[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Rules and Regulations]
[Pages 10003-10007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03928]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0253; FRL-9919-59]


Clothianidin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-
methyl-N''-nitroguanidine, in or on fruit, citrus, group 10-10. 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 citrus. This regulation establishes 
a maximum permissible level for residues of clothianidin in or on 
citrus. The time-limited tolerance expires on December 31, 2017.

DATES: This regulation is effective February 25, 2015. Objections and 
requests for hearings must be received on or before April 27, 2015, and 
must be filed in accordance with the instructions provided in 40 CFR 
part

[[Page 10004]]

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-2014-0253, 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:
    [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-
2014-0253 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 April 27, 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-2014-0253, 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) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited tolerance for residues of clothianidin, 
(E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N''-nitroguanidine, in 
or on fruit, citrus, group 10-10 at 0.07 parts per million (ppm). 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 of 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 Clothianidin in or on Immature Citrus 
Trees and FFDCA Tolerances

    The Florida Department of Agriculture and Consumer Services 
requested the EPA Administrator to issue a specific exemption for the 
use of clothianidin as a soil drench application on immature citrus 
trees to control the transmission of Huanglongbing (HLB) disease 
vectored by the Asian Citrus Psyllid (ACP). The applicant asserts that 
clothianidin is needed to control HLB disease due to the lack of 
effective available alternatives for season long control practices, and 
that significant economic losses will occur if this

[[Page 10005]]

urgent, non-routine disease is not controlled.
    Further, the Applicant asserts that an emergency condition exists 
in accordance with the criteria for approval of an emergency exemption, 
and issued a crisis exemption under FIFRA section 18 to allow the use 
of clothianidin on immature citrus trees for control of the 
transmission of HLB disease vectored by the ACP in Florida. After 
having reviewed the submission, EPA concurred that an emergency 
condition exists for Florida citrus growers and authorized a specific 
emergency exemption under FIFRA section 18 for control of clothianidin 
on immature citrus trees to control the transmission of HLB disease 
vectored by the ACP.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of clothianidin 
in or on citrus. 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 
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 fruit, citrus, 
group 10-10 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 the 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 
clothianidin meets FIFRA's registration requirements for use on fruit, 
citrus, group 10-10 or whether a permanent tolerance 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 clothianidin 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 Florida to use this pesticide on the 
applicable crop under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for clothianidin 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. . . 
.''
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of clothianidin 
in or on citrus. 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.
    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 emergency 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 and 
the time-limited tolerance for residues of clothianidin in or on fruit, 
citrus, group 10-10 at 0.07 ppm.
    EPA recently evaluated the currently approved uses of clothianidin 
when establishing tolerances for residues of clothianidin in three non-
citrus commodity groups in the March 29, 2013 Federal Register (78 FR 
19130) (FRL-9378-6). A summary of the human risk assessment 
toxicological endpoints is discussed in Units 111.A. and B. of the 
March 29, 2013 Final Rule.
    EPA has also recently evaluated the dietary exposure that would 
result from a similar use of clothianidin on citrus that would result 
in clothianidin residues of 0.60 ppm. This is significantly higher than 
the 0.07 ppm time-limited tolerance level established in today's final 
rule. In order to expedite this time-limited tolerance rule, EPA has 
relied on its previous dietary risk assessment assuming clothianidin 
residues of 0.60 ppm on citrus. The higher application rates and 
concentrations assure that exposure and risk resulting from the 
emergency use are not underestimated. In addition, the estimated 
drinking water concentrations based on the clothianidin use on citrus 
resulted in higher acute drinking water estimates than those previously 
assessed. The chronic analysis drinking water estimate remains the same 
as it was in the previous dietary assessment. Even with these 
conservative assumptions, the revised acute dietary risk estimates from 
exposure to clothianidin through food and water are below the Agency's 
level of concern for all population subgroups.
    In its aggregate assessment of exposures and risk associated with 
clothianidin, including use on citrus which was assessed at a 
significantly higher use rate, EPA concluded that the acute dietary 
exposure from food and water to clothianidin would occupy 28% of the 
acute population adjusted dose (aPAD) for children 1-2 years old, the 
population subgroup receiving the greatest exposure; and that chronic 
exposure to clothianidin from food and water would utilize 28% of the 
chronic population adjusted dose (cPAD) for children 1-2 years old, the 
population subgroup receiving the greatest exposure. These population 
adjusted doses represent the levels below which exposure is not of 
health concern. Because these levels of dietary exposures for the most 
exposed subpopulations would be well below the aPAD and cPAD, the 
expected lower levels of dietary exposures are not of concern.
    There are no new residential uses of clothianidin at this time. 
However, existing uses of clothianidin on turf, ornamental plants, and/
or indoor surfaces for bed bug control may result in human exposure in 
a residential setting. Such exposures may occur during application of 
products containing clothianidin (handler exposure) as well as 
following application (post-application exposure) and are expected to 
be of short-term (1-30 days) duration.

[[Page 10006]]

    For clothianidin, residential handler and post-application risk 
estimates are considered to be of potential concern when the dermal 
margin of exposure (MOE) is less than 100, the inhalation MOE is less 
than 1,000, and/or the aggregate risk index (ARI), reflecting combined 
dermal and inhalation exposure, is less than one. The residential 
handler and post-application risk estimates are not of concern (ARIs 
range from 1.9 to 990). The aggregate ARIs, which combine residential 
and dietary exposure, ranged from 1.2 to 6.5, which are not of concern 
(i.e. when the ARI is greater 1).
    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 clothianidin residues as a result of 
existing uses and the proposed section 18 use pattern.
    Refer to the March 29, 2013 final rule, available at http://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 under 
docket ID number EPA-HQ-OPP-2014-0253.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology, based on solvent extraction 
and liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/
MS) separation, identification, and quantification, is available for 
plant (Morse Method#Meth-164-modified, RM-39C-1, or Bayer Method 00552) 
matrices to enforce the tolerance expression. The limit of quantitation 
(LOQ) for clothianidin in plant commodities is 0.01 ppm. Clothianidin 
and its major metabolites are not adequately recovered using any of the 
United States Food and Drug Administration (FDA) multi-residue methods.
    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: 
[email protected].

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 established MRLs for clothianidin in or on citrus 
fruits at 0.07 ppm, the same level the U.S. is establishing for the 
time-limited-tolerance.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
clothianidin, in or on fruit, citrus, group 10-10 at 0.07 ppm. This 
tolerance expires on December 31, 2017.

VII. Statutory and Executive Order Reviews

    This final rule 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 final rule has been exempted from review under 
Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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 13, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 10007]]

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.  180.586, revise paragraph (b) to read as follows:


Sec.  180.586  Clothianidin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance 
specified in the following table is established for residues of 
clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N''-
nitroguanidine, in or on the specified agricultural commodity, 
resulting from use of the pesticide pursuant to FIFRA section 18 
emergency exemptions. This tolerance expires on the date specified in 
the table.

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
------------------------------------------------------------------------
Fruit, citrus, group 10-10....................        0.07     12/31/17
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-03928 Filed 2-24-15; 8:45 am]
BILLING CODE 6560-50-P