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Interpretation Response #09-0043 ([Otto Environmental Systems] [Mr. Rob Ellis])

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

Interpretation Response Details

Response Publish Date:

Company Name: Otto Environmental Systems

Individual Name: Mr. Rob Ellis

Location State: NC Country: US

View the Interpretation Document

Response text:

August 24, 2009

 

 

Mr. Rob Ellis

Director of Market Development

Otto Environmental Systems

12700 General Drive

Charlotte, NC 28273

Reference No. 09-0043

Dear Mr. Ellis:

This is in response to your February 22, 2009 letter requesting clarification of the packaging requirements for "UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG II" under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We have paraphrased your questions and answered them in order. We apologize for the delay in responding and any inconvenience this may have caused.

Q1. Based on the regulatory language in § 173.134, are packaging requirements applicable to regulated medical waste (RMW) limited to those prescribed in § 173.197 that were revised on October 1, 2007?

A1. No. Regulated medical waste that contains a Category A infections substance must be described as "UN2814, Infectious substances, affecting humans, 6.2" or "UN2900, Infectious substances, affecting animals, 6.2", as appropriate, and packaged in accordance with the requirements in §173.196. Regulated medical waste that contains a Category B infectious substance may be placed in packagings that meet the requirements in § 173.6 (materials of trade), 173.134 (exceptions), or 173.197 (regulated medical waste), as applicable. Section 173.6(a)(4)(ii) requires RMW to be placed in a combination packaging; § 173.196(a) requires RMW to be placed in a triple packaging; and §§ 173.134(c)(1) and (c)(2), and 173.197 require RMW to be placed in a single or combination packaging depending on the packaging's design type and performance.

Q2. May RMW be transported in a bulk outer packaging (BOP) such as a plastic 32 g, 65 g, 95 g, 660 L or 770 L cart with an appropriate inner container such as a standard "red bag" and with an appropriate exterior label on the plastic cart (examples attached).

A2. Yes. Under the HMR, regulated medical waste may be transported in a BOP provided the packaging conforms to the requirements in § 173.197(a), (d), and (e).

Q3. May chemotherapeutic waste be transported in a BOP such as a plastic 32 g, 65 g, 95 g, 660 L or 770 L cart with an appropriate inner container such as an approved chemotherapeutic yellow container and appropriate labeling (examples attached).

A3. The hazard class assigned to chemotherapeutic waste is based on its chemical composition, concentration of ingredients, and hazard characteristics. Under § 173.22, the shipper is responsible for determining if a material meets the definition of a hazard class, and for assigning the material an appropriate proper shipping name and selecting the appropriate packaging, markings, and labels. Division 6.2 chemotherapeutic waste may be placed in a BOP that conforms to the packaging requirements prescribed in § 173.197 (c), (d), and (e). Section 173.134(d) requires a Division 6.2 material listed in the exceptions under § 173.134(b) and (c) that also meets the definition of another hazard class, or that is a hazardous substance, hazardous waste, or marine pollutant to comply with the applicable requirements of the HMR for each hazard class it contains, which includes, if applicable, placing the Division 6.1 label on the outside of the package. Please note that chemotherapeutic waste that meets more than one hazard class must be classed in accordance with the provisions contained in § 173.2a, and, as stated earlier, must conform to the applicable requirements for each hazard class. Also, § 173.2a(c)(3) requires a Division 6.2 material that also meets the definition of another hazard class, which may include a limited quantity Class 7 material but no other type of Class 7 material, to be classed as Division 6.2.

Q4. May sharps be transported in a BOP such as a plastic 32 g, 65 g, 95 g, 660 L or 770 L cart with an appropriate inner container such as an approved sharps container and appropriate labeling (examples attached).

A4. Yes. Under the HMR, sharps that are regulated medical waste may be transported in a BOP provided the packaging complies with § 173.197(a), (d), (e) introductory paragraph, and (e)(3).

I hope this satisfies your request.

Sincerely,

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

173.197, 173.196, 173.6, 173.134, 173.2a

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.197 Regulated medical waste
173.22 Shipper's responsibility