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)

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, 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.

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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]]

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[FR Doc. 2015-31518 Filed 12-15-15; 8:45 am]
 BILLING CODE 6560-50-P