24428 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

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: April 20, 2010. 

G. Jeffrey Herndon, 

Acting 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 180.474 is amended by 

revising the introductory text of 

paragraphs (a)(1), (a)(2), and (c) and 

alphabetically add the commodity 

‘‘vegetable, fruiting, group 8’’ to the table 

in paragraph (a)(1) to read as follows: 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

tebuconazole, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

tebuconazole (alpha-[2-(4- 

chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol), in or on the commodity. 

Commodity Parts per million 

* * * * * 

Vegetable, fruiting, 

group 8 .............. 1.3 

* * * * * 

(2) Tolerances are established for 

residues of the fungicide tebuconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only the sum of tebuconazole 

(alpha-[2-(4-chlorophenyl)ethyl]-alpha- 

(1,1-dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol) and its diol metabolite (1-(4- 

chlorophenyl)-4,4-dimethyl-3-(1H 

-1,2,4-triazole-1-yl-methyl)-pentane-3,5- 

diol), calculated as the stoichiometric 

equivalent of tebuconzole, in or on the 

commodity. 

* * * * * 

(c) Tolerances with Regional 

Registrations. Tolerances are established 

for residues of the fungicide 

tebuconazole, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only tebuconazole, alpha-[2- 

(4-chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on the commodity. 

* * * * * 

[FR Doc. 2010–10406 Filed 5–4–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0139; FRL–8820–4] 

Spirodiclofen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spirodiclofen 

per se (3-(2,4-dichlorophenyl)-2-oxo-1- 

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate) in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

5, 2010. Objections and requests for 

hearings must be received on or before 

July 6, 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–2009–0139. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Rita 

Kumar, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 


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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 24429 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8291; e-mail address: 

kumar.rita@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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–2009–0139 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 6, 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 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–2009–0139, 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 June 10, 

2009 (74 FR 27538) (FRL–8915–5), 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 8F7500) by Bayer 

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

Alexander Dr., Research Triangle Park, 

N.C. 27709. The petition requested that 

40 CFR 180.608 be amended by 

establishing tolerances for residues of 

the insecticide spirodiclofen,(3-(2,4- 

dichlorophenyl)-2-oxo-1- 

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate), in or on avocado, 

black sapote, canistel, mamey sapote, 

mango, papaya, sapodilla, and star 

apple at 1.3 parts per million (ppm). 

That notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerances to 1.0 ppm; and 

changed the tolerance expression to 

spirodiclofen per se (3-(2,4- 

dichlorophenyl)-2-oxo-1- 

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate). 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 spirodiclofen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spirodiclofen 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. 

Spirodiclofen has a low acute toxicity 

via the oral, dermal, and inhalation 

routes. It is not an eye or dermal irritant. 

However, it is a potential skin 

sensitizer. Following oral 

administration, spirodiclofen is rapidly 

absorbed, metabolized, and excreted via 

urine and feces. A rat whole body 

autoradiography study showed no 

accumulation in any specific organs or 

tissues following oral administration. 

Evidence of developmental toxicity was 

not observed in the rabbit 

developmental toxicity study. The rat 


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developmental toxicity study resulted in 

an increased incidence of slight 

dilatation of the renal pelvis 1,000 

milligrams/kilograms/day (mg/kg/day); 

highest dose tested (HDT) at a dose 

which did not cause maternal toxicity. 

In the 2-generation reproductive toxicity 

study, developmental effects were 

observed in F1 males (i.e., delayed 

sexual maturation, decreased testicular 

spermatid and epididymal sperm counts 

(oligospermia); and atrophy of the 

testes, epididymides, prostate, and 

seminal vesicles) and F1 females (i.e., 

increased severity of ovarian luteal cell 

vacuolation/degeneration) but at a 

higher dose (1,750 ppm) than the 

systemic effects seen for parents and 

offspring (350 ppm). Spirodiclofen did 

not show any evidence of neurotoxicity 

in the acute and subchronic 

neurotoxicity studies. In a 

developmental neurotoxicity study 

(DNT), a decrease in retention was 

observed in the memory phase of the 

water maze for postnatal day (PND) 60 

females at all doses. In this DNT study, 

the morphometric measurements were 

not performed at the low- and middoses; therefore, the registrant 

conducted a new study using identical 

experimental conditions as the previous 

study. The results of the new study 

demonstrated no treatment related 

maternal or offspring toxicity at the 

HDT. Therefore, it can be concluded 

that spirodiclofen is unlikely to be a 

neurotoxic or developmentally 

neurotoxic compound. 

Spirodiclofen has been shown to have 

adverse effects on several organs of the 

endocrine system at relatively low 

doses. Testicular effects were observed 

in dogs, rats, and mice, manifested as 

Leydig cell vacuolation in dogs, 

hypertrophy in dogs and mice, and 

hyperplasia progressing to adenomas in 

rats, following chronic exposure. In 

female rats, increased incidence of 

uterine nodules and uterine 

adenocarcinoma were observed at 

terminal sacrifice in the chronic toxicity 

study. Cytoplasmic vacuolation in the 

adrenal cortex, accompanied by 

increased adrenal weight, was 

consistently observed in rats, dogs, and 

mice of both sexes. 

Chronic toxicity and carcinogenicity 

studies showed increased incidence of 

uterine adenocarcinoma in female rats, 

Leydig cell adenoma in male rats, and 

liver tumors in mice. EPA classified 

spirodiclofen as ‘‘likely to be 

carcinogenic to humans’’ by the oral 

route based on evidence of testes Leydig 

cell adenomas in male rats, uterine 

adenomas and/or adenocarcinoma in 

female rats, and liver tumors in mice. 

Mutagenicity studies conducted with 

the technical spirodiclofen formulation 

and its major metabolites did not 

demonstrate any mutagenic potential. 

EPA has determined that quantification 

of human cancer risk using a linear lowdose extrapolation approach is 

appropriate. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spirodiclofen 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 

‘‘Human Health Risk Assessment 

Associated with the Section 3 

Registration Application for Avocado, 

Black Sapote, Canistel, Mamey Sapote, 

Mango, Papaya, Sapodilla, and Star 

Apple,’’ p.10 in docket ID number EPA– 

HQ–OPP–2009–0139. 

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 spirodiclofen used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Human Health Risk Assessment 

Associated with the Section 3 

Registration Application for Avocado, 

Black Sapote, Canistel, Mamey Sapote, 

Mango, Papaya, Sapodilla, and Star 

Apple,’’ p. 12 in docket ID number EPA– 

HQ–OPP–2009–0139. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spirodiclofen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spirodiclofen tolerances in 40 

CFR 180.608. EPA assessed dietary 

exposures from spirodiclofen 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 spirodiclofen; 

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 

Continuing Survey of Food Intake 

(CSFII). As to residue levels in food, 

EPA assumed the following: 

a. Average field trial residues; 

b. Experimentally determined 

processing factors for apple and grape 

processed commodities and for citrus 

oil, peeled citrus, and citrus peel (DEEM 

(ver 7.81) defaults assumed for the 

remaining processed commodities); and 

c. Maximum reasonably balanced 

livestock diets. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. Based 

on the data summarized in Unit III.A., 

EPA has classified spirodiclofen as 

‘‘Likely to be Carcinogenic to Humans’’ 

and used a linear approach to quantify 

cancer risk. Exposure for evaluating 

cancer risk was assessed using the same 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

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

to use available data and information on 

the anticipated residue levels of 


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pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

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

and authorized under FFDCA section 

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

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Average field trial residues were 

assumed for chronic and cancer 

analysis. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition A: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition B: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition C: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: Hop (92%), 

pome fruit (15%), stone fruit (10%), 

grape (7%), and citrus (14%). 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition A, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions B and C, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which spirodiclofen may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spirodiclofen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spirodiclofen. 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 PRZM/EXAMS and 

Screening Concentration in Ground 

Water (SCI-GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of spirodiclofen for chronic 

exposures for non-cancer assessments 

are estimated to be 4.99 ppb for surface 

water and 0.44 ppb for ground water. 

The EDWCs of spirodiclofen for chronic 

exposures for cancer assessments are 

estimated to be 1.67 ppb for surface 

water and 0.44 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 4.99 

ppb was used to assess the contribution 

to drinking water. 

For cancer dietary risk assessment, 

the water concentration of value 1.67 

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). 

Spirodiclofen 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 spirodiclofen to 

share a common mechanism of toxicity 

with any other substances, and 

spirodiclofen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that spirodiclofen 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. 

The spirodiclofen toxicity database is 

adequate to evaluate the potential 

increased susceptibility of infants and 

children. In 2004, the Agency 

determined that there is no evidence 

(qualitative or quantitative) of increased 


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24432 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

susceptibility in the rabbit 

developmental toxicity study or in the 

rat reproduction toxicity study 

following in utero and/or pre-/post-natal 

exposure of spirodiclofen. However, 

evidence for quantitative susceptibility 

was observed in a rat developmental 

toxicity study where an increased 

incidence of slight dilatation of the 

renal pelvis was observed at a dose 

(1,000 mg/kg/day; the limit dose) which 

did not cause any maternal toxicity. 

Two rat developmental neurotoxicity 

(DNT) studies were submitted to EPA 

following the assessment in 2004. The 

first study demonstrated increased 

susceptibility in the offspring based on 

the observed decreased retention in the 

memory phase of the water maze for 

postnatal day 60 females at all doses 

(LOAEL 6.5 mg/kg/day) and changes in 

brain morphometric parameters at the 

HDT (135.9 mg/kg/day; caudate 

putamen, parietal cortex, hippocampal 

gyrus, and dentate gyrus); there was no 

maternal toxicity at doses up to and 

including 135.9 mg/kg/day HDT. EPA 

requested information concerning the 

brain morphometric parameters in the 

low and mid doses with the petitioner 

indicating that the brain tissues were 

not appropriately preserved and 

analysis was therefore not possible. As 

a result, a second rat DNT study was 

submitted which also indicated 

increased susceptibility in offspring 

based on decreased pre-weaning body 

weight and body weight gain in males 

and females and decreased postweaning body weights in males (LOAEL 

= 119.2 mg/kg/day; NOAEL = 28.6 mg/ 

kg/day). Neurotoxicity was not observed 

in offspring in the second DNT study, 

and there was no maternal toxicity 

observed at doses up to and including 

119.2 mg/kg/day. 

EPA determined that the degree of 

concern is low for the quantitative 

susceptibility seen in the developmental 

toxicity study in rats. The increased 

incidence of slight renal pelvic dilation 

was observed at the limit-dose only 

without statistical significance and dose 

response. Renal pelvic dilation was 

considered to be a developmental delay 

and not a severe effect for 

developmental toxicity. The low 

background incidences in this study 

may be idiosyncratic to the strain of rats 

tested (Wistar), since renal pelvis 

dilations are commonly seen at higher 

incidences in other strains (SpragueDawley or Fisher) of rats. In addition, 

doses selected for risk assessment of 

spirodiclofen are much lower than the 

dose that caused these developmental 

delays. The two DNT studies suggest 

increased susceptibility of offspring due 

to exposure to spirodiclofen. However, 

there is no concern for the increased 

susceptibility seen in the first DNT 

study because the results were not 

reproduced in the second DNT study 

conducted using the identical doses and 

experimental conditions. The concern 

for increased susceptibility in the 

second DNT study is low because there 

is a well established NOAEL, marginal 

toxicity (slight changes in body 

weights), and all developmental/ 

functional parameters were comparable 

to controls. In addition, doses selected 

for risk assessment of spirodiclofen are 

much lower than the dose that caused 

these marginal changes in the body 

weights of offspring in the second DNT 

study. There was no evidence of 

increased susceptibility in the 

developmental toxicity study in rabbits 

or the 2-generation reproduction study 

in rats. 

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 

spirodiclofen is complete except for an 

immunotoxicity study which is required 

as a part of new data requirements in 

the 40 CFR part 158. However, the 

Agency does not believe that conducting 

a functional immunotoxicity study will 

result in a lower POD than that 

currently used for overall risk 

assessment. The toxicology database for 

spirodiclofen does not show any 

evidence of treatment-related effects on 

the immune system. The overall weight 

of evidence suggests that this chemical 

does not target the immune system. 

Therefore, a database uncertainty factor 

(UFDB) is not needed to account for the 

lack of this study. 

ii. Based on the results of acute, 

subchronic and developmental 

neurotoxicity studies in rats (see Units 

III.A. and III.D.2.), EPA has concluded 

that there is no indication that 

spirodiclofen is a neurotoxic chemical. 

iii. There is no evidence (qualitative 

or quantitative) of increased 

susceptibility in the rabbit 

developmental toxicity study or in the 

rat reproduction toxicity study 

following in utero and/or pre-/post-natal 

exposure of spirodiclofen. However, 

evidence for quantitative susceptibility 

was observed in a rat developmental 

toxicity study and the second DNT 

study. See Unit III.D.2. for a detailed 

discussion of why EPA determined that 

the degree of concern is low for the 

quantitative susceptibility seen in this 

studies. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed using reliable PCT 

information and anticipated residue 

values calculated from residue field trial 

results. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to spirodiclofen in 

drinking water. Residential exposures 

are not expected. These assessments 

will not underestimate the exposure and 

risks posed by spirodiclofen. 

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, spirodiclofen 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 spirodiclofen 

from food and water will utilize 3.3% of 

the cPAD for all infants < 1 year old the 

population group receiving the greatest 

exposure. There are no residential uses 

for spirodiclofen. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Spirodiclofen is not registered for any 

uses that would result in residential 

exposure. Therefore the short-term/ 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

spirodiclofen through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in Unit III.C.1.iii. 

for cancer, EPA has concluded that 

exposure to spirodiclofen to cancer from 


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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 24433 

food and water will result in a life-time 

cancer risk of 3 x 10-6. EPA generally 

considers cancer risks in the range of 

10-6 or less to be negligible. The 

precision which can be assumed for 

cancer risk estimates is best described 

by rounding to the nearest integral order 

of magnitude on the log scale; for 

example, risks falling between 3 x 10-7

and 3 x 10-6 are expressed as risks in the 

range of 10-6. Considering the precision 

with which cancer hazard can be 

estimated, the conservativeness of lowdose linear extrapolation, and the 

rounding procedure described above in 

this Unit, cancer risk should generally 

not be assumed to exceed the 

benchmark level of concern of the range 

of 10-6 until the calculated risk exceeds 

approximately 3 x 10-6. This is 

particularly the case where some 

conservatism is maintained in the 

exposure assessment. For the reasons 

explained below in this Unit, EPA 

concludes that there are significant 

conservatisms in the spirodiclofen 

exposure assessment. First, residue 

values are based on average field trial 

levels and not monitoring data. 

Monitoring data tends to be significantly 

lower than field trial data and the 

spirodiclofen monitoring data confirms 

this (all less than the limit of detection 

(LOD); LOD = 0.001-0.05 ppm; 2.5-23x 

lower than the residue used in the 

cancer assessment). Second, based on a 

critical commodity analysis conducted 

in DEEM-FCID, the major contributors 

to the cancer risk were hops (40% of the 

total exposure), water (19% of the total 

exposure), and orange juice (16% of the 

total exposure) and conservative residue 

estimates were used for these three 

commodities as follows: 

i. Hops. Dietary exposure from hops is 

the result of beer consumption. DEEMFCID assumes that 100% of the residue 

in hops are transferred to beer during 

the brewing process (no residue remain 

in/on the spent hops). Since 

spirodiclofen has low water solubility, 

this is a conservative assumption; 

ii. Drinking water. The water residue 

estimate assumed 87% of the basin is 

cropped with 100% of the crops treated. 

Spirodiclofen is proposed/registered for 

application to orchard crops (pome 

fruit, citrus fruit, stone fruit, tree nuts, 

grape, and tropical fruits) which are 

unlikely to occupy 87% of a water 

basin. In addition, it is unlikely that 

spirodiclofen will capture the entire 

market within a water basin. 

iii. Orange juice. Pending the 

submission of a new orange processing 

study, default grapefruit (2.1x), lemon 

(2.0x), lime (2.0x), orange (1.8x), and 

tangerine (2.3x) juice processing factors 

were assumed. In all likelihood this 

exaggerates exposure estimates given 

that grape and apple processing studies 

with spirodiclofen resulted in a 

reduction in residues in juice. 

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 spirodiclofen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(a liquid chromatography (LC)/mass 

spectrometry (MS)/(MS) method) 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 

There are no Codex, Canadian, or 

Mexican maximum residue limits 

(MRLs) in/on these crops. 

C. Response to Comments 

There were no comments received in 

response to the notice of filing of the 

pesticide petition 8F7500. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the proposed 

tolerance levels and tolerance 

expression of spirodiclofen in/on the 

following commodities: Avocado from 

1.3 ppm to 1.0 ppm; black sapote from 

1.3 ppm to 1.0 ppm; canistel from 1.3 

ppm to 1.0 ppm; mamey sapote from 1.3 

ppm to 1.0 ppm; mango from 1.3 ppm 

to 1.0 ppm; papaya from 1.3 ppm to 1.0 

ppm; sapodilla from 1.3 ppm to 1.0 

ppm; and star apple from 1.3 ppm to 1.0 

ppm. Based on review of the residue 

chemistry data submitted in support of 

this petition, EPA concluded that 1.0 

ppm tolerance for residues of 

spirodiclofen per se in/on these crops is 

appropriate. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spirodiclofen per se, (3- 

(2,4-dichlorophenyl)-2-oxo-1- 

oxaspiro[4,5]dec-3-en-4-yl 2,2- 

dimethylbutanoate), in or on avocado, 

black sapote, canistel, mamey sapote, 

mango, papaya, sapodilla, and star 

apple at 1.0 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 


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24434 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations 

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: April 20, 2010. 

G. Jeffrey Herndon, 

Acting 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 § 180.608, alphabetically add the 

following commodities to the table in 

paragraph (a)(1) to read as follows: 

§ 180.608 Spirodiclofen; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

* * * * * 

Avocado .................... 1.0 

Black sapote ............. 1.0 

Canistel ..................... 1.0 

* * * * * 

Mamey sapote .......... 1.0 

Mango ....................... 1.0 

* * * * * 

Papaya ...................... 1.0 

* * * * * 

Sapodilla ................... 1.0 

Star apple .................. 1.0 

* * * * * 

[FR Doc. 2010–10129 Filed 5–4–10; 8:45 am] 

BILLING CODE 6560–50–S 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Parts 300–3, 301–10, 301–51, 

301–52, 301–70, 301–75, Appendix C to 

Chapter 301, 302–6, and 302–9 

[FTR Amendment 2010–02; FTR Case 2010– 

302; Docket Number 2010–0010, sequence 

1] 

RIN 3090–AJ02 

Federal Travel Regulation (FTR); 

Transportation in Conjunction With 

Official Travel and Relocation 

AGENCY: Office of Governmentwide 

Policy, General Services Administration 

(GSA). 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Federal Travel Regulation (FTR), by 

adding new terms and definitions for 

‘‘Official travel’’ and ‘‘Transit system’’; 

clarifies reimbursement for 

transportation at an official station 

while en route to and/or from an 

authorized temporary duty (TDY) 

location; clarifies reimbursement for 

transportation expenses within the 

surrounding area of a TDY location and 

provisions for payment under the FTR; 

and clarifies when the Government 

contractor-issued travel charge card 

must be used while on official travel. 

Clarification of this rule is addressed in 

the supplementary information below. 

DATES: Effective date: This final rule is 

effective June 4, 2010. Applicability 

date: This final rule is applicable to 

travel performed on and after June 4, 

2010. 

FOR FURTHER INFORMATION CONTACT: The 

Regulatory Secretariat (MVCB), Room 

4041, GS Building, Washington, DC 

20405, (202) 501–4755, for information 

pertaining to status or publication 

schedules. For clarification of content, 

contact Rick Miller, Office of 

Governmentwide Policy, at (202) 501– 

3822 or e-mail at rodney.miller@gsa.gov. 

Please cite FTR Amendment 2010–02, 

FTR case 2010–302. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Title 5, United States Code § 5707 (5 

U.S.C. 5707), authorizes the 

Administrator of General Services to 

prescribe necessary regulations to 

implement laws regarding Federal 

employees who are traveling while in 

the performance of official business 

away from their official stations. 

Similarly, 5 U.S.C. 5738 mandates that 

the Administrator of General Services 

prescribe regulations relating to official 

relocation. The overall implementing 

authority is the Federal Travel 

Regulation (FTR), codified in Title 41 

Code of Federal Regulations, Chapters 

300–304 (41 CFR chapters 300–304). 

Expenses incurred at an employee’s 

official station not in conjunction with 

TDY and/or relocation do not fall under 

the authority of the FTR. Therefore, this 

final rule adds terms and definitions for 

‘‘Official travel’’ and ‘‘Transit system’’ 

and also removes references to ‘‘local 

travel,’’ ‘‘local transit system,’’ ‘‘local 

transportation,’’ ‘‘local transportation 

system,’’ ‘‘local telephone calls,’’ and 

‘‘local metropolitan transportation 

fares,’’ for reimbursement that is not in 

conjunction with TDY and/or 

relocation. Federal employees should 

adhere to their agency’s policies for 

reimbursement of expenses incurred for 

transportation within the vicinity of 

their official stations when expenses do 

not pertain to TDY or relocation. This 

final rule clarifies that the Government 

contractor-issued travel charge card will 

only be used for the purposes of official 

travel-related expenses and not for 

personal use while on an official travel 

authorization. 

B. Executive Order 12866 

This is not a significant regulatory 

action and, therefore, was not subject to 

review under Section 6(b) of Executive 

Order 12866, Regulatory Planning and 

Review, dated September 30, 1993. This 

final rule is not a major rule under 5 

U.S.C. 804. 

C. Regulatory Flexibility Act 

This final rule will not have a 

significant economic impact on a 

substantial number of small entities 

within the meaning of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq., 

because the revisions are not considered 

substantive. This final rule is also 

exempt from the Regulatory Flexibility 

Act per 5 U.S.C. 553(a)(2) because it 

applies to agency management. 

D. Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply because the changes to the 

FTR do not impose recordkeeping or 

information collection requirements, or 

the collection of information from 

offerors, contractors, or members of the 

public that require the approval of the 

Office of Management and Budget under 

44 U.S.C. 3501, et seq. 


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