7778 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

‘‘ADDRESSES’’ at the beginning of this

document.

Written comments filed pursuant to

this notice, will be available in the

Public Response and Program Resources

Branch, Field Operations Division at the

address provided from 8:30 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays. It is suggested that

persons interested in reviewing the

application file, telephone this office at

(703–305–5805), to ensure that the file

is available on the date of intended visit.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.

Dated: February 6, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–4195 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–714; FRL–5589–4]

Abbott Laboratories; 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 biochemical pesticide

aminoethoxyvinylglycine in or on

apples and pears. This notice includes

a summary of the petition that was

prepared by the petitioner, Abbott

Laboratories.

DATES: Comments, identified by the

docket control number [PF–714], must

be received on or before March 24, 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, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA.

Comments and data may also be

submitted electronically by sending

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

submitting disks. 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 docket control

number [PF–714]. 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.

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 rulemaking record, which will

also include all comments submitted

directly in writing.

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

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

No CBI should be submitted through email. 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.

FOR FURTHER INFORMATION CONTACT:

Denise Greenway, Regulatory Action

Leader, Biopesticides and Pollution

Prevention Division (7501W),

Environmental Protection Agency,

Washington, DC 20460, Office location,

telephone number, and e-mail address:

Crystal Station I, 2800 Crystal Dr.,

Arlington, VA 22202. (703) 308–8263; email:

greenway.denise@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP–

6F4632) from Abbott Laboratories, 1401

Sheridan Road, North Chicago, IL

60064–4000. 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 to establish tolerances for residues

of the biochemical pesticide

aminoethoxyvinylglycine (AVG) in or

on apples and pears at 0.08 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 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. The proposed

analytical method is high pressure

liquid chromatography (HPLC).

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (FQPA)

(Pub. L. 104–170), Abbott Laboratories

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 Abbott Laboratories; 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. Abbott Laboratories’ Petition

Summary

A. Residue Chemistry

1. Plant metabolism. AVG signifies

the active ingredient L-alpha-(2-

aminoethoxyvinyl)glycine

hydrochloride in its pure form. An

alternative nomenclature for AVG is [S]-

trans-2-amino-4-[2-aminoethoxy]-3-

butanoic acid hydrochloride. N-acetyl

AVG is the primary metabolite of AVG

in apples.

2. Analytical method. Abbott

Laboratories has determined that

residues of AVG are not expected in/on

apples and pears at detectable levels

when orchards are treated at the label

use rate and pre-harvest interval. The

Limit of Quantitation (LOQ) is 0.075

ppm and the Limit of Detection (LOD)

is 0.03 ppm by HPLC analysis. There is

no concentrating of residues in the

processed commodities (i.e., apple juice

or wet apple pomace).

3. Magnitude of the residue. In the

magnitude of the residue study in

apples, the maximum residue at day 0

following treatment at the label use rate

was 0.131 ppm. By day 21, there were

no quantifiable residues present. The

exposure assessments (below) indicate

that there will be large margins of

exposure (MOEs) from aggregate

exposure to AVG. The proposed HPLC

method used is deemed adequate by

Abbott Laboratories to measure residues

and the company argues that no

additional analytical method for

detecting and measuring residue levels

is needed.

B. Toxicological Profile

1. Acute toxicity. The acute

mammalian toxicological data

considered in this proposed tolerance

for AVG include: an acute oral toxicity

study in rats, an acute dermal toxicity

study in rabbits, an acute inhalation

toxicity study in rats, a primary eye

irritation study in rabbits, a dermal

irritation study in rabbits, and a dermal

sensitization study in guinea pigs.

The results of these studies indicate

that AVG has an acute oral LD50 of 6,400
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices 7779

milligrams active ingredient per

kilogram of body weight (mg a.i./kg bwt)

in rats, an acute dermal LD50 greater

than 2,000 mg a.i./kg bwt in rabbits, an

acute inhalation LD50 of 1,130 mg/m3 in

rats, causes slight eye and dermal

irritation in rabbits, and is not a dermal

sensitizer in guinea pigs.

2. Genotoxicity. Abbott Laboratories

concludes that AVG was not mutagenic

in an Ames Salmonella gene mutation

assay with or without metabolic

activation. The company maintains that

there was no mutagenic activity

associated with AVG in cultures of

mouse lymphoma cells (L5178Y tk ±)

with or without metabolic activation. In

a rat bone marrow cell micronucleus

test in vivo, Abbott Laboratories reports

that there was no indication that AVG

was genotoxic.

3. Developmental toxicity. In a

developmental toxicity study in rats by

oral gavage, a no observable effect level

(NOEL) of 1.77 mg a.i./kg bwt/day was

determined for both developmental and

maternal toxicity.

4. Subchronic toxicity. A Reference

Dose (RfD) of 0.002 mg a.i./kg bwt/day

was derived from a 90–day feeding

study in rats in which there was

decreased food consumption, body

weight and food efficiency (body-weight

gain/food consumption), and fatty

changes in kidney and liver at dosage

levels of 9 mg a.i./kg bwt/day or higher.

The NOEL in this study was 2.2 mg a.i./

kg bwt/day.

In a 21–day dermal toxicity study in

rats, the NOEL was greater than 1,000

mg a.i./kg/day.

In a 28–day dietary immunotoxicity

study in rats with a NOEL of 5 mg a.i./

kg/day, decreases in several immune

response parameters are considered

secondary to the decreased food

consumption, body weight, and food

efficiency in the treated rats.

5. Reproductive toxicity; chronic

toxicity; animal metabolism; metabolite

toxicity. AVG is classified as a

biochemical due to its proposed use

pattern, its low use rate, and its natural

occurrence. Due to the nature of this

biochemical pesticide, the requirements

for reproductive and chronic toxicity

studies as well as animal metabolism

and metabolite toxicity have not been

triggered in the Tier Toxicity Testing

approach.

C. Aggregate Exposure

Dietary exposure—food and drinking

water/non-dietary exposure. Expected

dietary exposures from residues of AVG

would occur through apples, pears, and

processed apples and pears. Spray drift

may lead to exposure to residues in

drinking water. There are no proposed

home and garden uses for AVG. AVG is

used in a commercial floral

preservative. There is no exposure to

infants and children through this floral

preservative. The only potential

exposure from this floral preservative

would be dermal exposure.

For estimations of maximum

anticipated residues, non-detectable

residues were assigned a value one half

of the LOD. For the two instances in

which residues were detectable on one

of the replicates, the full LOD was used.

The maximum anticipated residues of

AVG were calculated to be 0.018 ppm

in the apple raw agricultural

commodity.

The processed commodities examined

were apple juice and wet apple pomace.

Processing factors were calculated from

apples without washing prior to

processing to provide the highest

possible estimate of anticipated residues

in the juice and pomace. The mean

apple juice processing factor was

determined to be 0.8; for wet apple

pomace the processing factor was 0.9.

A chronic dietary exposure analysis

was conducted for AVG using the

anticipated residues in apples for both

apples and pears. Residues were rarely

detected in field trials conducted at the

maximum rate and minimum interval

between application and harvest. The

anticipated residue of 0.018 ppm

represents about half of the LOD.

Low residues are expected in wet

apple pomace, so finite residues of AVG

are not expected in meat and milk;

therefore, these foods were not included

in the exposure analysis.

Tap water, non-tap water, and water

in commercially prepared food were

also included in the analysis. Residue

levels in water were assumed to be

0.0012 ppm. This was based upon

calculations for airblast application of

AVG onto late season trees. It is

estimated that a negligible amount of

the applied dose could drift into nearby

drinking water sources. The following

table summarizes the results from the

chronic aggregate exposure analysis

based upon anticipated residues for the

overall U.S. population and the five

most highly exposed population

subgroups. The exposure estimate was

compared against the RfD of 0.002 mg

a.i./kg bwt/day:

Population subgroup Exposure mg

a.i./kg bwt

Percent

of

RfD

U.S. Population ......... 0.000055 ....... 2.5

All Infants .................. 0.000206 ....... 10.3

Non-nursing Infants <

1 yr.

0.000258 ....... 12.9

Children 1–6 yrs ....... 0.000099 ....... 5.0

Population subgroup Exposure mg

a.i./kg bwt

Percent

of

RfD

Children 7–12 yrs ..... 0.000077 ....... 3.8

Females 13–50 yrs ... 0.000040 ....... 2.0

As seen in the above table, even for

the most highly exposed population

subgroup, less than 13% of the RfD was

used.

Chronic aggregate exposure to AVG

also was estimated using proposed

tolerance-level residues. Exposure was

estimated using the same consumption

data that were used for the anticipated

residue exposure calculation.

The following table summarizes

results of the chronic exposure analyses

using proposed tolerances for the

overall U.S. population and the five

most highly exposed population

subgroups.

Population subgroup Exposure mg

a.i./kg bwt

Percent

of

RfD

U.S. Population ......... 0.000111 ....... 5.6

All Infants .................. 0.000538 ....... 26.9

Non-nursing Infants <

1 yr.

0.000638 ....... 31.9

Children 1–6 yrs ....... 0.000324 ....... 16.2

Children 7–12 yrs ..... 0.000173 ....... 8.7

Females 13+/nursing 0.000133 ....... 6.7

An examination of the summary table

demonstrates that chronic aggregate

exposure represents no more than 32%

of the chronic RfD for any population

subgroup. These calculations were

performed assuming that 100% of the

apple and pear crops in the United

States would contain AVG residues at

tolerance levels. Assuming that 100% of

all apple products consumed would

contain tolerance-level residues is the

worst-case scenario and yields a gross

overestimate of dietary exposure.

An acute exposure analysis based

upon anticipated residues was

conducted using EPA’s Tier 2 method

with anticipated residues. For blended

commodities (e.g., apple juice and pear

nectar), the mean anticipated residue

level was used. For single serving

commodities (e.g., raw apples and

pears), the LOQ of 0.075 ppm was used

as a worst-case estimate of high end

exposure because AVG residues were

not quantifiable in the few samples in

which residues were detected.

A separate exposure analysis was

conducted for infants because baby

foods are blended commodities. For

these analyses, only raw forms of apples

and pears were assumed to be

consumed as single servings containing

the high-end residue value of 0.075
7780 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

ppm. All prepared and processed foods

were assumed to be blended foods

containing the mean anticipated residue

of 0.018 ppm. The following table

summarizes the exposure analysis at the

95th percentile:

Population subgroup Exposure mg

a.i./kg bwt MOE

U.S. Population ........ 0.000276 ...... 6,510

All Infants ................. 0.000598 ...... 3,009

Non-nursing Infants

< 1 yr.

0.000551 ...... 3,269

Children 1–6 yrs ...... 0.000756 ...... 2,381

Children 7–12 yrs .... 0.000448 ...... 4,022

Females 13–50 yrs .. 0.000198 ...... 9,091

The MOE of the most highly exposed

population subgroup, children 1 to 6

years old, is more than 23–fold higher

than a level considered to provide

adequate protection.

The acute exposure summary (below)

in which proposed tolerance-level

residues were used shows that

estimated exposures provide adequate

MOEs, even at the 95th percentile of

exposure. In this analysis, acute

exposure was calculated for the entire

population rather than for consumers

only, a procedure recommended by the

EPA in their proposed method for acute

dietary risk assessment.

Population subgroup Exposure mg

a.i./kg bwt MOE

U.S. Population ........ 0.000406 ...... 4,432

All Infants ................. 0.002188 ...... 823

Non-nursing Infants

< 1 yr.

0.002191 ...... 822

Children 1–6 yrs ...... 0.001384 ...... 1,301

Children 7–12 yrs .... 0.000663 ...... 2,845

Females 13–50 yrs .. 0.000245 ...... 7,336

The most highly exposed population

subgroup, non-nursing infants, has an

estimated MOE of 822, greater than 8–

fold higher than a level considered to

provide adequate protection.

D. Cumulative Effects

AVG is a structurally unique

biochemical pesticide and is a naturally

occurring L-α-amino acid. Its proposed

mode of action for mammalian toxicity

is the inhibition of the enzymeγcystathionase. Other agents which

inhibit this enzyme include naturally

occurring amino acids such as alanine,

cysteine, glutamic acid, and

homoserine. Given the expected

exposure, Abbott Laboratories maintains

that inhibition of this enzyme would not

occur at levels that would pose a human

health risk.

E. Endocrine Effects

Abbott Laboratories reports that there

have been no indications of treatmentrelated effects from AVG to suggest that

the pesticide may have an endocrine

disruption activity.

F. Safety Determination

1. U.S. population. AVG is a naturally

occurring amino acid. Based upon

expected residues in apples, pears, and

water, Abbott Laboratories concludes

that there is a reasonable certainty of no

harm resulting from aggregate exposure

of AVG to the general population.

2. Infants and children. The effects

demonstrated in the developmental and

immune toxicity studies are considered

secondary to the adverse effects upon

body weight gain, food consumption

and food efficiency in the treated rats.

These data indicate to Abbott

Laboratories that AVG is not a

developmental or immunological

toxicant, and that infants and children

are not sensitive subpopulations. The

company concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure of AVG

to infants and children.

G. International Tolerances

There are no Codex maximum residue

levels established for residues of AVG

on apples or pears.

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

Abbott Laboratories concludes that there

is a reasonable certainty that no harm

will result from aggregate exposure to

residues of AVG, including all

anticipated dietary exposure and all

other non-occupational exposures.

II. Public Record

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a notation

indicating the docket control number

[PF–714].

A record has been established for this

notice under docket control number

[PF–714] (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 Room 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 an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, 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 rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

List of Subjects

Environmental protection,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

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

Dated: February 10, 1997.

Janet L. Anderson,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–4114 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–F

[PF-709; FRL–5588–5]

Good Bugs, Inc.; Pesticide Tolerance

Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of a

temporary exemption from the

requirement of the tolerance for residues

of Burkholderia (pseudomonas) cepacia

strain AMMD in or on American

ginseng, carrots, peas, potatoes, snap

beans, supersweet and sweet corn,

tomatoes, and turf in California, Florida,

Illinois, Minnesota, Missouri, Ohio,

Washington, and Wisconsin for the

1997-1999 growing seasons. The

summary of the petition was prepared

by the petitioner, Good Bugs, Inc.

DATES: Comments, identified by the

docket control number [PF-709], must

be received on or before March 24, 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: Crystal Mall #2, Room