Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60321 

(d) Effective/applicability date. This 

section is applicable beginning 

November 6, 2006. 

■ Par. 8. Section 300.6 is amended by 

adding paragraph (d) to read as follows: 

§ 300.6 Renewal of enrollment of enrolled 

agent fee. 

* * * * * 

(d) Effective/applicability date. This 

section is applicable beginning 

November 6, 2006. 

■ Par. 9. Section 300.7 is amended by 

adding paragraph (d) to read as follows: 

§ 300.7 Enrollment of enrolled actuary fee. 

* * * * * 

(d) Effective/applicability date. This 

section is applicable beginning January 

22, 2008. 

■ Par. 10. Section 300.8 is amended by 

adding paragraph (d) to read as follows: 

§ 300.8 Renewal of enrollment of enrolled 

actuary fee. 

* * * * * 

(d) Effective/applicability date. This 

section is applicable beginning January 

22, 2008. 

■ Par. 11. Section 300.9 is added to read 

as follows: 

§ 300.9 Fee for obtaining a preparer tax 

identification number. 

(a) Applicability. This section applies 

to the application for and renewal of a 

preparer tax identification number 

pursuant to 26 CFR 1.6109–2(d). 

(b) Fee. The fee to apply for or renew 

a preparer tax identification number is 

$50 per year, which is the cost to the 

government for processing the 

application for a preparer tax 

identification number and does not 

include any fees charged by the vendor. 

(c) Person liable for the fee. The 

individual liable for the application or 

renewal fee is the individual applying 

for and renewing a preparer tax 

identification number from the IRS. 

(d) Effective/applicability date. This 

section is applicable beginning 

September 30, 2010. 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: August 24, 2010. 

Michael Mundaca, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2010–24652 Filed 9–28–10; 11:15 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0616; FRL–8844–1] 

Spinosad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises 

tolerances for residues of spinosad in or 

on hog, fat; hog, meat; hog, meat 

byproducts; poultry meat byproducts. 

Elanco Animal Health (A Division of Eli 

Lilly & Company) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 30, 2010. Objections and 

requests for hearings must be received 

on or before November 29, 2010, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0616. 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: 

Samantha Hulkower, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0683; e-mail address: 

hulkower.samantha@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. 

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–2009–0616 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 November 29, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 


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60322 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

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–2009–0616, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of October 26, 

2009 (74 FR 55003) (FRL–8794–2), 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 9F7543) by Elanco 

Animal Health (A Division of Eli Lilly 

& Company), 2001 West Main Street, 

Greenfield, IN 46140. The petition 

requested that 40 CFR 180.495 be 

amended by reducing established 

tolerances for residues of the insecticide 

spinosad, a fermentation product of 

Saccharopolyspora spinosa, which 

consists of two related active 

ingredients: Spinosyn A (Factor A: CAS 

No. 131929–60–7) or 2–[(6–deoxy– 

2,3,4–tri-O-methyl-a-L-mannopyranosyl)oxy]-13-[[5-(dimethylamino)- 

tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- 

9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione; and Spinosyn D (Factor D; CAS 

No. 131929–63–0) or 2–[(6–deoxy– 

2,3,4–tri-O-methyl-a-L-mannopyranosyl)oxy]-13-[[5-(dimethyl-amino)- 

tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- 

9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione, in or on milk from 7 parts per 

million (ppm) to 5 ppm; milk, fat from 

80 ppm to 40 ppm; cattle, goat, and 

sheep, fat from 50 ppm to 30 ppm; hog, 

meat from 1.5 ppm to 0.2 ppm; hog, 

meat byproducts from 8 ppm to 0.6 

ppm; and hog, fat from 33 ppm to 2.0 

ppm. The petition additionally 

requested increases in the existing 

tolerances for residues of spinosad in or 

on poultry meat byproducts from 0.1 

ppm to 0.2 ppm and poultry, fat from 

1.3 ppm to 1.5 ppm. That notice 

referenced a summary of the petition 

prepared by Elanco Animal Health, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

concluded that revision of the proposed 

tolerances in or on hog, fat from 2.0 

ppm to 5.0 ppm; hog, meat from 0.2 

ppm to 0.50 ppm; hog, meat byproducts 

from 0.6 ppm to 2.0 ppm; poultry, meat 

byproducts from 0.10 ppm to 0.20 ppm 

is necessary and revision of the 

currently-established ruminant fat (i.e., 

cattle, goat, and sheep) and poultry, fat 

tolerances, as proposed by Elanco 

Animal Health in the petition, is 

unnecessary. The reason for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for spinosad 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spinosad 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. Spinosad has low 

acute toxicity via the oral and dermal 

routes of exposure. It is not a dermal 

sensitizer, nor inhalation, primary eye, 

or primary skin irritant. In subchronic 

toxicity studies conducted in mice 

treatment-related findings included 

vacuolation of cells of the lymphoid 

organs, liver, kidney, stomach, female 

reproductive tract, and epididymis, and 

less severely in the heart, lung, 

pancreas, adrenal cortex, bone marrow, 

tongue, pituitary gland, and anemia. In 

rats, thyroid follicle epithelial cell 

vacuolation, anemia, multifocal 

hepatocellular granuloma, 

cardiomyopathy, and splenic 

histiocytosis were observed following 

subchronic exposure, in dogs 

microscopic changes in a variety of 

tissues, anemia, and possible liver 

damage were seen with short-term 

repeated dosing. In a chronic feeding 

study in dogs, increases in serum 

alanine aminotransferase, aspartate 

aminotransferase, and triglycerides 

levels, and the presence of tissue 

abnormalities, including vacuolated cell 

aggregations, arteritis, and glandular cell 

vacuolation (parathyroid) were seen. 

Vacuolation of thyroid follicular cells, 

increased absolute and relative thyroid 

weights were observed in a chronic oral 

toxicity study in rats. Spinosad is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on lack 

of evidence for carcinogenicity of 

spinosad in mice and rats. No 

neurotoxic effects were seen in the acute 

or subchronic neurotoxicity study in 

rats. In developmental toxicity studies, 

there is no evidence of increased 

susceptibility following in utero 

exposures in rats and rabbits. In the 2– 

generation reproduction study, no 

adverse effects were observed on the 

offspring at dose levels that produced 

parental toxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spinosad 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 

‘‘Spinosad and Spinetoram. HumanHealth Risk Assessment for Direct-Spray 


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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60323 

Use on Poultry and Discontinuation by 

Voluntary Cancellation of the Cattle 

Pour-On and Direct Cattle Spray 

Registrations,’’ p. 12 in docket ID 

number EPA–HQ–OPP–2009–0616. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors (U/SF) are used in 

conjunction with the POD to calculate a 

safe exposure level – generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD) – and a safe 

margin of exposure (MOE). For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for spinosad used for human 

risk assessment can be found at http:// 

www.regulations.gov in document 

‘‘Spinosad and Spinetoram. HumanHealth Risk Assessment for Direct-Spray 

Use on Poultry and Discontinuation by 

Voluntary Cancellation of the Cattle 

Pour-On and Direct Cattle Spray 

Registrations,’’ p. 5 in docket ID number 

EPA–HQ–OPP–2009–0616. 

The Agency has concluded that 

spinosad should be considered 

toxicologically identical to another 

pesticide, spinetoram. This conclusion 

is based on the following: Spinetoram 

and spinosad are large molecules with 

nearly identical structures; and the 

toxicological profiles for each are 

similar (generalized systemic toxicity) 

with similar doses and endpoints 

chosen for human-health risk 

assessment. Spinosad and spinetoram 

should be considered toxicologically 

identical in the same manner that 

metabolites are generally considered 

toxicologically identical to the parent. 

Although, as just stated, the doses and 

endpoints for spinosad and spinetoram 

are similar, they are not identical due to 

variations in dosing levels used in the 

spinetoram and spinosad toxicological 

studies. EPA compared the spinosad 

and spinetoram doses and endpoints for 

each exposure scenario and selected the 

lower of the two doses for use in human 

risk assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spinosad/spinetoram, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spinosad/spinetoram tolerances 

in 40 CFR 180.495 and 180.635. EPA 

assessed dietary exposures from 

spinosad in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for spinosad; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, the chronic analysis 

assumed 100 percent crop treated (PCT) 

for all food crop commodities excluding 

those listed below where PCT estimates 

were incorporated to refine the livestock 

dietary burden estimates; used average 

field-trial residues for apple, Brassica 

leafy vegetables, citrus, fruiting 

vegetables, herbs, banana, grape, several 

cereal grains, and strawberry; used 

tolerance-level residues for the 

remaining food crop commodities; and 

used Dietary Exposure Evaluation 

Model DEEM(TM) (ver. 7.81) default 

processing factors for all commodities 

excluding orange juice, field corn (meal, 

starch, flour, and oil), grape juice, and 

wheat (flour and germ) where the results 

from processing factors were assumed; 

and modeled drinking water estimates. 

Tolerance level hog and poultry 

residues were assumed while the 

ruminant residue estimates were refined 

through the incorporation of average 

residues from the feeding/dermal 

magnitude of the residue studies and 

incorporation of the following projected 

combined spinosad/spinetoram PCT 

estimates to refine the ruminant dietary 

burden: Leaves of root and tuber 

vegetables – 50%; grain sorghum grain 

– 5%; soybean seed – 5%; and sweet 

corn forage – 39%. 

Spinosad is registered for application 

to all of the same crops as spinetoram, 

with similar pre-harvest and retreatment 

intervals, and application rates greater 

than or equal to spinetoram. Further, 

both products control the same pest 

species. For this reason, EPA concluded 

it would overstate exposure to assume 

that residues of both spinosad and 

spinetoram would appear on the same 

food. Rather, EPA aggregated exposure 

by either assuming that all commodities 

contain spinosad residues (because sideby-side spinetoram and spinosad 

residue data indicated that spinetoram 

residues were less than or equal to 

spinosad residues) or summing the 

percentage of a crop that would be 

treated with spinosad and the 

percentage that would be treated with 

spinetoram. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in rats and 

mice, EPA has classified spinosad as 

‘‘not likely to be carcinogenic to 

humans;’’ therefore a quantitative 

exposure assessment to evaluate cancer 

risk is unnecessary. 

iv. Anticipated residue and 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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 


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60324 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

Tolerance level hog and poultry 

residues were assumed while the 

ruminant residue estimates were refined 

through the incorporation of average 

residues from the feeding/dermal 

magnitude of the residue studies and 

incorporation of the following projected 

combined spinosad/spinetoram PCT 

estimates to refine the ruminant dietary 

burden uses as follows: 39% sweet corn 

forage; 50% leaves of root and tuber 

vegetables; 5% sorghum grain; and 5% 

soybean seed meal. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which spinosad may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spinosad in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of spinosad. 

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 Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

spinosad/spinetoram for acute 

exposures are estimated to be 14.419 

parts per billion (ppb) for surface water 

and 0.072 ppb for ground water. For 

chronic exposures for non-cancer 

assessments are estimated to be 6.171 

ppb for surface water and 0.072 ppb for 

ground water. EDWCs for spinosad for 

acute exposures are estimated to be 34.5 

parts per billion (ppb) for surface water 

and 1.1 ppb for ground water. For 

chronic exposures for non-cancer 

assessments are estimated to be 10.5 

ppb for surface water and 1.1 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 10.5 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). 

Spinosad is currently registered for 

the following uses that could result in 

residential exposures: Application to 

turfgrass and ornamentals. EPA assessed 

residential exposure using the following 

assumptions: The Agency has 

concluded that spinosad and 

spinetoram are toxicologically 

equivalent; therefore, residential 

exposure to both spinosad and 

spinetoram was evaluated. Spinosad is 

currently registered for homeowner 

application to turf grass and 

ornamentals. Spinetoram is registered 

for homeowner applications to gardens, 

lawns/ornamentals and turf grass. Since 

spinosad and spinetoram control the 

same pests, EPA concludes that these 

products will not be used for the same 

uses in combination with each other 

and thus combining spinosad and 

spinetoram residential exposures would 

overstate exposure. 

There is potential for residential 

handler and post-application exposures 

to both spinosad and spinetoram. 

However, since no dermal endpoints for 

either spinetoram or spinosad were 

identified, only short-term incidental 

oral exposures to toddlers are 

anticipated from the registered turf and 

ornamental application scenarios for 

spinosad and spinetoram and short-term 

inhalation exposure to handler/ 

applicators is anticipated for the 

registered home garden, turf, and 

ornamental application scenarios. 

Based on the low application rates, 

granular formulation, and/or low vapor 

pressure, quantitative residential 

inhalation post-application exposure 

assessments were not performed for 

spinosad or spinetoram. The Agency 

notes that the spinetoram residentialhandler inhalation MOEs were 

≥4,300,000 for house garden, home 

lawns and ornamental use; based on this 

and the low vapor pressure for 

spinosad, the Agency anticipates the 

post-application residential inhalation 

risks to be negligible. 

EPA notes that for spinosad the 

registered fruit fly bait application 

scenario permits application to noncrop vegetation and this use may result 

in residential exposures. Based on the 

application rates (fruit fly bait – 0.0003 

pounds active ingredients/acre (lb ai/ 

acre); turf/ornamental – 0.41 lbs ai/ 

acre), EPA concludes that residential 

exposure resulting from the fruit fly 

application will be insignificant when 

compared to the exposure resulting from 

homeowner uses on the turf/ 

ornamentals. Therefore, quantitative 

analysis of the residential exposure 

resulting from the fruit fly bait 

application was not performed. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

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 


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pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found spinosad/ 

spinetoram to share a common 

mechanism of toxicity with any other 

substances, and spinosad/spinetoram 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that spinosad/spinetoram 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 

Food Quality Protection Act (FQPA) SF. 

In applying this provision, EPA either 

retains the default value of 10X, or uses 

a different additional SF 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 and rabbit fetuses to 

in-utero exposure to spinosad or 

spinetoram. In the spinosad and 

spinetoram rat and rabbit 

developmental toxicity studies, no 

developmental toxicity was observed at 

dose levels that did not induce maternal 

toxicity. In the spinosad 2–generation 

reproduction studies, maternal and 

offspring toxicity were equally severe, 

indicating no evidence of increased 

susceptibility. In the spinetoram 2– 

generation reproduction study, no 

adverse effects were observed on the 

offspring at dose levels that produced 

parental toxicity. Therefore, there is no 

evidence of increased susceptibility and 

there are no concerns or residual 

uncertainties for pre-natal and/or postnatal toxicity. 

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 spinetoram 

is complete, except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(OPPTS Harmonized Test Guideline 

870.7800) required for pesticide 

registration; however, the existing data 

are sufficient for endpoint selection for 

exposure/risk assessment scenarios, and 

for valuation of the requirements under 

the FQPA. 

There was some evidence of adverse 

effects on the organs of the immune 

system at the LOAEL in three short-term 

studies with spinosad or spinetoram. In 

these studies, anemia was observed in 

multiple species (rats, mice and dogs) 

with the presence of histiocytic 

aggregates of macrophages in various 

organs and tissues (lymph nodes, 

spleen, thymus, and bone marrow). 

Aggregation of macrophages was 

indicative of immune stimulation in 

response to insults of the chemical 

exposure and was considered secondary 

effects of the toxic effect to the 

hematopoetic system. Therefore, these 

effects are not considered to be 

indicative of frank immunotoxicity. In 

the chronic study with dogs, areteritis 

and necrosis of the areterial walls of the 

thymus was seen in one female dog at 

the highest dose tested (HDT). This 

finding is attributed to the exacerbation 

of the spontaneous arteritis present in 

genetically predisposed Beagle dogs 

(‘‘Beagle Pain Syndrome’’), not 

immunotoxicity. Further, a clear 

NOAEL was attained in each of these 

studies, and the observed 

histopathologies were generally 

observed in the presence of other organ 

toxicity. In addition, spinosad and 

spinetoram do not belong to a class of 

chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. 

Based on the considerations in this 

Unit, EPA does not believe that 

conducting a special series 870.7800 

immunotoxicity study will result in a 

POD less than the NOAEL of 2.49 mg/ 

kg/day already set for spinosad and 

spinetoram. Consequently, an additional 

database UF does not need to be 

applied. 

ii. There is no indication that 

spinosad is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that spinosad 

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 

utilized 100 PCT and tolerance-level 

residues, and DEEMTM default 

processing factors for all registered and 

proposed crop commodities and all food 

commodities from livestock except 

commodities from ruminants. EPA used 

PCT information when calculating 

livestock dietary burdens for ruminants 

from sweet corn forage, leaves of root 

and tuber vegetables, sorghum grain, 

and soybean seed meal. EPA believes 

that the PCT estimates used are 

conservative estimates. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

spinosad/spinetoram in drinking water. 

EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by spinosad/spinetoram. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, spinosad is not 

expected to pose an acute risk. 

2. Chronic risk. Since there are no 

registered/proposed uses which result 

in chronic residential exposures, the 

chronic aggregate exposure assessment 

consists of exposure from food and 

water. Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 

chronic exposure to spinosad and 

spinetoram from food and water will 

utilize 94% of the cPAD for children 1– 

2 years old the population group 

receiving the greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 


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60326 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

(considered to be a background 

exposure level). 

Spinosad and spinetoram are 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to spinosad and spinetoram. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of ≥160 for all population 

subgroups. As the aggregate MOEs are 

greater than 100 for all population 

subgroups, including infants and 

children, short-term aggregate exposure 

to spinosad and spinetoram is not of 

concern to EPA. 

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). 

Spinosad and spinetoram are 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 the exposure to 

spinosad and spinetoram 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. Based on the lack of 

evidence of carcinogenicity in rats and 

mice at doses that were judged to be 

adequate to assess the carcinogenic 

potential, spinosad and spinetoram 

were classified as ‘‘not likely to be 

carcinogenic to humans,’’ and are not 

expected to pose a cancer risk to 

humans. 

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 spinosad and 

spinetoram residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methods are available for 

enforcement of the ruminant and hog 

tolerances. Method RES 94094 (GRM 

95.03; ruminant and hog); Method RES 

95114 (ruminant and hog); GRM 95.15 

(poultry). Data pertaining to 

Multiresidue Methods (MRMs) testing of 

spinosyns A, D, B, and K and Ndemethyl spinosyn D were forwarded to 

the Food and Drug Administration 

(FDA) for review. 

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 

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

The Codex Alimentarius is a joint U.N. 

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. 

Codex does have a MRLs for 

combined residues of spinosyn A and D 

in/on fat from mammals other than 

marine at 2 ppm and edible offal at 0.5 

ppm and Canada does have MRLs for 

residues of spinosyn A and D in/on hog 

fat at 5.0 ppm, hog meat byproducts at 

1.0 ppm, and hog meat at 0.2 ppm. For 

the most part, these international 

tolerances are lower than the level of the 

hog tolerances being established today. 

The Codex values were set in 2004. At 

that time only the diets of cattle (beef 

and dairy) were considered in 

establishing the MRLs, which were then 

considered adequate for all mammals, 

including hogs. However, the United 

States calculates hog exposure based on 

specific diets for finishing and breeder 

hogs. These diets are high in grains and 

grain byproducts and would not have 

included forages and other commodities 

present in the cattle diet. The diets 

considered were different, leading to 

different calculated exposures, leading 

to different MRL/tolerance estimates for 

the hog commodities. Accordingly, 

given the manner in which the Codex 

values were chosen, EPA does not 

believe it is appropriate to harmonize 

with the Codex levels. 

C. Revisions to Petitioned-For 

Tolerances 

Elanco Animal Health requested 

registration for direct spray of Elector 

PSP (EPA Reg. No. 72642–2) to poultry 

and discontinuation by voluntary 

cancellation of the cattle pour-on and 

direct cattle spray registrations for 

Elector Insect Control Product (EPA Reg. 

No. 72642–1). The petitioner also 

requested an increase in the currentlyestablished poultry fat (1.3 ppm to 1.5 

ppm), poultry meat (0.10 ppm to 0.2 

ppm), and poultry meat byproducts 

(0.10 ppm to 0.2 ppm) tolerances and a 

decrease in the currently-established 

milk (7.0 ppm to 5 ppm), milk fat (85 

ppm to 40 ppm), hog fat (33 ppm to 2.0 

ppm), hog meat (1.5 ppm to 0.2 ppm), 

hog meat byproducts (8.0 ppm to 0.6 

ppm), and ruminant fat (cattle, goat, and 

sheep – 50 ppm to 30 ppm) tolerances 

(tolerances for combined residues of 

spinosyns A and D). 

With the elimination of cattle pour-on 

and direct cattle spray uses, ruminants 

may be exposed to spinosad via 

consumption of treated feed, premise 

application, and through the feedthrough (cattle only) and ear tag uses 

(cattle only). Based on the elimination 

of the cattle dermal application scenario 

and a recalculation of spinosad residues 

in ruminant commodities from the 

consumption of treated feed, the 

petitioner requested a reduction in the 

milk, milk fat, and ruminant (cattle, 

goat, and sheep) fat tolerances. Based on 

a comparison of the estimated total 

residue without the dermal/premise 

application and the currentlyestablished tolerances, the EPA 

concludes that revision of the currentlyestablished ruminant tolerances is 

unnecessary. Since elimination of the 

dermal uses does not necessitate a 

change in the current ruminant 

tolerances, the EPA concludes that 

residues resulting from premise treated 

are insignificant when compared to the 

residue estimates from the other routes 

of exposure. 

The petitioner requested a reduction 

in the hog fat, meat, and meat 

byproducts tolerances. The current hog 

tolerances were established as part of 

the registration for application of 

spinosad to stored grains where a hog 

dietary burden of 41.2 ppm was 

calculated. As a conservative surrogate 

for residues following premise 

treatment, the results from the cattle 

dermal magnitude of the residue study 

were used (residue data following only 

premise treatment are not available). 

EPA notes that hogs have a significantly 

lower maximum reasonably balanced 

dietary burden (MRDB) than ruminants 

and the residues resulting from the 

premise treatment were therefore 

considered when establishing a 

tolerance (this is on contrast to 

ruminants where residues resulting 

from premise treatment were not 


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considered). Based on these 

calculations, the EPA concludes that 

hog tolerance should be lowered as 

follows: Hog, meat – 0.50 ppm; hog, fat 

– 5.0 ppm; and hog, meat byproducts – 

2.0 ppm. 

As part of the current request, the 

petitioner submitted a poultry 

magnitude of the residue study 

monitoring spinosad residues following 

both the proposed dermal application 

scenario (0.9x) and the currentlyregistered premise treatment (1x). Based 

on these data and the current poultry 

MRDB, the EPA concludes that the 

poultry meat byproducts tolerance 

should be increased to 0.20 ppm 

(tolerance for the combined residues of 

spinosyns A and D). All other poultry 

tolerances remain adequate. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spinosad in or on poultry 

at 0.20 ppm poultry, meat byproducts; 

and tolerances are increased as 

indicated for the following established 

commodities: Hog, fat 5.0 ppm; hog, 

meat 0.50 ppm; hog, meat byproducts 

2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 24, 2010. 

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 180.495 is amended by 

revising the following entries in the 

table in paragraph (a) to read as follows: 

§ 180.495 Spinosad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Hog, fat ........................... 5.0 

Hog, meat byproducts .... 2.0 

Hog, meat ....................... 0.50 

* * * * * 

Poultry, meat byproducts 0.20 

* * * * * 

* * * * * 

[FR Doc. 2010–24573 Filed 9–29–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0677; FRL–8845–7] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluoxastrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Arysta LifeScience North 

America, LLC requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 30, 2010. Objections and 

requests for hearings must be received 

on or before November 29, 2010, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0677. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 


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