80_FR_78384 80 FR 78143 - Extension of Pesticide Residue Tolerances for Emergency Exemptions (Multiple Chemicals)

80 FR 78143 - Extension of Pesticide Residue Tolerances for Emergency Exemptions (Multiple Chemicals)

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 241 (December 16, 2015)

Page Range78143-78146
FR Document2015-31518

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.

Federal Register, Volume 80 Issue 241 (Wednesday, December 16, 2015)
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78143-78146]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31518]


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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 http://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 http://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: [email protected].

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 http://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: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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



                                                          Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                        78143

                                            Senate, the U.S. House of                               granting of emergency exemptions                        • Pesticide manufacturing (NAICS
                                            Representatives, and the Comptroller                    under the Federal Insecticide,                        code 32532).
                                            General of the United States prior to                   Fungicide, and Rodenticide Act (FIFRA)
                                                                                                                                                          B. How can I get electronic access to
                                            publication of the rule in the Federal                  authorizing use of these pesticides. In
                                                                                                                                                          other related information?
                                            Register. This action is not a ‘‘major                  addition, the Federal Food, Drug, and
                                            rule’’ as defined by 5 U.S.C. 804(2).                   Cosmetic Act (FFDCA) requires EPA to                    You may access a frequently updated
                                                                                                    establish a time-limited tolerance or                 electronic version of 40 CFR part 180
                                            List of Subjects in 40 CFR Part 180                     exemption from the requirement for a                  through the Government Printing
                                              Environmental protection,                             tolerance for pesticide chemical                      Office’s e-CFR site at http://
                                            Administrative practice and procedure,                  residues in food that will result from the            www.ecfr.gov/cgi-bin/text-
                                            Agricultural commodities, Pesticides                    use of a pesticide under an emergency                 idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                            and pests, Reporting and recordkeeping                  exemption granted by EPA.                             40tab_02.tpl.
                                            requirements.                                           DATES: This regulation is effective
                                                                                                                                                          C. How can I file an objection or hearing
                                              Dated: December 3, 2015.                              December 16, 2015. Objections and
                                                                                                                                                          request?
                                            Robert McNally,                                         requests for hearings must be received
                                            Director, Biopesticides and Pollution                   on or before February 16, 2016, and                     Under FFDCA section 408(g), 21
                                            Prevention Division, Office of Pesticide                must be filed in accordance with the                  U.S.C. 346a, any person may file an
                                            Programs.                                               instructions provided in 40 CFR part                  objection to any aspect of this regulation
                                                                                                    178 (see also Unit I.C. of the                        and may also request a hearing on those
                                              Therefore, 40 CFR chapter I is
                                                                                                    SUPPLEMENTARY INFORMATION).                           objections. You must file your objection
                                            amended as follows:
                                                                                                    ADDRESSES: The docket for this action,                or request a hearing on this regulation
                                            PART 180—[AMENDED]                                      identified by docket identification (ID)              in accordance with the instructions
                                                                                                    number EPA–HQ–OPP–2015–0766, is                       provided in 40 CFR part 178. To ensure
                                            ■ 1. The authority citation for part 180                available at http://www.regulations.gov               proper receipt by EPA, you must
                                            continues to read as follows:                           or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                                Authority: 21 U.S.C. 321(q), 346a and 371.          Regulatory Public Docket (OPP Docket)                 OPP–2015–0766 in the subject line on
                                                                                                    in the Environmental Protection Agency                the first page of your submission. All
                                            ■ 2. Revise § 180.1128 to read as
                                                                                                    Docket Center (EPA/DC), West William                  requests must be in writing, and must be
                                            follows:
                                                                                                    Jefferson Clinton Bldg., Rm. 3334, 1301               received by the Hearing Clerk on or
                                            § 180.1128 Bacillus amyloliquefaciens                   Constitution Ave. NW., Washington, DC                 before February 16, 2016. Addresses for
                                            MBI600; exemption from the requirement of               20460–0001. The Public Reading Room                   mail and hand delivery of objections
                                            a tolerance.                                            is open from 8:30 a.m. to 4:30 p.m.,                  and hearing requests are provided in 40
                                              An exemption from the requirement                     Monday through Friday, excluding legal                CFR 178.25(b).
                                            of a tolerance is established for residues              holidays. The telephone number for the                  In addition to filing an objection or
                                            of the biofungicide Bacillus                            Public Reading Room is (202) 566–1744,                hearing request with the Hearing Clerk
                                            amyloliquefaciens MBI600 (antecedent                    and the telephone number for the OPP                  as described in 40 CFR part 178, please
                                            Bacillus subtilis MBI600) in or on all                  Docket is (703) 305–5805. Please review               submit a copy of the filing (excluding
                                            food commodities, including residues                    the visitor instructions and additional               any Confidential Business Information
                                            resulting from post-harvest uses, when                  information about the docket available                (CBI)) for inclusion in the public docket.
                                            applied or used in accordance with                      at http://www.epa.gov/dockets.                        Information not marked confidential
                                            good agricultural practices.                            FOR FURTHER INFORMATION CONTACT:                      pursuant to 40 CFR part 2 may be
                                            [FR Doc. 2015–31462 Filed 12–15–15; 8:45 am]            Susan Lewis, Registration Division                    disclosed publicly by EPA without prior
                                            BILLING CODE 6560–50–P                                  (7505P), Office of Pesticide Programs,                notice. Submit the non-CBI copy of your
                                                                                                    Environmental Protection Agency, 1200                 objection or hearing request, identified
                                                                                                    Pennsylvania Ave. NW., Washington,                    by docket ID number EPA–HQ–OPP–
                                            ENVIRONMENTAL PROTECTION                                DC 20460–0001; main telephone                         2015–0766 by one of the following
                                            AGENCY                                                  number: (703) 305–7090; email address:                methods:
                                                                                                    RDFRNotices@epa.gov.                                    • Federal eRulemaking Portal: http://
                                            40 CFR Part 180                                                                                               www.regulations.gov. Follow the online
                                                                                                    SUPPLEMENTARY INFORMATION:
                                            [EPA–HQ–OPP–2015–0766; FRL–9939–95]                                                                           instructions for submitting comments.
                                                                                                    I. General Information                                Do not submit electronically any
                                            Extension of Pesticide Residue                          A. Does this action apply to me?                      information you consider to be CBI or
                                            Tolerances for Emergency Exemptions                                                                           other information whose disclosure is
                                                                                                       You may be potentially affected by
                                            (Multiple Chemicals)                                                                                          restricted by statute.
                                                                                                    this action if you are an agricultural
                                            AGENCY:  Environmental Protection                       producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                            Agency (EPA).                                           pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                    list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.,
                                            ACTION: Final rule.
                                                                                                    Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                            SUMMARY:   This regulation extends                      not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                            existing time-limited tolerances for                    provides a guide to help readers                      arrangements for hand delivery or
                                            residues of the pesticides bifenthrin in                determine whether this document                       delivery of boxed information, please
                                            or on apple, peach and nectarine;                       applies to them. Potentially affected                 follow the instructions at http://
tkelley on DSK3SPTVN1PROD with RULES




                                            dinotefuran in or on pome fruit and                     entities may include:                                 www.epa.gov/dockets/contacts.html.
                                            stone fruit; imidacloprid in or on                         • Crop production (NAICS code 111).                  Additional instructions on
                                            sugarcane, cane and sugarcane                              • Animal production (NAICS code                    commenting or visiting the docket,
                                            molasses; and streptomycin in or on                     112).                                                 along with more information about
                                            grapefruit and grapefruit, dried pulp.                     • Food manufacturing (NAICS code                   dockets generally, is available at
                                            These actions are in response to EPA’s                  311).                                                 http://www.epa.gov/dockets.


                                       VerDate Sep<11>2014   16:18 Dec 15, 2015   Jkt 238001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\16DER1.SGM   16DER1


                                            78144        Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations

                                            II. Background and Statutory Findings                   relevant information on these pesticides              published in the Federal Register of
                                               EPA published final rules in the                     indicates that the residues are not safe.             May 17, 2013 (78 FR 29049) (FRL–9385–
                                            Federal Register for each chemical                         Tolerances for the use of the following            3).
                                                                                                    pesticide chemicals on specific
                                            listed. The initial issuance of these final                                                                   III. International Residue Limits
                                                                                                    commodities are being extended:
                                            rules announced that EPA, on its own
                                                                                                       Bifenthrin. EPA has authorized under                  In making its tolerance decisions, EPA
                                            initiative, under FFDCA section 408, 21                 FIFRA section 18 the use of bifenthrin
                                            U.S.C. 346a, was establishing time-                                                                           seeks to harmonize U.S. tolerances with
                                                                                                    on apple, peach, and nectarine for                    international standards whenever
                                            limited tolerances for residues of a                    control of the brown marmorated
                                            pesticide in or on one or more food                                                                           possible, consistent with U.S. food
                                                                                                    stinkbug in multiple states. This                     safety standards and agricultural
                                            commodities.                                            regulation extends existing time-limited
                                               EPA established the tolerances                                                                             practices. EPA considers the
                                                                                                    tolerances for residues of the insecticide            international maximum residue limits
                                            because FFDCA section 408(l)(6)                         bifenthrin, including its metabolites and
                                            requires EPA to establish a time-limited                                                                      (MRLs) established by the Codex
                                                                                                    degradates, in or on apple, peach, and                Alimentarius Commission (Codex), as
                                            tolerance, or exemption from the                        nectarine at 0.5 part per million (ppm)
                                            requirement for a tolerance, for                                                                              required by FFDCA section 408(b)(4).
                                                                                                    for an additional 3-year period. These                The Codex Alimentarius is a joint
                                            pesticide chemical residues in food that                tolerances will expire and are revoked
                                            will result from the use of a pesticide                                                                       United Nations Food and Agriculture
                                                                                                    on December 31, 2018. The time-limited                Organization/World Health
                                            under an emergency exemption granted                    tolerances were originally published in
                                            by EPA under FIFRA section 18. Such                                                                           Organization food standards program,
                                                                                                    the Federal Register of September 14,                 and it is recognized as an international
                                            tolerances can be established without                   2012 (77 FR 56782) (FRL–9361–6).
                                            providing notice or time for public                                                                           food safety standards-setting
                                                                                                       Dinotefuran. EPA has authorized
                                            comment.                                                                                                      organization in trade agreements to
                                                                                                    under FIFRA section 18 the use of
                                               EPA received requests to extend the                                                                        which the United States is a party. EPA
                                                                                                    dinotefuran on pome fruit and stone
                                            emergency use of these chemicals for                                                                          may establish a tolerance that is
                                                                                                    fruit for control of the brown
                                            this year’s growing season. After having                                                                      different from a Codex MRL; however,
                                                                                                    marmorated stinkbug in multiple states.
                                            reviewed these submissions, EPA                                                                               FFDCA section 408(b)(4) requires that
                                                                                                    This regulation extends existing time-
                                            concurs that emergency conditions                                                                             EPA explain the reasons for departing
                                                                                                    limited tolerances for residues of the
                                            continue to exist. EPA assessed the                                                                           from the Codex level.
                                                                                                    insecticide dinotefuran, including its
                                            potential risks presented by residues for               metabolites and degradates, in or on                     The Codex has not established MRLs
                                            each chemical. In doing so, EPA                         fruit, pome, group 11 and fruit, stone,               for bifenthrin in/on apple, peach, or
                                            considered the safety standard in                       group 12 at 2.0 ppm for an additional                 nectarine; dinotefuran in/on pome fruit
                                            FFDCA section 408(b)(2), and decided                    three-year period. These tolerances will              or stone fruit; imidacloprid in/on
                                            that the necessary tolerance under                      expire and are revoked on December 31,                sugarcane, cane or sugarcane molasses;
                                            FFDCA section 408(l)(6) would be                        2018. The time-limited tolerances were                nor streptomycin in/on grapefruit or
                                            consistent with the safety standard and                 originally published in the Federal                   grapefruit, dried pulp.
                                            with FIFRA section 18.                                  Register of November 9, 2012 (77 FR                   IV. Statutory and Executive Order
                                               The data and other relevant material                 67282) (FRL–9366–3), and revised in the               Reviews
                                            have been evaluated and discussed in                    Federal Register of January 22, 2014 (79
                                            the final rules originally published to                 FR 3508) (FRL–9402–8).                                   This action establishes tolerances
                                            support these uses. Based on that data                     Imidacloprid. EPA has authorized                   under FFDCA sections 408(e) and
                                            and information considered, the Agency                  under FIFRA section 18 the use of                     408(l)(6). The Office of Management and
                                            reaffirms that extension of these time-                 imidacloprid on sugarcane for control of              Budget (OMB) has exempted these types
                                            limited tolerances will continue to meet                the West Indian cane fly in Louisiana.                of actions from review under Executive
                                            the requirements of FFDCA section                       This regulation extends existing time-                Order 12866, entitled ‘‘Regulatory
                                            408(l)(6). Therefore, each of the time-                 limited tolerances for residues of the                Planning and Review’’ (58 FR 51735,
                                            limited tolerances is extended until the                insecticide imidacloprid, including its               October 4, 1993). Because this action
                                            date listed, when they will expire and                  metabolites and degradates, in or on                  has been exempted from review under
                                            become revoked. EPA intends to publish                  sugarcane, cane at 6.0 ppm and                        Executive Order 12866, this action is
                                            a document in the Federal Register to                   sugarcane, molasses at 50 ppm for an                  not subject to Executive Order 13211,
                                            remove the revoked tolerances from the                  additional 3-year period. These                       entitled ‘‘Actions Concerning
                                            Code of Federal Regulations (CFR).                      tolerances will expire and are revoked                Regulations That Significantly Affect
                                            Although these tolerances will expire                   on December 31, 2018. The time-limited                Energy Supply, Distribution, or Use’’ (66
                                            and are revoked on the dates listed,                    tolerances were originally published in               FR 28355, May 22, 2001) or Executive
                                            under FFDCA section 408(l)(5), residues                 the Federal Register of June 5, 2013 (78              Order 13045, entitled ‘‘Protection of
                                            of a pesticide not in excess of the                     FR 33736) (FRL–9387–9).                               Children from Environmental Health
                                            amount specified in the tolerance                          Streptomycin. EPA has authorized                   Risks and Safety Risks’’ (62 FR 19885,
                                            remaining in or on a commodity after                    under FIFRA section 18 the use of                     April 23, 1997). This action does not
                                            that date will not be unlawful, provided                streptomycin on grapefruit for control of             contain any information collections
                                            the residues are present as a result of an              citrus canker in Florida. This regulation             subject to OMB approval under the
                                            application or use of the pesticide at a                extends existing time-limited tolerances              Paperwork Reduction Act (PRA) (44
                                            time and in a manner that was lawful                    for residues of the pesticide                         U.S.C. 3501 et seq.), nor does it require
                                            under FIFRA, a tolerance was in place                   streptomycin, including its metabolites               any special considerations under
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                                            at the time of the application, and the                 and degradates, in or on grapefruit at                Executive Order 12898, entitled
                                            residues do not exceed the level that                   0.15 ppm and grapefruit, dried pulp at                ‘‘Federal Actions to Address
                                            was authorized by the tolerance. EPA                    0.40 ppm for an additional 3-year                     Environmental Justice in Minority
                                            will take action to revoke these                        period. These tolerances will expire and              Populations and Low-Income
                                            tolerances earlier if any experience                    are revoked on December 31, 2018. The                 Populations’’ (59 FR 7629, February 16,
                                            with, scientific data on, or other                      time-limited tolerances were originally               1994).


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                                                               Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                                                                         78145

                                               Since tolerances and exemptions that                                      1999) and Executive Order 13175,                                             Register. This action is not a ‘‘major
                                            are established under FFDCA sections                                         entitled ‘‘Consultation and Coordination                                     rule’’ as defined by 5 U.S.C. 804(2).
                                            408(e) and 408(l)(6), such as the                                            with Indian Tribal Governments’’ (65 FR                                      List of Subjects in 40 CFR Part 180
                                            tolerances in this final rule, do not                                        67249, November 9, 2000) do not apply
                                            require the issuance of a proposed rule,                                     to this action. In addition, this action                                       Environmental protection,
                                            the requirements of the Regulatory                                           does not impose any enforceable duty or                                      Administrative practice and procedure,
                                            Flexibility Act (RFA) (5 U.S.C. 601 et                                       contain any unfunded mandate as                                              Agricultural commodities, Pesticides
                                            seq.), do not apply.                                                         described under Title II of the Unfunded                                     and pests, Reporting and recordkeeping
                                                                                                                         Mandates Reform Act (UMRA) (2 U.S.C.                                         requirements.
                                               This action directly regulates growers,
                                            food processors, food handlers, and food                                     1501 et seq.).                                                                  Dated: December 8, 2015.
                                            retailers, not States or tribes, nor does                                      This action does not involve any                                           Daniel J. Rosenblatt,
                                            this action alter the relationships or                                       technical standards that would require                                       Acting Director, Registration Division, Office
                                            distribution of power and                                                                                                                                 of Pesticide Programs.
                                                                                                                         Agency consideration of voluntary
                                            responsibilities established by Congress                                     consensus standards pursuant to section                                        Therefore, 40 CFR chapter I is
                                            in the preemption provisions of FFDCA                                        12(d) of the National Technology                                             amended as follows:
                                            section 408(n)(4). As such, the Agency
                                                                                                                         Transfer and Advancement Act                                                 PART 180—[AMENDED]
                                            has determined that this action will not
                                                                                                                         (NTTAA) (15 U.S.C. 272 note).
                                            have a substantial direct effect on States
                                            or tribal governments, on the                                                                                                                             ■ 1. The authority citation for part 180
                                                                                                                         V. Congressional Review Act
                                            relationship between the national                                                                                                                         continues to read as follows:
                                            government and the States or tribal                                            Pursuant to the Congressional Review                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                            governments, or on the distribution of                                       Act (5 U.S.C. 801 et seq.), EPA will
                                                                                                                                                                                                      ■ 2. In § 180.245, revise the table in
                                            power and responsibilities among the                                         submit a report containing this rule and                                     paragraph (b) to read as follows:
                                            various levels of government or between                                      other required information to the U.S.
                                            the Federal Government and Indian                                            Senate, the U.S. House of                                                    § 180.245 Streptomycin; tolerances for
                                            tribes. Thus, the Agency has determined                                      Representatives, and the Comptroller                                         residues.
                                            that Executive Order 13132, entitled                                         General of the United States prior to                                        *       *    *            *      *
                                            ‘‘Federalism’’ (64 FR 43255, August 10,                                      publication of the rule in the Federal                                           (b) * * *

                                                                                                                                                                                                                                             Expiration/
                                                                                                                      Commodity                                                                                        Parts per million   revocation date

                                            Grapefruit .........................................................................................................................................................                    0.15        12/31/2018
                                            Grapefruit, dried pulp .......................................................................................................................................                          0.40        12/31/2018



                                            *     *     *     *     *                                                    § 180.442 Bifenthrin; tolerances for                                             (b) * * *
                                            ■ 3. In § 180.442, revise the table in                                       residues.
                                            paragraph (b) to read as follows:                                            *         *         *         *         *

                                                                                                                                                                                                                                             Expiration/
                                                                                                                      Commodity                                                                                        Parts per million   revocation date

                                            Apple ................................................................................................................................................................                   0.5        12/31/2018
                                            Nectarine ..........................................................................................................................................................                     0.5        12/31/2018
                                            Peach ...............................................................................................................................................................                    0.5        12/31/2018



                                            *     *     *     *     *                                                    § 180.472 Imidacloprid; tolerances for                                           (b) * * *
                                            ■ 4. In § 180.472, revise the table in                                       residues.
                                            paragraph (b) to read as follows:                                            *         *         *         *         *

                                                                                                                                                                                                                                             Expiration/
                                                                                                                      Commodity                                                                                        Parts per million   revocation date

                                            Sugarcane, cane ..............................................................................................................................................                           6.0        12/31/2018
                                            Sugarcane, molasses ......................................................................................................................................                                50        12/31/2018



                                            *     *     *     *     *                                                    § 180.603 Dinotefuran; tolerances for                                            (b) * * *
                                            ■ 5. In § 180.603, revise the table in                                       residues.
                                            paragraph (b) to read as follows:                                            *         *         *         *         *
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                                                                                                                                                                                                                                             Expiration/
                                                                                                                      Commodity                                                                                        Parts per million   revocation date

                                            Fruit, pome, Group 11 .....................................................................................................................................                              2.0        12/31/2018
                                            Fruit, stone, Group 12 .....................................................................................................................................                             2.0        12/31/2018




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                                            78146        Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations

                                            *      *     *       *      *                           number: (703) 305–7090; email address:                2015–0023, by one of the following
                                            [FR Doc. 2015–31518 Filed 12–15–15; 8:45 am]            BPPDFRNotices@epa.gov.                                methods:
                                            BILLING CODE 6560–50–P                                  SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                                                                                                                                          www.regulations.gov. Follow the online
                                                                                                    I. General Information                                instructions for submitting comments.
                                            ENVIRONMENTAL PROTECTION                                A. Does this action apply to me?                      Do not submit electronically any
                                            AGENCY                                                                                                        information you consider to be CBI or
                                                                                                       You may be potentially affected by                 other information whose disclosure is
                                            40 CFR Part 180                                         this action if you are an agricultural                restricted by statute.
                                                                                                    producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                            [EPA–HQ–OPP–2015–0023; FRL–9935–81]                     pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                    list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                            Choline Chloride; Exemption From the
                                                                                                    Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                            Requirement of a Tolerance
                                                                                                    not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                            AGENCY:  Environmental Protection                       provides a guide to help readers                      arrangements for hand delivery or
                                            Agency (EPA).                                           determine whether this document                       delivery of boxed information, please
                                            ACTION: Final rule.                                     applies to them. Potentially affected                 follow the instructions at http://
                                                                                                    entities may include:                                 www.epa.gov/dockets/contacts.html.
                                            SUMMARY:   This regulation establishes an                  • Crop production (NAICS code 111).                Additional instructions on commenting
                                            exemption from the requirement of a                        • Animal production (NAICS code                    or visiting the docket, along with more
                                            tolerance for residues of the Choline                   112).                                                 information about dockets generally, is
                                            Chloride (Acetyl Choline) in or on all                     • Food manufacturing (NAICS code                   available at http://www.epa.gov/
                                            food commodities when applied/used                      311).                                                 dockets.
                                            pre-harvest and used in accordance with                    • Pesticide manufacturing (NAICS
                                                                                                    code 32532).                                          II. Background and Statutory Findings
                                            label directions and good agricultural
                                            practices. CP Bio, Inc., submitted a                                                                             In the Federal Register of March 4,
                                                                                                    B. How can I get electronic access to                 2015 (80 FR 11611) (FRL–9922–68),
                                            petition to EPA under the Federal Food,                 other related information?
                                            Drug, and Cosmetic Act (FFDCA),                                                                               EPA issued a document pursuant to
                                            requesting an exemption from the                          You may access a frequently updated                 FFDCA section 408(d)(3), 21 U.S.C.
                                            requirement of a tolerance. This                        electronic version of 40 CFR part 180                 346a(d)(3), announcing the filing of a
                                            regulation eliminates the need to                       through the Government Printing                       pesticide tolerance petition (PP 4F8287)
                                            establish a maximum permissible level                   Office’s e-CFR site at http://                        by CP Bio, Inc., 4802 Murrieta Street,
                                            for residues of Choline Chloride.                       www.ecfr.gov/cgi-bin/text-                            Chino, CA 91710. The petition
                                                                                                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  requested that 40 CFR part 180 be
                                            DATES: This regulation is effective
                                                                                                    40tab_02.tpl.                                         amended by establishing an exemption
                                            December 16, 2015. Objections and
                                                                                                                                                          from the requirement of a tolerance for
                                            requests for hearings must be received                  C. How can I file an objection or hearing             residues of Choline Chloride in or on all
                                            on or before February 16, 2016, and                     request?                                              food commodities (when applied pre-
                                            must be filed in accordance with the                      Under FFDCA section 408(g), 21                      harvest). That document referenced a
                                            instructions provided in 40 CFR part                    U.S.C. 346a, any person may file an                   summary of the petition prepared by the
                                            178 (see also Unit I.C. of the                          objection to any aspect of this regulation            petitioner CP Bio, Inc., which is
                                            SUPPLEMENTARY INFORMATION).
                                                                                                    and may also request a hearing on those               available in the docket, http://
                                            ADDRESSES: The docket for this action,                  objections. You must file your objection              www.regulations.gov. There were no
                                            identified by docket identification (ID)                or request a hearing on this regulation               substantive comments received in
                                            number EPA–HQ–OPP–2015–0023, is                         in accordance with the instructions                   response to the notice of filing.
                                            available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                   Section 408(c)(2)(A)(i) of FFDCA
                                            or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       allows EPA to establish an exemption
                                            Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     from the requirement for a tolerance (the
                                            in the Environmental Protection Agency                  OPP–2015–0023 in the subject line on                  legal limit for a pesticide chemical
                                            Docket Center (EPA/DC), West William                    the first page of your submission. All                residue in or on a food) only if EPA
                                            Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 determines that the exemption is ‘‘safe.’’
                                            Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       Section 408(c)(2)(A)(ii) of FFDCA
                                            20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   defines ‘‘safe’’ to mean that ‘‘there is a
                                            is open from 8:30 a.m. to 4:30 p.m.,                    before February 16, 2016. Addresses for               reasonable certainty that no harm will
                                            Monday through Friday, excluding legal                  mail and hand delivery of objections                  result from aggregate exposure to the
                                            holidays. The telephone number for the                  and hearing requests are provided in 40               pesticide chemical residue, including
                                            Public Reading Room is (202) 566–1744,                  CFR 178.25(b).                                        all anticipated dietary exposures and all
                                            and the telephone number for the OPP                      In addition to filing an objection or               other exposures for which there is
                                            Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                reliable information.’’ This includes
                                            the visitor instructions and additional                 as described in 40 CFR part 178, please               exposure through drinking water and in
                                            information about the docket available                  submit a copy of the filing (excluding                residential settings, but does not include
                                            at http://www.epa.gov/dockets.                          any Confidential Business Information                 occupational exposure. Pursuant to
                                            FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            FFDCA section 408(c)(2)(B), in
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                                            Robert McNally, Biopesticides and                       Information not marked confidential                   establishing or maintaining in effect an
                                            Pollution Prevention Division (7511P),                  pursuant to 40 CFR part 2 may be                      exemption from the requirement of a
                                            Office of Pesticide Programs,                           disclosed publicly by EPA without prior               tolerance, EPA must take into account
                                            Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               the factors set forth in FFDCA section
                                            Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              408(b)(2)(C), which require EPA to give
                                            DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       special consideration to exposure of


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Document Created: 2015-12-16 01:01:01
Document Modified: 2015-12-16 01:01:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 78143 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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