56892 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(379) * * * 

(i) * * * 

(B) San Diego County Air Pollution 

Control District. 

(1) Rule 2, ‘‘Definitions,’’ Rev. 

Adopted and Effective on June 30, 1999, 

Table 1—Exempt Compounds: Rev. and 

Effective on November 4, 2009. 

* * * * * 

[FR Doc. 2010–23128 Filed 9–16–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009––0623; FRL–8844–6] 

Fenarimol; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of fenarimol 

including its metabolites and degradates 

in or on vegetable, cucurbit, group 9. 

Gowan Company requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 17, 2010. Objections and 

requests for hearings must be received 

on or before November 16, 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–2009–0623. 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: 

Mary L. Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@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. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How 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–2009–0623 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 16, 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–2009–0623, 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 issue of 

September 4, 2009 (74 FR 45848) (FRL– 

8434–4), EPA issued a notice pursuant 

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

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

pesticide petition (PP 9E7566) by 

Gowan Company, 370 South Main St., 

Yuma, AZ 85364. The petition 

requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

residues of the fungicide fenarimol and 

its metabolites in or on cucurbits at 0.2 

parts per million (ppm). That notice 

referenced a summary of the petition 

prepared by Gowan Company, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

EPA has revised the commodity 

expression for cucurbits and has revised 

the tolerance expression for all 


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established commodities to be 

consistent with current Agency policy. 

The reason for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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 fenarimol 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenarimol 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. 

Fenarimol has a relatively low order 

of acute toxicity via the oral, dermal, 

and inhalation routes of exposure. It is 

not a dermal sensitizer. It is a moderate 

eye irritant and causes corneal opacity 

in rabbits. Chronic studies indicate that 

the liver is a target organ for toxicity. 

Liver toxicity was manifested by liver 

weight increases and the presence of 

‘‘fatty liver’’ in rats. In dogs, increased 

liver weights and increases in serum 

enzymes, indicative of liver toxicity, 

were noted. However, the effects of 

fenarimol on aromatase, an enzyme 

involved in the conversion of androgens 

to estrogens, is the basis for toxicity 

endpoints. The inhibition of aromatase 

by fenarimol results in adverse effects in 

both males and females as indicated in 

the reproduction and developmental 

studies. There were no indications of a 

direct effect of fenarimol on the immune 

system. Fenarimol has been classified as 

not likely to be a human carcinogen, 

and demonstrates no mutagenic effects. 

Developmental and/or reproductive 

toxicity studies showed no evidence of 

increased sensitivity or susceptibility of 

young rats or rabbits. However, 

fenarimol affects the male’s 

reproductive performance and in 

females results in dystocia. Fenarimol 

was evaluated in two special studies in 

females rats, a pubertal assay which 

screened for estrogenic and thyroid 

activity during sexual maturation and 

for abnormalities associated with sex 

organs, puberty markers, and thyroid 

tissue and an uterotrophic assay which 

screened for estrogenic effects including 

uterine weight changes measured in 

ovariectomised and immature animals. 

In the pubertal assay at 50 and 250 

milligram/kilogram/day (mg/kg/day) for 

21 days, no adverse effects were found 

except for a decrease in the thyroid 

hormone T4 and an increase in 

circulating thyroid-stimulating hormone 

(TSH) levels. In the uterotrophic assay, 

a dose of 200 mg/kg/day resulted in a 

significant increase of uterine weights 

which were accompanied by an increase 

in serum follicle-stimulating hormone 

(FSH) levels and a decrease in serum T3 

levels but at much higher doses than the 

regulatory endpoints selected. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenarimol 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 

‘‘Fenarimol. Human Health Risk 

Assessment for the Proposed New Food 

Use of Fenarimol in/on Imported 

Cucurbit Vegetables, Crop Group 9’’ at 

pp. 46–49 in docket ID number EPA– 

HQ–OPP–2009–0623. 

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 (LOC) 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 fenarimol used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENARIMOL 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 

(All populations) 

Not applicable Not applicable No appropriate hazard was identified for single-dose risk assessment. 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENARIMOL FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Chronic dietary 

(All populations) 

NOAEL= 0.6 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.006 

mg/kg/day 

cPAD = 0.006 mg/kg/ 

day 

Rat reproduction LOAEL = 1.2 mg/kg/day based on decreased live born litter size 

Dermal short-term 

(1 to 30 days) 

LOAEL = 35 mg/kg/day (dermal absorption rate = 5% 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x (as an UFL) 

LOC for MOE = 1,000 Special Reproduction Study (Rat) LOAEL = 35 mg/kg/day 

based on decreased fertility and dystocia, an indication of 

hormonal effects 

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 fenarimol, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fenarimol tolerances in 40 CFR 180.421. 

EPA assessed dietary exposures from 

fenarimol 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 fenarimol; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food 

Intakes by Individuals (CSFII). The 

chronic dietary exposure assessment for 

fenarimol is highly refined using 

anticipated residues based on USDA 

Pesticide Data Program (PDP) 

monitoring data for apples, bananas, 

cherries, grapes, and pears. Field trial 

residue data were used for cantaloupe, 

cucumber, filberts, hops, pecans, and 

summer squash. Tolerance level 

residues were assumed for all other 

commodities. Percent crop treated (PCT) 

information was used for apples, 

cherries, grapes, and pears, and 100 PCT 

was assumed for all other crops. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenarimol 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. Section 

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

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

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

and authorized under FFDCA section 

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

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

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: 

• Apples – 15%. 

• Cherries – 5%. 

• Grapes – 20%. 

• Pears – 5%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (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%. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenarimol and its degradates (U-1, U2, U-6, and U-7) in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenarimol. 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) for 


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chronic exposures for non-cancer 

assessments are estimated to be 66 parts 

per billion (ppb) for surface water and 

19 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 66 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). 

Fenarimol is currently registered for 

use on professionally managed turf 

areas, such as stadia and golf course 

tees, greens, and fairways. Short-term 

post-application dermal exposure to 

golfers is possible. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/trac/science/ 

trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found fenarimol to share 

a common mechanism of toxicity with 

any other substances, and fenarimol 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fenarimol 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 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 database for prenatal 

developmental (in rats and rabbits) and 

reproductive (in rats) toxicity is 

complete and includes special studies 

in addition to conventional guideline 

studies. The rat developmental study 

showed evidence of hydronephrosis in 

fetuses at dose levels equal to or 

possibly lower than doses causing 

maternal toxicity; however, a special 

study showed this effect to be reversible 

and therefore not considered an adverse 

effect. 

Additionally, the decreased live born 

litter size and survival indices in the rat 

multi-generation reproduction study are 

considered to be a secondary 

consequence of parental effects (e.g., 

dystocia and fertility), and is not an 

indicator of increased susceptibility. 

Therefore, there is no evidence of 

increased susceptibility of fetuses 

following in utero exposure in the rat or 

rabbit developmental toxicity study or 

of offspring following prenatal and 

postnatal exposure in the rat 

reproduction study, and there are no 

concerns or residual uncertainties for 

prenatal and/or postnatal toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X for assessing 

chronic risk. That decision is based on 

the following findings: 

i. The toxicity database for fenarimol 

is complete except for immunotoxicity 

testing. Changes to 40 CFR part 158 

make immunotoxicity testing (OPPTS 

Harmonized Test Guideline 870.7800) 

required for pesticide registration; 

however, the available data for 

fenarimol do not show the potential for 

immunotoxicity. Consequently, the EPA 

believes the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios and for evaluation 

of the requirements under the FQPA, 

and an additional database UF does not 

need to be applied. 

ii. There is no indication that 

fenarimol 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 

fenarimol 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 chronic dietary food exposure 

assessment utilized tolerance-level 

residues, anticipated residue data that 

are based on reliable field trial data, or 

food monitoring data collected by USDA 

under the PDP. For several currently 

registered commodities, the chronic 

assessment also utilized PCT data that 

have a valid basis and are considered to 

be reliable. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fenarimol in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

residential exposure. These assessments 

will not underestimate the exposure and 

risks posed by fenarimol. 

EPA has retained a 10X FQPA SF for 

assessing short-term risk because the 

study used in assessing short-term risk 

did not identify a NOAEL for the effects 

observed. The Agency is confident that 

the 10X FQPA SF is adequate (as 

opposed to a larger SF) for assessing 

risks from short-term exposure to 

fenarimol based on the following weight 

of evidence considerations. 

• The most sensitive endpoint for 

target organ toxicity (potential 

interaction with the androgen and/or 

estrogen pathway) is being used for 

these (short-term) exposure scenarios 

and this selection is supported by and 

comparable to the endpoint 

(reproductive effects) used in assessing 

dietary and non-dietary risks for 

intermediate and chronic exposures. 

• Fenarimol has been evaluated in two 

of the Tier 1 assays developed by the 

Agency’s Endocrine Disruption 

Screening Program, the ‘‘Female 

Pubertal Assay’’ and the ‘‘Uterotrophic 

Assay.’’ 

• In the female pubertal assay, 

following oral exposure for 21 days- 

(which is comparable to the short-term 

exposure scenario of concern)- no 

adverse effects on sexual maturation, 

abnormalities associated with sex organ, 

or pubertal markers were seen at doses 

up to and including 250 mg/kg/day. 

• In the uterotrophic assay, 

following oral exposure for 3 days, a 

dose of 200 mg/kg/day resulted in 

increased uterine weight. 

• As noted in Unit III.A., the 

uterotrophic response was seen at a 

much higher dose (200 mg/kg/day) than 

the regulatory doses used for overall risk 

assessments: Extrapolated NOAEL of 3.5 

mg/kg/day for short-term and a NOAEL 

of 0.6 mg/kg/day for assessing 

intermediate and long-term dietary and 

non-dietary risks. 


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• Specifically, the extrapolated 

NOAEL of 3.5 mg/kg/day used for shortterm assessments is approximately 60– 

fold lower than the uterotrophic 

response found in rats at 200 mg/kg/ 

day. 

This weight of evidence provides 

sufficient confidence that the default 

10X FQPA SF is adequate (i.e, the LOC 

is a MOE of 1,000) and it would not 

underestimate short-term risk from 

exposure to fenarimol. 

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, fenarimol 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 fenarimol from 

food and water will utilize 77% 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 fenarimol 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). 

Fenarimol is currently registered for 

use on professionally managed turf, 

including stadia and golf course tees, 

greens, and fairways which could result 

in short-term post-application dermal 

exposure to golfers. The Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to fenarimol. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 1,800 for adults 20–49 years 

old. While the residential scenario is 

based on an adult population, careful 

analyses of body weight-to-surface area 

ratios and durations of exposure 

resulted in the conclusion that 

mitigation for this population subgroup 

will also be protective for all population 

subgroups including young adults and 

children. Because EPA’s LOC for 

fenarimol is a MOE of 1,000 or below, 

these MOEs are not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenarimol 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 fenarimol 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC) with an 

electrolytic conductivity detector (ECD)) 

is available to enforce the tolerance 

expression. PAM Volume II lists three 

GC/ECD methods, designated as 

Methods I (AM-AA-CA-R039-AB-755), II 

(AM-AA-CA-R072-AA-755), and III 

(AM-AA-CA-R124-AA-755) for tolerance 

enforcement. 

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 section 408(b)(4) of FFDCA. 

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, section 408(b)(4) of FFDCA 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has established an MRL for 

fenarimol in or on melons, except 

watermelon at 0.05 ppm. This MRL is 

different than the tolerance of 0.20 ppm 

for vegetable, cucurbit, group 9 

established for fenarimol in the United 

States. The tolerances cannot be 

harmonized because the field trial data 

demonstrated higher residues than the 

Codex MRL. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the petitioned-for 

tolerance ‘‘cucurbits’’ to ‘‘vegetable, 

cucurbit, group 9’’ to agree with the 

Agency’s Food and Feed Commodity 

Vocabulary. Additionally, the Agency 

has revised the tolerance expression to 

clarify that, as provided in section 

408(a)(3), of FFDCA the tolerance covers 

metabolites and degradates of fenarimol 

not specifically mentioned, and 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, a tolerance is established 

for residues of fenarimol, alpha-(2 

chlorophenyl)-alpha-(4-chlorophenyl)-5- 

pyrimidinemethanol, in or on vegetable, 

cucurbit, group 9 at 0.20 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 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 56897 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 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 § 180.421, revise the 

introductory text of paragraph (a) and 

add alphabetically the entry ‘‘vegetable, 

cucurbit, group 9’’ to the table in 

paragraph (a) to read as follows: 

§ 180.421 Fenarimol; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of fenarimol, 

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 fenarimol alpha-(2 

chlorophenyl)-alpha-(4-chlorophenyl)-5- 

pyrimidinemethanol. 

Commodity Parts per million 

* * * * * 

Vegetable, 

cucurbit, group 

9* ....................... 0.20 ppm 

*There are no U.S. registrations as of August 27, 2010. 

* * * * * 

FR Doc. 2010–23120 Filed 9–16–10; 8:45 am 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0814; FRL–8842–3] 

S-metolachlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for the residues of Smetolachlor in or on multiple 

commodities which are identified and 

discussed later in this document. The 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 17, 2010. Objections and 

requests for hearings must be received 

on or before November 16, 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–2009–0814. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1