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Interpretation Response #11-0314 ([BioStorage Technologies] [Ms. Darcy Britt])

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

Interpretation Response Details

Response Publish Date:

Company Name: BioStorage Technologies

Individual Name: Ms. Darcy Britt

Location State: IN Country: US

View the Interpretation Document

Response text:

March 6, 2012

 

 

Ms. Darcy Britt
Global Logistics Compliance Supervisor
BioStorage Technologies
2910 Fortune Circle West Drive, Suite E
Indianapolis, IN  46241

Reference No. 11-0314

Dear Ms. Britt:

This is in response to your December 19, 2011 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to human specimens collected from multiple patients at their residences as part of a clinical trial to develop diagnostic tests for detecting colon cancer or pre-cancerous cells. 

Specifically, you state when a sufficient number of the samples have been collected, the parent company conducting the study ships them in bulk packages on dry ice to a third-party warehouse where they are held for long-term storage at -80 ºC.  You also state at a future date these samples will be shipped from the third-party warehouse to a clinical laboratory for routine testing, but at no point will they be tested to determine their hazard class " so it is unknown.  In addition, you state the parent company employees are hazmat trained in accordance with 49 CFR Part 172, Subparts H (training) and I (security), and have determined the proper classification of the specimens is "Exempt Human Specimen," a designation authorized under Section 6.3.2.3.6 of the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transportation of Dangerous Goods by Air (Technical Instructions).  We have paraphrased your questions and answered them in the order you provided. 

Q1.      Do batched shipments of numerous, different patient specimens classed by trained personnel as "Exempt Human Specimen," and shipped in bulk packages from a parent company to a third-party warehouse for long-term, ultra-cold storage qualify as excepted from regulation under the HMR in conformance with § 173.134(b)(11)? 

A1.      The answer is yes.  Under § 173.134(b)(11), a human or animal sample being transported for routine testing not related to the diagnosis of an infectious disease and for which there is a low probability that the sample is infectious is not subject to regulation under the HMR.  For your information, please note that "Exempt Human Specimen" is not a hazard class or wording that appears in the HMR.  It is a marking required under Part 2, Chapter 6, § 6.3.2.3.6 of the ICAO Technical Instructions for patient specimens for which professional judgment has been used to determine that there is minimal likelihood pathogens are present, and the specimens are packaged in conformance with that section and offered or intended for transportation by aircraft.  49 CFR Part 171, Subpart C, and, specifically, §§ 171.22, 171.23 and 171.24 authorize the use of the ICAO Technical Instructions for the transportation of hazardous materials by aircraft.  However, since the specimens you describe are excepted from regulation under the HMR, use of the "Exempt Human Specimen" marking is neither required nor prohibited.

Q2.      Is it a violation of the HMR to label these shipments "Exempt Human Specimen" and claim the exception under § 173.134(b)(11) when ordered by the parent company to ship these specimens to a clinical laboratory for routine testing?

A2.      The answer is no.  See Answer A1.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

173.134,171.22, 171.23, 171.24

Regulation Sections

Section Subject
171.22 Authorization and conditions for the use of international standards and regulations
171.23 Requirements for specific materials and packagings transported under the ICAO Technical Instructions, IMDG Code, Transport Canada TDG Regulations, or the IAEA Regulations
171.24 Additional requirements for the use of the ICAO Technical Instructions
173.134 Class 6, Division 6.2-Definitions and exceptions