Regulatory Guide 8.11: Difference between revisions

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{{Adams
{{Adams
| number = ML003739450
| number = ML15054A618
| issue date = 06/30/1974
| issue date = 06/30/2015
| title = Applications of Bioassay for Uranium
| title = Applications of Bioassay for Uranium
| author name =  
| author name = Sun C
| author affiliation = NRC/RES
| author affiliation = NRC/RES/DSA
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person =  
| contact person = Karagiannis H
| document report number = RG-8.11
| case reference number = RG 8.11
| document report number = DG-8054
| package number = ML15054A611
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 31
| page count = 11
}}
}}
{{#Wiki_filter:June 1974 U.S. ATOMIC ENERGY COMMISSION
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION  
                                    REGULATORY
July 2015 OFFICE OF NUCLEAR REGULATORY RESEARCH
                                    DIRECTORATE OF REGULATORY STANDARDS
Revision 1 REGULATORY GUIDE
                                                                                                                                          GUIDE
 
                                                                    REGULATORY GUIDE 8.11 APPLICATIONS OF BIOASSAY FOR URANIUM
Technical Lead Casper Sun 
 
Written suggestions regarding this guide or development of new guides may be submitted through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.
 
Electronic copies of this regulatory guide, previous versions of this guide, and other recently issued guides are available through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory guide is also available through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html,  under ADAMS Accession No. ML15054A618. The regulatory analysis may be found in ADAMS
under Accession No. ML14133A612 and the staff responses to the public comments on DG-8054 may be found under ADAMS Accession No.
 
ML15014A269.
 
REGULATORY GUIDE 8.11 (Draft was issued as DG-8054, dated September 2014)
 
APPLICATIONS OF BIOASSAY FOR URANIUM  


==A. INTRODUCTION==
==A. INTRODUCTION==
DAC. It must be demonstrated that air sample results used for this purpose are representative of personnel Section 20.108, "Orders Requiring Furnishing of                                        exposure.
Purpose 


Bioassay Services," of 10 CFR Part 20, "Standards for Protection Against Radiation," states that the Atomic                                      3. Under the minimum program, bioassays are per Energy Commission may incorporate in any license                                            formed semiannually or annually for all workers to provisions requiring bioassay measurements as necessary                                    monitor the accumulatiorý of uranium in the lung and or desirable to aid in determining the extent of an bone. More frequent bioassays are performed for a individual's exposure to concentrations of radioactive                                      sample of the most highly exposed workers as a check material. As used by the Commission, the term bioassay on the air sampling program; these bioassays are per includes in vivo measurements as well as measurements formed at sufficient frequency to assure that a signifi of radioactive material in excreta. This guide provides cant single intake of uranium will be identified before criteria acceptable to the Regulatory staff for the biological elimination of the uranium renders the intake development and implementation of a bioassay program undetectable.
This regulatory guide (RG) describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for the development and implementation of a bioassay program for monitoring the intake of mixtures of uranium isotopes (U-234, U-235, and U-238) by occupationally exposed workers. This RG applies to holders of special nuclear material licenses under Title 10 of the Code of Federal Regulations (10 CFR), part 70, Domestic Licensing of Special Nuclear Material, (Ref. 1).    


for mixtures of the naturally occurring isotopes of uranium            U-234, U-235, and U-238. The guide is programmatic in nature and does not deal with labora                                        4. If a work area does not qualify for the minimum tory techniques and procedures. Uranium may enter the                                      program, bioassays in addition to the minimum program body through inhalation or ingestion, by absorption                                        are performed at increasingly higher frequencies, de through normal skin, and through lesions in the skin.                                      pending on the magnitude of air sample results.
Applicable Rules and Regulations


However, inhalation is by far the most prevalent mode of entry for occupational exposure. The bioassay pro                                        5. A model is used which correlates bioassay measure gram described in this guide is applicable to thi                                          ment results with radiation .dose or with uptake of inhalation of uranium and its compounds, but does not                                      uranium in the blood (chemical toxicity).
*
  include the more highly transportable compounds UF
10 CFR 20.1204(a), Determination of Internal Exposure (Ref. 2), states that each licensee shall, when required under 10 CFR 20.1502, Conditions Requiring Individual Monitoring of External and Internal Occupational Dose, take suitable and timely measurements of: (1) concentrations of radioactive materials in air in work areas, (2) quantities of radionuclides in the body,
                                                                                    6      6. Actions are specified, depending upon the dose or and U0 2 F 2 .
(3) quantities of radionuclides excreted from the body, or (4) combinations of these measurements.
                                                                                            uptake indicated by bioassay results. These actions are corrective in nature and are intended to ensure adequate Significant features of the bioassay program devel                                    worker protection.


oped in this guidb ar listed below:
*
                                                                                            7. Guidance is referenced for the difficult task of
10 CFR 20.1201(e), Occupational Dose Limits for Adults, requires licensees to limit the soluble uranium intake by an individual to 10 milligrams per week in consideration of the chemical toxicity.
  1. A bioassay program                is necessary if air sampling is                      determining, from individual data rather than models, necessary for purposes                of personnel protection. The extent of the bioassay                                                                      the quantity of uranium in body organs, the rate of program is determined by the                        elimination, and the dose commitment.


magnitude of air sample              results.
Related Rules and Regulations


2. A work area qualifies for the "minimum bioassay                                              This bioassay program encourages improvement in program" so long as the quarterly average of air sample                                    the confinement of uranium and in air, sampling tech results is <1% of the Derived Air Concentration (DAC)                                      niques by specifying bioassays only to-ihe extent that confinement and air sampling can not be entirely relied and the maximum used to obtain the average is <25% of upon for personnel protection.
*
10 CFR 20.1703(i), Use of Individual Respiratory Protection Equipment, allows for an estimated dose based upon an assumption that the concentration of radioactive material that is inhaled when respirators are worn is equal to the ambient concentration in air without respiratory protection divided by the assigned protection factor. This regulation requires that if the dose is later found to be greater than the estimated dose, the corrected value must be used; if the dose is later found to be less than the estimated dose, the corrected value may be used.


USAEC REGULATORY GUIDES
RG 8.11, Rev. 1, Page 2
                                                                                        C*0vPp of piutiishedguidtosmay be obtained by requet indicating the divisions Regulatory Guides we issued to describe and make available                                  testirend to the US. Atomic Energy Condmmd.on Washington D.C.


to the public                                                                                    20*45, rnelhods acceptable to ite AEC Regulatory staff of impmenmeting                        Attention.    Director of Regulatory Stan<erde. Comments and sugestions specific parts of  irorsrovesents in t hes guides ae encouraged                                        for the Cominrnstion's regulations, to delineate lechniques, -ed by                                                                             and Should be sent to the Secretary the Staff in  of the Commetuon, US. Atomic Energv Ielliusting specific problems or postulated accidents. or to provide                                                                    Commission Wahington, D.C. 20545.
*
10 CFR 20.2202, Notification of Incidents, sets forth the criteria for those events involving byproduct, source, or special nuclear material possessed by the licensee that require either immediate notification or notification within 24 hours.


guidance to   Attention: Chief Public Proceedings aplitants Reglatory Guides ore not substitutes for regulations                                                                    Staff.
*
10 CFR 20.2203, Reports of Exposure, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Constraints or Limits, sets forth the criteria for submitting a written report to the NRC on a reportable event.


with them is not required. Methods and solutions different from      and  complianci thoKiat set    nm The    uide* are issued in the following ten the guidlsl will be acscaptable if they provide a basts for the findings                                                              broad divisions:
*
                                                                          requisite to the iesuance or continuance of a permit or *icense by the Commission.
10 CFR 20.2205, Reports to individuals of exceeding dose limits, provides that when a licensee is required by 10 CFR 20.2203 or 2204 to send a report to the Commission of any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide the individual a report of the exposure data included in the report to the Commission.


===1. Power Reactors===
*
10 CFR part 70, Domestic Licensing of Special Nuclear Material, establishes procedures and criteria for the issuance of licenses to receive title to, own, acquire, deliver, receive, possess, use, and transfer special nuclear material and provide for the terms and conditions upon which the Commission will issue such licenses.


===6. Products===
Related Guidance
                                                                                          2.  A emrch and Test Reactors
                                                                                                                                          7. Transportation Published *uides will be revised periodicalt-.i    at apropr~ate, to accommodatei          3.  Fuels med Materials Facilities
                                                                                                                                          8. Occupation*l Health commnrs amtdto relfle new information or experience.                                      4.  Enronmental and Siting
                                                                                                                                          9, Antitrust Review S.  Meegesair and Plant Protection
                                                                                                                                        1


===0. General===
*
RG 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program (Ref. 3), provides methods acceptable to the NRC staff for estimating intake of radionuclides using bioassay measurements.
 
*
RG 8.22, Bioassay at Uranium Mills (Ref. 4), describes a bioassay program acceptable to the NRC staff for uranium mills (and applicable portions of uranium conversion facilities where the possibility of exposure to yellowcake dust exists), including exposure conditions with and without the use of respiratory protection devices.
 
*
RG 8.25, Air Sampling in the Workplace (Ref. 5), provides guidance on air sampling in restricted areas of the workplace.
 
*
RG 8.30, Health Physics Surveys in Uranium Recovery Facilities (Ref. 6), provides guidance on health physics surveys that are acceptable to the NRC staff for protecting workers at uranium recovery facilities (e.g., uranium mills, in-situ leach facilities, ion exchange recovery facilities, heap leach facilities) from radiation and the chemical toxicity of uranium.
 
*
RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination)-Effluent Streams and the Environment (Ref. 7), provides quality assurance (QA) guidance on monitoring measurements that support the radiation and environmental protection programs.
 
*
The National Council on Radiation Protection and Measurements (NCRP) Report 161, Management of Persons Contaminated with Radionuclides (Ref. 8), provides guidance for emergency treatment if a severe intake of uranium substances were to occur.
 
RG 8.11, Rev. 1, Page 3
 
Purpose of Regulatory Guides 
 
The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the NRCs regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to licensees and applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance, continuance or amendment of a permit or license by the Commission.
 
Paperwork Reduction Act
 
This regulatory guide contains information collection requirements covered by 10 CFR part 20,
Standards for Protection Against Radiation, and 10 CFR part 70 Domestic Licensing of Special Nuclear Material, that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0014 and 3150-0009, respectively. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.


==B. DISCUSSION==
==B. DISCUSSION==
Maximum Permissible Annual Dose (MPAD)             The annual maximum occupational radiation          dose The topics treated in this guide include determining                  recommended by the ICRP for the body or part ul'
Reason for Revision
(1) whether bioassay procedures are necessary, (2) which                  the body.
 
RG 8.11 was issued in June 1974 to provide guidance to NRC licensees on methods the staff found acceptable to demonstrate compliance with the then-current version of NRCs radiation protection regulations in 10 CFR part 20. In a 1991 rulemaking (May 21, 1991; 56 FR 23360), the NRC
promulgated amendments to its 10 CFR part 20 regulations, including a renumbering of those regulations.
 
As such, this revision to the guide seeks to achieve alignment with the regulatory structure of 
10 CFR part 20 by updating the guides cross-references to the current 10 CFR part 20 regulations.
 
In addition, this revision identifies the bioassay interpretation methods described in NUREG/CR-4884, Interpretation of Bioassay Measurement (Ref. 9) and RG 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program, as being acceptable methods for the interpretation of bioassay data to estimate intakes and doses. This revision also approves for use certain sections of a voluntary consensus standard, namely, the American National Standards Institute/Health Physics Society (ANSI/HPS) N13.22-2013 standard, Bioassay Program for Uranium, (Ref.10) as a means for licensees to demonstrate compliance with the NRC regulations
10 CFR 20.1201(e) and 10 CFR 20.1204(a).  


bioassay techniques to use and how often, (3) who should participate, (4) the action to take as based on                Maximum Permissible Dose Commitment (MPDc)              I
Background This RG pertains to uranium bioassay programs in general; however, it does not address issues related to bioassay measurement techniques such as whole body counting and excreta bioassay sampling and measurements.
bioassay results, and (5) the particular results which                    A dose commitment numerically equivalent to the should initiate such action. Taken together, these topics                Maximum Permissible Annual Dose.


comprise an exposure control program. Technical bases for the criteria appearing in the guide are provided in                Measurement Sensitivity Limit The smallest quan
Specific information regarding uranium intake during mining (extracting natural uranium ore from the earth) and milling (leaching uranium from the ore and concentrating it to produce yellowcake, including UO2F2, ammonium diuranate ((NH4)2U2O7), uranyl peroxides (UO4*nH2O), and uranium trioxide (UO3)) can be found in RG 8.22, Bioassay at Uranium Mills.
"Applications of Bioassay for Uranium," WASH-1251,                       tity or concentration of radioactive material that which is available from the Superintendent of Docu                        can be measured with a specified degree of ments, U.S. Government Printing Office, Washington,                      accuracy and precision.


D.C. 20402.
RG 8.11, Rev. 1, Page 4


Nontransportable- Slowly removed from the pul After an exposure to uranium has occuired, the                        monary region of the lung by gradual dissolution difficult problems of estimating the quantity present in                .in extracellular fluids, or in particulate form by the body and the anticipated dose commitment arise.                       translocation to the GI tract, blood, or lymphatic This subject is treated in considerable detail in WASH                    system; Class (W), nontransportable dust with
Licensee determinations regarding participation in the uranium bioassay program should be based on estimates of the type and quantity of intakes that may occur using procedures that are expected to take place at each facility during the monitoring year. The program is confirmatory in that low or zero results may indicate that the measures in the workplace to control uranium materials are effective, and that no unexpected intakes have occurred. Based on operational experience, licensees may be able to justify adjustments in their bioassay program, such as a reduction in bioassay routine monitoring frequency, the inclusion of fewer workers in the bioassay program, or licensees may seek an alternative bioassay program.
1251.                                                                    50-day biological half-life in the lung. Class (Y),
                                                                          nontransportable dust with 500-day biological


==C. REGULATORY POSITION==
Harmonization with International Standards
half-life in the lung.


!. Special Terminology                                                Transportable- Dissolved upon contact with extra cellular fluids and translocated to the blood- Class Several of the terms used in this guide have been                    (D), transportable dust with rapid clearance from given special definitions and are listed in this section for              the lung.
The NRC has a goal of harmonizing its guidance with international standards, to the extent practical. The International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency (IAEA) have issued a significant number of standards, guidance and technical documents, and recommendations addressing good practices in most aspects of radiation protection. The guidance of this RG is generally consistent with the guidance in the following documents:


the convenience of the reader.
*
ICRP Publication 30, Limits for Intakes of Radionuclides by Workers (Ref. 11),


Uptake -- The quantity of radioactive material enter Bioassay - The determination of the kind, quantity                    ing the nose and/or mouth during inhalation that or concentration, and location of radioactive                      is not exhaled and enters extracellular fluids.
*
ICRP Publication 60, Recommendations of the International Commission on Radiological Protection (Ref. 12),


material in the human body by direct (in vivo)
*
      measurement or by analysis of materials excreted                w/o U-235        Percentage by weight of the isotope or removed from the body.                                        U-235 in a mixture of U--234, U-235, and U-238 (w/o U-235 in natural uranium is 0.72).
ICRP Publication 66, Human Respiratory Tract Model for Radiological Protection (Ref. 13),
    Derived Air Concentration (DAC) -- Equivalent to the concentrations listed in Appendix B to 10              2. Programmatic Guidance CFR Part 20.


The following programmatic guides are applicable Dowe Commitment (Dc) -- The total radiation dose where personnel are occupationally exposed to uranium equivalent to the body or specified part of the in respirable form and in sufficient quantity that body that will be received from an intake of measurements of uranium concentrations in air are radioactive material during the 50-year period considered to be necessary for the protection of workers following the intake.                                     in ccmpliance with Regulatory requirements, including license conditions.
*
ICRP Publication 68, Dose Coefficients for Intakes of Radionuclides by Workers (Ref. 14),  


Exposure - The product of the average concentration of radioactive material in air and the period of time during which an individual was exposed to               a. Basic Requirements and Minimum Capabilities that average concentration (jICi-hr/cc).
*
                                                                        The following guides establish basic requirements Intake - The quantity of radioactive material                and minimum capabilities which should he found in a entenng the nose and/or mouth during inhalation;          program for protection against internal exposure from the product of the exposure and the breathing              operations with uranium:
ICRP Publication 71, Age-Dependent Doses to Members of the Public from Intake of RadionuclidesPart 4 Inhalation Dose Coefficients (Ref. 15),
      rate.


(1) Responsibilities foi protection against ura In Vivo Measurements - Measurement of gamma or                nium contamination should be weil defined and under X-radiation emitted from radioactive material              stood by all personnel concerned and should be specified located within the body, for the purpose of               in direct;ves from management estimating the quantity of radioactive material                  (2) A comprehensive and technically sound protec present.                                                  tion program should be developed and implemented.
*
IAEA Safety Guide RS-G-1.2, Assessment of Occupational Exposure due to Intake of Radionuclides (Ref. 16), and  


8.11-2                                                              L
*
International Organization for Standardization (ISO/IEC) 17025, General requirements for the competence of testing and calibration laboratories (Ref. 17). The ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers consensus testing and calibration methods for QA.


(3) Personnel, space, equipment, and support              3. Operational Guidance resources should be provided as necessary to conduct the program.                                                             a. Criteria for Determining the Need for a Bioasay
The NRC encourages licensees to consult these and other international documents and implement good practices, where applicable, that are consistent with NRC regulations. It should be noted that some of the recommendations issued by these international organizations do not correspond to the requirements specified in the NRCs regulations. In all cases, the NRCs requirements take precedence.
      (4) An effective method of periodic internal audit Program of the protection program should be maintained.


(5) Before assigning employees to work in an area                Where air sampling is required for purposes of where exposure to uranium contamination may occur,              occupational exposure control, bioassay measurements action should be taken to ensure that facility and              are also needed (Table 1) The bioassay frequency equipment safeguards necessary for adequate radiation            should be determined by air sample results as averaged protection are present and operable, that the employees          over I quarter.
Documents Discussed in Staff Regulatory Guidance


are properly trained, that adequate procedures are prepared and approved, that an adequate surface and air                Testing should be performed to determine whether contamination survey capability exists, that a bioassay          awi sampling is representative of personnel exposures. Air program at least equivalent to the program described in          sample results which have been verified as representative this guide will be maintained, and that survey and              may be used to determine the quarterly average.
This regulatory guide endorses, in part, the use of one or more codes or standards developed by external organizations, and other third party guidance documents. These codes, standards and third party guidance documents may contain references to other codes, standards or third party guidance documents (secondary references). If a secondary reference has itself been incorporated by reference into NRC
regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in a regulatory guide as an acceptable


bioassay records will be kept.
RG 8.11, Rev. 1, Page 5


If the 1-quarter average does not exceed 10% of b. Bioassay Program                                          the appropriate Derived Air Concentration (DAC) from Appendix B to 10 CFR Part 20 and if the maximum In the development of a bioassay program the             result used in the calculation of the average does not following guides should be implemented:                        exceed 25% of DAC, only a minimum bioassay program is necessary (Table 2). If the 1-quarter average exceeds
approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC
      (1)  Necessity                                            10% DAC, or if the maximum result exceeds 25% of the DAC, additional bioassays are necessary (Table 3),
staff for meeting that regulatory requirement as described in the specific regulatory guide. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither a legally-binding requirement nor a generic NRC approved acceptable approach for meeting an NRC requirement. However, licensees and applicants may consider and use the information in the secondary reference, if appropriately justified, consistent with current regulatory practice, and consistent with applicable NRC requirements.
          The determination of the need for bioassay          except as noted below. Frequency criteria for both cases measurements should be based on air contamination              are discussed in Section C.3.c. The approach is illus monitoring results in accordance with criteria contained        trated in Figure 1.


in this guide.
C. STAFF REGULATORY GUIDANCE


The additional bioassays are not performed for a
The NRC staff considers certain sections of ANSI/HPS N13.22-2013, Bioassay Programs for Uranium, acceptable for use as stated in the staff regulatory positions listed below.
      (2) Preparatory Evaluation                              specific individual if the licensee can demonstrate that the air sampling system used to protect the individual is Before assigning an employee to work in an          adequate to detect any significant intake- and that area where substantial exposure to uranium contami              procedures exist for diagnostic bioassays following nants may occur, his condition with respect to radio            detection of an apparently large intake.


active material of similar chemical behavior previously deposited and retained in his body should be determined                The necessity for bioassay measurements may also and the necessity for work restrictions evaluated.            arise following an incident such as a fire, spill, equip ment malfunction, or other departure from normal
1.
      (3) Exposure Control                                    operations which caused, or could have caused, abnor mally high concentrations of uranium An air. Criteria for The bioassay program should include, as appro      determining this necessity are shown in Pigure 2. (The priate, capabilities for excreta analyses and in vivo          term "Early Information" refers to an instrumented air measurements, made separately or in combination at a          sampler with an alarm device.) Reliance cannot be sufficiently high frequency to assure that engineered          placed on nasal swab results from mouth breathers.


confinement and air and surface contamination surveys          bioassays should be performed.
Participation Criteria Licensees should ensure that the appropriate individuals are assigned on a scheduled basis (e.g.,
quarterly) to submit specimens for bioassay or to report for in-vivo measurements in the bioassay program. Decisions about which individuals should participate in bioassay programs should be based on the criteria described below: 


are adequate for employee protection. The program should include all potentially exposed employees.                     Special bioassay measurements should be per formed to evaluate the effectiveness of respiratory
a. individuals who could receive certain doses as stated in 10 CFR 20.1502(a) or (b); 
      (4) Diagnostic Evaluation                              protection devices. If an individual wearing a respiratory protection device is subjected to a concentration of The bioassay program should include capabili        transportable uranium in air within a period of I week, ties for excreta analyses and in vivo measurements as          such that his exposure with no respiratory protection necessary to estimate the quantity of uranium deposited        device would have exceeded 40 x DAC ,Ci-hr/cc, in the body and/or in affected organs and the rate of          urinalysis should be performed to determine the result elimination from the body and/or affected organs.              ing actual uranium uptake. If an individual wearing a
                                                        8.11-3


TABLE I
b. individuals who work with uranium or who are close enough to the chemical process using uranium that exposure and intake is possible (e.g., within a few meters and in the same room as the worker handling the radioactive material); or
                                    SELECTION OF BIOASSAY MEASUREMENT TECHNIOUES
                                                            Transportable                        Non transportable Purpose                              Compounds                              Compounds Choice of Measurement
                                                                                      1st                2nd'                  3rd Preparatory Evaluationb                                            uc                ivc                  fr                    u Exposure Control Check on Air Sampling Program                                    u                iv                    f                    u Monitoring of Lung Burden Buildup                              -                  iv                    f                    u Monitoring of Bone Burden Buildup                              u                  u Detection of Unsuspected Intake                                  u                iv                  f Diagnostic Evaluation                                              u                  iv                  f                    u Work Restriction Removal                                            i                iv                    f                    u alf for any reason air sampling is not adequately effective, and the appearance of urinary uranium is long delayed by extreme nontransportability, the buildup of uranium in the lung pmay continue undetected until a positive in vivo result is obtained. Fecal analysis is an excellent and highly recommended early indicator in such cases. Fecal analysis should be considered if in vivo measurements are too infrequent to permit early identification of an unfavorable trend.


bDiagnostic evaluation necessary if results are positive.
c. individuals described in Section 5 (Selection of Individuals for Bioassay) of ANSI/HPS N13.22-2013 and individuals who work under the specified conditions listed in Table 1 (Implementation Levels: Mass or Activity Levels Above Which at Least Minimum Uranium Bioassay Program Shall be Implemented) of ANSI/HPS N13.22-2013.


Cu, urinalysis; f, fecal analysis; iv. in vivo.
2.


respiratory protection device is subjected to a concen                  would also aid in estimating the retention function and tration of nontranrsportable uranium in air within a                    dose commitment. Work restriction removal refers to period of 13 weeks, such that his exposure with no                      bioassays performed for employees who, because of past respiratory protection device would have exceeded                      depositions of radionuclides, have been restricted by
Conditions under which Bioassay Should Be Performed 
520 x DAC jiCi-hr/cc, the resulting actual uranium                      management in their work involving exposure to radio deposition in the lung should be determined using in                    active material until the magnitude of such depositions is vivo measurements and/or fecal analyses. These special                  reduced sufficiently to permit the removal of these work bioassay procedures should also be conducted if for any                restrictions.


reason the magnitude of the exposure (with no respira tory protection device) is unknown.                                        c. Selection of Measurement Frequency b. Selection of Measurement Techniques                                      Acceptable frequencies for the minimum bioassay program are given in Table 24Table 3 gives acceptable The appropriate selection of bioassay techniques                frequencies when additianal bioassay measurements are appears in Table 1. Preparatory evaluation refers to                    necessary to detect unsuspected single intakes, unless the bioassays performed for job applicants or existing                      measurement capability is the limiting factor. Figures 3 employees prior to an assignment involving potential                    through 7 present the maximum time between measure exposure to uranium. Exposure control refers to bio                    ments based on measurement sensitivity considerations;
Licensees should ensure that bioassays are performed for appropriate conditions. Section 3 (Establishing the Need for an Internal Dosimetry Program) of ANSI/HPS N13.22-2013 describes acceptable conditions under which a uranium bioassay should be performed.
assays performed to assure that engineered confinement                  the figures should be used to determine the measure and the air sampling program are sufficiently effective in              ment frequency unless the interval specified in Table 3 is the control and evaluation of exposures. Diagnostic                    shorter. The Class (W) curve in Figure 5 may be used for evaluation refers to bioassays performed following a                    Class (Y) materials if it is known that Class (D) or Class known significant exposure. These evaluations are per                  (W) materials are present.


formed to determine the location and magnitude of uranium deposition, which would in turn aid in deter                          Table 2 specifies, for the minimum program, mining whether therapeutic procedures are indicated and                semiannual or annual bioassays for monitoring the whether work restrictions are necessary. The evaluations                accumulation of uranium in the lung and bone, plus
3.
                                                                8.11-4


(
Types of Bioassay Monitoring that Should Be Performed
                                                                                              TABLE 2 BIOASSAY FREQUENCY FOR EXPOSURE CONTROL
                  Program                                  Objective                        Dust              Measurement                                  Frequency Classification          Techniquea Check on air sampling                        (D)                        u            Use Figures 3 and 4 program and on con-                    (W)                      iv            Use Figure 6 finement procedures                    (Y)                        iv            Semiannual Minimum"                                  and equipment.


Adequate if                          Monitor lung burden                          (W)                      iv            AnnualF
Licensees should ensure that the types of monitoring implemented by the bioassay program are appropriate for the types of material present at the licensees facility. For example, inhaled materials of different lung classes will likely call for different monitoring techniques. The procedures and methods described in ANSI/HPS N13.22-2013 are considered acceptable for selecting and implementing the appropriate monitoring techniques.
        QA < I/ I 0DA(                            buildup.                                 (Y)                      iv            Serruannualc and M < 1/4 DAC
                                              Monitor bone burden                          (D)                        u            Semiannual buildup.                                (W)                        u            Semiannual (Y)                        u            Class (D) or Class (W) Not Present, Annuald (Y)                        u            Class (D) or Class (W) Present, Semiannuald Additional                            Detect unsuspected                            (D)                        u            Use Table 3e
00                                                  intake.                                  (W)                  iv, f, or u        Use Table 3 e Acceptable it                                                                      (Y)                  iv, f. or u        Use Table 3e QA > 1/10 DAC
        and/or M > 1/4 DAC
    aiv, n vivo; u, urinalysis; f, fecal analysis.


bQA, quarterly average of air sample results; M, maximum result used to determine QA
4.
    CThese frequencies are applicable if no individuals are near work restriction limits. Quarterly or even monthly iv may become necessary as workers approach these limits dSpecial urinalysis should be performed each time exposure to new Class (Y) material begins to determine if more transportable component is present.


eThese measurements are additional to those listed above for the minimum program. If it is demonstrated that air sampling provided for a specific individual is adequate to detect any sigmficant intake and that procedures exist for diagnostic bioassays following detection of an apparently large intake, these additional measurements need not be performed.
Bioassay Frequency


TABLE 3 FAEQUENCYa FOR ADDITIONAL BIOASSAYS BASED ON CONCENTRATION OR EXPOSURE
In any particular facility, the frequency of bioassays should be based on estimates of the type and quantity of intakes that are likely to occur during the monitoring year.
QA      Most recent quarterly average of concentration or most recent quarterly average of weekly exposures M        Maximum result used in the calculation of the quarterly average u        urinalysis iv    -  it vivo Multiply numbers in first column by DAC pCi/cc or by 40 DAC pCi-hr/cc. Frequencies are given in bioassaysper year at equally spaced intervals.


Air Sample Results                          Class (D)                          Class(W)                        Class (Y)
RG 8.11, Rev. 1, Page 6
                                                  u                        U                iv              ub              iv O<QA< 1/10
1/4<M< I                                                                    2                1              2 I <M< 10                                          4                        4                2              4                2
10<M                                            12                        12                4              12                4 I/i0<QA< 1/4
0<M< I                                                                      2                1              4 I <M<10                                          4                        4                2              12                4
10< M                                          12                        12                4            26                4
1/4<QA< 1/2 C<M< I                                                                      4                2                                4
                                                  2c
                                                                                                            12 i<M< !0                                          4                        12                4            26                4 ii < M                                        12                        26                12            52              12
  1i2<QA< I
0<M< 10                                        12                        26                12            26              12
  10<M                                          26                        52                12            52              12 a Low frcqucncic&#xfd; indicated may be precluded by measurement capability limitations: see Figures 3 through 7 bAppicable if Class (D) or Class (W) materials are known to be present;convert 52 and 26 to 12 if they are not present. Fecal analysis may be substituted for urinalysis.


c Frequency possible only for high w/o U-235; naturally occurring urinary uranium prohibits detection otherwise.
The bioassay frequencies for routine sampling, as well as for bioassays in other situations, that are described in Section 4.2 (Frequencies) of ANS/HPS N13.22-2013, are acceptable. If special circumstances exist at the licensees facility, a submittal should be provided to NRC for review and assessment of the proposed frequencies. Table 8 of ANSI/HPS N13.22-2013 prescribes the minimum frequencies of bioassays that are acceptable. Section 4.2.2 (Other Frequency Situations) of ANSI/HPS N13.22-2013 describes those situations where it may be necessary to sample more frequently than is indicated in Table 8.


more frequent bioassays (based on measurement sensi                      who is protected by a monitoring system that essentially tivity) to check on the air sampling program. Section                    assures detection of any significant intake.
5.


C.3.d indicates that all workers should participate in the bioassay program for purposes of monitoring the organ                          Although fecal analysis is not shown in Table 3, buildup, while only a sample of workers is sufficient for                this procedure is preferred over urinalysis for Class (W)
Action Levels and the Associated Actions
checking the air sampling program. If a working area                    and Class (Y) materials and may be substituted for does not qualify for the minimum program, additional                    urinalysis in the table. If in vivo measurements are made bioassays are specified in Table 3 at somewhat higher                  at the frequency shown for urinalysis, Class (W) and frequencies. Any urinalysis procedure performed for one                Class (Y), the unnalyses are unnecessary; the urinalyses of these purposes may be used to satisfy a urinalysis                  prescribed in Table 2 are adequate.


requirement for another purpose, provided the fre quency criteria are met. A similar statement may be                            The bioassay measurement frequency, as deter made regarding in vivo measurements.                                    mined from Table 2 or 3 (or the associated figures),
Licensees should ensure that the appropriate actions are taken based on bioassay results. The action levels for bioassay that are listed in Table 2 (Urinalysis Action Levels) and Table 7 (Action Levels for Special Class Y Uranium) and described in Section 6 (Action Levels and Follow-up Actions) of ANSI/HPS N13.22-2013 are acceptable. However, where exposure conditions and the characteristics of the materials differ significantly from those recommended in the ANSI standard, the licensee may modify the derivation of the action levels to conform to local conditions at the facility.
                                                                        should not be decreased because of consistently low The purpose of the additional bioassay measure                  bioassay results; bioassay measurements are needed as a ments is the timely detection of unsuspected exposures                  final check on the contamination confinement capability not detected by the air sampling program. Therefore, the               and on the effectiveness of the air sampling program.


additional bioassays are not necessary for an individual                Consistently high bioassay results may suggest that more
6.
                                                                8.11-6


frequent bioassays should be performed even though                        A monthly in vivo frequency may be reduced to there is no such indication from air samples. In this case,        quarterly if weekly fecal analyses are made, with an in however, improvements in the air sampling program are                vivo measurement at the end of the quarter. An in vivo required rather than more frequent bioassays. The                  measurement should be performed as soon as practicable appropriate frequency can be determined from air                    if the excretion rate exceeds 7 pCi/day Class (Y) or 700
Limiting Chemical Toxicity and Work Restrictions   
  sample data if the air sampling program is adequately              pCi/day Class (W). For lower results the following representative of inhalation exposures.                            procedure should be followed. Results from the first 4 weekly specimens should be plotted (semilog) against If workers are exposed to a mixture of uranium              time, and a best fitting curve should be extrapolated to t compounds, the DAC for the mixture, DACm, should be                = 0. thus obtaining an estimate of the initial excretion calculated as                                                      rate, (dP Idt)o, and the individual's half-lifel T. The dose commitment, Dc, should be estimated using these values
                                        -I                          with the following equation:
              DACm      [i, Dn=      f Zi DAC1
                                      ]                                                  Dc= 8.4 T2 [
  where DACi is the DAC for the ith compound and fi is a fraction representing the contribution of the ith com              where T is in days and (dP/dt)o is in MOCt/day. The pound. The calculation of fi depends on the exposure                actions indicated in Table 4 should then be taken. This mode. If the material is a mixture, fi is the activity              procedure should be repeated at the end of 8 weeks fraction. For exposure in more than one area, fi is the            when results from 8 specimens are available. At the end time fraction spent in the ith area. As an alternative              of the quarter D. should be evaluated using results from DACm may be taken as the lowest DACi. As to the                      all 12 specimens. If the indicated Dc is < 3 rems, the in quarterly average for air samples, if the material is a            vivo measurement may be considered unnecessary If the mixture and exposure occurs in only one area, the                  Dc indicated by the fecal data exceeds 3 reins, the in quarterly average calculation, applicable to all workers in        vivo measurement should be performed.


the area, should be performed as for non-mixtures, i.e.,
Soluble uranium is a Class D or Type F aerosol as defined in ICRP Publications 30 and 66, respectively, based on the retention time in the pulmonary region. The NRC regulation,  
from samples characterizing conditions in the area. If                      A quarterly in vivo frequency may be reduced to exposures occur in several areas, the quarterly average            semiannual if monthly fecal analyses are made, with an for the mixture may be a time-weighted average for the              in vivo measurement at the end of 6 months If any individual, using ( arterly average air samples that                result exceeds 7 pCi/day Class (Y) or 460 pCi/day Class characterize full-time conditions in each area. i.e.,               (W). an in vivo measurement should be performed as soon as practicable. For lower results the following n                                      procedure should be followed. Results from the first 3 QAm= 2 fi QAi                                    specimens should be plotted (semilog) against time, and i=l                                    a best-fitting straight line should be extrapolated to t= 0. Values for (dP /dt)o and T for the individual should be obtained and used in the above equation to where QAi is the quarterly average for the ith area and fi          estimate Dc. The actions indicated in Table 4 should is the time fraction of the quarter that the individual              then be taken. At the end of the fourth and fifth month, worked in the ith area. As an alternative, QAm may be              Dc should again be evaluated using results from all taken as the highest QAi.                                          specimens. At the end of the 6-month period, the in vivo measurement should be performed.
10 CFR 20.1201(e) requires that licensees limit the soluble uranium intake by an individual to 
10 milligrams in a week in consideration of chemical toxicity, which may cause damage to the kidneys.


Figure 5 indicates that a urinalysis measurement sensitivity of about 0.7 pCi/I is required to detect the                    Fecal specimens used for this purpose should be equivalent of I MPDc following a single exposure to                obtained after 2 or more days of no exposure. In the Class (Y) materials with neither Class (D) nor Class (W)            extrapolation of excretion rate data to t=
Paragraph 20.1201(e) also directs licensees to footnote 3 of appendix B of 10 CFR part 20; footnote 3 concerns soluble mixtures of U-234, U-235 and U-238 in air. Licensees should develop the required procedures to prevent soluble uranium exposures from exceeding this non-radiological limit.


===0. it is===
7.
"'tracer" dusts present. To obtain this sensitivity, a        necessary to ignore data points obtained for less than 2 chemical concentration procedure is necessary. Fecal                days after exposure.


analysis is recommended as an alternative, using the frequency schedule given for urinalysis.                                d. Participation If work restrictions that have been imposed do not                  All personnel whose regular iob assignmentN
Bioassay Interpretation 
involve total exclusion from restricted areas, it is                involve work in an area where bioassay ineasurernenI,,
necessary to ensure that bioassay measurements made                are required should participate in the bioassay program for the purpose of removing work restrictions are                  However, as long as air sainple results qualify the area performed at least as frequently as would be required for          and group of workers tor the minimum bioasssa purposes of exposure control.                                      program, special consideration may be given in the case
                                                            8.1 1-7


of bioassays obtained for the purpose of checking on the          ensure that the measurement results are carefully air sampling program, i.e., the first objective shown in          reviewed by qualified personnel and that appropriate Table 2. For these bioassays it is acceptable to limit            action is taken if the results are considered high. Action participation to a representative sample of the group.            should be based on the organ burden, the dose commit The sample should be composed of the most highly                  ment, or chemical damage to the kidney as indicated exposed or potentially exposed personnel and should              (however roughly) by the result. Appropriate actions are include at least 10% of the workers who have regular job          shown in Tables 4 and 5 for single intakes. In the case of assignments in the area if the total number of such              chronic exposure, when bioassay results indicate that the workers is 100 or more. If the total is between 100 and         organ burden is continuing to rise, action should be
Licensees should ensure that bioassay data is interpreted to estimate intakes and doses using the retention and excretion data. RG 8.9, Section 4 (Interpretation of Bioassay Measurements), or in NUREG/CR-4884, Interpretation of Bioassay Measurements, provide guidance on bioassay interpretation.
10 workers, there should be 10 participants. If the total        taken to assure that additional buildup will not interfere is less than 10 workers, all should participate. Thus,           with the worker's career. When urinalysis indicates 50%
where the minimum bioassay program is being con                  or more of the maximum permissible lung burden for ducted, all workers would participate either semi                nontransportable uranium, in vivo measurements should annually or annually for monitoring of uranium buildup          be undertaken. Work restrictions should be tmposed in the lung or bone, in addition, those in the sample            without waiting for in vivo measurements if urinalysis group would participate more frequently if required to          indicates more than I permissible lung burden.


do so by Figures 3, 4, or 6. (Note that the in vivo frequency for Class (Y) materials is semiannual in every                (3) Diagnostic Evaluation case.) This sampling procedure will be of particular usefulness to those using Figure 4. Where bioassays in addition to the minimum program are conducted, all                        Diagnostic bioassay measurements are made to workers should participate (see Table 2, footnote e, for        .estimate the quantity and distribution of radionuclides exception).                                                      in the body after determination that a large deposition has occurred. Actions to be based on diagnostic results Personnel whose duties involve only observance            include (I) selection of subsequent measurement tech and who spend less than 25% of the work week in areas            niques and frequencies, (2) imposition or removal of where bioassay is required may participate on a limited          work restrictions, (3) referral to a physician, and (4) the basis. The interval between bioassay measurements for            physician's decision to attempt acceleration of the such personnel should be a matter of judgement based            nuclide elimination process.
In addition, commercial software is available for bioassay interpretations and internal dose calculations. For NRC staff to accept the calculations developed by such software, the assumptions relied upon by the licensee, including the conditions of the uranium and sampling information associated with the bioassay result, should be presented to NRC. The licensee should demonstrate the accuracy of its assumptions (i.e., by verification and validation).


on the magnitude of the exposure.
8.


f. Action Points e. Action Based on Results Appropriate action as based on bioassay results is              This -section presents acceptable correlations be dependent first on the underlying purpose of the                tween organ burden, dose commitment, or uranium measurement.                                                    uptake and the quantities actually measured using bioassay techniques, thus providing action point criteria
Uranium Air Concentrations 
        (!) Preparatory Evaluation                                for purposes of exposure control. Guidance is also given for work restrictions and for referral to a physician.


Where urinalysis for uranium is used to screen personnel prior to job assignment, the presence of any                  These correlations are derived entirely from urinary uranium, as detected by routine laboratory              models. This approach is acceptable for purposes of procedures, should trigger an investigation. Information        exposure control. However, these correlations would regarding the location and quantity of uranium in the            actually predict the dose commitment or uranium body should be sought, and conservative predictions as          uptake only if the bioassay result was without error and td future retention in the body should be made. This            if every condition of the models was actually achieved.
Licensees should ensure that uranium concentration in air is appropriately determined. Methods for airborne uranium surveillance and for determining uranium air concentrations are described in RG 8.25, Air Sampling in the Workplace and in RG 8.30, Health Physics Surveys in Uranium Recovery Facilities.  The guidance in RG 8.22, Bioassay at Uranium Mills, may also be applicable depending on involvement of uranium materials at the licensees facility.


information can usually be derived from a review of the worker's previous exposure history, including previous
RG 8.11, Rev. 1, Page 7
                                                                        (1) Dose Commitment and Uptake Correiations, bioassay results, and from subsequent bioassay measure mrents as necessary. Findings should be compared with                      Single Intake, Class (D) Dust criteria given in Section C.3.f.(8), or with other accept able criteria, and a decision should be made to approve                    The correlation between dose commitment to the job assignment if acceptable criteria are met, or to        the bone and urinary uranium concentration is shown in impose a delay otherwise.                                        Figure 8 for Class (D) materials. In the right hand margin of the figure the recommended actions, from Table 4,
        (2) Exposure Control                                      are indicated. The correlation between uptake of uranium by the blood and urinary uranium concen When work is in progress, and bioassay mea            tration is shown in Figure 9 for Class (D) materials.


surements are being made routinely, it is essential to          Recommended actions, from Table 5, are indicated.
===9.     ===
Quality Assurance (QA)


8.11-8
The Quality Assurance procedures of licensee bioassay programs that satisfy the requirements of the ASME standard NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facilities (with Addenda) will be deemed acceptable to the NRC staff. The reference to this ASME standard is also included in RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination)-Effluent Streams and the Environment and in ANSI/HPS
N13.22-2013, Section 7, Quality Assurance and Control.


TABLE 4 ACTION DUE TO BIOASSAY MEASUREMENT RESULTS, RADIATION DOSE
10.
Result < 1/5 MPDca Contamination confinement and air sampling capabilities are confirmed. No action required.


1/5 < Result < 1/2 MPDc Contamination confinement and/or air sampling capabilities are marginal. If a result in this range was expected because of past experience or a known incident, any corrective action to be taken presumably has been or is being accomplished; no action is required by the bioassay result. If the result was unexpected:
Reports and Notifications to the NRC and Exposed Individual
  (I) Confirm result (air sample data review, comparison with other bioassay data, additional bioassay measurements).
  (2) Identify probable cause and, if necessary, correct or initiate additional control measures.


(3) Determine whether others could have been exposed and perform bioassay measurements for them.
If an overexposure occurs, licensees are subject to the NRC incident reporting requirements in 
10 CFR 20.2203 and 20.2205. Licensees should be familiar with these reporting requirements.


(4) If exposure (indicated by excreta analysis) could have been to Class (W) or Class (Y) dust, consider the perfor mance of diagnostic in vivo measurements.
==D. IMPLEMENTATION==
The purpose of this section is to provide information on how licensees may use this RG. In addition, it describes how the NRC staff complies with the backfitting provisions in 10 CFR 70.76(a)(1).  


1/2 < Result < 1 MPDc Contamination confinement and/or air sampling capabilities are unreliable unless a result in this range was expected because of a known unusual cause, in such cases, corrective action in the work area presumably has been or is being taken, and action due to the bioassay result includes action (7) only. Conditions under which a result in this range would be routinely expected are undesirable. If the result was due to such conditions or was actually unexpected, take actions (1) through (4) and:
Use by Licensees
  (5) If exposure (indicated by excreta analysis) could have been to Class (W) or Class (Y) dust, assure that diagnostic in vivo measurements are performed.


(6) Review the air sampling program, determine why air samples were not representative and make necessary corrections.
Licensees may voluntarily use the guidance in this RG to demonstrate compliance with the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees (i.e., persons holding a NRC issued license as of the date of issuance of this RG) may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged. The acceptable guidance may be from the previous version of this RG. Licensees may use the information in this RG for actions which do not require NRC review and approval. Licensees may also use the information in this RG to resolve regulatory or inspection issues.


(7) Perform additional bioassay measurements as necessary to make a preliminary estimate of the critical organ burden; consider work limitations to ensure that the MPDc is not exceeded.
Use by NRC Staff


(8) If exposure could have been to Class (Y) dust, bring expert opinion to bear on cause of exposure, and continue operations only if it is virtually certain that the limit of I MPDc will not be exceeded by any worker.
The NRC staff does not intend or approve any imposition or backfitting of the guidance in this RG. The NRC staff does not expect any current licensee to use or commit to using the guidance in this RG, unless such licensee makes a change to its licensing basis. The NRC staff does not expect or plan to initiate NRC regulatory action that would require the use of this RG. Examples of such regulatory actions include the issuance of an order or generic communication, or the promulgation of a rule, requiring the use of this RG without further backfit consideration.


Result > I MPDc Contamination confinement and/or air sampling capabilities are not acceptable, unless a result of this magnitude was expected because of a known unusual cause: in such cases, corrective action in the work area presumably has been ov is being taken, and action due to the bioassay result includes actions (10) and (11) only. Prevalent conditions under which a result in this range would be expected are not acceptable. If the result was due to such conditions or was actually unexpected, take actions(I) through (7) and:
During regulatory discussions on licensee-specific operational issues, the NRC staff may discuss with licensees various actions consistent with staff positions in this RG, as one acceptable means of meeting the underlying NRC regulatory requirements. Such discussions would not ordinarily be considered backfitting, even if prior versions of this RG are part of the licensees licensing basis.
  (9) Take action (8), regardless of dust classification.


(10) Establish work restrictions as necessary for affected employees.
However, unless this RG is part of the licensees licensing basis, the staff may not represent to the licensee that the licensees failure to comply with the positions in this RG constitutes a violation.


(11) Perform individual case studies (bioassays) for affected employees.
If a current licensee voluntarily seeks a license amendment or change and (1) the NRC staffs consideration of the request involves a regulatory issue directly relevant to this RG and (2) the specific subject matter of this RG is an essential consideration in the staffs determination of the acceptability of the licensees request, then the staff may request that the licensee either follow the guidance in this


aThe annual MPDC is a 50-yr integrated dose of 15 rems to the lung or 30 reins to the bone.
RG 8.11, Rev. 1, Page 8


8.11-9
regulatory guide or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. Such a request by the NRC staff is not considered backfitting as defined in 10 CFR 70.76(a)(1).  


TABLE 5 ACTION DUE TO BIOASSAY MEASUREMENT RESULTS, CHEMICAL TOXICITY
If a licensee believes that the NRC is either using this RG or requesting or requiring the licensee to implement the methods or processes in this RG in a manner inconsistent with the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in accordance with the guidance in NRC Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection (Ref. 18) and NUREG-1409, Backfitting Guidelines (Ref. 19).
  Result < 1/2 L4 Contamination confinement and air sampling capabilities are adequate. No action require


====d.     I====
RG 8.11, Rev. 1, Page 9
  1/2 L < Result < L
Contamination confinement and/or air sampling capabilities do not provide an adequate margin of safety. If a result in this range was expected because of past experience or a known incident, any corrective action to be taken presumably has been or is being accomplished; no action is required by the bioassay result. If the result was unexpected:
(1) Confirm result (air sample data review, comparison with other bioassay data, additional bioassay measurements).
(2)  Identify probable cause and, if necessary, correct or initiate additional control measures.


(3)  Determine whether others could have been exposed and perform bioassay measurements for them.
REFERENCES1


(4) Determine why the bioassay result was not predicted by the air sampling program and make necessary corrections.
1.


(5) Consider work limitations to ensure that L is not exceeded.
Title 10 of the Code of Federal Regulations, (10 CFR), part 70, Domestic Licensing of Special Nuclear Material. U.S. Nuclear Regulatory Commission (NRC), Washington, DC.


(6) If bioassay result was near L, bring expert opinion to bear on cause of exposure, and continue operations only if it is virtually certain that L will not be exceeded by any worker.
2.


Result > L
10 CFR part 20, Standards for Protection against Radiation. NRC, Washington, DC.
Contaminatiow confinement and/or air sampling capabilities are not acceptable, unless a result of this magnitude was expected because of a known unusual cause; in such cases, corrective actuon in the work area presumably has been or is being taken, and action due to the bioassay result includes actions (7) and (8) only. Prevalent conditions under which a result in this range would be expected are not acceptable. If the result was due to such conditions or was actually unexpected, take actions ( I ) through (6) and:
(7) Establish work restrictions as necessary for affected employees.


(8) Have additional urine specimen tested for albuminuria under direction of a physician.
3.


aL is 2.7 ing of uranium in the bWood. Assume uptake is 43% of intake.
NRC, Regulatory Guide (RG) 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program. NRC, Washington, DC.


(2) Class (D) Dust, Dual Action Requirements                          (3) Dose Commitment Correlation, Single Intake, Class (W)and Class (Y) Dust, Excreta Analysis If the urinary uranium concentration is suf ficiently large, action due to both radiation dose and                            The correlation between dose commitment to chemical toxicity may be necessary. Both Figures 8 and                  the lung, urinary uranium concentration, and uraniuirn
4.
10 should be consulted for this determination. Figure I I              fecal excretion rate is shown in Figures 12 through 14 presents values of specific activity acceptable for con                for Class (W) and Class (Y) materials. Recommended verting activity to gravimetric units.                                  actions, from Table 4, are indicated.


For exposure to multiple enrichments, values                      (4) Dose Commitment Correlation, Single Intake, from Figure 11 should be weighted to obtain an                                    Clan (W) and Class (Y) Dust, In Vivo appropriate specific activity. If the weighting factors are unknown, the smallest specific activity present shou!d be                        The correlation between dose commitment to used.                                                                  the lung and the mass of U-235 measured in the thorax
NRC, RG 8.22, Bioassay at Uranium Mills. NRC, Washington, DC.
                                                              8.11-10


by in vivo techniques is shown in Figure 15 for Class (W)            control the chronic levels due to continuous intake do materials and in Figure 16 for Class (Y) materials.                  not alter the approach outlined for the detection of Recommended actions, from Table 4, are indicated.                    single intakes.
5.


These figures are applicable to uranium of 20 w/o U-235; scaling factors are provided in Figure 17 for                              The correlation between in vivo measurements other enrichments.                                                   of U-235 and lung burden is shown in Figure 19. In.vivo measurements are considered to be much more reliable
NRC, RG 8.25, Air Sampling in the Workplace. NRC, Washington, DC.
        (5) Exposure to Mixtures                                      than urinalysis for Class (W) and Class (Y) materials.


However, urinalysis may be used to indicate that in vivo If a positive urinalysis specimen is obtained              measurements are promptly needed. rThe average value following exposure to a mixture that included significant            from several urinalysis results (R) can be used with quantities of Class (Y) materials, actions (1) through                Figure 20 to estimate the number of maximum per
6.
  (11) in Table 4 should be taken.                                      missible lung burdens (MPLB = 0.016 pCi). Arrange ments for in vivo measurements should be undertaken if the exposure was to a mixture of Class (W)              when AR is found to exceed 0.5. If &#xfd;'R >1, additional dust and-Class (D) dust with chemical toxicity limiting,            exposure should be avoided until in vivo results are the urinary uranium mass concentration should be                    available.


determined and the curves in Figure 9 used to determine the required actions from Table 5; the activity concen                      (7) Referral to a Physician tration should also be determined, using Figure 12 with Table 4.                                                                         When confirmed bioassay measurement results indicate that the Maximum Permissible Annual Dose If exposure was to a mixture of Class (W) dust            (MPAD) to the lung or bone has been or will be and Class (D) dust with bone dose limiting, it is                    exceeded by a factor of 2, the affected individual should necessary to estimate the fraction of the dust inhaled                be so informed, and referral to a physician knowledge that was Class (W), fw, and the fraction that was Class              able in the biological effects of radiation and conversant (D), fd. It is also necessary to determine the urinary                in the nature and purpose of regulatory dose limits excretion factors, Ew and Ed, that would be applicable                should be considered.
NRC, RG 8.30, Health Physics Surveys in Uranium Recovery Facilities. NRC, Washington, DC.


at the timie the specimen was obtained; Figure 18 may be used for this purpose. If R represents the bioassay                            When confirmed bioassay results indicate that result in pCi/day, Rd the Class (D) component and Rw                  an exposure to uranium has resulted in an uptake by the the Class (W) component, such that R = Rd + Rw, then                  blood of more than 2.7 mg within 7 consecutive days or less, the affected individual should be informed of his Rd = fdEdR/(fdEd + fwEw)                            exposure and referred to a physician knowledgeable in the chemical effects of internally administered uranium.
7.


aw = fwEwR/(fdEd + fwEw)
NRC, RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination) - Effluent Streams and the Environment. NRC,
                                                                              (8) Work Restrictions These results should be converted to concentra tion using the factor 1.4 I/day. Then the curves in                              AEC regulations establish an upper limit on Figure 8 or Figure 12 should be used to determine the                exposures during a specified period of time; it follows required actions from Table 4.                                        that work restrictions may be necessary to prevent exposures from exceeding this limit. Such restrictions If positive in vivo results are obtained following        may also be necessary to prevent the deposition of exposure to a mixture of Class (W) and Class (Y)                      uranium in the body in such quantity that:
Washington, DC.
materials, Figure 16 should be used to determine the required actions from Table 4.                                                       (i) the mass of uranium entering the blood will exceed 2.7 mg in 7 consecutive days;
        (6) Lung Burden Correlations, Continuous Intake                            (ii) the activity present in the lung will pro duce an annual dose-equivalent to the In some working areas airborne uranium is                                    pulmonary region exceeding 15 reins;
routinely present and is responsible for the chronic                              (iii) the activity present in the bone will appearance of uranium in urine. Continuous intakes of                                    produce an annual dose-equivalent to the this nature may also be responsible for chronically                                      bone exceeding 30 reins.


positive in vivo measurement results. Under these condi tions positive bioassay results are expected, and the                            For personnel who have a body burden of monitonng tasks are to measure the lung burden buildup                uranium that is producing an annual dose-equivalent and to identify single intake peaks above this expected              greater than 15 rems to the pulmonary region of the level. Thus it is evident that for purposes of exposure              lung or 30 reins to the bone or both, work restrictions
8.
                                                            8.111-11


may be imposed as necessary to assure that the                  to chemical toxicity, the objective is to determine additional radiation dose from sources under the control        whether the uranium uptake was sufficient to cause of the employer would be considered negligible by a            kidney damage. The radiological objectives are to esti qualified health physicist.                                    mate (1) the quantity of uranium present in the organ of reference, (2) the rate of elimination, (3) the magnitude
National Council on Radiation Protection and Measurements (NCRP) Report 161, Management of Persons Contaminated with Radionuclides. National Council on Radiation Protection and Measurements, Bethesda, MD, 2008.2
4. Diagnostic Guidance                                          of the original deposition, and (4) the dose commitment.  I
                                                                As with exposure control monitoring, use of models is In previous sections a monitoring program has been          necessary. However, it is usually possible in a given described which should detect every instance of serious        individual's case to use factual data rather than some of deposition of uranium in the body. Once a deposition of        the assumptions, and every opportunity for such refine this nature has been identified, the bioassay purpose          ment .should be taken. This subject is treated in changes from exposure control to diagnosis. With respect      considerab!e detail in WASH-1251, Section V.


8.11-12
9.


A4R SAMPLING DATA
NUREG/CR-4884, Interpretation of Bioassay Measurement. NRC, Washington, DC.
          NOT REPRESENTATIVE                    I                REPRESENTATIVE
                                                  1 - QTR. AVE,_<10% DAC  1 - QTR. AVE.>10% DAC
                                                    MAXIMUM_< 25% DAC      MAXIMUM >25% DAC
  USE OF NON-REPRESENTATIVE AIR                  [MINIMUM BIOASSAY PROGRAM]
SAMPLING DATA IS NOT ACCEPTABLE
  IN DETERMINING THE 1 - QTR. AVE.


SADDITIONAL BIOASSAYS I
10.
          Figure 1 Criteria for Initiating Additional Bioassays, Routine Conditions Figure 2 Criteria for Diagnostic Bioassays Durings Special Investigations
                                              8.1 1-13


~i2 LU
American National Standards Institute/Health Physics Society Standard, N13.22-2013, Bioassay Programs for Uranium. American National Standards Institute: Health Physics Society, McLean, VA.3
    z wig laj
010
        100 101                  102                10310
                      MEASUREMENT SENSITIVITY LIMIT (pCi/I)
              Figure 3 Maximumn Time Between Specimens to Detect 1 MPDc, Class (D) Uranium Dust, w/o U-235 >80


,
11.
          3    1 1I                          I      I TII1  l            I1111 " V!    IIIT _
    S102 u      -                                        USE FIGURE    11 TO CONVERT
                                                    TO ACTIVITY UNITS.


wI
International Commission on Radiological Protection (ICRP) Publication 30, Limits for Intakes of Radionuclides by Workers:  Part 1. International Commission on Radiological Protection, Pergamon Press, Oxford, England, 1979.4
9- 0
  uJ 101 -
      100 -  I I  11111        I    111        X1 I    1 11111 III1                  I  I I I
        10-1          100                101                  102            103            104 MEASUREMENT SENSITIVITY LIMIT (pg/I)
                        Figure 4 Maximum Time Between Specimens to Detect Uptake of
                                    2.7 mg Class (D) Uranium, w/o U-235:580


103                                                      4  6 .I-12..
1 Publicly available NRC-published documents are available online through the NRC Library on the NRCs public Web site at http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed online or printed for a fee in the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC
                                                                0 WJ
PDR, Washington, DC 20555; telephone 301-415-4737 or (800) 397-4209; fax (301) 415-3548; and e-mail pdr.resource@nrc.gov.
                                                                            I I I I I III      I  I I( iiY)
                                                                                                CLASS (Y)
                                                              10 2q_
zLu z
2                                                              10
UA
uj I                                            I I I I I Iif      I  I
    100 ,  I  1 1 1 Hill                                      *llv          I A L= a .....      .  .  . . ....
                      102                                              10-1                100                101
        101                                Lo3 MEASUREMENT SENSITIVITY
                                  LIMIT (pCi/I)                      MEASUREMENT SENSITIVITY LIMIT (pCi/I)
                          Figure 5 Maximum Time Between Specimens to Detect 1 MPDc, Class (W) or Class (Y) Uranium V


C
2 Copies of the National Council on Radiation Protection and Measurements documents may be obtained through the organizations Web site: http://www.ncrponline.org/Publications/Publications.html] or by writing to NCRP at 7910
        -- I
Woodmont Avenue, Suite 400, Bethesda, MD  20814-3095, telephone 301-657-2652, fax: 301-907-8768.
        I'j I I 11111            i      I I 1111U                I I 111111                I I I 11111        I      ! I III_
    Ln zU.                                                                                             20 w/o U-235 I-  102                                                                                          w z
    2 Lu cn U.1 w
    Lu
--4 uz
                                                                                                    93% U-235
        .- I,,
        III',
        IV
                                    I.                                I                          4                    6-.
    t-.
        1001        I I  I I I III          I --
                                                  I
                                                  .
                                                      I IIIll
                                                      .-  I. . .I .. -- ..
                                                                            I  I  I
                                                                                  .
                                                                                    IIIII
                                                                                    .    . . ..
                                                                                                        I  I 1 11111
                                                                                                            . . . . .
                                                                                                                          I III
                                                                                                                                  I I I lll
                                                                                                                                11  1 1 1 1 i
              10 0                101                            102                        103 MEASUREMENT SENSITIVITY LIMIT (pg U-235)
                                      Figure 6 Maximum Time Between Measurements to Detect 1 MPDc In Vivo, Class (W)


TIME BETWEEN MEASUREMENTS (DAYS)
3 Copies of American National Standards Institute documents may be purchased through their Web site at:
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http://webstore.ansi.org/.  
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4 Copies of the International Commission on Radiological Protection (ICRP) documents may be obtained through the organizations Web site: http://www.icrp.org/ or by writing to ICRP at 280 Slater Street, Ottawa, Ontario K1P 5S9, CANADA, telephone +1(613) 947-9750, fax: +1(613) 944-1920.
              ~~~~~~~  ,,t,/                               3ris1M~          --  TABLE
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      100                  101                    102                      103 URINARY URANIUM CONCENTRATION (pCi/I)
              Figure 8  Dose Commitment Indicated by Model vs. Urinary Uranium Concentration, Class (D), Single Intake
                                          8.11-19


104I        1    1I 1 I 1II                            I  l I I
RG 8.11, Rev. 1, Page 10  
    103 E
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  CL100
                                                                              AI
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          10-                100                  101                102 URINARY URANIUM CONCENTRATION (pg/I)
              Figure 9 Uptake in Blood Indicated by Model vs. Urinary Uranium Concentration, Class (D), Single Intake
                                          8.11-20


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                                                    RESULTS LEFT OF BAND REQUIRE NO ACTION.


RESULTS WITHIN BAND REQUIRE ACTIONS
ICRP Publication 60, Recommendations of the International Commission on Radiological Protection. ICRP, Pergamon Press, Oxford, England, 1991.
                                                    (1) THRU (6), TABLE 5 RESULTS RIGHT OF BAND REQUIRE ACTIONS
                                                    (1) THRU (8), TABLE 5
    10"1  __      1_ 1        _ 1 !1_
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                                                                                                  1
        10-1          100                    101                102                  103            104 URINARY URANIUM CONCENTRATION (pCi/I)
                      Figure 10    Action Guide for Urinalysis Results Following Single Intake of Uranium, Chemical Toxicity


I .
13.
  10.4
              --I            1                            0
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                                              _                  _
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              <                                        0 GULF DATA
              U.o                                        IAEA SS NO. 6 uli                                      A ORO-651 EQUATIOF
                                            S (U-dep)  3.6 x 10-7 Ci/gm
            0    20        40        60        80      100
                                  WITHOUT U-235, E
        Figure 11    Specific Activity for Mixtures of U-238, U-234 and U-235
                                    8.11-22


1I                        III                    II
ICRP Publication 66, Human Respiratory Tract Model for Radiological Protection, 1st Edition, Pergamon Press, Oxford, England, 1994.
                                              ... CLASS (Y)
                                    ol*  o*
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            ......................    ......                  .
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                                                                  ........... !........... elm
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                    S--                                                                    __ 1/5<R
                                                                                                ACTIO
                              UU
    lo-                              000
                      S~REE
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        100                        101                          102                        103 URINARY URANIUM CONCENTRATION (pCi/l)
                  Figure 12    Dose Conmmitment Indicated by Model vs. Urinary Uranium Concentration, Class (W) and (Y), Single Intake
                                                      8.11-23


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102                                                                    1 R E SU LT    M P Oc
ICRP Publication 68, Dose Coefficients for Intakes of Radionuclides by Workers. ICRP,  
                                                                                            >1 oQ
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                                                                  .......   TABLE 4
                                                                                      (1) THRU 11)
                                                                            1/2 eRESULT S1I MPD,
                                                                            ACTIONS (11) THRU W(
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              LL
                                          .. .......... .... .... ..      1/5 < RESULT S1 /2 MPO,
                                                                        -ACTIONS      (1) T44RU 14)
                                  A;                                          RESULT -1 /5 MPDC
0    100                                                              !          NO ACTION
                Lkl
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    10-2    1 1 1      1              1l
        100              101                      102                103 URANIUM FECAL EXCRETION RATE (pCi/DAY)
              Figure 13    Dose Commitment Indicated by Model vs. Uranium Fecal Excretion Rate, Class (W), Single Intake L
                                          8.11-24


102 REI
15.
                                                                                    ACT 10
                                                                                    TABLI
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  10.


1
ICRP Publication 71, Age-Dependent Doses to Members of the Public from Intake of RadionuclidesPart 4 Inhalation Dose Coefficients. ICRP, Pergamon Press, Oxford, England,  
            _, ......... . . . . s............u      ,.. . . . . . . . . . ,.. _    1/2< F
1995.
                                                                                    ACTIC
                                                                                    1/6< R
                                                                                    ACTIO
2  100
20
  10-1
        100                    101                    102                      103 URANIUM FECAL EXCRETION RATE (pCi/DAY)
                  Figure 14  Doss Commitment Indicated by Model Vs. Uranium Fecal Excretion Raft, Class (Y), Single Intake
                                              8.11-25


104 S20 w/o U-235
16.
                                                            15-ein.1 PDCT"
0    101                  120                                  35 IM
                                                                reins      A
                                                                          1/
                                    tN y!yo (p U-235)
                  Figure 15 Dose Commitment Indicated by Model vs. In Vivo Result, Cless (W), Single Intake
                                        3. 11-26


104
IAEA, Safety Guide No. RS-G-1.2, Assessment of Occupational Exposure due to Intake of Radionuclides. International Atomic Energy Agency, Safety Standards Series, Vienna.1999.5
    10
            20 w/o U-235A
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  102
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I
International Organization for Standardization (ISO/IEC) 17025:2005, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization, Geneva, Switzerland. 2005.6 http://www.iso.org/iso/Catalogue_detail?csnumber=39883.
2)                                                                                              ACTIONS (1) THRU 111)
                                                                  Is rams      1 MPD,           TABLE 4
                                                                                                1/2- RESULTS!_I MPD&#xa2;
    101                                                                  7.5 rin    1            ACTIONS (1) THRU 68)
                                      .. ~ .......            .................
                                                                          ag
                                                                                                1f5 <RESULTS1I2 MPO,
                                                                                                ACTIONS (1) THRU (4)
    100
                                                                                                  RESULT *r1/5 MPD,
                                                                                                      NO ACTION
  10"1
        101                    102                          103                              104 IN VIVO RESULT (pg U-235)
                  ,Figure 16      Don Commitment Indicated by Model vs. In Vivo Result, Class (Y), Single Intake
                                                    8.11-27


U
18.
                              At  !    11  I                  I      I            r I    t
      711 I.5      -
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          U  EU  zu      30        40        50        60      70      80    90    100
                                                w/o U-235 Figure 17  fmiichiment Scaling Factors for Model Dose Commitment Curves, InViyD Measurement Following Single Exposure to Class (Wl or Class (Y) Uranium Dust


'4
NRC Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection. NRC, Washington, DC.
- 10
0
    10-4 z
    10
      100              1011013 TIME (DAYS AFTER INTAKE)
          Figure 18 Urinary Uranium Excretion Factors for Determining RD and Rw
                                8.11-29


LO)
19.
    200
    100 -    l      1      1        L        1        L        L        1            I
      0  10    20    30        40      50        60      70      80        90      100
                                          w/o U-235 FIGURE 19 Equilibrium Mass of U-235 in the Lung Equivalent to 1 Ma, n rrn Permissible Lung Burden


102            1111                  1 11I1!111 IuI                I    I I I 1
NUREG-1409, Backfitting Guidelines. NRC, Washington, DC
      101
      100
0.


a.
5 Copies of International Atomic Energy Agency (IAEA) documents may be obtained through their Web site at:
http://www.iaea.org or by writing the International Atomic Energy Agency P.O. Box 100 Wagramer Strasse 5, A-1400
Vienna, Austria. Telephone (+431) 2600-0, Fax (+431) 2600-7, or E-Mail at Official.Mail@IAEA.org.


IL
6 Copies of International Organization for Standardization (ISO) documents may be obtained through their Web site at:
      10-11 w
http://www.iso.org or by writing the International Central Secretariat, 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland. Telephone (+41) 22 749 01 11, Fax (+41) 22 733 34 30, or E-Mail at Central@ISO.org.}}
            101                  102                    103                    104 TIME AFTER BEGINNING OF EXPOSURE (DAYS)
            Figure 20 Model for Interpreting Urinalysis Results During Continuous Exposure to Constant Concentration of Uranium in Air
                                      8,11-31}}


{{RG-Nav}}
{{RG-Nav}}

Revision as of 14:11, 10 January 2025

Applications of Bioassay for Uranium
ML15054A618
Person / Time
Issue date: 06/30/2015
From: Casper Sun
NRC/RES/DSA
To:
Karagiannis H
Shared Package
ML15054A611 List:
References
RG 8.11 DG-8054
Download: ML15054A618 (11)
v • d • e


U.S. NUCLEAR REGULATORY COMMISSION

July 2015 OFFICE OF NUCLEAR REGULATORY RESEARCH

Revision 1 REGULATORY GUIDE

Technical Lead Casper Sun

Written suggestions regarding this guide or development of new guides may be submitted through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.

Electronic copies of this regulatory guide, previous versions of this guide, and other recently issued guides are available through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory guide is also available through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession No. ML15054A618. The regulatory analysis may be found in ADAMS

under Accession No. ML14133A612 and the staff responses to the public comments on DG-8054 may be found under ADAMS Accession No.

ML15014A269.

REGULATORY GUIDE 8.11 (Draft was issued as DG-8054, dated September 2014)

APPLICATIONS OF BIOASSAY FOR URANIUM

A. INTRODUCTION

Purpose

This regulatory guide (RG) describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for the development and implementation of a bioassay program for monitoring the intake of mixtures of uranium isotopes (U-234, U-235, and U-238) by occupationally exposed workers. This RG applies to holders of special nuclear material licenses under Title 10 of the Code of Federal Regulations (10 CFR), part 70, Domestic Licensing of Special Nuclear Material, (Ref. 1).

Applicable Rules and Regulations

10 CFR 20.1204(a), Determination of Internal Exposure (Ref. 2), states that each licensee shall, when required under 10 CFR 20.1502, Conditions Requiring Individual Monitoring of External and Internal Occupational Dose, take suitable and timely measurements of: (1) concentrations of radioactive materials in air in work areas, (2) quantities of radionuclides in the body,

(3) quantities of radionuclides excreted from the body, or (4) combinations of these measurements.

10 CFR 20.1201(e), Occupational Dose Limits for Adults, requires licensees to limit the soluble uranium intake by an individual to 10 milligrams per week in consideration of the chemical toxicity.

Related Rules and Regulations

10 CFR 20.1703(i), Use of Individual Respiratory Protection Equipment, allows for an estimated dose based upon an assumption that the concentration of radioactive material that is inhaled when respirators are worn is equal to the ambient concentration in air without respiratory protection divided by the assigned protection factor. This regulation requires that if the dose is later found to be greater than the estimated dose, the corrected value must be used; if the dose is later found to be less than the estimated dose, the corrected value may be used.

RG 8.11, Rev. 1, Page 2

10 CFR 20.2202, Notification of Incidents, sets forth the criteria for those events involving byproduct, source, or special nuclear material possessed by the licensee that require either immediate notification or notification within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

10 CFR 20.2203, Reports of Exposure, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Constraints or Limits, sets forth the criteria for submitting a written report to the NRC on a reportable event.

10 CFR 20.2205, Reports to individuals of exceeding dose limits, provides that when a licensee is required by 10 CFR 20.2203 or 2204 to send a report to the Commission of any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide the individual a report of the exposure data included in the report to the Commission.

10 CFR part 70, Domestic Licensing of Special Nuclear Material, establishes procedures and criteria for the issuance of licenses to receive title to, own, acquire, deliver, receive, possess, use, and transfer special nuclear material and provide for the terms and conditions upon which the Commission will issue such licenses.

Related Guidance

RG 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program (Ref. 3), provides methods acceptable to the NRC staff for estimating intake of radionuclides using bioassay measurements.

RG 8.22, Bioassay at Uranium Mills (Ref. 4), describes a bioassay program acceptable to the NRC staff for uranium mills (and applicable portions of uranium conversion facilities where the possibility of exposure to yellowcake dust exists), including exposure conditions with and without the use of respiratory protection devices.

RG 8.25, Air Sampling in the Workplace (Ref. 5), provides guidance on air sampling in restricted areas of the workplace.

RG 8.30, Health Physics Surveys in Uranium Recovery Facilities (Ref. 6), provides guidance on health physics surveys that are acceptable to the NRC staff for protecting workers at uranium recovery facilities (e.g., uranium mills, in-situ leach facilities, ion exchange recovery facilities, heap leach facilities) from radiation and the chemical toxicity of uranium.

RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination)-Effluent Streams and the Environment (Ref. 7), provides quality assurance (QA) guidance on monitoring measurements that support the radiation and environmental protection programs.

The National Council on Radiation Protection and Measurements (NCRP) Report 161, Management of Persons Contaminated with Radionuclides (Ref. 8), provides guidance for emergency treatment if a severe intake of uranium substances were to occur.

RG 8.11, Rev. 1, Page 3

Purpose of Regulatory Guides

The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the NRCs regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to licensees and applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance, continuance or amendment of a permit or license by the Commission.

Paperwork Reduction Act

This regulatory guide contains information collection requirements covered by 10 CFR part 20,

Standards for Protection Against Radiation, and 10 CFR part 70 Domestic Licensing of Special Nuclear Material, that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0014 and 3150-0009, respectively. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.

B. DISCUSSION

Reason for Revision

RG 8.11 was issued in June 1974 to provide guidance to NRC licensees on methods the staff found acceptable to demonstrate compliance with the then-current version of NRCs radiation protection regulations in 10 CFR part 20. In a 1991 rulemaking (May 21, 1991; 56 FR 23360), the NRC

promulgated amendments to its 10 CFR part 20 regulations, including a renumbering of those regulations.

As such, this revision to the guide seeks to achieve alignment with the regulatory structure of

10 CFR part 20 by updating the guides cross-references to the current 10 CFR part 20 regulations.

In addition, this revision identifies the bioassay interpretation methods described in NUREG/CR-4884, Interpretation of Bioassay Measurement (Ref. 9) and RG 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program, as being acceptable methods for the interpretation of bioassay data to estimate intakes and doses. This revision also approves for use certain sections of a voluntary consensus standard, namely, the American National Standards Institute/Health Physics Society (ANSI/HPS) N13.22-2013 standard, Bioassay Program for Uranium, (Ref.10) as a means for licensees to demonstrate compliance with the NRC regulations

10 CFR 20.1201(e) and 10 CFR 20.1204(a).

Background This RG pertains to uranium bioassay programs in general; however, it does not address issues related to bioassay measurement techniques such as whole body counting and excreta bioassay sampling and measurements.

Specific information regarding uranium intake during mining (extracting natural uranium ore from the earth) and milling (leaching uranium from the ore and concentrating it to produce yellowcake, including UO2F2, ammonium diuranate ((NH4)2U2O7), uranyl peroxides (UO4*nH2O), and uranium trioxide (UO3)) can be found in RG 8.22, Bioassay at Uranium Mills.

RG 8.11, Rev. 1, Page 4

Licensee determinations regarding participation in the uranium bioassay program should be based on estimates of the type and quantity of intakes that may occur using procedures that are expected to take place at each facility during the monitoring year. The program is confirmatory in that low or zero results may indicate that the measures in the workplace to control uranium materials are effective, and that no unexpected intakes have occurred. Based on operational experience, licensees may be able to justify adjustments in their bioassay program, such as a reduction in bioassay routine monitoring frequency, the inclusion of fewer workers in the bioassay program, or licensees may seek an alternative bioassay program.

Harmonization with International Standards

The NRC has a goal of harmonizing its guidance with international standards, to the extent practical. The International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency (IAEA) have issued a significant number of standards, guidance and technical documents, and recommendations addressing good practices in most aspects of radiation protection. The guidance of this RG is generally consistent with the guidance in the following documents:

ICRP Publication 30, Limits for Intakes of Radionuclides by Workers (Ref. 11),

ICRP Publication 60, Recommendations of the International Commission on Radiological Protection (Ref. 12),

ICRP Publication 66, Human Respiratory Tract Model for Radiological Protection (Ref. 13),

ICRP Publication 68, Dose Coefficients for Intakes of Radionuclides by Workers (Ref. 14),

ICRP Publication 71, Age-Dependent Doses to Members of the Public from Intake of RadionuclidesPart 4 Inhalation Dose Coefficients (Ref. 15),

IAEA Safety Guide RS-G-1.2, Assessment of Occupational Exposure due to Intake of Radionuclides (Ref. 16), and

International Organization for Standardization (ISO/IEC) 17025, General requirements for the competence of testing and calibration laboratories (Ref. 17). The ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers consensus testing and calibration methods for QA.

The NRC encourages licensees to consult these and other international documents and implement good practices, where applicable, that are consistent with NRC regulations. It should be noted that some of the recommendations issued by these international organizations do not correspond to the requirements specified in the NRCs regulations. In all cases, the NRCs requirements take precedence.

Documents Discussed in Staff Regulatory Guidance

This regulatory guide endorses, in part, the use of one or more codes or standards developed by external organizations, and other third party guidance documents. These codes, standards and third party guidance documents may contain references to other codes, standards or third party guidance documents (secondary references). If a secondary reference has itself been incorporated by reference into NRC

regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in a regulatory guide as an acceptable

RG 8.11, Rev. 1, Page 5

approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC

staff for meeting that regulatory requirement as described in the specific regulatory guide. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither a legally-binding requirement nor a generic NRC approved acceptable approach for meeting an NRC requirement. However, licensees and applicants may consider and use the information in the secondary reference, if appropriately justified, consistent with current regulatory practice, and consistent with applicable NRC requirements.

C. STAFF REGULATORY GUIDANCE

The NRC staff considers certain sections of ANSI/HPS N13.22-2013, Bioassay Programs for Uranium, acceptable for use as stated in the staff regulatory positions listed below.

1.

Participation Criteria Licensees should ensure that the appropriate individuals are assigned on a scheduled basis (e.g.,

quarterly) to submit specimens for bioassay or to report for in-vivo measurements in the bioassay program. Decisions about which individuals should participate in bioassay programs should be based on the criteria described below:

a. individuals who could receive certain doses as stated in 10 CFR 20.1502(a) or (b);

b. individuals who work with uranium or who are close enough to the chemical process using uranium that exposure and intake is possible (e.g., within a few meters and in the same room as the worker handling the radioactive material); or

c. individuals described in Section 5 (Selection of Individuals for Bioassay) of ANSI/HPS N13.22-2013 and individuals who work under the specified conditions listed in Table 1 (Implementation Levels: Mass or Activity Levels Above Which at Least Minimum Uranium Bioassay Program Shall be Implemented) of ANSI/HPS N13.22-2013.

2.

Conditions under which Bioassay Should Be Performed

Licensees should ensure that bioassays are performed for appropriate conditions. Section 3 (Establishing the Need for an Internal Dosimetry Program) of ANSI/HPS N13.22-2013 describes acceptable conditions under which a uranium bioassay should be performed.

3.

Types of Bioassay Monitoring that Should Be Performed

Licensees should ensure that the types of monitoring implemented by the bioassay program are appropriate for the types of material present at the licensees facility. For example, inhaled materials of different lung classes will likely call for different monitoring techniques. The procedures and methods described in ANSI/HPS N13.22-2013 are considered acceptable for selecting and implementing the appropriate monitoring techniques.

4.

Bioassay Frequency

In any particular facility, the frequency of bioassays should be based on estimates of the type and quantity of intakes that are likely to occur during the monitoring year.

RG 8.11, Rev. 1, Page 6

The bioassay frequencies for routine sampling, as well as for bioassays in other situations, that are described in Section 4.2 (Frequencies) of ANS/HPS N13.22-2013, are acceptable. If special circumstances exist at the licensees facility, a submittal should be provided to NRC for review and assessment of the proposed frequencies. Table 8 of ANSI/HPS N13.22-2013 prescribes the minimum frequencies of bioassays that are acceptable. Section 4.2.2 (Other Frequency Situations) of ANSI/HPS N13.22-2013 describes those situations where it may be necessary to sample more frequently than is indicated in Table 8.

5.

Action Levels and the Associated Actions

Licensees should ensure that the appropriate actions are taken based on bioassay results. The action levels for bioassay that are listed in Table 2 (Urinalysis Action Levels) and Table 7 (Action Levels for Special Class Y Uranium) and described in Section 6 (Action Levels and Follow-up Actions) of ANSI/HPS N13.22-2013 are acceptable. However, where exposure conditions and the characteristics of the materials differ significantly from those recommended in the ANSI standard, the licensee may modify the derivation of the action levels to conform to local conditions at the facility.

6.

Limiting Chemical Toxicity and Work Restrictions

Soluble uranium is a Class D or Type F aerosol as defined in ICRP Publications 30 and 66, respectively, based on the retention time in the pulmonary region. The NRC regulation,

10 CFR 20.1201(e) requires that licensees limit the soluble uranium intake by an individual to

10 milligrams in a week in consideration of chemical toxicity, which may cause damage to the kidneys.

Paragraph 20.1201(e) also directs licensees to footnote 3 of appendix B of 10 CFR part 20; footnote 3 concerns soluble mixtures of U-234, U-235 and U-238 in air. Licensees should develop the required procedures to prevent soluble uranium exposures from exceeding this non-radiological limit.

7.

Bioassay Interpretation

Licensees should ensure that bioassay data is interpreted to estimate intakes and doses using the retention and excretion data. RG 8.9, Section 4 (Interpretation of Bioassay Measurements), or in NUREG/CR-4884, Interpretation of Bioassay Measurements, provide guidance on bioassay interpretation.

In addition, commercial software is available for bioassay interpretations and internal dose calculations. For NRC staff to accept the calculations developed by such software, the assumptions relied upon by the licensee, including the conditions of the uranium and sampling information associated with the bioassay result, should be presented to NRC. The licensee should demonstrate the accuracy of its assumptions (i.e., by verification and validation).

8.

Uranium Air Concentrations

Licensees should ensure that uranium concentration in air is appropriately determined. Methods for airborne uranium surveillance and for determining uranium air concentrations are described in RG 8.25, Air Sampling in the Workplace and in RG 8.30, Health Physics Surveys in Uranium Recovery Facilities. The guidance in RG 8.22, Bioassay at Uranium Mills, may also be applicable depending on involvement of uranium materials at the licensees facility.

RG 8.11, Rev. 1, Page 7

9.

Quality Assurance (QA)

The Quality Assurance procedures of licensee bioassay programs that satisfy the requirements of the ASME standard NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facilities (with Addenda) will be deemed acceptable to the NRC staff. The reference to this ASME standard is also included in RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination)-Effluent Streams and the Environment and in ANSI/HPS

N13.22-2013, Section 7, Quality Assurance and Control.

10.

Reports and Notifications to the NRC and Exposed Individual

If an overexposure occurs, licensees are subject to the NRC incident reporting requirements in

10 CFR 20.2203 and 20.2205. Licensees should be familiar with these reporting requirements.

D. IMPLEMENTATION

The purpose of this section is to provide information on how licensees may use this RG. In addition, it describes how the NRC staff complies with the backfitting provisions in 10 CFR 70.76(a)(1).

Use by Licensees

Licensees may voluntarily use the guidance in this RG to demonstrate compliance with the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees (i.e., persons holding a NRC issued license as of the date of issuance of this RG) may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged. The acceptable guidance may be from the previous version of this RG. Licensees may use the information in this RG for actions which do not require NRC review and approval. Licensees may also use the information in this RG to resolve regulatory or inspection issues.

Use by NRC Staff

The NRC staff does not intend or approve any imposition or backfitting of the guidance in this RG. The NRC staff does not expect any current licensee to use or commit to using the guidance in this RG, unless such licensee makes a change to its licensing basis. The NRC staff does not expect or plan to initiate NRC regulatory action that would require the use of this RG. Examples of such regulatory actions include the issuance of an order or generic communication, or the promulgation of a rule, requiring the use of this RG without further backfit consideration.

During regulatory discussions on licensee-specific operational issues, the NRC staff may discuss with licensees various actions consistent with staff positions in this RG, as one acceptable means of meeting the underlying NRC regulatory requirements. Such discussions would not ordinarily be considered backfitting, even if prior versions of this RG are part of the licensees licensing basis.

However, unless this RG is part of the licensees licensing basis, the staff may not represent to the licensee that the licensees failure to comply with the positions in this RG constitutes a violation.

If a current licensee voluntarily seeks a license amendment or change and (1) the NRC staffs consideration of the request involves a regulatory issue directly relevant to this RG and (2) the specific subject matter of this RG is an essential consideration in the staffs determination of the acceptability of the licensees request, then the staff may request that the licensee either follow the guidance in this

RG 8.11, Rev. 1, Page 8

regulatory guide or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. Such a request by the NRC staff is not considered backfitting as defined in 10 CFR 70.76(a)(1).

If a licensee believes that the NRC is either using this RG or requesting or requiring the licensee to implement the methods or processes in this RG in a manner inconsistent with the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in accordance with the guidance in NRC Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection (Ref. 18) and NUREG-1409, Backfitting Guidelines (Ref. 19).

RG 8.11, Rev. 1, Page 9

REFERENCES1

1.

Title 10 of the Code of Federal Regulations, (10 CFR), part 70, Domestic Licensing of Special Nuclear Material. U.S. Nuclear Regulatory Commission (NRC), Washington, DC.

2.

10 CFR part 20, Standards for Protection against Radiation. NRC, Washington, DC.

3.

NRC, Regulatory Guide (RG) 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program. NRC, Washington, DC.

4.

NRC, RG 8.22, Bioassay at Uranium Mills. NRC, Washington, DC.

5.

NRC, RG 8.25, Air Sampling in the Workplace. NRC, Washington, DC.

6.

NRC, RG 8.30, Health Physics Surveys in Uranium Recovery Facilities. NRC, Washington, DC.

7.

NRC, RG 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination) - Effluent Streams and the Environment. NRC,

Washington, DC.

8.

National Council on Radiation Protection and Measurements (NCRP) Report 161, Management of Persons Contaminated with Radionuclides. National Council on Radiation Protection and Measurements, Bethesda, MD, 2008.2

9.

NUREG/CR-4884, Interpretation of Bioassay Measurement. NRC, Washington, DC.

10.

American National Standards Institute/Health Physics Society Standard, N13.22-2013, Bioassay Programs for Uranium. American National Standards Institute: Health Physics Society, McLean, VA.3

11.

International Commission on Radiological Protection (ICRP) Publication 30, Limits for Intakes of Radionuclides by Workers: Part 1. International Commission on Radiological Protection, Pergamon Press, Oxford, England, 1979.4

1 Publicly available NRC-published documents are available online through the NRC Library on the NRCs public Web site at http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed online or printed for a fee in the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC

PDR, Washington, DC 20555; telephone 301-415-4737 or (800) 397-4209; fax (301) 415-3548; and e-mail pdr.resource@nrc.gov.

2 Copies of the National Council on Radiation Protection and Measurements documents may be obtained through the organizations Web site: http://www.ncrponline.org/Publications/Publications.html] or by writing to NCRP at 7910

Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, telephone 301-657-2652, fax: 301-907-8768.

3 Copies of American National Standards Institute documents may be purchased through their Web site at:

http://webstore.ansi.org/.

4 Copies of the International Commission on Radiological Protection (ICRP) documents may be obtained through the organizations Web site: http://www.icrp.org/ or by writing to ICRP at 280 Slater Street, Ottawa, Ontario K1P 5S9, CANADA, telephone +1(613) 947-9750, fax: +1(613) 944-1920.

RG 8.11, Rev. 1, Page 10

12.

ICRP Publication 60, Recommendations of the International Commission on Radiological Protection. ICRP, Pergamon Press, Oxford, England, 1991.

13.

ICRP Publication 66, Human Respiratory Tract Model for Radiological Protection, 1st Edition, Pergamon Press, Oxford, England, 1994.

14.

ICRP Publication 68, Dose Coefficients for Intakes of Radionuclides by Workers. ICRP,

Pergamon Press, Oxford, England, 1994.

15.

ICRP Publication 71, Age-Dependent Doses to Members of the Public from Intake of RadionuclidesPart 4 Inhalation Dose Coefficients. ICRP, Pergamon Press, Oxford, England,

1995.

16.

IAEA, Safety Guide No. RS-G-1.2, Assessment of Occupational Exposure due to Intake of Radionuclides. International Atomic Energy Agency, Safety Standards Series, Vienna.1999.5

17.

International Organization for Standardization (ISO/IEC) 17025:2005, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization, Geneva, Switzerland. 2005.6 http://www.iso.org/iso/Catalogue_detail?csnumber=39883.

18.

NRC Management Directive 8.4, Management of Facility-Specific Backfitting and Information Collection. NRC, Washington, DC.

19.

NUREG-1409, Backfitting Guidelines. NRC, Washington, DC

5 Copies of International Atomic Energy Agency (IAEA) documents may be obtained through their Web site at:

http://www.iaea.org or by writing the International Atomic Energy Agency P.O. Box 100 Wagramer Strasse 5, A-1400

Vienna, Austria. Telephone (+431) 2600-0, Fax (+431) 2600-7, or E-Mail at Official.Mail@IAEA.org.

6 Copies of International Organization for Standardization (ISO) documents may be obtained through their Web site at:

http://www.iso.org or by writing the International Central Secretariat, 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland. Telephone (+41) 22 749 01 11, Fax (+41) 22 733 34 30, or E-Mail at Central@ISO.org.


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