Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53581 

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). 

VIII. 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: August 20, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR part 180 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. In §180.920 add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

* * * * * * * 

Choline hydroxide (CAS Reg No. 123–41–1) Without limitation Neutralizer 

* * * * * * * 

[FR Doc. 2010–21544 Filed 8–31–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0682; FRL–8841–9] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiromesifen 

in or on leaf petioles subgroup 4B, dry 

pea seed, spearmint tops, and 

peppermint tops. The Interregional 

Research Project Number 4 (IR-4) and 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 1, 2010. Objections and 

requests for hearings must be received 

on or before November 1, 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–2009–0682. 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: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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 

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53582 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

identify docket ID number EPA–HQ– 

OPP–2009–0682 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 1, 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 

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–2009–0682, 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 March 24, 

2010 (75 FR 14156) (FRL–8815–6), 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) 0E7684 by IR-4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540 and PP 9F7602 by 

Bayer CropScience, 2 T.W. Alexander 

Drive, P.O. Box 12014, Research 

Triangle Park, NC 27709. The petitions 

requested that 40 CFR 180.607 be 

amended by establishing tolerances for 

residues of the insecticide spiromesifen, 

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

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

dimethylbutanoate, and its enol 

metabolite, 4-hydroxy-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-2-one, calculated as parent 

compound equivalents, in or on pea, 

dry, seed at 0.15 parts per million 

(ppm); spearmint, tops at 25 ppm; and 

peppermint, tops at 25 ppm (PP 0E7684) 

and vegetable, leafy petiole, crop 

subgroup 4B at 6.0 ppm (PP 9F7602). 

The notice referenced summaries of the 

petitions 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. 

Based upon review of the data 

supporting the petition, EPA has 

recommended for tolerances levels 

different from those proposed in the 

petitions for dry pea seed, spearmint 

tops, and peppermint tops. 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 spiromesifen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spiromesifen 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 

titled ‘‘Spiromesifen: Human-Health 

Risk Assessment for Proposed Section 3 

Uses on Leaf Petioles Subgroup 4B; Pea, 

Dry, Seed; Spearmint, Tops; and 

Peppermint, Tops’’ on pages 22 to 26 in 

docket ID number EPA–HQ–OPP–2009– 

0682. 

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 

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are identified (the LOAEL). 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) 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. 

A summary of the toxicological 

endpoints for spiromesifen used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROMESIFEN 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 and 

all population subgroups An endpoint of concern attributable 

to a single dose was not identified. 

An aRfD was not established. 

Chronic dietary 

(All populations) NOAEL= 2.2 mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.022 mg/kg/day 

cPAD = 0.022 mg/kg/day 

2-generation reproduction study in 

rats. 

The parental systemic LOAEL: 13.2 

mg/kgbw/day based on significantly 

decreased spleen weight (absolute 

and relative in parental females and 

F1 males) and significantly 

decreased growing ovarian follicles 

in females. 

Cancer 

(Oral, dermal, inhalation) Spiromesifen has been classified as ‘‘not likely to be carcinogenic to humans.’’ 

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. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

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 and 

spearmint and peppermint tops and oil 

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 lettuce metabolism studies 

to create a tolerance-equivalent value for 

the parent spiromesifen and the BSN 

2060-4-hydroxymethyl metabolite to 

estimate residues in leafy crops. Dietary 

Exposure Evaluation Model (DEEM) 

7.81 default processing factors and 100 

percent crop treated were assumed for 

all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that spiromesifen does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

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. As discussed above, 

for the leafy-greens and leafy Brassica 

greens subgroups (4A and 5B) and 

spearmint and peppermint tops and oil, 

the residue values were adjusted 

upward to account for the metabolite 

BSN 2060-4-hydroxymethyl (free and 

conjugated). 

2. Dietary exposure from drinking 

water. 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. 

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 exposures for 

non-cancer assessments are estimated to 

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be 188 ppb for surface water and 86 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 188 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). 

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 

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 2-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: 

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 PCT 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 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, 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 78% of 

the cPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for spiromesifen. 

3. Short- and intermediate-term risk. 

Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A short-term and intermediate-term 

adverse effect was identified; however, 

spiromesifen is not registered for any 

use patterns that would result in shortterm or intermediate-term residential 

exposure. Short-term and intermediateterm risk is assessed based on shortterm and intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term or 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term and intermediate-term 

risk), no further assessment of shortterm or intermediate-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term and intermediateterm risk for spiromesifen. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53585 

adequate rodent carcinogenicity studies, 

spiromesifen is not expected to pose a 

cancer risk to humans. 

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 

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. 

No Codex or Canadian MRLs have 

been established for spiromesifen in/on 

leaf petioles subgroup 4B; pea, dry, 

seed; spearmint, tops; and peppermint, 

tops. 

C. Revisions to Petitioned-For 

Tolerances 

Pea, dry, seed: The Agency is 

modifying the tolerance from the 

proposed level of 0.15 to 0.20. The 

adjusted field trial data for dry peas 

were evaluated using the Agency’s 

maximum-likelihood estimation (MLE) 

spreadsheet and then the Agency’s 

maximum-residue limit (MRL) tolerance 

spreadsheet as described in the 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data 

SOP to determine the appropriate 

tolerance level. The tolerance 

spreadsheet recommended a tolerance 

of 0.20 ppm for total residues of 

spiromesifen in/on dry peas. 

Spearmint, tops and peppermint, 

tops: The Agency is modifying the 

tolerances from the proposed level of 25 

ppm to 45 ppm. The adjusted field trial 

data for mint were evaluated using the 

Agency’s MRL tolerance spreadsheet as 

described in the Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data SOP to determine the 

appropriate tolerance level. The 

tolerance spreadsheet recommended a 

tolerance of 45 ppm for total residues of 

spiromesifen for both spearmint and 

peppermint tops. 

Finally, EPA has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

spiromesifen not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide/miticide 

spiromesifen, including its metabolites 

and degradates, determined by 

measuring only the sum 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), calculated 

as the stoichiometric equivalent of 

spiromesifen, in or on pea, dry, seed at 

0.20 ppm; spearmint, tops at 45 ppm; 

peppermint, tops at 45 ppm; and leaf 

petiole subgroup 4B at 6.0 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 

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53586 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

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: August 20, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Program. 

■ 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 

commodities to the table in paragraph 

(a)(1) and revising paragraphs (a)(1) 

introductory text, (a)(2) introductory 

text, (b) introductory text, and (d) 

introductory text to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide/miticide spiromesifen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of spiromesifen [2-oxo-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-4-yl 3,3-dimethylbutanoate] and 4- 

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

oxaspiro[4.4]non-3-en-2-one, calculated 

as the stoichiometric equivalent of 

spiromesifen, in or on the following 

primary crop commodities: 

Commodity Parts per million 

* * * * * 

Leaf petiole subgroup 4B ........... 6.0 

* * * * * 

Pea, dry, seed ...... 0.20 

Peppermint, tops .. 45 

Spearmint, tops .... 45 

* * * * * 

(2) Tolerances are established for 

residues of the insecticide/miticide 

spiromesifen, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of spiromesifen [2-oxo-3- 

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

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

dimethylbutanoate] and its metabolites 

containing the 4-hydroxy-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-2-one and 4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

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

calculated as the stoichiometric 

equivalent of spiromesifen, in the 

following livestock commodities: 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the insecticide/miticide 

spiromesifen, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of spiromesifen [2-oxo-3- 

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

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

dimethylbutanoate] and 4-hydroxy-3- 

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

oxaspiro[4.4]non-3-en-2-one, calculated 

as the stoichiometric equivalent of 

spiromesifen, in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

inadvertent or indirect residues of the 

insecticide/miticide spiromesifen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of spiromesifen [2-oxo-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-4-yl 3,3-dimethylbutanoate], 4- 

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

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

metabolites containing the 4-hydroxy-3- 

[4-(hydroxymethyl)-2,6- 

dimethylphenyl]-1-oxaspiro[4.4]non-3- 

en-2-one moiety, calculated as the 

stoichiometric equivalent of 

spiromesifen, in the following rotational 

crop commodities: 

* * * * * 

[FR Doc. 2010–21686 Filed 8–31–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0890; FRL–8840–9] 

Bifenazate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bifenazate in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project #4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation additionally deletes the timelimited tolerance for potato, as the 

tolerance expired on December 31, 

2006, and deletes the time-limited 

tolerances for tart cherry, soybean hulls, 

soybean meal, soybean refined oil, and 

soybean seed, as the tolerances expired 

on December 31, 2009. 

DATES: This regulation is effective 

September 1, 2010. Objections and 

requests for hearings must be received 

on or before November 1, 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–2009–0890. 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

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