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Nuclear Medicine: Introduction to U.S. & International Regulations and Clinical Practice Resources: International Regulations

Overview of International Regulations

This page is included because the legal regime for international shipment of radioisotopes is a critical component of the supply of radioisotopes for medical use.  While the typical nuclear medicine professional will never deal directly with international shipment or other international nuclear materials issues, both lawyers and nuclear medicine practitioners should be familiar with these issues.

The international supply of medical radioisotopes has been a topic of special interest during the early 2000's due to the world-wide shortage of key medical radioisotopes.  80% of diagnostic nuclear medicine uses technetium-99m (Tc-99m) as the radioactive tracer in the radiopharmaceuticals administered to patients.  Tc-99m has a half-life of six hours, meaning that one-half of its radiation is emitted every six hours. The Tc-99m its entire radioactivity, becoming Tc-99 (no "m"), in about sixty hours.  Tc-99m is produced from Molybdenum-99 which has a half-life of 2.75 days (emitting all of its radiation in about a month).  Therefore, there must be a constant supply of Molybdenum to provide a constant supply of Tc-99m. 

Unfortunately, there are only five large-scale reactors that produce Molybdenum for medical use.  None of those reactors are in the U.S.  One is in Canada.  There are also reactors in Belgium, France, the Netherlands, and South Africa. There are smaller regional reactors in Argentina and Indonesia.  Therefore, the U.S. supply of medical radioisotopes is highly dependent on international shipment of radioactive materials.

All of the large-scale reactors are over forty years old. As a result, they often must be shut down for maintenance or repairs.  This has caused recurrent world-wide shortages of technetium-99m which has significantly impacted patient care in recent years.  There is no long-term solution for this problem at this time.  There are proposals for new regional and large-scale reactors, but these will take several years to plan and construct.

The International Atomic Energy Agency is actively overseeing this issue and has issued a helpful report. The IAEA also has a separate staff report on the current efforts to streamline transport of medical radioisotopes.

Conventions and Agreements

Several international treaties, conventions, and agreements have been ratified that deal with nuclear materials, nuclear accidents, and other areas of nuclear safety. The International Atomic Energy Agency (IAEA) is the depository for many of these documents. Those relevant to the international transport of nuclear materials include:

Convention on the Physical Protection of Nuclear material (CPPNM, 1980)

Regulations for the Safe Transport of Radioactive Materials, TS-R-1  (2009)

Convention relating to Civil Liability in the field of Maritime Carriage of Nuclear Materials (1971)

Guidelines for Nuclear Transfers, 1993 Revision of NSG London Guidelines

Technical Guidance:  Monitoring for Radioactive Material in International Mail Transported by Public Postal Operators (2006)

A number of Information Circulars are available that compile the regulations regarding Nuclear Material Import and Export Provisions.

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Euratom, the European Atomic Energy Community, has extensive resources including the Euratom Treaty and legislation (directives and regulations).

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The World Nuclear Transport Institute has compiled Safety Regulations Governing the Transport of Radioactive Material which includes a list of sources of international and regional regulations. They also have a fact sheet concerning Package Types used for Transporting Radioactive Materials.

The World Nuclear Association, which represents organizations of nuclear energy profession, has a detailed description of the issues involved with the transport of radioactive materials.

International Codes

The International Atomic Energy Agency (IAEA) is the Intergovernmental Organization that oversees all aspects of the peaceful uses of nuclear energy.  While they are often thought of regarding nuclear reactors and nuclear materials safeguards, the agency also has active efforts in clinical nuclear medicine as well as other areas involving the peaceful uses of radioisotopes.

Part of the IAEA's statutory mandate is the development and promotion of standards and guides, also known as "Codes."  While these are non-binding, they are highly respected and have been adopted by most of the member states. The current Codes, available for free in PDF format in six languages, are:

Code of Conduct on the Safety and Security of Radioactive Sources (2004)

Code of Practice on the International Transboundary Movement of Radioactive Waste (1990)

Code of Conduct on the Safety of Research Reactors (2006)

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