Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices 6777

TABLE 1. — REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS

EPA Reg No. Product Name Active Ingredient Delete From Label

000228–00267 Riverdale MCPA 10E MCPA, isooctyl ester Rice, aquatic food uses, aquatic non-food

uses

000279–01380 Thiodan 50 WP Insecticide Endosulfan Alfalfa (grown for forage), artichokes, barley,

oats, rye, wheat, peas (seed crop only), safflower, sunflower, sugar beets

000279–02149 Methyl Parathion 2 Thiodan 3 EC Endosulfan; Methyl

Parathion

Broccoli, celery, lettuce, potatoes

000279–02306 Endosulfan Technical Insecticide Endosulfan Alfalfa (grown for forage), artichokes, barley,

oats, rye, wheat, peas (seed crop only), safflower, sunflower, sugar beets

000279–02609 Methyl Parathion 1.0 Thiodan 2.0

C.O. EC

Endosulfan; Methyl

Parathion

Artichokes, broccoli, celery, lettuce

000279–02659 Thiodan 2 C.O. EC Insecticide Endosulfan Artichokes, barley oats, rye, wheat, broccoli,

celery, cherries, corn (seed crop only), potatoes, safflower, sunflower, sugar beets,

sweet corn, sweet potatoes

000279–02735 Thiodan Pyrenone C.O. Insecticide Endosulfan; Piperonyl

butoxide; Pyrethrins

Artichokes, celery, cucumbers, melons, pumpkin, summer and winter squash, eggplant,

lettuce, peppers, potatoes, sweet corn; field

tomatoes

000279–02822 Thiodan 2 Pyrenone 0.3–0.03 EC InsecticideEndosulfan; Piperonyl

butoxide; Pyrethrins

Alfalfa (grown for forage), artichokes, barley,

oats, rye, wheat, broccoli, celery, cherries,

corn (seed crop only), cucumbers, melon,

pumpkin, summer & winter squash, eggplant, grapes, lettuce, peas (seed crop

only), peppers, potatoes, safflower, sunflower, sugar beets, sweet corn, field tomatoes

000279–02924 Thiodan 3 EC Insecticide Endosulfan Alfalfa (grown for forage), artichokes, barley,

oats, rye, wheat, peas (seed crop only), safflower, sunflower, sugar beets

000279–03129 Thiodan WSB Insecticide Endosulfan Alfalfa (grown for forage), artichokes, barley,

oats, rye, wheat, peas (seed crop only), safflower, sunflower, sugar beets

The following Table 2 includes the names and addresses of record for all registrants of the products in Table

1, in sequence by EPA company number.

TABLE 2. — REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS

Company No. Company Name and Address

000228 Riverdale Chemical Co., 425 West 194th Street, Glenwood, IL 60425.

000279 FMC Corporation, 1735 Market Street, Philadelphia, PA 19103.

III. Existing Stocks Provisions

The Agency has authorized registrants

to sell or distribute product under the

previously approved labeling for a

period of 18 months after approval of

the revision, unless other restrictions

have been imposed, as in special review

actions.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: February 3, 1997.

James H. Kearns,

Acting Director, Program Management and

Support Division, Office of Pesticide

Programs.

[FR Doc. 97–3515 Filed 2–12–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–710; FRL–5588–9]

Appropriate Technology Limited;

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

regulation for an exemption from the

requirement of a tolerance for residues

of extract from Quercus falcata (red

oak), Rhus aromatic (sumac),

Rhizophora mangle (mangrove), and

Opuntia lindheimeri (prickly pear

cactus) in or on all raw agricultural

commodities. The summary was

prepared by Appropriate Technology

Limited.
6778 Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices

DATES: Comments, identified by the

docket number [PF–710], must be

received on or before, April 14, 1997.

ADDRESSES: By mail, submit written

comments to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St. SW.,

Washington, DC 20460. In person, bring

comments to RM 1132, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted electronically be sending

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

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by docket number

[PF–710]. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries. Additional

information on electronic submissions

can be found below this document.

Information submitted as a 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: Teung F. Chin c/o (PM 90),

Biopesticides and Pollution Prevention

Division, Office of Pesticide Programs,

U.S. Environmental Protection Agency,

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

Office location, telephone number and

e-mail address: 5th floor, CS#1, 2800

Crystal Drive, Arlington, VA 22202,

Telephone No. 703–308–1259, e-mail:

chin.teung@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

8F3635) from Appropriate Technology

Limited, 3601 Garden Brook, Dallas, TX

75234 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

an exemption from the requirement of a

tolerance the residues of Plant Extract

620. Pursuant to section 408(d)(2)(A)(i)

of the FFDCA, as amended, Appropriate

Technology Limited has submitted the

following summary of information, data

and arguments in support of their

pesticide petition. This summary was

prepared by Appropriate Technology

Limited 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 to

clarify that the conclusions and

arguments were the petitioner’s and not

necessarily EPA’s and to remove certain

extraneous material, or the summary

was not clear that it reflected the

conclusion of the petitioner and not

necessarily EPA.

I. Petition Summary

A. Product Identity/Chemistry

Appropriate Technology Limited

states that Plant Extract 620 is an

aqueous extract derived from Quercus

falcata (red oak), Rhus aromatic

(sumac), Rhizophora mangle

(mangrove), and Opuntia lindheimeri

(prickly pear cactus). The resulting

botanical extracts are used in the

preparation of end-use formulations.

Agrispon and Sincocin are waterbased products containing trace

minerals and Plant Extract 620.

Agrispon is a plant growth regulator

that may be applied to turf and

agricultural products to stimulate root

growth and increase a plant’s ability to

withstand pests and environmental

stresses. Sincocin is used to control

plant parasitic nematodes by reducing

the feeding vigor of nematodes.

Studies submitted by Appropriate

Technology Limited show that the

identified active constituents known to

be present in the subject plant extracts

are present naturally in many plants and

would, therefore, be indistinguishable

from existing natural background levels.

This petition proposes an exemption for

the requirement of a tolerance;

therefore, Appropriate Technology

Limited does not believe an analytical

method is necessary to protect the

human health and environment.

B. Proposed Use Practices

Plant extract from Quercus falcata,

Rhus aromatic, Rhizophora mangle, and

Opuntia lindheimeri is the sole active

ingredient in the end-use products

Agrispon and Sincocin. Both products

are mixed with enough water to evenly

cover the desired area at the

recommended rate of application. The

maximum recommended application

rate for any use pattern would not

exceed 60 grams of plant extract/acre/

application; the maximum application

rate for food crops would not exceed 18

grams of plant extract/acre/application.

Agrispon is diluted with water to

evenly cover the desired area at an

application rate of 13 fluid ounces/acre

(oz/acre) for annuals, and greenhouses.

The recommended timing and

frequency of applications depends on

the plant growth cycle length. A single

application is recommended for plants

with a growth cycle of 60 days or less.

A second application, 45 to 60 days

after the first, is recommended for

plants with a growing cycle of 60 to 120

days. For long season plants, or those

having a growing cycle longer than 120

days, Agrispon may be applied every

45 to 60 days during the period when

the plant is growing vigorously.

Agrispon is applied to the soil surface

under trees at a rate of 13 fluid oz/acre,

with an additional 6 fluid oz/acre

applied to the tree canopy. For

evergreens, applications are

recommended every 60 days. Deciduous

trees should first be treated at bud break

or leaf flush in the spring. Subsequent

applications are recommended every 60

days until dormancy occurs.

Sincocin is applied to food crops

and orchards at a rate of 26 fluid

ounces/acre. For both food crops and

orchards, the first application should be

made during initial root flush with

subsequent applications every 60 days

during active growth. The application

rate for turf and ornamentals is 2.75

gallons (87 fluid ounces)/acre. Golf

greens and tee boxes should be treated

every day for root pathogens or every 30

days for nematode control. Golf fairways

should be treated every 30 days.

Ornamentals should first be treated at

root flush, with subsequent applications

every 30 to 60 days during active

growth.

C. Toxicological Profile

Plant Extract 620 is derived from

Quercus falcata (red oak), Rhus

aromatic (sumac), Rhizophora mangle

(mangrove), and Opuntia lindheimeri

(prickly pear cactus). Plant Extract 620

will not itself be offered for sale, but is

used by the manufacturer in formulating

the end-use products Agrispon and

Sincocin . Agrispon and Sincocin

are the only products to which

consumers and the public could be

exposed. The following table

summarizes the toxicological data

Appropriate Technology Limited has

submitted in support of the exemption

from the requirement of a tolerance:
Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices 6779

Study Product Result Toxicity Category

Acute Oral ............................................................................................................. Plant Extract 620 LD50 >5,000 mg/kg IV

Acute Dermal ........................................................................................................ Plant Extract 620 LD50 >5,000 mg/kg IV

Acute Inhalation .................................................................................................... Sincocin LD50 >2.04 mg/l IV

Eye Irritation .......................................................................................................... Plant Extract 620 unwashed eyes: severely irritatingI

........................................................................................................................... washed eyes: moderately irritatingIII

........................................................................................................................... Agrispon unwashed eyes: minimally irritatingIV

........................................................................................................................... Sincocin unwashed eyes: minimally irritatingIV

Dermal Irritation ..................................................................................................... Plant Extract 620 moderately irritating III

Ames Mutagenicity ................................................................................................ Agrispon not mutagenic n/a

........................................................................................................................... Sincocin not mutagenic n/a

Appropriate Technology Limited

states that Agrispon and Sincocin, the

products that will be available for

distribution, are toxicity categories III

and IV for all routes and responses.

Based on the results of the acute

toxicology and mutagenicity data

summarized above, the Agency has

determined that all toxicology data

requirements have been satisfied.

Subchronic, chronic, immune,

endocrine, and non-dietary cumulative

exposure data requirements have been

waived. Appropriate Technology

Limited believes the submitted data are

sufficient to demonstrate that there are

no foreseeable human health hazards

likely to arise from the use of either

Agrispon or Sincocin.

D. Aggregate Exposure

Occupational exposure will be

mitigated through the use of proper

personal protective equipment.

Appropriate Technology Limited

believes the lack of mammalian toxicity

and low active ingredient concentration

of the end-use products illustrate that

health risks resulting from inhalation

and dermal exposure of applicators and

other handlers is negligible.

Appropriate Technology Limited

states that dietary exposure will be

extremely small due to the low

application rate of 18 grams/acre or less,

washing off of foliage and fruit by

rainfall or during food processing and

handling, and likely by degradation of

the plant extracts by soil microflora.

Furthermore, the oral toxicity of Plant

Extract 620 is so low that Appropriate

Technology Limited asserts that any

foreseeable residues would be of little

consequence.

Appropriate Technology Limited

states that exposure to drinking water

will be minimal. Neither Agrispon or

Sincocin will be applied directly to

water. The active ingredient

concentration of any potential spray

drift will be extremely minimal due to

the low active ingredient concentration.

The active ingredient concentration of

both products is 0.56% and the

products are diluted with water prior to

application, further reducing the

concentration. Additionally, the subject

plant extracts are of natural origin and

therefore subject to degradation by soil

microorganisms. Finally, if residues of

Plant Extract 620 do occur in drinking

water, Appropriate Technology Limited

believes that toxicity data demonstrate

that there is no foreseeable human

health hazard.

E. Cumulative Effects

Appropriate Technology Limited

believes that none of the active

constituents are known or suspected to

have any cumulative effect. The water

solubility of the constituents in this

aqueous extract are likely to be easily

excreted resulting in no tissue

accumulations. Furthermore, there is no

indication of mammalian toxicity.

F. Safety Determination

Appropriate Technology Limited

believes the toxicology data are

sufficient to demonstrate that there are

no foreseeable human health hazards

likely to arise from the use of plant

extracts derived from Quercus falcata,

Rhus aromatic, Rhizophora mangle, and

Opuntia lindheimeri. Furthermore, the

identified active ingredients known to

be present in these plant extracts are

present naturally in many plants.

G. Existing Tolerances

No tolerances or tolerance exemptions

have previously been granted for

extracts from Quercus falcata, Rhus

aromatic, Rhizophora mangle, and

Opuntia lindheimeri.

II. Public Record

Interested persons are invited to

submit comments on this notice of

filing. Comments must bear a notation

indicating the document control

number, [PF–710].

A record has been established for this

notice under docket number [PF–710]

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,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.
6780 Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Notices

Dated: February 6, 1997.

Janet L. Anderson,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–3517 Filed 2–12–97; 8:45 am]

BILLING CODE 6560–50–F

[PF-708; FRL-5587-3]

ISK Biosciences Corporation;

Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the establishment of a regulation for

residues of chlorothalonil in or on

almonds and almond hulls. The notice

includes a summary of the petition

prepared by the petitioner, ISK

Biosciences Corporation.

DATES: Comments, identified by the

docket number [PF-708], must be

received on or before March 17, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to Rm. 1132, CM #2, 1921

Jefferson Davis Highway, Arlington, VA.

Comments and data may also be

submitted electronically by sending

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

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

docket number [PF-708]. Electronic

comments on this notice of filing 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 comments

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

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

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Product

Manager (PM 22), Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Crystal Mall #2, Room

229, 1921 Jefferson Davis Highway,

Arlington, VA, 703-305-7740, e-mail:

giles-parker.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

5F4558), originally published in the

Federal Register on November 15, 1995

(60 FR 57419) (FRL-4971-5), from ISK

Biosciences Corporation (‘‘ISK’’), 5966

Heisley Road, P.O. Box 8000, Mentor,

Ohio 44061, 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 180.275 by

establishing tolerances for residues of

the fungicide chlorothalonil and its

metabolite, 4-hydroxy-2,5,6-

trichloroisophthalonitrile (SDS-3701) in

or on the raw agricultural commodity

(RAC) almonds (nutmeats) at 0.05 parts

per million (ppm) and almond hulls at

1.0 ppm. The proposed analytical

method is by electron capture gas

chromatography. 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (FQPA)

Pub. L. 104-170, ISK 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 ISK.

EPA is in the process of evaluating the

petition. As required by section

408(d)(3) of the FFDCA, EPA is

including the summary as a part of this

notice of filing. EPA has made minor

edits to the summary for the purpose of

clarity.

I. Petition Summary

A. Residue Chemistry Data

1. Plant/animal metabolism. The

nature of the residue of chlorothalonil

in plants and animals, including

ruminants, is well understood.

Chlorothalonil is not systemic in plants.

Any chlorothalonil residue found on

almond nutmeats occurs as a surface

residue from transfer of the residue

during harvesting and shelling

operations. Chlorothalonil is rapidly

metabolized in the ruminant and is not

transferred to meat and milk from the

dietary consumption by animals.

Furthermore, chlorothalonil is not stable

in meat or milk.

2. Analytical method. An adequate

analytical method (gas chromatography)

is available for enforcement purposes.

The method is listed in the Pesticide

Analytical Manual, Vol. II (PAM II).

3. Magnitude of the residues. Residue

data from studies conducted with

almonds support a tolerance of 0.05

ppm for combined residues of

chlorothalonil and its metabolite, 4-

hydroxy-2,5,6-trichloroisophthalonitrile

in/on almond nutmeats and 1.0 ppm in/

on almond hulls. Residues of

chlorothalonil on plants are surface

residues. Nutmeats are not systemically

exposed to chlorothalonil since

chlorothalonil is not a systemic

fungicide in plants. Chlorothalonil

residues are not directly translocated to

the nutmeats, but residues from the

hulls that contaminate the almond

shells during harvest may be transferred

to the nutmeats during the shelling

process.

B. Toxicological Profile

The following studies on file with the

Agency support this petition.

1. Acute toxicity. Acute toxicity

studies include an acute oral rat study

on technical chlorothalonil with an LD50

>10,000 milligram/kilogram (mg/kg), an

acute dermal toxicity study in the rabbit

with an LD50 >20,000 mg/kg, a 4-hour

inhalation study with finely ground

technical chlorothalonil resulting in a

LC50 of 0.092 mg/L (actual airborne

concentration), a primary eye irritation

study with irreversible eye effects in the

rabbit at 21 days, a primary dermal

irritation study showing technical

chlorothalonil is not a dermal irritant,

and a dermal sensitization study

showing technical chlorothalonil is not

a skin sensitizer.

2. Genotoxicity. The mutagenic

potential of chlorothalonil has been

evaluated in a large number of studies

covering a variety of endpoints. ISK

concludes that chlorothalonil is not

mutagenic.

Mutagenicity studies with

chlorothalonil include gene mutation

assays in bacterial and mammalian

cells; in vitro and in vivo chromosomal

aberration assays; DNA repair assays in

bacterial systems; and cell