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RE: PHARMACEUTICAL WASTE



Bose Surojit [Surojit.Bose@in.eyi.com] asked:

	> Could anyone give any information on environmental aspects and
their controls in the hormone manufacturing industry? 
	> I am particularly interested in hazardous waste and solvent
disposal practices as well as a general overview of 
	> the environmental impacts and mitigation. 

Bose -- 

If you haven't done so already, you might want to take a look at the EPA's
Pharmaceutical Sector Notebook, which includes a decent regulatory overview
as well as specific pollution prevention strategies and identification of
some of the more direct environmental aspects.  Note that you'll still need
to do some additional research to characterize some of the aspects which
don't have immediate regulatory drivers.

I've copied the following from the EPA Office of Enforcement and Compliance
Assurance (OECA) web site, describing each of the three notebook sections
and their contents.  The final document is a 1997 data supplement and
probably is of marginal value to you based on your question but I've
included it for completeness' sake. 

                                     First Section: 64 pages, 379Kb PDF file

	
http://es.epa.gov/oeca/sector/sectornote/pdf/pharmapt1.pdf
                                          Table of Contents 
                                          Chapter I - Introduction to the
Sector Notebook Project 
                                          Chapter II - Introduction to the
Industry 
                                          Chapter III - Industrial Process
Description 

                                     Second Section: 42 pages, 156Kb PDF
file 
	
http://es.epa.gov/oeca/sector/sectornote/pdf/pharmapt2.pdf
                                          Chapter IV - Chemical Release and
Transfer Profile 
                                          Chapter V - Pollution Prevention
Opportunities 

                                     Third Section: 53 pages, 215Kb PDF file

	
http://es.epa.gov/oeca/sector/sectornote/pdf/pharmapt3.pdf
                                          Chapter VI - Summary of Applicable
Federal Statutes and Regulations 
                                          Chapter VII - Compliance and
Enforcement History 
                                          Chapter VIII - Compliance
Activities and Initiatives 
                                          Chapter IX -
Contacts/Acknowledgments/References 


			1997 supplemental data update (includes 1995 TRI
data)
	
http://es.epa.gov/oeca/sector/sectornote/refresh97/pharm.pdf

You might also want to check out the following two articles from the
ChemAlliance site.  These were written for a broader chemical industry
audience, not specifically to the Pharma industry, but many of the pollution
prevention strategies are relevant nonetheless.

		Pollution Prevention Options for Chemical Manufacturers
	
http://www.chemalliance.org/Columns/improving/P2_Options_for_Chem_Manufactur
ers.htm

		Designing P2 into the Process 
	
http://www.chemalliance.org/Columns/Improving/Improving_the_bottom_line.htm

Finally, I've taken the liberty of sending your question on to the
ChemAlliance Chemical Industry Regulatory Issues Discussion list
(http://www.chemalliance.org/Lists/listinfo.htm) since several of the
subscribers work in or with the Pharma industry.  
Perhaps you'll get some additional insights from that posting.  

Hope this helps.

Scott Butner (butner@battelle.org) 
Senior Research Scientist, Environmental Technology Division
Pacific Northwest National Laboratory
4500 Sandpoint Way, Seattle WA   98105
(206)-528-3290 voice/(206)-528-3552 fax
http://www.chemalliance.org/