[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Notices]
[Pages 77521-77528]
[FR Doc No: 2011-31916]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9503-5]

California State Nonroad Engine Pollution Control Standards;
Commercial Harbor Craft Regulations; Notice of Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Decision.

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SUMMARY: EPA has granted the California Air Resources Board (CARB) its
request for an authorization to adopt and enforce regulations for the
control of emissions of particulate matter and oxides of nitrogen from
new and in-use diesel-fueled engines on commercial harbor craft.

DATES: Petitions for review must be filed by February 13, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
EPA-HQ-OAR-2011-0549. All documents relied upon in making this
decision, including those submitted to EPA by CARB, are contained in
the public docket. Publicly available docket materials are available
either electronically through www.regulations.gov or in hard copy at
the Air and Radiation Docket in the EPA Headquarters Library, EPA West
Building, Room 3334, located at 1301 Constitution Avenue NW.,
Washington, DC. The Public Reading Room is open to the public on all
federal government working days from 8:30 a.m. to 4:30 p.m.; generally,
it is open Monday through Friday, excluding holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>. The Air and Radiation
Docket and Information Center's Web site is http://www.epa.gov/oar/docket.html. The electronic mail (email) address for the Air and
Radiation Docket is<EMAIL_ADDRESS>the telephone number is
(202) 566-1742, and the fax number is<PHONE_NUMBER>. An electronic
version of the public docket is available through the federal
government's electronic public docket and comment system. You may
access EPA dockets at http://www.regulations.gov. After opening the
www.regulations.gov Web site, enter EPA-HQ-OAR-2011-0549 in the ``Enter
Keyword or ID'' fill-in box to view documents in the record. Although a
part of the official docket, the public docket does not include
Confidential Business Information (``CBI'') or other information whose
disclosure is restricted by statute.
    EPA's Office of Transportation and Air Quality (``OTAQ'') maintains
a Web page that contains general information on its review of
California waiver requests. Included on that page are links to prior
waiver Federal Register notices, some of which are cited in today's
notice. The page can be accessed at http://www.epa.gov/otaq/cafr.htm.

FOR FURTHER INFORMATION CONTACT: Kristien G. Knapp, Attorney-Advisor,
Compliance Division, Office of Transportation and Air Quality, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue (6405J) NW.,
Washington, DC 20460. Telephone:<PHONE_NUMBER>. Fax:<PHONE_NUMBER>.
Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. California's Commercial Harbor Craft Regulations

    In a letter dated April 12, 2010, CARB submitted to EPA its request
pursuant to section 209(e) of the Clean Air Act (``CAA'' or ``the
Act''), regarding its regulations to enforce emission standards for new
and in-use commercial harbor craft operated within California waters
and twenty-four nautical miles of the California baseline (``commercial
harbor craft regulations'').\1\ The CARB Board approved the commercial
harbor craft regulations at its November 15, 2007 hearing (by
Resolution 07-47).\2\ After making modifications, as directed by the
Board, CARB's Executive Officer formally adopted the rulemaking in
Executive Order R-08-007 on September 2, 2008.\3\ CARB's commercial
harbor craft regulations became operative under California state law on
November 19, 2008.\4\ The regulations are codified in title 13,
California Code of Regulations (CCR), section 2229.5 and title 17, CCR
section 93118.5.\5\
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    \1\ Letter from James Goldstene to Lisa P. Jackson, EPA-HQ-OAR-
2011-0549-0001.
    \2\ CARB, Resolution 07-47, EPA-HQ-OAR-2011-0549-0027.
    \3\ CARB, Executive Order R-08-007, EPA-HQ-OAR-2011-0549-0030.
    \4\ See CARB, Approval Notice, EPA-HQ-OAR-2011-0549-0035.
    \5\ See CARB, Final Regulation Order, EPA-HQ-OAR-2011-0549-0034.
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    California's commercial harbor craft regulations establish emission
standards, requirements related to the control of emissions, and
enforcement provisions. The requirements are applicable to diesel
propulsion and auxiliary engines on new and in-use commercial harbor
crafts, with some exceptions.\6\ Commercial harbor craft include a
variety of different types of vessels, including ferries, excursion
vessels, tugboats, towboats, and commercial and charter fishing boats.
Approximately eighty percent of commercial harbor craft engines
operating in California are previously unregulated diesel engines,
accounting for approximately 3.3 tons per day (tpd) of diesel
particulate matter (PM) and 73 tpd of oxides of nitrogen
(NOX). California's commercial harbor craft regulations aim
to reduce these emissions so that California can meet the 2014 National
Ambient Air Quality Standards (NAAQS) deadline for PM2.5 in
the South Coast Air Basin. The commercial harbor craft regulations
apply separately to new and in-use engines used on harbor craft.\7\
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    \6\ See CARB, Authorization Support Document, p. 5, EPA-HQ-OAR-
2011-0549-0002 (hereinafter ``CARB Support Document'').
    \7\ CARB Support Document, pp. 2-6.
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    For new harbor craft, each propulsion and auxiliary diesel engine
on the vessel is required to be certified to the most stringent federal
new marine engine emission standards for that engine's power rating and
displacement in effect at the time of sale, lease, rent, or
acquisition.\8\ The regulation imposes additional requirements for
larger new ferries (with the capacity to transport seventy-five or more
passengers), either by using best available control technology
(``BACT''),\9\ or by using a federal Tier 4 certified propulsion
engine.
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    \8\ CARB Support Document at 2.
    \9\ BACT is the diesel emission control strategy (DECS)
determined by CARB to be the greatest feasible reduction of
NOX or PM.
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    For in-use harbor craft, new or in-use diesel engines may not be
sold, offered for sale, leased, rented, or acquired unless the diesel
propulsion or auxiliary engines are certified to at least the federal
Tier 2 or Tier 3 marine emission standards for new engines of the same
power rating and displacement.\10\ In-use emission requirements are
imposed on Tier 0 and Tier 1 marine engines in ferries, excursion
vessels, tugboats, towboats, push boats, and multipurpose harbor craft.
Those harbor craft are required to meet emission limits equal to or
cleaner than the federal new marine engine certification standards in
effect for the year that in-use engine compliance is required.
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    \10\ CARB Support Document at 3.
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    California's commercial harbor craft regulations also impose
requirements related to monitoring, reporting and recordkeeping of
compliance on owners and operators of new and in-use harbor craft.\11\
Subject to CARB approval, harbor craft owners and operators may opt to
meet requirements by implementing alternative emission control
strategies.
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    \11\ CARB Support Document at 5.
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B. Clean Air Act Nonroad Engine and Vehicle Authorizations

    Section 209(e)(1) of the Act permanently preempts any State, or
political subdivision thereof, from adopting or attempting to enforce
any standard or other requirement relating to the control of emissions
for certain new nonroad engines or vehicles. Section 209(e)(2) of the
Act requires the Administrator to grant California authorization to
enforce its own

standards for new nonroad engines or vehicles that are not listed under
section 209(e)(1), subject to certain restrictions. On July 20, 1994,
EPA promulgated a rule that sets forth, among other things, the
criteria, as found in section 209(e)(2), which EPA must consider before
granting any California authorization request for new nonroad engine or
vehicle emission standards. On October 8, 2008, the regulations
promulgated in that rule were moved to 40 CFR part 1074, and modified
slightly.\12\ As stated in the preamble to the section 209(e) rule, EPA
has historically interpreted the section 209(e)(2)(iii) ``consistency''
inquiry to require, at minimum, that California standards and
enforcement procedures be consistent with section 209(a), section
209(e)(1), and section 209(b)(1)(C) (as EPA has interpreted that
subsection in the context of section 209(b) motor vehicle waivers).\13\
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    \12\ The applicable regulations, now in 40 CFR part 1074,
subpart B, Sec.  1074.105, provide:
    (a) The Administrator will grant the authorization if California
determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as otherwise applicable
federal standards.
    (b) The authorization will not be granted if the Administrator
finds that any of the following are true:
    (1) California's determination is arbitrary and capricious.
    (2) California does not need such standards to meet compelling
and extraordinary conditions.
    (3) The California standards and accompanying enforcement
procedures are not consistent with section 209 of the Act.
    (c) In considering any request from California to authorize the
state to adopt or enforce standards or other requirements relating
to the control of emissions from new nonroad spark-ignition engines
smaller than 50 horsepower, the Administrator will give appropriate
consideration to safety factors (including the potential increased
risk of burn or fire) associated with compliance with the California
standard.
    \13\ See 59 FR 36969 (July 20, 1994).
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    In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. To be consistent with section
209(e)(1), California's nonroad standards and enforcement procedures
must not attempt to regulate engine categories that are permanently
preempted from state regulation. To determine consistency with section
209(b)(1)(C), EPA typically reviews nonroad authorization requests
under the same ``consistency'' criteria that are applied to motor
vehicle waiver requests. Pursuant to section 209(b)(1)(C), the
Administrator shall not grant California a motor vehicle waiver if she
finds that California ``standards and accompanying enforcement
procedures are not consistent with section 202(a)'' of the Act.
Previous decisions granting waivers and authorizations have noted that
state standards and enforcement procedures are inconsistent with
section 202(a) if: (1) There is inadequate lead time to permit the
development of the necessary technology giving appropriate
consideration to the cost of compliance within that time, or (2) the
federal and state testing procedures impose inconsistent certification
requirements.

C. Burden of Proof

    In Motor and Equip. Mfrs Assoc. v. EPA, 627 F.2d 1095 (D.C. Cir.
1979) (``MEMA I''), the U.S. Court of Appeals stated that the
Administrator's role in a section 209 proceeding is to:

consider all evidence that passes the threshold test of materiality
and * * * thereafter assess such material evidence against a
standard of proof to determine whether the parties favoring a denial
of the waiver have shown that the factual circumstances exist in
which Congress intended a denial of the waiver.\14\
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    \14\ MEMA I, 627 F.2d at 1122.

The court in MEMA I considered the standards of proof under section 209
for the two findings related to granting a waiver for an ``accompanying
enforcement procedure'' (as opposed to the standards themselves): (1)
Protectiveness in the aggregate and (2) consistency with section 202(a)
findings. The court instructed that ``the standard of proof must take
account of the nature of the risk of error involved in any given
decision, and it therefore varies with the finding involved. We need
not decide how this standard operates in every waiver decision.'' \15\
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    \15\ Id.
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    The court upheld the Administrator's position that, to deny a
waiver, there must be ``clear and compelling evidence'' to show that
proposed procedures undermine the protectiveness of California's
standards.\16\ The court noted that this standard of proof also accords
with the congressional intent to provide California with the broadest
possible discretion in setting regulations it finds protective of the
public health and welfare.\17\
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    \16\ Id.
    \17\ Id.
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    With respect to the consistency finding, the court did not
articulate a standard of proof applicable to all proceedings, but found
that the opponents of the waiver were unable to meet their burden of
proof even if the standard were a mere preponderance of the evidence.
Although MEMA I did not explicitly consider the standards of proof
under section 209 concerning a waiver request for ``standards,'' as
compared to accompanying enforcement procedures, there is nothing in
the opinion to suggest that the court's analysis would not apply with
equal force to such determinations. EPA's past waiver decisions have
consistently made clear that: ``[E]ven in the two areas concededly
reserved for Federal judgment by this legislation--the existence of
`compelling and extraordinary' conditions and whether the standards are
technologically feasible--Congress intended that the standards of EPA
review of the State decision to be a narrow one.'' \18\
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    \18\ See, e.g., 40 FR 21102-103 (May 28, 1975).
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    Opponents of the waiver bear the burden of showing that the
criteria for a denial of California's waiver request have been met. As
found in MEMA I, this obligation rests firmly with opponents of the
waiver in a section 209 proceeding:

[t]he language of the statute and its legislative history indicate
that California's regulations, and California's determinations that
they must comply with the statute, when presented to the
Administrator are presumed to satisfy the waiver requirements and
that the burden of proving otherwise is on whoever attacks them.
California must present its regulations and findings at the hearing
and thereafter the parties opposing the waiver request bear the
burden of persuading the Administrator that the waiver request
should be denied.\19\
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    \19\ MEMA I, 627 F.2d at 1121.

The Administrator's burden, on the other hand, is to make a reasonable
evaluation of the information in the record in coming to the waiver
decision. As the court in MEMA I stated: ``here, too, if the
Administrator ignores evidence demonstrating that the waiver should not
be granted, or if he seeks to overcome that evidence with unsupported
assumptions of his own, he runs the risk of having his waiver decision
set aside as `arbitrary and capricious.' '' \20\ Therefore, the
Administrator's burden is to act ``reasonably.'' \21\
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    \20\ Id. at 1126.
    \21\ Id. at 1126.
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D. EPA's Administrative Process in Consideration of California's
Commercial Harbor Craft Regulations

    Upon review of CARB's request, EPA offered an opportunity for a
public hearing, and requested written comment on issues relevant to a
full section 209(e) authorization analysis, by publication of a Federal
Register notice on June 29, 2011.\22\ Specifically, we

requested comment on: (a) Whether CARB's determination that its
standards, in the aggregate, are at least as protective of public
health and welfare as applicable federal standards is arbitrary and
capricious, (b) whether California needs such standards to meet
compelling and extraordinary conditions, and (c) whether California's
standards and accompanying enforcement procedures are consistent with
section 209 of the Act.
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    \22\ 76 FR 38153 (June 29, 2011).
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    In response to EPA's June 29, 2011 Federal Register notice, EPA
received two written comments. The written comments are from the
American Waterways Operators (``AWO'') \23\ and K-Sea Transportation
Partners L.P. (``K-Sea'').\24\ AWO initially requested a public
hearing, and later withdrew that request. After the close of the
comment period, EPA met with AWO to discuss comments from their
members.\25\
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    \23\ The American Waterways Operators (``AWO''), Comments, EPA-
HQ-OAR-2011-0549-0038 (hereinafter ``AWO Comments'').
    \24\ K-Sea Transportation Partners L.P. (``K-Sea''), Comments,
EPA-HQ-OAR-2011-0549-0037 (hereinafter ``K-Sea Comments'').
    \25\ EPA, ``Memorandum from Tayyaba Waqar to Docket EPA-HQ-OAR-
2011-0549,'' EPA-HQ-OAR-2011-0549-0039.
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    AWO comments that California does not need the new standards to
meet compelling and extraordinary conditions. AWO also comments that
California's standards and enforcement procedures are not consistent
with the Clean Air Act section 209. Additionally, AWO expressed other
concerns in their comments related to the commercial harbor craft
regulation's compliance schedules.
    K-Sea comments that the new regulations are not consistent with
section 202(a) of the Clean Air Act. K-Sea also comments that
California does not need the new regulations to meet compelling and
extraordinary conditions. Additionally, K-Sea does not believe that
CARB adequately assessed the financial impacts and compliance costs
associated with implementation of California's commercial harbor craft
regulations.

II. Discussion

A. California's Protectiveness Determination

    Section 209(e)(2)(i) of the Act instructs that EPA cannot grant an
authorization if the agency finds that CARB was arbitrary and
capricious in its determination that its standards are, in the
aggregate, at least as protective of public health and welfare as
applicable federal standards. CARB's Board made a protectiveness
determination in Resolution 07-47, finding that California's commercial
harbor craft regulation will not cause the California emission
standards, in the aggregate, to be less protective of public health and
welfare than applicable federal standards.\26\ CARB asserts that EPA
has no basis to find that the CARB Board's determination is arbitrary
or capricious.\27\ CARB points out that most of the commercial harbor
craft requirements (for new diesel engines in newly acquired harbor
craft and ferry propulsion engines) are identical to the federal
requirements for those engines. CARB also highlights that its
requirements for new propulsion diesel engines in larger new ferries
are more stringent that federal standards because they additionally
require BACT technology. With respect to the commercial harbor craft
regulation's in-use requirements, CARB additionally asserts that its
requirements are more stringent than applicable federal regulations
because EPA does not have the authority to regulate in-use nonroad
engines.
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    \26\ ``BE IT FURTHER RESOLVED that the Board hereby determines,
in accordance with section 209(e)(2) of the CAA, that to the extent
the regulation approved herein affects nonroad engines as defined in
CAA section 216(10) and (11), the emission standards and other
requirements related to the control of emissions in the regulation
approved herein are, in the aggregate, at least as protective of
public health and welfare as applicable federal standards;
California needs its nonroad emission standards to meet compelling
and extraordinary conditions; and the standards and accompanying
enforcement procedures approved herein are consistent with CAA
section 209.'' CARB Resolution 07-47, EPA-HQ-OAR-2011-0549-0028.
    \27\ CARB Support Document at 7-8.
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    No commenter expressed an opinion or presented evidence suggesting
that CARB was arbitrary and capricious in making its above-noted
protectiveness findings or that CARB's requirements are not, in the
aggregate, as stringent as applicable federal standards. Therefore,
based on the record before us, EPA finds that opponents of the
authorization have not shown that California was arbitrary and
capricious in its determination that its standards are, in the
aggregate, at least as protective of public health and welfare as
applicable federal standards.

B. Need for California Standards to Meet Compelling and Extraordinary
Conditions

    Section 209(e)(2)(ii) of the Act instructs that EPA cannot grant an
authorization if the agency finds that California ``does not need such
California standards to meet compelling and extraordinary conditions.''
This criterion restricts EPA's inquiry to whether California needs its
own mobile source pollution program to meet compelling and
extraordinary conditions, and not whether any given standards are
necessary to meet such conditions.\28\ As discussed above, for over
forty years CARB has repeatedly demonstrated the need for its motor
vehicle emissions program to address compelling and extraordinary
conditions in California. In its Resolution 07-47, CARB re-affirmed its
longstanding position that California continues to need its nonroad
emission standards to meet its serious air pollution problems.
Likewise, EPA has consistently recognized that California continues to
have the same ``geographical and climatic conditions that, when
combined with the large numbers and high concentrations of automobiles,
create serious pollution problems.'' \29\
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    \28\ See 74 FR 32744, 32761 (July 8, 2009); 49 FR 18887, 18889-
18890 (May 3, 1984).
    \29\ 49 FR 18887, 18890 (May 3, 1984); see also 76 FR 34693
(June 14, 2011), 74 FR 32744, 32763 (July 8, 2009), and 73 FR 52042
(September 8, 2008).
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    AWO asserts that California does not need the commercial harbor
craft regulations to meet compelling and extraordinary conditions. AWO
focuses on California's goal of improving upon the South Coast Air
Basin's non-attainment status by reducing NOX and
PM2.5 levels. AWO states that there is no justification for
CARB to adopt statewide regulations of NOX and
PM2.5 in order to meet the 2014 NAAQS deadline for
PM2.5 in the South Coast Air Basin. AWO reviewed CARB's
Initial Statement of Reasons (``ISOR'') and believes that the ISOR does
not provide sufficient detail to explain the relationship between
pollutant exceedances and commercial harbor craft emissions.
Additionally, AWO believes that the data CARB used from 2006 and
earlier for its analysis of commercial harbor craft's contribution to
NOX and PM2.5 levels is inaccurate and outdated
in that it does not represent the most current operation of tugboats in
California waters. AWO also points to CARB's statements regarding
decrease in emissions for diesel NOX and PM2.5
because of other effects and factors. Further, in comparing data for
emission reductions with and without the proposed standards, AWO
concludes that CARB's emission reduction goals would be met without
implementing the commercial harbor craft regulation.
    K-Sea also asserts that California does not need the commercial
harbor craft regulation to meet compelling and extraordinary
conditions. K-Sea argues that California used data from 2006 and
earlier in its rulemaking, which is

outdated and inaccurate. K-Sea bases that argument on its belief that
because of the recession, which started in 2008, emissions have already
been in decline. K-Sea also states that the data CARB used to assess
harbor craft emissions from tugboats in coastwise service did not
accurately capture their duty cycles or operations within the 24-mile
zone of the California regulated waters.
    AWO and K-Sea have both presented arguments and information
suggesting that California does not need its commercial harbor craft
regulations to meet compelling and extraordinary conditions. However,
as discussed above, EPA's inquiry under the section 209(e)(2)(ii)
criterion restricts EPA's inquiry to whether California needs its own
mobile source air pollution program to meet compelling and
extraordinary conditions, and not whether any given standards are
necessary to meet such conditions.\30\ Congress decided in 1977 to
allow California to promulgate individual standards that are not as
stringent as comparable federal standards, as long as the standards are
``in the aggregate, at least as protective of public health and welfare
as applicable federal standards.'' This decision by Congress requires
EPA to allow California to promulgate individual standards that are
part of California's overall approach to reducing mobile source
emissions to address air pollution problems. Congress intended to
provide California the ``broadest possible discretion'' in selecting
the best means to protect its citizens and the public welfare and did
not intend for EPA to weigh which particular regulations are most
appropriate for California to implement to protect public health and
welfare. Consequently, Congress provided EPA a much more limited role
in considering objections raised by opponents of the waiver.
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    \30\ See 74 FR 32744, 32761 (July 8, 2009); 49 FR 18887, 18889-
18890 (May 3, 1984).
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    Although AWO and K-Sea believe that California does not need its
commercial harbor craft regulations to meet compelling and
extraordinary conditions, CARB has provided evidence that it does. In
the California rulemaking, CARB explained its need for the commercial
harbor craft regulation.\31\ Regarding the comment that California's
air quality problems are limited to the South Coast Air Basin, EPA has
never suggested in previous authorization or waiver proceedings that
localized air quality concerns are not sufficient to receive
authorization under this criterion. However, even if EPA were to accept
this comment for the sake of argument, CARB has explained that it has
statewide goals and federal Clean Air Act requirements to reduce
NOX and PM2.5 emissions. CARB explained that
NOX and PM2.5 reductions are necessary because of
the relationship between those pollutants and the federal non-
attainment status in both the South Coast and San Joaquin Valley air
basins:
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    \31\ CARB, Technical Support Document, EPA-HQ-OAR-2011-0549-
0007, pp. I-1-I-3.

    The South Coast and San Joaquin Valley air basins are the two
areas in the State that exceed the annual PM2.5
standards. These areas are required by federal law to develop State
Implementation Plans (SIPs) describing how they will attain the
standards by 2015. The U.S. EPA further requires that all necessary
emission reductions be achieved one calendar year sooner--by 2014--
in recognition of the annual average form [sic] the standard.
NOX emission reductions are needed because NOX
leads to formation in the atmosphere of both ozone and
PM2.5; diesel PM emission reductions are needed because
diesel PM contributes to ambient concentrations of PM2.5.
San Joaquin Valley and South Coast air basins are also in non-
attainment for the federal ozone standard.* * *
    While all sources of NOX emissions are important,
marine vessels, which include commercial harbor craft engines, are
one of several key contributors to PM2.5 that will
determine whether California is able to meet the 2014 deadline for
PM2.5 attainment in the South Coast air basin.
    * * * Staff projects that the regulation would reduce in-use
harbor craft diesel PM emissions about 70 percent and NOX
emissions about 60 percent from the 2004 baseline by 2020. These
emission reductions would occur in areas along waterways, near
ports, and in those communities surrounding these areas, as well as
further inland.
    The regulation would also reduce diesel PM and NOX
emissions that contribute to exceedances throughout the State of
ambient air quality standards for both PM2.5 and ozone.
These reductions would assist California in its goal of achieving
state and federal air quality standards.
    The emission reductions from the proposed regulation would
result in lower ambient PM levels and reduced exposure to diesel PM.
Staff estimates that approximately 310 premature deaths statewide
would be avoided by year 2025 from implementation of the proposed
regulation. The estimated cost benefit of the avoided premature
deaths and other health benefits due to the emission reductions are
estimated to range from $1.3 to $2.0 billion.\32\

    \32\ Id.
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Thus, contrary to AWO's argument, CARB presents that it does need
statewide commercial harbor craft regulations, because NOX
and PM pollution problems affect the entire state.
    Although AWO and K-Sea claim that California's 2006 data is
outdated, because emissions have decreased since 2008 due to the
recession and other emission reduction strategies, they have not
presented evidence proving this to be the case. EPA must rely on the
record in front of us. Moreover, while both AWO and K-Sea suggest that
California may have overstated the emission contributions from harbor
craft, they do not show that harbor craft do not contribute to
emissions that affect California's air quality. While the level of air
pollution may go to the overall benefits of the program, it is not
relevant for determining the need for California's nonroad engine
program. Indeed, AWO's comments make clear that the harbor craft
regulations will result in emission reductions.\33\
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    \33\ For example, AWO analyzed CARB's ISOR, and found that
California's commercial harbor craft regulation would achieve ``only
10 percent'' of California's total estimated statewide PM emission
reductions and ``only 6 percent'' of California's total estimated
statewide NOX reductions.
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    Moreover, AWO's argument relies on California's other emission
reduction strategies to make its case, but it is inappropriate for EPA
to decide which California regulations are needed, and which are not.
CARB presented that they expect the emission reductions from the
commercial harbor craft regulation to benefit the entire state in
meeting federal standards and reaching their statewide emission
reduction goals. While AWO believes California's state goals will be
met without the commercial harbor craft regulation, they do not present
evidence to support that belief, nor do they suggest that the San
Joaquin or South Coast air basins would actually meet federal ozone and
PM standards without the commercial harbor craft regulation. Nor would
it be appropriate for EPA to decide that the other emission controls on
which AWO relies are necessary but the controls on commercial harbor
craft are not. Aside from the fact that all sources of pollution could
argue that other sources should be regulated instead of them, EPA's
review is not intended to replace the policy decisions of California in
determining the appropriate emission control strategies it will use to
meet its air quality needs.
    Based on the above, those opposing the authorization have not met
the burden of proof necessary for EPA to find that California no longer
needs a separate mobile source emissions program to address compelling
and extraordinary conditions in California. Therefore, EPA has
determined that we cannot deny California authorization for its
commercial harbor craft regulations under section 209(e)(2)(ii).

C. Consistency With Section 209 of the Clean Air Act

    Section 209(e)(2)(iii) of the Act instructs that EPA cannot grant
an authorization if California's standards and enforcement procedures
are not consistent with section 209. As described above, EPA has
historically evaluated this criterion for consistency with sections
209(a), 209(e)(1), and 209(b)(1)(C).
1. Consistency With Section 209(a)
    To be consistent with section 209(a) of the Clean Air Act,
California's commercial harbor craft regulations must not apply to new
motor vehicles or new motor vehicle engines. California's commercial
harbor craft regulations apply to nonroad engines, not on-highway motor
vehicles or engines. CARB states that the new vessel requirements
regulate new diesel engines, and apply only to nonroad engines that are
neither new motor vehicles nor new motor vehicle engines. No commenter
presented otherwise; therefore, EPA cannot deny California's request on
the basis that California's commercial harbor craft regulations are not
consistent with section 209(a).
2. Consistency With Section 209(e)(1)
    To be consistent with section 209(e)(1) of the Clean Air Act,
California's commercial harbor craft regulations must not affect new
farming or construction vehicles or engines that are below 175
horsepower, or new locomotives or their engines. CARB presents that
commercial harbor craft engines are not used in locomotives and are not
primarily used in farm and construction equipment vehicles. No
commenter presented otherwise; therefore, EPA cannot deny California's
request on the basis that California's commercial harbor craft
requirements are not consistent with section 209(e)(1).
3. Consistency With Section 209(b)(1)(C)
    The requirement that California's standards be consistent with
section 209(b)(1)(C) of the Clean Air Act effectively requires
consistency with section 202(a) of the Act. California standards are
inconsistent with section 202(a) of the Act if there is inadequate
lead-time to permit the development of technology necessary to meet
those requirements, giving appropriate consideration to the cost of
compliance within that time. California's accompanying enforcement
procedures would also be inconsistent with section 202(a) if the
federal and California test procedures were not consistent. The scope
of EPA's review of whether California's action is consistent with
section 202(a) is narrow. The determination is limited to whether those
opposed to the authorization or waiver have met their burden of
establishing that California's standards are technologically
infeasible, or that California's test procedures impose requirements
inconsistent with the federal test procedure.\34\
---------------------------------------------------------------------------

    \34\ MEMA I, 627, F.2d at 1126.
---------------------------------------------------------------------------

a. Technological Feasibility
    Congress has stated that the consistency requirement of section
202(a) relates to technological feasibility.\35\ Section 202(a)(2)
states, in part, that any regulation promulgated under its authority
``shall take effect after such period as the Administrator finds
necessary to permit the development and application of the requisite
technology, giving appropriate consideration to the cost of compliance
within such period.'' Section 202(a) thus requires the Administrator to
first determine whether adequate technology already exists; or if it
does not, whether there is adequate time to develop and apply the
technology before the standards go into effect. The latter scenario
also requires the Administrator to decide whether the cost of
developing and applying the technology within that time is feasible.
Previous EPA waivers are in accord with this position.\36\ For example,
a previous EPA waiver decision considered California's standards and
enforcement procedures to be consistent with section 202(a) because
adequate technology existed as well as adequate lead-time to implement
that technology.\37\ Subsequently, Congress has stated that, generally,
EPA's construction of the waiver provision has been consistent with
congressional intent.\38\
---------------------------------------------------------------------------

    \35\ H.R. Rep. No. 95-294, 95th Cong., 1st Sess. 301 (1977).
    \36\ See, e.g., 49 FR 1887, 1895 (May 3, 1984); 43 FR 32182,
32183 (July 25, 1978); 41 FR 44209, 44213 (October 7, 1976).
    \37\ 41 FR 44209 (October 7, 1976).
    \38\ H.R. Rep. No. 95-294, 95th Cong., 1st Sess. 301 (1977).
---------------------------------------------------------------------------

    CARB presents that the technological feasibility of most of the
commercial harbor craft requirements are ``clearly technologically
feasible'' because they mirror requirements that EPA has already
adopted and determined were technologically feasible after considering
cost of compliance when setting its Tier 2, 3, and 4 emission
standards.\39\ Such is the case for the new vessel engine requirements,
for which compliance is based on meeting applicable federal Tier 2, 3,
or 4 emission standards. Larger new ferry propulsion engines must
similarly meet applicable federal standards, with those that meet Tier
2 or 3 federal standards also required to be equipped with BACT. CARB
states that the BACT requirement is technologically feasible because a
BACT determination is made on a case-by-case assessment of
technological availability for each specific ferry application. If no
BACT is available for a specific ferry application, compliance with
federal Tier 2 or 3 standards is all that is required. This aspect of
California's commercial harbor craft regulations is the only aspect
which does not rely upon compliance with a federal standard; for this
aspect, CARB contends that the cost of compliance on ferry owners and
operators will largely be passed along to customers without significant
economic disruption. CARB's in-use requirements also rely on compliance
with federal emission standards and includes four compliance options:
(1) Engine replacement with new federal Tier 2 or 3 compliant engines,
(2) demonstrating compliance with federal Tier 2 or 3 standards (e.g.,
rebuilding), (3) demonstrating that a vessel will not operate more than
three hundred hours in a compliance year, and (4) flexibility through
exemptions and compliance extensions.
---------------------------------------------------------------------------

    \39\ CARB Support Document at 9-13.
---------------------------------------------------------------------------

    EPA did not receive any comments suggesting that California's
commercial harbor craft regulations are technologically infeasible. EPA
did receive comments--from AWO and K-Sea--suggesting that CARB did not
adequately address the cost of compliance within the lead-time
provided.
    AWO asserts that California's commercial harbor craft regulations
are inconsistent with section 202(a) because there has been inadequate
lead-time to permit the development and widespread commercial
availability of the technology necessary to comply, and CARB has not
given appropriate consideration to the cost of compliance within the
lead-time provided. AWO further asserts that approximately four-fifths
of the towing vessel fleet is equipped with pre-Tier 1 or Tier 1
certified engines, and current regulations only require use of an EPA-
approved kit, if available; California's commercial harbor craft
regulations, on the other hand, will require these vessels to rebuild
with a Tier 2 kit or completely repower. AWO also asserts that CARB
does not address the cost of a retrofit versus the cost of replacement;
this, AWO believes, is a failure to provide adequate lead-time, ``with
appropriate consideration to the cost of compliance.'' AWO emphasizes
that its

members cannot afford these costs, particularly because ninety percent
of the towing industry is comprised of small businesses. Additionally,
AWO stresses that these cost concerns (e.g., vessel downtime required
during drydocks, the residual value of engine replacement, cost of
installation and maintenance, equipment and shipyard availability) were
not given full consideration by CARB. AWO believes that many towing
companies may be forced to cease operations in California. Furthermore,
even though California provides funding options, AWO asserts that such
funding is largely unavailable for AWO members because they do not
primarily operate within California. AWO believes that the cost
increases associated with the commercial harbor craft regulation will
drive up the cost of waterways transportation.
    K-Sea also believes that CARB did not adequately assess the
financial impacts and cost of compliance. K-Sea emphasizes that out of
its 18 tugs, they would need to replace 13. K-Sea informs EPA that they
cannot afford this, and will be forced to either make a radical capital
investment to comply, or cease operating in California. K-Sea
represents that they cannot obtain CARB funding because it does not
operate primarily in California. K-Sea also states that they could
relocate compliant vessels to California, which would merely shift
pollution out of state. K-Sea believes this renders the ``necessity of
the regulation to be `arbitrary and capricious' * * *''
    EPA's review with regard to cost of compliance occurs within the
context of its review of whether California's commercial harbor craft
regulations are consistent with section 202(a) of the Clean Air Act. As
described above, EPA's review here is narrow. That is, section 202(a)
consistency calls for a limited review of technological feasibility,
including analysis of the cost of new technology, if technology does
not currently exist. Section 202(a) does not allow EPA to conduct a
more searching review of whether the costs are outweighed by the
overall benefits of the California regulations. In this case, no party
has objected to CARB's demonstration that technologies are in existence
and are being used in actual operation; AWO and K-Sea only challenge
the cost of compliance. EPA's traditional review of costs considers
whether the cost of compliance per engine would render the regulation
cost prohibitive and thus infeasible. Here, CARB understands that there
are significant costs associated with compliance, but it expects those
costs to eventually be passed on to the consumer, without significant
impact on the industry. AWO and K-Sea, on the other hand, present that
compliance with the commercial harbor craft regulations would impose
unreasonable costs that could lead operators to cease operations in
California. AWO and K-Sea did not further express that the costs
associated with compliance would render compliance entirely infeasible.
Notably, CARB responded to similar if not identical concerns from
industry--including comments from AWO--during the California
rulemaking.\40\ In response to comments with respect to the significant
costs of compliance and impact on the industry, CARB stood by its
rulemaking findings. CARB addressed the many points AWO and K-Sea now
raise in this proceeding. Specifically, CARB stated, among other
things, that it does not believe the commercial harbor craft regulation
will have significant economic impacts; that the potential impacts on
affected tugboat and towboat businesses will, on average, decrease a
business's return on investment by 3.6 and 0.5 percent, respectively;
that engine replacement is the most expensive compliance option, but
there may be other less costly options, including rebuilding, employing
emission control technologies, applying for approval of alternative
control of emissions plan, or applying for compliance extensions; that
tugboats will be able to pass on the added compliance costs to their
customers; that the regulation will not result in job losses or
significant impact on tugboat businesses because they provide a
necessary service that will continue to be in high demand; and that
CARB has given six years of lead-time for businesses to plan for
compliance in which they may apply for incentive funds or choose other
less costly compliance options. In previous waiver and authorization
determinations, EPA has consistently given California substantial
deference on its policy judgments, including those related to the costs
associated with compliance. For example, in a previous authorization
determination where cost of compliance was an issue, EPA stated:
``CARB's regulations are feasible with respect to cost objectively;
i.e., all fleet operators face the same cost per unit to comply. While
this cost may have different impacts on fleets of varying sizes, EPA
recognizes that it is up to CARB to choose who it will regulate under
its standards.'' \41\ Similarly here, EPA is in no position to second-
guess CARB's regulatory choices. Because the cost of compliance is not
so burdensome to render compliance options out of reach, the fact that
some operators may have difficulties with the cost of compliance does
not render the program infeasible.
---------------------------------------------------------------------------

    \40\ CARB, ``Final Statement of Reasons for Rulemaking,'' EPA-
HQ-OAR-2011-0549-0032, pp. 57-67.
    \41\ EPA, Authorization of In-Use Emission Standards for
Transport Refrigeration Unit Engines,'' January 9, 2009, at 63.
---------------------------------------------------------------------------

    Therefore, based on the record before us, EPA finds that opponents
of the authorization have not met their burden of proof. Consequently,
EPA cannot deny California's authorization based on technological
infeasibility.
b. Consistency of Certification Procedures
    California's standards and accompanying enforcement procedures
would also be inconsistent with section 202(a) if the California test
procedures were to impose certification requirements inconsistent with
the federal certification requirements. Such inconsistency means that
manufacturers would be unable to meet both the California and federal
testing requirements using the same test vehicle or engine.\42\
---------------------------------------------------------------------------

    \42\ See, e.g., 43 FR 32182 (July 25, 1978).
---------------------------------------------------------------------------

    CARB presents that none of the commercial harbor craft requirements
pose any inconsistency as between California and federal test
procedures. CARB asserts that the compliance methods for new vessel
engines are EPA's Tier 2, 3, or 4 federal marine engine test
procedures. For larger new ferries, CARB also relies on federal marine
engine test procedures, and asserts that the added BACT requirement is
not inconsistent with federal procedures because EPA has no comparable
requirement. The regulation's in-use requirements also rely on federal
marine engine test procedures. CARB further presents that the in-use
requirements are not inconsistent with federal requirements because EPA
does not have any comparable in-use standards and test procedures.
    EPA received no comments suggesting that CARB's commercial harbor
craft requirements pose a test procedure consistency problem.
Therefore, based on the record, EPA cannot find that CARB's testing
procedures are inconsistent with section 202(a). Consequently, EPA
cannot deny CARB's request based on this criterion.

D. Other Issues

    AWO requests that the compliance dates for the affected vessels be
reset

according to the date that EPA approves California's authorization
request to facilitate compliance. AWO also expressed concerns about
inconsistent regulation for vessels engaged in interstate commerce. K-
Sea echoed a similar concern, stating that the regulations will shift
the burden of dealing with emissions to other states because companies
may choose to relocate a non-CARB compliant engine to operations
elsewhere. With respect to AWO's request for a delayed compliance
schedule, EPA cannot change an aspect of California's regulation. EPA
is only authorized to review California's standards to determine
compliance with section 209. It is not authorized to change
California's regulations. With respect to the AWO and K-Sea comments
regarding the interstate implications of California's commercial harbor
craft regulations, that issue is also beyond the scope of EPA's review
under the three section 209(e)(2) criteria. As EPA has stated on
numerous occasions, sections 209(b) and 209(e) of the Clean Air Act
limit our authority to deny California requests for waivers and
authorizations to the three criteria listed therein. As a result, EPA
has consistently refrained from denying California's requests for
waivers and authorizations based on any other criteria.\43\ In
instances where the U.S. Court of Appeals has reviewed EPA decisions
declining to deny waiver requests based on criteria not found in
section 209(b), the Court has upheld and agreed with EPA's
determination.\44\ Neither of these other issues AWO and K-Sea raises
is among--or fits within the confines of--the criteria listed under
section 209(e).\45\ It is clear that Congress intended that California
have the ability to promulgate standards that are more stringent than
those that would otherwise apply to mobile sources under federal
regulations. Indeed, other states could also promulgate such standards
if they are identical to California's. Therefore, in considering
California's commercial harbor craft regulations, EPA may not deny
authorization based on these issues.
---------------------------------------------------------------------------

    \43\ See, e.g., 74 FR 32744, 32783 (July 8, 2009).
    \44\ See Motor and Equipment Manufacturers Ass'n v. Nichols, 142
F.3d 449, 462-63, 466-67 (DC Cir. 1998), Motor and Equipment
Manufacturers Ass'n v. EPA, 627 F.2d 1095, 1111, 1114-20 (DC Cir.
1979).
    \45\ AWO and K-Sea may raise these issues in a direct challenge
to California's regulations in other forums, but these issues are
not relevant to EPA's limited review under section 209.
---------------------------------------------------------------------------

E. Authorization Determination for California's Commercial Harbor Craft
Regulations

    After a review of the information submitted by CARB and other
parties to this proceeding, EPA finds that those opposing California's
request have not met the burden of demonstrating that an authorization
for California's commercial harbor craft regulations should be denied
based on any of the three statutory criteria of section 209(e)(2). For
this reason, EPA finds that an authorization for California's
commercial harbor craft regulations should be granted.

III. Decision

    The Administrator has delegated the authority to grant California
section 209(b) waivers of preemption and section 209(e) authorizations
to the Assistant Administrator for Air and Radiation. After evaluating
California's commercial harbor craft regulations, CARB's submissions,
and the public comments from AWO and K-Sea, EPA is granting an
authorization to California for its commercial harbor craft
regulations.
    My decision will affect not only persons in California, but also
entities outside the State who must comply with California's
requirements. For this reason, I determine and find that this is a
final action of national applicability for purposes of section
307(b)(1) of the Act. Pursuant to section 307(b)(1) of the Act,
judicial review of this final action may be sought only in the United
States Court of Appeals for the District of Columbia Circuit. Petitions
for review must be filed by February 13, 2012. Judicial review of this
final action may not be obtained in subsequent enforcement proceedings,
pursuant to section 307(b)(2) of the Act.

IV. Statutory and Executive Order Reviews

    As with past authorization and waiver decisions, this action is not
a rule as defined by Executive Order 12866. Therefore, it is exempt
from review by the Office of Management and Budget as required for
rules and regulations by Executive Order 12866.
    In addition, this action is not a rule as defined in the Regulatory
Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a
supporting regulatory flexibility analysis addressing the impact of
this action on small business entities.
    Further, the Congressional Review Act, 5 U.S.C. 801, et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, does not apply because this action is not a rule for purposes of
5 U.S.C. 804(3).

    Dated: December 5, 2011.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2011-31916 Filed 12-12-11; 8:45 am]
BILLING CODE 6560-50-P


870.5375
Cytogenetics/
In vitro
Chromosomal
Aberration
43709038 (1991)
Acceptable/Guideline
In an in vitro assay for chromosome aberrations in Chinese
hamster ovary (CHO) cells, cyprodinil gave negative results
up to cytotoxic concentrations (
≥
50  g/mL without S9, 18-
or 42-hour cell harvest or
≥
25  g/mL with S9, 18- hour cell
harvest) or to the highest sub-cytotoxic concentration (50
μg/mLwith S9, 42-hour cell harvest).
870.5395
Cytogenetics/
In vivo bone marrow
micronucleus
43709039 (1990)
Acceptable/Guideline
In an in vivo bone marrow micronucleus assay, cyprodinil
was negative when administered orally (gavage) at 5000
mg/kg (HDT) to both sexes of Tif:MAGF mice.  No signs of
overt toxicity or clear evidence of cytotoxicity for the target
organ were noted at any dose or sacrifice time.
870.5550
UDS
43709035 (1991)
Acceptable/Guideline
In an UDS assay in primary rat hepatocytes, cyprodinil was
negative up to a cytotoxic concentration (80  g/mL)
870.7485
Metabolism and
pharmacokinetics
43709040 (1992)
Acceptable/Guideline
Single oral doses (0.5 or 100 mg/kg bw) of phenyl or
pyrimidyl-radiolabelled CGA 219417 (purity
≥
98%) were
administered to Tif:RAIf(SPF) rats, with one low-dose
group receiving unlabelled CGA 219417 (purity
≥
99%) for
2 weeks prior to treatment with radiolabelled compound.
Absorption was very rapid (t
cmax
= 0.3 hours) with rapid
clearance (t
cmax/2
=1.2 hours).  A minimum of 75% of the
administered dose was absorbed.  Excretion was rapid and
almost complete, with urine as the principle route of
excretion (48-68%), and >90% of the administered dose
detected in the urine and feces within 48 hours.  Excretion,

Page 27 of 36
Table 2..  Toxicity Profile of Cyprodinil Technical.
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
distribution and metabolite profiles were essentially
independent of dose level, pretreatment, and type of label,
although there were some quantitative differences sex-
dependent qualitative differences in two urinary metabolite
fractions.
870.7485
Metabolism and
pharmacokinetics
43709041 (1992)
Acceptable/guideline
Must be considered with MRID 43709040.
Excreta (Group D1 and D2) and bile (Group G1) from
radiolabelled CGA 219417-treated Tif:RAIf(SPF) rats of a
previous ADME study (MRID 43709040) were used to
characterize, isolate and identify CGA 219417 metabolites
(MRID 43709041).  Eleven metabolites were isolated from
urine, feces and bile, and the metabolic pathways in the rat
were proposed.  All urinary and biliary metabolites (with the
exception of 7U) were conjugated with glucuronic acid or
sulfonated, and excreted.  CGA 219417 was almost
completely metabolized by hydroxylation of the phenyl ring
(position 4) or pyrimidine ring (position 5), followed by
conjugation.  An alternative pathway involved oxidation of
the phenyl ring followed by glucuronic acid conjugation.  A
quantitative sex difference was observed with respect to
sulfonation of the major metabolite that formed 6U.  The
monosulfate metabolite (1U) was predominant in females,
whereas equal amounts of mono- and disulfate (6U)
conjugates were noted in males.  Most of the significant
metabolites in feces were exocons of biliary metabolites
(2U, 3U, 1G).  These were assumed to be deconjugated in
the intestines, partially reabsorbed into the general
circulation, conjugated again, and eliminated renally.  The
major metabolic pathways of CGA 219417 were not
significantly influenced by the dose, treatment regimen, or
sex of the animal.
870.7600
Dermal Absorption
(rat)
45906102 (1999)
In review
6 µg/cm or 870 µg/cm
2
2
In a dermal absorption study with CGA 219417 formulated
as SWITCH 62.5 WG in the rat, the maximum systemic
absorption was 21.71% (at 24 hours).  An additional 12% of
the applied dose (that is potentially available for absorption)
remained on the treated skin at 24 hours.

2.0
– METABOLIC PROFILE
Chemical Name/Code
Chemical Structure
Cyprodinil (CGA-219417)
4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine
N
N
CH
3
N
H
CGA-232449
6-cyclopropyl-2-(phenylamino)-4-
pyrimidinemethanol
N
N
OH
N
H
CGA-304075
4-[(4-cyclopropyl-6-methyl-2-2-
pyrimidinyl)amino]-phenol
N
N
CH
3
N
H
O
H
CGA-304076
N
N
N
H
CH
3
OH
NOA-413167
N
N
N
H
OH
CH
3
Page 28 of 36

Page 29 of 36
Chemical Name/Code
Chemical Structure
CGA-249287
4-cyclopropyl-6-methyl-2-pyrimidinamine
N
N
CH
3
N
H
2
NOA-422054
4-cyclopropyl-6-hydroxymethyl-2-pyrimidinamine
N
N
OH
N
H
2
CGA-263208
phenylguanidine
N
H
NH
NH
2

Page 30 of 36
3.0
ADDITIONAL TOXICOLOGY STUDIES
Dermal Toxicity – Rat (MRID 43709029)
The HIARC downgraded the 28-day dermal-toxicity study in the rat (MRID 43709029)
to Unacceptable/Guideline and recommended the submission of an acceptable 28-day dermal-
toxicity study.  This study was reclassified as Unacceptable by the July 9, 2002 HIARC because:
1) Cyprodinil has marginal toxicity via the dermal route (LD
50
>2000 mg/kg); 2) The chemical
structure does not suggest dermal absorption; 3) There is no pattern of toxicity that is consistent
with the other toxicity studies.  For example, there is a questionable sex specificity (i.e., a 40-
fold difference was noted between the original LOAEL for females (25 mg/kg/day) and males
(1000 mg/kg/day) that has not been observed in acute, subchronic or chronic studies in rat, rabbit
or dog test species.  Similarly, clinical signs used to set the LOAEL for females (piloerection
and/or hunched posture) are suggestive of a neurotoxic effect.  However, there is no evidence of
neurotoxicity in repeated dose studies throughout the cyprodinil database.  The HIARC also
recommended that the LOAEL/NOAEL for females be increased to 125/25 mg/kg/day based on
both hunched posture and piloerection due to the questionable biological significance of the
piloerection seen in females at 25 mg/kg/day in the absence of other signs at the same dose level
in this study.  Based on all these considerations, HIARC concluded that there was a lack
confidence in this study.
Subchronic Oral Toxicity – Rat (MRID 43866301)
In a range finding subchronic toxicity study (MRID 43866301), CGA-219417
(cyprodinil; >95% ai; Batch No. HE 15083) was administered in the diet to Tif:RAIf(SPF)
albino rats, 5 rats/sex/dose level at 0, 100, 600, 3000 or 15000 ppm (males - 0, 10.3, 64.8, 316 or
1460 mg/kg/day; females - 0, 10.1, 62.2, 299 or 1390 mg/kg/day) for 28 days. There was no
effect on mortality and no clinical signs of toxicity. Treatment-related effects included lower
body weight gains in 15000 ppm males (30 %) and slight decreases in 3000 (9%) and 15000 ppm
(10%) females; decreased food consumption in high-dose animals (8-15% lower); decreased
water consumption (10-40 % depending on week), decreased erythrocyte, haemoglobin, and
haematocrit levels, and significantly increased cholesterol and phospholipid levels in 3000 and
15000 ppm animals; increased absolute and relative liver weights in 3000 and 15000 ppm
females; microcytosis, hepatocyte hypertrophy and thyroid follicular hypertrophy in 3000 and
15000 ppm males, hypochromasia in 15000 ppm males, and glycogen depletion in 15000 ppm
males and
females. The slight increases in platelets, cholesterol and phospholipid levels at 600 ppm
were not considered to be adverse in this study, as there were no associated histopathological
findings at this dose. The LOAEL is 3000 ppm (316 and 299 mg/kg/day for males and females,
respectively) based on lower body weight gains, microcytosis, increased cholesterol and
phospholipid levels and hepatocyte hypertrophy. The NOAEL is 600 ppm (64.8 and 62.2
mg/kg/day for males and females, respectively).

Page 31 of 36
Subchronic Feeding Study – Dog (MRID 43709028)
A 3-month study was carried out in Beagle dogs where animals (4/sex/dose) were fed
diets containing 0,200! 1500,  7000 or 20000 ppm (actual concentrations: males - 0, 6.07, 45.87,
210.33 or 559.66 mg/kg/day; females- 0, 6.79, 52.75, 231.93 or 580.95 mg/kgfday) CGA
219417.
There was no effect on mortality, or clinical chemistry parameters. Vomiting was observed in all
high-dose females during the first week of treatment, and an increase in mean platelet count was
noted in high-dose females at weeks 7 and 13. Lower bodyweight gains (64-76%) and decreased
food consumption were apparent in high-dose males and females throughout the study period.
There was a transient decrease in bodyweight gain and food consumption in 7000 ppm females,
which was noted after the first week of treatment only, and this was considered non-adverse. The
LOAEL is 20,000 ppm (males -560, females -581 mg/kg/day) based on lower bodyweight gains
and decreased food consumption in both sexes. The NOAEL is 7000 ppm (males -210, females -
232 mg/kg/day).
Subchronic Feeding Study – Mice  (MRID 43709027)
A 3-month study (MRID 43709027) was carried out in Tif:MAGf(SPF) albino mice where
animais (10 mice/sex/dose) were fed diets containing 0, 500,2000 or 6000 ppm (actual
concentrations: males - 0, 73.3, 257 or 849 mg/kg/day; females -0, 103, 349 or 1121 mg/g’day)
of CGA 2i19417 technical (99.5% a.i., Batch No- P 912004).  There was no effect on mortality,
or haematology parameters, and no clinical sighs of toxicity. Treatment-related effects included
increased absolute and relative liver weights (112-118 %) in 6000 ppm males, and hepatic
changes in mid- and high dose males and females that consisted of multifocal hepatocyte
necrosis in 2000 and 6000 ppm males (30 % as compared to 0 in the control and low dose
groups) and glycogen depletion in 2000 and 6000 ppm females (10, 10, 70 and 100% from
controls to high dose). The LOAEL is 2000 ppm based on histopathological changes in the liver.
The NOAEL is 500 ppm (malts - 73.3; females - 103 mg/kg/day).
Carcinogenicity Study in Mice (MRID 43709031)
An 18-month oncogenicity study was carried out in Tif:MAGf(SPF)
albino mice where animals (50 mice/sex/dose - carcinogenicity portion, plus 10/sex/dose -
hematology) were fed diets containing 0, 10, 150, 2000 or 5000 ppm (actual concentrations:
males - 0, 1.15, 16.1, 212.4 or 630; females - 0, 1.08, 14.7, 196.3 or 558.1 mg/kg/day) of
CGA 219417 (99.0-99.5% a.i., Batch No. P 912006). There was no effect on mortality, or
hematology parameters, and no clinical signs of toxicity. Treatment-related effects included
lower body weight and body weight gain (males - 10%, females - 27%) at 5000 ppm,
reduced food efficiency and increased relative liver weights (16%) in high-dose males and
females, and a dose-related increase in minimal to marked pancreatic acinar cell hyperplasia
in 2000 and 5000 ppm males (8, 8, 10, 16, 28% incidence, from control to high dose). The

Page 32 of 36
LOAEL was 2000 ppm (males - 212.4 mg/kg/day) based on a dose-related increase in the
incidence of focal and multifocal hyperplasia of the exocrine pancreas in males. The
NOAEL was 150 ppm (males - 16.1 mg/kg/day). This study was tested to adequate levels
based on signs of toxicity in males at 2000 ppm and females at 5000 ppm.
Mutagenicity
(i) Gene Mutation
In a reverse gene mutation assay with Salmonella typhimurium/Escherichia coli,
cyprodinil was negative up to concentrations ($1250 :g/plate +/-S9) that produced reproducible
cytotoxicity for the majority of strains. Compound insolubility was reported at $313
:g/plate (MRID No. 43709037).
In a Chinese hamster V79 cell HGPRT forward gene mutation assay, cyprodinil was
negative up to cytotoxic concentrations ($96.0 :g/mL with S9) ($24 :g/mL without S9)
(MRID No. 43709036).
(ii). Chromosome Aberrations
In an in vitro assay for chromosome aberrations in Chinese hamster ovary (CHO) cells,
cyprodinil gave negative results up to cytotoxic concentrations ($50 :g/mL without S9,
18- or 42-hour cell harvest or $25 :g/mL with S9, 18- hour cell harvest) or to the highest
sub-cytotoxic concentration (50 :g/mL with S9, 42-hour cell harvest) (MRID No.
43709038).
In an in vivo bone marrow micronucleus assay, cyprodinil was negative when
administered orally (gavage) at 5000 mg/kg (HDT) to both sexes of Tif:MAGF mice. No signs
of overt toxicity or clear evidence of cytotoxicity for the target organ were noted at any dose or
sacrifice time (MRID No. 43709039).
(iii) Other Mutagenic Mechanisms
In an unscheduled DNA synthesis assay in primary rat hepatocytes, cyprodinil was
negative up to a cytotoxic concentration (80 :g/mL) (MRID No. 43709035).

4.0
TOXICOLOGY STUDY REFERENCES
82-1       Subchronic Oral Toxicity: 90-Day Study
MRID
Citation Reference
43709026
Frankhauser, H. (1991) CGA-219417 Technical: 3-Month Oral Toxicity Study in Rats
(Administration in Food): Amended: Lab Project Number: 891321. Unpublished study
prepared by Ciba-Geigy Ltd. 436 p.
43709027
Frankhauser, H. (1991) CGA-219417 Technical: 3-Month Range Finding Toxicity Study
in Mice: (Final Report): Lab Project Number: 891320. Unpublished study prepared by
Ciba-Geigy Ltd. 219 p.
43709028
Altmann, B. (1991) CGA-219417 Technical: 3-Month Subchronic Oral Toxicity Study in
Beagle Dogs: Amended (Final Report): Lab Project Number: 891323. Unpublished study
prepared by Ciba-Geigy Ltd. 323 p.
43737601
Frankhauser, H. (1991) CGA-219417 Technical: 28-Day Oral Cumulative Toxicity Study
in Rats: Amended (Final Report): Lab Project Number: 891322. Unpublished study
prepared by Ciba-Geigy Ltd. 264 p.
43866301
Bachman, M. (1989) CGA-219417: 28-Days Range Finding Study in Rats:
(Administration in Food): Lab Project Number: 891050. Unpublished study prepared by
Ciba-Geigy Ltd. 263 p.
45614706
Altmann, B. (2002) 90-Day Oral Toxicity Study in Rat (Administration in Food): CA1139
A: Final Report: Lab Project Number: 20013024: 2692-01. Unpublished study prepared
by RCC Ltd. 599 p. {OPPTS 870.3100}
82-2       21-day dermal-rabbit/rat
MRID
Citation Reference
43709029
Hagemann, C. (1991) CGA-219417 Technical: 28-Day Repeated Dose Dermal Toxicity
Study in the Rat: Amended (Final Report): Lab Project Number: 901078. Unpublished
study prepared by Ciba-Geigy Ltd. 230 p.
82-7       Subchronic Neurotoxicity
MRID
Citation Reference
45906101
Classen, W. (1997) 90-Day Subchronic Neurotoxicity Study in Rats: Final Report: Lab
Project Number: 963031. Unpublished study prepared by Novartis Crop Protection AG.
367 p. {OPPTS 870.6200}
83-1       Chronic Toxicity
MRID
Citation Reference
43709030
Altmann, B. (1992) CGA-219417 Technical: 12-Month Chronic Dietary Toxicity Study in
Beagle Dogs: Amended (Final Report): Lab Project Number: 891324. Unpublished study
prepared by Ciba-Geigy Ltd. 455 p.
Page 33 of 36

43737602
Frankhauser, H. (1994) CGA-219417 Technical: 24-Month Carcinogenicity and Chronic
Toxicity Study in Rats: Lab Project Number: 891326. Unpublished study prepared by
Ciba-Geigy Ltd. 1255 p.
44417902
Fankhauser, H. (1994) 24-Months Carcinogenicity and Chronic Toxicity Study in Rats:
Cyprodinil Technical (CGA-219417): Addendum: Lab Project Number: 891326.
Unpublished study prepared by Novartis Crop Protection, Inc. 374 p.
83-2       Oncogenicity
MRID
Citation Reference
43709031
Frankhauser, H. (1994) CGA-219417 Technical: 18-Month Carcinogenicity Study in
Mice: Amended (Final Report): Lab Project Number: 891325. Unpublished study
prepared by Ciba-Geigy Ltd. 828 p.
43737602
Frankhauser, H. (1994) CGA-219417 Technical: 24-Month Carcinogenicity and Chronic
Toxicity Study in Rats: Lab Project Number: 891326. Unpublished study prepared by
Ciba-Geigy Ltd. 1255 p.
44417901
Fankhauser, H. (1994) 18-Month Carcinogenicity Study in Mice: Cyprodinil Technical
(CGA-219417): Addendum: Lab Project Number: 891325. Unpublished study prepared
by Novartis Crop Protection, Inc. 348 p.
44417902
Fankhauser, H. (1994) 24-Months Carcinogenicity and Chronic Toxicity Study in Rats:
Cyprodinil Technical (CGA-219417): Addendum: Lab Project Number: 891326.
Unpublished study prepared by Novartis Crop Protection, Inc. 374 p.
83-3       Teratogenicity -- 2 Species
MRID
Citation Reference
43709032
Marty, J. (1991) CGA-219417 Technical: Developmental Toxicity Study in Rats:
Amended (Final Report): Lab Project Number: 891327. Unpublished study prepared by
Ciba-Geigy Ltd. 299 p.
43709033
Marty, J. (1991) CGA-219417 Technical: Developmental Toxicity (Teratogenicity Study
in Rabbits): Amended (Final Report): Lab Project Number: 891329. Unpublished study
prepared by Ciba-Geigy Ltd. 238 p.
43886301
Marty, J. (1990) CGA-219417 Technical: Preliminary Oral Toxicity Study with CGA-
219417 Technical in Pregnant Rabbits: (Dose Rangefinding Study): Lab Project


[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Notices]
[Pages 72133-72134]
[FR Doc No: 2013-28837]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting.

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Wednesday,
December 4, 2013 at 10:30 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session and

determined that no earlier notice thereof was possible.
    The subject matter of the Closed Meeting will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.

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

    Dated: November 26, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-28837 Filed 11-27-13; 11:15 am]
BILLING CODE 8010-01-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Issued by the Department of Transportation on December 23, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-99-6559

________________________________________________________________________
_____________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   Delta Air Lines, Inc.   filed  7/28/03  to:

XX  Renew for two years exemption pursuant to 49 U.S.C. §40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States and the following points
in Africa: Lilongwe and Blantyre, Malawi; Maputo, Mozambique; Windhoek,
Namibia; a point or points in Tanzania; Lusaka, Zambia; and Victoria
Falls and Bulawayo, Zimbabwe, and to integrate these services with its
existing certificate and exemption authority.  Delta provides service to
these points via South Africa under a third-country code-share
arrangement with South African Airways (SAA).

Applicant rep:  Robert E. Cohn<PHONE_NUMBER> 	DOT Analyst:  Sylvia
Moore<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (see below).

The above action was effective when taken:   December 23, 2003, through
 December 23, 2005, or until 90 days after final Department action on
Delta’s corresponding certificate application in Docket OST-1999-6246,
whichever occurs earlier.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX   The authority granted is consistent with the aviation agreements
between the United States and South Africa, the United States and
Namibia, the United States and Tanzania, and the overall state of
aviation relations between the United States and Malawi, Mozambique,
Zambia, and Zimbabwe.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

		XX  Holder’s certificates of public convenience and necessity

		XX  Standard Exemption Conditions (attached)

		XX  Statement of authorization for Delta/SAA code-share operations

	                      granted January 5, 2000, and conditions therein

(See Reverse Side)

2

Conditions:   The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with the applicable bilateral aviation agreements between the
United States and the foreign countries involved.  Furthermore, (a)
nothing in the award of the route integration authority requested should
be construed as conferring upon Delta additional rights (including
fifth-freedom intermediate and/or beyond rights) to serve markets where
U.S. carrier entry is limited unless Delta first notifies the Department
of its intent to serve such a market and unless and until the Department
has completed any necessary carrier selection procedures to determine
which carrier(s) should be authorized to exercise such rights; and (b)
should there be a request by any carrier to use the limited-entry route
rights that are included in Delta’s authority by virtue of the route
integration authority granted here, but that are not then being used by
Delta, the holding of such authority by route integration will not be
considered as providing any preference for Delta in a competitive
carrier selection proceeding to determine which carrier(s) should be
entitled to use the authority at issue.

____________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the exemption was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this order is available on the World Wide Web
at

http://dms.dot.gov//reports/reports_ aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										8/2003


[Federal Register: June 29, 2007 (Volume 72, Number 125)]
[Notices]
[Page 35704]
[DOCID:fr29jn07-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-69-000]

Western Systems Power Pool Agreement; Notice of Institution of
Proceeding and Refund Effective Date

June 22, 2007.
    On June 21, 2007, the Commission issued an order that instituted a
proceeding in the above-referenced docket, pursuant to section 206 of
the Federal Power Act (FPA), 16 U.S.C. 824c, to investigate whether the
Western Systems Power Pool Agreement ceiling rate is just and
reasonable for a public utility seller in markets in which such seller
has been found to have market power or is presumed to have market
power. Western System Power Pool, 119 FERC ] 61,302 (2007).
    The refund effective date in the above-docketed proceeding,
established pursuant to section 206(b) of the FPA, will be the date of
publication of this notice in the Federal Register.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-12611 Filed 6-28-07; 8:45 am]

BILLING CODE 6717-01-P