Flonicamid; Pesticide Tolerances, 31468-31471 [2017-14339]
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31468
Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. Parties with
objections to this direct final rule are
encouraged to file a comment in
response to the parallel notice of
proposed rulemaking for this action
published in the proposed rules section
of today’s Federal Register, rather than
file an immediate petition for judicial
review of this direct final rule, so that
EPA can withdraw this direct final rule
and address the comment in the
proposed rulemaking action.
This action approving Pennsylvania’s
2006 RACT SIP may not be challenged
later in proceedings to enforce its
requirements. (See section 307(b)(2).)
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Ozone, Particulate matter, Reporting
and recordkeeping requirements,
Volatile organic compounds.
Dated: June 22, 2017.
Cecil Rodrigues,
Acting Regional Administrator, Region III.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
*
*
Reasonably Available Control Technology
(RACT) for the 1997 ozone national ambient air quality standard (NAAQS).
*
Statewide ...................
*
*
*
*
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0013; FRL–9962–15]
Flonicamid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flonicamid 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,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July
7, 2017. Objections and requests for
hearings must be received on or before
September 5, 2017, and must be filed in
accordance with the instructions
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SUMMARY:
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52.2020
Identification of plan.
*
*
(e) * * *
(1) * * *
*
*
1. The authority citation for part 52
continues to read as follows:
State submittal
date
*
2. In § 52.2020, the table in paragraph
(e)(1) is amended by adding an entry for
‘‘Reasonably Available Control
Technology (RACT) for the 1997 ozone
national ambient air quality standard
(NAAQS)’’ at the end of the table to read
as follows:
■
■
Applicable geographic
area
[FR Doc. 2017–14204 Filed 7–6–17; 8:45 am]
Subpart NN—Pennsylvania
*
Name of non-regulatory SIP revision
*
Authority: 42 U.S.C. 7401 et seq.
List of Subjects in 40 CFR Part 52
9/25/2006
EPA approval date
Additional explanation
*
*
7/7/2017, [Insert Federal
Register citation].
*
Pertaining only to control
technique guideline
(CTG) source categories and three nonCTG volatile organic
compound (VOC)
source categories: Manufacture of surface active agents, mobile
equipment repair and
refinishing, and ethylene
production plants. Remainder of submittal
withdrawn 6/27/2016.
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–2016–0013, 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:
Michael L. Goodis, Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
PO 00000
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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).
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Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
B. How can I get electronic access to
other related information?
II. Summary of Petitioned-For
Tolerance
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
In the Federal Register of May 19,
2016 (81 FR 31581) (FRL–9946–02),
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) 5E8428
submitted by IR–4 Project Headquarters,
Rutgers, The State University of New
Jersey, 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requests that 40 CFR 180.613 be
amended by establishing tolerances for
residues of the fungicide flonicamid, N(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its
metabolites, TFNA (4trifluoromethylinicotinic acid), TFNA–
AM (4-trifluoromethylnicotinamide),
and TFNG, N-(4trifluoromethylnicotinoyl)glycine,
calculated as the stoichiometric
equivalent of flonicamid, in or on pea
and bean, dried shelled, except soybean,
subgroup 6C at 3.0 parts per million
(ppm); Pea and bean, succulent shelled,
subgroup 6B at 6.0 ppm; and Vegetable,
legume, edible podded, subgroup 6A at
4.0 ppm. This petition contains an
additional request to increase the
existing tolerance on Vegetable, fruiting,
group 8–10 from 0.4 to 1.50 ppm, but
EPA has already taken action on that
specific request, in a final tolerance rule
published in the Federal Register on
May 11, 2017 (82 FR 21941) (FRL–9959–
91).
A summary of the petition prepared
by ISK Biosciences Corporation, the
registrant, is available in the docket,
https://www.regulations.gov, at docket #:
EPA–HQ–OPP–2016–0013. One
comment was received on the notice of
filing. EPA’s response to the comment is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA is
establishing a tolerance for Pea and
bean, succulent shelled, subgroup 6B
that varies slightly from what the
petitioner requested. The reason for this
change is explained in Unit IV.D.
asabaliauskas on DSKBBXCHB2PROD with RULES
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–2016–0013 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 September 5, 2017. 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–
2016–0013, 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.
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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
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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), and the factors specified in
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 flonicamid
including exposure resulting from the
tolerances established by this action,
consistent with FFDCA section
408(b)(2).
In the Federal Register of May 11,
2017 (82 FR 21941) (FRL–9959–91),
EPA established tolerances for residues
of flonicamid in or on several
commodities. The risk assessments
supporting that action aggregated
dietary and non-occupational exposures
from existing and proposed uses of
flonicamid, including from the
exposures associated with the tolerances
requested in this action. That
assessment, which included the
tolerances in today’s action, concluded
that the tolerances are safe; therefore,
EPA is relying upon that Federal
Register document and the risk
assessments supporting the findings in
that document to support the safety
finding for the tolerances that are the
subject of this action.
Specific information on the studies
received and the nature of the adverse
effects caused by flonicamid as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document,
‘‘Subject: Flonicamid. Human Health
Risk Assessment for New Uses on
Legume Vegetables, Subgroups 6A, 6B,
and 6C; Add Directions for use on
Greenhouse Grown Peppers and
Increase the Tolerance for Residues on
Fruiting Vegetables, Group 8–10; New
Use on Citrus Fruits, Group 10–10; and
a Tolerance without U.S. Registration
for residues in/on Dried Tea’’ in docket
ID number, EPA–HQ–OPP–2016–0013.
Based on the findings of the May 11,
2017 Federal Register document and
the supporting documents, EPA
concludes that there is a reasonable
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certainty that no harm will result to the
general population, or to infants and
children from aggregate exposure to
flonicamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(FMC Method No. P–3561M, a liquid
chromatography with tandem mass
spectrometry (LC/MS/MS) method) is
available to enforce the tolerance
expression for flonicamid and its
metabolites in or on plant commodities.
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.
The Codex has not established a MRL
for flonicamid.
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C. Response to Comments
Comment: One anonymous comment
on the notice of filing of petition 5E8428
was received. The commenter claims
that flonicamid is a ‘‘toxic pesticide’’
and residues at any level in food
commodities should not be allowed and
requested that EPA deny setting
tolerances for the petition-for new uses
of flonicamid. The comment stated that
the proposed flonicamid use would add
to about 25,000 toxic chemicals
currently in the environment and
combine to create even more toxic
chemical residues in food and drinking
water further increasing harmful effects
to humans and environment.
Agency response: The Agency
recognizes that some individuals believe
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that pesticides should be banned
completely. However, under the existing
legal framework provided by FFDCA
section 408, EPA is authorized to
establish pesticide tolerances or
exemptions where persons seeking such
tolerances or exemptions have
demonstrated that the pesticide meets
the safety standard imposed by that
statute. In this instance, EPA has
examined all the relevant and available
data and concluded that the tolerances
are safe. The commenter has not
provided any information to support a
conclusion by the Agency that the
tolerances are not safe.
D. Revisions to Petitioned-For
Tolerances
EPA is establishing a slightly higher
tolerance for Pea and bean, succulent
shelled, subgroup 6B at 7.0 ppm
compared to the petitioner’s request of
a tolerance at 6.0 ppm. EPA’s decision
is based on the Organization for
Economic Cooperation and
Development (OECD) tolerance
calculation procedures and available
field trial data.
V. Conclusion
Therefore, tolerances are established
for residues of flonicamid, N(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its
metabolites, TFNA (4trifluoromethylinicotinic acid), TFNA–
AM (4-trifluoromethylnicotinamide),
and TFNG, N-(4trifluoromethylnicotinoyl)glycine,
calculated as the stoichiometric
equivalent of flonicamid, in or on Pea
and bean, succulent shelled, subgroup
6B at 7.0 ppm; Pea and bean, dried
shelled, except soybean, subgroup 6C at
3.0 ppm; and Vegetable, legume, edible
podded, subgroup 6A at 4.0 ppm.
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
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
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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 tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
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).
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Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 2, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
forage; grain, cereal, forage, fodder, and
straw, group 16, hay; grain, cereal,
forage, fodder, and straw, group 16,
straw; and grain, cereal, group 15.
Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective July
7, 2017. Objections and requests for
hearings must be received on or before
September 5, 2017, 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:
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0218, is
■ 2. In § 180.613, add alphabetically the
available at https://www.regulations.gov
following commodities ‘‘Pea and bean,
or at the Office of Pesticide Programs
succulent shelled, subgroup 6B’’; ‘‘Pea
and bean, dried shelled, except soybean, Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
subgroup 6C’’; and ‘‘Vegetable, legume,
Docket Center (EPA/DC), West William
edible podded, subgroup 6A’’ to the
Jefferson Clinton Bldg., Rm. 3334, 1301
table in paragraph (a)(1) to read as
Constitution Ave. NW., Washington, DC
follows:
20460–0001. The Public Reading Room
§ 180.613 Flonicamid; tolerances for
is open from 8:30 a.m. to 4:30 p.m.,
residues.
Monday through Friday, excluding legal
(a) * * *
holidays. The telephone number for the
(1) * * *
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Parts per Docket is (703) 305–5805. Please review
Commodity
million
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
*
*
*
*
*
Pea and bean, succulent shelled,
FOR FURTHER INFORMATION CONTACT:
subgroup 6B ..............................
7.0 Michael L. Goodis, Registration Division
Pea and bean, dried shelled, ex(7505P), Office of Pesticide Programs,
cept soybean, subgroup 6C ......
3.0
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
*
*
*
*
*
DC 20460–0001; main telephone
Vegetable, legume, edible podded, subgroup 6A .....................
4.0 number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Authority: 21 U.S.C. 321(q), 346a and 371.
*
*
*
*
I. General Information
*
[FR Doc. 2017–14339 Filed 7–6–17; 8:45 am]
A. Does this action apply to me?
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0218; FRL–9962–97]
asabaliauskas on DSKBBXCHB2PROD with RULES
Prosulfuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of prosulfuron in
or on grain, cereal, forage, fodder, and
straw, group 16, stover; grain, cereal,
forage, fodder, and straw, group 16,
SUMMARY:
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17:43 Jul 06, 2017
Jkt 241001
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).
PO 00000
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Sfmt 4700
31471
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
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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–2016–0218 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 September 5, 2017. 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–
2016–0218, 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.
E:\FR\FM\07JYR1.SGM
07JYR1
Agencies
[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31468-31471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14339]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0013; FRL-9962-15]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
flonicamid 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, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July 7, 2017. Objections and
requests for hearings must be received on or before September 5, 2017,
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-2016-0013, 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: Michael L. Goodis, Director,
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).
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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 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-2016-0013 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
September 5, 2017. 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-2016-0013, 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 May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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)
5E8428 submitted by IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requests that 40 CFR 180.613 be
amended by establishing tolerances for residues of the fungicide
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on pea and bean, dried shelled, except
soybean, subgroup 6C at 3.0 parts per million (ppm); Pea and bean,
succulent shelled, subgroup 6B at 6.0 ppm; and Vegetable, legume,
edible podded, subgroup 6A at 4.0 ppm. This petition contains an
additional request to increase the existing tolerance on Vegetable,
fruiting, group 8-10 from 0.4 to 1.50 ppm, but EPA has already taken
action on that specific request, in a final tolerance rule published in
the Federal Register on May 11, 2017 (82 FR 21941) (FRL-9959-91).
A summary of the petition prepared by ISK Biosciences Corporation,
the registrant, is available in the docket, https://www.regulations.gov,
at docket #: EPA-HQ-OPP-2016-0013. One comment was received on the
notice of filing. EPA's response to the comment is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA is
establishing a tolerance for Pea and bean, succulent shelled, subgroup
6B that varies slightly from what the petitioner requested. The reason
for this change is explained in Unit IV.D.
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), and the factors
specified in 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 flonicamid including exposure
resulting from the tolerances established by this action, consistent
with FFDCA section 408(b)(2).
In the Federal Register of May 11, 2017 (82 FR 21941) (FRL-9959-
91), EPA established tolerances for residues of flonicamid in or on
several commodities. The risk assessments supporting that action
aggregated dietary and non-occupational exposures from existing and
proposed uses of flonicamid, including from the exposures associated
with the tolerances requested in this action. That assessment, which
included the tolerances in today's action, concluded that the
tolerances are safe; therefore, EPA is relying upon that Federal
Register document and the risk assessments supporting the findings in
that document to support the safety finding for the tolerances that are
the subject of this action.
Specific information on the studies received and the nature of the
adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document, ``Subject: Flonicamid. Human
Health Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A,
6B, and 6C; Add Directions for use on Greenhouse Grown Peppers and
Increase the Tolerance for Residues on Fruiting Vegetables, Group 8-10;
New Use on Citrus Fruits, Group 10-10; and a Tolerance without U.S.
Registration for residues in/on Dried Tea'' in docket ID number, EPA-
HQ-OPP-2016-0013.
Based on the findings of the May 11, 2017 Federal Register document
and the supporting documents, EPA concludes that there is a reasonable
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certainty that no harm will result to the general population, or to
infants and children from aggregate exposure to flonicamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (FMC Method No. P-3561M, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method) is
available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities.
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.
The Codex has not established a MRL for flonicamid.
C. Response to Comments
Comment: One anonymous comment on the notice of filing of petition
5E8428 was received. The commenter claims that flonicamid is a ``toxic
pesticide'' and residues at any level in food commodities should not be
allowed and requested that EPA deny setting tolerances for the
petition-for new uses of flonicamid. The comment stated that the
proposed flonicamid use would add to about 25,000 toxic chemicals
currently in the environment and combine to create even more toxic
chemical residues in food and drinking water further increasing harmful
effects to humans and environment.
Agency response: The Agency recognizes that some individuals
believe that pesticides should be banned completely. However, under the
existing legal framework provided by FFDCA section 408, EPA is
authorized to establish pesticide tolerances or exemptions where
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. In
this instance, EPA has examined all the relevant and available data and
concluded that the tolerances are safe. The commenter has not provided
any information to support a conclusion by the Agency that the
tolerances are not safe.
D. Revisions to Petitioned-For Tolerances
EPA is establishing a slightly higher tolerance for Pea and bean,
succulent shelled, subgroup 6B at 7.0 ppm compared to the petitioner's
request of a tolerance at 6.0 ppm. EPA's decision is based on the
Organization for Economic Cooperation and Development (OECD) tolerance
calculation procedures and available field trial data.
V. Conclusion
Therefore, tolerances are established for residues of flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Pea and bean, succulent shelled,
subgroup 6B at 7.0 ppm; Pea and bean, dried shelled, except soybean,
subgroup 6C at 3.0 ppm; and Vegetable, legume, edible podded, subgroup
6A at 4.0 ppm.
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 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
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).
[[Page 31471]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 2, 2017.
Michael L. Goodis,
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. 180.613, add alphabetically the following commodities ``Pea
and bean, succulent shelled, subgroup 6B''; ``Pea and bean, dried
shelled, except soybean, subgroup 6C''; and ``Vegetable, legume, edible
podded, subgroup 6A'' to the table in paragraph (a)(1) to read as
follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pea and bean, succulent shelled, subgroup 6B................. 7.0
Pea and bean, dried shelled, except soybean, subgroup 6C..... 3.0
* * * * *
Vegetable, legume, edible podded, subgroup 6A................ 4.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-14339 Filed 7-6-17; 8:45 am]
BILLING CODE 6560-50-P