Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 61599

Note: This document was received at the 

Office of the Federal Register on October 13, 

2004.

Dated: January 12, 2004. 

S. A. Kenney, 

Commander, JAGC, U.S. Navy, Deputy 

Assistant Judge Advocate, General (Admiralty 

and Maritime Law).

[FR Doc. 04–23215 Filed 10–19–04; 8:45 am] 

BILLING CODE 3510–FF–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0327; FRL–7682–1]

Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of cyprodinil, 4-

cyclopropyl-6-methyl-N-phenyl-2-

pyrimidinamine, in or on almond, hulls; 

bean, dry; bean, succulent; and leafy 

greens subgroup 4A, except spinach. 

Interregional Research Project Number 4 

(IR–4) 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 

October 20, 2004. Objections and 

requests for hearings must be received 

on or before December 20, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0327. 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 South 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:

Maria I. Rodriguez, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., 

NW.,Washington, DC 20460–0001; 

telephone number: (703) 305–6710; email address: rodriguez.maria@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 at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of April 21, 

2003 (68 FR 19528) (FRL–7301–6), 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 3E6530; note that 

this PP was inadvertently reported as PP 

2E6530 in the unit entitled Summary of 

Petition of that notice) by IR–4, 681 U.S. 

Highway #1 South, New Brunswick, NJ 

08902–3390. The petition requested that 

40 CFR 180.532 be amended by 

establishing tolerances for residues of 

the fungicide cyprodinil, 4-cyclopropyl6-methyl-N-phenyl-2-pyrimidinamine, 

in or on almond, hulls at 8.0 parts per 

million (ppm). That notice included a 

summary of the petition prepared by IR–

4, the registrant. There were no 

comments received in response to the 

notice of filing.

In the Federal Register of September 

1, 2004 (69 FR 53436) (FRL–7676–4), 

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 petitions (PP 3E6638 and PP 

3E6700) by IR–4, 681 U.S. Highway #1 

South, New Brunswick, NJ 08902–3390. 

The petition requested that 40 CFR 

180.532 be amended by establishing a 

tolerance for residues of the fungicide 

cyprodinil, 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine, in or on leafy 

greens subgroup 4A, except spinach at 

30 ppm (PP 3E6638); bean, dry and 

bean, succulent at 0.6 ppm each (PP 

3E6700). That notice included a 

summary of the petition prepared by IR–

4, the registrant. Comments were 

received from one individual in New 

Jersey opposing and objecting the 

establishment of tolerances for residues 

of cyprodinil. The individual criticized 

IR–4’s involvement in the pesticide 

registration as well as EPA’s way of 

conducting pesticide registration. EPA’s 

response to the public comments 

received is in Unit V. of this document.

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 

61600 Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 

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 tolerances for residues of 

cyprodinil in or on almond, hulls at 8.0 

ppm; bean, dry and bean, succulent at 

0.6 ppm each; and leafy greens 

subgroup 4A, except spinach at 30 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 cyprodinil as 

well as the no observed adverse effect 

level (NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed are discussed 

in the Federal Register of September 19, 

2003 (68 FR 54808) (FRL–7326–4).

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. An 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 

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 cyprodinil used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of September 19, 

2003 (68 FR Page 54808) (FRL–7326–4).

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.532) for the 

residues of cyprodinil, in or on a variety 

of raw agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

cyprodinil 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 oneday 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 United 

States Department of Agriculture 

(USDA) 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: An unrefined, 

Tier 1 acute dietary exposure 

assessment (using tolerance-level 

residues, DEEM default processing 

factors and assuming 100% crop treated 

for all proposed commodities) was 

conducted for the females 13–49 years 

old population subgroup.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: An 

unrefined, Tier 1 chronic dietary 

Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 61601

exposure assessment (using tolerancelevel residues, DEEM default processing 

factors, and assuming 100% crop treated 

for all proposed commodities) was 

conducted for the general U.S. 

population and various population 

subgroups.

iii. Cancer. A quantitative cancer 

aggregate-exposure assessment was not 

performed because cyprodinil is not 

carcinogenic.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

cyprodinil 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 

cyprodinil.

The Agency uses the FQPA Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/

EXAMS), to produce estimates of 

pesticide concentrations in an index 

reservoir. The SCI-GROW model is used 

to predict pesticide concentrations in 

shallow ground water. For a screeninglevel assessment for surface water EPA 

will use FIRST (a tier 1 model) before 

using PRZM/EXAMS (a tier 2 model). 

The FIRST model is a subset of the 

PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. Both FIRST and PRZM/

EXAMS incorporate an index reservoir 

environment, and both models include 

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 cyprodinil 

they are further discussed in the 

aggregate risk sections in Unit III.E.

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

for acute exposures are estimated to be 

73 parts per billion (ppb) for surface 

water and 0.062 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 61 ppb for surface water 

and 0.062 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).

Cyprodinil 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 

cyprodinil and any other substances and 

cyprodinil 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 cyprodinil 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 data base 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. 

There are no concerns or uncertainties 

for pre- and/or post-natal exposure.

3. Conclusion. There is a complete 

toxicity data base for cyprodinil and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

10X default safety factor (SF) to protect 

infants and children has been reduced 

to 1X. The basis for the recommendation 

has been discussed in Unit III.D. of the 

final rule published in the Federal 

Register of September 19, 2003 (68 FR 

54808) (FRL–7326–4).

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 

61602 Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 

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 cyprodinil will 

occupy, 4% of the aPAD of 1.5 mg/kg/

day for females 13 to 49 years. For the 

general population, no toxic effects of 

concern that could be attributed to a 

single exposure were observed in the 

oral toxicity studies, including the 

developmental toxicity studies in rats 

and rabbits. Therefore, cyprodinil is not 

expected to pose an acute risk to this 

population subgroup. In addition, there 

is potential for acute dietary exposure to 

cyprodinil 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 1. of this 

unit:

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CYPRODINIL

Population Subgroup aPAD (mg/

kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

Females (13–49 years old) 1.5 4 73 0.062 43,000

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to cyprodinil from food 

will utilize 38% of the cPAD of 0.03 mg/

kg/day for the U.S. population, and 67% 

of the cPAD for the most highly exposed 

population subgroup, children 1–2 years 

old. There are no residential uses for 

cyprodinil that result in chronic 

residential exposure to cyprodinil. In 

addition, there is potential for chronic 

dietary exposure to cyprodinil 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 cPAD, as shown 

in Table 2. of this unit:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CYPRODINIL

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.03 38 61 0.062 650

Children (1–2 years old) 0.03 67 61 0.062 100

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Cyprodinil 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 aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Cyprodinil 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. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, cyprodinil was classified as 

‘‘not likely to be carcinogenic to 

humans.’’ Therefore, cyprodinil is not 

expected to pose a cancer risk to 

humans.

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to cyprodinil 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. Head and leaf lettuce, lima 

bean, dry bean, and snap bean were 

analyzed using Novartis working 

method AG–631B. The method uses 

High Performance Liquid 

Chromatography (HPLC) with Column 

Switching. Almonds were analyzed 

using Syngenta tolerance enforcement 

method AG–631A. The method uses 

HPLC with Column Switching, with 

modifications. The confirmatory method 

uses HPLC with Ultraviolet detection 

(HPLC/UV). 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

Canada, Codex, and Mexico do not 

have maximum residue limits (MRLs) 

Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 61603

for residues of cyprodinil in/on the 

proposed crops. Therefore, 

harmonization is not an issue.

V. EPA’s Response to Public Comments 

Received Regarding the Notice of Filing

Comments were received from one 

individual in New Jersey opposing and 

objecting the establishment of tolerances 

for residues of cyprodinil. The 

individual criticized IR–4’s involvement 

in the pesticide registration as well as 

EPA’s way of conducting pesticide 

registration. The comments were in 

response to the notice of filing 

published in the Federal Register of 

September 1, 2004 (69 FR 53436) (FRL–

7676–4).

One comment indicated that IR–4 and 

Rutgers University are profiteering by 

registering pesticides for Syngenta. The 

IR–4 program was created by Congress 

in 1963 in order to assist minor crop 

growers in the process of obtaining 

pesticide registrations. IR–4 National 

Coordinating Headquarters is located at 

Rutgers University in New Jersey and 

receives the majority (90%) of its 

funding from the USDA. It is the only 

publicly funded program that conducts 

research and submits petitions for 

tolerances. IR–4 operates in 

collaboration with USDA, the Land 

Grant University System, the 

agrochemical industry, commodity 

associations, and EPA. IR–4 identifies 

needs, prioritizes accordingly, and 

conducts research. The majority (over 

80%) of IR–4’s research is conducted on 

reduced-risk chemicals. Under the 

Pesticide Registration Improvement Act 

(PRIA), IR–4 works in cooperation with 

the registrant to request a waiver for the 

registration services. The waiver may be 

granted if the application is solely 

associated by simultaneous submission 

with a tolerance petition in connection 

with IR–4 and if it is in the public 

interest. This fee waiver serves as an 

incentive to pursue registration of minor 

uses supported by the IR–4 program. In 

addition to the work done in pesticide 

registration, IR–4 develops risk 

mitigation measures for existing 

registered products. Therefore, IR–4 and 

Rutgers University are not profiteering 

from registering pesticides.

Another comment alleged that 

according to information on the fifth 

page of the notice of filing, there is no 

data at EPA to support the pesticide 

registration. The comment applies to the 

use of ‘‘available data’’ concerning the 

cumulative effects of the pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

In this case, EPA did not assume that 

this chemical has a common mechanism 

of toxicity with other substances as the 

chemical does not generate metabolites 

produced also by other chemicals. For 

specific information regarding EPA’s 

approach to the use of common 

mechanism of toxicity to evaluate the 

cumulative effects of chemicals, please 

refer to EPA’s website at http://

www.epa.gov/pesticides/cumulative/ to 

see policy statements.

An additional comment indicated that 

during animal testing, rabbits are 

abused, tortured, and fed toxic 

chemicals. EPA test guidelines 

recommend rabbits as test animals in 

acute eye irritation studies as well as in 

longer term studies such as 

developmental toxicity and 

reproduction studies. Results obtained 

from studies conducted with animals (in 

general) are relevant to humans because 

cells and molecules of humans can be 

very similar to those of animals. 

Therefore, if a pesticide causes toxicity 

in animals, it is likely to do so in 

humans as well. EPA supports the use 

of the least possible number of animals 

in the pertinent studies. In addition, it 

should be noted that currently there are 

no in vitro studies that can address the 

concerns these studies satisfy. EPA is 

working with the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM) to investigate in vitro

methods to determine the toxicological 

concerns associated with the use of 

pesticides.

VI. Conclusion

Therefore, the tolerances are 

established for residues of cyprodinil, 4-

cyclopropyl-6-methyl-N-phenyl-2-

pyrimidinamine, in or on almond, hulls 

at 8.0 ppm; bean, dry and bean, 

succulent at 0.6 ppm each; and leafy 

greens subgroup 4A, except spinach at 

30 ppm.

VII. 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 

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–2004–0327 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 December 20, 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 VII.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–2004–0327, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

61604 Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 

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).

VIII. 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, 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 

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.

IX. 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: October 6, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR part 180 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 180.532 is amended as 

follows:

■ a. By revising the commodity 

‘‘Almond, hulls’’ in the table in 

paragraph (a).

■ b. By alphabetically adding 

commodities to the table in paragraph 

(a).

§ 180.532 Cyprodinil; tolerances for 

residues.

(a) * * *

Federal Register / Vol. 69, No. 202 / Wednesday, October 20, 2004 / Rules and Regulations 61605

Commodity Parts per 

million 

Almond, hulls ............................ 8.0

*** * *

Bean, dry .................................. 0.6

Bean, succulent ........................ 0.6

*** * *

Leafy greens subgroup 4A, except spinach .......................... 30

*** * *

* * * * *

[FR Doc. 04–23261 Filed 10–19–04; 8:45 am]

BILLING CODE 6560–50–S

DEPARTMENT OF TRANSPORTATION

Maritime Administration 

46 CFR Part 310

[Docket Number: MARAD–2004–19397] 

RIN 2133–AB61

Amended Service Obligation Reporting 

Requirements for State Maritime 

Academy Graduates

AGENCY: Maritime Administration, 

Department of Transportation.

ACTION: Interim final rule with request 

for comments. 

SUMMARY: In this interim final rule, the 

Maritime Administration (MARAD, we, 

us, or our) will change the service 

obligation reporting requirements for 

State maritime academy graduates who 

receive Student Incentive Payments 

(SIPs). The new reporting requirements 

create standard reporting dates that 

coincide with the U.S. Naval Reserve/

Merchant Marine Reserve (USNR/MMR) 

service reporting dates. This rulemaking 

also provides for the electronic 

submission of reports as the primary 

means of submission to MARAD.

DATES: This interim final rule is 

effective October 20, 2004. However, 

MARAD will consider comments 

received not later than November 19, 

2004.

ADDRESSES: You may submit comments 

(identified by DOT DMS Docket Number 

MARAD–2004–19397) by any of the 

following methods: 

• Web site: http://dms.dot.gov. 

Follow the instructions for submitting 

comments on the DOT electronic docket 

site. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

7th St., SW., Nassif Building, Room PL–

401, Washington, DC 20590–001. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 7th St., SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

Instructions: All submissions must 

include the agency name and docket 

number for this rulemaking. Note that 

all comments received will be posted 

without change to http://dms.dot.gov

including any personal information 

provided. Please see the Privacy Act 

heading under Regulatory Notices. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

dms.dot.gov at any time or to Room PL–

401 on the plaza level of the Nassif 

Building, 400 7th St., SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal 

Holidays.

FOR FURTHER INFORMATION CONTACT: Rita 

Jackson, Academies Program Officer, 

Office of Policy and Plans, Maritime 

Administration, Department of 

Transportation, 400 7th St., SW., Room 

7123, Washington, DC 20590, telephone: 

(202) 366–0284.

SUPPLEMENTARY INFORMATION: The 

Student Incentive Payment Program 

provides financial assistance to certain 

eligible State maritime academy 

students to help offset educational costs. 

Students who receive Student Incentive 

Payments must sign service obligation 

contracts that obligate the students to 

certain post-graduate service obligation 

requirements. The requirements 

include: (1) Serving for three (3) years 

after graduation in the foreign or 

domestic commerce or the national 

defense of the United States in 

maritime-related employment; (2) 

maintaining a valid license as an officer 

in the merchant marine of the United 

States for at least six (6) years following 

the date of graduation, accompanied by 

the appropriate national and 

international endorsements and 

certification as required by the United 

States Coast Guard for service aboard 

vessels on domestic and international 

voyages, and (3) accepting if tendered 

an appointment as, and serving as a 

commissioned officer in the United 

States Naval Reserve, the United States 

Coast Guard Reserve, or any other 

reserve unit of an armed force of the 

United States for six (6) years following 

graduation. The above requirements are 

set forth in 46 U.S.C. 1295c(g)(3)(C), (D), 

and (E). In addition to the above service 

obligations, graduates are required, 

under 46 U.S.C. 1295c(g)(3)(F), to 

submit reports to MARAD indicating 

compliance with their service 

obligations. 

Under the current regulations at 46 

CFR 310.7(b)(6)(i), State maritime 

academy SIP graduates are required to 

submit their service obligation reports 

thirteen (13) months following 

graduation and each succeeding twelve 

(12) months for a total of three (3) years. 

The three (3) year reporting period, 

however, does not accurately reflect the 

requirement in 46 U.S.C. 1295c(g)(3)(F) 

that graduates report compliance with 

all of their service obligations, because 

graduates must submit reports 

indicating their compliance not only 

with the three (3) year service (i.e., 

employment) requirement, but also with 

the six (6) year licensing and reserve 

components of the service obligation. 

Thus, under the law, graduates must 

submit compliance reports for a 

minimum of six (6) years to account for 

all of their service obligations. The six 

(6) year reporting requirement dates 

back to the Maritime Education and 

Training Act of 1980 (Pub. L. 96–453) 

but has not been reflected in MARAD’s 

regulations. However, as a matter of 

agency practice, MARAD has long 

required graduates to submit reports for 

six (6) years to report compliance with 

their service obligation requirements. 

In this interim final rule, MARAD is 

amending its regulations to reflect the 

requirement that graduates report for six 

(6) years (or until all components of the 

service obligation are fulfilled, 

whichever is latest). In addition, 

MARAD is amending the service 

obligation reporting requirements to 

require each graduate to file a report 

between January 1 and March 1 

following graduation and during the 

same January 1 to March 1 time frame 

for a minimum of six (6) years 

thereafter. 

The new reporting dates coincide 

with the USNR/MMR’s service reporting 

dates to create a standard reporting 

period. This standardized reporting 

period should make reporting less 

burdensome because graduates will be 

able to compile and submit information 

to MARAD and to the USNR during the 

same time frame each year. 

This rulemaking will also provide for 

the electronic submission of reports as 

the primary means of submission. 

Graduates must submit annually the 

Maritime Administration Service 

Obligation Compliance Report and 

Merchant Marine Reserve, U.S. Naval 

Reserve (USNR), Annual Report (Form 

MA–930). Graduates may submit their 

Service Obligation Compliance Reports 

electronically via the Maritime Service