Document ID: EPA-HQ-OPP-2009-0139-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Spirodiclofen
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Rules and Regulations]               
[Page 24428-24434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0139; FRL-8820-4]

 
Spirodiclofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-
3-en-4-yl 2,2-dimethylbutanoate) 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 5, 2010. Objections and 
requests for hearings must be received on or before July 6, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0139. 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

[[Page 24429]]

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 cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0139 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 6, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0139, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8915-
5), 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 
8F7500) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, N.C. 27709. The petition requested that 40 CFR 
180.608 be amended by establishing tolerances for residues of the 
insecticide spirodiclofen,(3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate), in or on avocado, 
black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and 
star apple at 1.3 parts per million (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.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerances to 1.0 ppm; and changed the tolerance 
expression to spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate). The reason for these 
changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for spirodiclofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with spirodiclofen 
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.
    Spirodiclofen has a low acute toxicity via the oral, dermal, and 
inhalation routes. It is not an eye or dermal irritant. However, it is 
a potential skin sensitizer. Following oral administration, 
spirodiclofen is rapidly absorbed, metabolized, and excreted via urine 
and feces. A rat whole body autoradiography study showed no 
accumulation in any specific organs or tissues following oral 
administration. Evidence of developmental toxicity was not observed in 
the rabbit developmental toxicity study. The rat

[[Page 24430]]

developmental toxicity study resulted in an increased incidence of 
slight dilatation of the renal pelvis 1,000 milligrams/kilograms/day 
(mg/kg/day); highest dose tested (HDT) at a dose which did not cause 
maternal toxicity. In the 2-generation reproductive toxicity study, 
developmental effects were observed in F1 males (i.e., delayed sexual 
maturation, decreased testicular spermatid and epididymal sperm counts 
(oligospermia); and atrophy of the testes, epididymides, prostate, and 
seminal vesicles) and F1 females (i.e., increased severity of ovarian 
luteal cell vacuolation/degeneration) but at a higher dose (1,750 ppm) 
than the systemic effects seen for parents and offspring (350 ppm). 
Spirodiclofen did not show any evidence of neurotoxicity in the acute 
and subchronic neurotoxicity studies. In a developmental neurotoxicity 
study (DNT), a decrease in retention was observed in the memory phase 
of the water maze for postnatal day (PND) 60 females at all doses. In 
this DNT study, the morphometric measurements were not performed at the 
low- and mid-doses; therefore, the registrant conducted a new study 
using identical experimental conditions as the previous study. The 
results of the new study demonstrated no treatment related maternal or 
offspring toxicity at the HDT. Therefore, it can be concluded that 
spirodiclofen is unlikely to be a neurotoxic or developmentally 
neurotoxic compound.
    Spirodiclofen has been shown to have adverse effects on several 
organs of the endocrine system at relatively low doses. Testicular 
effects were observed in dogs, rats, and mice, manifested as Leydig 
cell vacuolation in dogs, hypertrophy in dogs and mice, and hyperplasia 
progressing to adenomas in rats, following chronic exposure. In female 
rats, increased incidence of uterine nodules and uterine adenocarcinoma 
were observed at terminal sacrifice in the chronic toxicity study. 
Cytoplasmic vacuolation in the adrenal cortex, accompanied by increased 
adrenal weight, was consistently observed in rats, dogs, and mice of 
both sexes.
    Chronic toxicity and carcinogenicity studies showed increased 
incidence of uterine adenocarcinoma in female rats, Leydig cell adenoma 
in male rats, and liver tumors in mice. EPA classified spirodiclofen as 
``likely to be carcinogenic to humans'' by the oral route based on 
evidence of testes Leydig cell adenomas in male rats, uterine adenomas 
and/or adenocarcinoma in female rats, and liver tumors in mice. 
Mutagenicity studies conducted with the technical spirodiclofen 
formulation and its major metabolites did not demonstrate any mutagenic 
potential. EPA has determined that quantification of human cancer risk 
using a linear low-dose extrapolation approach is appropriate.
     Specific information on the studies received and the nature of the 
adverse effects caused by spirodiclofen 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 ``Human Health Risk Assessment 
Associated with the Section 3 Registration Application for Avocado, 
Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and 
Star Apple,'' p.10 in docket ID number EPA-HQ-OPP-2009-0139.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirodiclofen used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Human Health Risk Assessment Associated with the Section 3 
Registration Application for Avocado, Black Sapote, Canistel, Mamey 
Sapote, Mango, Papaya, Sapodilla, and Star Apple,'' p. 12 in docket ID 
number EPA-HQ-OPP-2009-0139.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spirodiclofen, EPA considered exposure under the 
petitioned-for tolerances as well as all existing spirodiclofen 
tolerances in 40 CFR 180.608. EPA assessed dietary exposures from 
spirodiclofen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
spirodiclofen; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Continuing Survey of Food Intake (CSFII). As to residue levels 
in food, EPA assumed the following:
    a. Average field trial residues;
    b. Experimentally determined processing factors for apple and grape 
processed commodities and for citrus oil, peeled citrus, and citrus 
peel (DEEM (ver 7.81) defaults assumed for the remaining processed 
commodities); and
    c. Maximum reasonably balanced livestock diets.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier non-cancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has classified spirodiclofen as ``Likely to be Carcinogenic 
to Humans'' and used a linear approach to quantify cancer risk. 
Exposure for evaluating cancer risk was assessed using the same 
estimates as discussed in Unit III.C.1.ii.
    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

[[Page 24431]]

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. Average 
field trial residues were assumed for chronic and cancer analysis.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition A: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition B: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition C: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: Hop 
(92%), pome fruit (15%), stone fruit (10%), grape (7%), and citrus 
(14%).
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition A, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions B and C, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which spirodiclofen may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spirodiclofen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of spirodiclofen. 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 PRZM/EXAMS and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of spirodiclofen for chronic exposures for non-cancer assessments are 
estimated to be 4.99 ppb for surface water and 0.44 ppb for ground 
water. The EDWCs of spirodiclofen for chronic exposures for cancer 
assessments are estimated to be 1.67 ppb for surface water and 0.44 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of 
value 4.99 ppb was used to assess the contribution to drinking water.
    For cancer dietary risk assessment, the water concentration of 
value 1.67 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).
    Spirodiclofen 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 spirodiclofen to share a common mechanism of 
toxicity with any other substances, and spirodiclofen does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spirodiclofen does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The spirodiclofen toxicity 
database is adequate to evaluate the potential increased susceptibility 
of infants and children. In 2004, the Agency determined that there is 
no evidence (qualitative or quantitative) of increased

[[Page 24432]]

susceptibility in the rabbit developmental toxicity study or in the rat 
reproduction toxicity study following in utero and/or pre-/post-natal 
exposure of spirodiclofen. However, evidence for quantitative 
susceptibility was observed in a rat developmental toxicity study where 
an increased incidence of slight dilatation of the renal pelvis was 
observed at a dose (1,000 mg/kg/day; the limit dose) which did not 
cause any maternal toxicity. Two rat developmental neurotoxicity (DNT) 
studies were submitted to EPA following the assessment in 2004. The 
first study demonstrated increased susceptibility in the offspring 
based on the observed decreased retention in the memory phase of the 
water maze for postnatal day 60 females at all doses (LOAEL 6.5 mg/kg/
day) and changes in brain morphometric parameters at the HDT (135.9 mg/
kg/day; caudate putamen, parietal cortex, hippocampal gyrus, and 
dentate gyrus); there was no maternal toxicity at doses up to and 
including 135.9 mg/kg/day HDT. EPA requested information concerning the 
brain morphometric parameters in the low and mid doses with the 
petitioner indicating that the brain tissues were not appropriately 
preserved and analysis was therefore not possible. As a result, a 
second rat DNT study was submitted which also indicated increased 
susceptibility in offspring based on decreased pre-weaning body weight 
and body weight gain in males and females and decreased post-weaning 
body weights in males (LOAEL = 119.2 mg/kg/day; NOAEL = 28.6 mg/kg/
day). Neurotoxicity was not observed in offspring in the second DNT 
study, and there was no maternal toxicity observed at doses up to and 
including 119.2 mg/kg/day.
    EPA determined that the degree of concern is low for the 
quantitative susceptibility seen in the developmental toxicity study in 
rats. The increased incidence of slight renal pelvic dilation was 
observed at the limit-dose only without statistical significance and 
dose response. Renal pelvic dilation was considered to be a 
developmental delay and not a severe effect for developmental toxicity. 
The low background incidences in this study may be idiosyncratic to the 
strain of rats tested (Wistar), since renal pelvis dilations are 
commonly seen at higher incidences in other strains (Sprague-Dawley or 
Fisher) of rats. In addition, doses selected for risk assessment of 
spirodiclofen are much lower than the dose that caused these 
developmental delays. The two DNT studies suggest increased 
susceptibility of offspring due to exposure to spirodiclofen. However, 
there is no concern for the increased susceptibility seen in the first 
DNT study because the results were not reproduced in the second DNT 
study conducted using the identical doses and experimental conditions. 
The concern for increased susceptibility in the second DNT study is low 
because there is a well established NOAEL, marginal toxicity (slight 
changes in body weights), and all developmental/functional parameters 
were comparable to controls. In addition, doses selected for risk 
assessment of spirodiclofen are much lower than the dose that caused 
these marginal changes in the body weights of offspring in the second 
DNT study. There was no evidence of increased susceptibility in the 
developmental toxicity study in rabbits or the 2-generation 
reproduction study in rats.
    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 spirodiclofen is complete except for 
an immunotoxicity study which is required as a part of new data 
requirements in the 40 CFR part 158. However, the Agency does not 
believe that conducting a functional immunotoxicity study will result 
in a lower POD than that currently used for overall risk assessment. 
The toxicology database for spirodiclofen does not show any evidence of 
treatment-related effects on the immune system. The overall weight of 
evidence suggests that this chemical does not target the immune system. 
Therefore, a database uncertainty factor (UFDB) is not needed to 
account for the lack of this study.
    ii. Based on the results of acute, subchronic and developmental 
neurotoxicity studies in rats (see Units III.A. and III.D.2.), EPA has 
concluded that there is no indication that spirodiclofen is a 
neurotoxic chemical.
    iii. There is no evidence (qualitative or quantitative) of 
increased susceptibility in the rabbit developmental toxicity study or 
in the rat reproduction toxicity study following in utero and/or pre-/
post-natal exposure of spirodiclofen. However, evidence for 
quantitative susceptibility was observed in a rat developmental 
toxicity study and the second DNT study. See Unit III.D.2. for a 
detailed discussion of why EPA determined that the degree of concern is 
low for the quantitative susceptibility seen in this studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed using 
reliable PCT information and anticipated residue values calculated from 
residue field trial results. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to spirodiclofen in drinking water. Residential exposures are 
not expected. These assessments will not underestimate the exposure and 
risks posed by spirodiclofen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
spirodiclofen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spirodiclofen from food and water will utilize 3.3% of the cPAD for all 
infants < 1 year old the population group receiving the greatest 
exposure. There are no residential uses for spirodiclofen.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Spirodiclofen is not registered for any uses that would result in 
residential exposure. Therefore the short-term/intermediate-term 
aggregate risk is the sum of the risk from exposure to spirodiclofen 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in Unit III.C.1.iii. for cancer, EPA has 
concluded that exposure to spirodiclofen to cancer from

[[Page 24433]]

food and water will result in a life-time cancer risk of 3 x 
10-6. EPA generally considers cancer risks in the range of 
10-6 or less to be negligible. The precision which can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the log scale; for example, 
risks falling between 3 x 10-7 and 3 x 10-6 are 
expressed as risks in the range of 10-6. Considering the 
precision with which cancer hazard can be estimated, the 
conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above in this Unit, cancer risk should generally 
not be assumed to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. For the reasons explained 
below in this Unit, EPA concludes that there are significant 
conservatisms in the spirodiclofen exposure assessment. First, residue 
values are based on average field trial levels and not monitoring data. 
Monitoring data tends to be significantly lower than field trial data 
and the spirodiclofen monitoring data confirms this (all less than the 
limit of detection (LOD); LOD = 0.001-0.05 ppm; 2.5-23x lower than the 
residue used in the cancer assessment). Second, based on a critical 
commodity analysis conducted in DEEM-FCID, the major contributors to 
the cancer risk were hops (40% of the total exposure), water (19% of 
the total exposure), and orange juice (16% of the total exposure) and 
conservative residue estimates were used for these three commodities as 
follows:
    i. Hops. Dietary exposure from hops is the result of beer 
consumption. DEEM-FCID assumes that 100% of the residue in hops are 
transferred to beer during the brewing process (no residue remain in/on 
the spent hops). Since spirodiclofen has low water solubility, this is 
a conservative assumption;
    ii. Drinking water. The water residue estimate assumed 87% of the 
basin is cropped with 100% of the crops treated. Spirodiclofen is 
proposed/registered for application to orchard crops (pome fruit, 
citrus fruit, stone fruit, tree nuts, grape, and tropical fruits) which 
are unlikely to occupy 87% of a water basin. In addition, it is 
unlikely that spirodiclofen will capture the entire market within a 
water basin.
    iii. Orange juice. Pending the submission of a new orange 
processing study, default grapefruit (2.1x), lemon (2.0x), lime (2.0x), 
orange (1.8x), and tangerine (2.3x) juice processing factors were 
assumed. In all likelihood this exaggerates exposure estimates given 
that grape and apple processing studies with spirodiclofen resulted in 
a reduction in residues in juice.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to spirodiclofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography (LC)/mass 
spectrometry (MS)/(MS) method) 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

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) in/on these crops.

C. Response to Comments

    There were no comments received in response to the notice of filing 
of the pesticide petition 8F7500.

D. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerance levels and tolerance 
expression of spirodiclofen in/on the following commodities: Avocado 
from 1.3 ppm to 1.0 ppm; black sapote from 1.3 ppm to 1.0 ppm; canistel 
from 1.3 ppm to 1.0 ppm; mamey sapote from 1.3 ppm to 1.0 ppm; mango 
from 1.3 ppm to 1.0 ppm; papaya from 1.3 ppm to 1.0 ppm; sapodilla from 
1.3 ppm to 1.0 ppm; and star apple from 1.3 ppm to 1.0 ppm. Based on 
review of the residue chemistry data submitted in support of this 
petition, EPA concluded that 1.0 ppm tolerance for residues of 
spirodiclofen per se in/on these crops is appropriate.

V. Conclusion

    Therefore, tolerances are established for residues of spirodiclofen 
per se, (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-
dimethylbutanoate), in or on avocado, black sapote, canistel, mamey 
sapote, mango, papaya, sapodilla, and star apple at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the

[[Page 24434]]

Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of 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: April 20, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.608, alphabetically add the following commodities to 
the table in paragraph (a)(1) to read as follows:

Sec.  180.608  Spirodiclofen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Avocado...................................  1.0
Black sapote..............................  1.0
Canistel..................................  1.0
                                * * * * *
Mamey sapote..............................  1.0
Mango.....................................  1.0
                                * * * * *
Papaya....................................  1.0
                                * * * * *
Sapodilla.................................  1.0
Star apple................................  1.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-10129 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S