[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Rules and Regulations]
[Pages 54723-54725]
[FR Doc No: 2015-22716]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0380; FRL-9933-65-Region 5]

Air Plan Approval; Indiana; SO2 Revision for Walsh and
Kelly

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
request submitted by the Indiana Department of Environmental Management
(IDEM) on June 1, 2015, to revise the Indiana state implementation plan
(SIP) for sulfur dioxide (SO2). The revision updates
information regarding Walsh and Kelly, Incorporated, a hot mix asphalt
plant located in Griffith, Lake County, Indiana. Walsh and Kelly,
Incorporated, is replacing its aggregate drum dryer. The revision does
not change any of the SO2 control requirements and will not
result in an increase in SO2 emissions.

DATES: This rule is effective on November 10, 2015, unless EPA receives
adverse written comments by October 13, 2015. If EPA receives adverse
comments, EPA will publish a timely withdrawal of the rule in the
Federal Register and inform the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0380, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2015-0380. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly

available docket materials are available either electronically in
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Charles Hatten, Environmental Engineer,
(312) 886-6031 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. General Information
II. What is EPA approving?
III. What are the changes from the current Rule?
IV. What action is EPA taking?
V. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. General Information

A. Does this action apply to me?

    This action only applies to Walsh and Kelly, Incorporated, located
in Griffith, Lake County, Indiana.

B. Has public notice been provided?

    IDEM published a public notice of the revisions to the SIP on
February 4, 2015, to update its SO2 rules that apply
specifically to Walsh and Kelly, Incorporated. A public hearing on the
revisions was held on March 11, 2015. There were no comments received.

II. What is EPA approving?

    EPA is approving a revision to Indiana's SO2 SIP for
Walsh and Kelly, Incorporated, a hot mix asphalt plant located in
Griffith, Lake County, Indiana.
    Indiana's SO2 emission limits for Lake County are
contained in Title 326 of the Indiana Administrative Code (IAC) in rule
7-4.1 (326 IAC 7-4.1). The SO2 emission limits pertaining to
the Walsh and Kelly, Incorporated, facility are found at 326 IAC 7-4.1-
21.

III. What are the changes from the current Rule?

    In 2013, Walsh and Kelly, Incorporated replaced its aggregate drum
dryer. The older aggregate drum dryer burner design capacity was rated
at 120 million British thermal units per hour (MMBtu/hr). The new
aggregate drum dryer burner has a smaller design capacity, rated at 115
MMBtu/hr.
    IDEM made an administrative change to update rule 326 IAC 7-4.1-
21(b) to reference the new 115 MMBtu/hr aggregate drum dryer. Rule 326
IAC 7-4.1-21 provides SO2 emission limits for the Walsh and
Kelly, Incorporated aggregate drum dryer, and allows the unit limited
use of waste oil as a back-up fuel. IDEM did not revise any of the
requirements that apply to using waste oil as a fuel. The
SO2 emission limits of 42 pounds per hour and 25 tons per
year remain unchanged.
    EPA finds the change to rule 326 IAC 7-4.1-21 approvable.

IV. What action is EPA taking?

    EPA is approving revisions to Indiana's SO2 SIP which
revise 326 IAC 7-4.1-21 for Walsh and Kelly, Incorporated, located in
Griffith, Lake County, Indiana. The SIP revision will not result in an
increase in SO2 emissions at the facility because the
emission limits remain the same.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective November 10,
2015 without further notice unless we receive relevant adverse written
comments by October 13, 2015. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time. If we do not receive any comments, this
action will be effective November 10, 2015.

V. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Indiana
regulations described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
generally available electronically through www.regulations.gov and/or
in hard copy at the appropriate EPA office (see the ADDRESSES section
of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the CAA
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 10, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. 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, Emissions
Reporting, Incorporation by reference, Reporting and recordkeeping
requirements, Sulfur dioxide.

    Dated: August 28, 2015.
Susan Hedman,
Regional Administrator, Region 5.
    40 CFR part 52 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.

0
2. Section 52.770, the table in paragraph (c) is amended by revising
the entry for Rule 7-4.1-21 ``Walsh and Kelly sulfur dioxide emission
limitations'' under the subheading entitled ``Rule 4.1 Lake County
Sulfur Dioxide Emission Limitations'' under the heading entitled
``Article 7. Sulfur Dioxide Rules'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Indiana Regulations
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                                                              Indiana
        Indiana citation                 Subject          effective date  EPA Approval date         Notes
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                                                  * * * * * * *
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                                         Article 7. Sulfur Dioxide Rules
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                                                  * * * * * * *
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                            Rule 4.1 Lake County Sulfur Dioxide Emission Limitations
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                                                  * * * * * * *
7-4.1-21.......................  Walsh and Kelly sulfur        5/29/2015  9/11/2015,
                                  dioxide emission                         [insert Federal
                                  limitations.                             Register
                                                                           citation].

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[FR Doc. 2015-22716 Filed 9-10-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72961-72962]
[FR Doc No: 2015-29765]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13642-003]

GB Energy Park, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Unconstructed Major Project.
    b. Project No.: 13642-003.
    c. Date filed: October 1, 2015.
    d. Applicant: GB Energy Park, LLC.
    e. Name of Project: Gordon Butte Pumped Storage Project.
    f. Location: Approximately 3 miles west of the City of Martinsdale,
Meagher County, Montana. The proposed project would not occupy any
federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)--825(r).
    h. Applicant Contact: Carl. E. Borgquist, President, GB Energy
Park, LLC, 209 Wilson Avenue, P.O. Box 309, Bozeman, MT 59771; (406)
585-3006<EMAIL_ADDRESS>    i. FERC Contact: Mike Tust,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene and protests using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>(866) 208-
3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, please send a paper copy to: Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426. The
first page of any filing should include docket number P-13642-003.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. Project Description: The Gordon Butte Pumped Storage Project
would

consist of the following new facilities: (1) A manually operated head
gate on an existing irrigation canal that provides initial fill and
annual make-up water to the lower reservoir from the existing
irrigation canal; (2) a 3,000-foot-long, 1,000-foot-wide upper
reservoir created by a 60-foot-high, 7,500-foot-long concrete-faced
rockfill dam; (3) a reinforced concrete intake/outlet structure at the
upper reservoir with six gated intake bays converging into a central
18-foot-diameter, 750-foot-long vertical shaft; (4) an 18-foot-
diameter, 3,000-foot-long concrete and steel-lined penstock tunnel
leading from the upper reservoir to the lower reservoir; (5) a 2,300-
foot-long, 1,900-foot-wide lower reservoir created by a combination of
excavation and two 60-foot-high, 500- and 750-foot-long concrete-faced
rockfill dams; (6) a partially buried 338-foot-long, 109-foot-wide, 74-
foot-high reinforced concrete and steel powerhouse with four 100-
megawatt (MW) ternary Pelton turbine/pump/generators; (7) a 600-foot-
long, 200-foot-wide substation at the powerhouse site with 13.8-
kilovolt (kV) to 230-kV step-up transformers; (8) a 5.7-mile-long, 230-
kV transmission line; (9) a substation with a 230-kV to 500-kV step-up
transformer, connecting to an existing non-project 500-kV transmission
line; and (11) appurtenant facilities. The project is estimated to
provide 1,300 gigawatt-hours annually. No federal lands are included in
the project.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site 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 Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
protests or motions to intervene must be received on or before the
specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title ``MOTION
TO INTERVENE'' or ``PROTEST''; (2) set forth in the heading the name of
the applicant and the project number of the application to which the
filing responds; (3) furnish the name, address, and telephone number of
the person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application.
    A copy of all other filings in reference to this application must
be accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.

    Dated: November 16, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-29765 Filed 11-20-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 14, 2007 (Volume 72, Number 49)]
[Rules and Regulations]
[Page 11777-11784]
[DOCID:fr14mr07-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0312; FRL-8113-6]

Prothioconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of prothioconazole and prothioconazole-

desthio calculated as parent in or on barley, grain/hay/straw; grain,
aspirated grain fractions; pea and bean, dried shelled, except
soybeans, subgroup 6C; peanut; peanut hay; rapeseed, seed; wheat,
grain/forage/hay/straw; and for combined residues of prothioconazole,
prothioconazole-desthio and conjugates that can be converted to these
two compounds by acid hydrolysis, calculated as parent in or on cattle,
meat/meat byproducts/fat/milk; poultry, liver; goat, fat/meat/meat
byproducts; hog, meat byproducts; horse, fat/meat/meat byproducts;
sheep, fat/meat/meat byproducts. Bayer CropScience requested tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 14, 2007. Objections and
requests for hearings must be received on or before May 14, 2007, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0312. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2005-0312 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before May 14, 2007.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0312, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of November 30, 2005 (70 FR 71831) (FRL-
7747-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F6830) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle
Park, NC 27709. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the fungicide
prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, in or on barley,
grain at 0.2 parts per million (ppm); barley, hay at 7.0 ppm; barley,
straw at 2.0 ppm; barley, pearled at 0.2 ppm; barley, bran at 0.4 ppm;
black mustard, seed at

0.1 ppm; borage, seed at 0.1 ppm; canola, seed at 0.1 ppm; crambe, seed
at 0.1 ppm; field mustard, seed at 0.1 ppm; flax, seed at 0.1 ppm;
grain, aspirated fractions at 13.0 ppm; Indian mustard, seed at 0.1
ppm; Indian rapeseed 0.1 ppm; pea and bean, dried shelled (except
soybeans) at 0.8; peanut, nutmeat at 0.02 ppm; peanut, hay at 5.0 ppm;
peanut, meal at 0.3 ppm; rapeseed, seed at 0.1 ppm; rice, grain at 0.25
ppm; rice, straw at 1.5 ppm; rice, hulls at 1.0 ppm; wheat, grain at
0.06 ppm; wheat, bran at 1.5 ppm; wheat, forage at 7.0 ppm; wheat, germ
at 0.15 ppm; wheat, hay at 4.0 ppm; wheat, straw at 2.3 ppm and for
combined residues of prothioconazole, its desthio and 4-hydroxy
metabolites, and conjugates of each in cattle, meat at 0.01 ppm;
cattle, meat byproducts at 1.2 ppm; cattle, fat at 0.1 ppm; and milk at
0.006 ppm. That notice included a summary of the petition prepared by
Bayer CropScience, the registrant. Comments were received on the notice
of filing. EPA's response to these comments is discussed in Unit IV.C.
    For the reasons stated in Unit V., EPA is not establishing at this
time the following petitioned-for tolerances: Rice; black mustard;
borage; flax; Indian mustard; barley, pearled barley; barley, bran;
canola; crambe; field mustard; Indian rapeseed; peanut, meal; wheat,
bran; and wheat, germ.
    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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/oppfead1/trac/science
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of
prothioconazole and prothioconazole-desthio, calculated as parent in or
on barley, grain at 0.35 ppm; barley, hay at 7.0 ppm; barley, straw at
4.0 ppm; grain, aspirated grain fractions at 11.0 ppm; pea and bean,
dried shelled, except soybeans, subgroup 6C at 0.9; peanut at 0.02 ppm;
peanut, hay at 6.0 ppm; rapeseed, seed at 0.15 ppm; wheat, grain at
0.07 ppm; wheat, forage at 6.0 ppm; wheat, hay at 4.5 ppm; wheat, straw
at 5.0 ppm and for combined residues of prothioconazole,
prothioconazole-desthio, and conjugates that can be converted to these
two compounds by acid hydrolysis, calculated as parent in or on cattle,
meat at 0.02 ppm; cattle, meat byproducts at 0.2 ppm; cattle, fat at
0.1 ppm; goat, fat at 0.1 ppm; goat, meat at 0.02 ppm; goat, meat
byproducts at 0.2 ppm; hog, meat byproducts at 0.05 ppm; horse, fat at
0.1 ppm; horse, meat at 0.02 ppm; horse, meat byproducts at 0.2 ppm;
milk at 0.02 ppm; poultry, liver at 0.02 ppm; sheep, fat at 0.1 ppm;
sheep, meat at 0.02 ppm and sheep, meat byproducts at 0.2 ppm.
    EPA's assessment of exposures and risks associated with
establishing the tolerance 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. Specific information on the studies received and the nature
of the toxic effects caused by prothioconazole 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
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, and estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at:
    1. http://www.epa.gov/oppfead1/trac/science    2. http://www.epa.gov/pesticides/factsheets/riskassess.htm.

.htm.

    Both prothioconazole and prothioconazole-desthio have low acute
toxicities by oral, dermal, and inhalation routes. Neither compound is
a dermal sensitizer, nor a skin or eye irritant.
    Subchronic toxicity studies show that the target organs at the
LOAEL include the liver, kidney, urinary bladder, thyroid, and blood.
NOAEL/LOAEL values across the family of chemicals (i.e.,
prothioconazole, and metabolites prothioconazole-desthio, and
prothioconazole sulfonic acid potassium salt) in the toxicity database
indicate that prothioconazole-desthio is a more toxic chemical.
    The profile of chronic toxicity is similar to that of subchronic
toxicity, and also includes body weight and food consumption changes,
and toxicity to the lymphatic and gastrointestintal (GI) systems. The
relative potency of prothioconazole-desthio is greater than
prothioconazole.
    The data from developmental toxicity studies indicate that
prothioconazole and the three metabolites evaluated (i.e.,
prothioconazole-desthio, prothioconazole sulfonic acid potassium salt,
and prothioconazole-deschloro) variously produce prenatal developmental
effects at levels equal to or below maternally toxic levels.
Prothioconazole-desthio is a developmental neurotoxicant,

producing changes in brain morphometrics and increases in the
occurrence of peripheral nerve lesions in the neonate. A NOAEL was not
determined, since these observations were looked for only at the high
dose level. Prothioconazole-desthio is the most toxic orally or
dermally, with LOAELs significantly below that of the other chemicals.
    In reproduction studies in the rat, conducted using prothioconazole
and prothioconazole-desthio, reproductive and offspring toxicities are
observed only in the presence of parental toxicity. The nature of
parental toxicity is similar to what was observed in the subchronic
studies, such as body weight and food consumption changes, liver
effects, etc. Reproductive effects include decreases in reproductive
indices such as those that indicate pup survival and growth. Offspring
toxicity is manifested by decreased pup weights and malformations such
as cleft palate. The data show that prothioconazole-desthio is more
toxic by an order of magnitude.
    Acute and subchronic neurotoxicity studies were conducted in the
rat using prothioconazole. The acute neurotoxicity study produced
reduced motor and locomotor activity at a relatively high dose level,
while no neurotoxicity was observed in the subchronic neurotoxicity
study. As mentioned in the discussion of developmental toxicity, a
developmental neurotoxicity study was conducted in the rat using
prothioconazole-desthio, and neurotoxic effects were at the high dose
level only were included in the report. Judging from these three
neurotoxicity studies, prothioconazole-desthio is the more potent
neurotoxicant, which is consistent with its relative potency in other
areas of toxicity.
    A battery of mutagenicity studies was conducted using both
prothioconazole and its desthio metabolite. In addition,
carcinogenicity studies were conducted in rats and mice using these two
chemicals. The available data indicate that neither of these compounds
is mutagenic or carcinogenic in the species tested, which mitigates
against concern for carcinogenicity in humans.
    A summary of the toxicological endpoints for prothioconazole used
for human risk assessment is shown in Table 1 of this unit:

   Table 1.--Summary of Toxicological Dose and Endpoints for Prothioconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,        FQPA safety factor (SF)
          Exposure/scenario                interspecies and       and level of concern   Study and toxicological
                                         intraspecies and any     for risk assessment            effects
                                            traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 2.0 milligram/   FQPA SF = 10X            Developmental Toxicity
(Females 13-49 years of age).........   kilogram/day (mg/kg/    acute population          study in rabbits
                                        day)                     adjusted dose (aPAD) =  LOAEL = 10 mg/kg/day
                                       UF = 100 X acute          acute RfD/Special FQPA   based on structural
                                        reference dose (RfD) =   SF = 0.002 mg/kg/day.    alterations including
                                        0.002 mg/kg/day.                                  malformed vertebral
                                                                                body and ribs,
                                                                                arthrogryposis, and
                                                                                multiple malformations
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 1.1 mg/kg/day     FQPA SF = 10X            Chronic/Oncogenicity
(All populations)....................  UF = 100 X chronic RfD   chronic population        study in rats
                                        = 0.001 mg/kg/day.       adjusted dose (cPAD) =  LOAEL = 8.0 mg/kg/day
                                                                 chronic RfD/FQPA SF =    based on liver
                                                                 0.001 mg/kg/day.         histopathology
                                                                                (hepatocellular
                                                                                vacuolation and fatty
                                                                                change (single cell,
                                                                                centrilobular, and
                                                                                periportal))
----------------------------------------------------------------------------------------------------------------
Cancer                                  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
(Oral, dermal, inhalation)...........         absence of significant tumor increases in two adequate rodent
                                                                carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
Note: The toxicity endpoints for prothioconazole-desthio were used for the prothioconazole risk assessment
  because they were slightly more conservative than those for prothioconazole per se.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have not
been previously established for the combined residues of
prothioconazole and prothioconazole-desthio, calculated as parent, in
or on a variety of raw agricultural commodities and combined residues
of prothioconazole and prothioconazole-desthio and conjugates that can
be converted to these two compounds by acid hydrolysis, calculated as
parent, in or on milk and edible animal products. Risk assessments were
conducted by EPA to assess dietary exposures from prothioconazole 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.
    In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\, version 2.03), which incorporates food
consumption data as reported by respondents in the U.S. Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: A moderately refined acute dietary
exposure assessment was conducted for prothioconazole. Empirical
processing factors (PFs) and livestock maximum residues were
incorporated, and 100 percent crop treated (PCT) was assumed for the
acute assessment. Average residue levels were also used, since all of
the plant commodities included in this assessment are blended food
forms.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID\TM\, version 2.03, which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 CSFII, and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A moderately refined chronic dietary exposure

assessment was performed. Empirical PFs, average residues, and
livestock maximum residues were incorporated into the chronic
assessment and 100 PCT was assumed.
    iii. Cancer. The Agency classified prothioconazole and/or its
metabolites as ``Not likely to be Carcinogenic to Humans'' according to
the 2005 Cancer Guidelines, based on available studies in the mouse and
rat that showed no increase in tumor incidence. Accordingly, no
exposure assessment is necessary for assessing cancer risk.
    iv. Anticipated residue and PCT information. For assessment of
acute dietary risk, empirical PFs and livestock maximum residues were
incorporated, and 100 PCT was assumed for the acute assessment. Average
residue levels were also used, since all of the plant commodities
included in this assessment are blended food forms. Likewise for the
assessment of chronic dietary risk, empirical PFs, average residues,
and livestock maximum residues were incorporated into the chronic
assessment and 100 PCT was also assumed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for prothioconazole in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of prothioconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
prothioconazole for acute exposures are estimated to be 22 parts per
billion (ppb) for surface water. The EDWCs for chronic exposures are
estimated to be 11 ppb for surface water. EPA used the EDWCs for
surface water in assessing the risk from prothioconazole because the
EWDCs for ground water are minimal in comparison to surface 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).
    Prothioconazole is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Prothioconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

    Prothioconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including prothioconazole, EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of UFs) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X FQPA SF for the protection of infants and children. The assessment
includes evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's complete risk
assessment is found in the propiconazole reregistration docket at
http://www.regulations.gov, docket ID number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional SF
value based on the use of traditional UFs and/or special FQPA SFs, as
appropriate.
    2. Prenatal and postnatal sensitivity--i. Prenatal. Available
evidence from rat developmental toxicity studies with prothioconazole
(oral) and its desthio (oral and dermal) and sufonic acid K salt (oral)
metabolites, rabbit developmental with desthio metabolite (oral), and
rat developmental neurotoxicity with desthio metabolite (oral), as well
as a multi-generation reproduction study with the desthio metabolite,
indicate that there is concern for prenatal toxicity. Effects include
skeletal structural abnormalities, such as cleft palate, deviated
snout, malocclusion, and extra ribs; developmental delays; other
effects include changes in brain morphometry, peripheral nerve lesions,
and death.
    ii. Postnatal. Available data also show that the skeletal effects
such as extra ribs are not completely reversible after birth in the
rat, but persist as development continues. Data from the developmental
neurotoxicity study also show that brain morphometry is

abnormal postnatally, and there is an increased incidence of lesions of
the peripheral nerves postnatally.
    3. Conclusion. The toxicity database for prothioconazole (and its
metabolites) is adequate for endpoint selection for exposure risk
assessment scenarios and for FQPA evaluation, with the exception of
missing data on brain morphometry at lower does from the developmental
neurotoxicity study. Effects are seen in the 2-generation reproduction
studies in rats; developmental studies in rats and rabbits; and a
developmental neurotoxicity study in rats which suggest that pups are
more susceptible: Pup effects were seen at levels below the LOAELs for
maternal toxicity and, in general, were of comparable or greater
severity compared to the effects observed in adults. Additionally,
there is uncertainty concerning the LOAEL/NOAEL for developmental
effects seen in the developmental neurotoxicity study in rats (abnormal
brain morphometry at high dose) due to a lack of information on brain
morphometry at lower doses. Given that both quantitative and
qualitative sensitivity was observed in pups in several studies and in
more than one species and in at least one of these studies there is
uncertainty concerning identification of the LOAEL/NOAEL for
developmental effects, the additional 10X factor for the protection of
infants and children is being retained.

E. Aggregate Risks and Determination of Safety

    To assess aggregate risk, drinking water estimates were
incorporated directly into the dietary analysis, rather than using
back-calculated drinking water levels of comparison (DWLOCs). To better
evaluate aggregate risk associated with exposure through food and
drinking water, EPA is no longer comparing EDWCs generated by water
quality models with DWLOCs. Instead, EPA is now directly incorporating
the actual water quality model output concentrations into the risk
assessment. This method of incorporating water concentration into our
aggregate assessments relies on actual CSFII-reported drinking water
consumptions and more appropriately reflects the full distribution of
drinking water concentrations.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
prothioconazole will occupy 11% of the aPAD for females 13 years and
older, the only population subgroup of concern. In addition, there is
potential for acute dietary exposure to prothioconazole in drinking
water. The acute dietary exposure from food plus water to
prothioconazole will occupy 60% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
prothioconazole from food will utilize 12% of the cPAD for the U.S.
population, 17% of the cPAD for all infants (<  1 year old), and 48% of
the cPAD for children 1-2 years old, the subpopulation at greatest
exposure. There are no residential uses for prothioconazole that result
in chronic residential exposure to prothioconazole. In addition, there
is potential for chronic dietary exposure to prothioconazole in
drinking water. The chronic dietary exposure for food plus water will
occupy 86% of the cPAD for all infants (<  1 year old). All other
population subgroups are lower.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Prothioconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Prothioconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    5. Aggregate cancer risk for U.S. population. The available
toxicology studies in the mouse and rat showed no increase in tumor
incidence, and therefore the Agency concluded that prothioconazole or
its metabolites are not carcinogenic, and classified ``Not Likely to be
Carcinogenic to Humans'' according to the 2005 Cancer Guidelines.
Therefore, prothioconazole is not expected to pose a cancer risk.
    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, and to infants and children from aggregate
exposure to prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies high performance liquid
chromatography/tandem mass spectrometry (HPLC-MS/MS) and liquid
chromatography (with electrospray ionization) and tandem mass
spectrometry (LC-MS/MS)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are currently no U.S., Canadian, Mexican, or international
Codex tolerances established for prothioconazole. There are no maximum
residue limits (MRLs) established for prothioconazole in Codex or in
Mexico. Maximum residue limits have been established in Canada as a
result of this Joint Review.

C. Response to Comments

    A private citizen responded to PP 4F6830. Comments were received on
November 30, 2005, objecting to sale and use of this product. The
comments further stated that there are not enough long-term testing,
short-term testing is useless and unreliable and that research is not
exhaustive enough to support use.
    The Agency response is as follows: The Agency considers the
database for prothioconazole to be complete and adequate for exposure
risk assessment, including several long-term studies. The commenter
submitted no scientific information to support the claims.
    These comments, as well as related comments regarding animal
testing, have been responded to by the Agency on several occasions. For
example, 70 FR 1349 (January 7, 2005) (FRL-7691-4) and 69 FR 63083
(October 29, 2004) (FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for combined residues of
prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and
prothioconazole-desthio, [alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-
chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, calculated as parent
in or on barley, grain at 0.35 ppm; barley, hay at 7.0 ppm; barley,
straw at 4.0 ppm; grain, aspirated grain fractions at 11.0 ppm; pea and
bean, dried shelled, except soybeans, subgroup 6C at 0.9; peanut at
0.02 ppm; peanut, hay at 6.0 ppm; rapeseed, seed at 0.15 ppm; wheat,
grain at 0.07 ppm; wheat, forage at 6.0 ppm; wheat, hay at 4.5 ppm;
wheat, straw at 5.0 ppm and for combined residues of prothioconazole,
2-[2-(1-

chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-
1,2,4-triazole-3-thione, and prothioconazole-desthio, [alpha]-(1-
chlorocyclopropyl)-[alpha]-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-
1-ethanol, and conjugates that can be converted to these two compounds
by acid hydrolysis, calculated as parent in or on cattle, meat at 0.02
ppm; cattle, meat byproducts at 0.2 ppm; cattle, fat at 0.1 ppm; goat,
fat at 0.1 ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.2
ppm; hog, meat byproducts at 0.05 ppm; horse, fat at 0.1 ppm, horse,
meat at 0.02 ppm; horse, meat byproducts at 0.2 ppm; milk at 0.02 ppm;
poultry, liver at 0.02 ppm; sheep, fat at 0.1 ppm; sheep, meat at 0.2
ppm and sheet, meat byproducts at 0.2 ppm.
    Using upper bound residues for water derived from the proposed use
in rice, acute dietary estimates exceeded the Agency's level of concern
for food plus water. Further data is needed to resolve uncertainties
regarding residues of prothioconazole in rice application. Therefore, a
tolerance for rice is not established at this time.
    Additional crop field trial data are needed to support tolerances
for black mustard, borage, flax and Indian mustard. Tolerances for
these commodities are not established at this time.
    Separate tolerances are not needed for barley, pearled barley;
barley, bran; peanut, meal; wheat, bran; and wheat, germ. As per 40 CFR
180.1(h), the tolerance for rapeseed will cover the following
commodities: Canola seed, crambe seed, field mustard seed, and Indian
rapeseed.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that 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.'' This final rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, 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 in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 this final rule in the Federal
Register. This final rule 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: March 2, 2007.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.626 is added to subpart C to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues
of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-
chlorophenyl)-

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and
prothioconazole-desthio, [alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-
chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, calculated as parent
in or on the following commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Barley, grain.........................................                                                      0.35
Barley, hay...........................................                                                       7.0
Barley, straw.........................................                                                       4.0
Grain, aspirated grain fractions......................                                                        11
Pea and bean, dried shelled, except soybean, subgroup                                                        0.9
 6C...................................................
Peanut................................................                                                      0.02
Peanut, hay...........................................                                                       6.0
Rapeseed, seed........................................                                                      0.15
Wheat, forage.........................................                                                       6.0
Wheat, grain..........................................                                                      0.07
Wheat, hay............................................                                                       4.5
Wheat, straw..........................................                                                       5.0
----------------------------------------------------------------------------------------------------------------

    (2) Tolerances are established for combined residues of the
fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-
chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione,
and prothioconazole-desthio, [alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-
chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, and conjugates that
can be converted to these two compounds by acid hydrolysis, calculated
as parent in or on the following commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Cattle, fat...........................................                                                       0.1
Cattle, meat..........................................                                                      0.02
Cattle, meat byproducts...............................                                                       0.2
Goat, fat.............................................                                                       0.1
Goat, meat............................................                                                      0.02
Goat, meat byproducts.................................                                                       0.2
Hog, meat byproducts..................................                                                      0.05
Horse, fat............................................                                                       0.1
Horse, meat...........................................                                                      0.02
Horse, meat byproducts................................                                                       0.2
Milk..................................................                                                      0.02
Poultry liver.........................................                                                      0.02
Sheep, fat............................................                                                       0.1
Sheep, meat...........................................                                                      0.02
Sheep, meat byproducts................................                                                       0.2
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E7-4405 Filed 3-13-07; 8:45 am]

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[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Proposed Rules]
[Page 14715]
[FR Doc No: 2012-5763]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2011-0118; A-1-FRL-9644-5]

Approval and Promulgation of Air Quality Implementation Plans;
Rhode Island; Reasonably Available Control Technology (RACT) for the
1997 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to approve four State Implementation Plan
(SIP) revisions submitted by the Rhode Island Department of
Environmental Management (RI DEM). These revisions demonstrate that the
State of Rhode Island meets the requirements of reasonably available
control technology (RACT) for oxides of nitrogen (NOX) and
volatile organic compounds (VOCs) set forth by the Clean Air Act (CAA)
with respect to the 1997 8-hour ozone standard. The intended effect of
this action is to propose approval of Rhode Island's RACT demonstration
and the submitted regulations. Additionally, EPA is proposing to
approve Rhode Island's negative declarations for several categories of
VOC sources. This action is being taken in accordance with the CAA.

DATES: Written comments must be received on or before April 12, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2011-0118 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R01-OAR-2011-0118,'' Anne Arnold, U.S. Environmental
Protection Agency, New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
Mail Code OEP05-02, Boston, MA 02109-3912.
    5. Hand Delivery or Courier: Deliver your comments to: Anne Arnold,
U.S. Environmental Protection Agency, New England Regional Office,
Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post
Office Square--Suite 100, Mail Code OEP05-02, Boston, MA 02109-3912.
Such deliveries are only accepted during the Regional Office's normal
hours of operation. The Regional Office's official hours of business
are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal
holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: David Mackintosh, U.S. Environmental
Protection Agency, New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office Square--Suite 100,
Mail Code OEP05-02, Boston, MA 02109-3912, telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP revisions as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: February 9, 2012.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2012-5763 Filed 3-12-12; 8:45 am]
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