# Requirements for Distribution of Byproduct Material > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-17711 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** July 25, 2012 - **Citation:** 77 FR 43666 ## Text NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 31, 32, 40, and 70 RIN 3150-AH91 [NRC-2008-0338] Requirements for Distribution of Byproduct Material AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations to make requirements for distributors of byproduct material clearer, less prescriptive, and more risk-informed and up to date. The Commission is also redefining categories of devices to be used under exemptions, adding explicit provisions regarding the sealed source and device registration process, and adding flexibility to the licensing of users of sealed sources and devices. This action is primarily intended to make licensing processes more efficient and effective. These changes will affect manufacturers and distributors of sources and devices containing byproduct material and future users of some products currently used under a general or specific license. DATES: Effective Date: This final rule is effective on October 23, 2012. ADDRESSES: Please refer to Docket ID NRC-2008-0338 when contacting the NRC about the availability of information for this final rule. You may access information and comment submittals related to this final rulemaking, which the NRC possesses and are publicly available, by any of the following methods: • Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0338. • NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . To begin the search, select “ ADAMS Public Documents ” and then select “ Begin Web-based ADAMS Search .” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov . • NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-6264, email: Catherine.Mattsen@nrc.gov . SUPPLEMENTARY INFORMATION: I. Background A. Introduction B. Regulatory Framework II. Discussion A. Actions Related to Sealed Source and Device Registration B. Establish a New Class Exemption for Certain Industrial Products C. Remove Unnecessary Limitations from the Class Exemption for Gas and Aerosol Detectors D. Update the Regulations on Certain Static Eliminators and Ion Generating Tubes E. Remove Prescriptive Requirements for Distributors of Generally Licensed Devices and Exempt Products F. Make the Requirements for Distributors of Exempt Products More Risk-Informed G. Minor Clarifying or Administrative Revisions III. Summary and Analysis of Public Comments on the Proposed Rule A. Actions Related to Sealed Source and Device Registration B. Establish a New Class Exemption for Certain Industrial Products C. Remove Unnecessary Limitations from the Class Exemption for Gas and Aerosol Detectors D. Remove Prescriptive Requirements for Distributors of Generally Licensed Devices and Exempt Products E. Other Issues F. Comments on Issues Outside of the Scope of the Rule IV. Summary of Final 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. Plain Writing X. Paperwork Reduction Act Statement XI. Regulatory Analysis XII. Regulatory Flexibility Certification XIII. Backfit Analysis XIV. Congressional Review Act I. Background A. Introduction The Commission has authority to issue both general and specific 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). A general license is provided by regulation, grants authority to a person for particular activities involving byproduct material as described within the general license, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. Requirements for general licensees appear in the regulations and are designed to be commensurate with the specific circumstances covered by each general license. A specific license is issued to a named person who has filed an application with the Commission. 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.” (Section 81(a) of the Act, 42 U.S.C. 2111.) As beneficial uses of radioactive material were developed and experience grew, new products intended for use by the general public were invented and the regulations were amended to accommodate the use of new products. Although presenting very low risks of significant individual doses to members of the general public, exempt products are a source of routine exposure to the public. A substantial portion of the population uses and enjoys benefits from exempt products, such as smoke detectors, but also receives some radiation exposure from those products. In keeping with its consumer product policy, which calls for the Commission to evaluate the total effect of consumer products on the public, the Commission conducted a systematic reevaluation of the exemptions from licensing. A major part of the effort was an assessment of the potential and likely doses to workers and the public under these exemptions. Dose assessments for most of these exemptions can be found in NUREG-1717, 1 “Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials,” June 2001. Actual exposures of the public likely to occur are in line with Commission policy concerning acceptable doses from products and materials used under exemptions. For some exemptions, there was a significant difference between potential and likely doses because the use of the exemption 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 or see: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1717/ . The NRC has reviewed the regulations governing the distribution of byproduct material to persons for use under the exemptions, as well as other regulations governing distribution of products containing byproduct material. The Commission decided to make these regulations more flexible, user-friendly, and performance-based, and to improve its ability to risk-inform its regulatory program. These concepts were considered in developing potential revisions to the regulatory program in the area of distribution of byproduct material. In a final rule published October 16, 2007 (72 FR 58473), some of these revisions that could be more readily completed were made, including the removal of obsolete exemptions. This action is a follow-on to that effort for revisions that required more detailed development. To make optimal use of rulemaking resources, both for the NRC and the Agreement States who must develop conforming regulations, several issues have been combined into this rule. The proposed rule containing these amendments was published for public comment in the Federal Register on June 24, 2010 (75 FR 36212). The public comment period closed September 7, 2010. Ten comment letters were received. The NRC has considered these comments in this final rule. B. Regulatory Framework The Commission's regulations in part 30 of Title 10 of the Code of Federal Regulations (10 CFR) contain the basic requirements for licensing of byproduct material. Part 30 includes a number of provisions that exempt the end user from licensing requirements, so-called “exemptions.” Some exemptions are product-specific, intended only for specific purposes which are narrowly defined by regulation. More broadly defined are the general materials exemptions, which allow the use of many radionuclides in many chemical and physical forms subject to limits on activity, and which are specified in §§ 30.14 and 30.18 for exempt concentrations and exempt quantities, respectively. The Commission's regulations currently also include two “class exemptions”—for self-luminous products and gas and aerosol detectors, in §§ 30.19 and 30.20, respectively—which cover a broad class of products not limited to certain quantities or radionuclides. In the case of class exemptions, many products can be approved for use through the licensing process if the applicant for a distribution license demonstrates that the specific product is within the class and meets certain radiation dose criteria. Part 31 of 10 CFR provides general licenses for the use of certain items containing byproduct material and the requirements associated with these general licenses. Part 32 of 10 CFR sets out requirements for the manufacture or initial transfer (distribution) of items containing byproduct material to persons exempt from licensing requirements and to persons using a general license. It also includes requirements applicable to certain manufacturers and distributors of products and materials to be used by specific licensees. The requirements for manufacturers and initial transferors (distributors) address such measures as prototype testing, labeling, reporting and recordkeeping, quality control, and, in some cases, specific sampling procedures. II. Discussion This final rule is making 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. The changes are intended to improve the efficiency and effectiveness of certain licensing actions. A. Actions Related to Sealed Source and Device Registration A.1 Updating Regulations To Add Registration Requirements Section 32.210 provides for the registration of sealed sources and devices containing sealed sources intended for use under a specific license. Manufacturers or distributors may submit a request to the NRC for an evaluation of radiation safety information for a product and for registration of the product. After satisfactory completion of the evaluation, the NRC issues a certificate of registration to the person making the request. Subsequently, under § 30.32(g), specific licensees or applicants for a specific license who wish to use the registered product need only identify the source or device by manufacturer and model number, as registered with the Commission under § 32.210 or with an Agreement State, in their applications. Because the source or device has already been evaluated and its safety information is a matter of record, the users are not required to submit the detailed radiation safety information for the source or device in their license applications. This greatly simplifies the licensing process for the users of specifically licensed sources and devices. The registration system is referred to as the Sealed Source and Device (SS & D) Registry. Many Agreement States have a similar registration process. Registration certificates for the sources and devices reviewed and approved by the Agreement States are also added to the national SS & D Registry. However, some Agreement States do not include the evaluation and registration of sealed sources and devices in their agreements; in these cases, authority for these reviews remains under NRC regulatory jurisdiction. A definition of the registry is included in § 35.2 as follows: “Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.” This definition is being added to part 32 by this action, as the information requirements for the SS & D review and registration are in part 32. The SS & D Registry is maintained in a computer database, which is available to the Agreement States, as well as U.S. government agencies and some foreign regulators. While this process, in which the manufacturer or initial distributor obtains a registration certificate for the source or device, is generally used for most specifically licensed sources and devices, in some cases of custom-made sources or devices, the planned user will sometimes submit the detailed radiation safety information. As a matter of licensing practice, such a custom device, if containing more than certain quantities of radioactive material, is also registered; however, it only allows for the use of the custom-made source or device by the specified user. As § 30.32(g) requires the radiation safety information to be submitted by applicants to use sealed sources and devices if they are not registered, manufacturers and distributors generally register the sources and devices that are to be used under a specific license. Sealed source or device review and registration are conducted for most sealed sources and devices to be used under a specific license. This registration process has also been extended to many generally licensed and some exempt products. The regulations in part 32 contain requirements for submittal of radiation safety information concerning these products by the manufacturer or initial distributor. Although registration of these products by the manufacturer or initial distributor was not previously addressed by the regulations, the NRC's licensing practice has been to issue registration certificates for certain of these products based on the radiation safety information submitted. Also, fees are assessed based on whether or not a “sealed source and/or device review” is required. The products in each of these categories for which the registration process has been used as part of the licensing process have been indicated in guidance, e.g., NUREG-1556, Vol. 3, Rev. 1, “Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration”; NUREG-1556, Vol. 8, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses”; and NUREG-1556, Vol. 16, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees.” For a number of categories of specifically licensed sources and devices, an explicit requirement for registration is included in the regulations. Existing specific requirements include §§ 35.400, 35.500, 35.600, 36.21, and 39.41(f). These concern certain medical use products, sealed sources installed in irradiators after July 1, 1993, and energy compensation sources (a specific type of reference source used in well logging). The only products used under exemption from licensing for which the NRC issues registration certificates are those distributed for use under a “class exemption.” As noted earlier, a class exemption allows for the use under exemption of a category of products with the safety decision for individual products made through the licensing process. The safety review for these products includes evaluating the product against specific safety criteria contained in the regulations in part 32. The regulations currently contain two class exemptions. These are found in § 30.19, Self-luminous products containing tritium, krypton-85, or promethium-147, and § 30.20, Gas and aerosol detectors containing byproduct material, and equivalent Agreement State regulations. As discussed later in this document, this rule establishes a third class exemption for certain industrial products. In the case of generally licensed products, sealed source and device registration certificates have been issued for products distributed for use under §§ 31.3, 31.5, 31.7, and 31.10, and equivalent Agreement State regulations. (Note that this registration is distinct and different in scope and purpose from the registration of devices by some general licensees under § 31.5(c)(13).) Neither general licensees nor persons exempt from licensing requirements need to submit any safety information in order to obtain a product. For these products, however, the registration process also serves the important purpose of providing information to the regulators in all jurisdictions. Products are approved by the NRC and, in some cases, by the various Agreement States for distribution to all jurisdictions. For those products that are registered by the manufacturer or distributor, the registration information is available to the NRC and to the Agreement States through the SS & D Registry. In this way, the various jurisdictions can be assured of the radiation safety of the products being used under their regulations that have been evaluated by another jurisdiction. The registration of products by model number also assists in the tracking of generally licensed devices by the NRC and the Agreement States. In some cases, a secondary distributor of a generally licensed device may refer to the registration certificate obtained by the manufacturer, or more frequently a source to be installed in a generally licensed device may be manufactured by a different entity who has registered the source separately. For those products used under a product-specific exemption, for which registration certificates are not issued, the safety of the product has been evaluated based primarily on the constraints contained in the regulations, such as a quantity limit for a specific radionuclide, and what can be projected about the life cycle of the product and how it is used. Some of these evaluations are documented in NUREG/CR-1775, “Environmental Assessment of Consumer Products Containing Radioactive Material,” October 1980 (ADAMS Accession No. ML082910862), and NUREG-1717. The applicable requirements in § 32.14(b) require information to be submitted to allow an evaluation of the potential radiation exposure and, in accordance with § 32.14(d), the NRC makes a determination that the byproduct material is “properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling.” But the information to support this evaluation of the particular product is not considered necessary to routinely provide to the Agreement States through the SS & D Registry. No sealed source and device review is conducted for the products used under the general licenses in §§ 31.8 or 31.11. The general license in § 31.8 is specifically for no more than 0.185 MBq (5 µCi) 1 of americium-241 or radium-226 in the form of calibration and reference sources, and applies only to specific licensees. The safety of these sources is also well established, with the individual product being reviewed and approved in the licensing process. The general license in § 31.11 pertains to in-vitro clinical or laboratory testing using prepackaged units containing certain limited quantities of byproduct material, e.g., iodine-125 in units not exceeding 10 µCi (0.37 MBq). These in-vitro kits are not sealed sources or devices. They can be used only by physicians, clinical laboratories, hospitals, and practitioners of veterinary medicine who preregister with the Commission and by part 35 licensees. There is also no SS & D registration for the recently added general license in § 31.12, which covers only items produced prior to the NRC gaining jurisdiction over radium-226. Because there is no allowance for future production of items to be used under this general license, there are no associated distributor requirements and thus, no requirement for a product to be registered in the SS & D Registry. These products are mostly antiquities produced before States had regulations similar to NRC's. 1 The NRC's policy on units calls for new and amended regulations to use the International System of Units (SI) with the English unit equivalent following in parentheses. In this document, a number of references are made to existing regulations that are currently in English units; in referencing such values, the actual regulatory value is given first with the SI unit equivalent, sometimes a rounded approximation, following in parentheses. Also, when discussing comments, units used by the commenter are used. Registration certificates are issued for most specifically licensed sealed sources and devices. The exceptions are for small calibration and reference sources and for sources and devices to be used by (1) broad scope licensees under 10 CFR part 33 and equivalent Agreement State regulations, (2) research and development licensees, and (3) licensees for whom the source or device was built to their unique specifications and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide. These three categories of licensees must be qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form as indicated in their license(s). Under these circumstances, licensing these three types of users does not rely on the inherent safety features of the source or device; users will be evaluated under the criteria in § 30.33(a)(2) and (3) and licensed to handle equivalent quantities of the materials in any form. If the source is registered but not the device, the users must be licensed to handle equivalent quantities of the materials in unshielded form. For specifically licensed calibration and reference sources, the quantity cutoffs being established for small sources excluded from the requirement for registration are 0.37 MBq (10 µCi) for alpha emitters and 37 MBq (1 mCi) for beta and/or gamma emitters. This is a simplification from previous licensing practice, which used a limit of 3.7 MBq (100 µCi) or 10 times the quantity specified in § 30.71, whichever is greater, for beta and/or gamma emitters. The limits using that guidance for beta/gamma emitters range from 3.7 MBq (100 µCi) to 370 MBq (10 mCi). Thus, for any particular radionuclide, the new criterion is no more than 10 times higher to 10 times lower than previous practice. As certificates typically cover a large number of radionuclides for this type of sealed source, this change is not expected to affect the overall number of registration certificates issued. This final rule explicitly adds registration requirements to the regulations for byproduct material in products used under certain general licenses and under certain exemptions from licensing requirements, as well as for additional specifically licensed sources and devices for which this is not currently addressed by the regulations. This will make it easier for potential applicants for a license to distribute these products to determine the applicable requirements and associated fees. These provisions are in large part consistent with previous licensing practice and appear in §§ 32.22(a)(3)(ii), 32.26(c)(2), 32.30(c)(3), 32.51(a)(6), 32.53(f), 32.61(g), 32.74(a)(4), and 32.210. A.2 Adding Provisions for Amendment, Modification and Revocation, Review, and Inactivation of Registration Certificates The Commission is adding a number of other explicit provisions to the regulations concerning sealed source and device registration certificates. Many certificates are revised and updated from time to time as a result of amendment requests made by manufacturers or distributors to accommodate desired changes in a product or associated procedures or to add new products to a registration certificate covering a series of models. Sections 30.38 and 30.39, which previously addressed only amendment of licenses, are being revised to also address amendment of registration certificates. The final rule is also revising § 30.38 to remove the requirement to use Form NRC-313 for requesting amendments to licenses, because as a practical matter, many amendments are requested and obtained without use of the form. Unlike specific licenses, registration certificates are not issued with expiration dates. If a significant safety issue arises with a product, regulatory means are available to address it, such as an order issued to a distributor to cease distribution until the safety issue is resolved. The Commission has had authority to request additional information or to modify requirements under the general provisions in §§ 2.204, 30.34(e), and 30.61. In addition, since the Commission has authority to revoke a license, and registration is used as part of the licensing process, the Commission has had the authority to revoke a registration certificate, if, for example, it determined that the registration was inconsistent with regulatory standards or the certificate had been obtained by providing falsified information. However, the regulations have not referenced this authority. Therefore, § 30.61 is being revised to explicitly implement the Commission's authority to modify or revoke registration certificates. As a registration certificate, in conjunction with a license, authorizes distribution of a product, a certificate may be reevaluated at the time of license renewal. Generally, this has not been the practice of the NRC, but may be the case for some Agreement States. In the case of licenses authorizing distribution to exempt persons, a limited review of the certificate(s), when applicable, has typically been conducted to ensure that the information is complete and accurate with respect to any changes that may have occurred since issuance of the certificate. For all types of certificates, it is important that there be consistency between the license and the certificate(s). The Commission does not believe that it is necessary to conduct a complete reevaluation of sealed sources and devices at the time that distribution licenses are renewed, usually every 10 years, since generally, there are fewer safety significant aspects that are likely to change reflected in the registration certificate than those addressed in the license. The Commission does recognize a need to update registration certificates and relies, for the most part, on certificate holders to request amendments of certificates, as appropriate. One factor is that the NRC is required to consider the application of industry standards, for example, as reflected in § 32.210(d). These industry standards may be revised to provide improved safety. Also, licensees are required by § 20.1101 to implement radiation protection programs and to use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). Thus, it is appropriate for licensees to consider new developments in technology and standards as they may impact ALARA in the design of products. However, because § 32.210(f) requires the certificate holder to manufacture and distribute products in accordance with the provisions of the registration certificate and any statements made in the request for registration, and no reevaluation of a source or device, once approved, is normally required, the regulatory structure may limit rather than encourage industry improvement. There may be reasons to reevaluate a sealed source or device in some circumstances with regard to either the actual design of a source or device, or such other aspects as quality assurance or information provided to the user on safe use. While the current regulations provide adequate authority to do so, recalling a registration certificate for review and reissuance in the absence of a significant safety problem with the product is an activity very rarely conducted by the NRC in the past. This final rule also includes an explicit provision to specifically address such a process in § 32.210(h). The Commission will complete such an evaluation in accordance with the criteria specified in § 32.210. As noted under Section II. A.1, “Updating Regulations to Add Registration Requirements,” of this document, this final rule adds specific provisions delineating which sealed sources and devices must be registered in the SS & D Registry, broadening the applicability of § 32.210 to some generally licensed and exempt products. The Commission may use the new provision in § 32.210(h) to update the certificate with respect to applicable current regulatory standards or to ensure the quality of the summary of safety information and the information on conditions of use contained in the registration certificate that is available to the various jurisdictions. Generally, the Commission has not made standards more restrictive with regard to products to be used under a general license or under an exemption from licensing, so as to restrict further distribution of a previously approved product. However, such a decision in the future may necessitate a reevaluation of a registration certificate. Registrations in the SS & D Registry are kept active until a distributor who is no longer distributing the particular sources or devices, requests to change the status. At this point, the registration is changed to inactive status, meaning that the covered products are no longer authorized to be distributed. Annual fees are assessed by the NRC only for active registration certificates. The SS & D registrations are kept indefinitely in inactive status after authorization to distribute has ceased, so that the registration information is available for sources and devices previously distributed and possibly still in use. Because some States do not have annual fees for maintaining active SS & D certificates, distributors do not consistently request inactivation of certificates, leaving active certificates in the database that do not reflect any continued distribution. This somewhat limits the information available to other jurisdictions as to what sources and devices are authorized for continued distribution. This rule includes a provision for inactivation (§ 32.211), which will require distributors to request inactivation of certificates normally within 2 years after distribution of the source(s) or device(s) covered by the certificate has ceased. Two years was chosen to minimize any impact on certificate holders. NRC certificate holders typically request inactivation of certificates within about a year. The inactivation provision has been modified in the final rule from the proposed wording of that section to recognize that a decision to cease distribution may occasionally occur more than 2 years after the last initial transfer of a covered source or device has been made. In this situation, a distributor must provide a brief explanation of the circumstances that led to requesting inactivation of the certificate after more than 2 years of no transfers. This provision is expected to improve the consistency of this approach across jurisdictions through the addition of equivalent provisions to Agreement State regulations, and thus, the quality of the information concerning current distribution available to regulators. A.3 Adding Flexibility for Licensing Users of Sealed Sources and Devices As noted, the safety information for every sealed source and device to be used under a specific license is not included in the SS & D Registry. However, the wording of § 30.32(g) has not allowed as much flexibility as was expected when this provision was added to the regulations. In some circumstances, it has been impractical or impossible for users to provide all of the information required by § 30.32(g). This has caused some applicants and licensees renewing their licenses to seek exemptions from § 30.32(g) for the use of products for which the manufacturer or distributor has not obtained an SS & D registration. In addition to providing criteria in a revision to § 32.210 for situations where an SS & D registration is not required, revisions to § 30.32(g) are also being made to accommodate exceptions made in the SS & D registration process. In order to better accommodate the new provisions clearly, paragraph (g) of § 30.32 has been slightly restructured in the final rule. A new § 30.32(g)(3) (which appeared as § 30.32(g)(4) in the proposed rule) provides that limited information is required for the smaller calibration and reference sources that are not registered. Also included is a provision to allow for licenses to be issued without the need for every individual sealed source or device to be used to be identified by the applicant. A new § 30.32(g)(4) (which appeared in § 30.32(g)(5) in the proposed rule) allows an applicant to propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used as an alternative to identifying each sealed source and device individually when it is not feasible to do so. This latter provision is not intended as a broadly applied change in the approach to licensing the use of sealed sources and devices. This change is intended to accommodate certain expected situations in which having to identify each sealed source or device presents an undue burden. For example, military applicants are sometimes unable to identify exactly which product they may be procuring. This provision could also be used by the types of applicants/licensees identified in § 32.210(g)(2), namely those licensed for research and development (R & D), those licensed under part 33, and certain custom users who have adequate training and experience and facilities and equipment to handle comparable quantities of material in other forms. It may also be reasonable to use such an approach to provide some flexibility in the case of calibration and reference sources. The words, “If it is not feasible to identify each sealed source and device individually,” have been included in the final rule text to clarify the limited applicability of this provision. It is anticipated that except for the R & D licensees, part 33 licensees, and certain custom users, one of the constraints would be that the sealed sources and devices are registered, as it is generally not practical for an applicant to supply adequate information to demonstrate that the radiation safety properties of unspecified sources or devices are inherently adequate to protect health and minimize danger to life and property. The use of the SS & D registration process as a tool for licensing was intended to provide a more efficient and effective licensing process than to have all users provide detailed information about the sources and devices to be used, and for license reviewers to evaluate the safety of the sources and devices in conjunction with the evaluation of the applicant's training and experience and facilities and equipment. The changes to §§ 30.32(g) and 32.210(g) are intended to further improve the efficiency and effectiveness of the licensing process by eliminating the need for unnecessary exemptions for recognized situations that are not unique to a particular applicant. A.4 Extending Requirements Concerning Legacy Sources and Devices to All Byproduct Material Covered by Part 30 In the final rule published October 1, 2007 (72 FR 55863), which amended the Commission's regulations to incorporate the new categories of byproduct material added by the Energy Policy Act of 2005 (EPAct), a revision was made to § 30.32(g) to facilitate licensing the use of legacy sealed sources and devices. These are older sources and devices for which the manufacturer is no longer in existence and for which it may be impossible to provide all of the categories of information identified in § 32.210(c), as required by § 30.32(g)(1)(ii), formerly § 30.32(g)(2). Generally, that amendment was intended to cover sources and devices manufactured before the promulgation of § 32.210. This provision, formerly in § 30.32(g)(3), delineates additional information that is required to license the use of a sealed source or device for which all of the information previously required is not available. The information must include a description of the source or device, a description of radiation safety features, intended use and associated operating experience, and results of a recent leak test. The NRC licensing staff will review the submitted information to make a licensing decision regarding possession and use of the source or device. However, that amendment limited the provision to sealed sources and devices containing naturally occurring and accelerator-produced radioactive material (NARM), because the scope of that rule was limited to such materials. There are, however, a number of legacy sealed sources and devices containing pre-EPAct byproduct material, i.e., byproduct material as defined in section 11e.(1) of the AEA, for which it may also be impossible to provide all of the information required under § 32.210(c). This final rule is extending that provision to legacy sources and devices containing any byproduct material, as defined in part 30; it is now designated § 30.32(g)(2). B. Establish a New Class Exemption for Certain Industrial Products As noted in Section I.B., “Regulatory Framework,” class exemptions allow the Commission to exempt categories of products or devices with similar characteristics and purposes, rather than requiring individual exemptions for each product. For example, the class exemption in § 30.20 for gas and aerosol detectors was established in April 1969. Since that time, new products possessing similar attributes were allowed to be licensed for distribution under § 30.20 as they were developed. This regulatory structure allowed the new detectors to be used without product-specific exemptions, which would have required additional rulemaking. The health and safety of the public is ensured by evaluating each specific product against safety criteria contained in the regulations that apply to all products in a class. There are a number of products used under the general license in § 31.5 that could meet similar safety criteria but do not come under either of the existing classes, i.e., §§ 30.19 and 30.20. Certain industrial devices were identified by the NRC staff for possible use under an exemption from licensing requirements because of their low risk; i.e., static eliminators and ion generators containing polonium-210, beta backscatter and transmission devices, electron capture detectors for gas chromatographs, x-ray fluorescence analyzers, and calibration and reference sources. Dose assessments were conducted for these categories of products assuming use under an exemption from licensing and included in NUREG-1717. For each of the types of licensed products suggested for possible use under an exemption and included in the dose evaluations of NUREG-1717, some of the products clearly result in doses so low that requiring use under a license could be considered an unnecessary regulatory burden and an unnecessary expenditure of user and NRC resources. However, it is not clear that each type of device would necessarily qualify for exemption for all of the radionuclides and quantities used. Therefore, the NRC is adding a new class exemption, rather than attempting to create a number of additional product-specific exemptions with appropriate limitations, such as radionuclide-specific quantity limits. The new class exemption in § 30.22, covering a broad range of industrial devices, will maintain protection of public health and safety and, at the same time, relieve regulatory burden. Presently, most of these products are licensed under the general license in § 31.5 and equivalent Agreement State regulations. In order for a product to be distributed for use under the new class exemption, the manufacturer or importer will be required to demonstrate that a particular device meets certain safety criteria, with NRC review and approval. This class exemption will also allow for the development of new products within the class or category of industrial devices that could be approved for use under exemption without the need for additional rulemaking to add product-specific exemptions. This approach allows for a broader number of devices to be exempted and for variations on a product or new products in the class to be approved for use under exemption from licensing without further need for rulemaking. The exemption may lead to more devices being developed with appropriately low risk that meet the criteria for the exemption. Thus, additional benefit to society may accrue if more people make use of the types of products in this class. Although some calibration and reference sources are currently licensed under § 31.5, a clarification is included in the new exemption that such sources are not covered, since it is more difficult to assess likely scenarios of handling and use for sources not incorporated into a specific device with a specific purpose; in particular, the number of sources that might be used or stored in close proximity is apt to be greater and more uncertain. Also, calibration and reference sources are frequently used by persons using other radioactive materials under a license, minimizing the benefit of an exemption in this case. Many of these are already used under the exemption in § 30.18. Some containing americium-241 and radium-226 are also covered by the general license in § 31.8. Therefore, it is not believed that the type of exemption being added is an appropriate regulatory approach for calibration and reference sources. The exemption covers industrial devices with the same list of purposes as are covered by the general license in § 31.5 with the exception of that of producing light. The class exemption for self-luminous products is considered adequate and appropriate to provide for exempt use of products of this type. The new exemption for industrial products has a lower dose criterion for routine use than that associated with the general license and includes consideration of potential doses from disposal. Devices used under § 31.5 must be returned to a specific licensee, such as a vendor (distributor) or waste broker, and ultimately disposed of as low-level radioactive waste. Under the new exemption from licensing requirements, there are no controls on disposal; the devices will be disposed without regard to their radioactivity. Thus, the potential impacts of uncontrolled disposal need to be evaluated in the licensing process for each particular device. The information to be submitted by an applicant to distribute a device for use under this new class exemption is delineated in § 32.30; these requirements are very similar to those for applications to distribute a product for use under the other class exemptions, for example, under § 32.26 for gas and aerosol detectors. The safety criteria are similar to the criteria for licensing the manufacture or distribution of gas and aerosol detectors (contained in §§ 32.27 and 32.28). However, those criteria include more organ-specific limits, because they were based on the dose limitation methodology recommended by the International Commission on Radiation Protection (ICRP) in 1959 in ICRP-2, “Report of ICRP Committee II on Permissible Dose for Internal Radiation,” whereas more recently developed approaches to radiation protection rely less on individual organ dose limits or constraints, particularly when doses are low, and include weighting organ dose contributions to overall dose. These newer approaches involve calculating doses in total effective dose equivalent as in 10 CFR part 20, based on ICRP-26, “Recommendations of the International Commission on Radiological Protection,” or effective dose, based on the subsequent recommendations of the ICRP. The safety criteria for the new class exemption will not require that the exposures be estimated specifically in terms of total effective dose equivalent (TEDE) or effective dose. The intent is to provide flexibility so that the most up-to-date dose calculation methodology may be used. However, the staff will normally accept the use of the current approved methodology such as that now reflected in part 20. The NRC notes that the ICRP issued its latest recommendations in ICRP-103, “The 2007 Recommendations of the International Commission on Radiological Protection.” The specific dose conversion factors based on those recommendations have not yet been calculated. However, as the safety criteria for the class exemption are design criteria, it is preferable to have the flexibility to use the latest information for considering risk during design. For the purposes of these provisions, a definition of a generic term for internal dose, “committed dose,” is being added to § 32.2 to encompass this approach, which includes weighting of organ and tissue doses, but not strictly under one system. The definition of “committed dose” has been changed in the final rule to remove the reference to specific definitions in part 20 and of ICRP, but maintain the basic approach. The revised definition includes the term “tissue weighting factors.” The NRC would normally accept dose estimates based on the weighting factors in part 20 or the tissue weighting factors in ICRP-60, “1990 Recommendations of the International Commission on Radiological Protection,” or ICRP-103. The dose criterion for routine use of these devices is 200 µSv (20 mrem)/year, which is significantly higher than that for gas and aerosol detectors (5 mrem (50 µSv)/year). This exemption covers industrial type devices, used almost exclusively on the job, meaning that routine doses will normally be occupational, i.e., doses received by individuals in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material. In a small proportion of cases, a user might not be a worker, but a student, for example. However, these instances are likely to involve a limited amount of time for exposure over the year, reducing doses to these types of users. Due to the industrial purpose of the devices, these products are not expected to be sold in the large quantities possible for consumer products, such as smoke detectors. Therefore, these products will contribute to the exposures of many fewer people. Doses to members of the public would generally be smaller, usually much less than that to the user. In order to provide reasonable assurance that members of the public are not routinely exposed to more than a few mrem/year (few 10's of µSv/year), the regulation also includes a criterion that the device is unlikely to be routinely used by members of the general public in a non-occupational environment. The Commission's policy for consumer products is for the general public to receive no more than a small fraction of the public dose limit from exempt products, so that their exposures from all sources are not likely to routinely exceed the public dose limit, which is now 100 mrem (1 mSv)/year. The fact that industrial products are not as widely used as items commonly used in the home will tend to limit the contribution by these products to disposal doses; e.g., the exposures of landfill workers. Nonetheless, the safety criteria include a separate criterion for disposal, 10 µSv (1 mrem)/year. This criterion is lower than the criterion for routine use, because the same individuals are apt to be exposed to all products disposed in any particular landfill or municipal incinerator. Accident criteria are similar to those for products to be used under §§ 30.19 and 30.20. The higher of these limits, that for the lowest probability accident, is also used in the safety criteria for the general license in § 31.5, under which many of the devices potentially covered by the new class exemption are currently used (§ 32.51(a)(2)(iii)). However, the safety criteria for the new class exemption include an additional criterion to ensure that the radionuclide quantities allowed for use under the exemption are limited, such that the maximum possible dose is controlled, even if the circumstances leading to such a dose are extremely improbable. The accident criteria currently in § 32.23(d), § 32.24, Column IV, § 32.27(c), § 32.28, Column III, and § 32.51(a)(2)(iii) were expected to limit the total amount of radioactive material likely to be approved for use under the relevant exemption or general license, irrespective of the design to contain or shield the material. However, designs to contain the material even under severe conditions of use or accident have resulted in relatively large quantities of materials being approved in some cases. Although the radiological risk is well controlled by these designs, possible scenarios of misuse are not required to be evaluated. For this new exemption, a criterion is included requiring that specific scenarios of misuse be analyzed and shown to meet certain dose limits. The analysis required to meet this misuse criterion will be relatively simple. Evaluating actual risk from possible misuse would be much more difficult, but such risks will be limited by this misuse criterion. The basis for this criterion is to ensure public health and safety. The criterion is 100 mSv (10 rem), plus an additional skin dose criterion. This criterion is slightly lower than the accident criterion of 15 rem (150 mSv) applicable to products covered by the existing class exemptions and the general license in § 31.5. This criterion is considered to be a more appropriate value given the high level of uncertainty in estimates of doses under accident conditions. Limiting the radionuclide quantities allowed for use under the exemption, even if well contained, has the additional benefits of: (1) Minimizing risks associated with devices becoming subject to scrap metal recycling, such as property damage due to contamination resulting from smelting; (2) further controlling overall impacts to waste disposal workers; (3) minimizing overall impacts to the environment from uncontrolled disposal of products used under exemptions from licensing; and (4) minimizing the potential problems of products exempted by the NRC being detected at and sometimes rejected for disposal in landfills and municipal incinerators by State and local restrictions. In the proposed rule, an additional fixed limit for radionuclides of concern, in terms of a small fraction of the Category 2 threshold as listed in Appendix E of part 20, was also included (as proposed § 32.30(c)(4)). This additional limit is not included in the final rule. The Commission has determined that there is no safety or security basis for a quantity limit, that the safety criteria will adequately protect public health and safety from products approved for use under the new class exemption, and that the misuse criterion in particular will adequately control the quantities of material that will be approved for use in such products to obtain the additional benefits described above. Except for the removal of this specific quantity limit and the change to the definition of “committed dose,” the rule is essentially identical to the proposed regulatory text related to this new class exemption with one minor change made in response to public comment. That change involves the specific distances at which applicants will measure the radiation field around devices they seek to distribute for use under the exemption. This is discussed further under Section III, “Summary and Analysis of Public Comments on the Proposed Rule.” C. Remove Unnecessary Limitations From the Class Exemption for Gas and Aerosol Detectors The class exemption in § 30.20 is for gas and aerosol detectors “designed to protect life or property from fires and airborne hazards.” At the time that this exemption was added to the regulations, the applications of these types of devices under consideration were smoke detectors and devices to detect chemicals that would constitute an airborne hazard if inhaled. The words “designed to protect life or property from fires and airborne hazards” were included to ensure that the products provided a clear societal benefit. Products similar to those allowed, but not quite fitting the “class,” cannot be approved for use under this exemption. For example, drug detectors were rejected for distribution for use under this exemption because they do not specifically protect life or property from fires or airborne hazards. The NRC believes that there is a clear societal benefit from this application and allowing its use under the exemption is justified, as long as a particular device meets the applicable safety standards. A minor modification, therefore, is being made to allow for a slightly broader class of product without eliminating the expectation of a societal benefit. “Designed to protect life or property from fires and airborne hazards” is replaced with, “designed to protect health, safety, or property.” This will allow other potential applications under an existing regulatory framework, which has safety criteria designed to adequately protect public health and safety. D. Update the Regulations on Certain Static Eliminators and Ion Generating Tubes Section 31.3 provided a general license for certain static eliminators and ion generating tubes. The static eliminators distributed for use under this provision include those intended for use by the general public. There were no requirements associated with this general license; however, the provision did not explicitly contain an exemption from 10 CFR parts 19, 20, and 21. Nonetheless, the Commission has generally treated products covered by this provision as if the users were exempt from licensing. Distribution had to be authorized only by the NRC and not by the Agreement States. There were no distribution requirements specified in part 32. Distributors were licensed under part 30, with particular license conditions related to distribution determined on a case-by-case basis. Reporting requirements in licenses were similar to exempt distribution reporting requirements. This inconsistency resulted from the fact that the use of the static eliminators covered by this general license predated the regulations in parts 19, 20, 21, 31, and 32. The general license for static eliminators was first issued in part 30 in the 1950s shortly before the formalization of radiation protection requirements was completed by issuance of part 20. Therefore, the original general license did not include an exemption from part 20. Training requirements were separated from part 20 and issued in part 19 at a later date. The ion generating tubes covered by paragraph (d) of § 31.3 were also covered by the general license in part 30 prior to the recodification of byproduct material regulations into 10 CFR parts 30, 31, 32, 33, 34, 35, and 36 in 1965. The general licenses for byproduct material were moved from part 30 to part 31 at that time. In 1971 (36 FR 6015; April 1, 1971), the Commission proposed to change this general license to an exemption, and also to expand it into a class exemption under which additional static elimination devices and ion generating tubes with differing radionuclides and quantities could be approved for use under the exemption through licensing actions. As a result of competing priorities for staff effort at the time, that rule was never finalized. Although these products have a long history of use, there have been relatively few licensed distributors. Nonetheless, this situation caused some confusion in the licensing process. The Commission is changing this general license into an exemption from licensing in § 30.15(a)(2). The current licensed distributor will not be required to amend its license in order to continue distribution, but any future distributors will come under the distributor provisions associated with § 30.15; i.e., §§ 32.14, 32.15, and 32.16. This change is intended to have no effect on any current distributor or user of these products, only to remove an inconsistency in the regulations and to make any future licensing decisions in this regard more efficient and effective. With respect to the issue of requirements for sealed source and device review, this change removes the need for a registration certificate if these products are distributed under the authority of a license issued under § 32.14. The licensing practice of using the sealed source and device review and registration process for products to be used under the general license in § 31.3 primarily resulted from the lack of specific requirements for a distribution license in the regulations. Thus, § 32.210 provided the types of information to be provided concerning the product for NRC review. E. Remove Prescriptive Requirements for Distributors of Generally Licensed Devices and Exempt Products The Commission determined that the requirements for manufacturers or initial distributors of exempt and generally licensed products were in some cases overly prescriptive, particularly in the areas of prototype testing and acceptance sampling/quality control (QC) procedures. Such a prescriptive approach is easy to implement and regulate, but is relatively inflexible. When evaluating a new or redesigned product, the NRC requires prototype testing to validate the design of products and their ability to contain byproduct material. Acceptance sampling (a specific QC process) monitors the effectiveness of the manufacturing process for safety-significant parts to minimize the likelihood of failures and events caused by inadequate manufacturing quality. This rule is intended to focus the regulations on performance, rather than procedures. The regulations retain general requirements and provide general standards by which performance may be judged, rather than specifying detailed procedures that must be followed, except for products for which oversight of these activities would no longer be required as discussed under Section II.F., “Make the Requirements for Distributors of Exempt Products More Risk-Informed.” The NUREG-1556 series of documents provides guidance to licensees and applicants on acceptable approaches to meeting these requirements. The procedures being removed from the regulations are generally acceptable to meet the new performance-based requirements. Safety benefits of the changes being made in this area will primarily be gained indirectly by removing overly burdensome and possibly counterproductive procedures and, more importantly, by accommodating the use of new technologies. The intent is for the revised regulatory requirements to be equivalent to previous practices (except as noted), so that existing licensees will not have to change their procedures as a result of this rulemaking. However, the revised provisions are written so that applicants and licensees have flexibility in the methods that they use to determine the design quality (prototype tests) and manufacturing quality (acceptance sampling/QC) of these products. In keeping with national and international best manufacturing standards, manufacturers and the distributors that represent them are expected to maintain a quality management system that stresses continual improvement. Examples of such system requirements can be found in the International Organization for Standardization standard, ISO 9001:2008, “Quality Management Systems—Requirements.” While the focus of ISO 9001:2008 is on customer satisfaction, it contains some quality management concepts that are appropriate to the distribution of generally licensed and exempt products containing byproduct material. Prototype Test Procedures This final rule simplifies the prescriptive regulations for prototype testing for new products proposed for use under general license. The revised provisions include only those aspects that are results-oriented, rather than specifying detailed procedures that must be followed. An applicant may choose to follow current prototype test procedures, as they would satisfy the outcomes required by this rule in every situation. The specific procedures are being removed from the regulations and included as example acceptable procedures in guidance documents. In the case of generally licensed products, regulations that had contained prescriptive requirements for prototype testing were: • Paragraph (d)(4) of § 32.53, “Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer,” standard to pass tests described in § 32.101; • Paragraph (d)(2) of § 32.57, “Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer,” standard to pass tests described in § 32.102; • Paragraph (e)(4) of § 32.61, “Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer,” standard to pass tests described in § 32.103; • Section 32.101, “Schedule B—prototype tests for luminous safety devices for use in aircraft”; • Section 32.102, “Schedule C—prototype tests for calibration or reference sources containing americium-241 or radium-226”; and • Section 32.103, “Schedule D—prototype tests for ice detection devices containing strontium-90.” No prescriptive prototype testing requirements pertaining to manufacturers of exempt products remained in the regulations, as they had been previously removed. Most recently, §§ 32.14(d)(2) and 32.40 were removed by a rule published October 16, 2007 (72 FR 58473). Acceptance Sampling and Quality Control Procedures In the case of generally licensed products, regulations that contained prescriptive requirements for acceptance sampling/quality control procedures were: • Paragraphs (a) though (d) of § 32.55, “Same: Quality assurance; prohibition of transfer” (“Same” refers to “Luminous safety devices for use in aircraft”); • Section 32.59, “Same: Leak testing of each source” (“Same” refers to “Calibration or reference sources containing americium-241 or radium-226”); • Paragraphs (a) through (e) of § 32.62, “Same: Quality assurance; prohibition of transfer” (“Same” refers to “Ice detection devices containing strontium-90”); and • Section 32.110, “Acceptance sampling procedures under certain specific licenses.” The prescriptive requirements for acceptance sampling/quality control procedures pertaining to manufacturers of exempt products were paragraphs (a)(2), (a)(3), and (c)(2) of § 32.15, “Same: Quality assurance, prohibition of transfer, and labeling.” (“Same” refers to “Certain items containing byproduct material.”) These all included specified procedures; §§ 32.15(a) and (c), 32.55(b) and (d), and 32.62(c) and (e) specifically referred to § 32.110. The NRC intends to allow acceptance sampling to be performance-based, rather than specifying procedural details. Section 32.110 provided that a random sample shall be taken from each inspection lot of specified devices for which testing is required in accordance with the appropriate sampling table in that section. If the number of defectives in the sample does not exceed the acceptance number in the appropriate sampling table, the lot was not to be accepted, while if the number of defectives exceeds the acceptance number, the entire inspection lot was to be rejected. There is no longer a need for the NRC to maintain the acceptance sampling tables that were in § 32.110, which provided the number of acceptable defective units in various lot sizes for a variety of Lot Tolerance Percent Defective values. Note: Lot Tolerance Percent Defective is defined in § 32.2 as the poorest quality in an individual inspection lot that should be accepted. The table in § 32.110(b)(6), Lot Tolerance Percent Defective 5.0 percent, correlated with the standard in the above cited regulations. However, the other seven tables in § 32.110 apparently had been little used since their publication in 1974, as there were no specific standards in part 32 requiring Lot Tolerance Percent Defectives other than 5 percent. Licensees can now easily use widely available computer software to determine their own acceptance sampling procedures to best monitor their manufacturing processes. This final rule removes § 32.110. Acceptance sampling criteria continue to be specified in §§ 32.15, 32.55, and 32.62, specifying the values required for quality (Lot Tolerance Percent Defective) and confidence. Section 32.59 requires leak testing of each source for calibration or reference sources containing americium-241 or radium-226 generally licensed under § 31.8, rather than sampling of lots. This final rule does not change that provision other than providing minor clarifications. Previously, the NRC required the affected categories of licensees to perform acceptance sampling in accordance with § 32.110 or propose alternative procedures (under § 32.15(b), § 32.55(c), or § 32.62(d)) which provided a Lot Tolerance Percent Defective of 5.0 percent at a consumer's risk of 0.10. This “consumer's risk” criterion is equivalent to 90 percent confidence that the Lot Tolerance Percent Defective will not be exceeded. The applicant's quality control procedures, including any alternate procedures proposed, are reviewed and approved by the NRC. This final rule does not change the 5 percent criterion for Lot Tolerance Percent Defective (i.e., 95 percent acceptance). The value of consumer risk of 10 percent was more relaxed than others used by the NRC, such as in inspections, which use standards of no more than 5 percent defective at 5 percent risk. The final rule revises the acceptance sampling standard to no more than 5 percent risk, expressed as “95 percent confidence,” for those categories of products for which the acceptance criteria are specified in the regulations. The term “confidence” is now more commonly used in this context. Most of NRC's statistical acceptance criteria today—such as in inspections—are, at least, 95 percent acceptance with 95 percent confidence. Raising the required confidence level from 90 percent to 95 percent may be an increase in burden, but is justified, because the 90 percent standard was inconsistent with other agency practices, as well as industry standards. However, it is expected that because of the nature of the products covered by these regulations, the lot sizes apt to be used, and other factors, the revision is unlikely to change the approaches used by the limited number of current licensees under these provisions. Another change in NRC's acceptance sampling regulations is a clarification of the prohibition on the transfer of any defective lot. The prohibition of transfer of rejected lots, previously appearing in §§ 32.15(c)(2), 32.55(d)(2), and 32.62(e)(2), is being revised. The prohibition of transfer appeared to apply only to individual items found to be defective, rather than addressing all items in a sampled lot that do not meet the acceptance standard. These revisions concerning rejected lots appear in §§ 32.15(b)(2), 32.55(d)(2), and 32.62(e)(2). From a statistical standpoint, unless a lot is sampled and tested in such a way as to demonstrate compliance with the required measures of quality assurance, the entire lot should be rejected. The final rule requires that distribution of any part, or sub-lot, of a rejected lot must be in accordance with procedures spelled out in the license, and that testing after repairs must be performed by an independent reviewer. The provision for an independent reviewer is a new requirement, but it is a recommendation of the International Atomic Energy Agency (IAEA), and may have been used voluntarily as an industry best practice. The IAEA recommends that, based on sound statistical theory, depending on the safety significance of the defective item or lot, the independent reviewer may be a different inspector from the one that performed the original sampling, or an inspector from a third party. In the case of the products for which these changes are being made, the risk is low and it is sufficient for the independent inspector to simply be another qualified employee. Individual worker accountability plays an important role in an effective quality assurance (QA) program, and an independent reviewer, besides adding another layer of assurance that the sub-lot or part is acceptable, will add accountability to the program. The sampling plan will normally be detailed in the license, which will ensure that the quality assurance program is systematic and planned where justified, such as for lot sizes, sample sizes, criteria, and procedures. The primary source of guidance on quality control and quality assurance is NUREG-1556, Vol. 3, Rev. 1. This guidance indicates that the NRC may accept a certificate of accreditation in lieu of a full set of QA/QC plans or procedures. The vendor providing certification must, however, make the commitment that the generic QA/QC program includes provisions that address the specific requirements in the regulations for the fabrication of the sealed sources or devices. Depending on the specific requirements of the fabrication process, such provisions would include: • Verifying that the design conforms fully with the statements and commitments submitted in support of the application (including materials, dimensions within stated tolerances, manufacturing methods, assembly methods, labeling), using sampling methods that meet applicable provisions, such as § 32.55. • Leak testing all units to 185 Bq (0.005 μCi). • Testing all units for proper operation of all safety features. • Verifying that, for all units, the radiation levels do not exceed the maximum values stated in the application. The proper treatment and definition of lots is essential from a statistical perspective, and relevant to acceptance sampling procedures. For the purposes of acceptance sampling, a “lot” should consist of homogeneous products manufactured from the same or similar machines, interchangeable in terms of their intended use or function. Similarly, from a statistical perspective, a sampling plan must demonstrate certain characteristics to sufficiently guarantee quality: • Manufacturer compliance with predetermined lot sizes, sample sizes, sampling methodology, and acceptance criteria. • Agreement with a one-time decision to accept or reject a lot in its entirety. • Separate, predetermined treatment of sub-lots. • The calculation and reporting of separate measures for quality and for confidence. It should be emphasized, however, that the regulatory requirement for acceptance sampling is not an attempt to control overall product quality, but to minimize the possibility that a distributed product has inadequate or malfunctioning safety features. In summary, this final rule revises the cited paragraphs concerning prototype testing and quality control, including specific sampling requirements, to make these requirements for distributors more flexible and performance-based rather than prescriptive. Guidance on quality assurance methods is included in NUREG-1556, Vol. 3, Rev. 1, including specifically Appendix G. Less prescriptive, more flexible, performance-based regulations will continue to specify performance requirements. Generally, the specific procedures being removed from the regulations continue to be considered acceptable. The NRC normally evaluates products using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria in consultation with the manufacturer or distributor. References to appropriate industry and consensus standards are included in NUREG-1556, Vol. 3, Rev. 1, Appendix F. Updated guidance will be provided when a new or revised industry standard becomes available that the NRC considers more appropriate. The licensee will be free to propose alternative methods to those presented in industry standards and guidance, provided that the methods provide sufficient evidence that all safety related components are capable of performing their intended functions. Current licensees will need to make any necessary upgrades to their QC programs when this rule becomes effective. However, because license conditions are written broadly, it is not expected that any such changes in the QC programs will be inconsistent with an existing license (or registration certificate). Any changes needed in the license to better ensure consistency with the revised requirements will likely be made at the time of the next license renewal or related amendment of the license. F. Make the Requirements for Distributors of Exempt Products More Risk-Informed To a large extent, the NRC has applied similar requirements throughout part 32 on manufacturers and distributors of all categories of products, irrespective of the quantity of byproduct material within or the risk of a product. However, given the low risk of some exempt products, some of the requirements are believed to be unnecessary, and not commensurate with the associated risk. This was particularly true in the areas of prototype testing and quality control requirements for products to be used under exemptions from licensing. The NRC considered whether some of the products used under an exemption from licensing present such low levels of radiation exposures, both routinely and in the event of accidents, that continued NRC oversight of the specific prototype tests and/or the quality control/quality assurance to be applied by the manufacturer or distributor would not be warranted. Although many products distributed under the class exemptions would likely meet such a low-risk standard, the Commission does not believe it prudent to eliminate any of these requirements for the class exemptions. The safety criteria for each class exemption are intended to ensure that the risks associated with any product approved for use under the associated exemption are quite low. Nonetheless, because of the nature of a class exemption to allow for new products to be approved, it is not possible to conclude that elimination of oversight of prototype testing or quality control procedures for an entire class of products is prudent. The evaluation of the safety of the individual product may depend on knowledge of such procedures. The NRC evaluated the inherent potential for radiation exposures from products containing byproduct material used under product-specific exemptions and the likelihood of increases in risks if oversight of the subject procedures were removed. The product-specific exemptions appear in § 30.15. There were four types of products listed in that provision for which future distribution is allowed, specifically timepieces, ionization chamber smoke detectors, electron tubes, and ionizing radiation measuring instruments. (Note that in the discussion under Section II. D., “Update the Regulations on Certain Static Eliminators and Ion Generating Tubes,” the Commission is adding another exemption to § 30.15.) The requirements of this type for manufacturers and distributors of products used under § 30.15 were contained in: § 32.14(b)(4), on submittal of information on prototype test procedures used and the results; § 32.14(b)(5), on submittal of quality control procedures to be used; and §§ 32.15(a)(2) and (a)(3) and 32.110, on specific sampling procedures for quality control. Paragraph 32.15(c) also contained a prohibition on transferring any defective lot or item to exempt persons. Even without the NRC's continuing oversight of these procedures, licensees would be motivated to retain them as good business practices. There are a number of factors that will likely cause manufacturers and distributors to continue to conduct prototype testing and at least some form of quality control/assurance. In some cases, functionality testing closely aligns with testing for containment of radioactive material. The consideration of risk for these products, however, did not rely on this expectation, beyond some reasonable bounding assumptions about the likelihood and consequences of distributing defective products. For example, failures that result in functional failure may happen more frequently, but it is not reasonable to assume that manufacturers would continue to distribute a large percentage of defective devices over long periods. The NRC used NUREG-1717 as a primary resource concerning estimates of doses that result from the distribution, use, maintenance and repair, disposal, and accidents involving these products. The NRC considered the extent to which these doses might be affected if the lack of oversight over prototype testing resulted in a product design that was less effective in containing or shielding the byproduct material. The NRC also considered the extent that doses or probability of accidents could be affected if the lack of oversight of quality control/quality assurance significantly reduced the effectiveness of licensees' programs in this area. This assessment was semi-qualitative as there is no data available on products used without regulatory control, which could support a quantitative probabilistic risk assessment. This final rule eliminates NRC oversight for these types of activities for a few of the exempt products as not justified, based on risk. Requirements to submit information on prototype tests in § 32.14(b)(4) are eliminated for products exempt under § 30.15(a)(7) and (8), ionization chamber smoke detectors and electron tubes respectively. This requirement is also removed for timepieces under § 30.15(a)(1) containing promethium-147 or tritium in the form of gaseous tritium light sources. Oversight of quality control/quality assurance is eliminated for these same products as well as for products to be used under the new exemption in § 30.15(a)(2), static eliminators and ion generating tubes formerly covered by the general license in § 31.3. This is in revised § 32.14(b)(5), which now requires that quality control procedures be submitted for approval only for ionizing radiation measuring instruments and timepieces containing tritium in the form of paint. Other requirements in the application for a license to distribute these products remain, such as the submittal (under § 32.14(b)) and evaluation (§ 32.14(d)) of basic design features intended to contain the byproduct material. Based on the assessment of the inherent safety of these products, it is estimated that even if a lack of appropriate prototype testing resulted in lower quality product designs in the future or poor quality control resulted in degradation of production quality, the potential increases in individual doses would be less than 10 μSv (1 mrem)/year in any situation where significant numbers of products could be affected. Also, in the extreme case of a significant change in future distributor behavior, some individual doses could be increased by somewhat higher amounts in non-routine situations. Overall, considering both potential increases in doses and the probability of circumstances resulting in those increases, the potential incremental risk is estimated to be insignificant. Unnecessary regulatory burden on distributors of these products is reduced. Because, as noted above, licensees are not likely to eliminate such procedures as a result of discontinued NRC oversight, the benefits assumed are only those associated with eliminating the submittal of testing/sampling procedures for review and approval, eliminating the submittal of prototype testing results, and allowing added flexibility to change procedures in response to other factors, including competitive demands for continuous quality improvement, without NRC permission. Current licensees authorized to distribute products affected by this change will need to amend their license in order to not be held accountable for continuing to follow the QC/QA program as delineated in their license. This will be a simple amendment as the regulations will be clear that this license condition is no longer required. G. Minor Clarifying or Administrative Revisions Other minor revisions are being made to better organize, clarify, or update the regulations in these parts, such as the renaming of subparts C and D and the movement of §§ 32.72 and 32.74 from subpart B to subpart C. These two sections are being moved because they do not cover generally licensed items. Minor conforming amendments are included in parts 40 and 70 because the delineation of the delegation of licensing programs to the Regions is written broadly in these parts. Such revisions are noted in Section IV., “Summary of Final Amendments by Section.” III. Summary and Analysis of Public Comments on the Proposed Rule The NRC reviewed the public comments received on the June 24, 2010 (75 FR 36212), proposed rule. The comment period ended on September 7, 2010. Ten comment letters were received. The commenters included the Organization of Agreement States (OAS), the State of Wisconsin, the radiation safety officer of a university, and an individual. The remainder were manufacturers and distributors and organizations representing manufacturers and distributors. Two commenters requested an extension to the comment period. Although an extension was not granted, all comments were considered. In addition to inviting comments on any aspects of the proposed rule, the NRC posed specific questions for consideration. A discussion of the comments and the NRC's responses follow. A. Actions Related to Sealed Source and Device Registration A.1 Updating Regulations To Add Registration Requirements Comment: While only one commenter specifically supported the overall change to add requirements for registration of the various categories of sources and devices and to add the definition of the sealed source and device registry to part 32, most appeared to generally support these changes. One commenter specifically noted the importance of the Compatibility Category B for SS & D related changes in order to ensure consistency throughout all jurisdictions. Response: No changes to this aspect of the rule have been made. The Commission agrees with the importance of national consistency in this regard. Compatibility Category B applies as proposed to the paragraphs in part 32 relevant to requirements to obtain SS & D registration (except for those sections that are NRC only because the NRC retains authority over all distribution to exempt persons). Also as proposed, Compatibility Category D continues to apply to § 32.210 for those States that do not issue registration certificates. A.2 Adding Provisions for Amendment, Modification and Revocation, Review, and Inactivation of Registration Certificates A large portion of the comments received on the proposed rule concerned the provisions for inactivation of certificates and for reevaluation of certificates. There were four specific questions raised in the notice of proposed rulemaking concerning the updating of registration certificates. The following comments relate primarily to these two questions: Q.1 Updating of registration certificates in the SS & D Registry: (a) Under what circumstances should proposed § 32.210(h) be used to require a reevaluation? How should such a reevaluation be conducted with minimum impact to industry? Q.1 (d) In general, how might the NRC use the proposed provision for review in § 32.210(h) in relation to changes in standards for products or limits in addressing continued distribution and the timing for changes to the authority to distribute tied to the registration certificate? Comment: Commenters on this subject were manufacturers and distributors and representatives of the industry. These commenters recommended that a re-evaluation of registration certificates be conducted: (1) Upon request by the manufacturer or initial distributor due to changes [that would affect regulatory compliance]; (2) to ensure compliance with regulations; (3) based on indications of radiological safety concerns or when new regulations implement more restrictive dose constraints; or (4) when the regulations that apply to those sealed sources or devices change to an extent that compliance with the regulation could require modification of the conditions of the registration. One commenter supported the recommendation that no reevaluation was needed except to ensure compliance with the regulations or if there are reports of defects that would affect regulatory compliance, by indicating that the fundamentals of radiation protection or technology are not likely to undergo any change significant enough to create a compelling need for reevaluation of a device certificate. Response: Generally, the NRC agrees with the circumstances recommended by the various commenters for reevaluation of a registration certificate. Another possible situation in which a review might be required would be in the case of an older certificate that has not been revised by request of the holder and that has limited information related to the original demonstration of safety. However, at this time, the NRC does not envision the routine auditing of certificates for adequacy of information. Comment: One commenter recommended that if the regulations for sealed sources and devices change to an extent that compliance with the regulation could require modification of the conditions of the registration, then the affected licensees should be notified of those requirements, and the date by which compliance is required. Likewise, licensees could be required to make a notification that no design changes are required. Response: The approach suggested by the commenter is a reasonable one for the NRC to take in such a circumstance; however, such an occurrence is rare and implementation details would be decided on a case-by-case basis. Comment: One commenter agreed that it is not necessary to conduct a complete reevaluation of sealed sources and devices at the time that distribution licenses are reviewed, but also stated that the NRC should change NUREG-1556 guidance to explicitly require a review of certificates at the time of license renewal to ensure that the information is complete, accurate, and that the source or device remains current considering the application of the current industry standards. Response: The NRC agrees that it is not necessary to conduct a complete reevaluation of sealed sources and devices at the time that distribution licenses are reviewed for renewal, although some review of certificates for consistency with the license is appropriate at that time. The NRC staff is currently updating the guidance in NUREG-1556 series concerning such matters. Comment: One commenter suggested that the NRC conduct a comprehensive audit of all certificates in the registry and reconcile them with NRC and Agreement States Distribution License issued. This commenter noted problems, such as licenses being amended without amendment of the accompanying registration certificates and the existence of certificates still listed for active vendors when the company's distribution license had been previously terminated. Response: This is not something to be addressed in rulemaking. The NRC sometimes identifies such problems as the commenter has noted and corrects them. The NRC could not conduct a complete audit of all certificates, as the Agreement States have responsibility for ensuring the consistency of their distributor licenses with the relevant certificates. The addition of the inactivation provision in § 32.211 is intended to improve the consistency in this aspect of the SS & D registration process. Comment: The NRC should monitor changes to relevant ANSI [American National Standards Institute] and ISO standards for reference during the review process. Response: The NRC generally keeps current with respect to such standards, in some cases participating on the committees making the revisions. This comment did not call for any particular change to the current rulemaking language in this final rule. Comment: Two commenters expressed the opinion that § 32.210(h) was redundant and therefore not necessary, given that the NRC already has authority under § 30.61 to request additional information or to modify requirements, if necessary, to revoke a license and registration certificate. One stated that § 32.210(h) would not ensure consistency between licenses and certificates and that instead of adding this provision, §§ 30.34(e) and 30.61 should be designated Compatibility Category B or A for Agreement States because of the transboundary implications associated with source or device registrations, which could be distributed in all fifty states and worldwide. This commenter also suggested that this would grant Agreement States the ability to review, revoke, inactivate, or modify certificates based on significant safety issues. Response: The NRC disagrees that § 32.210(h) is duplicative of the general authority provided under § 30.61. The intent of this rule concerning sealed source and device registration certificates is to make the regulations more explicit as to how the registration process is used in the licensing process. The details of this process should be specified in part 32. It would not be appropriate to designate §§ 30.34(e) and 30.61 Compatibility Category B for Agreement States, which is the program element assigned when there are significant direct transboundary implications, in order to address the transboundary implications associated with source or device registrations. These provisions cover a broad range of licenses for which there are no transboundary implications. The importance of national consistency for sealed source and device registrations is more appropriately handled in the categorization of the appropriate part 32 provisions, such as §§ 32.210 and 32.211. However, the Commission has decided that the transboundary implications of § 32.210(h) are not significant enough to require identical treatment by each jurisdiction, so this one paragraph within § 32.210 has been assigned Compatibility Category C (for Agreement States who perform SS & D evaluations); thus, those States would adopt the essential objectives of § 32.210(h), rather than essentially the same language. Comment: One commenter suggested that § 32.210(h) include a backfit provision, suggesting an approach where certificate holders would be given a certain amount of time to reevaluate their source or device to determine whether it meets new dose criteria. This suggested approach also included actions that could be taken to control user doses if the source or device does not meet the criteria. Response: Requiring previously approved products to meet new standards established in the regulations is not an action the NRC would anticipate taking very often, particularly given that overall standards for radiation protection are not expected to change dramatically in the foreseeable future. There are no new dose criteria in this rule to be applied to previously approved products. It is not appropriate to incorporate an implementation provision into this rule as suggested by the commenter to cover potential future changes in regulations concerning dose criteria. Specific implementation provisions of this type can only reasonably be provided in the regulations in connection with a specific regulatory change being implemented. The NRC deals with such circumstances within the rulemaking process which makes such a change. The following comments respond to this question posed: Q 1.(b) How might registration certificates best be updated so as not to discourage improvement in the design of sources or devices, more readily allow for the application of updated industry standards, and ensure that information in the certificates is fully consistent with current practices? (For example, in addition to the proposed provision in § 32.210(h), other options could include reviewing certificates at the time of license renewal, in part or in whole; adding separate expiration dates to certificates with typically longer terms than licenses, e.g., 10 to 20 years; and explicitly allowing licensees to make changes without NRC approval, if these changes do not reduce safety margins.) Comment: Two of the commenters suggested that device certificates should expire and be renewed at intervals of 10 years or longer, and that at the time of renewal, the certificate be updated to meet current industry standards. One of these commenters thought that this could be done in lieu of requiring inactivation of a device certificate after 2 years, stating that the inactivation provision would severely restrict business and put an undue burden on both the State and NRC programs, and companies with small distributions. The other stated that expiration dates should be specific to each device, based on its certificate approval date, and that the renewal should be easily performed requiring only a request to renew and an explanation of any changes needed to comply with current radiation safety standards. In contrast, one commenter stated that requiring reviews of certificates in conjunction with license renewal or placing expiration dates on certificates is unnecessary. Response: The option of adding expiration dates and then conducting a renewal process would not appropriately replace the inactivation process. If a distributor is no longer distributing products covered by a certificate, there would be no reason to renew the certificate. The inactivation provision is discussed further later in this section. If the NRC were to institute a policy of adding expiration dates to registration certificates, the expiration date would be specific to the certificate and the sources or devices covered by the certificate based on the issuance date as suggested by the commenter. Although the Commission agrees there is value in using an expiration/renewal process for registration certificates, instituting such a system nationally would be a significant change from the process in place for some time and would put additional burdens on the Agreement States that issue certificates at a time when resources are limited. There are other means to deal with changes that should be made to certificates, such as the use of the new provision in § 32.210(h). Comment: One commenter suggested that the NRC should explicitly list which criteria constitute an amendment such as change in product name, company name, or any component directly related to radiation safety. Another commenter suggested that if certificates are not written in an overly specific manner, most minor product changes or improvements could be handled by submittals regarding the change which show that the device meets the original requirements. Additionally, the NRC could amend the certificate's tie-down condition to reference the registrant's revised submissions by date. Response: Paragraph (f) of § 32.210 requires the certificate holder to manufacture and distribute products in accordance with the provisions of the registration certificate and any statements made in the request for registration. It would be complicated and not feasible for this provision to be revised to indicate exactly which aspects must be followed. Such an approach could increase risks that a distributor may make changes with unintended impacts on safety. The NRC has modified administrative practices concerning the content of registration certificates so as to minimize the inclusion of details not important to safety on the certificate. The NRC does amend certificates to reference new submissions as appropriate. Comment: Another commenter also recommended that the NRC add amendment criteria to § 32.210 providing suggested regulatory text which is similar to the approach in 10 CFR 50.59. This suggested approach would allow distributors to make changes based on their own evaluation as to the potential impact on safety and require them to keep records of the changes and report them to the NRC within 24 months. Response: The NRC staff did consider recommending such a provision in part 30 in particular when conducting the systematic assessment of exemptions. However, because of the difficulties expected developing such a provision for the broad range of products and facilities involved in the use of byproduct material, the staff did not recommend such a provision for parts 30 and/or 32. The approach suggested by the commenter included the need for complex analyses by the distributor concerning safety that would not be reported to the NRC for up to 24 months. The NRC believes that this may lead to compromises in safety. Also, at one time, fees charged for amendment of licenses and registration certificates were a deterrent to licensees proposing changes; however, changes were made to the fee structure, so that this is no longer the case. The following comments respond to this question posed: Q.1(c) How should certificates for previously approved devices be handled if the device does not meet current standards, such as in the case of the separately proposed (August 3, 2009; 74 FR 38372) quantity limit in the general license in § 31.5 (and comparable Agreement State provisions)? How should registration certificates be handled in this situation? (For example, in some cases, the distributor may be able to limit the quantity of affected radionuclides, rather than change its certificate to one for specifically licensed devices.) Comment: A few commenters recommended that previously approved devices be grandfathered when standards are changed, one recommending this for devices in use, others for future distributions under existing active certificates as well. One of those supporting allowing continued distribution of previously approved devices recommended that the grandfathering of previously approved devices should be a Compatibility Category B for Agreement States. Generally, these commenters did not believe it justified to change the status of previously approved devices unless there was a significant impact on health, safety, security, or the environment. One of these commenters stated that such actions should only be taken if well justified in terms of benefit versus cost and that revised standards should only apply to devices distributed after a certain date. Related to the referenced proposed rule, which would have added an activity limit to the general license in § 31.5, two of the commenters indicated that the registration certificates would have to be revised to address distribution to both general and specific licensees. One commenter stated that it disagrees with the content of the proposed rule on limiting the amount of byproduct material in generally licensed devices. Response: The Commission has decided against adopting a final rule based on the referenced proposed rule. That proposed rule would not have grandfathered devices already in use under the general license. The impact that the rule would have had on current users played a role in the decision not to adopt a final rule on that subject. Generally, the NRC agrees with the comment that it would not be justified to change the status of previously approved devices unless there was a significant impact on health, safety, security, or the environment. The NRC recognizes that the appropriate regulatory action may be different when considering a change for (1) products to be approved in the future, (2) the continued distribution of products previously approved, and (3) products previously manufactured and already in use. Comment: A few commenters recommended that new and re-distributed devices, devices manufactured after a certain date, or devices with significant changes, should require a new or updated certificate that complies with current or revised standards. Response: Because of existing requirements in § 32.210(f), a certificate would have to be amended before devices with significant changes could be distributed. As to changes made to regulatory requirements that may necessitate a change to an existing certificate, the NRC makes decisions on implementation of a revised regulation on a case-by-case basis considering the risks involved and benefits associated with the particular change. Comment: One commenter proposed that an independent screening review be performed to identify the set of devices likely to result in occupational dose in excess of 500 mrem TEDE and a public dose of 50 mrem in 1 year, and then establish notification or review criteria for the certificate holders accordingly. This commenter suggested that the NRC notify each certificate holder with devices exceeding the dose criteria and request a factual accuracy review, comments regarding the calculations, and the cost to recall and make changes to ensure compliance with the dose values. This recommendation went on to suggest that, if occupational doses could exceed 500 mrem/year, the distributor should be required to notify users that they should comply with part 20 (or the Agreement State regulations), and that if public doses could exceed 50 mrem, but not 100 mrem, the NRC should require an ALARA review similar to that required by 10 CFR 20.1101(d). Response: This proposal did not suggest revising the regulations. However, in looking at a possible screening process, it should be noted that acceptable potential doses that workers and the general public may receive from a device depends on whether it is to be used under an exemption from licensing, a general license, or a specific license. Devices to be used under certain exemptions and the general license in § 31.5 are evaluated against specific safety criteria in part 32. There are no specific criteria for devices used under specific license; the safety of workers and the public being primarily protected by part 20, which applies to all specific licensees. Applying such a process as suggested by the commenter across the board would be inappropriate. In particular, the recommended criteria would be inappropriate for evaluating products used under exemptions from licensing. Also, in the absence of an indication of a problem or adverse operational experience, the NRC does not believe it necessary to conduct a screening for all previously approved devices. The Inactivation Provision in § 32.211 The only issue that received a significant number of objections was the proposed inactivation requirement. However, much of this reaction resulted from apparent misinterpretation of the intent of the provision and because of unforeseen impacts that could result if devices are transferred only occasionally with two years passing without a transfer of a device for which some continued distribution is anticipated. Comment: A few commenters indicated that it was not uncommon for 2 years to pass between transfers of particular devices and that the requirement to inactivate in this instance would be burdensome to business. Comments were that compliance with this proposed rule would not be practical, that licensees may not know in advance when their last manufacture or transfer of a sealed source or device will take place, and that the certificate holders should decide when to inactivate certificates based on their business needs and intentions. Commenters specifically suggested that one may anticipate new applications for a product, development of new markets, etc., and that it might force inactivation of a certificate for a device which may be required again in another few months. Two commenters noted that the costs of maintaining the certificate, including the fees, provide incentive to inactivate a certificate when there are no prospects of future sales; one of these commenters recognized the rationale for desiring registrations to be inactivated if there is no intent to manufacture and/or distribute within a reasonable period. One commenter stated that the existing certificates already must be renewed periodically. This commenter suggested a 5-year time limit to apply for inactivation. Response: The primary intent of the amendments concerning the sealed source and device registry, including the inactivation provision, is to make the regulations more explicit and transparent with respect to the use of registration certificates as part of the licensing process and also to improve national consistency in the processes used, thus improving the quality of the information in the registration database. This provision was not intended to interfere with business decisions or processes, but rather was proposed to alleviate any confusion as to which sources and devices are authorized for continued distribution, as well as providing a mechanism for regulators to help ensure the continued availability of qualified device service providers. The NRC would not want distributors to unnecessarily inactivate a certificate as a result of this provision and then need to apply for an active certificate again in the case of product with a limited market. The intent of the language of the proposed rule text was that the request would be made when two conditions are met: (1) There is no ongoing intent to distribute and (2) 2 years have passed since distribution has ceased. However, the Statement of Considerations for the proposed rule did not address the condition in the regulation that the distributor must have no intention to make further transfers. As the commenters have noted, an unintended consequence of the rule as proposed might have been that if a distributor does not make the decision to make no further transfers more than 2 years after the last transfer, it could be in noncompliance with the regulations. The text in this final rule has therefore been revised to clarify that no action need be taken after 2 years without a transfer until it is determined that there will be no future transfers. However, within 90 days of such a determination, inactivation must be requested and some brief explanation must be provided if more than 2 years has elapsed since distribution of any source or device covered by the certificate has ceased. If a licensee is concerned that an inspection could identify a certificate that it is being kept active in anticipation of future sales, even though no sale has been made in 2 years, it may document its intent to continue sales; however, this would not be required. There may be existing evidence available of an expectation to continue to distribute. In some cases, there are capabilities that must be maintained in order to continue to be able to and/or be authorized to distribute, particularly for a manufacturer. There may be such documents as marketing materials, including catalogues of available products, or internal memos, which indicate either an ongoing intent to sell or a decision to cease distribution. In addition, the situation of not transferring any source or device for more than 2 years with the intent to continue sales is expected to be relatively rare, particularly because individual certificates frequently include numerous models that have been approved for distribution. While distributors should update certificates to indicate which models are no longer being sold, the NRC did not make doing so a requirement or set a deadline for this type of amendment of certificates. The text of § 32.211 has also been revised to clarify that inactivation is necessary when all sources or devices covered by a certificate are no longer being distributed and to clarify that certificates must be inactivated before the associated distribution license is terminated. The specific address for submitting inactivation requests is also added. Comment: Some commenters expressed concern that the proposed language of § 32.211 did not appear to allow redistributions or other transfers of sources or devices after inactivation of a certificate. Two commenters specifically suggested that the proposed wording of the fourth sentence in proposed § 32.211 should be changed to include the word “initially” so that it reads: “A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use.” Another commenter was also concerned about redistribution, stating that it should be authorized even if the certificate is inactive. This commenter believed that an inactive certificate does not allow for the transfer or redistribution of registered sources or devices by specific licensees and noted that a source or device no longer being initially distributed is nonetheless safe for use by persons authorized to use the source in accordance with the conditions of the registration certificate. Response: The intent of proposed § 32.211 in this regard is that only the unique authority provided to the distributor by the registration certificate (along with the associated license) to initially transfer a source or device ceases, without any effect on any other transfers of the covered source(s) or device(s). The suggested addition of the word, “initially,” has been made for clarification. The inactivation of a certificate does not limit the use or transfer of previously manufactured sources and devices. The Commission agrees that a source or device that is no longer being distributed is nonetheless safe for use by persons authorized to use it in accordance with the conditions of the certificate. The only concern after the inactivation of a certificate is that proper servicing continues to be available. The inactivation provision clarifies that a device shall be serviced as provided in the certificate and the inactivation process alerts the regulator that servicing may not be available from the original distributor. A.3 Adding Flexibility for Licensing Users of Sealed Sources and Devices Two specific questions were posed in the proposed rule concerning this issue: Q.5 Proposal in § 30.32(g)(5) to allow some licenses to specify only constraints on the number and type of sealed sources and devices to be used and the conditions under which they are to be used: (a) In view of the expectation that this authorization would only be granted in limited situations and due to special circumstances, how can NRC make it clear that approval of this approach would be at the NRC's discretion, rather than this being an open-ended option for anyone, or should the regulation specify when this approach is acceptable? Comment: In response to this question, two commenters requested that the NRC be as clear and detailed or practical as possible when imposing new requirements. Additionally, one commenter suggested that the NRC add an example of an exemption in NUREG-1556. Response: The text of the final rule has been revised to clarify that this approach may be used if it is not feasible to identify each sealed source and device individually. Examples of situations where use of this approach is acceptable were discussed in the proposed rule as well as in the discussion of this issue in Section II. A.3., “Adding Flexibility for Licensing Users of Sealed Sources and Devices.” Such examples and additional guidance are being provided in the interim guidance [Docket ID NRC-2012-0074] developed for this rulemaking, and will ultimately be included in the revisions to applicable volumes of NUREG-1556. A notice concerning the availability of the interim guidance for comment was published in the Proposed Rules section of this issue of the Federal Register . However, one situation that is not considered appropriate for this approach is in applying for the renewal of a license that had been previously issued without identification of individual sources and devices where it is simply inconvenient to provide an inventory of currently held sources and devices. Q.5(b) Are there other situations besides those discussed, when identifying all of the sealed sources and devices to be licensed is particularly impractical? Comment: Two commenters responded to this question. One comment concerned not applying any limits on the quantities distributed to generally licensed or exempt devices. The other commenter suggested that the definition of “sealed source” in § 30.4 (and part 70) lacks specificity and should be revised to focus on only those sources manufactured and distributed pursuant to an SS & D registration. This commenter indicated that this would address confusion as to the applicability of certain requirements, in particular, leak testing requirements, to sources that are contained in ways that could be construed to constitute a sealed source, under the current definition. The suggested revision would have limited sealed sources to those that are registered in the SS & D Registry. Response: The provision proposed in § 30.32(g)(5) and in the final rule as § 30.32(g)(4) is not applicable to generally licensed or exempt devices, which do not have to be listed on a specific license. Addressing concerns related to the applicability of leak testing requirements for specifically licensed sources is outside of the scope of this rule. Limiting the definition of “sealed source” to registered sources would be inconsistent with aspects of this rule (in particular § 32.210(g)) and other provisions in NRC regulations. B. Establish a New Class Exemption for Certain Industrial Products Only about half of the commenters made any statements about the proposed new class exemption. The comments received were mostly supportive, although some concerns were noted. Support for the proposed exemption came primarily from a major manufacturer and from the OAS. The manufacturer indicated that research and development of new devices is expensive and time-consuming, that the uncertainty in the regulatory outcome and the lengthy rulemaking process to obtain a product-specific exemption made exempt product development risky, and that creating a class exemption for industrial devices with risk-informed, performance-based criteria would reduce uncertainty, speed approvals, and lower barriers to innovation, and would provide a nationwide standard. This manufacturer also pointed out the difficulties of general licensing for low-risk devices with inconsistencies in Agreement State licensing of portable devices even though the SS & D Registry authorizes distribution to general licensees. This commenter noted the complications of marketing and distribution of such products on a nationwide basis as well as those for users who may be authorized to use a device under a general license in State A, but if they transport the device to State B, a specific license is required. Both this manufacturer and the OAS suggested that manufacturers would be more inclined to develop products using lower quantities of radioactive materials in order to meet the criteria for exemption, with one commenter suggesting that this would result in a reduction in some hazards to workers, members of the public, and the environment. Comment: One manufacturer/distributor expressed concern that the health and safety of the public or the environment might not be adequately protected, noting the possibility that the increased number of devices allowed to be disposed of in landfills and scrap metal reprocessing streams would potentially increase the number of alarms at landfills, scrap metal facilities, and metal recycling facilities and ultimately create a burden on State regulatory authorities as a result. However, this commenter also said that the number of devices exempted by this provision would be very small and that this could be handled on an individual source or device basis and that the exception could be included in the NUREG-1556 guidance. Response: Granting an exemption from licensing and all of the associated requirements is not appropriately handled through guidance. Although an individual can request specific exemptions under § 30.11, it is not practical for a manufacturer to distribute a product to be used by persons who individually have to request an exemption from licensing. The NRC normally does not issue exemptions from all of the licensing requirements of part 30 except through rulemaking to establish a broadly applicable exemption from licensing. Although the NRC cannot ensure that exempt products do not occasionally cause alarms at such places as landfills, scrap metal facilities, and metal recycling facilities, the NRC does not believe that this possibility alone would justify not exempting products for which the safety of the public is adequately protected. This would unnecessarily limit the benefits society may derive from the uses of radioactive material. This new exemption has been designed to ensure that quantities of byproduct materials approved for use in products are well controlled. This includes the misuse scenario in § 32.31(b), which ensures that relatively high quantities are not approved based on the material being well contained and well shielded. One of the benefits of such criteria is limiting the possibility that quantities of material in any products approved for use under the new class exemption are sufficient to cause such problems during disposal as raised by the commenter. In addition, labeling requirements help to minimize the efforts that are ultimately spent toward resolving what to do in these cases. When a product is identified in the waste that caused the alarm, the label should be intact in most cases and this provides the information necessary to determine if the product can be accepted or what the disposal options are for it. Most products covered by an exemption do not contain quantities of byproduct material large enough to set off alarms, particularly when shielded within a quantity of waste. How much byproduct material can result in an alarm depends on the practices at the site for handling and sorting waste and when the waste passes any alarm system. Comment: A few commenters discussed the values in the safety criteria in § 32.31, particularly the 20 mrem/year routine use criterion, although not all specifically in response to [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-17711. Public record. Not legal advice.