Pall Corporation — Hazardous Materials Safety Interpretation

Page 1= U.S.Department of Transportation 400 Seventh Street, S.W. Washington, D.C. 20590 Research and Administration Special Programs FEB 25 1998 Ms. Susan Morrissey Environmental Services Consultant Pall Corporation 25 Harbor Park Drive Port Washington, NY 11050 Dear Ms. Morrissey: This is in response to your letter of May 5, 1997, requesting clarification of requirements for transporting used medical devices and human donor blood under the Hazardous Material Regulations (HMR; 49 CFR Parts 171-180). You stated in your letter and in a subsequent telephone conversation, on September 17, 1997, with Mr. Charles Betts of my staff that neither the medical devices or the human donor blood contained known infectious agents. The HMR define an "infectious substance" in § 173.134 (a)(1) as a viable microorganism, or its toxin, which causes or may cause disease in humans or animals. This includes agents listed in 42 CFR 72.3 of the regulations of the Department of Health and Human Services and any other agent that causes or may cause severe, disabling, or fatal disease. Biological products (i.e., human donor blood) and medical equipment (i.e., used medical devices that conforms to 29 CFR 1910.1030 of the regulations of the Occupational Safety and Health Administration of the Department of Labor) are excepted, under §§ 173.134 (b)(1)(i) and 173.134 (b) (ill) respectively, from the requirements of the HIMR if the items as packaged do not contain any material that would otherwise be subject to any other Department of Transportation hazard class. Therefore, based on the information you provided, it appears that the medical devices and human donor blood would not be subject to the HMR. I hope this information is helpful. Should you have further questions, do not hesitate to contact uS. : Sincerely, Hotter. Mithelo Hattie L. Mitchell, Chief 1 Regulatory Review and Reinvention Office of Hazardous Materials Standards :#

Page 2Betto File: 173.134 Pall Corporation SC: 133,132 - Phone 516-484-3600 • FAX 516-484-3651 25 Harbor Park Drive • Port Washington, NY 11050 • USA May 5, 1997 Mr. Edward T. Mazzullo RSPA U.S. Department of Transportation Attention: DHM-10 400 7* Street SW Washington, D.C., 20590 - -- - ---- Re: Pall Corporation Request for Determination of a Hazardous Material Dear Mr. Mazzullo: We are writing to your attention to request guidance on forming a hazardous material determination for transporting: (1) returned medical devices and (2) human donor blood. These medical devices are potentially infectious because they are returned goods from hospitals used in patient care and may have been in contact with potentially infectious materials such as human blood, platelets and intravenous fluids. The human donor blood is tested and screened for infectious disease markers. Neither of these materials contain known infectious agents. Please advise how these materials should be classified and packaged for transport / (i1) 48 -doi;, ext theris further information that we may provide, please contact me at We this it!' Sincerely, PALL CORPORATION susan Morrissey Susan Morrissey Environmental Services Consultant#

Page 3Scientific & Laboratory Services Dept. ) all Corporation • 25 Harbor Park Drive Port Washington, NY 11050 • USA Mr. Edward T. Mazzullo U.S. Department of Transportation RSPA ATTN: DHM-10 400 7th Street SW Washington, DC, 20590#