Oxathiapiprolin; Pesticide Tolerance, 44942-44945 [2017-20747]
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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations
asabaliauskas on DSKBBXCHB2PROD with RULES
section 180.411(a) since it will now
have a national registration.
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
VerDate Sep<11>2014
17:24 Sep 26, 2017
Jkt 241001
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).
potato, subgroup 1D’’ to the table in
paragraph (a);
■ h. Add alphabetically the
commodities ‘‘Fescue, forage’’; and
‘‘Fescue, hay’’ to the table in paragraph
(c); and
■ i. Remove the commodity ‘‘Rhubarb’’
from the table in paragraph (c).
The additions read as follows:
§ 180.411 Fluazifop-P-butyl; tolerances for
residues.
(a) * * *
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: August 30, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
*
*
*
*
Bushberry subgroup 13–07B ......
Caneberry subgroup 13–07A .....
*
0.30
0.08
*
*
*
*
Fruit, small vine climbing, except
fuzzy kiwifruit, subgroup 13–
07F ..........................................
*
*
*
*
*
*
Onion, bulb, subgroup 3–07A ....
Onion, green ...............................
*
0.50
1.5
*
*
*
*
Rhubarb ......................................
*
0.50
*
*
*
*
Strawberry ..................................
Vegetable, tuberous and corm,
except potato, subgroup 1D ...
*
*
*
*
(c) * * *
*
Frm 00064
Fmt 4700
Sfmt 4700
3.0
5.0
3.0
1.5
*
Parts per
million
Commodity
■
■
PO 00000
0.03
*
*
*
*
Lettuce, head ..............................
Lettuce, leaf ................................
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.411:
a. Add alphabetically the
commodities ‘‘Bushberry subgroup 13–
07B’’; ‘‘Caneberry subgroup 13–07A’’;
and ‘‘Fruit, small vine climbing, except
fuzzy kiwifruit, subgroup 13–07F’’ to
the table in paragraph (a);
■ b. Remove the commodity ‘‘Grape’’ in
the table in paragraph (a);
■ c. Add alphabetically the
commodities ‘‘Lettuce, head’’ and
‘‘Lettuce, leaf’’ to the table in paragraph
(a);
■ d. Remove the commodity ‘‘Onion,
bulb’’ in the table in paragraph (a);
■ e. Add alphabetically the
commodities ‘‘Onion, bulb, subgroup 3–
07A’’; ‘‘Onion, green’’; ‘‘Rhubarb’’; and
‘‘Strawberry’’;
■ f. Remove the commodity ‘‘Sweet
potato, roots’’ in the table in paragraph
(a);
■ g. Add alphabetically the commodity
‘‘Vegetable, tuberous and corm, except
Parts per
million
Commodity
*
*
*
*
Fescue, forage ............................
Fescue, hay ................................
*
*
*
*
*
*
*
*
*
4.0
15
*
*
[FR Doc. 2017–20748 Filed 9–26–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0049; FRL–9966–68]
Oxathiapiprolin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations
This regulation establishes a
tolerance for residues of the fungicide
oxathiapiprolin in or on cacao bean,
dried bean. Interregional Research
Project Number 4 (IR–4) requested the
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 27, 2017. Objections and
requests for hearings must be received
on or before November 27, 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–2016–0049, 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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. General Information
asabaliauskas on DSKBBXCHB2PROD with RULES
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?
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/Title40/40
tab_02.tpl.
In the Federal Register of Tuesday,
December 20, 2016 (81 FR 92758) (FRL–
9956–04), 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# 6E8505) by
Interregional Research Project Number 4
(IR–4). The petition requested that 40
CFR 180.685 be amended by
establishing tolerances for residues of
the fungicide oxathiapiprolin, 1-[4-[4-[5(2,6-difluorophenyl)-4,5-dihydro-3isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on cacao
bean, bean at 0.10 parts per million
(ppm); cacao bean, roasted bean at 0.15
ppm; cacao bean, chocolate at 0.15 ppm;
and cacao bean, cocoa powder at 0.15
ppm. A summary of the petition
prepared by IR–4 is available in the
docket, https://www.regulations.gov.
There were no comments received on
the notice of filing.
Based upon review of the data
supporting the petition, EPA is
establishing tolerances that differ from
what the petitioner requested including;
the commodity definition, tolerance
level, and for which commodities. The
reasons for these changes are explained
in Unit IV.C.
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–2016–0049 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 November 27, 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–
2016–0049, 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.
PO 00000
Frm 00065
Fmt 4700
Sfmt 4700
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
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Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for oxathiapiprolin
including exposure resulting from the
tolerance established by this action,
consistent with FFDCA section
408(b)(2).
In the Federal Register of Monday,
December 5, 2016 (81 FR 87463) (FRL–
9954–69), EPA established tolerances
for residues of oxathiapiprolin in or on
several food commodities. The risk
assessments supporting that action
aggregated dietary and non-occupational
exposures from existing and proposed
uses of oxathiapiprolin, 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 incorporating the findings in that
Federal Register document and the
supporting risk assessments as the basis
for the safety finding in this tolerance
rulemaking. In brief, the Agency
determined that the lack of toxicity of
oxathiapiprolin warranted a qualitative
risk assessment, without the need for
the additional Food Quality Protection
Act safety factor to protect infants and
children.
Specific information on the studies
received and the nature of the adverse
effects caused by oxathiapiprolin as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document,
‘‘Oxathiapiprolin—New Active
Ingredient Human Health Risk
Assessment of Uses on Turf,
Ornamentals, and a Number of Crops’’
dated June 25, 2015, in docket ID
number EPA–HQ–OPP–2016–0049–
0018. In addition, an abbreviated human
health risk assessment document was
developed to support the proposed uses
of oxathiapiprolin on multiple crops,
including cacao. That document,
‘‘SUBJECT: Oxathiapiprolin. Human
Health Risk Assessment to Support the
Registration of New Uses of the
Fungicide on Various Crops’’ dated
October 31, 2016 is available in docket
ID number EPA–HQ–OPP–2016–0049–
0017.
In conclusion, based on the findings
of the December 5, 2016 Federal
Register document and the supporting
documents, 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 oxathiapiprolin residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Method 30422 (Supplement No. 1)
was developed for plant commodities,
and Method 31138 was developed for
livestock commodities. Residues of
oxathiapiprolin and associated
metabolites are extracted from crop or
livestock commodity samples using a
solution of formic acid, water and
acetonitrile, and diluted with
acetonitrile and water. Both methods
use liquid chromotography with tandem
mass spectrometry (LC/MS/MS),
specifically reverse-phase liquid
chromatography (LC), and detection by
electrospray tandem mass spectrometry
(MS/MS).
The FDA multi-residue methods are
not suitable for detection and
enforcement of oxathiapiprolin residues
or associated metabolites. However, the
European Multiresidue Method (DFG
Method S19) and the QuEChERS
Multiresidue Method have shown
success in some matrices.
Adequate enforcement methodology
(LC/MS/MS) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch/BEAD/OPP,
Environmental Science Center, 701
Mapes Rd., Ft. George G. Meade, MD
20755–5350; telephone number: (410)
305–2905; email address: residue
methods@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
maximum residue limits (MRLs) for
oxathiapiprolin.
PO 00000
Frm 00066
Fmt 4700
Sfmt 4700
C. Revisions to Petitioned-For
Tolerances
A tolerance is established for ‘‘Cacao
bean, dried bean’’, rather than ‘‘Cacao
bean, bean’’, to comply with current
Agency crop-naming policy. Also, EPA
determined that tolerances for residues
of oxathiapiprolin in or on the
processed commodities of cacao bean,
roasted bean; cacao bean, chocolate; and
cacao bean, cocoa powder are
unnecessary because these commodities
are covered by cacao bean, dried bean
tolerance. Finally, the tolerance for
cacao bean, dried bean is being
established at 0.15 ppm, rather than at
0.1 ppm as requested, based on the
available residue data.
V. Conclusion
Therefore, a tolerance is established
for residues of the fungicide
oxathiapiprolin, 1-[4-[4-[5-(2,6difluorophenyl)-4,5-dihydro-3isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on cacao
bean, dried bean at 0.15 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
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
E:\FR\FM\27SER1.SGM
27SER1
Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations
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).
asabaliauskas on DSKBBXCHB2PROD with RULES
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 29, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
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17:24 Sep 26, 2017
Jkt 241001
Authority: 21 U.S.C. 321(q), 346a and 371.
44945
post-crash conditions, NHTSA adopts
electrical safety requirements to protect
against direct and indirect contact of
high voltage sources during everyday
operation of electric-powered vehicles.
Also, NHTSA adopts an optional
method of meeting post-crash electrical
safety requirements, consistent with that
§ 180.685 Oxathiapiprolin; tolerances for
in GTR No. 13, involving use of physical
residues.
barriers to prevent direct or indirect
(a) * * *
contact (by occupants, emergency
services personnel and others) with high
Parts per
voltage sources.
Commodity
million
DATES:
Effective date: This final rule is
*
*
*
*
*
effective September 27, 2017.
Cacao bean, dried bean .............
0.15
Compliance date: The compliance
date for the amendments in this final
*
*
*
*
*
rule is September 27, 2018. Optional
early compliance is permitted.
*
*
*
*
*
Petitions for reconsideration: Petitions
[FR Doc. 2017–20747 Filed 9–26–17; 8:45 am]
for reconsideration of this final rule
BILLING CODE 6560–50–P
must be received not later than
November 13, 2017.
ADDRESSES: Petitions for reconsideration
DEPARTMENT OF TRANSPORTATION of this final rule must refer to the docket
and notice number set forth above and
National Highway Traffic Safety
be submitted to the Administrator,
Administration
National Highway Traffic Safety
Administration, 1200 New Jersey
49 CFR Part 571
Avenue SE., Washington, DC 20590.
[Docket No. NHTSA–2017–0085]
Note that all petitions received will be
posted without change to https://
RIN 2127–AL68
www.regulations.gov, including any
personal information provided.
Federal Motor Vehicle Safety
Privacy Act: Please see the Privacy
Standards; Electric-Powered Vehicles:
Act heading under Rulemaking
Electrolyte Spillage and Electrical
Analyses and Notices.
Shock Protection
FOR FURTHER INFORMATION CONTACT: For
AGENCY: National Highway Traffic
technical issues, you may call William
Safety Administration (NHTSA),
´
J. Sanchez, Office of Crashworthiness
Department of Transportation (DOT).
Standards (telephone: 202–493–0248)
ACTION: Final rule.
(fax: 202–493–2990). For legal issues,
you may call Deirdre Fujita, Office of
SUMMARY: NHTSA is issuing this final
Chief Counsel (telephone: 202–366–
rule to amend Federal Motor Vehicle
2992) (fax: 202–366–3820). Address:
Safety Standard (FMVSS) No. 305,
National Highway Traffic Safety
‘‘Electric-powered vehicles: Electrolyte
Administration, U.S. Department of
spillage and electrical shock
Transportation, 1200 New Jersey
protection,’’ to adopt various electrical
Avenue SE., West Building,
safety requirements found in Global
Washington, DC 20590.
Technical Regulation (GTR) No. 13,
SUPPLEMENTARY INFORMATION:
‘‘Hydrogen and fuel cell vehicles,’’ and
other sources. This final rule updates
Table of Contents
FMVSS No. 305 using modern and
I. Executive Summary
harmonized safety requirements and
a. Overview
facilitates the introduction of new
b. Summary of the Final Rule and
technologies, including hydrogen fuel
Highlighted Differences With the NPRM
cell vehicles (HFCVs) and 48-volt mild
1. Every Day (Normal) Vehicle Operations
i. Direct Contact Protection From High
hybrid technologies. This final rule is a
Voltage Sources
deregulatory action. It imposes no costs
ii. Indirect Contact Protection From High
and adjusts FMVSS No. 305 to give
Voltage Sources
more flexibility to manufacturers not
iii. Electrical Isolation of High Voltage
only to use modern electrical safety
Sources
designs to produce electric vehicles, but
iv. Monitoring Systems
also to introduce new technologies to
v. Electrical Safety During Charging
the U.S. market. To expand FMVSS No.
vi. Mitigating Driver Error
305’s performance requirements beyond
2. Post-Crash Safety
2. In § 180.685, redesignate paragraph
(a)(1) as paragraph (a) and add
alphabetically the following commodity
‘‘Cacao bean, dried bean’’ to the table in
paragraph (a) in alphabetical order to
read as follows:
■
PO 00000
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]]>Agencies
[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Rules and Regulations]
[Pages 44942-44945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20747]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0049; FRL-9966-68]
Oxathiapiprolin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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[[Page 44943]]
SUMMARY: This regulation establishes a tolerance for residues of the
fungicide oxathiapiprolin in or on cacao bean, dried bean.
Interregional Research Project Number 4 (IR-4) requested the tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 27, 2017. Objections and
requests for hearings must be received on or before November 27, 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-2016-0049, 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).
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-2016-0049 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
November 27, 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-2016-0049, 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 Tuesday, December 20, 2016 (81 FR 92758)
(FRL-9956-04), 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# 6E8505) by Interregional Research Project Number 4 (IR-
4). The petition requested that 40 CFR 180.685 be amended by
establishing tolerances for residues of the fungicide oxathiapiprolin,
1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-
1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
ethanone, in or on cacao bean, bean at 0.10 parts per million (ppm);
cacao bean, roasted bean at 0.15 ppm; cacao bean, chocolate at 0.15
ppm; and cacao bean, cocoa powder at 0.15 ppm. A summary of the
petition prepared by IR-4 is available in the docket, https://www.regulations.gov. There were no comments received on the notice of
filing.
Based upon review of the data supporting the petition, EPA is
establishing tolerances that differ from what the petitioner requested
including; the commodity definition, tolerance level, and for which
commodities. The reasons for these changes are explained in Unit IV.C.
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
[[Page 44944]]
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for oxathiapiprolin including exposure resulting
from the tolerance established by this action, consistent with FFDCA
section 408(b)(2).
In the Federal Register of Monday, December 5, 2016 (81 FR 87463)
(FRL-9954-69), EPA established tolerances for residues of
oxathiapiprolin in or on several food commodities. The risk assessments
supporting that action aggregated dietary and non-occupational
exposures from existing and proposed uses of oxathiapiprolin, 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
incorporating the findings in that Federal Register document and the
supporting risk assessments as the basis for the safety finding in this
tolerance rulemaking. In brief, the Agency determined that the lack of
toxicity of oxathiapiprolin warranted a qualitative risk assessment,
without the need for the additional Food Quality Protection Act safety
factor to protect infants and children.
Specific information on the studies received and the nature of the
adverse effects caused by oxathiapiprolin 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, ``Oxathiapiprolin--New Active
Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals,
and a Number of Crops'' dated June 25, 2015, in docket ID number EPA-
HQ-OPP-2016-0049-0018. In addition, an abbreviated human health risk
assessment document was developed to support the proposed uses of
oxathiapiprolin on multiple crops, including cacao. That document,
``SUBJECT: Oxathiapiprolin. Human Health Risk Assessment to Support the
Registration of New Uses of the Fungicide on Various Crops'' dated
October 31, 2016 is available in docket ID number EPA-HQ-OPP-2016-0049-
0017.
In conclusion, based on the findings of the December 5, 2016
Federal Register document and the supporting documents, 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 oxathiapiprolin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Method 30422 (Supplement No. 1) was developed for plant
commodities, and Method 31138 was developed for livestock commodities.
Residues of oxathiapiprolin and associated metabolites are extracted
from crop or livestock commodity samples using a solution of formic
acid, water and acetonitrile, and diluted with acetonitrile and water.
Both methods use liquid chromotography with tandem mass spectrometry
(LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and
detection by electrospray tandem mass spectrometry (MS/MS).
The FDA multi-residue methods are not suitable for detection and
enforcement of oxathiapiprolin residues or associated metabolites.
However, the European Multiresidue Method (DFG Method S19) and the
QuEChERS Multiresidue Method have shown success in some matrices.
Adequate enforcement methodology (LC/MS/MS) is available to enforce
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch/BEAD/OPP, Environmental Science Center, 701
Mapes Rd., Ft. George G. 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 maximum residue limits (MRLs) for
oxathiapiprolin.
C. Revisions to Petitioned-For Tolerances
A tolerance is established for ``Cacao bean, dried bean'', rather
than ``Cacao bean, bean'', to comply with current Agency crop-naming
policy. Also, EPA determined that tolerances for residues of
oxathiapiprolin in or on the processed commodities of cacao bean,
roasted bean; cacao bean, chocolate; and cacao bean, cocoa powder are
unnecessary because these commodities are covered by cacao bean, dried
bean tolerance. Finally, the tolerance for cacao bean, dried bean is
being established at 0.15 ppm, rather than at 0.1 ppm as requested,
based on the available residue data.
V. Conclusion
Therefore, a tolerance is established for residues of the fungicide
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on cacao bean, dried
bean at 0.15 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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
[[Page 44945]]
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: August 29, 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. 180.685, redesignate paragraph (a)(1) as paragraph (a) and
add alphabetically the following commodity ``Cacao bean, dried bean''
to the table in paragraph (a) in alphabetical order to read as follows:
Sec. 180.685 Oxathiapiprolin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cacao bean, dried bean...................................... 0.15
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-20747 Filed 9-26-17; 8:45 am]
BILLING CODE 6560-50-P
