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
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices 7781

1132, 1921 Jefferson Davis Highway,

Arlington, VA. Comments and data may

also be submitted electronically by

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 in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by docket control

number [PF-709]. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries.

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). 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 Room 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: Teung F. Chin c/o (PM 90),

Regulatory Action Leader, Biopesticides

and Pollution Prevention Division,

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: 5th Floor, Crystal

Station #1, 2800 Crystal Drive,

Arlington, VA, 703-308-1259, e-mail:

chin.teung@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition [PP–

7G4796] from Good Bugs, Inc., P.O. Box

939, New Glarus, WI 53574, proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act, 21 U.S.C.

346a(d), to amend 40 CFR part 180 by

establishing a temporary exemption

from the requirement of a tolerance for

residues of the microbial pesticide,

Burkholderia (pseudomonas) cepacia

strain AMMD in or on the raw

agricultural commodities American

ginseng, carrots, peas, potatoes, snap

beans, supersweet and sweet corn,

tomatoes, and turf. Pursuant to section

408(d)(2)(A)(i) of the FFDCA, as

amended, Good Bugs Inc. has submitted

the following summary of information,

data, and arguments in support of their

pesticide petition. This summary was

prepared by Good Bugs Inc. and EPA

has not fully evaluated the merits of the

petition. The summary may have been

edited by EPA if the terminology used

was unclear, the summary contained

extraneous material, or the summary

was not clear that it reflected the

conclusion of the petitioner and not

necessarily EPA.

I. Petition Summary

A. Proposed Use Practices

1. Foliar applications of Burkholderia

(pseudomonas) cepacia strain AMMD

for potatoes, carrots, tomatoes, and turf

will be at the rate of 4 oz/acre/

application, 20 applications per acre per

year. In Wisconsin, 20 acres of potatoes

will be treated in 1997, 100 acres in

1998, and 500 acres in 1999; 5 acres of

carrots will be treated in 1997, 10 acres

in 1998, and 10 acres in 1999; 10 acres

of turf will be treated in 1997, 100 acres

in 1998, and 100 acres in 1999. In

Minnesota, 20 acres of turf will be

treated in 1997, 100 acres in 1998, and

100 acres in 1999. In California, 10 acres

of carrots will be treated in 1998 and 10

acres in 1999; 100 acres of potatoes will

be treated in 1998 and 100 acres in

1999; 100 acres of tomatoes will be

treated in 1998 and 100 acres in 1999.

In Ohio, 5 acres of tomatoes will be

treated in 1997, 20 acres in 1998, and 20

acres in 1999; 5 acres of turf will be

treated in 1997, 100 acres in 1998, and

100 acres in 1999. In Florida, 10 acres

of potato will be treated in 1997, 100

acres in 1998, and 100 in 199; 5 acres

of tomatoes will be treated in 1997, 100

acres in 1998, and 100 in 1999; 5 acres

of turf will be treated in 1997, 100 acres

in 1998, and 100 acres in 1999. In

Missouri, 5 acres of turf will be treated

in 1997, 100 acres in 1998, and 500

acres in 1999. For foliar applications on

American ginseng, 4 oz/acre/

application, 12 applications/acre/year

will be applied in Wisconsin on 4,000

acres in 1997, 1998, and 1999.

2. For seed treatment of peas and

sweet corn, the rate of application is 3

oz. per 100 lbs of seed, for snap beans

2 oz. per 100 lbs of seed and for

supersweet corn, 4.5 oz. per 100 lbs of

seed. In Wisconsin, 5 acres of peas will

be treated in 1997, 50 acres in 1998, and

200 acres in 1999; 5 acres of snap beans

will be treated in 1997, 50 acres in 1998,

and 200 acres in 1999; 5 acres of sweet

corn will be treated in 1997, 50 acres in

1998, and 200 acres in 1999; 5 acres of

supersweet corn will be treated in 1997,

50 acres in 1998, and 200 acres in 1999.

In Minnesota, 5 acres of peas will be

treated in 1997, 50 in 1998, and 200 in

1999; 5 acres of snap beans will be

treated in 1997, 50 acres in 1998, and

200 in 1999; 5 acres of sweet corn will

be treated in 1997, 50 acres in 1998, and

200 acres in 1999; 5 acres of supersweet

corn will be treated in 1997, 50 acres in

1998, and 200 acres in 1999. In Illinois,

5 acres of peas will be treated in 1997,

50 acres in 1998, and 200 acres in 199

9; 5 acres of sweet corn will be treated

in 1997, 50 acres in 1998, and 200 acres

in 1999; 5 acres of supersweet corn will

be treated in 1997, 50 acres in 1998, and

200 acres in 1999. In Washington, 5

acres of peas will be treated in 1997, 50

acres in 1998, and 200 acres in 1999.

B. Product Identity/Chemistry

1. Burkholderia (pseudomonas)

cepacia strain AMMD was originally

isolated from the rhizosphere of a pea

plant. The cells of this strain are gram

negative, aerobic, rod shaped and

produce poly-beta-hydroxybutyrate

granules intracellularly. Colonies are

convex and white, but eventually

become crenulated on nutrient broth

yeast extract agar plates. Two colony

morphologies, smooth and rough are

present. Fluorescent pigments are not

produced on King’s Medium B. The

species Burkholderia (pseudomonas)

cepacia was first identified using gas

chromatography fatty acid (GC-FAME)

analysis.

2. Burkholderia (pseudomonas)

cepacia strain AMMD residues are not

anticipated at the time of harvest by

Good Bugs, Inc. Treatment of aerial

plant parts and seeds are the only uses

for this proposed microbial pesticide.

Residues from seed treatments are not

expected as the bacteria does not grow

systemically in the plant. The above

ground parts of potatoes, American

ginseng, and carrots are not eaten. Based

on conducted studies, Good Bugs, Inc.

believes that strain AMMD does not

survive well in the phyllosphere.

Populations were no longer detectable 4

days after spray application to snap

bean leaves and flowers. An

enforcement method for residues is not

needed to protect human health.

3. Good Bugs, Inc. believes that an

analytical method for detecting and

measuring the levels of this microbial

pesticide residue is not needed to

protect human health due to lack of

signficant exposure.

C. Mammalian Toxicological Profile

Good Bugs, Inc. believes that acute

oral limit toxicity testing of

Burkholderia (pseudomonas) cepacia

strain AMMD showed no evidence of

toxicity or pathogenicity in rats dosed
7782 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

once by oral gavage with strain AMMD.

Normal weight gains were observed in

all test animals during the observation

period. No lesions were observed in any

test animal. A waiver for genotoxicity,

reproductive and developmental

toxicity, subchronic toxicity, and

chronic toxicity is requested. This

testing is not generally required for

microbial pesticides and the lack of

toxicity along with the lack of exposure

does not warrant such testing.

D. Aggregate Exposure

1. Dietary exposure. The species

Burkholderia (pseudomonas) cepacia is

a common inhabitant of soils, plant

surfaces, and fresh water. Good Bugs,

Inc. believes that use of this microbial

pesticide as outlined is not expected to

increase dietary exposure via food or

water consumption. Transfer of the

microbial pesticide to drinking water is

unlikely due to the low survivability of

the organism in the environment. Any

low levels of oral exposure that may

occur would not be harmful due to the

lack of mammalian toxicity.

2. Non-dietary exposure of

Burkholderia (pseudomonas) cepacia

strain AMMD. Good Bugs, Inc. believes

that treatment of turf as outlined in the

experimental plan will be on limited

acreage and, due to the low survivability

of the organism, exposure will be

minimal.

3. Worker exposure via dermal

exposure or inhalation. Good Bugs, Inc.

believes that worker exposure will be

minimized by the label requirements of

long-sleeved shirt, long pants, gloves,

and the wearing of a respirator.

E. Cumulative Exposure

Biological control agents of this type

generally work by outcompeting the

disease organisms, therefore, not having

a toxic mode of action that can be

shared. However, other exposure can

occur since another strain of

Burkholderia (pseudomonas) cepacia is

already registered with the Agency.

Good Bugs, Inc. believes that since the

Agency has registered this other strain

and granted an exemption from

tolerance, this added exposure does not

present a hazard to human health in and

of itself and thus does not add to

cumulative exposure.

F. Safety Determination

1. Good Bugs, Inc. believes the safety

of the U.S. population and that of

infants and children will not be

adversely affected by the use of

Burkholderia (pseudomonas) cepacia

strain AMMD. Strain AMMD was

originally isolated from the rhizosphere

of a pea and strains of Burkholderia

(pseudomonas) cepacia are widely

distributed in nature and are readily

isolated from soil, fresh water, and plant

roots and leaves. Strain AMMD does not

survive well in the phyllosphere and

cannot be detected after 4 days.

2. Some strains of Burkholderia

(pseudomonas) cepacia are infectious to

individuals with cystic fibrosis or

compromised immune systems. Some

strains of Burkholderia (pseudomonas)

cepacia can also cause skin infection of

feet known as swamp rot. In addition,

this bacterium has been isolated from

nosocomial sources such as

contaminated indwelling medical

devices and antiseptic solutions. Good

Bugs, Inc. believes that because of the

importance of these clinical strains, it is

critical that Burkholderia

(pseudomonas) cepacia strain AMMD is

distinguished from other strains. Two

recent studies have determined that

plant associated strains are distinct from

clinical isolates. Molecular

phyllogenetic studies based on

deoxyribonucleic acid (DNA)-DNA and

DNA-ribosomal ribonucleic acid (RNA)

hybridization of 150 isolates have

identified 4 genomovars of Burkholderia

(pseudomonas) cepacia. All cystic

fibrosis isolates cluster in genomovar III;

while environmental isolates (including

phytopathogenic type strain) belong to

genomovar I.

G. Existing Tolerances

1. A tolerance exemption for

Burkholderia (pseudomonas) cepacia,

Wisconsin isolate/strain M36 (a.k.a.

Blue Circle Inoculant), was granted in

1992 by EPA.

2. It is not known if any international

tolerance exemptions exist.

II. Public Record

Interested persons are invited to

submit comments on the this notice of

filing. Comments must bear a notation

indicating the docket control number,

[PF-709].

A record has been established for this

notice under docket control number

[PF-709] 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 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

notice.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 6, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–4115 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL FINANCIAL INSTITUTIONS

EXAMINATION COUNCIL

Revised Policy Statement on

‘‘Interagency Coordination of Formal

Corrective Action by the Federal Bank

Regulatory Agencies’’

AGENCY: Federal Financial Institutions

Examination Council.

ACTION: Notice of revised policy

statement.

SUMMARY: The Task Force on

Supervision, acting under delegated

authority from the Federal Financial

Institutions Examination Council

(FFIEC), has revised the policy

statement on ‘‘Interagency Coordination

of Formal Corrective Action by the

Federal Bank Regulatory Agencies’’

dated December 18, 1979, and is

recommending that the FFIEC member

agencies adopt and implement the

updated policy statement. The revised

policy statement entitled ‘‘Interagency

Notification and Coordination of

Enforcement Actions by the Federal

Bank Regulatory Authorities’’ appears

below.