Interpretation Response #24-0002

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

Interpretation Response Details

Response Publish Date: 03/27/2024

Company Name: International Isotopes Inc.

Individual Name: John J. Miller

Location State: ID Country: US

View the Interpretation Document

Response text:

March 27, 2024

John J. Miller, CHP
Radiation Safety Officer
International Isotopes Inc.
4137 Commerce Circle
Idaho Falls, ID  83401

Reference No. 24-0002

Dear Mr. Miller:

This letter is in response to your January 8, 2024, letter and subsequent emails requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to a shipper's certificate for radioactive material transported aboard a passenger-carrying aircraft. Specifically, you describe the offering and transportation of shipments containing short-lived radiopharmaceuticals—including radioisotopes—that are active pharmaceutical ingredients used in the production of radiopharmaceuticals. You explain that you are uncertain regarding the return shipment of “empty” packages intended to be reused for these products when transported aboard a passenger-carrying aircraft, as many of these packages utilize depleted uranium as shielding, which results in the "empty" packages being returned for reuse having an external dose rate exceeding 0.005 mSv/h (0.5 mrem/h). Furthermore, you explain that this requires the "empty" packages to be shipped to the radiopharmaceutical's supplier as an LSA-I shipment and not as "UN2908, Radioactive material, excepted package-empty packaging, 7." Therefore, regarding the requirement found in § 172.204(c)(4) for the shipper's certificate for radioactive material transported aboard a passenger-carrying aircraft, you ask for clarification regarding the phrase "intended for use in, or incident to, research, or medical diagnosis or treatment" as it relates to these "empty" packages.

Note that § 173.448(f) details the requirement linked to § 172.204(c)(4) and specifies that no person shall offer for transportation aboard a passenger-carrying aircraft any Class 7 (radioactive) material unless that material is intended for use in, or incident to, research, medical diagnosis, or treatment.

We have paraphrased and answered your questions as follows:

Q1. You ask whether an "empty" package that was used for the shipment of radiopharmaceuticals containing either residual radioactive material or depleted uranium shielding can be considered radioactive material intended for use in, or incident to, research, or medical diagnosis or treatment when it is returned to the radiopharmaceutical supplier.

A1. The answer is yes. It is the opinion of this Office that an "empty" package that contains residual radioactive material or depleted uranium shielding as described in your letter that is being returned to the radiopharmaceutical supplier for reuse would meet the intent of a radioactive material offered aboard a passenger-carrying aircraft for research, medical diagnosis, or treatment.

Q2. You ask whether disused sealed sources such as Cobalt-57 (Co-57) flood and line sources, Germanium-68 (Ge-68) phantoms and line sources, and Sodium-22 (Na-22) markers that were used in or incidental to medical diagnosis or treatment can be considered to meet the requirements of being a radioactive material that is intended for use in, or incident to, research, medical diagnosis, or treatment when it is shipped back to the source manufacturer for end-of-life management. When one of these sources is returned to the manufacturer, the contact dose rate on the package can exceed 0.5 mrem/h and the source would then be returned as "UN2915, Radioactive material, Type A package non-special form, non-fissile or fissile excepted, 7."

A2. The answer is yes.

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

Dirk Der Kinderen
Chief, Standards Development Branch
Standards and Rulemaking Division

173.448(f), 172.204(c)(4)

Regulation Sections