Quiero saber acerca de...

Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Proposed Rules positions of the aforementioned advisory bodies; the comments and recommendations of NCI, NIOSH, and the EPA; the October 28, 2015, recommendation of the ACMUI; and its own professional and technical judgment, the NRC has determined that the LNT model continues to provide a sound regulatory basis for minimizing the risk of unnecessary radiation exposure to both members of the public and occupational workers.
Consequently, the NRC will retain the dose limits for occupational workers and members of the public in 10 CFR
part 20 radiation protection regulations.
Petitioners Assertion That Hormesis Disproves the LNT Model The petitioners advance the concept of hormesis, in which low levels of potentially stressful agents, such as toxins, other chemicals, ionizing radiation, etc., protect against the deleterious effects that high levels of these stressors produce and result in beneficial effects e.g., lower cancer rates. 78 Thus, the petitioners assert that low doses of radiation are beneficial to humans in that such doses may enhance the immune response or DNA
repair processes. The petitioners request that the NRC amend its regulations to raise the dose limit for members of the public to be the same as the occupational dose limit.79
NRCs Response
khammond on DSKJM1Z7X2PROD with PROPOSALS

There is scientific uncertainty and no compelling evidence as to whether the hormesis concept is valid for application to radiation protection requirements. None of the national and international authoritative scientific advisory bodies described above support the hormesis concept as a regulatory model for radiation protection. Of note, the BEIR VII report produced by NAS included a strong conclusion against applying the hormesis concept to radiation protection:
Although examples of apparent stimulatory or protective effects can be found in cellular and animal biology, the preponderance of available experimental information does not support the contention that low levels of ionizing radiation have a beneficial effect.
The mechanism of any such possible effect remains obscure. At this time, the assumption that any stimulatory hormetic effects from low doses of ionizing radiation will have a significant health benefit to humans that exceeds potential detrimental 78 Marcus
petition PRM2028, at 12.
at 7 Why deprive the public of the benefits of low dose radiation?.
79 Id.,
VerDate Sep<11>2014

16:34 Aug 16, 2021

Jkt 253001

45929

effects from radiation exposure at the same dose is unwarranted.80

provided by national and international authoritative scientific advisory bodies.

Similarly, the NCRP has found that there is not strong support for the hormesis concept in the scientific literature.81 The NRC has determined that it is prudent to continue to rely upon the LNT model as a basis for the NRCs radiation protection regulations.
Consequently, the NRC will retain the dose limits for occupational workers and members of the public in 10 CFR
part 20 radiation protection regulations.

Petitioners Assertion That the Cost of Compliance With LNT-Based Regulations Is Enormous The petitioners assert that the cost of complying with LNT-based regulations is enormous and incalculable.

Petitioners Assertion That the NRC has a Conflict of Interest The petitioners suggest a conflict of interest, because the NRC is one of the Federal agencies that funded the development of the BEIR VII report by the NAS and has funded, and is funding, research by the NCRP.
NRCs Response Sections 31.a and 161.c of the AEA
authorize the NRC to enter into arrangements with organizations such as the NAS and the NCRP. Specifically, section 31.a of the AEA authorizes the NRC to enter into arrangements, with either public or private institutions or persons, for research and development and to expand theoretical and practical knowledge in the various fields specified in section 31.a, including radiological health and safety.82
Additionally, section 161.c authorizes the NRC to make such studies and investigations, obtain such information . . . as the Commission may deem necessary or proper to assist it in exercising any authority provided in the AEA. 83
The petitioners merely allege a conflict of interest. The NRC did not influence or direct the findings of either the NAS or the NCRP, and the NRC is not aware of any irregularities in the methods invoked by NAS or NCRP
technical experts who analyzed the data and prepared the respective reports. The petitioners did not present any evidence to the contrary. Moreover, the petitioners did not demonstrate that the findings of either the BEIR VII report or any of the various NCRP reports that were funded in part by the NRC are either technically or scientifically unsound. The NRC will continue to review and consider recommendations on radiation protection regulations 80 NAS

BEIR VII, at 315.
Report No. 136, at 196; see also NCI
2015, at 3 there is little data to suggest a threshold in dose, or possible hormetic beneficial effects of low-dose radiation exposure.
82 42 U.S.C. 2051a.
83 42 U.S.C. 2201c.
81 NCRP

PO 00000

Frm 00007

Fmt 4702

Sfmt 4702

NRCs Response In 1991, the NRC issued the 10 CFR
part 20 final rule, which established the current regulatory framework for the NRCs radiation protection regulations.
In issuing that final rule, the Commission concluded that the rule provides for a substantial increase in the overall protection of the public health and safety and that the direct and indirect costs of its implementation are justified in terms of the quantitative and qualitative benefits associated with the rule. 84 Although the NRC
acknowledges the costs involved in complying with its regulations, the NRC
continues to conclude that its regulatory provisions that rely on LNT, such as the ALARA concept, remain both beneficial, in terms of the health and safety benefits they provide to both members of the public and occupational workers, and are cost-justified.85 The petitioners have not provided any new information that would cause the NRC to revisit its findings with respect to cost that it made in 1991.
Moreover, in the 1991 final rule, the Commission further noted that if it had determined that the rule was not costjustified, the Commission would have still issued the rule because the changes made to part 20 also amount to a redefinition of the level of adequate protection. 86 Adequate protection is the NRCs fundamental safety standard and is derived from various provisions of the AEA.87 An adequate protection 84 56

FR at 23389.
NRC regulations define ALARA as making every 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. 20.1003. Those individuals and entities that hold NRC licenses are required, to the extent practical, to incorporate ALARA into their procedures and engineering controls in accordance with 20.1101b. The NRCs Regulatory Guide RG
8.10, Operating Philosophy for Maintaining Occupational and Public Radiation Exposures As Low As Is Reasonably Achievable, Rev. 2 August 2016, provides guidance to NRC licensees on complying with the ALARA requirement. Other NRC regulatory guides provide additional ALARA
guidance to licensees in specific categories, e.g., RG
8.8 power reactor licensees and RG 8.18 medical licensees.
86 56 FR at 23389.
87 E.g., Section 182a. of the AEA, with respect to reactor applications, requires the Commission to 85 The
E:FRFM17AUP1.SGM

Continued
17AUP1