Interpretation Response #07-0057 ([Stericycle, Inc.] [Ms. Selin Hoboy ])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 03/19/2007

Company Name: Stericycle, Inc.

Individual Name: Ms. Selin Hoboy 

Location State: IL Country: US

View the Interpretation Document

Response text:

Mar 19, 2007

Ms. Selin Hoboy                 Reference No. 07-0057
Stericycle, Inc.
2333 Waukegan Road
Bannockburn, Illinois 60015

Dear Ms. Hoboy:

This responds to your March 9, 2007 letter requesting clarification of the requirements for transporting regulated medical waste under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask about the exception in § 173.134(c) applicable to the transportation of waste cultures and stocks and for clarification of the types of materials that may be transported on the same vehicle as waste cultures and stocks in accordance with the exception.

The exception in § 173.134(c)(2) permits a waste stock or culture of a Category B infectious substance to be offered for transportation and transported as a regulated medical waste when it is packaged in a rigid non-bulk packaging conforming to the general packaging requirements of § 173.24 and 173.24a and packaging requirements specified in 29 CFR 1910.1030 and transported by a private or contract carrier in a vehicle used exclusively to transport regulated medical waste. As your letter notes, in a final rule published [insert date] under docket number HM -226A, we amended the language in this section to insert the phrase “used exclusively to transport regulated medical waste” in place of the phrase “dedicated to the transportation of regulated medical waste”.

The change in terminology in § 173.134(c)(2) was intended to be a non-substantive editorial change to standardize terminology used throughout the HMR. The terms “dedicated” and “used exclusively” are synonymous. “Exclusive use” is not defined in the HMR, for other than transport of radioactive materials. As used in the HMR, the terms “dedicated” and “used exclusively” mean the vehicle is used for the transportation of a single commodity or class of commodities.

According to your letter, it is difficult to identify and segregate waste cultures and stocks from other types of medical waste generated by laboratories, hospitals, and similar facilities. You note that typically waste cultures and stocks are treated to neutralize any infectious pathogens prior to transportation, although untreated waste cultures and stocks may also be transported. You indicate that waste generators may ask Stericyle to transport other types of medical waste in addition to waste cultures and stocks, including:

• Plant and animal waste regulated by the Animal and Plant Health Inspection Service, U.S. Department of Agriculture;
• Waste pharmaceutical materials;
• Laboratory and recyclable wastes, such as fixer/developer, amalgam, lead foil, and disinfectant materials;
• Infectious substances, including Category A infectious substances, that h been treated to eliminate or neutralize pathogens;
• Forensic materials being transported for final destruction;
• Rejected or recalled health care products; and
• Documents intended for destruction in accordance with HIPAA requirements.
• You indicate that all these waste materials are transported to facilities designated for the disposal of medical waste.

As described above, the. exception in § 173.134(c)(2) permits Category B waste cultures and stocks to be transported as regulated medical waste in a rigid non-bulk packaging conforming to certain general packaging requirements when transported by a private or contract carrier in a vehicle used exclusively to transport regulated medical waste. An exclusive-use vehicle is one used for the transportation of a single commodity or class of commodities; transportation in an exclusive-use vehicle in accordance with the exception prevents inadvertent contamination of other types of materials, including non-medical waste materials. The operations you describe for the transportation of waste cultures and stocks appear to meet the intent of this exception. While the materials you transport on the same vehicle as waste cultures and stocks are not regulated medical waste, as that term is defined in the HMR, all the materials are considered medical waste and are transported to facilities designated by local authorities and designed for the disposal of medical waste.

Further, under  § 173.134(c)(2), you may transport medical or clinical equipment and laboratory products on the same vehicle as the waste cultures and stocks covered by the exception, provided they are properly packaged and secured against exposure or contamination. The term “laboratory products” is not defined in the HMR. However, the materials you describe are generated from laboratories and health care facilities and, thus, may be considered laboratory products for the purposes of the exception.

Therefore, it is the opinion of this Office that the transportation operation you describe is consistent with the terms of the exception in § 173.134(c)(2). Therefore, you may transport the types of medical waste described in your letter on the same vehicle you use to transport waste cultures and stocks.

I hope this information is helpful. Please let me know if I can be of further assistance.

Sincerely,

Susan Gorsky
Regulations officer
Office of Hazardous Materials
   Standards

173.134

Regulation Sections