Frequently Asked Questions About the Proposed Rule on Limiting the Quantity of Byproduct Material in a Generally Licensed Device
On this page:
- What is the proposed rule?
- What is a generally licensed device (GLD)?
- What is a general licensee?
- Why did the U.S. Nuclear Regulatory Commission (NRC) propose this rule?
- Which general licensees would be affected by the proposed rule?
- What are the source "categories" established by the International Atomic Energy Agency (IAEA)?
- What is the health and safety risk of a device currently held under a general license?
- Why does the NRC consider the current requirements inadequate for GLDs that contain quantities of radioactive material above 1/10 of the IAEA's Category 3 threshold values?
- Does 10 CFR 31.5 currently impose any limits on the amount of radioactive material in a GLD?
- What would the proposed rule do?
- Why is the NRC using IAEA values to limit the quantity of byproduct material in a GLD?
- What is the rationale for requiring a specific license for devices containing sources at or above one-tenth (1/10) of the IAEA's Category 3 threshold?
- What steps would a general licensee take to apply for a specific license if the proposed rule is adopted?
- How long will it take for a licensee to receive a specific license after submitting the application?
- How much does it cost to apply for an NRC specific license and to renew that license each year?
- Do Agreement States charge the same fees as the NRC for license application and renewal?
- Will general licensees who are currently registering their GLDs with the NRC need to continue to register their devices if they also need to be specifically licensed?
- What do Agreement State Compatibility Categories represent?
- Why is the NRC proposing to change 10 CFR 31.5(a), (c)(13)(i), and 31.6 to refer to Category C, rather than Category B?
- What is the practical result of changing 10 CFR 31.5(a), (c)(13)(i), and 31.6 to refer to Category C, rather than Category B?
- Has the NRC considered how the proposed Compatibility Category changes will affect GLD manufacturers and distributors?
- Will current general licensees have to comply with any new requirements to obtain a specific license and retain it over time?
- What if I do not want to be subject to the proposed new rule?
- What is the implementation period for the proposed new rule?
- How can I comment on the proposed rule?
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In the proposed rule (74 FR 38372), published in the Federal Register on August 3, 2009, the U.S. Nuclear Regulatory Commission (NRC) proposed changing the criteria for generally licensed devices (GLDs), so that certain devices that are now available under a general license (GL) would require specific licenses. Compared to general licensees, specific licensees must comply with many more requirements, including a requirement to secure licensed radioactive material.
Under Title 10, Section 31.5, of the Code of Federal Regulations (10 CFR 31.5), "Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere," a "generally licensed device" is defined as a device containing radioactive material in a sealed source (that is, a shielded, sealed housing). Such devices must be designed and manufactured with inherent radiation safety features so that they may be safely used by someone with no special radiation training or experience. Examples include static eliminators, ice detection devices, gas chromatographs used in chemical analysis, and certain in vitro kits used in clinical or laboratory testing. Owners of such devices must fulfill certain recordkeeping requirements, but because of the built-in safety features, they do not have to apply to the NRC or a State regulatory agency for a specific license to possess or use the radioactive material. For additional information, see our Frequently Asked Questions About General Licenses.
Under Title 10, Section 31.5, of the Code of Federal Regulations (10 CFR 31.5), "Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere," a "general licensee" is a person or organization that acquires, uses, or possesses a generally licensed device (GLD), and has received that device through an authorized transfer by the device manufacturer/distributor or by a change of company ownership where the device remains in use at a particular location. For additional information, see our Frequently Asked Questions About General Licenses.
The NRC proposed to amend its regulations to strengthen oversight of radioactive materials by limiting the amount of byproduct material allowed in generally licensed devices (primarily fixed industrial gauges). Requiring specific licenses for such devices would improve their safety, security, and control by subjecting them to increased regulation, and increasing licensees' accountability for the devices and the radioactive materials they contain. Thus, the more stringent requirements of the specific licensing process would make it more difficult to accumulate a risk-significant amount of radioactive material, or to procure a device through subterfuge. For that reason, the proposed rule would improve the NRC's monitoring of the location and use of radioactive materials of higher activity, thereby enhancing the NRC's ability to protect public health and safety. In addition, the proposed rule would clarify the applicable requirements when a device authorized under a general license is instead held under a specific license.
Under the proposed rule, general licensees would be required to apply for and obtain a specific license if they possess one or more device(s) containing any of the following radionuclides at or above one-tenth (1/10) of the Category 3 thresholds established by the International Atomic Energy Agency (IAEA):
|Radionuclide *||1/10 of the IAEA's Category 3 Threshold **|
|Terabecquerel (TBq) ***||Curie (Ci) ***|
* Most affected devices contain Am-241, Co-60, or Cs-137.
** For these purposes, one-tenth (1/10) of the IAEA's Category 3 thresholds is the same as one-hundredth (1/100) of the Category 2 thresholds.
*** The Terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values are provided only for practical purposes and are rounded following conversion [1 Ci = 1,000 mCi and 1 TBq = 1,000 GBq].
The IAEA has established five categories of radioactive sources based on the extent to which the specific sources in each category pose a risk to public health and safety, as follows:
Category 1: Sources in Category 1 are considered to be the most dangerous because they can pose a very high risk to human health if not managed safely and securely. These sources have activities greater than or equal to the Category 1 threshold [e.g., 810 Curies (Ci) for Cobalt-60 (Co-60)], and are typically used in irradiators, radiation therapy, and radiothermal generators.
Category 2: These sources have activities less than the Category 1 threshold, but equal to or greater than the Category 2 threshold (that is, 1/100 of Category 1; e.g., 8.1 Ci for Co-60). These sources are typically used in industrial gamma radiography.
Category 3: These sources have activities less than the Category 2 threshold, but equal to or greater than the Category 3 threshold (that is, 1/10 of Category 2; e.g., 0.81 Ci for Co-60). These sources are typically used in fixed industrial gauges involving high-activity sources.
Category 4: These sources have activities less than the Category 3 threshold, but equal to or greater than the Category 4 threshold (that is, 1/100 of Category 3; e.g., 0.0081 Ci for Co-60).
Category 5: Sources in Category 5 are considered to be the least dangerous, although they could still result in doses that exceed the dose limits if not properly controlled. These sources have activities ranging from less than the Category 4 threshold down to IAEA exempt quantities.
Because of the robust design of generally licensed devices, there is little to no health or radiological safety risk when these devices are properly installed, used, controlled, and transferred for disposal. (Proper disposal requires the services of an NRC or Agreement State specific licensee.) However, a licensee's loss of control of radioactive sources, whether inadvertent or through a deliberate act, could result in significant adverse health effects, which could constitute a threat to public health and safety. Consequently, one goal of the general license restrictions in the proposed rule is to enhance the accountability of certain radioactive sources and devices by requiring a specific license for their possession and use.
Under the current regulations, a general licensee is not subject to the same regulatory controls (i.e., pre-licensing review, inspection, and safety and security requirements) as specific licensees that possess similar quantities of radioactive material. Placing certain generally licensed devices under the specific licensing process would subject them to aspects of oversight beyond those associated with the general licensing process, including the license application and review process, security requirements, and an increased number of routine inspections.
No, but such limits are imposed by Title 10, Section 32.51, of the Code of Federal Regulations (10 CFR 32.51), "Byproduct material contained in devices for use under §31.5; requirements for license to manufacture or initially transfer." Specifically, 10 CFR 32.51 includes safety criteria to limit the potential doses that are likely to result from the use of GLDs, or from accidents involving such devices. In particular, one criterion is that a GLD must be designed and manufactured with inherent radiation safety features so that they may be safely used by someone with no special radiation training or experience.
The proposed rule would require approximately 280 NRC-regulated general licensees (in non-Agreement States) to apply for specific licenses in order to keep their current GLDs. In addition, an estimated 1,400 general licensees nationwide would be affected when Agreement States make similar changes to their general license provisions. These additional general licensees are regulated by the Agreement State in which they are located, and will be subject to any new requirements when they are adopted by the given Agreement State.
The specific devices that would be affected by the proposed rule include those GLDs that fall into Category 3 (or the upper limits of Category 4) in the IAEA's categorization of radioactive sources. The U.S. government has adopted the IAEA's Code of Conduct on the Safety and Security of Radioactive Sources. That Code of Conduct explicitly defines Category 1–3 sources as dangerous, and considers Category 1 and 2 sources to be the most sensitive from a security standpoint. While sources in Categories 3–5 are considered less sensitive, the NRC is concerned that a small group of Category 3 sources, or certain Category 4 sources, assembled together, could contain an aggregate amount of radioactive material equivalent to a Category 2 source.
The NRC supports U.S. Government efforts to establish consistent and uniform international guidance for the safety and security of radioactive materials of concern, which resulted in a major revision of the IAEA's Code of Conduct on the Safety and Security of Radioactive Sources. In particular, the Code of Conduct contains a recommendation that each IAEA Member State develop a national source registry.
Generally, limiting the quantity of byproduct material to 1/10 of the IAEA's Category 3 threshold would achieve the following objectives:
- Improve the accountability and control of certain existing GLDs, thereby enhancing the NRC's ability to protect public health and safety by subjecting these devices to more stringent regulatory oversight.
- Address potential security vulnerabilities.
- Increase public confidence in the protection of public health and safety.
NRC general licensees can obtain a specific license by following the process outlined in Title 10, Sections 30.32 – 30.34, of the Code of Federal Regulations (10 CFR 30.32, 10 CFR 30.33, and 10 CFR 30.34) and filing an NRC Application for Materials License (NRC Form 313). Licensees who currently possess GLDs are not required to apply for a specific license until after the publication of the final rule. When the final rule is issued, the NRC will publish specific requirements and guidance for converting affected GLDs to specifically licensed devices.
Similarly, following the NRC's issuance of the final rule and its adoption by a given Agreement State, that State's general licensees should contact the State's radiation control program for information on how to apply for a specific license. For the regulation status and contact information, see the map of Agreement and Non-Agreement States.
Typically, the NRC will issue a specific license in less than 90 days. As long as the licensee submits the application within the allowed time, the licensee's authority to use its current GLDs under a general license would not lapse while the license application is pending.
The NRC's license fees structure is subject to change each year. Currently, general licensees that would be subject to the proposed rule would pay a one time application fee of $1,400 (10 CFR 170.31), and an annual fee of $3,700 (10 CFR 171.16).
No. Each Agreement State has its own license fee schedule. Agreement State general licensees should contact their State’s radiation control program for information about fee schedules. For contact information, see the map of Agreement and Non-Agreement States.
No. Once the licensee transfers its GLDs to a specific license, none of the requirements in Title 10, Section 31.5, of the Code of Federal Regulations (10 CFR 31.5) would apply, and the affected devices would no longer need to be registered. When the final rule is issued, the NRC will publish specific requirements and guidance for converting affected GLDs to specifically licensed devices. Those requirements and guidance will include procedures to ensure that any registered GLDs that are converted to specific licenses are removed from the registration process.
An Agreement State radiation control program is compatible with the NRC's regulatory program when its program does not create conflicts, duplications, or gaps, or other conditions that would jeopardize orderly regulation of agreement-related material on a nationwide basis. Toward that end, elements of the NRC's regulatory program (including regulations) can be divided into the following compatibility categories:
Compatibility Category A: NRC program elements in this category include basic radiation protection standards, as well as scientific terms and definitions that are necessary to understand radiation protection concepts. Related program elements adopted by an Agreement State should be essentially identical to those of the NRC to ensure uniform regulation of agreement material on a nationwide basis.
Compatibility Category B: NRC program elements in this category apply to activities that have direct and significant transboundary implications. Agreement States should adopt related program elements essentially identical to those of the NRC.
Compatibility Category C: NRC program elements in this category do not meet the criteria of Categories A or B. Rather, they outline the essential objectives that an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize orderly regulation of agreement material on a nationwide basis. Consequently, Agreement States should adopt the essential objectives of the NRC's program elements.
Compatibility Category D: NRC program elements in this category do not meet any of the criteria of Categories A, B, or C. Consequently, Agreement States do not need to adopt these elements for purposes of compatibility.
Compatibility Category H&S: Program elements in this category are not required for purposes of compatibility, but they do have particular health and safety (H&S) significance. Consequently, Agreement States should adopt the essential objectives of such program elements in order to maintain an adequate radiation control program.
Compatibility Category NRC: These NRC program elements address aspects of regulation that cannot be relinquished to Agreement States pursuant to the Atomic Energy Act or provisions of the NRC's regulations in Title 10 of the Code of Federal Regulations (10 CFR). Agreement States should not adopt these program elements.
The NRC is proposing these changes to allow Agreement States the flexibility to adopt additional requirements, if necessary, based on their individual circumstances and needs. For example, these changes would allow Agreement States to adopt additional requirements for tracking the movements of service providers and the locations of GLDs within the State's jurisdiction.
The proposed changes would have the following practical results:
- Under 10 CFR 31.5(a), Agreement States could require specific licensing for devices containing quantities of byproduct material less than the limits imposed for NRC licensees.
- Under 10 CFR 31.5(c)(13)(i), Agreement States could require registration of a larger universe of devices held under a general license.
- Under 10 CFR 31.6, Agreement States could include additional requirements for installers and servicers of GLDs that are licensed by another jurisdiction, such as requiring notifications under State regulations equivalent to 10 CFR 150.20.
The NRC staff has not quantified the costs associated with the proposed Compatibility Category changes because of the uncertainty regarding the specific requirements that may be imposed by Agreement States, which will have some flexibility in the language that they adopt for their State-specific regulations.
Although the proposed amendment only involves changes to Title 10, Part 31, of the Code of Federal Regulations (10 CFR Part 31), existing general licensees that become specific licensees would be required to comply with the NRC's regulations for specific licensees, such as those in 10 CFR Part 19, Part 20, and Part 30. This would include developing a radiation protection program, as required by 10 CFR 20.1101.
Agreement State general licensees should contact the individual State's radiation control program for information on how to obtain a specific license. For contact information, see the map of Agreement and Non-Agreement States.
If a general licensee does not want to be subject to this new rule, they can transfer or properly dispose of their existing GLDs that would be subject to the new rule. Options for transferring these devices are limited, however, subject to the requirements in 10 CFR 31.5(c)(8). Specifically, these devices can only be transferred to the following licensed entities:
- specifically licensed GLD distributors or waste brokers (for subsequent disposal)
- another specific licensee authorized to receive them, but only with prior NRC approval
The proposed rule would become effective 60 days after the final rule is published in the Federal Register. NRC General licensees affected by the rule would have an additional 90 days beyond the effective date to submit an application for a specific license (i.e., 150 days after the final rule is published in the Federal Register). As noted, general licensees in Agreement States will be affected only when their State changes its requirements. The Commission generally allows 3 years after the effective date of an NRC regulation for States to update their rules, but some States may do so sooner.
The Addresses section of the related Federal Register notice (74 FR 38372), published on August 3, 2009, offers a variety of options. One popular way is to use Regulations.gov, and search for the Docket ID NRC-2008-0272. For additional information, see Documents for Comment, paying particular attention to how to "Search for a Specific Rule or Action" under the Rulemaking-Related Documents heading.