Mr. Aaron Hackman — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration Administrator 1200 New Jersey Avenue. SE. Washington. DC 20590 1:'\' j ~ 6 Aaron Hackman, BA, RT(R) CT 121 EI 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Hazardous Materials Regulations (HMR: 49 CFR Parts 171-180) applicable to packagings your company uses to collect fluid withdrawn from the bodies of patients.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 typicall y 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, PO 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 mI, 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#

Page 2requirements 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-Sf. Francis Health Services 2222 North Nevada Avenue Colorado Springs, CO 80907 2#

Page 3Edmonson, Eileen (PHMSA) From: Hackman, Aaron [AaronHackman@Centura.Org] Sent: Wednesday, October 19, 2011 6:51 PM To: Edmonson, Eileen (PHMSA) Subject: RE: Evacuated Containers Eileen, Thank you again for the time spent with me today confirming our compliance with shipping our ascites filled evacuated containers. I realized you may not have an address to send the official letter to, so I am providing two, if I may. I would humbly ask that you send a letter to my personal address and work address so that I increase my probability of receiving at least one of them. © Aaron Hackman Radiology Manager, SFMC 6001 East Woodmen Rd. Colorado Springs, CO 80923 Home: Aaron Hackman 121 EI Dorado Lane Colorado Springs, CO 80919 Sincerely, Aaron Hackman, BA, RT(R} CT Manager, Imaging Services Penrose-St Francis Health Services 719-571-1337 From: eileen.edmonson@dot.gov [mailto:eileen.edmonson@dot.gov] Sent: Thursday, October 13, 2011 9:22 AM To: Hackman, Aaron Subject: My Contact Information Eileen Edmonson Transportation Regulations Specialist Pipeline and Hazardous Material Safety Administration U.S. Department of Transportation 1200 New Jersey Avenue, SE, PHH-12 Washington, DC 20590 202-366-4481 (w) 202-366-7041 (f) 202-366-3753 (info ctr fax) http://www.phmsa.dot.gov/hazmat (website) eileen.edmonson@dot.qov (e-mail) infocntr@dot.gov (Hazmat Info Center e-mail) 1#