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[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Rules and Regulations]
[Pages 75037-75039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30617]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0441; FRL-9372-9]

Difenzoquat; Data Call-in Order for Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final order.

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SUMMARY: This order requires the submission of various data to support 
the continuation of the tolerances for the pesticide, difenzoquat. 
Pesticide tolerances are established under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). Following publication of this order, persons who 
are interested in the continuation of the difenzoquat tolerances must 
notify the Agency by completing and submitting the required section 
408(f) Order Response Form (available in the docket) within 90 days. If 
the Agency does not receive within 90 days after publication of the 
final order a section 408(f) Response Form identifying a person who 
agrees to submit the required data, EPA will revoke the difenzoquat 
tolerances.

DATES: This final order is effective December 19, 2012. A section 
408(f) Order Response Form must be received on or before March 19, 
2013.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2012-0441. All documents in the 
docket are listed in the docket index available at http://www.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 the Environmental 
Protection Agency Docket Center (EPA/DC), EPA West 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 (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.
    Submit your section 408(f) Order Response Form, identified by 
docket identification (ID) number EPA-HQ-OPP-2012-0441, by one of the 
following methods:
     Federal eRulemaking Portal: Follow the on-line 
instructions for submitting comments.
     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.htm.

FOR FURTHER INFORMATION CONTACT: Christina Scheltema, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-2201; email 
address: scheltema.christina@epa.gov.

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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines,'' which is listed under 
``Documents related to our mission.''

II. Background

A. What action is the agency taking?

    In this document EPA is issuing an order requiring the submission 
of various data to support the continuation of the difenzoquat 
tolerances at 40 CFR 180.369, under section 408 of FFDCA, 21 U.S.C. 
346a. Difenzoquat is not currently registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The last FIFRA registration for difenzoquat was canceled in 2010. 
However, 25 FFDCA tolerances remain for residues of difenzoquat on the 
following commodities: Barley, cattle, goat, hog, horse, poultry, 
sheep, and wheat (40 CFR 180.369). Because there are currently no 
domestic registrations for difenzoquat, these tolerances are referred 
to as ``import tolerances.'' It is these tolerances that are addressed 
by the Data Call-In order.

[[Page 75038]]

B. What is the agency's authority for taking this action?

    Under section 408(f) of the FFDCA, EPA is authorized to require, by 
order, submission of data ``reasonably required to support the 
continuation of a tolerance'' when such data cannot be obtained under 
the Data Call-In authority of FIFRA section 3(c)(2)(B), or section 4 of 
the Toxic Substances Control Act (``TSCA''), 15 U.S.C. 2603. A FFDCA 
section 408 Data Call-In order may only be issued following publication 
of notice of the order and a 60-day public comment provision.
    A section 408(f) Data Call-In order must contain the following 
elements:
    1. A requirement that one or more persons submit to EPA a notice 
identifying the person(s) who commit to submit the data required in the 
order.
    2. A description of the required data and the required reports 
connected to such data;
    3. An explanation of why the required data could not be obtained 
under section 3(c)(2)(B) of FIFRA or section 4 of TSCA.
    4. The required submission date for the notice identifying one or 
more interested persons who commit to submit the required data and the 
required submission dates for all the data and reports required in the 
order (21 U.S.C. 346a(f)(1)(C)).
    EPA may by order modify or revoke the affected tolerances if any 
one of the following submissions is not made in a timely manner:
    1. A notice identifying the one or more interested persons who 
commit to submit the data.
    2. The data itself.
    3. The reports required under a section 408(f) order are not 
submitted by the date specified in the order (21 U.S.C. 346a(f)(2)).

C. What preliminary steps were taken by EPA prior to issuing this final 
order?

    On July 6, 2012 (77 FR 44181) (FRL-9352-9), EPA issued a proposed 
Data Call-In order for the pesticide difenzoquat in connection with 
tolerances for that pesticide under section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. The proposed Data Call-
In order included the following studies:
     Neurotoxicity Screening Battery (870.6200).
     Immunotoxicity Study (870.7800).
     Crop Field Trials (860.1500)--(wheat hay, wheat forage, 
and barley hay).

III. Summary of Public Comments Received and Agency Response to 
Comments

    EPA received no comments in response to the July 6, 2012, Federal 
Register notice announcing the Agency's proposed Data Call-In order for 
difenzoquat. In addition, the Agency has not received any of the data 
identified in the proposed order as needed to support the difenzoquat 
tolerances.

IV. Final Data Call-in Order

    Because no comments were submitted on the proposal and the data 
deficiencies identified in the proposed order remain, EPA is issuing 
this final Data Call-In order under FFDCA section 408(f)(1)(C) for 
difenzoquat in the same form as the proposed order and for the reasons 
set forth in that proposed order. Specifically, this order:
    1. Requires notice of intent to submit data. A notice identifying 
the person or persons who commit to submit the data and reports in 
accordance with Unit IV.2. must be submitted to EPA if any person 
wishes to support the difenzoquat tolerances. The notice must be 
submitted on a section 408(f) Order Response Form which is available in 
the electronic docket, http://www.regulations.gov, under docket ID 
number EPA-HQ-OPP-2012-0441.
    2. Establishes a deadline for submission of notice identifying data 
submitters. The notice described in Unit IV.1., identifying data 
submitters, must be submitted to and received by EPA on or before March 
19, 2013. Instructions on methods for responding to this order 
(referred to in this order as a ``section 408(f) Order Response Form'') 
are set out under the ADDRESSES section above.
    3. Describes data and reports required to support continuation of 
the difenzoquat tolerances, requires submission of those data and 
reports, and establishes deadlines for submission. The table in this 
Unit describes the data and reports required to be submitted on 
difenzoquat under this order and the deadlines for the submission of 
each study and report. The required submission date is calculated from 
March 19, 2013. Thus, for example, if EPA generally allows 12 months to 
complete a study, the required submission date for such a study under 
this order would be 15 months from the date of publication of the order 
in the Federal Register. Studies, study protocols, and reports should 
be submitted to the person listed under FOR FURTHER INFORMATION 
CONTACT.

                         Table--Data and Reports Required To Be Submitted on Difenzoquat
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                                                                Timeframe for
  OCSPP harmonized guideline No.          Study title          protocol  report    Timeframe for data submission
                                                                  submission
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870.6200.........................  Neurotoxicity Screening   Not Required.......  March 19, 2015.
                                    Battery.
870.7800.........................  Immunotoxicity Study....  6 months...........  March 19, 2014.
860.1500.........................  Crop Field Trials (wheat  Not Required.......  March 19, 2015.
                                    hay, wheat forage, and
                                    barley hay).
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    EPA provided a description of why the required data could not be 
obtained under section 3(c)(2)(B) of FIFRA or section 4 of TSCA in the 
proposed order and relies on that description in this final order.

V. Failure to Submit Notice of Intent to Submit Data or Data and 
Reports

    If, by March 19, 2013 the Agency does not receive a section 408(f) 
Order Response Form identifying a person who agrees to submit the 
required data, EPA will revoke the difenzoquat tolerances at 40 CFR 
180.369. Such revocation is subject to the objection and hearing 
procedure in FFDCA section 408(g)(2) but the only material issue in 
such a procedure is whether a submission required by the order was made 
in a timely fashion.
    Additional events that may be the basis for modification or 
revocation of difenzoquat tolerances include, but are not limited to 
the following:
    1. No person submits on the required schedule an acceptable 
protocol report when such report is required to be submitted to the 
Agency for review.
    2. No person submits on the required schedule acceptable data as 
required by the final order.

[[Page 75039]]

VI. Statutory and Executive Order Reviews

    This action, which requires the submission of data in support of 
tolerances in accordance with FFDCA section 408, is in the form of an 
order and not a rule (21 U.S.C. 346a(f)(1)(C)). Under the 
Administrative Procedures Act (APA), orders are expressly excluded from 
the definition of a rule (5 U.S.C. 551(4)). Accordingly, the regulatory 
assessment requirements imposed on a rulemaking do not apply to this 
action, as explained further in the following discussion.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    Because this order is not a ``regulatory action'' as that term is 
defined in Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not subject to review by the Office of Management and Budget 
(OMB) under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 
2011).

B. Paperwork Reduction Act

    This action does not impose additional burdens that require 
approval by OMB under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.). The information collection activities associated with the 
order requesting data from any party interested in supporting certain 
tolerances are already approved by OMB under OMB Control No. 2070-0174, 
and are identified by EPA ICR No. 2288.01. Burden is defined at 5 CFR 
1320.3(b). Under the PRA, an Agency may not conduct or sponsor, and a 
person is not required to respond to a collection of information that 
requires OMB approval under PRA, unless it has been approved by OMB and 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations in title 40 of the CFR, after appearing in the 
Federal Register, are listed in 40 CFR part 9, and included on the 
related collection instrument, or form, if applicable.

C. Regulatory Flexibility Act

    Since this order is not a rule under the APA (5 U.S.C. 551(4)), and 
does 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.

D. Unfunded Mandates Reform Act; Executive Order 13132: Federalism; and 
Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    This order requests data from any party interested in supporting 
certain tolerances and does not impose obligations on any person or 
entity including States or tribes; nor does this action alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
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 (64 FR 43255, August 10, 1999) and Executive Order 13175 (65 FR 
67249, November 9, 2000) do not apply to this order. In addition, this 
order 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. 1531-1538).

E. Executive Orders 13045: Protection of Children From Environmental 
Health Risks and Safety Risks; Executive Order 13211: Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use, and Executive Order 12898: Federal Actions To 
Address Environmental Justice in Minority Populations and Low Income 
Populations

    As indicated previously, this action is not a ``regulatory action'' 
as defined by Executive Order 12866. As a result, this action is not 
subject to Executive Order 13045 (62 FR 19885, April 23, 1997) and 
Executive Order 13211 (66 FR 28355, May 22, 2001). In addition, this 
order also does not require any special considerations under Executive 
Order 12898 (59 FR 7629, February 16, 1994).

F. National Technology Transfer and Advancement Act

    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

    The Congressional Review Act, 5 U.S.C. 801 et seq. does not apply 
because this action is not a rule as that term is defined in 5 U.S.C. 
804(3).

List of Subjects in 40 CFR Part 180

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

    Dated: December 12, 2012.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2012-30617 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P
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