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Interpretation Response #14-0086 ([Fairview Hospital] [Ms. Christina D. Cahill CNMT. RT (R)])

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

Interpretation Response Details

Response Publish Date:

Company Name: Fairview Hospital

Individual Name: Ms. Christina D. Cahill CNMT. RT (R)

Location State: LA Country: US

View the Interpretation Document

Response text:

July 8, 2014

Ms. Christina D. Cahill CNMT, RT(R)
Lead Technologist
Fairview Hospital
29 Lewis Ave.
Great Barrington, MA 01230

Ref. No.: 14-0086

Dear Ms. Cahill:

This is in response to your email dated April 18, 2014, requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) relating to the transportation requirements for radioactive surgical specimens.  You state that your radioactive specimens have an activity of 1.0 millicuries or less prior to injection, and after injection there is some residual in the syringe.  You state that there will be less than .27 millicuries of Technetium-99m (Tc-99m) by the time the driver would handle any radioactive material.  Your questions are paraphrased and answered below:

Q1.      You ask if training for personnel and couriers must comply with the training requirements found in Subpart H of Part 172 of the HMR.

A1.      Section 173.436 sets activity concentrations for exempt material and activity limits for exempt consignments.  The activity limit for exempt consignments of Tc-99m is less than .27 millicuries.  If the only radionuclide present is Tc-99m, and the total activity in the consignment is less than either the activity concentration limit or the activity limit for consignments shown in § 173.436, that consignment would not be considered to be a radioactive material under the HMR.  Assuming the specimen does not meet the definition of any other hazard class, the material is not regulated as a hazardous material and none of the training requirements of Subpart H of Part 172 of the HMR are applicable. 

Q2.      Surgical specimens containing Tc-99m can be transported from one RAM licensed facility to another licensed facility as stated in the licenses?

A2.      The licensing you mention does not appear to be an HMR requirement.  Please direct this question to the appropriate authority.

Q3.      Must specimens be labeled with a radioactive material label until the less than .27 millicures activity limit is met for “exemption”?

A3.      If offered as a fully regulated radioactive material under the HMR, yes, labeling would be required.  Depending on the activity present (see § 173.425), your specimens may qualify to be offered as Radioactive material, excepted package-instruments or articles, UN 2910 and further excepted from labeling as a radioactive material. 

Q4.      Until a specimen reaches the “activity limit for exempt consignment” in accordance with § 173.436, there is no requirement for radioactive labeling?

A4.      See A1.

I trust this information is helpful.  If you have further questions, please do not hesitate to contact this office.

Sincerely,

Shane C. Kelley
Acting International Standards Coordinator
Standards and Rulemaking Division

 

173.436, 173.425

Regulation Sections

Section Subject
173.425 Table of activity limits-excepted quantities and articles
173.436 Exempt material activity concentrations and exempt consignment activity limits for radionuclides