Date: Sat, 12 Jun 2010 15:54:36 -0700
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: Roger McClellan <roger.o.mcclellan**At_Symbol_Here**ATT.NET>
Subject: Re: Question about regulations
Comments: To: Frankie Wood-Black
In-Reply-To: <C1B0E660BCCF465CAEB7AF6A804366AC**At_Symbol_Here**acere817fae0d8>
To all:
   This e xchange ,as are many others on DCHAS-L, is very interesting!! I make t he following comment in the abstract without regard to this specific questi on.
     Sometimes I think the questions are framed very tightly in terms of what does the Institution need to do to achieve regulatory compliance, ie show that we followed the rules and dott ed the i's and crossed the t's.
     I suggest that the more appropriate approach is -- do we have in plac e the proper policies and procedures, training programs, the required facities and equipment and Institutional culture to ensure that ALL fa culty, staff and students are carrying out all activities in a safe manner with the lowest potential for the occurence of untoward  events that m ay impact on their health and well-being? After answering that question it is appropriate to ask, are we meeting all applicable regulations, meeting t he regulations is secondary to what I outlined.
     Best wishes to all for providing a safe work environment for all . and, by the way, meeting the regs.
    & nbsp;   Roger

Roger O. McClellan


Advisor, Toxicology and Human Health Risk Analysis

13701 Q uaking Aspen Place NE
Albuquerque, NM 87111
Tel: 505-296-7083
Fax: 505-296-9573
E-mail: clellan**At_Symbol_Here**

From: Frankie Wood-Black <fwblack**At_Symbol_Here** t;
To: DCHAS-L**At_Symbol_Here**LIST.UVM. EDU
Sent: Sat, June 12, 2010 12:15:52 PM
Subject: Re: [DCHAS-L] Question about regulations

Key issues under TSCA - you need to have a Technic ally Qualified Individual and applicable safety information - it does not h ave to be an MSDS - however - you need to have the TQI assigned ahead of ti me.  Feel free to contact me - I used to do this for R&D organizat ions.
----- Original Message -----
To: DCHAS-L**At_Symbol_Here**LIST.UVM.EDU
Sent: Saturday, June 12, 2010 7:49 AM
Subject: Re: [DCHAS-L] Question a bout regulations

...on the OSHA side however, any notion that one can simp ly claim that "it=E2=80=99s R&D=" or that "it=E2 =80=99s small quantity=" and then cite one=E2=80=99s control banding system or the lab standard won=E2=80=99t get you out of issues regarding M SDS development, etc. if sending samples, etc. off-site /pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=203 90 TATIONS&p_id=24782


On a developing note, I suggest keeping an eye on debate and likely promulgation of the updated HazCom Std. as it relates to hazard classification.< /P>


http:// 0062




Steve Crooks, MS, CIH, CSP

People, Property & Environmental Protection, Inc.

12 Reynard Place

Hillsboroug h, NC 27278






From:< /B> DCHAS-L Disc ussion List [mailto:DCHAS-L**At_Symbol_Here**] On Behalf Of Michael Coope r
Sent: Thursday, June 10, 2010 8:06 PM
To: DCHAS-L**At_Symbol_Here**LIS T.UVM.EDU
Subject: Re: [DCHAS-L] Question about regulations


Karen -

If the violation was based on EPA TSC A rules then the University should be able to claim < SPAN style="FONT-FAMILY: Consolas">a R&D exemption - this assumes that the quantity limits are met and the R&D materials would not find thei r way into commercial use with out further evaluation.  On the OSHA side, handling/use issues likewise arise in industrial laboratories doing synthesis work with "new or unknown" ch emicals.  There are several schemes patterned after the chemical banding approach (fi rst promulgated in the Pharma industry) to categorize chemic als for handling/use when little information about toxicity has been gather ed.  These can be shared - let me know if needed.

With regards,

Mik e

Mi chael N. Cooper MS, MPH, CIH

Senior Managing Scientist

Exponent / Failure Analysis Associates

149 Commonwealth Drive

Menlo Park, California  94025

< P>mcooper**At_Symbol_Here**exponent.c om

c ell (408) 313-2127

office (650) 688-1760


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


My name is Karen Humphrey and I'm the safe ty 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 docume ntation for new chemicals made by our research groups involved with synthes is. 

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

T hank you in advance for your help.

Karen Humphrey

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