28482 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

Al at 2.5 mg/kg/day. This RfD is based

on a NOAEL of 250 mg/kg/day from a

2–year feeding study in dogs and the

use of a 100 fold safety factor to account

for interspecies and intraspecies

differences. No appropriate endpoint

attributable to a single dose exposure

was identified in oral toxicity studies.

Therefore, an acute RfD was not

established and there is no expectation

of acute risk. Since no dermal or

systemic toxicity was seen at the limit

dose following repeated dermal

applications in the 21–day toxicity

study using rats, no endpoint value was

calculated for short- and intermediateterm exposure and risk. The Agency has

concluded that fosetyl-Al is unlikely to

pose a carcinogenic hazard to humans.

Therefore, a cancer exposure and risk

assessment is not appropriate.

i. Food. For all currently registered

uses of fosetyl-Al, chronic food

exposure for various subgroups of the

U.S. population was estimated by EPA

through the use of the Dietary Exposure

Evaluation Model (DEEM) software. The

DEEM analysis evaluated the individual

food consumption as reported by

respondents in the USDA 1989-1991

nationwide Continuing Surveys of Food

Intake by Individuals. As the risk

estimate was low for even the most

highly exposed subpopulation, no

anticipated residues were used. One

hundred percent crop treated and

tolerance level residues were assumed

for all crops. Based on the results of this

conservative analysis, exposure to

fosetyl-Al residues from the proposed

uses is expected to be minimal. Aventis

Crop Science concludes that dietary

exposure to fosetyl-Al resulting from the

currently registered and the proposed

uses of the product will be well below

the Agency’s level of concern.

ii. Drinking water. There is no

established maximum contaminant level

or health advisory level for fosetyl-Al.

The potential for ground water and/or

surface water contamination by fosetylAl and its degradates is expected to be

very low, in most cases, due to the rapid

degradation of the compound in soil to

non-toxic degradates under both aerobic

and anaerobic conditions. Under aerobic

laboratory conditions, the half-life of

fosetyl-Al is between 1 and 1.5 hours in

loamy sand, silt loam and clay loam and

20 minutes in sandy loam soil. The

degradation proceeds through the

hydrolysis of the ethyl ester bond,

resulting in the formation of

phosphorous acid and ethanol. The

ethanol is further degraded into carbon

dioxide. Based on the short half-life of

fosetyl-Al and the known fate of

phosphates under anaerobic conditions,

EPA determined that an anaerobic soil

metabolism study was not necessary. An

anaerobic aquatic soil metabolism study

was conducted. When anaerobic

conditions were established by flooding

soil, the half-life was 40 hours with silty

clay loam and 14 hours with sandy loam

soil. Aventis Crop Science expects that

potential fosetyl-Al residues in drinking

water are not a significant contribution

to aggregate exposure.

2. Non-dietary exposure. Fosetyl-Al is

currently registered for residential use

on turf and ornamental plants. Chronic

exposure is not expected for residential

uses. There is also no expectation of

acute risk. No appropriate endpoint

attributable to a single dose exposure

was identified in oral toxicity studies

and consequently, an acute RfD cannot

be calculated. No endpoint value is

calculable for short- and intermediateterm exposure and a risk analysis

cannot be performed since no dermal or

systemic toxicity was seen at the limit

dose following repeated dermal

applications in the 21–day toxicity

study using rats. The Agency has

previously concluded that fosetyl-Al is

unlikely to pose a carcinogenic hazard

to human. Therefore, a cancer exposure

and risk assessment is not appropriate.

Thus, Aventis Crop Science concludes

that the ornamental and turf uses do not

add significantly to the aggregate

exposure for fosetyl-Al.

D. Cumulative Effects

Effects associated with fosetyl-Al are

unlikely to be cumulative with any

other compound. The formation of

calculi and bladder tumors in rats is the

only significant toxicological effect

observed with fosetyl-Al. These effects

were observed in rat only at a dose

which not only exceeds estimated

human exposure by several orders of

magnitude but is in excess of the EPA

dose limit for carcinogenicity studies.

Therefore, an aggregate assessment

based on common mechanisms of

toxicity is not appropriate as exposure

to humans will be well below the levels

producing calculi and bladder tumors in

rats. Further, considering the rapid

elimination of fosetyl-Al in the rat

metabolism study, any effects associated

with fosetyl-Al are unlikely to be

cumulative with any other compound.

Based on these reasons, only the

potential risks of fosetyl-Al are

considered in the exposure assessment.

E. Safety Determination

1. U.S. population. Chronic risk

estimates associated with exposure to

fosetyl-Al in food and water are

expected to be well below the Agency’s

level of concern. The DEEM chronic

exposure analysis previously performed

by the Agency for all currently

registered food uses shows that

exposure to fosetyl-Al utilizes 3.1% of

the cPAD for the U.S. population, 2.7%

of the cPAD for females (13–50 years),

6.3% of the cPAD for children 1-6 years

old, and 4.2% of the cPAD for nonHispanic (other than black or white).

This analysis was conducted assuming

100% crop treated and tolerance level

residue values for all crops. The

contribution of fosetyl-Al residues in

surface and ground water to chronic

aggregate exposure is expected to be

minimal. Therefore, Aventis Crop

Science concludes that even when

considering the potential incremental

risk resulting from the proposed uses,

there is a reasonable certainty that no

harm will result from aggregate

exposure to fosetyl-Al residues.

2. Infants and children. No indication

of increased susceptibility of rat or

rabbit fetuses to in utero and/or

postnatal exposure was noted in the

developmental and reproductive

toxicity studies. The Agency has

previously determined that no

additional safety factor to protect infants

and children is necessary for this

product.

Using the conservative assumptions

described in the exposure section,

aggregate exposure to fosetyl-Al from

currently registered food uses will

utilize up to 6.3% of the RfD for infants

and children. Even when considering

the potential incremental dietary risk

resulting from the proposed uses, the

potential for exposure to residues in

drinking water and from non-dietary,

non-occupational exposure, the

aggregate exposure to fosetyl-Al is

expected to be well below 100% of the

RfD. Aventis Crop Science concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

fosetyl-Al residues.

F. International Tolerances

There are presently no Codex

Alimentarius Commission maximum

residue levels established for residues of

fosetyl-Al.

[FR Doc. 01–12906 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1023; FRL–6782–5]

Notice of Filing a Pesticide Petition to

Establish a Tolerance fora Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28483

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1023, must be

received on or before June 22, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

PF–1023 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joseph M. Tavano, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–8375; e-mail address:

tavano.joseph@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’’ 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 PF–

1023. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, 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 Highway,

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.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–1023 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: opp-docket@epa.gov, or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

WordPerfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–1023. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

28484 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 11, 2001.

Richard P. Keigwin, Jr., Acting,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announces the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Rohm and Haas Company

1F6259

EPA has received a pesticide petition

(1F6259) from Rohm and Haas

Company, 100 Independence Mall West,

Philadelphia, PA 19106–2399

proposing, pursuant to section 408(d) of

the FFDCA, 21 U.S.C. 346a(d), to amend

40 CFR part 180 by establishing a

tolerance for residues of

methoxyfenozide benzoic acid, 3-

methoxy-2-methyl-,2-(3,5-

dimethylbenzoyl)-2-(1,1-dimethylethyl)

hydrazide in or on the raw agricultural

commodity stone fruits crop group and

prunes at 5 and 7 parts per million

(ppm) respectively. EPA has determined

that the petition contains data or

information regarding the elements set

forth in section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The qualitative

nature of methoxyfenozide residues in

plants and animals is adequately

understood and was previously

published in the Federal Register of

July 5, 2000 (65 FR 41355) (FRL–6496–

5).

2. Analytical method. An high

performance liquid chromotography

using ultra-violet detection (HPLC/UV)

method TR 34–00–109 for the

enforcement of tolerances in stone fruits

has been developed. Confirmatory

method validation data have been

submitted for this method. The

validated limit of quantitation (LOQ) of

the analytical method was 0.02 ppm in

all matrices for methoxyfenozide.

3. Magnitude of residues.

Geographically representative field

trials with methoxyfenozide 80WP and

2F formulations were conducted to

support the proposed crop group

tolerance for the stone fruit

representative crops peaches, plums and

cherries. The results of the field trials

indicate that residues of

methoxyfenozide will not exceed the

proposed crop group tolerance of 5.0

ppm for stone fruits or 7.0 ppm for

prunes.

B. Toxicological Profile

The toxicological profile and

endpoints for methoxyfenozide which

supports this petition to establish

tolerances were previously published in

the Federal Register of July 5, 2000 (65

FR 41355).

B. Aggregate Exposure

1. Dietary exposure—i. Food. Acute

exposure and risk. Acute dietary risk

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

indicated the possibility of an effect of

concern occurring as a result of a 1–day

or single exposure. No appropriate

toxicological endpoint attributable to a

single exposure was identified in the

available toxicology studies on

methoxyfenozide including the acute

neurotoxicity study in rats, the

developmental toxicity study in rats and

the developmental toxicity study in

rabbits. Since no acute toxicological

endpoints were established, Rohm and

Haas considers acute aggregate risk to be

negligible.

Rohm and Haas used the Dietary

Exposure Evaluation ModelTM (DEEM)

V.7.075; Novigen Sciences, Washington,

DC) software for conducting a chronic

dietary (food) risk analysis. DEEM is a

dietary exposure analysis system that is

used to estimate exposure to a pesticide

chemical in foods comprising the diets

of the U.S. population, including

population subgroups. DEEM contains

food consumption data as reported by

respondents in the USDA continuing

surveys of food intake by individuals

conducted in 1994–1996. Rohm and

Haas assumed 100% of crops would be

treated and contain methoxyfenozide

residues at the tolerance level. The

following tolerance levels were used in

the analysis:

Commodity Tolerance level,

ppm

Bulb vegetables 0.1 ppm

Corn, aspirated grain

fractions

1.0 ppm

Corn, field, forage 15 ppm

Corn, field, grain 0.05 ppm

Corn, field, stover

(fodder)

105 ppm

Corn, oil 0.2 ppm

Corn, silage 5.0 ppm

Corn, sweet, forage 30 ppm

Corn, sweet

(K+CWHR)

0.05 ppm

Corn, sweet, stover

(fodder)

60 ppm

Cotton, undelinted

seed

2.0 ppm

Fat* 0.5 ppm

Fruiting vegetables 2.0 ppm

Grapes 1.0 ppm

Head and stem brassica (5A)6.5 ppm

Herbs and spices 8 ppm

Leaf petioles (4B) 10.0 ppm

Leafy brassica

greens (5B)

20.0 ppm

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28485

Commodity Tolerance level,

ppm

Leafy vegetables

(4A)

25 ppm

Leaves of root and

tuber vegetables

0.1 ppm

Legume vegetables 0.05 ppm

Liver 0.4 ppm

Meat* 0.02 ppm

Meat byproducts*

(except liver)

0.1 ppm

Milk 0.1 ppm

Pome fruit 1.5 ppm

Prunes 7.0 ppm

Raisins 1.5 ppm

Root and tuber

vegetables

0.05 ppm

Stone fruits 5.0 ppm

* Of cattle, goats, hogs, horses, and sheep.

Processing factors were also applied

to grape juice (1.2x), grape juice

concentrate (3.6x), apple juice/cider

(1.3x), apple juice concentrate (3.9x),

dried apples (8x), dried pears (6.25x),

tomato juice (1.5x), tomato puree (3.3x),

tomato paste (5.4x), tomato catsup

(2.5x), dried tomatoes (14.3x),

dehydrated onions (9x), white dry

potatoes (6.5x), sprouted soybean seeds

(0.33x), corn grain sugar (high fructose

corn syrup; 1.5x), dried beef (1.92x),

dried veal (1.92x), dried apricots (6.0x),

dried cherries (4.0x), cherry juice (1.5x),

dried peaches (7.0x), dried plums (5.0x),

and plum/prune juice (1.4x). The

processing factors are default values

from DEEM.

As shown in the following table, the

resulting dietary food exposures occupy

up to 37.6% of the chronic population

adjusted dose (PAD) for the most highly

exposed population subgroup, children

1 to 6 years old. These results should be

viewed as conservative (health

protective) risk estimates. Refinements

such as use of percent crop-treated

information and/or anticipated residue

values would yield even lower estimates

of chronic dietary exposure.

SUMMARY: CHRONIC DIETARY EXPOSURE ANALYSIS BY DEEM (TIER 1)

Population

subgroup

Exposure

milligram/

kilogram/day

(mg/kg/day)

Percent of

chronic PAD

U.S. population—48

contiguous

States

0.0189 18.9

All infants

(<1–year)

0.0315 31.5

Nursing infants <1–

year old

0.0134 13.4

Non-nursing

infants <1–

year old

0.0368 36.8

Children 1 to

6 years old

0.0376 37.6

Children 7 to

12 years

old

0.0216 21.6

Females 13+

(nursing)

0.0156 19.1

U.S. population (autumn season)0.0191 19.1

U.S. population

(spring season)

0.0190 19.0

Northeast region0.0206 20.6

Western region0.0210 21.0

Hispanics 0.0191 19.1

Non-Hispanic/

non-white/

non-black

0.0249 24.8

Percent chronic PAD = (Exposure

divided by chronic PAD) x 100%.

The subgroups listed are:

1. The U.S. population (total).

2. Those for infants and children.

3. The other subgroup(s), if any, for

which the percentage of the chronic

PAD occupied is greater than that

occupied by the subgroup U.S.

population (total).

4. The most highly exposed of the

females subgroups (in this case, females,

(13+ years, nursing).

ii. Drinking water. There are no waterrelated exposure data from monitoring

to complete a quantitative drinking

water exposure analysis and risk

assessment for methoxyfenozide.

Generic expected environmental

concentration (GENEEC) and/or EPA’s

pesticide root zone model/exposure

analysis modeling system (PRZM/

EXAMS) (both produce estimates of

pesticide concentration in a farm pond)

are used to generate estimated

environmental concentrations (EECs) for

surface water and screening

concentration in ground water (SCIGROW) (an empirical model based upon

actual monitoring data collected for a

number of pesticides that serve as

benchmarks) predicts EECs in ground

water. These models take into account

the use patterns and the environmental

profile of a pesticide, but do not include

consideration of the impact that

processing 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

at this stage is to provide a coarse screen

for assessing whether a pesticide is

likely to be present in drinking water at

concentrations which would exceed

human health levels of concern.

A drinking water level of comparison

(DWLOC) is the concentration of a

pesticide in drinking water that would

be acceptable as a theoretical upper

limit in light of total aggregate exposure

to that pesticide from food, water, and

residential uses. HED uses DWLOCs

internally in the risk assessment process

as a surrogate measure of potential

exposure associated with pesticide

exposure through drinking water. In the

absence of monitoring data for a

pesticide, the DWLOC is used as a point

of comparison against the conservative

EECs provided by computer modeling

(SCI-GROW, GENEEC, PRZM/EXAMS).

a. Acute exposure and risk. Because

no acute dietary endpoint was

determined, Rohm and Haas concludes

that there is a reasonable certainty of no

harm from acute exposure from drinking

water.

b. Chronic exposure and risk. Tier II

screening-level assessments can be

conducted using the simulation models

SCI-GROW and PRZM/EXAMS to

generate EECs for ground and surface

water, respectively. The modeling was

conducted based on the environmental

profile and the maximum seasonal

application rate proposed for

methoxyfenozide (1.0 lb ai/acre/season).

PRZM/EXAMS was used to generate the

surface water EECs, because it can factor

the persistent nature of the chemical

into the estimates.

The EECs for assessing chronic

aggregate dietary risk used by HED are

6 parts per billion (ppb) (in ground

water, based on SCI-GROW) and 98.5

parts per billion (ppb) (in surface water,

based on the PRZM/EXAMS, long-term

mean).The back-calculated DWLOCs for

28486 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

assessing chronic aggregate dietary risk

range from 624 ppb for the most highly

exposed population subgroup (children

1 to 6 years old) to 2,839 ppb for the

U.S. population (48 contiguous States—

all seasons).

The SCI-GROW and PRZM/EXAMS

chronic EECs are less than the Agency’s

level of comparison (the DWLOC value

for each population subgroup) for

methoxyfenozide residues in drinking

water as a contribution to chronic

aggregate exposure. Rohm and Haas

thus concludes with reasonable

certainty that residues of

methoxyfenozide in drinking water will

not contribute significantly to the

aggregate chronic human health risk and

that the chronic aggregate exposure from

methoxyfenozide residues in food and

drinking water will not exceed the

Agency’s level of concern (100% of the

chronic PAD) for chronic dietary

aggregate exposure by any population

subgroup. EPA generally has no concern

for exposures below 100% of the

chronic PAD, because it is a level at or

below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to the health and

safety of any population subgroup. This

risk assessment is considered high

confidence, conservative, and very

protective of human health.

DWLOC FOR CHRONIC EXPOSURE TO METHOXYFENOZIDE

Population subgroup Chronic PAD

(mg/kg/day)

Food exposure

(mg/kg/day)

Maximum water

exposure (mg/kg/

day)

SCI-GROW (μg/

L)

GENEEC 56–day

Average (μg/L) DWLOC (μg/L)

U.S. population–48

contiguous states

0.0189 0.0811 2,839

Females 13+ (nursing)0.0191 0.0809 2,427

Non-nursing infants

<1–year old

0.10 0.0368 0.0632 6 98.5 632

Children 1 to 6 years

old

0.0376 0.0624 624

Children 7 to 12

years old

0.0216 0.0784 784

Notes: Maximum water exposure (mg/kg/day) = chronic PAD (mg/kg/day) - chronic food exposure. DWLOC (μg/L) = (Maximum water exposure

(mg/kg/d) x body weight (kg)) divided by (1/1,000 mg/μg x water consumed daily (L/day)). Body weights (kg) for adults is 70, for females 13+ is

60 kg and for all children is 10 kg. Drinking water consumption is 2 liters per day for adults and 1 liter per day for children.

2. Non-dietary exposure.

Methoxyfenozide is not currently

registered for use on any residential

non-food sites. Therefore, there is no

non-dietary acute, chronic, short- or

intermediate-term exposure.

D. Cumulative Effects

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

methoxyfenozide 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,

methoxyfenozide does not appear to

produce a toxic metabolite produced by

other substances. For the purposes of

this tolerance action, therefore, it is

assumed that methoxyfenozide does not

have a common mechanism of toxicity

with other substances.

E. Safety Determination

1. U.S. population. Using the DEEM

exposure assumptions described in this

unit, Rohm and Haas has concluded that

aggregate exposure to methoxyfenozide

from food will utilize 18.9% of the

chronic PAD for the U.S. population.

The major identifiable subgroup with

the highest aggregate exposure is

children 1 to 6 years old at 37.6% of the

chronic PAD and is discussed below.

EPA generally has no concern for

exposures below 100% of the chronic

PAD because the chronic PAD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to methoxyfenozide in

drinking water, the aggregate exposure

is not expected to exceed 100% of the

chronic PAD. Rohm and Haas concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to methoxyfenozide residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

methoxyfenozide, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a 2–generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional ten-fold

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 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.

EPA believes that reliable data support

using the standard uncertainty factor

(UF) (usually 100 for combined

interspecies and intraspecies variability)

and not the additional ten-fold MOE/UF

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28487

concerns regarding the adequacy of the

standard MOE/safety factor.

The toxicology data base for

methoxyfenozide included acceptable

developmental toxicity studies in both

rats and rabbits as well as a 2–

generation reproductive toxicity study

in rats. The data provided no indication

of increased sensitivity of rats or rabbits

to in utero and/or postnatal exposure to

methoxyfenozide. There is a complete

toxicity data base for methoxyfenozide

and exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. Based

on the completeness of the data base

and the lack of prenatal and postnatal

toxicity, EPA determined that an

additional safety factor was not needed

for the protection of infants and

children.

Since no acute toxicological

endpoints were established, acute

aggregate risk is considered to be

negligible. Using the exposure

assumptions described in this unit,

Rohm and Haas has concluded that

aggregate exposure to methoxyfenozide

from food will utilize 37.6% of the

cPAD for infants and children. EPA

generally has no concern for exposures

below 100% of the cPAD because the

cPAD represents the level at or below

which daily aggregate dietary exposure

over a lifetime will not pose appreciable

risks to human health. Despite the

potential for exposure to

methoxyfenozide in drinking water,

Rohm and Haas does not expect the

aggregate exposure to exceed 100% of

the cPAD. Short and intermediate term

risks are judged to be negligible due to

the lack of significant toxicological

effects observed. Based on these risk

assessments, Rohm and Haas concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

methoxyfenozide residues.

F. International Tolerances

There are no established or proposed

Codex, Canadian or Mexican limits for

residues of methoxyfenozide in/on plant

or animal commodities. Therefore, no

compatibility issues exist with regard to

the proposed U.S. tolerances.

[FR Doc. 01–12904 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–50885; FRL–6777–9]

Issuance of an Experimental Use

Permit

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has granted an

experimental use permit (EUP) to the

following pesticide applicant. An EUP

permits use of a pesticide for

experimental or research purposes only

in accordance with the limitations in

the permit.

FOR FURTHER INFORMATION CONTACT: By

mail: Barbara Mandula, Biopesticides

and Pollution Prevention Division

(7511C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: 1921

Jefferson Davis Hwy., Rm. 9016, Crystal

Mall #2, Arlington, VA; (703) 308–7378;

e-mail address:

mandula.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. Although this action may be

of particular interest to those persons

who conduct or sponsor research on

pesticides, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the information in this action,

consult the designated contact person

listed for the individual EUP.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

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/.

II. EUP

EPA has issued the following EUP:

73417–EUP–1. Issuance. Greenville

Farms, 1689 N. 1200 E. Logan, Utah

84341. This EUP allows the use of 83

pounds of the herbicide dyers woad rust

on 12 acres of rangeland to evaluate the

control of dyers woad. The program is

authorized only in the State of Utah.

The EUP is effective from March 1, 2001

to March 1, 2002.

Persons wishing to review this EUP

are referred to the designated contact

person. Inquiries concerning this permit

should be directed to the person cited

above. It is suggested that interested

persons call before visiting the EPA

office, so that the appropriate file may

be made available for inspection

purposes from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection,

Experimental use permits.

Dated: May 2, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 01–12902 Filed 5–22–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6982–8]

Massachusetts Marine Sanitation

Device Standard; Receipt of Petition

Notice is hereby given that a petition

has been received from the State of

Massachusetts requesting a

determination of the Regional

Administrator, U.S. Environmental

Protection Agency, pursuant to section

312(f)(3) of Public Law 92–500 as

amended by Public Law 95–217 and

Public Law 100–4, that adequate

facilities for the safe and sanitary

removal and treatment of sewage from

all vessels are reasonably available for

the Three Bay/Centerville Harbor Area

in the Town of Barnstable, County of

Barnstable, State of Massachusetts, to

qualify as a ‘‘No Discharge Area’’ (NDA).

The areas covered under this petition

include Cotuit Bay, West Bay, East Bay,

and Squaw Island Marsh, north of a line

drawn 500 feet south of their mouths at

Nantucket Sound. The area also

includes the following sub-embayments:

North Bay, Prince Cove, Marstons Mills

River South of Route 28, Scudder Bay

South of Bumps River Road, Bumps

River East of Bumps River Road,

Centerville River West of Craigville

Beach Road, and Halls Creek South of