Comparison of Specific Exemption Regulations for Consumer Products Containing Radioactive Isotopes
Article information
Abstract
Background
Practices involving radionuclides at levels below the International Atomic Energy Agency (IAEA) generic exemptions are exempt from regulation without further consideration. Practices involving radionuclides at levels above those generic exemptions may also be exempt from regulation if they meet certain conditions. These are known as specific exemptions, and each country has established its own specific exemption criteria based on the conditions set out in the IAEA General Safety Requirements (GSR) Part 3. Those conditions relate to the physical or chemical form of the radioactive material as well as to its use or the means of its disposal.
Materials and Methods
The specific exemption criteria of eight countries (i.e., the United States of America [US], Japan, France, China, Australia, Canada, the United Kingdom of Great Britain and Northern Ireland [UK], and Germany) were analyzed. Their similarities and differences as compared with the specific exemption criteria of the Republic of Korea (ROK) were analyzed, and suggestions for revision of the Korean regulations were formulated.
Results and Discussion
Each country’s specific exemption criteria are defined based mostly on the IAEA criteria but tailored to its domestic circumstances. The nine countries with their specific exemption criteria can be broadly categorized into three groups: nuclide-specific exemptions for specific products (the ROK and the US), common criteria for all nuclides without specification of particular products (Japan, France, and China), and both specific and common criteria (Australia, Canada, the UK, and Germany).
Conclusion
The specific exemption criteria of the different countries examined in this study could be helpful in reviewing the ROK’s specific exemption criteria. Development of common criteria alongside specific criteria for products requiring special attention may be a good way to determine whether new consumer products containing radioisotopes should be regulated.
Introduction
The International Atomic Energy Agency (IAEA) has established the following exemption criteria for radioisotopes in Part 3 of the General Safety Requirements (GSR): (1) ‘The equipment containing radioactive material is of a type approved by the regulatory body’; (2) ‘The radioactive material is in the form of a sealed source that effectively prevents any contact with the radioactive material and prevents its leakage; or is in the form of an unsealed source in a small amount such as sources used for radioimmunoassay’; (3) ‘In normal operating conditions, the equipment does not cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/hr at a distance of 0.1 m from any accessible surface of the equipment’; and (4) ‘Necessary conditions for disposal of the equipment have been specified by the regulatory body’ [1]. On this basis, the IAEA proposes that consumer products containing radioisotopes in quantities above the general exemption criteria may yet be exempted from regulation if certain conditions are met [2–5]. The conditions are that (1) there must be a benefit to be gained from using a product containing radioactive material; (2) the dose assessment results for all foreseeable scenarios must meet the criteria set forth by the IAEA; and (3) the design and performance of the product must be tested. The IAEA dose assessment criteria are that the effective dose to the general population is 10 μSv/yr or less per year for all foreseeable scenarios, and that an additional criterion of a maximum of 1 mSv/yr may be applied to account for low probability scenarios [6]. Many countries have developed specific exemption criteria based on these IAEA conditions to suit their own circumstances. In the Republic of Korea (ROK), the ‘Regulation on substances excluded from radioisotopes’ (i.e., the exemption regulation for radioisotopes) and the ‘Regulation on kinds and quantities of nuclear fuel materials not subject to acquisition of a permit for use’ (i.e., the exemption regulation for nuclear fuel materials) define exemptions based on use [7, 8]. Under these notices, consumer products containing radioisotopes have been marketed without regulation. However, as the specifications and usage of consumer products containing radioisotopes change over time, it is necessary to periodically review the validity of exempting them from safety regulations. In this regard, studies have been conducted to develop foreseeable exposure scenarios and evaluate the risks of consumer products containing radioisotopes, taking into account their distribution and use [9–12]. In this study, in order to determine the validity of the exemption criteria set out in the domestic Korean exemption notices, we compared the national (ROK) criteria with the specific exemption criteria of various countries.
Materials and Methods
1. Republic of Korea
The ROK provides exemption criteria for products containing radioisotopes or nuclear fuel material. It identifies the specific products that can be exempted from regulation, and sets different exemption criteria for each use and nuclide. The official name of the exemption regulation for radioisotopes is ‘Regulation on substances excluded from radioisotopes,’ and the products covered are (1) smoke detectors; (2) safety indicator lights (3H); (3) luminescent materials for aircraft (147Pm); (4) luminescent materials embedded in gauges or indicators (including watches); (5) electrical and gas appliances; (6) military equipment (241Am, 3H, 147Pm, 63Ni); (7) sealed sources for calibration; and (8) 14C certified as a radiopharmaceutical for diagnosis. In addition, there is the exemption regulation for nuclear fuel materials, formally known as the ‘Regulation on kinds and quantities of nuclear fuel materials not subject to acquisition of a permit for use.’ This regulation sets standards for products containing uranium, thorium, and plutonium, including (1) uranium for aircraft counterweights; (2) shielding uranium contained in irradiators; (3) shielding uranium in design-approved transport containers; (4) natural thorium for chemical analysis; (5) thorium-containing vacuum tubes, indoor lamps, germicidal or outdoor lamps, welding rods, gas-lamp wicks, optical lenses, alloys (nickel, tungsten, or magnesium); and (6) natural water. The products and exemption criteria for both regulations (i.e., the exemption regulation for radioisotopes and nuclear fuel materials) are summarized in Table 1.
2. United States of America
In the United States of America (US), ‘Certain items containing byproduct material’ (i.e., 10 Code of Federal Regulations [CFR] Part 30.15) provides criteria for products that can be exempted from regulation for those who receive, possess, use, transfer or acquire them [13]. In addition, ‘Self-luminous products containing 3H, krypton-85, or promethium-147,’ ‘Gas and aerosol detectors containing byproduct material,’ ‘Radioactive drug: capsules containing carbon-14 urea for in vivo diagnostic use for humans,’ and ‘Certain industrial devices’ (i.e., 10 CFR Parts 30.19-22) specify products that are exempt from regulation for activities other than manufacturing, processing, production, and sale, without criteria [14–17]. Anyone who intends to apply or incorporate byproduct material into an exempt product, or who intends to initially transfer it for sale or distribution, must apply for a special license under 10 CFR 32, and anyone who intends to use a radiopharmaceutical for research involving human subjects must apply for a special license under 10 CFR 35. There is no generic exemption for thorium, uranium, and plutonium, which are source materials and special nuclear materials, and a license is required to handle them. However, there are exceptions: products that meet the conditions listed in 10 CFR 40.13 may be transferred, possessed, used, or given away without a license [18]. The relevant regulatory exemption products and exemption criteria are summarized in Table 2.
3. Japan
In Japan, Article 12(2) of Law No. 167 of Showa 32 requires that equipment containing radioisotopes be approved by the Nuclear Safety and Technology Center, a registered certification body, for its prevention of radiation interference during storage and transportation and, thus, clearance for manufacture or importation [19]. Additionally, Article 12(3) states that a design certification (i.e., common criteria) or specific design certification (i.e., nuclide-specific exemptions for specific products) shall be granted if the equipment to be approved meets the technical criteria specified in the rules of the Nuclear Regulation Authority (NRA). The technical criteria are set out in Article 14(3) of Prime Ministerial Decree No. 56 and include criteria for (1) the design of functions to prevent interference and (2) conditions of use, storage, and transport [20]. The design certification threshold is 1,000 times the general exemption limit for each type of radioisotope. Specific design certification targets are specified in Article 12 of Law No. 259 of showa and the ‘Notification of subdivisions on technical standards for design certification,’ etc. [21, 22]. These standards cover smoke detectors, switching discharge tubes for radar receivers, and devices designated by the NRA (i.e., contact potentiometers and thermoparticulate sensors) as having a dose equivalent rate of 1 μSv/hr or less at a distance of 10 cm from a surface. When selling or leasing an appliance that has received such certification, a document stating the certification number of the appliance and the conditions for its use, storage, transportation, and disposal must be included. The technical criteria for design certification and regulatory exemption in Japan are summarized in Table 3. In the case of nuclear fuel materials, a license must be obtained in accordance with Article 52 of the Nuclear Reactor Regulation Act. However, a license is not required for the use of nuclear fuel materials within the types and amounts of nuclides specified in Article 39 of the Enforcement Decree of the Nuclear Reactor Regulation Act (even in this case, a license as an internationally controlled material is required pursuant to Article 61(3) of the Nuclear Reactor Regulation Act). In addition, the “Guidelines for ensuring safety of raw materials and products containing uranium or thorium” provides its own safety management guidelines for materials not regulated by the Nuclear Reactor Regulation Act (e.g., gas mantles containing thorium, high-intensity discharge lamps, welding rods, etc.) [23].
4. France
In France, Chapter III: Ionising Radiation (Articles R.1333-1 to R.1333-93) of the Public Health Code provides for the exemption of consumer and construction products that meet certain conditions, and Directive 2013/59/Euratom provides common criteria for the exemption of products containing radioisotopes above the general exemption limits [24, 25]. In addition, the ‘Implementing Regulations of 5 May 2009’ specify the content to be included in the application for exemption, and two notices list the types of cement and certain lamps that are exempt from regulation [26–28]. The detailed exemption criteria presented in each regulation are summarized in Table 4.
5. China
In China, Circular No. 49 of the ‘General Administration of Ecology and Environment’ authorizes the preparation of exemption applications for equipment that meets the requirements for general and conditional exemptions [29]. In addition, the ‘Basic standards for protection against ionizing radiation and safety of radiation sources’ specifies the conditions under which general and conditional exemptions can be granted [30]. The detailed exemption criteria presented in each regulation are summarized in Table 5.
6. Australia
The Australian Radiation Protection and Nuclear Safety Act 1998 provides for exemptions from regulation [31]. The Australian Radiation Protection and Nuclear Safety Regulations 2018 also provide specific exemption criteria for specific products that are exempt from regulation, along with common criteria for exempting products that are not listed [32]. The detailed exemption criteria presented in each regulation are summarized in Table 6.
7. Canada
The Nuclear Substances and Radiation Devices Regulations provide exemptions for deuterium-containing compounds, aircraft counterweights, natural uranium, depleted uranium, and natural thorium [33]. The regulations also provide more detailed exemption criteria for smoke detectors, 3H safety labels, devices containing radium-luminous compounds, and calibration sources. Even if a nuclide is not presented as a specific consumer product, it is exempt from transfer, import, export, storage, use, and disposal if it is a radiation device rather than an exposure device and is less than 10 times the general exemption quantity. As the term is used herein, an exposure device is a radiographic instrument designed to perform gamma radiography and includes the components of the instrument such as the sealed source assembly, the drive mechanism, the sealed source assembly guide tube, and the exposure head. A radiation device is a device containing more than an exempt amount of nuclear material and capable of using nuclear material for its radiological properties, including a device containing a radium-luminescent compound. The detailed exemption criteria presented in the regulations are summarized in Table 7.
8. United Kingdom of Great Britain and Northern Ireland (UK)
The Ionising Radiations Regulations 1999—Schedule 1 provides both general and common criteria for the exemption of products containing radioisotopes above the general exemption limit [34]. In addition, the scope of and exemptions from the radioactive substances legislation in England, Wales and Northern Ireland: guidance document details the exemption criteria for various products and provides a table of radioacivity levels by nuclides and their respective products [35]. The detailed exemption criteria for each regulation are summarized in Table 8.
9. Germany
The radiation protection ordinance provides specific design criteria for regulatory exemptions (i.e., Article 45(1) of the Radiation Protection Act) and establishes exemption criteria for products’ specific purposes, such as inert gas extraction and use of natural radioactive materials in educational contexts [36]. The detailed exemption criteria presented in the regulations are summarized in Table 9.
Results and Discussion
A comparison of the nine countries’ exemption criteria shows that each country has established its own specific exemption standards based mostly on the IAEA criteria but tailored to domestic circumstances. For example, the ROK and the US specify design conditions for specific products and radioactivity criteria for each nuclide contained therein. Japan, France, and China, on the other hand, do not specify products but allow exemptions to be applied for if certain exemption criteria are met. Canada, the UK, Australia, and Germany each have both types of standard, one standard for all nuclides and another for specific products. Of the countries with common standards, all except France and Australia have an exemption for a surface dose rate of 1 μSv/hr or less at a distance of 10 cm. In addition, France, Australia, and Germany have an exemption for an expected dose to an individual of less than 10 μSv/yr, and Australia, Japan, and France have an additional exemption of 1 mSv/yr. Canada and Germany provide a special exemption threshold of 10 times the general exemption threshold, with Germany providing an additional 1,000 times. Countries with exemptions for specific products typically include smoke detectors containing 241Am, luminescent materials containing 3H or 147Pm, radiopharmaceuticals, and calibration sources. The classification by type of specific exemption criteria for each country is shown in Fig. 1. Table 10 summarizes the similarities and differences in specific exemption criteria among the countries examined in this study.
Conclusion
Currently, the ROK exempts products with radioactive materials above the general exemption limit for specific purposes under the exemption regulations for radioisotopes and nuclear fuel materials, based on IAEA standards. The regulations need to be periodically reviewed, because products’ domestic usage status as well as the types of consumer products containing radioisotopes change over time. Therefore, to review the validity of the ROK’s current exemption criteria, the present study examined the corresponding criteria of various countries and compared them with the case of the ROK. The specific exemption criteria of the nine countries, including the ROK, can be broadly categorized as (1) ROK and the US, which provide nuclide-specific exemption criteria for specific products; (2) Japan, France, and China, which provide common criteria for all nuclides without specifying specific products; and (3) Canada, the UK, Australia and Germany, which provide both specific and common criteria. The number of products containing radioisotopes is increasing but, at the same time, there are products that are no longer in use and have been replaced by other products that do not contain radioisotopes. It is therefore necessary to amend the regulations to remove some products that are no longer manufactured and, where appropriate, to create a regulatory regime for new types of products. The specific exemption criteria of the various countries examined in this study are expected to be helpful in revising the ROK’s specific exemption criteria. Additionally, the establishment of common criteria together with specific criteria for products requiring special attention may be a good way to determine whether new consumer products containing radioisotopes should be regulated.
Notes
Conflict of Interest
No potential conflict of interest relevant to this article was reported.
Ethical Statement
This article does not contain any studies with human participants or animals performed by any of the authors.
Author Contribution
Conceptualization: Seo H, Lee S. Methodology: Shin J. Formal analysis: Shin J, Bang Y. Funding acquisition: Seo H. Project administration: Park B, Lee J, Kim M. Visualization: Shin J. Writing - original draft: Shin J. Writing - review & editing: Seo H. Approval of final manuscript: all authors.
Acknowledgements
This study was supported by the Korea Institute of Nuclear Safety (KINS). This study was also supported by the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT (RS-2023-00277188). This research was also supported by the Korea Institute of Marine Science & Technology Promotion (KIMST) funded by the Ministry of Oceans and Fisheries, Korea (20210671) and by the research grant from the Korea Institute of Ocean Science and Technology (PEA0202).