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Interpretation Response #08-0035 ([BD Medical - Medical Surgical Systems] [Mr. Lane Arbittier])

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

Interpretation Response Details

Response Publish Date:

Company Name: BD Medical - Medical Surgical Systems

Individual Name: Mr. Lane Arbittier

Location State: CA Country: US

View the Interpretation Document

Response text:

March 21, 2008

 

Mr. Lane Arbittier

Director, Quality Assurance and Regulatory Affairs

BD Medical B Medical Surgical Systems

4665 North Avenue

Oceanside, CA 92056

Reference No. 08-0035

Dear Mr. Arbittier:

This is in response to your January 14, 2008 e-mail asking how hospitals may properly package drugs, chemicals (including those contained in vials, syringes, intravenous tubing, and intravenous bags), and infectious substance wastes in one package and transport them for disposal under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if hospitals may combine these materials in one "super" package at the Packing Group I level without having to comply with the HMR"s segregation requirements, what design features this package should have, and what materials may and may not be combined.

Under the HMR, shippers may combine hazardous materials with other hazardous or non-hazardous materials in the same package provided these materials are not capable of reacting dangerously with each other or causing combustion; a dangerous evolution of heat; evolution of flammable, poisonous, or asphyxiant gases or vapors; or forming an unstable or corrosive material. See §§ 173.21(e) and 173.24(e)(4). Additional requirements regarding the interaction of different hazardous materials within one package, with their packaging materials, and within a transport vehicle are prescribed in § 173.24(b), the remaining paragraphs in §§ 173.24(e), and 173.24a(a) and (c), 173.24b, 174.81, 175.78, as well as Subpart D of Part 176, and Subpart C of Part 177.

If the materials and method a hospital wants to use, such as a super "all purpose" package to combine and ship these materials, do not conform with the existing HMR requirements, the hospital may wish to seek authorization to transport these materials under the terms of a special permit. The procedures for submitting an application for a special permit are



prescribed in § 107.105. Please note the application must contain sufficient information to demonstrate that, if a special permit is issued, a level of safety will be achieved that is equal to or greater than that required under the HMR.

I hope this satisfies your request.

Sincerely,

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

173.21(e) 173.24(e)(4)

 

Regulation Sections

Section Subject
173.197 Regulated medical waste
173.21 Forbidden materials and packages
173.24 General requirements for packagings and packages