Interpretation Response #04-0279 ([Daniels Sharpsmart, Inc.] [Mr. Terry Grimmond])

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

Interpretation Response Details

Response Publish Date: 06/29/2005

Company Name: Daniels Sharpsmart, Inc.

Individual Name: Mr. Terry Grimmond

Country: NZ

View the Interpretation Document

Response text:

Jun 29, 2005

Mr. Terry Grimmond                 Reference No. 04-0279

Clinical Director

Daniels Sharpsmart, Inc.

3 Tarbett Road Hillcrest

Hamilton 2001, New Zealand

Dear Mr. Grimmond:

This is in response to your letter and electronic mail concerning how to classify and transport chemotherapeutic and pharmaceutical wastes under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We paraphrased your questions and answered them in the order provided. We apologize for the delay in responding and any inconvenience this may have caused.

Question 1.     What hazard classes are chemotherapeutic and pharmaceutical wastes?

Answer 1.      The hazard class assigned to a material is based on its chemical composition, concentration of ingredients, and hazard characteristics. Under § 173.22 of the HMR, the shipper is responsible for determining if a material meets the definition of a hazard class, assigning the material an appropriate proper shipping name, and selecting the appropriate package, markings, and labels. Sometimes, more than one proper shipping name from the Hazardous Materials Table (HMT; § 172.101) may describe the same material. For example, a shipper may assign a waste chemotherapy drug that meets the definition of a Division 6.1 (poison) hazard class the generic proper shipping description "Waste Medicine, solid, toxic, n.o.s., 6.1, UN 3249, PG II," or "Waste Toxic solids, organic, n.o.s., 6.1, UN 2811, PG II," or, if applicable, assign it a proper shipping description based on a specific chemical name.

For your reference, § 171.8 defines a hazardous waste to mean a waste material that is subject to the Uniform Hazardous Waste Manifest (UHWM) requirements of the US. Environmental Protection Agency specified in 40 CFR Part 262. A waste that does not require completion of a UHWM is not considered a "hazardous waste" for purposes of the HMR and is not subject to the HMR unless it meets the definition of a hazardous material under the HMR. Further, when a shipper chooses a proper shipping name, the accompanying information for that entry on the HMT must be used in its entirety and may not be interchanged with that of any other entry. If a material does not meet the definition of a HMR hazard class, and. it is not a hazardous waste, hazardous substance, or marine pollutant, it is not regulated as a hazardous material under the HMR.

Question 2.     What UN numbers apply to chemotherapeutic and pharmaceutical wastes? Neither term is assigned a UN number in Column 4 of the HMT. Does this mean these materials are not hazardous under the Department of Transportation"s regulations? The UN numbers on the HMT do mention "Medicine liquid, toxic, n.o.s., 6.1, UN 1851, PG II or III" and "Medicine, solid, toxic, n.o.s., 6.1, UN 3249, PG II or III."

Answer 2.    The same answer as in Al.

Question 3.   If chemotherapeutic and/or pharmaceutical wastes are mixed with

Division 6.2 (infectious) sharps, does the Division 6.2 hazard class take precedence? In discussions with Ms. Eileen Edmonson of your staff, she said Division 6.2 takes precedence over chemotherapeutic and pharmaceutical waste and referred to § 173.1 97(d)(3 )(vi).

Answer 3.    Section 173 .2a specifies how to classify a material having more than one hazard under the HMR. Under § 173.2a(c)(3), a material that meets the definition of a Division 6.2 hazard class and another hazard class, which may include a limited quantity Class 7 material but no other type of Class 7 material, must be classed as Division 6.2.

Question 4.    If chemotherapeutic and/or pharmaceutical wastes are mixed with Division 6.2 sharps, are neither Division 6.1 or Division 6.2 labels required if a BIOHAZARD marking is present on the sharps container?

Answer 4.    Sections 172.400 and 172.402(a) require the outside of each package containing a hazardous material to be labeled as specified for the material in the HMT, including those for the subsidiary hazard class if applicable. The HMR include an exception from labeling in §173.134(c)(l) for "Regulated medical waste, 6.2 (infectious), UN 3291, PG II" (RMW) transported by a private or contract carrier in a non-specification, rigid, non-bulk package conforming to § 173.24 and 173.24a, and 29 CFR 1910.1030. If a package of RMW meets the requirements of the exception, a shipper may place the BIOHAZARI) marking conforming to 29 CFR. 1910.1030, and shown in § 172.323, on the outside of the package in place of the INFECTIOUS SUIBSTANCE label shown in

§ 173.432. To qualify for this exception, § 173.1 34(c)(l)(ii) requires that the package not contain a waste culture or stock of a Division 6.2 material. Further, § 173.134(d) requires that 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 comply with the applicable requirements of the HMR for each hazard class it contains, which include, if applicable, placing the Division 6.1 label on the outside of the package.

I hope this information is helpful.

Sincerely,

Hattie L. Mitchell, Chief

Regulatory Review and Reinvention

Office of Hazardous Materials Standards

173.197(d)(1)(vi)

Regulation Sections