Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58385

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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule ’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: September 21, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.314 is revised to read

as follows:

§ 180.314 Triallate; tolerances for

residues.

(a) General. Tolerances are

established for residues of the herbicide

(S-2,3,3-trichloroallyl

diisopropylthiocarbamate) in or on the

following raw agricultural commodities:

Commodity Parts per million

Barley, grain ......... 0.05

Barley, straw ......... 0.05

Lentils ................... 0.05

Lentils, hay ........... 0.05

Peas ...................... 0.05

Peas, forage ......... 0.05

Peas, hay .............. 0.05

Wheat, grain ......... 0.05

Wheat, straw ......... 0.05

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. Tolerances are established

for residues of the herbicide triallate (S2,3,3-trichloroallyl

diisopropylthiocarbamate) and its

metabolite 2,3,3-trichloroprop-2-

enesulfonic acid in or on the following

food commodities:

Commodity Parts per million

Sugar beet, pulp ... 0.2

Sugar beet, root .... 0.1

Sugar beet, top ..... 0.5

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–24942 Filed 9–28–00; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301062; FRL–6747–9]

RIN 2070–AB78

Dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-

dimethoxyphenyl)-1-oxo-2-

propenyl]morpholine; Pesticide

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for residues of

dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-dimethoxyphenyl)-

1-oxo-2- propenyl]morpholine in or on

dried hops cones, grapes, raisins, tomato

fruit, and tomato paste. American

Cyanamid Company requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301062,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301062 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Mary Waller, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

308–9354; and e-mail address:

waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

58386 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

Categories NAICS

Examples of Potentially Affected

Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301062. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of March 26,

1997, 62 FR 14418 (FRL–5594–7) and

March 8, 2000, 65 FR 12244 (FRL–6491–

4), EPA issued notices pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

346a as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) announcing the filing of

pesticide petitions (7F4816 and 8F4946)

for tolerances by American Cyanamid

Company, P.O. Box 400, Princeton, NJ

08543–0400. These notices included

summaries of the petitions prepared by

American Cyanamid Company, the

registrant. There were no comments

received in response to the notice of

filing.

The petitions requested that 40 CFR

180.493 be amended by establishing

tolerances for residues of the fungicide

dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-dimethoxyphenyl)-

1-oxo-2-propenyl]morpholine, in or on

dried hops cones at 60 ppm, grapes at

3.5 ppm, raisins at 6.0 ppm, tomato fruit

at 0.5 ppm, and tomato paste at 1.0 part

per million (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) 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) 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 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),

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), for a tolerance for

residues of dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-dimethoxyphenyl)-

1-oxo-2-propenyl]morpholine on dried

hops cones at 60 ppm, grapes at 3.5

ppm, raisins at 6.0 ppm, tomato fruit at

0.5 ppm, and tomato paste at 1.0 ppm.

EPA’s assessment of exposures and risks

associated with establishing the

tolerances are as follows.

A. Toxicological Profile

EPA has previously 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 considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The toxicological

profile for dimethomorph was

addressed in the risk assessment

published in the Federal Register final

rule of October 13, 1998 (63 FR 54587)

(FRL–6036–7).

B. Toxicological Endpoints

The toxicological endpoints for

dimethomorph were addressed in the

risk assessment published in the

Federal Register final rule of October

13, 1998 (63 FR 54587) (FRL–6036–7).

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.493) for the

residues of dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)- 3-(3,4-

dimethoxyphenyl)-1-oxo-2-

propenyl]morpholine in or on potatoes

at 0.05 ppm, potatoes, wet peel at 0.15

ppm and time-limited tolerances have

been established for cantaloupe,

cucumber, squash and watermelon at 1

ppm (expires September 30, 2001) and

on the cereal grains group: fodder at

0.15 ppm, forage and grain at 0.05 ppm,

hay at 0.10 ppm, and straw at 0.15 ppm.

Risk assessments were conducted by

EPA to assess dietary exposures from

dimethomorph 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. EPA did not

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58387

select a dose and endpoint for an acute

dietary risk assessment because of the

lack of toxicological effects attributable

to a single exposure (dose) in either the

rat or the rabbit developmental toxicity

studies.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEMDM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following very conservative

assumptions were made for the chronic

exposure assessments: that all

commodities having dimethomorph

tolerances will contain residues of

dimethomorph and those residues will

be at the level of the tolerance. These

assumptions result in an overestimate of

human dietary exposure. All Section 18

tolerances (cantaloupes, watermelons,

cucumbers, and squash) are included in

this dietary risk assessment. Using the

assumptions and data parameters

described above, the DEEM–89 exposure

analysis results in a theoretical

maximum residue contribution (TMRC)

that is equivalent to the following

percentages of the PAD/RfD. The

following Table 1 summarizes the

estimated food exposures for the U.S.

population, all infants (<1 year old), the

population subgroups that include

children, and the most highly exposed

female and male subgroups.

TABLE 1.—SUMMARY OF FOOD EXPOSURE TO DIMETHOMORPH

Population Subgroup Exposure (mg/kg

body wt/day) %PAD/RfD

U.S. Population (total) 0.002547 3

All Infants (<1 year 0.005947 6

Children 1–6 years 0.007407 7

Children 7–12 years 0.002939 3

Females 13–50 years 0.001936 2

Males (20+years) 0.001840 2

2. From drinking water. EPA used

SCI–GROW (Screening Concentration In

Ground Water) and GENEEC (Generic

Estimated Environmental

Concentration) models to determine the

estimated environmental concentrations

(EECs) of dimethomorph residues in

ground and surface water. The EEC

reported for dimethomorph residues in

ground water is 0.26 parts per billion

(ppb). The EEC for surface water is 28

ppb for acute and 24 ppb for chronic

(56-day).

i. Acute exposure and risk. Because

no acute dietary endpoint was

determined, no acute risks are posed by

exposure to dimethomorph.

ii. Chronic exposure and risk. EPA

conducts the drinking water risk

assessment by using the worst case

scenario of estimated environmental

concentration (EEC) found from either

ground or surface water. The EEC

reported for dimethomorph residues in

ground water using SCI–GROW is 0.26

ppb. This is much less than the surface

water EEC (24 ppb for 56 days)

generated using GENEEC. Therefore,

only the surface water EEC will be used

in conducting the aggregate dietary

(food + water) risk assessment. Based on

the chronic food exposure and using

default body weights and water

consumption figures, chronic drinking

water levels of comparison (DWLOCs)

for drinking water were calculated. To

calculate the chronic DWLOC, the

chronic food exposure (from DEEM

analysis) is subtracted from the chronic

PAD/RfD. DWLOCs are then calculated

using the default body weights and

drinking water consumption figures.

EPA’s surface drinking water levels of

comparison from chronic exposure to

dimethomorph using modeling data are

3,400 ppb for U.S. population and for

males (20+ years), 2,900 ppb for females

13–50, 970 ppb for children 7–12 years,

940 ppb for infants <1 year and 930 ppb

for children 1–6 years. These levels are

all greater than the GENEEC

concentration level (24 ppb for 56 days).

Therefore, EPA does not expect

exposure to dimethomorph in drinking

water to be above the level of concern.

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).

Dimethomorph is not registered for use

on any sites that would result in

residential exposure.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

dimethomorph has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, dimethomorph

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 dimethomorph 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 final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. In general. FFDCA section 408

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 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 margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

2. Prenatal and postnatal sensitivity.

EPA assessed the potential for

additional sensitivity of infants and

children to residues of dimethomorph

in the Federal Register final rule of

58388 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

October 13, 1998 (63 FR 54587)(FRL–

6036–7).

3. Conclusion. There is a complete

toxicity database for dimethomorph and

exposure data are complete or are

estimated based on data that reasonably

account for potential exposures. EPA

determined that the 10x factor to protect

infants and children be removed.

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 the model

estimates of a pesticide’s concentration

in water (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 USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

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

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater 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. No acute dietary

endpoint was identified; therefore, EPA

concludes that dimethomorph poses no

appreciable acute risk.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to dimethomorph from

food will utilize 3% of the cPAD for the

U.S. population, 6 % of the cPAD for

infants (<1 year) and 7% of the cPAD for

children (16 years). There are no

residential uses for dimethomorph that

result in chronic residential exposure to

dimethomorph. The aggregate risk

assessment for chronic (non-cancer)

exposure to dimethomorph is shown in

the following Table 2:

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

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.1 3 8 3,400

All infants (<1 year) 0.1 6 8 940

Children 16 years 0.1 7 8 930

Children 7–12 years 0.1 3 8 970

Females 13–50 years 0.1 2 8 2,900

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).

Dimethomorph 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). Dimethomorph 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. Dimethomorph was

classified as ‘‘not likely’’ to be a human

carcinogen.

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

dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Method FAMS 002–04 high

performance liquid chromatography

using ultra-violet detection (HPLC, UV

detection) is adequate for determining

residues of dimethomorph in tomatoes,

grapes or hops. Confirmatory methods

are available for tomatoes, raisins, and

hops. Cyanamid Method 2577 can be

used for tomatoes, FAMS 076–01 can be

used for raisins, and FAMS 073–03 can

be used for hops. The method may be

requested from: Calvin Furlow, PRRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Canadian, Mexican, or

Codex MRLs established for

dimethomorph for the commodities

associated with this request;

consequently, a discussion of

international harmonization is not

relevant.

V. Conclusion

Therefore, tolerances are established

for residues of dimethomorph, (E,Z) 4-

[3-(4-chlorophenyl)-3-(3,4-

dimethoxyphenyl)-1-oxo-2-

propenyl]morpholine on dried hops

cones at 60 ppm, grapes at 3.5 ppm,

raisins at 6.0 ppm, tomato fruit at 0.5

ppm, and tomato paste at 1.0 ppm.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58389

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 of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) 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 FFDCA sections 408 and 409.

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 control

number OPP–301062 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 28, 2000.

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 (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. 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) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by email at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. 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 Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301062, 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. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@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 file

format 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. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) 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). 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and LowIncome

Populations (59 FR 7629, February 16,

1994); or require 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 FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

58390 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: September 21, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.493 is amended by

alphabetically adding commodities to

the table in paragraph (a) to read as

follows:

§ 180.493 Dimethomorph, tolerances for

residues.

(a) * * *

Commodity Parts per

million

Grapes1 3.5

Hops, cones, dried1 60

*** **

Raisins1 6.0

Tomatoes, fruit 0.5

Tomatoes, paste 1.0

1 There are no U.S. registrations as of August 25, 2000, for the use of dimethomorph on

the growing crops, grapes, hops, and raisins.

* * * * *

[FR Doc. 00–25053 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301057; FRL–6745–8]

RIN 2070–AB78

Propamocarb hydrochloride; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride known as

propamocarb hydrochloride in or on

potatoes. Aventis CropScience USA LP

requested this tolerance under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301057,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301057 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Mary L. Waller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–9354; and e-mail

address: Waller.Mary@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of Potentially Affected

Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental