Interpretation Response #11-0261 ([Mr. Aaron Hackman])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name:
Individual Name: Mr. Aaron Hackman
Location State: CO Country: US
View the Interpretation Document
Response text:
January 26, 2012
Mr. Aaron Hackman, BA, RT(R) CT
121 El Dorado Lane
Colorado Springs, CO 80919
Reference No. 11-0261
Dear Mr. Hackman:
This is in response to your October 13, 2011 telephone conversation with a member of my staff, and October 19, 2011 e-mail requesting clarification of the Hazardous Materials Regulations (HMR: 49 CFR Parts 171-180) applicable to packagings your company uses to collect fluid withdrawn from the bodies of patients. You state these fluids typically contain minor amounts of the patient"s blood, may meet the definition of a Category B, Division 6.2 (infectious substance) material, and are described as "UN 3291, Regulated medical waste, 6.2, PG II," (RMW). You also state a contract carrier supplies your company with these packagings and transports them for disposal by motor vehicle.
You describe the packagings as being composed of 6 vacuum-sealed glass bottles that range in size from 250 ml to 1,000 ml, each placed in a fiberboard box and separated by a 6-place divider insert composed of fiberboard. You state two bottles of Vital Care Super Solidifier absorbent powder are emptied into this box, which is then closed by folding one corner on each flap at the top of the box under the corner of the adjoining flap. You also state two of these boxes are placed in a red polyethylene bag that is folded closed and then secured within a red polyethylene bin that is closed with a lid that snaps shut. In addition, you state the outer surface of the bin has directional arrows as prescribed § 172.312(a)(2), and the BIOHAZARD symbol as prescribed in § 172.323(c). You also provide pictures of the packaging"s components. You ask if these packagings comply with § 173.134(c) of the HMR.
The answer is no. It is the opinion of this Office that use of both the folded polyethylene bag and snap shut lid on the polyethylene box would not be effective in preventing the liquid contents of this packaging from being released if one or more of the inner bottles were to break. However, this condition may be avoided if the polyethylene bag were closed in a manner (e.g., twist-tied closed or sealed) that prevented it from releasing its liquid contents.
To be excepted from the specification packaging requirements for RMW prescribed in § 173.197, the HMR require that the package comply with the requirements prescribed in § 173.134(c)(1). These requirements specify that the packaging must be rigid, conform to the general packaging requirements in §§ 173.24 and 173.24a, and comply with the requirements prescribed in 29 CFR 1910.1030 of the Department of Labor, Occupational Safety and Health Administration"s requirements for bloodborne pathogens. Sections 173.24(b)(1) and 173.24(f)(1)(i) require that the packagings and their closures must be designed and closed so that under transportation conditions normally incident to transportation, there is no identifiable release of hazardous material to the environment from the packaging or from the opening to which the closure is applied. Section 173.24(f)(1)(ii) also requires that the packaging closures must also be leakproof and secured against loosening. Additionally, the packaging must: 1) be transported by motor vehicle by a private or contract carrier; 2) not contain any RMW waste cultures or stock; and 3) display the BIOHAZARD marking in accordance with 29 CFR 1910.1030 to be excepted from having to display the INFECTIOUS SUBSTANCE label.
I hope this satisfies your request.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
cc: Mr. David Linebaugh
Safety Officer
Penrose-St. Francis Health Services
2222 North Nevada Avenue
Colorado Springs, CO 80907
172.312, 172.323, 173.134, 173.24, 173.197