[Federal Register: September 25, 2007 (Volume 72, Number 185)]
[Rules and Regulations]
[Page 54361-54363]
[DOCID:fr25se07-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2007-0174; FRL-8473-1]

Technical Amendments to Approval and Promulgation of Air Quality
Implementation Plans; Pennsylvania; Correction of Effective Date Under
Congressional Review Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction of effective date under Congressional
Review Act.

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SUMMARY: On July 25, 2007 (72 FR 40746), the EPA published in the
Federal Register a final rule that approved a request that the Franklin
County nonattainment area (``Franklin County Area'' or ``Area'') be
redesignated as attainment for the 8-hour ozone national ambient air
quality standard (NAAQS) and that approved the maintenance plan and the
2002 base-year emissions inventory as revisions to the Pennsylvania SIP
in accordance with the requirements of the Clean Air Act (CAA). That
July 25, 2007 final rule established an effective date of July 25,
2007. This document corrects the effective date of the rule to July 27,
2007 to be consistent with sections 801 and 808 of the Congressional
Review Act, enacted as part of the Small Business Regulatory
Enforcement Fairness Act, 5 U.S.C. 801 and 808.

EFFECTIVE DATE: This rule is effective on September 25, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-0174. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) 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 www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Christopher Cripps,<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 801 of the Congressional review Act precludes a rule from
taking effect until the agency promulgating the rule submits a rule
report, which includes a copy of the rule, to each House of Congress
and to the Comptroller General of the Government Accountability Office
(GAO). After publication of the July 25, 2007 final rule (72 FR 40746)
EPA discovered that it had inadvertently failed to submit the above
rule as required; thus, although the rule was promulgated on July 25,
2007 (72 FR 40746), by operation of law, the rule did not take effect
on July 25, 2007, as stated therein. After EPA discovered this error,
EPA complied with its obligations under the Congressional Review Act by
submitting the rule to both Houses of Congress and the GAO on July 27,
2007. This document corrects certain dates displayed in 40 CFR parts 52
and 81 to reflect the date on which EPA satisfied the procedural
requirements of the Congressional Review Act.
    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, an agency may issue a rule without providing
notice and an opportunity for public comment. EPA has determined that
there is good cause for making today's rule final without prior
proposal and opportunity for comment because EPA merely is
memorializing in this action that EPA's compliance with the
congressional review requirements of the Congressional Review Act, has
as a matter of law, changed the effective date of the July 25, 2007
action, and EPA has no discretion in this matter. Thus, notice and
public procedure are unnecessary. The Agency finds that this
constitutes good cause under 5 U.S.C. 553(b)(B). Moreover, because
today's action does not create any new regulatory requirements and the
submittal of the rule to Congress has, by operation of law, changed the
effective date of the July 25, 2007 rule to July 27, which this action
merely memorializes, EPA finds that good cause exists to provide for an
immediate effective date pursuant to 5 U.S.C. 553(d)(3). Because the
delay in the effective date was caused by EPA's inadvertent failure to
submit the rule under the Congressional Review Act, EPA does not
believe that affected entities that acted in good faith relying upon
the effective date stated in the July 25, 2007, Federal Register should
be penalized if they were complying with the rule as promulgated.

II. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Redesignation of an area to attainment under section 107(d)(3)(e) of
the Clean Air Act does not impose any new requirements on small
entities. Redesignation is an action that affects the status of a
geographical area and does not impose any new regulatory requirements
on sources.
    Accordingly, the Administrator certifies that this rule will not
have a significant economic impact on a substantial number of small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Because this rule approves pre-existing requirements under state law
and does not impose any additional enforceable duty beyond that
required by state law, it 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). This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000). Because this
action allows the state to avoid adopting or implementing other
requirements, affects the status of a geographical area, or does not
impose any new requirements on sources, this action also does not have
Federalism implications because it does not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999). This action
merely approves a state rule implementing a Federal requirement, and
does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal
standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission; to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    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 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 rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    This final rule only amends the effective date of the underlying
rule as promulgated on July 25, 2007 (72 FR 40746); it does not amend
any substantive requirements contained in the rule. Accordingly, to the
extent it is available, judicial review of today's final rule is
limited to the amended effective date. 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 November 26, 2007. Filing a petition for reconsideration by the
Administrator of this final rule does not affect the finality of this
rule for the purposes 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 amending consistent with the provisions of the
Congressional Review Act the effective date of the July 25, 2007 (72 FR
40746) rule approving the redesignation of the Franklin County Area to
attainment for the 8-hour ozone NAAQS, the associated maintenance plan,
the 2002 base-year emissions inventory, and the MVEBs identified in the
maintenance plan, may not be challenged later in proceedings to enforce
its requirements.

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

40 CFR Part 81

    Air pollution control, National parks, Wilderness areas.

    Dated: September 14, 2007.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by
revising the entry for the 8-Hour Ozone Maintenance Plan and the 2002
Base Year Emissions Inventory for the Franklin County, Pennsylvania
Area to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory  SIP         Applicable      State submittal                            Additional
            revision                geographic area          date        EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan     Franklin County             9/20/06,  7/25/07, 72 FR       The SIP effective
 and 2002 Base Year Emissions      Area (Franklin             11/08/06   40746.               date is
 Inventory.                        County).                                                  7/27/07.

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

0
3. Section 52.2037 is amended by revising paragraph (m) to read as
follows:

Sec.  52.2037  Control strategy plans for attainment and rate-of-
progress: Ozone.

* * * * *
    (m) Determination--EPA has determined that, as of July 27, 2007,
the Franklin County ozone nonattainment

area has attained the 1-hour ozone standard and that the following
requirements of section 172(c)(2) of the Clean Air Act do not apply to
this area for so long as the area does not monitor any violations of
the 1-hour ozone standard of 40 CFR 50.9: the attainment demonstration
and reasonably available control measure requirements of section
172(b)(1), the reasonable further progress requirement of section
172(b)(2), and the related contingency requirements of section
172(c)(9). If a violation of the 1-hour ozone NAAQS is monitored in the
Franklin County 1-hour ozone nonattainment area, these determinations
shall no longer apply.

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. In Sec.  81.339, the table entitled ``Pennsylvania-Ozone (8-Hour
Standard)'' is amended by revising the entry for the Franklin County,
PA Area to read as follows:

Sec.  81.339  Pennsylvania.

* * * * *

                                      Pennsylvania--Ozone (8-Hour Standard)
----------------------------------------------------------------------------------------------------------------
                                          Designation \a\                      Category/classification
        Designated area        ---------------------------------------------------------------------------------
                                    Date \1\            Type               Date \1\                 Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Franklin Co., PA: Franklin      July 27, 2007...  Attainment......
 County.

                                                 * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian County located in each county or area, except otherwise noted.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
 [FR Doc. E7-18835 Filed 9-24-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Notices]
[Page 46632]
[DOCID:fr10se09-101]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 In the Matter of Super Nova Resources, Inc.; Order of Suspension
of Trading

September 8, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Super Nova Resources, Inc. because questions have arisen regarding the
trading in the company's stock, and the accuracy and adequacy of
publicly available information concerning, among other things, the
company's business operations.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT, on
September 8, 2009, through 11:59 p.m. EDT, on September 21, 2009.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-21924 Filed 9-8-09; 11:15 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Page 38280]
[FR Doc No: 2019-16798]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4438-DR; Docket ID FEMA-2019-0001]

Oklahoma; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4438-DR), dated June 1, 2019, and
related determinations.

DATES: This amendment was issued July 16, 2019.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include permanent work
under the Public Assistance program for those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of June 1, 2019.

    Muskogee, Tulsa, and Wagoner Counties for Public Assistance
[Categories C-G] (already designated for Individual Assistance and
assistance for debris removal and emergency protective measures
[Categories A and B], including direct federal assistance, under the
Public Assistance program).
    Le Flore, Osage, Pawnee, and Sequoyah Counties for Public
Assistance [Categories A and C-G] (already designated for Individual
Assistance and assistance for emergency protective measures
[Category B], limited to direct federal assistance, under the Public
Assistance program).
    Alfalfa, Canadian, Cherokee, Craig, Creek, Delaware, Garfield,
Kingfisher, Logan, Mayes, Nowata, Payne, Pottawatomie, Rogers,
Washington, and Woods Counties for Public Assistance, including
direct federal assistance, under the Public Assistance program
(already designated for Individual Assistance).
    Adair, Beaver, Beckham, Blaine, Custer, Dewey, Ellis, Grady,
Grant, Greer, Harper, Jackson, Lincoln, Okfuskee, Pittsburg,
Pushmataha, Roger Mills, and Washita Counties for Public Assistance,
including direct federal assistance, under the Public Assistance
program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-16798 Filed 8-5-19; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79877-79878]
[FR Doc No: 2015-32275]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-33-000]

Town of Walnut, Mississippi; Notice of Application

    Take notice that on December 11, 2015, the Town of Walnut,
Mississippi (Walnut), PO Box 540, 621 Main Street, Walnut, Mississippi
38683, filed an application pursuant to section 7(f) of the Natural Gas
Act (NGA) requesting a service area determination within which it may
enlarge or expand its natural gas distribution facilities without
further Commission authorization. Walnut also requests a determination
that it qualifies as a local distribution company for purposes of
section 311 of the Natural Gas Policy Act of 1978 (NGPA) and a waiver
of all reporting, accounting, and other rules and regulations under the
NGA and NGPA that are normally applicable to natural gas companies.
Walnut's proposed service area is intended to encompass the segments of
the two 4-mile, 2-inch diameter Gas Supply lines that are located in
Tennessee and the Walnut facilities located in Tennessee that are used
to serve 33 residential customers and one industrial customer, all as
more fully set forth in the application which is on file with the
Commission and open to public inspection. The filing is available for
review at the Commission in the Public Reference Room or may be viewed
on the Commission's Web site web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>. Any questions regarding
the application may be directed to Joshua L. Menter, McCarter & English
LLP, 1015 15th Street NW., 12th Floor, Washington, DC 20005, by
telephone at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice, the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA

in the Commission's public record for this proceeding or the issuance
of a Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and five copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.
    Comment Date: January 7, 2015.

    Dated: December 17, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-32275 Filed 12-22-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Rules and Regulations]
[Pages 57333-57339]
[FR Doc No: 2018-24974]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0744; FRL-9985-45]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on beet, sugar, roots and vegetable, root, except
sugar beet, subgroup 1B. Syngenta Crop Protection, LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 15, 2018. Objections and
requests for hearings must be received on or before January 14, 2019,
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-2017-0744, 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.

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-2017-0744 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
January 14, 2019. 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-2017-0744, 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/contacts.html. 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 Tolerance

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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
7F8590) by Syngenta Crop Protection, LLC, 18300 Greensboro Road, NC.
The petition requested that 40 CFR 180.507 be amended by establishing
tolerances for residues of the fungicide azoxystrobin, in or on beet,
sugar, roots at 5.0 parts per million (ppm) and vegetable, root,
subgroup 1B at 0.5 ppm. The petition also requested that the tolerance
for vegetable, root, subgroup 1A be removed once these new tolerances
are established. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing the tolerance level for vegetable, root, subgroup 1B at
1.0 ppm instead of 0.5 ppm. Additionally, the Agency has revised the
commodity name to vegetable, root, except sugar beet, subgroup 1B. The
reason for these changes are explained in Unit IV.D.

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 azoxystrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with azoxystrobin 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.
    With repeated dosing by the oral route, the liver and bile ducts
were consistently affected by azoxystrobin. Liver and biliary effects
were seen in rats (increased liver weights, gross and histopathological
lesions of the bile duct and liver), and in dogs (increased liver
weights, clinical observations including fluid feces and salivation)
and clinical chemistry alterations (including increased serum levels of
alkaline phosphatase, and gamma-glutamyl transferase; and decreases in
serum albumin). The effects seen are indicative of changes to liver/
biliary function. Decreased body weight (rats and mice)

and decreased body weight gain (rats and rabbits) were also consistent
findings across studies and species. Other effects including decreased
food intake/utilization, increased diarrhea and other clinical toxicity
observations such as urinary incontinence, salivation, hunched postures
and distended abdomens were also seen in various studies (developmental
toxicity, reproduction, and 90-day oral toxicity) in rats. Inhalation
exposure to a soluble-concentrate (SC) formulation of azoxystrobin
resulted in adverse microscopic changes in the nasal cavity and larynx.
    No developmental effects were seen in the rabbit and rat
developmental toxicity studies and no reproductive or offspring effects
were seen in the 2-generation rat reproduction study. In the
reproduction study, decreased body weights and increased adjusted liver
weights were observed at the same dose in both offspring and parental
animals. Therefore, the toxicity data showed no increased
susceptibility in the young.
    In the acute and subchronic neurotoxicity studies, there were no
consistent indications of treatment-related neurotoxicity. There was no
evidence of neurotoxicity seen in the acute neurotoxicity study in rats
from a single gavage dose up to 2,000 mg/kg. There was also no evidence
of neurotoxicity seen in the subchronic neurotoxicity study in rats up
to the highest dose tested (201 mg/kg/day). Based on the toxicity
profile of azoxystrobin, a developmental neurotoxicity study in rats is
not needed.
    Although azoxystrobin induced a weak mutagenic response in the
mouse lymphoma assay (non-linear, slight but significant increases in
the mutation frequency of mouse lymphoma cells), the activity expressed
in vitro is not expected to be expressed in whole animals. There was no
evidence of carcinogenicity in rats and mice at acceptable tested dose
levels; therefore, azoxystrobin is classified as ``not likely to be
carcinogenic to humans''.
    Azoxystrobin has a low order of acute toxicity via oral, dermal and
inhalation routes of exposure. Azoxystrobin is not an eye or skin
irritant and is not a skin sensitizer.
    Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin 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 Azoxystrobin: Human Health Risk
Assessment for a New Post-Harvest Use on Sugar Beets and Amend the
existing Vegetable, Root, Subgroup 1A to Vegetable, Root, Subgroup 1B
(except Sugar Beets) at pages 11-18 in docket ID number EPA-HQ-OPP-
2017-0744.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                   Point of departure and     RfD, PAD, LOC for
       Exposure/scenario         uncertainty/safety factors    risk assessment   Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All              LOAEL = 200 mg/kg/day.......  Acute RfD = 0.67   Acute Neurotoxicity--Rat.
 populations).                  UFA = 10x...................   mg/kg/day.        LOAEL = 200 mg/kg/day based on
                                UFH = 10x...................  aPAD = 0.67 mg/kg/  diarrhea at two-hours post
                                                               day.               dose at all dose levels
                                                                                tested.
                                FQPA SF = 3x
Chronic dietary (All            NOAEL = 18 mg/kg/day........  Chronic RfD =      Combined Chronic Toxicity/
 populations).                  UFA = 10x...................   0.18 mg/kg/day.    Carcinogenicity Feeding Study--
                                UFH = 10x...................  cPAD = 0.18 mg/kg/  Rat.
                                                               day.              LOAEL = 82.4/117 mg/kg/day (M/
                                                                                F) based on reduced body
                                                                                weights in both sexes and bile
                                                                                duct lesions in males.
                                FQPA SF = 1x
Episodic granule ingestion      LOAEL = 200 mg/kg/day.......  Residential LOC    Acute Neurotoxicity--Rat.
 (Children 1 to <2 years old).  UFA = 10x...................   for MOE = 300.    LOAEL = 200 mg/kg/day based on
                                UFH = 10x...................                      diarrhea at two-hours post
                                                                                dose at all dose levels
                                                                                tested.
                                FQPA SF = 3x
Incidental oral short-term (1-  NOAEL = 35 mg/kg/day........  Residential LOC    2-generation reproduction
 30 days) (Intermediate-term    UFA= 10x....................   for MOE = 100.     study--Rats.
 (1-6 months)).                 UFH = 10x...................                     LOAEL = 165 mg/kg/day based on
                                                                                decreased pup weights in both
                                                                                males and females ([darr]8-
                                                                                21%).
                                FQPA SF = 1x
Inhalation (All durations)....  Inhalation study NOAEL = 3.8  LOC for MOE = 30.  28-Day inhalation toxicity
                                 [micro]g/L (inhalation                           study in rats on SC
                                 absorption rate = 100%).                         formulation\+\.
                                UFA = 3x....................                     LOAEL = 12.2 [micro]g/L based
                                                                                on adverse histopathological
                                                                                changes in the larynx
                                                                                (squamous metaplasia) and
                                                                                nasal cavity (metaplasia of
                                                                                the respiratory epithelium).
                                                                                There was an increase in
                                                                                severity with increases in the
                                                                                test concentrations.
                                UFH = 10x
                                FQPA SF = 1x................
                               ---------------------------------------------------------------------------------
Cancer (Oral, dermal,              Azoxystrobin is classified as ``not likely to be carcinogenic to humans''.
 inhalation).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary exposures from azoxystrobin 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. Such effects were identified
for azoxystrobin. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to
residue levels in food, the acute dietary analysis was obtained from
the Dietary Exposure Evaluation Model using the Food Commodity Intake
Database (DEEM-FCID; version 3.16). The assessment is based on 100% of
the registered crops treated, and tolerance-level residues for all
existing and proposed commodities, except citrus fruits where the
highest field trial residue was used as a refinement.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA Nationwide
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food,
the chronic dietary analysis was obtained from the Dietary Exposure
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID;
version 3.16). The assessment was partially refined, and used
tolerance-level residues for all commodities and average percent crop
treated (PCT) estimates when available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that azoxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    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 PCT for existing uses for the chronic
dietary exposure assessment as follows: Almonds, 20%; apricots, 10%;
artichokes, 20%; asparagus, <2.5%; barley, <2.5%; green beans, 15%;
blueberries, 15%; broccoli, 10%; cabbage, 10%; caneberries, 5%;
cantaloupes, 20%; carrots, 10%; cauliflower, <2.5%; celery, 10%; corn,
<2.5%; cotton, <2.5%; cotton (seed treatment), 25%; cucumbers, 20%; dry
beans/peas, <2.5%; eggplant, 30%; garlic, 70%; grapefruit, 20%; grapes,
5%; hazelnuts, 5%; lemons, <2.5%; lettuce, <2.5%; nectarines, <2.5%;
onions, 5%; oranges, 5%; peaches, 5%; peanuts, 20%; peanuts (seed
treatment), 30%; green peas, <2.5%; pecans, 5%; peppers, 20%;
pistachios, 5%; plums/prunes, <2.5%; potatoes, 40%; potatoes (seed
treatment), <1%; pumpkins, 20%; rice, 40%; soybeans, 5%; soybeans (seed
treatment), <1%; spinach, 10%; squash, 20%; strawberries, 25%; sugar
beets, 10%; sugar beets (seed treatment), <2.5%; sweet corn, 15%;
tangelos, 25%; tangerines, 10%; tobacco, 15%; tomatoes, 25%; walnuts,
<2.5%; watermelons, 15%; wheat, 5%; wheat seed (seed treatment), <1%.
For crops not specified, 100 PCT was used.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    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 azoxystrobin 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 azoxystrobin in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of azoxystrobin for
acute exposures are estimated to be 70.2 parts per billion (ppb) for
surface water and 3.1 ppb for ground water. For chronic exposures for
non-cancer assessments the EDWCs of azoxystrobin are estimated to be
48.5 ppb for surface water and 3.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 70.2 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 48.5 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). Azoxystrobin is
currently registered for the following uses that could result in
residential exposures: Conventional residential use on turf and
ornamentals and antimicrobial uses as a materials preservative in
paints and plastics. The proposed use will not result in additional
residential exposures. Existing residential uses result in (1) short-
term handler dermal and inhalation exposures for adults; (2) short-term
post-application dermal exposures for adults, youth 11 to 16 years old,
children 6 to 11 years old, and children 1 to <2 years old; and (3)
short-term incidental oral exposures to children 1 to <2 years old.
Since the effects from inhalation exposure differ from effects from
oral exposure, the residential handler exposures are not aggregated
with dietary exposures. No hazard was identified for dermal exposure.
The Agency's assessment of risk aggregates residential exposure from
hand-to-mouth incidental oral exposures to children 1 to <2 years old
from preserved vinyl flooring.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin 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://www2.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. No developmental effects
were seen in the rabbit and rat developmental toxicity studies, and no
reproductive or offspring effects were seen in the 2-generation rat
reproduction study. In the reproduction study, decreased body weights
and increased adjusted liver weights were observed at the same dose in
both offspring and parental animals. Therefore, the toxicity data
showed no increased susceptibility in the young.
    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 for all exposure scenarios except acute
exposure and episodic granule ingestion. For assessing acute dietary
risk and episodic oral ingestion of granules, EPA is retaining an FQPA
factor of 3X to account for the use of a LOAEL from the acute
neurotoxicity study to derive an acute reference dose. The Agency
believes that a 3X FQPA SF (as opposed to a 10X) will be adequate to
extrapolate a NOAEL in assessing acute risk based on the following
considerations:
     The LOAEL is based on a transient effect (diarrhea in
rats) expected to be relatively insignificant in nature. This effect is
also seen in other chemicals of the same class.
     The diarrhea was only seen in studies using gavage dosing
in the rat, but not in studies using repeat dosing through dietary
administration in rats or mice, and not through gavage dosing in
rabbits.
     The very high dose level needed to reach the acute oral
lethal dose (LD)50 (>5,000 mg/kg), and the overall low
toxicity of azoxystrobin.
    The decision to reduce the FQPA safety factor to 1X for the
assessment of the remaining exposure scenarios is based on the
following findings:
    i. The toxicity database for azoxystrobin is considered sufficient
for selecting toxicity endpoints and PODs for risk assessment.
    ii. There is no indication that azoxystrobin is a neurotoxic
chemical. There was no evidence of neurotoxicity seen in the acute
neurotoxicity study in rats from a single gavage dose up to 2,000 mg/
kg. There was also no evidence of neurotoxicity seen in the subchronic
neurotoxicity study in rats up to the highest dose tested (201 mg/kg/
day). Therefore, there is no need for a developmental neurotoxicity
study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that azoxystrobin 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. In the reproduction study, the offspring and the parental
effects occurred at the same dose level.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary (food) exposure assessments utilized
conservative upper-bound inputs including assuming 100% CT and
tolerance-level residues for all commodities except citrus fruits where
the highest field trial residue was

used as a refinement. The chronic dietary exposure assessment was
partially refined, and used tolerance-level residues for all
commodities and PCT information for selected crops. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to azoxystrobin in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by azoxystrobin.

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. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
azoxystrobin will occupy 82% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
azoxystrobin from food and water will utilize 18% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
azoxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Azoxystrobin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to azoxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 390 for children
1 to <2 years old. Because EPA's level of concern for azoxystrobin is a
MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
azoxystrobin is not expected to pose an intermediate-term risk.
Therefore, the intermediate-term aggregate risk would be equivalent to
the chronic dietary exposure estimate.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, azoxystrobin is not expected to pose a cancer risk to humans.
    6. 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 azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen-
phosphorus detector (GC/NPD) method, RAM 243/04) is available to
enforce the tolerance expression for residues of azoxystrobin and its
Z-isomer in crop commodities. This method (designated RAM 243, dated 5/
15/98) has been submitted to FDA for inclusion in the Pesticide
Analytical Manual (PAM, Volume II).
    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 established MRLs for azoxystrobin in or on root and
tuber vegetables (except potato) at 1.0 ppm. This MRL is the same as
the tolerance being established for azoxystrobin in the United States.

C. Response to Comments

    EPA received ten comments to the docket EPA-HQ-OPP-2017-0744.
However, only three comments were in response to the petition filed by
Syngenta Crop Protection. One comment (ID: EPA-HQ-OPP-2017-0744-0007)
among the three, is inclusive of the other two comments (ID: EPA-HQ-
OPP-2017-0744-0008 and EPA-HQ-OPP-2017-0744-0009), and describes
portions of the content of the Federal Register notice EPA published on
March 6, 2018 (83 FR 9471), and expresses support for tolerances. The
remaining seven comments were not germane to this action, therefore no
further response from the Agency is required.

D. Revisions to Petitioned-For Tolerances

    The Agency recommends increasing the tolerance for vegetable, root,
except sugar beet, subgroup 1B from the proposed 0.5 ppm to 1.0 ppm to
harmonize with the existing Codex MRL. Additionally, the Agency is
revising the significant figure on root vegetables subgroup 1B based on
current policy and revising the commodity definition to reflect the
common commodity vocabulary currently used by the Agency. The commodity
definition was revised from vegetable, root, subgroup 1B to vegetable,
root, except sugar beet, subgroup 1B.

V. Conclusion

    Therefore, tolerances are established for residues of azoxystrobin,
in or on beet, sugar, roots at 5.0 ppm and vegetable, root, except
sugar beet, subgroup 1B at 1.0 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) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997) nor is it considered a regulatory action under
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: November 1, 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.  180.507:
0
a. Remove the entry for ``Vegetable, root, subgroup 1A'' from the table
in paragraph (a)(1).
0
b. Add alphabetically ``Beet, sugar, roots''; and ``Vegetable, root,
except sugar beet, subgroup 1B'' to the table in paragraph (a)(1).
    The additions read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

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

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

                                * * * * *
Beet, sugar, roots..........................................         5.0

                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B.............         1.0

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

* * * * *
[FR Doc. 2018-24974 Filed 11-14-18; 8:45 am]
 BILLING CODE 6560-50-P