Federal Register / Vol. 76, No. 96 / Wednesday, May 18, 2011 / Rules and Regulations 28675 

TABLE 4 OF APPENDIX A—PROCEDURES FOR ESTIMATING So

If the estimated LOD (LOD1, expected approximate LOD concentration 

level) is no more than twice the calculated LOD, use Procedure I as 

follows. Estimate the LOD (LOD1) and prepare a test standard at this 

level. The test standard could consist of a dilution of the analyte described in Section 5.0.

If the estimated LOD (LOD1, expected approximate LOD concentration 

level) is greater than twice the calculated LOD, use Procedure II as 

follows. Prepare two additional standards (LOD2 and LOD3) at concentration levels lower than the standard used in Procedure I 

(LOD1). 

Using the normal sampling and analytical procedures for the method, 

sample and analyze this standard at least 7 times in the laboratory.

Sample and analyze each of these standards (LOD2 and LOD3) at 

least 7 times. 

Calculate the standard deviation, S1, of the measured values ................ Calculate the standard deviation (S2 and S3) for each concentration 

level. 

Calculate the LOD0 (referred to as the calculated LOD) as 3 times S1, 

where S0 = S1.

Plot the standard deviations of the three test standards (S1, S2 and S3) 

as a function of concentration. 

Draw a best-fit straight line through the data points and extrapolate to 

zero concentration. The standard deviation at zero concentration is 

So. 

Calculate the LOD0 (referred to as the calculated LOD) as 3 times So. 

* * * * * 

[FR Doc. 2011–12058 Filed 5–17–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0263; FRL–8865–8] 

Spirotetramat; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spirotetramat, 

including its metabolites and 

degradates, in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

18, 2011. Objections and requests for 

hearings must be received on or before 

July 18, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0263. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Rita 

Kumar, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8291; e-mail address: 

kumar.rita@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods & Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0263 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 18, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0263, by one of 

the following methods: 


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• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of June 10, 

2009 (74 FR 27538) (FRL–8417–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9F7537) by Bayer 

CropScience LLC, 2 T. W. Alexander 

Drive, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.641 be amended by 

establishing tolerances for residues of 

the insecticide spirotetramat, (cis-3-(2,5- 

dimethylphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate]) and its metabolites BYI 

08330-enol (cis-3-(2,5-dimethylphenyl)- 

4-hydroxy-8-methoxy-1- 

azaspiro[4.5]dec-3-en-2-one), BYI 

08330-ketohydroxy (cis-3-(2,5- 

dimethylphenyl)-3-hydroxy-8-methoxy1-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 

pistachio at 0.25 parts per million 

(ppm); cotton, undelinted seed at 0.4 

ppm; acerola, atemoya, avocado, birida, 

black sapote, canistel, cherimoya, 

custard apple, feijoa, guava, ilama, 

jaboticaba, longan, mamey sapote, 

mango, passionfruit, persimmon, 

pulasan, rambutan, sapodilla, soursop, 

Spanish lime, star apple, starfruit, sugar 

apple, wax jambu, and white sapote at 

1.5 ppm; vegetables, legume, group 06 

(except soybean) at 4 ppm; plum, prune, 

dried at 4.5 ppm; vegetables, foliage of 

legume, except soybean, subgroup 07A 

at 5 ppm; cotton, gin byproducts at 7 

ppm; soybean at 4 ppm; soybean, forage 

at 9 ppm; soybean, aspirated grain 

fractions at 10 ppm; lychee at 12 ppm; 

and soybean, hay at 16 ppm and okra at 

2.5 ppm. That notice referenced a 

summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. A correction notice was 

published in the Federal Register on 

July 23, 2009 (74 FR 36487) (FRL–8425– 

2), and August 21, 2009 (74 FR 42302) 

(FRL–8427–1), to add papaya at 1.5 

ppm. There were no comments received 

in response to the correction notice. 

In the Federal Register of October 26, 

2009 (74 FR 54999) (FRL–8794–2) 

(docket number EPA–HQ–OPP–2009– 

0735), EPA also published a notice 

pursuant to section 3(c)(4) of the Federal 

Insecticide, Rodenticide, and Fungicide 

Act (FIFRA) as amended, announcing 

receipt of an application from Bayer 

CropScience to register new uses for 

Spirotetramat Technical and three end 

use products (EPA Registration 

Numbers 264–1049, 264–1050, 264– 

1051, 264–1065), on cotton; soybeans; 

vegetable, legume, crop group 6; acerola; 

atemoya; avocado; birida; black sapote; 

canistel; cherimoya; custard apple; 

feijoa; guava; Ilama; jaboticaba; longan; 

mamey sapota; mango; papaya; 

passionfruit; persimmon; pulasan; 

rambutan; sapodilla; soursop; Spanish 

lime; star apple; starfruit; sugar apple; 

wax jambu; white sapote; lychee; okra; 

pistachio; and dried prune. The Agency 

provided 30 days for the public to 

comment on this notice, and a comment 

dated November 25, 2009 was received 

from the Natural Resources Defense 

Council (NRDC), expressing concerns 

about both human health and 

environmental effects of spirotetramat. 

The heading of those comments 

referenced the Federal Register citation 

of October 26, 2009 (FRL–8794–2) for 

the Notice of Receipt (NOR) under 

FIFRA, but the docket number for this 

Notice of Filing (NOF) under the FFDCA 

(EPA–HQ–OPP–2009–0263). Although 

that comment was timely submitted for 

purposes of the NOR, it was not timely 

submitted for purposes of the present 

NOF. Nevertheless, the Agency has 

responded to the human health portion 

of the comments, which is relevant to 

the present NOF. The NRDC comment 

and the Agency’s response to the human 

health portion of the comment can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2009– 

0263. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance expression; and also 

revised the proposed tolerances on most 

of the commodities. In addition, EPA 

will be establishing import only 

tolerances for cotton, undelinted seed, 

and cotton gin byproduct at this time. 

The reasons for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for spirotetramat 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spirotetramat follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The acute, short-term, and long-term 

toxicity of spirotetramat is well 

understood. Spirotetramat technical 

demonstrated moderate to low acute 

toxicity via the oral, dermal, and 

inhalation routes. Spirotetramat is 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 


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toxicity studies in the dog; whereas, the 

testes-epididymides were the target 

organs following subchronic oral 

treatment of rats. Long-term toxicity 

studies reflected the short-term 

toxicological profile of spirotetramat 

with the thymus and thyroid as target 

organs following 1-year oral exposure of 

dogs. Chronic exposure of rats to 

spirotetramat also reflected the 

subchronic pattern of testicular toxicity. 

No evidence of tumor formation was 

found following long-term studies of 

rodents, and spirotetramat was also 

negative for mutagenicity and 

clastogenicity in several standard in 

vivo and in vitro assays. 

The reproductive and developmental 

toxicity potential of spirotetramat was 

tested in rats and rabbits. In addition to 

testicular histopathology observed 

following subchronic and chronic 

exposure of rats to spirotetramat, male 

reproductive toxicity was recorded in a 

2-generation reproductive toxicity 

study. However, development of the 

sexual organs of offspring (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. 

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 in/on 

Cotton, Legume Vegetables including 

Soybean (Crop Groups 6 and 7a), and 

Tropical Fruit’’; Appendix A pp 39–47 

in docket ID number EPA–HQ–OPP– 

2009–0263. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL of concern are identified. 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a population-adjusted dose (PAD) 

(a = acute or c = chronic) or a reference 

dose (RfD)—and a safe margin of 

exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROTETRAMAT FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary ..................................

(General population including infants and children).

NOAEL = 100 milligrams/kilogram/day (mg/kg/day).

UFA = 10x .....................................

UFH = 10x .....................................

FQPA SF = 1x ..............................

Acute RfD = 1.0 mg/kg/day ..........

aPAD = 1.0 mg/kg/day .................

Acute neurotoxicity (rat; gavage) 

LOAEL = 200 mg/kg/day based 

on clinical signs male and female (M&F) and decreased 

motor activity (M). 

Chronic dietary ...............................

(All populations) 

NOAEL= 5 mg/kg/day ...................

UFA = 10x .....................................

UFH = 10x .....................................

FQPA SF = 1x ..............................

Chronic RfD = 0.05 mg/kg/day .....

cPAD = 0.05 mg/kg/day ...............

Chronic toxicity (dog; dietary) 

LOAEL = 20 mg/kg/day based 

on thymus involution. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on lack of evidence of carcinogenicity in 

two oral rodent carcinogenicity studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spirotetramat, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spirotetramat tolerances in 40 

CFR 180.641. EPA assessed dietary 

exposures from spirotetramat in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

Such effects were identified for 

spirotetramat. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed 100 percent crop 

treated (PCT) and tolerance-level 

residues for all foods. Empirical and 

Dietary Exposure Evaluation Model 

(DEEMTM) (ver. 7.81) default processing 

factors were used for processed 

commodities. Drinking water was 

incorporated directly in the dietary 

assessment using the acute 

concentrations for surface water 

generated by the First Index Reservoir 

Screening Tool (FIRST) model. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

conducted a conservative chronic 

dietary assessment assuming average 

field-trial residues, empirical and 


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DEEMTM (ver. 7.81) default processing 

factors, and 100 PCT. Drinking water 

was incorporated directly in the dietary 

assessment using the chronic 

concentrations for surface water 

generated by the FIRST model. 

iii. Cancer. No evidence of 

carcinogenicity was seen in the cancer 

studies performed with spirotetramat on 

rats and mice, and EPA has classified 

spirotetramat as ‘‘not likely’’ to be a 

human carcinogen by any relevant route 

of exposure. Therefore, an exposure 

assessment to evaluate cancer risk was 

not conducted. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Tolerance-level residues and 100 PCT 

were assumed for all food commodities. 

The chronic dietary assessment 

assumed average field-trial residues and 

100 PCT. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spirotetramat in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spirotetramat. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the FIRST, and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

spirotetramat for acute exposures are 

estimated to be 0.212 parts per billion 

(ppb) for surface water and 3.96 × 10¥4

ppb for ground water. 

For chronic exposures, non-cancer 

assessments are estimated to be 1.37 × 

10¥3 ppb for surface water and 3.96 × 

10¥4 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 0.212 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 1.37 × 

10¥3 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to 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 Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of rat or rabbit to prenatal 

or postnatal exposure to spirotetramat. 

In the rat developmental toxicity study, 

toxicity to offspring was observed at the 

same dose as maternal toxicity, which 

was also the limit dose. In the 

developmental toxicity study in the 

rabbit, only maternal toxicity was 

observed. In both reproductive toxicity 

studies, toxicity to offspring (decreased 

body weight) was observed at the same 

dose as parental toxicity. Therefore, no 

evidence of increased susceptibility of 

offspring was found across four relevant 

toxicity studies with spirotetramat. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

spirotetramat is complete except for an 

immunotoxicity study and a subchronic 

neurotoxicity study which are required 

due to recent amendments to the data 

requirements in 40 CFR part 158. 

Despite the absence of these studies, 

EPA has reliable data showing an 

additional safety factor is not necessary 

to protect infants and children. 

Although the toxicology database for 

spirotetramat shows effects in the 

thymus gland, an organ of the immune 

system, this finding does not raise 

uncertainty given the lack of an 

immunotoxicity study. The endpoint 

selected for risk assessment was based 

on accelerated thymus involution and 

decreased thyroid hormone levels in the 

dog. Thymus involution has been 

demonstrated to occur in animals when 

the thyroid is induced to decrease 

hormone levels, so it is reasonable to 

conclude that the thymus involution in 

these dogs was secondary to the thyroid 

effects, rather than a direct effect on the 

immune system. The dose at which 

these effects were observed was chosen 

as a point of departure because there 

was some consistency of dose and effect 

seen across the subchronic and chronic 

toxicity studies. However, the effects 

occurred in relatively few animals and 

thus selection of this endpoint is 

considered a very protective point of 

departure; it is at least tenfold lower 

than any other potential point of 

departure. With respect to 

immunotoxicity, no immunotoxic 

effects were seen in rats or mice, the 

species in which immunotoxicity 

studies are conducted. Thus, the Agency 

does not believe that conducting a 

functional immunotoxicity study in any 

rodent species will result in a lower 

POD than that currently used for overall 

risk assessment. For this reason and 

because the current POD is considered 

extremely protective, a UFDB is not 


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needed to account for the lack of this 

study. Data regarding neurotoxicity is 

discussed in Unit III. D.3.ii. 

ii. EPA has concluded that 

spirotetramat is not a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. Although a subchronic 

neurotoxicity study is now required as 

part of the revisions to 40 CFR part 158, 

the existing toxicological database 

indicates that spirotetramat is not a 

neurotoxic chemical in mammals. The 

only clinical signs at any dose in the 

acute neurotoxicity study were staining 

of the fur or perianal region with urine 

and decreased motor activity. The urine 

staining that was identified is not 

considered a neurotoxic effect and was 

likely due to a colored metabolite that 

was excreted into the urine or feces or 

to a change in the pH of the urine due 

to an excreted metabolite. The 

decreased motor activity observed is not 

considered evidence of neurotoxicity 

because there were no effects on 

movement or gait and there were no 

confirmatory findings of neurological 

pathology. Thus, both of these effects 

are considered signs of general toxicity 

(malaise). Further, the effects seen in the 

acute neurotoxicity study are not 

corroborated by any other study in the 

database. Although brain dilation was 

found in one dog in the 1-year dog 

study, EPA concluded that this effect 

was most likely not caused by 

administration of spirotetramat given 

evidence showing this to be a congenital 

anomaly in the test species, and because 

there is no other evidence of brain 

pathology in the database. Finally, the 

conclusion that spirotetramat is not a 

neurotoxic chemical is supported by the 

fact that the acute, subchronic and 

developmental neurotoxcity studies 

available for structurally-related 

compounds (spirodiclofen and 

spiromesifen) do not show evidence of 

neurotoxicity in adults or young. 

iii. There is no evidence that 

spirotetramat results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level or average field-trial 

residues. The submitted residue data for 

tropical fruit is not appropriate for the 

proposed use pattern as the trials were 

conducted at 2X use rate. The Agency 

is thus requesting that the petitioner 

conduct bridging studies with lychee 

and guava (one trial each with four 

samples per treatment regimen) in order 

to determine the relationship between 

residues resulting from the labeled use 

pattern and that used in the submitted 

field trials. Based on this relationship, 

the submitted residue data will be 

adjusted and the appropriate tolerances 

determined. As the recommended 

tolerances are based on exaggerated-rate 

field trial data, it is likely that any 

future adjustment of these tolerances 

will be to a lower level. This risk 

assessment is thus likely to overestimate the dietary risk from 

spirotetramat residues in/on tropical 

fruit. Use of tolerance levels based on 

exaggerated application rates in a risk 

assessment will tend to overstate 

exposure even more than the 

overestimate usually supplied by use of 

the assumption of tolerance level 

residues. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to spirotetramat in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by spirotetramat. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

spirotetramat will occupy 11% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to spirotetramat 

from food and water will utilize 93% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for spirotetramat. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Spirotetramat is not registered for any 

use patterns that would result in shortterm residential exposure. Therefore, 

the short-term aggregate risk is the sum 

of the risk from exposure to 

spirotetramat through food and water, 

which has already been addressed, and 

will not be greater than the chronic 

aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Spirotetramat is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to spirotetramat through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. No evidence of tumor 

formation was found following longterm studies of rodents, and 

spirotetramat was also negative for 

mutagenicity and clastogenicity in 

several standard in vivo and in vitro 

assays. Spirotetramat has been classified 

as ‘‘not likely’’ to be a human carcinogen 

by any relevant route of exposure and is 

not expected to pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to spirotetramat 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometry (HPLC–MS/MS) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 


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required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for spirotetramat. Canadian MRLs have 

been established and are harmonized 

with the United States. 

C. Response to Comments 

There were no timely comments 

received in response to the notice of 

filing. However, as described in Unit II, 

the NRDC did submit comments well 

after the close of the comment period on 

the notice of filing that pertain, in part, 

to the risk determinations made in this 

rulemaking. Both the comment and the 

Agency’s response to the human health 

portion of the comment can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2009–0263. 

In brief, NRDC challenged EPA’s 

determination to remove the children’s 

safety factor on two grounds. First, 

NRDC questioned whether EPA had 

accurately determined, based on several 

developmental studies, that the young 

did not demonstrate any quantitative 

sensitivity compared to adults. NRDC 

did not assert that the studies showed 

quantitative sensitivity but suggested 

that, given the wide dose spacing in the 

studies, if the studies had used a tighter 

dose spacing, they might have shown 

that maternal and fetal effects did not 

occur at the same dose. While NRDC 

makes an interesting theoretical point, 

the fact of the matter is that the best data 

available showed no sensitivity in the 

young and, more importantly, these data 

identify a clear NOAEL for the effects 

seen in the young. Thus, EPA has a 

reliable basis for choosing a safe dose 

that is protective of the safety of infants 

and children. A finding on the 

sensitivity of the young is not 

determinative by itself on the safety of 

the pesticide or on the applicability of 

the children’s safety factor; rather, the 

fundamental question is whether there 

are reliable data on safety. Moreover, the 

impact of use of the wide dose spacing 

here compared to a narrower spacing of 

doses is likely to provide a larger margin 

of safety for infants and children. A 

tighter dose spacing may provide greater 

precision with regard to the level at 

which effects occur and do not occur in 

the maternal compared to the juvenile 

animals; however, to the extent these 

revised dose levels provide more precise 

information on the NOAEL, that NOAEL 

could only be higher (and potentially 

significantly higher given the wide dose 

spacing). Thus, the wide dose spacing 

may very well provide a lower POD (by 

overstating the NOAEL), and thus a 

more conservative basis, for assessing 

risk. 

Second, NRDC argued that EPA did 

not adequately take into account the 

severity of the effects relating to the 

young seen in the spirotetramat 

database. NRDC cites malformations and 

skeletal defects in the rat developmental 

study, thyroid effects in the chronic dog 

study, neurotoxicity (staining of the fur 

with urine) in a rat study, and the 

potential that spirotetramat ‘‘may impair 

the synthesis of lipids that are necessary 

for the formation of cell membranes— 

including those of brain cells—and for 

hormone synthesis.’’ EPA adequately 

considered each of these effects. As to 

the malformations and skeletal defects, 

EPA notes that while these effects are 

serious they occurred at a dose level 

10,000 to 20,000 times higher than the 

safe dose level chosen by EPA. With 

regard to the thyroid effects, EPA 

believes that it took a very conservative 

approach to even treating the observed 

decrease in thyroid levels as an adverse 

effect given the absence of any 

corroborating signs of thyroid toxicity in 

the relevant studies. Notably, these 

studies show no decreases in thyroid 

weight, no thyroid histopathology, no 

compensatory increases in thyroid 

stimulating hormone (TSH), no effect on 

UDP-glucuronosyltransferase activity, 

and no clinical signs of toxicity or 

changes in body weight that might 

result from decreased thyroid output. In 

any event, there was a clear NOAEL for 

these minimal thyroid effects and EPA 

reduced this NOAEL by a 100X SF in 

deriving a safe dose for spirotetramat. 

Next, EPA disputes NRDC’s claim that 

spirotetramat has neurotoxic effects. 

The staining of the fur seen in one study 

is not a neurotoxic effect but likely the 

result of the use of a colored metabolite 

in the study that was excreted in the 

urine. No other effects in the database 

could be corroborated as neurotoxic. 

Finally, NRDC’s speculation that 

spirotetramat may interfere with the 

synthesis of lipids necessary to cell 

growth is not supported by the 

spirotetramat mammalian toxicity 

database. While spirotetramat does 

interfere with lipid biosynthesis in 

insects, the mammalian database shows 

no effects on plasma lipid parameters 

such as plasma triglycerides and plasma 

cholesterol which would be indicative 

of disruption of lipid biosynthesis in 

mammals. 

D. Revisions to Petitioned-for 

Tolerances 

Based on residue data submitted with 

this petition, several petitioned-for 

tolerances were revised. Additionally, 

as a result of the potential for increased 

dietary exposure to livestock, it was 

considered necessary to establish a 

tolerance for eggs and for meat 

byproducts of hog and poultry, and 

revise the tolerances on meat 

byproducts of cattle, goat, horse, and 

sheep. The proposed tolerance on dried 

prunes was not required as residues in 

the processed commodity are not 

expected to exceed the tolerance 

established for the raw agricultural 

commodity. A crop group tolerance on 

tropical fruits was not established 

because this is not a recognized crop 

group. Instead, tolerances on several 

individual tropical fruit commodities 

were established. Tolerances on sugar 

apple, atemoya, custard apple, 

cherimoya, ilama, soursop, and birida 

were not established, because field trial 

residue data were not submitted. A 

chart listing the petitioned-for 

tolerances and EPA recommended 

tolerances can be found at http:// 

www.regulations.gov in document 

‘‘Spirotetramat. Human-Health Risk 

Assessment for Proposed Uses in/on 

Cotton, Legume Vegetables including 

Soybean (Crop Groups 6 and 7a), and 

Tropical Fruits’’ at page 47 in docket ID 

number EPA–HQ–OPP–2009–0263. 

EPA has also revised the tolerance 

expression in paragraphs (a)(1) and 

(a)(2) to clarify that, as provided in 

FFDCA section 408(a)(3), the tolerance 

covers metabolites and degradates of 

spirotetramat not specifically 

mentioned; and that compliance with 

the specified tolerance levels is to be 

determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

EPA has also added a footnote to 

currently established tolerances for 

onion, bulb, subgroup 3A–07 and 

strawberry to indicate that currently 

there are no U.S. registrations for these 

commodities. Use on these two 

commodities was assessed for import 

tolerances only. 

EPA is establishing import only 

tolerances for cotton, undelinted seed, 

and cotton gin byproducts at this time, 

because the use on cotton under FIFRA, 

7 U.S.C. 136 et seq., has not been 

approved. The Agency has concerns 

with potential hazard of toxicity to bees, 

and use on cotton cannot be approved 


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until these concerns have been 

addressed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spirotetramat, including 

its metabolites and degradates, in or on 

the commodities listed in the regulatory 

text. Compliance with the tolerance 

levels is to be determined by measuring 

only the sum of spirotetramat and its 

metabolites calculated as the 

stoichiometric equivalent of 

spirotetramat, in or on the commodities. 

In addition, the proposed uses and the 

submitted data also support permanent 

tolerances for residues of the insecticide 

spirotetramat, including its metabolites 

and degradates, in or on the 

commodities listed in the regulatory 

text. Compliance with the tolerance 

levels is to be determined by measuring 

only the sum of spirotetramat and its 

metabolite, calculated as the 

stoichiometric equivalent of 

spirotetramat, in or on the commodities. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 2, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 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 amended by 

revising paragraph (a) to read as follows: 

§ 180.641 Spirotetramat; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide spirotetramat, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of spirotetramat 

(cis-3-(2,5-dimethlyphenyl)-8-methoxy2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate) and its metabolites cis-3-(2,5- 

dimethylphenyl)-4-hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one, cis-3- 

(2,5-dimethylphenyl)-3-hydroxy-8- 

methoxy-1-azaspiro[4.5]decane-2,4- 

dione, cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro[4.5]dec-3-en4-yl beta-D-glucopyranoside, and cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]decan-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on the 

following commodities. 

Commodity Parts per 

million 

Acerola ........................................ 2 .5 

Almond, hulls .............................. 9 .0 

Aspirated grain fractions ............. 10 .0 

Avocado ...................................... 0 .60 

Black sapote ............................... 0 .60 

Brassica, head and stem, subgroup 5A ................................. 2 .5 

Brassica, leafy, subgroup 5B ..... 8 .0 

Canistel ....................................... 0 .60 

Citrus, oil ..................................... 6 .0 

Cotton gin byproducts1 ............... 10 .0 

Cotton, undelinted seed1 ............ 0 .30 

Feijoa .......................................... 0 .30 

Fruit, citrus, group 10 ................. 0 .60 

Fruit, pome, group 11 ................. 0 .70 

Fruit, stone, group 12 ................. 4 .5 

Grape, raisin ............................... 3 .0 

Guava ......................................... 2 .5 

Hop, dried cones ........................ 10 .0 

Jaboticaba .................................. 2 .5 

Longan ........................................ 13 .0 

Lychee ........................................ 13 .0 

Mamey sapote ............................ 0 .60 

Mango ......................................... 0 .60 

Nut, tree, group 14 ..................... 0 .25 

Okra ............................................ 2 .5 

Onion, bulb, subgroup 3A–071 ... 0 .30 

Papaya ........................................ 2 .5 

Passionfruit ................................. 2 .5 

Pistachio ..................................... 0 .25 

Potato, flakes .............................. 1 .6 

Pulasan ....................................... 13 .0 

Rambutan ................................... 13 .0 

Sapodilla ..................................... 0 .60 


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Commodity Parts per 

million 

Small fruit vine climbing subgroup, except fuzzy kiwifruit, 

subgroup 13–07F .................... 1 .3 

Soybean forage .......................... 8 .0 

Soybean hay ............................... 16 .0 

Soybean seed ............................. 5 .0 

Spanish lime ............................... 0 .60 

Star apple ................................... 0 .60 

Starfruit ....................................... 2 .5 

Strawberry1 ................................. 0 .40 

Vegetable, cucurbit, group 9 ...... 0 .30 

Vegetable, foliage of legume, except soybean, subgroup 07A .. 7 .0 

Vegetable, fruiting, group 8 ........ 2 .5 

Vegetable, legume, group 06, 

except soybean ....................... 2 .5 

Vegetable, leafy, except brassica, group 4 ........................... 9 .0 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0 .60 

Wax jambu .................................. 2 .5 

Commodity Parts per 

million 

White sapote ............................... 0 .60 

1 Import tolerance only. There are no U.S. 

registrations for cotton, onion or strawberry. 

(2) Tolerances are also established for 

residues of the insecticide spirotetramat, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of spirotetramat (cis-3-(2,5- 

dimethlyphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate]) and its metabolite cis-3-(2,5- 

dimethylphenyl)-4-hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on the 

following commodities: 

Commodity Parts per 

million 

Cattle, fat ...................................... 0.02 

Cattle, meat .................................. 0.02 

Cattle, meat byproducts ............... 0.20 

Eggs .............................................. 0.02 

Goat, fat ........................................ 0.02 

Goat, meat .................................... 0.02 

Goat, meat byproducts ................. 0.20 

Hog, meat byproducts .................. 0.02 

Horse, fat ...................................... 0.02 

Horse, meat .................................. 0.02 

Horse, meat byproducts ............... 0.20 

Milk ............................................... 0.01 

Poultry, meat byproducts .............. 0.02 

Sheep, fat ..................................... 0.02 

Sheep, meat ................................. 0.02 

Sheep, meat byproducts .............. 0.20 

* * * * * 

[FR Doc. 2011–11937 Filed 5–17–11; 8:45 am] 

BILLING CODE 6560–50–P 


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