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UNITED 6`E44NIRONMENTAL PROTECTION AGENCY 

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' WASHINGTON, 1NASHINGTON, D.C. 20460 

2010 FEB -5 ff, 1 : 26 

DEC 11 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 

TOXIC SUBSTANCES 

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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 . EPA received 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 . EPA has since made several requests of Aceto to obtain 

the needed data: 

" On August 28, 2007, EPA informed 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, EPA contacted you by phone to ask for Aceto's response to 

the e-mail, and you denied receiving the e-mail . 

" On December 4, 2007, EPA resent the e-mail, and, in an e-mail dated January 6, 

2008, you forwarded 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 a test of a chemical which Aceto was no 

longer importing. EPA requested that you explain your cost concerns in a letter, but 

EPA did not receive such letter from Aceto. 

" In my letter dated December 11, 2008, EPA reminded you of Aceto'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. EPA also provided the name of a 

company that could assist Aceto with 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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(Celsis) was finalized, which was expected to occur within a week. To date, EPA has 

not received any such letter. 

" On August 25, 2009, EPA sent you an e-mail stating that no letter was received and 

asking you to resend it . EPA has not received any response . 

If Aceto 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 of Aceto'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