5522 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

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: January 25, 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 180.621 is revised to read 

as follows: 

§ 180.621 Dithianon; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of dithianon, 

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 

dithianon, 5, 10-dihydro-5,10- 

dioxonaphtho(2,3-b)-1,4-dithiin-2,3- 

dicarbonitrile. 

Commodity Parts per 

million 

Fruit, pome, group 111 ......... 5 

Grape 2 ................................. 3 

Hop, dried cones1 ................. 100 

1No U.S. registration as of September 5, 

2006. 2No U.S. registration as of January 29, 

2010. 

(b)Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–2145 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0262; FRL–8436–9] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for the inadvertent or indirect 

combined residues of spiromesifen (2- 

oxo-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate) its enol metabolite 

(4-hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one), and its 

metabolites containing the 4- 

hydroxymethyl moiety (4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one), 

calculated as the parent compound 

equivalents, in or on the following 

commodities from crops grown as 

rotational crops: bulb vegetables. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 3, 2010. Objections and 

requests for hearings must be received 

on or before April 5, 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–2008–0262. 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: 

Jennifer Gaines, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305-5967; e-mail address: 

gaines.jennifer@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5523 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0262 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before April 5, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0262, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of November 

5, 2008 (73 FR 65851) (FRL–8385–1), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 8F7398) by Bayer 

CropScience, P.O. Box 12014, 2 T. W. 

Alexander Dr., Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.607 be amended by 

establishing tolerances for the 

inadvertent or indirect combined 

residues of the insecticide spiromesifen 

(2-oxo-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate), its enol metabolite 

(4-hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one), and its 

metabolites containing the 4- 

hydroxymethyl moiety (4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one), 

calculated as the parent compound 

equivalents, in or on the following 

commodities from crops grown as 

rotational crops: vegetable, bulb, group 

3-07 at 0.07 parts per million (ppm). 

That notice is available to the public in 

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

One comment was received on the 

notice of filing. EPA’s response to this 

comment is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for inadvertent or indirect 

combined residues of spiromesifen, (2- 

oxo-3-(2,4,6- trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate), its enol metabolite 

(4-hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one), and its 

metabolites containing the 4- 

hydroxymethyl moiety (4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one), 

calculated as the parent compound 

equivalents, on the following 

commodities from crops grown as 

rotational crops: vegetable, bulb, group 

3-07. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Spiromesifen shows low acute 

toxicity via the oral, dermal and 

inhalation routes of exposure. It was 

neither an eye nor dermal irritant, but 

showed moderate potential as a contact 

sensitizer. In short- and long-term 

animal toxicity tests, the critical effects 

observed were loss of body weight, 

adrenal effects (discoloration, decrease 

in fine vesiculation, and the presence of 

cytoplasmic eosinophilia in zona 

fasciculata cells), thyroid effects 

(increased thyroid stimulating hormone, 

increased thyroxine binding capacity, 

decreased T3 and T4 levels, colloidal 

alteration and thyroid follicular cell 

hypertrophy), liver effects (increased 

alkaline phosphatase, ALT and 

decreased cholesterol, triglycerides), 

and spleen effects (atrophy, decreased 

spleen cell count, and increased 

macrophages). Spiromesifen shows no 

significant developmental or 

reproductive effects, is not likely to be 

carcinogenic based on bioassays in rats 

and mice, and lacks in vivo and in vitro 

mutagenic effects. Spiromesifen is not 

considered a neurotoxic chemical based 

on the chemical’s mode of action and 

the available data from multiple studies, 

including acute and subchronic 

neurotoxicity studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spiromesifen 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 the document 

‘‘Spiromesifen: Human-Health Risk 

Assessment for Request to Reduce 

Rotational Crop Plantback Interval (PBI) 

for Bulb Vegetables (Crop Group 3),’’ at 

pages 11-16 in docket ID number EPA– 

HQ–OPP–2008–0262 and memo, 

D363706, June 11, 2009. 

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5524 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for spiromesifen used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document ‘‘Spiromesifen: HumanHealth Risk Assessment for Request to 

Reduce Rotational Crop Plantback 

Interval (PBI) for Bulb Vegetables (Crop 

Group 3),’’ at page 17 in docket ID 

number EPA–HQ–OPP–2008–0262. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spiromesifen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spiromesifen tolerances in (40 

CFR 180.607). EPA assessed dietary 

exposures from spiromesifen 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 spiromesifen; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Cummulative Survey of Food Intake by 

Individuals. As to residue levels in food, 

EPA assumed tolerance-level residues 

for all commodities except for the leafygreens and leafy Brassica greens 

subgroups (4A and 5B). The tolerance 

values for leafy vegetables were adjusted 

upward to account for the metabolite 

BSN 2060-4-hydroxymethyl (free and 

conjugated), which is a residue of 

concern in leafy vegetables for risk 

assessment purposes only. EPA used 

data from the metabolism studies to 

create a tolerance-equivalent value for 

the parent spiromesifen and the BSN 

2060-4-hydroxymethyl metabolite to 

estimate residues in leafy vegetables. 

Dietary Exposure Evaluation Model 

(DEEM) 7.81 default processing factors 

and 100% crop treated (CT) were 

assumed for all commodities. 

iii. Cancer. Due to no evidence of 

carcinogenic effects in the submitted rat 

and mouse cancer studies, spiromesifen 

has been classified as ‘‘not likely to be 

carcinogenic to humans.’’ Therefore, an 

exposure assessment to evaluate cancer 

risk was not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for spiromesifen. Tolerance level 

residues were used for all food 

commodities except for the leafy-greens 

and leafy Brassica greens subgroups (4A 

and 5B). For these subgroups, the 

residue values were adjusted to account 

for the metabolite BSN 2060-4- 

hydroxymethyl (free and conjugated), 

which is a residue of concern in leafy 

vegetables for risk assessment purposes 

only. The Agency assumed 100% CT for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

spiromesifen in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, the 

Agency used screening level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

spiromesifen in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

spiromesifen. 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. 

Parent spiromesifen is not likely to 

persist in the environment as it readily 

undergoes both biotic and abiotic 

degradation; however, its primary 

degradate, BSN2060-enol, is expected to 

persist. While parent spiromesifen 

strongly sorbs to sediment and is not 

likely to be mobile, its major degradates, 

BSN2060-enol and BSN2060-carboxy, 

do not sorb to sediment and are 

expected to leach into groundwater. 

Spiromesifen has limited solubility in 

water (130 micrograms/Liter (μg/L) at 

25° C) and in some cases has been 

reported to have a practical solubility of 

40 to 50 μg/L. The pesticide degrades 

primarily through aerobic soil 

metabolism and hydrolysis; however, in 

clear shallow water it will readily 

undergo photolysis. Field studies 

indicate that spiromesifen readily 

dissipates with field dissipation halflives ranging from 2 to 10 days. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

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

water concentrations (EDWCs) of 

spiromesifen for chronic exposure are 

188 parts per billion (ppb) for surface 

water and 86 ppb for ground water. For 

chronic dietary risk assessment, the 

water concentration of value 188 ppb 

was used to assess the contribution to 

drinking water. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

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). 

Spiromesifen 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 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5525 

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 spiromesifen to 

share a common mechanism of toxicity 

with any other substances, and 

spiromesifen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that spiromesifen does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

spiromesifen. In the prenatal 

developmental toxicity studies in rats 

and rabbits and in the two-generation 

reproduction study in rats, 

developmental toxicity to the offspring 

occurred at equivalent or higher doses 

than parental 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: 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 

spiromesifen is complete and no 

additional immunotoxicity or 

neurotoxicty testing is required. The 

rationale is described below: 

a. Because spleen effects were seen in 

several toxicity studies, the registrant 

pursued specialized immunotoxicity 

studies in rats and mice that were both 

negative. These studies satisfy the 

revised 40 CFR part 158 requirement for 

immunotoxicity testing. In addition, the 

endpoints selected for the risk 

assessment are considered protective of 

any possible immunotoxic effects. 

b. There is no concern for 

neurotoxicity resulting from exposure to 

spiromesifen. Neurotoxic effects such as 

reduced motility, spastic gait, increased 

reactivity, tremors, clonic-tonic 

convulsions, reduced activity, labored 

breathing, vocalization, avoidance 

reaction, piloerection, limp, cyanosis, 

squatted posture, and salivation were 

observed in two studies (5–day 

inhalation and subchronic oral rat) at 

high doses (134 and 536 milligrams/ 

kilogram/day (mg/kg/day), respectively). 

These effects were neither reflected in 

neurohistopathology nor in other 

studies. Because these effects were not 

observed in the acute and subchronic 

neurotoxicity studies, they were not 

considered reproducible. Thus, based 

on the chemical’s mode of action and 

the available data from multiple studies, 

the chemical is not considered 

neurotoxic. 

ii. There is no evidence that 

spiromesifen 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. A developmental 

neurotoxicity study is not required. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to spiromesifen 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by spiromesifen. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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, spiromesifen is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to spiromesifen 

from food and water will utilize 77% of 

the cPAD for infants (<1 year old), the 

population group receiving the greatest 

exposure. 

3. Short-term risk and intermediateterm risk. Short-term and intermediateterm aggregate exposure takes into 

account short-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Spiromesifen is not 

registered for any use patterns that 

would result in residential exposure. 

Therefore, the short-term aggregate risk 

is the sum of the risk from exposure to 

spiromesifen through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Spiromesifen has been 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ Spiromesifen 

is not expected to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to spiromesifen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography/mass spectroscopy 

(HPLC/MS/MS)/Method 00631/M001 

and Method 110333) 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 

No Codex, Canadian, or Mexican 

maximum Residue Limits have been 

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5526 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

established for residues of spiromesifen 

and its metabolites on the requested 

crops. 

C. Response to Comments 

One comment was received from an 

anonymous citizen who objected to the 

proposed use of spiromesifen because of 

the amounts of pesticides already 

approved and being approved. The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned completely. However, 

under the existing legal framework 

provided by section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA) 

EPA is authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. 

D. Revisions to Petitioned-For 

Tolerances 

Vegetable, bulb, group 3-07. Due to 

the detection of residues on onion after 

performing an extensive rotational crop 

study, Bayer then proposed changing 

the tolerance from 0.07 ppm to 0.09 

ppm. The Agency concurred with this 

proposed tolerance. Using the North 

American Free Trade Agreement 

(NAFTA) Maximum Residue Limits/ 

Tolerance Harmonization Workgroup 

methodology for evaluating field trial 

data, the Agency determined that the 

requested establishment of permanent 

tolerances in/on vegetable, bulb, group 

3-07 proposed at 0.09 ppm should be 

made. 

V. Conclusion 

Therefore, tolerances are established 

for inadvertent or indirect combined 

residues of the insecticide spiromesifen, 

(2-oxo-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate), its enol metabolite 

(4-hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one), and its 

metabolites containing the 4- 

hydroxymethyl moiety (4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one), 

calculated as the parent compound 

equivalents, in or on vegetable, bulb, 

group 3-07 at 0.09 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: January 25, 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 180.607 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (d) 

to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

* * * * * 

Vegetable, bulb, group 3-07 ......... 0.09 

* * * * * 

* * * * * 

[FR Doc. 2010–2144 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0261; FRL–8809–3] 

Chlorantraniliprole; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

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