Interpretation Response #19-0014
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Attorney at Law
Individual Name: Lawrence W. Bierlein
Location State: DC Country: US
View the Interpretation Document
Response text:
September 18, 2019
Lawrence W. Bierlein
Attorney at Law
1101 30th Street NW
Suite 500
Washington, DC 20007
Reference No. 19-0014
Dear Mr. Bierlein:
This letter is in response to your February 11, 2019, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to medical devices. Specifically, you ask whether an offeror can utilize the exception provided in § 173.134(b)(12)(i) for used medical devices shipped for refurbishment when some of the devices may be "rejected" as determined by the consignee's facility and then disposed of.
The exception provided in § 173.134(b)(12)(i) is for laundry or medical equipment conforming to the regulations of the Occupational Safety and Health Administration of the Department of Labor in 29 CFR 1910.1030 and includes medical equipment intended for use, design, and refurbishment. This exception does not apply to medical equipment being transported for disposal. Once an offeror determines the laundry or medical equipment is not capable of being cleaned or refurbished and is to be disposed of, the provision in § 173.134(b)(12)(i) cannot be utilized. Therefore, an offeror cannot knowingly ship hazardous material meant for disposal under the provision in § 173.134(b)(12)(i). Please note that no person may offer or accept a hazardous material for transportation in commerce unless the hazardous material is properly classed, described, packaged, marked, labeled, and in condition for shipment.
I hope this information is helpful. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention
Standards and Rulemaking Division
173.134(b)(12)(i)
Regulation Sections
| Section | Subject |
|---|---|
| 173.134 | Class 6, Division 6.2-Definitions and exceptions |