Difenzoquat; Denial of Objections, 57289-57292 [2013-22603]
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Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Rules and Regulations
Dated: September 9, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, alphabetically add the
following polymer to the table to read as
follows:
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Therefore, 40 CFR chapter I is
amended as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
PART 180—[AMENDED]
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CAS No.
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2,5-Furandione, polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated, minimum number average molecular weight (in amu), 5,816 ......................................................................................................................................
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0441; FRL–9396–7]
Difenzoquat; Denial of Objections
Environmental Protection
Agency (EPA).
ACTION: Order.
AGENCY:
In this Denial of Objections
Order, EPA is denying the objections
submitted by Amvac Chemical
Corporation (AMVAC) to a Revocation
Order EPA issued in May 2013 under
the Federal Food, Drug, and Cosmetic
Act (FFDCA) revoking all tolerances for
the pesticide difenzoquat. EPA revoked
the tolerances, consistent with the terms
of a previously issued Data Call-In
Order, because no notices of intent to
submit the required data were
submitted, as directed by that Data CallIn Order. In its objections, AMVAC
requested that EPA delay the effective
date for revoking the difenzoquat
tolerances for 41⁄2 years to allow for
importation of food commodities that
will be treated with the pesticide in
Canada over the next 2 years. EPA
denies AMVAC’s objections because
AMVAC has not filed a proper objection
to the Revocation Order.
DATES: This order is effective September
18, 2013.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0441, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
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SUMMARY:
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Regulatory Public Docket (OPP 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 https://www.epa.gov/dockets.
[FR Doc. 2013–22601 Filed 9–17–13; 8:45 am]
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1. The authority citation for part 180
continues to read as follows:
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Polymer
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57289
FOR FURTHER INFORMATION CONTACT:
Joseph Nevola, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–8037; email address:
nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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II. Introduction
A. What action is the agency taking?
In this Denial of Objections Order,
EPA is denying the objections submitted
by AMVAC to a Revocation Order
issued by EPA in the Federal Register
of May 29, 2013 (Ref. 1), in which EPA
ordered the revocation of all tolerances
for the pesticide difenzoquat under
FFDCA section 408, 21 U.S.C. 346a.
EPA revoked the tolerances, consistent
with the terms of a previously issued
Data Call-In Order (Ref. 2), because no
notices of intent to submit the required
data were received by EPA as directed
by that Data Call-In Order. In its
objections (Ref. 3), AMVAC requested
that EPA delay the effective date for the
revocation of the difenzoquat tolerances
for 41⁄2 years to allow for importation of
food commodities that will be treated
with the pesticide in Canada over the
next 2 years. EPA denies AMVAC’s
objections because AMVAC has not
filed a proper objection to the
Revocation Order. The AMVAC
objections are discussed in Unit IV., and
EPA’s denial is discussed in Unit V.
B. What is the agency’s authority for
taking this action?
The procedure for filing objections to
tolerance actions and EPA’s authority
for acting on such objections is
contained in FFDCA section 408(g), 21
U.S.C. 346a(g), and 40 CFR part 178. For
orders issued under FFDCA section
408(f)(2), the only material issue for
consideration is whether a submission
required under a FFDCA section
408(f)(1)(C) order was made by the time
specified in that FFDCA section
408(f)(1)(C) order. 21 U.S.C. 346a(f)(2).
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III. Background
A. Statutory Background
1. In general. EPA regulates the use of
pesticides under the authority of two
Federal statutes: The Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), 7 U.S.C. 136–136y, and
FFDCA, 21 U.S.C. 346a. FIFRA provides
the basis for the regulation, sale,
distribution, and use of pesticides in the
United States, and authorizes EPA to
review and register pesticides for
specified uses. EPA also has the
authority to suspend or cancel the
registration of a pesticide if subsequent
information shows that continued use
would pose unreasonable risks. EPA
establishes maximum residue limits, or
‘‘tolerances,’’ for pesticide residues in
food under FFDCA section 408. Without
such a tolerance or an exemption from
the requirement of a tolerance, a food
containing a pesticide residue is
‘‘adulterated’’ under FFDCA section 402
and may not be legally moved in
interstate commerce. 21 U.S.C. 331 and
342. Monitoring and enforcement of
pesticide tolerances are carried out by
the U.S. Food and Drug Administration
(FDA) and the U.S. Department of
Agriculture.
2. Safety standard for pesticide
tolerances. A pesticide tolerance may
only be promulgated by EPA if the
tolerance is ‘‘safe.’’ 21 U.S.C.
346a(b)(2)(A)(i). ‘‘Safe’’ is defined by the
statute 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.’’ 21 U.S.C.
346a(b)(2)(A)(ii). Section 408 of FFDCA
directs EPA, in making a safety
determination, to ‘‘consider, among
other relevant factors . . . available
information concerning the aggregate
exposure levels of consumers (and
major identifiable subgroups of
consumers) to the pesticide chemical
residue and to other related substances,
including dietary exposure under the
tolerance and all other tolerances in
effect for the pesticide chemical residue,
and exposure from other nonoccupational sources.’’ 21 U.S.C.
346a(b)(2)(D)(vi).
3. Data required for supporting
tolerances. In determining whether to
establish, modify, or revoke a tolerance,
EPA considers data to evaluate whether
that tolerance meets the FFDCA safety
standard. Generally, these data are
provided in support of an application
for registration of a pesticide under
FIFRA, and a petition to establish a
pesticide tolerance under FFDCA. If
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additional data are needed for an
existing tolerance, EPA’s first recourse
is to use the broad data call-in authority
in FIFRA section 3(c)(2)(B), 7 U.S.C.
136a(c)(2)(B). In some situations where
there is no domestic pesticide
registration and 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, FFDCA section
408(f)(1)(C) authorizes EPA to require,
by order, submission of data
‘‘reasonably required to support the
continuation of a tolerance. . . .’’ 21
U.S.C. 346a(f).
Under FFDCA section 408(f)(1)(C),
EPA can issue a data call-in order
following notice and a comment period
of not less than 60 days. 21 U.S.C.
346a(f)(1)(C). After the comment period
closes, the Agency will respond to
comments, if appropriate, and may issue
a final order requiring the data
necessary to support the continuation of
a tolerance. Section 408(f)(1)(C) of
FFDCA requires that a data call-in order
contain the following elements:
i. 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
and the date by which such notice(s)
must be submitted.
ii. A description of the data necessary
to support the tolerance, reports
connected to such data, a requirement to
submit such data and reports, and the
date(s) by which such data and reports
must be submitted.
iii. An explanation of why the
required data could not be obtained
under FIFRA section 3(c)(2)(B) or TSCA
section 4.
If EPA issues a FFDCA section
408(f)(1)(C) data call-in order and any
submission required by that order is not
made by the time specified in that order,
EPA may revoke, by order published in
the Federal Register, the tolerance that
is the subject of that data call-in order.
21 U.S.C. 346a(f)(2). 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.
4. Procedures for objections. Upon
issuing an order under FFDCA section
408(f)(2), any affected party has 60 days
to file objections with EPA and seek an
evidentiary hearing on those objections.
21 U.S.C. 346a(g)(2). For FFDCA section
408(f)(2) orders, the only material issue
for review of such order is whether a
submission required by the order was
made by the time specified in the
FFDCA section 408(f)(1)(C) order.
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5. Channels of trade provision for
revoked tolerances. The FFDCA
specifically addresses the legality of
pesticide residues entering or remaining
in the channels of trade following
revocation of the associated tolerance.
21 U.S.C. 346a(l)(5). Under FFDCA
section 408(l)(5), any residues of the
pesticide in or on such food does not
render the food adulterated so long as it
is shown to the satisfaction of FDA that:
i. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA.
ii. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates that the
pesticide was applied to such food.
B. Regulatory Background
1. Difenzoquat tolerances.
Difenzoquat is a herbicide that was
previously registered under FIFRA for
sale and distribution in the United
States. The last FIFRA registration was
canceled in 2010, although tolerances
remained for this pesticide on the
following commodities: Barley, cattle,
goat, hog, horse, poultry, sheep, and
wheat (40 CFR 180.369). In August
2011, in response to AMVAC’s interest
in maintaining the difenzoquat
tolerances for import purposes, the
Agency completed a screening-level
evaluation for difenzoquat (ScreeningLevel Memorandum) (Ref. 4). 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, in order to
determine whether it was appropriate to
continue the tolerances, additional
data—a neurotoxicity battery; an
immunotoxicity study; and residue data
for barley hay, wheat forage, and wheat
hay—were needed to conduct a new
dietary risk assessment on exposure
from imported food commodities. The
neurotoxicity battery and
immunotoxicity study were required in
accordance with the data requirements
rule, which was updated in 2007 to add
these tests (Ref. 5). In addition, EPA
required, consistent with its guidance
on applying U.S. data requirements to
import tolerances (Ref. 6), that field trial
data on crops mentioned in this unit be
conducted at the maximum application
rates and in the countries where the
pesticide would be used so that EPA
could evaluate what level of residues
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may be present on imported treated food
commodities (Ref. 4, p. 6).
2. EPA’s FFDCA section 408(f) Data
Call-In Order. On July 6, 2012, EPA
issued in the Federal Register a
proposed Data Call-In Order under
FFDCA section 408(f)(1), 21 U.S.C.
346a(f)(1), proposing to require the
submission of data for the pesticide
difenzoquat to support the continuation
of tolerances associated with that
pesticide (Ref. 7). The proposed Data
Call-In Order identified the following
studies for submission as reasonably
required to support the difenzoquat
tolerances: Neurotoxicity screening
battery (OPPTS 870.6200) (Ref. 8);
immunotoxicity study (OPPTS
870.7800) (Ref. 9); and crop field trials
(OPPTS 860.1500) (Ref. 10) for barley
hay, wheat forage, and wheat hay (Ref.
7, p. 39964). The proposed Data Call-In
Order explained, in accordance with the
statutory requirements, why the data
could not be obtained under FIFRA
section 3(c)(2)(B) or TSCA section 4. In
addition, the proposed Data Call-In
Order proposed dates for submission of
the data and related reports. Finally, the
proposed Data Call-In Order requested
comment by September 4, 2012. EPA
received no comments in response to
the proposed Data Call-In Order and
issued a final Data Call-In Order in the
Federal Register on December 19, 2012
(Ref. 2). Consistent with the proposed
Data Call-In Order and statutory
obligations, the final Data Call-In Order
included the following elements:
• EPA required that any person who
wishes to support the difenzoquat
tolerances must submit a notice
identifying that person or persons who
commit to submit the data and reports
in accordance with the terms of the final
Data Call-In Order. EPA explained that
the notice must be submitted on a Data
Call-In Response form, how to obtain
that form, and that the deadline for
submitting that form was March 19,
2013.
• EPA described the data and reports
that were required to support the
continuation of the difenzoquat
tolerances and required them to be
submitted by certain dates.
• EPA explained that it would
proceed to revoke the difenzoquat
tolerances at 40 CFR 180.369 under
FFDCA section 408(f) if it did not
receive by March 19, 2013, a Data CallIn Response form identifying the person
or persons who commit to submit the
required data and reports.
3. International notification of EPA’s
FFDCA section 408(f) Data Call-In
Order. Shortly after publishing the
proposed Data Call-In Order, EPA
notified the World Trade Organization
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of the proposed order pursuant to its
obligations under the Agreement on the
Application of Sanitary and
Phytosanitary Measures, January 1, 1995
(Refs. 11 and 12). The U.S. notification,
which referenced and included a link to
the proposed Data Call-In Order (Ref. 7),
alerted potential U.S. trading partners to
EPA’s need for data to support the
continuation of the difenzoquat
tolerances and that if no notices of
intent to submit such data were received
by the Agency by March 19, 2013, EPA
would proceed to revoke the
difenzoquat tolerances, which would
prohibit the export to the United States
of food commodities bearing
difenzoquat residues that did not
qualify under the channels of trade
provision (Ref. 12).
4. EPA’s FFDCA section 408(f)
Revocation Order. Subsequent to the
issuance of the final Data Call-In Order,
EPA received no submissions of the
Data Call-In Response form within the
required 90-day period. Therefore, in
the Federal Register on May 29, 2013
(Ref. 1), EPA issued an order revoking
all difenzoquat tolerances (Revocation
Order) in accordance with the terms of
its final Data Call-In Order and FFDCA
section 408(f)(2), which allows EPA to
revoke by order any tolerances that are
the subject of a final Data Call-In Order
for which a submission required by that
final Data Call-In Order is not received
by the date specified in that order. The
Revocation Order was effective upon the
date of publication in the Federal
Register, which means that food
commodities bearing difenzoquat
residues after May 29, 2013, are
considered adulterated unless the
commodities qualified under the
channels of trade provision. The
Revocation Order explained that it was
subject to the objection and hearing
procedure in FFDCA section 408(g)(2)
and that the only material issue for
review of the Revocation Order was
whether a submission required by the
final Data Call-In Order was made in a
timely fashion. The Revocation Order
established July 29, 2013, as the date by
which objections must be received by
the Agency.
IV. AMVAC’s Objections
On June 24, 2013, AMVAC submitted
its formal objections to the Revocation
Order. See AMVAC Objections (Ref. 3).
Rather than actually challenging the
revocation itself, AMVAC submitted its
objections solely for the ‘‘purpose of
. . . seek[ing] an extension of the
effective date of the revocation. . . .’’
AMVAC makes two specific objections
to the timing of the Revocation Order.
First, citing to its recent shipment of
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57291
difenzoquat to Canadian growers for use
through 2015, AMVAC argues that
‘‘insufficient time has been afforded to
foreign growers that continue to rely on
these tolerances.’’ Second, AMVAC
asserts that immediate revocation, or
even revocation in 2015, is unrealistic
because the FFDCA channels of trade
provision is ‘‘unworkable in practice.’’
In support of this latter claim, AMVAC
claims that barley and wheat, two crops
covered by difenzoquat tolerances,
‘‘may be stored for a protracted period
and that treated grain might also be
intermingled with untreated grain while
in storage.’’ These factors, AMVAC
asserts, make it ‘‘difficult, if not
impossible, to provide the information
concerning the time that these crops
were treated, which EPA requires as a
means of providing evidence that the
food was lawfully treated.’’ Based on its
expectation that difenzoquat will be
used in Canada through 2015 and the
alleged unworkability of the FFDCA
channels of trade provision, AMVAC
requests an extension of the revocation
date until December 31, 2017.
AMVAC concedes that it did not raise
these concerns by commenting on the
proposed Data Call-In Order or
responding to the final Data Call-In
Order within the time periods provided.
Further, AMVAC does not assert that it
submitted any Data Call-In Response
form indicating its intent to submit the
required data by the date specified in
the final Data Call-In Order.
V. EPA’s Response to AMVAC’s
Objections
EPA denies AMVAC’s objections
because AMVAC has not filed a proper
objection to the Revocation Order.
Section 408(f)(2) of FFDCA restricts the
substance of objections the Agency may
consider in reviewing an order issued
under FFDCA section 408(f)(1) to the
following limited issue: ‘‘Whether a
submission required under [an order
issued under 408(f)(1)(C)] was not made
by the time specified.’’ 21 U.S.C.
346a(f)(2). In its objections, AMVAC
does not contend that it made a timely
submission of a notice of intent to
submit data, made any submission of
data, or intends to submit any required
data as specified in the final Data CallIn Order. Rather, AMVAC concedes that
it overlooked the notices and did not
submit any comments on the proposed
Data Call-In Order nor any response to
the final Data Call-In Order. In addition,
AMVAC does not disagree with the
revocation of the tolerances, just to the
timing of the effectiveness of the
Revocation Order. Because AMVAC has
not argued that ‘‘a submission required
[by the final Data Call-In Order] was [
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] made by the time specified,’’ see 21
U.S.C. 346a(f)(2), its objections do not
provide a proper basis for review of the
Revocation Order under FFDCA section
408(f)(2).
AMVAC’s arguments concerning the
need for additional time for Canadian
farmers to use their recently purchased
difenzoquat stocks and to simplify
enforcement of the channels of trade
provision are, by law, simply not
relevant at this stage of the revocation
proceeding under FFDCA section
408(f)(2). AMVAC or other interested
parties had two opportunities to raise
such concerns when EPA issued the
proposed Data Call-In Order and when
it issued the final Data Call-In Order. At
this point, it would be advisable for
Canadian farmers who have used
difenzoquat prior to the revocation date
of the tolerance to document the timing
of that usage to show compliance with
the FFDCA’s channels of trade
provision. EPA has alerted FDA, which
monitors pesticide residues in imported
food, of the possibility that food
qualifying under the channels of trade
provision may be entering the country
and will work with FDA to ensure that
this provision is applied properly.
Going forward, if Canadian farmers
choose to use difenzoquat, they—like
any foreign grower who uses a pesticide
for which there is no U.S. tolerance—
will need to take steps to ensure that
commodities they produce that are
treated with and contain residues of
difenzoquat are segregated from
commodities intended for export to the
United States.
VI. Statutory and Executive Order
Reviews
This action, which denies an
objection to a Revocation Order, is an
adjudication in the form of an order and
not a rule. 21 U.S.C. 346a(g)(2)(C).
Under the Administrative Procedure 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.
• Because this order is not a
‘‘regulatory action’’ as that term is
defined in Executive Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993),
this order is not subject to review by the
Office of Management and Budget
(OMB) under Executive Orders 12866
and 13563, entitled ‘‘Improving
Regulation and Regulatory Review’’ (76
FR 3821, January 21, 2011).
• For the same reason, this order does
not require Agency considerations
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under Executive Order 13045, entitled
‘‘Protection of Children From
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997);
Executive Order 13211, entitled
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001); and Executive Order 12898,
entitled ‘‘Federal Actions To Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
• This order does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.).
• 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 (5 U.S.C. 601 et seq.) do
not apply.
• This order does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
order will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination With Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this 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 (2 U.S.C. 1531–1538).
• This order 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 (15
U.S.C. 272 note).
• The Congressional Review Act (5
U.S.C. 801 et seq.), does not apply to
this order because it is not a rule for
purposes of 5 U.S.C. 804(3).
VII. References
The following is a listing of the
documents that are specifically
referenced in this order. The docket for
this order, which is identified under
ADDRESSES at the beginning of this
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document, includes these documents
and other information considered by
EPA, including documents that are
referenced within the documents that
are included in the docket, even if the
referenced document is not physically
located in the docket. For assistance in
locating these other documents, please
consult the person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. Difenzoquat; Order Revoking
Tolerances; Revocation order. Federal
Register (78 FR 32155, May 29, 2013)
(FRL–9386–5).
2. EPA. Difenzoquat; Data Call-in Order for
Pesticide Tolerances; Final order.
Federal Register (77 FR 75037,
December 19, 2012) (FRL–9372–9).
3. AMVAC. EPA–HQ–OPP–2012–0441:
Objection to Order Revoking Difenzoquat
Tolerances. June 24, 2013.
4. Memorandum from Susan Hummel (OPP)
to Eric Miederhoff (OPP). Difenzoquat
Methyl Sulfate: Human Health Screening
Level Document for Maintaining
Tolerances for Import Use. August 11,
2011.
5. EPA. Pesticides; Data Requirements for
Conventional Chemicals; Final rule.
Federal Register (72 FR 60934, October
26, 2007) (FRL–8106–5).
6. EPA. Pesticides; Guidance on Pesticide
Import Tolerances and Residue Data for
Imported Food; Request for Comment;
Notice. Federal Register (65 FR 35069,
June 1, 2000) (FRL–6559–3).
7. EPA. Difenzoquat; Proposed Data Call-in
Order for Pesticide Tolerance; Proposed
order. Federal Register (77 FR 39962,
July 6, 2012) (FRL–9352–9).
8. EPA. Health Effects Test Guidelines:
OPPTS 870.6200 Neurotoxicity
Screening Battery. EPA 712–C–98–238.
Available at https://www.regulations.gov.
9. EPA. Health Effects Test Guidelines:
OPPTS 870.7800 Immunotoxicity. EPA
712–C–98–351. Available at https://
www.regulations.gov.
10. EPA. Residue Chemistry Test Guidelines:
OPPTS 860.1500 Crop Field Trials. EPA
712–C–96–183. Available at https://
www.regulations.gov.
11. Agreement on the Application of Sanitary
and Phytosanitary Measures, January 1,
1995. 1867 U.N.T.S. 493.
12. United States. Notification. G/SPS/N/
USA/2421. July 16, 2012.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 5, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2013–22603 Filed 9–17–13; 8:45 am]
BILLING CODE 6560–50–P
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18SER1
Agencies
[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57289-57292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22603]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0441; FRL-9396-7]
Difenzoquat; Denial of Objections
AGENCY: Environmental Protection Agency (EPA).
ACTION: Order.
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SUMMARY: In this Denial of Objections Order, EPA is denying the
objections submitted by Amvac Chemical Corporation (AMVAC) to a
Revocation Order EPA issued in May 2013 under the Federal Food, Drug,
and Cosmetic Act (FFDCA) revoking all tolerances for the pesticide
difenzoquat. EPA revoked the tolerances, consistent with the terms of a
previously issued Data Call-In Order, because no notices of intent to
submit the required data were submitted, as directed by that Data Call-
In Order. In its objections, AMVAC requested that EPA delay the
effective date for revoking the difenzoquat tolerances for 4\1/2\ years
to allow for importation of food commodities that will be treated with
the pesticide in Canada over the next 2 years. EPA denies AMVAC's
objections because AMVAC has not filed a proper objection to the
Revocation Order.
DATES: This order is effective September 18, 2013.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0441, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 308-8037; email address:
nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
II. Introduction
A. What action is the agency taking?
In this Denial of Objections Order, EPA is denying the objections
submitted by AMVAC to a Revocation Order issued by EPA in the Federal
Register of May 29, 2013 (Ref. 1), in which EPA ordered the revocation
of all tolerances for the pesticide difenzoquat under FFDCA section
408, 21 U.S.C. 346a. EPA revoked the tolerances, consistent with the
terms of a previously issued Data Call-In Order (Ref. 2), because no
notices of intent to submit the required data were received by EPA as
directed by that Data Call-In Order. In its objections (Ref. 3), AMVAC
requested that EPA delay the effective date for the revocation of the
difenzoquat tolerances for 4\1/2\ years to allow for importation of
food commodities that will be treated with the pesticide in Canada over
the next 2 years. EPA denies AMVAC's objections because AMVAC has not
filed a proper objection to the Revocation Order. The AMVAC objections
are discussed in Unit IV., and EPA's denial is discussed in Unit V.
B. What is the agency's authority for taking this action?
The procedure for filing objections to tolerance actions and EPA's
authority for acting on such objections is contained in FFDCA section
408(g), 21 U.S.C. 346a(g), and 40 CFR part 178. For orders issued under
FFDCA section 408(f)(2), the only material issue for consideration is
whether a submission required under a FFDCA section 408(f)(1)(C) order
was made by the time specified in that FFDCA section 408(f)(1)(C)
order. 21 U.S.C. 346a(f)(2).
[[Page 57290]]
III. Background
A. Statutory Background
1. In general. EPA regulates the use of pesticides under the
authority of two Federal statutes: The Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y, and FFDCA, 21 U.S.C.
346a. FIFRA provides the basis for the regulation, sale, distribution,
and use of pesticides in the United States, and authorizes EPA to
review and register pesticides for specified uses. EPA also has the
authority to suspend or cancel the registration of a pesticide if
subsequent information shows that continued use would pose unreasonable
risks. EPA establishes maximum residue limits, or ``tolerances,'' for
pesticide residues in food under FFDCA section 408. Without such a
tolerance or an exemption from the requirement of a tolerance, a food
containing a pesticide residue is ``adulterated'' under FFDCA section
402 and may not be legally moved in interstate commerce. 21 U.S.C. 331
and 342. Monitoring and enforcement of pesticide tolerances are carried
out by the U.S. Food and Drug Administration (FDA) and the U.S.
Department of Agriculture.
2. Safety standard for pesticide tolerances. A pesticide tolerance
may only be promulgated by EPA if the tolerance is ``safe.'' 21 U.S.C.
346a(b)(2)(A)(i). ``Safe'' is defined by the statute 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.'' 21 U.S.C. 346a(b)(2)(A)(ii). Section 408 of
FFDCA directs EPA, in making a safety determination, to ``consider,
among other relevant factors . . . available information concerning the
aggregate exposure levels of consumers (and major identifiable
subgroups of consumers) to the pesticide chemical residue and to other
related substances, including dietary exposure under the tolerance and
all other tolerances in effect for the pesticide chemical residue, and
exposure from other non-occupational sources.'' 21 U.S.C.
346a(b)(2)(D)(vi).
3. Data required for supporting tolerances. In determining whether
to establish, modify, or revoke a tolerance, EPA considers data to
evaluate whether that tolerance meets the FFDCA safety standard.
Generally, these data are provided in support of an application for
registration of a pesticide under FIFRA, and a petition to establish a
pesticide tolerance under FFDCA. If additional data are needed for an
existing tolerance, EPA's first recourse is to use the broad data call-
in authority in FIFRA section 3(c)(2)(B), 7 U.S.C. 136a(c)(2)(B). In
some situations where there is no domestic pesticide registration and
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, FFDCA section 408(f)(1)(C) authorizes EPA to
require, by order, submission of data ``reasonably required to support
the continuation of a tolerance. . . .'' 21 U.S.C. 346a(f).
Under FFDCA section 408(f)(1)(C), EPA can issue a data call-in
order following notice and a comment period of not less than 60 days.
21 U.S.C. 346a(f)(1)(C). After the comment period closes, the Agency
will respond to comments, if appropriate, and may issue a final order
requiring the data necessary to support the continuation of a
tolerance. Section 408(f)(1)(C) of FFDCA requires that a data call-in
order contain the following elements:
i. 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 and the date by which such notice(s) must be submitted.
ii. A description of the data necessary to support the tolerance,
reports connected to such data, a requirement to submit such data and
reports, and the date(s) by which such data and reports must be
submitted.
iii. An explanation of why the required data could not be obtained
under FIFRA section 3(c)(2)(B) or TSCA section 4.
If EPA issues a FFDCA section 408(f)(1)(C) data call-in order and
any submission required by that order is not made by the time specified
in that order, EPA may revoke, by order published in the Federal
Register, the tolerance that is the subject of that data call-in order.
21 U.S.C. 346a(f)(2). 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.
4. Procedures for objections. Upon issuing an order under FFDCA
section 408(f)(2), any affected party has 60 days to file objections
with EPA and seek an evidentiary hearing on those objections. 21 U.S.C.
346a(g)(2). For FFDCA section 408(f)(2) orders, the only material issue
for review of such order is whether a submission required by the order
was made by the time specified in the FFDCA section 408(f)(1)(C) order.
5. Channels of trade provision for revoked tolerances. The FFDCA
specifically addresses the legality of pesticide residues entering or
remaining in the channels of trade following revocation of the
associated tolerance. 21 U.S.C. 346a(l)(5). Under FFDCA section
408(l)(5), any residues of the pesticide in or on such food does not
render the food adulterated so long as it is shown to the satisfaction
of FDA that:
i. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
ii. The residue does not exceed the level that was authorized at
the time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.
B. Regulatory Background
1. Difenzoquat tolerances. Difenzoquat is a herbicide that was
previously registered under FIFRA for sale and distribution in the
United States. The last FIFRA registration was canceled in 2010,
although tolerances remained for this pesticide on the following
commodities: Barley, cattle, goat, hog, horse, poultry, sheep, and
wheat (40 CFR 180.369). In August 2011, in response to AMVAC's interest
in maintaining the difenzoquat tolerances for import purposes, the
Agency completed a screening-level evaluation for difenzoquat
(Screening-Level Memorandum) (Ref. 4). 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, in order to
determine whether it was appropriate to continue the tolerances,
additional data--a neurotoxicity battery; an immunotoxicity study; and
residue data for barley hay, wheat forage, and wheat hay--were needed
to conduct a new dietary risk assessment on exposure from imported food
commodities. The neurotoxicity battery and immunotoxicity study were
required in accordance with the data requirements rule, which was
updated in 2007 to add these tests (Ref. 5). In addition, EPA required,
consistent with its guidance on applying U.S. data requirements to
import tolerances (Ref. 6), that field trial data on crops mentioned in
this unit be conducted at the maximum application rates and in the
countries where the pesticide would be used so that EPA could evaluate
what level of residues
[[Page 57291]]
may be present on imported treated food commodities (Ref. 4, p. 6).
2. EPA's FFDCA section 408(f) Data Call-In Order. On July 6, 2012,
EPA issued in the Federal Register a proposed Data Call-In Order under
FFDCA section 408(f)(1), 21 U.S.C. 346a(f)(1), proposing to require the
submission of data for the pesticide difenzoquat to support the
continuation of tolerances associated with that pesticide (Ref. 7). The
proposed Data Call-In Order identified the following studies for
submission as reasonably required to support the difenzoquat
tolerances: Neurotoxicity screening battery (OPPTS 870.6200) (Ref. 8);
immunotoxicity study (OPPTS 870.7800) (Ref. 9); and crop field trials
(OPPTS 860.1500) (Ref. 10) for barley hay, wheat forage, and wheat hay
(Ref. 7, p. 39964). The proposed Data Call-In Order explained, in
accordance with the statutory requirements, why the data could not be
obtained under FIFRA section 3(c)(2)(B) or TSCA section 4. In addition,
the proposed Data Call-In Order proposed dates for submission of the
data and related reports. Finally, the proposed Data Call-In Order
requested comment by September 4, 2012. EPA received no comments in
response to the proposed Data Call-In Order and issued a final Data
Call-In Order in the Federal Register on December 19, 2012 (Ref. 2).
Consistent with the proposed Data Call-In Order and statutory
obligations, the final Data Call-In Order included the following
elements:
EPA required that any person who wishes to support the
difenzoquat tolerances must submit a notice identifying that person or
persons who commit to submit the data and reports in accordance with
the terms of the final Data Call-In Order. EPA explained that the
notice must be submitted on a Data Call-In Response form, how to obtain
that form, and that the deadline for submitting that form was March 19,
2013.
EPA described the data and reports that were required to
support the continuation of the difenzoquat tolerances and required
them to be submitted by certain dates.
EPA explained that it would proceed to revoke the
difenzoquat tolerances at 40 CFR 180.369 under FFDCA section 408(f) if
it did not receive by March 19, 2013, a Data Call-In Response form
identifying the person or persons who commit to submit the required
data and reports.
3. International notification of EPA's FFDCA section 408(f) Data
Call-In Order. Shortly after publishing the proposed Data Call-In
Order, EPA notified the World Trade Organization of the proposed order
pursuant to its obligations under the Agreement on the Application of
Sanitary and Phytosanitary Measures, January 1, 1995 (Refs. 11 and 12).
The U.S. notification, which referenced and included a link to the
proposed Data Call-In Order (Ref. 7), alerted potential U.S. trading
partners to EPA's need for data to support the continuation of the
difenzoquat tolerances and that if no notices of intent to submit such
data were received by the Agency by March 19, 2013, EPA would proceed
to revoke the difenzoquat tolerances, which would prohibit the export
to the United States of food commodities bearing difenzoquat residues
that did not qualify under the channels of trade provision (Ref. 12).
4. EPA's FFDCA section 408(f) Revocation Order. Subsequent to the
issuance of the final Data Call-In Order, EPA received no submissions
of the Data Call-In Response form within the required 90-day period.
Therefore, in the Federal Register on May 29, 2013 (Ref. 1), EPA issued
an order revoking all difenzoquat tolerances (Revocation Order) in
accordance with the terms of its final Data Call-In Order and FFDCA
section 408(f)(2), which allows EPA to revoke by order any tolerances
that are the subject of a final Data Call-In Order for which a
submission required by that final Data Call-In Order is not received by
the date specified in that order. The Revocation Order was effective
upon the date of publication in the Federal Register, which means that
food commodities bearing difenzoquat residues after May 29, 2013, are
considered adulterated unless the commodities qualified under the
channels of trade provision. The Revocation Order explained that it was
subject to the objection and hearing procedure in FFDCA section
408(g)(2) and that the only material issue for review of the Revocation
Order was whether a submission required by the final Data Call-In Order
was made in a timely fashion. The Revocation Order established July 29,
2013, as the date by which objections must be received by the Agency.
IV. AMVAC's Objections
On June 24, 2013, AMVAC submitted its formal objections to the
Revocation Order. See AMVAC Objections (Ref. 3). Rather than actually
challenging the revocation itself, AMVAC submitted its objections
solely for the ``purpose of . . . seek[ing] an extension of the
effective date of the revocation. . . .'' AMVAC makes two specific
objections to the timing of the Revocation Order. First, citing to its
recent shipment of difenzoquat to Canadian growers for use through
2015, AMVAC argues that ``insufficient time has been afforded to
foreign growers that continue to rely on these tolerances.'' Second,
AMVAC asserts that immediate revocation, or even revocation in 2015, is
unrealistic because the FFDCA channels of trade provision is
``unworkable in practice.'' In support of this latter claim, AMVAC
claims that barley and wheat, two crops covered by difenzoquat
tolerances, ``may be stored for a protracted period and that treated
grain might also be intermingled with untreated grain while in
storage.'' These factors, AMVAC asserts, make it ``difficult, if not
impossible, to provide the information concerning the time that these
crops were treated, which EPA requires as a means of providing evidence
that the food was lawfully treated.'' Based on its expectation that
difenzoquat will be used in Canada through 2015 and the alleged
unworkability of the FFDCA channels of trade provision, AMVAC requests
an extension of the revocation date until December 31, 2017.
AMVAC concedes that it did not raise these concerns by commenting
on the proposed Data Call-In Order or responding to the final Data
Call-In Order within the time periods provided. Further, AMVAC does not
assert that it submitted any Data Call-In Response form indicating its
intent to submit the required data by the date specified in the final
Data Call-In Order.
V. EPA's Response to AMVAC's Objections
EPA denies AMVAC's objections because AMVAC has not filed a proper
objection to the Revocation Order. Section 408(f)(2) of FFDCA restricts
the substance of objections the Agency may consider in reviewing an
order issued under FFDCA section 408(f)(1) to the following limited
issue: ``Whether a submission required under [an order issued under
408(f)(1)(C)] was not made by the time specified.'' 21 U.S.C.
346a(f)(2). In its objections, AMVAC does not contend that it made a
timely submission of a notice of intent to submit data, made any
submission of data, or intends to submit any required data as specified
in the final Data Call-In Order. Rather, AMVAC concedes that it
overlooked the notices and did not submit any comments on the proposed
Data Call-In Order nor any response to the final Data Call-In Order. In
addition, AMVAC does not disagree with the revocation of the
tolerances, just to the timing of the effectiveness of the Revocation
Order. Because AMVAC has not argued that ``a submission required [by
the final Data Call-In Order] was [
[[Page 57292]]
] made by the time specified,'' see 21 U.S.C. 346a(f)(2), its
objections do not provide a proper basis for review of the Revocation
Order under FFDCA section 408(f)(2).
AMVAC's arguments concerning the need for additional time for
Canadian farmers to use their recently purchased difenzoquat stocks and
to simplify enforcement of the channels of trade provision are, by law,
simply not relevant at this stage of the revocation proceeding under
FFDCA section 408(f)(2). AMVAC or other interested parties had two
opportunities to raise such concerns when EPA issued the proposed Data
Call-In Order and when it issued the final Data Call-In Order. At this
point, it would be advisable for Canadian farmers who have used
difenzoquat prior to the revocation date of the tolerance to document
the timing of that usage to show compliance with the FFDCA's channels
of trade provision. EPA has alerted FDA, which monitors pesticide
residues in imported food, of the possibility that food qualifying
under the channels of trade provision may be entering the country and
will work with FDA to ensure that this provision is applied properly.
Going forward, if Canadian farmers choose to use difenzoquat, they--
like any foreign grower who uses a pesticide for which there is no U.S.
tolerance--will need to take steps to ensure that commodities they
produce that are treated with and contain residues of difenzoquat are
segregated from commodities intended for export to the United States.
VI. Statutory and Executive Order Reviews
This action, which denies an objection to a Revocation Order, is an
adjudication in the form of an order and not a rule. 21 U.S.C.
346a(g)(2)(C). Under the Administrative Procedure 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.
Because this order is not a ``regulatory action'' as that
term is defined in Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993), this order is not
subject to review by the Office of Management and Budget (OMB) under
Executive Orders 12866 and 13563, entitled ``Improving Regulation and
Regulatory Review'' (76 FR 3821, January 21, 2011).
For the same reason, this order does not require Agency
considerations under Executive Order 13045, entitled ``Protection of
Children From Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); Executive Order 13211, entitled ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001); and Executive Order
12898, entitled ``Federal Actions To Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
This order does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (44 U.S.C.
3501 et seq.).
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 (5 U.S.C. 601 et seq.)
do not apply.
This order does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of FFDCA section 408(n)(4). As such, the
Agency has determined that this order will not have a substantial
direct effect on States or tribal governments, on the relationship
between the national government and the States or tribal governments,
or on the distribution of power and responsibilities among the various
levels of government or between the Federal Government and Indian
Tribes. Thus, the Agency has determined that Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled ``Consultation and Coordination With Indian
Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to
this 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 (2 U.S.C. 1531-1538).
This order 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 (15 U.S.C. 272 note).
The Congressional Review Act (5 U.S.C. 801 et seq.), does
not apply to this order because it is not a rule for purposes of 5
U.S.C. 804(3).
VII. References
The following is a listing of the documents that are specifically
referenced in this order. The docket for this order, which is
identified under ADDRESSES at the beginning of this document, includes
these documents and other information considered by EPA, including
documents that are referenced within the documents that are included in
the docket, even if the referenced document is not physically located
in the docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Difenzoquat; Order Revoking Tolerances; Revocation order.
Federal Register (78 FR 32155, May 29, 2013) (FRL-9386-5).
2. EPA. Difenzoquat; Data Call-in Order for Pesticide Tolerances;
Final order. Federal Register (77 FR 75037, December 19, 2012) (FRL-
9372-9).
3. AMVAC. EPA-HQ-OPP-2012-0441: Objection to Order Revoking
Difenzoquat Tolerances. June 24, 2013.
4. Memorandum from Susan Hummel (OPP) to Eric Miederhoff (OPP).
Difenzoquat Methyl Sulfate: Human Health Screening Level Document
for Maintaining Tolerances for Import Use. August 11, 2011.
5. EPA. Pesticides; Data Requirements for Conventional Chemicals;
Final rule. Federal Register (72 FR 60934, October 26, 2007) (FRL-
8106-5).
6. EPA. Pesticides; Guidance on Pesticide Import Tolerances and
Residue Data for Imported Food; Request for Comment; Notice. Federal
Register (65 FR 35069, June 1, 2000) (FRL-6559-3).
7. EPA. Difenzoquat; Proposed Data Call-in Order for Pesticide
Tolerance; Proposed order. Federal Register (77 FR 39962, July 6,
2012) (FRL-9352-9).
8. EPA. Health Effects Test Guidelines: OPPTS 870.6200 Neurotoxicity
Screening Battery. EPA 712-C-98-238. Available at https://www.regulations.gov.
9. EPA. Health Effects Test Guidelines: OPPTS 870.7800
Immunotoxicity. EPA 712-C-98-351. Available at https://www.regulations.gov.
10. EPA. Residue Chemistry Test Guidelines: OPPTS 860.1500 Crop
Field Trials. EPA 712-C-96-183. Available at https://www.regulations.gov.
11. Agreement on the Application of Sanitary and Phytosanitary
Measures, January 1, 1995. 1867 U.N.T.S. 493.
12. United States. Notification. G/SPS/N/USA/2421. July 16, 2012.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 5, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2013-22603 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P