Extension of Pesticide Residue Tolerances for Emergency Exemptions (Multiple Chemicals), 78143-78146 [2015-31518]
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Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations
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: December 3, 2015.
Robert McNally,
Director, Biopesticides and Pollution
Prevention 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:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1128 to read as
follows:
■
§ 180.1128 Bacillus amyloliquefaciens
MBI600; exemption from the requirement of
a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the biofungicide Bacillus
amyloliquefaciens MBI600 (antecedent
Bacillus subtilis MBI600) in or on all
food commodities, including residues
resulting from post-harvest uses, when
applied or used in accordance with
good agricultural practices.
[FR Doc. 2015–31462 Filed 12–15–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
granting of emergency exemptions
under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
authorizing use of these pesticides. In
addition, the Federal Food, Drug, and
Cosmetic Act (FFDCA) requires EPA to
establish a time-limited tolerance or
exemption from the requirement for a
tolerance for pesticide chemical
residues in food that will result from the
use of a pesticide under an emergency
exemption granted by EPA.
DATES: This regulation is effective
December 16, 2015. Objections and
requests for hearings must be received
on or before February 16, 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–2015–0766, 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:
[EPA–HQ–OPP–2015–0766; FRL–9939–95]
I. General Information
Extension of Pesticide Residue
Tolerances for Emergency Exemptions
(Multiple Chemicals)
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).
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation extends
existing time-limited tolerances for
residues of the pesticides bifenthrin in
or on apple, peach and nectarine;
dinotefuran in or on pome fruit and
stone fruit; imidacloprid in or on
sugarcane, cane and sugarcane
molasses; and streptomycin in or on
grapefruit and grapefruit, dried pulp.
These actions are in response to EPA’s
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
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78143
• 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 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–2015–0766 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
received by the Hearing Clerk on or
before February 16, 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–
2015–0766 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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78144
Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations
II. Background and Statutory Findings
EPA published final rules in the
Federal Register for each chemical
listed. The initial issuance of these final
rules announced that EPA, on its own
initiative, under FFDCA section 408, 21
U.S.C. 346a, was establishing timelimited tolerances for residues of a
pesticide in or on one or more food
commodities.
EPA established the tolerances
because FFDCA section 408(l)(6)
requires EPA to establish a time-limited
tolerance, or exemption from the
requirement for a tolerance, for
pesticide chemical residues in food that
will result from the use of a pesticide
under an emergency exemption granted
by EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or time for public
comment.
EPA received requests to extend the
emergency use of these chemicals for
this year’s growing season. After having
reviewed these submissions, EPA
concurs that emergency conditions
continue to exist. EPA assessed the
potential risks presented by residues for
each chemical. In doing so, EPA
considered the safety standard in
FFDCA section 408(b)(2), and decided
that the necessary tolerance under
FFDCA section 408(l)(6) would be
consistent with the safety standard and
with FIFRA section 18.
The data and other relevant material
have been evaluated and discussed in
the final rules originally published to
support these uses. Based on that data
and information considered, the Agency
reaffirms that extension of these timelimited tolerances will continue to meet
the requirements of FFDCA section
408(l)(6). Therefore, each of the timelimited tolerances is extended until the
date listed, when they will expire and
become revoked. EPA intends to publish
a document in the Federal Register to
remove the revoked tolerances from the
Code of Federal Regulations (CFR).
Although these tolerances will expire
and are revoked on the dates listed,
under FFDCA section 408(l)(5), residues
of a pesticide not in excess of the
amount specified in the tolerance
remaining in or on a commodity after
that date will not be unlawful, provided
the residues are present as a result of an
application or use of the pesticide at a
time and in a manner that was lawful
under FIFRA, a tolerance was in place
at the time of the application, and the
residues do not exceed the level that
was authorized by the tolerance. EPA
will take action to revoke these
tolerances earlier if any experience
with, scientific data on, or other
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Jkt 238001
relevant information on these pesticides
indicates that the residues are not safe.
Tolerances for the use of the following
pesticide chemicals on specific
commodities are being extended:
Bifenthrin. EPA has authorized under
FIFRA section 18 the use of bifenthrin
on apple, peach, and nectarine for
control of the brown marmorated
stinkbug in multiple states. This
regulation extends existing time-limited
tolerances for residues of the insecticide
bifenthrin, including its metabolites and
degradates, in or on apple, peach, and
nectarine at 0.5 part per million (ppm)
for an additional 3-year period. These
tolerances will expire and are revoked
on December 31, 2018. The time-limited
tolerances were originally published in
the Federal Register of September 14,
2012 (77 FR 56782) (FRL–9361–6).
Dinotefuran. EPA has authorized
under FIFRA section 18 the use of
dinotefuran on pome fruit and stone
fruit for control of the brown
marmorated stinkbug in multiple states.
This regulation extends existing timelimited tolerances for residues of the
insecticide dinotefuran, including its
metabolites and degradates, in or on
fruit, pome, group 11 and fruit, stone,
group 12 at 2.0 ppm for an additional
three-year period. These tolerances will
expire and are revoked on December 31,
2018. The time-limited tolerances were
originally published in the Federal
Register of November 9, 2012 (77 FR
67282) (FRL–9366–3), and revised in the
Federal Register of January 22, 2014 (79
FR 3508) (FRL–9402–8).
Imidacloprid. EPA has authorized
under FIFRA section 18 the use of
imidacloprid on sugarcane for control of
the West Indian cane fly in Louisiana.
This regulation extends existing timelimited tolerances for residues of the
insecticide imidacloprid, including its
metabolites and degradates, in or on
sugarcane, cane at 6.0 ppm and
sugarcane, molasses at 50 ppm for an
additional 3-year period. These
tolerances will expire and are revoked
on December 31, 2018. The time-limited
tolerances were originally published in
the Federal Register of June 5, 2013 (78
FR 33736) (FRL–9387–9).
Streptomycin. EPA has authorized
under FIFRA section 18 the use of
streptomycin on grapefruit for control of
citrus canker in Florida. This regulation
extends existing time-limited tolerances
for residues of the pesticide
streptomycin, including its metabolites
and degradates, in or on grapefruit at
0.15 ppm and grapefruit, dried pulp at
0.40 ppm for an additional 3-year
period. These tolerances will expire and
are revoked on December 31, 2018. The
time-limited tolerances were originally
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published in the Federal Register of
May 17, 2013 (78 FR 29049) (FRL–9385–
3).
III. 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 MRLs
for bifenthrin in/on apple, peach, or
nectarine; dinotefuran in/on pome fruit
or stone fruit; imidacloprid in/on
sugarcane, cane or sugarcane molasses;
nor streptomycin in/on grapefruit or
grapefruit, dried pulp.
IV. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). 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).
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Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations
Since tolerances and exemptions that
are established under FFDCA sections
408(e) and 408(l)(6), 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).
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: December 8, 2015.
Daniel J. Rosenblatt,
Acting 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:
■
V. 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
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.245, revise the table in
paragraph (b) to read as follows:
■
§ 180.245 Streptomycin; tolerances for
residues.
*
*
*
(b) * * *
Commodity
*
*
*
*
3. In § 180.442, revise the table in
paragraph (b) to read as follows:
■
§ 180.442 Bifenthrin; tolerances for
residues.
*
*
*
*
0.15
0.40
*
*
*
*
4. In § 180.472, revise the table in
paragraph (b) to read as follows:
Parts per million
§ 180.472 Imidacloprid; tolerances for
residues.
*
*
*
*
0.5
0.5
0.5
*
*
*
*
5. In § 180.603, revise the table in
paragraph (b) to read as follows:
Parts per million
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§ 180.603 Dinotefuran; tolerances for
residues.
*
*
*
*
6.0
50
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12/31/2018
*
Fruit, pome, Group 11 .....................................................................................................................................
Fruit, stone, Group 12 .....................................................................................................................................
16:18 Dec 15, 2015
Expiration/
revocation date
(b) * * *
Commodity
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12/31/2018
12/31/2018
*
Sugarcane, cane ..............................................................................................................................................
Sugarcane, molasses ......................................................................................................................................
■
Expiration/
revocation date
(b) * * *
Commodity
*
12/31/2018
12/31/2018
*
Apple ................................................................................................................................................................
Nectarine ..........................................................................................................................................................
Peach ...............................................................................................................................................................
■
Expiration/
revocation date
(b) * * *
Commodity
*
*
Parts per million
Grapefruit .........................................................................................................................................................
Grapefruit, dried pulp .......................................................................................................................................
*
*
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revocation date
12/31/2018
12/31/2018
78146
Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations
*
*
*
*
number: (703) 305–7090; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
*
[FR Doc. 2015–31518 Filed 12–15–15; 8:45 am]
BILLING CODE 6560–50–P
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
A. Does this action apply to me?
40 CFR Part 180
[EPA–HQ–OPP–2015–0023; FRL–9935–81]
Choline Chloride; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of the Choline
Chloride (Acetyl Choline) in or on all
food commodities when applied/used
pre-harvest and used in accordance with
label directions and good agricultural
practices. CP Bio, Inc., submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Choline Chloride.
DATES: This regulation is effective
December 16, 2015. Objections and
requests for hearings must be received
on or before February 16, 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–2015–0023, 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:
Robert McNally, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
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SUMMARY:
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16:18 Dec 15, 2015
Jkt 238001
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 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–2015–0023 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 February 16, 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–
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
2015–0023, 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. Background and Statutory Findings
In the Federal Register of March 4,
2015 (80 FR 11611) (FRL–9922–68),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 4F8287)
by CP Bio, Inc., 4802 Murrieta Street,
Chino, CA 91710. The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of Choline Chloride in or on all
food commodities (when applied preharvest). That document referenced a
summary of the petition prepared by the
petitioner CP Bio, Inc., which is
available in the docket, https://
www.regulations.gov. There were no
substantive comments received in
response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(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. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require EPA to give
special consideration to exposure of
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]]>Agencies
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78143-78146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31518]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0766; FRL-9939-95]
Extension of Pesticide Residue Tolerances for Emergency
Exemptions (Multiple Chemicals)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation extends existing time-limited tolerances for
residues of the pesticides bifenthrin in or on apple, peach and
nectarine; dinotefuran in or on pome fruit and stone fruit;
imidacloprid in or on sugarcane, cane and sugarcane molasses; and
streptomycin in or on grapefruit and grapefruit, dried pulp. These
actions are in response to EPA's granting of emergency exemptions under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of these pesticides. In addition, the Federal Food,
Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA.
DATES: This regulation is effective December 16, 2015. Objections and
requests for hearings must be received on or before February 16, 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-2015-0766, 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 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-2015-0766 in the subject line on the first
page of your submission. All requests must be in writing, and must be
received by the Hearing Clerk on or before February 16, 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-2015-0766 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.
[[Page 78144]]
II. Background and Statutory Findings
EPA published final rules in the Federal Register for each chemical
listed. The initial issuance of these final rules announced that EPA,
on its own initiative, under FFDCA section 408, 21 U.S.C. 346a, was
establishing time-limited tolerances for residues of a pesticide in or
on one or more food commodities.
EPA established the tolerances because FFDCA section 408(l)(6)
requires EPA to establish a time-limited tolerance, or exemption from
the requirement for a tolerance, for pesticide chemical residues in
food that will result from the use of a pesticide under an emergency
exemption granted by EPA under FIFRA section 18. Such tolerances can be
established without providing notice or time for public comment.
EPA received requests to extend the emergency use of these
chemicals for this year's growing season. After having reviewed these
submissions, EPA concurs that emergency conditions continue to exist.
EPA assessed the potential risks presented by residues for each
chemical. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18.
The data and other relevant material have been evaluated and
discussed in the final rules originally published to support these
uses. Based on that data and information considered, the Agency
reaffirms that extension of these time-limited tolerances will continue
to meet the requirements of FFDCA section 408(l)(6). Therefore, each of
the time-limited tolerances is extended until the date listed, when
they will expire and become revoked. EPA intends to publish a document
in the Federal Register to remove the revoked tolerances from the Code
of Federal Regulations (CFR). Although these tolerances will expire and
are revoked on the dates listed, under FFDCA section 408(l)(5),
residues of a pesticide not in excess of the amount specified in the
tolerance remaining in or on a commodity after that date will not be
unlawful, provided the residues are present as a result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA, a tolerance was in place at the time of the
application, and the residues do not exceed the level that was
authorized by the tolerance. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on these pesticides indicates that the residues
are not safe.
Tolerances for the use of the following pesticide chemicals on
specific commodities are being extended:
Bifenthrin. EPA has authorized under FIFRA section 18 the use of
bifenthrin on apple, peach, and nectarine for control of the brown
marmorated stinkbug in multiple states. This regulation extends
existing time-limited tolerances for residues of the insecticide
bifenthrin, including its metabolites and degradates, in or on apple,
peach, and nectarine at 0.5 part per million (ppm) for an additional 3-
year period. These tolerances will expire and are revoked on December
31, 2018. The time-limited tolerances were originally published in the
Federal Register of September 14, 2012 (77 FR 56782) (FRL-9361-6).
Dinotefuran. EPA has authorized under FIFRA section 18 the use of
dinotefuran on pome fruit and stone fruit for control of the brown
marmorated stinkbug in multiple states. This regulation extends
existing time-limited tolerances for residues of the insecticide
dinotefuran, including its metabolites and degradates, in or on fruit,
pome, group 11 and fruit, stone, group 12 at 2.0 ppm for an additional
three-year period. These tolerances will expire and are revoked on
December 31, 2018. The time-limited tolerances were originally
published in the Federal Register of November 9, 2012 (77 FR 67282)
(FRL-9366-3), and revised in the Federal Register of January 22, 2014
(79 FR 3508) (FRL-9402-8).
Imidacloprid. EPA has authorized under FIFRA section 18 the use of
imidacloprid on sugarcane for control of the West Indian cane fly in
Louisiana. This regulation extends existing time-limited tolerances for
residues of the insecticide imidacloprid, including its metabolites and
degradates, in or on sugarcane, cane at 6.0 ppm and sugarcane, molasses
at 50 ppm for an additional 3-year period. These tolerances will expire
and are revoked on December 31, 2018. The time-limited tolerances were
originally published in the Federal Register of June 5, 2013 (78 FR
33736) (FRL-9387-9).
Streptomycin. EPA has authorized under FIFRA section 18 the use of
streptomycin on grapefruit for control of citrus canker in Florida.
This regulation extends existing time-limited tolerances for residues
of the pesticide streptomycin, including its metabolites and
degradates, in or on grapefruit at 0.15 ppm and grapefruit, dried pulp
at 0.40 ppm for an additional 3-year period. These tolerances will
expire and are revoked on December 31, 2018. The time-limited
tolerances were originally published in the Federal Register of May 17,
2013 (78 FR 29049) (FRL-9385-3).
III. 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 MRLs for bifenthrin in/on apple,
peach, or nectarine; dinotefuran in/on pome fruit or stone fruit;
imidacloprid in/on sugarcane, cane or sugarcane molasses; nor
streptomycin in/on grapefruit or grapefruit, dried pulp.
IV. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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).
[[Page 78145]]
Since tolerances and exemptions that are established under FFDCA
sections 408(e) and 408(l)(6), 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).
V. 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: December 8, 2015.
Daniel J. Rosenblatt,
Acting 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. 180.245, revise the table in paragraph (b) to read as
follows:
Sec. 180.245 Streptomycin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Grapefruit.......................... 0.15 12/31/2018
Grapefruit, dried pulp.............. 0.40 12/31/2018
------------------------------------------------------------------------
* * * * *
0
3. In Sec. 180.442, revise the table in paragraph (b) to read as
follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Apple............................... 0.5 12/31/2018
Nectarine........................... 0.5 12/31/2018
Peach............................... 0.5 12/31/2018
------------------------------------------------------------------------
* * * * *
0
4. In Sec. 180.472, revise the table in paragraph (b) to read as
follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Sugarcane, cane..................... 6.0 12/31/2018
Sugarcane, molasses................. 50 12/31/2018
------------------------------------------------------------------------
* * * * *
0
5. In Sec. 180.603, revise the table in paragraph (b) to read as
follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Fruit, pome, Group 11............... 2.0 12/31/2018
Fruit, stone, Group 12.............. 2.0 12/31/2018
------------------------------------------------------------------------
[[Page 78146]]
* * * * *
[FR Doc. 2015-31518 Filed 12-15-15; 8:45 am]
BILLING CODE 6560-50-P
