From: Vaiju Bagal <vaiju.bagal**At_Symbol_Here**EMDGROUP.COM>
Subject: [DCHAS-L] Why are QC/Qa labs not covered by the Lab Standard?
Date: Thu, 4 Feb 2016 13:40:17 +0000
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: e05722910fb14c21a6d3e13004c702c4**At_Symbol_Here**

All –


I’ve looked at the lab standard directly on the OSHA site and also at the comments from 1991 memorandum from Patricia Clark to John Miles.


1.       QC/QA labs are not covered under the lab standard, because they support production.

a.       Yet, they use laboratory scale quantities of reagents, which are also very often different from the materials used in production.

b.      These lab people experience the same scales of exposure, waste management and handling situations as those in independent labs, not just like their production line coworkers.


2.       Bench-scale operations that look at substitutes for processes – because they are considered R&D and not QC/QA

a.       Yet for sure they support production.

b.      Usually these chemical quantities are larger than in QC/QA.

c.       The reagents may or may not be different from what is used in production, but the scale of use is larger than in any lab, certainly a quality lab even if considered “lab-scale.”


3.       Repetitive procedures in workplaces which are not production sites

a.       Even a small amount produced for subsequent scale invalidates coverage under lab standard. This I understand,

b.      These are repetitive just like QC/ QA. They are also unlikely to change. So why are they covered by lab standard?


I do not understand the point of the distinction. The end result would be to bind QC/QA labs to the OSHA regulations for large production level quantities of chemicals.


Can anyone enlighten me?





Ujjvala (Vaiju) Bagal
Quality Scientist/QM Key User/Chemical Hygiene Officer

EMD - Living Innovation

EMD Performance Materials Corp. 110 EMD Blvd. Savannah, GA 31407 USA
Phone: 912-966-4421 Fax 912-966-5917
Email:   vaiju,bagal**At_Symbol_Here** -
EMD Performance Materials Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany



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