[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Rules and Regulations]
[Pages 37579-37587]
[FR Doc No: 2019-16229]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2017-0145; FRL-9996-93-Region 6]

Approval and Promulgation of Implementation Plans; Oklahoma

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
revisions to the State Implementation Plan (SIP) for Oklahoma as
proposed on March 22, 2018, and October 5, 2018. The revisions
submitted by Oklahoma were contained in annual SIP updates for 2013,
2014, 2015, and 2016, and incorporate the latest changes to the EPA
regulations. The overall intended outcome of this rulemaking is to make
the approved Oklahoma SIP consistent with current Federal and State
requirements. We are taking this action in accordance with the federal
Clean Air Act (CAA, the Act).

DATES: This rule is effective on September 3, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2017-0145. All documents in the docket are
listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through https://www.regulations.gov or
in hard copy at the EPA Region 6 Office, 1201 Elm Street, Dallas, Texas
75270.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar, EPA Region 6 Office,
SO2 and Regional Haze Section (6ARSH), 1201 Elm Street,
Dallas, TX 75270,<PHONE_NUMBER><EMAIL_ADDRESS>To inspect the hard
copy materials, please schedule an appointment with Mr. Alan Shar or
Mr. Bill Deese at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' mean the EPA.
    Acronyms and Abbreviations. A number of acronyms and abbreviations
are used in this preamble. While this may not be an exhaustive list, to
ease the reading of this preamble and for reference purposes, the
following terms and acronyms are defined:

ACI Air Curtain Incinerator
AQAC Air Quality Advisory Committee
BACT Best Available Control Technology
CAA Clean Air Act
CFR Code of Federal Regulations
CRA Congressional Review Act
EPA U.S. Environmental Protection Agency
FR Federal Register
NAAQSvNational Ambient Air Quality Standards
OAC Oklahoma Administrative Code
ODEQ Oklahoma Department of Environmental Quality
PSD Prevention of Significant Deterioration
SIP State Implementation Plan
SNPR Supplemental Notice of Proposed Rulemaking
TSD Technical Support Document

Table of Contents

I. Background
II. Public Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

    The background for this action is discussed in detail in the March
22, 2018 (83 FR 12514) Proposal.\1\ After the close of the comment
period, the Oklahoma Department of Environmental Quality (ODEQ)
submitted additional information by letter dated July 31, 2018
(hereinafter ``ODEQ's July 31, 2018 Letter''),\2\ concerning the SIP
rule revisions addressed in the March 22, 2018 Proposal. The
information submitted by ODEQ was intended to clarify the rule
revisions and their applicability as well as to further demonstrate how
the revisions improve the Oklahoma SIP. On October 5, 2018, we
published a Supplemental Notice of Proposed Rulemaking (SNPR) \3\ at 83
FR 50312. The October 5, 2018 SNPR reopened the comment period based on
the information submitted by Oklahoma and our analysis of it. We also
withdrew the proposed action concerning Commercial and Industrial Solid
Waste Incineration Units because the State did not submit it for
approval as a SIP revision. The Proposal, the SNPR, the Technical
Support Document (TSD),\4\ and Supplement 3 to the TSD \5\ provide a
detailed description and rationale for EPA's proposal to approve into
the Oklahoma SIP certain revisions to Oklahoma Administrative Code
(OAC) Title 252 Department of Environmental Quality (ODEQ), Chapter 100
Air Pollution Control (OAC:252:100) that Oklahoma submitted to the EPA
on February 14, 2017. Specifically, the Proposal and the SNPR concern
revisions to OAC:252:100 Subchapters 13 Open Burning, 17 Incinerators,
25 Visible Emissions and Particulates, 31 Control of Emission of Sulfur
Compounds, Appendix E Primary Ambient Air Quality Standards, and
Appendix F Secondary Ambient Air Quality Standards. The criteria used
to evaluate these SIP revisions are found primarily in section 110 of
the Act.
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    \1\ See the Proposal, document ID No. EPA-R06-OAR-2017-0145-0001
at Regulations.gov.
    \2\ ODEQ letter dated July 31, 2018 to EPA concerning March 22,
2018 (83 FR 12514) Proposal, document ID No. EPA-R06-OAR-2017-0145-
0026 at Regulations.gov.
    \3\ See the SNPR, document ID No. EPA-R06-OAR-2017-0145-0023 at
Regulations.gov.
    \4\ See the TSD, document ID No. EPA-R06-OAR-2017-0145-0002 at
Regulations.gov.
    \5\ See Supplement 3 to the TSD, document ID No. EPA-R06-OAR-
2017-0145-0024 at Regulations.gov.
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II. Public Comments

    We received 19 comments on the March 22, 2018 (83 FR 12514)
Proposal during the comment period that closed on April 23, 2018, and
all comments are available in docket for this action. Eighteen of the
19 comments were submitted anonymously and did not provide information
relevant or specific to the provisions proposed for approval into the
Oklahoma SIP. Upon review, the EPA determined that the 18 anonymous
comments merit no further response or discussion.\6\ The remaining
comment, submitted by the Sierra Club and the Center for Biological
Diversity (commenters), included relevant comments on the March 22,
2018 (83 FR

12514) Proposal.\7\ Primarily, the commenters assert that sections
110(l) and 193 of the Act have not been satisfied, and that revisions
to OAC:252:100 Subchapters 13, 17, 25, and 31 of the Oklahoma SIP
should not be approved. A summary of those comments and our responses
are found below. We did not receive comments on the October 5, 2018 (83
FR 50312) SNPR during the additional comment period that closed on
November 5, 2018.
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    \6\ See the EPA Response to Comments, Memorandum document ID No.
EPA-R06-OAR-2017-0145-0025 at Regulations.gov.
    \7\ See document ID No. EPA-R06-OAR-2017-0145-0022 at
Regulations.gov.
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    Comment 1: OAC 252:100, Subchapter 13--Open Burning. The commenters
note that the revisions would exempt hydrocarbon waste flaring and the
use of air curtain incinerators from the open burning time limitations
in OAC 252:100:13-9(4) of the existing SIP. Commenters claim that these
revisions allow flaring operations and air curtain incinerators to
operate an average of 18 more hours per day than allowed under the
existing SIP and thus allow dramatically increased emissions of
particulate matter, hydrocarbons, carbon monoxide, nitrogen oxides, and
possibly sulfur compounds, including sulfur dioxide. Commenters
maintain that the revision constitutes a SIP relaxation requiring a CAA
section 110(l) analysis (subject to public notice and opportunity for
public comment) of the impacts of the revision on the NAAQS and PSD
increments, and a determination that the SIP relaxation will not
interfere with the attainment or maintenance of the NAAQS and PSD
increments. Finally, commenters note that the EPA must ensure that the
requirements in CAA section 193 (relating to equivalent emission
reductions) are being met.
    Response: The February 14, 2017 submittal included revisions to OAC
252:100-9(4) that exempt open burning allowed under OAC 252:100-13-
7(6)(B) (concerning hydrocarbon waste flaring) and OAC 252:100-13-8
(concerning air curtain incinerators) from the time restrictions
otherwise applicable to open burning. As noted in ODEQ's July 31, 2018
Letter, the rule only requires that initial burning begin in the time
frame of 3 hours after sunrise to 3 hours before sunset. Open burning
is allowed outside of this timeframe so long as no additional fuel is
added.
    The revisions to OAC 252:100-9(4) exempt hydrocarbon waste flaring
under OAC 252:100-13-7(6)(B) from the time restrictions associated with
open burning. Pages 1-2 of ODEQ's July 31, 2018 Letter read:

    As discussed in the Air Quality Advisory Council (AQAC)
transcripts included in the SIP submittal, DEQ recognized the need
to correct the omission of the exemption for hydrocarbon flaring,
and a new version of Subchapter 13 with the exemption was taken to
the AQAC in 2003 and 2004, and approved by the Environmental Quality
Board (EQB) in 2004. There are many continuous processes that use
flares as a control device, and for those processes that cannot be
turned off, the flare must be used continuously. If the flare is
turned off, it could cause an air quality issue or a safety hazard.
Many of these flares are also included in facility permits with the
requirement to be operated continuously to reduce emissions. Many of
these same flares are also subject to regulation under federal New
Source Performance Standards (NSPSs) or National Emission Standards
for Hazardous Air Pollutants (NESHAPs), which require them to
operate continuously. DEQ never intended hydrocarbon flaring to be
subject to the operational time limitations in Subchapter 13, and
enforcement of such limitations would conflict with the state and
federal requirements discussed above. In addition, the proposed
revision to Subchapter 13 would not result in any increase in
emissions and would not interfere with any NAAQS or PSD increment.

    We agree with ODEQ's conclusion that time limits on the operation
of hydrocarbon flares are inappropriate and, if actually implemented,
could cause a life or safety hazard and result in an increase in
emissions of hydrocarbons while the flare is not in use. As such, the
removal of the operating time restriction would reduce emissions of
VOCs, if one assumes the restrictions had been enforced. However, as
ODEQ notes, the restriction on hydrocarbon flaring could not have been
practically enforced without introducing life or safety hazards. As
such, the time limits on the operation of hydrocarbon flares could not
have been implemented and, in fact, have never been implemented because
they are inconsistent with several state and federal requirements, as
noted above. Removing the time restriction is not expected to result in
any actual change in emissions, and, therefore, its removal will not
increase emissions or interfere with attainment or PSD increments.
    The other exemption from the open burning time restriction included
in the proposed SIP revision of OAC 252:100-13-9(4) concerns the use of
air curtain incinerators (ACIs) under OAC 252:100-13-8. As noted in
ODEQ's July 31, 2018 Letter, the use of ACIs under OAC 252:100-13-8 is
limited to ``combustible material or refuse that is allowed to be
burned under this Chapter (emphasis added).'' In addition, ODEQ's July
31, 2018 Letter at page 2 notes:

    DEQ exempted open burning using an ACI from the time limitation
because an ACI is a control device that reduces the pollution
created by open burning. ACIs are also a safer means of reducing
waste by lowering the risk of escaped fires and embers. As compared
to open burning without ACIs, an ACI reduces air pollution by about
90%, and specifically particulate matter by 97%, greatly reducing
the probability of creating an air quality hazard or nuisance. One
of the reasons DEQ eliminated the time restriction on the use of an
ACI was to remove a barrier for anyone who could, to use an ACI.
Please note the use of an ACI for any day where an Ozone or PM watch
has been declared in a Metropolitan Statistical Area (MSA) or county
is prohibited in OAC 252:100-13-9(5). It is also very important to
note that the volume of materials being burned would not change
based on this rule revision. However, the use of an ACI to burn that
same volume, regardless of the time of day, would result in fewer
emissions released to the environment. As such, the proposed
revision to Subchapter 13 promotes a better pollution control
measure which would neither result in any increase in emissions nor
interfere with any NAAQS or PSD increment.

    The EPA finds ODEQ's conclusion that the volume of material being
burned would not change based on this rule revision is reasonable. In
considering the allowed open burning activities listed in OAC 252:100-
13-7, there is no reason to believe that removal of barriers to air
curtain incinerators will result in more material being burned. For
example, the EPA sees no reason, and the commenter provided no reason
to expect, that more land would need clearing--an activity for which
open burning is allowed under OAC 252:100-13-7(4)--due to the lifting
of the time restrictions otherwise applicable to open burning for this
activity. Instead, it is expected that if more air curtain incinerators
are used relative to open burning, the air curtains would provide more
efficient combustion and, as a result, less pollution. We also note
that open burning of refuse and other combustible material may occur
only if the burning is conducted so that the contaminants do not
adversely affect the ambient air quality of a city or town. See OAC
252:100-13-9 (3). Open burning of refuse and other combustible material
may occur only if no public nuisance is or will be created, and the
burning is controlled so that a visibility hazard is not created on any
roadway, rail track or air field as a result of the air contaminants
being emitted. See OAC 252:100-13-9(1) and (2), respectively. Also, use
of an ACI is prohibited for any day where an Ozone or PM watch has been
declared by ODEQ in a Metropolitan Statistical Area (MSA) or county.
See OAC 252:100-13-9(5). Furthermore, persons who conduct open burning
in accordance with the provisions of Subchapter 13 are not exempt or
excused from the

consequences, damages, or injuries that may result from such conduct,
nor are they exempt or excused from complying with all applicable laws,
ordinances, rules, and orders. See OAC 252:100-13-11.
    Finally, we note that the requirements of CAA section 193 are
inapplicable to the proposed revision to the Oklahoma SIP discussed
above. In confirmation of the statement in ODEQ's July 31, 2018 Letter
that ``Oklahoma has never relied upon Subchapter 13 as a control
measure for any nonattainment plans adopted before November 15, 1990,''
we searched the EPA's Greenbook site for the Designated Area Design
Values for NAAQS of 1987 PM10, 1971 SO2, 1978 Pb,
1971 CO, and 1971 NO2, and did not find information
concerning any pre-November 15, 1990 nonattainment plan in place for
these criteria pollutants in Oklahoma. See the chart \8\ on page 5 of
Supplement 3 to TSD. We believe that the additional information
provided in ODEQ's July 31, 2018 Letter and presented above supports
approval of the revisions to OAC 252:100-13-9(4) and that such
revisions would not interfere with any applicable requirement
concerning attainment or any other applicable requirement of the Clean
Air Act.
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    \8\ https://www3.epa.gov/airquality/greenbook/ndtc.html (URL
dated May 15, 2018).
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    With respect to commenters concern regarding the opportunity for
public comment on our analysis, we note that ODEQ's July 31, 2018
Letter was made available to the public as part of the October 5, 2018
SNPR. See document ID Nos. EPA-R06-OAR-2017-0145-0026 and EPA-R06-OAR-
2017-0145-0023, respectively, at www.regulations.gov. The public was
provided an opportunity to comment on the contents of ODEQ's letter and
our analysis of it. Additionally, our Supplement 3 to TSD, prepared in
conjunction with our publication of the supplemental notice, was also
made available in the docket on October 5, 2018. See document ID. No.
EPA-R06-OAR-2017-0145-0024. In the SNPR, the EPA notes that it is
``reopening the comment period based on information submitted by
Oklahoma in a letter dated July 31, 2018, and our analysis of it.'' (83
FR 50312, October 5, 2018). Thus, through the supplemental notice, the
EPA provided a fulsome opportunity for public comment on the additional
information relevant to EPA's CAA section 110(l) analysis. The EPA did
not receive comments on its October 5, 2018 supplemental notice action.
For the reasons explained above, no changes have been made to the
proposed approval of this rule revision as a result of this comment.
    Comment 2: OAC 252:100-17--Incinerators. Commenters note that the
revisions would exclude New Source Performance Standard (NSPS) subpart
AAAA \9\ and subpart CCCC \10\ sources from the incinerator
requirements in OAC 252:100-17 (Subchapter 17) of the existing SIP.
Commenters assert that neither the EPA nor Oklahoma provided any
analysis to show that the NSPS requirements are as stringent as the
Oklahoma Subchapter 17 requirements. Commenters note that Subchapter 17
imposes particulate matter limits that do not include any exemptions
for startup and shutdown, while the emission limits in NSPS subpart
AAAA do not apply during startup, shutdown or malfunction (40 CFR
60.1220). Commenters claim this SIP revision requires a CAA section
110(l) analysis to ensure any emission increases resulting from the
revision would not adversely impact compliance with the NAAQS or PSD
increments. The commenter also asserts that the EPA has not compared
the emission limits in NSPS subparts AAAA and CCCC to Subchapter 17 to
ensure that the SIP revision will not result in relaxing emission
limits that apply to these sources under the current SIP, including the
particulate matter requirements for fuel-burning units pursuant to OAC
252:100-17-1.3 and 252:100-19 of the existing SIP that apply to
incinerators that also generate useful heat energy.
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    \9\ 40 CFR part 60, subpart AAAA--Standards of Performance for
Small Municipal Waste Combustion Units for Which Construction is
Commenced After August 30, 1999 or for Which Modification or
Reconstruction is Commenced After June 6, 2001.
    \10\ 40 CFR part 60, subpart CCCC--Standards of Performance for
Commercial and Industrial Solid Waste Incineration Units.
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    Response: As the commenters correctly note, the February 14, 2017
submittal includes a revision to OAC 252:100-17-2 which adds NSPS
subpart AAAA and NSPS subpart CCCC to the list of sources exempt from
the requirements applicable to general purpose incinerators. As stated
on page 2 of ODEQ's July 31, 2018 Letter,

    It has always been DEQ's intention that Part 3 of Subchapter 17
apply to general purpose incinerators that are not otherwise covered
by a more specific and applicable state or federal regulation. The
addition of NSPS Subpart AAAA and CCCC to the list of exemptions is
intended to ensure that small municipal waste combustion units and
commercial and industrial solid waste incinerators are appropriately
required to follow the NSPS specific to that type of unit, rather
than the generic opacity and particulate matter regulations in OAC
252:100-17-3 and 100-17-4.

    As an initial matter, the EPA believes it is reasonable for
Oklahoma make efforts to remove requirements that overlap with Federal
requirements when consistent with the Act. Further, as noted on page 3
of ODEQ's July 31, 2018 Letter,

    Oklahoma currently has no incinerators subject to the small
municipal waste combustion rule of NSPS Subpart AAAA. The facilities
subject to NSPS Subpart CCCC in Oklahoma are subject due to the
presence of an ACI and are required to have a Title V permit.
Emission inventories are required annually per OAC 252:100-5 and
include state rule OAC 252:100-9 emission reporting. There is no
regulatory or emissions reporting gap created by exempting these
units from Subchapter 17.

    So, with regard to incinerators subject to NSPS subpart AAAA, there
will be no increase in emissions due to exempting sources subject to
this standard, as there are no known sources currently subject to NSPS
subpart AAAA in Oklahoma. In addition, and as discussed below, any
increase in emissions due to exempting subpart CCCC sources will be de
minimus.
    An inquiry for sources subject to NSPS subpart CCCC requirements in
Oklahoma reveals that such sources have an estimated or reported total
annual PM10 emissions of 2.337 tons (based on 2017 emission
inventory data and permitted rate). To the extent that revisions to OAC
252:100-17 might have resulted in any increased emissions from this
source category when compared to the total state-wide national emission
inventory of 10,693.06 tons of PM10, the resulting ratio is
so small (2.337/10,693.06 = 0.000219, or less than three-one hundredth
of one percent) that it is reasonable to conclude that such a de
minimus amount would not interfere with the attainment or maintenance
of the NAAQS, PSD increment, or any other applicable requirement of the
Act relating to SIPs.\11\ The commenter also specifically noted that
emissions during startup and shutdown are exempt under NSPS subpart
AAAA, but since there are no NSPS subpart AAAA sources in Oklahoma,
this is not a concern with respect to CAA section 110(l).
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    \11\ All air quality control regions in Oklahoma are currently
designated as unclassifiable/attainment for PM2.5. See 40
CFR 81.337.
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    NSPS subpart AAAA and CCCC sources previously subject to the
General Purpose requirements of OAC 252:100-17, Part 3 would be subject
to the emission requirements in the applicable federal NSPS rather than
the

particulate matter emission limits provided by OAC 252:100, Appendix
A.\12\ Comparatively, the type of pollutants and the control
requirements in 40 CFR part 60, subparts AAAA and CCCC are more robust
and provide for better air quality protection than the out of date
empirical formula found in Appendix A of the 1972 Oklahoma SIP. We
believe it is reasonable for Oklahoma to remove old and duplicative
requirements. Finally, according to the 2016 State's Air Data Report,
Oklahoma has better ambient air quality than required under the
PM2.5 NAAQS, for both the primary and secondary, and the
PM10 NAAQS. See the charts on page 5 of Supplement 3 to
TSD.\13\
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    \12\ Appendix A in the Oklahoma SIP is part of an arcane
Regulation 5 which uses a process weight formula to calculate a
corresponding particulate emission rate based on its capacity.
    \13\ See http://www.deq.state.ok.us/AQDnew/airreport2016/PM25.html (URL dated May 1, 2018) and http://www.deq.state.ok.us/AQDnew/airreport2016/PM10.html (URL dated May 1, 2018).
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    We note that under the Oklahoma SIP, should a source become subject
to NSPS subpart AAAA or subpart CCCC in the future, new source review
(NSR) permitting requirements would be triggered which require emission
limitations for all periods of normal operation, including periods of
startup and shutdown. In addition, 40 CFR 60.2145(a)(1) of NSPS subpart
CCCC states that the emission standards and operating requirements set
forth in this subpart apply at all times. Furthermore, affected sources
subject to NSPS subparts AAAA or CCCC in the future would trigger
Oklahoma NSR SIP and Title V requirements that ensure emissions from
such sources do not interfere with attainment or any other applicable
requirement of the CAA. Stationary sources subject to NSPS subparts
AAAA or CCCC must obtain an air permit that includes operational
conditions and limitations necessary to assure compliance with all
applicable requirements, including the NAAQS. See OAC 252:100-8-3 and
OAC 252:100-8-6(a) of the Oklahoma SIP. See also OAC 252:100-4 of the
Oklahoma SIP. The federal NSPS requirements in combination with the NSR
SIP requirements will ensure that any emission increases due to
exempting NSPS subpart AAAA and CCCC sources from the requirements of
OAC 252:100-17, Part 3 will be de minimus and will not interfere with
any applicable requirement concerning attainment or any other
applicable requirement of the Act.
    In addition, we are only approving into the SIP, the revision to
OAC 252-100-17-2 discussed above. We have not proposed action related
to the provisions of OAC 252:100-17, Part 9 Commercial and Industrial
Solid Waste Incineration Units--specifically OAC 252:100-17-60 thru 17-
76--as discussed in the March 22, 2018 (83 FR 12515) notice and the
SNPR. These provisions were not submitted to the EPA for SIP approval
as part of the February 14, 2017 SIP submittal and include provisions
that pertain to CAA sections 111(d) and 129, instead, which will be
acted upon separately in the future.\14\ Therefore, no changes have
been made to the proposed approval of the rule revision as a result of
this comment.
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    \14\ OAC 252:100-17-60 thru 17-76 are not directly related to
CAA section 110 (State implementation Plans for NAAQS) and pertain
to CAA sections 111(d) (Standards of performance for existing
sources; remaining useful life of source) and 129 (Solid waste
combustion) standards. These Subchapter 17 revisions were submitted
by the Oklahoma Department of Environmental Quality to EPA, by
letter dated September 15, 2017, as an update to Oklahoma's Air
Quality State Plan for Commercial and Industrial Solid Waste
Incinerators (CISWI) units, under CAA sections 111(d) and 129.
Pursuant to those statutory provisions and EPA's implementing
regulations related thereto, EPA will be evaluating and acting upon
the September 15, 2017 Submittal in a separate action.
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    Comment 3: OAC 252:100- 25--Visible Emissions and Particulates. The
commenters state that the EPA is proposing to remove the requirement
for the EPA and ODEQ to jointly approve alternative monitoring
requirements and instead allow only ODEQ to make such determinations on
a case-by-case basis, thereby essentially allowing changes to the
opacity monitoring requirements of the SIP without going through the
SIP revision process. The commenters claim that the provision in the
currently existing SIP, requiring both EPA and ODEQ approval, ensures
that EPA would evaluate the alternative opacity monitoring requirements
to make certain that the alternative monitoring does not represent a
relaxation of the SIP limits. Citing to 40 CFR 51.212(c), the
commenters note that the SIP requirements for source testing provide
that a state may use test methods in Appendix M of 40 CFR part 51 or
Appendix A of 40 CFR part 60; or the state may use an alternative
opacity monitoring method that is not identified in those two
Appendices following review and approval of that method by the EPA.
Commenters conclude that to the extent ODEQ uses an alternative
monitoring method not identified in the above-referenced Appendices, it
must obtain EPA's approval.
    Response: OAC 252:100-25-5 imposes continuous opacity monitoring
requirements on sources subject to 40 CFR part 51, appendix P and is,
therefore, governed by the requirements in appendix P. The February 14,
2017 submittal includes a revision to OAC 252:100-25-5(c) which
eliminates the words ``and EPA'' from the rule's requirement concerning
the case-by-case approval of alternative monitoring requirements
different from the provisions of parts 1 through 5 of 40 CFR part 60,
appendix P if continuous monitoring cannot be implemented by a source
due to physical plant limitations or extreme economic reasons. Thus,
OAC 252:100-25-5(c) concerns the installation and operation of emission
monitoring systems as required by 40 CFR 51.214 and not the
requirements related to enforceable test methods or alternative test
methods as provided in 40 CFR 51.212 and cited to by the commenters.
More specifically, 40 CFR 51.214(c) requires that the type of sources
set forth in 40 CFR part 51, appendix P meet the applicable
requirements therein. In turn, appendix P states that SIPs may include
provisions that provide for approval, on a case-by-case basis, of
alternative monitoring requirements if the installation of a continuous
monitoring system cannot be implemented by a source due to physical
limitations or extreme economic reasons. See 40 CFR part 51, appendix
P, part 6.0, Special Consideration. Importantly, there is no
requirement that the state obtain EPA's approval when making such
determinations. The state rulemaking record for the changes to OAC
252:100-25-5(c) support ODEQ's position that the provisions therein are
based on the special consideration language of part 6 of 40 CFR part
51, appendix P, which describes the powers and duties of the state and
alternatives to monitoring for sources with certain conditions. See
pages 16-17 of the Transcript of Proceedings of the Air Quality Council
Meeting, dated November 14, 2014, included in the February 14, 2017
submittal.\15\ Based upon Oklahoma's statements as well as the
discussion above, no changes are made to the proposed approval of this
rule revision as a result of this comment, and we are approving the
submitted revision to OAC 252:100-25 into the Oklahoma SIP.
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    \15\ See document ID No. EPA-R06-OAR-2017-0145-0003 at
Regulations.gov.
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    Comment 4: OAC 252:100-31--Control of Emission of Sulfur Compounds.
The commenter notes that the revisions would eliminate the
SO2 ambient standards (exposure limits) in the existing SIP
at OAC 252:100-31-12 (renumbered OAC 252:100-31-7). The

commenters claim that, contrary to ODEQ's assertion, the removed
standards can still be considered protective of the current (2010)
SO2 NAAQS. More specifically, the commenters note that the
averaging times and calculation methodologies underlying the existing
SO2 SIP ambient (exposure) standards are significantly
different than the 2010 SO2 NAAQS averaging times and
methodologies. Due to the form of the SO2 standards in the
existing SIP being significantly different (5-minute) than the form of
the 2010 (1-hour) SO2 NAAQS and the its application to
existing equipment, the commenters assert that OAC 252:100-31-12 in the
existing SIP may provide protections in addition to those provided by
the 2010 SO2 NAAQS. The commenters questioned the CAA
section 110(l) noninterference demonstration submitted by ODEQ as well
as the EPA's proposed finding that the CAA section 110(l) requirements
have been met. In addition, the commenters assert that removal of the
SO2 standards from the SIP could lead to increased emissions
and relaxation of limits previously taken by some sources in order to
meet these SIP requirements. The commenters note that such emission
increases would need to be evaluated under CAA section 110(l) and
determined not to adversely impact the NAAQS or PSD increments. In
addition, they assert that the EPA must determine that other
requirements in 40 CFR 51.166(a) and 40 U.S.C. 7410 and 7471 have been
met. Finally, the commenters assert that record should include an
analysis demonstrating that the requirements of CAA section 193 and 40
CFR 51.165(a)(2) have been met.
    Response: As the commenters note, the February 14, 2017 submittal
includes a revision to OAC 252:100-31 which removes SO2
ambient standards (exposure limits) in the existing SIP at OAC 252:100-
31-12 (renumbered OAC 252:100-31-7).\16\ Oklahoma's SIP submittal also
includes a CAA section 110(l) Noninterference Demonstration. The
purpose of a CAA section 110(l) demonstration is to ensure that the
proposed SIP revision does not interfere with any applicable
requirement concerning attainment of the NAAQS or any other applicable
requirement of the CAA. See 42 U.S.C. 7410(l). The revision which must
be evaluated under CAA section 110(l) (to determine if it interferes
with attainment or maintenance of the NAAQS or any other CAA
requirement) is the removal of the SO2 state standards in
the existing SIP at OAC 252:100-31-12 (renumbered OAC 252:100-31-7).
---------------------------------------------------------------------------

    \16\ As noted in Supplement 3 to the TSD included in the docket
for this action, the replaced SO2 standards are state
standards (i.e., not required by the EPA SIP regulations) that have
been approved into the Oklahoma SIP. See document ID No. EPA-R06-
OAR-2017-0145-0002 at Regulations.gov.
---------------------------------------------------------------------------

    As noted on pages 3-4 of ODEQ's July 31, 2018 Letter:

    ``Because the state standards have been replaced with the
national standards, provisions are in place to prevent Oklahoma
sources' emissions from interfering with the 2010 1-hour NAAQS. . .
. And, if one of the permits, due to the removal of these [state]
standards, had resulted in significant increases in emissions from a
major stationary source, the permit would have required a Prevention
of Significant Deterioration (PSD) review. Additionally, the Data
Requirements Rule (DRR) in 40 CFR part 51 has resulted in additional
SO2 monitors and modeling in Oklahoma. This modeling
shows the areas around the DRR sources to be in attainment of the
2010 SO2 1-hour NAAQS. Ambient air monitoring is ongoing,
but data collected to date indicate that monitored areas are
attaining the SO2 NAAQS. These factors support DEQ's
110(1) demonstration that there has been no deterioration of air
quality in Oklahoma due to the removal of these state standards.''

    As stated above, Oklahoma opted to revise its state law to remove
the outmoded SO2 standards in OAC 252:100-31-12 (renumbered
to OAC 252:100-31-7), in light of the EPA's 2010 SO2 NAAQS
and its incorporation into OAC 252:100, Appendix E. It now asks the EPA
to approve this revision into the SIP. Since the removal of OAC
252:100-31-12 from the SIP cannot interfere with the attainment of the
2010 SO2 NAAQS, the Oklahoma SIP contains provisions to
ensure that SO2 sources do not interfere with the current
SO2 NAAQS as discussed below.
    In response to commenters concern that existing sources may seek
modifications to remove or change SO2 emission limits
previously taken in air permits in order to meet the replaced state
SO2 standard, ODEQ notes provisions are in place to prevent
Oklahoma sources from interfering with the 2010 SO2 NAAQS.
Such provisions are found in Oklahoma's major and minor NSR SIP
programs. For example, under OAC 252:100-7 (permits for minor
facilities), which has been approved into the Oklahoma SIP,
construction and operating permits must contain provisions that
prohibit exceedances of ambient air quality standards contained in OAC
252:100-3, including the 2010 SO2 NAAQS. See OAC 252:100-7-
15(d) and 7-18(f). In addition, as noted in ODEQ's July 13, 2018 Letter
and under OAC 252:100-8 of the EPA-approved Oklahoma SIP, permits for
Part 70 sources (including PSD sources) must include operational
conditions and limitations necessary to assure compliance with all
applicable requirements, including the 2010 SO2 NAAQS and
other SIP requirements. See OAC 252:100-8-6(a) and OAC 252:100-8-2
(definition of applicable requirement). Therefore, should a source
submit a permit application to revise an emissions limitation
previously taken to meet the state SO2 standard, ODEQ would
need to conduct an evaluation of the impacts associated with an
increase of emissions on the NAAQS and PSD increments as well as ensure
that the requirements of 40 CFR 51.166(a) and other applicable
requirements of the CAA have been met, including those cited by the
commenter. See, e.g., OAC 252:100-8, Part 7 of the federally-approved
Oklahoma SIP; see also 40 CFR part 52, subpart LL.
    Finally, in confirmation of ODEQ's July 31, 2018 Letter which
states that ``Oklahoma has never relied upon Subchapter 31 as a control
measure for any nonattainment plans adopted before November 15, 1990''
in relation to CAA section 193, we searched EPA's Greenbook site for
the Designated Area Design Values for NAAQS of 1987 PM10,
1971 SO2, 1978 Pb, 1971 CO, and 1971 NO2 and did
not find information concerning any pre-November 15, 1990 nonattainment
plan in place for these criteria pollutants in Oklahoma. See the chart
on page 14 of Supplement 3 to TSD.\17\ As such, the requirements of CAA
section 193 are not applicable to this rulemaking action. Therefore,
based upon Oklahoma's statements as well as the analysis presented in
the record and discussed above, the proposed revision would not
interfere with any applicable requirement concerning attainment or any
other applicable requirement of the Act. Therefore, no changes have
been made to the proposed approval of this rule revision as a result of
this comment.
---------------------------------------------------------------------------

    \17\ See https://www3.epa.gov/airquality/greenbook/ndtc.html
(URL dated May 15, 2018).
---------------------------------------------------------------------------

    In addition, from a historical perspective of SO2 NAAQS
review, we note the Clean Air Scientific Advisory Committee stated that
the Risk and Exposure Assessment (REA) had presented a ``convincing
rationale'' for a one-hour standard, and that ``a 1-hour standard is
the preferred averaging time'' and has been ``in agreement with having
a short-term standard and finds that the REA supports a one-hour
standard as protective of public health.'' (74 FR 64833, December 8,
2009).\18\ For

example, the existing OAC 252:100-31-12(a), in part, sets forth an
ambient air concentration of sulfur dioxide at 1300 [mu]g/m3 (0.50 ppm)
in a five (5) minute period. In developing the SO2 NAAQS,
EPA wrote,
---------------------------------------------------------------------------

    \18\ The Clean Air Scientific Advisory Committee is designed to
provide independent advice to the EPA Administrator on the technical
bases for EPA's NAAQS, and the Risk and Exposure Assessment is a
planning document EPA develops when establishing NAAQS for criteria
pollutants.

    ``When evaluating alternative forms in conjunction with specific
levels, the REA considered the adequacy of the public health
protection provided by the combination of level and form to be the
foremost consideration. In addition, the REA recognized that it is
important that the standard have a form that is reasonably stable.
As just explained in the context of a five-minute averaging time, a
standard set with a high degree of instability could have the effect
of reducing public health protection because shifting in and out of
attainment could disrupt an area's ongoing implementation plans and
---------------------------------------------------------------------------
associated control programs (74 FR 64833, December 8, 2009).''

    In addition, as a part of final FR SO2 NAAQS in the 1996
rulemaking \19\ regarding a 5-minute standard CASAC wrote:
---------------------------------------------------------------------------

    \19\ https://www.govinfo.gov/content/pkg/FR-1996-05-22/pdf/96-12863.pdf, Page 25579.

    ``3. It was the consensus of CASAC that any regulatory strategy
to ameliorate such exposures be risk-based-targeted on the most
likely sources of short-term sulfur dioxide spikes rather than
imposing short term standards on all sources. All of the nine CASAC
Panel members recommended that Option 1, the establishment of a new
5-minutes standard, not be adopted. Reasons cited for this
recommendation included: the clinical experiences of many ozone
experts which suggest that the effects are short-term, readily
reversible, and typical of response seen with other stimuli.
Further, the committee viewed such exposures as rare events which
will even become rarer as sulfur dioxide emissions are further
reduced as the 1990 amendments are implemented. In addition, the
committee pointed out that enforcement of a short-term NAAQS would
require substantial technical resources. Furthermore, the committee
did not think that such a standard would be enforceable. 4. CASAC
questioned the enforceability of a 5-minute NAAQS or ``target
level.'' Although the Agency has not proposed an air monitoring
strategy, to ensure that such a standard or ``target level'' would
not be exceeded, we infer that potential sources would have to be
surrounded by concentric circles of monitors. The operation and
maintenance of such monitoring networks would be extremely resource
intensive. Furthermore, current instrumentation used to routinely
monitor sulfur dioxide does not respond quickly enough to accurately
---------------------------------------------------------------------------
characterize 5-minute spikes.''

    Upon inquiry we were informed that the State did not collect 5-
minute (short term) SO2 monitoring data and such information
does not exist for us to evaluate or compare the State-only standard
with the 2010 1-Hour SO2 NAAQS for CAA section 110(l)
purposes.
    To the extent sources were subject to the 5-minute standard, it
would have arisen during the permitting process if a modeling
demonstration had indicated more stringent permit limits would be
necessary to protect the five minute average. As noted by ODEQ above,
any attempt to remove those limitations would trigger PSD requirements
(e.g., BACT analysis) had there been a significant SO2
emissions increase.
    No comments pertaining to February 14, 2017 revisions to OAC
252:100 Appendix E--Primary Ambient Air Quality Standards, and OAC
252:100 Appendix F--Secondary Ambient Air Quality Standards were
received. Therefore, approval of these two Appendices as a revision to
the Oklahoma SIP will be finalized as proposed.
    This concludes our response to relevant comments received. No
changes to the Proposal and the SNPR have been made as a result of the
comments received; therefore, we are finalizing proposed revisions
noted in the Proposal and the corresponding SNPR into the Oklahoma SIP,
as submitted on February 14, 2017.

III. Final Action

    We are approving rule revisions to OAC:252:100 Subchapters 13 Open
Burning, 17 Incinerators, 25 Visible Emissions and Particulates, 31
Control of Emission of Sulfur Compounds, Appendix E Primary Ambient Air
Quality Standards, and Appendix F Secondary Ambient Air Quality
Standards as submitted on February 14, 2017. Our approval will
incorporate these changes into the SIP for Oklahoma.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.4, the EPA is finalizing the incorporation by reference of the
revisions to the Oklahoma regulations as described in the Final Action
section above. The EPA has made, and will continue to make, these
documents generally available electronically through
www.regulation.gov, Docket ID. No. EPA-R06-OAR-2017-0145 and at the EPA
Region 6 office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993); and 13563 (76 FR 3821, January
21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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;
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 30, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposed of
judicial review nor does it extend the time within which a petition for
judicial review may be filed and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: July 25, 2019.
David Gray,
Acting Regional Administrator, Region 6.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart LL--Oklahoma

0
2. In Sec.  52.1920, the table in paragraph (c), under the heading
entitled ``Chapter 100 (OAC:252:100). Air Pollution Control,'' is
amended:
0
a. Under Subchapter 13 by:
0
i. Revising the entries for ``252:100-13-2'' and ``252:100-13-7'',
under Subchapter 13;
0
ii. Adding an entry for ``252:100-13-8''; and
0
iii. Revising the entry for ``252:100-13-9'';
    b. Under Subchapter 17 by:
0
i. Revising the heading for Part 3; and
0
ii. Revising the entry for ``252:100-17-2``;
0
c. Under Subchapter 25 by revising the entry for ``252:100-25-5'';
0
d. Under Subchapter 31 by:
0
i. Revising the entries for ``252:100-31-1'' and ``252:100-31-2'';
0
ii. Removing the entry for ``252:100-31-3'';
0
iii. Adding a heading entitled ``Part 2. Ambient Air Concentration
Limits or Impacts for New and existing Equipment, Sources, or
Facilities'' immediately after the entry for 252:100:31-2;
0
iv. Adding an entry for ``252:100-31-7'' under added Part 2;
0
v. Removing the entries for ``252:100-31-12'' and ``252:100-31-14''
under Part 3;
0
vi. Revising the entries for ``252:100-31-13'' and ``252:100-31-15''
under Part 3;
0
vii. Adding an entry for ``252:100-31-16'' under Part 3;
0
viii. Revising the entries for ``252:100-31-25'' and ``252:100-31-26''
under Part 5; and
0
f. Under Appendices for OAC 252: Chapter 110 by revising the entries
for ``252:100, Appendix E'' and ``252:100, Appendix F''.
    The revisions and additions read as follows:

Sec.  52.1920  Identification of plan.

* * * * *
    (c) * * *

                                                            EPA Approved Oklahoma Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
           State citation                 Title/subject             State effective date           EPA approval date               Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Chapter 100 (OAC:252-100). Air Pollution Control
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Subchapter 13. Open Burning
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-13-2.......................  Purpose...............  07/01/2013                         8/1/2019 [Insert
                                                                                Federal Register
                                                                                citation].

                                                                      * * * * * * *
252:100-13-7.......................  Allowed open burning..  07/01/2013                         8/1/2019 [Insert
                                                                                Federal Register
                                                                                citation].
252:100-13-8.......................  Use of air curtain      07/01/2013                         8/1/2019 [Insert
                                      incinerators.                                              Federal Register
                                                                                citation].
252:100-13-9.......................  General conditions and  07/01/2013                         8/1/2019 [Insert
                                      requirements for                                           Federal Register
                                      allowed open burning.                                      citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Subchapter 17. Incinerators
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Part 3. General Purpose Incinerators
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-17-2.......................  Applicability.........  09/12/2014                         8/1/2019 [Insert        ................................
                                                                                Federal Register
                                                                                citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Subchapter 25. Visible Emissions and Particulates
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-25-5.......................  Continuous emission     07/01/2013                         8/1/2019 [Insert
                                      monitoring for                                             Federal Register
                                      opacity.                                                   citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Subchapter 31. Control of Emission of Sulfur Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Part 1. General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-31-1.......................  Purpose...............  07/01/2012                         8/1/2019 [Insert
                                                                                Federal Register
                                                                                citation].
252:100-31-2.......................  Definitions...........  07/01/2012                         8/1/2019 [Insert
                                                                                Federal Register
                                                                                citation].
--------------------------------------------------------------------------------------------------------------------------------------------------------
                       Part 2. Ambient Air Concentration Limits or Impacts for New and existing Equipment, Sources, or Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-31-7.......................  Allowable hydrogen      07/01/2012                         8/1/2019 [Insert
                                      sulfide (H2S) ambient                                      Federal Register
                                      air concentrations                                         citation].
                                      for new and existing
                                      sources.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Part 3. Existing Equipment Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-31-13......................  Requirements for        07/01/2012                         8/1/2019 [Insert
                                      existing sulfuric                                          Federal Register
                                      acid plants.                                               citation].
252:100-31-15......................  Requirements for        07/01/2012                         8/1/2019 [Insert
                                      existing kraft pulp                                        Federal Register
                                      mills.                                                     citation].
252:100-31-16......................  Requirements for        07/01/2012                         8/1/2019 [Insert
                                      existing fossil fuel-                                      Federal Register
                                      fired steam                                                citation].
                                      generators.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Part 5. New Equipment Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
252:100-31-25......................  Requirements for new    07/01/2013                         8/1/2019 [Insert
                                      fuel-burning                                               Federal Register
                                      equipment.                                                 citation].
252:100-31-26......................  Requirements for new    07/01/2012                         8/1/2019 [Insert
                                      petroleum and natural                                      Federal Register
                                      gas processes.                                             citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Appendices for OAC 252: Chapter 100
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
252:100, Appendix E................  Primary Ambient Air     09/15/2016                         8/1/2019 [Insert
                                      Quality Standards.                                         Federal Register
                                                                                citation].
252:100, Appendix F................  Secondary Ambient Air   09/15/2016                         8/1/2019 [Insert
                                      Quality Standards.                                         Federal Register
                                                                                citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-16229 Filed 7-31-19; 8:45 am]
 BILLING CODE 6560-50-P


observed in increased incidence in both sexes at this dose.  Minimal to
moderate nephropathy was observed in increased incidence for both male
and female mice, but was not a factor contributory to death at this
dose.

In male and female mice, the 7000 ppm dose level produced significant
systemic effects in addition to significant nephropathy.  For both
sexes, the nephropathy at this dose was considered a factor contributory
to death in a majority of the mice.  In addition, survival in female
mice by the end of the study was below 25%, which exceeds the guideline
criteria for survival in a mouse carcinogenicity study.  Although
changes in liver weight were observed at both 5000 and 7000 ppm for male
and female mice, these changes could not be related to any histological
alterations in the liver.  Therefore, the LOAEL is considered to be 851
mg/kg/day in males; 1008 mg/kg/day in females (7000 ppm).  The NOAEL is
considered to be 590 mg/kg/day in males; 715 mg/kg/day in females (5000
ppm).

Discussion of Tumor Data:  	There was no evidence of increased incidence
of tumors in this study for male and female mice.

Adequacy of the Dose Levels Tested:  The 7000 ppm dose level is
considered adequate for testing of the carcinogenic potential in male
mice, based on the significant systemic effects and nephropathy observed
at this dose.  For female mice, the 7000 ppm dose level is considered
excessive, based on the reduction in survival at this dose which exceeds
the guideline limit.  An adequate dose for testing of carcinogenicity in
female mice is considered to be between 5000-7000 ppm, based on the
observation of significant systemic effects at 7000 ppm but excessive
reductions in survival, and a lack of sufficient effects at 5000 ppm,
supporting a dose level in between these 2 doses for female mice.

870.4300		Chronic/Oncogenicity

Study Selected:   Combined Chronic Toxicity/Carcinogenicity Study - Rat

MRID No.: 43080037

Executive Summary:   In a combined chronic toxicity/carcinogenicity
study, rats were fed fludioxonil technical in the diet at concentrations
of either 0, 10, 30, 100, 1000 or 3000 ppm for either 12 or 24 months
(males: 0, 0.37, 1.1, 3.7, 37 or 113 mg/kg/day, respectively; females:
0, 0.44, 1.3, 4.4, 44 or 141 mg/kg/day, respectively).  In addition,
rats from the control and 3000 ppm groups were fed the test diets for 12
months and then allowed to recover for one month prior to sacrifice.

Males in the 1000 and 3000 ppm groups and females in the 3000 ppm group
had a higher incidence of dark stool and urine and staining (mostly
blue) around the pelvic region and abdomen.  The 3000 ppm group males
also had a higher frequency of diarrhea. Mean body weight and body
weight gain in the 3000 ppm group males and females were decreased in
comparison to the control throughout the study.  Body weight gain for
the 3000 ppm group males and females at Week 13 was 90 and 92% of the
control value, respectively.  There was no treatment-related effect on
food or water consumption.  Food efficiency was significantly reduced
for the 1000 and 3000 ppm group males during the first 13 weeks of the
study.

Females in the 3000 ppm group had some evidence of slight anemia at the
12-month evaluation.  At necropsy, there was an increased incidence in
the following changes in males: enlarged livers in the 3000 ppm group;
kidneys with cysts in the 1000 and 3000 ppm groups; and kidneys with
discolored foci or general discoloration in the 3000 ppm group. In the
females, there was an increased incidence of kidneys with general
discoloration in the 1000 and 3000 ppm groups.  There were no
treatment-related effects on organ weight.  On histopathology, males in
the 3000 ppm group had an increased incidence of kidney cysts and a
higher frequency and increased severity of progressive nephropathy.
Males and females in the 3000 ppm group had an increased incidence and
more severe grade of histopathological changes in the liver.

There was an increased incidence of hepatocellular tumors in both sexes
of the 3000 ppm group, however the increase in males was not
statistically significant.  The only statistically significant finding
in females was an increase in combined adenomas and carcinomas (0/70,
1/60, 0/60, 1/60, 2/60 and 5/70 in the 0, 10, 30, 100, 1000 and 3000 ppm
groups, respectively). Males and females in the 3000 ppm group had an
increased incidence of basophilic foci in the liver; males also had an
increase in hepatocellular hypertrophy.  There were no differences
between the control and the 3000 ppm group males or females in the
recovery phase evaluations.

The LOAEL for males and females was 113 and 141 mg/kg/day, respectively
(3000 ppm) based on decreased body weight and weight gain, slight anemia
in females at 12 months, and increased incidence and severity of
histopathology changes in the liver. The NOAEL for males and females was
37 and 44 mg/kg/day, respectively (1000 ppm).

Discussion of Tumor Data:  Fludioxonil technical was not carcinogenic in
male rats.  There was a statistically significant increase in the
incidence of combined adenomas and adenocarcinomas of the liver in
female rats in the 3000 ppm (141 mg/kg/day) group.

Adequacy of the Dose Levels Tested:  The 3000 ppm dose level was
considered adequate for carcinogenicity testing, based on decreased body
weight and body weight gain in both sexes, slight anemia in females at
12 months,  and an increased incidence and severity of liver
histopathology changes in both sexes.

A.3.6	Mutagenicity

870.5100 	Mutagenicty – Bacterial; Ames Salmonella Assay

MRID No.:  43080038

Executive Summary:  Fludioxonil technical was tested in two independent
trials for the ability to cause mutations in Salmonella typhimurium
strains TA-1535, 1537, 98, and 100  in the absence and presence of
metabolic activation (Arochlor 1254 induced rat liver S-9).  Fludioxonil
technical was also tested for mutagenic effects on the
tryptophan-auxotrophic strain E. coli WP2uvrA.  Fludioxonil technical at
concentrations of 0, 20, 78, 313, 1250, or 5000 µg/plate in the absence
and presence of metabolic activation failed to produce an increase in
revertant colonies in either Salmonella or E. coli.  Doses greater than
313 µg/plate were insoluble.  There was evidence of cytotoxicity at the
1250 and 5000 µg/plate concentrations for the Salmonella strains
tested.  Positive controls appeared adequate for all strains of
Salmonella tested and for the strain of E. coli tested.

870.5300 	Mutagenicty – Bacterial; Point Mutation Test – Chinese
hamster

MRID No.:  43152501

Executive Summary:  Fludioxonil technical was tested for the ability to
cause mutations in Chinese hamster V79 ovary cells in vitro in the
absence and presence of metabolic activation (Aroclor 1254 induced rat
liver S-9).   Cells were treated without microsomal activation for 21
hours and for 5 hours with microsomal activation.  Doses used were:
non-activation, 0.5-10.0 µg/ml (initial experiment); 1.0-20.0 µg/ml
(confirmatory experiment); activation, 1.5-30.0 µg/ml (initial
experiment); 3.0-60.0 µg/ml (confirmatory experiment).  Doses > 16
µg/ml in the absence of S9 reduced cell survival by >90%, and
approximately 20% of the cells survived treatment with 60 µg/ml in the
presence of S9.  Fludioxonil technical at the concentrations tested in
this study produced no increase in number of thioguanine-resistant
colonies, mutant frequency, or in the mutant factor in Chinese hamster
V79 cells in the absence or presence of metabolic activation.   Under
conditions of non-activation and activation, positive control materials
produced the expected increases in mutant frequency and the mutant
factor, indicating the sensitivity and validity of the assay.

870.5375 	Mutagenicty – Structural Chromosomal Aberrations; In vitro
Chromosomal Aberration

MRID No.:  43080040

Executive Summary:  In an in vitro chromosome aberration assay in
Chinese hamster ovary (CHO) cells, CHO cells were exposed to ten
non-activated and ten S9-activated doses of fludioxonil technical
ranging from 1.37 to 700 µg/ml for 3 hours and harvested 21 hours
postexposure.  Cultures treated with 0, 10.94, 21.88, or 43.75 µg/ml
-S9 or 0, 5.47, 10.94, 21.88, 43.75, 87.5, 175 or 350 µg/ml +S9 were
scored for chromosome aberrations.  In a subsequent experiment, cells
were exposed to nonactivated doses of 1.37-700 µg.ml for 24 hours and
were harvested immediately following treatment.  Cultures treated with
2.73, 5.47, or 10.94 µg/ml were examined for aberrant cells.  The S9
fraction was derived from Aroclor 1254-induced male RAI rats and the
test material was delivered to the test system in dimethyl sulfoxide
(DMSO).

Severe cytotoxicity occurred at nonactivated doses > 87.5 µg/ml (3 hour
cell treatment) and > 43.75 µg/ml (24 hour cell treatment).  In the
presence of S9 activation, the test material was less cytotoxic, with
severe cytotoxicity only observed at 700 µg/ml.  The nonactivated test
material induced structural aberrations and polyploidy at 21.88 and
43.75 µg/ml following the 3 hour treatment.  Following the continuous
24-hour exposure to the nonactivated test material, a dramatic
dose-related increase in polyploids was seen; increases were 4- to
82-fold higher than the solvent control at concentrations ranging from
2.73-10.94 µg/ml, respectively.  Under S9-activated conditions, a
doubling of the mitotic index (MI) at 175 and 350 µg/ml was not
accompanied by scorable chromosome damage at the high dose. However, as
the test material concentration was lowered, increased yields of both
structural and numerical aberrations occurred.  Peak clastogenesis was
noted at 87.5-175 µg/ml and increases in polyploidy of 8-, 53-, and
12-fold over the solvent control were induced at 43.75, 87.5, and 175
µg/ml, respectively. Although the test material was genotoxic in both
the absence and presence of S9 activation, the reduction of cytotoxicity
under S9 activated conditions permitted the detection of fludioxonil
technical as a powerful inducer of mitotic arrest.  As the S9-activated
dose decreased, increasing proportions of the treated population were
able to recover from mitotic block and manifest the chromosome damage in
the subsequent cell division.  Overall, the results indicating
nondisjunction of chromosomes point to an effect on the mitotic spindle.

870.5375 	Mutagenicty – Structural Chromosomal Aberrations; In vivo
Chromosomal Aberration

MRID No.:  43080042

Executive Summary:  In an in vitro cytogenetic assay in Chinese hamster
bone marrow cells, Chinese hamsters received either a single oral gavage
administration of 0, 1250, 2500, or 5000 mg/kg fludioxonil technical.
Based on the analytical determinations, the applied concentration of the
high dose was 3785-4380 mg/kg.  At 16, 24, or 48 hours
post-administration of the high dose, animals were sacrificed and bone
marrow cells were collected and examined for structural and numerical
chromosome aberrations.  The harvest time for mid- and low-dose animals
was 24 hours.  The test material was delivered to the animals as
suspensions prepared in 0.5% carboxymethyl cellulose.  There was no
evidence of compound toxicity in the treated animals or cytotoxic
effects on the target cell.  There was also no indication that the test
material induced a clastogenic effect in male or female Chinese hamster
somatic cells.  Although less than the limit dose was tested, it is
unlikely that increasing the level to 5000 mg/kg would alter the
conclusions relative to structural chromosome damage.  The results with
the positive control confirmed the sensitivity of the test system to
detect damage to chromosome morphology in Chinese hamster bone marrow
cells.  Nevertheless, the occurrence of hyperploidy in one mid-dose
female and trisomy in one high dose male was noted.

870.5395 	Mutagenicty – In Vivo Cytogenetics; In vivo Hepatocyte
Micronucleus Assay

MRID No.:  43080043

Executive Summary:  In an in vivo rat hepatocyte micronucleus assay,
male rats received either single oral gavage doses of 1250, 2500, or
5000 mg/kg fludioxonil either 3 days prior to mitogenic stimulation with
1000 mg/kg 4-acetylaminofluorene (4-AAF; Phase 1) or 29 hours
post-mitogenic stimulation (Phase 2).  Hepatocytes were recovered 3 days
post-treatment with 4-AAF (Phase 1) or 3 days post-treatment with the
test material (Phase 2), and harvested liver cells were scored for the
frequency of micronucleated hepatocytes (MHs). The test material was
delivered to the test animals as suspensions prepared in 0.5%
carboxymethyl cellulose.  The test material was neither overtly toxic to
the rats nor cytotoxic to the target cell.  In Phase 1, there was also
no significant or dose-related increase in MHs. However, results from
Phase 2 showed significant increases in MHs at the intermediate (p =
0.02) and low (p < 0.0001) dose but no increases at the high dose.  The
study author considered this finding to be of no biological
significance.  However, the results are striking because of their
similarity to the dose-response obtained in the in vitro Chinese hamster
ovary (CHO) cell cytogenetic assay conducted with fludioxonil technical
(see MRID # 43080040).  In this study, fludioxonil technical caused
profound mitotic arrest at the highest assayed dose, and since metaphase
block was complete, damage to the chromosomes was not apparent.  As the
dose decreased, the incidence of both structural and numerical
(polyploid) chromosome aberrations increased presumably because
sufficient cells recovered from the mitotic block and were able to
express the chromosome damage.  The findings are of particular interest
owing to the dramatic increases in polyploidy.  By analogy to the in
vitro results, the possibility exists, therefore, that a similar
mechanism may be operating in vivo in the rat hepatocytes but could not
be fully characterized with the available information.  Based on these
considerations, HED considers that sufficient doubts have been raised to
preclude us from reaching definitive conclusions and to justify the
recommendation that the study be repeated using lower doses.  HED
further believe that only Phase 2 warrants additional investigation
since the data do suggest that fludioxonil may only induce genetic
damage in actively dividing hepatocytes.

It is noted that an acceptable bone marrow micronucleus assay was
submitted (MRID 43080041).  Nevertheless, HED believes that the in vivo
rat hepatocyte study should be repeated since the utility of the study
in uncovering the mechanism(s) by which the test material could induce
genetic damage is of primary interest

870.5550 	Mutagenicty – Other; Unscheduled DNA Synthesis - Rat

MRID No.:  45050502

Executive Summary:  In an unscheduled DNA synthesis (UDS) assay, rat
hepatocyte cultures from male Sprague-Dawley rats orally dosed once with
fludioxonil (96.4% a.i. Lot/Batch# P.910007) in 0.5% carboxymethyl
cellulose at 2500 or 5000 mg/kg, were observed for DNA damage.
Hepatocytes were harvested after a 4-hour exposure to the test material
or vehicle alone; dimethylnitosamine (DMN; cell harvest after 2 hour
exposure) served as the positive control.  The criteria for a positive
mutagenic response was either, the mean gross number and the mean net
number of grains per nucleus with an increase at any dose level compared
to the vehicle control and the mean net value of 2.0 or higher; or the
percentage distribution of the gross and net numbers of grains show an
obvious shift to higher values at any dose level compared to the vehicle
control distribution.  In addition, an independent replicative DNA
synthesis (RDS) assay was performed to determine if the test compound
may cause hepatotoxicity.  The hepatocytes were harvested after a
38-hour exposure to the test compound (2500 or 5000 mg/kg), vehicle
alone, or positive control, 4-acetylaminofluorene (4-AAF).

Fludioxonil was tested up to the limit dose (5000 mg/kg).  There was no
evidence that unscheduled DNA synthesis, as determined by nuclear silver
grain counts, was induced at 2500 or 5000 mg/kg.  The response for
induction of replicative DNA synthesis by fludioxonil was equivocal,
because only 1/4 of the 5000 mg/kg cultures showed an increase compared
to vehicle controls and none of the 2500 mg/kg cultures showed an
increase.  Vehicle control values were within the historical range and
the ability of the test system to detect DNA damaging agents was
adequately shown by the response induced by the positive controls.

870.5550 	Mutagenicty – Other; In Vitro Unscheduled DNA Synthesis
Assay

MRID No.:  43080039

Executive Summary: In two independently conducted in vitro unscheduled
DNA synthesis (UDS) assays, primary rat hepatocytes were exposed to
eight fludioxonil technical doses ranging from 4.1 to 5000 µg/ml
(initial trial) and six doses ranging from 4.1 to 1000 µg/ml
(confirmatory trial).  The test material was delivered to the test
system in dimethyl sulfoxide (DMSO).  Compound precipitation occurred at
doses > 37 µg/ml and cytotoxicity was apparent at 313 µg/ml.  There
was, however, no indication of genotoxicity at any insoluble (> 37
µg/ml) or soluble level (4.1 or 12.3 µg/ml).  Hepatocytes responded in
the expected manner to the genotoxic action of the positive controls.

870.5550 	Mutagenicty – Other; Dominant Lethal Assay - Mice

MRID No.:  43080044

Executive Summary:  In a dominant lethal assay, male mice received
either a single oral gavage administration of 0, 1250, 2500, or 5000
mg/kg fludioxonil technical and were sequentially mated with untreated
females (1:2) for 8 consecutive weeks.  The test material was delivered
to the test system as suspensions prepared in 0.5% carboxymethyl
cellulose.  There was no evidence of compound toxicity in the treated
males, adverse effects on reproductive performance or cytotoxic effects
on the target cell. There was also no indication that the test material
induced dominant lethal mutations in male mouse germinal cells sampled
over the entire period of spermatogenesis.  The results with the
positive control confirmed the sensitivity of the test system to detect
genetic damage in male mouse germinal cells.

870.5550 	Mutagenicty – Other; Point Mutation Test

MRID No.:  43152501

Executive Summary:  Fludioxonil technical was tested for the ability to
cause mutations in Chinese hamster V79 ovary cells in vitro in the
absence and presence of metabolic activation (Aroclor 1254 induced rat
liver S-9).   Cells were treated without microsomal activation for 21
hours and for 5 hours with microsomal activation.  Doses used were:
non-activation, 0.5-10.0 µg/ml (initial experiment); 1.0-20.0 µg/ml
(confirmatory experiment); activation, 1.5-30.0 µg/ml (initial
experiment); 3.0-60.0 µg/ml (confirmatory experiment).  Doses > 16
µg/ml in the absence of S9 reduced cell survival by >90%, and
approximately 20% of the cells survived treatment with 60 µg/ml in the
presence of S9.  Fludioxonil technical at the concentrations tested in
this study produced no increase in number of thioguanine-resistant
colonies, mutant frequency, or in the mutant factor in Chinese hamster
V79 cells in the absence or presence of metabolic activation.   Under
conditions of non-activation and activation, positive control materials
produced the expected increases in mutant frequency and the mutant
factor, indicating the sensitivity and validity of the assay.

870.5550 	Mutagenicty – Other; Micronucleus Assay - Mice

MRID No.:  43080041

Executive Summary:  In a mutagenicity study, fludioxonil technical
(97.5% a.i.) was evaluated in the mouse bone marrow micronucleus test to
detect possible damage of chromosomes or the mitotic apparatus.
Fludioxonil at doses up to and including the limit dose of 5000 mg/kg
was not overtly toxic to the test animals, cytotoxic to the target
organ, and produced no statistically significant increase in the number
or percentage of micronucleated polychromatic erythrocytes in male and
female mice.

870.5550 	Mutagenicty – Other; Micronucleus Assay - Rat

MRID No.:  45050503

Executive Summary:  In a primary rat hepatocyte micronucleus assay, 6
male rats/dose were administered fludioxonil (96.4% a.i., Lot/Batch#
P.910007), in 0.5% carboxymethyl cellulose, once by oral gavage (10
mL/kg) at 50, 250, or 1250 mg/kg.  Approximately 30 hours prior to
dosing, the rats were treated with the known mitogen
4-acetylaminofluorene (4-AAF), in arachis oil, once by oral gavage (1000
mg/kg; dose volume 10 mL/kg). Cyclophosamide (CPA), in distilled water,
at 20 mg/kg was used as the positive control and was administered via
intraperitoneal injection (5 mL/kg).  Hepatocytes were harvested at
approximately 72 hours after treatment by in situ perfusion and scored
for micronuclei.

Fludioxonil was tested up to 1250 mg/kg. No clinical signs related to
treatment with fludioxonil were observed.  Dark yellow urine and
chromodacryorrhea one to two days after treatment with 4-AAF were
observed. Fludioxonil did not significantly increase the number of
micronucleated hepatocytes at any dose, compared to the vehicle control.
 The vehicle control values were within the historical range provided.
The positive control produced significant increases in micronucleated
hepatocytes.  Individual treated and positive control animals showed
marked increases in the frequency of hepatocytes in apoptosis; however,
the group means were not significantly different compared to the vehicle
control.  It was stated that the increase in apoptosis may be attributed
to synergistic effects of 4-AAF and fludioxonil or 4-AAF and the
positive control, respectively.

Based on the lack of a statistically significant increase in the number
of micronucleated hepatocytes in the treated groups, fludioxonil is
considered not to be mutagenic in rats in this in vivo micronucleus
assay.

870.6200	Neurotoxicity - Rat

Not applicable.

870.6300	Developmental Neurotoxicity – Rat

Not applicable.

A.3.8	Metabolism

870.7600		Dermal Absorption – Rat

An upper bound dermal absorption factor of 40% was extrapolated
comparing the ratio of the LOAEL of 428 mg/kg/day in the 90 day oral
toxicity study in rats and the NOAEL of 1000 mg/kg/day (assumed to be a
LOAEL; worst case scenario) in the 21-day dermal toxicity study in rats.

Appendix B:	REFERENCES (in MRID order)

43080019	Hartmann, P. (1989) Acute Inhalation Toxicity in the Rat:
CGA-173506 Technical: Lab Project Number: 881491. Unpublished study
prepared by Ciba-Geigy Limited. 30 p.

43080024	Schneider, P. (1988) Skin Sensitization Test in the Guinea Pig
with CGA-173506 Technical Maximisation Test Report: Lab Project Number:
881490. Unpublished study prepared by Ciba-Geigy Limited. 30 p.

43124105	Glaza, S. (1991) Acute Oral Toxicity Study of CGA-173506
Technical in Rats: Lab Project Number: HWI 10200144: AMENDMENT NO. 1:
TP3013. Unpublished study prepared by Hazleton Wisconsin, Inc. 29 p.

43124106	Hartmann, P. (1988) Acute Dermal Toxicity in the Rat with
CGA-173506 Technical: Lab Project Number: 881489: AMENDMENT NO. 1.
Unpublished study prepared by Ciba-Geigy Limited. 19 p.

43124107	Glaza, S. (1991) Primary Eye Irritation Study of CGA-173506
Technical in Rabbits: Lab Project Number: HWI 10200147A: TP2012.
Unpublished study prepared by Hazleton Wisconsin, Inc. 32 p.

43124108	Glaza, S. (1991) Primary Dermal Irritation Study of CGA-173506
Technical in Rabbits: Lab Project Number: HWI 10200146: TP3014.
Unpublished study prepared by Hazleton Wisconsin, Inc. 22 p.

43080031	Vallet, L. (1982) Toxicity Study by Repeated Oral (Dietary)
Administration for 52 Weeks in Beagle Dogs: CGA 173506 Technical: Lab
Project Number: 5577 TCC: 881174. Unpublished study prepared by Centre
International De Toxicologie. 547 p.

43080032	Chang, J.; Wyand, D. (1993) 18-Month Dietary Oncogenicity Study
with CGA-173506 in Mice: Lab Project Number: F-00019. Unpublished study
prepared by Ciba-Geigy Corp. 1354 p.

43080033	Chang, J.; Wyand, D. (1993) 18-Month Dietary Oncogenicity Study
with CGA-173506 in Mice: Final Report: Lab Project Number: F-00071.
Unpublished study prepared by Ciba-Geigy Corp. 1549 p.

43080034	Savary, M. (1988) Assessment of Possible Embryotoxic or
Teratogenic Effects in Rats by Oral Route: CGA 173506 Technical: Lab
Project Number: 4517 RSR: 881177. Unpublished study prepared by Centre
International De Toxicologie. 165 p.

43080035	Savary, M. (1989) Assessment of Possible Embryotoxic or
Teratogenic Effects in Rabbits by Oral Route: CGA 173506 Technical: Lab
Project Number: 4801 RSL: 881728. Unpublished study prepared by Centre
International De Toxicologie. 147 p.

43080036	Singh, A.; Hazelette, J.; Yau, E. (1992) A Two-generation
Reproductive Toxicity Study in Rats: CGA 173506 Technical: Lab Project
Number: 902001: 2-074-01: 3979. Unpublished study prepared by Ciba-Geigy
Corp., Pharmaceuticals Div. 1029 p.

43080037	Chang, J.; Richter, A. (1993) 2-Year Chronic Toxicity/
Oncogenicity Study in Rats: CGA 173506 Technical: Lab Project No.
F-00018. Unpublished study prepared by Ciba-Geigy Corp., Plant
Protection Div. 2347 p.

43080038	Ogorek, B. (1989) Salmonella/Mammalian-Microsome Mutagenicity
Test: CGA 173506 Technical: Lab Project Number: 881495. Unpublished
study prepared by Ciba-Geigy Limited, Genetic Toxicology. 65 p.

43080039	Hertner, T. (1989) Autoradiographic DNA Repair Test on Rat
Hepatocytes: CGA 173506 Technical: Lab Project Number: 881494.
Unpublished study prepared by Ciba-Geigy Limited. 105 p.

43080040	Strasser, F. (1989) Chromosome Studies on Chinese Hamster Ovary
Cell Line CCL 61 In vitro: CGA 173506 Technical: Lab Project Number:
881496. Unpublished study prepared by Ciba-Geigy Limited. 37 p.

43080041	Hertner, T. (1990) Micronucleus Test, Mouse: CGA 173506
Technical: Lab Project Number: 881493. Unpublished study prepared by
Ciba-Geigy Limited. 41 p.

43080042	Hertner, T. (1993) Chromosome Studies on Somatic Cells of
Chinese Hamster: CGA 173506 Technical: Lab Project Number: 923099.
Unpublished study prepared by Ciba-Geigy Limited. 32 p.

43080043	Meyer, A. (1991) In vivo Micronucleus Test on Rat Hepatocytes:
CGA 173506 Technical: Lab Project Number: 901145. Unpublished study
prepared by Ciba-Geigy Limited. 59 p.

43080044	Hertner, T. (1992) Dominant Lethal Test, Mouse, 8 Weeks: CGA
173506 Technical: Lab Project Number: 923068. Unpublished study prepared
by Ciba-Geigy Limited. 84 p.

43152501	Dollenmeier, P. (1989) CGA 173506 Technical: Point Mutation
Test with Chinese Hamster Cells V79: Lab Project Number: 881497.
Unpublished study prepared by Ciba-Geigy Ltd. 50 p.

45050502	Hertner, T. (1993) In vivo/In vitro Unscheduled and Replicative
DNA Synthesis in Rat Hepatocytes: CGA-173506 Technical: Final Report:
Lab Project Number: 641-93. Unpublished study prepared by Novartis Crop
Protection AG. 70 p. {OPPTS 870.5550}

45050503	Ogorek, B. (1999) In vivo Micronucleus Test on Rat Hepatocytes:
CGA-173506 Technical: Final Report: Lab Project Number: 1195-98:
9831167. Unpublished study prepared by Novartis Crop Protection AG. 40
p.

Appendix C:  REVIEW OF HUMAN RESEARCH

No MRID - PHED Surrogate Exposure Guide

Appendix D:	INTERNATIONAL HARMONIZATION

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

	Common Name:

Fludioxonil 	x Proposed tolerance

( Reevaluated tolerance

( Other	Date: 4/4/08

Codex Status (Maximum Residue Limits)	U. S. Tolerances

( No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested	Petition
Number: 7E7234 & 2E6462

DP#s: 345970 & 349725

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0.45

Star apple 	0.45

Basil	10	Herb Subgroup 19A, fresh 	10

Basil, dry	50	Herb Subgroup 19A, dried 	65

Chives	10

Chives, dry	50

Leaves of root and tuber vegetables	40

Root vegetables, except sugar beet subgroup	0.50

Citrus fruits	7	Lemon 	0.25

Citrus fruits	7	Lime 	0.25

Cucumber

	0.3

	Cucurbits 	0.60

Tuberous and corm vegetables, except potato subgroup	4.0

Melons (except watermelon)	0.03

Squash, summer	0.3

Carrot	0.7	Carrot 	0.75

Turnip, greens 	10

Radish, tops	None

Citrus oil	None

Grapefruit oil	500

Limits for Canada	Limits for Mexico

( No Limits

( No Limits for the crops requested	( No Limits

( No Limits for the crops requested

Residue.

4-(2,2-difluoro-1,3-benzodioxol-4-yl) 1Hpyrrole-

3-carbonitrile

	Residue definition:

fludioxonil

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:  S.Funk, 04/08/2008.

 PAGE   36

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