9358 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 12, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.474 is amended by 

revising the entry for the commodity 

‘‘Cherry’’ in the table in paragraph (a)(1) 

to read as follows: 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) General.***

(1) * * * 

Commodity Parts per million 

* * * * * 

Cherry, sweet, pre- and 

post-harvest ................ 5.0 

Cherry, tart, pre- and 

post-harvest ................ 5.0 

* * * * * 

* * * * * 

[FR Doc. E9–4373 Filed 3–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1192; FRL–8400–9] 

Famoxadone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of famoxadone in 

or on caneberry subgroup 13–07A; 

cilantro, leaves; onion, bulb, subgroup 

3–07A; onion, green, subgroup 3–07B; 

spinach; and vegetable, leafy, except 

Brassica, group 4, except spinach. It also 

removes existing tolerances on lettuce, 

head; and caneberry, subgroup 13A that 

are superseded by the new tolerances on 

vegetable, leafy, except Brassica, group 

4, except spinach; and caneberry 

subgroup 13–07A. Interregional 

Research Project Number 4 (IR-4) 

requested these amendments under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or 

before May 4, 2009, 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–2007–1192. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9359 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site 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–2007–1192 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before May 4, 2009. 

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–2007–1192, 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 March 12, 

2008 (73 FR 13225) (FRL–8354–6), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 7E7280 and 

7E7281) by Interregional Research 

Project Number 4 (IR-4), 500 College 

Road East, Suite 201 W, Princeton, NJ 

08540. The petitions requested that 40 

CFR 180.587 be amended by 

establishing tolerances for residues of 

the fungicide, famoxadone, 3-anilino-5- 

methyl-5-(4-phenoxyphenyl)-1,3- 

oxazolidine-2,4-dione, in or on leaf 

petioles, subgroup 4B at 25 parts per 

million (ppm) (PP 7E7280); leafy greens, 

subgroup 4A and cilantro at 50 ppm; 

bulb vegetables, group 3–07 at 40 ppm; 

and caneberry, subgroup 13–07A at 10 

ppm (all in PP 7E7281). IR-4 also 

proposed in petition 7E7281 to remove 

the existing tolerances in 40 CFR 

180.587 for residues of the fungicide 

famoxadone in or on the food 

commodities lettuce, head; and 

caneberry, subgroup 13A, which would 

be superseded by the tolerances on 

leafy, greens, subgroup 4A; and 

caneberry, subgroup 13–07A. That 

notice referenced a summary of the 

petition prepared on behalf of IR-4 by 

E.I. du Pont de Nemours and Company, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

determined that separate tolerances at 

different levels are needed for the bulb 

and green onion subgroups of bulb 

vegetables group 3–07. EPA has also 

determined that tolerances should be 

established on ‘‘vegetable, leafy, except 

Brassica, group 4, except spinach’’ at 25 

ppm with a separate tolerance of 50 

ppm on spinach, rather than the 

proposed tolerances on subgroups 4A at 

50 ppm and 4B at 25 ppm. The reasons 

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 the petitioned-for 

tolerances for residues of famoxadone 

on caneberry subgroup 13–07A at 10 

ppm; cilantro, leaves at 25.0 ppm; 

onion, bulb, subgroup 3–07A at 0.45 

ppm; onion, green, subgroup 3–07B at 

40 ppm; spinach at 50 ppm; and 

vegetable, leafy, except Brassica, group 

4, except spinach at 25 ppm. EPA’s 

9360 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

assessment of exposures and risks 

associated with establishing these 

tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Famoxadone has low acute toxicity by 

the oral, dermal and inhalation routes of 

exposure. It is a moderate eye and skin 

irritant but is not a dermal sensitizer. In 

subchronic and chronic feeding studies 

in rats, mice, dogs and cynomolgus 

monkeys, famoxadone generally caused 

decreased body weights and body 

weight gains, often accompanied by 

decreased food consumption and food 

efficiency. A mild regenerative 

hemolytic anemia was also regularly 

observed in these animals as evidenced 

by decreased erythrocyte counts, 

hemoglobin and/or hematocrit, 

increased reticulocytes, and other 

related changes in hematologic 

parameters. Famoxadone also induced a 

mild hepatotoxicity in treated animals 

characterized by elevated levels of 

clinical chemistry enzymes indicative of 

liver damage (increased alkaline 

phosphatase, alanine aminotransferase, 

aspartate aminotransferase, and/or 

sorbitol dehydrogenase) and by 

histopathological lesions in the liver 

(single cell or focal necrosis, 

hepatocellular degeneration, diffuse 

fatty change, foci of eosinophilic 

cellular alteration, apoptosis and 

increased mitotic figures). Both the 

anemia and the hepatotoxicity were 

mild and did not significantly 

compromise the overall health status of 

the treated animals. In repeated dose 

studies the anemia, which occurred 

early in the studies, often appeared to be 

fully compensated for in the latter stages 

of the studies. Although the 

hepatotoxicity persisted throughout the 

duration of the studies, it was mild or 

moderate in intensity and not severe or 

life-threatening. 

Additional treatment-related effects 

were observed in dogs that were not 

observed in other species. In a 13-week 

feeding study, clinical signs of 

neurotoxicity (myotonic twitches) were 

observed in male and female dogs at the 

highest dose tested throughout the 

duration of the study. These twitches 

were not observed, however, at lower 

doses in the same study or in a 1-year 

feeding study in dogs. Also, in both 

male and female dogs, famoxadone 

induced treatment-related cataracts in 

the lens of the eye in the 13-week 

feeding study and in the 1-year feeding 

study. The eye effects were observed at 

dose levels below those at which any 

other effects were observed in any other 

species and served as the basis for many 

of the risk assessments in humans. 

There was no indication of increased 

quantitative or qualitative susceptibility 

of fetuses or offspring to famoxadone 

exposure in the developmental toxicity 

studies in rats and rabbits or the 2- 

generation reproduction toxicity study 

in rats. In a developmental toxicity 

study in rats, no developmental toxicity 

was observed in the fetuses at the 

highest dose tested. Transient decreases 

in body weight gain and food 

consumption were noted in the dams in 

this study. In a developmental toxicity 

study in rabbits, an increased incidence 

of abortions was observed. The does 

which aborted had markedly decreased 

body weight, body weight gain and food 

consumption. There was also an 

equivocal increase in percent 

postimplantation loss and mean number 

of resorptions per doe in this study. In 

the reproduction toxicity study in rats, 

offspring toxicity (decreased body 

weights for F1 and F2 pups throughout 

lactation) was noted at a dose that also 

resulted in parental toxicity (decreased 

body weight, body weight gain, and 

food consumption; and hepatotoxicity). 

No reproductive toxicity was observed 

in this study at the highest dose tested. 

In an acute neurotoxicity study in 

rats, there was equivocal evidence of a 

possible slight neurotoxic effect at the 

limit dose. In this study, an increased 

incidence of palpebral (eyelid) closure 

was observed, but only in males and 

only on day one. Other than this 

equivocal evidence and the clinical 

observations in the 13-week feeding 

study in dogs of myotonic twitching in 

the high dose male and female animals, 

there was no evidence of treatmentrelated neurotoxicity in the toxicity 

studies on famoxadone, including a 

subchronic neurotoxicity study in rats. 

In 28-day immunotoxicity studies in 

rats and mice, there was no evidence of 

immunotoxicity following exposure to 

famoxadone. 

In carcinogenicity studies in male and 

female rats and mice, famoxadone did 

not demonstrate any biologically 

significant evidence of carcinogenic 

potential. Famoxadone is classified as 

‘‘not likely to be carcinogenic to 

humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by famoxadone as well as 

the no-observed-adverse-effect-level and 

the lowest-observed-adverse-effect-level 

from the toxicity studies can be found 

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

document Famoxadone. Human Health 

Risk Assessment for the Proposed Food 

Use of Famoxadone on Bulb Vegetables, 

Crop Group 3; Leafy Greens, Subgroup 

4A; Leaf Petioles, Subgroup 4B; and 

Cilantro at page 54 in docket ID number 

EPA–HQ–OPP–2007–1192. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

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

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for famoxadone used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document Famoxadone. Human Health 

Risk Assessment for the Proposed Food 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9361 

Use of Famoxadone on Bulb Vegetables, 

Crop Group 3; Leafy Greens, Subgroup 

4A; Leaf Petioles, Subgroup 4B; and 

Cilantro at page 31 in docket ID number 

EPA–HQ–OPP–2007–1192. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to famoxadone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing famoxadone tolerances in 40 

CFR 180.587. EPA assessed dietary 

exposures from famoxadone 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 famoxadone; 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 U.S. Department of Agriculture 

(USDA) 1994–1996, and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA used average residues from 

field trials for most plant commodities 

and anticipated residues based on the 

anticipated dietary burdens of livestock 

for animal commodities. Empirical 

processing factors were used to refine 

the residue estimates of processed 

tomato, pepper, potato and grape 

commodities. For leafy vegetables, 

empirically-derived reduction factors 

were applied to account for reduction of 

residues from washing and removal of 

outer leaves. Percent crop treated (PCT) 

and projected PCT estimates were used 

to further refine exposure estimates for 

many of the existing and new uses of 

famoxadone. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified famoxadone as ‘‘not 

likely to be carcinogenic to humans;’’ 

therefore, an exposure assessment for 

evaluating cancer risk is not needed for 

this chemical. 

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 used PCT information as 

follows: 

Cucumbers 5%, peppers 5%, potatoes 

5%, pumpkins 5%, squash 1%, 

tomatoes 10% and watermelons 1%. 

In most cases, EPA uses available data 

from U.S. 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 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 used projected percent 

crop treated (PPCT) information for 

certain new crops (celery, lettuce, and 

spinach) as well as the currently 

registered crop, grapes. Since 

famoxadone has only been registered on 

grapes for 1 year, PCT estimates based 

on actual usage data were not deemed 

sufficient indicators of potential usage 

on grapes. The following PPCT 

estimates were used in the chronic 

dietary exposure assessment: Celery 

39%, grapes (wine and table) 5%, grape 

(juice) 50%, lettuce (head) 67%, lettuce 

(other) 62%, and spinach 39%. 

EPA estimates PPCT for a new 

pesticide use by assuming that the 

percent crop treated (PCT) during the 

pesticide’s initial 5 years of use on a 

specific use site will not exceed the 

average PCT of the dominant pesticide 

(i.e., the one with the greatest PCT) on 

that site over the three most recent 

surveys. Comparisons are only made 

among pesticides of the same pesticide 

type (i.e., the dominant fungicide on the 

use site is selected for comparison with 

a new fungicide). The PCTs included in 

the average may be each for the same 

pesticide or for different pesticides 

since the same or different pesticides 

may dominate for each year selected. 

Typically, EPA uses USDA/NASS data 

as the source for raw PCT data because 

it is publicly available and does not 

have to be calculated from other 

available data. When a specific use site 

is not surveyed by USDA/NASS, EPA 

uses proprietary data and calculates the 

estimated PCT. 

This estimated PPCT, based on the 

average PCT of the market leader, is 

appropriate for use in the chronic 

dietary risk assessment. This method of 

estimating a PPCT for a new use of a 

registered pesticide or a new pesticide 

produces a high-end estimate that is 

unlikely, in most cases, to be exceeded 

during the initial 5 years of actual use. 

The predominant factors that bear on 

whether the estimated PPCT could be 

exceeded are whether the new pesticide 

use is more efficacious or controls a 

broader spectrum of pests than the 

dominant pesticide(s), whether there are 

concerns with pest pressures as 

indicated in emergency exemption 

requests (http://www.epa.gov/ 

opprd001/section18/) or other readily 

available information, and/or other 

factors based on analysis of additional 

information. All information readily 

available has been considered for 

famoxadone on celery, lettuce and 

spinach, and it is the opinion of EPA 

that it is unlikely that actual PCTs for 

famoxadone on these sites will exceed 

the corresponding estimated PPCTs 

during the next 5 years. 

A discussion of the factors considered 

in making this determination can be 

found in the document PPCT for the Use 

of Fungicide Famoxadone (PC 113202) 

9362 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

on celery (DP 357845), lettuce and 

spinach (DP 357847), and grapes (no 

BEAN). Additional Factors Revised in 

this Memorandum. The referenced 

document is available at 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2007–1192. 

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 famoxadone 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 famoxadone in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

famoxadone. 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 Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) and Screening 

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

water concentrations (EDWCs) of 

famoxadone for acute exposures are 

estimated to be 6.2 parts per billion 

(ppb) for surface water and 0.01 ppb for 

ground water. EDWCs of famoxadone 

for chronic exposures for non-cancer 

assessments are estimated to be 0.189 

ppb for surface water and 0.01 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 0.189 ppb 

was used to assess the contribution to 

drinking water. As explained in Unit 

III.C.1.i. an acute dietary risk assessment 

for famoxadone is unnecessary. 

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). 

Famoxadone 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 famoxadone to 

share a common mechanism of toxicity 

with any other substances, and 

famoxadone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that famoxadone 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 prenatal and postnatal toxicity 

database for famoxadone includes rat 

and rabbit developmental toxicity 

studies and a 2-generation reproduction 

toxicity study in rats. There was no 

evidence of increased quantitative or 

qualitative susceptibility of in utero rats 

or rabbits in the developmental toxicity 

studies or of offspring in the rat 

reproduction study. 

3. Conclusion. EPA has determined 

that the FQPA safety factor of 10X must 

be retained as a database uncertainty 

factor for the chronic dietary exposure 

assessment. That decision is based on 

the following findings: 

i. Although the toxicity database for 

famoxadone is complete, there is 

uncertainty related to the 13-week 

feeding study in dogs that was selected 

to assess chronic dietary exposures to 

famoxadone. EPA has determined that 

the 10X FQPA safety factor must be 

retained to account for the uncertainty 

arising due to the lack of a NOAEL in 

this study and extrapolation from a 

subchronic to chronic exposure 

duration. A 10X uncertainty factor is 

considered to provide an adequate 

margin of safety during development, 

based on several considerations. First, 

the LOAEL appeared to be a threshold 

effect level based on the minimal 

findings observed. The endpoint 

(microscopic lens lesions, cataracts, in 

the eyes of female dogs) was of minimal 

severity at the lowest dose tested (1.4 

milligrams/kilogram/day (mg/kg/day)). 

This finding would probably have very 

little effect on vision, and no evidence 

of cataracts was observed in the 

ophthalmologic examination. Second, 

although the microscopic data in the 

chronic dog study were not considered 

acceptable due to fixation artifact, there 

was no evidence of cataracts in the 

ophthalmologic examination at a similar 

dose (1.2 mg/kg/day), suggesting that 

progression with time was minimal at 

that dose. Finally, there was no 

evidence of cataracts in monkeys 

administered famoxadone for 1-year at 

doses up to 1,000 mg/kg/day. The lack 

of cataracts in a primate species 

provides suggestive evidence that 

humans may be less sensitive than dogs 

for this effect. 

ii. There was equivocal evidence of a 

slight neurotoxic effect (eyelid closure) 

at the limit dose in the acute 

neurotoxicity study in rats, and 

myotonic twitching was noted at the 

high dose in male and female dogs in 

the 13-week feeding study. In this same 

study, one female dog in the high dose 

group also had convulsions and ataxia 

on day 34. Since there was no evidence 

of treatment-related neurotoxicity at 

lower doses in these studies or in any 

other famoxadone toxicity studies, 

including a subchronic neurotoxicity 

study in rats and the 1-year feeding 

study in dogs, EPA has concluded that 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9363 

there is not a concern for neurotoxicity 

from exposure to famoxadone, and there 

is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

famoxadone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were refined for most commodities 

using reliable PCT/PPCT information 

and anticipated residue values 

calculated from valid field trial data. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to famoxadone in drinking water. 

Residential exposure to famoxadone is 

not expected. These assessments will 

not underestimate the exposure and 

risks posed by famoxadone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, famoxadone 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 famoxadone 

from food and water will utilize 65% of 

the cPAD for adult males, 20 years and 

older, the population group receiving 

the greatest exposure. There are no 

residential uses for famoxadone. 

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). Famoxadone is not 

registered for any use patterns that 

would result in residential exposure. 

Therefore, the short-term aggregate risk 

is the sum of the risk from exposure to 

famoxadone through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Famoxadone is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to famoxadone through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Famoxadone is classified as 

‘‘not likely to be carcinogenic to 

humans’’ and is, therefore, not expected 

to pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to famoxadone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography with Nitrogen 

Phosphorus Detection (GC/NPD)) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no CODEX maximum 

residue limits (MRLS) established for 

famoxadone on the commodities 

associated with these petitions. 

C. Response to Comments 

Comments were received from a 

private citizen objecting to EPA’s 

reliance on animal toxicity testing on 

the basis that it is inhumane and not 

indicative of the potential for pesticides 

to cause toxicity in humans. The 

Agency disagrees with the commenter’s 

claims regarding animal testing. Since 

humans and animals have complex 

organ systems and mechanisms for the 

distribution of chemicals in the body, as 

well as processes for eliminating toxic 

substances from their systems, EPA 

relies on laboratory animals such as rats 

and mice to mimic the complexity of 

human and higher-order animal 

physiological responses when exposed 

to a pesticide. EPA is committed, 

however, to reducing the use of animals 

whenever possible. EPA-required 

studies include animals only when the 

requirements of sound toxicological 

science make the use of an animal 

absolutely necessary. The Agency’s goal 

is to be able to predict the potential of 

pesticides to cause harmful effects to 

humans and wildlife by using fewer 

laboratory animals as models and EPA 

has been accepting data from alternative 

(to animals) test methods for several 

years. As progress is made on finding or 

developing non-animal test models that 

reliably predict the potential for harm to 

humans or the environment, EPA 

expects that it will need fewer animal 

studies to make safety determinations. 

Finally, because the commenter has not 

provided the Agency with a specific 

rationale (including supporting 

information) as to why the Agency’s 

action is inconsistent with the legal 

standards in section 408 of FFDCA, EPA 

can not provide any more detailed 

response to the commenter’s 

disagreement with the Agency’s 

decision. 

D. Revisions to Petitioned-For 

Tolerances 

IR-4 proposed a tolerance of 40 ppm 

on the crop group ‘‘vegetable, bulb, 

group 3.’’ Based on the results of field 

trials showing a greater than 5-fold 

difference in residues on bulb and green 

onions, EPA determined that separate 

tolerances are required for these 

subgroups. Therefore, EPA is 

establishing tolerances of 0.45 ppm on 

onion, bulb, subgroup 3–07A and 40 

ppm on onion, green, subgroup 3–07B. 

EPA determined the appropriate 

tolerance levels for bulb and green 

onions based on analyses of the residue 

field trial data using the Agency’s 

Tolerance Spreadsheet in accordance 

with the Agency’s Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data. 

IR-4 proposed tolerances on leaf 

petioles, subgroup 4B at 25 ppm and on 

leafy greens, subgroup 4A and cilantro, 

leaves at 50 ppm. Based on the results 

of field trial data indicating higher 

residues in spinach than the other 

members of subgroup 4A, EPA 

determined that a tolerance of 25 ppm 

would be adequate for members of the 

entire crop group 4 (including 

9364 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

subgroups 4A and 4B), except spinach, 

and cilantro leaves. Therefore, EPA is 

establishing tolerances of 25 ppm on 

vegetable, leafy, except Brassica, group 

4, except spinach; 25 ppm on cilantro, 

leaves; and 50 ppm on spinach. 

V. Conclusion 

Therefore, tolerances are established 

for residues of famoxadone, 3-anilino-5- 

methyl-5-(4-phenoxyphenyl)-1,3- 

oxazolidine-2,4-dione, in or on 

caneberry subgroup 13–07A at 10 ppm; 

cilantro, leaves at 25.0 ppm; onion, 

bulb, subgroup 3–07A at 0.45 ppm; 

onion, green, subgroup 3–07B at 40 

ppm; spinach at 50 ppm; and vegetable, 

leafy, except Brassica, group 4, except 

spinach at 25 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 12, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.587 is amended by 

removing the tolerances for Caneberry, 

Subgroup 13A and Lettuce, head; and 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.587 Famoxadone; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

Caneberry subgroup 13–07A .............................................................................................................................................. 10 

*****

Cilantro, leaves .................................................................................................................................................................... 25 

*****

Onion, bulb, subgroup 3–07A .............................................................................................................................................. 0.45 

Onion, green, subgroup 3–07B ........................................................................................................................................... 40 

*****

Spinach ................................................................................................................................................................................ 50 

*****

Vegetable, leafy, except Brassica, group 4, except spinach .............................................................................................. 25 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9365 

* * * * * 

[FR Doc. E9–4357 Filed 3–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1106; FRL–8402–7] 

Chlorothalonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

chlorothalonil and its 4-hydroxy 

metabolite in or on lychee and starfruit. 

The United States Department of 

Agriculture (USDA) requested that EPA 

establish these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or 

before May 4, 2009, 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–2007–1106. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2007–1106 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before May 4, 2009. 

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–2007–1106, 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. Background 

In the Federal Register of December 3, 

2008 (73 FR 73632) (FRL–8390–1), EPA 

issued a proposed rule pursuant to 

sections 408(e) of FFDCA, 21 U.S.C. 

346a(d)(3). The rule proposed that 40 

CFR 180.275 be amended by 

establishing tolerances for combined 

residues of chlorothalonil and its 4- 

hydroxy metabolite in or on lychee at 15 

parts per million (ppm) and starfruit at 

3.0 ppm. The USDA requested that EPA 

establish these tolerances. Because 

USDA did not submit a petition in 

support of establishing these tolerances, 

EPA did not publish a Notice of Filing 

of a petition for these tolerances. Rather, 

EPA issued a proposed rule that 

included a summary of the exposure 

assessment prepared by the Agency and 

explained the basis for EPA’s 

conclusion that there is a reasonable 

certainty that no harm will result to the 

general population, or to infants and 

children, from aggregate exposure to 

chlorothalonil. The proposal established 

a 60–day public comment period. 

Comments were received in response to 

the proposed rule. EPA’s response to 

these comments is discussed in Unit III.