Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 39251 

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: June 26, 2008 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.568 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Corn, field, forage ........... 0.02 

Corn, field, grain ............. 0.02 

Corn, field, stover ........... 0.02 

* * * * * 

* * * * * 

[FR Doc. E8–15316 Filed 7–8–08; 8:45 am] 

BILLING CODE 6560–50–S 

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-monohydroxy, 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 


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39252 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 

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-methoxy1-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 nonirritating to the skin, although it is an 

irritant to the eyes and exhibits a skinsensitization 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 


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Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 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 (balanopreputial 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-observedadverse-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 (SCIGROW) 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 noncancer 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 


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39254 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 

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 nonoccupational, 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. Shortterm, intermediate-term, and chronicterm 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 


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Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 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 NonBrassica 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-methoxy2-oxo-1-azaspiro [4.5] dec-3-en-4-ylethyl 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-hydroxy8-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-Dglucopyranoside), and BYI 08330-monohydroxy (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 dec3-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 


dwashington3 on PRODPC61 with RULES
39256 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 

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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.641 is added to read as 

follows: 

§ 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-hydroxy8-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-Dglucopyranoside), and BYI 08330-monohydroxy (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 

Commodity Parts per million 

Potato, flakes .................. 1.6 

Small fruit vine climbing 

subgroup, except fuzzy 

kiwifruit, subgroup 13- 

07F .............................. 1.3 

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-methoxy2-oxo-1-azaspiro [4.5] dec-3-en-4-ylethyl 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0893; FRL–8370–9] 

Sethoxydim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

sethoxydim and its metabolites 

containing the 2-cyclohexen-1-one 

moiety, in or on various oilseed 

commodities. Interregional Research 

Project Number 4 (IR-4) 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–2007–0893. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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). 


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