98-19540. Minor Corrections, Clarifying Changes, and a Minor Policy Change  

  • [Federal Register Volume 63, Number 141 (Thursday, July 23, 1998)]
    [Rules and Regulations]
    [Pages 39477-39483]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-19540]
    
    
    
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    Federal Register / Vol. 63, No. 141 / Thursday, July 23, 1998 / Rules 
    and Regulations
    
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    NUCLEAR REGULATORY COMMISSION
    
    10 CFR Parts 20, 32, 35, 36, and 39
    
    RIN 3150-AF46
    
    
    Minor Corrections, Clarifying Changes, and a Minor Policy Change
    
    AGENCY: Nuclear Regulatory Commission.
    
    ACTION: Final rule.
    
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    SUMMARY: The Nuclear Regulatory Commission is amending its regulations 
    to make minor corrections and clarifying changes to the NRC's 10 CFR 
    Part 20, ``Standards for Protection Against Radiation.'' The final rule 
    is also intended to conform other regulations with the Commission's 
    1991 revised radiation protection requirements. In addition, the final 
    rule includes a minor policy change that raises the monitoring criteria 
    for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for 
    declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) 
    during their pregnancies. The 0.1 rem (1 mSv) in a year deep dose 
    equivalent monitoring criterion is consistent with the public dose 
    limit and represents a quantity more consistent with the measurement 
    sensitivity of individual personnel dosimetry. Licensees are still 
    required to ensure that the occupational dose limit of 0.5 rem (5 mSv) 
    in a year is not exceeded for minors, that the dose limit of 0.5 rem (5 
    mSv) to an embryo/fetus due to occupational exposure of a declared 
    pregnant woman is not exceeded during the course of the pregnancy, and 
    that sufficient effort is made to ensure that substantial variations 
    above a uniform monthly exposure rate for a declared pregnant woman are 
    avoided. These changes to the threshold for monitoring exposures to 
    radiation and radioactive material to demonstrate compliance with the 
    limits do not change the occupational dose limits for minors or 
    declared pregnant workers.
    
    EFFECTIVE DATE: This regulation becomes effective on August 24, 1998.
    
    FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear 
    Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
    Washington, DC 20555, telephone (301) 415-6219, e-mail JMM2 @ nrc.gov.
    
    SUPPLEMENTARY INFORMATION:
    I. Introduction
    II. Background
    III. Summary of Final Rule
    IV. Analysis of Public Comments and Staff Response
    V. Agreement State Compatibility
    VI. Environmental Impact: Categorical Exclusion
    VII. Paperwork Reduction Act Statement
    VIII. Regulatory Analysis
    IX. Backfit Analysis
    
    I. Introduction
    
        On May 21, 1991 (56 FR 23360), a final rule was published in the 
    Federal Register that amended 10 CFR Part 20 to update the NRC's 
    ``Standards for Protection Against Radiation.'' Subsequent amendments 
    were published to (1) change the mandatory implementation to January 1, 
    1994, and make conforming changes to the text to reflect the new 
    implementation date (57 FR 38588; August 26, 1992), (2) remove or 
    modify provisions to reflect the new implementation date for NRC's 
    revised ``Standards for Protection Against Radiation'' (58 FR 67657; 
    December 22, 1993), and (3) restore provisions inadvertently removed or 
    modified (59 FR 41641; August 15, 1994; and 60 FR 20183; April 25, 
    1995).
        Since then, several inconsistencies have come to light. The Nuclear 
    Regulatory Commission (NRC) is amending its regulations regarding 
    standards for protection against radiation to make minor corrections 
    and clarifying changes that will remove the inconsistencies and further 
    facilitate implementation. This final rule also establishes conforming 
    amendments to 10 CFR Parts 32, 35, 36, and 39. In addition, a minor 
    policy change raises the monitoring criteria for minors from 0.05 rem 
    (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women 
    from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies.
    
    II. Background
    
        On October 7, 1996, the NRC published a proposed rule for comment 
    in the Federal Register (61 FR 52388) to amend 10 CFR Part 20 of its 
    regulations to make minor corrections and clarifying changes regarding 
    standards for protection against radiation; to conform other 10 CFR 
    Parts with the Commission's revised radiation protection requirements; 
    and to revise the deep dose equivalent monitoring criteria for minors 
    from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared 
    pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their 
    pregnancies. The proposed rule noted that the monitoring criteria would 
    not raise the dose limit for an embryo/fetus due to occupational dose 
    to the declared pregnant woman or the dose limit for minors. Changing 
    the criteria for monitoring does not, in any way, change the dose 
    limits for declared pregnant women, for the embryo/fetus, or for 
    minors. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring 
    criterion is consistent with the public dose limit and represents a 
    quantity more consistent with the measurement sensitivity of individual 
    personnel dosimetry. The current criteria of 0.05 rem (0.5 mSv), if 
    received uniformly in a year or throughout the gestation period, would 
    result in an average monthly dose of less than 0.005 rem (0.05 mSv). 
    The most routinely utilized individual monitoring devices cannot 
    accurately measure doses below 0.01 rem (0.1 mSv), which is greater 
    than the average monthly dose of 0.005 rem (0.05 mSv).
        The public comment period closed on December 23, 1996. A discussion 
    of the issues raised by public comment is covered in Section IV, below.
    
    III. Summary of Final Rule
    
        This final rule makes the following changes:
        (1) In Sec. 20.1003, ``Definitions,'' clarifying changes and minor 
    corrections are made to the following:
        (a) The definition of ``Declared pregnant woman'' is revised to 
    specify that the written declaration of pregnancy is to be given to the 
    licensee rather than the employer, unless the employer is also the 
    licensee. This is necessary to ensure that the entity responsible for 
    work assignments involving radiation exposure (the
    
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    licensee) is aware of the declaration of pregnancy to facilitate timely 
    and appropriate protective action. The change also specifies that the 
    declaration, as well as associated dose restrictions, remains in effect 
    until it is withdrawn in writing or until the woman is no longer 
    pregnant. The determination that a declared pregnant woman is no longer 
    pregnant should be based on a discussion between the declared pregnant 
    woman and the licensee.
        (b) The definitions of ``High radiation area'' and ``Very high 
    radiation area'' are revised to make it clear that these area 
    designations exist solely to note radiation levels from sources 
    external to an individual who may receive the dose.
        (c) The definition of ``Individual monitoring devices'' is revised 
    to correct the misuse of the term thermoluminescent to describe 
    thermoluminescence dosimeters.
        (d) The term ``Lens dose equivalent (LDE)'' replaces ``Eye dose 
    equivalent'' (EDE) to avoid confusion between the initialisms for dose 
    to the lens of the eye and effective dose equivalent (EDE). This should 
    pose no procedural burden on licensees because the required NRC Forms 4 
    and 5 for records and reports were revised in August 1995 to reflect 
    the new terminology, and these or their equivalent are required to be 
    used by existing Sec. 20.2104, Sec. 20.2106(c), and Sec. 20.2206(b).
        (2) In Sec. 20.1101(b), the word ``practicable'' is changed to 
    ``practical'' to remove the basis for an incorrect perception among 
    some licensees that, by using the word ``practicable'' in this section, 
    the NRC is requiring licensees to use any dose averting technique that 
    is capable of being used even if the technique is unproven or 
    impractical.
        (3) In Secs. 20.1201(a)(2)(i) and (c); 20.1203; 20.2101; 
    20.2106(a)(1); and 20.2202(a)(1)(ii) and (b)(1)(ii), ``eye dose 
    equivalent'' is replaced by ``lens dose equivalent'' as described above 
    in the change to Sec. 20.1003.
        (4) In Sec. 20.1206, Planned special exposures, paragraph (a) is 
    revised to clarify what was intended by the term ``higher exposure'' 
    used in the rule previously. The phrase applies to dose estimates 
    performed prior to authorizing the planned special exposure (PSE). The 
    new wording states that PSE's are authorized only in exceptional 
    situations when alternatives that might avoid the dose estimated to 
    result from the PSE are unavailable or impractical. Improved 
    clarification will avoid possible misinterpretation of a PSE criterion.
        (5) In Sec. 20.1208(a), (c), (c)(2), and (d), the phrase ``dose to 
    an embryo/fetus'' is changed to read ``dose equivalent to the embryo/
    fetus'' to make it clear that the dose limit specifically applies to 
    the dose equivalent, which is the technically correct term to denote 
    effect of dose to an organ.
        (6) In Sec. 20.1501(a)(2)(i), the phrase ``The extent of radiation 
    levels; * * *'' is revised to read ``The magnitude and extent of 
    radiation levels; * * *'' to clarify the intended meaning that surveys 
    should evaluate both the area covering the dose field as well as the 
    amount of dose in that area.
        (7) In Sec. 20.1501(a)(2)(iii), the phrase ``The potential 
    radiological hazards that could be present'' is revised to read ``The 
    potential radiological hazards'' in order to remove redundancy.
        (8) In Sec. 20.1502, the words ``from licensed and unlicensed 
    radiation sources under the control of the licensee'' are added after 
    ``exposure to radiation'' in paragraph (a) to improve clarity and to 
    make it clear that, in determining whether or not monitoring is 
    required, a licensee need not take into account sources of radiation 
    not under its control. It should be noted that, although the criterion 
    for monitoring includes only radiation from sources under the control 
    of the licensee, occupational dose includes dose from licensed and 
    unlicensed material, whether in the possession of the licensee or other 
    person.
        (9) In Sec. 20.1502(a)(2) and (b)(2), monitoring requirements for 
    minors and pregnant women are revised. In addition, for minors the dose 
    limits referenced in paragraph (a)(2) apply for an entire year, while 
    for a declared pregnant woman the dose limit referenced in paragraph 
    (b)(2) applies only to the 9-month gestation period. These paragraphs 
    are separated and revised accordingly to make this section consistent 
    with Sec. 20.1208 and technically correct. The criteria for monitoring 
    the deep dose equivalent are changed for minors from 0.05 rem (0.5 mSv) 
    to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 
    rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. Changing the 
    criteria for monitoring does not, in any way, change the dose limits 
    for declared pregnant women, for the embryo/fetus, or for minors. This 
    change constitutes a small licensee burden reduction while maintaining 
    the current adequate level of protection of health and safety of minors 
    and declared pregnant women. The 0.1 rem (1 mSv) in a year deep dose 
    equivalent monitoring criterion is consistent with the public dose 
    limit and represents a quantity more consistent with the measurement 
    sensitivity of individual personnel dosimetry. This value also is 
    consistent with the 100 mrem (1 mSv) training criterion in revised 
    Sec. 19.12 (60 FR 36038; July 13, 1995).
        Licensees are still required to ensure that the occupational dose 
    limits for minors in Sec. 20.1207 are not exceeded, that the dose limit 
    of 0.5 rem (5 mSv) to the embryo/fetus from occupational dose to the 
    declared pregnant woman is not exceeded during the course of the 
    pregnancy, and that sufficient effort is made to ensure that 
    substantial variations above a uniform monthly exposure rate for a 
    declared pregnant woman are avoided. All of the occupational dose 
    limits in Sec. 20.1201 continue to be applicable to the declared 
    pregnant woman as long as the embryo/fetus dose limit is not exceeded. 
    Note that the monitoring criteria for lens dose equivalent and shallow 
    dose equivalent for skin and extremities continue to apply to 
    determining the occupational exposure of declared pregnant women even 
    though they are not applicable to the embryo/fetus.
        (10) The proposed change to the posting requirement in 
    Sec. 20.1902(d), ``Posting of Airborne Radioactivity Area,'' has not 
    been adopted because the Commission has determined that the benefit 
    achieved from replacing signs to use more precise terminology is 
    outweighed by the cost to the licensees to comply with the proposed 
    change. This issue does not have any health and safety implications and 
    was proposed only to make an acceptable term more precise.
        (11) In Sec. 20.1903, a new paragraph is added to exempt 
    teletherapy rooms in a hospital from posting requirements as long as 
    access is controlled by the licensee to prevent the exposure of 
    workers, other patients, and members of the public to radiation. The 
    purpose of this change is to bring the regulation into conformity with 
    existing licensing practices which are intended to avoid the 
    unwarranted and potentially unsettling effect that ``GRAVE DANGER, VERY 
    HIGH RADIATION AREA'' signs may have on patients undergoing medical 
    treatment.
        (12) In Sec. 20.1906(d), a revision requires licensees to notify 
    the NRC Operations Center instead of an NRC Regional Office when, upon 
    receiving and opening packages, radiation levels exceed regulatory 
    limits. This provides for consistency by having all prompt notification 
    requirements direct licensees to contact a single location. A 
    conforming change also is made to the notification requirements in 
    Sec. 20.2202.
        (13) In Sec. 20.2101, a revision permits licensees to add the new 
    SI units to the old (special) units of dose on records
    
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    required by this part. Each of the recorded dose quantities is to be 
    recorded in the appropriate special unit and, if so desired, followed 
    by the appropriate SI unit in parentheses.1 The term ``eye 
    dose equivalent'' is replaced by ``lens dose equivalent'' as discussed 
    under the amendment to Sec. 20.1003.
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        \1\ Part 20 was implemented prior to the NRC's Statement of 
    Policy on Conversion to the Metric System (61 FR 31169); therefore, 
    in order to be consistent with the approach used in Part 20 in its 
    presentation of dual units, this rule does not follow the NRC's 
    metrication policy which supports presenting the SI units first, 
    followed by the English (or special) units shown in brackets.
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        (14) In Sec. 20.2106 (a)(2) and (a)(3), the references to ``body 
    burden'' are removed because this term is obsolete. Section 
    20.2106(a)(4) is revised by adding a reference to Sec. 20.1204(a), that 
    requires licensees to take measurements of (1) concentrations of 
    radioactive materials in air in work areas, or (2) quantities of 
    radionuclides in the body, or (3) quantities of radionuclides excreted 
    from the body, or (4) combinations of these measurements in order to 
    determine internal dose when required by Sec. 20.1502 to monitor 
    internal dose. This, in effect, uses recorded concentrations of 
    radioactive material in air, quantities of radioactive material 
    determined to be in the body or excreta, or any combination of these 
    that would be needed, for assessing the committed effective dose 
    equivalent (CEDE). The NRC believes that this information is necessary 
    to support the recorded results of the licensee's calculation of CEDE. 
    Adding this reference would not impose any additional recordkeeping 
    burden on licensees because they are required to obtain this 
    information in order to calculate CEDE under Sec. 20.1204.
        (15) A revision to Sec. 20.2202(d) results in the application of 
    the same incident reporting requirements to all licensees. Previously, 
    this section required that all licensees with an installed Emergency 
    Notification System make reports to the NRC Operations Center, but all 
    other licensees must submit both a telephone report to the NRC 
    Operations Center and a telegram, mailgram, or facsimile to the 
    Regional Office. This change now requires all licensees to report 
    incidents by telephone to the NRC Operations Center to ensure 
    consistency in the prompt notification requirements contained elsewhere 
    in this part and results in a reduction in the information collection 
    burden.
        (16) In Sec. 32.54(a), the reference to ``Sec. 20.203(a)'' is 
    corrected to read ``Sec. 20.1901.''
        (17) The proposed change has not been adopted in Sec. 35.20 because 
    this issue is being addressed as part of a major revision to 10 CFR 
    Part 35.
        (18) Safety precautions and survey requirements for restricted and 
    unrestricted areas are specified in Secs. 35.315, 35.415, 35.641, and 
    35.643. The proposed changes to Secs. 35.315(a)(4) and 35.415(a)(4) 
    have not been adopted because these issues are being addressed as part 
    of a major revision to 10 CFR Part 35. Sections 35.641(a)(2)(i) and 
    (a)(2)(ii) and 35.643(a) are revised to be consistent with the dose 
    limits for occupationally exposed individuals and members of the 
    public. Also, in Sec. 35.643(a)(1), a misreference to Sec. 20.1301(c) 
    is corrected to read Sec. 20.1301. The 0.5 rem (5 mSv) limit specified 
    in Sec. 20.1301(c) was never intended to be required under this section 
    in Part 35. Rather, it was always the intent of the NRC to apply the 
    0.1 rem (1 mSv) limit in Sec. 20.1301(a) to this section, with a 
    provision for licensees to request the 0.5 rem (5 mSv) limit specified 
    in Sec. 20.1301(c).
        (19) In Sec. 36.23(g), posting requirements for a panoramic 
    irradiator are revised to conform with posting requirements for high or 
    very high radiation areas in Sec. 20.1902. The previous posting 
    requirements in Part 36 required a posting appropriate to a high 
    radiation area only, which may not be appropriate for all panoramic 
    irradiators.
        (20) In Sec. 39.33, ``Radiation detection instruments,'' a 
    conforming change to paragraph (a) is made by replacing the term 
    milliroentgens with the terms millisieverts (mSv) and millirem (mrem) 
    to be consistent with revised Part 20 terminology. However, the NRC 
    recognizes that most licensees may still use radiation detection 
    instruments that measure radiation in units of roentgens. Measurements 
    taken in roentgens may continue to be recorded in terms of the 
    roentgen, provided that the measurements can be readily converted to 
    rem for records required under 10 CFR Part 20.2101(a).
        (21) In Sec. 39.71(b), the reference to ``Sec. 20.3'' is corrected 
    to read ``Sec. 20.1003.''
        Appropriate conforming changes to regulatory guides such as 8.7, 
    8.13, 8.34, 8.35, and 8.36 are under consideration by the Commission.
        One matter in the proposed rule was not adopted. The proposed rule 
    would have changed the term ``Airborne radioactivity area'' to 
    ``Airborne Radioactive Material Area'' because it is more precise 
    language. While the Commission recognizes that the current language is 
    somewhat imprecise, it has determined that the burden imposed on 
    licensees to revise procedures and change signs would outweigh any 
    benefits. In addition, the proposed change to this term does not 
    constitute a health and safety improvement. The proposed conforming 
    changes to Secs. 20.1203 and 20.1902(d) also have not been adopted.
    
    IV. Analysis of Public Comments and Staff Response 
    
        Four letters of public comment were received on the proposed rule. 
    Comments were received from the Council on Radionuclides and 
    Radiopharmaceuticals, Inc., the Nuclear Energy Institute, Commonwealth 
    Edison Company, and the U.S. Department of Health and Human Services.
        Several suggestions for additional changes in 10 CFR Part 20 were 
    submitted and have been referred to the appropriate program offices for 
    consideration. Comments specific to the scope of issues addressed by 
    this rulemaking and the NRC staff's response are as follows:
        One commenter observed that frequent minor changes to the 
    regulations require licensees to make numerous changes to written 
    procedures and training content, thus constituting a burden. It was 
    observed by the commenter that the costs of revising procedures and 
    training programs in response to a minor rulemaking such as this can 
    range from $12,000.00 to $20,000.00 per licensee site in the nuclear 
    power industry. In response to this comment, and others, the proposed 
    change in terminology from ``Airborne radioactivity area'' to 
    ``Airborne radioactive material area'' has been deleted in this final 
    rule. Although supported by the comments, it was also criticized as a 
    change having associated costs and little benefit. The NRC staff agrees 
    that the costs outweigh the benefit and has removed this proposed 
    change from the final rule. The regulatory analysis contained in 
    Section VIII now reflects this adjustment in cost estimate and 
    concludes that the benefits of improved clarity and consistency in NRC 
    regulations remaining in this final rule will offset any remaining 
    costs.
        Similar comments regarding costs and limited benefit were received 
    regarding the proposed change to lens dose equivalent (LDE), and one 
    commenter suggested that NRC Forms 4 and 5 should be revised to use the 
    new term, ``lens dose equivalent (LDE).'' The NRC staff believes any 
    costs incurred by licensees to implement this change in terminology 
    would be minimal since the required NRC Forms 4 and 5 have already been 
    revised to reflect the new terminology and have been used by licensees 
    since August 1995.
    
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        Several suggestions were received regarding the definition and 
    meaning of total effective dose equivalent (TEDE) and effective dose 
    equivalent (EDE). Revision of 10 CFR Part 20, based on the recent ICRP-
    60 publication, was recommended. These suggestions, though having 
    merit, go far beyond the scope of this clarifying rulemaking and will 
    be held for future consideration.
        Several commenters agreed that the declaration of pregnancy must go 
    to the licensee, rather than the employer, as the party responsible for 
    taking timely protective action. Guidance was requested on how 
    licensees could determine the duration of pregnancy and thus, how long 
    dose restrictions would remain in effect. The Commission suggests that 
    licensees establish an appropriate duration of restriction based on 
    discussion with the declared pregnant worker. However, it is not the 
    Commission's intent to require activities which might violate the 
    individual's right to privacy.
        One commenter suggested that an important reason for increasing the 
    monitoring threshold for minors and declared pregnant women to 100 mrem 
    (1 mSv) was the difficulty in measuring 50 mrem (0.5 mSv) in a year or 
    during the gestation period. The NRC agrees and considered this in the 
    adoption of the final rule change.
        Another commenter observed that the change in the monitoring 
    threshold for minors and declared pregnant women will reduce 
    unnecessary burden on licensees while maintaining the current adequate 
    level of protection of health and safety.
        One commenter suggested that consistency with the public dose limit 
    of 100 mrem (1 mSv) is not adequate justification for changing the 
    monitoring criteria for minors and declared pregnant women. The NRC did 
    not rely on consistency with the public dose limit as sole 
    justification; however, it lends support to the underlying scientific 
    basis to revise the criteria. Since the public dose limit of 100 mrem 
    (1 mSv) is considered to be an acceptable level of risk for all members 
    of the public, and the occupational dose limit for minors and the dose 
    limit for the embryo-fetus of declared pregnant women is 500 mrem (5 
    mSv), monitoring for exposures of less than 100 mrem (1 mSv) does not 
    provide an additional level of protection and is not necessary to 
    comply with the dose limits. The final rule requires monitoring of 
    minors and declared pregnant women when it is likely that they would 
    receive over 100 mrem (1 mSv) in 1 year (or during the entire 
    pregnancy).
    
    V. Agreement State Compatibility
    
        This rulemaking will be a matter of compatibility between the NRC 
    and the Agreement States, thereby providing consistency among State and 
    Federal safety requirements. Four categories of compatibility (A 
    through D), as well as a category identifying rules of Health and 
    Safety significance (H&S), have been assigned to portions of this rule. 
    Category A means the provisions affect a basic radiation protection 
    standard or related definitions, signs, labels, or terms necessary for 
    a common understanding of radiation protection that the State should 
    adopt with (essentially) identical language. The NRC has assigned a 
    Category A level of compatibility to the changes to the definitions 
    Declared pregnant woman, High radiation area, Lens dose equivalent 
    (LDE), and Very high radiation area in Sec. 20.1003. Also included 
    under the Category A level of compatibility are the changes to 
    Secs. 20.1201 and 20.1208.
        Category B means the provisions affect a program element with 
    significant direct transboundary implications that the State should 
    adopt with essentially identical language. The NRC has assigned a 
    Category B level of compatibility to the changes in Sec. 32.54.
        Category C means the provisions affect a program element, the 
    essential objectives of which should be adopted by the State to avoid 
    conflicts, duplications or gaps. The manner in which the essential 
    objectives are addressed need not be the same as NRC provided the 
    essential objectives are met. The NRC has assigned a Category C level 
    of compatibility to the changes in Secs. 20.1003 (Definition of 
    Individual monitoring devices), 20.2101, 20.2106, 20.2202, 39.33, and 
    39.71.
        Category D means the provisions are not required for purposes of 
    compatibility; however, if adopted by the State, they should be 
    compatible with NRC. The NRC has assigned a Category D level of 
    compatibility to the changes in Secs. 20.1101, 20.1206, 20.1501, 
    20.1502, 20.1903, 20.1906, 35.641, 35.643, and 36.23.
        Category H&S means the provisions are not required for 
    compatibility; however, they do have particular health and safety 
    significance. The State should adopt the essential objectives of such 
    provisions in order to maintain an adequate program. The Category H&S 
    has been assigned to the changes in Secs. 20.1101, 20.1501, 20.1502, 
    20.1906, and 36.23.
    
    VI. Environmental Impact: Categorical Exclusion
    
        The NRC has determined that this final rule is the type of action 
    described in the categorical exclusion in 10 CFR 51.22(c)(2). 
    Therefore, neither an environmental impact statement nor an 
    environmental assessment has been prepared for this final rule.
    
    VII. Paperwork Reduction Act Statement
    
        This final rule amends information collection requirements that are 
    subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
    seq.). These requirements were approved by the Office of Management and 
    Budget, approval number 3150-0014, 3150-0001, 3150-0010, 3150-0158, and 
    3150-0130.
        Because the rule will reduce existing information collection 
    requirements by eliminating written incident reports and allowing 
    licensees to submit incident reports by telephone, the public burden 
    for this information collection is expected to be reduced by 
    approximately 250 hours per year over the entire industry. This 
    reduction includes the time required for reviewing instructions, 
    searching existing data sources, gathering and maintaining the data 
    needed, and completing and reviewing the information collection. Send 
    comments on any aspect of this information collection, including 
    suggestions for further reducing the burden, to the Information and 
    Records Management Branch (T-6F33), U.S. Nuclear Regulatory Commission, 
    Washington, DC 20555-0001, or by Internet electronic mail at 
    [email protected]; and to the Desk Officer, Office of Information and 
    Regulatory Affairs, NEOB-10202 (3150-0014), Office of Management and 
    Budget, Washington, DC 20503.
    
    Public Protection Notification
    
        If a document used to impose an information collection does not 
    display a currently valid OMB control number, the NRC may not conduct 
    or sponsor, and a person is not required to respond to, the information 
    collection.
    
    VIII. Regulatory Analysis
    
        This final rule makes minor correcting and clarifying amendments to 
    the requirements in 10 CFR Part 20 and conforms 10 CFR Parts 32, 35, 
    36, and 39 to 10 CFR Part 20. The final rule imposes one-time only, 
    minor additional costs at a maximum of $12,000 per licensee site in the 
    nuclear power industry for changing written procedures and possibly 
    training associated with correcting and clarifying
    
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    several definitions and minor changes to requirements addressing 
    standards for protection against radiation. It is expected that the 
    cost for other classes of licensees may be substantially less. The NRC 
    staff believes that the cost of revising procedures will be small and 
    is offset by the benefits of improved clarity and consistency in the 
    NRC's regulations.
        The final amendments include a conforming change in 10 CFR Part 36 
    to make the posting requirements for a panoramic irradiator consistent 
    with posting requirements in 10 CFR Part 20 for high or very high 
    radiation areas. Licensees in compliance with the Part 20 posting 
    requirements are also in compliance with Part 36 posting requirements; 
    therefore, this is a conforming change to make the language in the two 
    sections consistent, and no impact is expected to result from this 
    action.
        The final amendments also result in a minor reduction in burden to 
    licensees by eliminating written incident reports and allowing 
    licensees to submit incident reports by telephone. This change is 
    consistent with the Paperwork Reduction Act of 1995.
        The final requirements also waive posting requirements in 
    teletherapy rooms in hospitals to remove the unsettling effects that 
    the signs may have on patients. There would be no decrease in safety 
    because the safety precautions in 10 CFR Part 35 are considered 
    adequate to protect individuals from inadvertent exposure to radiation, 
    and this change may have a beneficial effect on patients.
        In addition, these final amendments change the deep dose equivalent 
    monitoring requirements for minors and pregnant women from one-tenth of 
    the applicable limit or 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) for the 
    following reasons:
        (1) The value is consistent with the 100 mrem (1 mSv) training 
    criterion in the recently revised 10 CFR 19.12 (60 FR 36038; July 13, 
    1995).
        (2) The value is consistent with the 0.1 rem (1 mSv) dose limit for 
    members of the public in 10 CFR 20.1301(a). There is little benefit to 
    require monitoring of workers who are expected to receive less dose 
    than is permitted for members of the public.
        No cost is associated with this rule change, and there may be some 
    reduction in burden. However, any reduction is likely to be small 
    because many factors impact the decision as to whether personal 
    dosimeters will be worn and it is impossible to assess the extent of 
    this burden reduction.
        This discussion constitutes the regulatory analysis for this final 
    rule.
    
    IX. Backfit Analysis
    
        The NRC has determined that the backfit rules in Secs. 50.109, 
    72.62, and 76.76 do not apply to this final rule and, therefore, that a 
    backfit analysis is not required for this final rule because these 
    amendments do not involve any provision that would impose backfits as 
    defined in Secs. 50.109(a)(1), 72.62(a), and 76.76(a).
    
    Small Business Regulatory Enforcement Act
    
        In accordance with the Small Business Regulatory Enforcement 
    Fairness Act of 1996, the NRC has determined that this action is not a 
    ``major rule'' and has verified this determination with the Office of 
    Information and Regulatory Affairs, Office of Management and Budget.
    
    List of Subjects
    
    10 CFR Part 20
    
        Byproduct material, Criminal penalties, Licensed material, Nuclear 
    materials, Nuclear power plants and reactors, Occupational safety and 
    health, Packaging and containers, Radiation protection, Reporting and 
    recordkeeping requirements, Special nuclear material, Source material, 
    Waste treatment and disposal.
    
    10 CFR Part 32
    
        Byproduct material, Criminal penalties, Labeling, Nuclear 
    materials, Radiation protection, Reporting and recordkeeping 
    requirements.
    
    10 CFR Part 35
    
        Byproduct material, Criminal penalties, Drugs, Health facilities, 
    Health professions, Medical devices, Nuclear materials, Occupational 
    safety and health, Radiation protection, Reporting and recordkeeping 
    requirements.
    
    10 CFR Part 36
    
        Byproduct material, Criminal penalties, Nuclear materials, Oil and 
    gas exploration--well logging, Reporting and recordkeeping 
    requirements, Scientific equipment, Security measures, Source material, 
    Special nuclear material.
    
    10 CFR Part 39
    
        Byproduct material, Criminal penalties, Nuclear materials, Oil and 
    gas exploration--well logging, Reporting and recordkeeping 
    requirements, Scientific equipment, Security measures, Source material, 
    Special nuclear material.
    
        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. 552 and 553, the NRC is adopting 
    the following amendments to 10 CFR Parts 20, 32, 35, 36, and 39.
    
    PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
    
        1. 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, sec. 1701, 
    106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 
    2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 
    Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
    
        2. In Sec. 20.1003, the definition of Eye dose equivalent is 
    removed. The definition of Lens dose equivalent (LDE) is added in 
    alphabetical order, and the definitions of Declared pregnant woman, 
    High radiation area, Individual monitoring devices, and Very high 
    radiation area are revised to read as follows:
    
    
    Sec. 20.1003  Definitions.
    
    * * * * *
        Declared pregnant woman means a woman who has voluntarily informed 
    the licensee, in writing, of her pregnancy and the estimated date of 
    conception. The declaration remains in effect until the declared 
    pregnant woman withdraws the declaration in writing or is no longer 
    pregnant.
    * * * * *
        High radiation area means an area, accessible to individuals, in 
    which radiation levels from radiation sources external to the body 
    could result in an individual receiving a dose equivalent in excess of 
    0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source 
    or 30 centimeters from any surface that the radiation penetrates.
    * * * * *
        Individual monitoring devices (individual monitoring equipment) 
    means devices designed to be worn by a single individual for the 
    assessment of dose equivalent such as film badges, thermoluminescence 
    dosimeters (TLDs), pocket ionization chambers, and personal (``lapel'') 
    air sampling devices.
    * * * * *
        Lens dose equivalent (LDE) applies to the external exposure of the 
    lens of the eye and is taken as the dose equivalent at a tissue depth 
    of 0.3 centimeter (300 mg/cm2).
    * * * * *
    
    [[Page 39482]]
    
        Very high radiation area means an area, accessible to individuals, 
    in which radiation levels from radiation sources external to the body 
    could result in an individual receiving an absorbed dose in excess of 
    500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1 
    meter from any surface that the radiation penetrates.
    * * * * *
        3. In Sec. 20.1101, paragraph (b) is revised to read as follows:
    
    
    Sec. 20.1101  Radiation protection programs.
    
    * * * * *
        (b) The licensee shall 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).
    * * * * *
        4. In Sec. 20.1201, paragraphs (a)(2)(i) and (c) are revised to 
    read as follows:
    
    
    Sec. 20.1201  Occupational dose limits for adults.
    
        (a) * * *
        (2) * * *
        (i) A lens dose equivalent of 15 rems (0.15 Sv), and
    * * * * *
        (c) The assigned deep-dose equivalent and shallow-dose equivalent 
    must be for the part of the body receiving the highest exposure. The 
    deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent 
    may be assessed from surveys or other radiation measurements for the 
    purpose of demonstrating compliance with the occupational dose limits, 
    if the individual monitoring device was not in the region of highest 
    potential exposure, or the results of individual monitoring are 
    unavailable.
    * * * * *
        5. In Sec. 20.1203, the introductory text is revised to read as 
    follows:
    
    
    Sec. 20.1203  Determination of external dose from airborne radioactive 
    material.
    
        Licensees shall, when determining the dose from airborne 
    radioactive material, include the contribution to the deep-dose 
    equivalent, lens dose equivalent, and shallow-dose equivalent from 
    external exposure to the radioactive cloud (see appendix B to part 20, 
    footnotes 1 and 2).
    * * * * *
        6. In Sec. 20.1206, paragraph (a) is revised to read as follows:
    
    
    Sec. 20.1206  Planned special exposures.
    
    * * * * *
        (a) The licensee authorizes a planned special exposure only in an 
    exceptional situation when alternatives that might avoid the dose 
    estimated to result from the planned special exposure are unavailable 
    or impractical.
    * * * * *
        7. In Sec. 20.1208, the section heading, paragraph (a), the 
    introductory text of paragraph (c), and paragraphs (c)(2) and (d) are 
    revised to read as follows:
    
    
    Sec. 20.1208  Dose equivalent to an embryo/fetus.
    
        (a) The licensee shall ensure that the dose equivalent to the 
    embryo/fetus during the entire pregnancy, due to the occupational 
    exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). 
    (For recordkeeping requirements, see Sec. 20.2106.)
    * * * * *
        (c) The dose equivalent to the embryo/fetus is the sum of--
    * * * * *
        (2) The dose equivalent to the embryo/fetus resulting from 
    radionuclides in the embryo/fetus and radionuclides in the declared 
    pregnant woman.
        (d) If the dose equivalent to the embryo/fetus is found to have 
    exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, 
    by the time the woman declares the pregnancy to the licensee, the 
    licensee shall be deemed to be in compliance with paragraph (a) of this 
    section if the additional dose equivalent to the embryo/fetus does not 
    exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
        8. In Sec. 20.1501, paragraphs (a)(2)(i) and (a)(2)(iii) are 
    revised to read as follows:
    
    
    Sec. 20.1501  General.
    
        (a) * * *
        (2) * * *
        (i) The magnitude and extent of radiation levels; and
    * * * * *
        (iii) The potential radiological hazards.
    * * * * *
        9. In Sec. 20.1502, paragraph (a)(3) is redesignated as (a)(4) and 
    new paragraphs (a)(3) and (b)(3) are added; and the introductory text 
    of paragraph (a) and paragraphs (a)(2), (b)(1), and (b)(2) are revised 
    to read as follows:
    
    
    Sec. 20.1502  Conditions requiring individual monitoring of external 
    and internal occupational dose.
    
    * * * * *
        (a) Each licensee shall monitor occupational exposure to radiation 
    from licensed and unlicensed radiation sources under the control of the 
    licensee and shall supply and require the use of individual monitoring 
    devices by--
    * * * * *
        (2) Minors likely to receive, in 1 year, from radiation sources 
    external to the body, a deep dose equivalent in excess of 0.1 rem (1 
    mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a 
    shallow dose equivalent to the skin or to the extremities in excess of 
    0.5 rem (5 mSv);
        (3) Declared pregnant women likely to receive during the entire 
    pregnancy, from radiation sources external to the body, a deep dose 
    equivalent in excess of 0.1 rem (1 mSv); 2 and
    ---------------------------------------------------------------------------
    
        \2\ All of the occupational doses in Sec. 20.1201 continue to be 
    applicable to the declared pregnant worker as long as the embryo/
    fetus dose limit is not exceeded.
    ---------------------------------------------------------------------------
    
    * * * * *
        (b) * * *
        (1) Adults likely to receive, in 1 year, an intake in excess of 10 
    percent of the applicable ALI(s) in table 1, Columns 1 and 2, of 
    appendix B to Secs. 20.1001-20.2402;
        (2) Minors likely to receive, in 1 year, a committed effective dose 
    equivalent in excess of 0.1 rem (1 mSv); and
        (3) Declared pregnant women likely to receive, during the entire 
    pregnancy, a committed effective dose equivalent in excess of 0.1 rem 
    (1 mSv).
        10. In Sec. 20.1903, a new paragraph (d) is added to read as 
    follows:
    
    
    Sec. 20.1903  Exceptions to posting requirements.
    
    * * * * *
        (d) Rooms in hospitals or clinics that are used for teletherapy are 
    exempt from the requirement to post caution signs under Sec. 20.1902 
    if--
        (1) Access to the room is controlled pursuant to 10 CFR 35.615; and
        (2) Personnel in attendance take necessary precautions to prevent 
    the inadvertent exposure of workers, other patients, and members of the 
    public to radiation in excess of the limits established in this part.
        11. In Sec. 20.1906, the introductory text of paragraph (d) is 
    revised to read as follows:
    
    
    Sec. 20.1906  Procedures for receiving and opening packages.
    
    * * * * *
        (d) The licensee shall immediately notify the final delivery 
    carrier and the NRC Operations Center (301-816-5100), by telephone, 
    when--
    * * * * *
        12. In Sec. 20.2101, paragraph (b) is redesignated as paragraph 
    (c), paragraph (c) is redesignated as paragraph (d) and revised, and a 
    new paragraph (b) is added to read as follows:
    
    [[Page 39483]]
    
    Sec. 20.2101  General provisions.
    
    * * * * *
        (b) In the records required by this part, the licensee may record 
    quantities in SI units in parentheses following each of the units 
    specified in paragraph (a) of this section. However, all quantities 
    must be recorded as stated in paragraph (a) of this section.
    * * * * *
        (d) The licensee shall make a clear distinction among the 
    quantities entered on the records required by this part (e.g., total 
    effective dose equivalent, shallow-dose equivalent, lens dose 
    equivalent, deep-dose equivalent, committed effective dose equivalent).
        13. In Sec. 20.2106, paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) 
    are revised to read as follows:
    
    
    Sec. 20.2106  Records of individual monitoring results.
    
        (a) * * *
        (1) The deep-dose equivalent to the whole body, lens dose 
    equivalent, shallow-dose equivalent to the skin, and shallow-dose 
    equivalent to the extremities;
        (2) The estimated intake of radionuclides (see Sec. 20.1202);
        (3) The committed effective dose equivalent assigned to the intake 
    of radionuclides;
        (4) The specific information used to assess the committed effective 
    dose equivalent pursuant to Sec. 20.1204(a) and (c), and when required 
    by Sec. 20.1502;
    * * * * *
        14. In Sec. 20.2202, paragraphs (a)(1)(ii), (b)(1)(ii), and (d)(2) 
    are revised to read as follows:
    
    
    Sec. 20.2202  Notification of incidents.
    
        (a) * * *
        (1) * * *
        (ii) A lens dose equivalent of 75 rems (0.75 Sv) or more; or
        (b) * * *
        (1) * * *
        (ii) A lens dose equivalent exceeding 15 rems (0.15 Sv); or
        (d) * * *
        (2) All other licensees shall make the reports required by 
    paragraphs (a) and (b) of this section by telephone to the NRC 
    Operations Center (301) 816-5100.
    * * * * *
    
    PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
    CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
    
        15. The authority citation for Part 32 continues to read as 
    follows:
    
        Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
    as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
    1242, as amended (42 U.S.C. 5841).
    
    
    Sec. 32.54  [Amended]
    
        16. In Sec. 32.54, paragraph (a) is amended by revising the 
    reference to``Sec. 20.203(a)'' to read ``Sec. 20.1901.''
    
    PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
    
        17. The authority citation for Part 35 continues to read as 
    follows:
    
        Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
    as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
    1242, as amended (42 U.S.C. 5841).
    
        18. In Sec. 35.641, paragraphs (a)(2)(i) and (a)(2)(ii) are revised 
    to read as follows:
    
    
    Sec. 35.641  Radiation surveys for teletherapy facilities.
    
        (a) * * *
        (2) * * *
        (i) Radiation dose rates in restricted areas are not likely to 
    cause any occupationally exposed individual to receive a dose in excess 
    of the limits specified in Sec. 20.1201 of this chapter; and
        (ii) Radiation dose rates in controlled or unrestricted areas are 
    not likely to cause any individual member of the public to receive a 
    dose in excess of the limits specified in Sec. 20.1301 of this chapter.
    * * * * *
        19. In Sec. 35.643, paragraphs (a) introductory text and (a)(1) are 
    revised to read as follows:
    
    
    Sec. 35.643  Modification of teletherapy unit or room before beginning 
    a treatment program.
    
        (a) If the survey required by Sec. 35.641 indicates that any 
    individual member of the public is likely to receive a dose in excess 
    of the limits specified in Sec. 20.1301 of this chapter, the licensee 
    shall, before beginning the treatment program:
        (1) Either equip the unit with stops or add additional radiation 
    shielding to ensure compliance with Sec. 20.1301 of this chapter.
    * * * * *
    
    PART 36--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
    
        20. The authority citation for Part 36 continues to read as 
    follows:
    
        Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
    953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 
    U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
    amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
    5841, 5842, 5846).
    
        21. In Sec. 36.23, paragraph (g) is revised to read as follows:
    
    
    Sec. 36.23  Access control.
    
    * * * * *
        (g) Each entrance to the radiation room of a panoramic irradiator 
    and each entrance to the area within the personnel access barrier of an 
    underwater irradiator must be posted as required by 10 CFR 20.1902. 
    Radiation postings for panoramic irradiators must comply with the 
    posting requirements of 10 CFR 20.1902, except that signs may be 
    removed, covered, or otherwise made inoperative when the sources are 
    fully shielded.
    * * * * *
    
    PART 39--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL 
    LOGGING
    
        22. The authority citation for Part 39 continues to read as 
    follows:
    
        Authority: Secs. 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 
    188, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as 
    amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2073, 2077, 
    2092, 2093, 2095, 2099, 2111, 2112, 2201, 2232, 2233, 2236, 2282); 
    secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 
    1246 (42 U.S.C. 5841, 5842, 5846).
    
        23. In Sec. 39.33, paragraph (a) is revised to read as follows:
    
    
    Sec. 39.33  Radiation detection instruments.
    
        (a) The licensee shall keep a calibrated and operable radiation 
    survey instrument capable of detecting beta and gamma radiation at each 
    field station and temporary jobsite to make the radiation surveys 
    required by this part and by part 20 of this chapter. To satisfy this 
    requirement, the radiation survey instrument must be capable of 
    measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 
    mrem) per hour.
    * * * * *
    
    
    Sec. 39.71  [Amended]
    
        24. In Sec. 39.71, paragraph (b) is amended by revising the 
    reference to ``Sec. 20.3'' to read ``Sec. 20.1003.''
    
        Dated at Rockville, Maryland, this 9th day of July 1998.
    
        For the Nuclear Regulatory Commission.
    L. Joseph Callan,
    Executive Director for Operations.
    [FR Doc. 98-19540 Filed 7-22-98; 8:45 am]
    BILLING CODE 7590-01-P
    
    
    

Document Information

Effective Date:
8/24/1998
Published:
07/23/1998
Department:
Nuclear Regulatory Commission
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-19540
Dates:
This regulation becomes effective on August 24, 1998.
Pages:
39477-39483 (7 pages)
RINs:
3150-AF46: Minor Corrections and Clarifying Changes and a Minor Policy Change
RIN Links:
https://www.federalregister.gov/regulations/3150-AF46/minor-corrections-and-clarifying-changes-and-a-minor-policy-change
PDF File:
98-19540.pdf
CFR: (21)
10 CFR 20.1902(d)
10 CFR 19.12
10 CFR 20.1003
10 CFR 20.1101
10 CFR 20.1201
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