Spirotetramat; Pesticide Tolerances, 28507-28513 [2013-11195]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 94 (Wednesday, May 15, 2013)]
[Rules and Regulations]
[Pages 28507-28513]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11195]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0107; FRL-9382-8]


Spirotetramat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spirotetramat in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
several permanent and time-limited tolerances, because they are 
superseded by new tolerances established by this document. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 15, 2013. Objections and 
requests for hearings must be received on or before July 15, 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-2012-0107, is available at https://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

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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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     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 https://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 
July 15, 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-2012-0107, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 4, 2012 (77 FR 20334) (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 
1E7958) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.641 be amended by 
establishing tolerances for residues of the insecticide 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-(2,5-dimethylphenyl)-4-
hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, cis-3-(2,5-
dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-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-dimethylphenyl)-4-hydroxy-8-
methoxy-1-azaspiro[4.5]decan-2-one, calculated as spirotetramat 
equivalents, in or on taro, leaves at 9 parts per million (ppm); 
watercress at 1.5 ppm; pomegranate at 0.5 ppm; banana at 4 ppm; 
vegetable, bulb, group 3-07 at 0.6 ppm; berry, low growing, except 
strawberry, subgroup 13-07H at 0.3 ppm; bushberry, subgroup 13-07B at 3 
ppm; artichoke, globe at 2 ppm; vegetable, fruiting, group 8-10 at 2.5 
ppm; fruit, pome, group 11-10 at 0.7 ppm; fruit, citrus, group 10-10 at 
0.6 ppm; pineapple at 0.3 ppm; pineapple, process residue at 0.36 ppm; 
coffee, green beans at 0.2 ppm; and coffee, roast beans at 0.32 ppm. 
The petition additionally requested to remove the established 
spirotetramat tolerances in 40 CFR 180.641 for onion, bulb, subgroup 
3A-07 at 0.30 ppm; fruit, citrus, group 10 at 0.60 ppm; fruit, pome, 
group 11 at 0.70 ppm; okra at 2.5 ppm; and vegetable, fruiting, group 8 
at 2.5 ppm, because they would be superseded by new tolerances.
    That document referenced a summary of the petition prepared on 
behalf of IR-4 by Bayer CropScience, the registrant, which is available 
in the docket, https://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 
revised the tolerance levels for several proposed commodities. The 
Agency has also determined that the proposed tolerances on pineapple, 
process residue, and coffee, roast beans, are not necessary and a 
tolerance on coffee, instant, should be established. The reasons for 
these changes are explained in Unit IV.C.

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

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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 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.
    The thyroid and thymus glands were target organs in oral subchronic 
toxicity studies in dogs, the most sensitive species tested. The 
thyroid effects in dogs consisted of lower circulating levels of 
thyroid hormones along with a reduction in follicle size, a possible 
indication of reduced amount of colloid. Thymus effects in dogs were 
described microscopically as involution, which also resulted in 
decreased organ weight. In rats, the testes were the target organs 
following subchronic and chronic oral treatments. The effects on the 
rat testes consisted of abnormal spermatozoa and hypospermia in the 
epididymis, decreased testicular weights, and testicular degenerative 
vacuolation.
    The 2-generation rat reproductive toxicity study showed evidence of 
male reproductive toxicity similar to chronic and subchronic studies 
with adult rats. However, development of the sexual organs in the 
offspring (balano-preputial separation, vaginal opening) was 
unaffected. In an investigative study designed to explore the time of 
onset of testicular toxicity in rats, decreased epididymal sperm counts 
were noted after 10 days of exposure. Similar effects were observed 
after repeated dosing with the enol metabolite of spirotetramat. In the 
rat developmental toxicity study, offspring toxicity (reduced fetal 
weight and increased incidences of malformations and skeletal 
deviations) was observed at the same dose level (limit dose) as 
maternal toxicity (decreased maternal body weight and food 
consumption). In the developmental toxicity study in the rabbit, late 
abortions and other signs of systemic toxicity were observed only in 
the presence of impaired maternal food and water consumption and body 
weight loss.
    The only evidence of neurotoxicity in the rat acute neurotoxicity 
study was based on decreased motor and locomotor activity, which 
occurred only at relatively high dose levels. EPA's preliminary review 
of a recently submitted rat subchronic neurotoxicity study does not 
indicate a concern for neurotoxicity, even at relatively high dose 
levels. The results of an immunotoxicity study in rats do not indicate 
any functional deficits in immune function. No evidence of tumor 
formation was found following long-term carcinogenicity studies in mice 
and rats, and spirotetramat was also negative for mutagenicity and 
clastogenicity in several standard in vivo and in vitro assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by spirotetramat 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 https://www.regulations.gov in document: ``Spirotetramat. Human-Health Risk 
Assessment for the Proposed Uses in/on Taro, Leaves; Watercress; 
Pomegranate; Banana; Vegetable, Bulb, Group 3-07; Low growing Berry 
Subgroup 13-07H, Except Strawberry and Lowbush Blueberry; Bushberry 
Subgroup 13-07B; Artichoke, Globe; Vegetable, Fruiting, Group 8-10; 
Fruit, Pome, Group 11-10; Fruit, Citrus, Group 10-10; Pineapple; and 
Coffee; and Tolerances without U.S. Registration in/on Corn, Sweet, 
Kernel Plus Cob with Husks Removed as Part of the U.S.-Canada 
Regulatory Cooperation Council (RCC) Pilot Project'' at pp. 38-43 in 
docket ID number EPA-HQ-OPP-2012-0107.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirotetramat used for 
human risk assessment is discussed in Unit III. B. Toxicological Points 
of Departure/Levels of Concern of the final rule published in the 
Federal Register issue of May 18, 2011 (76 FR 28675) (FRL-8865-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spirotetramat, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spirotetramat 
tolerances in 40 CFR 180.641. EPA assessed dietary exposures from 
spirotetramat 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. Such effects were identified 
for spirotetramat.
    In estimating acute dietary exposure, EPA used Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 3.16, which uses food consumption data from the 
U.S. Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003 
through 2008. As to residue levels in food, EPA assumed 100 percent 
crop treated (PCT) and tolerance-level residues for all commodities. 
DEEM version 7.81 default processing factors were used for processed 
commodities, where provided.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used 100 PCT, average 
field trial residues for some commodities, and tolerance-level residues 
for the remaining commodities. Empirical processing factors were used 
for apple, grape, orange, pineapple, and tomato juices; applesauce; and 
dried apple and tomato. DEEM version 7.81 default processing factors 
were used for other processed commodities, where provided.

[[Page 28510]]

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that spirotetramat 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 information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water for risk assessment purposes are spirotetramat and the 
metabolites spirotetramat-enol and spirotetramat-ketohydroxy. The 
Agency used screening level water exposure models in the dietary 
exposure analysis and risk assessment for spirotetramat and its 
metabolites in drinking water. These simulation models take into 
account data on the physical, chemical, and fate/transport 
characteristics of spirotetramat and its metabolites. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) model, the estimated drinking water 
concentrations (EDWCs) of spirotetramat and its metabolites for surface 
water are estimated to be 395 parts per billion (ppb) for acute and 
chronic exposures. For ground water, the EDWCs are estimated to be 1.24 
x 10-3 ppb for acute and chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute and chronic 
dietary risk assessments, the water concentration value of 395 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). Spirotetramat 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 
spirotetramat to share a common mechanism of toxicity with any other 
substances, and spirotetramat does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that spirotetramat 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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children (Start)

    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 Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased qualitative or quantitative susceptibility of rats or rabbits 
to prenatal or postnatal exposure to spirotetramat. In the rat 
developmental toxicity study, offspring toxicity was observed at the 
same dose as maternal toxicity, at the limit dose. In the developmental 
toxicity study in the rabbit, only maternal toxicity was observed. In 
both reproductive toxicity studies, offspring toxicity (decreased body 
weight) was observed at the same dose as parental toxicity. Therefore, 
no evidence of increased susceptibility of offspring was found across 
four relevant toxicity studies with spirotetramat.
    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 spirotetramat is complete. 
Immunotoxicity and subchronic neurotoxicity studies were reported as 
data gaps for spirotetramat in the last published final rule, published 
in the Federal Register issue of May 18, 2011. Since that final rule, 
an immunotoxicity study in rats has been submitted and reviewed by the 
Agency. Although the toxicology database for spirotetramat shows 
effects in the thymus gland in dog studies, the results of the rat 
immunotoxicity study do not indicate any functional deficits in the 
immune function. Thymus involution has been demonstrated to occur when 
hypothyroidism is induced in animals, so it is reasonable to conclude 
that the thymus involution in dogs was secondary to thyroid effects, 
rather than a direct effect on the immune system.
    The Agency has also recently received the subchronic neurotoxicity 
study in rats. Though a complete review of the study is pending, a 
preliminary review of the recently submitted subchronic rat 
neurotoxicity study does not indicate a concern for neurotoxicity, even 
at relatively high dose levels, which is consistent with the Agency's 
conclusions regarding the potential neurotoxicity of spirotetramat in 
the May 18, 2011 final rule, and consistent with what the Agency 
expects for structurally related compounds. In the available acute 
neurotoxicity study, the only evidence of neurotoxicity was based on 
decreased motor and locomotor activity, which occurred only at 
relatively high dose levels (200 milligrams/kilogram body weight (mg/kg 
bw)). The observed decreased motor activity was not considered evidence 
of direct neurotoxicity because there were no effects on movement or 
gait and there were no confirmatory findings of neurological pathology 
observed at relatively high doses. Moreover, the existing toxicological 
database indicates that spirotetramat is not a neurotoxic chemical in 
mammals. Finally, the acute, subchronic, and developmental 
neurotoxicity studies available for structurally related compounds 
(spirodiclofen and spiromesifen) do not show evidence of neurotoxicity 
in adults or the young.
    ii. There is no evidence that spirotetramat results in increased

[[Page 28511]]

susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iii. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments were 
performed based on 100 PCT and tolerance-level or average field trial 
residues. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to spirotetramat in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by spirotetramat.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to spirotetramat will occupy 16% of the aPAD for children 1-2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spirotetramat from food and water will utilize 76% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for spirotetramat.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
spirotetramat is not registered for any use patterns that would result 
in short- or intermediate-term residential exposure. Short- and 
intermediate-term risks are assessed based on short- and intermediate-
term residential exposures plus chronic dietary exposure. Because there 
are no short- or intermediate-term residential exposures 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- and intermediate-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for spirotetramat.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spirotetramat 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 spirotetramat residues.

IV. 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established a MRL for spirotetramat in or on pome 
fruit at 0.7 ppm, which is harmonized with the pome fruit group 11-10 
tolerance in the United States. However, Codex has established other 
MRLs for which the United States cannot harmonize tolerances: A Codex 
MRLs on fruiting vegetables except chili pepper at 1 ppm, chili pepper 
at 2 ppm, and dried chili pepper at 15 ppm are not harmonized with the 
U.S. tolerance on fruiting vegetable group 8-10 at 2.5 ppm; and a Codex 
MRL for citrus at 0.5 ppm is not harmonized with a U.S. tolerance on 
citrus 0.60 ppm. These MRLs are different than the tolerances 
established for spirotetramat in the United States because the residue 
definition in the United States includes additional metabolites not 
included in the Codex residue definition. Because of the differences in 
the residue definition, the residue field trial information in the 
United States results in different calculated tolerances than those 
established by Codex; therefore, the United States cannot harmonize 
with Codex.

C. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA is revising the 
proposed tolerances in or on watercress from 1.5 ppm to 2.0 ppm; 
vegetable, bulb, group 3-07 from 0.6 ppm to 0.80 ppm; and artichoke, 
globe from 2 ppm to 1.5 ppm. The Agency revised these tolerance levels 
based on analysis of the residue field trial data using the 
Organization for Economic Co-operation and Development (OECD) tolerance 
calculation procedures. Additionally, the Agency determined that the 
proposed tolerances in or on pineapple, process residue, and coffee, 
roast beans, are not necessary because the calculated tolerance values 
for these processed commodities are less than the recommended 
tolerances in or on pineapple and coffee, green bean. Finally, based on 
the available processing data, EPA determined that a tolerance should 
be established in or on coffee, instant at 0.50 ppm.

V. 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-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
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-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, in or 
on taro, leaves at 9.0 ppm; watercress at 2.0 ppm; pomegranate at 0.50 
ppm; banana at 4.0 ppm; vegetable, bulb,

[[Page 28512]]

group 3-07 at 0.80 ppm; berry, low growing, except strawberry, subgroup 
13-07H at 0.30 ppm; bushberry subgroup 13-07B at 3.0 ppm; artichoke, 
globe at 1.5 ppm; fruit, pome, group 11-10 at 0.70 ppm; vegetable, 
fruiting, group 8-10 at 2.5 ppm; fruit, citrus, group 10-10 at 0.60 
ppm; pineapple at 0.30 ppm; coffee, green bean at 0.20 ppm; and coffee, 
instant at 0.50 ppm. This regulation additionally removes established 
tolerances of spirotetramat in or on onion, bulb, subgroup 3A-07 at 
0.30 ppm; fruit, citrus, group 10 at 0.60 ppm; fruit, pome, group 11 at 
0.70 ppm; okra at 2.5 ppm; and vegetable, fruiting, group 8 at 2.5 ppm. 
Finally, this final rule removes the time-limited tolerances in or on 
onion, dry bulb at 0.3 ppm and watercress at 1.5 ppm because they are 
superseded by new permanent tolerances.

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: May 1, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.641:
0
i. Remove from the table in paragraph (a)(1) the commodities ``Fruit, 
citrus, group 10,'' ``Fruit, pome, group 11,'' ``Okra,'' ``Onion, bulb, 
subgroup 3A-07 \1\,'' and ``Vegetable, fruiting, group 8.''
0
ii. Add alphabetically to the table in paragraph (a)(1) the following 
commodities.
0
iii. Revise paragraphs (b) and (c).
    The amendments read as follows:


Sec.  180.641  Spirotetramat; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe...........................................         1.5
 
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H.....         0.30
 
                                * * * * *
Bushberry subgroup 13-07B..................................         3.0
 
                                * * * * *
Coffee, green bean.........................................         0.20
Coffee, instant............................................         0.50
 
                                * * * * *
Fruit, citrus, group 10-10.................................         0.60
Fruit, pome, group 11-10...................................         0.70
 
                                * * * * *
Pineapple..................................................         0.30
 
                                * * * * *
Pomegranate................................................         0.50
 
                                * * * * *
Taro, leaves...............................................         9.0
Vegetable, bulb, group 3-07................................         0.80
 
                                * * * * *
Vegetable, fruiting, group 8-10............................         2.5
 
                                * * * * *
Watercress.................................................         2.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the insecticide 
spirotetramat, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the

[[Page 28513]]

tolerance levels specified below is to be determined by measuring only 
the sum 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-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
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-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, 
calculated as the stoichiometric equivalent of spirotetramat, in or on 
the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................         4.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-11195 Filed 5-14-13; 8:45 am]
BILLING CODE 6560-50-P