[Federal Register: October 16, 2007 (Volume 72, Number 199)] [Rules and Regulations] [Page 58473-58489] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16oc07-2] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 31, 32 and 150 RIN 3150-AH41 Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending several regulations governing the distribution of byproduct material. The reporting requirements for licensees distributing byproduct material to persons exempt from licensing are being changed, obsolete provisions are being deleted, certain regulatory provisions are being clarified, and smoke detector distribution regulations are being simplified. In addition, this final rule modifies the process for transferring a generally licensed device for use under a specific license. Aspects of this rule will affect distributors of exempt byproduct material, some general licensees, and some users of exempt products. These actions are intended to [[Page 58474]] make the licensing of distribution to exempt persons more effective and efficient, reduce unnecessary regulatory burden to certain general licensees, and better ensure the protection of public health and safety. DATES: Effective Date: This final rule is effective on December 17, 2007. FOR FURTHER INFORMATION CONTACT: Andy Imboden, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, (301) 415-2327, asi@nrc.gov. SUPPLEMENTARY INFORMATION: I. Background A. Introduction B. Regulatory Framework II. Discussion A. Improved Reporting of Distribution to Persons Exempt From Licensing Requirements B. NRC Licensing of the Introduction of Exempt Concentrations C. Bundling of Exempt Quantities D. Obsolete Provisions E. New Product-Specific Exemption for Smoke Detectors F. Specific Licenses and Generally Licensed Devices-- Clarification III. Summary of Public Comments on the Proposed Rule A. Meaning of the Term ``Byproduct Material'' B. Exempt Quantity Distribution Reports C. Transfer of Generally Licensed Devices D. New Product-Specific Exemption for Smoke Detectors E. NRC--Agreement State Jurisdictional Issues F. Disposal of Exempt and Generally Licensed Devices IV. Amendments by Section V. Criminal Penalties VI. Agreement State Compatibility VII. Voluntary Consensus Standards VIII. Environmental Assessment and Finding of No Significant Environmental Impact: Availability IX. Paperwork Reduction Act Statement X. Regulatory Analysis XI. Regulatory Flexibility Certification XII. Backfit Analysis XIII. Congressional Review Act I. Background A. Introduction The Commission has authority to issue both specific and general licenses for the use of byproduct material, and also to exempt byproduct material from regulatory control under section 81 of the Atomic Energy Act of 1954, as amended (hereafter, ``the Act'' or the AEA). In considering its exemptions from licensing, the Commission is directed by the Act to make ``a finding that the exemption of such classes or quantities of such material or such kinds of uses or users will not constitute an unreasonable risk to the common defense and security and to the health and safety of the public.'' To ensure that its exemptions meet the requirements of the Act, the Commission specifies limits for the radiological properties of what is distributed to persons exempt from licensing, and carefully oversees the manufacture and distribution of the approved products and materials. As beneficial uses of byproduct material were developed and experience grew, new products intended for use by the public were invented, and the regulations were amended to accommodate their use under various exemptions from licensing. These products and materials present very low risks of significant individual doses. However, a substantial portion of the public uses these products--more than 100 million smoke detectors are in use in this country--and as a result, is routinely exposed to some ionizing radiation. Therefore, in the 1990s, the Commission conducted a systematic reevaluation of the exempt materials and products, most of which had been approved before 1970. A major part of the effort was an assessment of the potential and likely doses to workers and the public under the existing regulations governing the distribution of exempt products. Dose assessments associated with most exempt products can be found in NUREG-1717,\1\ ``Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials,'' June 2001. Generally, the systematic assessment of exemptions determined that no significant problems exist with the current uses of byproduct materials under the exemptions from licensing. Actual exposures of the public likely to occur are in line with Commission policy concerning acceptable doses from exempt products and materials. For some exempt products, there was a significant difference between potential and likely doses because the use of the exempt product is limited (or nonexistent) or significantly lower quantities are used in products than is potentially allowed under the exemption. --------------------------------------------------------------------------- \1\ NUREG-1717 is a historical document developed using the models and methodology available in the 1990s. The NUREG provides the estimate of the radiological impacts of the various exemptions from licensing based on what was known about distribution of material under the exemptions in the early 1990s. NUREG-1717 was used as the initial basis for evaluating the regulations for exemptions from licensing requirements and determining whether those regulations adequately ensured that the health and safety of the public were protected consistent with NRC policies related to radiation protection. The agency will not use the results presented in NUREG-1717 as a sole basis for any regulatory decisions or future rulemaking without additional analysis. Copies of NUREGs may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies are also available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. A copy is also available for inspection and/ or copying for a fee at the NRC public Document Room, One White Flint North, 11555 Rockville Pike, Public File Area O1-F21, Rockville, MD. --------------------------------------------------------------------------- The Commission is also revising a certain general license within this final rule. General licenses are provided by regulation, grant authority to a person for certain activities involving byproduct material, and are effective without the filing of an application with the Commission or the issuance of licensing documents to particular persons. Separate and distinct from either exemptions or specific licenses, general licenses are designed to be commensurate with the specific circumstances covered by each general license. However, the NRC has determined that its regulations were not clear with respect to certain transfers of generally licensed devices. This has led to inefficiencies in licensing oversight and may negatively impact public confidence. Thus, the NRC is clarifying and simplifying its regulations related to this issue. This final rule reflects the Commission's goals to make its regulations more flexible, user-friendly, and performance-based, and to improve its ability to risk-inform its regulatory program. These concepts continue to be considered in developing potential revisions to the regulatory program in the area of distribution of byproduct material to exempt persons. To make optimal use of rulemaking resources, both for the NRC and the States who must develop conforming regulations, several issues have been combined into this final rule. A proposed rule containing these amendments was published for public comment in the Federal Register on January 4, 2006 (71 FR 275). The public comment period closed March 20, 2006. Nine comment letters were received. The NRC has considered these comments in this final rule. B. Regulatory Framework The Commission's regulations in Part 30 contain the basic requirements for licensing of byproduct material. Part 30 includes a number of regulations that exempt the end user from licensing requirements, so-called ``exemptions.'' Many of these exemptions are product-specific, intended only for specific purposes which are narrowly defined by regulation. More broadly defined are the general materials exemptions, which [[Page 58475]] allow the use of many radionuclides in many chemical and physical forms subject to limits on activity, and which are specified in Sec. Sec. 30.14 and 30.18 for exempt concentrations and exempt quantities, respectively. The Commission's regulations also include two class exemptions--for self-luminous products and gas and aerosol detectors, in Sec. Sec. 30.19 and 30.20, respectively--which cover a broad class of products not limited to certain quantities or radionuclides. Under the class exemptions, many products can be approved for use through the licensing process if the applicant demonstrates that the specific product is within the class and meets certain radiation dose criteria. Part 31 provides general licenses for the use of certain items containing byproduct material and the requirements associated with these general licenses. Part 32, Subpart A, sets out requirements for the manufacture or initial transfer (distribution) of items containing byproduct material to persons exempt from licensing requirements. Part 150 sets out regulations for all States that have entered into agreements with the Commission under subsection 274b of the Act. II. Discussion This final rule makes a number of revisions to the regulations governing the use of byproduct material under exemptions from licensing and under general license, and to the requirements for those who distribute products and materials for use under exemptions from licensing. The changes are intended to better ensure the protection of public health and safety and improve the efficiency and effectiveness of certain licensing actions. A. Improved Reporting of Distribution to Persons Exempt From Licensing Requirements The reporting and recordkeeping requirements for distributors of products containing byproduct material to persons exempt from licensing in Part 30 are being amended to improve the quality of data available to the NRC. The changes set forth in this rule have been made in such a way that there is an insignificant effect on these licensees' reporting and recordkeeping burdens. The reporting and recordkeeping requirements for these distributors are found in Sec. Sec. 32.12, 32.16, 32.20, 32.25(c), and 32.29(c). Before 1983, reporting of transfers of exempt byproduct material was required on an annual basis. The NRC amended its regulations in 1983 to change the reporting requirement to once every 5 years to minimize administrative burden. The 1983 reporting regulations required that an additional materials transfer report be submitted when filing for license renewal or notifying the NRC of a decision to cease licensed activities. However, subsequent experience with the 5-year reporting frequency has shown that it does not provide the NRC with complete, accurate, or timely information on products and materials containing byproduct material distributed for use under exemptions from licensing. A 5-year reporting cycle does not produce timely information for the NRC to fully determine the products and amount of byproduct material distributed annually for exempt use. The lack of timely information limits the NRC's ability to evaluate the overall net impact of such distribution on public health and safety. Because the date of reporting for each licensee is different and the information is not necessarily reported by year, it is difficult to estimate the amount or types of exempt products containing byproduct material distributed each year or to detect emerging trends. A 5-year reporting period also negatively affects the availability of current information. The limitations of the information about the products and materials and quantities distributed for use under exemption greatly impacted the effort involved in developing the dose assessments in NUREG-1717 and contributed to uncertainties in the results. Reevaluation of the reporting requirements suggests that annual reporting may also be administratively more efficient than a 5-year cycle for both the NRC and licensees. There have been more implementation problems with the longer cycle than with annual reporting. For example, because of the long interval between reports, licensees frequently neglect to file reports in compliance with the regulations. This lapse sometimes results in the need for the NRC to request that additional information be sent so that an application for renewal or termination of license can be processed. The long interval between reports also may lead to licensee inefficiencies in collecting the data. Routine annual reporting should be more straightforward and easier for licensees to comply with than consolidating and reporting 5 years of distribution information. This final rule requires that material transfer reports covering transfers made during the calendar year be submitted annually by January 31 of the following year. In the first report made after the change, licensees are being required to submit information on transfers made since the previous report, so that there are no gaps in coverage. The requirements added in 1983 for licensees to file a special material transfer report when filing for license renewal (contained in the existing Sec. Sec. 32.12, 32.16, 32.20, 32.25, and 32.29) are being deleted. Another change is being made to the same sections so that material transfer reports are required 30 days after ceasing authorized activities, rather than at the point of notifying the Commission of the decision to cease authorized activities. In addition to the lengthy period between the 5-year reports, the manner in which product information and licensee information has been submitted in the reports has not always been clear, making the data more difficult to use. This final rule modifies how information is to be provided, improving clarity by making the reporting provisions more specific. Under the revised provisions, as specified in Sec. Sec. 32.12(a)(1), 32.16(a)(1), 32.20(b)(1), 32.25(c)(1), and 32.29(c)(1), the report must clearly identify the specific licensee submitting the report, including the license number. In addition, as specified in Sec. Sec. 32.12(a)(2), 32.16(a)(2), 32.20(b)(2), 32.25(c)(2), and 32.29(c)(2), the report is required to reference the specific exemption provision under which the products or materials are being distributed. The current regulations require that the licensee must identify the distributed product; however, different licensees have complied with this requirement in a number of ways, some of which necessitated that the NRC obtain additional information to fully interpret what was being distributed. Licensees have frequently included model numbers in the reports, but often as the only identification of the type of product being transferred. This final rule adds the requirement to report model numbers, when applicable, as part of the required information. Other changes are being made to reduce the licensees' reporting and recordkeeping burden. Under the prior framework, licensees were required to send a copy of the transfer reports to both the NRC headquarters and the appropriate Regional office. The requirement to send a copy of the reports to the Regional offices will be removed. Instead, the information will be distributed by the NRC internally to the appropriate personnel. To make the NRC's internal document handling more efficient, the address to which reports are to be sent will contain the line, [[Page 58476]] ``ATTN: Document Control Desk/Exempt Distribution.'' The addressee also has been changed from that specified in the proposed rule to be consistent with the recent reorganization of the NRC's materials programs. Finally, the period for which licensees must retain records, i.e., 1 year after transfers are included in a report, will be up to 4 years shorter than under the existing requirements. These factors are expected to make the reporting process more efficient and to improve the quality of the information submitted. As a result of these changes, the NRC expects to receive information on distribution to exempt persons that is more useful for evaluating both potential individual doses to the public from multiple sources and collective doses to the public from these products and materials than that provided under the previous requirements. The NRC will have a stronger basis for informing the public about these exposures. These changes also will provide a better basis for considering any future regulatory changes in this area and for allocating NRC resources. B. NRC Licensing of the Introduction of Exempt Concentrations For most exemptions from licensing in Part 30, distributors must have an NRC license even if they are in Agreement States. There are two exemptions for which this is not the case. One obsolete exemption, Sec. 30.16, ``Resins containing scandium-46 and designed for sand- consolidation in oil wells,'' is being removed by this final rule, as discussed in section II.D of this document. The other exception to NRC- only licensing of distribution of exempt byproduct material is in Sec. 30.14, ``Exempt concentrations.'' The exempt concentration exemption in Sec. 30.14 is a general materials exemption, broadly defined and not limited to a particular use. The exemption allows for various practices to be evaluated on a case-by-case basis through the licensing process. Section 30.14, paragraph (c), contains an exemption from licensing by the NRC for manufacturers, processors, or producers in Agreement States if the introduction of byproduct material into their product or material is conducted by an NRC specific licensee whose license authorizes this introduction. Previously, there were provisions in the NRC's regulations that allowed Agreement State licensing of the introduction of exempt concentrations. Agreement State licensing was added in 1963, soon after the regulations governing the Agreement State program were established the previous year (10 CFR part 150 was established in 1962). At the time, the only practices being regulated under these provisions related to quality control procedures and other radiotracer activities. Byproduct material was permitted to be introduced into oil, gasoline, plastics, and similar commercial and industrial materials. Also, at the time these provisions were added, it was expected that the NRC and the Agreement States would develop a system to obtain copies of the transfer reports submitted to the different regulatory bodies by licensees so that the NRC would have national information on distribution. Such a system was never implemented. All practices involving exempt concentrations result in increased radioactivity in the products. A number of different practices have been evaluated and conducted under Sec. 32.11, including the neutron irradiation of gemstones, silicon semiconductor materials, and luggage and cargo in explosive detection systems. These practices did not exist in the early 1960s, and involve consideration of issues including extensive national distribution. These practices involve a more complex dose evaluation than did the earlier practices, which were characterized by a single radionuclide dispersed within a product. For the case of irradiation of gemstones, the NRC has since required authorization only by an NRC license. It is important for the NRC to obtain information on all distributions of byproduct material to exempt persons in order to effectively and efficiently assess the overall impact of such distributions on the public. NRC licensing of all such distribution will facilitate this goal. Also, the concentration limits in Sec. 30.70 do not provide the sole assurance of protection of public health and safety. The evaluation done in connection with the licensing process is also important. The previous regulatory framework allowing multiple licensing jurisdictions to have the authority to issue these licenses had the potential to result in inconsistency in the licensing process. A regulatory framework in which there is one licensing authority is inherently more efficient than a framework with multiple jurisdictions from an administrative standpoint. A sole licensing authority automatically would possess data on the nationwide amount of byproduct material introduced into products distributed to the general public. In addition, because the introduction of exempt concentrations is a rarely used exemption, NRC-only licensing would avoid a situation in which every Agreement State would have to maintain resources, regulations, and procedures to license this practice, despite the fact that it would be unlikely for any individual State to have a significant number of these licensees. This final rule requires that the entity introducing byproduct material into products and materials for use under the exempt concentration provisions must have an NRC license specifically authorizing this practice. Specifically, the final rule changes Sec. Sec. 32.11 and 32.12 to compatibility category NRC. Compatibility categories and their meanings are explained in Section VI, ``Agreement State Compatibility.'' This change necessitates conforming amendments to related paragraphs (Sec. Sec. 30.14(c), 30.14(d), 32.11, 32.13, and 150.20) so that only NRC may authorize the introduction of byproduct material into products and materials to be distributed for use under Sec. 30.14. Consistent with the practice for other exempt byproduct material distribution, a person introducing byproduct material into products and materials for use under the exempt concentration provision may have possession and use of the byproduct material authorized by an Agreement State and a distribution license from the NRC. To accommodate this framework, Sec. 32.11 is revised to exempt Agreement State licensees from Sec. 30.33(a)(2) and (3), so as not to duplicate the licensee's Agreement State license conditions associated with possession and use. Currently, the only known entities licensed under Sec. 32.11 (or equivalent Agreement State regulations) are a small number of radiotracer firms, licensed by the NRC, who introduce byproduct material into material like gas and oil, and steel companies who use sources to monitor refractory lining wear in blast furnaces. No Agreement State licensees of these types were identified by the NRC in 2002, when the States were asked to comment on the rulemaking plan, or in 2005, when the NRC was assessing potential effects of this rule. Changing the licensing of introduction of exempt concentrations to NRC-only in this regulation will allow the NRC to obtain complete national data on products and materials containing byproduct material distributed to persons exempt from licensing and regulation. In addition, because the NRC licenses all other distributions of exempt material, NRC-only licensing of introduction of exempt concentrations will be consistent with the other types of exempt distribution. Since no Agreement State licensees have been identified who introduce [[Page 58477]] byproduct material into products received by persons exempt from licensing under Sec. 30.14, there should be no impact on distributors as a result of this change. A person who introduces byproduct material into materials or products distributed to persons exempt from licensing under Sec. 30.14 must, as a result of this rule, hold a license from the NRC under Sec. 32.11. Under Sec. 30.14, the byproduct material activity concentration applicable to this practice must be less than the limits established by Sec. 30.70, ``Schedule A--Exempt concentrations.'' C. Bundling of Exempt Quantities In accordance with Sec. 30.18, ``Exempt quantities,'' a person is exempt from the requirements for a license to the extent that the person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities, each of which does not exceed the applicable quantity in Sec. 30.71, Schedule B. This exemption is being amended to explicitly prohibit the end user from combining, or ``bundling'' multiple sources. Commercial distributors of exempt quantities are presently prohibited from incorporating the exempt byproduct material into any manufactured or assembled commodity, product, or device by regulation (under Sec. 32.18, ``Manufacture, distribution and transfer of exempt quantities of byproduct material''). However, until this final rule, there had been no regulation prohibiting the end-user from bundling sources. The NRC became aware that some persons holding byproduct material under the general materials exemption in Sec. 30.18 had been combining (bundling) multiple exempt quantities within an individual device that had not been evaluated or approved by the NRC. The devices were manufactured without any radioactive material, but were designed to be used with multiple exempt quantity sources of byproduct material. After becoming aware of this issue, the NRC originally determined in June 1994 that, under certain limited circumstances, the bundling of exempt sources did not present a health and safety hazard and therefore no action was taken. Later, the NRC became concerned that the number of exempt sources bundled in unlicensed devices could reach a point where a general or specific license would otherwise be required. As long as the bundled sources were considered exempt, the NRC would have no mechanism to ensure their safe possession, use, and disposal. As a result, the NRC issued Generic Letter 99-01, ``Recent Nuclear Material Safety and Safeguards Decision on Bundling Exempt Quantities,'' on May 3, 1999, to clarify that bundling was not appropriate under the existing regulation. This position was supported by the language in Sec. 32.19(d)(2), which directs the distributor to provide a label or accompanying brochure with any distributed exempt quantities that includes the statement ``Exempt Quantities Should Not Be Combined.'' However, the NRC has since concluded that the regulations in Sec. 30.18 should be amended to specifically prohibit bundling by the end user under the exemption. This final rule revises the exempt quantities provision in Sec. 30.18 to explicitly prohibit combining sources to create an increased radiation level. The original basis for the quantities chosen for the exemption in Sec. 30.18 was the more restrictive of: (1) The quantity of material inhaled by a reference individual exposed for 1 year at the highest average concentration permitted in air for members of the general public in unrestricted areas, or (2) for gamma emitters, the quantity of material that would produce a radiation level of 1 mR/hr at 10 cm from a point source. This basis provides reasonable assurance of protection because, under the conditions of the exemption, it is unlikely that any individual would inhale (or ingest) more than a very small fraction of any radioactive material being used or receive excessive doses of external radiation when realistic source-to-receptor distances and exposure times are assumed. Should bundling be permitted, the NRC could not assure that the exposures would not exceed the levels originally intended under the exemption. In addition, there would be the potential for other undesirable consequences, such as the disposal of devices containing multiple exempt sources through ordinary commercial waste streams or metal recycling channels resulting in inappropriate contamination of property. Because of the NRC's 1994 determination that, under certain limited circumstances, bundling of exempt sources did not present a health and safety hazard, the May 3, 1999, generic letter affirmed that the NRC did not plan to take any action regarding the devices initially produced for use with a limited number of exempt quantity sources or their users unless a radiological safety hazard were to be identified. The NRC has no indication that significant exposures are resulting or will result from the continued use of the devices evaluated in 1994, therefore this rule will allow continued exempt use of those devices distributed before 1999. This exclusion is intended to avoid imposing a regulatory burden on those persons (if any are still using the devices) who otherwise might be impacted by this clarification in the regulation who are continuing to use devices in use before the generic letter was issued. Additionally, this regulation is not intended to impact normal storage methods of the materials held under the exemption in Sec. 30.18. D. Obsolete Provisions Some exemptions from licensing are considered obsolete in that no products are being distributed for use under the exemption. In some cases, no products covered by the exemption remain in use. In others, there are no records of any products ever having been used. Generally, this has occurred because new technologies have made the use of radioactive material unnecessary or less cost-effective. The Commission is deleting exemptions for products that are no longer being used or manufactured, or revising the regulations to restrict further distribution while allowing for the continued possession and use of previously distributed items. Obsolete exemptions in part 30 were for: automobile lock illuminators (formerly Sec. 30.15(a)(2)), balances of precision (Sec. 30.15(a)(3)), automobile shift quadrants (formerly Sec. 30.15(a)(4)), marine compasses (Sec. 30.15(a)(5)), thermostat dials and pointers (formerly Sec. 30.15(a)(6)), spark gap irradiators \2\ (formerly Sec. 30.15(a)(10)), and resins containing scandium-46 for sand consolidation in oil wells (formerly Sec. 30.16). --------------------------------------------------------------------------- \2\ This particular exemption is for a product designed to minimize spark delay in some electrically ignited commercial fuel- oil burners, and is different than some products referred to as ``spark gaps'' or ``spark gap tubes,'' which are a category of electron tube and exempted by Sec. 30.15(a)(8). No change is being made to Sec. 30.15(a)(8) at this time. --------------------------------------------------------------------------- Of these, the exemption for resins containing scandium is the only one that could have resulted in significant doses, based on preliminary dose assessments. Because the exemption was no longer being used, the preliminary dose assessments were not refined or included in NUREG- 1717. These preliminary estimates indicated a potential for exposures higher than are appropriate for materials being used under an exemption from licensing. The removal of this exemption, as a result of this final rule, provides assurance that health and safety are adequately protected from possible future exempt distribution. With the exception of resins covered by Sec. 30.16, only the NRC has licensed distributors of these products. The [[Page 58478]] primary bases for determining that products are obsolete are the NRC's records on its licensees. Industry contacts were also used to collect historical information concerning the use of the various products. For these obsolete exemptions, the specific requirements for manufacturers and initial distributors are being removed in their entirety. These include regulations for the manufacture or distribution of resins containing scandium-46 (formerly Sec. 32.17) and the prototype test procedures for automobile lock illuminators formerly specified in Sec. 32.40 and formerly required by Sec. 32.14(d)(2). The NRC's research has shown that the distribution of thermostat dials or pointers, spark gap irradiators, and resins containing scandium-46 for sand consolidation in oil wells ceased so long ago that it is highly unlikely that any remain in use. Therefore, the complete removal of these exemptions is not expected to have any negative effect on any persons. In the unlikely event that a person currently possesses any of these products for which the governing regulations have been removed, this action is not intended to change the regulatory status of any products previously distributed in conformance with the provisions of the regulations applicable at the time the device was distributed: the user remains exempt. The distribution of balances of precision and marine compasses has ceased; however, some devices may still be in use. Therefore, these exemptions will not be completely removed. Instead, the regulations have been changed to limit exempt use to previously distributed products. Deleting these unnecessary and obsolete provisions will simplify the regulations. This action will also eliminate the need for the Commission to reassess the potential exposure of the public from possible future distributions of these products. Agreement State regulations will be shortened as well. Most importantly, eliminating obsolete exemptions adds assurance that future use of products in these categories will not contribute to exposures of the public. E. New Product-Specific Exemption for Smoke Detectors One of the most widely distributed products used under an exemption from licensing is the ionization chamber smoke detector. From April 1969 until this final rule, smoke detectors have been used under the class exemption for gas and aerosol detectors in Sec. 30.20 (and equivalent regulations of the Agreement States). The Commission established this class exemption so that detectors with similar purposes could be licensed for distribution without the need for establishing many product-specific exemptions through extensive rulemaking procedures. For example, the class exemption in Sec. 30.20 has also been successfully used to cover new chemical agent detectors. Modern ionization chamber smoke detectors have been manufactured and used for many years, with consistency in the design of products. Earlier smoke detector designs sometimes incorporated larger amounts of radioactive material than what is typical today, and in some cases incorporated other radionuclides--such as radium-226--whereas americium-241 is the only radionuclide that is widely used in these devices today. Current designs are very consistent, in that they almost always entail using 1 [mu]Ci or less of americium-241, contained in a foil, and surrounded by an ionization chamber. Potential doses from the distribution, use, handling, and disposal of these detectors have been estimated in NUREG/CR-1156, ``Environmental Assessment of Ionization Chamber Smoke Detectors Containing Am-241,'' November 1979, and more recently in NUREG-1717 (2001). Dose assessments have been performed in numerous license applications under the existing class exemption structure. The estimated doses under normal, routine conditions are well under the safety criterion for routine use of 5 mrem/year (5 [mu]Sv/year) whole body, and the associated individual organ limits. Because the doses from smoke detectors are well understood, and modern designs are very consistent, this rule establishes a product- specific exemption from licensing requirements for smoke detectors. This is intended to apply to ionization chamber smoke detectors containing no more than 1 [mu]Ci (37 kBq) of americium-241 in the form of a foil, and whose primary function is the protection of life and property. Based on records of currently active device designs,\3\ there are 106 smoke detector models that are approved for distribution under the class exemption. Of these, 92 percent (97 out of 106) appear to qualify for the new product-specific exemption because those devices are limited to no more than the amount 1 [mu]Ci of americium-241 in the form of a foil. The new product-specific exemption for ionization chamber smoke detectors is established as Sec. 30.15(a)(7).\4\ The requirements for licensees (and applicants) to distribute these products are contained in Sec. Sec. 32.14, 32.15, and 32.16, as revised by this final rule. --------------------------------------------------------------------------- \3\ Data taken from the sealed source and device (SS&D) registry September 2006. \4\ Section 30.15(a)(7) had been used before to provide an exemption for a different product. A product-specific exemption from licensing was provided in Sec. 30.15(a)(7) for ``glow lamps'' in the 1960s. Later, it was determined that glow lamps should be exempted along with other types of electron tubes under Sec. 30.15(a)(8), and Sec. 30.15(a)(7) was removed. See 34 FR 6651 (April 18, 1969). Because Sec. 30.15(a)(7) has not been used in such a long time, no confusion is expected from this designation for the product-specific exemption for smoke detectors. --------------------------------------------------------------------------- The primary difference between this new exemption and the existing class exemption in Sec. 30.20 is that an applicant for a license to distribute smoke detectors for use under the new exemption would not be required to submit dose assessments to demonstrate that doses from the various stages of the life cycle of the product do not exceed certain values. The applicant would still be required to submit basic design information consistent with that required from applicants to distribute products for use under other product-specific exemptions, specifically for those products used under Sec. 30.15. The specific requirements for obtaining a license to manufacture, process, produce, or initially transfer gas and aerosol detectors intended for use under the existing class exemption in Sec. 30.20 are contained in Sec. 32.26. Conditions of these licenses are contained in Sec. 32.29, and include requirements for quality control, labeling, recordkeeping, and the reporting of transfers. The safety criteria (contained in Sec. Sec. 32.27 and 32.28) for the existing class exemption include: (1) Radiation dose limits for individuals from normal handling, storage, use, and disposal of these products; and (2) radiation dose limits for individuals, in conjunction with approximate associated probabilities of occurrence, for accidents. The primary emphasis of the new requirements imposed on the applicant is to provide assurance that the byproduct material is properly contained within the product and will not be released under the most severe conditions encountered in normal use and handling. Requirements for those licensed to distribute smoke detectors to be used under the new product-specific exemption are contained in Sec. Sec. 32.15 and 32.16. These regulations denote the quality assurance, labeling, recordkeeping, and reports of transfer. The labeling requirements for the existing class exemption are found in Sec. 32.29(b), and to make the product-specific labeling requirements [[Page 58479]] equivalent to those of the class exemption, minor amendments were made to Sec. 32.15. The NRC believes that an applicant who wishes to distribute a qualifying smoke detector will find the process easier and less expensive under the new product-specific exemption than under the class exemption. Compared with the existing class exemption, under the new exemption, license applicants are not required to perform and submit dose assessments to demonstrate that doses from the various stages of the life cycle of the product do not exceed certain values. It is the NRC staff's licensing practice to issue licenses for the distribution of products to be used under a class exemption only after a sealed source and device (SS&D) review and registration of the model in the SS&D registry. Detectors to be used under the new product-specific exemption will not be required to undergo the SS&D review, and devices qualifying for a product-specific exemption may be distributed without an SS&D certificate. As a result, distributors of qualifying smoke detectors will be in a different fee category for the application and annual fees, and likely will be charged lower fees. Relevant application fees both with or without SS&D review and registration are published in Sec. 170.31. Annual fees for licensees distributing devices both with or without SS&D registration are published in Sec. 171.16. Although the fees vary, and future fees are difficult to project with accuracy, the fees are typically more expensive if an SS&D review and registration is needed. Consistent with the requirements of the other product-specific exemptions, the applicant for a license to distribute under the new exemption is required to submit basic design information. However, compared with the process established for the existing class exemption, under the new exemption a sealed source and device certificate need not be obtained (or maintained) to distribute smoke detectors that meet the requirements of the new exemption. The new product-specific exemption allows licensees a new option for distributing smoke detectors to the public that is less costly. It is not compulsory for all smoke detectors to be manufactured and distributed for use only under the new product-specific exemption. Furthermore, this final rule does not modify the existing regulation exempting users of smoke detectors from licensing (Sec. 30.20). A smoke detector manufacturer that produces devices that do not conform with the product-specific exemption (for example, if the devices contain 4 [mu]Ci, or another radionuclide such as nickel-63) may distribute them under the broader class exemption for gas and aerosol detectors. The net effect of this new product-specific exemption is that the regulatory burden and fees are reduced for applicants for licenses to distribute qualifying ionizing chamber smoke detectors. Licensees who currently distribute qualifying smoke detectors (1 [mu]Ci or less of americium-241 in the form of a foil) for use under the class exemption, may also realize benefits if they amend their licenses to distribute the devices under the new product-specific exemption. Additionally, the change is expected to reduce the NRC staff time needed to review these applications, because an evaluation of dose assessments is no longer necessary. Given the wide distribution these products have already experienced, this change is not expected to affect the overall number of smoke detectors distributed in the future. Thus, this change improves the efficiency of the regulatory process, without any impacts to the health and safety of the public or the environment. F. Specific Licenses and Generally Licensed Devices--Clarification A device possessed and used under Sec. 31.5 is a generally licensed device. An entity who holds a specific license may use and possess such a device under the authority of the general license provided by regulation, or, if certain requirements are met, the entity may transfer the device to the authority provided by its specific license. This final rule amends Sec. 31.5 to explicitly state the actions necessary to successfully perform this type of transfer, and eliminates the need to obtain prior NRC approval. Following a revision to the general license provided by Sec. 31.5 (65 FR 79161; December 18, 2000) that became effective in February 2001, an increased number of specific licensees transferred their authorization to possess and use some devices under the Sec. 31.5 general license to the authority provided by their specific license. Licensees were motivated to transfer their devices in this way primarily to avoid the newly established registration fees. There are also other, non-fee-related reasons why one would make such a transfer. It should be noted that this final rule does not compel eligible licensees to make this type of transfer. There has been some confusion about the licensee's responsibilities in enacting such a transfer. A necessary condition for this type of transfer is that the licensee must verify that the conditions of the specific license authorize the possession and use of the device. If the specific license does not authorize the possession of the particular radionuclides or activity, the licensee is unable to transfer a generally licensed device to its specific license. For example, the generally licensed device to be transferred may contain americium-241, but the specific license does not authorize the possession of transuranic radionuclides (americium is a transuranic element). If this is the case, the specific licensee must apply for an appropriate amendment to the specific license before transferring the device. A major issue when transferring a generally licensed device to the authority of a specific license has been the label of the device. The general license in Sec. 31.5, under paragraph (c)(1), requires that the original label on the device be maintained. This label, among other things, indicates the regulatory status (as a generally licensed device), provides safety instructions, and may refer to operating and service manuals. Retaining the label is problematic because, once the device is transferred to the authority of a specific license, instructions to the general licensee may be inappropriate. For example, instructions may indicate that the licensee may not conduct its own leak tests, which is an unnecessary restriction once the device is transferred to the authority of a specific license. Another problem with the label of the transferred device is that the labels of all devices held by a specific licensee must conform with Sec. 20.1904, ``Labeling containers,'' whereas, before the transfer, these requirements were not applicable. It is not acceptable for a device being held under a specific license to be labeled in accordance with Sec. 32.51(a)(3); i.e., a general license label. Thus, if a device is transferred from generally licensed status to the authority of a specific license, the licensee must consider what changes should be made to the labeling and how those changes are to be made. The licensee is responsible for ensuring that the label of the transferred device meets the content requirements of Sec. 20.1904, that any inappropriate restrictions that may have been on the label are resolved, and that any changes to the label are done in a manner that does not damage the device. The licensee must also ensure that the information on the manufacturer, model number, and serial number is retained on the labeling. Persons who have previously transferred generally licensed devices to the authority of their specific license should review the status of the label of [[Page 58480]] the device, to ensure compliance with Sec. 20.1904 and to resolve any inappropriate restrictions that may have been left on the label. Another issue when transferring a generally licensed device to the authority of a specific license concerns maintenance. A specific licensee who plans to conduct its own maintenance activities, including required leak tests, must have information concerning the appropriate methods particular to the device. This information may have been provided if the device had been distributed as specifically licensed. However, because the device was generally licensed and, in some cases, the end user was not permitted to perform certain maintenance, this information may not have been provided when the device was obtained. A specific licensee who transfers a generally licensed device to the authority of its specific license and does not already have this information, could contact the manufacturer, a service provider, another knowledgeable licensee, or a regulatory agency to obtain information on the proper procedures for conducting leak testing and other required maintenance activities. Finally, this final rule simplifies reporting requirements for this type of transfer. Before this rulemaking, two reports were required: A report before the transfer (requesting permission), and a report concurrent with the transfer (reporting the transfer). The NRC believes that there is little benefit in requesting written approval from the NRC before the transfer; therefore, the regulations have been revised. To maintain the integrity of the general license tracking systems operated by the NRC, any transfer of a generally licensed device must be reported, but two reports are not needed. Therefore, Sec. 31.5(c)(8)(iii) is amended so that the pre-transfer report (requesting permission) is no longer required. To keep the appropriate tracking systems up-to-date, it is still necessary for the licensee to file a transfer report per Sec. 31.5(c)(8)(ii). III. Summary of Public Comments on the Proposed Rule The proposed rule on Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements, was published on January 4, 2006 (71 FR 275). The comment period ended on March 20, 2006. Nine letters were received commenting on the proposed rule. One comment letter was submitted by a smoke detector manufacturer, and another by a manufacturer of sources used in smoke detectors. One comment was received from the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR), representing manufacturers and distributors of exempt quantities of byproduct material. One comment was received from the Radiation Safety Officer (RSO) of a university. One comment was received from a member of the public who did not identify an affiliation. Officials from two Agreement States (Alabama and Texas) and staff from two others (Illinois and Georgia) also submitted comments. A discussion of the comments and the NRC's responses follow. A. Meaning of the Term ``Byproduct Materia'' Comment: One commenter noted that the Energy Policy Act of 2005 changed the definition of ``byproduct material'' in the AEA. It was suggested that the NRC explain how ``byproduct material'' is defined in this rule. Response: The definition of byproduct material that applies to this rule is in 10 CFR 30.4, which currently reads: ``Byproduct material means any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.'' As noted in the comment, the Energy Policy Act of 2005 (EPAct) expanded and revised the definition of byproduct material under the NRC's jurisdiction by incorporating certain naturally occurring and accelerator-produced radioactive material. The EPAct required that the NRC promulgate revisions to its regulations to incorporate the new byproduct material. The NRC published its proposed rule on July 28, 2006 (71 FR 42952) in response to this requirement, to revise its regulations and revise the definition of byproduct material in certain of its regulations, including 10 CFR 30.4. The final rule was published October 1, 2007 (72 FR 55863). When the revised definition becomes effective November 30, 2007, the new definition will apply. Distributors of the newly defined byproduct material will be regulated by the NRC, and therefore required to follow the regulations as amended by this final rule. However, as these distributors are already licensed by the NRC for distribution of other radioactive materials, the impact of this final rule on these distributors will be no greater than the impact on other NRC exempt distribution licensees. B. Exempt Quantity Distribution Reports Comment: One commenter submitted a comment on the NRC's new reporting requirements in Sec. 32.20(c) for distributors and manufacturers of materials distributed to persons exempt under Sec. 30.18, ``Exempt quantities.'' The commenter noted that a requirement for a report that indicates the chemical and physical form of each exempt quantity could be excessively burdensome. The commenter suggested that the NRC should specify the names that may be used by licensees to describe commonly distributed materials. Response: The final rule was changed as a result of this comment. The NRC has evaluated the impact of exempt quantities on the public health and safety and the environment to weigh the effectiveness and appropriateness of its regulatory program for this exemption. The NRC does this for all exempt products and materials. During the last evaluation of exempt distribution, it was believed that knowledge of both the chemical and physical form of material distributed as ``exempt quantities'' would provide information that could increase the NRC's ability to estimate the impacts of this exemption on public health and safety and the environment. The proposed rule language, therefore, required that distributors of exempt quantities of radioactive material must report, among other things, both the chemical and physical form of the radioactive material. However, the NRC agrees that providing chemical information would be excessively burdensome for licensees, and that the NRC can perform the necessary evaluations based on the information provided on physical form. The Commission has changed the final rule language to address the commenter's concerns. The language in the final rule retains the annual reporting requirement for exempt quantity distribution and the requirement to report physical form. However, the NRC will not require reporting of the chemical form. The NRC notes that while terms such as ``solid,'' ``liquid,'' or ``gas'' are appropriate to use for reporting the physical form of exempt quantities, other descriptive terms such as ``metal'' or ``powder'' are also acceptable. The NRC does not intend to restrict licensees to use of particular terms; doing so may impose additional burden in reporting. If a licensee has made a substantial number of distributions, and has documentation that more quickly and easily provides essentially the same information and allows the NRC to determine the physical form of the [[Page 58481]] distributed material, a licensee may choose to report using its own terminology instead (e.g., ``solution'' instead of ``liquid'' or ``sealed source'' instead of ``solid''). However, terms that are ambiguous (e.g., ``calibration standard,'' or ``radiolabeled research compounds'') do not specify the physical form and are not acceptable for reporting exempt quantity distribution. Reports covering any time period before the effective date of this final rule are only required to contain data on the total quantity of each radionuclide distributed. Although a report of physical form would be useful for historical distributions, there is no requirement to report the physical form before the effective date of this rule. This was clarified in the final rule text. C. Transfer of Generally Licensed Devices Comment: Some commenters noted that the rule language as proposed in Sec. 31.5(c)(8)(iii)(C) would have required that the licensee obtain maintenance information from the manufacturer to transfer the device to its specific license, which would be impossible if the manufacturer is no longer in business or otherwise unwilling to provide maintenance information. Response: The final rule was changed in response to this comment. The intent in the proposed rule was that a specific licensee is responsible for maintenance activities, but the maintenance instructions may not have been provided to the licensee when the device was first purchased. Although the specific licensee must have sufficient expertise to conduct adequate maintenance activities, in some cases there are procedures developed by the manufacturer (and reviewed and approved by the NRC or Agreement State) that are unique to the device. There is no universal requirement for manufacturers to provide this information to general licensees, because general licensees are only allowed to perform maintenance activities in limited circumstances, and at the time of distribution it was not known that the device would eventually be used under the authority of a specific license. Therefore, it was proposed that a licensee must obtain maintenance information that would be applicable under the specific license. The language in the proposed rule could have been interpreted to limit licensees to obtaining this information directly from the device manufacturer (or initial transferor). This would be problematic if the manufacturer were no longer in business. The final rule has been changed to clarify that the needed information on maintenance is that originated by the manufacturer (or initial distributor), and that it need not be obtained directly. The information may be obtained from not only the device manufacturer, but a service provider, a regulatory agency, or another knowledgeable licensee. The NRC believes that service providers, in particular, should have the maintenance information readily available, and there should be an established relationship between a service provider and the general licensee for the devices in question. The important goal is that the specific licensee is aware of any device-specific maintenance instructions important to safety. Comment: Several commenters noted potential problems with the proposed labeling procedure in Sec. 31.5(c)(8)(iii)(B) that would require a licensee to remove and replace the label before the transfer of a generally licensed device to the authority of a specific license. One commenter indicated that the proposed requirement may conflict with the requirement in Sec. 31.5(c)(1) that prohibits a general licensee from removing the label, and it was suggested that a specifically licensed third party would be needed to complete the transaction. It was also noted that the NRC's labeling requirements could lead to the loss of additional safety warnings or leak testing instructions from generally licensed devices, or that the provenance of the device would be lost. Other commenters identified potential problems, such as damage to the device that could occur during the process of removing the old label. One commenter recommended that the NRC consider that when a generally licensed device is added to a specific license, the conditions of the specific license supersede the general license requirements. For instance, a specific license condition specifying leak tests would supersede the general license label limitations. Response: The final rule was changed in response to this comment. The proposed rule addressed the labeling procedure that would accompany the transfer of a generally licensed device to the authority of a specific license to address the case where an old label was unnecessarily restrictive on the end user, or where the old label would not comply with the requirements of Sec. 20.1904, or any circumstance where the old label would conflict with the device's new status and the licensee's new responsibilities, such as if the original label of the device continued to indicate that it was a generally licensed device. In addition, as noted by one commenter, some labels on generally licensed devices contain stipulations that restrict actions by the end user, such as indications that the licensee shall not conduct its own leak tests. This prohibition would be in force as long as the device is held under a general license; however, once the device is transferred to the authority of a specific license, this restriction would be inappropriate. The intent of the labeling change in the proposed rule was not to remove safety information, but to remove inappropriate restrictions that may be on some labels and to reflect the change in status from generally licensed to specifically licensed. As noted in one comment, the conditions of the specific license supercede the requirements of the general license once the device is transferred to the authority of the specific license. To address this and other potential conflicts, the NRC proposed that the licensee remove the existing label and replace it with another. The final rule has been changed to allow licensees several acceptable options--including those suggested by commenters--for the labeling procedure that will accompany the transfer of a generally licensed device to the authority of a specific license. As originally stated in the proposed rule, the old label may be removed entirely. However, the final rule provides an additional option that the old label may be covered or altered in whole or in part. Alternatively, the specific licensee may leave the old label on the device and conspicuously affix a new label, so long as the resulting arrangement makes it clear (to an inspector, for example) that the old label is superceded. If a licensee believes that the process of removing the old label would affect the integrity of a device's shielding or would otherwise damage the device, the licensee must use another method to comply with the labeling requirement, such as covering the old label. The final rule has also been changed to specifically identify the information that must be on a device that is transferred from generally licensed to specifically licensed status. The final rule has been clarified to require that the device's manufacturer, model number, and serial number be retained. In any case, the new label must comply with the requirements for all containers of specifically licensed radioactive material (in this case, a device) in Sec. 20.1904, and also include the device's manufacturer, model number, and serial number. The requirement that the device be labeled in accordance with Sec. 20.1904 is not a new requirement, as [[Page 58482]] that section applies to all devices held under the authority of a specific license; however, the requirement has been clarified in the final rule. The device's manufacturer, model number, and serial number is information that is not required by Sec. 20.1904; however, the final rule clarifies that this information must be retained for tracking purposes and so that the provenance, or origin, of the device is not lost. Concerning the comment that an existing regulation (Sec. 31.5(c)(1)) prohibits a general licensee from removing a label, the regulation would no longer apply once the device is transferred to the authority of a specific license. It is also not necessary for a specifically licensed third party (such as a vendor) to change the label to accompany the change in status; a specific licensee who possesses the device is authorized to change the label. Comment: A commenter objected to removing the requirement in Sec. 31.5(c)(iii) for prior approval for this category of transfer, as prior approval would ensure appropriate tracking and licensing of the device. Response: The NRC disagrees with this comment and the final rule is not changed. As part of transferring the device to the specific license, the licensee must still report the transfer under the existing requirement in Sec. 31.5(c)(8)(ii). The NRC believes this report is sufficient to allow for appropriate tracking and licensing and that prior approval of the transfer is unnecessary. Comment: Some commenters suggested additional regulatory provisions with regard to the transfer of a generally licensed device to the authority of a specific license. One commenter suggested that, along with the proposed simplified mechanism for transferring a generally licensed device to a specific license (GL to SL transfer), there should also be a mechanism for transferring a device from a specific licensee back to generally licensed status (SL to GL transfer). A separate suggestion was made that a requirement be added to Sec. 31.5(c)(8)(iii)(C) requiring the general licensee to initiate a program to leak test the device at a frequency specified under conditions of the specific license. A third suggestion was made that the NRC ``consider'' that when a generally licensed device is added to a specific license, the conditions of the specific license, such as the leak test condition, would supercede the conditions in the general license. Response: No change has been made to the final rule as a result of these comments. This final rule only affects the transfer of generally licensed devices to specifically licensed status, and does not address the transfer of a device from a specific license back to its original status as generally licensed. The general license in Sec. 31.5 only applies to devices received from a Sec. 32.51 specific licensee (or Agreement State equivalent) to ensure that the device may be used by persons with no radiological training, and for tracking purposes. With regard to the suggestion to add a provision to Sec. 31.5(c) to require the general licensee to leak test the device at a frequency specified under conditions of a specific license, once the device is transferred to the authority of a specific license, the regulations in Part 31 do not apply, because the device is no longer generally licensed. Therefore, any rule change to this part will be ineffective in governing licensee actions after the device is transferred. No rule change is necessary, moreover, because the commenter's concerns that the device continue to be leak tested in accordance with the terms of the specific license will be addressed on the specific license following the transfer. The NRC recognizes that the conditions of the specific license supersede the requirements of the general license once the device is transferred to the authority of the specific license. The rule language does not need to be changed to ensure that conditions of the specific license supersede the conditions in the general license. Comment: One commenter stated that the proposed revision to Sec. 31.5(c)(8)(iii) ``is requiring additional regulation not required of general l