[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Proposed Rules]
[Pages 44001-44005]
[FR Doc No: 2015-18081]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0257; FRL-9931-04-Region 9]

Approval of Air Plans; California; Multiple Districts; Prevention
of Significant Deterioration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing approval of five permitting rules
submitted for inclusion in the California State Implementation Plan
(SIP). The State of California (State) is required under the Clean Air
Act (CAA or Act) to adopt and implement a SIP-approved Prevention of
Significant Deterioration (PSD) permit program. This SIP revision
proposes to incorporate PSD rules for five local California air
districts into the SIP to establish a PSD permit program for pre-
construction review of certain new and modified major stationary
sources in attainment and unclassifiable areas. The local air districts
with PSD rules that are the subject of this proposal are the Feather
River Air Quality Management District (Feather River or FRAQMD), Great
Basin Unified Air Pollution Control District (Great Basin or GBUAPCD),
Butte County Air Quality Management District (Butte or BCAQMD), Santa
Barbara County Air Pollution Control District (Santa Barbara or
SBAPCD), and San Luis Obispo County Air Pollution Control District (San
Luis Obispo or SLOAPCD)--collectively, the Districts. We are soliciting
public comment on this proposal and plan to follow with a final action
after consideration of comments received.

DATES: Any comments must be submitted no later than August 24, 2015.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2015-0257, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the
online instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Lisa Beckham (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
the disclosure of which is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and the EPA will
not know your identity or contact information unless you provide it in
the body of your comment. If you send email directly to the EPA, your
email address will be automatically captured and included as part of
the public comment. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment.
    Docket: The index to the docket for this proposed action is
available electronically at www.regulations.gov, docket number EPA-R09-
OAR-2015-0257, and in hard copy at EPA Region IX, 75 Hawthorne Street,
San Francisco, California. While all documents in the docket are listed
in the index, some information may be publicly available only at the
hard copy location (e.g., copyrighted material), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section below. Due to building security procedures, appointments must
be scheduled at least 48 hours in advance.

FOR FURTHER INFORMATION CONTACT: Lisa Beckham, Permits Office (AIR-3),
U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating these rules?
    B. Do the rules meet the evaluation criteria?
    C. Significant impact levels and significant monitoring
concentrations for PM2.5.
    D. Greenhouse Gases
    E. Transfer of existing permits issued by the EPA
    F. Public comment and proposed action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 identifies the rules on which we are proposing action along
with the dates on which each rule was adopted by the local air district
and submitted to the EPA by the California Air Resources Board (CARB).
On June 1, 2015, CARB requested the withdrawal from its earlier SIP
submittals of these local air district rules the portion of each rule
that incorporates a specific federal PSD rule provision--40 CFR
52.21(b)(49)(v). As such, our proposed approval of these local air
district rules does not include the rules' incorporation by reference
of 40 CFR 52.21(b)(49)(v).

                                            Table 1--Submitted Rules
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            Local agency                   Rule No.             Rule title            Adopted        Submitted
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FRAQMD..............................  10.10               Prevention of                 8/1/2011       4/22/2013
                                                           Significant
                                                           Deterioration.
GBUAPCD.............................  221                 Prevention of                 9/5/2012        2/6/2013
                                                           Significant
                                                           Deterioration (PSD)
                                                           Permit Requirements
                                                           for New Major
                                                           Facilities or Major
                                                           Modifications in
                                                           Attainment or
                                                           Unclassifiable Areas.
BCAQMD..............................  1107                Prevention of                6/28/2012        2/6/2013
                                                           Significant
                                                           Deterioration (PSD)
                                                           Permits.
SBAPCD..............................  810                 Federal Prevention of        6/20/2013       2/10/2014
                                                           Significant
                                                           Deterioration (PSD).
SLOAPCD.............................  220                 Federal Prevention of        1/22/2014       5/13/2014
                                                           Significant
                                                           Deterioration.
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    The submitted rules were found to meet the completeness criteria in
40 CFR part 51, appendix V, which must be met before formal review by
the EPA.

B. Are there other versions of these rules?

    There are no previous versions of the rules in Table 1 in the
California SIP.

C. What is the purpose of the submitted rules?

    Section 110(a) of the CAA requires states to adopt and submit
regulations for the implementation, maintenance and enforcement of the
primary and secondary NAAQS. Specifically, sections 110(a)(2)(C),
110(a)(2)(D)(i)(II), and 110(a)(2)(J) of the Act require such state
plans to meet the applicable requirements of section 165 relating to a
pre-construction permit program for the prevention of significant
deterioration of air quality and visibility protection. The rules
reviewed for this action are intended to implement a pre-construction
PSD permit program as required by section 165 of the CAA for certain
new and modified major stationary sources located in attainment and
unclassifiable areas. Because the State does not currently have a SIP-
approved PSD program within the Districts, the EPA is currently the PSD
permitting authority within these Districts. Approval of the Districts'
PSD rules into the SIP will transfer PSD permitting authority from the
EPA to the Districts. The EPA would then assume the role of overseeing
the Districts' PSD permitting programs, as intended by the CAA.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating these rules?

    The relevant statutory provisions for our review of the submitted
rules include CAA sections 110(a), 110(l), and 165 and part 51, Sec.
51.166 of title 40 of the Code of Federal Regulations (40 CFR 51.166).
Section 110(a) requires, among other things, that SIP rules be
enforceable, while section 110(l) precludes the EPA's approval of SIP
revisions that would interfere with any applicable requirements
concerning attainment and reasonable further progress. Section 165 of
the CAA requires states to adopt a pre-construction permitting program
for certain new and modified major stationary sources located in
attainment areas and unclassifiable areas. 40 CFR 51.166 establishes
the specific requirements for SIP-approved PSD permit programs that
must be met to satisfy the requirements of section 165 of the CAA.

B. Do the rules meet the evaluation criteria?

    With some exclusions and revisions, the Districts' PSD rules
incorporate by reference the EPA's PSD permit program requirements at
40 CFR 52.21, as of particular dates. We generally consider the EPA's
PSD permit program requirements at 40 CFR 52.21 to be consistent with
the criteria for SIP-approved PSD permit programs in 40 CFR 51.166.
However, we conducted a review of each District PSD rule to ensure that
all requirements of 40 CFR 51.166 were met by each such rule. Our
detailed evaluation is available as an attachment to the technical
support document (TSD) for this proposed rulemaking action. We also
reviewed the revisions that the Districts made to the provisions of 40
CFR 52.21 that were incorporated by reference into each rule, such as
revising certain terms and definitions to reflect that the Districts,
rather than the EPA, will be the PSD permitting authority. In addition,
we reviewed revisions made to 40 CFR 51.166 and 40 CFR 52.21 after each
District adopted its PSD rule. Please see the TSD for additional
information. Based on our review of these rules, the underlying
statutes and regulations, and clarifying information that the Districts
provided in letters dated November 13, 2014, November 25, 2014,
December 16, 2014, December 18, 2014, April 8, 2015, and April 15,
2015, we are proposing to find the SIP revision for the Districts' PSD
rules acceptable under CAA sections 110(a), 110(l) and 165 and 40 CFR
51.166.
    The EPA's TSD for this rulemaking action has more information about
these rules, including our evaluation and recommendation to approve
them into the SIP.

C. Significant Impact Levels and Significant Monitoring Concentrations
for PM2.5

    On January 22, 2013, the U.S. Court of Appeals for the District of
Columbia (D.C. Circuit or Court) in Sierra Club v. EPA, 705 F.3d 458,
granted a request from the EPA to vacate and remand to the EPA the
portions of two PSD rules (40 CFR 51.166(k)(2) and 40 CFR 52.21(k)(2))
addressing the significant impact levels (SILs) for PM2.5 so
that the EPA could voluntarily correct an error in these provisions.
The D.C. Circuit also vacated the parts of these two PSD rules (40 CFR
51.166(i)(5)(i)(c) and 40 CFR 52.21(i)(5)(i)(c)) establishing a
PM2.5 significant monitoring concentration (SMC), finding
that the EPA was precluded from using the PM2.5 SMC to
exempt permit applicants from the statutory requirement to compile and
submit preconstruction monitoring data as part of a complete PSD
application. On December 9, 2013, revisions to 40 CFR 51.166 and 52.21
were published in the Federal Register to remove the affected
provisions from the PSD regulations, effective as of that date. 78 FR
73698.

    As Feather River Rule 10.10 incorporates 40 CFR 52.21 by reference
as in effect prior to the D.C. Circuit's decision, the rule
incorporates by reference an earlier version of 40 CFR 52.21 that
contains the PM2.5 SILs \1\ and SMC provisions that were
later vacated by the D.C. Circuit and removed from 40 CFR 52.21 by the
EPA. Accordingly, the EPA requested clarification from Feather River
concerning its interpretation of Rule 10.10 to the extent that it
incorporates by reference these provisions.
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    \1\ The PSD rules submitted by Great Basin, Butte, and San Luis
Obispo specifically excluded the PM2.5 SILs from their
incorporation by reference of 40 CFR 52.21. Santa Barbara's PSD rule
incorporated by reference 40 CFR 52.21 as in effect after the
PM2.5 SILs were vacated by the Court and no longer in
effect, and thus does not include the PM2.5 SILs.
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    Great Basin Rule 221 and Butte Rule 1107 also incorporate 40 CFR
52.21 by reference as in effect prior to January 22, 2013. While these
two District PSD rules specifically exclude the PM2.5 SILs
provisions that were vacated by the D.C. Circuit, they do contain the
PM2.5 SMC provisions that were vacated by the Court and
removed from 40 CFR 52.21 by the EPA.\2\ Accordingly, the EPA requested
clarification from Great Basin and Butte concerning their
interpretation of Rules 221 and 1107, respectively, to the extent they
incorporate by reference these PM2.5 SMC provisions.
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    \2\ San Luis Obispo's PSD rule specifically revised its rule
language concerning the PM2.5 SMC to be consistent with
the Court's decision. Santa Barbara's PSD rule incorporated by
reference 40 CFR 52.21 as in effect after the PM2.5 SMC
was vacated by the Court and no longer in effect, and thus does not
include the PM2.5 SMC.
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    With respect to the PM2.5 SILs, Feather River Rule 10.10
incorporates by reference an earlier version of 40 CFR 52.21 that
contained the PM2.5 SILs provisions that were later vacated
by the D.C. Circuit and removed from 40 CFR 52.21 by the EPA. 40 CFR
52.21(k)(1) requires that a source applying for a new PSD permit
demonstrate that any allowable emission increases from the proposed
source or modification, in conjunction with all other applicable
emissions increases or reductions, will not cause or contribute to a
violation of any NAAQS or any applicable increment. In the preamble to
the 2010 final rule adding the 40 CFR 52.21(k)(2) provision, the EPA
advised that, ``notwithstanding the existence of a SIL, permitting
authorities should determine when it may be appropriate to conclude
that even a de minimis impact will `cause or contribute' to an air
quality problem and to seek remedial action from the proposed new
source or modification.'' Prevention of Significant Deterioration (PSD)
for Particulate Matter Less than 2.5 Micrometers (PM2.5)--
Increments, Significant Impact levels (SILs) and Significant Monitoring
Concentration (SMC), 75 FR 64,864, 64,892 (Oct. 20, 2010). In another
passage of the preamble, the EPA also observed that ``the use of a SIL
may not be appropriate when a substantial portion of any NAAQS or
increment is known to be consumed.'' Id. at 64,894. The D.C. Circuit's
decision in Sierra Club v. EPA held that, contrary to these statements
in the preamble, the text of the (k)(2) provision ``does not give
permitting authorities sufficient discretion to require a cumulative
air quality analysis'' under such circumstances. 705 F.3d at 464.
    Consistent with the Court's decision in Sierra Club v. EPA and the
statements by the EPA in the preamble to the 2010 final rule that are
discussed above, Feather River affirmed in a letter dated December 18,
2014 that it does not interpret Sec.  52.21(k)(2), as incorporated by
reference in Rule 10.10, to preclude FRAQMD from exercising discretion
to determine when it may be appropriate to conclude that an impact
below the PM2.5 SIL values in Sec.  52.21(k)(2) will cause
or contribute to an air quality problem and to seek remedial action
from the proposed new source or modification. Such discretion is
necessary to ensure adherence to the requirement of the Clean Air Act
that a PSD project not cause or contribute to a violation of any NAAQS
or any applicable increment. Based on this interpretation, the District
affirmed in the December 18, 2014 letter that it will not read Sec.
52.21(k)(2), as incorporated by reference in District Rule 10.10, as an
absolute ``safe harbor,'' but will exercise discretion to determine
whether a particular application of the PM2.5 SIL values is
appropriate when a substantial portion of the PM2.5 NAAQS or
increment is known to be consumed. The District confirmed that it
retains the discretion to require additional information from a permit
applicant as needed to assure that the source will not cause or
contribute to a violation of any NAAQS or applicable increment pursuant
to Sec.  52.21(k)(1).
    As noted above, Feather River Rule 10.10, Great Basin Rule 221, and
Butte Rule 1107 also incorporated by reference an earlier version of
the federal regulation at Sec.  52.21(i)(5)(i) that contains the
PM2.5 SMC, which provides that each District may exempt a
proposed major stationary source or major modification from the
requirements of paragraph (m) of this section, with respect to
monitoring for a particular pollutant, if the emissions increase or net
emissions increase is below the applicable SMC. Feather River, Butte,
and Great Basin confirmed in their letters dated December 18, 2014,
April 8, 2015, and April 15, 2015 that this provision, specifically at
Sec.  52.21(i)(5)(i)(c), as incorporated into each rule, provides the
Districts with the discretion to determine whether it is appropriate to
apply the SMC for PM2.5 to exempt a permit applicant from
the requirement to compile and submit preconstruction ambient
monitoring data for PM2.5 as part of a complete PSD
application. Consistent with the D.C. Circuit's decision in Sierra Club
v. EPA vacating the PM2.5 SMC, the Districts affirmed in
their letters dated December 18, 2014, April 8, 2015, and April 15,
2015 that they will not exercise their discretionary authority to use
the PM2.5 SMC in order to exempt PSD permit applicants from
the requirement in Clean Air Act section 165(e)(2) that ambient
monitoring data for PM2.5 be included in applications
subject to the PSD program for PM2.5. Accordingly, the
Districts' APCOs will require all applicants requesting a PSD permit
from the District to submit ambient PM2.5 monitoring data in
accordance with Clean Air Act requirements when proposed increases of
direct PM2.5 emissions or any emissions of a
PM2.5 precursor equal or exceed a significant amount.
    In summary, Feather River has clarified and confirmed that it
intends to implement its PSD program with respect to the
PM2.5 SILs consistent with the Sierra Club Court's decision.
In addition, Feather River, Great Basin, and Butte have clarified and
confirmed that they intend to implement their PSD programs with respect
to the PM2.5 SMC consistent with the Sierra Club Court's
decision. Upon review of the Districts' PSD rules and the
clarifications provided by the Districts, we find that the PSD SIP
submittals including the PM2.5 SILs and SMC language are
approvable and consistent with the Act and the requirements for a PSD
program.

D. Greenhouse Gases

    The PSD permitting requirements applied to greenhouse gases (GHGs)
for the first time on January 2, 2011. 75 FR 17004 (Apr. 2, 2010). On
June 3, 2010, the EPA issued a final rule, known as the Tailoring Rule,
which phased in permitting requirements for GHG emissions from
stationary sources under the CAA PSD and title V permitting programs.
75 FR 31514. Under its understanding of the CAA at the time, the EPA
believed the Tailoring Rule was

necessary to avoid a sudden and unmanageable increase in the number of
sources that would be required to obtain PSD and Title V permits under
the CAA because the sources emitted GHG emissions over applicable major
source and major modification thresholds. In Step 1 of the Tailoring
Rule, which began on January 2, 2011, the EPA limited application of
PSD requirements to sources of GHG emissions only if the sources were
subject to PSD ``anyway'' due to their emissions of pollutants other
than GHGs. These sources are referred to as ``anyway sources.'' In Step
2 of the Tailoring Rule, which began on July 1, 2011, the EPA applied
the PSD requirements under the CAA to sources that were then-classified
as major, and, thus, required to obtain a permit, based solely on their
potential GHG emissions and to modifications of otherwise major sources
that required a PSD permit because they increased only GHG emissions
above applicable levels in the EPA regulations.
    On June 23, 2014, the Supreme Court issued a decision in Utility
Air Regulatory Group (UARG) v. Environmental Protection Agency, 134 S.
Ct. 2427, 189 L. Ed. 2d 372 (2014), holding that the EPA may not treat
GHGs as an air pollutant for purposes of determining whether a source
is a major source (or a modification thereof) required to obtain a PSD
permit. The Supreme Court's decision also said that the EPA could
continue to require that PSD permits, otherwise required based on
emissions of pollutants other than GHGs, contain limitations on GHG
emissions based on the application of BACT. The Supreme Court decision
effectively upheld PSD permitting requirements for GHG emissions under
Step 1 of the Tailoring Rule for ``anyway sources'' and invalidated PSD
permitting requirements for GHG emissions for Step 2 sources. In
accordance with the Supreme Court decision, on April 10, 2015, the D.C.
Circuit issued an amended judgment vacating the regulations that
implemented Step 2 of the Tailoring Rule, including 40 CFR
52.21(b)(49)(v), but not the regulations that implement Step 1 of the
Tailoring Rule. Coalition for Responsible Regulation, Inc. v. EPA, No.
09-1322, (D.C. Cir. April 10, 2015) (Amended Judgment).
    In light of the Supreme Court's UARG decision, and consistent with
the D.C. Circuit's amended judgment, each of the five Districts with
PSD rules under consideration in this action requested that CARB notify
the EPA that CARB and the respective Districts would like to withdraw
from the respective Districts' PSD rule SIP submittals the portion of
each District PSD rule that incorporates by reference 40 CFR
52.21(b)(49)(v). CARB sent a letter to the EPA dated June 1, 2015
making this withdrawal request for the five District PSD submittals.
These withdrawals were designed to ensure that the EPA can act on the
District's SIP submittals consistent with the Supreme Court's UARG
decision concerning Step 2 of the GHG Tailoring Rule and the D.C.
Circuit's amended judgment.\3\ With this withdrawal request from CARB,
the EPA's action on these PSD SIP submittals will not include the
provisions of 40 CFR 52.21(b)(49)(v) as incorporated by reference into
the five PSD rules. This approach will ensure that the EPA's action is
consistent with the Supreme Court's UARG decision and the D.C. Circuit
Court's April 10, 2015 amended judgment.
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    \3\ See letter to EPA dated June 1, 2015 from Richard Corey,
Executive Officer, California Air Resources Board.
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    The EPA intends to revise the PSD rules at 40 CFR 52.21 and 40 CFR
51.166 as a result of the UARG decision and the D.C. Circuit's amended
judgment. However, in the meantime, the EPA and the states will need to
ensure that ``anyway'' sources obtain PSD permits meeting the
requirements of the CAA. The CAA continues to require that PSD permits
issued to ``anyway sources'' satisfy the BACT requirement for GHGs.
Based on the language that remains applicable under 52.21(b)(49)(iv),
the EPA will continue to limit the application of BACT to GHG emissions
to those circumstances where a source emits GHGs in the amount of
75,000 tons per year on a CO2e basis. The EPA's intention is
for this to serve as an interim approach until the EPA can complete
revisions to its PSD rules consistent with the Supreme Court decision.
Each of the five Districts has confirmed that it intends to apply 40
CFR 52.21 as incorporated by reference into its PSD rule in a manner
consistent with the EPA's interpretation of the Supreme Court's UARG
decision and the EPA guidance and policy with respect to application of
section 52.21 while revisions to the PSD regulations are pending.\4\
Although the Districts provided this information to the EPA prior to
the D.C. Circuit's amended judgment vacating the relevant rule
provisions, this confirmation is consistent with that amended judgment.
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    \4\ See letters dated November 13, 2014 from Butte, November 13,
2014 from Great Basin, November 25, 2014 from Santa Barbara,
December 16, 2014 from San Luis Obispo, and December 18, 2014 from
Feather River.
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E. Transfer of existing permits issued by the EPA

    With the exception of San Luis Obispo, the Districts requested
approval to exercise their authority to administer the PSD program with
respect to those sources located in the Districts that have existing
PSD permits issued by the EPA or by the Districts as part of a
delegation agreement under 40 CFR 52.21(u).\5\ This would include
authority to conduct general administration of these existing permits,
authority to process and issue any and all subsequent PSD permit
actions relating to such permits (e.g., modifications, amendments, or
revisions of any nature), and authority to enforce such permits.
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    \5\ There are no such active permits in San Luis Obispo, thus
San Luis Obispo is not requesting such approval.
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    Consistent with section 110(a)(2)(E)(i) of the Act, the SIP
submittals and additional information provided by the Districts make
clear that each District has the authority under State statute and rule
to administer the PSD permit program, including but not limited to the
authority to administer, process and issue any and all permit
decisions, and enforce PSD permit requirements within each District.
This applies to PSD permits that the Districts will issue and to
existing PSD permits issued by the EPA that are to be transferred to
the Districts upon the effective date of the EPA's approval of the PSD
SIP submittals.

F. Public comment and proposed action

    Because the EPA believes the submitted rules fulfill all relevant
CAA requirements, we are proposing to fully approve them as a revision
to the California SIP pursuant to section 110(k)(3) of the Act.
Specifically, we are proposing to approve the rules listed in Table 1,
except for Step 2 of the GHG Tailoring Rule found at 40 CFR
52.21(b)(49)(v) as incorporated by reference into each rule, which was
subsequently withdrawn from CARB's request for SIP approval. Our
determination is based, in part, on the clarifications provided by the
Districts related to the implementation of the PSD program, including
the clarifications related to PM2.5 SILs and SMC, in letters
dated November 13, 2014, November 25, 2014, December 16, 2014, December
18, 2014, April 8, 2015, and April 15, 2015. We intend to include these
clarification letters as additional material in the SIP.
    We will accept comments from the public on this proposal until
August 24, 2015.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the rules listed in Table 1 of this preamble, except for the
portion of each rule that incorporates Step 2 of the GHG Tailoring Rule
at 40 CFR 52.21(b)(49)(v). The EPA has made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate office of
the EPA (see the ADDRESSES section of this preamble for more
information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Act. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

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

    Dated: July 7, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015-18081 Filed 7-23-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Rules and Regulations]
[Pages 8006-8011]
[FR Doc No: 2018-03760]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0360; FRL-9972-30]

Quizalofop ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quizalofop ethyl in or on the commodities wheat germ and milled
byproducts, and increases the tolerances in or on wheat forage, hay,
and straw. Albaugh, LLC requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 23, 2018. Objections and
requests for hearings must be received on or before April 24, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0360, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0360 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 24, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0360, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of December 20, 2016 (81 FR 92758) (FRL-
9956-04), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8476) by Albaugh, LLC, P.O. Box 2127, Valdosta, GA 31604. The
petition requested that 40 CFR part 180.441 be amended by establishing
tolerances for residues of the herbicide quizalofop ethyl, in or on
wheat, bran at 0.40 parts per million (ppm); wheat, forage at 2.0 ppm;
wheat, germ at 0.40 ppm; wheat, hay at 2.0 ppm; wheat, milled
byproducts at 0.40 ppm; and wheat, straw at 0.80 ppm. That document
referenced a summary of the petition prepared by Albaugh, LLC, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    EPA determined that a separate tolerance is not needed for wheat
bran. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for quizalofop ethyl, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with quizalofop
ethyl follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as

the relationship of the results of the studies to human risk. EPA has
also considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Quizalofop ethyl is a 50/50 racemic mixture of R- and S-
enantiomers. Quizalofop-P-ethyl, the purified R-enantiomer, is the
pesticidally-active isomer. Since the toxicological profiles of
quizalofop ethyl and quizalofop-P-ethyl are similar, the available
toxicity studies are adequate to support both compounds. For the
purposes of this final rule, both quizalofop ethyl and quizalofop-P-
ethyl are collectively referred to as ``quizalofop ethyl.''
    Quizalofop ethyl has very low acute toxicity via the oral, dermal,
and inhalation routes of exposure, is not an eye or skin irritant, and
is not a skin sensitizer. There were no adverse effects observed in the
oral toxicity studies that could be attributable to a single-dose
exposure.
    Repeated-dose toxicity studies indicate the liver as the target
organ, as evidenced by increased liver weights and histopathological
changes. Following oral administration, quizalofop ethyl is rapidly
excreted via urine and feces. In the subchronic oral toxicity rat
study, effects of decreased body weight gains, increased liver weight,
and centrilobular liver cell enlargement were observed. In the
subchronic oral toxicity dog study, an increased incidence of
testicular atrophy was observed. In the combined chronic toxicity/
carcinogenicity study in rats, an increased incidence of centrilobular
liver cell enlargement was observed in both sexes and mild anemia in
males.
    No dermal toxicity effects were observed in the subchronic dermal
toxicity rabbit study at up to the limit dose. Subchronic inhalation
toxicity is assumed to be equivalent to oral toxicity. In the chronic
oral toxicity dog study, no toxicity effects were observed at the
highest dose tested.
    In the rat and rabbit developmental toxicity studies, maternal
effects including decreased body weight gains and food consumption were
observed; no developmental effects were observed up to the highest dose
tested. In the 2-generation reproduction toxicity study in rats,
maternal effects including decreased body weight and decreased body
weight gains were observed at the same dose level that resulted in
prenatal and postnatal effects (decreased percentage of pups born alive
and decreased pup weights); no evidence of adverse effects on the
functional development of pups was observed.
    Although tumors were observed in male and female mice after
exposure to quizalofop ethyl, the overall evidence for carcinogenicity
is weak, as discussed in supporting documents. Additionally, the point
of departure used for establishing the chronic reference dose for
quizalofop ethyl is significantly lower (30X) than the dose that
induced tumors in male and female mice. EPA has determined that
quantification of cancer risk using a non-linear approach would
adequately account for all chronic toxicity, including carcinogenicity,
which could result from exposure to quizalofop ethyl.
    Based on the results of acceptable toxicity studies, quizalofop
ethyl does not show evidence of neurotoxicity or neuropathology.
Quizalofop ethyl showed no evidence of immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by quizalofop ethyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Quizalofop-P-ethyl. Human Health Risk
assessment in Support of the Proposed New Use on Rice in docket ID
number EPA-HQ-OPP-2015-0412.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for quizalofop ethyl used
for human risk assessment is discussed in Unit II.B. of the final rule
published in the Federal Register of December 1, 2016 (81 FR 86581)
(FRL-9950-89).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quizalofop ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing quizalofop ethyl
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from
quizalofop ethyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for quizalofop ethyl;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues, average percent crop treated (PCT)
information, and default processing factors for all processed
commodities except sunflower oil, where an empirical factor was used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the chronic reference dose will be protective of any
potential carcinogenicity; therefore, a separate dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residues and percent crop treated (PCT)
information. EPA did not use anticipated residue information to assess
exposure for these tolerances; rather, EPA used tolerance-level
residues in its exposure assessment.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food

derived from such crop is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows:
Barley: 1%; beans, green: 2.5%; canola: 5%; cotton: 1%; dry beans/peas:
15%; peas, green: 2.5%; soybeans: 2.5%; sugar beets: 2.5%; and
sunflowers: 5%. For all other existing uses, including the amended use
on wheat, 100% of the crop treated was assumed.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 to 7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT value for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and is rounded to the nearest multiple of 5%
for use in the analysis; unless the average PCT value is estimated at
less than 2.5% or 1%, in which case the Agency uses 2.5% or 1%,
respectively, as the average PCT value in the analysis.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which quizalofop ethyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quizalofop ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Modified Tier 1 Rice Model and Pesticide Root Zone
Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of quizalofop ethyl for chronic exposures for
non-cancer assessments are estimated to be 125 parts per billion (ppb)
for surface water and 89 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 125 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quizalofop ethyl is
not registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found quizalofop ethyl to share a common mechanism of
toxicity with any other substances, and quizalofop ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
quizalofop ethyl does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. As summarized in Unit
III.A., results from the rat and rabbit developmental toxicity and the
2-generation rat reproduction toxicity studies indicated no qualitative
or quantitative evidence of increased susceptibility in developing
fetuses or in the offspring following prenatal and/or postnatal
exposure to quizalofop ethyl.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for quizalofop ethyl is complete.
    ii. There is no indication that quizalofop ethyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no qualitative or quantitative evidence that
quizalofop ethyl results in increased susceptibility in in utero rats
or rabbits in the prenatal developmental studies or in young rats in
the 2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on tolerance-level residues, average PCTs for certain existing uses,
and 100 PCT for other existing uses including the amended wheat use.
EPA made conservative

(protective) assumptions in the ground and surface water modeling used
to assess exposure to quizalofop ethyl in drinking water. These
assessments will not underestimate the exposure and risks posed by
quizalofop ethyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single-dose oral
exposure was identified and no acute dietary endpoint was selected.
Therefore, quizalofop ethyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quizalofop ethyl from food and water will utilize 84% of the cPAD for
all infants less than 1-year old, the population group receiving the
greatest exposure. Most of the dietary exposure is attributed to
drinking water, utilizing 75% of the cPAD for all infants less than 1-
year old. There are no residential uses for quizalofop ethyl.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
residential uses, quizalofop ethyl is not expected to pose short- or
intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has concluded that regulating on the chronic reference dose
will be protective of potential carcinogenicity. Based on the results
of the chronic risk assessment, EPA concludes that quizalofop ethyl is
not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (Morse Meth-147, a liquid
chromatography method using tandem mass spectrometry detection (LC-MS/
MS) for plant commodities including wheat) is available to enforce the
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for quizalofop ethyl.

C. Revisions to Petitioned-For Tolerances

    EPA determined that a separate tolerance is not needed for wheat
bran, since it is included in the commodity definition for wheat,
milled byproducts, which includes wheat bran, middlings, and shorts.

V. Conclusion

    Therefore, tolerances are established for residues of quizalofop
ethyl in or on wheat, germ at 0.40 ppm and wheat, milled byproducts at
0.40 ppm. Existing tolerances are increased for residues of quizalofop
ethyl in or on wheat, forage from 0.05 to 2.0 ppm; wheat, hay from 0.05
to 2.0 ppm; and wheat, straw from 0.05 to 0.80 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply

to this action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 9, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.441,
0
a. Add alphabetically the entries ``Wheat, germ'' and ``Wheat, milled
byproducts'' to the table in paragraph (a)(1).
    b. Revise the entries ``Wheat, forage''; ``Wheat, hay''; and
``Wheat, straw'' in the table in paragraph (a)(1).
    The additions and revisions read as follows:

Sec.  180.441   Quizalofop ethyl; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Wheat, forage...............................................         2.0
Wheat, germ.................................................        0.40

                                * * * * *
Wheat, hay..................................................         2.0
Wheat, milled byproducts....................................        0.40
Wheat, straw................................................        0.80
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03760 Filed 2-22-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Notices]
[Page 79528-79530]
[DOCID:fr29de08-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59111; File No. SR-FICC-2007-04]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Order Approving a Proposed Rule Change Relating to Applicant and Member
Disqualification Criteria

December 17, 2008.

I. Introduction

    On April 30, 2007, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'').\1\ On February 7, 2008, and March 19,
2008, FICC amended the proposed rule change. On July 9, 2008, the
Commission published notice of the proposed rule change to solicit
comments from interested persons.\2\ The Commission received two
comment letters in response to the proposed rule change.\3\ For the
reasons discussed

below, the Commission is approving the proposed rule change, as
amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 58128, 73 FR 40893 (July
16, 2008).
    \3\ Letters from Susanne Trimbath, Ph.D., STP Advisory Services,
LLC (Aug. 27, 2008) and Nikki M. Poulos, Managing Director, General
Counsel, FICC (Nov. 7, 2008).
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II. Description

    The proposed rule change will amend FICC's Government Securities
Division's (``GSD'') and Mortgage Backed Securities Division's
(``MBSD'') (collectively, ``Divisions'') rules concerning applicant and
member disqualification criteria by making the Divisions' rules
consistent with the rules of FICC's affiliated clearing agencies, the
National Securities Clearing Corporation (``NSCC'') and The Depository
Trust Company (``DTC''). The proposed rule changes cover the following
areas:

1. Management Consideration of Disqualification Criteria \4\

    Prior to this rule change, GSD's membership qualification rules
required FICC's Board of Directors to determine whether the presence of
certain negative factors affecting a membership application should
constitute the basis for denying membership to such applicant.
Information that might have disqualified an applicant (referred to in
GSD's rules as ``disqualification criteria'') include the applicant
being subject to a statutory disqualification \5\ or conviction of
various crimes such as bribery. The disqualification criteria in GSD's
rules similarly apply as standards for continued membership.
---------------------------------------------------------------------------

    \4\ GSD Rule 2A, Section 3(d).
    \5\ The definition of ``statutory disqualification'' is found at
15 U.S.C. 78c(a)(39).
---------------------------------------------------------------------------

    Under the rule change, FICC will amend GSD's disqualification
criteria to allow FICC's management, instead of FICC's Board, to
determine whether the presence of a potential disqualifier should
prevent an entity from obtaining or continuing membership in GSD. Such
change would conform to the rules of MBSD, DTC, and NSCC, which allow
such determinations to be made by management.

2. Associated and Affiliated Persons

    GSD's and MBSD's rules also apply certain applicant and member
disqualification criteria to persons ``associated'' (in GSD's rules) or
``affiliated'' (in MBSD's rules) with the applicant or member firm.
FICC states that it is not always practical for it to ascertain which
individuals are ``associated'' or ``affiliated'' with a particular
entity and therefore proposes to amend these rules to conform them to
its internal surveillance procedures and make them consistent across
both Divisions. Accordingly, references to persons ``associated'' or
``affiliated'' with the member or applicant are being changed to
references to ``controlling management,'' which include those officers
of the applicant or member that are currently screened by FICC's Risk
Management department pursuant to internal procedures.\6\ In addition,
FICC will add language to its rules to require applicants to inform
FICC as to any member of its controlling management that is or becomes
subject to statutory disqualification.
---------------------------------------------------------------------------

    \6\ New GSD Rule 1 and MBSD Article I (``The term `controlling
management' shall mean the Chief Executive Officer, the Chief
Financial Officer, and the Chief Operations Officer, or their
equivalents, of an applicant of Participant.'').
---------------------------------------------------------------------------

3. Monitoring of Objective Disqualification Criteria

    GSD's disqualification criteria is being amended to reflect an
approach that such criteria should be objectively and practically
monitored. Specifically, FICC will delete one disqualification
criterion that refers to an applicant being subject to ``closer than
normal'' surveillance by a regulatory body. FICC states that this event
might not be reported in a regulatory background check.
    In addition, prior to this rule change, MBSD's rules contained only
two criteria that could be the basis for denial of a membership
application. These were: (i) An applicant's subjection to a statutory
disqualification or similar order by another examining authority and
(ii) an applicant or an associated person of the applicant making a
misstatement of a material fact in connection with its membership
application or thereafter. Under this rule change, MBSD will add GSD's
remaining disqualification criteria relating to unlawful acts by the
applicant's or member's Controlling Management or the applicant's or
member's suspension or expulsion from a self-regulatory organization.
These additions to MBSD's rules will result in both Divisions having
identical disqualification criteria.
    Finally, FICC will add a provision to both Divisions' rules that
clarifies FICC's right to deny membership to an applicant or member if
FICC learns of any factor or circumstance that might impact the
suitability of that particular applicant or member as a participant.

4. Additional Changes

    FICC will make the following changes to provide additional
uniformity among the rules of the Divisions, NSCC, and DTC:
    (i) Adding to both Divisions' disqualification criteria violations
of the Investment Company Act and Investment Advisers Act,\7\ since
those statutes apply to their current membership base.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 80a-1 et seq. and 15 U.S.C. 80b-1 et seq.,
respectively.
---------------------------------------------------------------------------

    (ii) Amending GSD's definition of ``self-regulatory organization''
to include those entities that are foreign equivalents. The same
definition for ``self-regulatory organization'' would be added to
MBSD's rules.
    (iii) Removing the word ``willful'' from both Divisions'
disqualification criteria concerning an applicant's or an applicant's
controlling management's violation of the specified federal statutes or
any rule or regulation promulgated thereunder. FICC believes that a
violation of these provisions, whether or not willful, should be
considered as a potential disqualification criterion.
    (iv) Deleting references in GSD's rules to Section 153 of Chapters
25 and 47 of Title 18 of the United States Code (``Code'') because the
crimes covered by these statutes (i.e., embezzlement, forgery, false
statements, etc.) are captured by the current disqualification
criteria. References to those portions of the Code that deal with mail
and wire fraud (Sections 1341, 1342 and 1343) would remain. This
provision will also be added to MBSD's rules.
    Changes are being made to the cease to act provisions of GSD's
rules (Rule 21, ``Restrictions on Access to Services'') in order to
ensure consistency within the rules and across the Divisions.

III. Comment Letters \8\

    Susanne Trimbath, PhD., of STP Advisory Services, LLC, suggested
that FICC should also consider an entity's ability to deliver
securities for settlement when determining an applicant's or member's
suitability as a participant. Ms. Trimbath pointed out that this
recommendation is consistent with the Section 17A(a)(5)(C) of the Act
\9\ and claimed thatthe cost of FICC members failing to deliver
securities at settlement is significant and harms fellow FICC members
and investors.
---------------------------------------------------------------------------

    \8\ See supra note 3.
    \9\ 15 U.S.C. 78q-1(a)(c)(5) (``A registered clearing agency may
summarily suspend and close the accounts of a participant who * * *
is in default of any delivery of funds or securities to the clearing
agency.'').
---------------------------------------------------------------------------

    Nikki Poulos, FICC's General Counsel, responded to Ms. Trimbath's
comment. While Ms. Poulos acknowledged securities transactions fails as
a serious issue for the securities industry, she argued that FICC has
attempted to reduce the risks posed by fails.\10\

Moreover, Ms. Poulos believes that including a participant's fails as a
criterion by which FICC would have to assess participation ``would only
create more risks in that these open obligations would be processed (or
not) outside of FICC, without the benefit of, i.e., re-netting.''
---------------------------------------------------------------------------

    \10\ See, e.g., Securities Exchange Act Release Nos. 52157 (July
28, 2005), 70 FR 44959 (Aug. 4, 2005) [FICC-2005-11] (establishing a
daily fail netting process basis allowing participants to net
outstanding fail obligations with current settlement activity in
order to reduce risk exposure among FICC participants) and 54487
(Sept. 22, 2006), 71 FR 58025 (Oct. 2, 2006) [FICC-2005-17] (FICC
assumes certain fails of blind brokered repurchase transactions at
GSD and obtains financing as necessary in connection with such
assumptions).
---------------------------------------------------------------------------

IV. Discussion

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of a clearing agency be designed to assure the safeguarding
of securities and funds which are in its custody or control or for
which it is responsible.\11\ The proposed rule change should enhance
FICC's surveillance and assessment of applicants' and members'
regulatory conditions. In addition, the proposed rule change will
harmonize both of FICC's division's application and membership
requirements and will make clear to all applicants and members of the
breadth of information that FICC will require and review in order to
develop an accurate risk profile to evaluate an applicant's or member's
condition. Accordingly, the proposed rule should strengthen FICC's
ability to mitigate financial risk to itself and to its members and
therefore should enhanced FICC's ability to assure the safeguarding of
securities and funds that are in its custody or control or for which it
is responsible.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission also agrees that the issue of ``fails'' is a serious
one for the securities industry. The Commission will continue to
monitor developments in this area and will use its regulatory authority
if needed to better ensure that appropriate safeguards are in place to
facilitate the prompt and accurate clearance and settlement of
securities transactions and to protect investors. In this regard, the
Commission expects FICC, as a self-regulatory organization and
registered clearing agency, to similarly continue to scrutinize its
participants' effectiveness in delivering funds and securities in
fulfillment of their obligations when using FICC's clearing facilities.

V. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular Section 17A \12\ of the Act and the rules and regulations
thereunder.\13\
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    \12\ 15 U.S.C. 78q-1.
    \13\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\14\ that the proposed rule change (File No. SR-FICC-2007-04), as
amended, be and hereby is approved. For the Commission by the Division
of Trading and Markets, pursuant to delegated authority.\15\
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    \14\ 15 U.S.C. 78s(b)(2).
    \15\ 17 CFR 200.30-3(a)(12).

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-30786 Filed 12-24-08; 8:45 am]

BILLING CODE 8011-01-P


              RFS Cellulosic Biofuel Producer Questionnaire Form
                                                                Issue Date: DD/MM/YYY
											   Revised: N/A

Facilities that anticipate producing cellulosic biofuel eligible to generate D3 or D7 RINs at any point in the current or subsequent year may prepare and submit this data form by March 31 each year.

Who must report
 The RFS Cellulosic Biofuel Producer Questionnaire is a voluntary form. All parties that intend to generate cellulosic biofuel RINs (D3 or D7 RINs) for fuel used as a transportation fuel in the United States are welcome to complete the questionnaire.
Reporting deadlines
 The RFS Cellulosic Biofuel Producer Questionnaire is due on an annual basis, by March 31[st] of each year.
How to submit reports
 EPA maintains report templates, electronic submission procedures and additional support options at http://www.epa.gov/otaq/fuels/reporting/cdx.htm.

Field Instructions

Field No.
Field Name
Units
Field Formats, Codes & Special Instructions
1.
Report Form ID

AAAAAAA; Character
Enter RFSXXXX
2.
Report Type

A; Character
Specify if the data submitted in this report is original or if it is being resubmitted. Submit only one original report; any corrections or updates should be marked as a resubmission.
O = Original
R = Resubmission
3.
CBI

A; Character
Specify if the data contained within the report is claimed as Confidential Business Information (CBI) under 40 CFR Part 2, subpart B.
Y = Confidential Business Information
N = Non-Confidential Business Information
4.
Report Date

MM/DD/YYYY; Character
Enter the date the original or resubmitted report is created.
5.
Company/Entity ID

AAAA; Character
Enter the EPA-assigned four-character Company ID of the renewable fuel producer. If the company is not registered under the RFS program enter N/A
6.
Company Name

AAAA...; Character
Enter the reporting party's company name (your company name).
7.
Facility ID

AAAAA; Character
Enter the EPA-assigned five-character facility ID of the renewable fuel producer.  If the facility is not registered under the RFS program enter N/A
8.
Facility Name

AAAA...; Enter the reporting party's facility name (your facility name).
9.
Nameplate Capacity
Gallons
999999999; Number
Enter the nameplate capacity (annual production capacity) of the facility.  If the facility produces multiple categories of fuel, enter only the volume that corresponds to cellulosic biofuel production (D3 or D7 RINs).
10.
Process Description

AAAA...; Character
Enter a general description of the technology and process used to produce cellulosic biofuel
11.
Technology Partners

AAAA...; Character
Enter the name(s) of all providers of key portions of cellulosic biofuel production technology (enzymes, catalyst, pre-treatment, yeast, etc.) and a brief description of the nature of the partnership/agreement
12.
Construction Completion Date

MM/DD/YYYY; Character
Enter the date of mechanical completion of the facility.  If a previously existing facility is being modified to enable the production of cellulosic biofuel, enter the date of mechanical completion of these modifications.  If the facility is not yet mechanically complete enter the projected completion date.
13.
First Commercial Scale Fuel Production Date

MM/DD/YYYY; Character
Enter the date of the first production of commercial scale (salable) gallons of cellulosic biofuel (fuel eligible to generate D3 or D7 RINs).  If commercial scale production has not yet begun enter projected date.
14.
Full Production Rate Date

MM/DD/YYYY; Character
Enter the date the facility achieved full production (nameplate) rate of cellulosic biofuel.  If full production rate has not yet been achieved, enter the projected date.
15.
Date of Facility Registration

MM/DD/YYYY; Character
Enter the date the facility completed registration under the RFS program to produce cellulosic biofuel (D3 or D7 RINs).  If facility is not yet registered enter projected date.
16.
Fuel Off-take Agreements

AAAA...; Character (5,000 Character Limit)
Enter the name(s) of any companies with which the facility has fuel off-take agreements for cellulosic biofuel, and a brief description of these agreements
17.
Additional Information

AAAA...; Character (5000 Character limit)
Enter any information you believe would aid EPA in projecting production volumes of cellulosic biofuel from the facility not covered above

                       Paperwork Reduction Act Statement
The public reporting and recordkeeping burden for this collection of information is disclosed in the estimates of the individual report form instructions. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.