contributing to lead air pollution in the environment. As explained in
section II.A. of this document, once emitted from covered aircraft,
lead may be transported and distributed to other environmental media,
where it presents the potential for human exposure through air and non-
air pathways before the lead is removed to deeper soils or waterbody
sediments. In reaching this final finding, the Administrator takes into
consideration different air quality scenarios in which emissions of the
lead air pollutant from engines in covered aircraft may cause or
contribute to lead air pollution. Among these considerations, he places
weight on the fact that current lead emissions from covered aircraft
are an important source of air-related lead in the environment and that
engine emissions of lead from covered aircraft are the largest single
source of lead to air in the U.S. in recent years. In this regard, he
notes that these emissions contributed over 50 percent of lead
emissions to air starting in 2008, when approximately 560 tons of lead
was emitted by engines in covered aircraft (of the total 950 tons of
lead) and, more recently, in 2017, when approximately 470 tons of lead
was emitted by engines in covered aircraft (of the total 670 tons of
lead).\326\
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    \326\ The lead inventories for 2008, 2011 and 2014 are provided
in the U.S. EPA (2018b) Report on the Environment Exhibit 2.
Anthropogenic lead emissions in the U.S. Available at https://cfpub.epa.gov/roe/indicator.cfm?i=13#2. The lead inventories for
2017 are available at https://www.epa.gov/air-emissions-inventories/2017-national-emissions-inventory-nei-data#dataq.
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    Additionally, he takes into account the fact that in some
situations lead emissions from covered aircraft have contributed and
may continue to contribute to air concentrations that exceed the lead
NAAQS. The NAAQS are standards that have been set to protect public
health, including the health of sensitive groups, with an adequate
margin of safety and to protect public welfare from any known or
anticipated adverse effects associated with the presence of the
pollutant in the ambient air. For example, the EPA's monitoring data
show that lead concentrations at two airports, McClellan-Palomar and
San Carlos, violated the lead NAAQS. The EPA's model-extrapolated
estimates of lead also indicate that some U.S. airports may have air
lead concentrations above the NAAQS in the area of maximum impact from
operation of covered aircraft.\327\ Given that the lead NAAQS are
established to protect public health and welfare, contributions to
concentrations that exceed the lead NAAQS are of particular concern to
the Administrator and are persuasive support for the conclusion that
lead emissions from engines in covered

aircraft cause or contribute to the endangering air pollution.
---------------------------------------------------------------------------

    \327\ EPA (2020) Model-extrapolated Estimates of Airborne Lead
Concentrations at U.S. Airports Table 7. EPA-420-R-20-003, 2020.
Available at https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100YG52.pdf.
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    The Administrator is also concerned about the likelihood for these
emissions to continue to be an important source of air-related lead in
the environment in the future, if uncontrolled. While recognizing that
national consumption of leaded avgas is forecast to decrease slightly
from 2026 to 2041 commensurate with overall piston-engine aircraft
activity, the Administrator also notes that these changes are not
expected to occur uniformly across the U.S.\328\ For example, he takes
note of the FAA forecasts for airport-specific aircraft activity out to
2045 that project decreases in activity by general aviation at some
airports, while projecting increases at other airports.\329\ Although
there is some uncertainty in these projections, they indicate that lead
emissions from covered aircraft may increase at some airports in the
future. Thus, even assuming that consumption of leaded avgas and
general aviation activity decrease somewhat overall, as projected, the
Administrator anticipates that current concerns about these sources of
air-related lead will continue into the future, without controls.
Accordingly, the Administrator is considering both current levels of
emissions and anticipated future levels of emissions from covered
aircraft. In doing so, the Administrator finds that current levels
cause or contribute to pollution that may reasonably be anticipated to
endanger public health and welfare. He also is taking into
consideration the projections that some airports may see increases in
activity while others see decreases, as well as the uncertainties in
these predictions. The Administrator therefore considers all this
information and data collectively to inform his judgment on whether
lead emissions from covered aircraft cause or contribute to endangering
air pollution.
---------------------------------------------------------------------------

    \328\ FAA Terminal Area Forecast provides projections of
aircraft activity at airports. The forecast is available at https://taf.faa.gov and the FAA Terminal Area Forecast for Fiscal Years
2020-2045 describes the forecast method, data sources, and review
process for the TAF estimates, available at: https://taf.faa.gov/Downloads/TAFSummaryFY2020-2045.pdf.
    \329\ Geidosch. Memorandum to Docket EPA-HQ-OAR-2022-0389. Past
Trends and Future Projections in General Aviation Activity and
Emissions. June 1, 2022. Docket ID EPA-HQ-2022-0389.
---------------------------------------------------------------------------

    Accordingly, for all the reasons described, the Administrator
concludes that emissions of the lead air pollutant from engines in
covered aircraft cause or contribute to the lead air pollution that may
reasonably be anticipated to endanger public health and welfare.

VI. Statutory Authority and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review

    This action is a ``significant regulatory action'' as defined in
Executive Order 12866, as amended by Executive Order 14094.
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for Executive Order 12866 review. Documentation of any
changes made in response to the Executive Order 12866 review is
available in the docket. This action finalizes a finding that emissions
of the lead air pollutant from engines in covered aircraft cause or
contribute to the lead air pollution that may be reasonably anticipated
to endanger public health and welfare.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. The final endangerment and cause or contribute findings under
CAA section 231(a)(2)(A) do not contain any information collection
activities.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. The final
endangerment and cause or contribute findings under CAA section
231(a)(2)(A) do not in-and-of-themselves impose any new requirements on
any regulated entities but rather set forth the Administrator's finding
that emissions of the lead air pollutant from engines in covered
aircraft cause or contribute to lead air pollution that may be
reasonably anticipated to endanger public health and welfare.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or Tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications as specified in
Executive Order 13175. The final endangerment and cause or contribute
findings under CAA section 231(a)(2)(A) do not in-and-of-themselves
impose any new requirements but rather set forth the Administrator's
final finding that emissions of the lead air pollutant from engines in
covered aircraft cause or contribute to lead air pollution that may be
reasonably anticipated to endanger public health and welfare. Thus,
Executive Order 13175 does not apply to this action.
    Tribes have previously submitted comments to the EPA noting their
concerns regarding potential impacts of lead emitted by piston-engine
aircraft operating on leaded avgas at airports on, and near, their
Reservation Land.\330\ The EPA plans to continue engaging with Tribal
stakeholders on this issue and will offer a government-to-government
consultation upon request.
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    \330\ See Docket ID Number EPA-HQ-OAR-2006-0735. The Tribes that
submitted comments were: The Bad River Band of Lake Superior Tribe
of Chippewa Indians, The Quapaw Tribe of Oklahoma, The Leech Lake
Band of Ojibwe, The Lone Pine Paiute-Shoshone Reservation, The Fond
du Lac Band of Lake Superior Chippewa, and The Mille Lacs Band of
Ojibwe.
---------------------------------------------------------------------------

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects on
children of a planned regulation in setting Federal health and safety
standards. This action is not subject to Executive Order 13045 because
it does not propose to establish an environmental standard intended to
mitigate health or safety risks. Although the Administrator considered
health and safety risks as part of the endangerment and cause or
contribute findings under CAA section 231(a)(2)(A), the findings
themselves do not impose a standard intended to mitigate those risks.
However, the EPA's Policy on Children's Health applies to this action.
Consistent with this policy,

the Administrator considered lead exposure risks to children as part of
this final endangerment finding under CAA section 231(a)(2)(A).
Information on how the Policy was applied is available under
``Children's Environmental Health'' in the SUPPLEMENTARY INFORMATION
section B. of this document. A copy of the documents pertaining to the
impacts on children's health from emissions of lead from piston-engine
aircraft that the EPA references in this action have been placed in the
public docket for this action (Docket EPA-HQ-OAR-2022-0389).

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy. Further, we have concluded that this
action is not likely to have any adverse energy effects because the
final endangerment and cause or contribute findings under section
231(a)(2)(A) do not in-and-of themselves impose any new requirements
but rather set forth the Administrator's finding that emissions of the
lead air pollutant from engines in covered aircraft cause or contribute
to lead air pollution that may be reasonably anticipated to endanger
public health and welfare.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations; Executive
Order 14096: Revitalizing Our Nation's Commitment to Environmental
Justice for All

    The EPA believes that the human health or environmental conditions
that exist prior to this action result in or have the potential to
result in disproportionate and adverse human health or environmental
effects on communities with environmental justice concerns. The EPA
conducted an analysis of people living within 500 meters or one
kilometer of airports and found that there is a greater prevalence of
people of color and of low-income populations within 500 meters or one
kilometer of some airports compared with people living more distant.
The EPA provides a summary of the evidence for potentially
disproportionate and adverse effects among people of color and low-
income populations residing near airports in section II.A.5. of this
document. A copy of the documents pertaining to the EPA's analysis of
potential environmental justice concerns regarding populations who live
in close proximity to airports has been placed in the public docket for
this action (Docket EPA-HQ-OAR-2022-0389).
    The EPA believes that this action will not change existing
disproportionate and adverse effects on communities with environmental
justice concerns. In this action, the EPA finds, under section
231(a)(2)(A) of the Clean Air Act, that emissions of lead from engines
in covered aircraft may cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare. We are
not proposing emission standards at this time.
    The EPA additionally promoted fair treatment and meaningful
involvement for the public, including for communities with
environmental justice concerns, in this action by briefing Tribal
members on this action and providing information on our website in both
Spanish and English, as well as providing access to Spanish translation
during the public hearing.

K. Congressional Review Act (CRA)

    The EPA will submit a rule report to each House of the Congress and
to the Comptroller General of the United States. This action is not a
``major rule'' as defined by 5 U.S.C. 804(2).

L. Determination Under Section 307(d)

    Section 307(d)(1)(V) of the CAA provides that the provisions of
section 307(d) apply to ``such other actions as the administrator may
determine.'' Pursuant to section 307(d)(1)(V), the Administrator
determines that this action is subject to the provisions of section
307(d).

M. Judicial Review

    Section 307(b)(1) of the CAA governs judicial review of final
actions by the EPA. This section provides, in part, that petitions for
review must be filed in the D.C. Circuit: (i) when the agency action
consists of ``nationally applicable regulations promulgated, or final
actions taken, by the Administrator,'' or (ii) when such action is
locally or regionally applicable, but ``such action is based on a
determination of nationwide scope or effect and if in taking such
action the Administrator finds and publishes that such action is based
on such a determination.'' For locally or regionally applicable final
actions, the CAA reserves to the EPA complete discretion whether to
invoke the exception in (ii) described in the preceding sentence.\331\
---------------------------------------------------------------------------

    \331\ Sierra Club v. EPA, 47 F.4th 738, 745 (D.C. Cir. 2022)
(``EPA's decision whether to make and publish a finding of
nationwide scope or effect is committed to the agency's discretion
and thus is unreviewable''); Texas v. EPA, 983 F.3d 826, 834-35 (5th
Cir. 2020).
---------------------------------------------------------------------------

    This action is ``nationally applicable'' within the meaning of CAA
section 307(b)(1) because in issuing these final findings, the EPA
becomes subject to a statutory duty to propose and promulgate aircraft
engine emission standards under CAA section 231(a), which are
nationally applicable regulations for which judicial review is
available only in the U.S. Court of Appeals for the District of
Columbia Circuit (D.C. Circuit) pursuant to CAA section 307(b)(1).
Further, these emission standards would apply to covered aircraft,
wherever in the nation they are located. We note also that similar
actions, including the 2016 Endangerment and Cause or Contribute
Findings under CAA section 231 for greenhouse gases and the 2009
Endangerment and Cause or Contribute Findings under CAA section 202(a)
for greenhouse gases, were also nationally applicable \332\ and were
challenged in the D.C. Circuit.\333\
---------------------------------------------------------------------------

    \332\ 81 FR 54422 (Aug. 15, 2016) (2016 Findings); 74 FR 66496
(2009 Findings).
    \333\ Coalition for Responsible Regulation, Inc. v. EPA, 684
F.3d 102 (D.C. Cir. 2012) (subsequent history omitted) (affirming
2009 Findings); Biogenic CO2 Coalition v. EPA (Doc. No. 1932392, No.
16-1358, D.C. Cir., January 26, 2022) (granting petitioner's motion
to voluntarily dismiss petition for review of 2016 Findings).
---------------------------------------------------------------------------

    In the alternative, to the extent a court finds this final action
to be locally or regionally applicable, the Administrator is exercising
the complete discretion afforded to him under the CAA to make and
publish a finding that this action is based on a determination of
``nationwide scope or effect'' within the meaning of CAA section
307(b)(1).\334\ In issuing these final findings, the EPA becomes
subject to a statutory duty to propose and promulgate emissions
standards under CAA section 231(a), which would apply nationwide to
covered aircraft that travel and operate within multiple judicial
circuits. As described in section III. of this document, in making
these findings, the EPA is applying the same analytical framework that
the Agency applied in the 2016 Endangerment and Cause or

Contribute Findings under CAA section 231 for greenhouse gases and the
2009 Endangerment and Cause or Contribute Findings under CAA section
202(a) for greenhouse gases, both of which were challenged in the D.C.
Circuit, as noted above.
---------------------------------------------------------------------------

    \334\ In deciding whether to invoke the exception by making and
publishing a finding that an action is based on a determination of
nationwide scope or effect, the Administrator takes into account a
number of policy considerations, including his judgment balancing
the benefit of obtaining the D.C. Circuit's authoritative
centralized review versus allowing development of the issue in other
contexts and the best use of agency resources.
---------------------------------------------------------------------------

    The Administrator finds that this is a matter on which national
uniformity in judicial resolution of any petitions for review is
desirable, to take advantage of the D.C. Circuit's administrative law
expertise, and to facilitate the orderly development of the law under
the Act. The Administrator also finds that consolidated review of this
action in the D.C. Circuit will avoid piecemeal litigation in the
regional circuits, further judicial economy, and eliminate the risk of
inconsistent results, and that a nationally consistent approach to the
CAA's provisions related to making endangerment and cause or contribute
findings under section 231 of the CAA, including for lead air pollution
and emissions of lead from engines in covered aircraft as here,
constitutes the best use of agency resources.
    For these reasons, this final action is nationally applicable or,
alternatively, the Administrator is exercising the complete discretion
afforded to him by the CAA and finds that this final action is based on
a determination of nationwide scope or effect for purposes of CAA
section 307(b)(1) and is publishing that finding in the Federal
Register. Under section 307(b)(1) of the CAA, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the District of Columbia Circuit by December 19, 2023.

VII. Statutory Provisions and Legal Authority

    Statutory authority for this action comes from 42 U.S.C. 7571, 7601
and 7607.

List of Subjects

40 CFR Parts 87 and 1031

    Environmental protection, Air pollution control, Aircraft, Aircraft
engines.

40 CFR Part 1068

    Environmental protection, Administrative practice and procedure,
Confidential business information, Imports, Motor vehicle pollution,
Penalties, Reporting and recordkeeping requirements, Warranties.

Michael S. Regan,
Administrator.
[FR Doc. 2023-23247 Filed 10-19-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Page 52070]
[FR Doc No: 2017-24350]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3385-EM; Docket ID FEMA-2017-0001]

Florida; Amendment No. 2 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Florida (FEMA-3385-EM), dated September 5, 2017, and
related determinations.

DATES: This amendment was issued October 20, 2017.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective October 18, 2017.

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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-24350 Filed 11-8-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: July 10, 2008 (Volume 73, Number 133)]
[Notices]
[Page 39740]
[DOCID:fr10jy08-104]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 10A-1; SEC File No. 270-425; OMB Control No. 3235-0468.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 10A-1 (17 CFR 240.10A-1) implements the reporting requirements
in Section 10A of the Exchange Act (15 U.S.C. 78j-1), which was enacted
by Congress on December 22, 1995 as part of the Private Securities
Litigation Reform Act of 1995, Public Law No. 104-67, 109 Stat 737.
Under section 10A and Rule 10A-1 reporting occurs only if a
registrant's board of directors receives a report from its auditors
that (1) there is an illegal act material to the registrant's financial
statements, (2) senior management and the board have not taken timely
and appropriate remedial action, and (3) the failure to take such
action is reasonably expected to warrant the auditor's modification of
the audit report or resignation from the audit engagement. The board of
directors must notify the Commission within one business day of
receiving such a report. If the board fails to provide that notice,
then the auditor, within the next business day, must provide the
Commission with a copy of the report that it gave to the board.
    Likely respondents are those registrants filing audited financial
statements under the Securities Exchange Act of 1934 (15 U.S.C. 78a, et
seq.) and the Investment Company Act of 1940 (15 U.S.C. 80a-1, et
seq.).
    It is estimated that Rule 10A-1 results in an aggregate additional
reporting burden of 10 hours per year. The estimated average burden
hours are solely for purposes of the Paperwork Reduction Act and are
not derived from a comprehensive or even a representative survey or
study of the costs of SEC rules or forms.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312;
or send an e-mail to<EMAIL_ADDRESS>
    Dated: June 30, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-15676 Filed 7-9-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]
[Page 36366-36367]
[DOCID:fr26jn08-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57991; File No. SR-ISE-2008-47]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

June 19, 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 June 17, 2008, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') 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 the
Exhange. The ISE has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by the ISE under section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on 3 Premium Products.\5\ The text of
the proposed rule change is available on the ISE's Web site (http://
www.iseoptions.com), at the principal office of the ISE, and at the
Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ ``Premium Products'' is defined in the Schedule of Fees as
the products enumerated therein.
---------------------------------------------------------------------------

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

    In its filing with the Commission, the ISE 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 ISE 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
    The Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the
CurrencySharesSM Canadian Dollar Trust (``FXC''), the
CurrencySharesSM Swiss Franc Trust (``FXF'') \6\ and the
UltraShort Financials ProShares (``SKF'').\7\ The Exchange represents
that FXC, FXF and SKF are eligible for options trading because they
constitute ``Exchange-Traded Fund Shares,'' as defined by ISE Rule
502(h).
---------------------------------------------------------------------------

    \6\ CurrencySharesSM Canadian Dollar Trust and
CurrencySharesSM Swiss Franc Trust are service marks of
their respective owner(s). Rydex Distributors, Inc., an affiliate of
Rydex Investments and Rydex Specialized Products, is the distributor
of Rydex funds. Rydex Specialized Products LLC, d/b/a Rydex
Investments (``Rydex''), is the sponsor of FXC and FXF. Rydex has
not licensed or authorized ISE to (i) engage in the creation,
listing, provision of a market for trading, marketing, and promotion
of options on FXC and FXF or (ii) to use and refer to any trademarks
or service marks in connection with the listing, provision of a
market for trading, marketing, and promotion of options on FXC and
FXF or with making disclosures concerning options on FXC and FXF
under any applicable federal or state laws, rules or regulations.
Rydex does not sponsor, endorse, or promote such activity by ISE,
and is not affiliated in any manner with ISE.
    \7\ ``Dow Jones'' and ``Dow Jones U.S. FinancialsSM''
are service marks of Dow Jones & Company, Inc. (``Dow Jones'') and
has been licensed for use for certain purposes by ProFunds Trust.
All other trademarks and service marks are the property of their
respective owners. SKF is not sponsored, endorsed, issued, sold or
promoted by Dow Jones. Dow Jones has not licensed or authorized ISE
to (i) engage in the creation, listing, provision of a market for
trading, marketing, and promotion of options on SKF or (ii) to use
and refer to any of their trademarks or service marks in connection
with the listing, provision of a market for trading, marketing, and
promotion of options on SKF or with making disclosures concerning
options on SKF under any applicable federal or state laws, rules or
regulations. Dow Jones does not sponsor, endorse, or promote such
activity by ISE and is not affiliated in any manner with ISE.
---------------------------------------------------------------------------

    All of the applicable fees covered by this filing are identical to
fees charged by the Exchange for all other Premium Products.
Specifically, the Exchange is proposing to adopt an execution fee and a
comparison fee for all transactions in options on FXC, FXF and SKF.\8\
The amount of the execution fee and comparison fee for products covered
by this filing will be $0.15 and $0.03 per contract, respectively, for
all Public Customer Orders \9\ and Firm Proprietary orders. The amount
of the execution fee and comparison fee for all ISE Market Maker
transactions will be equal to the execution fee and comparison fee
currently charged by the Exchange for ISE Market Maker transactions in
equity options.\10\ Finally, the amount of the execution fee and
comparison fee for all non-ISE Market Maker transactions will be $0.37
and $0.03 per contract, respectively.\11\ Further, since options on
FXC, FXF and SKF are multiply-listed, the Exchange's Payment for Order
Flow fee will apply to all three products. The Exchange believes the
proposed rule change will further the Exchange's goal of introducing
new products to the marketplace that are competitively priced.
---------------------------------------------------------------------------

    \8\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2008, these fees
will also be charged to Linkage Principal Orders (``Linkage P
Orders'') and Linkage Principal Acting as Agent Orders (``Linkage P/
A Orders''). The amount of the execution fee charged by the Exchange
for Linkage P Orders and Linkage P/A Orders is $0.24 per contract
side and $0.15 per contract side, respectively. See Securities
Exchange Act Release No. 56128 (July 24, 2007), 72 FR 42161 (August
1, 2007) (SR-ISE-2007-55).
    \9\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person or entity that is
not a broker or dealer in securities.
    \10\ The execution fee is currently between $.21 and $.12 per
contract side, depending on the Exchange Average Daily Volume, and
the comparison fee is currently $.03 per contract side.
    \11\ The amount of the execution and comparison fee for non-ISE
Market Maker transactions executed in the Exchange's Facilitation
and Solicitation Mechanisms is $0.16 and $0.03 per contract,
respectively.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of section 6 of the Act,\12\ in general, and
furthers the objectives of section 6(b)(4),\13\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not 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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, the foregoing rule change
has become effective pursuant to section 19(b)(3)(A) of the Act \14\
and Rule 19b-4(f)(2) \15\ thereunder. At any time within 60 days of the
filing of such 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.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

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-ISE-2008-47 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2008-47. 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 such filing also will be available for
inspection and copying at the principal office of the ISE. 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-ISE-2008-47 and should be
submitted on or before July 17, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-14499 Filed 6-25-08; 8:45 am]

BILLING CODE 8010-01-P


Analytical Data Summary PFOS, Primary Standard  Test Control Reference #TCR 00017 046 SOLUBILITY IN WATER, NATURAL SEAWATER, AN AQUEOUS SOLUTION OF 3.5% SODIUM CHLORIDE, AND N OCTANOL WITH SUBSEQUENT CALCULATION OF THE N OCTANOL: WATER PARTITION COEFFICIENT (&,) OF PFOS FOR EACH OF THE AQUEOUS MATRICES Author Mark E. Ellefson Completion Date Date of signing Performing Laboratory 3M Environmental Laboratory Building 2 3E 09 935 Bush Avenue St. Paul, MN 55106 Project Identification Summary of Data Presented in Accordance with 3M Enivironmental Laboratory Study # FACT TCR002 (LIMS #E00 1716) Centre Analytical Laboratories Study # 023 021 Total Number of Pages 8 BACK TO MAIN TABLE OF CONTENTS Introduction ......................................................................................................................................... 4 Purpose .............................................................................................................................................. 4 Test Substance .................................................................................................................................. 4 Test Systems ..................................................................................................................................... 5 Summary of PFOS (TCR 00017 046) Solubility ................................................................................ 5 Determination of the Partition Coefficient (n octanoVwater) of PFOS (TCR 00017 046) for each of the Aqueous Matrices ........................................................................................................................ 6 Method Summaries ............................................................................................................................ 7 References ......................................................................................................................................... 7 Signature Page ................................................................................................................................... 8 Analytical Data Summary. Page 2 of 8 BACK TO MAIN LIST OF TABLES Table 1 .

Table 2 .

Table 3 .

Table 4 . Characterization of the Test Substance and Analytical Reference Substance ................... 5 Description of Test Systems ............................................................................................... 5 Solubi1: ity of PFOS TCR 00017 046 .................................................................................... 6 Calculated log K, for PFOS (TCR 00017 046) in Various Aqueous Matrices ................... 7 Analytical Data Summary. Page 3 of 8 BACK TO MAIN INTRODUCTION Solubility is an wwironmentally significant parameter because the spatial and temporal movement (mobility) of a substance through the environment is largely determined by its solubility in water. Water soluble substances gain ready access to humans and other living organisms. The knowledge of the solubility of a substance in water is a prerequisite for testing biological degradation and bioaccumulation in water and many other tests. Solubility data can also be used for comparative and modeling purposes.

Another significent parameter, the n octanoVwater partition coefficient (KO,), is defined as the ratio of the equilibriurn concentrations of a dissolved substance in a two phase system consisting of two largely immiscible solvents. The partition coefficient of a substance between water and a lipophilic solvent (n octanol) is one model variable which may be used to describe both the transfer of a substance from the aquatic environment into an organism and the potential bioaccumulatiori of the substance. Studies have shown there is a highly significant relationship between the partition coefficient of different substances in the system n octanoVwater and their bioaccumulatiori in fish, as described by Neely, W. B., et al. "Partition Coefficients to Measure Bioconcentration Potential of Organic Chemicals in Fish"; Environmental Science and Technology 8: 1113 (1975).

PURPOSE The purpose of this analytical data summary is to combine the solubility data for PFOS (TCR 00017 046) in ASTM Type I water, natural seawater, an aqueous solution of 3.5% sodium chloride, and n octanol into a single document. This data was previously reported in 3M Environmental L. aboratory Reports #E00 1716 Phase: Solubility of PFOS in Water, #E00 1716 Phase: Solubility of PFOS in Natural Seawater and an Aqueous Solution of 3.5% Sodium Chloride, and #EE00 1716 Phase: Solubility of PFOS in n Octanol.

In addition, calciAations were performed to determine the n octano1: water partition coefficient (KO,) for PFOS (TCR 00017 046) in each of the aqueous matrices. The calculated KO, values are also presented in this document.

TEST SUBSTANCE POTASSIUM PERFLUOROOCTANESULFONATE (PFOS) #TCR 00017 046 CAS Number: 2795 39 3 Chemical Formula: C, F$ 303K Molecular Weight: 538.22 g/ mol Analytical Data Summary, Page 4 of 8 BACK TO MAIN PFOS, Test Control Reference #TCR 00017 046 Table 1. Characterization of the Test Substance and Analytical Reference Substance I Re ctystallized by George Moore, 3M I Specialty Materials, Bldg. 236 1 B I 0 I SynQuest Labs 0 1 01 201 0 Not Available Storage C, onditions Frozen Frozen TCR 00017 047 Lot #Q75 30 TCR 00017 046 3M Laboratory Identification I Phvsical DescriDtion I White Powder I White Powder I I Purity I * 97.9% I *The punty of the PFOS used in 3M Environmental Laboratory Report #E00 1716 was determined to be 97.9%. The punty of THPFOS (i: unently being determined by Centre Analytical Laboratory) will not affect any analytical findings. The same lots/ source 0 1 both compounds were used throughout the entire study.

TEST SYSTEMS Table 2. Description of Test Systems Aldrich Millipore System EM Science Ocean Scientific International Expiration Date 2005 201 0 11/ 01/ 01 Storaae Conditions Ambient Ambient Ambient Flammable Cabinet [3McaboratOry 1 NA Identification Nurnber I I TN A: 4193 I TN A: 2458 I TN A: 4703 I Purity/ Grade I ASTMTypeI I Salinity35 I ACS Grade I 99%+ HPLC Grade I SUMMARY OF PFOS (TCR 00017 046) SOLUBILITY The approximate solubility of PFOS (TCR 00017 046) was determined in each of the solvents by performing a sollubility screen test, followed by a quantitative solubility determination via Shake Flask Method.

Results are presented in table 3:

Analytical Data Summary, Page 5 of 8 BACK TO MAIN Table 3. Solubility of PFOS TCR 00017 046 Natural Seawater Aqueous Solution of 3.5% Sodium Chloride I ASTM Type I Water I 680 pg/ mL * I 12.4 pg/ mL **

20.0 pg/ mL **

n Octanol 56.0 pg/ mL ***

All solubility determinations of PFOS TCR 00017 046 were conducted at 22 25 OC.

DETERMINATION OF THE PARTITION COEFFICIENT (N OCTANOL/ WATER) OF PFOS (TCR 00017 046) FOR EACH OF THE AQUEOUS MATRICES United States Environmental Protection Agency OPPTS 830.7550, "Partition Coefficient (n OctanolNVater), Shake Flask Method" and OECD 107, "Partition Coefficient (n octanol/ water): Shake Flask Method" guidelines define partition coefficient (K) as the ratio of the equilibrium concentrations of a dissolved substance in a two phase system consisting of two largely immiscible solvents. In the case of n octanol and water,

The partition coefficient (K) is the dimensionless quotient of two concentrations, and is usually expressed as its logarithm to base I O .

OPPTS and OECD guidelines for the determination of partition coefficient (n octanoVwater) by shake flask method state the method is not applicable to strong acids and bases, metal complexes, substances which react with the solvent, or surface active agents. Measurements should be made on ionizable substances in their non ionized form (free acid or free base) only by using an appropriate buffer with a pH below the pK for a free acid or above the pK for a free base.

The physical properties of PFOS do not allow one to determine the partition coefficient by the shake flask method. However, individual solubility determinations of PFOS in water, natural seawater, an aqueous solution of 3.5% sodium chloride, and n octanol have been conducted. The partition coefficient (n octanol/ water) was determined mathematically for each of the aqueous matrices. Results are summarized in Table 4.

Analytical Data Summary, Page 6 of 8 BACK TO MAIN Table 4. Calculated log kW for PFOS (TCR 00017446) in Various Aqueous Matrices I ASTM Type I Water 680 pg/ mL 1.08 12.4 pg/ mL 0.65 20.0 pg/ mL 0.45 Natural Seawater 3.5% Sodium Chloride METHOD SUMMARIES The solubility determination of PFOS (TCR 00017 046) in each of the solvents was performed according to United States Environmental Protection Agency OPPTS 830.7840, "Water Solubility: Column Elution Method; Shake Flask Method" and OECD 105, "Water Solubility" Guidelines, using the 3M Erivironmental Laboratory methods ETS 8 170.0 "Solubility Screen Test: Approximate Solubility Determination of a Test Substance in Various Solvents;" and ETS 8 172.0 "Shake Flask Method; Solubility Determination of a Test Substance in Various Solvents". All analyses were performed according to the 3M Environmental Laboratory method ETS 8 155.0 "Analysis of Perfluorooctanesulfonate or Other Fluorochemicals in Waste Stream or Water Extracts Using HPLC Electrospray/ Mass Spectrometry".

The n octanoVwater coefficient determinations of PFOS (TCR 00017 046) in each of the aqueous matrices were calculated according to United States Environmental Protection Agency OPPTS 830.7550 "Partition Coefficient (n OctanolNVater), Shake Flask Method" and OECD 107, "Partition Coefficient (n octanoVwater): Shake Flask Method" Guidelines.

REFERENCES 1.

2.

3.

4. Fate, Transport and Transformation Test Guidelines Office of Prevention, Pesticides and Toxic Substances (OPPTS) 830.7840 Water Solubility: Column Elution Method; Shake Flask Method. EPA 712 C 96 041, August 1996.

OECD 105: Water Solubility. Adopted 27July, 1995.

Product Properties Test Guidelines Office of Prevention, Pesticides and Toxic substances (OPPTS) 830.7550 Partition Coefficient (n OctanolNVater), Shake Flask Method, August 1996.

OECD 107: lPartition Coefficient (n octanoVwater): Shake Flask Method.

Analytical Data Summary, Page 7 of 8 BACK TO MAIN SIGNATURE PAGE We certify that this summary report is a true and complete representation of the data:

/ Mark E. Ellefson Project Lead William K. Reagen Laboratory Manager Date Analytical Data Summary, Page 8 of 8 BACK TO MAIN


[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Rules and Regulations]
[Pages 63079-63080]
[FR Doc No: 2015-26219]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0656; Directorate Identifier 2013-NM-224-AD;
Amendment 39-18295; AD 2015-21-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; removal.

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SUMMARY: We are removing Airworthiness Directive (AD) 2010-08-08, which
applied to certain Airbus Model A330-243, -341, -342, and -343
airplanes. AD 2010-08-08 required deactivating the water scavenge
automatic operation and revising the Limitations section of the
airplane flight manual (AFM). We are also removing AD 2011-06-04, which
applied to certain Airbus Model A330-243F airplanes. AD 2011-06-04
required revising the Limitations section of the AFM. We issued ADs
2010-08-08 and 2011-06-04 to prevent fuel flow restriction, caused by
ice, resulting in a possible engine surge or stall condition, and the
engine being unable to provide the commanded thrust. Since we issued AD
2010-08-08 and AD 2011-06-04, we received new data indicating that the
water scavenge system (WSS) operation does not induce any risk of fuel
feed system (including the engine) blockage by ice on the pipework or
pump inlets. We have also determined that the risk of fuel flow
restriction by ice at the fuel oil heat exchanger (FOHE) interface on
airplanes equipped with Rolls-Royce Trent 700 engines is now addressed
by a redesigned FOHE, which incorporates enhanced anti-icing and de-
icing performance.

DATES: This AD becomes effective November 23, 2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0656; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80;
email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus Model A330-
243, -243F, -341, -342, and -343 airplanes. The NPRM published in the
Federal Register on October 2, 2014 (79 FR 59468). The NPRM proposed to
remove AD 2010-08-08, Amendment 39-16263 (75 FR 19196, April 14, 2010),
and AD 2011-06-04, Amendment 39-16628 (76 FR 13075, March 10, 2011).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2010-0132-CN, dated October 14, 2013 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
cancel EASA AD 2010-0132R1, dated June 10, 2013, which superseded EASA
AD 2010-0132, dated June 28, 2010. The requirements of FAA AD 2010-08-
08, Amendment 39-16263 (75 FR 19196, April 14, 2010), and AD 2011-06-
04, Amendment 39-16628 (76 FR 13075, March 10, 2011), correspond to
EASA AD 2010-0132. The MCAI states:

    During an in-service event, the flight crew of a Trent 700
powered A330 aeroplane reported a temporary Engine Pressure Ratio
(EPR) shortfall on engine 2 during the takeoff phase of the flight.
The ENG STALL warning was set. The flight crew followed the standard
procedures which included reducing throttle to idle. The engine
recovered and provided the demanded thrust level for the remainder
of the flight.
    Data analysis confirmed a temporary fuel flow restriction and
subsequent recovery, and indicated that also engine 1 experienced a
temporary fuel flow restriction shortly after the initial event on
engine 2, again followed by a full recovery. The engine 1 EPR
shortfall was insufficient to trigger any associated warning and was
only noted through analysis of the flight data. No flight crew
action was necessary to recover normal performance on this engine.
The remainder of the flight was uneventful.
    Based on industry-wide experience, the investigation of the
event focused on the possibility for ice to temporarily restrict the
fuel flow. While no direct fuel system fault was identified, the
operation of the water scavenge system (WSS) at Rib 3 was considered
to have been a contributory factor.
    Prompted by these findings, EASA issued [EASA] Emergency AD
2010-0042-E [http://ad.easa.europa.eu/ad/2010-0042-E] [which
corresponds to FAA AD 2010-08-08, Amendment 39-16263 (75 FR 19196,
April 14, 2010] to require deactivation of the automatic Standby
Fuel Pump Scavenge System and to prohibit dispatch of an aeroplane
with one main fuel pump inoperative.
    Subsequently, EASA issued [EASA] AD 2010-0132 which superseded
EASA AD 2010-0042-E, retaining its requirements, to expand the
applicability to the newly certified model A330-243F [which
corresponds to FAA AD 2011-06-04, Amendment 39-16628 (76 FR 13075,
March 10, 2011, for the A330-243F requirements]. EASA AD 2010-0132
was later revised to remove the dispatch restriction with one main
fuel pump inoperative.
    Since EASA AD 2010-0132R1 was issued, extensive fuel system
icing risk investigations testing was conducted by Airbus and Rolls-
Royce, the results of which confirmed that the Rib 3 WSS operation
does not induce any risk of fuel feed system (including the engine)
blockage by ice accreted on the pipework and/or pump inlets. In
addition, it was demonstrated that the risk of fuel flow restriction
by ice at the Fuel Oil Heat Exchanger (FOHE) interface on aeroplanes
equipped with Trent 700 engines is now adequately addressed by
introduction of a re-designed FOHE, more tolerant to the release of
ice (modification 200218). The

modified FOHE (incorporating enhanced anti-icing and de-icing
performance) is required to be installed on all Trent 700 engines
through EASA AD 2009-0257 [http://ad.easa.europa.eu/ad/2009-0257]
[which corresponds to FAA AD 2010-07-01, Amendment 39-16244 (75 FR
15326, March 29, 2010)].
    Previously, the operation of the WSS at Rib 3 was no longer
considered as a main contributory factor on ice build-up and
subsequent release of ice into the fuel system. Based on the latest
information, the deactivation of the automatic Standby Fuel Pump
Scavenge System is no longer required.
    For the reasons described above, this Notice cancels EASA AD
2010-0132R1.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0656-0004.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 59468, October 2,
2014), or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 59468, October 2, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 59468, October 2, 2014).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0656; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone: 800-
647-5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
(a) Removing Airworthiness Directive (AD) 2010-08-08, Amendment 39-
16263 (75 FR 19196, April 14, 2010); and AD 2011-06-04, Amendment 39-
16628 (76 FR 13075, March 10, 2011), and
0
(b) Adding the following new AD:

2015-21-03 Airbus: Amendment 39-18295. Docket No. FAA-2014-0656;
Directorate Identifier 2013-NM-224-AD.

(a) Effective Date

    This AD becomes effective November 23, 2015.

(b) Affected ADs

    This AD removes AD 2010-08-08, Amendment 39-16263 (75 FR 19196,
April 14, 2010); and AD 2011-06-04, Amendment 39-16628 (76 FR 13075,
March 10, 2011).

(c) Applicability

    This AD applies to the airplanes specified in paragraphs (c)(1)
and (c)(2) of this AD.
    (1) Airbus Model A330-243, -341, -342, and -343 airplanes,
certificated in any category, all manufacturer serial numbers
equipped with Rolls-Royce Trent 700 engines, on which Airbus
Modification 56966MP16199 has been embodied in production or Airbus
Service Bulletin A330-28-3105 has been embodied in service.
    (2) Airbus Model A330-243F airplanes, certificated in any
category, all manufacturer serial numbers on which Airbus
Modification 56966H16199 has been embodied in production or Airbus
Service Bulletin A330-28-3105 has been embodied in service.

    Issued in Renton, Washington, on October 6, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-26219 Filed 10-16-15; 8:45 am]
BILLING CODE 4910-13-P


No hazard was identified for quantification of risk following dermal exposure.  In a 21-day dermal toxicity study (MRID 41833101), no systemic toxicity was seen following repeated dermal application of metolachlor (96.4% ai) to the intact skin of five New Zealand rabbits/sex/group at doses of 0, 10, 100 or 1000 mg/kg/day for 21 days.

A.3.6	Inhalation Exposure (Short -Term)

Study Selected: Developmental Toxicity Study in Rats
MRID No.:  43928925
Dose and Endpoint for Risk Assessment: 50 mg/kg/day based on an offspring NOAEL of 50 mg/kg/day and a LOAEL of 500 mg/kg/day based on is based on increased incidence of clinical signs, decreased body weight/body weight gain, food consumption and food efficiency seen in maternal animals.
Comments about Study/Endpoint/Uncertainty Factors:   Since an oral study was selected, a 100% absorption factor should be applied.  The total UF is 100 (10X for interspecies uncertainty factor and 10X for intraspecies variability.

A.3.7	Inhalation Exposure (Intermediate-Term)

Study Selected: Subchronic (6 month) Toxicity Study in the Dog
MRID No.:  00032174
Executive Summary:  See Appendix A, Guideline [§ 870.xxix]
Dose and Endpoint for Risk Assessment: NOAEL of 8.8 mg/kg/day based on decreased body weight gain at 29.4 mg/kg/day
Comments about Study/Endpoint/Uncertainty Factors:   Since an oral study was selected, a 100% absorption factor should be applied.  The total UF is 100 (10X for interspecies uncertainty factor and 10X for intraspecies variability.

A.4	Executive Summaries

A.4.1	Subchronic Toxicity

	870.3100	90-Day Oral Toxicity  -  Rat
In a 90-day subchronic oral toxicity limit study (MRID 44931710), groups of 10 male and 10 female Crl: CD BR rats were given CGA-354743 (Lot/Batch # KI-5408/6, 98% a.i.) administered in the diet at concentrations of 0, 360, 1200, 6000, or 20,000 ppm.  These concentrations were equivalent to 0, 25.1, 86.2, 427.0 or 1545.0 mg/kg/day for males and 0, 28.4, 98.3, 519.0 and 1685.0 mg/kg/day for females.  An additional 10 male and 10 female rats were given CGA-77102 (s-Metolachlor)(Lot/Batch # P.501001, 98.5% a.i.) administered in the diet at 5000 ppm (equivalent to 429 mg/kg/day for males and 563 mg/kg/day for females).  The study was designed to assess the subchronic oral toxicity of CGA-354743 technical and to compare its toxic effects with those of its parent compound, CGA-77102 technical.

No deaths or clinical signs of toxicity occurred during this study.  In addition, no statistically significant changes in body weight, body weight gain, food consumption, food efficiency, ophthalmologic examination, urinalysis, or histopathology was reported for animals fed CGA-354743.  Limited and sporadic statistically significant changes in hematology, clinical chemistry, water intake and organ weight data were not dose-dependent, and were of question - able toxicological and biological importance.

Dietary exposure to CGA-77102 produced a statistically significant decreased body weight gain (-20%, p  0.01) in males during week 1 only.  Females exposed to CGA-77102 showed decreased body weight gain (-19%) by week 13, but these changes were not statistically significant. The food efficiency of rats fed CGA-77102 was decreased relative to their respective control animals. Male and female rats had increased absolute and relative liver weights.  These results are consistent with a mild liver hypertrophy in females.

Based on the data presented in this study, the NOAEL is 20,000 ppm (1543 mg/kg/day and 1685 mg/kg/day for females) for CGA-354743.  A LOAEL could not be established.
At 5000 ppm (429 mg/kg/day in males and 563 mg/kg/day in females) CGA-77102 , there evidence of decreased body weight gain and food efficiency, increased absolute and relative liver weights and an increased incidence of hepatic centrilobular hypertrophy, although the effects were mild.

This subchronic oral toxicity study in rats is classified as Acceptable/Guideline [OPPTS 870.3100 (§82-1a)] and satisfies the guideline requirements.

	870.3100	90-Day Oral Toxicity  -  Rat

In a subchronic oral feeding study, (MRID 44929509), CGA-51202 technical (100% a.i.; batch No. JD 7069/3) was fed to groups of 10 male and 10 female albino rats at dose levels of 0, 300, 1000, or 15,000 ppm for 3 months. The average achieved doses for the corresponding groups were 0, 18.7, 62.1, and 1000 mg/kg bodyweight for males, and 0, 20.6, 67.3, and 1020 mg/kg for females.

All animals survived to study termination and no treatment-related clinical signs were observed.  There were no treatment-related effects on body weight, food consumption, ophthalmoscopic parameters, or urinalysis.  Platelet counts were decreased 16% (p<0.01) in high-dose males.  Total protein in high-dose males (5% decrease, p<0.01) and females (4% decrease, N.S.) was slightly decreased due to decreased globulin in males and decreased albumin and globulin fractions in females.  These effects were not considered biologically significant.  There were no treatment-related organ weight effects or macroscopic or microscopic lesions. Under the conditions of this study, the NOAEL is 15,000 ppm in the diet (1000 mg/kg for males, 1020 mg/kg for females, limit dose) based on no biologically significant effects.  A LOAEL was not identified.

This subchronic toxicity study in rats (82-1) is classified as Acceptable/Guideline.  It satisfies the guideline requirement for a subchronic dietary toxicity study in rodents.

	870.3150	90-Day Oral Toxicity  -  Dog

In a 90-day subchronic oral toxicity study (MRID 44931709), CGA-354743 technical (Batch Nos. KI-5408/4 and KI-5408/5, 99% a.i.) was administered to 4 pure - bred beagle dogs/sex/dose by capsule at dose levels of 0, 50, 200, 500, and 1000 mg/kg/day for 13 weeks.  An additional group of 4 males and 4 females received parent compound (CGA-77102 technical, Batch No. P.501001, 98.5% a.i.) at 200 mg/kg/day for 13 weeks.

There were no significant treatment related effects on mortality, body weight, food consumption, food conversion ratios, ophthalmological findings, hematology and urinalysis parameters, or gross and histopathological findings.  Vomiting did occur at a higher incidence in females treated with 1000 mg/kg/day of CGA-354743. Clinical signs in animals treated with CGA-77102 included vomiting, salivation and hematuria. Mean alkaline phosphatase activity was slightly increased in males receiving 1000 mg/kg/day CGA-354743 at weeks 7 and 13 to levels which were less than double the pretest mean for this group.  This finding correlated with slightly increased absolute liver weights, but there were no corresponding histopathological findings, or toxicologically significant increases in other biochemistry parameters.  In females, mean ALP activities remained within the reference range for untreated animals and mean GGT activity exceeded the reference range only at week 13 and only for the 500 mg/kg/day CGA-354743 group.  Absolute liver weights and liver weights relative to body weights were increased in females receiving 500 and 1000 mg/kg/day.  In the absence of corresponding histopathological findings or biologically significant increases in biochemistry parameters consistent with adverse hepatic effects, this finding is not considered toxicologically significant.

Mean ALP and GGT activities were significantly increased in both sexes at weeks 7 and 13 given CGA-77102.  In addition, ALT activity of males was increased at weeks 7 and 13.  Absolute and relative liver weights were significantly increased in males and females.  There were small increases in the incidences and severity of bile duct hyperplasia, perilobular fatty change in the livers of both sexes, and cystic hyperplasia of the gallbladder occurred only in the parent compound group.

The results appear to indicate that CGA-354743 may have effects (vomiting, slight increases in ALT and liver weight) similar to those of its parent compound, CGA-77102; however, at the limit dose, 1000 mg/kg/day, the effects observed were so slight and of questionable toxicological significance in CGA-35743-treated dogs that a definitive comparison of the two compounds cannot be made.

Based on the data presented in this study, the LOAEL was not determined, and the NOAEL was greater than or equal to 1000 mg/kg/day.

This subchronic oral toxicity study in dogs is classified as Acceptable/Guideline and satisfies the guideline requirements for a subchronic oral study [OPPTS: 870.3150 (§82-1b)] in dogs since the limit dose was tested.

	870.3200	21/28-Day Dermal Toxicity  -  Rat

	870.3465	90-Day Inhalation  -  Rat

A.4.2	Prenatal Developmental Toxicity

There was no evidence of maternal or developmental toxicity in the rat prenatal developmental study with CGA 354743 or CGA 51202 at the limit dose of 1000 mg/kg/day.

	870.3700a Prenatal Developmental Toxicity Study  -  Rat

In a developmental toxicity study (MRID 44931711), 28 presumed pregnant Wistar B: Hanlbm:WIST rats per group were administered CGA 354743 Technical (98%; Batch No. KI-5408/6) by gavage in 0.5% aqueous sodium carboxymethylcellulose in 0.1% aqueous polysorbate 80 at doses of 0, 250, 500, or 1000 mg/kg/day on gestation days (GD) 6-15, inclusive.  Controls were treated with 0.5% sodium carboxymethylcellulose in 0.1% aqueous polysorbate 80 (vehicle).  On GD 21, dams were sacrificed, subjected to gross necropsy, and all fetuses examined externally.  Approximately one-half of each litter was processed for visceral examination and the remaining one-half was processed for skeletal examination.
All animals survived to terminal sacrifice.  No clinical signs of toxicity were observed in any animal.  Maternal body weights, body weight gains, and food consumption were similar between the treated and control groups throughout the study.  Maternal necropsy was unremarkable.

Therefore, the maternal toxicity NOAEL is 1000 mg/kg/day and the maternal toxicity LOAEL was not identified.

No differences were observed between the treated and control groups for number of corpora lutea, number of implantation sites, live fetuses/dam, pre- and post-implantation losses, fetal body weights, or fetal sex ratios.

No treatment-related external, visceral, or skeletal malformations/variations were observed in any fetus from any group.

The high dose is equivalent to the limit dose for developmental toxicity studies.

Therefore, the developmental toxicity NOAEL is 1000 mg/kg/day and the developmental toxicity LOAEL was not identified.

This study is classified as Acceptable/Guideline and satisfies the requirements for a developmental toxicity study [870.3700 (§83-3a)] in rats.

	870.3700a Prenatal Developmental Toxicity Study - Rat

In a developmental toxicity study (MRID 44929510), 24 presumed pregnant Tif: RAI f (SPF) (hybrids of RII/1  RII/2) rats per group were administered CGA 51202 Technical (100%; Batch No. JD 7069/3) by gavage in  0.5% aqueous sodium carboxy - methylcellulose solution at doses of 0, 10, 100, or 1000 mg/kg/day on gestation days (GD) 6-15, inclusive.  Controls were treated with 0.5% sodium carboxymethylcellulose (vehicle).  On GD 21, dams were sacrificed, subjected to gross necropsy, and all fetuses examined externally.  Approximately one-half of each litter was processed for visceral examination and the remaining one-half was processed for skeletal examination.

One low-dose animal was sacrificed moribund on GD 20 with a urogenital infection.  All other animals survived to terminal sacrifice.  No clinical signs of toxicity were observed in any animal.  Maternal body weights and body weight gains were similar between the treated and control groups throughout the study.  Food consumption was not affected by treatment.  Maternal necropsy was unremarkable.

Therefore, the maternal toxicity NOAEL is 1000 mg/kg/day and the maternal toxicity LOAEL was not identified.

No differences were observed between the treated and control groups for number of corpora lutea, number of implantation sites, live fetuses/dam, pre- and post-implantation losses, fetal body weights, or fetal sex ratios.

No treatment-related external, visceral, or skeletal malformations/variations were observed in any fetus from any group.

The high dose is equivalent to the limit dose for developmental toxicity studies.

Therefore, the developmental toxicity NOAEL is 1000 mg/kg/day and the developmental toxicity LOAEL was not identified.

This study is classified as Acceptable/Guideline and satisfies the requirements for a develop - mental toxicity study [870.3700 (§83-3a)] in rats.

          870.3700b Prenatal Developmental Toxicity Study  -  Rabbit

In a developmental (teratology) study (MRID# 43928924), sexually mature virgin female New Zealand White, S.P.F. Rabbits (Strain: Har:PF/CF(NZW)BR) from H.A.R.E., Rabbits for Research, Hewitt, N.J. Received either 0, 20, 100, or 500 mg/kg/day CGA-77102 Technical (Lot No. FL-830813 with a purity of 89.6% (93.7% S isomer) suspension in 3% corn starch containing 0.5% Tween 80 by oral gavage from gestation days 7 through 19.

No treatment related mortality was noted.  There was a
dose related increase in little/none/soft stool observations at the 100 and 500 mg/kg/day dose levels.  The 500 mg/kg/day dose group had lower overall body weights at gestation days 19, 29 and corrected body weights at day 29 gained less weight than the control during the dosing period (gestation days 7-19) with a rebound weight gain following the dosing period (gestation days 19-29), an indicator of toxicity.  This group also had lower overall weight gain for the calculated periods of gestation days 7-29, 0-29 and corrected body weight gains for 0-29.  This was supported by reduced food consumption during the dosing period (gestation days 7-19) and for the overall periods (gestation days 7-28 and 0-28) with a rebound in food consumption following dosing (gestation days 19-28) at the 500 mg/kg/day dose level.  This is also reflected in reduced food efficiency for the same periods (719, 7-28, and 0-28) and increased food efficiency following dosing (19-28) at the 500 mg/kg/day dose level.  The maternal toxicity NOEL was 20 mg/kg/day with a LOEL of 100 mg/kg/day based on clinical signs of toxicity.

No significant treatment related developmental toxicity was noted at the dose levels tests.  The developmental toxicity was equal to or greater than 500 mg/kg/day, a LOEL was not reached.

This study is classified as Acceptable-Guideline and satisfies the guideline requirements [870.3700 (§83-3b)] for a teratology study in rabbits.

A.4.3	Reproductive Toxicity

	870.3800 Reproduction and Fertility Effects - Rat
In a two-generation reproduction study (MRID 00080897), metolachlor (95.4% a.i.) was administered in the diet to two consecutive generations of 15 male/30 female CD albino rats at dose levels of 0, 30, 300 or 1000 ppm (F0 males: 0, 2.4, 23.5 and 75.8 mg/kg/day; F0 females: 0, 2.5, 26.0 and 85.7 mg/kg/day; F1males: 0, 2.3, 23.7 and 76.6 mg/kg/day; F1 females: 0, 2.6, 25.7 and 84.5 mg/kg/day).

There were no deaths in the F0 generation. Two females of the F1 generation died during the pre-mating period, one in the 300 ppm group at 32 days and the other in the 1000 ppm group at 52 days. One female in the 300 ppm group was found dead on gestation day 19 and a control group female was sacrificed in a moribund condition on lactation day 1. Based on necropsy examinations, none of the deaths was treatment-related. There were no treatment-related clinical signs of toxicity in either generation. Body weight, body weight gain and food consumption were unaffected in the F0 generation. In the F1 generation, food consumption was significantly decreased in females of the 1000 ppm group at several timepoints; however, there was no effect on body weight/body weight gain. Therefore, this finding was not considered toxicologically significant. There were no treatment-related effects on organ weights or gross/microscopic necropsy examinations in either generation.

There was no evidence of a treatment-related effect on any of the reproductive parameters for either generation. Offspring body weight was significantly decreased in the F1 litter on lactation days 14 and 21 (91- 96% of control value) and in the F2 litter on lactation days 4, 7, 14 and 21 (92 - 95% of control value). Although the magnitude of the decrease is small, the finding is regarded as toxicologically significant.

The parental toxicity LOAEL was not established. The NOAEL was 1000 ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 mg/kg/day).

The reproductive toxicity LOAEL was not established. The NOAEL was 1000 ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 mg/kg/day).

The offspring LOAEL was conservatively established at 1000 ppm  (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 mg/kg/day) based on decreased body weight in F1 and F2 litters . The NOAEL is 300 ppm (F0 males/females: 23.5/ 26.0 mg/kg/day; F1males/females: 23.7/25.7 mg/kg/day).

The study is classified as Acceptable/guideline and satisfies the guideline requirements for a multi-generation reproduction study in rats (83-4; OPPTS 870.3800).

A.4.4	Chronic Toxicity

	870.4100a (870.4300) Chronic Toxicity  -  Rat
See Carcinogenicity section below.

	870.4100b Chronic Toxicity - Dog
In a chronic toxicity study (MRIDs  40980701, 41164501, 42218601 and 42218602), metolachlor (97% a.i.) was administered in the diet to Beagle dogs (6/sex/group for control and high dose groups; 4/sex/group for low- and mid-dose groups) at dose levels of 0, 100, 300 or 1000 ppm (males: 0, 3.5, 9.7 and 32.7 mg/kg/day, respectively; females: 0, 3.6, 9.7 and 33.0 mg/kg/day, respectively) for one year. Two dogs of each sex in the control and high-dose group designated as recovery animals were treated for 52 weeks and were then allowed a 4-week recovery period. An additional 4 dogs/sex/group were treated at the same dose levels and sacrificed at 13 weeks.

There were no treatment-related deaths or clinical signs of toxicity. Mean body weight gain was decreased in the 1000 ppm group females, considering both all animals (5-17% decrease) and only those treated for 52 weeks (5-17% decrease). Alkaline phosphatase was significantly increased in the 1000 ppm females at weeks 12, 26 and 40; however, the increase was not considered toxicologically significant due to the small magnitude of the effect and the lack of accompanying necropsy findings.
The LOAEL was 1000 ppm for females (33.0 mg/kg/day) based on decreased body weight gain. The NOAEL was 300 ppm (9.7 mg/kg/day). The LOAEL for males was not established. The NOAEL for males was 1000 ppm (32.7 mg/kg/day).

The study is classified as Acceptable/guideline and satisfies the guideline requirements for a chronic toxicity study in dogs (83-1; OPPTS 870.4100).

A.4.5	Carcinogenicity

	870.4200a Carcinogenicity Study - rat
In a chronic toxicity/carcinogenicity study (MRID 00129377), metolachlor (95.3%), was administered in the diet to 60 CD-Crl:CD albino rats/sex/group at dose levels of 0, 30, 300 or 3000 ppm (0, 1.5, 15 or 150 mg/kg/day) for two years.  An additional 10 rats/sex/group were administered either 0 ppm or 3000 ppm in the diet for 12 months; 5 rats/sex/group were sacrificed after treatment and the remaining 5/sex/group were allowed to recover for four weeks and then sacrificed.  Comparable mortality were observed in the treated and control animals.  There were no treatment-related clinical signs of toxicity.  Mean body weight gain was slightly decreased in the 3000 ppm females (6-17% decrease) throughout the study; the changes were not statistically significant.  Mean food consumption was slightly decreased (4-9% decrease) in the 3000 ppm females; the decrease was not statistically significant.  Absolute, relative and liver-to-brain weight were increased (7%, 13%, and 5%, respectively) in the 3000 ppm males.  These increases were also observed in the 3000 ppm males after four-week recovery period.  However, the toxicological significance of the finding is questionable as there were no accompanying clinical pathology or histologic changes.

For chronic toxicity, in males, the NOAEL was 3000 ppm (150 mg/kg/day), a LOAEL was not established.  For females, the NOAEL was 300 ppm (15 mg/kg/day) and the LOAEL was 3000 ppm (150 mg/kg/day) based on slightly decreased body weight gain and food consumption.

The study is classified as acceptable/guideline and satisfies the guideline requirements for a chronic toxicity study in rats (83-1; OPPTS 870.4200a).

	870.4200b Carcinogenicity (feeding) - Mouse
In a carcinogenicity study (MRID 00117597 ), metolachlor (reported to be 95% a.i.) was administered in the diet to 68 CD-1 mice/sex/group at doses of 0, 300, 1000 or 3000 ppm (0, 45, 150 or 450 mg/kg/day, based on 1ppm equals 0.150 mg/kg/day). Eight mice/sex/group were sacrificed at 12 and 18 months.  High dose females had a significant increased mortality rate due to a number of deaths during the first few weeks of treatment (control: 24/52; high dose females: 34/52 at termination).  Although the deaths were possibly attributable to a viral infection, the contribution of the test material can not be dismissed.  Body weight was statistically significantly decreased (91-95% of control value) throughout the study in the 3000 ppm males and during the latter half of the study in the 3000 ppm females (93-95%).  Body weight gain was consistently decreased in the 3000 ppm males (48-48%) and females (59-86%).   Food consumption was comparable between treated and control group until week 90 of treatment, at which time the 3000 ppm males consumed 10% less than controls.  The decrease was statistically significant at weeks 98, 102 and 104.  There was no significant effect on female food consumption.  There was no evidence of treatment-related effect on hematology or clinical chemistry parameters.   Organ weight was not affected except for a dose-related decrease in absolute and relative weight of the seminal vesicles of males which was statistically significant at the high dose.  However, there was no effect on testes weight and no accompanying histological changes in the seminal vesicles; therefore, the toxicological significance of the finding is questionable.  There were no treatment-related microscopic changes.  There were no treatment-related increases in tumor incidence in the study.

The NOAEL was 1000 ppm (150 mg/kg/day) and the LOAEL was 3000 ppm (450 mg/kg/day) based on possible treatment-related deaths in females and decreased body weight/body weight gain in males and females.

The study is classified as acceptable/guideline and satisfies the guideline requirements for a carcinogenicity toxicity study in mice (83-5; OPPTS 870.4200).

A.4.6	Mutagenicity
There was no evidence of mutagenicity in vitro or in vivo with either CGA 354743 or CGA 51202.
Mutagenicity Studies with CGA 354743

Gene Mutation
870.5100
Salmonella/Escherichia
bacterial reverse mutation assay

44931712 (1996)
acceptable/guideline
312.5, 625.0, 1250.0, 2500.0 and 5000.0 μg/plate in the presence and absence of mammalian metabolic activation (S9-mix)

Strains TA98, TA100, TA102, TA1535 and TA1537 of S. typhimurium and strain WP2(uvrA) of E. coli were exposed to CGA-354743 tech. in DMSO at con - cen - trations of 312.5- 5000.0 μg/plate in the presence and absence of mammalian metabolic activation (S9-mix). There was no evidence of induced mutant colonies over background.

Gene Mutation
870.5300
mammalian cell gene mutation assay at the HPRT locus, Chinese hamster V79 cells

44991102 (1999)
acceptable/guideline
concentrations of  185.19, 555.56, 1666.67, 5000.00 μg/mL in the presence and absence of mammalian metabolic activation (S9-mix).

Chinese hamster V79 cells in culture were exposed to CGA-354743 tech. in bidistilled water at concentrations of  185.19 - 5000.00 μg/mL in the presence and absence of mammalian metabolic activation (S9-mix).  There was suggestive (statistical) evidence of a possible induction of mutant colonies over background; however, the results are unlikely to be biologically significant because the absolute numbers of mutant colonies were low and within the testing laboratory's historical solvent control ranges.

Cytogenetics 870.5395 Micronucleus assay in mouse bone marrow cells

44931713 (1998)
acceptable/guideline
1250, 2500 and 5000 mg/kg body weight

Five mice/sex/dose were treated once each via oral gavage with CGA-354743 tech. at doses of 1250 - 5000 mg/kg body weight. There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any dose or treatment time.

Other Effects
870.5503, Unscheduled DNA Synthesis

44931714 (1998)
acceptable/guideline
concentrations of 9.77, 39.06, 156.25, 625.00, 2500.00, 5000.00 μg/mL

Primary rat hepatocyte cultures were exposed to CGA-354743 tech in bidistilled water at concentrations of 9.77 - 5000.00 μg/mL for 16 to 18 hours in an initial assay and to concentrations of 78.13 - 2500 μg/mL for 16 to 18 hours in a confirmatory assay. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures (nuclear silver grain counts), was induced.

Mutagenicity Studies with CGA 51202

                           Guideline No./ Study Type

                    MRID No. (year)/ Classification /Doses

                                    Results

Gene Mutation
870.5100
Salmonella/Escherichia
bacterial reverse mutation assay

44929512 (1992)
acceptable/guideline
312.5, 625, 1250, 2500, 5000 ug/plate

Strains TA98, TA100, TA1535 and TA1537 of S. typhimurium and strain WP2(uvrA) of E. coli  were exposed to CGA-51202 technical in DMSO at concen - tra - tions of 312.5 - 5000.0 μg/plate in the presence and absence of mammalian metabolic activation.

There was no evidence of induced mutant colonies over background.

Cytogenetics
870.5395, Micronucleus assay in mouse bone marrow cells

MRID 44929511 (1992)
600, 1200 or 2400 mg/kg
acceptable/guideline

Five mice/sex/dose were treated once via oral gavage with CGA-51202 technical at doses of 600-2400 mg/kg body weight. There was no biologically significant increase in the frequency of micronucleated poly - chromatic erythrocytes in bone marrow after any dose or treatment time used in the study.

Gene Mutation
870.5300
mammalian cell gene mutation assay at the HPRT locus, Chinese hamster V79 cells

MRID 45001201 (1999)
500, 1000, 2000 or 4000 ug/mL in initial assay; 375, 750, 1500 or 3000 ug/mL in confirmatory assay, in the presence and absence of mammalian metabolic activation (S9-mix).

CGA 51202 tech. was tested up to cytotoxic concentrations.   Statistically significant increases in mean mutant frequency were seen in the initial assay with S9-mix at 500 μg/mL (6.66 x  10[6]) and 1000 μg/mL (5.56 x 10[6]) compared to the solvent control value of 4.02 x 10[6] and without S9-mix at 500 μg/mL (15.35 x 10[6]) compared to the solvent control value of 12.90 x  10[6].  The increases were small and the actual mean mutant frequencies were within the range of historical solvent control values.  No positive dose-response was seen and no statistically significant increases in mean mutant frequencies were seen in the confirma - tory assay.  The solvent and positive controls induced the appropriate response.  There was no evidence of a biologically significant induction of mutant colonies over background.

A.4.8	Metabolism

	870.7485	Metabolism - Rat

In a metabolism study (MRID 44931715), groups of three male and three female rats were each given [phenyl-U-[14]C] CGA 77102 (batch no. ILS-143.1; purity 98.9%) and non-radiolabeled CGA 77102 (batch no. AMS 757-101; purity 99.8%) to provide a total single oral dose of 0.5 or 100 mg/kg.  Urinary and fecal excretion were monitored over 72 hours and major metabolites identified and quantified. The study focused on evaluating the presence of the metabolites CGA 354743, CGA 368208, and CGA 357704 in the excreta of rats.

There were no deaths or overt signs of toxicity attributed to the test material.  Actual adminis - tered doses were 3-8% greater than nominal.  Overall recovery of administered radio - activity was an acceptable 93.83-99.18%.  Urinary excretion and carcass burden data implied that absorption was approximately 38-49% of the administered dose.  Most (86.5-91.7%) of the radioactivity recovered at 72 hours post was associated with the urine and feces.  The available data suggested that urinary excretion was slightly greater in female rats  than male rats (42% for low- and high-dose females as compared to 30% and 32% of low- and high-dose males, respectively), and fecal elimination was expectedly less (approximately 13-15%) for females than for males.  However, the small sample size (three rats per sex) precludes a definitive assessment of gender-specific differences in excretory pattern. Time-course data for absorption and excretion were not provided.  Based upon the residual radioactivity in the carcasses, accumulation in the tissues was less than 10% of the administered dose at 72 hours after administration.

Both urinary and fecal metabolites were identified and quantified.   For both routes of elimina - tion, three major metabolites were identified but none represented more than 0.25% of the administered dose.  Characterization of these metabolites and comparison to known reference standards revealed them to be CGA 357704, CGA 354743, and CGA 368208.  In the feces, CGA 357704 and CGA 354743 represented a notably greater percent of the administered dose than in the urine.  The amounts of CGA 368208 were similar in the feces and urine.   Biliary excretion experiments were not performed and, therefore, no assessment can be made regarding biliary or gut microflora as the source of these biotransformation products in the feces.

This metabolism study in rats is Acceptable/Non-guideline.  Although not satisfying the requirements for a Metabolism and Pharmacokinetics study [OPPTS 870.7485 (85-1)], the study was well designed and conducted, and provided supplemental data regarding the quantitation and identification of urinary and fecal metabolites in rats given a single oral dose of CGA 77102.

Executive Summary: In a metabolism study (MRIDs 44931716 and 44931717), groups of four male and female and six male Tif: RAI f (SPF) rats were given single oral doses of [Phenyl-U-[14]C]-CGA-376944 (0.5 mg/kg nominal; Batch No. ILS-125.4 radiochemical purity >95.5%), for the metabolism and bile-duct cannulation studies, respectively.

There were no deaths or overt signs of toxicity that could be attributed to the test material.  Weight loss in bile-duct cannulated rats was attributed to surgical trauma.  Radioactivity inventory indicated an acceptable 96.46-99.01% recovery of the administered dose among the experimental groups. Based on urinary excretion, biliary excretion, and carcass burden, 17.35% of the administered radioactivity was absorbed following a single oral dose of 0.5 mg/kg of [Phenyl-U-[14]C]-CGA-376944.  Absorption was rapid but limited and most of the absorbed radioactivity (92.3%) was excreted within 24 hours; primarily in the bile.  At 72 hours, measurable radioactivity was found only in the liver of non-cannulated rats.  Carcass burdens accounted for <0.01% of the administered dose at necropsy.

Fecal elimination was the major route of excretion, accounting for most of the administered oral dose in non-cannulated rats (94.24-96.27%).  Fecal excretion was rapid with 98.8-99.2% of the fecal excretion occurring within 24 hours post-dosing.  Urinary excretion, accounted for only 2.1-4.4% of the dose in non-cannulated rats and 5.3% in bile-duct cannulated rats. Urinary excretion was rapid and nearly complete within 24 hours of dosing.  Biliary excretion  repre - sented 11.5% of the administered dose at 48 hours.  The majority of biliary excretion (99.2%) occurred within 24 hours after dosing.  In bile-duct cannulated animals, an additional 76.8% of the administered dose was excreted in the feces.  Based on these data, biliary excretion is a contributor to fecal elimination of the test material.  This appears consistent with the occurrence of enterohepatic circulation via the hepatic portal system and bile-duct.  Only a minor percentage of the dose (5.3%) appeared to enter the systemic circulation where it was rapidly excreted by the kidneys.  No biologically relevant gender-related differences were detected in the oral dose groups.

Blood pharmacokinetic parameters could not be calculated due to low blood concentrations and rapid clearance of the administered dose.  Blood levels of radioactivity peaked in both sexes within one hour post-dosing.

It is evident from the results of this study that the test material undergoes limited but rapid absorp - tion and nearly complete excretion within 24 hours.  The primary route of excretion is via the feces with biliary excretion products representing about 15.0% of the fecal excretion pro - ducts.  At the dose tested, [[14]C]-CGA-376944 exhibits little potential for accumulation in the tissues.  There were no significant gender-related differences in absorption and disposition of the test material.  The unchanged test material accounted for >90% of the dose in both males and females.  The unknown metabolites of urine and feces, separated by TLC accounted for 0.2-2.8% of the administered radioactivity and were not characterized further.

This combined metabolism study in rats is Acceptable/Guideline and satisfies the requirements for a Metabolism and Pharmacokinetics study [OPPTS 870.7485 (§85-1)].

A.4.9	Immunotoxicity

	870.7800	Immunotoxicity

In an immunotoxicity study (MRID 48783301), S-Metolachlor (98.6% a.i., Lot # CAB9J054) was administrered in the diet for 28 consecutive days (Days 0-27) to female Crl:CD-1 (ICR) mice (10 animals/dose) at doses of 0, 1500, 3000 or 5000 ppm (0, 304.3, 639.5 or 1108.5 mg/kg/day, respectively).  Four days prior to sacrifice, animals in all groups were immunized with a suspension of sheep red blood cells (SRBC) by intravenous injection (1 x 108 SRBC/animal, 0.2 mL/animal dose volume).  Animals in the positive control group received intraperitoneal injections of cyclophosphamide (50 mg/kg bw/day) on Days 24-27.  All animals were evaluated for mortality, clinical signs, body weight changes, and gross pathology.  On Day 28, animals were sacrificed and spleens were collected.  Spleen cell suspensions were prepared, spleen cell counts were performed, and the numbers of specific IgM antibody-forming cells directed towards the SRBC antigen were determined to measure the humoral immune response using the splenic Antibody-Forming Cell (AFC) assay.
There were no treatment-relaetd effects on clinical observations, body weigh, body weight gain, food consumption, and spleen or thymus weights.  A higher liver weight (absolute and adjusted) was noted at all dosage levels of S-Metolachlor, with significant differences noted in the mid and high doses.
The NOAEL for systemic toxicity in female mice is 5000 ppm (actual dose of 1108.5 mg/kg/ bw/day); the LOAEL was not determined, tested above the limit dose.

For immunotoxicity, there were no statistically significant treatment-related effects on anti-SRBC AFC response.  A high inter-individual variability was noted in all the treatment groups as well as in the control group.  Examination of individual animal data did not show any trend or distribution that would demonstrate significant suppression of the anti-SRBC AFC response.  The positive control group showed a statistically significant reduction in the anti-SRBC AFC response, confirming the validity of the immunotoxicity assay.

A natural killer (NK) cell activity assay was not performed.  The toxicology database for S-metolachlor does not reveal any evidence of treatment-related effects on the immune system.  The overall weight of evidence suggests that this chemical does not directly target the immune system.  Under HED guidance, a NK cell activity assay is not required at this time.

Under the conditions of this study, the NOAEL for immunotoxicity in female mice is 5000 ppm (actual dose of 1108.5 mg/kg/ bw/day).  The LOAEL for immunotoxicity was not determined.

This immunotoxicity study is classified acceptable/guideline and satisfies the guideline requirement for an immunotoxicity study (OPPTS 870.7800) in the mice.

Appendix B.  Metabolism Summary

Appendix C.  Physical/Chemical Properties

Table C1.	Physicochemical Properties of S-Metolachlor.
Parameter
Value
Reference
Melting point/range
Not applicable, liquid at room temperature
MRID 47121701 (DP#s 332846, etc., 10/21/08, D. McNeilly)
pH
7.8 at 25 ºC (1% aqueous dispersion)

Density
1.117 g/cm[3] at 20 ºC

Water solubility (25°C)
0.48 g/L

Solvent solubility (mg/L at 25°C)
Completely miscible with methanol, acetone, toluene, n-octanol, n-hexane, ethyl acetate, and dichloromethane.

Vapor pressure at 25°C
2.8 x 10[-5] mm Hg

Dissociation constant (pKa)
No dissociation constant in pH range 2-12

Octanol/water partition coefficient Log(KOW)
3.05 at 25 ºC

UV/visible absorption spectrum
Neutral:	534 L/mol::cm @ 266.4 nm
	443 L/mol::cm @ 274.4 nm
Acidic:	534 L/mol::cm @ 266.4 nm
	444 L/mol::cm @ 274.4 nm
Basic:	531 L/mol::cm @ 266.4 nm
	411 L/mol::cm @ 274.4 nm