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; PROI UNITED 6`E44NIRONMENTAL PROTECTION AGENCY t 1,~ ' WASHINGTON, 1NASHINGTON, D.C. 20460 

## 2010FEB -5 ff, 1 : 26



# DEC11 2009

Ms. Simone Miller, Corporate Director EHS &Regulatory Affairs Aceto Corporation One Hollow

Lane, Suite 201 Lake Success, New

York 11042 Dear Ms. Miller, OFFICE OF PREVENTION, PESTICIDES AND TOXICSUBSTANCES 

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This letter concerns the Aceto Corporation's commitment to sponsor the in vitro dermal absorption rate testing of p-nitroaniline (CAS No. 100-01-6) required by a TSCA section 4 test rule (69 FR 22402, April 26, 2004) . Aceto committed to sponsor pnitroaniline in a letter dated January 24, 2005. EPAreceived a study from Aceto on December 27, 2005. EPA, however, found that the study conducted by Celsis In Vitro Technologies, Inc. (Celsis), was inadequate to address the data need for dermal absorption rate of p-nitroaniline. EPAhas since made several requests ofAceto to obtain the needed data: " On August 28, 2007, EPAinformed you by e-mail that several errors were committed in performing the test and that the test had to be repeated. Aceto did not respond to the e-mail . " On December 4, 2007, EPAcontacted you by phone to ask for Aceto's response to the e-mail, and you denied receiving the e-mail . " On December 4, 2007, EPAresent the e-mail, and, in an e-mail dated January 6, 2008, youforwarded Celsis' plans to repeat the test. " In phone conversations with EPA in April and August 2008, you indicated Aceto's reluctance to bear the cost of repeating atest of a chemical which Aceto was no longer importing. EPArequested that you explain your cost concerns in a letter, but EPAdid not receive such letter from Aceto. " In my letter dated December 11, 2008, EPA reminded you ofAceto's unfulfilled commitment to provide a study to answer a data need and that Aceto would be in violation of the test rule if it were not provided. EPAalso provided the name of a company that could assist Acetowith the test costs because the other company was subject to the test cost reimbursements requirements for p-nitroaniline. You responded with an e-mail dated January 15, 2009, stating that Aceto would repeat the study and that an official letter, including an approximate timeframe for completion of the study, would be sent to EPA after the contract with the testing laboratory 

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.t4o~CBI Recycled/Recyclable e Printed with Vegetable Oil Based Inks on 100%Postconsumer, Process Chlorine Free Recycled Paper(Celsis) was finalized, which was expected to occur within a week. To date, EPAhas

not received any such letter. " On August 25, 2009, EPAsent you an e-mail stating that no letter was received and asking you to resend it. EPAhas not received any response. IfAceto does not provide tangible proof (e.g., signed contract with a testing laboratory) by December 31, 2009, that'Aceto intends to repeat the required test, or is in the process of repeating the test, and provide a reasonable timeline for completion (no more than one year), this matter will be referred to the Office of Enforcement and Compliance Assurance (OECA) for evaluation ofAceto's noncompliance and assessment of appropriate penalties.

41 s, Director al Control Division cc: Rosemarie Kelly, Director, Waste Enforcement Division, OECA [,zGerry Brown/ Docket No. EPA-HQ-OPPT-2003-0006 C . Roman