Federal Register, Volume 76 Issue 96 (Wednesday, May 18, 2011)

[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Rules and Regulations]
[Pages 28675-28682]
From the Federal Register Online via the Government Printing 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: kumar.rita@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. 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.
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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 (DEEM^TM) (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]]

DEEM^TM (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:
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

[[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:

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