Interpretation Response #98-0529 ([Pall Corporation] [Ms. Susan Morrissey])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Pall Corporation
Individual Name: Ms. Susan Morrissey
Location State: NY Country: US
View the Interpretation Document
Response text:
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)(l)(i) and 173.134 (b)(l)(iii) respectively, from the requirements of the HMR 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,
Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards
Regulation Sections
| Section | Subject |
|---|---|
| 173.134 | Class 6, Division 6.2-Definitions and exceptions |