15686 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

containing the active ingredient (methyl

(E)-2-[2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl]-3-methoxyacrylate at 50

percent, an active ingredient not

included in any previously registered

product.

The application was approved on

February 7, 1997, as Heritage Fungicide

for use to control certain diseases on

commercial turf (EPA Registration

Number 10182–408).

A conditional registration may be

granted under section 3(c)(7)(C) of

FIFRA for a new active ingredient where

certain data are lacking, on condition

that such data are received by the end

of the conditional registration period

and do not meet or exceed the risk

criteria set forth in 40 CFR 154.7; that

use of the pesticide during the

conditional registration period will not

cause unreasonable adverse effects; and

that use of the pesticide is in the public

interest.

The Agency has considered the

available data on the risks associated

with the proposed use of Azoxystrobin

(methyl (E)-2-[2-[6-(2-

cyanophenoxy)pyrimidin-4-

yloxy]phenyl]-3-methoxyacrylate, and

information on social, economic, and

environmental benefits to be derived

from such use. Specifically, the Agency

has considered the nature and its

pattern of use, application methods and

rates, and level and extent of potential

exposure. Based on these reviews, the

Agency was able to make basic health

and safety determinations which show

that use of Azoxystrobin (methyl (E)-2-

[2-[6-(2-cyanophenoxy)pyrimidin-4-

yloxy]phenyl]-3-methoxyacrylate during

the period of conditional registration

will not cause any unreasonable adverse

effect on the environment, and that use

of the pesticide is, in the public interest.

This product is conditionally

registered in accordance with FIFRA

section 3(c)(7)(C). If the conditions are

not complied with the registration will

be subject to cancellation in accordance

with FIFRA section 6(e).

Consistent with section 3(c)(7)(C), the

Agency has determined that this

conditional registration is in the public

interest. Use of the pesticides are of

significance to the user community, and

appropriate labeling, use directions, and

other measures have been taken to

ensure that use of the pesticides will not

result in unreasonable adverse effects to

man and the environment.

More detailed information on this

conditional registration is contained in

an EPA Pesticide Fact Sheet on

Azoxystrobin (methyl (E)-2-[2-[6-(2-

cyanophenoxy)pyrimidin-4-

yloxy]phenyl]-3-methoxyacrylate.

A copy of this fact sheet, which

provides a summary description of the

chemical, use patterns and

formulations, science findings, and the

Agency’s regulatory position and

rationale, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

In accordance with section 3(c)(2) of

FIFRA, a copy of the approved label, the

list of data references, the data and other

scientific information used to support

registration, except for material

specifically protected by section 10 of

FIFRA, are available for public

inspection in the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Rm. 1132, CM #2,

Arlington, VA 22202 (703–305–5805).

Requests for data must be made in

accordance with the provisions of the

Freedom of Information Act and must

be addressed to the Freedom of

Information Office (A-101), 401 M St.,

SW., Washington, D.C. 20460. Such

requests should: (1) Identify the product

name and registration number and (2)

specify the data or information desired.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.

Dated: March 24, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–8385 Filed 4–1–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–725; FRL–5594–8]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

agricultural commodities.

DATES: Comments, identified by the

docket control number PF–725, must be

received on or before May 2, 1997.

ADDRESSES: By mail submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Divison (7505C), Office of

Pesticides 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.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

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: Linda Hollis, Product Manager

(PM) 90, Biopesticides and Pollution

Prevention Division, (7501W), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Rm. 5th floor,

CS1, 2800 Crystal Drive, Arlington, VA.

22202, (703) 308–8733; e-mail:

hollis.linda@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various raw agricultural commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

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

these petitions contain 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 grantinig of

the petition. Additional data may be

needed before EPA rules on the petition.

The official record for this notice, as

well as the public version, has been

established for this notice of filing

under docket control number PF–725

(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
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices 15687

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

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

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. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number (PF–725) and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

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

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: March 24, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Below summaries of the pesticide

petitions are printed. The summaries of

the petitions were prepared by the

petitioners. 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.

1. AgriPhi Inc.

OPP–300357

EPA issued a notice OPP–300357,

(FRL–4906–6), which was published in

the Federal Register of September 7,

1994 (59 FR 46247–46248), announcing

the establishment of a temporary

tolerance exemption for residues of the

microbial pesticide bacteriophages

isolated from Xanthomonas campestris

subsp. vesicatoria in or on the raw

agricultural commodities, tomatoes and

peppers. EPA has received a pesticide

petition from AgriPhi Inc., which

proposes, pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), as recently amended by the

Food Quality Protection Act, 21 U.S.C.

section 346a, to amend 40 CFR part 180

to reestablish a temporary exemption

from the requirement of a tolerance for

residues of the plant pesticide

Xanthomonas campestris pv. vesicatoria

in or on the raw agricultural

commodities, tomatoes and peppers.

A. Proposed Use Practices

Recommended application method

and rate(s), frequency of application,

and timing of application. AgriPhi Inc.,

proposes to conduct testing of 120

gallons of bacteriophages isolated from

Xanthomonas campestris pv.

vesicatoria in Brandenton Florida and

Ruskin Florida. Total acreage for both

sites will occupy 25 acres. Tests will be

designed to evaluate the effectiveness of

the active ingredient for use in

controlling bacterial diseases of

tomatoes and peppers conducted all

year long (as needed) for two years.

Growing plants of tomato and pepper

and/or the soil around the growing

plants will be treated with

bacteriophages as a drench, spray or

through chemigation at a concentration

of approximately 10 —8 pfu per ml.

Plants will be given multiple treatments

at preplant and postmergence. Upon

termination of the tests the bactericide

and container will be boiled for 10

minutes and disposed of in accordance

with local state and federal regulations.

B. Product Identity/Chemistry

The product is a colorless to light

brown liquid with no to slight odor. The

liquid is non-corrosive and stable in

aqueous solutions (pH 5 to 9) but

denature by organic solvents. The liquid

has a density of 1.06 g/cc and is stored

stably for >1 year @ 4 degrees C but can

be degraded in four days if maintained

at room temperature.

1. Identity of the pesticide and

corresponding residues. AgriPhi Inc.,

believes that no pesticide residues are

expected.

2. Magnititude of residue anticipated

at the time of harvest and method used

to dermine the residue. AgriPhi Inc.,

believes that little concern exists for any

residues of phages as they are

ubiquitous in nature, found in soil,

water, raw produce, oysters and cheese.

Data from the published scientific

literature indicates that bacteriophages

are harmless to mammals, fish and

wildlife. Additionally, bacteriophages

are completely biodegradable and so

pose not threat to the environment.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. AgriPhi Inc., states that phage

residue at any level will pose no threat

to human health or the environment,

therefore an analytical method for

detecting and measuring residue levels

is not needed.

C. Mammalian Toxicological Profile

AgriPhi Inc., requested data waivers

for Acute Toxicity/Pathogenicity,

Genotoxicity, Reproductive and

Developmental Toxicity, Subchronic

Toxicity and Chronic Toxicity Studies.

These data waivers are supported by

data from the published scientific

literature which indicates that

bacteriophages are specific for their

bacterial host and present no unique

toxicity hazards to humans, fish and

wildlife or to the environment. In

addition to the phages effectiveness

against there has been no evidence to

suggest non-selective infection. Phages

have been documented as being active

against bacteria of many human

diseases. Daily exposure of phages are

evident in the human consumption of

raw produce, cheeses and water without

any adverse health effects. AgriPhi Inc.,

believes that inasmuch as each phage is

specific for its target bacterial plant

pathogen, they are nontoxic for growers

who would be applying page mixtures

to seed, soil or crops.

D. Aggregate Exposure

1. Dietary exposure. a. Food.

AgriPhi Inc., states that humans are

exposed daily to phages in the

consumption of raw produce and

cheeses without any adverse effects or

detriment to the human intestinal

microflora.

b. Drinking water. AgriPhi Inc., states

that phages are naturally occurring in

waters and that there have been no

reports of adverse effects to humans

exposed to municipal waters.

2. Non-dietary exposure (lawn care,

topical insect repellents, etc.). AgriPhi

Inc., states that the use for this pesticide

is agricultural, therefore, non-dietary

exposure pesticide will be minimal to

non-existent.

E. Cumulative Exposure

Exposure through other pesticides

and substances with the common mode

of toxicity as this pesticide. AgriPhi,

Inc., states that bacteriophages are

nontoxic to humans, fish and wildlife,

therefore, cumulative effects with other

pesticides and substances will be

minimal to non-existent.

F. Safety Determination

1. U.S. population. AgriPhi Inc., states

that phages are naturally occurring

entities found in soil, water and some

foods. AgriPhi Inc., believes that

because phages present no unique

toxicity hazard to humans, safety factors

are not appropriate. Phages have been
15688 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

active in the treatment of bacterial

human diseases and have been

consumed by humans without any

detectable or detrimental adverse

human health effects. Therefore,

AgriPhi Inc., believes that there is

reasonable certainty that no harm will

result to the U.S. population in general

from consumption of a bacteriophage.

2. Infants and children. AgriPhi Inc.,

states that data from the published

scientific literature reports that

bacteriophages have been used as a

prophylactic treatment for children

without any harmful effects.

Bacteriophages found in foods are not

likely to occur in different amounts in

foods consumed by children and

infants. Therefore, AgriPhi Inc.,

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

esposure to residues of bacteriophages.

G. Existing Tolerances

A temporary tolerance was granted for

this pesticide in August 1994 and

expired in August 1996.

H. International Tolerance

No known international tolerances

have been granted for this pesticide.

Therefore, based on the completeness

and reliability of the toxicity data from

the published literature and the

conservative exposure assessment,

AgriPhi Inc., concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

residues of the pesticide Bacteriophages

of Xanthomonas campestris pv.

vesicatoria including all anticipated

dietary exposure and all other nonoccupational exposures.

2. Asgrow Seed Company

PP 6E4670

EPA has received a pesticide petition

(PP) 6E4670 from Asgrow Seed

Company. 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 an exemption from the

requirement of a tolerance for the plantpesticide Coat Protein of Cucumber

Mosaic Virus and the genetic materail

necessary for its production in or on all

raw agricultural commodities.

A. Proposed Use Practices

Recommended application method

and rate(s), frequency of application,

and timing of application. Asgrow states

that the plant viral coat protein is

produced within tissues of the

engineered plant and is not to be

applied externally. Appropriate cultural

practices for growing seed with

genetically engineered virus resistance

will be determined by individual

growers, as such practices are for all

other plant varieties. Accordingly, no

special instructions for use will be

necessary.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Asgrow has

determined that the sequence of the

engineered viral coat protein expressed

in transformed plants is identical to a

viral coat protein found in nature.

2. Magnitude of residue anticipated at

the time of harvest and method used to

determine the residue. Asgrow states

that the viral coat protein is expressed

in plant tissues, and therefore, is not a

residue in the same manner as a

pesticide applied externally to growing

crop plants. Asgrow does not expect any

measurable residue of the engineered

viral coat protein to remain on or in

transformed raw agricultural

commodities (RACs).

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. The ELISA (Enzyme-Linked

Immunoabsorbent Assay) test can be

used to determine expression levels of

viral coat proteins in transformed

plants, fruits and leaves. However,

because the Agency proposes to exempt

all plant virus coat proteins from the

requirement of a tolerance, Asgrow

believes that an analytical method for

detecting and measuring the levels of

viral coat proteins in or on all RACs is

not required for enforcement purposes.

C. Mammalian Toxicological Profile

Viral Coat Proteins are substances that

viruses produce during a plant infection

to encapsulate and protect their genetic

material. When the genetic material

encoding the coat proeitn for a plant

virus is introduced into a plant’s

genome, the plant is able to resist

subsequent infections by that same virus

as will as strains closely related to the

donor virus. Virus-infected plants

currently are and ahve always been a

part of both the human and domestic

animal food supply, and Asgrow agrees

with EPA’s finding that plant viruses are

not known to be harmful to humans (59

FR 60519-60535, November 23, 1994).

All available data from the scientific

literature indicates that plant viruses are

not toxic to humans or other vertebrates.

Additionally, plant viruses are unable to

replicate in mammals or other

veterbrates, eliminating the possibility

of human infection. This has been

shown by injections of purified whole

virus into laboratory animals to develop

antibodies for ELISA tests.

More importantly, however, this

tolerance exemption will apply to that

portion of the viral genome coding for

the whole coat protein and any

subcomponent of the coat protein

expressed in the plant. This component

alone is incapable of forming infectious

particles. Because whole intact plant

viruses are not known to cause

deleterious human health effects,

Asgrow believes that it is reasonable to

assume that a subunit of these viruses

likewise will not cause adverse human

health effects.

D. Aggregate Exposure

1. Dietary exposure. a. Food. Asgrow

believes that the use of viral coat

protein-mediated resistance will not

result in any new dietary exposure to

plant viruses. Entire infectious particles

of Cucumber Mosaic Virus, including

the coat protein component, are found

in the fruit, leaves and stems of most

plants. Virus-infected food plants are

and have always been a part of the

human and domestic animal food

supply. Such food plants and food

derived from them have been concumed

with no detectable or observed adverse

effects to human health, including

children and infants. Given this

information, Asgrow believes that

exposure via the human diet provides a

direct and better method of establishing

the lack of toxicity versus animal

models of toxicity.

b. Drinking water. No measurable

residues of coat proteins from

engineered plant viruses are expected to

be in the drinking water. Plant viruses

are a natural component of the

environment and are present in soil and

water. Consequently, Asgrow believes

that coat proteins produced as plantpesticides would represent a negligible

addition to those existing in drinking

water.

2. Non-dietary exposure. Asgrow

believes that non-dietary exposure to

engineered coat proteins will be

minimal to non-existent because the

coat protein is expressed only within

the plant tissues.

E. Cumulative Exposure

Exposure through other pesticides

and substances with the common mode

of toxicity as this pesticide. Asgrow

believes that due to the lack of toxicity/

pathogenicity associated with plant

viruses or plant viral coat proteins,

cumulative effects with other pesticides

and substances will be non-existent.
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices 15689

F. Safety Determination

1. U.S. population. There is no known

toxicity associated with coat proteins

from plant viruses. Consequently, a

safety assessment is not needed for

these proteins. Given the long history of

mammalian consumption of the entire

plant virus particle in foods, without

any adverse human health effects,

Asgrow reasonable believes that

consumption of a noninfectious

component of the CMV plant virus is

safe. There are no known data that

indicate aggregate exposure to plant

viral coat proteins under normal

conditions will result in harm to any

person.

2. Infants and children. Viral coat

proteins are ubiquitious in foods,

including those foods consumed by

infants and children. Moreover, there is

no reason to believe that plant viral coat

proteins are likely to occur in different

amounts in foods, consumed by

children and infants. Further, there is

no scientific evidence that viral coat

proteins used as plant-pesticides would

have a different effect on children that

on adults. Viral coat proteins are not

toxic and, therefore, Asgrow believes

with reasonable certainty that no harm

will result to infants and children from

aggregate exposure to coat proteins from

plant viruses.

G. Existing Tolerances

No tolerance or exemption from

tolerance has been previously granted

for CMV coat protein.

H. International Tolerance

No international tolerance or

exemption from tolerance has been

previously granted for CMV coat

protein. Asgrow Seed Company

concludes that plant viruses, including

CMV coat proteins, are not harmful to

humans, and that there is a reasonable

certainty that no harm will result from

aggregate exposure to Coat Protein of

Cucumber Mosaic Virus and the genetic

material necessary for its production,

including all anticipated dietary

exposures and all other nonoccupational exposures. Accordingly,

Asgrow believes that the CMV coat

protein qualifies for an exemption from

the requirement of a tolerance in or on

all raw agricultural commodities.

3. Cornell University

PP 7F4813

EPA has received a pesticide petition

(PP) 7F4813 from Cornell University.

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 an exemption from the

requirement of a tolerance for the plantpesticide Coat Protein of Papaya

Ringspot Virus and the genetic material

necessary for its production in or on all

raw agricultural commodities.

A. Proposed Use Practices

Recommended application method

and rate(s), frequency of application,

and timing of application. Cornell

University states that because the

inserted genes are under the control of

a constitutive promoter, the coat

proteins will be continuously produced

by the plant and not applied externally.

In information accompanying the seeds

that are sold or provided to commercial

growers, the resistance of the resulting

plants to Papaya ringspot Virus will be

described. However, no special

instructions for use will be necessary.

Appropriate cultural practices will be

determined by individual growers, as

they are for all other plant varieties.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Cornell

University states that the pesticide is a

chimeric virus coat protein that is

produced by the transgenic papaya. The

coat protein that is produced consist of

16 amino acids from the cucumber

mosaic virus coat protein and the coat

protein of papaya ringspot virus which

consist of 289 amino acids. The

molecular weight of the chimeric coat

protein is 34,511.

2. Magnitude of residue anticipated at

the time of harvest and method used to

determine the residue. Cornell

University states that the viral coat

protein is expressed in plant tissues,

and therefore, is not a residue in the

same manner as a pesticide applied

externally to growing crop plants.

Cornell University does not expect any

measurable residue of the engineered

viral coat protein to remain on or in

transformed raw agricultural

commodities (RACs).

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. The ELISA (Enzyme-Linked

Immunoabsorbent Assay) test can be

used to determine expression levels of

viral coat proteins in transformed

plants, fruits and leaves. However,

because the Agency proposes to exempt

all plant virus coat proteins from the

requirement of a tolerance, Cornell

University believes that an analytical

method for detecting and measuring the

levels of viral coat proteins in or on all

RACs is not required for enforcement

purposes.

C. Mammalian Toxicological Profile

Viral Coat Proteins are substances that

viruses produce during a plant infection

to encapsulate and protect their genetic

material. When the genetic material

encoding the coat protein for a plant

virus is introduced into a plant’s

genome, the plant is able to resist

subsequent infections by that same virus

as will as strains closely related to the

donor virus. Virus-infected plants

currently are and have always been a

part of both the human and domestic

animal food supply, and Cornell

University agrees with EPA’s finding

that plant viruses are not known to be

harmful to humans (59 FR 60519–

60535, November 23, 1994). All

available data from the scientific

literature indicates that plant viruses are

not toxic to humans or other vertebrates.

Additionally, plant viruses are unable to

replicate in mammals or other

veterbrates, eliminating the possibility

of human infection. This has been

shown by injections of purified whole

virus into laboratory animals to develop

antibodies for ELISA tests.

More importantly, however, this

tolerance exemption will apply to that

portion of the viral genome coding for

the whole coat protein and any

subcomponent of the coat protein

expressed in the plant. This component

alone is incapable of forming infectious

particles. Because whole intact plant

viruses are not known to cause

deleterious human health effects,

Cornell University believes that it is

reasonable to assume that a subunit of

these viruses likewise will not cause

adverse human health effects.

D. Aggregate Exposure

1. Dietary exposure. a. Food. Cornell

University believes that the use of viral

coat protein-mediated resistance will

not result in any new dietary exposure

to plant viruses. Entire infectious

particles of Papaya Ringspot Virus,

including the coat protein component,

are found in the fruit, leaves and stems

of most plants. Virus-infected food

plants are and have always been a part

of the human and domestic animal food

supply. Such food plants and food

derived from them have been consumed

with no detectable or observed adverse

effects to human health, including

children and infants. Given this

information, Cornell Unversity believes

that exposure via the human diet

provides a direct and better method of

establishing the lack of toxicity versus

animal models of toxicity.

b. Drinking water. No measurable

residues of coat proteins from

engineered plant viruses are expected to
15690 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

be in the drinking water. Plant viruses

are a natural component of the

environment and are present in soil and

water. Consequently, Cornell University

believes that coat proteins produced as

plant-pesticides would represent a

negligible addition to those existing in

drinking water.

2. Non-dietary exposure. Cornell

University believes that non-dietary

exposure to engineered coat proteins

will be minimal to non-existent because

the coat protein is expressed only

within the plant tissues.

E. Cumulative Exposure

Exposure through other pesticides

and substances with the common mode

of toxicity as this pesticide. Cornell

University believes that due to the lack

of toxicity/pathogenicity associated

with plant viruses or plant viral coat

proteins, cumulative effects with other

pesticides and substances will be nonexistent.

F. Safety Determination

1. U.S. population. There is no known

toxicity associated with coat proteins

from plant viruses. Consequently, a

safety assessment is not needed for

these proteins. Given the long history of

mammalian consumption of the entire

plant virus particle in foods, without

any adverse human health effects,

Cornell University reasonably believes

that consumption of a noninfectious

component of the PRV plant virus is

safe. There are no known data that

indicate aggregate exposure to plant

viral coat proteins under normal

conditions will result in harm to any

person.

2. Infants and children. Viral coat

proteins are ubiquitious in foods,

including those foods consumed by

infants and children. Moreover, there is

not reason to believe that plant viral

coat proteins are likely to occur in

different amounts in foods, consumed

by children and infants. Further, there

is no scientific evidence that viral coat

proteins used as plant-pesticides would

have a different effect on children that

on adults. Viral coat proteins are not

toxic and, therefore, Cornell University

believes with reasonable certainty that

no harm will result to infants and

children from aggregate exposure to coat

proteins from plant viruses.

G. Existing Tolerances

No tolerance or exemption from

tolerance has been previously granted

for PRV coat protein.

H. International Tolerance

International tolerance levels for

Papaya Ringspot Virus Coat Protein

have not been determined. However,

papaya fruit from trees infected with

papaya ringspot virus are consumed by

numerous people throughout the world.

Cornell University concludes that

plant viruses, including PRV coat

proteins, are not harmful to humans,

and that there is a reasonable certainty

that no harm will result from aggregate

exposure to Coat Protein of Papaya

Ringspot Virus and the genetic material

necessary for its production, including

all anticipated dietary exposures and all

other non-occupational exposures.

Accordingly, Cornell University

believes that the PRV coat protein

qualifies for an exemption from the

requirement of a tolerance in or on all

raw agricultural commodities.

[FR Doc. 97–8396 Filed 4–1–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–723; FRL–5593–9]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

agricultural commodities.

DATES: Comments, identified by the

docket control number PF–723, must be

received on or before May 2, 1997.

ADDRESSES: By mail submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Divison (7505C), Office of

Pesticides 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.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

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: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Connie Welch (PM 21) .. Rm. 227, CM #2, 703–305–6226, e-mail:welch.connie@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

Cynthia Giles-Parker

(PM 22).

Rm. 229, CM #2, 703–305–5540, e-mail: giles-parker.cynthia@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various raw agricultural commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

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

these petitions contain 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 grantinig of

the petition. Additional data may be

needed before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number PF–723

(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 official