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Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Proposed Rules
and equipment, restricting access to radiation areas, and ensuring appropriate facility design. Therefore, ALARA practices should complement and work in concert with basic lab safety, rather than degrade it.
The ALARA definition and the associated regulatory requirement also involve the concept of reasonableness, meaning that the licensee should make every reasonable effort to implement ALARA measures and should use procedures and engineering controls based upon sound radiation protection principles to achieve ALARA, to the extent practical. 119 In addition, NRC
guidance indicates that non-radiological hazards should be considered in determining appropriate ALARA
measures. For example, RG 8.8, Information Relevant to Ensuring That Occupational Radiation Exposures at Nuclear Power Stations Will Be as Low as Is Reasonable Achievable, states that a comprehensive consideration of risks and benefits will include risks from nonradiological hazards. An action taken to reduce radiation risks should not result in a significantly larger risk from other hazards. 120 Similarly, RG
8.10, Operating Philosophy for Maintaining Occupational and Public Radiation Exposures as Low as Is Reasonably Achievable, states that the decision to implement measures to reduce occupational radiation doses should be weighed against the risk of any other occupational hazards in the workplace, to minimize the total risk to the workers health and safety. 121
Finally, the commenter did not provide any support for the assertion that a licensees compliance with ALARA or other NRC requirements based upon the LNT model undermines or otherwise impedes a licensees ability to comply with non-radiologic safety requirements.
Comments: Several commenters objected to the use of the ALARA
concept as a regulatory requirement by the NRC. Many of these commenters asserted that the implementation of ALARA results in excessive costs to licensees and as such, inhibits potential growth and innovation. Some commenters also asserted that ALARA
does not strike the appropriate balance between safety and economy. Virtually all of these commenters requested the removal of the ALARA requirement in order to reduce costs.
Response: The NRC disagrees with these comments. The NRC regulations define ALARA as making every 119 10

CFR 20.1003 and 10 CFR 20.1101b.
8.8, Rev. 3, at 2.
121 RG 8.10, Rev. 2, at 5.
120 RG

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reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken. 122 ALARA
takes into account the following, in relation to the utilization of nuclear energy and licensed materials in the public interest: 1 The state of technology, 2 the economics of improvements in relation to the state of technology, 3 the economics of improvements in relation to benefits to the public health and safety, and 4
other societal and socioeconomic considerations.123 The NRC requires that its licensees 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 ALARA. 124 Furthermore, the NRCs 1991 rule stated that the ALARA
concept is intended to be an operating principle rather than an absolute minimization of exposures. 125
The regulatory language of the ALARA definition sets out the considerations in making ALARA
determinations, several of which include the consideration of economic factors.126 The NRC guidance states that reasonably achievable is judged by considering the state of technology and the economics of improvements in relation to all the benefits from these improvements. 127 In general, the NRC
determines compliance with the ALARA requirement based on whether the licensee has incorporated measures to track and, if necessary, to reduce exposures; not whether exposures and doses represent an absolute minimum or whether the licensee has used all possible methods to reduce exposures.
Furthermore, the level of effort expended on radiation protection programs, including compliance with the ALARA concept, should reflect the magnitude of the potential exposures both the magnitude of average and maximum individual doses and, in facilities with large numbers of employees, collective population doses.128 Thus, the size of a licensees radiation protection program should be 122 10

CFR 20.1003.

123 Id.
124 10

CFR 20.1101b.
FR at 23366.
126 10 CFR 20.1003 the economics of improvements in relation to the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations.
127 RG 8.8, Rev. 3, at 2.
128 Id.
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commensurate with the scope and extent of the licensed activities. For example, a large organization, such as a nuclear power reactor licensee, would be expected to have a considerably larger and more extensive radiation protection program than a smaller organization that may maintain lower activity sealed sources.
In addition, ALARA is achieved by implementing such fundamental measures as effective planning, training of the appropriate personnel, provision of appropriate equipment e.g., dosimeters, controlling access to radiation areas, installation of radiation monitoring systems, and preparing appropriate facility designs.129 The regulated community has had decades of operational experience in implementing ALARA measures, and it is likely that most costs of ALARA
compliance have long since been optimized. Moreover, the NRC considers many of these measures to be simply the implementation of sound operating practices. Finally, other than their general assertions, the commenters have not provided any substantive evidence demonstrating that the ALARA concept or the LNT model inhibits innovation or growth. The NRC has determined that current ALARA requirements are consistent with the LNT model of radiation protection and reasonably account for economic considerations.
Comments Supporting the Petitions Assertion That the NRC Relies on the LNT Model as a Result of Political Pressure or Bias Comment: Several commenters stated that the LNT model continues to remain relevant as a regulatory framework only because of political pressure or ideological or scientific bias.
Response: The NRC disagrees with this comment. The NRC is an independent regulatory agency that establishes its radiation protection regulations based, in part, on the recommendations of domestic and international authoritative scientific advisory bodies such as the ICRP, the NAS, and the NCRP. As described previously in this document, three other Federal agencies and the ACMUI
recommend that the LNT model remain the basis for the NRCs radiation protection regulations. The commenters have not provided any substantive support for their assertion that political pressure or bias is motivating the NRC
to continue to rely upon the LNT model.
The NRC continues to conclude that, in the absence of convincing evidence that there is a dose threshold or that low 129 RG

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8.10, Rev. 2, at 5; see also RG 8.8, Rev. 3.

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