Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58285

promoters, terminators, and enhancers, 

that control the expression of the 

genetic material encoding the Cry1F 

protein.

[FR Doc. 04–21877 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0318; FRL–7680–8]

Dichlormid; Time-Limited Pesticide 

Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

the inert ingredient (herbicide safener) 

dichlormid (Acetamide, 2,2-dichloroN,N-di-2-propenyl-) in or on sweet corn 

commodities at 0.05 parts per million 

(ppm). Dow AgroSciences requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act, (FFDCA) as amended 

by the Food Quality Protection Act of 

1996 (FQPA). The tolerances will expire 

on December 31, 2005.

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. After submitting your 

original written objection or hearing 

request as instructed in Unit VI., you 

can use EDOCKET or regulations.gov to 

submit the requested copy (see also Unit 

VI.A.2.). EPA has established a docket 

for this action under Docket 

identification (ID) number OPP–2004–

0318. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

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

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Kathryn Boyle, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–305– 6304; e-mail 

address:boyle.kathryn@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:

• Industry (NAICS 111), e.g., Crop 

Production, e.g., agricultural workers; 

greenhouse, nursery, and floriculture 

workers; farmers.

• Industry (NAICS 112), e.g., Animal 

Production, e.g., cattle ranchers and 

farmers, dairy cattle farmers, livestock 

farmers.

• Industry (NAICS 311), e.g., Food 

Manufacturing, e.g., agricultural 

workers; farmers; greenhouse, nursery, 

and floriculture workers; ranchers; 

pesticide applicators.

• Industry (NAICS 32532), e.g., 

Pesticide Manufacturing, 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 November 

21, 2003 (68 FR 65708) (FRL–7333–7), 

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 3E6676) by Dow 

AgroSciences LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. This notice 

included a summary of the petition 

prepared by Dow AgroSciences, the 

petitioner.

The petition requested that 40 CFR 

180.469 be amended by establishing 

time-limited tolerances for residues of 

the herbicide safener dichlormid, (N,Ndiallyl-2,2-dichloroacetamide or 

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

propenyl-) (CAS Reg. No. 37764 –25–3), 

in or on sweet corn commodities at 0.05 

parts per million (ppm). There were no 

comments received in response to the 

notice of filing.

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 the 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 the 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 the 

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 the FFDCA, EPA has reviewed the 

available scientific data and other 

58286 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 the 

FFDCA, for time-limited tolerances for 

residues of dichlormid on sweet corn 

commodities at 0.05 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the timelimited tolerances follows.

A. Toxicological Profile and Endpoints

In 1999, the Agency prepared a risk 

assessment which was used as the basis 

for establishing time-limited tolerances 

for residues of dichlormid in or on field 

and pop corn commodities. A final rule 

for these time-limited tolerances 

published in the Federal Register of 

March 27, 2000 (65 FR 16143) (FRL–

6498–7). Based on that risk assessment, 

EPA concluded at that time that all of 

the risks were below the Agency’s level 

of concern and there was a reasonable 

certainty that no harm would result to 

the general population, and to infants 

and children from aggregate exposure to 

residues of dichlormid on corn 

commodities.

No additional toxicity data has been 

reviewed and evaluated by the Agency 

since that time. For a complete 

description of the toxicological profile 

and endpoints, the uncertainty factors, 

the exposure assessment which 

included dietary exposure for both food 

and drinking water, the safety factor for 

infants and children, and aggregate risk 

for dichlormid, see the final rule of 

March 27, 2000.

In response to the new petition, to 

establish time-limited tolerances for 

sweet corn commodities, the Agency 

has prepared a new assessment that 

evaluates the acute and chronic dietary 

and drinking water risks from exposure 

to dichlormid in or on field, pop and 

sweet corn commodities. The drinking 

water exposure estimates are the same 

as those in the March 27, 2000 Final 

Rule. Since, no other assessments or 

evaluations are needed for assessing the 

risk of dichlormid, only the acute and 

chronic scenarios are discussed in Unit 

III. below.

B. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Time-limited tolerances 

(expiring December 31, 2005) are 

established in 40 CFR 180.469 for 

residues of dichlormid, in or on field 

and pop corn commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

dichlormid in or on field, pop and sweet 

corn commodities 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 one 

day or single exposure.

In conducting the acute dietary risk 

assessment EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the 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: The acute dietary risk 

analyses incorporated tolerance level 

residues and assumed 100% of the corn 

commodities were treated with 

dichlormid.

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: The 

chronic dietary risk analyses 

incorporated tolerance level residues 

and assumed 100% of the corn 

commodities had been treated with 

dichlormid.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

dichlormid 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 

dichlormid.

For ground water, the Agency used its 

SCI-GROW (Screening Concentration in 

Ground Water) screening model and 

environmental fate data to determine 

the Estimated Environmental 

Concentration (EEC) of dichlormid in 

ground water. SCI-GROW is an 

empirical model based upon actual 

ground water monitoring data collected 

for the registration of a number of 

pesticides that serve as benchmarks for 

the model. The current version of SCIGROW appears to provide realistic 

estimates of pesticide concentrations in 

shallow, highly vulnerable ground water 

sites (i.e., sites with sandy soils and 

depth to ground water of 10 to 20 feet). 

The SCI-GROW ground water screening 

concentration is 0.046 ppb.

The Agency used the Generic 

Estimated Environmental Concentration 

(GENEEC) to estimate pesticide 

concentrations in surface water. 

GENEEC simulates a 1 hectare by 2 

meter deep edge-of-the-field farm pond 

which receives pesticide runoff from a 

treated 10 hectare field. GENEEC can 

substantially overestimate true pesticide 

concentrations in drinking water. It has 

certain limitations and is not the ideal 

tool for use in drinking water risk 

assessments. However, it can be used in 

screening calculations and does provide 

an upper bound on the concentration of 

true drinking water concentrations.

Using GENEEC and available 

environmental fate data, EPA calculated 

the following Tier 1 EECs for 

dichlormid:

• Peak (Acute) EEC: 27.29 ppb

• Average (Chronic) EEC 26.93 ppb

Interim Agency policy allows the 

average (chronic) GENEEC value to be 

divided by 3 to obtain a value of 8.98 

ppb for use in chronic risk assessment 

calculations.

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 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever 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 EECs from these models to 

quantify drinking water exposure and 

risk as a percent of reference dose 

(%RfD) or percent of 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. Since DWLOCs address 

total aggregate exposure to dichlormid 

they are further discussed in Unit III.D.

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). 

Dichlormid is not approved for use on 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58287

any sites that would result in residential 

exposure.

4. Cumulative Effects. Section 

408(b)(2)(D)(v) of the 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 

dichlormid. Dichlormid does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this action, therefore, EPA has not 

assumed that dichlormid 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 Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/

pesticides/cumulative/.

C. Safety Factor for Infants and Children

1. In general. Section 408 of the 

FFDCA provides that EPA shall apply 

an additional tenfold margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

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. Conclusion. The additional FQPA 

safety factor of 10X is retained for acute 

risks since: (1) There is qualitative 

evidence of increased susceptibility in 

the rabbit developmental study; and (2) 

the toxicity database is incomplete. 

There are data gaps for the 2-generation 

reproduction study in rats, and acute 

and subchronic neurotoxicity studies. 

The additional FQPA safety factor of 

30X is applied for chronic risks for the 

reasons discussed above for acute risks 

and for the data gap for the chronic 

toxicity study in dogs.

D. 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 the model 

estimates of a pesticide’s concentration 

in water. 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 USEPA Office of Water 

are used to calculate DWLOCs: 2 liter 

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

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

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. For dichlormid, a DWLOC 

was calculated for the acute and chronic 

scenarios for the U.S. population and for 

the most highly exposed population 

subgroup.

When EECs for surface water and 

groundwater are less than the calculated 

DWLOCs, the Office of Pesticide 

Programs (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 previously discussed for 

acute exposure, the acute dietary 

exposure from food to dichlormid will 

occupy 3% of the aPAD for the U.S. 

population, and 9% of the aPAD for 

non-nursing infants <1 year old. In 

addition, there is potential for acute 

dietary exposure to dichlormid in 

drinking water. Since the modeled 

groundwater and surface water 

concentrations are less than the 

DWLOCs, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD, as shown in the following 

Table 1:

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

Population Subgroup aPAD /(mg/

kg/day) 

%aPAD/

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

U.S. Population 0.01 3 27.29 <1 338

Non-nursing infants (<1 year old) 0.01 9 27.29 <1 91

2. Chronic risk. Using the exposure 

assumptions previously described for 

chronic exposure, EPA has concluded 

that exposure to dichlormid from food 

will utilize 5% of the cPAD for the U.S. 

population, and 11% of the cPAD for 

children 1–6 years old. In addition, 

there is potential for chronic dietary 

exposure to dichlormid drinking water. 

Since the modeled groundwater and 

surface water concentrations are less 

than the DWLOCs, EPA does not expect 

58288 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

the aggregate exposure to exceed 100% of the cPAD, as shown in the following 

Table 2:

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

Population Subgroup cPAD /(mg/

kg/day) 

%cPAD/

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 0.0022 5 8.98 <1 73

Children (1-6 years old) 0.0022 11 8.98 <1 20

3. Conclusion. 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 residues of the 

herbicide safener dichlormid, (N,Ndiallyl-2,2-dichloroacetamide or 

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

propenyl-) (CAS Reg. No. 37764 –25–3).

IV. Other Considerations

A. Endocrine Disruptor Effects

FQPA requires the Agency to develop 

a screening program to determine 

whether certain substances (including 

all pesticides and inerts or active 

ingredients) ‘‘may have an effect in 

humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine 

effect...’’ The Agency has been working 

with interested stakeholders to develop 

a screening and testing program as well 

as a priority setting scheme. As the 

Agency proceeds with implementation 

of this program, further testing of 

products containing the inert ingredient 

dichlormid for endocrine effects may be 

required.

B. Analytical Enforcement Methodology

Adequate enforcement methodology 

(gas chromatography with a nitrogen 

selective detector) is available to enforce 

the tolerance expression. The method 

may be requested from: Calvin Furlow, 

Public Information and Record Integrity 

Branch, Information Resources and 

Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 

telephone number: (703) 305–5229; email address: furlow.calvin@epa.gov.

C. International Residue Limits

There is neither a Codex proposal, nor 

Canadian or Mexican limits for residues 

of dichlormid in corn commodities.

D. Conditions

There are several data gaps which 

needed to be addressed before 

permanent tolerances can be 

established. The following studies have 

been submitted for Agency review and 

evaluation (1) 2-Generation 

Reproduction Study-Rat, (2) General 

Metabolism (3) Acute Neurotoxicity (4) 

Subchronic Neurotoxicity, (5) Crop 

Field Trials, and (6) Rotational Crop 

(Confined). The Agency will review and 

evaluate these studies, and then prepare 

a new risk assessment.

The data gaps are not as extensive as 

it would seem. For the crop field trials, 

both pre-and post-emergent data using 

dichlormid have been provided. The 

additional field trials are to fulfill the 

guideline requirements. To account for 

the incomplete toxicological database, 

the Agency retained an additional 10X 

safety factor for infants and children as 

to acute risk and an additional 30X 

safety factor as to chronic risk. 

V. Conclusion

Therefore, time-limited tolerances 

expiring December 31, 2005, are 

established for residues of the herbicide 

safener dichlormid, (N,N-diallyl-2,2-

dichloroacetamide or Acetamide, 2,2-

dichloro-N,N-di-2-propenyl-) (CAS Reg. 

No. 37764–25–3) in or on sweet corn 

commodities at 0.05 ppm. 

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as 

amended by the 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 the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the 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), as was provided in the 

old sections 408 and 409 of the 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–2004–0318 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 29, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

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

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

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

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58289

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Send us your 

copies, identified by docket ID number 

OPP-2004–0318, using one of the 

following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov/. Follow the online instructions for submitting 

comments.

• Agency Website: http://

www.epa.gov/edocket/. EDOCKET, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving electronic copies. 

Follow the on-line instructions for 

submitting materials to the docket.

• E-mail: 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.

• Mail: 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.

• Hand Delivery: In person or by 

courier, bring a copy to the location of 

the PIRIB described in ADDRESSES.

Do not include any CBI in the copy 

you submit for the public docket.

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 the 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 the 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 the 

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 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 23, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR chapter I is 

amended as follows:

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