Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3333 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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 7, 2013. 

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. In § 180.535, in paragraph (a), 

revise the introductory text and add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.535 Fluroxypyr 1-methylheptyl ester; 

tolerances for residues. 

(a) General. Tolerances are 

established for combined residues of 

fluroxypyr 1-methylheptyl ester [1- 

methylheptyl ((4-amino-3,5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid] in or on the following raw 

agricultural commodities. Compliance 

with the established tolerance levels is 

determined by measuring only the sum 

of fluroxypyr 1-methylheptyl ester [1- 

methylheptyl ((4-amino-3, 5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid] calculated as the stoichiometric 

equivalent of fluroxypyr. 

Commodity Parts per 

million 

* * * * * 

Rice, bran ..................................... 3.0 

Rice, grain .................................... 1.5 

* * * * * 

* * * * * 

[FR Doc. 2013–00562 Filed 1–15–13; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0038; FRL–9374–3] 

Spiromesifen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiromesifen 

in or on tea, dried. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 16, 2013. Objections and 

requests for hearings must be received 

on or before March 18, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0038, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

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; email 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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2012–0038 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 March 18, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0038, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 


srobinson on DSK4SPTVN1PROD with 
3334 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 

DC), (28221T), 1200 Pennsylvania Ave., 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of April 4, 

2012 (77 FR 20334–20337) (FRL–9340– 

4), EPA issued a document pursuant to 

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

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

pesticide petition (PP 1E7924) by Bayer 

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

Alexander Dr., Research Triangle Park, 

N.C. 27709. The petition requested that 

40 CFR 180.607 be amended by 

establishing tolerances for residues of 

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), in or on tea, dried at 50 parts 

per million (ppm). That document 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. Based 

upon review of the data supporting the 

petition, EPA has changed the tolerance 

for tea, dried from 50 ppm to 40 ppm. 

The reason for this change is 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 was classified as having 

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 skin 

contact sensitizer. In short- and longterm animal toxicity tests, the critical 

effects observed were loss of body 

weight, adrenal effects (discoloration, 

decrease in fine vesticulation, 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, alanine 

transaminase (ALT) and decreased 

cholesterol, and triglycerides), and 

spleen effects (atrophy, decreased 

spleen cell count, and increased 

macrophages). There were no 

developmental or reproductive effects of 

concern following oral administration of 

spiromesifen in rats or rabbits. EPA 

concluded that spiromesifen is not 

likely to be carcinogenic to humans 

based on a lack of evidence of cancer in 

bioassays in rats and mice. There were 

no in vivo or in vitro mutagenic effects 

in mutagenicity testing with 

spiromesifen. 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 document 

‘‘Spiromesifen: Human-Health Risk 

Assessment for Request for Tolerance 

without U.S. Registration in/on Tea.’’ at 

pages 20 to 24 in docket ID number 

EPA–HQ–OPP–2012–0038. 

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 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 

Table 1 of this unit. 


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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3335 

TABLE 1—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 including infants and 

children).

Not applicable .......... None ........................ 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 = 8.81 mg/kg/day based on significantly decreased 

spleen weight (absolute and relative in parental females and 

F1 males) and significantly decreased growing ovarian follicles in females. 

Dermal short-term (1 to 30 

days) and Intermediate-term 

(1 to 6 months).

None ........................ None ........................ No dermal, systemic, or developmental concerns. 

Inhalation short-term (1 to 30 

days) and Intermediate-Term 

(1 to 6 months).

Inhalation (or oral) 

study NOAEL = 

21.1 mg/kg/day 

(inhalation absorption rate = 100%).

HEC = 0.06 mg/L 

HED = 1.42 mg/kg/ 

bw/day 

LOC for MOE = 30 

(3X interspecies 

and 10X 

intraspecies extrapolations).

Subchronic (30-day) inhalation toxicity study in rats & 5-day inhalation toxicity study in rats. 

LOAEL (5-day) = 134.2 mg/kg/day based on the clinical signs 

(tremors, clonic-tonic convulsions, reduced activity, 

bradypnea, labored breathing, vocalization, avoidance reaction, giddiness, piloerection, limp, emaciation, cyanosis, 

squatted posture, apathy, salivation, gross pathology (dark 

red areas or foci in the lungs, bloated stomachs, and pale 

liver), and decreased spleen weights. 

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

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population-adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). HEC = human human-equivalent concentration. HED = human human-equivalent dose. 

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 

Cumulative Survey of Food Intake by 

Individuals, CSFII. As to residue levels 

in food, EPA assumed tolerance-level 

residues for all commodities except for 

the leafy-green and leafy-Brassica 

vegetable subgroups (4A, 4B, and 5B), 

spearmint and peppermint tops and oil, 

and tea. For these commodities, 

residues were also based on tolerance 

levels; however, a correction factor was 

applied to the tolerance levels to 

account for BSN 2060-4-hydroxymethyl 

metabolites of spiromesifen included in 

the risk assessment for these 

commodities. The additional 

metabolites, BSN 2060-4-hydroxymethyl 

and BSN 2060-4-hydroxymethylglucoside, were observed in the 

metabolism studies of lettuce only, 

comprising 21% of the total radioactive 

residues. Since the toxicity of the BSN 

2060-4-hydroxymethyl metabolites is 

expected to be comparable to the parent 

compound, it was included in the risk 

assessment for leafy crops (including 

tea, subgroups 4A, 4B, and 5B and 

spearmint and peppermint tops and oil). 

To account for this additional exposure, 

the recommended tolerance level was 

multiplied by a correction factor of 

1.3X, where 1.3 = (Metabolites in Risk 

Assessment)/(Metabolites in Tolerance 

Expression; concentrations from the 

lettuce metabolism study). Dietary 

Exposure Evaluation Model (DEEM) 

7.81 default processing factors and 100 

percent crop treated were assumed. 

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 in Unit 

III.C.1.ii., for the leafy-greens and leafy 

Brassica greens subgroups (4A, 4B, and 

5B) and spearmint and peppermint tops 

and oil, and tea, 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 Provisional Cranberry 

Model and Screening Concentration in 

Ground Water (SCI–GROW) models the 

estimated drinking water concentrations 

(EDWCs) of spiromesifen for chronic 

exposures for non-cancer assessments 

are estimated to be 188 ppb for surface 

water and 86 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 


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3336 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 

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 currently registered 

for the following uses that could result 

in residential exposures: Indoor and 

outdoor uses for the control of mites and 

whiteflies on ornamental plants in and 

around areas such as parks, golf courses, 

recreational areas, and residential and 

commercial buildings. EPA assessed 

residential exposure using the following 

assumptions: Residential handler 

inhalation exposure was assessed for 

adults mixing/loading/applying 

spiromesifen using handheld equipment 

to ornamentals. Details for the 

residential risk exposure and risk 

assessment are contained in the EPA 

public docket EPA–HQ–OPP–2012– 

0038 at http://www.regulations.gov in 

document ‘‘Spiromesifen: HumanHealth Risk Assessment for Request for 

Tolerance Without U.S. Registration in/ 

on Tea’’ on pp.15–19. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at 

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

USEPA-OPP-HED_Residential%20

SOPs_Oct2012.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 

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 Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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 following 

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. 

ii. There is no indication that 

spiromesifen 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 

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. 

iv. 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. 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 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. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

spiromesifen is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short-term 

adverse effect was identified, 

spiromesifen is not expected to pose a 

short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, spiromesifen is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

spiromesifen is 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 


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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Rules and Regulations 3337 

from aggregate exposure to spiromesifen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography/tandem mass 

spectroscopy (HPLC/MS/MS)/Method 

BS001–P09–01 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 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for spiromesifen in/on dried tea. 

C. Response to Comments 

There were no comments received. 

D. Revisions to Petitioned-For 

Tolerances 

Based on the analysis of the data 

supporting the petition, EPA has revised 

the proposed tolerance for tea, dried 

from 50 ppm to 40 ppm. EPA revised 

this tolerance level based on the 

highest-average field trial residue level 

and a processing factor for black tea. 

V. Conclusion 

Therefore, tolerances are established 

for 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), in or on 

tea, dried at 40 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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 4, 2013. 

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. In § 180.607, the table in paragraph 

(a)(1) is amended by adding, 

alphabetically, the commodity ‘‘Tea, 

dry’’ to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Tea, dry ...................................... 40 

* * * * * 

* * * * * 

[FR Doc. 2013–00728 Filed 1–15–13; 8:45 am] 

BILLING CODE 6560–50–P 


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