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U.S. Department of Transportation U.S. Department of Transportation Icon United States Department of Transportation United States Department of Transportation

Interpretation Response #10-0141 ([Triumvirate Environmental, Inc.] [Mr. John Menzigian])

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

Interpretation Response Details

Response Publish Date:

Company Name: Triumvirate Environmental, Inc.

Individual Name: Mr. John Menzigian

Location State: MA Country: US

View the Interpretation Document

Response text:

October 14, 2011

 

 

 

Mr. John Menzigian

Triumvirate Environmental, Inc.

61 Innerbelt Road

Somerville, MA 02143

Reference No. 10-0141

Dear Mr. Menzigian:

This is in response to your e-mail requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) regarding the regulated medical waste (RMW) exception in § 173.134(c)(2) that allows transportation of a stock or culture of a Category B infectious substance as RMW with laboratory products. You ask if the conditions described in a previous interpretation, i.e., RMW must be a laboratory product and accepted at a single facility, are required to use the § 173.134(c)(2) exception.

The answer is no. This exception does not require RMW and laboratory products to be accepted, or disposed of, at a single facility. Your question is based on an interpretation we issued on March 19, 2007 (Reference No. 07-0057) in which we state a private or contract carrier can use the exception for RMW containing a waste stock or culture of a Category B infectious substance when carrying "other types of hazardous materials." You state the incoming letter for that inquiry listed laboratory products that are not classified as RMW for disposal purposes by the Environmental Protection Agency (EPA). You also state that these products usually require disposal at separate hazardous waste facilities permitted to receive these materials, and generally cannot be accepted for disposal at a RMW facility.

We issued two interpretations in 2007 concerning this exception, Reference No. 07-0057, which you referred to in your request, and Reference No. 07-0094 (7/10/07). We developed these interpretations based on the information submitted by the letter writers. Upon reviewing your request, we have determined the information you have provided is not consistent with the information we considered when issuing these previous interpretations. Therefore, to answer your question, and also provide additional clarification for these previous interpretations, we present the following transportation scenarios and our guidance regarding the applicability of the RMW exception in § 173.134(c)(2) to these scenarios.



SCENARIO 1:

A private or contract carrier transports Category B infectious substances as RMW in a motor vehicle used exclusively to transport these materials along with other types of medical wastes which may not be regulated under the HMR, or are not hazardous but are typically generated by laboratories, hospitals, and similar facilities. These wastes include:



1) plant and animal waste regulated by the Animal and Plant Health Inspection Service, U.S. Department of Agriculture;

2) waste pharmaceutical materials;

3) laboratory and recyclable wastes, such as fixer/developer, amalgam, lead foil, and disinfectant materials;

4) infectious substances, including Category A infectious substances, that have been treated to eliminate or neutralize pathogens;

5) forensic materials being transported for final destruction;

6) rejected or recalled health care products; and

7) documents intended for destruction in accordance with Health Insurance Portability and Accountability Act (HIPAA) requirements.

The carrier believes these types of wastes are included under the exception prescribed in § 173.134(c)(2) because:



1) these wastes are difficult to identify and segregate from waste cultures and stocks;

2) waste generators may ask their carriers to transport other types of medical waste in addition to waste cultures and stocks;

3) 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; and

4) all of these waste materials are transported to facilities designated for the disposal of medical waste.

SCENARIO 1 RESPONSE:

The § 173.134(c)(2) exception requires that a waste stock or culture of a Category B infectious substance be transported by a private or contract carrier in a vehicle used exclusively to transport RMW. Under the HMR, "culture" means an infectious substance containing a pathogen that is intentionally propagated (see § 173.134(a)(3)). The term does not include human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention, such as excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles) (see § 173.134(a)(3) and (a)(4)).

Also, § 173.134(c)(2) requires that a waste stock or culture of a Category B infectious substance be packaged in a rigid non-bulk packaging in conformance with the packaging requirements in §§ 173.24, 173.24a and 29 CFR 1910.1030. 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 conformance with the exception prevents inadvertent contamination of other types of materials, including non-medical waste materials. Thus, non-medical waste materials must not be transported on the same vehicle as RMW that contains a Division 6.2 waste stock or culture. Additionally, if the material meets the definition of another hazard class or if it is a hazardous substance, hazardous waste, or marine pollutant, it must be offered for transportation and transported in accordance with the applicable requirements of the HMR.

Medical or clinical equipment and laboratory products may be transported on the same vehicle as a Category B waste stock or culture provided they are properly packaged and secured against exposure or contamination. While the term "laboratory products" is not defined in the HMR, the materials listed above are described as being generated from laboratories, hospitals, and similar facilities. Materials generated at these types of facilities have a greater opportunity to become cross-contaminated with Division 6.2 materials.

Further, all of the materials listed above are transported to facilities designated for the disposal of medical waste. Authorized medical waste disposal facilities are subject to federal, state, local, and tribal laws regarding the treatment and/or disposal of medical waste and are designed to contain potential biological hazards and prevent their release into the environment. Transporting these materials to authorized medical waste disposal facilities minimizes their ability to cross-contaminate other materials. Therefore, it is the opinion of this Office that the materials listed above, which are transported and disposed of in the manner that was described, may be considered laboratory products for the purposes of the § 173.134(c)(2) exception.

SCENARIO 2:

A private or contract carrier transports a Category B waste stock or culture as RMW in a motor vehicle used exclusively to transport these materials along with soiled linen and laundry, which may or may not be hazardous under the HMR, that is typically generated by laboratories, hospitals, and similar facilities. The Category B waste stock or culture is delivered to a facility that treats and/or manages Division 6.2 wastes. The soiled linen and laundry is not transported to a medical waste facility for disposal, but rather, is transported to a facility that cleans and manages medical laundry. The carrier believes the soiled linen and laundry are materials included under the § 173.134(c)(2) exception.

SCENARIO 2 RESPONSE:

It is the opinion of this Office that the soiled linen and laundry are not laboratory products as that term is used and understood for purposes of the HMR, and may not be transported on the same vehicle as a Category B waste stock or culture under the § 173.134(c)(2) exception. In our previous response to the Reference No. 07-0094 letter, we stated soiled linen and laundry are not medical waste as this term is defined in § 173.134(a)(5). Upon further review, we determined this statement is incorrect; soiled linen and laundry intended for disposal or reuse that is derived from the medical treatment of an animal or human meets the HMR definition of RMW. Therefore, soiled linen or laundry containing a Category A infectious substance must be classed as an infectious substance and assigned to identification number UN 2814 or UN 2900, as appropriate. Soiled linen or laundry containing a Category B infectious substance must be classed as an infectious substance and assigned identification number UN 3291.

Notwithstanding, if the laundry or medical equipment (not including medical equipment intended for disposal) conforms to 29 CFR 1910.1030, it is excepted from regulation under the HMR (see § 173.134(b)(12)(i)). We granted this exception in a final rule issued under Docket No. HM-181G because:

1) laundry is typically segregated from waste materials at the point of generation and specially handled and reprocessed by employees dealing exclusively with laundry;

2) we believe that OSHA requirements applicable to laundry and medical equipment provide an adequate level of safety in transportation; and

3) we believe it is unreasonable and impractical to require RMW packaging and hazard communication for laundry and medical equipment that are intended for reuse (see 60 FR 48780; 9/20/1995).

As we stated in our Scenario 1 Response, non-medical waste materials must not be transported on the same vehicle as RMW that contains a Division 6.2 waste stock or culture.

SCENARIO 3:

Most licensed waste facilities are not authorized to receive and treat both RMW and other types of waste products. Therefore, the same wastes packaged and transported on the same vehicle in the manner described in Scenario 1 are delivered to different facilities--the RMW is delivered to facilities authorized to receive RMW, and the other wastes are delivered to facilities authorized to treat the overall physical properties of these wastes but not the biological hazards they may contain.

SCENARIO 3 RESPONSE:

Although we have previously interpreted the wastes listed in Scenario 1 as laboratory products, this exception does not require RMW and laboratory products to be disposed at a single facility. In addition, please note that delivering RMW materials to locations not designed to manage these risks may increase the opportunity for their release. You would need to contact the facilities to determine such regulatory jurisdiction. State regulations vary. In some states, facilities are state run and in other states, facilities may be regulated by EPA requirements. Conflicts between the HMR and other federal agency requirements are resolved through this agency"s Office of Chief Counsel. Also, a requirement of a state, local, or tribal government that conflicts with requirements in the HMR is preempted, unless otherwise authorized by another Federal statute or a waiver of preemption issued by the Department of Transportation. This agency makes preemption determinations applicable to specific non-Federal requirements on a case-by-case basis. The regulatory procedures for administrative determinations of preemption are set forth in 49 CFR Part 107, Subpart C.

We further recommend that care should be taken when transporting materials on the same vehicle with a waste stock or culture of a Category B infectious substance. Waste cultures and stocks of Division 6.2 materials may remain pathogenic for a longer period of time than most medical wastes because they are often disposed with the host media used to intentionally propogate them. The surfaces of packages containing non-contaminated items may become contaminated by direct or indirect contact (e.g., transfer or aerosolization) with pathogenic materials emitted from or on the surface of RMW packages, their transport containers, or transport vehicles. As a result, clean items within these packages may inadvertently become contaminated when they come in contact with the hands or tools used to open them. We recommend when such transportation occurs that shippers and carriers take steps to prevent the contamination of the outer surfaces of these packages.

I hope this information is helpful. Please contact this office if you have additional questions.

Sincerely,

Charles E. Betts

Director

Standards and Rulemaking Division

cc: Ms. Selin Hoboy

Stericycle, Inc.

303 South Broadway, Suite 200 PMB#105

Denver, CO 80209

Mr. Neal Beenenga

District Manager

MTS Medical Waste

3152 North 34th Drive

Phoenix, AZ 85017

173.134, 173.24, 173.24a,

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.24 General requirements for packagings and packages
173.24a Additional general requirements for non-bulk packagings and packages