.
(1) Ozone Maintenance Plan, Salt Lake and Davis Counties. In the event
 that the contingency measures described in Section IX, Part D.2.h.(3)
 of the State Implementation Plan are triggered, the offset requirement
 in (2) below shall apply to emissions of both volatile organic
 compounds and oxides of nitrogen.
(2) The emission offset ratio must be at least 1.2.1, and offset must be
 obtained for the same pollutant for which the source or modification
 has been deemed ``major''.
------------------------------------------------------------------------

         Table 2--Revised Sections Submitted on August 20, 2013
------------------------------------------------------------------------

-------------------------------------------------------------------------
R307-420-1 (Purpose) the phrase: ``Except as provided in R307-420-2, the
 definitions in R307-403-1 apply to R307-420.''
R307-420-3 (Applicability) the new paragraph: (3) The applicability
 provision in R307-403-2(1)(a) through (f) and R307-403-2(2)(2) through
 (7) apply in R307-420.''
------------------------------------------------------------------------

    Please refer to the August 20, 2013 and June 29, 2017 submittal for
further details on these revisions.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the UDAQ
rules as described in the amendments to 40 CFR part 52 set forth in
this document. The EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and/or at the
EPA Region 8 office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).
    Therefore, these materials have been approved by the EPA for
inclusion in the SIP, have been incorporated by reference by the EPA
into that plan, are fully federally enforceable under sections 110 and
113 of the CAA as of the effective date of the final rulemaking of the
EPA's approval, and will be incorporated by reference by the Director
of the Federal Register in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
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V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
in a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General

of the United States. The EPA will submit a report containing this
action and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the rule in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 4, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See CAA section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Incorporation by reference, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: September 20, 2017.
Suzanne J. Bohan,
Acting Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart TT--Utah

0
2. Section 52.2320, paragraph (c), is amended as follows:
0
a. Under the centered heading ``R307-403. Permits: New and Modified
Sources in Nonattainment Areas and Maintenance Areas'':
0
i. By revising the table entry for ``R307-403.''
0
ii. By adding a table entry for ``R307-403-6'' in numerical order.
0
b. By adding a centered heading ``R307-420. Permits: Ozone Offset
Requirements in Davis and Salt Lake Counties'' and table entries for
``R307-420-1'', ``R307-420-2'', ``R307-420-3'', ``R307-420-4'', and
``R307-420-5'' in numerical order.
    The revision and additions read as follows:

Sec.  52.2320  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                                  State effective        Final rule
         Rule No.               Rule title              date           citation, date            Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
            R307-403. Permits: New and Modified Sources in Nonattainment Areas and Maintenance Areas
----------------------------------------------------------------------------------------------------------------
R307-403..................  Permits: New and              9/15/1998  71 FR 7679, 2/14/   Except for R307-403-1,
                             Modified Sources                         2006.               R307-403-2, R307-403-
                             in Nonattainment                                             6, R307-403-10, R307-
                             Areas and                                                    403-11.
                             Maintenance Areas.

                                                  * * * * * * *
R307-403-6................  Offsets: Ozone                9/15/1998  [insert Federal     .......................
                             Nonattainment                            Register
                             Areas.                                   citation], 10/5/
                                                                      2017.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  R307-420. Permits: Ozone Offset Requirements in Davis and Salt Lake Counties
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
R307-420-1................  Purpose...........   3/1/1999, 7/1/2013  [insert Federal     .......................
                                                                      Register
                                                                      citation], 10/5/
                                                                      2017.
R307-420-2................  Definitions.......   3/1/1999, 7/1/2013  [insert Federal     .......................
                                                                      Register
                                                                      citation], 10/5/
                                                                      2017.
R307-420-3................  Applicability.....   3/1/1999, 7/1/2013  [insert Federal     .......................
                                                                      Register
                                                                      citation], 10/5/
                                                                      2017.
R307-420-4................  General              3/1/1999, 7/1/2013  [insert Federal     .......................
                             Requirements.                            Register
                                                                      citation], 10/5/
                                                                      2017.
R307-420-5................  Contingency          3/1/1999, 7/1/2013  [insert Federal     .......................
                             Measure: Offsets                         Register
                             for Oxides of                            citation], 10/5/
                             Nitrogen.                                2017.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-21111 Filed 10-4-17; 8:45 am]
 BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: August 22, 2002 SUBJECT: Response to DuPont's Comments Concerning the HED Chapter for the Hexazinone Tolerance Reassessment Eligibility Decision. PC Code 107201. Case 0026. DP Barcode D284193.

FROM: Carol Christensen, MPH Reregistration Branch II Health Effects Division (7509C)

THRU: Al Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C)

TO: Dirk Helder, Chemical Review Manager Special Review and Reregistration Division (7508C)

This document acknowledges the comments received from the registrant, DuPont, citing errors in the HED Chapter for the Hexazinone Tolerance Reassessment Eligibility Decision (TRED) and related materials. The Agency has provided its response to these comments herein. The comments are also directly reflected in the Revised HED Chapter for the Hexazinone TRED (D275621, August 22, 2002) and accompanying disciplinary chapters and memoranda, where appropriate. The comments consisted primarily of editorial suggestions, an objection to the 28 day inhalation study requirement, and a statement that because the Agency has received a new developmental toxicity study in rabbits the 10X database uncertainty factor previously assigned for risk assessment be removed. Most of the editorial comments have been included. The comment objecting to the 28 day inhalation study requirement is rejected. The new developmental toxicity study in rabbits is acceptable and is included in the risk assessment and the database uncertainty factor for lack of a developmental toxicity study in the rabbit is removed. Four minor comments regarding the residue chemistry and dietary exposure and risk assessment are also reflected in the documentation for the hexazinone TRED. 2 The following comments were received from DuPont on July 2 nd , 2002. The comments are repeated here by document type and section followed by the Agency's numbered responses.

Toxicological Chapter for the TRED for Hexazinone Section 2.0 REQUIREMENTS C Guideline Numbers need to be filled in for Structural Chromosome Aberrations (870. 5375 and 870.5385) and Other Genotoxic Effects (870.5550)

Agency Response 1: The guideline study 870.5385 is unacceptable and will not be listed in Table 1 (of the Toxicology chapter). The guideline study 870.5395 (an acceptable study) will listed instead.

C Although not listed as a data gap, 870.5100 "Gene mutation  bacterial" is listed as a requirement that is not satisfied. DuPont has an Ames assay for the 75DF formulation that was conducted for another country. That assay was conducted in both Salmonella. and E. Coli at up to 5000 ug/ plate (= 3750 ug/ plate a. i.) and was negative for gene mutations in both. That study can be submitted, if needed, to satisfy this requirement.

Agency Response 2: The new study in Salmonella and E. coli (MRID# 457101001) has been received and is in review, however no data gap for mutagenicity was determined because there is an acceptable in vivo mutation study and there is insufficient evidence of carcinogenicity in acceptable studies.

Section 3.0 DATA GAPS C It is unclear as to why a 28 day inhalation study is being requested. For which risk assessment is it needed? There are no residential uses of hexazinone. Most of the use patterns are outside the scope of WPS. The Agency comments on page 24 of the HIARC document, that it already has an unreviewed 21 day inhalation study (MRID # 00063972, HLR 447 76). In that study, groups of ten male rats were exposed 6 hours/ day, 5 day/ week for 3 weeks to 0 (control) or 2.5 mg/ L of 90% wettable powder formulation of hexazinone (~ 600 mg a. i./ kg/ day). Histopathology examination indicated that lung changes were similar between control and hexazinone exposed rats. Intermittent weight losses were noted throughout the test period but all rats showed a normal rate of weight gain during the recovery period. The Registrant acknowledges that this is an old study which was conducted prior to issuance of current guidelines. However, it indicates that repeated exposure to hexazinone dust poses negligible inhalation risks and that no further inhalation testing should be required. 3 Agency Response 3: The 21 day inhalation study (MRID# 00063972) remains an unacceptable study (TXR No. 0051033); the study fails to meet the minimum standard for review. The 1976 study is unacceptable because it is a two page summary of a study, with no meaningful supporting data. In addition, there is considerable doubt about the particle size in the exposure chamber. A particle size expressed as an average instead of a mean mass areodynamic diameter is not meaningful. Other deficiencies exist, including: (1) failure to explain dust generator type; (2) failure to note the sampling area with respect to the exposed animal; (3) failure to supply concentrations of various mean mass areodynamic diameters of various particle sizes; (4) inconsistency in expression of particle sizes, i. e., average of 7.8 µm( 2.3 15 µm) and a note indicating that only 0.06% of the hexazinone was less than 10.9 µm; (5) no individual body weight data or individual pathology data was submitted; (6) only 5 of the 10 animals were subjected to gross and histological examination; (7) the study was not conducted under GLPs, which would at least confirm that the opinions expressed may have supporting data; and, (8) the particle size of 7.8 µm (even if incorrectly expressed as an average) is not sufficiently small to test the inhalation toxicity of hexazinone. The paucity of lung macrophages containing dust particles supports low exposure to the lung.

If the registrant can show that there is no inhalation exposure to handlers, a data waiver will be considered. If the registrant wishes to resubmit the 21 day inhalation study (MRID# 00063972) with the missing information and data, OPP will review it. Until this information is reviewed and accepted, the 21/ 28 day inhalation study is required for confirmation.

A new Rabbit Developmental Toxicity Study has recently been submitted. (DuPONT 7405, MRID 45677801).

Agency Response 4: The recently submitted developmental toxicity study in rabbits (MRID 42677801) is acceptable and will be included in the risk assessment of hexazinone (TXR# 0050786). The acceptability of the study and its use in risk assessment are reflected throughout the HED chapters of the Hexazinone TRED. The database uncertainty factor (10x) is removed from the assessment of risk as a result of hexazinone exposure.

Section 4.0 HAZARD ASSESSMENT Acute Toxicity, Page 5. References: The references for all the acute tox citations have been omitted from the reference list. Should they be included? 4 Agency Response 5: The references are included.

Acute Dermal Rabbit, add date (1973).

Agency Response 6: The date is added.

Acute Inhalation: Is not correct as written since an LC50> 3.94 mg/ L (4 hour) would be a toxicity category IV. Either add a note similar to that used in the HIARC document (Section 8) that this was on a 25% formulation AND/ OR cite the 1973 study on the technical material 00104975 LC50> 7.5 mg/ L (1 hour) ~ LC50 1.9 mg/ L (4 hours) that was mentioned in the HIARC report Section 8.0. Either study (3.94 x 0.25 or 7.5/ 4) would result in a toxicity category III.

Agency Response 7: Acute inhalation is correct as written and will not be changed. The acute inhalation study used to support the data requirements was changed from a study performed in 1973 to a study performed in 1990. The acute inhalation study performed in 1990 (MRID# 41756701) is a study of the technical grade of hexazinone and results in classification as an acute toxicity category III. This result is reflected in the HED Chapter of the risk assessment, the toxicology chapter and all HIARC documents (1/ 16/ 02, 4/ 29/ 02 and 8/ 12/ 02).

Subchronic Toxicity, 870.3200, Subchronic Dermal, Page 7. Should read " 870.3200 21/ 28 Day Dermal Toxicity  Rabbit" since the guideline is for either rats or rabbits and the study was conducted in rabbits.

Agency Response 8: The guideline toxicity study 870.3200 listed as a 21/ 28 day dermal toxicity study in the rat will be changed to 21/ 28 day dermal toxicity study in the rabbit since the study was conducted in this species.

90 Day Inhalation, 870.3465, Page 8. As described above, the registrant does not agree that this is a data gap because the Agency has an unreviewed 21 day repeated dose inhalation study.

Agency Response 9: See Agency Response 3 (above).

Prenatal Developmental, 870.3700b, Toxicity Study  Rabbit, Page 10. This should be updated to reflect that a new rabbit developmental study was submitted (5/ 19/ 02 MRID 45677801).

Agency Response 10: See Agency Response 4 (above).

4.7 Mutagenicity: Overview. For clarification, we recommend inserting the following wording into the last sentence of the mutagenicity overview. "Because unambiguous positive results were achieved, it was concluded that the study 5 provided adequate evidence that INA 3674 112 (hexazinone technical) is clastogenic in vitro in an acceptable study. [However, negative results were obtained in two studies which assessed chromosome damage in vivo."]

Agency Response 11: The in vivo studies for chromosomal damage are listed as negative. There is no reason to repeat the results in the last sentence of the 4.7 Mutagenicity Overview section of the Toxicology Chapter.

Page 20, 870.5375 Mid paragraph "In the presence of S 9 mix, no statistically significant increases in chromosome aberrations were seen in Trial 1; however, very low positive control values indicated a problem with the S9 mix." Delete the latter part of the sentence; it is incorrect. Positive control values in both trials produced strong positive results (Trial 1 28 32% abnormal cells, Trial 2 36 40% abnormal cells).

Agency Response 12: The statement will be deleted from the Toxicology chapter.

Page 21, 870.5385 After, "Unacceptable…. The study does not satisfy the requirement for FIFRA Test Guidelines." Add, "However this Guideline is fulfilled by an acceptable mouse micronucleus study."

Agency Response 13: Section 4.7.4 Guideline 870.5385: In vivo cytogenics assay in rat bone marrow cells will not be changed. The mouse micronucleus test is listed as acceptable in Section 4.7.5 and there is no reason to repeat the results in Section 4.7.4.

Page 22, 870.5395 Change the last sentence from "It satisfy the requirements…." to "It satisfies the requirements…."

Agency Response 14: The correction is accepted.

Section 6.0 FQPA CONSIDERATIONS Page 25. The Agency assigned an additional 10x database uncertainty factor (UFdb) because a rabbit developmental study was unacceptable due to uncertainties in the LOEL. Immediately after the HIARC report issued, the Registrant submitted a new rabbit developmental study (DuPont 7405, MRID 45677801) to the Agency. The new rabbit developmental study was conducted using current guidelines and confirmed the results of the previous rabbit developmental study. The maternal and fetal rabbit NOAEL was 50 mg/ kg/ day. The maternal and fetal LOAEL was 125 mg/ kg/ day. Once the new rabbit study is reviewed, if it is selected as the basis of the ARfD, the registrant believes the extra 10x UFdb should be removed. 6 Agency Response 15: See Agency Response 4.

Acute Toxicity Table. Header should read: "Acute Toxicity Data on HEXAZINONE" NOT "Acute Toxicity Data on FENBUTATIN OXIDE."

Agency Response 16: The heading for the table "Acute Toxicity Data on FENBUTATIN OXIDE" will be changed to "Acute Toxicity Data on HEXAZINONE."

Subchronic, Chronic, and Other Toxicity Tables. Registrant comments have been made above regarding removal of the 28 day inhalation study requirement, the submission/ MRID of a new prenatal developmental study, and the availability of an unsubmitted gene mutation assay (with a 75DF formulation) in Salmonella and E. Coli.

Agency Response 17: See Agency Responses 3, 4, and 2, respectively.

Summary of Toxicological Endpoints. Registrant restates that additional 10x UFdb should be removed after new rabbit developmental toxicity study is reviewed and questions the need for establishment of long term occupational endpoints.

Agency Response 18: See Agency Response 4. The Long Term endpoints were selected for completeness and for potential future need. 7 Hazard Identification and Review Committee (HIARC) Report Acute Dietary Reference Dose Females 13 50 pp. 3 5. For setting the acute reference dose (ARfD) for females of childbearing age, the Agency has selected a rat developmental study with NOAELs of 100 and 400 mg/ kg for maternal and fetal effects, respectively. The Agency assigned an additional 10x database uncertainty factor (UFdb ) because a rabbit developmental study was unacceptable due to uncertainties in the LOEL. A UFdb factor of 10x rather than 3x was used because, based on extrapolation to the rabbit pilot NOEL of 50 mg/ kg in the previous study, it was concluded the difference between rabbits and rats may be greater than 3x. The resulting ARfD was 0.4 mg/ kg (400 mg/ kg / 1000).

Immediately after the HIARC report issued, the Registrant submitted a new rabbit developmental study (DuPont 7405, MRID 45677801) to the Agency. The new rabbit developmental study was conducted using current guidelines and confirmed the results of the previous rabbit developmental study. The maternal and fetal rabbit NOEL was 50 mg/ kg/ day. The maternal and fetal LOEL was 125 mg/ kg/ day based on weight effects, which were only slight in the fetus. A higher dose, 175 mg/ kg/ day produced severe maternal toxicity.

Once the new rabbit study is reviewed, if it is selected as the basis of the ARfD, the registrant believes the extra 10x UFdb should be removed. If selected, this would result in an ARfD of 0.5 mg/ kg (50 mg/ kg / 100). This is essential the same (slight improvement) as the current ARfD, and thus there will be essentially no change in the acute dietary risk assessment.

Agency Response 19: The rabbit developmental toxicity study has been reviewed and accepted by the Agency. The database uncertainty factor of 10X is removed from the acute dietary risk assessment. However, the Agency retains the use of the developmental toxicity study in the rat as the basis for the acute reference dose for females 13 50 years of age (acute reference dose is 4.0 mg/ kg/ day).

Chronic Reference Dose, Last line page 6 – typographical error. "The LOAEL is… based on…[ findings listed] and clinical observations of thinnest in one male." Should read "thin appearance in one male."

Agency Response 20: The statement is changed to read "thinness in one male" (p. 12 of HIARC report TXR No. 0051033 dated August 12, 2002).

Occupational/ Residential Exposure. It is not clear to the Registrant why the occupational and residential exposure Sections 2.4.1 through 2.6 were included in a food Tolerance Reassessment. There are no residential uses of hexazinone, that could contribute to the aggregate exposure. It is the Registrant's understanding that occupational exposure assessment is beyond the scope of Tolerance Reassessment. 8 Occupational exposure was addressed under the 1994 Reregistration Eligibility Document. It was noted that a number of the major uses of hexazinone were outside the scope of the Worker Protection Standard (WPS). While agricultural uses and use on sod farms was within WPS; use on pastures, rangeland, plants grown for other than commercial purposes, ornamental plants in parks and golf course, and no agricultural uses such as vegetation along rights of way were outside of the scope of WPS. No worker exposure assessment was conducted.

Therefore the Registrant considers the selection of Occupational/ Residential endpoints (e. g., dermal and inhalation exposure scenarios) to not be relevant to Tolerance Reassessment. Nonetheless, we offer the following comments to the endpoint selection, should these endpoints be considered relevant in the future.

Agency Response 21: These comments will not be addressed as occupational and residential exposure as risk assessment was not performed for the HED Chapter of the Hexazinone TRED. These endpoints were selected for completeness of the toxicological database and for potential future need.

Dermal Absorption. The review states that "No dermal absorption study is available." It would be clearer to say that "No dermal penetration study is available. For an estimate of dermal penetration, the NOAEL from the 21 day rabbit dermal toxicity study…." Also, for clarification, add the MRID of the rabbit 21 day study (MRID 41309005).

The Agency extrapolated a dermal absorption factor by comparing the NOAEL in a 21 day dermal study in rabbits to the LOAEL from a rabbit developmental rangefinding study. A 25% dermal absorption factor was derived.

Rabbit Pilot Developmental LOAEL (oral) = 250 mg/ kg = 25% Rabbit 21 Day Dermal NOAEL 1000 mg/ kg However, the new rabbit developmental study (DuPont 7405, MRID 45677801) indicates there is a greater difference between oral and dermal toxicity than indicated by the above calculation. Further, since no LOAEL was actually established on the Rabbit 21 Day Dermal study, use of a dermal NOAEL in comparison to an oral LOAEL, overestimates the potential dermal penetration. Based on the new rabbit developmental study, dermal absorption is no greater than 12.5%

Rabbit Developmental LOAEL (oral) = 125 mg/ kg =< 12.5% Rabbit 21 Day Dermal NOAEL > 1000 mg/ kg 9 Agency Response 22: A dermal absorption factor of 12.5% is defined in the recent HIARC report. (TXR No. 0051033 dated August 12, 2002)

Short Term (1 Day – 1 Month) Dermal Exposure and Intermediate Term (1 6 Months) and Long Term (> 6 Months) Dermal Exposures.

Under 2.4.3, the Agency states the Dose and Endpoint for Risk Assessment for short term dermal Exposure is Not Applicable and that No Hazard and No Quantification are required (based on no effects in the 21 day dermal study in rabbits). However, in the next section (2.4.4) the Agency proceeds to select longer term dermal endpoints based on the chronic dog study NOEL (5 mg/ kg/ day) and a 25% dermal absorption factor (i. e. equivalent to 20 mg/ kg/ day). For intermediate term scenarios, we believe selection of a subchronic endpoint would be more appropriate than selection of the chronic dog study with a 25% absorption factor. It is also consistent wit the Agency guidance document, Toxicology Endpoint Selection Process (February, 1997). Based on the labeled uses for hexazinone, we do not believe a long term dermal exposure scenario is relevant. It is difficult to identify a scenario where there would be daily, lifetime uninterupted dermal exposure to hexazinone.

  The registrant believes that the route specific rabbit dermal study is the most appropriate study to estimate subchronic human dermal exposure. The Agency has concluded that the repeated dose rabbit study (MRID 41309005) meets guidelines and is acceptable. It measured the proper endpoints to identify hexazinone toxicity (including body weights, clinical chemistry, liver histology). Considering lifespan differences, it is of appropriate duration for short term and intermediate endpoint selection.

  However, if the Agency deems that the duration of the subchronic rabbit dermal study is insufficient, acceptable subchronic oral studies of longer duration (90 days) are available. The NOAELs from the rat and dog 90 day studies were 84 and 29 mg/ kg, respectively. Again the dog is the most sensitive species, but the subchronic NOAEL is more appropriate.

  As noted in the discussion above, the 25% absorption factor derived by comparing a LOAEL on a rabbit pilot developmental study to the NOAEL on the rabbit subchronic dermal study overestimated the Dermal Absorption Factor which, in reality, is likely to be less than 12.5%. Using the dog subchronic NOAEL (29 mg/ kg/ day) and applying a more appropriate dermal absorption factor <12.5% would result in an estimated dermal endpoint of > 232 mg/ kg/ day. This is much more comparable to the actual dermal NOAEL determined from the 21 day rabbit study. 10 Also typographical error in 2.4.4 "thinnest in one males" should read "thin appearance in one male"

Agency Response 23: The Agency's rationale for endpoint selection are included in the updated HIARC document (TXR No. 0051033 dated August 12, 2002) and the Agency will not comment further at this time. See Agency Response 22 concerning the dermal absorption factor.

Intermediate (1 6 Months) and Long Term (> 6 Months) Inhalation Exposure Typographical error "thinnest in one males" should read "thin appearance in one male."

Agency Response 24: This error is noted and will be changed in the Toxicology chapter.

Section 4.0 Mutagenicity For clarification, we recommend inserting the following wording into the last sentence of the mutagenicity overview (additions are in bold). "Because unambiguous positive results were achieved, it was concluded that the study provided adequate evidence that INA 3674 112 (hexazinone technical) is clastogenic in vitro in an acceptable study. However, negative results were obtained in two studies which assessed chromosome damage in vivo."

General Comment: for consistency with the rest of the document, INA 3674 112 should be changed to hexazinone or hexazinone technical.

Agency Response 25: See Agency Response 11.

Guideline 870.5300: Gene Mutation Assay in Mammalian Cells. Conclusion should be bolded as with others studies. "There was, however, no indication that INA 3674 112 induced mutagenic effect in either the presence or the absence of S9 activation."

Agency Response 26: The comment is accepted as suggested by the registrant. (Section 4.2, p. 21 of the 3 rd Report of the HIARC, TXR No. 0051033 dated August 12, 2002.)

Guideline 870.5395: Mouse Bone Marrow Micronucleus Assay. Change the last sentence from "It satisfy the requirements…." to "It satisfies the requirements…."

Agency Response 27: See Agency Response 14.

Guideline 870.5375: Structural Chromosome Aberration Assay; In vitro Cytogenetic Assay. Mid paragraph "In the presence of S 9 mix, no statistically 11 significant increases in chromosome aberrations were seen in Trial 1; however, very low positive control values indicated a problem with the S9 mix." Delete the latter part of the sentence; it is incorrect. Positive control values in both trials produced strong positive results (Trial 1 28 32% abnormal cells, Trial 2 36 40% abnormal cells).

Agency Response 28: See Agency Response 12.

Guideline 870.5385: Structural Chromosome Aberration Assay; In vivo Cytogenetic Assay. Fourth sentence of second paragraph, "Few or no analyzable cell were available…" should be "Few or no analyzable cells were available…"

Agency Response 29: Editorial comment will be made.

Section 4.5, Guideline 870.5395: After, "Unacceptable…. The study does not satisfy the requirement for FIFRA Test Guidelines." add, "However, this Guideline is fulfilled by an acceptable mouse micronucleus study."

Agency Response 30: See Agency Response 13.

Section 5 FQPA Considerations Developmental Toxicity, Developmental Toxicity in the Rabbit. Last paragraph should be upgraded to indicate a Rabbit Developmental Toxicity (45677801) has just been submitted but not yet been reviewed.

Agency Response 31: See Agency Response 4. The receipt and acceptance of the developmental toxicity study in the rabbit is reflected throughout the HED risk assessment documents, including the revised HIARC report (TXR No. 0051033 dated August 12, 2002.)

Determination of the Need for Developmental Neurotoxicity Study, Evidence that suggest requiring a Developmental Neurotoxicity Study. Atrazine should not be considered as evidence suggesting requirement of a developmental neurotoxicity. Although atrazine and hexazinone contain a triazine ring, there are significant structural differences that contribute substantial differences in the biological response to these molecules by laboratory animals. EPA reached a similar conclusion in the Toxicology Disciplinary Chapter for the Tolerance Reassessment and Evaluation Decision Document, Section 1.0 – Hazard Characterization (May 16, 2002). The critical structural differences include substitutions of a cyclohexyl and a methyl group on the ring nitrogens and the presence of two ring oxo groups in hexazinone. As a result, hexazinone is less aromatic in character than the chloro s triazines. Collectively, these structural differences are considered to contribute differences in toxicological properties. Hexazinone has been classified 12 as a triazine dione by EPA, which further indicates this Agency acknowledges its differences from the chloro s triazine herbicide class.

Hexazinone has been extensively tested for safety to mammals. A key difference between hexazinone and atrazine and other members of the chloro s triazine class is that chronic exposures to the latter produce a characteristic mammary tumor response in Sprague Dawley rats. The mode of action for this chloro s triazine induced tumor response has been associated with altered endocrine activity unique to this rat strain. In contrast hexazinone does not induce rat mammary tumors, which indicates the absence of the endocrine modulation responsible for this effect. Additional evidence supporting the absence of endocrine effects with hexazinone includes the absence of endocrine organ effects and effects on reproduction and development. The differences in chemical structures are considered to be critical to the observed differences in toxicological response between hexazinone and the chloro s triazines.

Agency Response 32: As stated in the HED Chapter of the hexazinone risk assessment, there was no evidence of endocrine disruption in the hexazinone toxicological database. However, when appropriate screening and/ or testing protocols have been developed through the Endocrine Disruptor Screening Program (EDSP) hexazinone may be subject to additional screening and/ or testing to further characterize effects related to endocrine disruption.

Section 7.0 Data Gaps "HIARC has requested a 28 day inhalation study because of the concern for inhalation exposure based on the use pattern"

  It is unclear as to which use pattern is being considered. There are no residential uses of hexazinone. Most of the use patterns are outside the scope of WPS. Since no use patterns of concern are identified, it is impossible to determine duration of exposure.

  On the same page that it requests a 28 day inhalation study, the Agency notes that it already has an unreviewed 21 day inhalation study (MRID # 00063972, HLR 447 76). In that study, groups of ten male rats were exposed 6 hours/ day, 5 day/ week for 3 weeks to 0 (control) or 2.5 mg/ L of 90% wettable powder formulation of hexazinone. Using the guidance in (Whalan EPA, 1997) this represents an exposure of greater than 600 mg/ kg/ day (2.25 mg hexazinone a. i./ L x 11.38 L/ hr respiration x 6 hr/ day exposure/ 0.25 kg body weight ). Histopathology examination indicated that lung changes were similar between control and hexazinone exposed rats. Intermittent weight losses were noted throughout the test period but all rats showed a normal rate of weight gain during the recovery period . 13 The Registrant acknowledges that this is an old study which was conducted prior to issuance of current guidelines. However, it clearly indicates that repeated exposure to hexazinone dust poses negligible inhalation risk. It also suggests that no further inhalation testing is required since no lung toxicity was identified and since the exposure producing minimal to moderate toxicity was two orders of magnitude higher than the chronic NOAEL that has just been selected by the Agency to set an inhalation endpoint. Therefore the oral endpoint selected is overly protective. In the interest of conservation of animals we strongly urge that available information be considered before the Agency request another study and the repeated dose inhalation be removed as a data gap.

Agency Response 33: See Agency Response 3 (above).

For the rabbit developmental toxicity data gap we recommend changing the statement "is expected to be submitted" to "was not submitted in enough time for review prior to issuance of this document"

Agency Response 34: This statement has been removed from the most recent HIARC report (August 12, 2002, TXR 0051033) and the receipt and acceptance of the developmental toxicity study in the rabbit is reflected appropriately in all supporting documentation to the HED risk assessment. 14 HED Chapter of the Hexazinone TRED Section 1.0 Executive Summary The most significant recommendation, in our view, contained in the draft documents pertains to the revocation of tolerances and associated use of hexazinone on grass. We acknowledge that guidelines and interpretations regarding the practicality of grower control over cattle grazing intervals have changed since data supporting this use pattern were last submitted. However, as indicated in your review, this is a rather minor use and our information indicates that the current label restrictions regarding cutting and grazing are being complied with. Therefore, the tolerances supporting the use are sufficient. Given the above, we request that the existing tolerances and use pattern be maintained while we conduct new residue work to support EPA's interpretation regarding a zero day grazing interval.

Agency Response 35: The Agency cannot reassess the tolerances for pasture and rangeland grasses without these data. These data remain outstanding for hexazinone and must be fulfilled before tolerance reassessment can be completed. Therefore, no changes are made to the Executive Summary concerning this issue.

We understand that our recently submitted Rabbit Developmental Toxicity Study (DuPont 7405, MRID 45677801) was not reviewed in time to be included in the Draft TRED. In view of the pivotal importance of this study to the overall conclusions of the final TRED (specifically, the current proposal to declare a significant gap in the toxicology data base, the selection of appropriate end points for regulatory purposes and the imposition of an additional 10X safety factor due to an incomplete data base), we respectfully request that this study be reviewed as quickly as possible to be included in the final TRED.

Agency Response 36: See Agency Response 4 (above).

We also note in the toxicology review that "Gene mutation – bacterial" is listed as an unsatisfied requirement. We have recently submitted (June 28, 2002, no MRID yet assigned) a new Ames assay with the 75 DF formulation which we believe will satisfy this requirement.

Agency Response 37: See Agency Response 2 (above).

Finally, we do not believe a 28 day inhalation study should be required until the existing and submitted 21 day inhalation study (MRID 00063972) has been reviewed. 15 Agency Response 38: See Agency Response 3 (above).

Section 3.0 Hazard Characterization Hazard Profile. Table 1: Acute Toxicity: For Inhalation LC50> 3.94 mg/ L (4 hour), add (25% formulation).

Agency Response 39: See Agency Response 7 (above).

Table 2: Toxicity Profile. 870.3465, "A 28 day inhalation study is required." As noted in the HIARC document, an unreviewed 21 day inhalation study is available (MRID 00063972) which indicates that repeated exposure to hexazinone dust poses negligible inhalation risks and that no further inhalation testing should be required. The Registrant requests that existing data be reviewed before additional testing is required.

Agency Response 40: See Agency Response 3 (above). No change is made in response to this comment.

870.3700b Prenatal Developmental Toxicity. Unacceptable/ Upgradeable. The registrant has submitted a new rabbit developmental study (DuPONT 7405, MRID 45677801) which addressed the deficiencies and supports the conclusions of the original study Agency Response 41: See Agency Response 4 (above). This study is acceptable and appropriately listed in the Toxicological Profile Table 2 in the HED Chapter of the Hexazinone Risk Assessment.

870.5100 Reverse mutation in Samonella Strains. Unacceptable: DuPont has conduct a Ames assay for the 75DF formulation in both Salmonella and E. Coli at up to 5000 ug/ plate (= 3750 ug/ plate a. i.) that can be submitted, if needed, to satisfy this requirement. The results were negative for gene mutations in both species.

Agency Response 42: See Agency Response 2 (above).

870.5385 In vivo Rat Bone Marrow Cytogenetics Assay. Unacceptable. Add, "However this Guideline is fulfilled by an acceptable mouse micronucleus study."

Agency Response 43: See Agency Response 13 (above).

FQPA Considerations and Dose Response Assessment: Acute Reference Dose Females 13 50. The Agency assigned an additional 10x database uncertainty factor because a rabbit developmental study was unacceptable due to uncertainties in the LOEL. A new rabbit developmental study (DuPont 7405, MRID 16 45677801) to the Agency which addresses the deficiencies and supports the previous study. Once the new rabbit study is reviewed, the registrant believes the extra 10x uncertainty factor should be removed.

Agency Response 44: See Agency Response 4 (above).

Acute Aggregate Risk Assessment. The headings for the last three columns for Table 11 (page 42) should specify µg/ l rather than g/ l.

Agency Response 45: The headings are written as µg/ l in Table 11. 17 Report of the FQPA Safety Factor Committee 3. Degree of Concern and Residual Uncertainties. For setting the acute reference dose (ARfD) for females of childbearing age, the Agency assigned an additional 10x database uncertainty factor (UFdb ) because a rabbit developmental study was unacceptable due to uncertainties in the LOEL. A UFdb factor of 10x rather than 3x was used because, based on extrapolation to the rabbit pilot NOEL of 50 mg/ kg in the previous study, it was concluded the difference between rabbits and rats may be greater than 3x.

Immediately after the HIARC report issued, the Registrant submitted a new rabbit developmental study (DuPont 7405, MRID 45677801) to the Agency. The new rabbit developmental study was conducted using current guidelines and confirmed the results of the previous rabbit developmental study. The maternal and fetal rabbit NOAEL was 50 mg/ kg/ day. The maternal and fetal LOAEL was 125 mg/ kg/ day based on weight effects, which were only slight in the fetus. A higher dose, 175 mg/ kg/ day produced severe maternal toxicity.

Once the new rabbit study is reviewed, if it is selected as the basis of the ARfD, the registrant believes the extra 10x UFdb should be removed.

Agency Response 46: See Agency Response 4 (above). The receipt and acceptance of the developmental toxicity study in the rabbit is also reflected in report Hexazinone 2 nd Report of the FQPA Safety Factor Committee (TXR No. 0051049 dated August 8, 2002.) 18 Dietary Risk Assessment An acute endpoint is only given for females 13 50. We assume this group is considered by EPA to be the most sensitive sub population.

Agency Response 47: The toxic endpoint with which acute dietary exposure is assessed is a decrease in male and female fetal body weight and increased incidence of malformations and variations of the fetus. Because the toxic endpoint for acute dietary exposure concerns in utero exposure, the risk assessment is performed for females of childbearing age (females 13 50) since only members of this group are at risk of being pregnant at the time of exposure.

In several places we note the risk assessment is based on the reassessed tolerances for blueberry, pineapple, and sugarcane. For blueberries and pineapple 0.3 ppm is utilized, presumably one half of the new proposed tolerance of 0.6 ppm. However, for sugarcane 0.6 ppm (tolerance) is utilized. This appears to be an inconsistency. Stated differently, it is not clear to us why 0.3 ppm was selected for blueberry and pineapple while 0.6 ppm was selected for sugarcane.

Agency Response 48: This was an error and has been corrected in the documents prepared for Phase III of the public participation process. Residue estimates for blueberry and pineapple are 0.6 ppm. (See Revised Acute and Chronic Dietary Exposure Assessment for the Hexazinone TRED, July 30, 2002.)

Clarity is needed around the definition of LOQ. There are both enforcement methods (sum of LOQs is 0.55 ppm) and data collection methods (sum of LOQs is 0.3 ppm). We recommend that the enforcement LOQs be used consistently throughout the document.

Agency Response 49: The LOQ's for the enforcement method is used for dietary exposure estimates.

We note that a more up to date consumption database exists, CSFII 94 96/ 98. Why was the older database, CSFII 89 92, used?

Agency Response 50: At this time, it is Agency policy to use the CSFII 1988 1992 food consumption database to perform dietary exposure and risk assessment.


[Federal Register: June 11, 2007 (Volume 72, Number 111)]
[Notices]
[Page 32150-32151]
[DOCID:fr11jn07-90]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold the following meetings during the week of
June 11, 2007:

    Open Meetings will be held on Tuesday, June 12, 2007 at 9 a.m.
and Wednesday, June 13, 2007 at 10 a.m., in the Auditorium, Room L-
002. A Closed Meeting will be held on Thursday, June 14, 2007 at 10
a.m.

    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.

    Commissioner Campos, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the Open Meeting scheduled for Tuesday, June
12, 2007 at 9 a.m. will be:

    The Commission will hold a roundtable discussion regarding
selective mutual recognition of foreign jurisdictions. The
discussion will address the implications of granting foreign market
participants access to U.S. investors under an abbreviated
registration system, provided those entities are supervised in a
foreign jurisdiction that has a securities regulatory regime
substantially comparable (but not necessarily identical) to that in
the United States. The roundtable will explore whether selective
mutual recognition would benefit U.S. investors by providing greater
cross-border access to foreign investment opportunities while
preserving investor protection.

    The subject matter of the Open Meeting scheduled for Wednesday,
June 13, 2007 at 10 a.m. will be:

    1. The Commission will consider whether to adopt amendments to
the grandfather provision of Rule 203 of Regulation SHO and the
market decline limitation of Rule 200(e)(3).
    2. The Commission will consider whether to re-propose amendments
to the options market maker exception to the close-out requirement
of Regulation SHO and the marking requirements of Rule 200(g) of
Regulation SHO.
    3. The Commission will consider whether to adopt amendments to
the short sale price test of Rule 10a-1. In addition, the Commission
will consider whether to adopt an amendment to the ``short exempt''
marking requirement of Regulation SHO.
    4. The Commission will consider whether to adopt amendments to
Rule 105 of Regulation M that would further safeguard the integrity
of the capital raising process and protect issuers from manipulative
activity that can reduce issuers' offering proceeds and dilute
security holder value.

    The subject matter of the Closed Meeting scheduled for Thursday,
June 14, 2007 will be:

Formal orders of investigations;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature;
Resolution of litigation claims;
Other matters related to enforcement proceedings; and
An adjudicatory matter.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

     Dated: June 6, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-11261 Filed 6-8-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Pages 7860-7861]
[FR Doc No: 2015-02938]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-7590-000]

Atwood, Donald G.; Notice of Filing

    Take notice that on February 5, 2015, Donald G. Atwood submitted
for filing, an application for authority to hold interlocking
positions, pursuant to section 305(b) of the Federal Power Act (FPA),
16 U.S.C. 825(b) and Part 45 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure, 18 CFR part
45.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214).

Protests will be considered by the Commission in determining the
appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Any person wishing to become a party must
file a notice of intervention or motion to intervene, as appropriate.
Such notices, motions, or protests must be filed on or before the
comment date. On or before the comment date, it is not necessary to
serve motions to intervene or protests on persons other than the
Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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>.
    Comment Date: 5:00 p.m. Eastern Time on February 26, 2015.

    Dated: February 6, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-02938 Filed 2-11-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 201 (Thursday, October 19, 2017)]
[Notices]
[Pages 48738-48739]
[FR Doc No: 2017-22650]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-24]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice and comment request.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces that FRA is forwarding the currently approved Information
Collection Requests (ICRs), abstracted below, to the Office of
Management and Budget (OMB) for review and comment. The ICRs describe
the information collections FRA is submitting for renewal and their
expected burden.

DATES: Comments must be submitted on or before November 20, 2017.

ADDRESSES: Send comments regarding these information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street NW., Washington, DC 20503, Attention: FRA Desk
Officer. Comments may also be sent via email to OMB at the following
address<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Safety
Regulatory Analysis Division, RRS-21, Federal Railroad Administration,
1200 New Jersey Avenue SE., Mail Stop 25, Washington, DC 20590
(Telephone:<PHONE_NUMBER>); or Ms. Kim Toone, Information Collection
Clearance Officer, Office of Administration, Office of Information

Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Avenue SE., Mail Stop 35, Washington, DC 20590 (Telephone: (202) 493-
6132). (These telephone numbers are not toll free.)

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. 44 U.S.C. 3506,
3507; 5 CFR 1320.5, 1320.8(d)(1), and 1320.12. On June 30, 2017, FRA
published a 60-day notice in the Federal Register soliciting comment on
the ICRs for which it is now seeking OMB approval. See 82 FR 29976. FRA
received no comments in response to the notice. The summaries below
describe the ICRs and their expected burden. FRA is submitting these
renewal requests for clearance by OMB, as the PRA requires.
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication.
5 CFR 1320.12(c); see also 60 FR 44983, Aug. 29, 1995.
    Comments are invited on the following ICRs regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    Title: Railroad Operating Rules.
    OMB Control Number: 2130-0035.
    Abstract: Title 49 CFR 217 requires Class I and Class II railroads
to file with FRA copies of their operating rules, timetables, timetable
special instructions, and subsequent amendments (49 CFR 217.7(a) and
(b)), while Class III railroads are required to retain copies of these
documents at their systems headquarters (49 CFR 217.7(c)). Also, 49 CFR
220.21(b) requires railroads to retain one copy of their current
operating rules with respect to radio communications at a specified
location. These railroads are also required to retain one copy of each
subsequent amendment thereto. These documents must be made available to
FRA upon request. FRA uses the information collected to determine the
railroads' rules and practices with respect to train operations and
instructions provided by the railroads to their operating employees.
    Type of Request: Extension with change of a currently approved
information collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Total Estimated Annual Responses: 188,591,125.
    Total Estimated Annual Burden: 4,797,590 hours.
    Title: Track Safety Standards; Concrete Crossties.
    OMB Control Number: 2130-0592.
    Abstract: On April 1, 2011, FRA amended 49 CFR 213 (Track Safety
Standards) to ensure safe operations over track constructed with
concrete crossties. FRA issued specific requirements for effective
concrete crossties, rail fastening systems connected to concrete
crossties, and automated inspections of track constructed with concrete
crossties. FRA uses the information collected under 49 CFR 213.234 to
ensure that automated track inspections of track constructed with
concrete crossties are carried out as specified in this section to
supplement visual inspections by Class I and Class II railroads,
intercity passenger railroads, and commuter railroads or small
governmental jurisdictions that serve populations greater than 50,000.
    Type of Request: Extension with change of a currently approved
information collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Total Estimated Annual Responses: 2,318.
    Total Estimated Annual Burden: 4,875 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to a collection of
information, unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Deputy Chief Counsel.
[FR Doc. 2017-22650 Filed 10-18-17; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Page 65006]
[FR Doc No: 2012-26207]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4080-DR; Docket ID FEMA-2012-0002]

Louisiana; Amendment No. 14 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4080-DR), dated August 29, 2012, and
related determinations.

DATES: Effective Date: October 9, 2012.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 29, 2012.

    The parish of West Baton Rouge for Individual Assistance
(already designated for Public Assistance [Category A and B],
including direct federal assistance).

(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.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-26207 Filed 10-23-12; 8:45 am]
BILLING CODE 9111-23-P