Interpretation Response #13-0077 ([Bellevue Hospital Center] [Mr. Kieran Toale])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Bellevue Hospital Center
Individual Name: Mr. Kieran Toale
Location State: NY Country: US
View the Interpretation Document
Response text:
July 31, 2013
Mr. Kieran Toale
Industrial Hygenist
and Haz Mat Coordinator
Safety Department
Bellevue Hospital Center
462 First Avenue, Admin. Bldg., Room 742
New York, NY 10016
Reference No. 13-0077
Dear Mr. Toale:
This is in response to your March 20, 2013 e-mail, which was forwarded to this Office on April 12, 2013, and your May 15, 2013 telephone conversation with a member of my staff concerning how to describe pharmaceutical wastes that are transported from your hospital’s healthcare clinic under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).
In your letter, you state that when transported from your hospital, these wastes are divided into two categories: those regulated by the Environmental Protection Agency (EPA) that are described as a hazardous waste, and everything else that is described as “UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG II.” You also state these wastes typically meet one or more of the following hazard classes or divisions: 2.1 (flammable gas), 2.2 (non-flammable gas), 3 (flammable liquid), 5.1 (oxidizer), 5.2 (organic peroxide), 6.1 (poisonous), 8 (corrosive), and 9 (miscellaneous), but rarely contain a Division 6.2 (infectious) material. In addition, you state the wastes are not regulated as hazardous substances under the EPA’s Resource Conservation and Recovery Act. You ask if your understanding is correct that wastes that do not meet the Division 6.2 hazard class may not be offered for transportation described as “UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG II.”
Typically, material, including pharmaceutical waste, that does not contain a pathogen, or in which the pathogen has been inactivated or neutralized so that it cannot cause disease, does not meet the definition of an infectious substances prescribed in § 173.134(a)(1) and must not be described or offered for transportation as a Division 6.2 material under the HMR (see § 173.134(b)(1)-(b)(3)). However, the exception prescribed in § 173.134(c)(2) permits waste pharmaceutical materials to be offered for transportation and transported as RMW when 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 RMW (see Docket No. PHMSA-2009-0151 (HM-218F), July 20, 2011 (76 FR 43530)). Waste pharmaceuticals that meet only one primary hazard class, are chemically compatible, and are placed in one packaging in conformance with the requirements prescribed in § 173.12(b) (lab pack) may be described with generic proper shipping names instead of specific chemical ones, and are excepted from the specification packaging requirements for combination packagings when transported for disposal or recovery by motor vehicle, railcar, or cargo vessel. If the pharmaceutical wastes you describe are not transported in conformance with one of these exceptions, they must be transported in conformance with the requirements prescribed in the HMR for each hazard class they meet. Please note that a person who offers or accepts a package that is not in conformance with the HMR is potentially subject to either a civil or criminal penalty (see §§ 107.329 and 107.333).
I hope this satisfies your request.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.134, 173.24, 173.24a