[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Rules and Regulations]
[Pages 11121-11124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04757]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0475; FRL-9942-10]


Fluensulfone; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-
sulfonic acid, resulting from use of fluensulfone in or on carrots in 
accordance with the terms of an emergency exemption issued under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). This action is in response to the issuance of a crisis 
emergency exemption under FIFRA section 18 authorizing use of the 
pesticide on carrots. This regulation establishes a maximum permissible 
level for residues of fluensulfone in or on carrots. The time-limited 
tolerance expires on December 31, 2017.

DATES:  This regulation is effective March 3, 2016. Objections and 
requests for hearings must be received on or before May 2, 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-2015-0475, 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 T. 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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]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.

[[Page 11122]]

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2015-0475 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before May 2, 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-2015-0475 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.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
a time-limited tolerance for residues of fluensulfone, to be enforced 
by measuring only the metabolite 3,4,4-trifluoro-but-3-ene-1-sulfonic 
acid, in or on carrots at 2.0 parts per million (ppm). There are no 
Canadian or Codex MRLs for residues of fluensulfone in or on carrot at 
this time. International harmonization is not an issue for this 
emergency exemption. This time-limited tolerance expires on December 
31, 2017.
    Section 408(l)(6) of 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 under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-
limited tolerance (the legal limit for a pesticide chemical residue in 
or on a food) only if EPA determines that the tolerance is ``safe.'' 
Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue, including all anticipated 
dietary exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fluensulfone on Carrots and FFDCA 
Tolerances

    The Michigan Department of Agriculture and Rural Development 
asserted that an emergency condition existed in accordance with the 
criteria for approval of an emergency exemption, and utilized a crisis 
exemption under FIFRA section 18 to allow the use of fluensulfone on 
carrots to control plant-parasitic nematodes in carrot fields in 
Michigan. The Michigan Department of Agriculture and Rural Development 
invoked the crisis exemption provision on April 14, 2015. After having 
reviewed the submission, EPA concurred on the emergency action in order 
to meet the needs of Michigan carrot growers who faced significant 
economic loss. The crisis exemption program expired on June 15, 2015.
    As part of its evaluation of the Michigan crisis exemption, EPA 
assessed the potential risks presented by residues of fluensulfone in 
or on carrots. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary time-limited 
tolerance under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this time-limited tolerance without notice and 
opportunity for public comment as provided in FFDCA section 408(l)(6). 
Although this time-limited tolerance expires on December 31, 2017, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on carrots 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this time-limited tolerance 
at the time of that application. EPA will take action to revoke this 
time-limited tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
fluensulfone meets FIFRA's registration requirements for use on carrots 
or whether permanent tolerances for this use would be appropriate. 
Under these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of fluensulfone 
by a State for special local needs under FIFRA section 24(c). Nor does 
this time-limited tolerance by itself serve as the authority for 
persons in any State other than Michigan to use this pesticide on the 
applicable crops under FIFRA

[[Page 11123]]

section 18 absent the issuance of an emergency exemption applicable 
within that State. For additional information regarding the crisis 
exemption for fluensulfone, contact the Agency's Registration Division 
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of the crisis exemption and this time-
limited tolerance for residues of fluensulfone on carrots at 2.0 parts 
per million (ppm), measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic 
acid. EPA's assessment of exposures and risks associated with 
establishing a time-limited tolerance follows.
    The Agency assessed the use of the fluensulfone use on carrots 
based on a 0.50 ppm residue level of the parent compound, which is the 
residue of concern for purposes of risk assessment on carrots (i.e., 
100% crop treated) and determined that there would be no resulting 
change in the estimates from the previous risk assessment for the 
chemical. Since the publication of the September 24, 2014 final rule, 
the toxicity profile of fluensulfone has not changed, and the risk 
assessments that supported the establishment of those tolerances 
published in the Federal Register remain valid. The dietary risk 
assessments for fluensulfone are based on residues of the parent 
compound only. Therefore, EPA relies upon those supporting risk 
assessments and the findings made in the September 24, 2014 Federal 
Register document, as well as an updated dietary exposure and risk 
assessment on carrots. EPA concludes that there is a reasonable 
certainty that no harm will result to the general population, or to 
infants and children from aggregate exposure to fluensulfone residues.
    A summary of the toxicological endpoints for fluensulfone used for 
human risk assessment were previously described in a final rule 
published in the Federal Register of September 24, 2014 (79 FR 56964) 
(FRL-9914-35). Please refer to this Federal Register document and its 
supporting documents, available at http://www.regulations.gov in docket 
ID number EPA-HQ-OPP-2012-0593 for a detailed discussion of the 
aggregate risk assessments and determination of safety for the proposed 
time-limited tolerance for residues of fluensulfone on carrots at 2.0 
parts per million (ppm) when measured as 3,4,4-trifluoro-but-3-ene-1-
sulfonic acid.

V. Analytical Enforcement Methodology

    An analytic method suitable for enforcement purposes has been 
approved by the Agency. That same method was used in the field trials 
for carrot and was shown to be appropriate for that crop. The method 
has an LOQ, defined as the lower limit of method validation, of 0.01 
ppm of 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. For carrot, the 
method has a calculated LOQ of 0.005 ppm of 3,4,4-trifluoro-but-3-ene-
1-sulfonic acid. Adequate enforcement methodology, a reverse-phase high 
performance liquid chromatography with dual mass spectrometry/mass 
spectrometry (HPLC-MS/MS), is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 a MRL for fluensulfone or 3,4,4-
trifluoro-but-3-ene-1-sulfonic acid, in or on carrot.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in 
or on carrots at 2.0 ppm. This tolerance expires on December 31, 2017.

VII. 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).
    Since tolerances and exemptions that are established in accordance 
with 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

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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).

VIII. 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: February 25, 2016.
Susan Lewis,
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.  180.680, revise paragraph (b) to read as follows:


Sec.  180.680  Fluensulfone; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
nematicide fluensulfone, including its metabolites and degradates, in 
or on the commodities in the table below, resulting from use of the 
pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. The 
tolerances expire on the date specified in the table.

------------------------------------------------------------------------
                                                 Parts per   Expiration
                   Commodity                      million       date
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Carrot.........................................       2.0      12/31/17
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[FR Doc. 2016-04757 Filed 3-2-16; 8:45 am]
 BILLING CODE 6560-50-P