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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### Moifcaio o CnsntOrePREAMBLE 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 awear-resistant material in automobile brake linings, diskpads, and clutch facings. Upon review ofP90-226, EPA determined that the information available to the Agency was insufficient to permit areasoned evaluation ofthe humanhealth effects ofthe PMIN substance and exposure to the PMN substance may result in an unreasonable risk offibrosis and/or cancer. Therefore, pursuant to section 5(e) ofTSCA, EPA issued a Consent Orderwhich was signed by the Agency on January 30, 1991 and by the Company on February 19, 1991. The Order became effective following expiration ofthe 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 ofthe 90-day study, a2-year, 2 species cancerbioassaybefore exceeding a secondproduction limit of[ ]; (2) label thePMN substance and provide Material SafetyData Sheets (MSDS) and worker training in accordance with the provisions ofthe Hazard Communication Program section; (3) notmanufacture the PMvN substance in the United States; (4)importthe PMIN substance manufactured only by the described by the Company in documents submitted in conjunction with the PMN; (5) not import the PMN substance ifthe 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)maintain certain relevant records. The Company satisfied the firsttestingrequirement ofthe Consent Order by submitting the results ofa 90-day subchronic inhalation study inrats. The Agency modified the Consent Order in 1997 by revoking the Hazard Communication Section inits entirety. In addition, as authorized by paragraph (d) ofthe Testing section ofthe Consent Order, the Agency notifiedthe 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 ofrespirable fibers. The Agency has reviewed the petition and determined that the manufacture ofthe PM4N substance by the proposed will not produce respirable fibers. Thus, EPA isnow modifying the 

### 5(e) Consent Order for P90-226 to allow manufacture ofthe 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 ismolecularly similar to part ofthe 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 of5mg/in3

.'S, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

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OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MODIFICATION OF CONSENT ORDER

Under the authority ofsection 

### 5 (e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2406(e)) and Part III ofthe Consent Order forPremanufacture 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) ofthe "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 ofthe 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 PaperAll other existing terms and conditions ofthe Consent Order for P90-226 remain unchanged. This modification is effective on the date ofsignature.

Date Philip S.Oshida, Acting Director Chemical Control Division Office ofPollution Prevention and Toxics

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