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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58391

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301057. 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 12,

1997 (62 FR 11433) (FRL–5589–7), EPA

issued a notice 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 a pesticide

petition (PP) for tolerance by Aventis

CropScience USA LP, 2 T.W. Alexander

Drive, Research Triangle Park, NC

27709. This notice included a summary

of the petition prepared by Aventis

CropScience, the registrant. There were

no comments received in response to

the notice of filing.

The petition requested that 40 CFR

180.499 be amended by establishing a

tolerance for residues of the fungicide

propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride, known as

propamocarb hydrochloride, in or on

potatoes, and the following livestock

commodities: meat, meat byproducts, fat

and milk of cattle, goats, hogs, horses

and sheep at 0.05 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 propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride on potatoes at 0.06

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 propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride are discussed in the

following Table 1 as well as the no

observed adverse effect level (NOAEL)

and the lowest observed adverse effect

level (LOAEL) from the toxicity studies

reviewed.

TABLE 1.—TOXICITY PROFILE OF PROPAMOCARB HYDROCHLORIDE

Guideline No. Study type Results

870.3100 90–Day oral toxicity in rodents NOAEL = 363 mg/kg/day in females and 646 mg/kg/day in males.

LOAEL = 716 mg/kg/day in females, based on decreased body

weight and body weight gain and decreased food efficiency.

LOAEL in males is 1363 mg/kg/day based on decreased food efficiency

870.3150 90–Day oral toxicity in nonrodents NOAEL was not achieved.

LOAEL = 22.75 mg/kg/day based upon body weight gain depression, decreased food efficiency and focal or multi-focal chronic

erosive gastritis

870.3200 21/28–Day dermal toxicity in rabbits NOAEL ≥ 150 mg/kg/day for both sexes.

LOAEL = 525 mg/kg/day based on dose-related skin irritation and

depressed body weight gain

870.3250 90–Day dermal toxicity in rats NA

870.3465 90–Day inhalation toxicity in rats NA

58392 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 1.—TOXICITY PROFILE OF PROPAMOCARB HYDROCHLORIDE—Continued

Guideline No. Study type Results

870.3700a Prenatal developmental toxicity in rats Maternal NOAEL = 221 mg/kg/day. LOAEL = 740 mg/kg/day

based on mortality. Developmental NOAEL = 221 mg/kg/day.

LOAEL = 740 mg/kg/day based on GD 20 fetal death and a possible increase in minor skeletal anomalies.

870.3700b Prenatal developmental toxicity in rabbitsMaternal NOAEL = 150 mg/kg/day. LOAEL = 300 mg /kg/day

based on decreased body weight gains for GD 6–18 and possible increased abortions. Developmental NOAEL = 150 mg/kg/

day.

LOAEL = 300 mg/kg/day based on increased post-implantation

loss.

870.3800 Reproduction and fertility effects in rats Parental/Systemic NOAEL = 65.41 mg/kg/day for males and 76.78

mg/kg/day for females. LOAEL = 406.69 mg/kg/day for males

and 467.13 mg/kg/day for females based on decreased body

weights. Reproductive/Offspring NOAEL = 65.41 mg/kg/day for

males and 76.78 mg/kg/day for females.

LOAEL = 406.69 mg/kg/day for males and 467.13 mg/kg/day for

females based on reduced pup weights

870.4100a Chronic toxicity in rodents NOAEL = ≥25.6 mg/kg/day.

LOAEL = >25.6 mg/kg/day. There were no signs of toxicity attributable to treatment at any dose level

870.4100b Chronic toxicity in dogs NOAEL was not achieved.

LOAEL = 22.75 mg/kg/day based upon body weight gain depression, decreased food efficiency and focal or multi-focal chronic

erosive gastritis

870.4200a Carcinogenicity in rats NOAEL = 84 mg/kg/day in males, 112 mg/kg/day in females.

LOAEL = 682 mg/kg/day in males, 871 mg/kg/day in females

based on decreased body weight and body weight gain, decreased food consumption, and an increased incidence of

vacuolation of choroid plexus ependymal cells in the brain in

both sexes and decreased water consumption in the females.

No evidence of carcinogenicity

870.4200b Carcinogenicity in mice NOAEL = 12 mg/kg/day in females and ≥ 690.0 mg/kg/day in

males.

LOAEL = 95 mg/kg/day in females based on decreased body

weight and body weight gains. No evidence of carcinogenicity

870.5100 Gene Mutation: reverse gene mutation

assay in bacteria

There was no evidence of induced mutant colonies over background

870.5375 Cytogenetics: in vitro mammalian cytogenetics assayIncreases in aberrant metaphases were within the historical control range

870.5395 Bone marrow micronucleus assay There was no significant increase in the frequency of

micronucleated polychromatic erythrocytes in bone marrow at

any dose tested.

870.5395 Bone marrow micronucleus assay There was no significant increase in the frequency of

micronucleated polychromatic erythrocytes in bone marrow after

any treatment time.

870.5575 Other Genotoxicity: Saccharomyces

cerevisiae, mitotic recombination,

gene conversion assay

There was no evidence of gene conversion in the tested strains

with activation.

870.5575 Saccharomyces cerevisiae, mitotic recombination, gene conversion assayThere was no evidence of gene conversion in the tested strains

without activation.

870.5575 Saccharomyces cerevisiae, mitotic recombination, gene conversion assayUnder the conditions of the study there was no evidence of gene

conversion.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58393

TABLE 1.—TOXICITY PROFILE OF PROPAMOCARB HYDROCHLORIDE—Continued

Guideline No. Study type Results

870.6200a Acute neurotoxicity screening battery in

rats

NOAEL = 200 mg/kg/day.

LOAEL = 2000 mg/kg/day based on soiled fur coat (both sexes)

and decreased motor activity 8 hours post-dosing (females

only)

870.6200b Subchronic neurotoxicity screening battery in ratsNOAEL = 1320.8 mg/kg/day in males and 1485.6 mg/kg/day in females.

LOAEL = not observed

870.6300 Developmental neurotoxicity in rats NA

870.7485 Metabolism in rats A higher dose (at least equivalent to levels of human exposure)

should have been tested, and the metabolites should have

been identified.

870.7600 Dermal penetration NA

NA Special studies The cholinesterase inhibition studies were of questionable quality.

The chemical does not cause any appreciable inhibition of cholinesterase.

B. Toxicological Endpoints

The dose at which 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 dose at

which the LOAEL of concern are

identified 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.

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 the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, 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 FQPA 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 is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride used for human risk

assessment is shown in the following

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PROPYL[3-(DIMETHYLAMINO)PROPYL]CARBAMATE

MONOHYDROCHLORIDE FOR USE IN HUMAN RISK ASSESSMENT1

Exposure scenario Dose used in risk assessment, UF

FQPA SF2 and level of concern for risk assessment Study and toxicological effects

Acute Dietary females 13–50

years of age

NOAEL = 150 mg ai/kg/day.

UF = 100. Acute RfD =

1.5 mg ai/ kg/day.

FQPA SF = 1X. aPAD =

acute RfD ÷ FQPA SF =

1.5 mg/kg/day

Developmental Toxicity Study—rabbit. Developmental LOAEL = 300 mg ai/kg/day based on

increased post-implantation loss

Acute Dietary general population

including infants and children

NOAEL = 200 mg ai/kg/day.

UF = 100. Acute RfD =

2.0 mg/kg/day.

FQPA SF = 1X. aPAD =

acute RfD ÷ FQPA SF =

2.0 mg/kg/day

Acute Neurotoxicity Screening Battery—rat.

LOAEL = 2000 mg ai/kg/day based on decreased body weight gain and decreased

motor activity

58394 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PROPYL[3-(DIMETHYLAMINO)PROPYL]CARBAMATE

MONOHYDROCHLORIDE FOR USE IN HUMAN RISK ASSESSMENT1—Continued

Exposure scenario Dose used in risk assessment, UF

FQPA SF2 and level of concern for risk assessment Study and toxicological effects

Chronic Dietary all populations NOAEL = 12 mg ai/kg/day.

UF = 100. Chronic RfD =

0.12 mg/kg/day.

FQPA SF = 1X. cPAD =

chronic RfD ÷ FQPA SF =

0.12 mg/kg/day

Carcinogenicity Study—mouse. LOAEL = 95 mg

ai/kg/day based on decreased body weight

and body weight gain in females

Short-Term (1–7 days) and Intermediate-Term (1 week–several months) Dermal (Occupational/Residential)dermal study NOAEL = 150

mg ai/kg/day.

LOC for MOE = 100 (Occupational). LOC for MOE =

100 (Residential)

21–Day Dermal Toxicity Study—rabbit. LOAEL

= 525 mg/kg/day based on decreased body

weight gain in females

Short-Term (1–7 days) and Intermediate-Term (1 week–several months) Inhalation (Occupational/Residential)inhalation (or oral) study

NOAEL = 150 mg ai/kg/

day (inhalation absorption

rate = 100%)

LOC for MOE = 100 (Occupational). LOC for MOE =

100. (Residential)

Developmental Toxicity Study—rabbit. Developmental LOAEL = 300 mg ai/ kg/day based on

increased post-implantation loss. Maternal

LOAEL = 300 mg ai/kg/day based on decreased body weight gain

Cancer (oral, dermal, inhalation) ‘‘not likely’’ not applicable Acceptable oral rat and mouse carcinogenicity

studies; no evidence of carcinogenic or mutagenic potential.

1 UF = uncertainty factor, FQPA SF = 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

2 The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. In addition to the currently

proposed tolerance for potatoes,

tolerances have been established under

the section 18 program (40 CFR 180.499)

for the residues of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride, in or on the raw

agricultural commodity, potatoes and

tomatoes. Risk assessments were

conducted by EPA to assess dietary

exposures from propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride in food as follows:

i. Acute Exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEM)

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

assumptions were made for the acute

exposure assessments: Tier 1 acute

analyses were performed for females

13–50 years old and the general U.S.

population (including infants and

children); therefore, the acute risk was

analyzed at the 95th percentile. The

aPAD for females 13–50 years old and

the general U.S. population (including

infants and children) are 1.5 mg/kg/day

and 2.0 mg/kg/day, respectively. For

acute dietary risk estimates, EPA’s level

of concern is >100% aPAD. The results

of the acute analysis indicate that the

acute dietary risk estimates for the

general U.S. population and all

population subgroups (at the 95th

percentile) associated with the proposed

uses of propamocarb hydrochloride do

not exceed EPA’s level of concern.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM 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 assumptions were made for

the chronic exposure assessments: A

Tier 1 chronic analysis was performed

for the general U.S. population and all

population subgroups. The cPAD for the

general U.S. population and all

subgroups is 0.12 mg/kg/day. For

chronic dietary risk estimates, EPA’s

level of concern is >100% cPAD. The

results of the chronic analysis indicate

that the chronic dietary risk estimates

for the general U.S. population and all

population subgroups associated with

the proposed uses of propamocarb

hydrochloride do not exceed EPA’s

level of concern.

iii. Cancer. There is no concern for

mutagenic potential, and there is no

evidence of carcinogenic potential in

either the rat or mouse. Propamocarb

hydrochloride has been classified as

‘‘not likely to be carcinogenic in

humans.’’ Therefore, a cancer dietary

exposure analysis was not performed.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride 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 propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

SCI–GROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58395

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 estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride they are further

discussed in the aggregate risk sections

below.

Based on the GENEEC and SCI–

GROW models the EECs of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride in surface water

and ground water for acute exposures

are estimated to be 1030 parts per

billion (ppb) for surface water and 2.08

ppb for ground water. The EECs for

chronic exposures are estimated to be

340 ppb for surface water and 2.08 ppb

for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride is currently

registered for use on the following

residential non-dietary sites: turfgrass

and ornamentals at residential,

recreational and golf course sites.

However, the usage information in the

1995 Reregistration Eligibility Decision

(RED) for propamocarb hydrochloride

and the label statement that only

protected handlers may be present in

the treated area during application,

indicate that only commercial

applicators will apply the registered

end-use product Banol (EPA

Registration Number 432–942, contains

66.5% propamocarb hydrochloride)

mainly on golf courses and there will be

no use on residential or recreational

turf. The risk assessment was conducted

using the following residential exposure

assumptions: An MOE of 100 is

adequate to ensure protection from

propamocarb hydrochloride via the

dermal and inhalation routes for

residential exposures. The high-end

scenario for residential post-application

exposure is the golf course use. The

post-application risk assessment is

based on generic assumptions as

specified by the newly proposed

Residential Standard Operating

Procedures (SOPs) and recommended

approaches by Health Effects Division’s

(HED’s) Exposure Science Advisory

Committee. Short-term post-application

exposures are expected for the adult and

adolescent golfer. Golfer exposure is

expected through minimal hand contact

with the golf ball and dermal contact to

the lower legs from treated plant

surfaces. Since it is assumed that the

adolescent golfer would have a

proportionally similar exposure to

adults, a dermal post-application

assessment was performed for the adult

golfer only. The calculated MOE for the

golfer is 980 and, therefore, does not

exceed EPA’s level of concern. Since the

short- and intermediate-term

toxicological endpoints are the same,

the golfer post-application exposure

assessment is expected to provide

adequate exposure estimates for both

the short- and intermediate-term. In the

event of intermediate-term exposure,

propamocarb hydrochloride residues are

expected to dissipate over time.

Therefore, this assessment is expected

to present a high-end conservative

estimate of actual 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

propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride 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, propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride 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 propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride 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. Safety factor for infants and

children—i. 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.

ii. Prenatal and postnatal sensitivity.

There is no evidence of quantitative or

qualitative enhanced susceptibility to

infants and children. In the rat,

developmental effects occur only at

doses that cause mortality in the dams.

The Maternal LOAEL of 740 mg ai/kg/

day is based on mortality. The Maternal

NOAEL is 221 mg ai/kg/day. The

Developmental LOAEL of 740 mg ai/kg/

day is based on increased gestation day

(GD) 20 fetal death and a possible

increase in minor skeletal anomalies.

The Developmental NOAEL is 221 mg

ai/kg/day.

In the rabbit, developmental effects

occur only at doses where there is

maternal toxicity. It was felt by the

Hazard Identification Assessment

Review Committee (HIARC) that the

post implantation loss is actually due to

the increased abortions in the does. The

Maternal LOAEL of 300 mg ai/kg/day is

based on decreased body weight gains

for GD 6–18 and possible increased

abortions. The Maternal NOAEL is 150

mg ai/kg/day. The Developmental

LOAEL of 300 mg ai/kg/day is based on

increased post-implantation loss. The

Developmental NOAEL is 150 mg ai/kg/

day.

In the reproduction toxicity study,

offspring effects only occurred at levels

resulting in maternal toxicity. The

LOAEL for systemic/parental toxicity is

8000 ppm based on decreased body

weights of F0 and F1 adults. The

systemic/parental toxicity NOAEL is

1250 ppm.

iii. Conclusion. There is a complete

toxicity data base for propyl[3-

(dimethylamino)propyl]carbamate

58396 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

monohydrochloride and exposure data

are complete or are estimated based on

data that reasonably accounts for

potential exposures. EPA determined

that the 10X safety factor to protect

infants and children should be removed.

The FQPA factor is removed because the

prenatal and postnatal toxicology

database is complete and there is no

indication of increased susceptibility. A

developmental neurotoxicity study is

not required. The dietary (food and

drinking water) exposure assessments

will not underestimate the potential

exposures for infants and children from

the use of propamocarb hydrochloride.

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

ground water 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 discussed in this unit for

acute exposure, the acute dietary

exposure from food to propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride will occupy 1 % of

the aPAD for the U.S. population, 1 %

of the aPAD for females 13 years and

older, 3% of the aPAD for all infants

(< 1 year old) and 3 % of the aPAD for

children 1–6 years old. In addition,

there is potential for acute dietary

exposure to propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride 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 the following

Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO PROPYL[3-(DIMETHYLAMINO)PROPYL]CARBAMATE

MONOHYDROCHLORIDE

Population Subgroup a PAD (mg/

kg)

% aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

All infants < 1year old 2.0 3 1030 2.08 19000

Children 1–6 years old 2.0 3 1030 2.08 19000

Females 13–50 years old 1.5 1 1030 2.08 45000

General U.S. population 2.0 1 1030 2.08 69000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride from food will

utilize 7% of the cPAD for the U.S.

population, 9% of the cPAD for all

infants < 1 year old and 23 % of the

cPAD for children 1–6 years old. It has

been assumed that there are no

residential uses for propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride that result in

chronic residential exposure to

propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride, as shown in the

following Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PROPYL[3-

(DIMETHYLAMINO)PROPYL]CARBAMATE MONOHYDROCHLORIDE

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

Infants < 1 year old 0.12 9 340 2.08 1100

Children 1–6 years old 0.12 23 340 2.08 920

Females 13–50 years old 0.12 5 340 2.08 3400

U.S. Population 0.12 7 340 2.08 3900

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58397

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).

Propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride is currently

registered for use that could result in

short-term residential exposure and the

Agency has determined that it is

appropriate to aggregate chronic food

and water and short-term exposures for

propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride.

Using the exposure assumptions

described in this unit for short-term

exposures, EPA has concluded that food

and residential exposures aggregated

result in aggregate MOEs of 950, 1100

and 1100 for females 13–50 years old,

males 13–19 years old and the general

U.S. population, respectively. The shortterm aggregate risk assessment estimates

risks likely to result from 1–7 day

exposure to propamocarb hydrochloride

residues in food, drinking water, and

residential pesticide uses. High-end

estimates of the residential exposure are

used in the short-term assessment.

Average values are used for food and

drinking water exposure.

For short-term aggregate exposure

risk, the oral and dermal exposures can

be combined since both are based on the

same toxicity endpoint (decreased body

weight). An MOE of 100 is adequate to

ensure protection from propamocarb

hydrochloride via the dermal route for

residential exposures.

According to the 1995 RED for

propamocarb hydrochloride (Estimated

Usage of Pesticide, p. 3), ‘‘almost all

usage of propamocarb hydrochloride in

the United States is concentrated on golf

courses with approximately 100,000 to

200,000 lbs ai applied per year’’. The

label for Banol states that only protected

handlers may be present in the treated

area during application. For these

reasons, it is assumed that this product

will be used by commercial applicators,

mainly on golf courses. The high-end

scenario for residential post-application

exposure is the golf course use of Banol.

Therefore, in aggregating short-term

risk, the Agency considered background

chronic dietary exposure (food and

drinking water) and short-term golfer

dermal exposure. These aggregate MOEs

do not exceed the Agency’s level of

concern for aggregate exposure to food

and residential uses. In addition, shortterm DWLOCs were calculated and

compared to the EECs for chronic

exposure of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride in ground and

surface water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect short-term aggregate

exposure to exceed the Agency’s level of

concern, as shown in the following

Table 5:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO PROPYL[3-

(DIMETHYLAMINO)PROPYL]CARBAMATE MONOHYDROCHLORIDE

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Short-Term

DWLOC

(ppb)

Females 13–50 years old 950 100 1030 2.08 40000

Males 13–19 years old 1100 100 1030 2.08 63000

General U.S. Population 1100 100 1030 2.08 63000

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). The short-term

aggregate assessment adequately

addresses both the short- and

intermediate-term golfer dermal

exposures. The short and intermediateterm dermal endpoints were chosen

from the 21–day dermal rabbit toxicity

study. The short-term golfer exposure

was calculated assuming 1–7 day

exposure to propamocarb

hydrochloride. The intermediate-term

aggregate risk assessment estimates risks

likely to result from 7 days to 3 months

exposure. In the event of intermediateterm exposure, propamocarb

hydrochloride residues are expected to

dissipate over time. Therefore, the shortterm aggregate assessment is expected to

present a high-end conservative

estimate of intermediate-term risk. As

the short-term aggregate risk assessment

represents the high-end scenario, an

intermediate-term assessment was not

performed.

5. Aggregate cancer risk for U.S.

population. An aggregate cancer risk

analysis was not performed since there

is no concern for mutagenic potential

and there is no evidence of carcinogenic

potential in either the rat or mouse.

Propamocarb has been classified as ‘‘not

likely to be carcinogenic in humans’’.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The petitioner utilized a gas

chromatography method for the

determination of propamocarb

hydrochloride residues in/on raw

agricultural commodity samples

collected from the potato field study

and field rotational crop study. The

reported limit of quantitation was 0.05

ppm. The method validation and

concurrent method recovery data

indicate that this method is adequate for

data collection.

An identical method is proposed for

tolerance assessment. The proposed

method has undergone a successful

independent lab validation and petition

validation method. EPA concludes that

the requirements for a plant

enforcement method have been fulfilled

for the purpose of this petition.

A ruminant feeding study is required.

Conclusions about the need for livestock

tolerances and appropriate enforcement

analytical method are deferred until

receipt of the ruminant feeding study

and determination of the residues of

concern in livestock.

B. International Residue Limits

No Codex limit has been established

for propamocarb hydrochloride in/on

the raw agricultural commodity (RAC)

potato or its processed commodities, or

animal (except poultry) commodities of

meat, meat byproducts, or milk.

Canadian and Mexican maximum

residue limits (MRLs) have been

established for the use on the RAC

potato at 0.5 ppm. Harmonization is not

possible because the submitted crop

58398 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

field data support the establishment of

a tolerance on potatoes at 0.06 ppm.

Canadian tolerances were established

based, in part, on field studies from

Europe where, in at least one test,

dosages higher than those proposed in

the U.S. were applied more frequently

and closer to harvest.

C. Conditions

The conditions of registration will

include submission of a livestock

feeding study (which determines the

metabolites N-oxide propamocarb, 2-

hydroxy propamocarb and oxazolidine)

and storage stability data from the

livestock feeding study. The need for a

livestock analytical enforcement method

and livestock tolerances will be

determined after receipt of the ruminant

feeding study and determination of the

residues of concern in livestock. A

corrosion characteristics study must be

submitted as soon as completed.

V. Conclusion

Therefore, the tolerance is established

for residues of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride, known as

propamocarb hydrochloride, in or on

potatoes at 0.06 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 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–301057 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 e-mail 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–301057, 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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58399

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 Low-Income

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

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.

Susan B. Hazen,

Acting 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 180.499 is amended by

adding text to paragraph (a) to read as

follows:

§ 180.499 Propamocarb hydrochloride;

tolerances for residues.

(a) General. Tolerances are

established for the residues of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride also known as

propamocarb hydrochloride in or on the

following raw agricultural commodity:

Commodity Parts per million

Potato 0.06

* * * * *

[FR Doc. 00–25049 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301055; FRL–6745–1]

RIN 2070–AB78

Dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica;

hexamethyldisilizane, reaction product

with silica; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

amendment to the exemptions from the

requirement of a tolerance for residues

of dimethyl silicone polymer with

silica; silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica; when used as inert

ingredients on growing crops, when

applied to raw agricultural commodities

after harvest, or to animals. Cabot

Corporation submitted a petition to EPA

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act 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 dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301055,

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 VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301055 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Vera Soltero, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9359 and e-mail address:

soltero.vera@epa.gov.

SUPPLEMENTARY INFORMATION: