August 1, 2005

Massachusetts Department of Environmental Protection

Bureau of Waste Prevention

672 Main Street

Worcester, MA 01608

ATTN: Lee Dillard Adams, Deputy Director

RE: Comments on the MA DEP Proposed Regulation to Streamline and Strengthen Environmental Requirements for Massachusetts Biotechnology Facilities.

MassMEDIC, representing 300 medical device companies in Massachusetts, would like to go on record as supporting the Massachusetts Department of Environmental Protection (MA DEP) Biotech Regulatory Package. We are pleased that the Executive Office of Environmental Affairs (EOEA) is working to make Massachusetts a more competitive place for medical device companies to locate their facilities. We are in competition with states like North Carolina, New York, Minnesota and California for several different reasons, workable environmental regulations being one of them.

Hazardous Waste

· MassMEDIC supports the change, which would allow generators to adjust the pH of corrosive solutions on-site (i.e., elementary neutralization) without having to get a license for treatment. This will be a regulatory relief for those companies that have laboratories.

· MassMEDIC supports the change, which would provide a formal process for hazardous waste generators a formal process to apply for a waiver of any regulatory requirement that applies to generators.

Air Pollution Control

• MassMEDIC supports the change, which would provide an unconditional exemption from MADEP preconstruction plan approval for a “biotechnology laboratory”, including research, development or support for medical devices.
• MassMEDIC supports the change, which would provide a conditional exemption for biotechnology surface disinfection processes in lieu of preconstruction plan approval. Although we don’t think it will apply to our industry as much as it will to biotech industry.

Industrial Waste Water

• MassMEDIC agrees with the MBC in that many of its members discharge to the MWRA and therefore would encourage DEP to expand the applicability of the regulations to medical device operations within the metropolitan Boston area. This will help eliminate confusion for companies seeking to site new facilities in Massachusetts.

I would be pleased to speak with you regarding these comments at any time. Please feel free to contact me at 617/414-1340.

Sincerely,

Thomas J. Sommer

President