Date: Fri, 11 Jun 2010 09:09:07 -0400
Reply-To: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
Sender: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
From: "Lipsky, David" <dlipsky**At_Symbol_Here**DEP.NYC.GOV>
Subject: Re: Question about regulations
In-Reply-To: <CE82A091FC41F7488B2C2E8F0FFF6BC804116EF189**At_Symbol_Here**>

This may have been answered already.  EPA has information on the limited reporting and documentation requirements for small production or R& amp;D chemicals.  See ewchems/pubs/whofiles.htm   This site contains a graphic that should help guide you through the process .   Of course you should consult with Counsel if you were audited by EPA and to ensure that you are properly complying.  
Some of this is excerpted below. 
Are any new substances exempt or excluded from PMN reporting?
Some new chemical substances are not subject to P MN reporting. These substances are either (1) excluded from TSCA reporting or (2) exempt from all or part of PMN reporting because EPA has determined that they do not warrant review or req uire only a short review.
EPA does not review new substances in the followi ng product categories, which are excluded from TSCA authority at section 3( 2)(B) of the Toxic Substances Control Act: tobacco and certain tobacco products, nuclear materials, munitions, fo ods, food additives, drugs, cosmetics, and substances used solely as pestic ides. These new substances fall under the jurisdiction of other federal law s and are reviewed by other federal programs. Substances used solely as pesticides are reveiwed by a separate < a href="">EPA Pe sticides Program. In addition, the following are excluded fr om PMN reporting under certain conditions: naturally-occurring materials, products of incidental reactions, products o f end-use reactions, mixtures (but not mixture components), impurities, byp roducts, substances manufactured solely for export, nonisolated intermediat es, and substances formed during the manufacture of an article. See 40 CFR sec tion 710.4(b) and 720.30(a)-(h) for more information abo ut exclusions from PMN reporting.
EPA has limited or no reporting requirements for new chemical substances in the following cases:
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-----Original Message-----
From: DCHAS-L Discussion List [mail to:DCHAS-L**At_Symbol_Here**LIST.UVM.EDU] On Behalf Of Humphrey, Karalyn J.
Sent: Thursday, June 10, 2010 5:14 PM
To: DCHAS-L**At_Symbol_Here**LIST.UVM.EDU
Subject: [DCHAS-L] Question about regulations
My name is Karen Humphrey and I'm the safety officer for Baylor's Chem istry Department.  I'm trying to sort out the violations we received f rom an EPA audit that was done recently.  One of the violations that w e 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 newl y synthesized chemicals?  All of the chemicals are for research and de velopment 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 t hese newly synthesized chemicals.  But how?  Do we need to genera te 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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