Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11433

Budget, Attention: Desk Officer for

EPA 725 17th Street, NW,

Washington, DC 20503.

Dated: March 5, 1997.

Joseph Retzer,

Director, Regulatory Information Division.

[FR Doc. 97–6211 Filed 3–11–97; 8:45 am]

BILLING CODE: 6560–50–P

[FRL–5708–6]

National Guidance on Source Water

Protection; Notice of Public Meetings

The Environmental Protection Agency

(EPA) Regional Offices are holding

public meetings for the purpose of

information exchange on various issues

related to the development of guidance

for State source water assessment and

protection programs. Under the new

provisions of the Safe Drinking Water

Act of 1996, States are required to

delineate the sources of all public water

supplies and identify potential sources

of contamination. States may allocate up

to 10% of monies available under the

Drinking Water State Revolving Fund

(SRF) for this purpose. Additional

monies from the Drinking Water SRF

can be allocated for non-mandatory

protection programs and support for

local protection efforts.

The protection of drinking water

supplies will require the active

participation of a great number of

stakeholders who have not traditionally

been directly involved with the public

water supply program. These include

various State agencies, local

governments, other Federal agencies,

environmental advocates, public health

professionals, the agricultural

community, watershed activists,

developers and many others. EPA is

inviting all interested members of the

public to attend these meetings and

actively provide viewpoints, ideas and

suggestions to EPA on its drinking water

protection activities. EPA encourages

the public’s response to EPA’s Source

Water Assessment and Protection

Guidance draft guidance which will be

issued in final by August 1996.

We hope you can join us and share

your experience and perspectives. We

also hope that your early involvement

will support the development of strong

State assessment and protection

programs. Space will be limited so we

encourage you to pre-register by calling

the Safe Drinking Water Hotline at 1–

800–426–4791 (9:00 a.m.–5:30 p.m.,

Monday–Friday) or send an e-mail

message to Hotlinesdwa@epamail.epa.gov.

The meetings are scheduled as

follows:

EPA region Location Date

1 .................. Worcester,

MA.

May 28,

1997.

Concord, NH May 29,

1997.

2 .................. Suffern, NY .. April 29,

1997.

3 and 4 ........ Raleigh, NC .. May 28 & 29,

1997.

3 .................. Pittsburgh,

PA.

May 21 & 22,

1997.

4 .................. Atlanta, GA ... May 6 & 7,

1997.

Raleigh, NC .. May 6, 1997.

5 .................. Lansing, MI .. April 1, 1997.

Springfield, IL April 11,

1997.

St. Cloud, MN April 22,

1997.

Indianapolis,

IN.

April 28,

1997.

Fond Du Lac,

WI.

To be scheduled.

6 .................. Dallas, TX .... April 2 & 3,

1997.

7 .................. Lenexa, KS .. May 14,

1997.

8 .................. Denver, CO .. April 22 & 23,

1997.

9 .................. Las Vegas,

NV.

April 16,

1997.

Los Angeles,

CA.

May 21,

1997.

10 ................ Salem, OR ... April 30,

1997.

Anchorage,

AK.

To be scheduled.

Boise, ID ...... To be scheduled.

Lacey, WA .... May 6, 1997.

Please call the Safe Drinking Water

Hotline 1–800–426–4791 ( 9:00 a.m.–

5:30 p.m. Monday–Friday) for updated

information.

For more information about EPA’s

Source Water Protection efforts and the

Regional Stakeholder meetings please

visit the Office of Ground Water and

Drinking Water home page at http://

www.epa.gov/OGWDW/swp.html. If

you are interested in receiving a copy of

the draft guidance and/or attending one

of the meetings, please call the EPA

Drinking Water Hotline at 1–800–426–

4791 (9:00 a.m.–5:30 p.m. Monday–

Friday) or send an e-mail message to

hotline-sdwa@epamail.epa.gov.

Written comments on the guidance

are requested to be sent by June 15, 1997

to EPA’s Office of Ground Water and

Drinking Water, Implementation and

Assistance Division, Prevention and

Support Branch, 401 M St. SW., Mail

Code 4606, Washington, DC. 20460.

Dated: March 4, 1997.

Cynthia C. Dougherty,

Director, Office of Ground Water and Drinking

Water.

[FR Doc. 97–6212 Filed 3–11–97; 8:45 am]

BILLING CODE: 6560–50–P

[FRL–5708–1]

Scientific Counselors Board Executive

Committee Meeting

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of meeting.

SUMMARY: Pursuant to the Federal

Advisory Committee Act, Public Law

92–463, as amended (5 U.S.C., App. 2),

notice is hereby given that the

Environmental Protection Agency

(EPA), Office of Research and

Development’s (ORD), Board of

Scientific Counselors (BOSC), will hold

its Executive Committee Meeting, April

7–8, 1997, at the Hyatt Arlington Hotel,

1325 Wilson Boulevard, Arlington,

Virginia. On Monday, April 7, the

meeting will begin at 1:00 pm and will

recess at 5:00 pm, and on Tuesday,

April 8, the meeting will begin at 8:00

am and will adjourn at 4:30 pm. All

times noted are Eastern time. Agenda

items include, but are not limited to,

BOSC Operating Principles, Laboratory

Peer Review Discussion, ORD Research

Plan Evaluation: Methods Development,

Use of Peer Review in ORD, and

Research Plan for Arsenic in Drinking

Water. Anyone desiring a draft BOSC

agenda may fax their request to Shirley

R. Hamilton (202) 260–0929. The

meeting is open to the public. Any

Member of the public wishing to make

comments at the meeting, should

contact Shirley Hamilton, Designated

Federal Officer, Office of Research and

Development (8701), 401 M Street, SW.,

Washington, DC 20460; by telephone at

(202) 260–0468. In general, each

individual making an oral presentation

will be limited to a total time of three

minutes.

FOR FURTHER INFORMATION CONTACT:

Shirley R. Hamilton, Designated Federal

Officer, U.S. Environmental Protection

Agency, Office of Research and

Development, NCERQA (MC8701), 401

M Street, SW., Washington, DC 20460,

202–260–0468.

Dated March 5, 1997.

Henry L. Longest II,

Acting Assistant Administrator for Research

and Development.

[FR Doc. 97–6214 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–M

[PF–716; FRL–5589–7]

AgrEvo USA Company; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.
11434 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices

SUMMARY: This notice announces the

filing of a pesticide petition proposing

regulations establishing tolerances for

residues of propamocarb (propyl-3-

[dimethyl-amino] propylcarbamate)

hydrochloride (hereafter referred to as

propamocarb) and its metabolites in or

on potatoes and their derived

commodities, as well as secondary

tolerances in meat and milk. This notice

includes a summary of the petition that

was prepared by the petitioner, AgrEvo

USA Company.

DATES: Comments, identified by the

docket control number [PF–716], must

be received on or before April 11, 1997.

ADDRESSES: By mail, submit written

comments to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St. SW.,

Washington, DC 20460. In person, bring

comments to Rm. 1132, CM #2. 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted electronically be sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or in ASCII file format. All

comments and data in electronic form

must be identified by docket control

number [PF–716]. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries.

Additional information on electronic

submissions can be found below this

document.

Information submitted as a comments

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

Mail, Connie Welch, Product Manager

(PM) 21, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Rm 227, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202, (703) 305–6226; e-mail:

welch.connie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP)

6F4707 from AgrEvo USA Company,

Little Falls Centre One, 2711 Centerville

Rd., Wilmington, DE 19808. The

petition proposes, pursuant to section

408 of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C. 346a,

to amend 40 CFR part 180 by

establishing tolerances for the

Propamocarb in or on potatoes at 0.5

part per million (ppm). EPA has

determined that the petition contains

data or information regarding the

elements set forth in section 408(d)(2);

however, EPA has not fully evaluated

the sufficieny 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act, AgrEvo

included in the petition a summary of

the petition and authorization for the

summary to be published in the Federal

Register in a notice of receipt of the

petition. The summary represents the

views of AgrEvo; EPA, as mentioned

above, is in the process of evaluating the

petition. As required by section

408(d)(3) EPA is including the summary

as a part of this notice of filing. EPA

may have made minor edits to the

summary for the purpose of clarity.

I. Petition Summary

A. Propamacarb Uses

Propamocarb is a specific pesticide

with specific activity against several

Oomycete species which cause seed,

seedling, root and stem rots and foliar

diseases in many edible crops and

ornamental plants. The mode of action

of propamocarb is different compared to

other Oomycete fungicides, which

provides for efficacy against strains that

have developed resistance to other

fungicides.

B. Metabolism and Analytical Method

1. Analytical method. A practical

analytical method utilizing gas/liquid

chromatography and N-FID or MSD is

available and has been validated for

detecting and measuring levels of

propamocarb in or on food. The limit of

quantification (LOQ) is 0.05 mg/kg

(ppm).

2. Metabolism. The absorption,

distribution, metabolism and excretion

of propamocarb has been evaluated in

rats. Propamocarb is rapidly absorbed,

extensively metabolized and rapidly

eliminated, primarily via the urine,

following oral administration.

Metabolite profiles were similar

following single and repeated oral

dosing and following intravenous

dosing. The primary route of

metabolism is oxidative degradation

with hydrolytic cleavage occurring as a

secondary pathway.

C. Residues in Plants and Animals

1. Nature and magnitude of the

residue in plants. The fate of

propamocarb in plants is clearly

understood. Metabolism studies in

cucumbers, potatoes and spinach

demonstrated that propamocarb is

degraded into carbon dioxide which is

reincorporated into natural plant

constituents. The primary residue found

in all crops, and the only residue of

concern, is the parent, propamocarb

hydrochloride.

More than 50 residue trials on

potatoes have been conducted

throughout the world. The results from

these studies indicated that residues of

propamocarb in raw potatoes from foliar

applications were below the LOQ, even

when applied at 2.5–times the

maximum proposed label rate of 4.5 lb

ai/A. No measurable residues of

propamocarb were detected in any of

the processed commodities following

treatment at 2.5–times the maximum

proposed label rate and a shorter than

proposed pre-harvest interval (3 days vs.

the proposed 14 days). An additional

processing study at 5–times the

proposed label rate (22.5 lb a.i./acre) is

now underway. Based on these results,

tolerances are proposed for the residues

of propamocarb in or on potato at 0.5

ppm.

Six residue trials have been

conducted on tomatoes, either in the

greenhouse or in arid climates where no

rainfall likely occurred. Based on these

data, AgrEvo USA expects that residues

in tomatoes would not exceed 0.3 ppm

when used as proposed. Typical

residues are anticipated to be

significantly lower.

2. Nature and magnitude of the

residue in animals. Data are not yet

available on the metabolism of

propamocarb in livestock. A cow

metabolism study was initiated in

September, 1996, and will be submitted

to the Agency during 1997. However, in

a rat metabolism study, propamocarb

was extensively degraded and rapidly

excreted, with >90 percent excreted in

the urine within 24 hours. Therefore,

AgrEvo believes that the potential for

residues to occur in animal
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11435

commodities from ingestion of potato

processing wastes which contain

propamocarb residues at or below 0.05

ppm is negligible.

C. Toxicological Profile

The toxicity of propamocarb has been

evaluated by EPA as part of previous

regulatory actions and is summarized

below. The conclusions presented are

those determined by the Agency as

reported by the registrant.

1. Acute toxicity. There are no acute

toxicity concerns with propamocarb.

The acute rat oral LD50 was 2,900 mg/

kg in males and 2,000 mg/kg in females.

The acute rat dermal LD50 was ≤3,000

mg/kg. The acute (4–hour) inhalation

LC50 in rats was >7.9 mg/l. Propamocarb

was not a skin sensitizer in guinea pigs.

Based on these results, propamocarb

hydrochloride was classified as Toxicity

Category III for acute oral and dermal

toxicity, and eye irritation, and Category

IV for acute inhalation toxicity and skin

irritation.

2. Subchronic toxicity. In a 90–day

feeding study, propamocarb was

administered to albino rats at

concentrations of 0, 20, 50, 100, and

500/1,000 ppm in the diet. The only

effects noted were slightly reduced food

efficiency and body weight gains at

1,000 ppm.

In a 90–day feeding study in beagle

dogs, propamocarb was administered in

the diet at concentrations of 0, 50, 100,

500, and 1,000/2,000 ppm. No

treatment-related findings were

observed.

A 21–day dermal toxicity study was

performed with propamocarb in

Sprague-Dawley rats at dose levels of 0,

100, 500 and 1,000 mg/kg/day, 6 hours

per day, 5 days per week over a 21–day

period. No treatment related effects

were observed.

A 21–day dermal toxicity study was

performed with propamocarb in rabbits

at dose levels of 0, 150, 525 and 1,500

mg/kg/day, 6 hours per day, 5 days per

week, over a 21–day period. The No

Obsereved Effects Level (NOEL) for this

study was considered by the Agency to

be 150 mg/kg/day based on dose-related

skin irritation in mid- and high-dose

animals and a decrease in weight gain

in mid-dose females.

3. Chronic toxicity/oncogenicity. A 2–

year feeding chronic toxicity/

carcinogenicity study was performed in

Sprague-Dawley rats with propamocarb

at dietary concentrations of 0, 40, 200 or

1,000 ppm. There was no evidence of

carcinogenicity or other treatmentrelated effect except for a possible

reduction in food intake in female rats

at the highest level tested. Thus, 1,000

ppm (41 mg/kg/day) was considered to

be the NOEL. However, this study did

not satisfy the Agency’s criteria for a

Maximum Tolerated Dose (MTD). A

new study at higher dose levels is now

in progress.

A 2–year feeding chronic toxicity/

carcinogenicity study was performed in

CD-1 mice with propamocarb at dietary

concentrations of 0, 20, 100 and 500

ppm. No evidence of carcinogenicity or

toxicity was noted at any dose level.

Thus, 1,000 ppm (53 mg/kg/day for

males and females, respectively), was

considered to be the NOEL. However,

this study did not meet the Agency’s

criteria for a MTD. A new study at

higher dose levels is now in progress.

A 2–year feeding study was

performed in beagle dogs with

propamocarb at dietary concentrations

of 0, 1,000, 3,000, 10,000 ppm.

Decreased weight gain, decreased food

efficiency and an increased incidence of

acute gastric mucosal erosions and/or

chronic erosive gastritis were noted in

all treated groups. Thus, a NOEL for this

study was not determined but was

considered to be slightly lower than the

lowest dose level tested (33.3 mg/kg/

day).

4. Genotoxicity. No evidence of

genotoxicity was observed in a battery

of studies including Salmonella and E.

coli gene mutation assays, 2 mouse

micronucleus assays, an in vitro

mammalian cytogenetic assay using

cultured human lymphocytes, a yeast

mitotic gene conversion assay and a

yeast mitotic recombination assay.

5. Reproduction and developmental

toxicity. In a developmental toxicity

study, rats were administered

propamocarb by gavage at dose levels of

0, 74, 221, 740, or 2,210 mg/kg/day on

gestation days 6–19. The NOEL for

maternal toxicity was 740 mg/kg/day

based on mortality, clinical observations

and decreased body weight gain at 2,210

mg/kg/day. The NOEL for

developmental toxicity was 221 mg/kg/

day based on increased postimplantation loss, decreased fetal

weights and increased incidence of

minor skeletal anomalies (retarded

ossification) at 740 and/or 2,210 mg/kg/

day.

In another developmental toxicity

study, rabbits were administered

propamocarb by gavage at dose levels of

0, 15, 45, 150, 300, or 600 mg/kg/day on

gestation days 6–18. The NOEL for both

maternal toxicity and developmental

toxicity was 150 mg/kg/day, based on

decreased maternal body weight gain

and increased post-implantation loss at

300 mg/kg/day.

A three-generation reproduction study

was conducted using rats fed diet

containing propamocarb at dietary

concentrations of 0, 40, 200, and 1,000

ppm for 100 days and then continuously

through 3 successive generations. No

treatment-related effects were noted on

either the parents or offspring.

6. Neurotoxicity. An acute

neurotoxicity study was performed in

rats at dose levels of 0, 20, 200 and

2,000 mg/kg of propamocarb

hydrochloride. The overall NOEL for

this study was determined to be 200 mg/

kg based on decreased weight gain,

soiled fur and decreased motor activity

in males and/or females at 2,000 mg/kg.

A 90–day neurotoxicity study was

conducted in rats at dietary

concentrations of propamocarb

hydrochloride of 0, 200, 2,000 and

20,000 ppm. No evidence of

neurotoxicity (FOB, motor activity or

neuropathology) was observed at any

dose level. Plasma, red blood cell and

brain cholinesterase levels were also not

affected. The NOEL was determined to

be 2,000 ppm (142 mg/kg/day) based on

decreased weight gain at 20,000 ppm.

7. Endocrine effects. No special

studies have been conducted to

investigate the potential of propamocarb

to induce estrogenic or other endocrine

effects. However, the standard battery of

required toxicity studies has been

completed. These studies include an

evaluation of the potential effects on

reproduction and development, and an

evaluation of the pathology of the

endocrine organs following repeated or

long-term exposure. These studies are

generally considered to be sufficient to

detect any endocrine effects yet no such

effects were detected. Thus, the

potential for propamocarb to produce

any significant endocrine effects is

considered to be minimal.

E. Aggregate Exposure

Propamocarb is registered for nonfood uses on turf and ornamental plants

(BANOL Fungicide, EPA Reg. No.

45639–88). As such, non-occupational

exposure would include exposures

resulting from consumption of potential

residues in food or water, as well as

exposure to residues from applications

to golf courses, commercial and

ornamental turf, home lawns, sod farms,

and ornamental plants. There are no

acute toxicity concerns with

propamocarb. Thus, only chronic

exposures are being addressed here.

1. Dietary exposure (food). Potential

dietary exposures from food under the

proposed tolerances and potential

emergency use time-limited tolerances

were estimated using the Exposure 1

software system (TAS, Inc.) and the

1977–78 USDA consumption data. For

the purposes of this assessment, AgrEvo

USA has made the very conservative
11436 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices

assumption that 100 percent of all

commodities will contain propamocarb

residues and that all of those residues

will be at the proposed tolerance levels.

(of: 0.05 ppm in potato tubers (whole

RAC), and the meat, milk, fat, liver,

kidney, and meat by-products of cattle,

goats, hogs, horses, and sheep; and for

future time-limited tolerances

supporting section 18 Emergency Uses,

0.3 ppm in tomatoes (whole RAC); 1.0

ppm in tomato juice, puree, and catsup;

3.0 ppm in tomato paste). Thus, this

estimate should result in a gross

overestimation of actual human

exposure. Copies of these dietary

exposure analyses are appended to this

document.

2. Dietary exposure (drinking water).

The potential for propamocarb to leach

into groundwater has been assessed in

four terrestrial field dissipation studies

conducted in several states and on

various soil types. These studies were

conducted using rates recommended for

application to turf, which are

approximately 24 lb a.i./acre, six times

(6X) higher than the total rate

recommended for use in potatoes and

tomatoes. The degradation of

propamocarb in these studies was rapid,

with half-lives ranging from a low of 6

days to a high of 17 days. This

compound adsorbs strongly to soil,

having a moderately high soil

adsorption coefficient (Kads) of 5.2 and

a Koc of 359 in sandy loam soil. The

compound did not leach under any of

the various climatic test conditions, in

contrast to it s high solubility in water,

and did not exhibit mobility in either

acidic or alkaline soil types. Based on

these environmental fate data and the

anticipated conditions of use, the

potential for movement of propamocarb

into groundwater is very low, and as

such the potential contribution of any

such residues to the total dietary intake

of propamocarb will be negligible. No

Maximum Contaminant Level or Health

Advisory Level for residues of

propamocarb in drinking water has been

established.

3. Non-dietary exposure. As a

professional use turf and ornamental

fungicide, propamocarb is used

primarily (>90 percent of use) on golf

courses for control of Pythium blight

(BANOL Fungicide, EPA Reg. No.

45639–88). Some limited use of BANOL

occurs on ornamental plants produced

in greenhouses or containers, and to a

very limited extent on sod farms or by

professional lawn care applicators to

commercial turf. The product is rarely

used on homeowner turf due to the fact

that the diseases it controls (Pythium,

Phytophthora) occurs primarily in high

fertility, high maintenance turf (e.g. golf

courses), not in homeowner turf. Thus,

although non-dietary exposures have

not been quantified, AgrEvo USA

expects them to be minimal since they

will occur primarily to golfers who will

be wearing shoes and socks and who

will not enter previously treated areas

until after the grass has dried.

Furthermore, based on the limited

frequency of use (no more than three

applications per year), these non-food

uses for propamocarb are not likely to

result in potential chronic exposure and

thus should not be factored into a

chronic exposure assessment.

G. Cumulative Effects

The potential for cumulative effects of

propamocarb and other substances

having a common mechanism of toxicity

must also be considered. The precise

mechanism of toxicity for propamocarb

is unknown. Although a member of the

carbamate group of pesticides,

propamocarb is not an n-methyl

carbamate, and demonstrated no

inhibitory effects on blood or brain

cholinesterase following either acute or

repeated oral administrations to rats and

dogs. In vitro studies using rat or dog

blood plasma showed very slight

cholinesterase inhibitory effects only at

extremely high dose levels, equivalent

to about 2,200 mg/kg bodyweight. This

level is 20,000X the established

Reference Dose for propamocarb. Thus,

AgrEvo USA anticipates no cumulative

effects with other substances.

H. Safety Determinations

1. U.S. population. The Agency has

previously established a Reference Dose

(RfD) value of 0.11 mg/kg/day for

propamocarb based on a LOEL of 1,000

ppm (33.3 mg/kg/day) from a 2–year dog

chronic toxicity study, applying an

uncertainty factor of 100 to account for

interspecies extrapolation and

intraspecies variation, plus an

additional factor of 3 to account for the

lack of a NOEL. The FAO/WHO/JMPR

have recommended an Acceptable Daily

Intake (ADI) of 0.1 mg/kg/day.

Using the conservative (worst-case)

dietary exposure assumptions described

above in paragraph E. 1., chronic dietary

exposure will utilize only 1 percent of

the RfD for the U.S. population. There

is generally no concern for exposures

below 100 percent of the RfD since it

represents the level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. Thus, AgrEvo USA

concludes that there is a reasonable

certainty that no harm will result to the

U.S. population in general from

aggregate exposure to propamocarb

residues.

2. Infants and children. Data from rat

and rabbit developmental toxicity

studies and rat multigeneration

reproduction studies are generally used

to assess the potential for increased

sensitivity of infants and children. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development. Reproduction studies

provide information relating to

reproductive and other effects on adults

and offspring from pre-natal and postnatal exposure to the pesticide.

No treatment-related effects to either

parental animals or offspring were noted

in a three-generation rat reproduction

study at dose levels up to 1,000 ppm

(33.3 mg/kg/day). No evidence of

teratogenicity was noted in either rat or

rabbit developmental toxicity studies,

even at maternally toxic dose levels.

Increased post-implantation loss was

noted in the rabbit study, but only at

maternally toxic dose levels. The NOEL

for both maternal and developmental

toxicity in rabbits was 150 mg/kg/day.

Decreased fetal weights, increased postimplantation loss and retarded

ossification were noted in rats, and the

developmental NOEL of 221 mg/kg/day

was lower than the maternal NOEL of

740 mg/kg/day. However, the Agency

has concluded that due to the high dose

at which fetal toxicity was observed, no

definite conclusion can be made

regarding developmental toxicity in this

study.

FFDCA section 408 provides that the

Agency may apply an additional safety

factor for infants and children to

account for pre- and post-natal toxicity

or incompleteness of the database. The

toxicology database for propamocarb

regarding potential pre- and post-natal

effects in children is complete according

to existing Agency data requirements

and does not indicate any particular

developmental or reproductive

concerns. Furthermore, the previously

established RfD of 0.11 mg/kg/day,

which is based on a 33.3 mg/kg/day

LOEL from the 2–year dog feeding

study, already provides for a safety

factor of 1,364 relative to the 150 mg/

kg/day developmental NOEL from the

rat developmental toxicity study. Thus,

AgrEvo USA considers the existing RfD

of 0.11 mg/kg/day to be appropriate for

assessing potential risks to infants and

children and an additional uncertainty

factor is not warranted.

Using the conservative assumptions

described above, aggregate exposure to

propamocarb is expected to utilize 3

percent of the RfD in non-nursing

infants and 2 percent of the RfD in

children aged 1–6. These numbers
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11437

would be significantly lower if

anticipated residues were utilized rather

than tolerance values. Therefore,

AgrEvo concludes that there is a

reasonable certainty that no harm will

result to infants or children from

aggregate exposure to propamocarb

residues.

I. International Tolerances

The Codex Alimentarius Commission

(Codex) has established tolerances

(MRLs) for propamocarb in the

following raw agricultural commodities:

Commodity Part per million

Beetroot 0.2 ppm

Brussels sprouts 1.0 ppm

Cabbage, head 0.1 ppm

Celery 0.2 ppm

Cucumber 2.0 ppm

Cauliflower 0.2 ppm

Lettuce, head 10.0 ppm

Pepper, sweet 1.0 ppm

Radish 5.0 ppm

Strawberry 0.1 ppm

Tomato 1.0 ppm

The FAO/WHO/JMPR have

recommended an Acceptable Daily

Intake (ADI) of 0.1 mg/kg/day.

J. Conclusions

AgrEvo USA believes that the

proposed use of propamacarb on

potatoes would not pose a significant

risk to human health, including that of

infants and children, and is in

compliance with the requirements of the

Food Quality Protection Act of 1996.

Moreover, the proposed tolerances for

propamocarb in potato commodities,

meat and milk, of 0.05 ppm, should be

established.

II. Public Record

Interested persons are invited to

submit comments on this notice of

filing. Comments must bear a notation

indicating the docket control number,

[PF–716]. All written comments filed in

response to this petition will be

available in the Public Response and

Program Resources Branch, at the

address given above from 8:30 a.m. to 4

p.m., Monday through Friday, except

legal holidays.

A record has been established for this

notice under docket control number

[PF–716] including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

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

excluding legal holidays. The public

record is located in Rm. 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as ASCII file avoiding the use

of special characters and any form of

encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 21 U.S.C. 346a.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

Dated: February 26, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–5681 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–712; FRL–5587–7]

The Cryolite Task Force; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

regulations establishing tolerances for

residues of the insecticidal fluorine

compounds cryolite and/or synthetic

cryolite (sodium aluminum fluoride or

sodium aluminofluoride) in or on

potatoes and in processed potato waste.

This notice includes a summary of the

petition that was prepared by the

petitioner, The Cryolite Task Force.

DATES: Comments, identified by the

docket control number [PF-712] must be

received on or before April 11, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted either in

ASCII format (avoiding the use of

special characters and any form of

encryption) or in WordPerfect in 5.1 file

format. All comments and data in

electronic form must be identified by

the docket control number [PF-712].

Electronic comments on this notice may

be filed online at many Federal

Depository Libraries. The official record

for this rulemaking, as well as the

public version described above, will be

kept in paper form. Additional

information on electronic submissions

can be found in Unit II. of this

document.

Information submitted as a comment

concerning this notice may be claimed

confidential by marking any part or all

of that information as ‘‘Confidential

Business Information’’ (CBI).

Information so marked will not be