ML22117A049
| ML22117A049 | |
| Person / Time | |
|---|---|
| Issue date: | 08/10/2022 |
| From: | Steven Garry NRC/NRR/DRA/ARCB |
| To: | |
| Karagiannis H | |
| Shared Package | |
| ML22117A037 | List: |
| References | |
| DG-8060 RG-8.034, Rev 1 | |
| Download: ML22117A049 (15) | |
Text
Response to Public Comments on Draft Regulatory Guide (DG)-8060, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses Proposed Revision 1 of Regulatory Guide 8.34 On December 17, 2021, the U.S. Nuclear Regulatory Commission (NRC) published a notice in the Federal Register (86 FR 71676) announcing that Draft Regulatory Guide (DG)-8060, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses (proposed Revision 1 of Regulatory Guide (RG) 8.34), was available for public comment. The public comment period closed on March 2, 2022, and the NRC staff received comments from the Wyoming Department of Environmental Quality (WDEQ), U.S. Navy, Nuclear Energy Institute (NEI), and Wyoming Mining Association (WMA), available in the Agencywide Documents Access and Management System (ADAMS) at the accession numbers given below.
Kyle Wendtland U.S. Navy Hilary Lane Travis Deti WDEQ ADAMS Accession Director, Fuel and Radiation WMA Telephone: 307-777-7046 No. ML22033A007 Safety, NEI Telephone: 307-635-0331 Email: Kyle.Wendtland@wyo.gov Telephone: 202-341-7951 Email: tdeti@wyomingmining.org ML22029A000 Email: hml@nei.org ML22032A175 ML22062A53 No. Commenter Comment NRC Resolution 1 Kyle Wendtland In Appendix A, the illustrative example uses Equation A.2 Comment accepted.
(WDEQ) for the demonstration of compliance with the 10 CFR 20.1201(e) limit of 10 mg per week of soluble The staff has revised the text and equation to U-nat compounds (Class D and W). The text states that provide exposure time in minutes. The APF is the licensee may use air sampling data, worker exposure, dimensionless and does not have units of and assigned respiratory protection factors (APF), milligrams; APF and the breathing rate were however the equation itself does not explicitly reflect the already defined in equation A.1 and need not be use of the exposure duration. In its current form the repeated.
equation indicates that the fraction of time in hours that the radiological worker is exposed to radiation is 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> (2400 minutes), or one full work week. It is recommended that the equation be updated to include a multiplicative term to account for the duration of exposure, so that it is
No. Commenter Comment NRC Resolution more generalized for use with any exposure period. The following suggested formula includes the exposure time in minutes.
0.001
, =
Where:
mi,U = the mass intake of uranium isotope i (mg),
SAi,U = the specific activity of uranium isotope i (Ci/g),
BR = the breathing rate of Reference Man under light work conditions (20,000 ml/minutes),
t = the exposure duration of time (minutes),
APF = the respiratory assigned protection factor (mg),
0.001 = a conversion constant that yields the mass intake in (mg) 2 Kyle Wendtland It would be helpful to cite RG 8.9 in Page A-2 under Comment accepted.
(WDEQ) Soluble Uranium Intakes subsection for the other acceptable methods of uranium intake estimate based on The sentence below was added to the end of the bioassay measurements. Alternatively, expanding the section on soluble uranium intakes:
example calculation given in Appendix A of the Draft Guidance to add the use of Intake Retention Fraction Regulatory Guide 8.9 describes acceptable (IRF) from NUREG/CR-4884 and using Equation 1 from methods for using bioassay measurements to Section 4.3 of RG 8.9 Rev 1, would be helpful. estimate uranium intakes.
3 Kyle Wendtland Table A-1 should be updated to include the three uranium Comment not accepted.
(WDEQ) isotope air concentrations, the Cs-137 and the Ce-144 concentrations used in the calculation of the intakes. In Equation A.1 shows the reader how intake is addition, the duration of the workers exposure duration in calculated for known values of radionuclide minutes and the APF used in the calculation of concentration in air, duration of the workers radionuclide intakes in Table A-1 need to be provided for exposure, and APF. It is not necessary to show illustration purposes. hypothetical values for these input parameters in table A-1.
4 Kyle Wendtland Under Committed Effective Dose Equivalent (CEDE) of Comment accepted.
(WDEQ) Appendix A, there is a typo, the data used in calculating
No. Commenter Comment NRC Resolution CEDE were actually taken from Table A-1 and not from Table A-2 as mentioned in the text.
5 Kyle Wendtland The rounding of the U-234 Specific Activity (SA) value Comment accepted.
(WDEQ) found in Table A-2 is incorrect, the value should be written as:
6.2E-3 (Ci/g) instead of 6.3E-3 (Ci/g).
6 Kyle Wendtland In Section 4.4.2, a statement is made that would be in an Comment accepted.
(WDEQ) overestimation of the CDE to a specific tissue or organ from the combined contributions from all inhaled or The statement has been removed.
ingested radionuclides. The statement is:
The CDE for all radionuclides combined is then the sum of the CDE from nonstochastic radionuclides and the CDE from stochastic radionuclides. The combined dose (i.e., combined CDE) should be the sum of the CDEs using the nonstochastic values (whether each value is the limiting conversion factor or not) for each radionuclide as found in Tables 2.1 and 2.2 in FGR No. 11 for inhalation and ingestion pathways, respectively.
7 U.S. Navy Comment 1.1
References:
Comment 1.1 accepted.
- a. ISO/IEC 17025, General requirements for the References a-e have been added to the competence of testing and calibration laboratories bibliography.
- d. ANSI/HPS N13.11:2009, Personnel Dosimetry PerformanceCriteria for Testing
No. Commenter Comment NRC Resolution
- e. ANSI/HPS N13.32:2008, Performance Testing of Extremity Dosimeter Comment 1.2 not accepted.
Comment 1.2 The regulations in 10 CFR 20.1501(d) do not Draft of Regulatory Guide DG-8060 states the following require all dosimeters (such as electronic on page 14, lines 20-34: dosimeters) to be processed by a processor accredited by the NVLAP. The regulations 3.7 Dosimeter Processing require that dosimeters that are processed to be processed and evaluated by a processor holding Personnel dosimetry that requires processing must be NVLAP accreditation.
processed and evaluated by a dosimetry processor holding accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) pursuant to 10 CFR 20.1501(c). The NRC interprets processing to mean a process, separate from and independent of the design of the dosimeter, that is required to extract dose information from the dosimeter after exposure to radiation. For example, film dosimeters, thermoluminescent dosimeters, and optically stimulated luminescence dosimeters, require processing by qualified technicians using separate equipment to obtain data to compute the dose measurement.
Conversely, dose measurements obtained from electronic dosimeters or digital output personnel dosimeters (e.g., direct ion storage dosimeters) do not require processing since the data is extracted directly from the dosimeter (i.e., through a process independent of dosimeter processing). Therefore, since processing is not required for this type of dosimeter, there is no requirement for processors to have NVLAP accreditation. (Italics added)
Comment 1.2.a Comment 1.2.a partially accepted.
Presented description of the NVLAP program is The draft RG does not describe the NVLAP incomplete and in some respect misleading. NVLAP process. It states only that if a dosimeter is accreditation is not limited to the requirements for the processed, the processor must hold NVLAP dosimeter processing. accreditation.
References [a-e] provide a comprehensive description of References a-e have been added to the the criteria for NVLAP accreditation and its process. bibliography.
Besides the requirement to have written procedures for dosimetry processing, it also includes management and technical requirements [a-c] and periodic proficiency testing [d-e]. Presence of a quality system which provides consistency in reporting valid doses to personnel is one of the key management requirements.
Maintenance of the metrological (NIST) traceability, acceptance testing of new dosimeters, evaluation of radiation dose uncertainty, periodic verification of dosimeters calibration are most important technical requirements.
Comment 1.2.b Comment 1.2.b not accepted.
NVLAP accreditation should be required for any dose An RG cannot establish new requirements. The assessment and assignment process used to determine proposed changes would require rulemaking to personal dose of record for workers in the United States, add requirements to 10 CFR 20.1501(d).
regardless of the measurement technology. Failure to do so could result in the use of sub-standard technology, equipment, algorithms, and review methods to determine occupational personnel dose of record. NVLAP accreditation requirements will ensure that correct doses will be recorded for the personnel. NVLAP accreditation ensures use of competent laboratories and equipment proven to meet NVLAP criteria. Moreover reference [4]
includes a description of proficiency testing with caveats for electronic dosimeters and Pacific Northwest National
No. Commenter Comment NRC Resolution Laboratory performs NVLAP and DOELAP proficiency testing of electronic dosimeters. Management and technical NVLAP requirements are equally important for electronic dosimeters as for passive dosimeters in supporting the production of quality dose of record results.
(Navys) Proposed language (underlined) is the following:
3.7 Dosimeter Processing Personnel dosimetry that requires processing must be processed and evaluated by a dosimetry processor holding accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) pursuant to 10 CFR 20.1501(c). The NRC interprets processing to mean a process, separate from and independent of the design of the dosimeter, that is required to extract dose information from the dosimeter after exposure to radiation. For example, film dosimeters, thermoluminescent dosimeters, and optically stimulated luminescence dosimeters, require processing by qualified technicians using separate equipment to obtain data to compute the dose measurement.
Conversely, dose measurements obtained from electronic dosimeters or digital output personnel dosimeters (e.g., direct ion storage dosimeters) do not require processing, since the data is extracted directly from the dosimeter (i.e., through a process independent of dosimeter processing). However, management and technical NVLAP requirements are equally important for electronic dosimeters as for passive ones. Monitoring by NVLAP ensures the presence of a quality system which provides consistency in reporting valid doses to
No. Commenter Comment NRC Resolution personnel. Maintenance of the metrological (NIST) traceability, acceptance testing of new dosimeters, evaluation of radiation dose uncertainty, periodic verification of dosimeters calibration are important technical requirements of NVLAP accreditation required for personnel dosimeter systems.
Additionally, all personnel dosimeters that are used by licensees to comply with 10 CFR 20.1201, with other applicable provisions of chapter 10 of the CFR, or with conditions specified in a license, must be processed and evaluated by a dosimetry processor holding accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) pursuant to 10 CFR 20.1501(c).
8 U.S. Navy Comment 2.1 (for clarity, Comment 2 has been Comment 2.1 not accepted.
renumbered into two parts, Comment 2.1 and Comment 2.2) The current wording does not specify the type of dosimeter. Electronic dosimeters or passive Section 3.2, page 13, second sentence: Further dosimeters may be used.
clarification is required. It does not take into consideration Electronic Dosimeters (ED) or passive/active dosimeters.
For ED and passive/active dosimeters dose results do not have to wait to the end of the year.
Comment 2.2 (for clarity, Comment 2 has been Comment 2.2 accepted.
renumbered into two parts, Comment 2.1 and Comment 2.2) The staff has updated the wording as follows to include the concept of dosimeter job-specific The radiation worker and licensee can process the monitoring and use of the monitoring data from dosimeter at a more frequent rate, therefore could make that job-specific monitoring period to determine a determination where in the body the dosimeter should the annual deep-dose equivalent (DDE).
be placed.
No. Commenter Comment NRC Resolution At the end of the job-specific monitoring period, the maximum DDE would be determined and used in determining the annual DDE.
9 Hilary Lane Section 2.1 Comment accepted.
(NEI) Footnote 1 appears to have a typo in the phrase the term should denote a recommendation Proposed Resolution:
Revise the footnote to use the term denotes instead of denote 10 Hilary Lane Section 2.5 Comment accepted.
(NEI) The following sentence appears to contain a typo (emphasis added): The staff has corrected the text in section 2.4 to state unplanned, unintended.
These scenarios do not involve required monitoring because the prospective dose evaluation determined that these types of unplanned, intended exposures may occur and were not likely to exceed occupational dose limits.
Proposed Resolution:
The phrase unplanned, intended exposures seems to be a typo which needs to be corrected. Based on the guidance in the DG it appears that the phrase should say unplanned, unintended exposures. If this is not a typo, additional guidance is needed on what this term means.
11 Hilary Lane Section 3.2 Comment accepted.
(NEI) The last two sentences of this Section appear to contradict each other: The staff has revised the text as follows:
At the end of the year, doses from each location would be summed. The DDE to be recorded would be that of At the end of the job-specific monitoring period, the dosimeter location receiving the highest dose. the maximum DDE would be determined and used in determining the annual DDE.
No. Commenter Comment NRC Resolution It is not possible to sum each location while also only recording the highest location. Clarification on this statement is needed.
Proposed Resolution:
NRC should revise the last two sentences of the section to clarify that the DDE is the sum of each location with the highest dose per wear period. Currently, the draft as written does not convey that meaning.
12 Hilary Lane Section 3.4 and similar wording in Section 4.5 Comment partially accepted.
(NEI) The following sentence contains unclear language (emphasis added): The NRC guidance is to use VARSKIN+ 1.0 or more recent versions. Older versions of the For hot particles or contamination on or near the skin, NUREG have outdated beta dosimetry models SDE may be calculated using methods described in that have been significantly improved in NUREG/CR-6918, Revision 4, VARSKIN+ 1.0, A Revision 4.
Computer Code for Skin Contamination and Dosimetry Assessments issued in 2021 (Ref. 25) or more updated In addition, the staff has revised the RG to versions. provide licensees with information on how to The reference to a specific revision of NUREG/CR-6918 obtain the most recent version of VARSKIN+ 1.0 and the terminology or more updated versions appears through the NRCs Radiation Protection to be limiting and may confuse the reader to infer or Computer Code and Maintenance Program interpret that an earlier version of Varskin (e.g., Varskin (RAMP) website.
5, etc.) cant be used.
Note: The most recent version of VARSKIN is Proposed Resolution: available on the NRCs website for the Radiation Protection Computer Code and Maintenance For clarity, we recommend not referring to a specific Program (RAMP).
revision of NUREG/CR-6918 and deleting the words or more updated versions.
No. Commenter Comment NRC Resolution 13 Hilary Lane Appendix A Comment accepted:
(NEI) In the Appendix A example, it is not clear to all readers how the uranium calculations are performed. I.e., from Equation A.1 provides a method of calculating the calculations of intake masses (Table A-2) to the the intake (in units of microcuries) of a mix of calculation of CEDE (Table A-3) radionuclides based on air sampling (or bioassay) for a worker who is wearing respiratory protection. Table A-1 is a data set showing radionuclides detected, their solubility class, the mode of intake, and the amount of intake (in units of microcuries).
In consideration of chemical toxicity, NRC establishes a limit on the mass intake of soluble uranium in 10 CFR 20.1201(e). Equation A.2 provides a method of calculating this intake of soluble uranium in units of milligrams, based on the results of radioactivity air sampling by converting microcuries of intake into mass of intake in units of milligrams.
Equation A.3 is a calculation of committed effective dose equivalent (CEDE) based on the example intake values from Table A-1. Table A-3 shows the results of the CEDE calculation based on Equation A.3 with intake values given in table A-1.
Proposed Resolution:
Section C.2.2 describes methods of performing It would be helpful if the RG provided some additional, prospective dose evaluations for both external more straightforward calculations of other scenarios.
and internal exposures. Guidance is given on the It would also be helpful to include an example, or acceptable use of historical surveys, anticipated additional guidance, on an acceptable situation for work activities, radiological surveys, and credit
No. Commenter Comment NRC Resolution documenting a prospective evaluation for the need for for use of protective clothing, use of respiratory monitoring, and how to properly evaluate and document equipment.
the situation.
14 Hilary Lane Appendix A Comment accepted.
(NEI) The last sentence before Table A-2 appears to have typo in the language If bioassay monitoring indicates additional intake occurred Proposed Resolution:
Revise the language to change the word intake to intakes.
15 Hilary Lane Appendix A Comment accepted.
(NEI) It appears that the statement Table A-2 shows the data used in calculating CEDE incorrectly refers to Table A-2 when it should refer to Table A-3.
Proposed Resolution:
Revise this to correctly refer to Table A-3 instead of Table A-2.
No. Commenter Comment NRC Resolution 16 Hilary Lane Appendix A Comment accepted.
(NEI) The Committed Dose Equivalent (CDE) section at the end of page A-3 appears to incorrectly refer to Table A-3 when it should refer to Table A-4.
Proposed Resolution:
Revise this to correctly refer to Table A-4 instead of Table A-3.
17 Hilary Lane Appendix A Comment accepted.
(NEI) The sentence below Table A-4 appears to incorrectly refer to Equation A.3 instead of Equation A.4.
Proposed Resolution:
Revise this to correctly refer to Equation A.4 instead of Equation A.3.
18 Travis Deti Use of Individual or Material-Specific Comment partially accepted and partially not (WMA) Information/Soluble Uranium Intakes accepted.
The draft document discusses the use of individual or material specific information and soluble uranium intakes. The commenter does not explain how the The document should also reference: referenced document either provides additional
- Brown, Steven & Chambers, Douglas. (2014). Worker support for existing recommendations in the draft Protection Implications of the Solubility and Human guide or uses an acceptable alternative Metabolism of Modern Uranium Mill Products in the U.S. approach.
Health physics. 107. 403-409.
10.1097/HP.0000000000000136.
However, this document has been added to the This recent (2014) paper should be considered in the bibliography.
documents preparation and referenced in it, since it
No. Commenter Comment NRC Resolution contains valuable uranium recovery industry specific information and also provides additional references specific to uranium mill products in the United States.
19 Travis Deti Voluntary Monitoring Comment accepted.
(WMA)
This section states: No change needed.
Voluntary monitoring beyond that required in 10 CFR 20.1502 may be performed. The results of voluntary monitoring obtained when monitoring was not required by 10 CFR 20.1502 are not subject to dose recording requirements. However, to keep the occupationally exposed individual better informed, a licensee should record and report the results of this monitoring or establish criteria for when to record and report voluntary monitoring (see RG 8.7).
The WMA supports this language since at some uranium recovery facilities monitoring may not be required by 10 CFR 20.1502 but may be performed to inform individuals of exposure conditions, or to alleviate safety concerns. The results of voluntary monitoring, for which reporting is not required, can be provided verbally to employees.
No. Commenter Comment NRC Resolution 20 Travis Deti Section 4.5Doses from Intakes through Wounds Comment accepted.
(WMA)
A portion of this document (Section 4.5) is devoted to The staff has added the proposed wording to doses from intakes through wounds. The section should section 4.5 as a recommendation.
clearly state that:
Decontamination or radiological assessment of any wound shall not interfere with or take precedence over proper medical or surgical care. First aid treatment shall always be given priority.
21 Travis Deti Bioassaying Comment accepted.
(WMA)
The document references RG 8.9, Acceptable Concepts, These documents have been added to the Models, Equations, and Assumptions for a Bioassay bibliography.
Program, and RG 8.22, Bioassay at Uranium Mills. It fails however to reference another relevant bioassay guidance specifically:
HPS N13.22-1995American National Standard Bioassay Programs for Uranium Health Physics Society JournalVolume 83, Number 5, Special Issue on Inhalation Intake Retention Fractions from Current ICRP Models NUREG-0874, Internal Dosimetry Model for Applications to Bioassay at Uranium Mills NUREG/CR-4884Interpretation of Bioassay Measurements These additional references should be incorporated.
No. Commenter Comment NRC Resolution In conclusion, the WMA believes that the document could be strengthened and made more useful, especially to uranium recovery licensees, through the use of additional references specific to uranium processing and bioassay for uranium.
The staff has incorporated the referenced minor In addition, the suggested minor modification specific to modification (regarding priority of medical care Doses from Intake through Wounds should be made. over radiological assessment) into section 4.5.