94-2394. Radiation Protection Requirements; Amended Definitions and Criteria  

  • [Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-2394]
    
    
    [[Page Unknown]]
    
    [Federal Register: February 3, 1994]
    
    
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    NUCLEAR REGULATORY COMMISSION
    
    10 CFR Parts 19 and 20
    
    RIN 3150-AE80-1
    
     
    
    Radiation Protection Requirements; Amended Definitions and 
    Criteria
    
    AGENCY: Nuclear Regulatory Commission.
    
    ACTION: Proposed rule.
    
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    SUMMARY: The Nuclear Regulatory Commission (NRC) proposes to amend its 
    regulations concerning radiation protection requirements. The proposed 
    rule would: Delete the definition of ``Controlled area'' to make it 
    clear that any area to which access is restricted for the purpose of 
    radiological protection is a restricted area as defined in the 
    regulation, revise the definition of ``Occupational dose'' to delete 
    reference to the ``Restricted area,'' revise the definition of 
    unrestricted area to be consistent with the deletion of controlled 
    area, revise the provision entitled ``Instruction to Workers,'' so that 
    radiation protection training will be provided to all persons with the 
    potential to be occupationally exposed and restore a provision to 
    provide that whenever licensees are required to report exposures of 
    individual members of the public to the NRC, then those individuals are 
    to receive copies of the report.
    
    DATES: Comment period expires April 4, 1994. Comments received after 
    this date will be considered if it is practical to do so, but the 
    Commission is able to assure consideration only for comments received 
    on or before this date.
    
    ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory 
    Commission, Washington, DC 20555, Attention: Docketing and Service 
    Branch.
        Deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
    between 7:45 am and 4:15 pm Federal workdays.
        Copies of the regulatory analysis, the environmental assessment and 
    finding of no significant impact, the supporting statement submitted to 
    OMB, and comments received may be examined at: The NRC Public Document 
    Room, 2120 L Street NW. (Lower Level), Washington, DC.
    
    FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear 
    Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 
    20555, telephone (301) 492-3740.
    
    SUPPLEMENTARY INFORMATION:
    
    Background
    
        On May 21, 1991, (56 FR 23360) the NRC amended 10 CFR part 20 to 
    add its revised ``Standards for Protection Against Radiation (10 CFR 
    20.1001-20.2402). Compliance became mandatory for all licensees on 
    January 1, 1994. Extensive discussion regarding interpretation and 
    implementation of the new rules has ensued both within the NRC and 
    Agreement State staffs and with licensees and other interested parties.
        The revised standards include a definition for the term 
    ``Controlled area.'' The term is defined to be an area outside of a 
    restricted area, but inside the site boundary access to which can be 
    limited for any reason (10 CFR 20.1003). The term ``Restricted area'' 
    was retained in the revised standards from the original regulation, 10 
    CFR part 20, and is defined as an area, ``access to which is limited by 
    the licensees for the purpose of protecting individuals against undue 
    risks from exposure to radiation or radioactive materials * * * (10 CFR 
    20.1003).'' Neither the revised standards themselves, nor the 
    supplemental information provide a basis for deciding whether to 
    designate a given area as a ``Restricted area'' or a ``Controlled 
    area.'' In discussions with licensees and Agreement States, the absence 
    of such a clear delineation appears to be the cause of considerable 
    uncertainty among a number of licensees regarding how to implement the 
    revised standards in this regard. The NRC believes that this situation 
    can be alleviated by eliminating the term ``Controlled area'' from the 
    regulations. This change has the effect of returning the regulation to 
    the former situation in which areas are either restricted or 
    unrestricted for purposes of radiation protection. As has always been 
    the case, licensees continue to have the option of controlling access 
    to areas for reasons other than radiation protection.
        The definition of ``Unrestricted area'' in the revised standard 
    acknowledges the existence of controlled areas and currently is defined 
    as an area ``access to which is neither limited nor controlled by the 
    licensee'' (10 CFR 20.1003). Deletion of the term ``Controlled area'' 
    permits return to the former situation in which areas are either 
    restricted or unrestricted for radiation protection purposes, and the 
    Commission now proposes to revise the definition of ``Unrestricted 
    area'' to make this clear.
        Under this proposal, licensees would continue to have the option to 
    control access for reasons other than radiation protection. As before, 
    the definitions of ``restricted area'' and of ``unrestricted area'' do 
    not preclude the existence of areas in which access is limited for 
    purposes other than protecting individuals against undue risks from 
    exposure to radiation and/or radioactive materials.
        ``Occupational dose'' is defined currently in the revised standards 
    ``as the dose received by an individual in a restricted area or in the 
    course of employment in which the individual's assigned duties involve 
    exposure to radiation and/or to radioactive materials * * *.'' (10 CFR 
    20.1003) Through meetings with licensees to discuss the revised 
    standards, the Commission has become aware that this definition can be 
    interpreted to allow individuals who are members of the public to 
    receive an ``occupational dose'' and exceed public dose limits if they 
    enter restricted areas. This was not the intention of the Commission in 
    promulgating the revised standards. A fundamental principle present in 
    the regulations is that a member of the public is subject to the limits 
    for a member of the public (Sec. 20.1301 (a)(1)), irrespective of that 
    individual's location. The Commission is separately considering 
    revisions to parts 20 and 35, whereby licensees who have been 
    administered radioactive materials to patients and released them in 
    accordance with Sec. 35.75 would be exempt from the provisions of 
    Sec. 20.1301 (a)(1) with regard to the radioactive material in the 
    released patient. Licensees must be able to ensure that a member of the 
    public, if present in a restricted area, as well as any other area, 
    will not exceed an exposure of 100 mrem/year. The suggestion that 
    permission to expose a member of the public to a dose in excess of 100 
    mrem in a year, is created by that individual's location in a 
    restricted area, can be removed by a simple modification to the 
    definition of occupational dose, specifically by eliminating reference 
    to dose received in a restricted area. In addition, ``radiation and/or 
    radioactive material'' should replace ``radiation and radioactive 
    material'' to correct a technical error in the text of the rule. With 
    these changes, it would become clear that occupational dose is dose 
    received as a result of an individual's employment in which assigned 
    duties involve exposure to radiation and/or radioactive material. These 
    changes would also make it clear that the dose received by a member of 
    the public cannot be permitted to exceed the public dose limit even if 
    the individual is receiving a portion of that dose while in a 
    restricted area. The remainder of the definition of occupational dose 
    would not be modified by this action, and maintains the description of 
    both what is included and what is excluded in occupational dose for 
    purposes of clarity.
        The regulation entitled ``Instruction to Workers,'' 10 CFR 19.12, 
    currently requires that all individuals working in or frequenting any 
    portion of a restricted area be instructed in the health protection 
    problems associated with exposure to radiation and in radiation 
    protection procedures needed to minimize exposure. Under this 
    provision, if a worker never enters a restricted area, he or she would 
    require no radiation protection training. On the other hand, members of 
    the public, such as delivery persons who might occasionally enter a 
    restricted area, would be required to be trained even though the nature 
    of their activities would perhaps not warrant such instruction. The 
    proposed change to Sec. 19.12 would make it clear that anyone in the 
    course of their employment in which the individual's assigned duties 
    involve the potential for exposure to radiation and/or radioactive 
    material would have to be provided appropriate radiation protection 
    training.
        Concern about training requirements has been expressed for certain 
    categories of workers and members of the public illustrated by the 
    following cases: Case (1) involves a member of the public who is 
    potentially exposed to some radiation while visiting a facility or 
    making deliveries, and, Case (2), a maintenance worker or contractor 
    who is exposed to radiation while performing repairs or cleaning. In 
    order to decide if training is required, and what type of training is 
    appropriate, certain provisions of the rules must be considered.
        First, after January 1, 1994, a member of the public cannot be 
    permitted to receive more than 100 mrem in a year unless specifically 
    approved by the Commission (10 CFR 20.1301).1 Second, training 
    commensurate with the potential radiological health protection problems 
    present would be required by the proposed 10 CFR 19.12 only for 
    individuals whose assigned duties involve a potential for exposure to 
    radiation and/or radioactive materials. In the first case above, the 
    individual's activities, i.e., visiting a facility or making 
    deliveries, were not assigned by the licensee or a licensee contractor. 
    Under these conditions, the individual is a member of the public, and 
    the licensee must ensure that exposures are less than 100 mrem in a 
    year, and further must be as low as is reasonably achievable (ALARA). 
    Doses to these individuals should be controlled by other measures that 
    would be included in an ALARA program, such as shielding, escorting, 
    removing radioactive sources during visits, and controlling stay-times. 
    Therefore, the Commission believes training is not required. However, 
    nothing in the rules prevents providing training to any individuals.
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        \1\As discussed above, the Commission is separately considering 
    revisions to parts 20 and 35 to address cases whereby licensees have 
    treated patients with radioactive material and released them under 
    the provisions of Sec. 35.75, and thus would not fall under the 
    provision of Sec. 20.1301(a)(1) with regard to the radioactive 
    material in the released patient.
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        In the second case, the individual's activities, i.e., performing 
    repairs or cleaning, are performed during the course of employment with 
    the licensee or a contractor to the licensee and the individuals' 
    assigned duties do involve the potential for exposure to radiation. 
    Although the individual may not enter a restricted area and, whether 
    this worker's dose exceeds 100 mrem in a year or not, if the worker has 
    the potential to receive some occupational exposure, training 
    ``commensurate with potential radiological health protection problems 
    present in the workplace'' is required to ensure informed consent and 
    control of exposure. This training does not have to be extensive. The 
    Commission believes that doses received by individual workers at a rate 
    greater than the 1mSv (100 mrem) in a year public dose limit constitute 
    a level of risk which requires training at least to a level which 
    provides information on the risks of exposure and methods for reducing 
    exposure in keeping with the ALARA principle.
        Prior to the promulgation of the revised standards, paragraph 
    20.409(b) of part 20 provided that whenever a licensee is required to 
    report to the Commission any exposure of an identified individual 
    worker or member of the public to radiation and/or radioactive 
    material, the licensee must also notify that individual.2 Although 
    it was the intent of the Commission that this provision remain in 10 
    CFR part 20, the requirement was inadvertently omitted from the revised 
    standards. Accordingly, Sec. 20.2205 is added to clearly restore to 10 
    CFR part 20 the intention that individual workers and individual 
    members of the public are to be notified of exposures in excess of the 
    dose limits that would require notifying the NRC. Under Sec. 20.2205, 
    the licensees' obligation to notify an individual will be triggered if 
    (and only if) the licensee's required report to NRC identifies that 
    individual by name as having received an exposure to radiation and/or 
    to radioactive material. The licensee's obligation to identify 
    individuals in a required report to the NRC is as provided for in 10 
    CFR 20.2203.
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        \2\See also 10 CFR 19.13(d) (When a licensee is required to 
    report to the Commission any exposure of an individual to radiation 
    or radioactive material, the licensee must also provide the 
    individual a report on their exposure data.)
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    Agreement States
    
        The proposed amendments would apply to all NRC licensees and 
    Agreement States (Definitions in 10 CFR part 20 are Division I matters 
    and are thus matters of compatibility). The proposed changes, with the 
    exception of the addition of Sec. 20.2205 and the revision of the 
    definition of unrestricted area, were discussed in June 1993 with 
    Agreement State representatives and the changes discussed were strongly 
    supported. Agreement States have the opportunity to comment further on 
    all of the proposed changes during the public comment period. The 
    Agreement States cannot be expected to modify their regulations before 
    the January 1, 1994, date. Some States will need as much as 3 years to 
    conform to the changes. In the interim, States may wish to consider 
    alternative methods to address the issues presented in this rulemaking.
        A draft of the proposed amendments, with the exception of the 
    addition of Sec. 20.2205 and the revision of the definition of 
    unrestricted area, was provided to the Agreement States prior to 
    submitting the amendments for publication in the Federal Register. 
    Several States submitted comments. One State suggested limiting public 
    doses to ``licensed'' sources of radiation while another observed that 
    keeping this provision general permitted the States to control exposure 
    from Naturally Occurring and Accelerator Produced Radioactive Material 
    (NARM) as well as byproduct material. The proposed rule is general and 
    does not specify licensed sources. This approach is consistent with the 
    rule, as expressed in Sec. 20.1001 to control doses from all sources of 
    radiation that are under the control of the licensee.
        Another State provided a revised definition of ``Member of the 
    Public'' which would not rely on the definition of ``Occupational 
    dose'' and would make clear that workers exposed to NARM are not 
    members of the public. The intent here was to minimize the change to 
    the definitions and still accomplish the needed clarifications of these 
    issues. For that reason and because ``Occupational dose'' is defined as 
    from ``licensed or unlicensed'' sources, this change is not made in the 
    proposed rule.
        Two States argued that the draft language restricting the training 
    requirements in 10 CFR 19.12 to individuals involved ``in licensed 
    activities'' and ``in the licensee's facility'' was too restrictive, 
    and might prevent workers such as housekeeping staff and security staff 
    from receiving minimal, but needed training. The language of the 
    training requirement is more inclusive in this proposed rule.
        One State proposed retaining in Sec. 20.2104(a) a requirement to 
    determine prior occupational dose if an individual enters the 
    restricted area. The NRC staff believes that retaining only the words 
    ``is likely to receive, in a year, an occupational dose requiring 
    monitoring,'' is sufficient to trigger a determination of prior dose. 
    The State also suggested wording which would make licensees responsible 
    for accounting for occupational exposure from nonlicensed activities. 
    This is consistent with the Commission's position and the draft is 
    revised accordingly.
    
    Description
    
        The provision in 10 CFR Part 20 for a ``Controlled area,'' its 
    definition and its use in several other sections of Part 20 would be 
    deleted. Licensees would continue to have the option to control access 
    to areas for reasons other than radiation protection.
        The proposed rulemaking would revise the definition of 
    ``Occupational dose'' to delete reference to the ``Restricted area'' so 
    that the occupational dose limit and its associated radiation 
    protection provisions, such as training and individual monitoring 
    requirements, would apply to an individual who in the course of 
    employment has assigned duties involving exposure to radiation and/or 
    to radioactive material. This change would also indicate that public 
    dose limits cannot be exceeded for members of the public even if they 
    enter a restricted area.
        The definition of ``Unrestricted area'' would be revised to make it 
    clear that for the purposes of radiation protection areas, are either 
    restricted or unrestricted and that access to unrestricted areas can be 
    controlled for reasons other than radiation protection.
        ``Instructions to Workers,'' 10 CFR 19.12, would be revised to make 
    clear that training commensurate with the hazards present must be 
    provided to all individuals who have the potential to be occupationally 
    exposed rather than just to individuals working in or frequenting any 
    portion of a restricted area.
        ``Reports to individuals of exceeding dose limits,'' 10 CFR 
    20.2205, is added to restore to part 20 the Commission's intent that 
    any identified individual, including members of the public, who 
    receives an exposure in excess of the dose limits for which a report to 
    the NRC is required, will receive notification of that exposure from 
    the licensee.
    
    Impact
    
        The Commission believes that these proposed changes will have some, 
    albeit relatively minor, impacts on licensees. The impacts associated 
    with each of the changes are outlined below.
        For the deletion of the definition of controlled area, the 
    Commission believes that there will be little impact on most power 
    reactor licensees. Although some confusion has surfaced associated with 
    the intent of the terms ``controlled area'' and ``occupational dose,'' 
    these definitions have been discussed extensively with and by industry 
    representatives, and the Commission believes that the proposed rule 
    generally reflects current and planned practices of many reactor 
    licensees. Licensees can continue to designate areas as controlled 
    areas for purposes other than radiological protection, irrespective of 
    whether the term appears in the rule or not.
        Some licensees have already implemented the revised standards, and 
    procedures have been written which would require changes as a result of 
    this proposed rulemaking if these procedures have employed the concept 
    of controlling areas for radiological protection.
        For those reactor licensees who have already formally implemented 
    the revised standards or who have a need for the additional flexibility 
    afforded by the use of the concept of controlled area for purposes of 
    radiological protection, the provisions for exemptions from the NRC's 
    regulations provides an avenue of relief. The NRC currently believes 
    that the elimination of the concept of ``Controlled area'' will have 
    such a small impact on most power reactor licensees that it does not 
    constitute a backfit as envisioned by 10 CFR 50.109. The action removes 
    flexibility but does not directly impose new procedures. However, the 
    NRC welcomes comments on whether this action does in fact constitute a 
    backfit, the degree of burden imposed by the action, particularly for 
    licensees who have already implemented the revised standards, and on 
    whether in the limited matter of ``Controlled area,'' provisions for 
    grandfathering should be provided in the final rule to avoid such 
    burdens.
        Revising the definition of ``Unrestricted area'' further makes 
    clear the NRC's intent that for purposes of radiation protection, areas 
    are either restricted or unrestricted. Some minor modifications to 
    procedures and training may be necessitated by this change.
        For the change involving the term occupational exposure, the 
    Commission believes that some minor editorial modifications of 
    procedures and training will be necessary. Occupational exposure was 
    previously defined to include both presence in a restricted area and 
    activities involving exposure to radiation and/or radioactive 
    materials. Elimination of the reference to restricted areas will not 
    change the scope of applicability of the term occupational dose for 
    most licensees' employees. Furthermore, this change as it relates to 
    doses to members of the public, makes it clear that doses to members of 
    the public must remain within the limits for members of the public, 
    even if they are present within a restricted area. This distinction may 
    result in some minor corrections to procedures and administrative 
    control levels. However, it should be noted that licensees have 
    controlled and continue to control the exposure of these individuals to 
    small fractions of the public dose limit. Thus, there should be no 
    significant change necessary in licensee activities.
        The conforming change to 10 CFR part 19 is minor and will affect 
    only a small number of licensees and will have a negligible impact. For 
    the modification of the training requirements to match the definition 
    of occupational exposure, the Commission believes that licensees will 
    need to make relatively minor modifications to training procedures to 
    reflect the new definition. Training remains ``commensurate with 
    potential radiological health protection problems'' and, thus, the 
    scope of the training activities is not anticipated to require 
    modification. The Commission also believes that any small incremental 
    increase in burden of additional occupationally exposed individuals 
    requiring training will be offset by the reduction in burden inherent 
    in the fact that members of the public entering a restricted area will 
    no longer be required to be trained in accordance with the provisions 
    of 10 CFR part 19.
        The addition to 10 CFR part 20 of a requirement to notify 
    individual workers and individual members of the public of exposures in 
    excess of the dose limits is not considered to impose any additional 
    burden on licensees.3 The addition would make clear in 10 CFR part 
    20, where such a requirement would normally be expected, that when 
    existing reporting requirements would result in reporting exposure 
    information on an identified individual member of the public to NRC, 
    then the identified individual would receive a report on his or her 
    exposure.
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        \3\See also 10 CFR 19.13(d) (When a licensee is required to 
    report to the Commission any exposure of an individual to radiation 
    or radioactive material, the licensee must also provide the 
    individual a report on their exposure data.)
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        The impact of these proposed rule changes on materials licensees is 
    considered to be minimal. The NRC believes that these changes will 
    provide additional clarity when implementing the revised 10 CFR part 20 
    and will not have an adverse impact on the health and safety of workers 
    or the public. Removing the implied option to establish controlled 
    areas for radiation protection purposes, and simplifying the definition 
    and administration of occupational dose will require minimal changes in 
    procedures and in some cases may even involve a net reduction in 
    burden. Licensees continue to have the option to control access to 
    areas for reasons other than radiological protection. Licensees who 
    have already written procedures including provisions for controlled 
    areas for radiation protection purposes would have the option to 
    request exemptions. Materials licensees, particularly those who have 
    already implemented the new regulations, are invited to comment on 
    whether or not the proposed changes impose significant burden.
    
    Finding of No Significant Environmental Impact: Availability
    
        The NRC has determined under the National Environmental Policy Act 
    of 1969, as amended, and the Commission's regulations in subpart A of 
    10 CFR part 51, that this rule, if adopted, would not be a major 
    Federal action significantly affecting the quality of the human 
    environment and therefore, an environmental impact statement is not 
    required.
        The option of establishing access control over an area owned by a 
    licensee for reasons of security, for example, exists whether or not 
    the term ``Controlled area'' is specifically defined in 10 CFR part 20. 
    The provision for controlled areas in the rule is not a requirement. 
    Deleting the term ``Controlled area'' from the rule is not expected to 
    result in a significant change in the number of areas to be controlled 
    or in an increase in exposure to any member of the public. Public 
    access to licensee owned facilities and land is expected to remain 
    unchanged as a result of this amendment. No other environmental impact 
    or benefit is associated with the ``Controlled area'' provision.
        Changing the definition of ``Occupational dose'' to make it clear 
    that individuals whose assigned duties involve exposure to radiation 
    and radioactivity are subject to radiation protection procedures 
    associated with occupational exposure and that members of the public 
    cannot be permitted to receive doses that exceed public dose limits 
    just by entering a restricted area is considered a benefit with no 
    environmental impact. This change would have no effect on the type or 
    quantity of material released into the environment and, if anything, 
    would make it less likely for members of the public to be exposed to 
    more than public dose limits.
        Revising the definition of ``Unrestricted area'' to make it clear 
    that for purposes of radiation protection, areas are either restricted 
    or unrestricted, has no perceived environmental impact.
        Amending the radiation protection training requirements to clarify 
    that they apply to individuals who in the course of employment are 
    potentially exposed to radiation and/or to radioactive material, 
    regardless of whether they may or may not be within a restricted area, 
    will result in no impact on the environment.
        Adding Sec. 20.2205 to part 20, which would clearly restore the 
    Commission's policy that individual workers and individual members of 
    the public are notified, whenever NRC is notified, that they have been 
    exposed to radiation or radioactive material in excess of the dose 
    limits, will have no impact on the environment.
        The environmental assessment and finding of no significant impact 
    on which this determination is based are available for inspection at 
    the NRC Public Document Room 2120 L Street, NW., (Lower Level), 
    Washington, DC. Single copies of the environmental assessment and 
    finding of no significant impact are available from Alan K. Roecklein, 
    U.S. NRC, 5650 Nicholson Lane, Rockville, MD 20852, (301) 492-3740.
    
    Paperwork Reduction Act Statement
    
        This proposed rule does not contain a new or amended information 
    collection requirement subject to the Paperwork Reduction Act of 1980 
    (44 U.S.C. 3501 et seq.). Existing requirements were approved by the 
    Office of Management and Budget, approval numbers 3150-0044, 3150-0014, 
    3150-0005, and 3150-0006.
    
    Regulatory Analysis
    
        The NRC has prepared a draft regulatory analysis on this proposed 
    regulation. The analysis examines the costs and benefits of the 
    alternatives considered by the NRC. The draft analysis is available for 
    inspection in the NRC Public Document Room, 2120 L Street NW. (Lower 
    Level), Washington, DC. Single copies of the draft analysis may be 
    obtained from Alan K. Roecklein, U.S. NRC, 5640 Nicholson Lane, 
    Rockville, MD 20852, (301) 492-3740.
        The NRC requests public comment on the draft regulatory analysis. 
    Comments on the draft analysis may be submitted to the NRC as indicated 
    under the ADDRESSES heading.
    
    Regulatory Flexibility Certification
    
        Based upon the information available at this stage of the 
    rulemaking proceeding and in accordance with the Regulatory Flexibility 
    Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule 
    will not have a significant economic impact upon a substantial number 
    of small entities. The proposed amendments would apply to all NRC and 
    Agreement State licensees. Because these amendments only clarify, 
    restore, and conform existing requirements to the 1991 version of part 
    20, they are considered to have no significant economic impact on any 
    large or small entities.
        However, the NRC is seeking comments and suggested modifications 
    because of the widely differing conditions under which small licensees 
    operate. Any small entity subject to this proposed regulation which 
    determines that, because of its size, it is likely to bear a 
    disproportionate adverse economic impact should notify the NRC of this 
    in a comment that indicates--
        (a) The licensee's size in terms of annual income or revenue, 
    number of employees and, if the licensee is a treatment center, the 
    number of beds and patients treated annually;
        (b) How the proposed regulation would result in a significant 
    economic burden upon the licensee as compared to that on a larger 
    licensee;
        (c) How the proposed regulations could be modified to take into 
    account the licensee's differing needs or capabilities;
        (d) The benefits that would be gained or the detriments that would 
    be avoided by the licensee if the proposed regulation was modified as 
    suggested by the commenter; and
        (e) How the regulation, as modified, would still adequately protect 
    the public health and safety.
    
    Backfit Analysis
    
        Because 10 CFR parts 19 and 20 apply to all NRC licensees, any 
    proposed changes to these parts must be evaluated to determine if these 
    changes constitute backfitting for reactor licensees such that the 
    provisions of 10 CFR 50.109, ``Backfitting,'' apply. The following 
    discussion addresses that evaluation.
        The proposed rule consists of five changes: (1) Deletion of the 
    definition and use of the term ``Controlled area,'' (2) deletion of the 
    phrase ``in a restricted area or'' contained in the definition of 
    occupational dose, (3) revising the definition of ``Unrestricted 
    area,'' (4) modification of the training requirement contained in 10 
    CFR 19.12, and (5) restoring a requirement that individuals members of 
    the public be notified when they are identified in reports to NRC on 
    exposures in excess of the limits.
        The deletion of the definition of controlled area is a corrective 
    change. The term was originally added with the 1991 revision of part 20 
    to acknowledge the need for licensees to control access to areas for 
    purposes other than radiation protection. The use of the term was not 
    intended to be mandatory. Numerous questions from licensees regarding 
    implementing Controlled areas have arisen. Since the staff believes 
    that the use of a controlled area has no radiation protection function 
    other than potential use in estimating the occupancy time for 
    demonstrating compliance with the 100 mrem/year limit, it is being 
    proposed that the term be deleted from part 20.
        For those reactor licensees who have already formally implemented 
    the revised standards or who have a need for the additional flexibility 
    afforded by the use of the concept of controlled area for purposes of 
    radiological protection, the provisions for exemptions from the NRC's 
    regulations provide an avenue of relief. The NRC currently believes 
    that the elimination of the concept of ``Controlled area'' will have 
    such a small impact on most power reactor licensees that it does not 
    constitute a backfit as envisioned by 10 CFR 50.109. The action removes 
    flexibility but does not directly impose new procedures. However, the 
    NRC welcomes comments on whether this action does in fact constitute a 
    backfit, the degree of burden imposed by the action, particularly for 
    licensees who have already implemented the revised 10 CFR part 20, and 
    on whether in the limited matter of ``Controlled area'' provisions for 
    grandfathering should be provided in the final rule to avoid such 
    burdens.
        The deletion of the phrase ``in a restricted area or,'' contained 
    in the definition of occupational dose is to ensure that the 
    Commission's intent to apply the dose limits of 10 CFR 20.1301 to 
    members of the public regardless of their physical location, is 
    properly implemented. Currently, only workers are subject to the higher 
    occupational dose limits and just because a member of the public is 
    permitted entry into a restricted area does not mean that he or she 
    should be allowed to receive an occupational dose and exceed the public 
    dose limit. For this reason, the reference to a restricted area is 
    being removed from the definition of occupational dose.
        Revising the definition of ``Unrestricted area,'' would make the 
    current staff position clear that for purposes of radiation protection, 
    areas are either restricted or unrestricted. This change is consistent 
    with the former 10 CFR part 20 and conforms to removing ``Controlled 
    area'' from the rule.
        The change to 10 CFR 19.12 will be consistent with the proposed 
    revised definition of occupational exposure. Since occupational dose is 
    to be based upon the individual's activities involving radiation and/or 
    radioactive materials, rather than the location of the work (e.g., 
    restricted area), a conforming change in part 19 is needed to ensure 
    that workers who receive an occupational dose are appropriately trained 
    regardless of the physical location where the work is performed. This 
    is also needed so that members of the public, such as delivery persons, 
    who occasionally enter a restricted area will not be required to 
    receive occupational training merely because they entered a restricted 
    area when their potential exposures do not exceed the 1 Msv (100 mrem) 
    public dose limit and their activities, therefore, would not subject 
    them to any significant risk.
        The NRC staff believes that the impact of the change to 10 CFR 
    19.12 is negligible for 10 CFR part 50 licensees, given that the 
    expected numbers of additional occupationally exposed individuals 
    requiring training is small relative to the number of workers already 
    receiving training at these facilities. The NRC staff also believes 
    that these licensees have been providing training to these individuals, 
    even though not specifically required by the regulations.
        The addition of 10 CFR 20.2205, ``Reports to individuals of 
    exceeding dose limits'' is considered to be the restoration of a 
    previous requirement. Section 20.409(b) of part 20 requires licensees 
    to notify an individual worker or member of the public whenever a 
    report to the NRC is required regarding an exposure of the identified 
    individual. This requirement was inadvertently omitted from the revised 
    standards. Although few incidents occur that involved exposure of a 
    member of the public in excess of dose limits, restoring this provision 
    to part 20 will ensure that licensees are aware of their obligation to 
    notify the individual if, and when, they are required to submit a 
    report to NRC of an occurrence that identifies that individual as 
    having received an exposure.
        The Commission believes that these proposed changes to 10 CFR part 
    20 will have some, albeit minor, impacts on reactor licensees. 
    Licensees who have already implemented the revised standards, or who 
    have written procedures to do so, will need to revise those procedures 
    to reflect the proposed changes if promulgated. Benefits such as 
    simplifying the use of restricted and unrestricted area designation, 
    making it clear that only workers can receive occupational dose, tying 
    training requirements to the potential to receive occupational exposure 
    and ensuring that overexposed individuals are notified, are considered 
    by the Commission to far outweigh the impacts. However, these benefits 
    are qualitative in nature, and are expressed in terms of reduced 
    uncertainty in regulatory requirements, clarity of regulatory intent, 
    and consistency of regulatory approach. Thus the NRC believes that the 
    modifications proposed are not backfits. However, the NRC invites 
    comments from affected licensees on whether these proposed changes 
    impose significant burdens and whether or not the actions constitute a 
    backfit.
    
    List of Subjects
    
    10 CFR Part 19
    
        Criminal penalties, Environmental protection, Nuclear materials, 
    Nuclear power plants and reactors, Occupational safety and health, 
    Packaging and containers, Radiation protection, Reporting and 
    recordkeeping requirements, Sex discrimination.
    
    10 CFR Part 20
    
        Byproduct material, Licensed material, Nuclear materials, Nuclear 
    power plants and reactors, Occupational safety and health, Packaging 
    and containers, Penalty, Radiation protection, Reporting and 
    recordkeeping requirements, Source material, Special nuclear material, 
    Waste treatment and disposal.
    
        For the reasons set out in the preamble and under the authority of 
    the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
    Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to 
    adopt the following amendment to 10 CFR parts 19 and 20.
    
    PART 19--NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION 
    AND INVESTIGATION
    
        1. The authority citation for part 19 continues to read as follows:
    
        Authority: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930, 
    933, 935, 936, 937, 948, 955, as amended, secs. 234, 88 Stat. 444, 
    as amended (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2236, 
    2282); secs. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). Public 
    Law 95-601, secs. 10, 92 Stat. 2951 (41 U.S.C. 5851).
    
        2. Section 19.12 is revised to read as follows:
    
    
    Sec. 19.12  Instructions to workers.
    
        (a) All individuals who in the course of employment in which the 
    individuals' assigned duties involve the potential for exposure to 
    radiation and/or radioactive material shall be--
        (1) Kept informed of the storage, transfer, or use of radiation 
    and/or radioactive material;
        (2) Instructed in the health protection problems associated with 
    exposure to radiation and/or radioactive material, in precautions or 
    procedures to minimize exposure, and in the purposes and functions of 
    protective devices employed;
        (3) Instructed in, and required to observe, to the extent within 
    the workers control, the applicable provisions of Commission 
    regulations and licenses for the protection of personnel from exposures 
    to radiation and/or radioactive material;
        (4) Instructed of their responsibility to report promptly to the 
    licensee any condition which may lead to or cause a violation of 
    Commission regulations and licenses or unnecessary exposure to 
    radiation and/or radioactive material;
        (5) Instructed in the appropriate response to warnings made in the 
    event of any unusual occurrence or malfunction that may involve 
    exposure to radiation and/or radioactive material; and
        (6) Advised as to the radiation exposure reports which workers may 
    request pursuant to Sec. 19.13.
        (b) The extent of these instructions must be commensurate with 
    potential radiological health protection problems present in the 
    workplace.
    
    PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
    
        3. The authority citation for part 20 continues to read as follows:
    
        Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
    Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 
    2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2282); sec. 
    201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 
    U.S.C. 5841, 5842, 5846).
        Sec. 20.408 also issued under secs. 135, 141, Public Law 97-425, 
    96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
    
        4. In Sec. 20.1003, remove the definition ``Controlled area.''
        5. In Sec. 20.1003, the definitions of ``Member of the public,'' 
    ``Occupational dose,'' ``Public dose,'' and ``Unrestricted area'' are 
    revised to read as follows:
    
    
    Sec. 20.1003  Definitions.
    
    * * * * *
        Member of the public means any individual except when that 
    individual is receiving an occupational dose.
    * * * * *
        Occupational dose means the dose received by an individual in the 
    course of employment in which the individual's assigned duties involve 
    exposure to radiation and/or to radioactive material from licensed and 
    unlicensed sources of radiation, whether in the possession of the 
    licensee or other person. Occupational dose does not include dose 
    received from background radiation, as a patient from medical 
    practices, from voluntary participation in medical research programs, 
    or as a member of the public.
    * * * * *
        Public dose means the dose received by a member of the public from 
    exposure to radiation and/or radioactive material released by a 
    licensee, or to any other source of radiation under the control of a 
    licensee. It does not include occupational dose or doses received from 
    background radiation, as a patient from medical practices, or from 
    voluntary participation in medical research programs.
    * * * * *
        Unrestricted area means any area that is not a restricted area.
    * * * * *
        6. In Sec. 20.1301 paragraph (b) is revised to read as follows:
    
    
    Sec. 20.1301  Dose limits for individual members of the public.
    
    * * * * *
        (b) If the licensee permits members of the public to have access to 
    restricted areas, the limits for members of the public continue to 
    apply to those individuals.
    * * * * *
        7. In Sec. 20.1302 paragraph (a) is revised to read as follows:
    
    
    Sec. 20.1302  Compliance with dose limits for individual members of the 
    public.
    
        (a) The licensee shall make or cause to be made, as appropriate, 
    surveys of radiation levels in unrestricted areas and radioactive 
    materials in effluents released to unrestricted areas to demonstrate 
    compliance with the dose limits for individual members of the public in 
    Sec. 20.1301.
    * * * * *
        8. Section 20.1801 is revised to read as follows:
    
    
    Sec. 20.1801  Security of stored material.
    
        The licensee shall secure from unauthorized removal or access 
    licensed materials that are stored in unrestricted areas.
    
        9. Section 20.1802 is revised to read as follows:
    
    
    Sec. 20.1802  Control of material not in storage.
    
        The licensee shall control and maintain constant surveillance of 
    licensed material that is in an unrestricted area and that is not in 
    storage.
    
        10. In Sec. 20.2104 the introductory text of paragraph (a) is 
    revised to read as follows:
    
    
    Sec. 20.2104  Determination of prior occupational dose.
    
        (a) For each individual who is likely to receive, in a year, an 
    occupational dose requiring monitoring pursuant to Sec. 20.1502 the 
    licensee shall--
    * * * * *
        11. Section Sec. 20.2205 is added as follows:
    
    
    Sec. 20.2205  Reports to individuals of exceeding dose limits.
    
        When a licensee is required, pursuant to the provisions of 
    Secs. 20.2203, 20.2204, or 20.2206, to report to the Commission any 
    exposure of an identified individual worker or member of the public to 
    radiation or radioactive material, the licensee shall also provide to 
    the individual, a written report on his or her exposure data included 
    therein. This report must be transmitted at a time no later than the 
    transmittal to the Commission.
    
        Dated at Rockville, Maryland, this 19th day of January, 1994.
    
        For the Nuclear Regulatory Commission.
    James M. Taylor,
    Executive Director for Operations.
    [FR Doc. 94-2394 Filed 2-2-94; 8:45 am]
    BILLING CODE 7590-01-P
    
    
    

Document Information

Published:
02/03/1994
Department:
Nuclear Regulatory Commission
Entry Type:
Uncategorized Document
Action:
Proposed rule.
Document Number:
94-2394
Dates:
Comment period expires April 4, 1994. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: February 3, 1994
CFR: (9)
10 CFR 19.12
10 CFR 20.408
10 CFR 20.1003
10 CFR 20.1301
10 CFR 20.1302
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