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
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices 34393

requests received, both pending and

expired. The information in this

document contains notices received

from May 1, 1998 to May 8, 1998.

ADDRESSES: Written comments,

identified by the document control

number ‘‘[OPPTS–51908]’’ and the

specific PMN number, if appropriate,

should be sent to: Document Control

Office (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Rm.

ETG–099 Washington, DC 20460.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to:

oppt.ncic@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/

6.1 file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPPTS–51908]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

under ‘‘SUPPLEMENTARY

INFORMATION’’.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three sanitized

copies of any comments containing

information claimed as CBI must also be

submitted and will be placed in the

public record for this notice. Persons

submitting information on any portion

of which they believe is entitled to

treatment as CBI by EPA must assert a

business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each such portion. This claim must be

made at the time that the information is

submitted to EPA. If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will consider

this as a waiver of any confidentiality

claim and the information may be made

available to the public by EPA without

further notice to the submitter.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–531, 401 M St., SW.,

Washington, DC, 20460, (202) 554–1404,

TDD (202) 554–0551; e-mail: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Under the

provisions of TSCA, EPA is required to

publish notice of receipt and status

reports of chemicals subject to section 5

reporting requirements. The notice

requirements are provided in TSCA

sections 5(d)(2) and 5(d)(3). Specifically,

EPA is required to provide notice of

receipt of PMNs and TME application

requests received. EPA also is required

to identify those chemical submissions

for which data has been received, the

uses or intended uses of such chemicals,

and the nature of any test data which

may have been developed. Lastly, EPA

is required to provide periodic status

reports of all chemical substances

undergoing review and receipt of

notices of commencement.

A record has been established for this

notice under docket number ‘‘[OPPTS–

51908]’’ (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 12 noon

to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in the TSCA

Nonconfidential Information Center

(NCIC), Rm. NEM–B607, 401 M St., SW.,

Washington, DC 20460.

Electronic comments can be sent

directly to EPA at:

oppt.ncic@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

document.

In the past, EPA has published

individual notices reflecting the status

of section 5 filings received, pending or

expired, as well as notices reflecting

receipt of notices of commencement. In

an effort to become more responsive to

the regulated community, the users of

this information and the general public,

to comply with the requirements of

TSCA, to conserve EPA resources, and

to streamline the process and make it

more timely, EPA is consolidating these

separate notices into one comprehensive

notice that will be issued at regular

intervals.

In this notice, EPA shall provide a

consolidated report in the Federal

Register reflecting the dates PMN

requests were received, the projected

notice end date, the manufacturer or

importer identity, to the extent that such

information is not claimed as

confidential and chemical identity,

either specific or generic depending on

whether chemical identity has been

claimed confidential. Additionally, in

this same report, EPA shall provide a

listing of receipt of new notices of

commencement.

EPA believes the new format of the

notice will be easier to understand by

the interested public, and provides the

information that is of greatest interest to

the public users. Certain information

provided in the earlier notices will not

be provided under the new format. The

status reports of substances under

review, potential production volume,

and summaries of health and safety data

will not be provided in the new notices.

EPA is not providing production

volume information in the consolidated

notice since such information is

generally claimed as confidential. For

this reason, there is no substantive loss

to the public in not publishing the data.

Health and safety data are not

summarized in the notice since it is

recognized as impossible, given the

format of this notice, as well as the

previous style of notices, to provide

meaningful information on the subject.

In those submissions where health and

safety data were received by the Agency,

a footnote is included by the

Manufacturer/Importer identity to

indicate its existence. As stated below,

interested persons may contact EPA

directly to secure information on such

studies.

For persons who are interested in data

not included in this notice, access can

be secured at EPA Headquarters in the

NCIC at the address provided above.

Additionally, interested parties may

telephone the Document Control Office

at (202) 260–1532, TDD (202) 554–0551,

for generic use information, health and

safety data not claimed as confidential

or status reports on section 5 filings.

Send all comments to the address

listed above. All comments received

will be reviewed and appropriate

amendments will be made as deemed

necessary.

This notice will identify: (I) PMNs

received; and (II) Notices of

Commencement to manufacture/import.
34394 Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices

I. 30 Premanufacture Notices Received From: 05/01/98 to 05/08/98

Case No. Received

Date

Projected

Notice

End Date

Manufacturer/Importer Use Chemical

P–98–0768 05/04/98 08/02/98 CBI (G) Petroleum product additive (G) Alkyl polyoxyalkylpropanamine

P–98–0769 05/01/98 07/30/98 Ashland Chemical

Company

(G) A binder component for the

production of sand foundry

shapes

(G) Modified isocyanic acid,

polymethylenepolyphenylene ester

P–98–0770 05/01/98 07/30/98 Ashland Chemical

Company

(G) A binder component for the

production of sand foundry

shapes

(G) Modified isocyanic acid,

polymethylenepolyphenylene ester

P–98–0771 05/01/98 07/30/98 Ashland Chemical

Company

(G) A binder component for the

production of sand foundry

shapes

(G) Modified isocyanic acid,

polymethylenepolyphenylene ester

P–98–0772 05/01/98 07/30/98 Ashland Chemical

Company

(G) A binder component for the

production of sand foundry

shapes

(G) Modified isocyanic acid,

polymethylenepolyphenylene ester

P–98–0773 05/01/98 07/30/98 Ashland Chemical

Company

(G) A binder component for the

production of sand foundry

shapes

(G) Modified isocyanic acid,

polymethylenepolyphenylene ester

P–98–0774 05/01/98 07/30/98 Ciba Specialty

Chemicals Corporation

(S) Chemical intermediate (G) Benzenesulfonic acid, 2,2′-(1,2-

ethenediyl)bis[(4,6-chloro-1,3,5-triazin-2-

yl)amino]-disodium salt; substituted with

dialkyl amines

P–98–0775 05/05/98 08/03/98 CBI (S) Curing agent in epoxy powder

coatings; curing agent in liquid

epoxy adhesives

(G) Phenyl, alkyl, hydroxyalkyl substituted

imidazole

P–98–0776 05/05/98 08/03/98 Applied power concepts, inc.(S) Surfactant in hard surface

cleaners or fabric softners or for

mixing oil and water products

(S) Ethanaminium, 2-(hexadecyloxy)-n,n,n,-

trimethyl-2-oxo,-chloride*

P–98–0777 05/05/98 08/03/98 Applied power concepts, inc.(S) A detergent surfactant used for

washing; application for

unsecticide has also been applied for

(S) Mixture of: alpha-d-glucopyranoside, ,1-

6-bis-o-(1-oxooctyl)-b-d-fructofuranosyl

and alpha-d-glucopyranoside, 6-o-(1-

oxooctyl)-b-d-fructofuranosyl*

P–98–0778 05/04/98 08/02/98 CBI (G) Chemical intermediate (G) Arylether sulfide

P–98–0779 05/06/98 08/04/98 CBI (G) Zinc plating additive (G) Metal carboxylic acid complex

P–98–0780 05/07/98 08/05/98 Clariant corporation (S) Corrosion inhibitor for metal removing(S) Hexanoic acid, 6–[(1-oxoisononyl)amino]-

, cmpd. with 2,2′ 2′′-nitrilotris[ethanol](1:1)*

P–98–0781 05/05/98 08/03/98 CBI (G) Surfactant in chemical specialities highly dispersive use(G) Fluorinated amine oxide

P–98–0782 05/05/98 08/03/98 CBI (G) Open, non dispersive (dyestuff) (G) Triazine azo dyestuff

P–98–0783 05/04/98 08/02/98 CBI (G) Chemical intermediate (G) Amine hydrochloride

P–98–0784 05/04/98 08/02/98 CBI (G) Chemical intermediate (G) Arylether sulfide

P–98–0785 05/04/98 08/02/98 CBI (G) Chemical intermediate (G) Arylether sulfide

P–98–0786 05/07/98 08/05/98 CBI (S) Epoxy curing agent (G) Amine fuctional epoxy curing agent

P–98–0787 05/05/98 08/03/98 CBI (G) Lubricant (G) Sulfited fatty amine¶

P–98–0788 05/04/98 08/02/98 CBI (S) Intermediate (G) Acid functional ester

P–98–0789 05/04/98 08/02/98 CBI (G) Open, non-dispersive use (G) Polyester oligomer

P–98–0790 05/04/98 08/02/98 CBI (G) Open, non-dispersive use (G) Polyester oligomer

P–98–0791 05/04/98 08/02/98 CBI (G) Open, non-dispersive use (G) Polyester oligomer

P–98–0792 05/04/98 08/02/98 CBI (G) Open, non-dispersive use (G) Polyester oligomer

P–98–0793 05/08/98 08/06/98 Bedoukian research,

inc.

(G) Chemical intermediate (G) Aliphatic-oxy-substituted, saturated

pyranyl magnesium halide*

P–98–0794 05/08/98 08/06/98 Bedoukian research,

inc.

(S) Chemical intermediate (G) Mono-halo-substituted alkene¶

P–98–0795 05/08/98 08/06/98 CBI (G) Coating components (G) Modified petroleum distillate

P–98–0796 05/08/98 08/06/98 CBI (S) Raw material/ reactant in the

synthesis of an organic compound

(G) Methoxy substituted aliphatic amine

P–98–0797 05/08/98 08/06/98 CBI (S) Intermediate in synthesis of another organic compound(G) Dimethyl substituted heteromonocyclic

amine

II. 12 Notices of Commencement Received From: 05/01/98 to 05/08/98

Case No. Received Date

Commencement/Import

Date

Chemical

P–92–0555 05/05/98 04/17/98 (G) Polyester/polyamide

P–95–0682 05/05/98 03/31/98 (G) Acrylic modified styrene/butadiene rubber

P–97–0685 05/05/98 04/05/98 (G) Sodium sulfonate polymer

P–97–0951 04/30/98 04/08/98 (G) Polyurethane

P–97–1023 05/01/98 04/18/98 (G) Phosphonomethylated polyamine
Federal Register / Vol. 63, No. 121 /Wednesday, June 24, 1998 / Notices 34395

II. 12 Notices of Commencement Received From: 05/01/98 to 05/08/98—Continued

Case No. Received Date

Commencement/Import

Date

Chemical

P–97–1077 04/30/98 04/16/98 (G) Benzenesulfonamide, 3-[(3-substituted-4,5-dihydro-5-oxo-1-phenyl-1h-pyrazol-4-yl)azo]-

n-n-bis[3-[[[3-(5,5-dimethyl-3-octadecyl-2-thiazolidinyl) 4-

hydroxyphenyl]sulfonyl]aminopropyl]-*

P–97–1092 05/05/98 04/20/98 (G) Azo red pigment

P–98–0030 04/30/98 04/17/98 (G) 2-naphthalenesulfonamide, n,n-bis(3-substituted propyl)-1-hydroxy-5-

[(methylsulfonyl)amino]-, sulfate (1:1)(salt)*

P–98–0263 05/05/98¶ 04/16/98 (G) Mixture of unsaturated polyesters, polyethers, and polyamide salts

P–98–0273 05/05/98 04/16/98 (G) Alkylol ammonium salt of a high-molecular weight carboxylic acid

P–98–0288 05/01/98 04/24/98 (G) Polyamine polyester

P–98–0293 05/05/98 04/20/98 (G) Polyurethane/acrylic grafted copolymer

List of Subjects

Environmental protection,

Premanufacture notices.

Dated: June 16, 1998.

Oscar Morales,

Acting Director, Information Management

Division, Office of Pollution Prevention and

Toxics.

[FR Doc. 98–16771 Filed 6–23–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–51907; FRL–5794–1]

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

requests received, both pending and

expired. The information in this

document contains notices received

from April 27, 1998 to April 30, 1998.

ADDRESSES: Written comments,

identified by the document control

number ‘‘[OPPTS–51907]’’ and the

specific PMN number, if appropriate,

should be sent to: Document Control

Office (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Rm.

ETG–099 Washington, DC 20460.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to:

oppt.ncic@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/

6.1 file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPPTS–51907]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

under ‘‘SUPPLEMENTARY

INFORMATION’’.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three sanitized

copies of any comments containing

information claimed as CBI must also be

submitted and will be placed in the

public record for this notice. Persons

submitting information on any portion

of which they believe is entitled to

treatment as CBI by EPA must assert a

business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each such portion. This claim must be

made at the time that the information is

submitted to EPA. If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will consider

this as a waiver of any confidentiality

claim and the information may be made

available to the public by EPA without

further notice to the submitter.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–531, 401 M St., SW.,

Washington, DC, 20460, (202) 554–1404,

TDD (202) 554–0551; e-mail: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Under the

provisions of TSCA, EPA is required to

publish notice of receipt and status

reports of chemicals subject to section 5

reporting requirements. The notice

requirements are provided in TSCA

sections 5(d)(2) and 5(d)(3). Specifically,

EPA is required to provide notice of

receipt of PMNs and TME application

requests received. EPA also is required

to identify those chemical submissions

for which data has been received, the

uses or intended uses of such chemicals,

and the nature of any test data which

may have been developed. Lastly, EPA

is required to provide periodic status

reports of all chemical substances

undergoing review and receipt of

notices of commencement.

A record has been established for this

notice under docket number ‘‘[OPPTS–

51907]’’ (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 12 noon

to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in the TSCA

Nonconfidential Information Center

(NCIC), Rm. NEM–B607, 401 M St., SW.,

Washington, DC 20460.

Electronic comments can be sent

directly to EPA at:

oppt.ncic@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