Meg McCarthy/DC/USEPA/US 

01/17/2007 03:06 PM	To

	greg.hill@novartis.com

	cc

	

	bcc

	Patricia Mercer/DC/USEPA/US@EPA; Kristin Fitzgerald/DC/USEPA/US@EPA;
James 

Michael/DC/USEPA/US@EPA

	Subject

	Follow-up Question on Novartis' Comment

	

	

Greg Hill

Director, Health, Safety and Environment

Novartis Corporation

1 S. Ridgedale Ave

East Hanover, NJ  07936

Dear Mr. Hill:

 Thank you for your comments on EPA’s Proposed Rule: Subpart
K—Standards 

Applicable to Academic Laboratories (71 Federal Register 29712) on
behalf 

of Novartis Corporation (Novartis).

 In response to Novartis’ comments (Docket Number 

EPA-HQ-RCRA-2003-0012-0106.1), EPA has a few follow-up questions.  On
page 

2 of Novartis’ comments, you recommend that Subpart K be expanded to 

include research laboratories.  EPA is very interested in any
information 

and data that Novartis can provide to help understand the similarities
and 

differences between pharmaceutical research laboratories and college and


university laboratories, as described in the proposed rule.  For
example, 

any information or data describing these laboratories, their activities 

and their hazardous waste generation patterns would be beneficial to EPA


in its development of the final rule.  What type of activities do these 

laboratories conduct?  Do their activities differ day-to-day or are they


fairly routine and/or repetitive?  What types of hazardous wastes are 

generated at these laboratories?  In what amounts are these wastes 

generated?  EPA would find it helpful if you could provide any answers, 

explanations or data relating to any of the above questions.  

Additionally, how does Novartis distinguish between laboratories and 

“production facilities” and “production support (QC)
laboratories” and 

research laboratories as described in Novartis’ comments?  Finally,
EPA 

would appreciate a timely response to allow us to incorporate any 

information you may provide into the decision-making process, as 

appropriate.  Please provide a response by February 16, 2007.  If you
are 

unable to provide a response by then, please contact us to let us know
if 

and when you could provide a timely response.  

Any supporting information you provide to EPA will be made publicly 

available in the docket for the rulemaking, unless the information is 

claimed as Confidential Business Information (CBI).  Therefore, if you 

submit any information that you claim as CBI, clearly mark all of the 

information that you claim to be CBI.  Information so marked will not be


disclosed, except in accordance with procedures set forth in 40 CFR part


2.  Please do not fax any information claimed as CBI.  For additional 

information on how to submit CBI, refer to page 29713, of the May 23, 

2006, Federal Register, proposed rule for academic laboratories, or 

contact LaShan Haynes, the Office of Solid Waste CBI contact, at (703) 

605-0516, Haynes.LaShan@epa.gov.

Again, thank you for your comments on the proposed standards for
academic 

laboratories.  Please direct any questions or response to this letter to


any member of EPA’s labs team:  

Patricia Mercer, (703) 308-8408, Mercer.Patricia@epa.gov

Meg McCarthy, (703) 308-8653, McCarthy.Meg@epa.gov

Kristin Fitzgerald, (703) 308-8286, Fitzgerald.Kristin@epa.gov

*********************************

Meg McCarthy

US Environmental Protection Agency

Office of Solid Waste

Hazardous Waste Identification Division

703-308-8653

mccarthy.meg@epa.gov

*********************************

