Document ID: EPA-HQ-OPP-2014-0643-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Sulfoxaflor
Posted Date: 2015-01-28T05:00Z

[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Rules and Regulations]
[Pages 4512-4515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01456]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0643; FRL-9920-45]

Sulfoxaflor; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of sulfoxaflor, N-[methyloxido[1-[6-(trifluoromethyl)-3-
pyridinyl]ethyl]- [lambda]\4\-sulfanylidene]cyanamide, including its 
metabolites and degradates in or on sorghum, grain; sorghum, forage; 
and sorghum, stover. This action is in response to EPA's granting of an 
emergency exemption under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on sorghum. 
This regulation establishes a maximum permissible level for residues of 
sulfoxaflor in or on these commodities. The time-limited tolerances 
expire on December 31, 2017.

DATES: This regulation is effective January 28, 2015. Objections and 
requests for hearings must be received on or before March 30, 2015, 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-2014-0643, 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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
    [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.

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-
2014-0643 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 March 30, 2015. 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-2014-0643, by one of 
the following methods:

[[Page 4513]]

     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) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of sulfoxaflor, N-
[methyloxido[1-[6-(trifluoromethyl)-3-pyridinyl]ethyl]-[lambda]\4\-
sulfanylidene]cyanamide, including its metabolites and degradates in or 
on sorghum, forage at 0.40 parts per million (ppm); sorghum, grain at 
0.30 ppm; and sorghum, stover at 0.90 ppm. These time-limited 
tolerances expire 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 
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 Sulfoxaflor on Sorghum and FFDCA 
Tolerances

    Numerous states requested emergency exemptions for the use of 
sulfoxaflor on sorghum to control sugarcane aphid (Melanaphis 
sacchari). Based on information provided by the states, this is either 
a new pest or new biotype of M. sacchari. There are no registered 
insecticides or economically or environmentally feasible alternative 
control practices available to adequately control this non-routine pest 
infestation. Unusually high populations of aphids can cause direct 
plant death from aphid feeding as well as indirect damage and 
harvesting issues from the aphid honeydew residue. The states asserted 
that without the use of sulfoxaflor, uncontrolled aphid infestations 
are likely to result in significant economic losses.
    After having reviewed the submissions, EPA determined that an 
emergency condition exists for these States, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of sulfoxaflor on 
sorghum for control of sugarcane aphid in Arkansas, Florida, Georgia, 
Louisiana, Mississippi, Missouri, Oklahoma, Tennessee, and Texas.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of sulfoxaflor 
in or on sorghum. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary 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 tolerance without notice and opportunity 
for public comment as provided in FFDCA section 408(l)(6). Although 
these time-limited tolerances expire 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 sorghum 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 these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
sulfoxaflor meets FIFRA's registration requirements for use on sorghum 
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 sulfoxaflor by 
a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance by itself serve as the authority for persons in any 
State other than those authorized to use this pesticide on the 
applicable crops under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for sulfoxaflor, contact 
EPA'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

[[Page 4514]]

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. . . .''
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of sulfoxaflor 
in or on sorghum, forage; sorghum, grain; and sorghum, stover. In doing 
so, EPA considered the safety standard in FFDCA section 408(b)(2), and 
EPA decided that the necessary tolerances under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18.
    EPA has evaluated this use of sulfoxaflor on sorghum, as well as 
its use on various other crops, and established tolerances for similar 
use patterns in the Federal Register of May 17, 2013 (78 FR 29041) 
(FRL-9371-4) in association with requests for tolerances to support 
registrations of sulfoxaflor under FIFRA section 3 .
    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 this emergency exemption request and 
the time-limited tolerances for residues of sulfoxaflor in or on 
sorghum, forage at 0.40 ppm; sorghum, grain at 0.30 ppm; and sorghum, 
stover at 0.90 ppm. There is an existing permanent tolerance for 
sulfoxaflor residues in/on aspirated grain fractions at 20 ppm and that 
tolerance is sufficient to address residues in/on aspirated grain 
fractions that may come from sorghum. In addition, sorghum commodities 
may be used as livestock feedstuffs. Inclusion of sorghum in the 
estimated reasonable balances livestock dietary burdens for cattle, 
poultry, and swine did not result in a need for revision of the 
existing tolerances for residues of sulfoxaflor in livestock 
commodities.
    In the May 17, 2013 Federal Register, EPA published a final rule 
establishing tolerances for residues of sulfoxaflor in 40 CFR 180.668 
in or on numerous commodities. A summary of the toxicological endpoints 
for sulfoxaflor for human risk assessment is discussed in Units III.A. 
and B. of the May 17, 2013 Federal Register final rule.
    In evaluating dietary exposure, the Agency has noted that estimated 
drinking water concentrations based on the sulfoxaflor use on sorghum 
resulted in lower estimates than those previously assessed and the food 
consumption database used to support the Agency's dietary exposure 
assessments does not report any consumption of sorghum, either as grain 
or as syrup. Therefore, the dietary exposure estimates from the 
previous assessment are not changed by the FIFRA section 18 use. 
Dietary risk estimates from exposure to sulfoxaflor through food and 
water are below the Agency's level of concern.
    In its aggregate assessment of exposures and risk associated with 
sulfoxaflor, EPA concluded the following: Acute dietary exposure from 
food and water to sulfoxaflor will occupy 16% of the acute population 
adjusted dose (aPAD) for children 1-2 years old and females 13-49 years 
old, the population groups receiving the greatest exposure; and chronic 
exposure to sulfoxaflor from food and water will utilize 18% of the 
chronic population adjusted dose (cPAD) for all infants, the population 
group receiving the greatest exposure. These estimates are well below 
100% and are, therefore, below the Agency's level of concern.
    There are no residential uses of sulfoxaflor at this time. 
Consequently, aggregate exposure and risk estimates are equivalent to 
the dietary (food + drinking water) exposure and risk estimates 
discussed in this unit.
    Therefore, EPA concluded there is a reasonable certainty that no 
harm will result to the general population and to infants and children 
from aggregate exposure to sulfoxaflor residues.
    Refer to the May 17, 2013 Federal Register final rule, available at 
http://www.regulations.gov, for a summary of the aggregate risk 
assessment and determination of safety. Detailed discussion of the 
aggregate risk assessments and the determinations of safety relied upon 
in this action may be found in the Agency reviews and human health risk 
assessments provided as supporting documents in the docket for this 
action (EPA-HQ-OPP-2014-0643).

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology is available to enforce the 
tolerance expression. In the submitted field trials, residues of 
sulfoxaflor and its metabolites in crops were determined using the Dow 
analytical method designated as 091031. The proposed method for 
tolerance enforcement in plant commodities is method 091116: 
``Enforcement Method for the Determination of Sulfoxaflor (XDE-208) and 
its Main Metabolites in Agricultural Commodities Using Offline Solid-
Phase Extraction and Liquid Chromatography with Tandem Mass 
Spectrometry Detection.'' Method 091116 extracts residues with 
acetonitrile/water and includes use of a deuterated internal standard, 
hydrolysis with sodium hydroxide to release base-labile conjugates, and 
clean up via solid-phase extraction. This method is applicable for the 
quantitative determination of residues of sulfoxaflor, N-
[methyloxido[1-[6-(trifluoromethyl)-3-pyridinyl]ethyl]-[lambda]\4\-
sulfanylidene]cyanamide and its metabolites, X11719474, N-
((methyl)oxido[1-[6-trifluoromethyl)pyridine-3-yl]ethyl]- [lambda]\4\-
sulfanylidene)urea and X11721061, 1-[6-(trifluoromethyl)pyridin-3-
yl]ethanol, in agricultural commodities and processed products. The 
method was adequately validated, with a limit of quantitation (LOQ) of 
0.010 milligram/kilogram (mg/kg) for all matrices, including sorghum. 
The Food and Drug Administration Multi-Residue Method was reported by 
the registrant to be not suitable for analysis of sulfoxaflor and/or 
its metabolites; the German multi-residue Method S-19 may be suitable.
    The methods 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: 
residuemethods@epa.gov.

B. 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 sulfoxaflor in/on sorghum commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
sulfoxaflor,

[[Page 4515]]

in or on sorghum, forage at 0.40 ppm; sorghum, grain at 0.30 ppm; and 
sorghum, stover at 0.90 ppm. These tolerances expire 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 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: January 15, 2015.
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.  180.668, revise paragraph (b) to read as follows:

Sec.  [emsp14]180.668  Sulfoxaflor; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
sulfoxaflor (N-[methyloxido[1-[6-(trifluoromethyl)-3-pyridinyl]ethyl]- 
[lambda]\4\-sulfanylidene]cyanamide), including its metabolites and 
degradates, in or on the specified agricultural commodities, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. Compliance with the tolerance levels specified in the 
following table is to be determined by measuring only sulfoxaflor in or 
on the commodity. The tolerances expire on the date specified in the 
table.

------------------------------------------------------------------------
                                                    Parts    Expiration/
                    Commodity                        per     revocation
                                                   million      date
------------------------------------------------------------------------
Sorghum, forage.................................      0.40      12/31/17
Sorghum, grain..................................      0.30      12/31/17
Sorghum, stover.................................      0.90      12/31/17
------------------------------------------------------------------------

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[FR Doc. 2015-01456 Filed 1-27-15; 8:45 am]
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