Document ID: EPA-HQ-OPP-2007-0475-0004
Agency: epa
Document Type: Rule
Title: Spirotetramat; Pesticide Tolerances
Posted Date: 2008-07-09T04:00Z

[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]               
[Page 39251-39256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy08-16]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0475; FRL-8367-1]

 
Spirotetramat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues 
of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-
ketohydroxy, BYI08330-enol-, and BYI 08330-mono-hydroxy, calculated as 
spirotetramat equivalents, in or on vegetable, tuberous and corm, 
subgroup 1C; potato, flakes; onion, bulb, subgroup 3A-07; vegetable, 
leafy, except brassica, group 4; brassica, head and stem, subgroup 5A; 
brassica, leafy greens, subgroup 5B; vegetable, fruiting, group 8; 
vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; 
fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; 
almond, hulls; small fruit vine climbing subgroup, except fuzzy 
kiwifruit, subgroup 13-07F; grape; raisin; strawberry; hop, dried 
cones; and for the combined residues of spirotetramat and its 
metabolite BYI 08330-enol, calculated as spirotetramat equivalents, in 
or on milk; and meat, fat, and meat byproducts of cattle, goat; sheep, 
and horse. Bayer CropScience requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and 
requests for hearings must be received on or before September 8, 2008, 
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-2007-0475. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any

[[Page 39252]]

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-2007-0475 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before September 8, 2008.
    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-2007-0475, 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'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 July 15, 2007 (FR 40877) (FRL-8137-1), 
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 6F7119) 
by Bayer CropScience LLC, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709 . The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the insecticide 
spirotetramat, (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro 
[4.5] dec-3-en-4-yl-ethyl carbonate, and its metabolite cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro4.5dec-3-en-2-one, 
calculated as spirotetramat equivalents, in or on the raw agricultural 
commodities vegetable, tuberous and corm, subgroup 1C at 1.0 parts per 
million (ppm); potato, granules/flakes at 2.5 ppm; onions, dry bulb, 
subgroup 3A at 0.3 ppm; vegetables, leafy, except brassica, group 4 at 
5.0 ppm brassica, head and stem, subgroup 5A at 3.0 ppm; brassica, 
leafy greens, subgroup 5B at 16.0 ppm; vegetables, fruiting, group 8 at 
1.0 ppm; tomato, dried pomace at 2.5 ppm; vegetable, cucurbit, group 9 
at 0.2 ppm; fruit, citrus, group 10 at 0.5 ppm; citrus, oil at 4.0 ppm; 
fruit, pome, group 11 at 0.5 ppm; fruit, stone, group 12 at 2.0 ppm; 
nut, tree, group 14 at 0.5 ppm; almond, hulls at 9.0 ppm; grape at 1.0 
ppm; grape, raisin at 2.5 ppm; hop at 10.0 ppm; strawberry at 0.5 ppm; 
cattle, goat, hog, sheep and horse, meat at 0.01 ppm; cattle, goat, 
hog, sheep and horse, fat at 0.01 ppm; cattle, goat, hog, sheep and 
horse, liver at 0.01 ppm; cattle, goat, hog, sheep and horse, meat 
byproducts, except liver at 0.02 ppm. That notice referenced a summary 
of the petition prepared by Bayer CropScience, the registrant, which is 
available to the public 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 tolerance expression for vegetable, tuberous and corm, subgroup 
1C; potato, granules/flakes; vegetables, leafy, except brassica, group 
4; brassica, head and stem, subgroup 5A; brassica, leafy greens, 
subgroup 5B; vegetables, fruiting, group 8; tomato, dried pomace; 
vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; 
fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; 
small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 
13-07F; grape; raisin; strawberry; cattle, goat, hog, sheep and horse, 
meat; cattle, goat, hog, sheep and horse, fat; cattle, goat, hog, sheep 
and horse, liver; cattle, goat, hog, sheep and horse, meat byproducts, 
except liver. A tolerance for milk was also included. 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 the petitioned-for 
tolerances for combined residues of spirotetramat. EPA's assessment of 
exposures and risks associated with establishing tolerances 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 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 one-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

[[Page 39253]]

testicular histopathology observed following subchronic and chronic 
exposure of rats to spirotetramat, male reproductive toxicity was 
recorded in the two-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. 
Therefore, repeated dosing with spirotetramat is necessary to produce 
male reproductive toxicity in rats. 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 on Citrus (Crop Group 10); Cucurbit 
Vegetables (Crop Group 9); Fruiting Vegetables (Crop Group 8); Grape 
(Crop Subgroup 13F); Hops; Leafy Brassica Vegetables (Crop Group 5); 
Leafy Non-Brassica Vegetables (Crop Group 4); Pome Fruit (Crop Group 
11); Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C); 
Stone Fruit (Crop Group 12); Tree Nuts (Crop Group 14); Onions; 
Strawberries; Livestock Commodities; and Greenhouses/Nurseries, pages 
38-58 in docket ID number EPA-HQ-OPP-2007-0475.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that 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 spirotetramat used for 
human risk assessment can be found at http://www.regulations.gov in 
document Spirotetramat Human-Health Risk Assessment for Proposed Uses 
on Citrus (Crop Group 10); Cucurbit Vegetables (Crop Group 9); Fruiting 
Vegetables (Crop Group 8); Grape (Crop Subgroup 13F); Hops; Leafy 
Brassica Vegetables (Crop Group 5); Leafy Non-Brassica Vegetables (Crop 
Group 4); Pome Fruit (Crop Group 11); Potato and Other Tuberous and 
Corm Vegetables (Crop Subgroup 1C); Stone Fruit (Crop Group 12); Tree 
Nuts (Crop Group 14); Onions; Strawberries; Livestock Commodities; and 
Greenhouses/Nurseries, page 21 in docket ID number EPA-HQ-OPP-2007-
0475.

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. 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 one-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States 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 DEEMTM (ver. 7.81) default processing factors 
were used for processed commodities. Drinking water was incorporated 
directly in the dietary assessment using the acute concentration for 
surface water generated by the First Index Resevoir 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 DEEMTM (ver. 7.81) default 
processing factors, and 100% CT. Drinking water was incorporated 
directly into the dietary assessment using the chronic concentration 
for surface water generated by the FIRST model.
    iii. Cancer. Spirotetramat was classified as ``not likely to be 
carcinogenic to humans.'' Therefore, a quantitative cancer dietary 
exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spirotetramat and its metabolites in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of spirotetramat. 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 and its metabolites:
    i. For acute exposures are estimated to be 0.212 parts per billion 
(ppb) for surface water and 3.96x10-4 ppb for ground water;
    ii. For chronic exposures for non-cancer assessments are estimated 
to be 1.37x10-3 ppb for surface water and 3.96x10-
4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. a. For acute dietary risk 
assessment, the water concentration value of 0.212 ppb was used to 
assess the contribution to drinking water. b. For chronic dietary

[[Page 39254]]

risk assessment, the water concentration of value 1.37x10-3 
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 website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of 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.
    ii. There is no indication that spirotetramat is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Clinical signs of 
toxicity and decreased motor activity were observed in adult rats 
following a single dose of spirotetramat in the acute neurotoxicity 
study in the rat; however, these effects only attained statistical 
significance at high doses and were not observed at the limit dose in 
the acute oral toxicity study in the rat. There is no concern for 
neurotoxicity with spirotetramat in the developing animal based on the 
fact that brain dilation in the one-year dog study is most likely a 
congenital anomaly that was not observed in any other study in the 
spirotetramat database, and the fact that the structurally related 
compounds spirodiclofen and spiromesifen are not neurotoxic in adults 
or young.
    iii. There is no evidence that spirotetramat results in increased 
susceptibility 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 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.
    v. There are no registered or proposed uses of spirotetramat which 
could result in residential exposure.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    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 10% 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 77% 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 residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to spirotetramat through food 
and water 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.Spirotetramat has been 
classified as ``Not Likely to be Carcinogenic to Humans.'' 
Spirotetramat 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

[[Page 39255]]

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

    If the method is not published in the Pesticide Analytical Manual, 
but has been approved by EPA, use the following:
    Adequate enforcement methodology liquid chromatography/mass 
spectrometry/mass spectrometry (LC/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

    There are no CODEX or Mexican maximum residue limits (MRLs) for 
spirotetramat. Canadian MRLs have been established and are harmonized 
with the US.

C. Response to Comments

    There were no comments received in response to the notice of 
filing.

D. Revisions to Petitioned-For Tolerances

    Based on residue chemistry data submitted with this petition, 
several petitioned-for tolerances were revised, and it was considered 
necessary to establish a tolerance for milk. 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 on Citrus (Crop Group 10); Cucurbit 
Vegetables (Crop Group 9); Fruiting Vegetables (Crop Group 8); Grape 
(Crop Subgroup 13F); Hops; Leafy Brassica Vegetables (Crop Group 5); 
Leafy Non-Brassica Vegetables (Crop Group 4); Pome Fruit (Crop Group 
11); Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C); 
Stone Fruit (Crop Group 12); Tree Nuts (Crop Group 14); Onions; 
Strawberries; Livestock Commodities; and Greenhouses/Nurseries page 65 
in docket ID number EPA-HQ-OPP-2007-0475.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro 
[4.5] dec-3-en-4-yl-ethyl carbonate]) and its metabolites 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 the following 
commodities: Fruit, citrus, group 10 at 0.60 ppm; citrus, oil at 6.0 
ppm; vegetable, leafy, except brassica, group 4 at 9.0 ppm; fruit, 
pome, group 11 at 0.70 ppm; fruit, stone, group 12 at 4.5 ppm; small 
fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F 
at 1.3 ppm; grape, raisin at 3.0 ppm; strawberry at 0.40 ppm; onion, 
bulb, subgroup 3A-07 at 0.30 ppm; vegetable, fruiting, group 8 at 2.5 
ppm; vegetable, cucurbit, group 9 at 0.30 ppm; brassica, head and stem, 
subgroup 5A at 2.5 ppm; brassica, leafy greens, subgroup 5B at 8.0 ppm; 
vegetable, tuberous and corm, subgroup 1C at 0.60 ppm; potato, flakes 
at 1.6 ppm; nut, tree, group 14 at 0.25 ppm; almond, hulls at 9.0 ppm; 
hop, dried cones at 10 ppm. Tolerances are also established for the 
combined residues of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-
methoxy-2-oxo-1-azaspiro 4.5 dec-3-en-4-yl-ethyl carbonate) and its 
metabolite BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-
methoxy-1-azaspiro 4.5 dec-3-en-2-one), calculated as spirotetramat 
equivalents, in/on the following livestock commodities: Milk at 0.01 
ppm; cattle, meat at 0.02 ppm; cattle, fat at 0.02 ppm; cattle, meat 
byproducts at 0.02 ppm; goat, meat at 0.02 ppm; goat, fat at 0.02 ppm; 
goat, meat byproducts at 0.02 ppm; sheep, meat at 0.02 ppm; sheep, fat 
at 0.02 ppm; sheep, meat byproducts at 0.02 ppm; horse, meat at 0.02 
ppm; horse, fat at 0.02 ppm; horse, meat byproducts at 0.02 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, Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

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

[[Page 39256]]

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: June 24, 2008.
Debra Edwards,
Director, 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. Section 180.641 is added to read as follows:

Sec.  180.641  Spirotetramat; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-
1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate) and its metabolites 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 the following raw 
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                9.0
Brassica, head and stem, subgroup 5A.................                2.5
Brassica, leafy, subgroup 5B.........................                8.0
Citrus, oil..........................................                6.0
Fruit, citrus, group 10..............................               0.60
Fruit, pome, group 11................................               0.70
Fruit, stone, group 12...............................                4.5
Grape, raisin........................................                3.0
Hop, dried cones.....................................               10.0
Nut, tree, group 14..................................               0.25
Onion, bulb, subgroup 3A-07..........................                0.3
Potato, flakes.......................................                1.6
Small fruit vine climbing subgroup, except fuzzy                     1.3
 kiwifruit, subgroup 13-07F..........................
Strawberry...........................................               0.40
Vegetable, cucurbit, group 9.........................               0.30
Vegetable, fruiting, group 8.........................                2.5
Vegetable, leafy, except Brassica, group 4...........                9.0
Vegetable, tuberous and corm, subgroup 1C                           0.60
------------------------------------------------------------------------

    (2) Tolerances are also established for the combined residues of 
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro 
[4.5] dec-3-en-4-yl-ethyl carbonate) and its metabolite BYI 08330-enol 
(cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-
en-2-one), calculated as spirotetramat equivalents, in or on the 
following commodities:

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

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Resereved]
    (d) Indirect or inadvertant residues. [Reserved]

[FR Doc. E8-15521 Filed 7-8-08; 8:45 am]

BILLING CODE 6560-50-S