Chlorantraniliprole; Pesticide Tolerances, 38601-38604 [2016-13910]
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Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations
§ 165.T08–0389 Safety Zone, Ohio River,
East Liverpool, OH.
do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969, (42
U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves a safety
zone lasting less than two hours that
will prohibit entry on the Ohio River
between mile 43.2 and mile 43.6, during
the barge-based firework event. It is
categorically excluded from further
review under paragraph 34 (g) of Figure
2–1 of the Commandant Instruction. An
environmental analysis checklist
supporting this determination and a
Categorical Exclusion Determination are
available in the docket where indicated
under ADDRESSES. We seek any
comments or information that may lead
to the discovery of a significant
environmental impact from this rule.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Marine safety, Navigation (water),
Reporting and recordkeeping
requirements, Security measures,
Waterways.
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Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
16:33 Jun 13, 2016
Jkt 238001
This regulation is effective June
14, 2016. Objections and requests for
hearings must be received on or before
August 15, 2016, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0235, 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), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (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:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
A. Does this action apply to me?
ENVIRONMENTAL PROTECTION
AGENCY
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
1. The authority citation for part 165
continues to read as follows:
the existing tolerance for egg that was
inadvertently omitted in a previous
action.
I. General Information
BILLING CODE 9110–04–P
Chlorantraniliprole; Pesticide
Tolerances
■
VerDate Sep<11>2014
[FR Doc. 2016–14027 Filed 6–13–16; 8:45 am]
[EPA–HQ–OPP–2013–0235; FRL–9946–75]
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
2. Add § 165.T08–0389 to read as
follows:
Dated: May 27, 2016.
L. McClain, Jr.,
Commander, U.S. Coast Guard, Acting
Captain of the Port Pittsburgh.
40 CFR Part 180
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
■
(a) Location. The following area is a
safety zone: Ohio River mile 43.2 to
mile 43.6.
(b) Enforcement. This rule will be
enforced, from 10:00 p.m. until 11:30
p.m. on July 2, 2016.
(c) Regulations. (1) In accordance with
the general regulations in § 165.23 of
this part, entry into this zone is
prohibited unless authorized by the
Captain of the Port Pittsburgh or a
designated representative.
(2) Persons or vessels requiring entry
into or passage through the zone must
request permission from the Captain of
the Port Pittsburgh or a designated
representative. The Captain of the
Pittsburgh representative may be
contacted at 412–221–0807.
(3) All persons and vessels shall
comply with the instructions of the
Captain of the Port Pittsburgh or their
designated representative. Designated
Captain of the Port representatives
include United States Coast Guard
commissioned, warrant, and petty
officers.
(d) Information broadcasts. The
Captain of the Port Pittsburgh or a
designated representative will inform
the public through broadcast notices to
mariners of the enforcement period for
the safety zone as well as any changes
in the planned schedule.
38601
This regulation establishes
tolerances for residues of
chlorantraniliprole in or on multiple
commodities which are identified and
discussed later in this document.
Interregional Research Project Number 4
(IR–4) requested the tolerances
associated with pesticide petition
number (PP) 5E8371, under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
Additionally, the Agency is amending
SUMMARY:
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You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
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the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0235 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before August 15, 2016. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2013–0235, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 26,
2015 (80 FR 51759) (FRL–9931–74),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
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pesticide petition (PP) 5E8371 by
Interregional Research Project Number 4
(IR–4), 500 College Road East,
Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of the insecticide
chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2pyridinyl)-1H-pyrazole-5-carboxamide,
in or on nut, tree, group 14–12 at 0.02
parts per million (ppm); and fruit, stone,
group 12–12 at 2.5 ppm. This petition
additionally requested that 40 CFR
180.628 be amended by revising the
existing tolerance in or on artichoke,
globe from 4.0 ppm to 2.0 ppm; and
hop, dried cones from 90 ppm to 40
ppm. Upon establishment of the
tolerances associated with (PP) 5E8371,
IR–4 requests to remove the following
existing tolerances in 40 CFR 180.628:
Nut, tree, group 14 at 0.04 ppm;
pistachio at 0.04 ppm; fruit, stone,
group 12–12, except cherry, chickasaw
plum, and damson plum at 4.0 ppm;
cherry, sweet at 2.0 ppm; cherry, tart at
2.0 ppm; plum, chickasaw at 2.0 ppm;
and plum, damson at 2.0 ppm. That
document referenced a summary of the
petition prepared on behalf of IR–4 by
DuPont Crop Protection, the registrant,
which is available in the docket EPA–
HQ–OPP–2013–0235 at https://
www.regulations.gov.
There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
available scientific data and other
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relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure for
chlorantraniliprole, consistent with
FFDCA section 408(b)(2).
In the Federal Register of February 7,
2014 (79 FR 7397) (FRL–9905–56), EPA
established tolerances for residues of
chlorantraniliprole in or on fruit, stone,
group 12–12, except cherry, chickasaw
plum, and damson plum at 4.0 ppm;
onion, green subgroup 3–07B at 3.0
ppm; peanut, hay at 90 ppm; and peanut
at 0.06 ppm. EPA is relying upon those
risk assessments and the findings made
in the February 7, 2014 Federal Register
document in support of this action. The
toxicity profile of chlorantraniliprole
has not changed. Moreover, because
EPA is simply lowering the previously
assessed tolerance levels (where the
EPA assumed tolerance-level residues
for all crops and including the tree nut
group 14–12 at 0.02 ppm), the previous
dietary estimates also do not change as
a result of this action. Therefore, the
previously published risk assessments
that supported the establishment of
those tolerances remain valid.
The petitioner requested to lower
currently established tolerances for
residues of chlorantraniliprole in/on
hops dried cones from 90 ppm to 40
ppm and globe artichoke from 4.0 ppm
to 2.0 ppm in order to harmonize with
the Codex maximum residue limits
(MRLs). Crop field trial studies were
submitted for hops and globe artichoke
that indicate lowering these tolerances
are appropriate and will support the
existing U.S. registrations. The
petitioner also requested to lower the
existing tolerance of 4.0 ppm for stone
fruit group 12–12, except cherry,
chickasaw plum, and damson plum and
remove the cherry, sweet; cherry, tart;
plum, chickasaw; and plum, damson
tolerances established at 2.0 ppm and
establish a tolerance for stone fruit crop
group 12–12 at 2.5 ppm to align with
the Canadian MRL. EPA has determined
that the existing residue chemistry data
support this new tolerance level, which
is lower than the current tolerances for
some commodities and higher for
others. Further, the petitioner requested
to convert the tree nut crop group 14 to
tree nut crop group 14–12 and to
remove the tolerance for pistachio to
lower the tolerance for the group (and
for the now-included pistachio
commodity) from 0.40 ppm to 0.02 ppm
to harmonize the U.S. tolerance with the
Codex and Canadian MRLs. EPA has
determined that the existing residue
chemistry data support the request for
crop group conversion and for lowering
the tolerance level.
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Furthermore, EPA issued a final rule
in the Federal Register of September 18,
2013, concerning the addition of certain
commodities to the 40 CFR 180.628. The
EPA determined that the tolerance level
for egg should be increased from 0.2
ppm to 1.0 ppm, and EPA assessed egg
using the tolerance of 1.0 ppm in 2013
as well as in February 2014. This was
inadvertently omitted from the table in
the 2013 Final Rule. Therefore, this
document corrects that omission.
Therefore, EPA relies upon the
findings made in the February 7, 2014,
Federal Register document, as well as
the review of the additional globe
artichoke and dried cones hop field trial
data and existing residue chemistry data
in support of this rule. EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
chlorantraniliprole residues.
For a detailed discussion of the
aggregate risk assessments and
determination of safety for these
tolerances, please refer to the February
7, 2014, Federal Register document and
its supporting documents, available at
https://www.regulations.gov in docket ID
number EPA–HQ–OPP–2013–0235.
Further information about EPA’s
determination that an updated risk
assessment was not necessary may be
found in the document,
‘‘Chlorantraniliprole (DPX–E2Y45):
Petition for Updating Crop Group
Tolerances for Nut Tree Group 14–12
and Fruit Stone Group 12–12, and
Amending Established Tolerances for
Chlorantraniliprole in/on Artichoke
Globe and Hop Dried Cones.’’ in docket
ID number EPA–HQ–OPP–2013–0235.
IV. Other Considerations
A. Analytical Enforcement Methodology
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Adequate enforcement methodology,
liquid chromatography mass
spectrometry/mass spectrometry (LC/
MS/MS); Method uPont-11374, 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: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
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international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
Based on the data supporting the
petition, EPA has harmonized
chlorantraniliprole tolerances in or on
artichoke, globe at 2.0 ppm; hop, dried
cones at 40 ppm; and nut, tree, group
14–12 at 0.02 ppm with established
Codex MRLs.
C. International Trade Considerations
In this rulemaking, EPA is reducing
the tolerances for hops, dried cones
from 90 ppm to 40 ppm; globe artichoke
from 4.0 ppm to 2.0 ppm; lowering the
existing tolerance of 4.0 ppm for stone
fruit group 12–12, except cherry,
chickasaw plum, and damson plum and
establishing a lower tolerance for stone
fruit crop group 12–12 at 2.5 ppm; and
converting and lowering the tree nut
crop group 14 and pistachio tolerances
to tree nut crop group 14–12 at 0.40
ppm to 0.02 ppm. The petitioner
requested these reductions in order to
harmonize with Codex and Canadian
MRLs. The reduction is appropriate
based on available data and residue
levels resulting from registered use
patterns.
In accordance with the World Trade
Organization’s (WTO) Sanitary and
Phytosanitary Measures Agreement,
EPA notified the WTO of the request to
revise these tolerances on September 14,
2015 as WTO notification G/SPS/N/
USA/2778. In this action, EPA is
allowing the existing higher tolerances
to remain in effect for 6 months
following the publication of this rule in
order to allow a reasonable interval for
producers in the exporting countries to
adapt to the requirements of these
modified tolerances. On December 14,
2016, those existing higher tolerances
will expire, and the new reduced
tolerances for artichoke, globe; fruit,
stone, group 12–12; hop, dried cones;
and nut, tree, group 14–12 will remain
to cover residues of chlorantraniliprole
on those commodities. Before that date,
residues of chlorantraniliprole on those
commodities would be permitted up to
the higher tolerance levels; after that
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38603
date, residues of chlorantraniliprole on
artichoke, globe; the commodities
contained in stone fruit group 12–12
and tree nut group 14–12; and hop,
dried cones will need to comply with
the new lower tolerance levels. This
reduction in tolerance is not
discriminatory; the same food safety
standard contained in the FFDCA
applies equally to domestically
produced and imported foods.
V. Conclusion
Therefore, tolerances are established
for residues of chlorantraniliprole, 3bromo-N-[4-chloro-2-methyl-6[(methylamino)-carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide, in or on in or on
artichoke, globe at 2.0 ppm; fruit, stone,
group 12–12 at 2.5 ppm; hop, dried
cones at 40 ppm; and nut, tree, group
14–12 at 0.02 ppm. Upon establishment
of the aforementioned tolerances, the
Agency is removing the tolerances for
cherry, sweet at 2.0 ppm; cherry, tart at
2.0 ppm; plum, chickasaw at 2.0 ppm;
and plum, damson at 2.0 ppm as they
are subsumed within the newly
established group 12–12 tolerances. The
Agency is adding an expiration date of
December 14, 2016 to the existing
tolerances for artichoke, globe at 4.0
ppm; nut, tree, group 14 at 0.04 ppm;
pistachio at 0.04 ppm; fruit, stone,
group 12–12, except cherry, chickasaw
plum, and damson plum at 4.0 ppm;
and hop, dried cones at 90 ppm.
Residues of chlorantraniliprole will be
covered by these higher tolerances until
the expiration date, after which time,
they will need to comply with the lower
tolerances being established today.
Finally, the Agency is amending the
existing tolerance for egg (increasing the
tolerance level from 0.2 ppm to 1.0
ppm) to finalize its efforts to establish
that tolerance in the Federal Register of
September 18, 2013.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
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Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
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16:33 Jun 13, 2016
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Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
Commodity
List of Subjects in 40 CFR Part 180
Hop, dried cones ..................
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 31, 2016.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
*
*
40
*
14 1
Nut, tree, group
.............
Nut, tree, group 14–12 .........
*
*
Pistachio 1
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
*
Parts per
million
*
*
0.04
0.02
*
.............................
*
*
*
*
0.04
*
*
1 This tolerance expires on December 14,
2016.
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.628, in the table in
paragraph (a):
■ a. Remove the entries for ‘‘Cherry,
sweet,’’ ‘‘Cherry, tart,’’ ‘‘Plum,
chickasaw,’’ and ‘‘Plum, damson;’’
■ b. Revise the entry for ‘‘Egg;’’
■ c. Amend the existing entries by
adding a footnote for ‘‘Artichoke,
globe,’’ ‘‘Fruit, stone, group 12–12,
except cherry, chickasaw plum, and
damson plum,’’ ‘‘Hop, dried cones,’’
‘‘Nut, tree, group 14,’’ and ‘‘Pistachio;’’
and
■ d. Add alphabetically the entries for
‘‘Artichoke, globe,’’ ‘‘Fruit, stone, group
12–12,’’ ‘‘Hop, dried cones,’’ and ‘‘Nut,
tree, group 14–12.’’
The additions and revisions read as
follows:
*
*
*
*
*
[FR Doc. 2016–13910 Filed 6–13–16; 8:45 am]
BILLING CODE 6560–50–P
■
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0749; FRL–9942–23]
Clofentezine; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of clofentezine in
or on multiple commodities which are
identified and discussed later in this
document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
§ 180.628 Chlorantraniliprole; tolerances
Drug, and Cosmetic Act (FFDCA).
for residues.
DATES: This regulation is effective June
(a) * * *
14, 2016. Objections and requests for
hearings must be received on or before
Parts per
Commodity
August 15, 2016, and must be filed in
million
accordance with the instructions
provided in 40 CFR part 178 (see also
*
*
*
*
*
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
Artichoke, globe 1 ..................
4.0
Artichoke, globe ....................
2.0 ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0749, is
*
*
*
*
*
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Egg .......................................
1.0
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
*
*
*
*
*
Jefferson Clinton Bldg., Rm. 3334, 1301
Fruit, stone, group 12–12 .....
2.5 Constitution Ave. NW., Washington, DC
Fruit, stone, group 12–12,
20460–0001. The Public Reading Room
except cherry, chickasaw
is open from 8:30 a.m. to 4:30 p.m.,
plum, and damson plum 1
4.0 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
Hop, dried cones 1 ................
90 Docket is (703) 305–5805. Please review
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
SUMMARY:
E:\FR\FM\14JNR1.SGM
14JNR1
Agencies
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Rules and Regulations]
[Pages 38601-38604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13910]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0235; FRL-9946-75]
Chlorantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
chlorantraniliprole in or on multiple commodities which are identified
and discussed later in this document. Interregional Research Project
Number 4 (IR-4) requested the tolerances associated with pesticide
petition number (PP) 5E8371, under the Federal Food, Drug, and Cosmetic
Act (FFDCA). Additionally, the Agency is amending the existing
tolerance for egg that was inadvertently omitted in a previous action.
DATES: This regulation is effective June 14, 2016. Objections and
requests for hearings must be received on or before August 15, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0235, 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), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through
[[Page 38602]]
the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0235 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 15, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0235, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP)
5E8371 by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Princeton, NJ 08540. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the
insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)-carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on nut, tree, group 14-12 at 0.02 parts per million
(ppm); and fruit, stone, group 12-12 at 2.5 ppm. This petition
additionally requested that 40 CFR 180.628 be amended by revising the
existing tolerance in or on artichoke, globe from 4.0 ppm to 2.0 ppm;
and hop, dried cones from 90 ppm to 40 ppm. Upon establishment of the
tolerances associated with (PP) 5E8371, IR-4 requests to remove the
following existing tolerances in 40 CFR 180.628: Nut, tree, group 14 at
0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group 12-12, except
cherry, chickasaw plum, and damson plum at 4.0 ppm; cherry, sweet at
2.0 ppm; cherry, tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum,
damson at 2.0 ppm. That document referenced a summary of the petition
prepared on behalf of IR-4 by DuPont Crop Protection, the registrant,
which is available in the docket EPA-HQ-OPP-2013-0235 at https://www.regulations.gov.
There were no comments received in response to the notice of
filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for chlorantraniliprole,
consistent with FFDCA section 408(b)(2).
In the Federal Register of February 7, 2014 (79 FR 7397) (FRL-9905-
56), EPA established tolerances for residues of chlorantraniliprole in
or on fruit, stone, group 12-12, except cherry, chickasaw plum, and
damson plum at 4.0 ppm; onion, green subgroup 3-07B at 3.0 ppm; peanut,
hay at 90 ppm; and peanut at 0.06 ppm. EPA is relying upon those risk
assessments and the findings made in the February 7, 2014 Federal
Register document in support of this action. The toxicity profile of
chlorantraniliprole has not changed. Moreover, because EPA is simply
lowering the previously assessed tolerance levels (where the EPA
assumed tolerance-level residues for all crops and including the tree
nut group 14-12 at 0.02 ppm), the previous dietary estimates also do
not change as a result of this action. Therefore, the previously
published risk assessments that supported the establishment of those
tolerances remain valid.
The petitioner requested to lower currently established tolerances
for residues of chlorantraniliprole in/on hops dried cones from 90 ppm
to 40 ppm and globe artichoke from 4.0 ppm to 2.0 ppm in order to
harmonize with the Codex maximum residue limits (MRLs). Crop field
trial studies were submitted for hops and globe artichoke that indicate
lowering these tolerances are appropriate and will support the existing
U.S. registrations. The petitioner also requested to lower the existing
tolerance of 4.0 ppm for stone fruit group 12-12, except cherry,
chickasaw plum, and damson plum and remove the cherry, sweet; cherry,
tart; plum, chickasaw; and plum, damson tolerances established at 2.0
ppm and establish a tolerance for stone fruit crop group 12-12 at 2.5
ppm to align with the Canadian MRL. EPA has determined that the
existing residue chemistry data support this new tolerance level, which
is lower than the current tolerances for some commodities and higher
for others. Further, the petitioner requested to convert the tree nut
crop group 14 to tree nut crop group 14-12 and to remove the tolerance
for pistachio to lower the tolerance for the group (and for the now-
included pistachio commodity) from 0.40 ppm to 0.02 ppm to harmonize
the U.S. tolerance with the Codex and Canadian MRLs. EPA has determined
that the existing residue chemistry data support the request for crop
group conversion and for lowering the tolerance level.
[[Page 38603]]
Furthermore, EPA issued a final rule in the Federal Register of
September 18, 2013, concerning the addition of certain commodities to
the 40 CFR 180.628. The EPA determined that the tolerance level for egg
should be increased from 0.2 ppm to 1.0 ppm, and EPA assessed egg using
the tolerance of 1.0 ppm in 2013 as well as in February 2014. This was
inadvertently omitted from the table in the 2013 Final Rule. Therefore,
this document corrects that omission.
Therefore, EPA relies upon the findings made in the February 7,
2014, Federal Register document, as well as the review of the
additional globe artichoke and dried cones hop field trial data and
existing residue chemistry data in support of this rule. EPA concludes
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to chlorantraniliprole residues.
For a detailed discussion of the aggregate risk assessments and
determination of safety for these tolerances, please refer to the
February 7, 2014, Federal Register document and its supporting
documents, available at https://www.regulations.gov in docket ID number
EPA-HQ-OPP-2013-0235. Further information about EPA's determination
that an updated risk assessment was not necessary may be found in the
document, ``Chlorantraniliprole (DPX-E2Y45): Petition for Updating Crop
Group Tolerances for Nut Tree Group 14-12 and Fruit Stone Group 12-12,
and Amending Established Tolerances for Chlorantraniliprole in/on
Artichoke Globe and Hop Dried Cones.'' in docket ID number EPA-HQ-OPP-
2013-0235.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, liquid chromatography mass
spectrometry/mass spectrometry (LC/MS/MS); Method uPont-11374, 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: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
Based on the data supporting the petition, EPA has harmonized
chlorantraniliprole tolerances in or on artichoke, globe at 2.0 ppm;
hop, dried cones at 40 ppm; and nut, tree, group 14-12 at 0.02 ppm with
established Codex MRLs.
C. International Trade Considerations
In this rulemaking, EPA is reducing the tolerances for hops, dried
cones from 90 ppm to 40 ppm; globe artichoke from 4.0 ppm to 2.0 ppm;
lowering the existing tolerance of 4.0 ppm for stone fruit group 12-12,
except cherry, chickasaw plum, and damson plum and establishing a lower
tolerance for stone fruit crop group 12-12 at 2.5 ppm; and converting
and lowering the tree nut crop group 14 and pistachio tolerances to
tree nut crop group 14-12 at 0.40 ppm to 0.02 ppm. The petitioner
requested these reductions in order to harmonize with Codex and
Canadian MRLs. The reduction is appropriate based on available data and
residue levels resulting from registered use patterns.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures Agreement, EPA notified the WTO of the
request to revise these tolerances on September 14, 2015 as WTO
notification G/SPS/N/USA/2778. In this action, EPA is allowing the
existing higher tolerances to remain in effect for 6 months following
the publication of this rule in order to allow a reasonable interval
for producers in the exporting countries to adapt to the requirements
of these modified tolerances. On December 14, 2016, those existing
higher tolerances will expire, and the new reduced tolerances for
artichoke, globe; fruit, stone, group 12-12; hop, dried cones; and nut,
tree, group 14-12 will remain to cover residues of chlorantraniliprole
on those commodities. Before that date, residues of chlorantraniliprole
on those commodities would be permitted up to the higher tolerance
levels; after that date, residues of chlorantraniliprole on artichoke,
globe; the commodities contained in stone fruit group 12-12 and tree
nut group 14-12; and hop, dried cones will need to comply with the new
lower tolerance levels. This reduction in tolerance is not
discriminatory; the same food safety standard contained in the FFDCA
applies equally to domestically produced and imported foods.
V. Conclusion
Therefore, tolerances are established for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)-
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in
or on in or on artichoke, globe at 2.0 ppm; fruit, stone, group 12-12
at 2.5 ppm; hop, dried cones at 40 ppm; and nut, tree, group 14-12 at
0.02 ppm. Upon establishment of the aforementioned tolerances, the
Agency is removing the tolerances for cherry, sweet at 2.0 ppm; cherry,
tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum, damson at 2.0
ppm as they are subsumed within the newly established group 12-12
tolerances. The Agency is adding an expiration date of December 14,
2016 to the existing tolerances for artichoke, globe at 4.0 ppm; nut,
tree, group 14 at 0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group
12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; and
hop, dried cones at 90 ppm. Residues of chlorantraniliprole will be
covered by these higher tolerances until the expiration date, after
which time, they will need to comply with the lower tolerances being
established today. Finally, the Agency is amending the existing
tolerance for egg (increasing the tolerance level from 0.2 ppm to 1.0
ppm) to finalize its efforts to establish that tolerance in the Federal
Register of September 18, 2013.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of
[[Page 38604]]
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 31, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.628, in the table in paragraph (a):
0
a. Remove the entries for ``Cherry, sweet,'' ``Cherry, tart,'' ``Plum,
chickasaw,'' and ``Plum, damson;''
0
b. Revise the entry for ``Egg;''
0
c. Amend the existing entries by adding a footnote for ``Artichoke,
globe,'' ``Fruit, stone, group 12-12, except cherry, chickasaw plum,
and damson plum,'' ``Hop, dried cones,'' ``Nut, tree, group 14,'' and
``Pistachio;'' and
0
d. Add alphabetically the entries for ``Artichoke, globe,'' ``Fruit,
stone, group 12-12,'' ``Hop, dried cones,'' and ``Nut, tree, group 14-
12.''
The additions and revisions read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Artichoke, globe \1\.................................... 4.0
Artichoke, globe........................................ 2.0
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Egg..................................................... 1.0
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Fruit, stone, group 12-12............................... 2.5
Fruit, stone, group 12-12, except cherry, chickasaw 4.0
plum, and damson plum \1\..............................
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Hop, dried cones \1\.................................... 90
Hop, dried cones........................................ 40
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Nut, tree, group 14 \1\................................. 0.04
Nut, tree, group 14-12.................................. 0.02
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Pistachio \1\........................................... 0.04
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 14, 2016.
* * * * *
[FR Doc. 2016-13910 Filed 6-13-16; 8:45 am]
BILLING CODE 6560-50-P