[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Proposed Rules]
[Page 52692-52701]
[DOCID:fr27au10-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2009-0656; FRL-9193-6]

Approval and Promulgation of Implementation Plans; New Mexico;
Interstate Transport of Pollution; Revisions to Prevention of
Significant Deterioration Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of New Mexico for the purpose of
addressing the ``good neighbor'' provisions of Clean Air Act (CAA)
section 110(a)(2)(D)(i) for the 1997 8-hour ozone National Ambient Air
Quality Standards (NAAQS or standards) and the 1997 PM2.5
NAAQS. This SIP revision addresses the requirement that the State of
New Mexico's SIP have adequate provisions to prohibit air emissions
from adversely affecting another state's

air quality through interstate transport. In this action, EPA is
proposing to approve the New Mexico Interstate Transport SIP provisions
that address the requirement of section 110(a)(2)(D)(i)(I) that
emissions from New Mexico sources do not interfere with maintenance of
the 1997 8-hour ozone NAAQS and the 1997 PM2.5 NAAQS in any
other state. In addition, EPA is proposing to approve the provisions of
this SIP submission that address the requirement of section
110(a)(2)(D)(i)(II) that emissions from New Mexico sources do not
interfere with measures required in the SIP of any other state under
part C of the CAA to prevent significant deterioration of air quality.
For purposes of the 1997 8-hour ozone NAAQS, EPA is also proposing to
approve a SIP revision that modifies New Mexico's Prevention of
Significant Deterioration (PSD) SIP for the 1997 8-hour ozone NAAQS to
include nitrogen oxides (NOX) as an ozone precursor. This
action is being taken under section 110 and part C of the Clean Air Act
(the Act or CAA).

DATES: Comments must be received on or before September 27, 2010.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2009-0656, by one of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov.
     Follow the online instructions for submitting comments.
     EPA Region 6 ``Contact Us'' Web site: http://epa.gov/
region6/r6coment.htm. Please click on ``6PD (Multimedia)'' and select
``Air'' before submitting comments.
     E-mail: Mr. Guy Donaldson at<EMAIL_ADDRESS>Please
also send a copy by e-mail to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
     Fax: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), at fax number<PHONE_NUMBER>.
     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Hand or Courier Delivery: Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are
accepted only between the hours of 8 a.m. and 4 p.m. weekdays, and not
on legal holidays. Special arrangements should be made for deliveries
of boxed information.
    Instructions: Direct your comments to Docket No. EPA-R06-OAR-2009-
0656. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or e-mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Planning Section
(6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER> to make an
appointment. If possible, please make the appointment at least two
working days in advance of your visit. There will be a 15 cent per page
fee for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The state submittal is also available for public inspection during
official business hours, by appointment, at the New Mexico Environment
Department, Air Quality Bureau, 1190 St. Francis Drive, Santa Fe, New
Mexico 87502.

FOR FURTHER INFORMATION CONTACT: Emad Shahin, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Outline

I. What action is EPA taking?
II. What is a SIP?
III. What is the background for this action?
IV. What is EPA's evaluation of the State's submission?
V. Statutory and Executive Order Reviews

I. What action is EPA taking?

    We are proposing to approve a submission from the State of New
Mexico demonstrating that New Mexico has adequately addressed two of
the required elements of CAA section 110(a)(2)(D)(i), the elements that
require that the State Implementation Plan prohibit air pollutant
emissions from sources within a state from interfering with maintenance
of the relevant NAAQS in any other state, and from interfering with
measures required to prevent significant deterioration of air quality
in any other state. We are proposing to determine that emissions from
sources in New Mexico do not interfere with the maintenance of the 1997
8-hour ozone NAAQS or of the 1997 PM2.5 NAAQS, or with
measures required to prevent significant deterioration of air quality,
with regards to these ozone or PM2.5 NAAQS in any other
state. In a separate prior action, we have addressed the element of
section 110(a)(2)(D)(i) that pertains to prohibiting air pollutant
emissions from within New Mexico from significantly contributing to
nonattainment of the 1997 8-hour ozone and 1997 PM2.5 NAAQS
in any other state (75 FR 33174). The remaining section 110(a)(2)(D)(i)
element which pertains to interference with measures required to
protect visibility in any other state will be addressed in a future
rulemaking.
    In conjunction with our proposed finding that emissions from
sources in

New Mexico are not interfering with any other state's PSD program, we
are also proposing to approve a portion of the SIP revision submitted
by the State of New Mexico with rule revisions to regulate NOx
emissions in its PSD permit program as a precursor to ozone. At this
time, EPA is not taking action on other portions of the SIP revisions
submitted by New Mexico together with the PSD revision.\1\ EPA intends
to act on the other revisions submitted together with the PSD program
revisions at a later time.
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    \1\ As noted later in this action, these revisions are separate
from the New Mexico PSD revisions and are to 20.2.2 NMAC,
Definitions and 20.2.79 NMAC, Permits-Nonattainment areas.
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    EPA proposes to approve the foregoing revisions relevant to section
110(a)(2)(D)(i) and the revisions to the PSD program pursuant to
section 110 and part C of the CAA.

II. What is a SIP?

    Section 110(a) of the Clean Air Act (CAA) requires each state to
develop a plan that provides for the implementation, maintenance, and
enforcement of the national ambient air quality standards (NAAQS). EPA
establishes NAAQS under section 109 of the CAA. Currently, the NAAQS
address six criteria pollutants: carbon monoxide, nitrogen dioxide,
ozone, lead, particulate matter, and sulfur dioxide.
    The plan developed by a state is referred to as the state
implementation plan (SIP). The content of the SIP is specified in
section 110 of the CAA, other provisions of the CAA, and applicable
regulations. SIPs can be extensive, containing state regulations or
other enforceable measures and various types of supporting information,
such as emissions inventories, monitoring networks, and modeling
demonstrations.
    A primary purpose of the SIP is to provide the air pollution
regulations, control strategies, and other means or techniques
developed by the state to ensure that the ambient air within that state
meets the NAAQS. However, another important aspect of the SIP is to
ensure that emissions from within the state do not have certain
prohibited impacts upon the ambient air in other states through
interstate transport of pollutants. This SIP requirement is specified
in section 110(a)(2)(D) of the CAA. Pursuant to that provision, each
state's SIP must contain provisions adequate to prevent, among other
things, emissions that interfere with maintenance of the NAAQS in any
other state or interfere with measures required to be included in the
SIP of any other state to prevent significant deterioration of air
quality in such other state.
    States are required to update or revise SIPs under certain
circumstances. One such circumstance is EPA's promulgation of a new or
revised NAAQS. Each state must submit these revisions to EPA for
approval and incorporation into the federally-enforceable SIP.

III. What is the background for this action?

    On July 18, 1997, EPA promulgated new NAAQS for 8-hour ozone and
for fine particulate matter (PM2.5). This action is being
taken in response to the promulgation of the 1997 8-hour ozone NAAQS
and 1997 PM2.5 NAAQS. This action does not address the
requirements for the 2006 PM2.5 NAAQS or the 2008 8-hour
ozone NAAQS; those standards will be addressed in later actions.
    Section 110(a)(1) of the CAA requires states to submit SIPs to
address a new or revised NAAQS within 3 years after promulgation of
such standards, or within such shorter period as EPA may prescribe.
Section 110(a)(2) lists the elements that such new SIPs must address,
as applicable, including section 110(a)(2)(D)(i), which pertains to
interstate transport of certain emissions. On August 15, 2006, EPA
issued its ``Guidance for State Implementation Plan (SIP) Submissions
to Meet Current Outstanding Obligations Under Section 110(a)(2)(D)(i)
for the 8-Hour Ozone and PM2.5 National Ambient Air Quality
Standards'' (2006 Guidance). EPA developed the 2006 Guidance to make
recommendations to states for making submissions to meet the
requirements of section 110(a)(2)(D)(i) for the 1997 8-hour ozone
standards and the 1997 PM2.5 standards.
    As identified in the 2006 Guidance, the ``good neighbor''
provisions in section 110(a)(2)(D)(i) require each state to submit a
SIP that prohibits emissions that adversely affect another state in the
ways contemplated in the statute. Section 110(a)(2)(D)(i) contains four
distinct requirements related to the impacts of interstate transport.
The SIP must prevent sources in the state from emitting pollutants in
amounts which will: (1) Contribute significantly to nonattainment of
the NAAQS in other states; (2) interfere with maintenance of the NAAQS
in other states; (3) interfere with provisions to prevent significant
deterioration of air quality in other states; or (4) interfere with
efforts to protect visibility in other states.
    On September 17, 2007, EPA received a SIP revision from the State
of New Mexico intended to address the requirements of section
110(a)(2)(D)(i) for both the 1997 8-hour ozone standards and the 1997
PM2.5 standards. In this rulemaking, EPA is addressing only
the requirements that pertain to preventing sources in New Mexico from
emitting pollutants that will interfere with maintenance of the 1997 8-
hour ozone NAAQS and the 1997 PM2.5 NAAQS in other states,
or that will interfere with measures required to prevent significant
deterioration of air quality in other states with respect to these
NAAQS. In its submission, the State of New Mexico indicated that its
current SIP is adequate to prevent such interference, and thus argued
that no additional emissions controls or other revisions are necessary
at this time to alleviate interstate transport for the 1997 8 hour
ozone NAAQS or the 1997 PM2.5 NAAQS. With this submission,
the state would meet the first and second elements of section
110(a)(2)(D)(i).
    On August 31, 2009, the New Mexico Environment Department (NMED)
also adopted revisions to its PSD SIP in response to revisions required
by EPA for the 1997 8-hour ozone NAAQS. EPA received these revisions on
September 21, 2009. These submitted PSD revisions included changes to
20.2.74 NMAC (New Mexico Administrative Code) for ``Permits--Prevention
of Significant Deterioration (PSD)'' necessary to address
NOX as a precursor for the 1997 8-hour ozone NAAQS. The
submittal contained revisions to Subsections <IP_ADDRESS> NMAC,
Definitions; <IP_ADDRESS>2 NMAC, Table 2, Significant Emission Rates
inclusion of nitrogen oxides rate for ozone; and <IP_ADDRESS>3 NMAC,
Table 3, Significant Monitoring Concentrations, Footnote b, inclusion
of baseline threshold for nitrogen oxides for requirements in ambient
impact analysis.
    With EPA's approval of this revision, that includes NOX
as a precursor of the 1997 8-hour ozone NAAQS, New Mexico's PSD SIP
will include changes necessary to implement the 1997 8-hour ozone NAAQS
within the state as contemplated in the 2006 Guidance for SIP
submissions to meet the third element of section 110(a)(2)(D). The
submittal also contained revisions to 20.2.2 NMAC, Definitions and
20.2.79 NMAC, Permits--Nonattainment Areas. At this time, EPA is not
taking action on these other SIP revisions submitted with the PSD SIP
revisions.

IV. What is EPA's evaluation of the State's submission?

A. EPA's Evaluation of Interference With Maintenance

    The second element of section 110(a)(2)(D)(i) requires that a
state's SIP must prohibit any source or other type of emissions
activity in the state from emitting pollutants that would ``interfere
with maintenance'' of the applicable NAAQS in any other state. This
term is not defined in the statute. Therefore, EPA has interpreted this
term in past regulatory actions, such as the 1998 NOX SIP
Call, in which EPA took action to remediate emissions of NOX
that significantly contributed to nonattainment, or interfered with
maintenance of, the then applicable ozone NAAQS through interstate
transport of NOX and the resulting ozone.\2\ The
NOX SIP Call was the mechanism through which EPA evaluated
whether or not the NOX emissions from sources in certain
states had such prohibited interstate impacts, and if they had such
impacts, required the states to adopt substantive SIP revisions to
eliminate those NOX emissions, whether through participation
in a regional cap and trade program or by other means.
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    \2\ See, 63 FR 57356 (October 27, 1998). EPA's general approach
to section 110(a)(2)(D) was upheld in Michigan v. EPA, 213 F.3d 663
(DC Cir. 2000), cert denied, 532 U.S. 904 (2001). However, EPA's
approach to interference with maintenance in the NOX SIP
Call was not explicitly reviewed by the court. See, North Carolina
v. EPA, 531 F.3d 896, 907-09 (DC Cir. 2008).
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    After promulgation of the 1997 8-hour ozone NAAQS and the 1997
PM2.5 NAAQS, EPA again recognized that regional transport
was a serious concern throughout the eastern U.S. and therefore
developed the 2005 Clean Air Interstate Rule (CAIR) to address
emissions of SO2 and NOX that exacerbate ambient
ozone and PM2.5 levels in many downwind areas through
interstate transport.\3\ Within CAIR, EPA likewise interpreted the term
``interfere with maintenance'' as part of the evaluation of whether or
not the emissions of sources in certain states had such impacts on
areas that EPA determined would either be in violation of the NAAQS, or
would be in jeopardy of violating the NAAQS, in a modeled future year
unless action were taken by upwind states to reduce SO2 and
NOX emissions. Through CAIR, EPA again required states that
had such interstate impacts to adopt substantive SIP revisions to
eliminate the SO2 and NOX emissions, whether
through participation in a regional cap and trade program or by other
means.
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    \3\ See, 70 FR 25162 (May 12, 2005).
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    EPA's 2006 Guidance addressed section 110(a)(2)(D) requirements for
the 1997 8-hour ozone NAAQS and 1997 PM2.5 NAAQS. For those
states subject to CAIR, EPA indicated that compliance with CAIR would
meet the two requirements of section 110(a)(2)(D)(i)(I) for these
NAAQS. For states not within the CAIR region, EPA recommended that
states evaluate whether or not emissions from their sources would
``interfere with maintenance'' in other states, following the
conceptual approach adopted by EPA in CAIR. After recommending various
types of information that could be relevant for the technical analysis
to support the SIP submission, such as the amount of emissions and
meteorological conditions in the state, EPA further indicated that it
would be appropriate for the state to assess impacts of its emissions
on other states using considerations comparable to those used by EPA
``in evaluating significant contribution to nonattainment in the
CAIR.'' \4\ EPA did not make specific recommendations for how states
should assess ``interfere with maintenance'' separately, and discussed
the first two elements of section 110(a)(2)(D) together without
explicitly differentiating between them.
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    \4\ 2006 Guidance at page 5.
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    In 2008, however, the U.S. Court of Appeals for the DC Circuit
found that CAIR and the related CAIR federal implementation plans were
unlawful.\5\ Among other issues, the court held that EPA had not
correctly addressed the second element of section 110(a)(2)(D)(i)(I) in
CAIR. The court noted that ``EPA gave no independent significance to
the `interfere with maintenance' prong of section 110(a)(2)(D)(i)(I) to
separately identify upwind sources interfering with downwind
maintenance.'' \6\. EPA's approach, the court reasoned, would leave
areas that are ``barely meeting attainment'' with ``no recourse'' to
address upwind emissions sources.\7\ The court therefore concluded that
a plain language reading of the statute requires EPA to give
independent meaning to the interfere with maintenance requirement of
section 110(a)(2)(D) and that the approach used by EPA in CAIR failed
to do so.
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    \5\ See, North Carolina v. EPA, 531 F.3d 896 (DC Circuit 2008).
    \6\ Id. 531, F.3d at 909.
    \7\ Id.
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    In addition to affecting CAIR directly, the court's decision in the
North Carolina case indirectly affects EPA's recommendations to states
in the 2006 Guidance with respect to the interfere with maintenance
element of section 110(a)(2)(D) because the agency's guidance suggested
that states use an approach comparable to that used by EPA in CAIR.
States such as New Mexico have already made SIP submissions that rely
upon the recommendations in EPA's 2006 Guidance, and accordingly may
not have sufficiently differentiated between the significant
contribution to nonattainment and interfere with maintenance elements
of the statute. Given the court decision on CAIR in the interim,
however, EPA believes that it is necessary to evaluate these state
submissions for section 110(a)(2)(D) in such a way as to assure that
the interfere with maintenance element of the statute is given
independent meaning and is appropriately evaluated using the types of
information that EPA recommended in the 2006 Guidance. To accomplish
this, EPA believes it is necessary to use an updated approach to
address this issue and to supplement the technical analysis provided by
the state in order to evaluate the submissions with the respect to the
interfere with maintenance element of section 110(a)(2)(D).
    EPA has recently proposed a new rule to address interstate
transport pursuant to section 110(a)(2)(D), the ``Federal
Implementation Plans to Reduce Interstate Transport of Fine Particulate
Matter and Ozone'' (Transport Rule Proposal), in order to address the
judicial remand of CAIR.\8\ As part of the Transport Rule Proposal, EPA
specifically reexamined the section 110(a)(2)(D) requirement that
emissions from sources in a state must not ``interfere with
maintenance'' of the 1997 8-hour ozone NAAQS and 1997 PM2.5
NAAQS in other states. In the proposal, EPA developed an approach to
identify areas that it predicts to be close to the level of the 1997 8-
hour ozone NAAQS and 1997 PM2.5 NAAQS, and therefore at risk
to become nonattainment for these NAAQS unless emissions from sources
in other states are appropriately controlled. This approach starts by
identifying those specific geographic areas for which further
evaluation is appropriate, and differentiates between areas where the
concern is with interference with maintenance, rather than with
significant contribution to nonattainment.
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    \8\ See ``Federal Implementation Plans to Reduce Interstate
Transport of Fine Particulate Matter and Ozone,'' 75 FR 45210
(August 2, 2010).
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    As described in more detail below, EPA's analysis evaluates data
from

existing monitors over three overlapping three year periods (i.e.,
2003-2005, 2004-2006, and 2005-2007), as well as air quality modeling
data, in order to determine which areas are predicted to be violating
the 1997 ozone and PM2.5 NAAQS in 2012, and which areas are
predicted to potentially have a difficulty with maintaining attainment
as of that date. In essence, if an area's projected data for 2012
indicates that it would be violating the NAAQS based on the average of
these three overlapping periods, then this monitor location is
appropriate for comparison for purposes of the significant contribution
to nonattainment element of section 110(a)(2)(D). If, however, an
area's projected data indicate that it would be violating the NAAQS
based on the highest single period, but not over the average of the
three periods, then this monitor location is appropriate for comparison
for purposes of the interfere with maintenance element of the
statute.\9\
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    \9\ A memorandum in the docket for this action provides the
information EPA used in order to identify monitors that are
receptors for evaluation of interference with maintenance for
certain states in the western United States. See, Memorandum from
Brian Timin of EPA's Office of Air Quality Planning and Standards,
Air Quality Modeling Group entitled ``Documentation of Future Year
Ozone and Annual PM2.5 Design Values for Western States''
(August 2010) (Timin Memo).
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    By this method, EPA has identified those areas with monitors that
are appropriate ``maintenance sites'' or maintenance ``receptors'' for
evaluating whether the emissions from sources in another state could
interfere with maintenance in that particular area. EPA then uses other
analytical tools to examine the potential impacts of emissions from
upwind states on these maintenance sites in downwind states. EPA
believes that this new approach for identifying those areas that are
predicted to have maintenance problems is appropriate to evaluate the
section 110(a)(2)(D) SIP submission of a state for the interfere with
maintenance element.\10\ EPA's 2006 Guidance did not provide this
specific recommendation to states, but in light of the court's decision
on CAIR, EPA will itself follow this approach in acting upon the New
Mexico submission.
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    \10\ To begin this analysis, EPA first identifies all monitors
projected to be in nonattainment or, based on historic variability
in air quality, projected to have maintenance problems in 2012. The
``problem'' is that these maintenance areas are at risk not to stay
in attainment because they are so close to the level of the 1997
ozone and PM2.5 NAAQS that minor variations in weather or
emissions could result in violations of the NAAQS in 2012.
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    As explained in the 2006 Guidance, EPA does not believe that
section 110(a)(2)(D) SIP submissions from all states necessarily need
to follow precisely the same analytical approach of CAIR. In the 2006
Guidance, EPA stated that: ``EPA believes that the contents of the SIP
submission required by section 110(a)(2)(D) may vary, depending upon
the facts and circumstances related to the specific NAAQS. In
particular, the data and analytical tools available at the time the
State develops and submits a SIP for a new or revised NAAQS necessarily
affects the contents of the required submission.'' \11\ EPA also
indicated in the 2006 Guidance that it did not anticipate that sources
in states outside the geographic area covered by CAIR were
significantly contributing to nonattainment, or interfering with
maintenance, in other states.\12\ As noted in the Transport Rule
Proposal, EPA continues to believe that the more widespread and serious
transport problems in the eastern United States are analytically
distinct.\13\ For the 1997 8-hour ozone NAAQS and the 1997
PM2.5 NAAQS, EPA believes that nonattainment and maintenance
problems in the western United States are relatively local in nature
with only limited impacts from interstate transport. In the Transport
Rule Proposal, EPA did not calculate interstate ozone or
PM2.5 contributions to or from Western States.
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    \11\ 2006 Guidance at 4.
    \12\ Id. at 5.
    \13\ See, Transport Rule Proposal, 75 FR 45210 (August 2, 2010)
at page 45227.
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    Accordingly, EPA believes that section 110(a)(2)(D) SIP submissions
for states outside the geographic area of the Transport Rule Proposal
may be evaluated using a ``weight of the evidence'' approach that takes
into account the available relevant information, such as that
recommended by EPA in the 2006 Guidance for states outside the area
affected by CAIR. Such information may include, but is not limited to,
the amount of emissions in the state relevant to the NAAQS in question,
the meteorological conditions in the area, the distance from the state
to the nearest monitors in other states that are appropriate receptors,
or such other information as may be probative to consider whether
sources in the state may interfere with maintenance of the 1997 8-hour
ozone NAAQS and 1997 PM2.5 NAAQS in other states. These
submissions can rely on modeling when acceptable modeling technical
analyses are available, but EPA does not believe that modeling is
necessarily required if other available information is sufficient to
evaluate the presence or degree of interstate transport in a given
situation.

B. New Mexico Transport SIP

    To meet the requirements of section 110(a)(2)(D), the State of New
Mexico made a SIP submission to address interstate transport for the
1997 8-hour ozone NAAQS and the 1997 PM2.5 NAAQS. EPA has
previously approved this submission for purposes of the significant
contribution to nonattainment element of section 110(a)(2)(D).\14\
Below, we discuss our evaluation of the state's submission with respect
to the interference with maintenance element and the interference with
measures required to prevent significant deterioration of air quality
element.
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    \14\ See, 75 FR 33174 (June 11, 2010).
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a. Interference With Maintenance
    The State's submittal focused primarily on whether emissions from
New Mexico sources significantly contribute to nonattainment of the
1997 8-hour ozone NAAQS and 1997 PM2.5 NAAQS in other
states. Following the 2006 Guidance and consistent with EPA's approach
in CAIR, New Mexico did not evaluate whether emissions from New Mexico
sources interfere with maintenance of these NAAQS in other states
separately from significant contribution to nonattainment in other
states. Instead, the state presumed that if New Mexico sources were not
significantly contributing to violations of the NAAQS in other states,
then no further specific evaluation was necessary for purposes of the
interfere with maintenance element of section 110(a)(2)(D). As
explained above, however, CAIR was remanded to EPA, in part because the
court found that EPA had not correctly addressed whether emissions from
sources in a state interfere with maintenance of the standards in other
states. Therefore, EPA must evaluate the New Mexico submission in light
of the decision of the court.
    On July 6, 2010, the EPA Administrator signed a proposed rule in
response to the judicial remand of CAIR. The Transport Rule Proposal
includes a new approach to determine whether emissions from a state
interfere with maintenance of the 1997 8-hour ozone NAAQS and the 1997
PM2.5 NAAQS in other states. EPA is using a comparable
approach to that of the Transport Rule Proposal in this action in order
to determine if emissions from New Mexico sources interfere with
maintenance of these NAAQS in other states.
    In the Transport Rule Proposal, EPA projected future concentrations
of ozone

and PM2.5 to identify areas that are expected to be out of
attainment with NAAQS or to have difficulty maintaining compliance with
the NAAQS in 2012. These areas are referred to as nonattainment and
maintenance receptors, respectively. These nonattainment and
maintenance receptors are based on projections of future air quality at
existing ozone and PM2.5 monitoring sites in those
locations. EPA then used these sites as the receptors for examining the
contributions of emissions from sources located in upwind states to
nonattainment and maintenance problems at these monitoring locations.
Monitoring data was obtained from EPA's Air Quality System (AQS).
    For ozone, EPA evaluated concentrations relevant to the 1997 8-hour
ozone NAAQS. The level of the 1997 8-hour ozone NAAQS is 0.08 parts per
million (ppm). The 8-hour ozone standard is met if the 3-year average
of the annual 4th highest daily maximum 8-hour ozone concentration is
less than or equal to 0.08 ppm (i.e., less than 0.085 ppm based on the
rounding convention in 40 CFR part 50 Appendix I). This 3-year average
is referred to as the ``design value.''
    For PM2.5, EPA evaluated concentrations of both the
annual PM2.5 NAAQS and the 24-hour PM2.5 NAAQS.
The 1997 annual PM2.5 NAAQS is met when the 3-year average
of the annual mean concentration is 15.0 micrograms per cubic meter
([mu]g/m\3\) or less. The 3-year average annual mean concentration is
computed at each site by averaging the daily Federal Reference Method
(FRM) samples by quarter, averaging these quarterly averages to obtain
an annual average, and then averaging the three annual averages to get
the design value. The 2006 24-hour PM2.5 NAAQS is met when
the 3-year average of the annual 98th percentile PM2.5
concentrations is 35 [mu]g/m\3\ or less. The 1997 24-hour
PM2.5 NAAQS is met when the 3-year average of the annual
98th percentiles is 65 [mu]g/m\3\ or less. The 3-year average mean 98th
percentile concentration is computed at each site by averaging the 3
individual annual 98th percentile values at each site. The 3-year
average 98th percentile concentration is referred to as the 24-hour
average design value. In this action, EPA is only evaluating whether
New Mexico's emissions impact other states' ability to maintain the
1997 annual and 24-hour PM2.5 NAAQS and the 1997 8-hour
ozone NAAQS, because those are the NAAQS at issue in this section
110(a)(2)(D) SIP submission. In later actions, the state and EPA will
evaluate the impacts of interstate transport from emissions from New
Mexico sources with respect to other NAAQS.
    To project future ozone and annual PM2.5 design values,
EPA projected future ozone values based on an average of three design
value periods which include the years 2003-2007 (i.e., design values
for 2003-2005, 2004-2006, and 2005-2007). The average of the three
design values creates a ``5-year weighted average'' value. The 5-year
weighted average values were then projected to the future years that
were analyzed for the Transport Rule Proposal.15 16 EPA used
the 5-year weighted average concentrations to project concentrations
anticipated in 2012 to determine which monitoring sites are expected to
be nonattainment in this future year. EPA also projected 2012 design
values based on each of the three-year periods (i.e., 2003-2005, 2004-
2006, and 2005-2007). The highest projection is referred to as the
``maximum design value'' and gives an indication of potential
variability in future projections due to differences in actual
meteorology and emissions from what was modeled.
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    \15\ See, the Transport Rule Proposal at 75 FR 45210 (August 2,
2010).
    \16\ Additional information concerning these weighted averages
is provided in the docket in the Timin Memo.
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    EPA identified those sites that are projected to be attainment
based on the 5-year weighted average design value, but that have a
maximum design value (based on a single three-year period) that exceeds
the NAAQS, as maintenance sites because EPA anticipates that there will
be more difficulty in maintaining attainment of the NAAQS at these
locations if there are adverse variations in meteorology or emissions.
These projected maintenance sites are the ones that EPA has used to
determine if emissions from New Mexico sources potentially interfere
with maintenance of the 1997 8-hour ozone NAAQS and 1997 annual
PM2.5 NAAQS in other states in this action.
    From the modeling analyses conducted for the Transport Rule
Proposal, EPA identified the following maintenance sites or receptors
for the 1997 8-hour ozone NAAQS: Several sites in the Dallas-Ft.Worth
(DFW) area; several sites in the Houston/Galveston/Brazoria (Houston)
area; and other more distant sites in Georgia, Pennsylvania, New York
and Connecticut.\17\ For assessing New Mexico's potential for impacts
on maintenance receptors, the DFW and Houston areas seem to have the
highest probability of potential impact from New Mexico emissions. For
the modeling analysis conducted for states not included in the
Transport Rule Proposal (i.e., states not included fully in the 12 km
Transport Rule Proposal modeling domain), EPA identified several
maintenance sites for the 1997 8-hour ozone NAAQS in southern and
central California using available 36 km modeling.\18\ The 12 km
Transport Rule Proposal modeling domain extends from Texas northward to
North Dakota and eastward from the Rocky Mountains to the East Coast
and includes 37 states and the District of Columbia. Significantly,
EPA's analysis did not identify any monitor sites in the states that
border New Mexico (Texas, Arizona, Colorado, Utah, and Oklahoma), other
than the noted Texas areas, as maintenance sites in the Transport Rule
Proposal.
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    \17\ Transport Rule Proposal, 75 FR 45210, (August 2, 2010),
pages 45253-45270, and Timin Memo.
    \18\ The Transport Rule Proposal identifies nonattainment and
maintenance receptors in the Eastern U.S. It does not include
modeling results for the West. The Timin Memo documents further
evaluation of the 2012 modeling to identify nonattainment and
maintenance receptors in the West.
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    For the annual PM2.5 NAAQS, EPA identified the following
sites as maintenance receptors: A site in Cook County, Illinois in the
Chicago area; a site in Harris County, Texas, in the Houston/Galveston/
Brazoria area; and two sites in southern California. As part of the
Transport Rule Proposal, EPA did not evaluate nonattainment receptors
for the 1997 24-hour PM2.5 NAAQS because there were no
violations of the standard in portions of the U.S. covered by the 12 km
grid, which consists of the continental U.S. east of the Rockies.\19\
In fact, based on recent monitoring data (2007-2009 design values that
are under final EPA review), the highest 24-hour PM2.5
design value in the 47 states of the continental U.S. (not including
California) is 50 [mu]g/m\3\, which is well below the level of the 1997
24-hour PM2.5 NAAQS of 65 [mu]g/m\3\.\20\ Therefore, outside
of California, there are no areas that we would expect to have
difficulty in maintaining the 1997 24-hour PM2.5 NAAQS. We
address the potential for interference with maintenance in California
for the 1997 24-hour PM2.5 NAAQS later in this notice.
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    \19\ Id., EPA did not calculate model projections for the 24-
hour PM2.5 NAAQS in the 36km modeling domain.
    \20\ Data undergoing review from EPA's Air Quality System which
is EPA's repository of ambient air quality data. (http://
www.epa.gov/ttn/airs/airsaqs/).
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    EPA has evaluated available analyses and conducted additional
analyses for each of these identified maintenance sites that may be
potentially impacted by emissions from sources in New Mexico. Using the
same proposed

screening thresholds for analyzing a state's impacts on another state's
maintenance sites that are used in the Transport Rule Proposal, we have
determined that emissions from New Mexico do not have a large enough
impact on any of these identified maintenance sites to interfere with
maintenance.\21\ For the reasons discussed below, EPA has determined
that emissions from New Mexico do not interfere with maintenance of
these NAAQS in any other state.
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    \21\ Transport Rule Proposal, 75 FR 45210 (August 2, 2010),
pages 45253-45270. The Transport Rule Proposal included proposed
screening thresholds, using 1% of the NAAQS, for determining if a
State should be evaluated for emission reductions from the Transport
Rule. The proposed thresholds were 0.15 [mu]g/m\3\ or more
contribution to annual PM2.5, 0.35 [mu]g/m\3\ or more
contribution to the 1997 24-hour PM2.5 NAAQS, and 0.8 ppb
or more contribution to the 1997 8-hour ozone NAAQS for States which
contribute to nonattainment or maintenance sites in another state.
In this notice, we are using the same 1% contribution thresholds in
this notice of 0.15 [mu]g/m\3\ for the annual PM2.5
NAAQS, 0.8 ppb or more for the 1997 8-hour ozone NAAQS. We are
proposing a similar 1% threshold of 0.65 [mu]g/m\3\ or more for the
1997 24-hour PM2.5 NAAQS.
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Ozone Interfere With Maintenance Evaluation
    EPA evaluated whether emissions from sources in New Mexico could
interfere with maintenance of the 1997 8-hour ozone NAAQS in other
states by considering the potential impacts of such sources on
projected maintenance sites in California, Texas, and points much
further to the east. As discussed in more detail in the Technical
Support Document (TSD) for this action, EPA concluded that such impacts
were most likely to be from New Mexico sources to the Houston and DFW
areas and that even those impacts are very small and below the level
EPA considered the initial threshold for further evaluation in the
Transport Rule Proposal.
    EPA did not separately determine the impacts of New Mexico's
emissions on other States as part of the Transport Rule Proposal
analysis because New Mexico was partially outside the 12 kilometer
grid. Other modeling was available to evaluate the impact of New
Mexico's emissions on the 8-hour ozone maintenance sites that EPA
identified in the Houston and DFW areas. EPA has conducted a modeling
estimate of impacts from New Mexico's emissions using the Central
Regional Air Planning Association (CENRAP) modeling of 2002 emissions
and meteorology.\22\ The CENRAP modeling that EPA utilized was an
earlier version of the CENRAP modeling that a number of states
submitted as part of their Regional Haze State Implementation Plan
submittals and is currently being reviewed by EPA. EPA's source
apportionment CENRAP modeling for the 8-hour ozone NAAQS was conducted
in 2006 to help provide New Mexico and other states with a technical
analysis for the 110(a)(2)(D) SIP submissions.
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    \22\ Appendix G of New Mexico's SIP submittal for
110(a)(2)(d)(i), ``110(a)(2)(d)(i) Modeling Technical Support
Document''.
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    As discussed above, the CENRAP modeling evaluated New Mexico's
impact based on emission and meteorological conditions in 2002. For the
reasons discussed below, EPA believes that this modeling is in fact a
more conservative approach to evaluate the potential for impacts on
other states since it uses a 2002 inventory rather than a 2010 or 2012
emission inventory. The 2002 analysis would include more emissions
within the modeling domain because of decrease in emissions after 2002
due to federal measures (such as fleet turnover and cleaner vehicles)
and local reductions in DFW, Houston, and other parts of the modeling
grid.
    As mentioned previously, the evaluation was based on an earlier
version of the model. Source apportionment results are not available
for the final version of the model. If results were available, we do
not expect them to be significantly different than the earlier version
and any differences would be more than offset by the conservative
nature of using the 2002 emissions.
    EPA analyzed source apportionment modeling with the 2002 based
CENRAP modeling and concluded that maximum impacts from the emissions
of New Mexico sources would be 0.2% of the NAAQS in the Dallas/Ft.
Worth area and 0.4% of the NAAQS in the Houston area, which are less
than the one percent of the NAAQS screening threshold (0.8 parts per
billion) which EPA used in the Transport Rule Proposal to identify
states for further analysis and the threshold that we are proposing for
our determination. The methodology EPA used in the Transport Rule
Proposal to determine if a state's emissions exceeded the one percent
of the NAAQS considered the average impact of a state on a downwind
monitoring site in another state. Comparing the maximum impacts shown
by the CENRAP modeling to the Transport Rule Proposal screening
threshold is a conservative approach, because the average impact over
all exceedance days at sites in DFW or Houston would be lower.
Furthermore, EPA considers the CENRAP modeling analysis conservative
because it relies on 2002 emission inventory levels, whereas additional
emission reductions have occurred in New Mexico and throughout the
modeling domain due to fleet turnover and other measures to reduce air
pollution between 2002 and 2010 that would result in lower overall
pollution levels if taken into account. EPA believes that using the
existing CENRAP analysis provides a conservative basis for concluding
that emissions from New Mexico do not have a substantial impact at 1997
8-hour ozone NAAQS maintenance receptors outside the state.
    In addition, EPA has reviewed other available information
concerning the cause of higher ozone concentration levels in the DFW
and Houston areas, and this further confirms that when these two areas
experience elevated ozone levels, the meteorological patterns only
rarely trace the origins of these air masses to the New Mexico
area.\23\ Because available evidence indicates that New Mexico
emissions are not impacting ozone levels in the DFW and Houston areas
to a degree that constitutes interference with maintenance, it is
improbable that New Mexico emissions would have such impacts at other
identified maintenance sites much farther to the east. EPA believes
that the only other identified maintenance sites for 1997 8-hour ozone
NAAQS that might be impacted by New Mexico sources are in southern and
central California. As further discussed in the TSD for this notice,
however, EPA has concluded that the meteorological patterns (e.g.,
prevailing winds and meteorology that occur when ozone exceedances
occur) do not transport emissions from New Mexico to California when
California has elevated ozone levels, and that the relatively long
distance and the intervening mountainous topography further support
this conclusion.
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    \23\ Further details are included in the Modeling TSD Memorandum
for this notice.
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PM2.5 Interfere With Maintenance Evaluation
    EPA evaluated whether emissions from sources in New Mexico could
interfere with maintenance in other states by considering the potential
impacts of such sources on projected maintenance receptors in Illinois,
California, and Texas. As discussed in more detail in the TSD for this
action, EPA concluded that such impacts were most likely to be from New
Mexico sources to the Houston area, and that those impacts are shown to
be very small.
    For the 1997 annual PM2.5 NAAQS site located in the
Chicago area, previous EPA modeling developed for the 2004 CAIR
proposal indicated that

impacts from New Mexico's emissions was 0.02 [mu]g/m\3\,\24\ which is
well below the one percent of the NAAQS (i.e., (0.15 [mu]g/m\3\))
threshold that EPA has proposed as the initial threshold for
interference with maintenance in the Transport Rule Proposal for the
1997 annual PM2.5 NAAQS. The CAIR proposal modeling used a
2010 future year assessment versus the 2012 year used in the Transport
Rule Proposal, but EPA believes that the emissions would be similar and
that the 2010 analysis would actually have included somewhat more
emissions within the modeling domain because it included two fewer
years of reductions from federal measures (e.g., fleet turnover). In
summary, the results of analysis using 2010 would be expected to be
similar to but slightly more conservative than would be expected for
2012. Therefore, we believe the 2004 CAIR modeling adequately
demonstrates that New Mexico's emissions do not interfere with
maintenance in the Chicago area.
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    \24\ EPA's ``Technical Support Document for the Interstate Air
Quality Rule Air Quality Modeling Analyses Appendix H,
PM2.5 Contributions to Downwind Nonattainment Counties in
2010'', January 2004.
---------------------------------------------------------------------------

    EPA did not separately calculate the impact of New Mexico's
emissions on the Houston area as part of the CAIR modeling or in the
Transport Rule Proposal modeling, but EPA believes that one can infer
from New Mexico's extremely small impact on other areas that New
Mexico's impact on the Houston area would also be less than one percent
of the NAAQS. The only modeling available that provided source
apportionment for annual PM2.5 values is the CAIR proposal
modeling. The CAIR source apportionment results that would be expected
to most closely match Houston from a transport phenomena perspective
are the results for potential impacts on St. Louis. St. Louis is
helpful for comparison because, while not the same direction from New
Mexico it is the closest area evaluated in the CAIR proposal modeling
that is to the east (in the same general transport direction) and at a
similar distance from New Mexico as Houston.
    For the St. Louis area, the CAIR proposal modeling indicated that a
maximum impact from New Mexico's emissions of 0.02 [mu]g/m\3\, which is
well below the 1% of the NAAQS screening threshold. The majority of the
emissions of PM2.5 and PM2.5 precursors from New
Mexico sources emanate from either the Albuquerque area or from points
father west, so it is a useful point from which to evaluate the
relative distances, The distance from Albuquerque to St. Louis,
Missouri is approximately 920 miles and the distance from Albuquerque
to Houston is about 750 miles, which is about 81.5% of the distance
from Albuquerque to St. Louis.\25\ Even if one conservatively assumed
that New Mexico emissions had twice the impact on Houston that EPA
determined they do on St Louis due to the shorter transport distances,
New Mexico's impact on Houston would still be significantly below the
1% of the NAAQS threshold in the Transport Proposal. Given that the
difference in distances is only 18.5%, this is a conservative analysis
that would indicate no significant impacts would be expected from New
Mexico on sites in Houston, Texas.
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    \25\ TSD. EPA believes that such a comparison is instructive
because the majority of relevant New Mexico emissions occur from
sources or activities located in the Albuquerque metropolitan area,
or in areas further to the west. Even if measured from the New
Mexico state border to St. Louis and Houston, however, the
proportional impact would presumably be comparable.
---------------------------------------------------------------------------

    Also, the relative amounts of emissions in New Mexico, when
compared to the emissions in Texas, support the conclusion that New
Mexico emissions do not interfere with maintenance in areas in Texas.
Using databases developed in connection with the Regional Haze (RH)
program and submitted with the RH SIPs, the Texas emissions of
SO2 are approximately 18 times larger than New Mexico's, the
NOX emissions are approximately 5 times greater than New
Mexico's, the fine particulate matter emissions are 12 times greater
than New Mexico's and the coarse particulate matter is 5.6 times
greater than New Mexico's emissions. The Transport Rule Proposal
modeling information also includes emission summaries that indicate
that Texas's emissions are 1,338,429 tpy of NOX and 639,505
tpy of SO2 whereas New Mexico's emissions are 240,892 tpy of
NOX and 24,930 tpy of SO2. Both sets of data
indicate that New Mexico's emissions are much lower than Texas's
emissions of PM2.5 precursors. Moreover, most of the sources
of PM2.5 precursor emissions in Texas are much closer to the
maintenance receptor in Houston, and therefore less dispersion of the
pollutants occurs, so Texas's own PM2.5 and PM2.5
precursors will have a much larger impact on PM2.5 levels in
Houston.
    In addition, the Texas Commission on Environmental Quality (TCEQ)
and several researchers have conducted research into the likely causes
of elevated annual and 24-hour PM2.5 monitoring values in
the Houston area. TCEQ and the researcher's analyses do not indicate
that emissions from New Mexico impact Houston to a degree to raise a
concern for purposes of the 1997 PM2.5 NAAQS. These analyses
indicate that meteorological patterns are transporting air masses from
other directions (i.e., not from the direction of New Mexico) when
Houston area sites are monitoring elevated PM2.5 levels that
have the greatest impact on the annual DV.\26\ As discussed further in
the TSD, distance between the emission sources and the maintenance
receptors and meteorological patterns during times of elevated
pollution levels in Chicago and Houston also support the conclusion
that New Mexico's emissions do not interfere with maintenance of the
NAAQS in these areas. In summary, considering the available evidence,
EPA concludes that New Mexico's emissions do not interfere with
maintenance of the 1997 PM2.5 NAAQS in Houston area.
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    \26\ ``Source Apportionment for PM2.5 at Houston
Clinton Drive'', David W. Sullivan, as The University of Texas at
Austin Center for Energy & Environmental Research and Richard Tropp,
University of Nevada Reno Desert Research Institute, TEXAQS II
Workshop May 29, 2007 and TCEQ Fact Sheet ``Harris County/Clinton
Drive 1997 Annual Fine Particulate Matter (PM2.5)''
November 2009.
---------------------------------------------------------------------------

    EPA also reviewed the potential for emissions from New Mexico
sources to impact other areas with identified maintenance sites. The
other such areas are located in California. As further discussed in the
TSD, EPA concludes that New Mexico sources are unlikely to have such
impacts given the geographic location of these areas and the
meteorological patterns that prevail in the western United States. With
respect to the 1997 PM2.5 24-hour standard of 65 [mu]g/m\3\,
the other identified maintenance sites that New Mexico sources might
impact are located in California. EPA has evaluated conceptual model
documents and field study reports that indicate that transport patterns
when elevated PM2.5 occurs in areas of California, the
meteorological patterns are not such that transport of emissions from
New Mexico to California is occurring to a degree to raise a
concern.\27\ EPA believes that it is rare for meteorological patterns
to occur that would transport emissions from New Mexico sources in such
a way that they would impact California's pollution levels, and that
the relatively long distance and the intervening mountainous topography
further support that transport of emissions from New Mexico is
unlikely. Therefore,

available information indicates that emissions from sources in New
Mexico do not impact areas of concern in California to the degree that
would interfere with maintenance of the 1997 NAAQS in those areas.
---------------------------------------------------------------------------

    \27\ ``Historical Meteorological Analysis in Support of the 2003
San Joaquin Valley PM10 State Implementation Plan'',
Shawn R. Ferreria, Air Quality Meteorologist/Atmospheric Scientist
And Evan M. Shipp, Supervising Air Quality Meteorologist San Joaquin
Valley Air Pollution Control District January 24, 2005.
---------------------------------------------------------------------------

b. Interference With PSD Measures in Other States
    The third element of section 110(a)(2)(D)(i) requires a SIP to
contain adequate provisions prohibiting emissions that interfere with
any other state's required measures to prevent significant
deterioration of its air quality. EPA's 2006 Guidance made
recommendations for SIP submissions to meet this requirement with
respect to both the 1997 8-hour ozone NAAQS and the 1997
PM2.5 NAAQS.
    EPA believes that New Mexico's submission is consistent with the
2006 Guidance, when considered in conjunction with other PSD program
revisions that EPA is proposing to approve in this action. The State's
submittal indicates in Section C, ``Impact on Prevention of Significant
Deterioration (PSD),'' that the State's SIP provisions include an EPA-
approved PSD program applicable to all regulated pollutants. New
Mexico's regulations for its PSD program were approved by EPA and made
part of the SIP on February 27, 1987 (52 FR 5694) at 52.1620/
52.1640(c)(37), effective March 30, 1987. On September 5, 2007, EPA
approved the New Mexico's PSD revisions incorporating EPA's December
31, 2002, NSR Reforms into the State's regulations (72 FR 50879), which
also recognized volatile organic compounds as a precursor for ozone.
    Consistent with EPA's November 29, 2005, Phase 2 rule for the 1997
8-hour ozone NAAQS (70 FR 71612), the State submitted a SIP revision to
modify its PSD provisions to address NOX as an ozone
precursor (20.2.74 NMAC). These revisions are further discussed below.
EPA believes that the PSD revision for the 1997 8-hour ozone NAAQS that
make NOX a precursor for ozone for PSD purposes, taken
together with the PSD SIP and the interstate transport SIP, satisfies
the requirements of the third element of section 110(a)(2)(D)(i) for
the 1997 8-hour ozone NAAQS, i.e., there will be no interference with
any other state's required PSD measures.
    For the PM2.5 NAAQS, New Mexico stated in its section
110(a)(2)(D)(i) submission that the State would follow EPA's interim
guidance on use of PM10 as a surrogate for PM2.5
as recommended in the 2006 Guidance. The New Mexico Environment
Department (NMED) clarified its interpretation of the New Mexico
Interstate Transport SIP for Implementation of the PM2.5
NAAQS in a July 23, 2010 letter to EPA. In the letter NMED stated that:
(1) It does not use PM10 as a surrogate for PM2.5
in its permitting programs, (2) it requires that applicants include
PM2.5 modeling and emissions in their PSD and minor source
permit applications, and (3) the record for the Department's permitting
decision includes an explanation of how PM2.5 emissions have
been appropriately analyzed and estimated. The NMED letter is included
in the electronic docket for this action. Because of clarifications to
EPA guidance, EPA believes that New Mexico's approach is appropriate.
    On the basis of the data and analysis presented above, EPA is
proposing to determine that the New Mexico SIP as revised with respect
to PSD program requirements, satisfactorily addresses the requirements
of elements (2) and (3) of section 110(a)(2)(D)(i) for the 1997 8-hour
ozone NAAQS and 1997 PM2.5 NAAQS.

C. New Mexico PSD SIP

    The New Mexico Environment Department (NMED) made a SIP submission
to meet requirements of the 8-hour ozone NAAQS by incorporating
NOX as a precursor for ozone. The submitted PSD SIP
revisions adding NOX as a precursor for ozone include the
following:
     The definition of ``Major stationary source'' states that
a major source that is major for NOX is considered major for
ozone (<IP_ADDRESS>.AF.(4) NMAC);
     The definition of ``Regulated new source review
pollutant'' specifically identifies NOX as an ozone
precursor (<IP_ADDRESS>.AR.(1) NMAC);
     When referring to a net emissions increase or potential to
emit, a rate of emissions that equals or exceeds 40 tons per year of
NOX is significant (<IP_ADDRESS>2 NMAC, Table 2, Significant
Emission Rates); and
     Any net emissions increase of 100 tons per year of
NOX subject to PSD would require an ambient impact analysis,
including the gathering of ambient air quality data (<IP_ADDRESS>3 NMAC,
Table 3, Footnote b).
    For the 8-hour ozone NAAQS, the revision to <IP_ADDRESS>.AF meets the
federal definition in 40 CFR 51.166(b)(1) to identify a major source of
nitrogen oxides as a major source for ozone. The revision to
<IP_ADDRESS>.AR NMAC meets the federal definition in 40 CFR 51.166(b)(49)
for NOX as an ozone precursor. The revision to <IP_ADDRESS>2
NMAC Table 2 meets the federal requirement for significant emission
rate for NOX emissions in 40 CFR 51.166(b)(23)(i). The
revision to <IP_ADDRESS>3 NMAC, Table 3 meets the federal requirement for
ambient air impact analysis for ozone precursors under the footnote for
40 CFR 166(i)(5)(i)(e). Thus, EPA is proposing approval of these
revisions as meeting the requirements of CAA section 110 and 40 CFR
51.166 for establishing NOX emissions as a precursor for
ozone.
    The State's SIP submittal also contains revisions to Parts 20.2.2
NMAC, Definitions; and 20.2.79 NMAC, Permits--Nonattainment areas.
These two submitted revisions are severable from each other, are
severable from the submitted revisions to 20.2.74 NMAC discussed above,
and are severable from the Transport SIP requirements addressed in this
proposed action. The EPA is still reviewing the approvability of the
submitted revisions to Parts 20.2.2 NMAC and 20.2.79 NMAC; therefore,
we are not proposing to take action on those revisions in this proposed
rulemaking. We intend to act on those revisions in a future rulemaking.
EPA wishes to note that it approved New Mexico's Nonattainment New
Source Review SIP on February 8, 2002 (67 FR 6147). In that same
action, EPA approved the NOX waiver for the Sunland Park 1-
hour ozone nonattainment area.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely proposes to approve state law as
meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described

in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: August 20, 2010.
Samuel Coleman,
Acting Regional Administrator, Region 6.
[FR Doc. 2010-21384 Filed 8-26-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28509-28510]
[FR Doc No: 2014-11427]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9910-98-Region-1]

Notice of Availability of Draft Npdes General Permits Mag250000
and Nhg250000 for Discharges of Non-Contact Cooling Water in
Massachusetts and New Hampshire: the Non-Contact Cooling Water General
Permit (NCCW GP)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Availability of Draft Npdes General Permits MAG250000
and NHG250000.

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SUMMARY: The Director of the Office of Ecosystem Protection, EPA--
Region 1, is providing a notice of availability of draft National
Pollutant Discharge Elimination System (NPDES) general permits for non-
contact cooling water discharges to certain waters of the Commonwealth
of Massachusetts and the State of New Hampshire. These General Permits
replace the Non-contact Cooling Water General Permit (NCCW GP) that
expired on July 31, 2013.

DATES: Comment on the draft general permits must be received on or
before June 16, 2014.
    Public Hearing Information: EPA will hold a public hearing, if
necessary, in accordance with 40 CFR 124.12 and will provide interested
parties with the opportunity to provide written and/or oral comments
for the official administrative record.

ADDRESSES: Comments on the draft NCCW GP shall be submitted by one of
the following methods:
    (1) Email<EMAIL_ADDRESS>or
    (2) Mail: Suzanne Warner, US EPA--Region 1, 5 Post Office Square--
Suite 100, Mail Code OEP06-4, Boston, MA 02109-3912.
    No facsimiles (faxes) will be accepted.
    The draft permit is based on an administrative record available for
public review at EPA-Region 1, Office of Ecosystem Protection, 5 Post
Office Square-Suite 100, Boston, Massachusetts 02109-3912. A reasonable
fee may be charged for copying requests. The fact sheet for the draft
general permit sets forth principal facts and the significant factual,
legal, methodological and policy questions considered in the
development of the draft permit and is available upon request. A brief
summary is provided as supplementary information below.

FOR FURTHER INFORMATION CONTACT: Additional information concerning the
draft NCCW GP may be obtained between the hours of 9 a.m. and 5 p.m.
Monday through Friday, excluding holidays, from Suzanne Warner, Office
of Ecosystem Protection, 5 Post Office Square--Suite 100, Boston, MA
02109-3912; telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    EPA is proposing to reissue two draft general permits for non-
contact cooling water discharges from facilities located in
Massachusetts and New Hampshire. While the draft general permits are
two distinct permits, for convenience, EPA has grouped them together in
a single document and has provided a single fact sheet for the two
draft general permits. This document refers to the draft general
``permit'' in the singular. The draft general permit, appendices and
fact sheet are available at: http://www.epa.gov/region1/npdes/nccwgp.html.
    The draft general permit establishes Notice of Intent (NOI)
requirements, effluent limitations, standards, prohibitions, and in
some cases best technology available (BTA) requirements for facilities
that discharge small amounts of non-contact cooling water in
Massachusetts and New Hampshire.
    The draft permit includes effluent limitations based on best
professional judgment (BPJ) and water quality considerations. The
effluent limits established in the draft permit assure that the surface
water quality standards of the receiving water are maintained and/or
attained.
    Non-contact cooling water is water used for cooling that does not
come into contact with any raw material, intermediate product, waste
product, or finished product; the only anticipated pollutant is heat.
Discharges composed of anything other than non-contact cooling water
will not be granted coverage under this general permit. Those
dischargers must seek coverage

under an individual permit or an appropriate general permit.
    The permit also contains BTA requirements for cooling water intake
structures for facilities that withdraw less than 1 MGD of surface
water for non-contact cooling in order to ensure source water
protection. For facilities that use groundwater or municipal drinking
water for non-contact cooling, the permit establishes effluent
limitations and/or additional monitoring for expected constituents
(metals and residual chlorine, respectively).

Other Legal Requirements

Endangered Species Act (ESA)

    EPA has updated the provisions and necessary actions and
documentation related to potential impacts to endangered species from
facilities seeking coverage under the NCCW GP. EPA has requested
concurrence from the appropriate federal services (U.S. Fish and
Wildlife Service and National Marine Fisheries Service) in connection
with this draft permit.

National Historic Preservation Act (NHPA)

    In accordance with NHPA, EPA has established provisions and
documentation requirements for facilities seeking coverage under the
NCCW GP to ensure that discharges or actions taken under this permit
will not adversely affect historic properties and places. EPA has
requested concurrence from the appropriate state historic preservation
officers (SHPOs) with the draft permit.

    Authority:  This action is being taken under the Clean Water
Act, 33 U.S.C. 1251 et seq.

    Dated: May 8, 2014.
Deborah Szaro,
Deputy Regional Administrator.
[FR Doc. 2014-11427 Filed 5-15-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32218-32219]
[FR Doc No: 2011-13821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0433] (formerly FDA-2003D-0474)

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Revised Guidance for Industry on ``Studies To Evaluate the Safety
of Residues of Veterinary Drugs in Human Food: General Approach To
Establish a Microbiological ADI'' (VICH GL-36(R)); Request for
Comments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft revised guidance for industry
(159) entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Establish a
Microbiological ADI'' (VICH GL36(R)). This draft revised guidance,
which updates a final guidance on the same topic for which a notice of
availability was published in the Federal Register of February 11,
2005, has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This draft revised VICH
guidance was revised to include Appendix D--Supplement to Section 2
Regarding the Determination of the Fraction of Oral Dose Available to
Microorganisms. This draft VICH guidance document is intended to
provide guidance for assessing the human food safety of residues from
veterinary antimicrobial drugs with regard to effects on the human
intestinal flora.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft revised guidance before it begins work on the final version of
the revised guidance, submit either electronic or written comments on
the draft revised guidance by August 2, 2011.

ADDRESSES: Submit written requests for single copies of the draft
revised guidance to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft revised guidance
document.
    Submit electronic comments on the draft revised guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Silvia A. Pineiro, Center for
Veterinary Medicine, (HFV-157), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies in
different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use (ICH) for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH) is a parallel
initiative for veterinary medicinal products. The VICH is concerned
with developing harmonized technical requirements for the approval of
veterinary medicinal products in the European Union, Japan, and the
United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also

participates in the VICH Steering Committee meetings.

II. Guidance on Microbiological Acceptable Daily Intake

    In February 2011, the VICH Steering Committee agreed that a draft
revised guidance entitled ``Studies to Evaluate the Safety of Residues
of Veterinary Drugs in Human Food: General Approach to Establish a
Microbiological ADI (Revision)'' (VICH GL36(R)) should be made
available for public comment. This draft revised VICH guidance is a
revision of a final guidance on the same topic for which a notice of
availability was published in the Federal Register of February 11, 2005
(70 FR 7278). This draft revised guidance was revised to include
Appendix D-Supplement to Section 2 Regarding the Determination of the
Fraction of Oral Dose Available to Microorganisms. This VICH guidance
provides guidance for assessing the human food safety of residues from
veterinary antimicrobial drugs with regard to effects on the human
intestinal flora. The objectives of this guidance are to: (1) Outline
the recommended steps in determining the need for establishing a
microbiological acceptable daily intake (ADI); (2) recommend test
systems and methods for determining no-observable adverse effect
concentrations (NOAECs) and no-observable adverse effect levels
(NOAELs) for the endpoints of health concern; and (3) recommend a
procedure to derive a microbiological ADI. It is recognized that
different tests may be useful. The experience gained with the
recommended tests may result in future modifications to this guidance
and its recommendations.
    The draft revised guidance is a product of the Quality Expert
Working Group of the VICH. Comments about this draft will be considered
by FDA and the VICH Quality Expert Working Group.

III. Paperwork Reduction Act of 1995

    This draft revised guidance refers to previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in this revised guidance have
been approved under OMB control number 0910-0032.

IV. Significance of Guidance

    This draft revised guidance, developed under the VICH process, has
been revised to conform to FDA's good guidance practices regulation (21
CFR 10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``must,'' ``shall,'' ``require'' or
``requirement'' unless FDA is using these words to describe a statutory
or regulatory requirement.
    This draft revised VICH guidance when finalized, will represent the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of applicable statutes and regulations.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft revised
guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13821 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

EPA Registration Division contact: Tony Kish,<PHONE_NUMBER>

I. Arysta LifeScience North America, LLC

9F7567

Summary of Petitions

	EPA has received a pesticide petition (9F7567) from (15401 Weston
Parkway, Suite 150, Cary, North Carolina 27513) proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180  by establishing a tolerance
for residues of Fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dih
ydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dih
ydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime] in or on the raw
agricultural commodities [wheat grain at 0.09 ppm; wheat bran at 0.2
ppm; wheat forage at 7 ppm; wheat hay at 17 ppm; wheat straw at 11 ppm;
aspirated grain fractions at 15 ppm; sweet corn (kernels plus cob with
husks removed) at 0.02 ppm; sweet corn forage at 13 ppm; sweet corn
stover at 10 ppm; and meat byproducts (cattle, goat, horse sheep) at 0.2
ppm.  EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

. The metabolism of fluoxastrobin in plants is adequately understood.
Studies have been conducted to delineate the metabolism of radiolabeled
fluoxastrobin in peanut, tomato, spring wheat, and various
representative rotational crops, all showing similar results. The
residue of concern is parent fluoxastrobin (sum of E and Z isomers).

. Adequate analytical methodology using HPLC/MS/MS detection is
available for enforcement purposes.

. Magnitude of residue and processing trials were conducted on wheat and
sweet corn.  Therefore, the data support the proposed tolerances.

B. Toxicological Profile

.  Oral and dermal LD50 values were >2000 mg/kg bw.  Inhalation LC50
values were >4998 mg/m3 air.  Fluoxastrobin technical was not irritating
to rabbit skin, was moderately irritating to eyes in rabbits and was
non-sensitizing dermally in the Magnusson/Kligman maximization test in
guinea pigs.  Acute toxicity studies for fluoxastrobin technical support
an overall toxicity Category III.

.  Several genotoxicity tests were conducted to test for point-mutagenic
activity, chromosome aberration in vitro and in vivo, and for DNA
repair.  All tests conducted were negative, indicating no evidence of
mutagenic or genotoxic potential.

.  An oral developmental toxicity study in rat did not reveal any
evidence of teratogenic potential.  The maternal NOAEL was 300 mg/kg and
the developmental NOAEL was 1000 mg/kg bw/day.  An oral developmental
toxicity study in rabbits demonstrated a maternal NOAEL of 25 mg/kg
bw/day, a developmental NOAEL of 100 mg/kg bw/day and did not reveal any
teratogenic potential.  A two-generation study in rats, with a parental
toxicity NOAEL of 73.7 mg/kg bw/day for males and 86.7 mg/kg bw/day for
females, did not reveal evidence of a primary reproductive toxicity
potential.  The reproductive NOAEL was 763.6 mg/kg bw/day for males and
806.5 mg/kg bw/day in females.

A subchronic toxicity feeding study with rats over 90 days demonstrated
a NOAEL of 7.3 and 18.3 mg/kg bw/day for males and females,
respectively, based on reduced body weights and alterations in several
urinary tract related clinical chemistry parameters, at the higher dose
levels.  In a subchronic feeding study in mice over 14 weeks a NOAEL was
not established based on decreased alanine aminotransferase (ALAT) and
increased absolute and relative liver weights at the low dose level
(21.7 and 35.3 mg/kg bw/day for males and females, respectively).  A
14-week feeding study in dogs demonstrated a NOAEL of 3.0 mg/kg bw/day
based on decreased body weights and food consumption, and liver effects
(enzyme induction, increased liver weights and cytoplasmic change) and
thyroid effects (decreased T3).

.  A 24-month chronic/oncogenicity feeding study in rats demonstrated a
NOAEL of 53.0 and 35.2 mg/kg bw/day for males and females, respectively.
 An oncogenicity study in the mouse revealed a NOAEL of 18.5 and 29.5
mg/kg bw/day for males and females, respectively based on liver effects.
 There was no indication in the rat or mouse for an oncogenic effect of
fluoxastrobin.  A one-year feeding study with dogs demonstrated a NOAEL
of 1.7 and 1.5 mg/kg bw/day for males and females, respectively based on
decreased body weights and slight  liver effects (increased alkaline
phosphatase (Aph) and liver weights).

. Metabolism and pharmacokinetic studies in the rats, lactating goats
and laying hens demonstrate that fluoxastrobin residues are rapidly
absorbed, metabolized and eliminated.  There was no evidence of
accumulation of residues in any tissues or organs.  The metabolic
pattern was always complex and numerous metabolites were identified.
The main metabolic reactions, however, are very comparable for all
tested animal species and most metabolites were present at low levels.
As per the meat and milk tolerances established in 40 CFR 180.609, the
tolerance expression includes fluoxastrobin (sum of E and Z isomers) and
its phenoxy-hydroxypyrimidine metabolite.

. The residues of concern are fluoxastrobin and its
phenoxy-hydroxypyrimidine metabolite.  This metabolite was investigated
for acute oral toxicity and point mutagenic activity in a bacterial
reverse mutation assay.  The phenoxy-hydroxypyrimidine metabolite did
not show mutagenic activity in the reverse mutation assay and the oral
LD50 was >300<500 mg/kg body weight.

.  There is no evidence to suggest that fluoxastrobin has any primary
endocrine disruptive potential.  Reproductive and developmental findings
provided no evidence of an enhanced sensitivity of the young.

C. Aggregate Exposure

.

.  A chronic dietary analysis was conducted to estimate exposure to
potential fluoxastrobin residues in/on wheat and sweet corn in addition
to all currently proposed and registered crops.  Acute analyses were not
conducted since, as per EPA’s 1/24/05 human health risk assessment,
there was no indication of an adverse effect attributable to a single
dose and therefore an acute reference dose (aRfD) was not established.
Tier I analysis was conducted for the chronic scenario using the
DEEM-FCID( (Exponent, Inc.) software.  Chronic dietary exposure
estimates from potential residues of fluoxastrobin for the US Population
was 17.8% of the chronic RfD.  The sub-population with the highest
exposure was Children 1-2 with 40.7% of the chronic RfD used. Tier I
assessments use tolerance residue values and 100% crop treated.  These
can be considered very conservative estimates of exposure.

. EPA has previously demonstrated (as per EPA’s 1/24/05 human health
risk assessment) that the use on turf is associated with the highest
potential impacts to surface water using PRZM/EXAMS, with the average
concentration in surface water of 28 ppb.  Groundwater concentrations
have been estimated to be <1 ppb.  Since the application rate on turf (4
applications at 0.55 lb ai/A) is higher than the rates on wheat (2
applications at 0.12 lb ai/A) and sweet corn (4 applications at 0.12 lb
ai/A), there is no need to evaluate potential drinking water impacts for
the proposed use on wheat and sweet corn. Therefore, the worst-case
assumption is 28 ppb fluoxastrobin in drinking water.

. [Residential Post-application Exposures: The proposed use on wheat and
sweet corn will not result in residential post-application exposures;
therefore residential post-application exposures are associated only
with adults and children who may contact treated turf. In EPA’s 2005
assessment, MOEs for residential post-application exposures were found
to be greater than 100 for all scenarios.

Aggregate Exposures: Short-term and intermediate-term aggregate
exposures were calculated.  Dietary exposures include the addition of
the wheat and sweet corn uses to all proposed and registered crops and
impacts to drinking water.  Short-term aggregate calculations include
only oral exposures because there is no short-term dermal endpoint.  The
intermediate-term aggregate calculations include both dermal and oral
exposures.  Aggregate MOEs are greater than 100 for adults and children
for both short- and intermediate-term exposure durations.

Aggregate exposures are not calculated for the long-term (i.e., chronic)
because only dietary exposures factor into the long-term scenario.
Therefore, the chronic dietary exposures are the same as the long-term
exposures.

D. Cumulative Effects

Fluoxastrobin is a novel strobilurin analog.  Arysta LifeScience North
America, LLC will submit information, if necessary, for EPA to consider
concerning potential cumulative effects of fluoxastrobin consistent with
the schedule established by EPA at 62 Federal Register 42020 (Aug. 4,
1997) and other EPA publications pursuant to the Food Quality Protection
Act.

E. Safety Determination

. Using the conservative assumptions described above, based on the
completeness and reliability of the toxicity data, it is concluded that
dietary exposure (food and water) from the proposed and registered uses
of fluoxastrobin will utilize at most 17.8% of the reference dose for
the US Population, and is likely to be much less as more realistic data
and models are developed.  EPA generally has no concern for exposures
below 100% of the RfD because the RfD represents the level at or below
which daily dietary (food plus water) exposure over a lifetime will not
pose appreciable risks to human health.  In addition, aggregate (food
and water dietary plus residential) MOEs are greater than 100 for adults
for both short- and intermediate-term exposure durations. Finally, all
handler exposure scenarios also have MOE greater than 100. Therefore,
there is a reasonable certainty that no harm will occur to the US
Population from aggregate exposure to fluoxastrobin.

. Consideration of the toxicology database as described above leads to
no additional concerns for infants and children.  Therefore the FQPA
safety factor can be established at 1X.  Using the conservative exposure
assumptions described in the exposure section above, the margins of
exposure that will result for short- and intermediate-term aggregate
exposure (food plus water plus residential) to residues of fluoxastrobin
are greater than 100 for children. This value is based on a worst-case
aggregate exposure calculation of a child 1-6 who has a background
dietary exposure to potential residues and plays on a maximally treated
lawn.  Therefore, there is a reasonable certainty that no harm will
occur to infants and children from aggregate exposure to residues of
fluoxastrobin.

F. International Tolerances

	Codex maximum residue levels (MRLs) are not yet established for
fluoxastrobin.

 PAGE  1

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