Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5639

therefore need to be reflected in the

quantitative benefit assessment.

While developing the primary benefit

estimates for reduced fatal cancer risks

in the proposed radon rule, questions

arose regarding the implementation of

adjustments for some factors, but not

others. For example, would it ever be

appropriate to adjust only for latency

periods, and not other factors, in the

valuation of reduced cancer deaths? The

Agency is requesting the SAB’s counsel

to help answer this and related

questions regarding the valuation of

cancer risks.

Charge to the Committee

The Agency has requested a review by

the SAB–EEAC of its ‘‘white paper’’ on

approaches to estimating the benefits of

reduced fatal cancer risks. The principal

questions for the Science Advisory

Board are:

(a) Does the white paper accurately

describe the empirical economic

literature relevant to the benefit transfer

issues that ensue when using the VSL

literature to estimate the VSCF in a

benefit-cost analysis?

(b) Does the white paper present the

important risk and demographic factors

that can affect benefit transfer

approaches that use VSL estimates for

VSCF?

(c) Does the white paper accurately

describe attempts in the economic

literature to measure VSCF directly?

(d) There are two numeric case

studies of environmental cancer risks

developed for the white paper. Each

presents risk assessment information

that forms the basis for quantifying the

number of statistical cancer fatalities

that will be reduced as a consequence

of a hypothetical proposed

environmental policy. The case studies

are used to illustrate the outcome of

using direct measures of the VSCF and

benefit transfer adjustments to VSL

estimates in order to calculate the VSCF.

(1) Which of the valuation approaches

applied to the case study designated as

ALPHA are valid to use? Does this case

study omit any credible alternative

protocols for valuing reductions in fatal

cancer risks for benefit-cost analyses of

environmental programs?

(2) Which of the valuation approaches

applied to the case study designated as

OMEGA are valid to use? Does this case

study omit any credible alternative

protocols for valuing reductions in fatal

cancer risks for benefit-cost analyses of

environmental programs?

(e) Which economic methods

illustrated with the case studies, or

additional methods identified by the

Committee under charge question d),

serve as credible protocols for the

Agency to use in representing

quantitative data, qualitative

information, and sensitivity analyses for

the economic value of reduced fatal

cancer risks reported in benefit-cost

analyses?

FOR FURTHER INFORMATION: Members of

the public desiring additional

information about the meeting should

contact Mr. Thomas Miller, Designated

Federal Officer, Environmental

Economics Advisory Committee (EEAC),

USEPA Science Advisory Board

(1400A), Room 6450, 1200 Pennsylvania

Avenue, NW, Washington, DC 20460;

telephone/voice mail at (202) 564–4558;

fax at (202) 501–0582; or via e-mail at

<miller.tom@epa.gov>. For a copy of the

draft meeting agenda, please contact Ms.

Dorothy Clark, Management Assistant at

(202) 564–4537 or by FAX at (202) 501–

0582 or via e-mail at

<clark.dorothy@epa.gov>. Single copies

of the background document, Valuing

Fatal Cancer Risk Reductions can be

obtained by contacting Mr. Brett Snyder,

U.S. Environmental Protection Agency,

Office of Policy and Reinvention (Mail

Drop 2172), 1200 Pennsylvania Ave.,

NW, Washington, DC, 20460, (202) 260–

5610, FAX (202) 260–2685, or via email

at: <snyder.brett@epa.gov>.

Providing Oral or Written Comments

Members of the public who wish to

make a brief oral presentation to the

Committee must contact Mr. Thomas

Miller, Designated Federal Officer for

the Environmental Economics Advisory

Committee, in writing (by letter or fax)

no later than 4:00 pm Eastern Time,

Thursday, February 17, 2000, at the

address noted above in order to be

included on the agenda. The request

should identify the name of the

individual who will make the

presentation, the organization (if any)

they will represent, any audio-visual

equipment (e.g., overhead projector, 35

mm projector, chalkboard, etc.), and at

least 35 copies of an outline of the

issues to be addressed or the

presentation itself. To discuss technical

aspects of the meeting, please contact

Mr. Miller by telephone at (202) 564–

4558. For a copy of the draft agenda

please contact Ms. Dorothy Clark,

Management Assistant, at (202) 564–

4537, or by FAX at (202) 501–0582 or

via e-mail at <clark.dorothy@epa.gov>.

Providing Oral or Written Comments at

SAB Meetings

The Science Advisory Board expects

that public statements presented at its

meetings will not be repetitive of

previously submitted oral or written

statements. In general, each individual

or group making an oral presentation

will be limited to a total time of ten

minutes. Written comments (at least 35

copies) received in the SAB Staff Office

sufficiently prior to a meeting date

(usually one week before the meeting),

may be mailed to the relevant SAB

committee or subcommittee; comments

received too close to the meeting date

will normally be provided to the

committee at its meeting, or mailed soon

after receipt by the Agency. Written

comments may be provided to the

relevant committee or subcommittee up

until the time of the meeting.

Additional information concerning

the Science Advisory Board, its

structure, function, and composition,

may be found on the SAB Website

(http://www.epa.gov/sab) and in the

Annual Report of the Staff Director

which is available from the SAB

Publications Staff at (202) 564–4533 or

via fax at (202) 501–0256.

Meeting Access

Individuals requiring special

accommodation at this meeting,

including wheelchair access, should

contact the appropriate DFO at least five

business days prior to the meeting so

that appropriate arrangements can be

made.

Dated: January 28, 2000.

Donald G. Barnes,

Staff Director, Science Advisory Board.

[FR Doc. 00–2477 Filed 2–3–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–908; FRL–6398–9]

Novartis Crop Protection; Notice of

Filing a Pesticide Petition To Establish

a Tolerance for Certain Pesticide

Chemicals in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–908, must be

received on or before March 6, 2000.

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.

5640 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–908 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker (PM 22),

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–7740; and e-mail

address: gilesparker.cynthia@epamail.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:

CategoriesNAICS

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–

908. 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 (CM #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–908 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, Ariel Rios Bldg., 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, CM #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–908. 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.

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 certain pesticide chemicals

in or on various food commodities

under section 408 of the Federal Food,

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5641

Drug, and Comestic 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 supports 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: January 24, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

9F6004

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.

EPA has received a pesticide petition

(9F6004) from Novartis Crop Protection,

P.O. Box 18300, Greensboro, NC 27419

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180 by establishing

a tolerance for residues of 1,2,3-

benzothiadiazole-7-carbothioic acid Smethyl ester (acibenzolar-S-methyl) in

or on the raw agricultural commodity

brassica leafy vegetables crop group and

bananas at 1.0 and 0.1 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Novartis believes

the metabolism of acibenzolar-S-methyl

has been well characterized. Only 4.6%

and 14.9% of the total radioactive

residue (TRR) was non-extractable in

lettuce at the recommended application

rate and three times the recommended

application rate, respectively. Nonextractables were also low in a tomato

metabolism study; 3.4% and 7.4% in

tomatoes and foliage, respectively. The

metabolism in these crops proceeded

via hydrolysis of benzo [1,2,3]

thiadiazole-7-carbothioic acid S-methyl

ester to benzo [1,2,3] thiadiazole-7-

carboxylic acid (BTCA), followed by

conjugation as ester, glycoside and/or

other plant constituents. The

metabolism profile supports the use of

an analytical enforcement method that

accounts for acibenzolar-S-methyl and

metabolites containing the benzo [1,2,3]

thiadiazole-7-carboxylic acid (BTCA)

moiety.

2. Analytical method. Novartis

Analytical Method AG-671A is a

practical and valid method for the

determination and confirmation of CGA245704 (acibenzolar-S-methyl) in raw

agricultural commodities (RAC) and

processing substrates from the tobacco,

leafy (including brassica) and fruiting

vegetable crop groups at a limit of

quantitation (LOQ) of 0.02 ppm. The

method involves extraction, solid phase

cleanup of samples with analysis by

high performance liquid

chromotography (HPLC) with ultraviolet

(UV) detection or confirmatory LC/MS.

The validity is demonstrated by the

acceptable accuracy and precision

obtained on numerous procedural

recovery samples (radiovalidation and

field trial sample sets), and by the

extractability and accountability

obtained by the analysis of weathered

radioactive substrates using Analytical

Method AG-671A. Novartis Analytical

Method REM 172.11 is a practical and

valid method for the determination and

confirmation of CGA-245704 in RAC of

bananas at a LOQ of 0.02 ppm. The

method involves hydrolytic extraction,

partitioning, and solid phase cleanup of

samples with analysis by two-column

HPLC switching with UV detection. The

validity is demonstrated by the

acceptable accuracy and precision

obtained on numerous procedural

recovery samples (banana, tomatoes,

cucumbers, and milk).

3. Magnitude of residues. This

petition is supported by 17 field trials

conducted on representative members of

the brassica leafy vegetable crop

groupings. All samples were analyzed

for by the total residue method (AG671A) to determine the combined

residues of acibenzolar-S-methyl and

metabolites which contain the benzo

[1,2,3] thiadiazole-7-carboxylic acid

(BTCA) moiety. In brassica leafy

vegetables, the maximum residues

found on representative commodities

were 0.63 ppm, 0.57 ppm, 0.31 ppm,

0.64 ppm, and 0.80 ppm, for broccoli

(flower, head and stem), cabbage head

(with wrapper leaves), cabbage head

(without wrapper leaves), cabbage

wrapper leaves, and mustard greens

leaves, respectively. A tolerance of 1.0

ppm for the brassica leafy vegetable

crop group has been proposed. This

petition is supported by 14 field trials

conducted on bananas. Banana samples

were analyzed for by the total residue

method REM 17.11 to determine the

combined residues of acibenzolar-Smethyl and metabolites which contain

the benzo [1,2,3] thiadiazole-7-

carboxylic acid (BTCA) moiety. The

maximum residue found in bananas was

0.08 ppm. A tolerance of 0.1 ppm in

bananas has been proposed.

B. Toxicological Profile

1. Acute toxicity. The risk from acute

dietary exposure to acibenzolar-Smethyl is considered to be very low.

CGA-245704 and the formulated 50 WG

product have low orders of acute

toxicity by the oral, dermal and

inhalation exposure routes. Results from

acute studies all fall within toxicity

rating categories of III or IV. CGA245704 technical has a low order of

acute toxicity, is only slightly irritating

to skin and eyes, but may cause

sensitization by skin contact. An LD50 of

greater than 5,000 milligrams/kilograms

(mg/kg) was observed for the acute oral

toxicity study in rats. The lowest no

observed adverse effect level (NOAEL)

in a short-term exposure scenario,

identified as 50 mg/kg in the rabbit and

rat teratology studies, is 10–fold higher

than the chronic NOAEL. Based on

worst case assumptions, the chronic

exposure assessments (see below) did

not result in any margin of exposure

(MOE) less than 3,330 for even the most

impacted population subgroup. Novartis

believes the MOE is greater than 100 for

any population subgroups; EPA

considers MOEs of 100 or more as

satisfactory. The following are results

from the acute toxicity tests conducted

on the technical material:

i. Rat oral LD50 > 5,000 mg/kg/bwt

male/female (M/F) toxicity Category IV.

ii. Rat dermal LD50 > 2,000 mg/kg/bwt

(M/F) toxicity Category III.

iii. Acute inhalation LC50 > 5,000 mg/

L (M/F) toxicity Category IV.

iv. Rabbit eye irritation: Minimally

irritating—toxicity Category III.

v. Rabbit dermal irritation: Slightly

irritating—toxicity Category IV.

vi. Dermal sensitization: Sensitizer.

2. Genotoxicty. CGA-245704 technical

was not mutagenic or clastogenic and

did not provoke unscheduled DNA

5642 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

synthesis when tested thoroughly in a

battery of standard in vivo, and in vitro

independent assays, using both

eukaryotes and prokaryotes, and with or

without metabolic activation. These

tests are summarized below:

i. Microbial/Microsome Mutagenicity

Assay: Non-mutagenic.

ii. Mammalian Cell Chinese Hampster

Ovary (CHO) Mutagenicity Assay: Nonmutagenic; Non-clastogenic.

iii. Chinese Hampster (CH) Bone

marrow: Non-clastogenic; negative for

chromosome aberrations.

iv. Mouse Micronucleus Test: Nonclastogenic; negative for chromosome

aberrations.

v. DNA Damage and Repair Rat

hepatocyte: Negative.

3. Reproductive and developmental

toxicity. Acibenzolar-S-methyl is not a

teratogenic hazard except at, or close to,

the maximum tolerated dose. In the rat

multigeneration study, CGA-245704

(acibenzolar-S-methyl) technical had no

effect on rat reproductive parameters

including gonadal function, estrus

cycles, mating behavior, conception,

parturition, lactation, weaning, and sex

organ histopathology. At 4,000 ppm,

parental body weights (bwt) were

reduced. This demonstrated by the

results of the following studies:

i. Rat oral teratology—Maternal

NOAEL of 200 mg/kg based on

embryotoxicity and teratogenic effects;

fetal NOAEL of 50 mg/kg.

ii. Rabbit oral teratology study—

Maternal NOAEL of 50 mg/kg based on

maternal toxicity and slightly delayed

ossification; fetal NOAEL of 300 mg/kg

based on changes in bwt.

iii. Rat 2-generation reproduction

study—NOAEL of 25 mg/kg based on

weight development in adults at 4,000

ppm and pups during lactation at 2,000

ppm and above. No adverse effects on

reproduction or fertility.

4. Subchronic toxicity. No signs of

neurotoxicity were noted with CGA245704 in both acute and subchronic

studies even at the highest dose levels

of 800 mg/kg and 8,000 ppm,

respectively. The evaluated parameters

included functional observation battery,

motor activity measurement and

neurohistopathologic assessment. These

tests are summarized below:

i. Rat 28-day dermal study—NOAEL

of 1,000 mg/kg/day.

ii. Dog 90-day feeding study—NOAEL

of 10 mg based on reduced bwt gain at

50 mg/kg/day.

iii. Mouse 90-day feeding—NOAEL of

< 30 mg/kg based on reduced bwt

development at 1,000 ppm and above.

iv. Rat 90-day feeding study—NOAEL

of 25 mg/kg based on inappetence and

reduced bwt development at higher

dose levels (4,000, and 8,000 ppm).

5. Chronic toxicity. Based on the

available chronic toxicity data, Novartis

Crop Protection, Inc. believes the

Reference Dose (RfD) for acibenzolar-Smethyl is 0.05 mg/kg/day. AcibenzolarS-methyl is not oncogenic in rats or

mice and is not likely to be carcinogenic

in humans. No carcinogenic activity was

detected in mice and rats at the

Maximum Tolerated Dose (MTD). There

was no evidence of carcinogenicity in

an 18-month feeding study in mice and

a 24-month feeding study in rats. Dosage

levels in both the mouse and the rat

studies were adequate for identifying a

cancer risk. Novartis believes

acibenzolar-S-methyl should be

classified as a ‘‘Not Likely’’ carcinogen

based on the lack of carcinogenicity in

rats and mice.

6. Animal metabolism. Metabolism

proceeded primarily via hydrolysis to

form the corresponding carboxylic acid

(BTCA) which was subsequently

conjugated with several amino acids

including glycine, lysine and ornithine.

Elimination was rapid in all cases.

Oxidation of the aromatic ring of the

acid was a very minor pathway

observed in goats. The metabolic fate of

CGA-245704 in plants paralleled that

observed in animals. The major

metabolite in all test systems was the

same hydrolysis product BTCA. Thus,

the metabolism profile supports the use

of an analytical enforcement method

that accounts principally for parent and

BTCA.

7. Metabolite toxicology. In short-term

toxicity studies in rats, CGA-210007 was

found to be of, at most, equal or less

toxicity than the parent compound. As

with parent CGA-245704, the

subchronic NOAEL for CGA-210007 was

100 mg/kg bwt.

8. Endocrine disruption. AcibenzolarS-methyl does not belong to a class of

chemicals known or suspected of having

adverse effects on the endocrine system.

Developmental toxicity studies in rats

and rabbits and a reproduction study in

rats gave no indication that acibenzolarS-methyl might have any effects on

endocrine function related to

development and reproduction.

Acibenzolar-S-methyl is not a

teratogenic hazard except at, or close to,

the maximum tolerated dose. The

chronic studies also showed no

evidence of a long-term effect related to

the endocrine system.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For the

purposes of assessing the potential

dietary exposure under the proposed

tolerances, Novartis has estimated

aggregate from the previously requested

tolerances for the raw agricultural

commodities: leafy vegetables

(excluding spinach) at 0.25 ppm;

spinach at 1.0 ppm; and fruiting

vegetables at 1.0 ppm (PP 8F4974); and

the requested tolerances for brassica

leafy vegetables at 1.0 ppm and bananas

at 0.1 ppm (PP 9F6004). Maximum

expected chronic exposure to CGA245704 in the diets of the most sensitive

sub-population, children (1–6 years),

was calculated to be 0.5% of the RfD.

For the U.S. population (48 contiguous

States) chronic exposure was 0.3% of

the RfD. Acute dietary exposure is also

minimal. Exposure to the most sensitive

sub-population, children (1–6 years),

was 2.17% of the acute RfD (aRfD).

Acute exposure to the U.S. population

was 1.2% of the aRfD. Dietary exposure

analyses for CGA-245704 (and CGA210007) were conducted using

anticipated residues generated from

field trials conducted at the maximum

use rate and minimum pre-harvest

interval (PHI). In addition, actual

dietary exposure would be much less

than the estimates made herein since

significant residue reduction often takes

place in commerce and during food

preparation and cooking. Projected

market share was included on all

commodities except bananas. One

hundred percent market share was

assumed for bananas. These results

(minimal exposure) show more than a

reasonable certainty of no harm.

ii. Drinking water. The potential for

exposure to CGA-245704 through

drinking water (surface or ground water)

is slight due to the minimal level of this

chemical anticipated to reach these

bodies of water. This expectation is

based on the rapid degradation of CGA245704 and the recommended low use

rates that will further restrict the

amount of chemical available for

leaching or run-off. A Maximum

Contaminant Level Goal (MCLG) of 350

parts per billion (ppb) has been

calculated for CGA-245704. This

calculated safe exposure value is

substantially above the levels that are

likely to be found in the environment

under proposed conditions of use.

2. Non-dietary exposure. Novartis

believes that the potential for nonoccupational exposure to the general

public is unlikely except for potential

residues in food crops discussed above.

The proposed uses for acibenzolar-Smethyl are for agricultural crops and the

product is not used residentially in or

around the home.

D. Cumulative Effects

Consideration of a common

mechanism of toxicity is not appropriate

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5643

at this time since there is no information

to indicate that toxic effects produced

by acibenzolar-S-methyl would be

cumulative with those of any other

chemicals. Acibenzolar-S-methyl is a

plant activator and no other compounds

in this class are registered in the United

States. Consequently, Novartis is

considering only the potential exposure

to acibenzolar-S-methyl in its aggregate

risk assessment.

E. Safety Determination

1. U.S. population. For the U.S.

population (48 contiguous States)

chronic exposure was 0.3% of the RfD.

Acute dietary exposure is also minimal.

Acute exposure to the U.S. population

was 1.2% of the aRfD. EPA usually has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Novartis concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to acibenzolar-S-methyl

residues.

2. Infants and children.

Embryotoxicity and fetotoxicity were

apparent at maternally toxic doses of

CGA-245704 technical in rats and

rabbits. The lowest NOAEL for this

effect was established in the 2-

generation reproduction study at 25 mg/

kg (200 ppm).

Maximum expected chronic exposure

to CGA-245704 in the diets of the most

sensitive sub-population, children (1–6

years), was calculated to be 0.5% of the

RfD. Acute dietary exposure is also

minimal. Exposure to the most sensitive

sub-population, children (1–6 years),

was 2.17% of the aRfD.

Additionally, CGA-245704 is not a

reproductive toxin. Some signs of

teratogenicity were found at, or close to,

maternally toxic doses. No neurotoxic

effects or oncogenic activity has been

observed with CGA-245704. From these

available toxicology data, no special

susceptibility of infants or children is

anticipated.

Dietary exposure analyses for CGA245704 (and CGA-210007) were

conducted using anticipated residues

generated from field trials conducted at

the maximum use rate and minimum

pre-harvest interval (PHI). In addition,

actual dietary exposure would be much

less than the estimates made herein

since significant residue reduction often

takes place in commerce and during

food preparation and cooking. Projected

market share was included on all

commodities except bananas. One

hundred percent market share was

assumed for bananas. These results

(minimal exposure) show more than a

reasonable certainty of no harm.

Acute Dietary Exposure for the U.S.

Population and the Most Sensitive

Population Sub-Groups at the

99.9th Percentile

Population Sub-group % aRfD

(Diet Only)

U.S. Population - 48 contiguous states - all seasons.1.20%

All infants (<1 year) .................. 1.54%

Nursing infants (<1year) ........... 0.41%

Non-nursing infants (<1 year) .. 1.80%

Children (1–6 years) ................ 2.17%

Children (7–12) ........................ 1.37%

Exposure to residues of CGA-245704

and CGA-210007 in consumed food is

minimal. Both chronic and acute

exposure estimates demonstrate the use

of CGA-245704 on crops results in more

than a reasonable certainty of no harm.

The results herein are conservative

since field trial residues utilized in

these assessments were generated under

maximum label use rates and minimum

pre-harvest intervals.

F. International Tolerances

Codex maximum residue levels

(MRLs) have not been established for

residues of CGA-245704 in or on raw

agricultural commodities from the

fruiting vegetable and leafy vegetable

crop groups. Maximum residue levels of

0.1 ppm have been established for CGA245704 on wheat in Switzerland and

Hungary. Proposed CODEX MRLs of 1.0

ppm on tomatoes and 0.1 ppm on

bananas, cereals, wheat, spring barley,

and rice have been proposed (Japan).

[FR Doc. 00–2484 Filed 2–3–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6533–5]

The QTRACER Program for TracerBreakthrough Curve Analysis for Karst

and Fractured-Rock Aquifers; and A

Lexicon of Cave and Karst

Terminology with Special Reference to

Environmental Karst Hydrology

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of two

final documents and CD–ROM.

SUMMARY: The U.S. Environmental

Protection Agency (EPA) announces the

availability of two final documents, The

QTRACER Program for TracerBreakthrough Curve Analysis for Karst

and Fractured-Rock Aquifers (EPA/600/

R–98/156a, February 1999) and CD–

ROM (EPA/600/R–98/156b, February

1999), and A Lexicon of Cave and Karst

Terminology with Special Reference to

Environmental Karst Hydrology (EPA/

600/R–99/006, January 1999), prepared

by the National Center for

Environmental Assessment—

Washington Office (NCEA–W), within

the Office of Research and

Development.

The QTRACER program was

developed to provide a fast and easy

method for evaluating tracerbreakthrough curves generated from

tracing studies conducted in karst and

fractured-rock aquifers. The results may

then be applied in solute-transport

modeling and risk assessment studies.

The QTRACER document will serve as

a technical guide to various groups who

must address potential and/or existing

ground-water contamination problems

in karst and fractured-rock terranes.

Tracing studies are always appropriate

and probably necessary, but analyses

can be difficult and tedious. This

document and associated computer

programs alleviate some of these

problems.

A Lexicon of Cave and Karst

Terminology with Special Reference to

Environmental Karst Hydrology was

prepared to satisfy the need to

understand the terminology common to

the field of karst. This document is a

glossary of most terms that have some

relationship to the field of

environmental karst, as well as specific

karst terms. It includes many foreign

terms because much karst research is

conducted in foreign countries and

published using local terminology. In

many instances common environmental

terms are defined in such a way as to

specifically reference karstic

phenomena. This document will serve

as a technical guide for those who must

read the karst literature or hold

discussion with karst researchers. It is

intended to remove much of the

confusion surrounding many karst

terms.

ADDRESSES: These documents are being

made available electronically from the

NCEA web site at http://www.epa.gov/

ncea. A limited number of copies of the

printed and CD–ROM version of the

QTRACER document is available from

EPA’s National Service Center for

Environmental Publications (NSCEP) in

Cincinnati, Ohio (telephone: 1–800–

490–9198, or 513–489–8190; facsimile

513–489–8695). Please provide the title

and EPA number when ordering from

NSCEP. Paper copies of both documents

also may be purchased from the

National Technical Information Service