[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Rules and Regulations]
[Pages 3333-3337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00728]



40 CFR Part 180

[EPA-HQ-OPP-2012-0038; FRL-9374-3]

Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
spiromesifen in or on tea, dried. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 16, 2013. Objections and 
requests for hearings must be received on or before March 18, 2013, 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-2012-0038, 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: Jennifer Gaines, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5967; email address: Gaines.Jennifer@epa.gov.


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://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0038 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 18, 2013. 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-2012-0038, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/

[[Page 3334]]

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.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 4, 2012 (77 FR 20334-20337) (FRL-
9340-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7924) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, N.C. 27709. The petition requested that 40 CFR 
180.607 be amended by establishing tolerances for residues of 
spiromesifen, (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on tea, 
dried at 50 parts per million (ppm). That document referenced a summary 
of the petition prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing. Based upon 
review of the data supporting the petition, EPA has changed the 
tolerance for tea, dried from 50 ppm to 40 ppm. The reason for this 
change is explained in Unit IV.D.

III. 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 spiromesifen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with spiromesifen follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
    Spiromesifen was classified as having low acute toxicity via the 
oral, dermal and inhalation routes of exposure. It was neither an eye 
nor dermal irritant, but showed moderate potential as a skin contact 
sensitizer. In short- and long-term animal toxicity tests, the critical 
effects observed were loss of body weight, adrenal effects 
(discoloration, decrease in fine vesticulation, and the presence of 
cytoplasmic eosinophilia in zona fasciculata cells), thyroid effects 
(increased thyroid stimulating hormone, increased thyroxine binding 
capacity, decreased T3 and T4 levels, colloidal alteration and thyroid 
follicular cell hypertrophy), liver effects (increased alkaline 
phosphatase, alanine transaminase (ALT) and decreased cholesterol, and 
triglycerides), and spleen effects (atrophy, decreased spleen cell 
count, and increased macrophages). There were no developmental or 
reproductive effects of concern following oral administration of 
spiromesifen in rats or rabbits. EPA concluded that spiromesifen is not 
likely to be carcinogenic to humans based on a lack of evidence of 
cancer in bioassays in rats and mice. There were no in vivo or in vitro 
mutagenic effects in mutagenicity testing with spiromesifen. 
Spiromesifen is not considered a neurotoxic chemical based on the 
chemical's mode of action and the available data from multiple studies, 
including acute and subchronic neurotoxicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Spiromesifen: Human-Health Risk 
Assessment for Request for Tolerance without U.S. Registration in/on 
Tea.'' at pages 20 to 24 in docket ID number EPA-HQ-OPP-2012-0038.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spiromesifen used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 3335]]

 Table 1--Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Acute dietary (General population  Not applicable......  None...............  An endpoint of concern
 including infants and children).                                              attributable to a single dose was
                                                                               not identified. An aRfD was not
Chronic dietary (All populations)  NOAEL= 2.2 mg/kg/day  Chronic RfD = 0.022  2-generation reproduction study in
                                   UFA = 10X...........   mg/kg/day..          rats. The parental systemic LOAEL
                                   UFH = 10X...........  cPAD = 0.022 mg/kg/   = 8.81 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 significantly decreased spleen
                                                                               weight (absolute and relative in
                                                                               parental females and F1 males)
                                                                               and significantly decreased
                                                                               growing ovarian follicles in
Dermal short-term (1 to 30 days)   None................  None...............  No dermal, systemic, or
 and Intermediate-term (1 to 6                                                 developmental concerns.
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 30     Subchronic (30-day) inhalation
 days) and Intermediate-Term (1     study NOAEL = 21.1    (3X interspecies     toxicity study in rats & 5-day
 to 6 months).                      mg/kg/day             and 10X              inhalation toxicity study in
                                    (inhalation           intraspecies         rats.
                                    absorption rate =     extrapolations).    LOAEL (5-day) = 134.2 mg/kg/day
                                    100%).                                     based on the clinical signs
                                   HEC = 0.06 mg/L.....                        (tremors, clonic-tonic
                                   HED = 1.42 mg/kg/bw/                        convulsions, reduced activity,
                                    day.                                       bradypnea, labored breathing,
                                                                               vocalization, avoidance reaction,
                                                                               giddiness, piloerection, limp,
                                                                               emaciation, cyanosis, squatted
                                                                               posture, apathy, salivation,
                                                                               gross pathology (dark red areas
                                                                               or foci in the lungs, bloated
                                                                               stomachs, and pale liver), and
                                                                               decreased spleen weights.
Cancer (Oral, dermal, inhalation)      Spiromesifen has been classified as ``not likely to be carcinogenic to
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). HEC = human human-equivalent concentration. HED = human human-
  equivalent dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in 40 
CFR 180.607. EPA assessed dietary exposures from spiromesifen in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for spiromesifen; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Cumulative Survey of Food Intake by Individuals, CSFII. As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities except for the leafy-green and leafy-Brassica vegetable 
subgroups (4A, 4B, and 5B), spearmint and peppermint tops and oil, and 
tea. For these commodities, residues were also based on tolerance 
levels; however, a correction factor was applied to the tolerance 
levels to account for BSN 2060-4-hydroxymethyl metabolites of 
spiromesifen included in the risk assessment for these commodities. The 
additional metabolites, BSN 2060-4-hydroxymethyl and BSN 2060-4-
hydroxymethyl-glucoside, were observed in the metabolism studies of 
lettuce only, comprising 21% of the total radioactive residues. Since 
the toxicity of the BSN 2060-4-hydroxymethyl metabolites is expected to 
be comparable to the parent compound, it was included in the risk 
assessment for leafy crops (including tea, subgroups 4A, 4B, and 5B and 
spearmint and peppermint tops and oil). To account for this additional 
exposure, the recommended tolerance level was multiplied by a 
correction factor of 1.3X, where 1.3 = (Metabolites in Risk 
Assessment)/(Metabolites in Tolerance Expression; concentrations from 
the lettuce metabolism study). Dietary Exposure Evaluation Model (DEEM) 
7.81 default processing factors and 100 percent crop treated were 
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spiromesifen does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for spiromesifen. As discussed in Unit III.C.1.ii., 
for the leafy-greens and leafy Brassica greens subgroups (4A, 4B, and 
5B) and spearmint and peppermint tops and oil, and tea, the residue 
values were adjusted upward to account for the metabolite BSN 2060-4-
hydroxymethyl (free and conjugated).
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spiromesifen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of spiromesifen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Provisional Cranberry Model and Screening 
Concentration in Ground Water (SCI-GROW) models the estimated drinking 
water concentrations (EDWCs) of spiromesifen for chronic exposures for 
non-cancer assessments are estimated to be 188 ppb for surface water 
and 86 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 

[[Page 3336]]

into the dietary exposure model. For chronic dietary risk assessment, 
the water concentration of value 188 ppb was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Spiromesifen is currently registered for the following uses that 
could result in residential exposures: Indoor and outdoor uses for the 
control of mites and whiteflies on ornamental plants in and around 
areas such as parks, golf courses, recreational areas, and residential 
and commercial buildings. EPA assessed residential exposure using the 
following assumptions: Residential handler inhalation exposure was 
assessed for adults mixing/loading/applying spiromesifen using handheld 
equipment to ornamentals. Details for the residential risk exposure and 
risk assessment are contained in the EPA public docket EPA-HQ-OPP-2012-
0038 at http://www.regulations.gov in document ``Spiromesifen: Human-
Health Risk Assessment for Request for Tolerance Without U.S. 
Registration in/on Tea'' on pp.15-19.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/USEPA-OPP-HED_Residential%20SOPs_Oct2012.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found spiromesifen to share a common mechanism of 
toxicity with any other substances, and spiromesifen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spiromesifen does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rats or rabbits following in utero and/or 
postnatal exposure to spiromesifen. In the prenatal developmental 
toxicity studies in rats and rabbits and in the 2-generation 
reproduction study in rats, developmental toxicity to the offspring 
occurred at equivalent or higher doses than parental toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
    i. The toxicity database for spiromesifen is complete.
    ii. There is no indication that spiromesifen is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spiromesifen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to spiromesifen in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
spiromesifen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spiromesifen from food and water will utilize 78% of the cPAD for all 
infants (<1 year old), the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
spiromesifen is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term adverse effect was identified, spiromesifen is not expected 
to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
spiromesifen is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spiromesifen is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children

[[Page 3337]]

from aggregate exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography/tandem mass spectroscopy (HPLC/MS/MS)/Method BS001-P09-
01 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: 

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 spiromesifen in/on dried 

C. Response to Comments

    There were no comments received.

D. Revisions to Petitioned-For Tolerances

    Based on the analysis of the data supporting the petition, EPA has 
revised the proposed tolerance for tea, dried from 50 ppm to 40 ppm. 
EPA revised this tolerance level based on the highest-average field 
trial residue level and a processing factor for black tea.

V. Conclusion

    Therefore, tolerances are established for residues of spiromesifen, 
(2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate) its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on tea, dried at 
40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition 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 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 on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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).

VII. 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 4, 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.  180.607, the table in paragraph (a)(1) is amended by 
adding, alphabetically, the commodity ``Tea, dry'' to read as follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

                                                               Parts per
                          Commodity                             million
                                * * * * *
Tea, dry....................................................          40
                                * * * * *

* * * * *
[FR Doc. 2013-00728 Filed 1-15-13; 8:45 am]