Interpretation Response #18-0059
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Global First
Individual Name: Mr. Thomas Brennan
Location State: OH Country: US
View the Interpretation Document
Response text:
September 13, 2018
Mr. Thomas Brennan
Vice President
Strategic Accounts & Life Sciences
Global First
10337 Allen Road
Pickerington, OH 43147
Reference No. 18-0059
Dear Mr. Brennan:
This letter is in response to your April 16, 2018, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to transporting cadaveric specimens. You ask for written confirmation of answers you received during an April 13, 2018, telephone conversation with a member of my staff.
You state the specimens are tested and determined to not contain bloodborne pathogens; therefore, they are considered non-infectious. In an April 13, 2018, telephone conversation with a member of my staff you also state the specimens do not meet any other hazard class, but when transported in formalin, they are described as “UN3373, Biological substance, Category B, 6.2 (infectious substance).”
We have paraphrased your questions and answered them as follows:
Q1. You seek confirmation of your understanding that cadaveric tissues, corpses, human remains, and anatomical parts used in research and education to and/or from biomedical skills laboratories are excepted from § 173.134(b)(1), (b)(5), and (b)(14) of the HMR applicable to Division 6.2 (infectious substance).
A1. You are correct that § 173.134(b)(14) provides that corpses, remains, and anatomical parts intended for interment, cremation, or medical research at a college, hospital, or laboratory are not subject to the requirements of the HMR as Division 6.2 materials. Further, a material that is not known or suspected to contain an infectious substance and does not meet the definition of another hazardous material is not regulated under the HMR (see §§ 171.2(k) and 173.134(b)(1)–(5)). Provided the described materials do not meet the definition of any other hazard class or division, the transportation of the remains is not regulated under the HMR.
Q2. You note that the cause of death is sometimes determined after transportation has ended. You ask if a material may be considered non-infectious and not further regulated as a Division 6.2 material in transportation in commerce if the cause of death is found to not require the material to be transported as a Division 6.2, Category A or B material, e.g., from pneumonia or sepsis.
A2. Section 172.101(c)(11) permits a material for which the hazard class is uncertain and which must be determined by testing to be assigned a tentative proper shipping name, hazard class, identification number and packing group, if applicable, based on the shipper’s tentative determination (see § 173.22). If a shipper determines, based on their knowledge of the material, that it is non-hazardous, the provisions of the HMR do not apply to that material.
Q3. You seek confirmation of your understanding that it is a violation of the HMR to designate non-infectious cadaveric specimens as “UN3373, Biological substances, Category B, 6.2.”
A3. Section 171.2(k) states that no person may, by marking or otherwise, represent that a hazardous material is present in a package, container, motor vehicle, rail car, aircraft, or vessel if the hazardous material is not present.
I hope this information is helpful. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.134(b)(1), (b)(5), (b)(14), 172.101(c)(11), 173.22, 171.2(k)