UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF A NEW CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION

In the matter of:- Premanufacture Notice Number:

Itocu Inernaiona, In. P9-22

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PREAMBLE

Pursuant to section 5(a) of the Toxic Substances Control Act ("TSCA"), ITOCHU

International Inc., formerly C. Itoch & Co. (America) Inc., ("the Company") submitted

premanufacture notice ("PMN") P90-226 to the Environental Protection Agency ("EPA" or "the

Agency") for the chemical substance

( ("the PMIN substance").

The substance is to be used as a wear-resistant material in automobile brake linings, disk pads, and

clutch facings.

Upon review of P90-226, EPA determined that the information available to the Agency was

insufficient to permit a reasoned evaluation of the human health effects of the PMIN substance and

exposure to the PMN substance may result in an unreasonable risk of fibrosis and/or cancer.

Therefore, pursuant to section 5(e) of TSCA, EPA issued a Consent Order which was signed by the

Agency on January 30, 1991 and by the Company on February 19, 1991. The Order became

effective following expiration of the PMN review period on February 20, 1991.

The Consent Order required the Company to: (1) perform a 90-day subchronic inhalation

study in rats before exceeding a production limit of [ kilograms and, dependent on the

results of the 90-day study, a 2-year, 2 species cancer bioassay before exceeding a second production

limit of [ ]; (2) label the PMN substance and provide Material Safety Data Sheets (MSDS)

and worker training in accordance with the provisions of the Hazard Communication Program

section; (3) not manufacture the PMvN substance in the United States; (4) import the PMIN substance

manufactured only by the described by the Company in documents submitted in

conjunction with the PMN; (5) not import the PMN substance if the bulk density measurements of

the PMN substance in its pure form are less than 0.4 g/cm' or greater than 0.6 g/cm 3; and (6)

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maintain certain relevant records.

The Company satisfied the first testing requirement of the Consent Order by submitting the

results of a 90-day subchronic inhalation study in rats. The Agency modified the Consent Order in

1997 by revoking the Hazard Communication Section in its entirety. In addition, as authorized by

paragraph (d) of the Testing section of the Consent Order, the Agency notified the Company that the

Company was no longer required to submit the results of the 2-year, 2-species bioassay via

inhalation. The Agency modified the Consent Order again in 1998, by revoking the bulk density

measurement requirements.

In a December 9, 2002 letter to the Agency, the Company petitioned the Agency to revoke

the restriction to import the PMN substance manufactured only by the This

restriction was intended to prevent inhalation of respirable fibers. The Agency has reviewed the

petition and determined that the manufacture of the PM4N substance by the proposed 

will not produce respirable fibers. Thus, EPA is now modifying the 5(e) Consent Order

for P90-226 to allow manufacture of the PNM substance by either the or the

provided the process used to manufacture the PM substance shall not

produce respirable acicular fibers with an average aspect ratio greater than five.

However, since the PMN substance is molecularly similar to part of the

Agency's "Poorly Soluble Particulate" category (see www.epa.gov/o=t/newchems/chemcat.htm),

there may be a concern for the PNINh substance as a respirable particulate. Thus, EPA strongly

recommends that the Company should comply with the OSHA Permissible Exposure Limit (PEL)

for of 5 mg/in3 .

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'S, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

1-4 PRO

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MODIFICATION OF CONSENT ORDER

Under the authority of section 5 (e) of the Toxic Substances Control Act ("TSCA") (15

U. S.C. 2406(e)) and Part III of the Consent Order for Premanufacture Notice P90-226, signed by

the Environental Protection Agency ("EPA" or "the Agency") on January 30, 1991, and by C.

Itoch & Co. (America) Inc. (now ITOCHU International Inc.) ("the Company") on February 19,

1991, EPA hereby modifies the Consent Order as follows:

In Part I., TERMS OF MANUFACTURE. IMPORT. PROCESSING. DISTRIBUTION

IN COMMERCE. USE. AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF

INFORMATION, Section (c) of the "Manufacturing/Importing" section shall now state:

(c) The Company shall not import the PMN substance unless:

(1) the PMN substance is manufactured by either the [

as described in the PMN and associated documents including the

December 9, 2002, petition to modify this Order, respectively; and

(2) the manufacturing method produces no respirable acicular fibers of the PMN

substance with an average aspect ratio greater than five.

Internet Address (URL) * http //www epa gay

Recycled/Recyclable .Printed with Vegetable Oil Based Inks on 100% Postconsumner, Process Chlorine Free Recycled Paper

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All other existing terms and conditions of the Consent Order for P90-226 remain

unchanged. This modification is effective on the date of signature.

Date Philip S. Oshida, Acting Director

Chemical Control Division

Office of Pollution Prevention and Toxics

-2-

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