Interpretation Response #14-00132 ([Quest Diagnostics] [Mr. Nicholas Pagerly])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Quest Diagnostics
Individual Name: Mr. Nicholas Pagerly
Location State: PA Country: US
View the Interpretation Document
Response text:
October 23, 2014
Nicholas Pagerly
Quest Diagnostics
159 Air Museum Dr.
Reading, PA 19605
Ref. No.: 14-0132
Dear Mr. Pagerly:
This responds to your June 24, 2014 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to Category B infectious substances packaged with dry ice. In your letter, you describe a packaging system that was certified by Ten-E Packaging Services, Inc. for Quest Diagnostics. The packaging system is comprised of a leak-proof primary packaging, contained in a secondary (95kPa compliant) packaging, consolidated in a third bag which is closed by a leak-proof seal. You note that dry ice is then poured on top of this third bag, and that if the completed package is not full, any additional space is filled with dunnage to prevent interior components from shifting during transportation. As such, you state that even when the dry ice sublimates, there is little to no additional room within the package for the secondary packagings to shift during transportation. You ask whether this certified Ten-E Packaging system is in compliance with the HMR.
The answer is yes. As described in your letter, it is the opinion of this Office that your packaging system for your Category B infectious substances packaged with dry ice would meet these requirements. As required by § 173.199(d)(1), dry ice must be placed outside the secondary packaging or in an overpack. Interior supports must be provided to secure the secondary packagings in the original position. If dry ice is used, the outside packaging must permit the release of carbon dioxide gas and otherwise meet the provisions in § 173.217. The primary receptacle and secondary packaging must maintain their integrity at the temperature of the refrigerant used, as well as the temperatures and pressures of transport by aircraft they could be subjected to if refrigeration were lost, and sufficient absorbent material must be provided to absorb all liquid, including melted ice. Furthermore, as required by § 173.199(d)(2), the package must be marked “Carbon dioxide, solid” or “Dry ice” and an indication that the material being refrigerated is used for diagnostic or treatment purposes (e.g., frozen medical specimens).
I trust this satisfies your inquiry. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.199(d)(1), 173.217, 173.199(d)(2)