Karen -

If the violation was based on EPA TSCA rules then the University should be able to claim a R&D exemption - this assumes that the quantity limits are met and the R&D materials would not find their way into commercial use without further evaluation.  On the OSHA side, handling/use issues likewise arise in industrial laboratories doing synthesis work with "new or unknown" chemicals.  There are several schemes patterned after the chemical banding approach (first promulgated in the Pharma industry) to categorize chemicals for handling/use when little information about toxicity has been gathered.  These can be shared - let me know if needed.

With regards,

Mike

Michael N. Cooper MS, MPH, CIH

Senior Managing Scientist

Exponent / Failure Analysis Associates

149 Commonwealth Drive

Menlo Park, California  94025

mcooper**At_Symbol_Here**exponent.com

cell (408) 313-2127

office (650) 688-1760

-----Original Message-----
From: DCHAS-L Discussion List [mailto:DCHAS-L**At_Symbol_Here**list.uvm.edu] On Behalf Of Humphrey, Karalyn J.
Sent: Thursday, June 10, 2010 2:14 PM
To: DCHAS-L**At_Symbol_Here**LIST.UVM.EDU
Subject: [DCHAS-L] Question about regulations

Hello,

My name is Karen Humphrey and I'm the safety officer for Baylor's Chemistry Department.  I'm trying to sort out the violations we received from an EPA audit that was done recently.  One of the violations that we received was for not having the proper documentation for new chemicals made by our research groups involved with synthesis. 

Do any of you have experience with the documentation required for newly synthesized chemicals?  All of the chemicals are for research and development purposes, and all are in small quantities.  According to the regulations, as I understand them, we have to provide notice of health risks that may be associated with exposure to these newly synthesized chemicals.  But how?  Do we need to generate some kind of MSDS, or is there a labeling system that is used?

Thank you in advance for your help.

Karen Humphrey

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