58290 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

PART180-[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 180.469 is amended by 

revising the section heading, and the 

introductory text of paragraph (a), and by 

adding alphabetically new commodities 

to the table in paragraph (a) to read as 

follows:

§ 180.469 Dichlormid; tolerances for 

residues.

(a) General. Tolerances are 

established for residues of dichormid; 

(Acetamide, 2,2-dichloro-N,N-di-2-

propenyl-)(CAS Reg. No. 37764–25–3) 

when used as an inert ingredient 

(herbicide safener) in pesticide 

formulations in or on the following food 

commodities:

Commodity Parts per 

million 

Expiration/

revocation 

date 

*****

Corn, sweet, forage 0.05 12/31/05

Corn, sweet, 

kernel plus 

cob with 

husks removed 0.05 12/31/05

Corn, sweet, 

stover 0.05 12/31/05

* * * * *

[FR Doc. 04–21930 Filed 9–29–04; 8:45 am]

BILLING CODE6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0211; FRL–7367–4]

Cyazofamid; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for the combined residues of 

cyazofamid and its metabolite CCIM in 

or on potatoes, tomatoes, cucurbits, and 

imported wine. ISK Biosciences 

Corporation 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 30, 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 ID 

number OPP–2004–0211. All 

documents in the docket are listed in 

the EDOCKET index athttp://

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:

Janet Whitehurst, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

(703) 305–6129; e-mail 

address:whitehurst.janet@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/. 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 May 7, 2003 

(68 FR 24463) (FRL–7305–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 1F06305) by ISK 

Biosciences Corporation, Concord, OH. 

That notice included a summary of the 

petition prepared by ISK Biosciences 

Corporation, the registrant. There were 

no comments received in response to 

the notice of filing.

The petition requested that 40 CFR 

part 180 be amended by establishing 

tolerances for combined residues of the 

fungicide cyazofamid, 4-chloro-2-cyanoN,N-dimethyl-5-(4-methylphenyl)-1Himidazole-1-sulfonamide and its 

metabolite CCIM, 4-chloro-5-(4-

methylphenyl)-1H-imidazole-2-

carbonitrile, expressed as cyazofamid, 

in or on cucurbit vegetables (Group 9) 

at 0.10 parts per million (ppm), potato 

at 0.01 ppm, tomato at 0.20 ppm, and 

grape wine at 1.0 ppm.

Following review of the residue and 

metabolism data, EPA has made several 

minor changes to the proposed 

tolerances. For cucurbits and potatoes, 

EPA expanded the tolerance expression 

to cover both cyazofamid and its 

metabolite CCIM, which is also a 

residue of concern. This expansion of 

the toleranceexpression necessitated a 

raising of the tolerance level for potatoes 

from 0.01 ppm to 0.02 ppm. No change 

in the tolerance values was needed for 

tomatoes. Finally, residue and 

processing data for grape wine showed 

that residues might slightly exceed 1.0 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58291

ppm; accordingly, the tolerance for 

grape wine was raised to 1.5 ppm.

Section 408(b)(2)(A)(i) of the 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 combined 

residues of cyazofamid on cucurbits at 

0.10 ppm, potatoes at 0.01 ppm, 

tomatoes at 0.2 ppm, and wine grape at 

1.0 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 cyazofamid are 

discussed in Table 1 of this unit as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed.

TABLE 1.—TOXICITY PROFILE OF CYAZOFAMID [IKF–916] TECHNICAL

Guideline No. Study Type Results 

870.3100 90–day oral toxicity in rats NOAEL = 29.5 [M] mg/kg/day 

LOAEL = 295 [M] mg/kg/day based on increased number of ‘‘basophilic kidney tubules,’’ and increased urinary volume, pH, and protein.

870.3150 90–Day oral toxicity in 

dogs

NOAEL = 1,000 [M/F] mg/kg/day 

LOAEL = not observed.

870.3200 28–Day dermal toxicity in 

rats

NOAEL = 1,000 [M/F] mg/kg/day 

LOAEL = not observed.

870.3700 Prenatal developmental in 

rats

Maternal NOAEL = 1,000 mg/kg/day 

LOAEL = not observed

Developmental NOAEL = 100 mg/kg/day

LOAEL = 1,000 mg/kg/day based on increased incidence of bent ribs.

870.3700 Prenatal developmental in 

rabbits

Maternal NOAEL = 1,000 mg/kg/day 

LOAEL = not observed

Developmental NOAEL = 1,000 mg/kg/day

LOAEL = not observed

870.3800 Reproduction and fertility 

effects in rats

Parental/Systemic NOAEL = 1,114/1,416 [M/F] mg/kg/day 

LOAEL = not observed

Reproductive NOAEL = 1,114/1,416 [M/F] mg/kg/day

LOAEL = not observed

Offspring NOAEL = 1,114/1,416 [M/F] mg/kg/day

LOAEL = not observed

870.4100 Chronic toxicity in rats NOAEL = 171/ 856 [M/F] mg/kg/day 

LOAEL = not observed.

870.4100 Chronic toxicity in dogs NOAEL = 200 [M/F] mg/kg/day 

LOAEL = 1,000 [M/F] mg/kg/day based on increased cysts in parathyroids in both 

sexes and increased pituitary cysts in females.

870.4200 Carcinogenicity rats NOAEL = 171/ 856 [M/F] mg/kg/day 

LOAEL = not observed.

No evidence of carcinogenicity

870.4300 Carcinogenicity mice NOAEL = 94.8 [M] mg/kg/day 

LOAEL = 985 [M] mg/kg/day based on increased incidence of skin lesions including 

hair loss, body sores, dermatitis, ulceration, and acanthosis.

No evidence of carcinogenicity

58292 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

TABLE 1.—TOXICITY PROFILE OF CYAZOFAMID [IKF–916] TECHNICAL—Continued

Guideline No. Study Type Results 

870.5100 Gene Mutation 

Bacterial reverse mutation 

assay

Negative ± S9 up to 5,000 μg/plate by standard plate and tube preincubation (not 

cytotoxic but there was precipitation at ≥ 1,500 μg/plate.

870.5300 Gene Mutation 

Mammalian cell culture

Negative ± S9 up to cytotoxic and precipitating concentration of 100 μg/mL

870.5375 Cytogenetics 

Chromosomal aberrations

Negative ± S9 for clastogenic/aneugenic activity up to cytotoxic and precipitating 200 

μg/mL

870.5395 Cytogenetics 

Micronucleus test on 

mouse

Negative up to the highest dose tested (limit dose) 2,000 mg/kg

870.5500 Other Effects 

Bacterial DNA repair test 

(Rec-assay)

Negative ± S9 up to limit of solubility at 8,000 μg/disc

870.7485 Metabolism and pharmacokinetics in ratsThere was rapid absorption (irrespective of dose tcmax = 0.25–0.5 hrs) and rapid 

elimination at the low dose (tc 4.4–5.8 hrs) while there was saturated absorption 

with prolonged elimination (tc of 7.6–11.6 hrs) at the high-dose. The extent of absorption (as per cent of administered dose) was highly dose-dependent being 

nearly 75% at the low dose and only about 5% at the high dose. Both the urine 

and feces were major routes of excretion at the low dose with most of the urinary 

radioactivity being a metabolite named CCBA (4-(4-chloro-2-cyanoimidazol-5-

yl)benzoic acid). The biliary elimination was highly variable at the low dose (∼12–

39% of the administered low dose) and negligible (<2%) in the high-dose groups. 

Urinary or biliary excretion in the high-dose groups was low (each ∼2%) with most 

of the radioactivity being CCBA. Irrespective of the dosing regimen, most of the 

recovered fecal radioactivity was unchanged parent compound; the major fecal 

metabolites were CCBA and 4-chloro-5-p-tolylimidazole-2-carbonitrile (CCIM) each 

of which being less than 5% of the administered dose. Tissue burdens at tc, tmax, 

and at 168 hours post dose indicated rapid clearance and low tissue burdens suggesting little or no bioaccumulation or sequestration.

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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58293

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 cyazofamid used for 

human risk assessment is shown in 

Table 2 of this unit:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYAZOFAMID

Exposure Scenario Dose Used in Risk Assessment, UF 

Special FQPA SF* and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13–50 

years of age)

NOAEL = 100 mg/kg 

UF = 100

Acute RfD = 1.0 mg/kg

FQPA SF = 1X 

aPAD = acute RfD ÷ FQPA 

SF = 1.0 mg/kg

Rat Prenatal Developmental Toxicity (MRID 

45408933) 

LOAEL = 1,000 mg/kg based on developmental 

toxicity findings of increased incidence of 

bent ribs.

Acute Dietary (General population including infants and 

children)

NOAEL = NA 

UF = NA

Acute RfD = NA

FQPA SF = NA 

aPAD = acute RfD ÷ FQPA 

SF = NA

Not Required. No adverse effects were observed which could be attributed to a singledose exposure.

Chronic Dietary (All populations) NOAEL= 94.8 mg/kg/day 

UF = 100

Chronic RfD = 0.95 mg/kg/

day

FQPA SF = 1X 

cPAD = chronic RfD ÷

FQPA SF = 0.95 mg/kg/

day

18–Month Mouse Oral Carcinogenicity (MRID 

45408932) 

LOAEL = 985 mg/kg/day based on increased 

skin lesions.

Short- (1–30 days) and Intermediate-Term (1 to 6 months) 

Incidental Oral

NOAEL= NA 

No Residential Uses

Residential LOC for MOE = 

NA 

Occupational = NA

NA

Short- (1–30 days) and Intermediate-Term (1 to 6 months) 

Dermal

Oral study NOAEL = 100 

mg/kg/day 

(dermal absorption rate = 

37%)

Residential LOC for MOE = 

NA 

Occupational LOC for MOE 

= 100

Rat Prenatal Developmental Toxicity (MRID 

45408933) 

LOAEL = 1,000 mg/kg based on developmental 

toxicity findings of increased incidence of 

bent ribs.

Long-Term Dermal (>6 months) Oral study NOAEL = 94.8 

mg/kg/day 

(dermal absorption rate = 

37%)

Residential LOC for MOE = 

NA 

Occupational LOC for MOE 

= 100

18–Month Mouse Oral Carcinogenicity (MRID 

45408932) 

LOAEL = 985 mg/kg/day based on increased 

skin lesions.

Short- (1–30 days) and Intermediate-Term (1 to 6 months) 

Inhalation

Oral study NOAEL = 100 

mg/kg/day

Residential LOC for MOE = 

NA 

Occupational LOC for MOE 

= 100

Rat Prenatal Developmental Toxicity (MRID 

45408933) 

LOAEL = 1,000 mg/kg based on developmental 

toxicity findings of increased incidence of 

bent ribs.

Long-Term Inhalation (>6 

months)

Oral study NOAEL = 94.8 

mg/kg/day

Residential LOC for MOE = 

NA 

Occupational LOC for MOE 

= 100

18–Month Mouse Oral Carcinogenicity (MRID 

45408932) 

LOAEL = 985 mg/kg/day based on increased 

skin lesions.

Cancer (oral, dermal, inhalation) Not Applicable NA NA

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of 

concern, NA = Not Applicable 

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Permanent and temporary 

tolerances for residues of cyazofamid 

and its metabolites are not currently 

established. Risk assessments were 

conducted by EPA to assess dietary 

exposures from the proposed uses of 

cyazofamid on food and feed crops 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) and 

LifelineTM, which incorporates food 

consumption data as reported by 

respondents in the 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: As an 

acute dietary endpoint was not 

identified for the general population 

including infants and children, the 

acute dietary analysis was performed for 

the population subgroup females 13 to 

49 years old only. The assumptions of 

this dietary exposure assessment are 

tolerance level residues and 100% croptreated.

At the 95th percentile of exposure, the 

Tier 1 acute DEEM-FCIDTM and 

LifelineTM analysis gave the results 

listed in Table 3. For the acute analysis, 

the exposure at the 95th percentile for 

Females 13 to 49 years old is 0.003769 

mg/kg/day for DEEM-FCIDTM or 

58294 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

0.004013 mg/kg/day for LifelineT, 

which utilizes <1% of the acute PAD for 

cyazofamid for both DEEM-FCIDTM and 

LifelineTM. The results of the LifelineTM

and DEEM-FCIDTM analyses are fully 

consistent.

A summary of the acute dietary 

exposure estimates for cyazofamid and 

its metabolote CCIM used for human 

risk assessment are shown in Table 3 of 

this unit:

TABLE 3.—ACUTE DIETARY EXPOSURE ESTIMATES FOR CYAZOFAMID

Population Subgroup aPAD (mg/

kg/day) 

DEEM-FCIDTM LifeLineTM 

Exposure 

(mg/kg/day) %aPAD1 Exposure (mg/kg/day) %aPAD1

Females 13–49 years old 1.0 0.003769 <1 0.004013 <1

1Percent Acute PAD = (Exposure ÷ Acute PAD) x 100%.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEM-FCIDTM and LifelineTM, 

which incorporates food consumption 

data as reported by respondents in the 

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 chronic exposure 

assessments: The assumptions of this 

dietary exposure assessment are 

tolerance level residues and 100% croptreated.

The Tier 1 chronic DEEM-FCIDTM and 

LifelineTM analysis gave the results 

listed in Table 4. For the chronic 

analysis, the most highly exposed 

population subgroup and the highest 

risk estimate was for Children 1 to 2 

years old. The chronic exposures for 

Children 1 to 2 years old are 0.004778 

mg/kg/day for DEEM-FCIDTM) or 

0.004529 mg/kg/day for LifelineTM), 

which utilize <1.0% (for both DEEMFCIDTM and Lifeline TM) of the chronic 

PAD for cyazofamid. The results of the 

LifelineTM and DEEM-FCIDTM analyses 

are fully consistent. 

A summary of the chronic dietary 

exposure estimates for cyazofamid used 

for human risk assessment is shown in 

Table 4 of this unit:

TABLE 4.—CHRONIC DIETARY EXPOSURE ESTIMATES FOR CYAZOFAMID

Population Subgroup cPAD (mg/

kg/day) 

DEEM-FCIDTM LifeLineTM

Exposure 

(mg/kg/day) %cPAD1 Exposure (mg/kg/day) %cPAD1

General U.S. Population 0.95 0.001016 <1 0.000988 <1

All Infants (<1 year old) 0.95 0.001448 <1 0.001501 <1

Children 1–2 years old 0.95 0.004778 <1 0.004529 <1

Children 3–5 years old 0.95 0.003101 <1 0.003236 <1

Children 6–12 years old 0.95 0.001338 <1 0.00131 <1

Youth 13–19 years old 0.95 0.000567 <1 0.000589 <1

Adults 20–49 years old 0.95 0.000684 <1 0.000751 <1

Adults 50+ years old 0.95 0.000774 <1 0.000802 <1

Females 13–49 years old 0.95 0.000720 <1 0.000816 <1

1Percent Chronic PAD = (Exposure ÷ Chronic PAD) x 100%. 

iii. Cancer. A cancer dietary 

assessment was not conducted because 

cyazofamid has been classified as ‘‘not 

likely to be carcinogenic to humans’’.

iv. Anticipated residue and percent 

crop treated (PCT) information. The 

Agency did not use anticicated residue 

estimates and PCT information in the 

cyazofamid dietary exposure 

assessment.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

cyazofamid and its metabolites 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 cyazofamid.

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 Screening Concentration 

in Groudwater (SCI-GROW) model is 

used to predict pesticide concentrations 

in shallow ground water. For a 

screening-level 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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58295

(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 

percent of the reference dose (%RfD) or 

percent of the population adjusted dose 

(%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.

Based on the FIRST and SCI-GROW 

models, the EECs of cyazofamid and its 

metabolites for acute exposures are 

estimated to be 6.436 parts per billion 

(ppb) for surface water and 0.002680 

ppb for ground water. The EECs for 

chronic exposure is estimated to be 

0.495 ppb for surface 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). 

Cyazofamid 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 

cyazofamid and any other substances 

and cyazofamid 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 cyazofamid 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 concernsor residual 

uncertainties for pre- and or postnatal 

toxicity.

3. Conclusion. EPA determined that 

the 10X safety factor to protect infants 

and children should be removed i.e., 

reduced to 1X. The FQPA factor is 

removed because:

i. In the prenatal developmental 

toxicity study in rabbits, there was no 

indication of increased susceptibility 

(qualitative or quantitative) of rabbit 

fetuses to in utero exposure to 

cyazofamid. No maternal or 

developmental effects were seen at any 

dose up to the limit dose of 1,000 mg/

kg/day.

ii. In the prenatal developmental 

toxicity study in rabbits, there was no 

indication of increased susceptibility 

(qualitative or quantitative) of rabbit 

fetuses to in utero exposure to 

cyazofamid. No maternal or 

developmental effects were seen at any 

dose up to the limit dose of 1,000 mg/

kg/day.

iii. In the two-generation reproduction 

study, the highest dose tested (>1,000 

mg/kg/day) did not cause maternal 

systemic toxicity nor did it elicit 

reproductive or offspring toxicity.

iv. The Agency concluded that the 

concern is low for the quantitative 

susceptibility seen in the rat 

developmental toxicity study and there 

are no residual uncertainties because:

a. The developmental effect is well 

identified with clear NOAEL/LOAEL.

b. The developmental effect 

(increased bent ribs) is a variation rather 

than a malformation.

c. The developmental effect is seen 

only at the limit dose of 1,000 mg/kg/

day.

d. This endpoint is used to establish 

the acute RfD for Females 13–49 years 

old.

e. The overall toxicity profile 

indicates that cyazofamid is not a very 

toxic compound.

v. There were no indications of preor postnatal toxicity and no residual 

uncertainties from the rabbit 

developmental study or the rat two 

generation reproduction study.

vi. The exposure assessments are Tier 

1, conservative, high-end assessments 

and will not underestimate the potential 

dietary (food and water) exposures.

vii. There are no proposed residential 

uses.

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 

58296 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 cyazofamid will 

occupy <1% of the aPAD for females 13 

years and older. In addition, there is 

potential for acute dietary exposure to 

cyazofamid 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 5 of this 

unit:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CYAZOFAMID

Population Subgroup aPAD (mg/

kg/day) 

Acute 95% 

Food Exposure1 (mg/

kg/day) 

Maximum 

Acute Water 

Exposure2

(mg/kg/day) 

Ground 

Water 

EDWC3

(ppb or μg/

L) 

Surface 

Water 

EDWC3

(ppb or μg/

L) 

Acute 

DWLOC4

(ppb or μg/

L) 

Females 13–49 years old 1.0 0.004013 1.0 0.495 6.436 3.0 x 104

1The exposure from the model producing the highest exposure estimate for the population subgroup was used. 

2 Maximum Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary (Food) Exposure. 

3The highest level was used. 

4 DWLOC(μg/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-3 mg/μg]. A body weight of 70 kg is 

assumed for adults, 60 kg for females and youth, and 10 kg for children; water consumption is assumed to be 2 L for adults and 1 L for children.

2. Chronic risk. The chronic dietary 

exposure analyses in this assessment for 

cyazofamid result in dietary risk (food 

only) estimates that are below the 

Agency’s level of concern for chronic 

dietary (food only) exposure. For the 

chronic analysis, the most highly 

exposed population subgroup and the 

highest risk estimate was for children 1 

to 2 years old. The chronic exposures 

for children 1 to 2 years old are 

0.004778 mg/kg/day for DEEM-FCIDTM

or 0.004529 mg/kg/day for LifelineTM, 

which utilize <1.0% (for both DEEMFCIDTM and LifelineTM) of the chronic 

PAD for cyazofamid. EPA does not 

expect the aggregate exposure to exceed 

100% of the cPAD, as shown in Table 

6 of this unit:

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CYAZOFAMID

Population Subgroup cPAD (mg/

kg/day) 

Chronic 

Food Exposure1 (mg/

kg/day) 

Maximum 

Chronic 

Water Exposure2 (mg/

kg/day) 

Ground 

Water 

EDWC3

(ppb or μg/

L) 

Surface 

Water 

EDWC3

(ppb or μg/

L) 

Chronic 

DWLOC4

(ppb or μg/

L) 

General U.S. Population 0.95 0.001016 0.95 NA NA 3.3 x 104

All Infants (<1 year old) 0.95 0.001501 0.95 NA NA 9.5 x 103

Children 1–2 years old 0.95 0.004778 0.95 NA NA 9.5 x 103

Children 3–5 years old 0.95 0.003236 0.95 NA NA 9.5 x 103

Children 6–12 years old 0.95 0.001338 0.95 0.495 8.085 9.5 x 103

Youth 13–19 years old 0.95 0.000589 0.95 NA NA 2.8 x 104

Adults 20–49 years old 0.95 0.000751 0.95 NA NA 3.3 x 104

Adults 50+ years old 0.95 0.000802 0.95 NA NA 3.3 x 104

Females 13–49 years old 0.95 0.000816 0.95 NA NA 2.8 x 104

1The exposure from the model producing the highest exposure estimate for the population subgroup was used.

2 Maximum Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary (Food) Exposure

3The highest level was used.

4 DWLOC(μg/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-3 mg/μg]. A body weight of 70 kg is 

assumed for adults, 60 kg for females and youth, and 10 kg for children; water consumption is assumed to be 2L for adults and 1L for children.

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). 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58297

Cyazofamid 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). 

Cyazofamid 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. The Agency classified 

cyazofamid as ‘‘not likely to be 

carcinogenic to humans.’’ Thus, 

cyazofamid is not expected to pose a 

risk.

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to cyazofamid 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The Food and Drug Administration’s 

(FDA’s) Multi-Residue Protocol D 

(without cleanup) is the acceptable 

enforcement method in crops. The 

petitioner should provide the Agency 

with a single modified method for all 

crops with the inclusion of the minor 

variations for crops as needed.

B. International Residue Limits

There are currently no Codex, 

Canadian, or Mexican MRL’s or 

tolerances for cyazofamid on cucurbits, 

tomato, potato, and wine. Therefore, 

international harmonization is not an 

issue for this petition.

C. Conditions

The following confirmatory data are 

needed for wheat. Data are listed below 

by guideline series. 

1. Harmonized guideline 860.1300—

Nature of the residue. The metabolism 

studies conducted on plants (grapes, 

potatoes, and tomatoes) and livestock 

(goats and hen) as well as the confined 

rotational crop study are deemed 

tentatively acceptable. To fully upgrade 

each study, the petitioner is required to 

provide information pertaining to dates 

of sample collection, extraction, and 

final analysis. This information is 

required for each study to determine 

actual sample storage intervals.

The metabolic profiles in crop 

matrices (grape, wine; potato and 

tomato) determined at the beginning 

and at the end of the analytical phase 

were not provided. Representative 

chromatograms of the radiolabeled 

residues taken before and after storage 

under frozen conditions should be 

submitted. In the future, additional 

metabolism data might be required if 

uses on additional crops are requested.

2. Harmonized guideline 860.1340—

Residue analytical methods. The 

petitioner has provided the proposed 

enforcement method entitled, 

‘‘Analytical Method for IKF–916 and 

CCIM in Tomato Samples’’ as an 

attachment to the ILV of the method. 

The Agency finds that the Residue 

Analytical Methods used for data 

collection may be used as a single 

analyte confirmatory method. However, 

the petitioner should provide the 

Agency with a single modified method 

for all crops with the inclusion of the 

minor variations for crops as needed. 

The FDA’s Multi-Residue Protocol D 

(without cleanup) is the acceptable 

enforcement method in crops.

3. Harmonized guideline 860.1380—

Storage stability. Storage stability data 

for 18 months on the representative 

commodities of the cucurbit group 

should be submitted to support the 

storage intervals and conditions of the 

crop field trials.

4. Harmonized guideline 860.1850—

Confined Accumulation in rotational 

Crops. The submitted study is 

tentatively deemed adequate to satisfy 

data requirements for a confined 

rotational crop study pending 

submission of information pertaining to 

extraction and analysis dates of samples 

from the 31–day PBI. These dates are 

required to determine the actual sample 

storage intervals and need for additional 

storage stability data. The supporting 

storage stability data from the current 

submission indicate that the parent and 

its metabolites CCIM and CCBA are 

relatively stable in fortified samples of 

carrot roots, lettuce, and wheat forage 

stored frozen for up to 4 months. The 

identities of the parent, CCIM, CCIMAM, and sugars are deemed adequately 

identified pending submission of 

representative TLC or data from TLC 

analyses.

5. Other data. Historical control data 

for dog toxicity studies.

V. Conclusion

Therefore, tolerances are established 

for the combined residues of 

cyazofamid, 4-chloro-2-cyano-N,Ndimethyl-5-(4-methylphenyl)-1Himidazole-1-sulfonamide, and its 

metabolite CCIM, 4-chloro-5-(4-

methylphenyl)-1H-imidazole-2-

carbonitrile, expressed as cyazofamid, 

in or on cucurbit vegetables (Group 9) 

at 0.10 ppm, potato at 0.02 ppm, tomato 

at 0.20 ppm, and grape, wine at 1.5 

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 

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–2004–0211 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 

58298 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 Street, 

NW., Suite 350, Washington, DC. 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–2004–0211 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, 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.

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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58299

and pests, Reporting and recordkeeping 

requirements.

Dated:lllllllllll

llllllllllllllll

Director, 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 180.601 is added to read as 

follows:

§ 180.601 Cyazofamid; tolerances for 

residues.

(a) General. Tolerances are 

established for the combined residues of 

cyazofamid, 4-chloro-2-cyano-N,Ndimethyl-5-(4-methylphenyl)-1Himidazole-1-sulfonamide, and its 

metabolite CCIM, 4-chloro-5-(4-

methylphenyl)-1H-imidazole-2-

carbonitrile, expressed as cyazofamid, 

in or on the following commodities:

Commodity Parts per million 

Cucurbit vegetables (Group 

9) ..................................... 0.10

Grape, wine,* import ........... 1.5

Potato ................................. 0.02

Tomato ................................ 0.20

*No domestic registrations. 

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional 

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 04–21931 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0298; FRL–7678–7]

Octanal; Exemption from the 

Requirement of a Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of octanal on 

growing crops or raw agricultural 

commodities (RAC) when used as an 

inert ingredient in pesticide 

formulations applied to growing crops, 

RAC after harvest, or to animals. 

Firmenich submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act (FQPA) 

of 1996, requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of octanal.

DATES: This regulation is effective 

September 30, 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 VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0298. 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., Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available 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:

Princess Campbell, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8033; e-mail address: 

campbell.princess@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)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

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 December 

20, 2000 (65 FR 79834) (FRL–6751–9), 

EPA issued a notice pursuant to section 

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

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

pesticide tolerance petition (6E4757) by 

Firmenich, P.O. 5880, Princeton, NJ 

08543.

Firmenich requested that octanal, also 

known as caprylic aldehyde, or 1-

octanal, be approved for use as an inert 

ingredient in pesticide formulations 

applied to growing crops, RACs after 

harvest, or to animals at an amount that 

was not to exceed 0.2% of the 

formulated product. This notice 

included a summary of the petition 

prepared by the petitioner Firmenich.

The petition requested that 40 CFR 

180.1001, (c) and (e), newly redesignated as § 180.910 and § 180.930 

April 28, 2004 (69 FR 23113) (FRL–

7335–4), be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of octanal, (CAS 

Registration No. 124–13–0). There were 

no comments received in response to 

the notice of filing.

Section 408(c)(2)(A)(i) of the FFDCA 

allows EPA to establish an exemption 

from the requirement for 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(c)(2)(A)(ii) 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