Document ID: EPA-HQ-OPP-2018-0717-0001
Agency: epa
Document Type: Rule
Title: Extension of Tolerances for Emergency Exemptions (Multiple Chemicals)
Posted Date: 2018-12-06T05:00Z

[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62730-62732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26346]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0717; FRL-9985-77]

Extension of Tolerances for Emergency Exemptions (Multiple 
Chemicals)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for the 
pesticides listed in this document. 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 6, 2018. Objections and 
requests for hearings must be received on or before February 4, 2019, 
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-2018-0717, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200

[[Page 62731]]

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. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select 
``Test Guidelines for Pesticides and Toxic Substances.''

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-2018-0717 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 4, 2019. 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-2018-0717, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA previously published final rules in the Federal Register for 
each chemical/commodity combination listed, establishing time-limited 
tolerances under FFDCA section 408, 21 U.S.C. 346a.
    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 on EPA's own initiative and without providing notice or 
time for public comment.
    EPA received requests to extend the uses of these chemicals for 
this year's growing season. After having reviewed these submissions, 
EPA concurs that emergency conditions exist. EPA assessed the potential 
risks presented by residues for each chemical in the listed 
commodities. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and decided that the necessary tolerances 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 those 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, the 
time-limited tolerances are extended until the dates listed. EPA will 
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 date listed, under FFDCA 
section 408(l)(5), residues of the pesticides not in excess of the 
amounts specified in the tolerances remaining in or on the named 
commodities after that date will not be unlawful, provided the residues 
are present as a result of an application or use of the pesticides at a 
time and in a manner that was lawful under FIFRA, the tolerances were 
in place at the time of the application, and the residues do not exceed 
the levels that were authorized by the tolerances. EPA will act to 
revoke these tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Tolerances for the uses 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 
three-year period. These tolerances will expire and are revoked on 
December 31, 2021. Time-limited tolerances 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, 2021. Time-limited tolerances originally published in the 
Federal Register of November 9, 2012 (77 FR 67282) (FRL-9366-3); and 
were revised in the Federal Register of January 22, 2014 (79 FR 3508) 
(FRL-9402-8).

[[Page 62732]]

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; nor dinotefuran in/on pome fruit or stone fruit.

IV. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to petitions submitted to the Agency. The Office of Management 
and Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993). Because this action has been exempted from 
review under Executive Order 12866, this action is not subject to 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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: November 9, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.

0
 2. In Sec.  180.442, in the table in paragraph (b), revise entries for 
``Apple'', ``Nectarine'' and ``Peach'' to read as follows:

Sec.  180.442  Bifenthrin; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
Apple.......................................           0.5      12/31/21
 
                                * * * * *
Nectarine...................................           0.5      12/31/21
Peach.......................................           0.5      12/31/21
 
                                * * * * *
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* * * * *

0
3. In Sec.  180.603, revise the table in paragraph (b) to read as 
follows:

Sec.  180.603  Dinotefuran; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
Fruit, pome, Group 11.......................           2.0      12/31/21
Fruit, stone, Group 12......................           2.0      12/31/21
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[FR Doc. 2018-26346 Filed 12-4-18; 8:45 am]
BILLING CODE 6560-50-P