Document ID: EPA-HQ-OPP-2009-0682-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Spiromesifen
Posted Date: 2010-09-01T04:00Z

[Federal Register: September 1, 2010 (Volume 75, Number 169)]
[Rules and Regulations]               
[Page 53581-53586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se10-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0682; FRL-8841-9]

 
Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spiromesifen in or on leaf petioles subgroup 4B, dry pea seed, 
spearmint tops, and peppermint tops. The Interregional Research Project 
Number 4 (IR-4) and Bayer CropScience requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 1, 2010. Objections and 
requests for hearings must be received on or before November 1, 2010, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0682. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 308-9367; e-mail address: ertman.andrew@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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.gpoaccess.gov/ecfr.

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

[[Page 53582]]

identify docket ID number EPA-HQ-OPP-2009-0682 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 November 1, 2010. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0682, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 24, 2010 (75 FR 14156) (FRL-8815-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 
0E7684 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540 
and PP 9F7602 by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 
12014, Research Triangle Park, NC 27709. The petitions requested that 
40 CFR 180.607 be amended by establishing tolerances for residues of 
the insecticide 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, calculated as parent compound equivalents, in or on pea, dry, 
seed at 0.15 parts per million (ppm); spearmint, tops at 25 ppm; and 
peppermint, tops at 25 ppm (PP 0E7684) and vegetable, leafy petiole, 
crop subgroup 4B at 6.0 ppm (PP 9F7602). The notice referenced 
summaries of the petitions 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 
recommended for tolerances levels different from those proposed in the 
petitions for dry pea seed, spearmint tops, and peppermint tops. The 
reason for these changes are 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 
children.
    Spiromesifen shows 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 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 vesiculation, 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, ALT 
and decreased cholesterol, triglycerides), and spleen effects (atrophy, 
decreased spleen cell count, and increased macrophages). Spiromesifen 
shows no significant developmental or reproductive effects, is not 
likely to be carcinogenic based on bioassays in rats and mice, and 
lacks in vivo and in vitro mutagenic effects. 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 the document titled ``Spiromesifen: Human-Health 
Risk Assessment for Proposed Section 3 Uses on Leaf Petioles Subgroup 
4B; Pea, Dry, Seed; Spearmint, Tops; and Peppermint, Tops'' on pages 22 
to 26 in docket ID number EPA-HQ-OPP-2009-0682.

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

[[Page 53583]]

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 the Table of this unit.

                      Table --Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Point of Departure and Uncertainty/
              Exposure/Scenario                         Safety Factors             RfD, PAD, LOC for Risk Assessment    Study and Toxicological Effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary                                             An endpoint of concern
 (general population and all population        attributable to a single dose was
 subgroups..................................     not identified. An aRfD was not
                                                                    established.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic dietary                                   NOAEL= 2.2 mg/kg/day UFA = 10x       Chronic RfD = 0.022 mg/kg/day  2-generation reproduction study in
(All populations)...........................                           UFH = 10x              cPAD = 0.022 mg/kg/day                               rats.
                                                                    FQPA SF = 1x                                       The parental systemic LOAEL: 13.2
                                                                                                                      mg/kgbw/day based on significantly
                                                                                                                       decreased spleen weight (absolute
                                                                                                                        and relative in parental females
                                                                                                                         and F1 males) and significantly
                                                                                                                               decreased growing ovarian
                                                                                                                                   follicles in females.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer
(Oral, dermal, inhalation)..................               Spiromesifen has been classified as ``not likely to be carcinogenic to humans.''
--------------------------------------------------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data
  or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

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 Cummulative Survey of Food Intake by Individuals. As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities except for the leafy-greens and leafy Brassica greens 
subgroups (4A and 5B). The tolerance values for leafy vegetables and 
spearmint and peppermint tops and oil were adjusted upward to account 
for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated), 
which is a residue of concern in leafy vegetables for risk assessment 
purposes only. EPA used data from the lettuce metabolism studies to 
create a tolerance-equivalent value for the parent spiromesifen and the 
BSN 2060-4-hydroxymethyl metabolite to estimate residues in leafy 
crops. Dietary Exposure Evaluation Model (DEEM) 7.81 default processing 
factors and 100 percent crop treated were assumed for all commodities.
    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 above, for the leafy-
greens and leafy Brassica greens subgroups (4A and 5B) and spearmint 
and peppermint tops and oil, 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 Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) 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

[[Page 53584]]

be 188 ppb for surface water and 86 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered 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 not 
registered for any specific use patterns that would result in 
residential exposure.
    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 website 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 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rats or rabbits to 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 
findings:
    i. The toxicity database for spiromesifen is complete and no 
additional immunotoxicity or neurotoxicty testing is required. The 
rationale is described below:
    a. Because spleen effects were seen in several toxicity studies, 
the registrant pursued specialized immunotoxicity studies in rats and 
mice that were both negative. These studies satisfy the revised 40 CFR 
part 158 requirement for immunotoxicity testing. In addition, the 
endpoints selected for the risk assessment are considered protective of 
any possible immunotoxic effects.
    b. There is no concern for neurotoxicity resulting from exposure to 
spiromesifen. Neurotoxic effects such as reduced motility, spastic 
gait, increased reactivity, tremors, clonic-tonic convulsions, reduced 
activity, labored breathing, vocalization, avoidance reaction, 
piloerection, limp, cyanosis, squatted posture, and salivation were 
observed in two studies (5-day inhalation and subchronic oral rat) at 
high doses (134 and 536 milligrams/kilogram/day (mg/kg/day), 
respectively). These effects were neither reflected in 
neurohistopathology nor in other studies. Because these effects were 
not observed in the acute and subchronic neurotoxicity studies, they 
were not considered reproducible. Thus, based on the chemical's mode of 
action and the available data from multiple studies, the chemical is 
not considered neurotoxic.
    ii. 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 
study. A developmental neurotoxicity study is not required.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT 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. These assessments 
will not underestimate the exposure and risks posed by spiromesifen.

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. There are no residential uses for spiromesifen.
    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-term and intermediate-
term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    A short-term and intermediate-term adverse effect was identified; 
however, spiromesifen is not registered for any use patterns that would 
result in short-term or intermediate-term residential exposure. Short-
term and intermediate-term risk is assessed based on short-term and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short-term or intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short-term and intermediate-term risk), no 
further assessment of short-term or intermediate-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short-term and intermediate-term risk for spiromesifen.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two

[[Page 53585]]

adequate rodent carcinogenicity studies, spiromesifen is not expected 
to pose a cancer risk to humans.
    5. 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 from aggregate 
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography/mass spectroscopy (HPLC/MS/MS)/Method 00631/M001 and 
Method 110333) 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; e-mail 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 U.N. 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.
     No Codex or Canadian MRLs have been established for spiromesifen 
in/on leaf petioles subgroup 4B; pea, dry, seed; spearmint, tops; and 
peppermint, tops.

C. Revisions to Petitioned-For Tolerances

    Pea, dry, seed: The Agency is modifying the tolerance from the 
proposed level of 0.15 to 0.20. The adjusted field trial data for dry 
peas were evaluated using the Agency's maximum-likelihood estimation 
(MLE) spreadsheet and then the Agency's maximum-residue limit (MRL) 
tolerance spreadsheet as described in the Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data SOP to determine the 
appropriate tolerance level. The tolerance spreadsheet recommended a 
tolerance of 0.20 ppm for total residues of spiromesifen in/on dry 
peas.
    Spearmint, tops and peppermint, tops: The Agency is modifying the 
tolerances from the proposed level of 25 ppm to 45 ppm. The adjusted 
field trial data for mint were evaluated using the Agency's MRL 
tolerance spreadsheet as described in the Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data SOP to determine the 
appropriate tolerance level. The tolerance spreadsheet recommended a 
tolerance of 45 ppm for total residues of spiromesifen for both 
spearmint and peppermint tops.
    Finally, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of spiromesifen not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide/miticide spiromesifen, including its metabolites and 
degradates, determined by measuring only the sum 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), calculated as the 
stoichiometric equivalent of spiromesifen, in or on pea, dry, seed at 
0.20 ppm; spearmint, tops at 45 ppm; peppermint, tops at 45 ppm; and 
leaf petiole subgroup 4B at 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of

[[Page 53586]]

Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule 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: August 20, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Program.

0
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. Section 180.607 is amended by alphabetically adding the following 
commodities to the table in paragraph (a)(1) and revising paragraphs 
(a)(1) introductory text, (a)(2) introductory text, (b) introductory 
text, and (d) introductory text to read as follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide/miticide spiromesifen, including its metabolites and 
degradates, in or on the commodities listed below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as 
the stoichiometric equivalent of spiromesifen, in or on the following 
primary crop commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Leaf petiole subgroup 4B.......................                      6.0
                                * * * * *
Pea, dry, seed.................................                     0.20
Peppermint, tops...............................                       45
Spearmint, tops................................                       45
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide/
miticide spiromesifen, including its metabolites and degradates, in or 
on the commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate] and its metabolites containing the 4-
hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4-
hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one moieties, calculated as the stoichiometric equivalent of 
spiromesifen, in the following livestock commodities:
* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
insecticide/miticide spiromesifen, including its metabolites and 
degradates, in or on the commodities listed below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as 
the stoichiometric equivalent of spiromesifen, in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FIFRA section 18 emergency exemptions. The tolerances expire and are 
revoked on the date specified in the table.
* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the inadvertent or indirect residues of the insecticide/miticide 
spiromesifen, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate], 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one, and its metabolites containing the 4-
hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one moiety, calculated as the stoichiometric equivalent of 
spiromesifen, in the following rotational crop commodities:
* * * * *
[FR Doc. 2010-21686 Filed 8-31-10; 8:45 am]
BILLING CODE 6560-50-S