58058 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

§ 3.4 Matters reserved for decision by the 

Governors.

* * * * *

(c) Election of the Chairman and Vice 

Chairman of the Board of Governors, 39 

U.S.C. 202(a).

* * * * *

PART 4—[AMENDED]

■ 3. The authority citation for part 4 

continues to read as follows:

Authority: 39 U.S.C. 202–205, 401(2), (10), 

402, 1003, 3013.

§ 4.2 [Amended]

■ 4. Amend § 4.2 by removing the words 

‘‘The Vice Chairman is elected by the 

Board’’ and adding the words ‘‘The Vice 

Chairman is elected by the Governors’’ in 

their place.

PART 6—[AMENDED]

■ 5. The authority citation for part 6 

continues to read as follows:

Authority: 39 U.S.C. 202, 205, 401(2), (10), 

1003, 3013; 5 U.S.C. 552b(e), (g).

§ 6.1 [Amended]

■ 6 Amend § 6.1 by revising the first 

sentence to read as follows:

§ 6.1 Regular meetings, annual meeting. 

The Board shall meet regularly on a 

schedule established annually by the 

Board. * * *

§ 6.6 [Amended]

■ 7. Amend § 6.6(f) by removing the 

numeral ‘‘5’’ and adding the numeral ‘‘4’’

in its place.

Stanley F. Mires, 

Chief Counsel, Legislative.

[FR Doc. 04–21557 Filed 9–28–04; 8:45 am] 

BILLING CODE 7710–12–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0255; FRL–7681–3]

Fenamidone; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of fenamidone 

(4H-imidazol-4-one, 3,5-dihydro-5-

methyl-2-(methylthio)-5-phenyl-3-

(phenylamino), (S)-) in or on garlic, 

bulb; garlic, great headed; grape 

(imported); leek; onion, dry bulb; onion, 

green; onion, welsh; shallot, bulb; 

shallot, fresh leaves; tomato; tomato, 

paste; tomato, puree; vegetable, 

cucurbit, group 09; vegetable, tuberous 

and corm, subgroup 01C and establishes 

tolerances for combined residues of 

fenamidone (4H-imidazol-4-one, 3,5-

dihydro-5-methyl-2-(methylthio)-5-

phenyl-3-(phenylamino), (S)-) and its 

metabolite RPA 717879 (2,4-

imidazolidinedione, 5-methyl-5-phenyl) 

in or on fat (beef, goat, and sheep); meat 

(beef, goat, and sheep); meat byproducts 

(beef, goat, and sheep); milk; wheat, 

grain; wheat forage; wheat, hay; and 

wheat, straw. Wheat tolerances are 

being established for inadvertent 

residues in/on a rotated crop. Bayer 

CropScience requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA).

DATES: This regulation is effective 

September 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0255. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Dennis McNeilly, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–6742; e-mail address: 

mcneilly.dennis@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:

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users.

This listing is not intended to be 

exhaustive, but rather provides 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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of January 28, 

2004 (69 FR 4138–4143) (FRL–7337–3), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 1F6300) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. This 

amended the petition previously

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58059

announced in the Federal Register of 

January 4, 2002 (67 FR 592–597) (FRL–

6812–2) by including raw agricultural 

commodity subgroup 01C. The petition 

requested that 40 CFR 180.579 be 

amended by establishing tolerances for 

combined residues of the fungicide 

fenamidone, and its metabolites in or on 

the raw agricultural commodities: 

Potato, 0.05 parts per million (ppm), 

tomato, 1.0 ppm; tomato paste, 3.5 ppm, 

tomato puree, 3.5 ppm, bulb vegetable 

crop group, 1.5 ppm; cucurbit crop 

group, 0.1 ppm; head lettuce, 15.0 ppm; 

leaf lettuce, 20.0 ppm; wheat grain, 0.05 

ppm, wheat straw, 0.5 ppm; wheat 

forage, 0.5 ppm, and wheat hay, 0.5 

ppm. Tolerances were also proposed for 

fenamidone and its metabolite RPA 

410193 on imported wine grapes at 0.5 

ppm. Agency review of the residue data 

indicates that the following tolerance 

levels are appropriate: Fenamidone, 4Himidazol-4-one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-, in or on garlic, bulb at 0.20 ppm; 

garlic, great headed at 0.20 ppm; grape 

(imported) at 1.0 ppm, leek at 1.5 ppm, 

onion, dry bulb at 0.20 ppm; onion, 

green at 1.5 ppm; onion, welsh at 1.5 

ppm; shallot, bulb at 0.20 ppm; shallot, 

fresh leaves at 1.5 ppm; tomato at 1.0 

ppm; tomato, paste at 2.2 ppm; tomato, 

puree at 2.0 ppm; vegetable, cucurbit, 

group 09 at 0.15 ppm and vegetable, 

tuberous and corm, subgroup 01C at 

0.02 ppm and also for the combined 

residues of fenamidone (4H-imidazol-4-

one, 3,5-dihydro-5-methyl-2-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino)) 

and its metabolite RPA 717879 (2,4-

imidazolidinedione, 5-methyl-5-phenyl) 

in or on fat (beef, goat, and sheep) at 

0.10 ppm; meat (beef, goat, and sheep) 

at 0,10 ppm, meat byproducts (beef, 

goat, and sheep) at 0.10 ppm; milk at 

0.02 ppm; wheat forage at 0.15 ppm; 

wheat, grain at 0.10 ppm; wheat, hay at 

0.50 ppm; wheat, straw at 0.35 ppm. 

The Agency is establishing tolerances 

for animal tolerances based on review of 

the residue data and evaluation of food 

animal diets, which could include 

wheat forage and hay. That notice 

included a summary of the petition 

prepared by Bayer CropScience, the 

registrant. There were no comments 

received in response to the notice of 

filing.

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and 

Determination of Safety

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

fenamidone, in or on garlic, bulb at 0.20 

ppm; garlic, great headed at 0.20 ppm; 

grape (imported) at 1.0 ppm, leek at 1.5 

ppm, onion, dry bulb at 0.20 ppm; 

onion, green at 1.5 ppm; onion, welsh 

at 1.5 ppm; shallot, bulb at 0.20 ppm; 

shallot, fresh leaves at 1.5 ppm; tomato 

at 1.0 ppm; tomato, paste at 2.2 ppm; 

tomato, puree at 2.0 ppm; vegetable, 

cucurbit, group 09 at 0.15 ppm and 

vegetable, tuberous and corm, subgroup 

01C at 0.02 ppm and also for the 

combined residues of fenamidone (4Himidazol-4-one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-) and its metabolite RPA 717879 

(2,4-imidazolidinedione, 5-methyl-5-

phenyl) in or on fat (beef, goat, and 

sheep) at 0.10 ppm; meat (beef, goat, 

and sheep) at 0,10 ppm, meat 

byproducts (beef, goat, and sheep) at 

0.10 ppm; milk at 0.02 ppm; wheat 

forage at 0.15 ppm; wheat, grain at 0.10 

ppm; wheat, hay at 0.50 ppm; wheat, 

straw at 0.35 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance 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. The nature of the 

toxic effects caused by fenamidone are 

discussed in the Federal Register of 

September 27, 2002 (67 FR 7196–7198). 

There have been no changes in the 

toxicological profile since that Federal 

Register notice and therefore, the 

Agency will not repeat the entire table 

in this final rule but refers to the 

original document.

B. Toxicological Endpoints

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. A UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

58060 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for fenamidone used for 

human risk assessment is shown in 

Table 1 of this unit:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENAMIDONE FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary 

(General population including 

infants and children)

NOAEL = 125 milligram/kilogram/day (mg/kg/day) UF 

= 1,000 Acute RfD = 0.13 

mg/kg/day

Special FQPA SF = 1X 

aPAD = acute RfD 

(0.13)/Special FQPA SF 

1X = 0.13 mg/kg/day

Acute Neurotoxicity Study in Rats 

LOAEL = 500 mg/kg/day based on urination, 

staining/soiling of the anogenital region, mucous in the feces, and unsteady gait in the 

females.

Chronic Dietary 

(All populations)

NOAEL= 2.83 male/femal (M/

F) mg/kg/day UF = 1,000 

Chronic RfD = 0.003 mg/

kg/day

Special FQPA SF = 1X 

cPAD = chronic RfD 

(0.003)/Special FQPA 

SF 1X = 0.003 mg/kg/

day

2-Year Chronic Toxicity/Carcinogenicity Study 

in Rats 

LOAEL = 7.07/9.24 mg/kg/day based on increase in severity of diffuse thyroid C-cell 

hyperplasia in both sexes.

Short-Term Dermal 

(1 to 7 days)

(Residential) 

Dermal (or oral) study 

NOAEL= 10.4 mg/kg/day 

LOC for MOE = 1,000 

(Residential) 

90-Day Feeding Study in Rats 

LOAEL = 68.27 mg/kg/day based on increased liver weights and incidences of 

ground glass appearance of the hepatocytes 

in males.

Intermediate-Term Dermal 

(1 week to several months)

(Residential)

Dermal (or oral) study 

NOAEL = 5.45 mg/kg/day 

LOC for MOE = 1,000 

(Residential)

2-Generation Reproduction Study in Rats 

LOAEL = 89.2 mg/kg/day based on decreased 

absolute brain weight in female F1 adults 

and females F2 offspring. 

Long-Term Dermal 

(Several months to lifetime)

(Residential)

Dermal (or oral) study 

NOAEL= 2.83 mg/kg/day

LOC for MOE = 1,000 

(Residential)

2-Year Chronic Toxicity/Carcinogenicity Study 

in Rats 

LOAEL = 7.07/9.24 mg/kg/day M/F based on 

increase in severity of diffuse thyroid C-cell 

hyperplasia in both sexes.

Short-Term Inhalation 

(1 to 7 days)

(Residential)

Inhalation (or oral) study 

NOAEL= 10.4 mg/kg/day 

(inhalation absorption rate 

= 100%)

LOC for MOE = 1,000 

(Residential)

90-Day Feeding Study in Rats 

LOAEL = 68.27 mg/kg/day based on increased liver weights and incidences of 

ground glass appearance of the hepatocytes 

in males.

Intermediate-Term Inhalation 

(1 week to several months)

(Residential)

Inhalation (or oral) study 

NOAEL = 5.45 mg/kg/day 

(inhalation absorption rate 

= 100%)

LOC for MOE = 1,000 

(Residential)

2-Generation Reproduction Study in Rats 

LOAEL = 89.2 mg/kg/day based on decreased 

absolute brain weight in female F1 adults 

and female F2 offspring.

Long-Term Inhalation 

(Several months to lifetime)

(Residential)

Inhalation (or oral) study 

NOAEL= 2.83 mg/kg/day 

(inhalation absorption rate 

= 100%)

LOC for MOE = 1,000

(Residential)

2-Year Chronic Toxicity/Carcinogenicity Study 

in Rats 

LOAEL = 7.07/9.24 mg/kg/day M/F based on 

increase in severity of diffuse thyroid C-cell 

hyperplasia in both sexes.

Cancer 

(Oral, dermal, inhalation)

Classification: ‘‘Not likely’’

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58061

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.579) for 

residues of fenamidone, in or on head 

and leaf lettuce. Risk assessments were 

conducted by EPA to assess dietary 

exposures from fenamidone in food as 

follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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. 

In conducting the acute dietary risk 

assessment EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the U.S. 

Department of Agriculture 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the acute exposure assessments: The 

acute analysis assumed 100% crop 

treated and field trial residue data 

treated at maximum labeled rate, 

minimum preharvest interval. 

Therefore, the acute analysis is 

considered conservative. The results, 

reported in Unit III.E. are for the general 

U.S. population, all infants (< 1 year 

old), children 1–2, children 3–5, 

children 6–12, youth 13–19, females, 

13–49, adults 20–49, and adults 50+ 

years. The acute dietary exposure 

estimates were ≤ 24% aPAD (95th

percentile; children 1–2 years old were 

the most highly exposed population).

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with DEEM-FCIDTM, 

which incorporates food consumption 

data as reported by respondents in the 

USDA 1994–1996 and 1998 CSFII, and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: The chronic 

analysis was refined through the use of 

projected percent crop treated (PCT) 

estimates and average field trial 

residues. Since the chronic analysis 

assumed that all meat/milk 

commodities will contain fenamidone 

residues (i.e., no adjustment for feed 

PCT) and since the analysis made use of 

field trial residues (treated at maximum 

labeled rate, minimum preharvest 

interval), the Agency concludes that the 

chronic exposure estimates are 

conservative. 

iii. Cancer. Fenamidone is classified 

as ‘‘not likely to be carcinogenic to 

humans’’ by all relevant routes of 

exposure based on adequate studies in 

two animal species.

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 chemicals that have 

been measured in food. If EPA relies on 

such information, EPA must require 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. Following the initial data 

submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. As required by 

section 408(b)(2)(E) of FFDCA, EPA will 

issue a data call-in for information 

relating to anticipated residues to be 

submitted no later than 5 years from the 

date of issuance of this tolerance.

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 the 

Agency can make the following 

findings:

Condition 1, that 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 such pesticide residue.

Condition 2, that the exposure 

estimate does not underestimate 

exposure for any significant 

subpopulation group.

Condition 3, if 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 section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT.

The Agency used PCT information in 

Table 2 of this unit as follows:

TABLE 2.—PERCENT CROP TREATED

ESTIMATES FOR FENAMIDONE

Commodity Acute % 

Crop Treated 

Chronic % 

Crop Treated 

Tomato 100% 31%

Potato 100% 20%

Lettuce 100% 24%

TABLE 2.—PERCENT CROP TREATED

ESTIMATES FOR FENAMIDONE—Continued

Commodity Acute % 

Crop Treated 

Chronic % 

Crop Treated 

Cucurbits 100% 9%

Bulb crops 100% 19%

For each crop, EPA projected a PCT 

estimate for fenamidone by assuming 

that fenamidone would duplicate the 

PCT of the fenamidone alternative that 

had the highest PCT and, like 

fenamidone, is a relatively new 

pesticide, targets the same pests as 

fenamidone, and tends to replace the 

same older pesticides (e.g., 

chlorothalonil and EBDCs). Further, 

fenamidone had to be price competitive 

with the alternative on which the 

projection was based.

The Agency believes that the three 

conditions listed in Unit III.C.1.iv. have 

been met. With respect to Condition 1, 

PCT estimates are derived from Federal 

and private market survey data on 

fenamidone alternatives, which are 

reliable and have a valid basis. EPA uses 

a weighted average PCT for chronic 

dietary exposure estimates. This 

weighted average PCT figure is derived 

by averaging State-level data for a 

period of up to 10 years, and weighting 

for the more robust and recent data. A 

weighted average of the PCT reasonably 

represents a person’s dietary exposure 

over a lifetime, and is unlikely to 

underestimate exposure to an individual 

because of the fact that pesticide use 

patterns (both regionally and nationally) 

tend to change continuously over time, 

such that an individual is unlikely to be 

exposed to more than the average PCT 

over a lifetime. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, 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 information on the 

58062 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

regional consumption of food to which 

fenamidone may be applied in a 

particular area.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

fenamidone in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

fenamidone.

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and Screening Concentration in 

Ground Water (SCI-GROW), which 

predicts pesticide concentrations in 

ground water. In general, EPA will use 

GENEEC (a tier 1 model) before using 

PRZM/EXAMS (a tier 2 model) for a 

screening-level assessment for surface 

water. The GENEEC model is a subset of 

the PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. GENEEC incorporates a farm 

pond scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

pond scenario. The PRZM/EXAMS 

model includes a percent crop area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to fenamidone 

they are further discussed in the 

aggregate risk sections in Unit III.E.2.

Based on the PRZM/EXAMS and SCIGROW models, the EECs of fenamidone 

for acute exposures are estimated to be 

10.47 parts per billion (ppb) for surface 

water and 8.19 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 2.58 ppb for surface 

water and 8.19 ppb for ground 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). 

Fenamidone is not registered for use on 

any sites 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fenamidone and any other substances 

and fenamidone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that fenamidone has 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 the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

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

cumulative/.

D. Safety Factor for Infants and 

Children

1.In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. 

The Agency concluded that there is not 

a concern for pre- and/or postnatal 

toxicity resulting from exposure to 

fenamidone. No quantitative or 

qualitative evidence of increased 

susceptibility of rat or rabbit fetuses to 

in utero exposure in the developmental 

toxicity studies was observed. There 

was no developmental toxicity in rabbit 

fetuses up to 100 mg/kg/day highest 

dose tested (HDT), which resulted in an 

increased absolute liver weight in the 

does. Since the liver was identified as 

one of the principal target organs in 

rodents and dogs, the occurrence of this 

finding in rabbits at 30 and 100 mg/kg/

day was considered strong evidence of 

maternal toxicity. In the rat 

developmental study, developmental 

toxicity manifested as decreased fetal 

body weight and incomplete fetal 

ossification in the presence of maternal 

toxicity in the form of decreased body 

weight and food consumption at the 

Limit Dose (1,000 mg/kg/day). The 

effects at the limit dose were 

comparable between fetuses and dams. 

No quantitative or qualitative evidence 

of increased susceptibility was observed 

in the 2-generation reproduction study 

in rats. In that study, both the parental 

and offspring based on decreased 

absolute brain weight in female F1 

adults and female F2 offspring at 89.2 

mg/kg/day. At 438.3 mg/kg/day, 

parental effects consisted of decreased 

body weight and food consumption, and 

increased liver and spleen weight. 

Decreased pup body weight was also 

observed at the same dose level of 438.3 

mg/kg/day. There were no effects on 

reproductive performance up to 438.3 

mg/kg/day (HDT).

3. Conclusion. Exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. The toxicity database is not 

complete because EPA has required that 

a developmental neurotoxicity (DNT) 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58063

study be conducted due to evidence 

from fenamidone studies of clinical 

signs of neurotoxicity and decreased 

brain weight. EPA has retained the 

FQPA additional 10X safety factor for 

the protection of infants and children 

because of the absence of the DNT 

study. This FQPA safety factor is in the 

form of a database uncertainty factor. A 

1,000-fold uncertainty factor (10x UFDB

for lack of a (DNT) study; 10X for 

interspecies extrapolation; and 10x for 

intraspecies variation) were 

incorporated into the acute and chronic 

RfD . The reference dose (RfD) for acute 

and chronic risks from fenamidone is 

equal to the applicable NOAEL divided 

by the 1000x uncertainty factor.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water [e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to fenamidone the 

highest exposed population subgroup 

was children 1-2 years old which 

accounted for 24% of the aPAD. The 

acute aggregate risk associated with the 

proposed use of fenamidone does not 

exceed the Agency’s level of concern for 

the general U.S. population or any 

population subgroups.. In addition, 

there is potential for acute dietary 

exposure to fenamidone in drinking 

water. After calculating DWLOCs and 

comparing them to the EECs for surface 

and ground water, EPA does not expect 

the aggregate exposure to exceed 100% 

of the aPAD, as shown in Table 3 of this 

unit:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO FENAMIDONE

Population Subgroup aPAD (mg/kg) % aPAD (Food 

DEEM) 

Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Acute DWLOC 

(ppb) 

General U.S. population 0.13 16% 10.47 8.19 3800

Children 1–2 yearsold 0.13 24% 10.47 8.19 990

Youth 13–19 yearsold 0.13 15% 10.47 8.19 330

Adults 20–49 yearsold 0.13 17% 10.47 8.19 3800

Females 13–49 years old 0.13 17% 10.47 8.19 3200

1. Maximum water exposure (mg/kg/day) = aPAD (mg/kg/day) - food exposure (mg/kg/day).

2. The crop producing the highest level was used.

3. DWLOC calculated as follows:

DWLOC = (maximum water exposure (mg/kg/day)) x (body weight (kg)) x (1,000 μg (gram)/mg) ÷ water consumption (L/day)

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that the chronic dietary exposure 

analysis was partially refined through 

the use of projected PCT estimates and 

average field trial residues. Since the 

chronic analysis assumed that all meat/

milk commodities will contain 

fenamidone residues (i.e. no adjustment 

for feed PCT) and since the analysis 

made use of field trial residues (treated 

at maximum labeled rate, minimum 

preharvest interval, samples frozen 

upon collection and remained frozen 

until analysis), EPA concludes that the 

chronic exposure estimates are 

conservative. The highest exposed 

population subgroup was children 1–2 

years old which occupies 69% of the 

cPAD. There are no residential uses for 

fenamidone that result in chronic 

residential exposure to fenamidon. EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD, as shown 

in Table 4 of this unit:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO FENAMIDONE

Population Subgroup cPAD mg/kg/day %cPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Chronic DWLOC 

(ppb) 

U.S. population 0.003 29% 2.58 8.19 74

58064 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO FENAMIDONE—Continued

Population Subgroup cPAD mg/kg/day %cPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Chronic DWLOC 

(ppb) 

Children 1–2 years old 0.003 69% 2.58 8.19 9.2

Youth 13–19 years old 0.003 26% 2.58 8.19 67

Adults 20–49 years old 0.003 26% 2.58 8.19 78

Females 13–49 years old 0.003 26% 2.58 8.19 67

3. Short-term risk. Short-term risk 

assessment was not performed because 

there are no existing or proposed 

residential uses for fenamidone.

Fenamidone is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

4. Intermediate-term risk. 

Intermediate-term risk assessment was 

not performed because there are no 

existing or proposed residential uses for 

fenamidone.

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Fenamidone is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

5. Aggregate cancer risk for U.S. 

population. A cancer aggregate risk 

assessment was not performed because 

fenamidone is not considered to be 

carcinogenic.

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, and to infants and children 

from aggregate exposure to fenamidone 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The registrant has proposed a liquid 

chromatograph/mass spectroscopy (LC/

MS) method for the enforcement of the 

plant tolerances (the method does not 

distinguish the S- and R-enantiomers). 

Adequate method validation, 

radiovalidation, and independent 

method validation (ILV) of the proposed 

enforcement method have been 

submitted.

The Agency concludes that livestock 

tolerances are necessary. The petitioner 

has proposed a livestock enforcement 

method and submitted an ILV for this 

method. The Agency notes that methods 

AR 200-99 (milk) and AR 178-98 (tissue) 

have been adequately radiovalidated for 

the determination of fenamidone, RPA 

717879, and RPA 408056. An ILV study 

has been submitted for the livestock 

enforcement method and it indicates 

that the method is satisfactory for 

enforcement purposes.

Adequate enforcement methodology 

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 currently no established 

Codex, Canadian, or Mexican maximum 

residue limits (MRLs) for fenamidone 

in/on requested crops; therefore, 

harmonization is not an issue for this 

petition.

C. Conditions

1. Toxicity data requirements. A DNT 

study in rats is required. The Agency 

concluded that the DNT was required 

based on the following:

i. Clinical signs of neurotoxicity were 

seen in the mutagenicity studies with 

parent and plant metabolites, 

particularly RPA 412636 and RPA 

412708.

ii. In the acute neurotoxicity study in 

rats, decreased brain weight in male rats 

was observed.

iii. In the 2-generation reproduction 

study in rats, decreased absolute brain 

weight was observed in the female F1 

adults and the female F2 offspring.

The Agency reassessed the 

requirement for a DNT study in rats for 

fenamidoene in response to the waiver 

request by Bayer CropSciences.

2. Residue chemistry data 

requirements—i. The Agency is 

requesting that the petitioner hydrolyze 

the extractable and non extractable 

residues from the N-phenyl studies to 

determine if conjugated aniline(s) are 

present (data validating the storage 

interval are also required).

ii. The Agency is also requiring 

additional identification/

characterization on the N-phenyl 

livestock samples to determine the 

metabolic fate of the N-phenyl ring in 

livestock (data validating the storage 

interval are also required).

iii. Submission of storage stability 

data for confined accumulation in 

rotational crop study.

V. Conclusion

Therefore, the tolerance is established 

for residues of fenamidone, 4Himidazol-4-one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-, in or on garlic, bulb at 0.20 ppm; 

garlic, great headed at 0.20 ppm; grape 

(imported) at 1.0 ppm, leek at 1.5 ppm, 

onion, dry bulb at 0.20 ppm; onion, 

green at 1.5 ppm; onion, welsh at 1.5 

ppm; shallot, bulb at 0.20 ppm; shallot, 

fresh leaves at 1.5 ppm; tomato at 1.0 

ppm; tomato, paste at 2.2 ppm; tomato, 

puree at 2.0 ppm; vegetable, cucurbit, 

group 09 at 0.15 ppm and vegetable, 

tuberous and corm, subgroup 01C at 

0.02 ppm and also for the combined 

residues of fenamidone (4H-imidazol-4-

one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-) and its metabolite RPA 717879 

(2,4-imidazolidinedione, 5-methyl-5-

phenyl) in or on fat (beef, goat, and 

sheep) at 0.10 ppm; meat (beef, goat, 

and sheep) at 0,10 ppm., meat 

byproducts (beef, goat, and sheep) at 

0.10 ppm; milk at 0.02 ppm; wheat 

forage at 0.15 ppm; wheat, grain at 0.10 

ppm; wheat, hay at 0.50 ppm; wheat, 

straw at 0.35 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58065

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0255 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 

on or before November 29, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0255, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

58066 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 21, 2004.

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 180.579 is amended by 

designating the text of paragraph (a) as 

paragraph (a)(1) and alphabetically 

adding new commodities to the table in 

paragraph (a)(1) and by adding new 

paragraph (a)(2) and text to paragraph (d) 

to read as follows:

§ 180.579 Fenamidone; tolerances for 

residues.

(a) * * *

(1) Tolerances are established for 

residues of fenamidone (4H-imidazol-4-

one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-) from the application of the 

fumgicide fenamidone in or on the 

following raw agricultural commodities:

Commodity Parts per 

million 

garlic, bulb ................................ 0.20

garlic, great headed .................. 0.20

Grape (imported) ...................... 1.0

Leek .......................................... 1.5

*****

Onion, dry bulb ......................... 0.20

Onion, green ............................. 1.5

Onion, welsh ............................. 1.5

Shallot, bulb .............................. 0.20

Shallot, fresh leaves ................. 1.5

Tomato ...................................... 1.0

Tomato, paste ........................... 2.2

Tomato, puree .......................... 2.0

Vegetable, cucurbit, group 09 .. 0.15

Vegetable, tuberous and corm, 

subgroup 01C ....................... 0.02

(2) Tolerances are established for the 

combined residues of fenamidone (4Himidazol-4-one, 3,5-dihydro-5-methyl-2-

(methylthio)-5-phenyl-3-(phenylamino), 

(S)-) and its metabolite RPA 717879 

(2,4-imidazolidinedione, 5-methyl-5-

phenyl), expressed as parent compound, 

in or on the following commodities:

Commodity Parts per 

million 

beef, fat ..................................... 0.10

beef, meat ................................. 0.10

beef, meat byproducts .............. 0.10

goat, fat ..................................... 0.10

goat, meat ................................. 0.10

goat, meat byproducts .............. 0.10

milk ........................................... 0.02

sheep, fat .................................. 0.10

sheep, meat .............................. 0.10

sheep, meat byproduct ............. 0.10

* * * * *

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of the fungicide fenamidone (4-Himidazol-4-one, 3,5-dihydro-5-methyl-2-

(methlthio)-5-phenyl-3-(phenylamino, 

(S)-) and its metabolite RPA 717879 

(2,4-imidazolidinedione, 5-methyl-5-

phenyl) in or on the following 

agricultural commodities when present 

therein as a result of application of 

fenamidone to the crops in paragraph 

(a)(1).

Commodity Parts per 

million 

Wheat, grain ............................. 0.10

Wheat, hay ............................... 0.50

Commodity Parts per 

million 

Wheat, forage ........................... 0.15

Wheat, straw ............................. 0.35

[FR Doc. 04–21694 Filed 9–28–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0300; FRL–7677–6]

Citrate Esters; Exemption from the 

Requirement of a Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of acetyl tributyl 

citrate (ATBC) also known as citric acid, 

2-(acetyloxy)-, tributyl ester (CAS Reg. 

No. 77–90–7) and triethyl citrate (TEC) 

also known as citric acid, triethyl ester 

(CAS Reg. No. 77–93–0) when used as 

inert ingredients in pesticide products. 

Morflex submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting the exemptions from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of ATBC or TEC.

DATES: This regulation is effective 

September 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit XI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0300. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is