34390 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices

LIST 2 INERT INGREDIENTS CURRENTLY

USED IN PESTICIDE PRODUCTS—

Continued

CAS Reg No. Chemical Name

108–90–7 ..... Monochlorobenzene

108–94–1 ..... Cyclohexanone

111–42–2 ..... Diethanolamine

111–76–2 ..... 2-Butoxy-1-ethanol

111–77–3 ..... Diethylene glycol monomethyl

ether

111–90–0 ..... Diethylene glycol monoethyl

ether

112–34–5 ..... Diethylene glycol monobutyl

ether

117–84–0 ..... Dioctyl phthalate

107–98–2 ..... 1-Methoxy-2-propanol

124–16–3 ..... 1-Butoxyethoxy-2-propanol

131–11–3 ..... Dimethyl phthalate

141–79–7 ..... Mesityl oxide

149–30–4 ..... Mercaptobenzothiazole

1330–20–7 ... Xylene

5131–66–8 ... 1-Butoxy-2-propanol

25498–49–1 Tripropylene glycol

monomethyl ether

29385–43–1 Tolyl triazole

29387–86–8 Propylene glycol monobutyl

ether

34590–94–8 Dipropylene glycol

monomethyl ether

No CAS

Number.

Petroleum hydrocarbons

No CAS

Number.

Xylene–range aromatic solvents

VI. Process for Future Removal of Inert

Ingredients that are No Longer Used as

Inert Ingredients

As a part of its ongoing inerts strategy,

the Agency will perform future reviews

of List 1, List 2, and List 3 inert

ingredients to identify those inert

ingredients which are no longer used.

The Agency will issue future Federal

Register notices removing those

chemicals from its list of inert

ingredients. Any associated exemptions

from the requirement of a tolerance for

such chemicals when used as inert

ingredients will also be revoked. The

Agency will not remove any List 4A or

4B inert ingredients from its list of inert

ingredients since sufficient data have

been presented to establish that the use

of these chemicals as inert ingredients

will not present a hazard to public

health or the environment.

In an effort to identify inert

ingredients which are no longer used,

the Agency may contact registrants of

pesticide products or manufacturers/

suppliers of substances which are used

as inert ingredients in pesticide

formulations which contain specific

inert ingredients the Agency believes

may not actually be in use. This action

may be necessary to verify the

information currently contained in the

Agency’s database relative to product

formulation information.

The Agency considers all alternate

formulations valid for purposes of

registration unless a registrant provides

specific written notice to the Agency

that a particular formulation will no

longer be used. Therefore, the Agency

wants to encourage registrants as part of

their pesticide product stewardship

program to provide the Agency with

written notice identifying specific

formulations that are no longer used as

part of the pesticide product registration

and amendment process. This action

will assist the Agency in better

identifying those inert ingredients that

are no longer used in pesticide products

as well as improving the overall

accuracy of the Agency’s product

formulation information.

VII. Public Record and Electronic

Submissions

The official record for this notice, as

well as the public version, has been

established for this notice under docket

control number [OPP-36192] (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 record is located

at the Virginia 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 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [OPP–

36192]. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries.

List of Subjects

Environmental protection, Pesticides

and pests.

Dated: June 11, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 98–16571 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–815; FRL–5795–9]

Pesticide Temporary Tolerance

Exemption Petition; Notice of Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the extension of the exemption from the

requirement of a temporary tolerance for

residues of Trichodex (Trichoderma

harzianum T-39) in and on all raw

agricultural commodities as granted in

Pesticide Petition 6G4622, concomitant

with the extension of the Experimental

Use Permit 11678–EUP–1. These

extensions are requested to comply with

the Food Quality Protection Act of 1997.

The summary of the petition in this

notice was prepared by the petitioner.

DATES: Comments, identified by the

docket control number PF–815, must be

received on or before July 24, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7502C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

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

person bring comments to: Rm. 119, CM

#2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow 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. 119 at the Virginia

address given above, from 8:30 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays.

FOR FURTHER INFORMATION CONTACT:

Shanaz Bacchus (PM-90) Biopesticides

and Pollution Prevention Division,
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices 34391

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington DC 20460.

Office location and telephone number:

5th floor, CS #1, 2800 Crystal Drive,

Arlington, VA 22202, Telephone

number 703 308–8097, e-mail:

bacchus.shanaz@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 food 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 granting 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–815]

(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

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 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [PF–815] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: June 15, 1998.

Kathleen D. Knox,

Acting Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

Makhteshim-Agan of North America

Inc.

PP 6G4622

EPA has received a request to extend

the pesticide petition (PP 6G4622) from

Makhteshim-Agan of North America

Inc., 551 Fifth Avenue, Suite 1100, New

York, NY 10176, proposing pursuant to

section 408(d) of the Federal Food, Drug

and Cosmetic Act, 21 U.S.C. section

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

extending the exemption from the

requirement of a temporary tolerance for

residues of the biofungicide Trichodex

(Trichoderma harzianum T-39) in and

on all raw agricultural commodities.

According to the proposed extension

request, 8,120 pounds (3,683 kg) of the

microbial pesticide are to be applied to

the sites previously described in the

original Experimental Use Permit which

has been in progress for 2 years.

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 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,

Makhteshim-Agan of North America

Inc. 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 the receipt of the

petition. The summary represents the

views of Makhteshim-Agan of North

America Inc.; 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

part of this notice of filing. EPA may

have made minor edits to the summary

for the purpose of clarity.

A. Proposed Use Practices

Recommended application method

and rate(s), frequency of application,

and timing of application. Trichodex

may be applied with conventional spray

equipment for control of Botrytis (gray

mold) on fruit and vegetable crops. The

rate of application is two to four pounds

of Trichodex per acre in sufficient

gallonage to insure adequate coverage.

The frequency and timing of application

vary with the crop being treated. For

example, one to four applications are

made to wine grapes in a rotational

program with conventional chemical

fungicides, while four to six

applications may be applied to wine

grapes when the product is used alone.

Table grapes are treated with one to

three applications during pre-bloom to

fruit set. Treatments on strawberry may

include up to eight applications (once

per week) throughout the growing

season from pre-bloom to harvest.

B. Product Identity/ Chemistry

1. Identity of the pesticide and

corresponding residues. The active

ingredient is Trichoderma harzianum, a

fungus which occurs naturally in the

environment worldwide, including in

the U.S. The strain of T. harzianum

used in Trichodex has been designated

as ‘‘T-39.’’ This strain has been

characterized by colony and structural

morphology, RFLP mapping and

classified by intraspecific DNA primers.

The strain is typical of T. harzianum

and does not express characteristics of

plant pathogenic strains. The organism

does not persist in the environment and

relies on repeated application to achieve

plant protection. The organism degrades

in the environment to natural organic

constituents.

2. Magnitude of residue anticipated at

the time of harvest and method used to

determine the residue. MakhteshimAgan of North America has requested

waivers for these data requirements. The

waiver requests were based on the

known low toxicity of Trichodex, the

natural occurrence of T. harzianum in

the environment, the non-toxic mode of

action, the submitted data and

information available in the open

literature.

3. Statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. Makhteshim-Agan of North

America has not proposed an analytical

method, because residues of T.

harzianum resulting from Trichodex
34392 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices

applications do not pose a hazard to

humans, plants and animals. T.

harzianum from naturally occurring

strains is commonly found in the

environment and can be reasonably

expected to exist whether or not

Trichodex has been applied to the

growing crop.

C. Mammalian Toxicological Profile

Provide the following or rationale for

waiver request.

1. Acute toxicity. The health effects

data submitted in the Makhteshim-Agan

of North America Inc. petition and all

other relevant material have been fully

evaluated by the EPA in their approval

of an Experimental Use Permit for large

scale field evaluation of Trichodex. The

mammalian toxicological data

considered in support of the extension

of the exemption from the requirement

of a temporary tolerance for Trichodex

include: an acute oral toxicity study in

rats, a primary eye irritation study in

rabbits and an acute inhalation study in

rats. All three studies were assigned

Toxicity Category III. The submitted

acute dermal toxicity study in rabbits,

primary dermal irritation study in

rabbits, and a dermal sensitization study

in guinea pigs were assigned Toxicity

Category IV.

The results of these studies indicated

that Trichodex has an acute oral LD50

greater than 500 milligrams/kilograms

(mg/kg) body weight in rats, an acute

dermal LD50 greater than 1,150-1,570

mg/kg body weight in rabbits. Trichodex

caused reversible eye irritation with

complete clearance after 7 days. No

dermal irritation in rabbits was

observed, however, the product was

found to be a delayed contact dermal

sensitizer in guinea pigs (based on the

modified Beuhler Assay). The acute

pulmonary toxicity/ pathogenicity study

in the rat showed no evidence of

pathogenicity or Trichodex

reproduction in the tissues examined.

Although the study was of insufficient

duration to achieve complete clearance

in the lung, the study demonstrated

clearance in brain, blood, lymph nodes,

kidney, liver, spleen, and caecum.

Toxicity Category III was assigned to

pulmonary exposure mitigated by label

instructions indicating personal

protective equipment for applicators.

2. Genotoxicity, reproductive and

developmental toxicity, subchronic

toxicity, and chronic toxicity. The T-39

strain of T. harzianum, the active

ingredient in Trichodex, does not

produce fungal metabolites as its

primary mode of action against target

plant pathogens. Submitted studies

using the Ames Test and Mouse

Micronucleus test show no indication of

genotoxic or reproductive effects.

D. Aggregate Exposure

1. Dietary exposure. i. Food.

Trichodex is based on a naturally

occurring organism normally found in

the environment. For the purposes of

assessing the potential dietary exposure

under this exemption, it should be

considered that T. harzianum may be

present in all RACs. Submitted studies

indicate that residues of Trichodex do

not pose a hazard to humans by route

of ingestion.

ii. Drinking water. Based on the

available studies presented for use in

the assessment of environmental risk, it

is not anticipated that drinking water

will provide a route of exposure to

residues of Trichodex. The anticipated

use pattern for Trichodex does not

include use in or on waterways. Even

though Trichodex can be washed off

treated plants by rain and during

processing of crops by water, it degrades

in an aqueous environment into organic

constituents by normal biological,

physical, and chemical processes.

2. Non-dietary exposure. Based on

label directions for use as a foliar

applied biofungicide, he only nondietary exposure is to applicators of the

product. However, exposure to

Trichodex resulting from its proper

application according to label directions

for the use of personal protective

equipment is not expected to present

any risk of adverse health effects.

E. Cumulative Exposure

Other than a possible allergic reaction

to spores present in the product

following repeated exposure, no

cumulative adverse health effects are

expected from long-term exposure to

Trichodex. Risk of dermal sensitization

is addressed on the label which

specifies proper personal protective

equipment to minimize exposure.

Exposure through other pesticides

and substances with a common mode of

toxicity with this pesticide.

Consideration of a common mechanism

of toxicity is not appropriate for several

reasons: (1) Trichodex has a non-toxic

mode of action, (2) Only a small number

of pesticidal products containing T.

harzianum as an active ingredient are

currently registered, (3) The species is

ubiquitous in nature, and, (4) The active

ingredient has been demonstrated to be

non-toxic in submitted acute studies.

F. Safety Determination

1. U.S. population in general.

Trichodex is based on a naturally

occurring organism normally found in

the environment and on crop plants.

The low toxicity of the subject active

ingredients is demonstrated by the data

summarized above. Based on this

information, it has been determined that

aggregate exposure to Trichodex over a

lifetime will not pose appreciable risks

to human health and there is a

reasonable certainty that no harm will

result from Trichodex residues. Since

people are exposed to T. harzianum

from natural sources, the incremental

exposure from its use in pesticide

products is expected to be negligible.

2. Infants and children. It has been

determined that the toxicity and

exposure data are sufficiently complete

to adequately address the potential for

additional sensitivity of infants and

children to residues of Trichodex. It is

concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to Trichodex residues.

G. Existing Tolerances

1. Existing tolerances or tolerance

exemptions. A temporary tolerance

exemption in conjunction with an

Experimental Use Permit for Trichodex

is currently in effect. EPA has also

promulgated permanent exemptions

from the requirement for a tolerance for

strains of T. harzianum other than T-39.

2. International tolerances or

tolerance exemptions. No maximum

residue level has been established for

Trichodex by the Codex Alimentarius

Commission. Exemptions from the

requirement of a tolerance have been

granted for Trichodex in all

international registrations.

[FR Doc. 98–16778 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–51908; FRL–5794–2]

Certain Chemicals; Premanufacture

Notices

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: Section 5 of the Toxic

Substances Control Act (TSCA) requires

any person who intends to manufacture

or import a new chemical to notify EPA

and comply with the statutory

provisions pertaining to the

manufacture or import of substances not

on the TSCA Inventory. Section 5 of

TSCA also requires EPA to publish

receipt and status information in the

Federal Register each month reporting

premanufacture notices (PMN) and test

marketing exemption (TME) application