[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Proposed Rules]
[Pages 39962-39965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16295]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0441; FRL-9352-9]
Difenzoquat; Proposed Data Call-in Order for Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed order.
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SUMMARY: This document proposes to require 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).
DATES: Comments must be received on or before September 4, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0441; FRL-9352-9, by one of the following
methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 347-8028; email
address: miederhoff.eric@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,
those involved with:
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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI
[[Page 39963]]
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. FFDCA Data Call-In Authority
In this document, EPA proposes to issue an order requiring the
submission of various data to support the continuation of the
difenzoquat tolerances at 40 CFR 180.369. Under section 408(f) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(f), 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 section
3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136a(c)(2)(B), or section 4 of the Toxic Substances
Control Act (TSCA), 15 U.S.C. 2603. A section 408(f) Data Call-In order
may only be issued following notice and a comment period of not less
than 60 days.
After the 60-day comment period closes, the Agency will respond to
comments, if appropriate, and may issue a final order requiring the
submission of various data for difenzoquat in the Federal Register. 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; and
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)).
If EPA issues such an order, persons who are interested in the
continuation of the difenzoquat tolerances must notify the Agency by
completing and submitting the required ``Sec. 408(f) Order Response''
form (available in the docket) within 90 days after publication in the
Federal Register.
The ``Sec. 408(f) Order Response Form'' requires the
identification of persons who will submit the required data and lists
the following options available to support the required data:
a. Develop new data,
b. Submit an existing study--submit existing data not submitted
previously to the Agency by anyone,
c. Upgrade a study--submit or cite data to upgrade a study
classified by EPA as partially acceptable and upgradable,
d. Cite an existing study--cite an existing study that EPA
classified as acceptable or an existing study that has been submitted
but not reviewed by the Agency.
If EPA does issue a final order requiring the submission of data on
difenzoquat and if the Agency does not receive a Sec. 408(f) Order
Response Form identifying a person who agrees to submit the required
data within 90 days after publication of the final order, EPA will
proceed to revoke the difenzoquat tolerances at 40 CFR 180.369. Such
revocation order 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 if a final order requiring data is
issued include, but are not limited to, the following:
1. No person submits on the required schedule an acceptable
proposal or final protocol when such is required to be submitted to the
Agency for review.
2. No person submits on the required schedule an adequate progress
report on a study as required by the order.
3. No person submits on the required schedule acceptable data as
required by the final order.
4. No person submits supportable certifications as to the
conditions of submitted data, where required by order and where no
other cited or submitted study meets the data requirements the study
was intended to fulfill.
III. Regulatory Background for Difenzoquat
Difenzoquat is an herbicide. It is not currently registered under
FIFRA. Difenzoquat's last FIFRA registration 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). Since there are currently no
domestic registrations for difenzoquat, these tolerances are referred
to as ``import tolerances.''
The Agency completed a Reregistration Eligibility Decision (RED)
for difenzoquat in September 1994. The RED evaluated the potential
human health and ecological risks associated with all registered uses
of difenzoquat, and concluded that difenzoquat products, when labeled
and used as specified in the RED, did not pose unreasonable risk or
adverse effects to humans or the environment. Additionally, in
connection with its obligation under the Food Quality Protection Act of
1996 (FQPA), the Agency evaluated whether all difenzoquat tolerances in
existence at the time of the passage of FQPA met the revised safety
standard that the FQPA adopted for FFDCA section 408. A Report of the
Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and
Risk Management Decision (TRED) for Difenzoquat was completed in April
2002. The TRED concluded that the risks of difenzoquat met the revised
safety standard in FFDCA section 408.
In August 2011, in response to a registrant's interest in
supporting tolerances for import purposes, the Agency completed a
screening-level evaluation for difenzoquat. As there are no domestic
registrations for difenzoquat products, the evaluation was limited to
the potential dietary risk from exposure to difenzoquat residues in
imported food commodities. The evaluation concluded that additional
data are needed to support a new dietary risk assessment on exposure
from imported food commodities. The necessary data include: a
neurotoxicity battery; residue data for wheat hay, wheat forage, and
barley hay; and an immunotoxicity study. These data
[[Page 39964]]
requirements are discussed in detail in Unit IV.
IV. Proposed Data Requirements
A. Proposed Data and Reports
Pursuant to FFDCA section 408(f), EPA has determined that
additional data are reasonably required to support the continuation of
the import tolerances for difenzoquat, which are codified at 40 CFR
180.369. These data cannot be obtained under FIFRA section 3(c)(2)(B)
because difenzoquat is not registered under FIFRA and the data call-in
authority under that section only extends to registered pesticides.
These data cannot be obtained under TSCA because pesticides are
excluded from coverage under that statute. 15 U.S.C. 2602(2)(B)(ii).
Accordingly, EPA proposes to issue a final order requiring the
submission of the following data:
1. Neurotoxicity Screening Battery (870.6200). Rationale. EPA does
not have a neurotoxicity screening battery (870.6200) for difenzoquat.
This is a data requirement under 40 CFR part 158 as a part of the data
requirements for registration of a pesticide (food and non-food uses)
and establishment of FFDCA tolerances. 40 CFR 158.500. The
Neurotoxicity Screening Battery (870.6200) is designed to evaluate the
potential adverse effects on the nervous system from exposure to
pesticide chemicals. The acute neurotoxicity study is required to
detect possible effects resulting from a single exposure. The
subchronic neurotoxicity study is intended to detect possible effects
resulting from repeated or long-term exposure.
2. Immunotoxicity Study (870.7800). A final report and protocol are
required. Rationale. EPA does not have a functional immunotoxicity
study (870.7800) for difenzoquat. This is a data requirement under 40
CFR Part 158 as a part of the data requirements for registration of a
pesticide (food and non-food uses) and for establishment of a
tolerance. 40 CFR 158.500. A functional immunotoxicity study under the
Immunotoxicity Test Guideline (870.7800) is designed to evaluate the
potential of a repeated chemical exposure to produce adverse effects
(i.e., suppression) on the immune system. Immunosuppression is a
deficit in the ability of the immune system to respond to a challenge
of bacterial or viral infections such as tuberculosis (TB), Severe
Acquired Respiratory Syndrome (SARS), or neoplasia.
3. Crop Field Trials (860.1500)--(wheat hay, wheat forage, and
barley hay) Rationale. EPA does not have crop field trials (860.1500)
for difenzoquat for the commodities wheat hay, wheat forage, or barley
hay. Field trials are required for each commodity/commodity group under
40 CFR part 158. These data are used to establish the legal maximum
residue that may remain on food and to assess the risk posed by the
pesticide residue.
EPA guidelines recommend that crop field trials be designed to take
into account where the crop is grown and how much of the crop is grown.
Field trials are generally needed for each type of formulation because
the formulation can have a significant effect on the magnitude of the
pesticide residue left on the crop. Residue trials also need to
represent the maximum application rate on the label and have a
geographic distribution representative of the commodity/commodity group
so that EPA can evaluate what level of residues may be present from use
of the pesticide. On June 1, 2000 (65 FR 35069) (FRL-6559-3), EPA
published in the Federal Register a Notice which provided detailed
guidance on applying current U.S. data requirements for the
establishment or continuance of tolerances for pesticide residues in or
on imported foods. A copy of that Notice is available in the docket of
this proposed order. That Notice contains instructions for determining
number and location of field trials.
EPA is requesting comment on these proposed data requirements.
B. Proposed Dates for Submission of Data/Reports
The table below lists the time proposed for both the completion and
submission of each study. The proposed submission date is calculated
from the date of publication in the Federal Register of the final
order.
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Timeframe for
data
Guideline requirement No. Study title Timeframe for protocol submission submission
(months)
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870.6200....................... Neurotoxicity Screening Not Required........................ 24
Battery.
870.7800....................... Immunotoxicity Study..... 6 months............................ 12
860.1500....................... Crop Field Trials (wheat Not Required........................ 24
hay, wheat forage, and
barley hay).
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V. Statutory and Executive Order Reviews
As required by statute, this document proposing to require
submission of data in support of tolerances is in the form of a
proposed order and not a rule. (21 U.S.C. 346a(f)(1)(C)). Under the
Administrative Procedures Act, orders are expressly excluded from the
definition of a rule. (5 U.S.C. 551(4)). Accordingly, the regulatory
assessment requirements imposed on rulemaking do not, therefore, apply
to this action.
This document proposes to require data from any party interested in
supporting certain tolerances. Because this proposed order is not a
significant regulatory action it is exempt from review by the Office of
Management and Budget (OMB) under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993), and also
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This proposed order also does not
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).
This proposed order does contain information collections that have been
approved by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq.
This document proposes to require 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
[[Page 39965]]
governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian tribes. Thus, the Agency has determined that Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000) do not apply to this
proposed final rule. In addition, this proposed order does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
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).
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: June 22, 2012.
Michael Goodis,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2012-16295 Filed 7-5-12; 8:45 am]
BILLING CODE 6560-50-P