[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Rules and Regulations]
[Pages 66649-66651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26643]



40 CFR Part 180

[EPA-HQ-OPP-2012-0107; FRL-9399-4]

Spirotetramat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
spirotetramat in or on corn, sweet, kernel plus cob with husks removed 
and persimmon and revises established tolerances in or on feijoa, 
papaya, and Spanish lime, under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective November 6, 2013. Objections and 
requests for hearings must be received on or before January 6, 2014, 
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-2012-0107, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].


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 EPA's 
tolerance regulations at 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-2012-0107 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 
January 6, 2014. 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-2012-0107, 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 
     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. 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 FFDCA section 408(b)(2)(D), and 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 for spirotetramat including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with spirotetramat 
    In the Federal Register of July 17, 2013 (78 FR 42736) (FRL-9391-
6), the EPA proposed, on its own initiative under FFDCA section 408(e), 
21 U.S.C. 346a(e), to establish a tolerance for residues of the 
insecticide spirotetramat in or on corn, sweet kernel plus cob with 
husks removed at 1.5 parts per million (ppm) and persimmon at 2.5 ppm. 
Additionally, EPA proposed to revise 40 CFR 180.641 by amending 
established tolerances in or on feijoa from 0.30 ppm to 2.5 ppm, papaya 

[[Page 66650]]

2.5 ppm to 0.40 ppm, and Spanish lime from 0.60 ppm to 13 ppm. The 
proposed rule referenced a recently published spirotetramat final rule 
printed in the Federal Register of May 15, 2013 (78 FR 28507) (FRL-
9382-8); in the risk assessments associated with that final rule, the 
EPA also considered these proposed uses. Since that time, the toxicity 
profile of spirotetramat has not changed, and the risk assessments that 
supported the establishment of those spirotetramat tolerances published 
in the May 15, 2013 Federal Register final rule remain valid. For a 
detailed discussion of the aggregate risk assessments and determination 
of safety that support these new and revised uses, please refer to the 
May 15, 2013 Federal Register final rule and its supporting documents, 
available at http://www.regulations.gov.
    Therefore, EPA concludes that there is a reasonable certainty that 
no harm will result to the general population and to infants and 
children from aggregate exposure to spirotetramat residues. EPA relies 
upon the findings made in the May 15, 2013 Federal Register final rule 
and the underlying risk assessments in order to establish the new and 
revised tolerances as detailed in the July 17, 2013 Federal Register 
proposed rule.

III. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high-performance liquid 
chromatography with tandem 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].

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 a MRL for spirotetramat in or on papaya 
at 0.4 milligram/kilogram (mg/kg). This MRL is the same as the 
tolerance established for spirotetramat in or on papaya at 0.40 ppm in 
the United States. There are no Codex MRLs established for the other 
commodities associated with this final rule.

C. Response to Comments

    The EPA received one comment to the proposed rule which stated that 
no tolerances should be allowed for spirotetramat. The commenter 
expressed a general opposition to the use of ``toxic chemicals'' on 
food and faulted EPA for not conducting toxicity testing that combined 
spirotetramat with the ``thousands'' of other approved pesticides. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that certain pesticide chemicals should not be 
permitted in our food. However, the existing legal framework provided 
by FFDCA section 408 states that tolerances may be set when the 
pesticide meets the safety standard imposed by that statute. The Agency 
is required by FFDCA section 408 to estimate the risk of the potential 
exposure to these residues. EPA has concluded that there is a 
reasonable certainty that no harm will result from aggregate human 
exposure to spirotetramat residues from these uses. As far as the 
toxicity testing relied upon by EPA, testing requirements for pesticide 
tolerances have been specified by rulemaking after allowing for notice 
and comment by the public and peer review by appropriate scientific 
bodies. See 40 CFR part 158. Toxicity testing of a pesticide in 
combination with all other approved pesticides is neither required by 
the testing regulations nor practical.

IV. Conclusion

    Therefore, tolerances are established for residues of 
spirotetramat, (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites, cis-3-
2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside-, and cis-3-(2,5-
calculated as the stoichiometric equivalent of spirotetramat, in or on 
corn, sweet, kernel plus cob with husks removed at 1.5 ppm; and 
persimmon at 2.5 ppm. Additionally, the regulation amends established 
tolerances in or on feijoa from 0.30 ppm to 2.5 ppm, papaya from 2.5 
ppm to 0.40 ppm, and Spanish lime from 0.60 ppm to 13 ppm.

V. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d). 
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).
    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

[[Page 66651]]

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).

VI. 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: October 25, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.641, in the table in paragraph (a)(1):
a. Add alphabetically ``corn, sweet, kernel plus cob with husks 
removed'' and ``persimmon''; and
b. Revise the entries for ``feijoa,'' ``papaya,'' and ``Spanish lime''.
    The additions and revisions read as follows:

Sec.  180.641  Spirotetramat; tolerances for residues.

    (a) * * *
    (1) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Corn, sweet, kernel plus cob with husks removed...........          1.5
                                * * * * *
Feijoa....................................................          2.5
                                * * * * *
Papaya....................................................          0.40
                                * * * * *
Persimmon.................................................          2.5
                                * * * * *
Spanish lime..............................................         13
                                * * * * *

* * * * *
[FR Doc. 2013-26643 Filed 11-5-13; 8:45 am]