[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Rules and Regulations]
[Pages 28675-28682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11937]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0263; FRL-8865-8]


Spirotetramat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spirotetramat, including its metabolites and degradates, in or on 
multiple commodities which are identified and discussed later in this 
document. Bayer CropScience requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 18, 2011. Objections and 
requests for hearings must be received on or before July 18, 2011, 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-2009-0263. 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: Rita Kumar, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8291; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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. To 
access the harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods & Guidelines.''

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-2009-0263 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 18, 2011. 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-2009-0263, by one of the following methods:

[[Page 28676]]

     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 June 10, 2009 (74 FR 27538) (FRL-8417-
7), 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 
9F7537) by Bayer CropScience LLC, 2 T. W. Alexander Drive, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.641 be 
amended by establishing tolerances for residues of the insecticide 
spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate]) and its metabolites BYI 
08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-
dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione), 
BYI08330-enol-Glc (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside), and BYI 08330-mono-
hydroxy (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]decan-2-one), calculated as spirotetramat equivalents, in 
or on pistachio at 0.25 parts per million (ppm); cotton, undelinted 
seed at 0.4 ppm; acerola, atemoya, avocado, birida, black sapote, 
canistel, cherimoya, custard apple, feijoa, guava, ilama, jaboticaba, 
longan, mamey sapote, mango, passionfruit, persimmon, pulasan, 
rambutan, sapodilla, soursop, Spanish lime, star apple, starfruit, 
sugar apple, wax jambu, and white sapote at 1.5 ppm; vegetables, 
legume, group 06 (except soybean) at 4 ppm; plum, prune, dried at 4.5 
ppm; vegetables, foliage of legume, except soybean, subgroup 07A at 5 
ppm; cotton, gin byproducts at 7 ppm; soybean at 4 ppm; soybean, forage 
at 9 ppm; soybean, aspirated grain fractions at 10 ppm; lychee at 12 
ppm; and soybean, hay at 16 ppm and okra at 2.5 ppm. That notice 
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. A correction notice was published in the Federal 
Register on July 23, 2009 (74 FR 36487) (FRL-8425-2), and August 21, 
2009 (74 FR 42302) (FRL-8427-1), to add papaya at 1.5 ppm. There were 
no comments received in response to the correction notice.
    In the Federal Register of October 26, 2009 (74 FR 54999) (FRL-
8794-2) (docket number EPA-HQ-OPP-2009-0735), EPA also published a 
notice pursuant to section 3(c)(4) of the Federal Insecticide, 
Rodenticide, and Fungicide Act (FIFRA) as amended, announcing receipt 
of an application from Bayer CropScience to register new uses for 
Spirotetramat Technical and three end use products (EPA Registration 
Numbers 264-1049, 264-1050, 264-1051, 264-1065), on cotton; soybeans; 
vegetable, legume, crop group 6; acerola; atemoya; avocado; birida; 
black sapote; canistel; cherimoya; custard apple; feijoa; guava; Ilama; 
jaboticaba; longan; mamey sapota; mango; papaya; passionfruit; 
persimmon; pulasan; rambutan; sapodilla; soursop; Spanish lime; star 
apple; starfruit; sugar apple; wax jambu; white sapote; lychee; okra; 
pistachio; and dried prune. The Agency provided 30 days for the public 
to comment on this notice, and a comment dated November 25, 2009 was 
received from the Natural Resources Defense Council (NRDC), expressing 
concerns about both human health and environmental effects of 
spirotetramat. The heading of those comments referenced the Federal 
Register citation of October 26, 2009 (FRL-8794-2) for the Notice of 
Receipt (NOR) under FIFRA, but the docket number for this Notice of 
Filing (NOF) under the FFDCA (EPA-HQ-OPP-2009-0263). Although that 
comment was timely submitted for purposes of the NOR, it was not timely 
submitted for purposes of the present NOF. Nevertheless, the Agency has 
responded to the human health portion of the comments, which is 
relevant to the present NOF. The NRDC comment and the Agency's response 
to the human health portion of the comment can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2009-0263.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance expression; and also revised the proposed 
tolerances on most of the commodities. In addition, EPA will be 
establishing import only tolerances for cotton, undelinted seed, and 
cotton gin byproduct at this time. The reasons 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 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 acute, short-term, and long-term toxicity of spirotetramat is 
well understood. Spirotetramat technical demonstrated moderate to low 
acute toxicity via the oral, dermal, and inhalation routes. 
Spirotetramat is non-irritating to the skin, although it is an irritant 
to the eyes and exhibits a skin-sensitization potential in animals and 
humans. The thyroid and thymus glands were target organs in oral 
subchronic

[[Page 28677]]

toxicity studies in the dog; whereas, the testes-epididymides were the 
target organs following subchronic oral treatment of rats. Long-term 
toxicity studies reflected the short-term toxicological profile of 
spirotetramat with the thymus and thyroid as target organs following 1-
year oral exposure of dogs. Chronic exposure of rats to spirotetramat 
also reflected the subchronic pattern of testicular toxicity. No 
evidence of tumor formation was found following long-term studies of 
rodents, and spirotetramat was also negative for mutagenicity and 
clastogenicity in several standard in vivo and in vitro assays.
    The reproductive and developmental toxicity potential of 
spirotetramat was tested in rats and rabbits. In addition to testicular 
histopathology observed following subchronic and chronic exposure of 
rats to spirotetramat, male reproductive toxicity was recorded in a 2-
generation reproductive toxicity study. However, development of the 
sexual organs of 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. Developmental toxicity was not observed with 
spirotetramat in the absence of maternal toxicity in either the rat or 
rabbit.
    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 http://www.regulations.gov in document ``Spirotetramat. Human-Health Risk 
Assessment for Proposed Uses in/on Cotton, Legume Vegetables including 
Soybean (Crop Groups 6 and 7a), and Tropical Fruit''; Appendix A pp 39-
47 in docket ID number EPA-HQ-OPP-2009-0263.

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 (LOC) 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 the NOAEL and the LOAEL of concern are 
identified. 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) (a = acute or c = chronic) 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.

 Table 1--Summary of Toxicological Doses and Endpoints for Spirotetramat for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary........................  NOAEL = 100 milligrams/  Acute RfD = 1.0 mg/kg/   Acute neurotoxicity
(General population including infants   kilogram/day (mg/kg/     day.                     (rat; gavage) LOAEL =
 and children).                         day).                   aPAD = 1.0 mg/kg/day...   200 mg/kg/day based on
                                       UFA = 10x..............                            clinical signs male
                                       UFH = 10x..............                            and female (M&F) and
                                       FQPA SF = 1x...........                            decreased motor
                                                                                          activity (M).
Chronic dietary......................  NOAEL= 5 mg/kg/day.....  Chronic RfD = 0.05 mg/   Chronic toxicity (dog;
(All populations)....................  UFA = 10x..............   kg/day.                  dietary) LOAEL = 20 mg/
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..   kg/day based on thymus
                                       FQPA SF = 1x...........                            involution.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not Likely to be Carcinogenic to Humans'' based on lack
                                            of evidence of carcinogenicity in two oral rodent carcinogenicity
                                                                        studies.
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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.

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 food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed 100 percent crop treated (PCT) and 
tolerance-level residues for all foods. Empirical and Dietary Exposure 
Evaluation Model (DEEMTM) (ver. 7.81) default processing 
factors were used for processed commodities. Drinking water was 
incorporated directly in the dietary assessment using the acute 
concentrations for surface water generated by the First Index Reservoir 
Screening Tool (FIRST) model.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a 
conservative chronic dietary assessment assuming average field-trial 
residues, empirical and

[[Page 28678]]

DEEMTM (ver. 7.81) default processing factors, and 100 PCT. 
Drinking water was incorporated directly in the dietary assessment 
using the chronic concentrations for surface water generated by the 
FIRST model.
    iii. Cancer. No evidence of carcinogenicity was seen in the cancer 
studies performed with spirotetramat on rats and mice, and EPA has 
classified spirotetramat as ``not likely'' to be a human carcinogen by 
any relevant route of exposure. Therefore, an exposure assessment to 
evaluate cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) 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. Tolerance-
level residues and 100 PCT were assumed for all food commodities. The 
chronic dietary assessment assumed average field-trial residues and 100 
PCT.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spirotetramat in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of spirotetramat. 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 FIRST, and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of spirotetramat for acute exposures are estimated to be 0.212 parts 
per billion (ppb) for surface water and 3.96 x 10-4 ppb for 
ground water.
    For chronic exposures, non-cancer assessments are estimated to be 
1.37 x 10-3 ppb for surface water and 3.96 x 10-4 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
0.212 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 1.37 x 10-3 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 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 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 was no evidence of 
increased susceptibility of rat or rabbit to prenatal or postnatal 
exposure to spirotetramat. In the rat developmental toxicity study, 
toxicity to offspring was observed at the same dose as maternal 
toxicity, which was also the limit dose. In the developmental toxicity 
study in the rabbit, only maternal toxicity was observed. In both 
reproductive toxicity studies, toxicity to offspring (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 except for 
an immunotoxicity study and a subchronic neurotoxicity study which are 
required due to recent amendments to the data requirements in 40 CFR 
part 158. Despite the absence of these studies, EPA has reliable data 
showing an additional safety factor is not necessary to protect infants 
and children. Although the toxicology database for spirotetramat shows 
effects in the thymus gland, an organ of the immune system, this 
finding does not raise uncertainty given the lack of an immunotoxicity 
study. The endpoint selected for risk assessment was based on 
accelerated thymus involution and decreased thyroid hormone levels in 
the dog. Thymus involution has been demonstrated to occur in animals 
when the thyroid is induced to decrease hormone levels, so it is 
reasonable to conclude that the thymus involution in these dogs was 
secondary to the thyroid effects, rather than a direct effect on the 
immune system. The dose at which these effects were observed was chosen 
as a point of departure because there was some consistency of dose and 
effect seen across the subchronic and chronic toxicity studies. 
However, the effects occurred in relatively few animals and thus 
selection of this endpoint is considered a very protective point of 
departure; it is at least tenfold lower than any other potential point 
of departure. With respect to immunotoxicity, no immunotoxic effects 
were seen in rats or mice, the species in which immunotoxicity studies 
are conducted. Thus, the Agency does not believe that conducting a 
functional immunotoxicity study in any rodent species will result in a 
lower POD than that currently used for overall risk assessment. For 
this reason and because the current POD is considered extremely 
protective, a UFDB is not

[[Page 28679]]

needed to account for the lack of this study. Data regarding 
neurotoxicity is discussed in Unit III. D.3.ii.
    ii. EPA has concluded that spirotetramat is not a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Although a subchronic 
neurotoxicity study is now required as part of the revisions to 40 CFR 
part 158, the existing toxicological database indicates that 
spirotetramat is not a neurotoxic chemical in mammals. The only 
clinical signs at any dose in the acute neurotoxicity study were 
staining of the fur or perianal region with urine and decreased motor 
activity. The urine staining that was identified is not considered a 
neurotoxic effect and was likely due to a colored metabolite that was 
excreted into the urine or feces or to a change in the pH of the urine 
due to an excreted metabolite. The decreased motor activity observed is 
not considered evidence of neurotoxicity because there were no effects 
on movement or gait and there were no confirmatory findings of 
neurological pathology. Thus, both of these effects are considered 
signs of general toxicity (malaise). Further, the effects seen in the 
acute neurotoxicity study are not corroborated by any other study in 
the database. Although brain dilation was found in one dog in the 1-
year dog study, EPA concluded that this effect was most likely not 
caused by administration of spirotetramat given evidence showing this 
to be a congenital anomaly in the test species, and because there is no 
other evidence of brain pathology in the database. Finally, the 
conclusion that spirotetramat is not a neurotoxic chemical is supported 
by the fact that the acute, subchronic and developmental neurotoxcity 
studies available for structurally-related compounds (spirodiclofen and 
spiromesifen) do not show evidence of neurotoxicity in adults or young.
    iii. There is no evidence that spirotetramat 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.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level or average field-trial residues. The 
submitted residue data for tropical fruit is not appropriate for the 
proposed use pattern as the trials were conducted at 2X use rate. The 
Agency is thus requesting that the petitioner conduct bridging studies 
with lychee and guava (one trial each with four samples per treatment 
regimen) in order to determine the relationship between residues 
resulting from the labeled use pattern and that used in the submitted 
field trials. Based on this relationship, the submitted residue data 
will be adjusted and the appropriate tolerances determined. As the 
recommended tolerances are based on exaggerated-rate field trial data, 
it is likely that any future adjustment of these tolerances will be to 
a lower level. This risk assessment is thus likely to over-estimate the 
dietary risk from spirotetramat residues in/on tropical fruit. Use of 
tolerance levels based on exaggerated application rates in a risk 
assessment will tend to overstate exposure even more than the 
overestimate usually supplied by use of the assumption of tolerance 
level residues. EPA made conservative (protective) assumptions in the 
ground water 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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 11% 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 93% 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-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).
    Spirotetramat is not registered for any use patterns that would 
result in short-term residential exposure. Therefore, the short-term 
aggregate risk is the sum of the risk from exposure to spirotetramat 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate 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).
    Spirotetramat is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to spirotetramat through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. No evidence of tumor 
formation was found following long-term studies of rodents, and 
spirotetramat was also negative for mutagenicity and clastogenicity in 
several standard in vivo and in vitro assays. Spirotetramat has been 
classified as ``not likely'' to be a human carcinogen by any relevant 
route of exposure and is not expected to pose a cancer risk.
    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 from aggregate 
exposure to spirotetramat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (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; e-mail address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as

[[Page 28680]]

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 spirotetramat. Canadian 
MRLs have been established and are harmonized with the United States.

C. Response to Comments

    There were no timely comments received in response to the notice of 
filing. However, as described in Unit II, the NRDC did submit comments 
well after the close of the comment period on the notice of filing that 
pertain, in part, to the risk determinations made in this rulemaking. 
Both the comment and the Agency's response to the human health portion 
of the comment can be found at http://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2009-0263.
    In brief, NRDC challenged EPA's determination to remove the 
children's safety factor on two grounds. First, NRDC questioned whether 
EPA had accurately determined, based on several developmental studies, 
that the young did not demonstrate any quantitative sensitivity 
compared to adults. NRDC did not assert that the studies showed 
quantitative sensitivity but suggested that, given the wide dose 
spacing in the studies, if the studies had used a tighter dose spacing, 
they might have shown that maternal and fetal effects did not occur at 
the same dose. While NRDC makes an interesting theoretical point, the 
fact of the matter is that the best data available showed no 
sensitivity in the young and, more importantly, these data identify a 
clear NOAEL for the effects seen in the young. Thus, EPA has a reliable 
basis for choosing a safe dose that is protective of the safety of 
infants and children. A finding on the sensitivity of the young is not 
determinative by itself on the safety of the pesticide or on the 
applicability of the children's safety factor; rather, the fundamental 
question is whether there are reliable data on safety. Moreover, the 
impact of use of the wide dose spacing here compared to a narrower 
spacing of doses is likely to provide a larger margin of safety for 
infants and children. A tighter dose spacing may provide greater 
precision with regard to the level at which effects occur and do not 
occur in the maternal compared to the juvenile animals; however, to the 
extent these revised dose levels provide more precise information on 
the NOAEL, that NOAEL could only be higher (and potentially 
significantly higher given the wide dose spacing). Thus, the wide dose 
spacing may very well provide a lower POD (by overstating the NOAEL), 
and thus a more conservative basis, for assessing risk.
    Second, NRDC argued that EPA did not adequately take into account 
the severity of the effects relating to the young seen in the 
spirotetramat database. NRDC cites malformations and skeletal defects 
in the rat developmental study, thyroid effects in the chronic dog 
study, neurotoxicity (staining of the fur with urine) in a rat study, 
and the potential that spirotetramat ``may impair the synthesis of 
lipids that are necessary for the formation of cell membranes--
including those of brain cells--and for hormone synthesis.'' EPA 
adequately considered each of these effects. As to the malformations 
and skeletal defects, EPA notes that while these effects are serious 
they occurred at a dose level 10,000 to 20,000 times higher than the 
safe dose level chosen by EPA. With regard to the thyroid effects, EPA 
believes that it took a very conservative approach to even treating the 
observed decrease in thyroid levels as an adverse effect given the 
absence of any corroborating signs of thyroid toxicity in the relevant 
studies. Notably, these studies show no decreases in thyroid weight, no 
thyroid histopathology, no compensatory increases in thyroid 
stimulating hormone (TSH), no effect on UDP-glucuronosyltransferase 
activity, and no clinical signs of toxicity or changes in body weight 
that might result from decreased thyroid output. In any event, there 
was a clear NOAEL for these minimal thyroid effects and EPA reduced 
this NOAEL by a 100X SF in deriving a safe dose for spirotetramat. 
Next, EPA disputes NRDC's claim that spirotetramat has neurotoxic 
effects. The staining of the fur seen in one study is not a neurotoxic 
effect but likely the result of the use of a colored metabolite in the 
study that was excreted in the urine. No other effects in the database 
could be corroborated as neurotoxic. Finally, NRDC's speculation that 
spirotetramat may interfere with the synthesis of lipids necessary to 
cell growth is not supported by the spirotetramat mammalian toxicity 
database. While spirotetramat does interfere with lipid biosynthesis in 
insects, the mammalian database shows no effects on plasma lipid 
parameters such as plasma triglycerides and plasma cholesterol which 
would be indicative of disruption of lipid biosynthesis in mammals.

D. Revisions to Petitioned-for Tolerances

    Based on residue data submitted with this petition, several 
petitioned-for tolerances were revised. Additionally, as a result of 
the potential for increased dietary exposure to livestock, it was 
considered necessary to establish a tolerance for eggs and for meat 
byproducts of hog and poultry, and revise the tolerances on meat 
byproducts of cattle, goat, horse, and sheep. The proposed tolerance on 
dried prunes was not required as residues in the processed commodity 
are not expected to exceed the tolerance established for the raw 
agricultural commodity. A crop group tolerance on tropical fruits was 
not established because this is not a recognized crop group. Instead, 
tolerances on several individual tropical fruit commodities were 
established. Tolerances on sugar apple, atemoya, custard apple, 
cherimoya, ilama, soursop, and birida were not established, because 
field trial residue data were not submitted. A chart listing the 
petitioned-for tolerances and EPA recommended tolerances can be found 
at http://www.regulations.gov in document ``Spirotetramat. Human-Health 
Risk Assessment for Proposed Uses in/on Cotton, Legume Vegetables 
including Soybean (Crop Groups 6 and 7a), and Tropical Fruits'' at page 
47 in docket ID number EPA-HQ-OPP-2009-0263.
    EPA has also revised the tolerance expression in paragraphs (a)(1) 
and (a)(2) to clarify that, as provided in FFDCA section 408(a)(3), the 
tolerance covers metabolites and degradates of spirotetramat not 
specifically mentioned; and that compliance with the specified 
tolerance levels is to be determined by measuring only the specific 
compounds mentioned in the tolerance expression.
    EPA has also added a footnote to currently established tolerances 
for onion, bulb, subgroup 3A-07 and strawberry to indicate that 
currently there are no U.S. registrations for these commodities. Use on 
these two commodities was assessed for import tolerances only.
    EPA is establishing import only tolerances for cotton, undelinted 
seed, and cotton gin byproducts at this time, because the use on cotton 
under FIFRA, 7 U.S.C. 136 et seq., has not been approved. The Agency 
has concerns with potential hazard of toxicity to bees, and use on 
cotton cannot be approved

[[Page 28681]]

until these concerns have been addressed.

 V. Conclusion

    Therefore, tolerances are established for residues of 
spirotetramat, including its metabolites and degradates, in or on the 
commodities listed in the regulatory text. Compliance with the 
tolerance levels is to be determined by measuring only the sum of 
spirotetramat and its metabolites calculated as the stoichiometric 
equivalent of spirotetramat, in or on the commodities.
    In addition, the proposed uses and the submitted data also support 
permanent tolerances for residues of the insecticide spirotetramat, 
including its metabolites and degradates, in or on the commodities 
listed in the regulatory text. Compliance with the tolerance levels is 
to be determined by measuring only the sum of spirotetramat and its 
metabolite, calculated as the stoichiometric equivalent of 
spirotetramat, in or on the commodities.

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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) (Pub. L. 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 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: May 2, 2011.
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. Section 180.641 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.641  Spirotetramat; tolerances for residues.

    (a) General. (1) Tolerances 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 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
------------------------------------------------------------------------
Acerola.....................................................        2.5
Almond, hulls...............................................        9.0
Aspirated grain fractions...................................       10.0
Avocado.....................................................        0.60
Black sapote................................................        0.60
Brassica, head and stem, subgroup 5A........................        2.5
Brassica, leafy, subgroup 5B................................        8.0
Canistel....................................................        0.60
Citrus, oil.................................................        6.0
Cotton gin byproducts\1\....................................       10.0
Cotton, undelinted seed\1\..................................        0.30
Feijoa......................................................        0.30
Fruit, citrus, group 10.....................................        0.60
Fruit, pome, group 11.......................................        0.70
Fruit, stone, group 12......................................        4.5
Grape, raisin...............................................        3.0
Guava.......................................................        2.5
Hop, dried cones............................................       10.0
Jaboticaba..................................................        2.5
Longan......................................................       13.0
Lychee......................................................       13.0
Mamey sapote................................................        0.60
Mango.......................................................        0.60
Nut, tree, group 14.........................................        0.25
Okra........................................................        2.5
Onion, bulb, subgroup 3A-07\1\..............................        0.30
Papaya......................................................        2.5
Passionfruit................................................        2.5
Pistachio...................................................        0.25
Potato, flakes..............................................        1.6
Pulasan.....................................................       13.0
Rambutan....................................................       13.0
Sapodilla...................................................        0.60

[[Page 28682]]

 
Small fruit vine climbing subgroup, except fuzzy kiwifruit,         1.3
 subgroup 13-07F............................................
Soybean forage..............................................        8.0
Soybean hay.................................................       16.0
Soybean seed................................................        5.0
Spanish lime................................................        0.60
Star apple..................................................        0.60
Starfruit...................................................        2.5
Strawberry\1\...............................................        0.40
Vegetable, cucurbit, group 9................................        0.30
Vegetable, foliage of legume, except soybean, subgroup 07A..        7.0
Vegetable, fruiting, group 8................................        2.5
Vegetable, legume, group 06, except soybean.................        2.5
Vegetable, leafy, except brassica, group 4..................        9.0
Vegetable, tuberous and corm, subgroup 1C...................        0.60
Wax jambu...................................................        2.5
White sapote................................................        0.60
------------------------------------------------------------------------
\1\ Import tolerance only. There are no U.S. registrations for cotton,
  onion or strawberry.

    (2) Tolerances are also established for residues of the insecticide 
spirotetramat, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the 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 metabolite cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
calculated as the stoichiometric equivalent of spirotetramat, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat..................................................       0.02
Cattle, meat.................................................       0.02
Cattle, meat byproducts......................................       0.20
Eggs.........................................................       0.02
Goat, fat....................................................       0.02
Goat, meat...................................................       0.02
Goat, meat byproducts........................................       0.20
Hog, meat byproducts.........................................       0.02
Horse, fat...................................................       0.02
Horse, meat..................................................       0.02
Horse, meat byproducts.......................................       0.20
Milk.........................................................       0.01
Poultry, meat byproducts.....................................       0.02
Sheep, fat...................................................       0.02
Sheep, meat..................................................       0.02
Sheep, meat byproducts.......................................       0.20
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-11937 Filed 5-17-11; 8:45 am]
BILLING CODE 6560-50-P