ML22035A082
| ML22035A082 | |
| Person / Time | |
|---|---|
| Issue date: | 08/23/2024 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| J Fisher, NMSS/MSST/MSEB | |
| Shared Package | |
| ML21165A155:ML22251A239 | List: |
| References | |
| Download: ML22035A082 (15) | |
Text
ML22035A082 Comment Resolution Document - External Summary of Comments for Interim SA-300, Reporting Material Events and the Handbook on Nuclear Material Event Reporting for the Agreement States (interim).
The interim SA-300 Procedure and the Handbook on Nuclear Material Event Reporting for the Agreement States (interim) were sent to the Agreement States, NRC NMSS, NRC Regions I, III, and IV for Comment in STC Letter 22-033, Notification of the Issuance of, and Opportunity to Comment, dated August 3, 2022. The comment period was for six months and ended on February 3, 2023. No comments on the interim SA-300 Procedure were received. All comments below are for the Handbook on Nuclear Material Event Reporting for the Agreement States (interim).
Comment No.
Source Location Comment Accepted Remarks 1
Arkansas Appendix A The title/statement at the top of Table A.1.
seems like it needs to be modified since all of Part 20 does not apply to all NRC licensees (e.g., some of the general licensees). Most of the general licenses are exempt from most of Part 20s provisions. Certain general licensees are subject to certain notification requirements.
Yes Change made.
2 California Appendix A Can the language Immediate and ASAP be consistent so that the chart is straightforward?
Yes Immediate and ASAP is the language used in the regulations and is the timeliness requirement for the licensee. These terms are still used in Column 2 of Appendix A, however the 3rd column was changed to Agreement State timeliness requirements for notifying the HOC. For both immediate and ASAP, a
timeliness requirement of 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> is applicable.
3 Texas Appendix A 10 CFR 39.77(c) 10 CFR 39.77(c) states that the Agreement Sates needs to notify the HOC after the source is determined to be irretrievable. This is a new requirement and unfair. The Agreement State has never been required to notify the HOC before.
Yes This error was corrected in STC-22-065 dated November 28, 2022 and in the revised interim SA-300 Handbook (ML22266A091).
These corrections were carried over into this version.
4 Texas Appendix A No NRC reg (10 CFR 20 or other) requires reporting of leaking sources in fixed or portable nuclear gauges.
Reporting for others is covered:
10 CFR 31.5 Leaking General License sources/devices 10 CFR 34.27 Leaking radiography sources 10 CFR 35.67 Leaking Medical sources 10 CFR 35.3067 Leaking Medical sources 10 CFR 39.35 Leaking well-logging sources Using standard License Conditions, NRC manages the reporting for specifically licensed fixed/portable nuclear gauges. The State of Texas manages it through state regulations rather than license conditions. It is unknown how other agreement states manage it.
We suggest adding an entry in Appendix A for reporting requirements for leaking sources other than the ones covered by the rules above.
Yes The section titled Leaking Sealed Sources was added to provide clarity.
NMED tracks all sealed sources with leak test results of 185 Bq (0.005
µCi) or more; if the leak test results are less than 185 Bq (0.005 µCi), the events are not entered into NMED.
This includes reports made to comply with reporting requirements in the compatible Agreement State regulations and in the license.
By adding these changes, this concern was addressed. Therefore, an additional entry was not added into Appendix A.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060) 5 Texas Section 3, Reporting Material Events In this section, the 3rd paragraph tries to assign definitions for reports that a written report is submitted to NMED. It also refers to the initial report to the HOC as just a report (in another section). This is confusing. If you call the HOC for your initial report, they have you send it in writing. If you email or fax, it is a written report. Consider using NMED Report or NMED written report for reports to NMED and use HOC Initial written report for reports that are submitted to HOC.
Consider including this information in the same paragraph (Section 3, 3rd paragraph) to define which is preferred. We believe these suggestions would address potential confusion.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The text referenced was removed. The Handbook now uses NMED report, as recommended.
The term Report to the HOC is used to refer to events reported to the HOC by the Agreement States.
An NMED report is defined as an event report or follow-up report submitted to the NMED contractor. A report submitted to NMED by file upload, email, or submission through the mail.
The term Event Report includes both events reported to the HOC and written reports.
Compatible Agreement State regulations require licensees to submit written reports. When the Agreement State staff receives these written reports from the licensee, they then submit them as an NMED report.
With this change, the terms NMED report and written report may no longer be used interchangeably.
6 Texas Section 3.1, Timeliness States immediate and as soon as NRC accepts possible reports on that business day. It does not define what is expected if you receive a report, for example, at 23:45 hours.
Immediate used to be defined as 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />. So maybe it should say end of the business day or 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />, whichever is longer. Also, business day is being used in relation to immediate and ASAP. Does this mean you dont report these events with the shortest notification requirement because they are serious events on weekendsif an event occurs on Friday, Saturday, or Sunday then it doesnt have to be reported until Monday?
Business day is not being used for the 24-hour reports. Allowing some additional time to get facts to report for these serious events is appreciated, but we dont think you want them waiting over a weekend to be reported.
We suggest removing business and using same day/next day.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes Added a chart to the Timeliness section to ensure that these nuances are addressed.
The business day and calendar day terms were removed from Appendix A.
Agreement State staff also communicated this message during the Government to Government meeting on November 15, 2022 that the additional leniency was not needed by the Agreement States.
During the discussion at the November 15th meeting, Agreement State participants stated a preference for consistency with past practice. As such, Immediate and ASAP reporting were changed back to Agreement State reporting within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of receipt of the licensee report.
7 Texas Section 3.2, Event Report Identification Number The agreement now states shall assign and reference an Event Report Identification Number for all reports to the HOC and all written reports, which tells how the number should be created. The NMED database does this. In 3.3, it states that you shall include the Event Report Identification Number for each reported event to the HOC, and in 5.5, it says that an NMED record is created after events are reported to the HOC.
It is not a big deal, but now I will have to make a file in the NMED database first to get the number to include in the initial report to HOC so that the created Event Report Identification Number is the same through the system.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The language was modified.
An Event Report Identification Number should be assigned to reports made to the HOC.
The Agreement State may use its own numbering convention or reference the Event Notification (EN)
Number as generated by the HOC. As an example, the Event Report Identification Number may consist of the two letter State agency ID, two-digit year corresponding to the reporting year, and a sequentially assigned four-digit ID number.
For the Agreement States that have developed their own numbering conventions, this practice is fine.
Please note: The Event Report Identification Number is NOT the NMED Item Number.
8 Texas Section 3.4.1, Sensitive Information This is a new section. Is it a correct interpretation to summarize if Cat 1 or Cat 2 quantities are involved, we must provide a bracketed copy and a redacted copy? Or, can we not include the actual activity in the Initial Yes Reports to the HOC The discussion on Sensitive Information is not pertinent to reports to the HOC. NRC licensees and Agreement
HOC Report but put it in NMED written report? We do not include personal information in written reports to HOC or NMED.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
States may continue to submit all necessary information to the HOC. The NRC staff reviews this information for SUNSI, and handles it accordingly.
NMED Reports NMED should not contain sensitive unclassified non-safeguards information (SUNSI) - security-related information.
NMED should not contain personally identifiable information (PII).
NMED is an electronic recordkeeping system with restricted access. NMED does not provide a function to limit the information to only individuals with a need to know, thus NMED should not contain SUNSI.
The Agreement States shall review all materials for sensitive information prior to submitting content into NMED. If sensitive information is required to describe the event, the Agreement State shall provide a copy of the
document that redacts PII and/or SUNSI - security-related information with a note to describe where the unredacted version can be obtained from.
9 Texas Section 3.4.2 This is new, saying event reports should (its not a shall) include the SI units as well as conventional unitsand it goes on the show how that should be done: SI units first with the traditional team equivalent following in parentheses. However, in 10 CFR 20 and others, conventional numbers are first and SI units in brackets after. Also, limits are listed in curies first and SI after, or just curies (example: table, 20.1005 Units of radioactivity). ALI and DAC limits use curies.
Should the event reports be consistent with the rule?
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The section titled Units was removed.
10 Texas Section 3.4.2 Also, our dose limits are listed in rems and sieverts, not gray. In the example, they use gray, and when submitting reports, there is mixed-use. We propose the term gray be used for absorbed dose in any material and rem for biological. Dose limits are traditional in rem. Please consider rewording for consistency.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The section titled Units was removed.
11 Texas Section 3.4.4 Follow-up Written Reports are the same as 2.4 in the previous SA-300 (March 2013).
Both state follow-up written reports to NMED should include all investigative information obtained through closeout of the event and document(s) or clear reference to documents on file that the Agreement State used to generate the NMED record. This sounds like they are asking states to submit more than a report of the pertinent facts related to the event, a summary of information, and facts from the investigation, root cause, and corrective actions. These two statements read like they want us to submit our investigation file. We suggest continued reporting as we have been and indicate the section be reworded during this revision unless they want additional documentation.
All documents and information are kept by each state and are available upon request if someone in NRC/NMED needs additional information.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The line, all investigative information obtained through closeout of the event, was deleted from the Handbook. The NRC does not want the entire investigative file included.
12 Texas Section 3.4.4 Also, you are removing on a monthly basis for follow-up reports that should be submitted. Is this a correct interpretation?
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The requirement to add updates to NMED on a monthly basis was removed.
This was a correct interpretation. The Agreement States should update NMED when the information is available. The Agreement States do not need to continue with the
practice of updating the file with No new information is available.
13 Texas Section 5.6 The two opening paragraphs are not easy to understand. We no longer report non-reportable events through NMED. They dont want a record of situations that dont fit reporting requirements but could be important, helpful to others, information sharing, etc. Is the request to report them to HOC for logbook entry voluntarily?
Since states cannot search logbook entries to find similar or potentially related non-reportable events, we suggest they still be submitted to NMED but under a category created for them. The same information form can be used, and the state can fill in general or applicable information. NMED would probably not be able to have a complete record for many of these, but that could be a non-requirement for the category. This would be a valuable opportunity to share information for state programs to access and search for information.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The section titled Voluntary Reports and Non-reportable Records was removed.
Records of voluntary reporting are no longer retained in NMED. This change in process was due to budgetary constraints.
Events that are reported to the HOC that do not meet the reportability thresholds will be shared with the NRC staff via a Logbook Entry.
This information is not retained as an agency record and is not uploaded to NMED. Logbook entries do not support operating experience and are not shared widely.
Agreement States are encouraged to voluntarily report suspicious activities, even if its lower than the reportability thresholds.
Clarification was added to demonstrate the agency actions related to voluntarily reporting suspicious activities to the HOC.
14 Texas Section 5.6.1 Is it a correct interpretation to say orphan sources below Appendix C quantities are no longer tracked; therefore, we dont have to make any report to HOC or NMED? Are Orphan Sources x 1,000 above Appendix C values where no licensee is reported to HOC or NMED? We suggest clarifications in this area.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes Yes. Orphan sources below the quantities listed in 10 CFR Part 20 Appendix C, Quantities of Licensed Materials Requiring Labeling, are no longer tracked in NMED. (These sources are less than the reporting requirement in 10 CFR 20.2201.) Clarification was added to the handbook.
Orphan sources that meet the reporting requirement in 10 CFR 20.2201, Reports of theft or loss of material, should be reported and are tracked in NMED.
15 Texas Section 5.6.2 Where (to whom, within what time frame, etc.) is a found source that was not reported previously as lost required to be reported?
We suggest clarification in this area.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes A section titled Found Sources was added to the handbook. The timeliness requirement and method of reporting is the same for a found source, as it is for a lost source. The reference to the regulations was added.
16 Texas Section 5.6.3 Section 5.6.3 Landfill Radiation Monitor Alarms, there should be some clarification on this topic. Also, what is the NMED Coding Manual?
Some of the points:
- Medical isotopes from residential (neighborhoods, nursing homes) and even commercial locations that are a business that Yes The NMED Coding Manual is a document maintained by the NMED Contractors.
The PDF can be obtained from the Help section on the NMED website.
For the points on medical isotopes, please see the
does not include medical RAM licensee would be excreta and would be exempt o Less than 120-day half-life o Could be multiple patients in a nursing home, so it could be a high activitybut its still exempt excreta going into a landfill where it will be covered overnot an issue
- Non-medical isotopes that exceed the reportable criteria should/would be reported regardless of where it was found: landfill, public domain, construction site, etc.
If there is an issue with some states trying to report every landfill alarm, then maybe it should be addressed with those states.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
RCPD 23-003 letter, Voluntary Information Request for the Management of Short-lived Medical Isotopes in Household and Municipal Waste, dated April 24, 2023.
Interpretations of this topic are not appropriate for the SA-300 Handbook.
17 Texas Appendix A Dose limits are the opposite of the rule, and Sieverts are used in this section. (see 3.4.4 comments)
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes The section titled Units was removed.
18 Texas Appendix A The reporting criteria for disconnect of radiography source still say 30 days, yet it states it falls under 30.50b2. It would be helpful if they matched.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes A section titled Industrial Radiography was added to provide clarity.
Incidents involving radiographic equipment (including unintentional disconnection of the source
assembly from the control cable) are reportable under 10 CFR 34.101, Notifications, section (a).
The licensee is required to provide a written report within 30 days of the occurrence and is in addition to the 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> report to the HOC if 10 CFR 30.50(b)(2) also applies.
19 Texas Appendix C Appendix C has Cause and corrective actions (Agreement State and licensees actions) listed twice.
REFERNCE: Texas Department of State Health Services, submitted October 4, 2022 (ML22279B060)
Yes This typo was fixed.
20 Government to Government meeting on November 15, 2022.
Section 3.1, Timeliness Agreement State representatives did not like the change in Immediate and ASAP reporting to Next Business Day report. While some Agreement State representatives appreciated the leniency, the majority wanted to return to ASAP = within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />, with a stress on clarity and consistency.
Yes This change was made.
21 Government to Government meeting on November 15, 2022.
For the discussion on jurisdiction with event reporting, its important to stress the importance of communication between stakeholders. Providing a couple of complex examples with the appropriate response would be helpful.
Yes The importance of communication between stakeholders was added to a new section titled Jurisdiction.
22 Government to Government meeting on Section 3.4.5, Follow-Up NMED Reports The interim Handbook removed the reference to a monthly update of information into NMED. In the past, the Agreement State representative explained that they used to enter on a monthly basis the phrase, no new Yes Added clarifying language that: Follow-up NMED reports should be submitted when the information becomes available.
November 15, 2022.
information. With the removal of this reference, the staff will no longer need to do this, and it is appreciated.
Agreement States do not need to add the phrase no new information on a monthly basis.
23 Government to Government meeting on November 15, 2022.
Section 3.4.5, Follow-Up NMED Reports Because of the wording of the interim Handbook, it makes it sound like we need to submit all of the information in the Follow-up NMED Report. It doesnt seem necessary to input it all. We might have a summary, but do you want the whole file or all the files?
Yes The NRC does not necessarily want the entire file or all the files. The goal is to close the event in NMED and to include the minimum event information listed in Appendix C. If an inspection report or letter includes all the information that is sought after, then you may upload the file. You may also input just the relevant text directly into NMED.
24 Government to Government meeting on November 15, 2022.
Section 9, Abnormal Occurrences On the topic of additional information, the events under consideration as an Abnormal Occurrence may get additional questions.
The NRC staff (RSAO, etc.) may be asking for some additional information needed to support the NRC's assessment of the potential AO and potentially on a more frequent periodicity. A clarification should be added in Section 9 of SA-300.
Yes Included.
25 Government to Government meeting on November 15, 2022.
Section 3.4.3, Units The interim Handbook should say SHOULD include the SI units, not a SHALL.
Yes The section titled Units was removed.
26 OAS Section 5.6.3, The Landfill Radiation Monitor Alarms section should be expanded to consider Yes A subsection titled Scrap Metal Recycling Facility and
Landfill Radiation Monitor Alarms nuclear material identified at unlicensed scrap metal recycling facilities and unlicensed incinerator facilities. Alternatively, an additional section could be added after section 5.6.3 to address these locations.
Reference:
OAS Letter, dated February 3, 2023 (ML23059A432)
Incinerator Facility was added.
27 OAS Appendix A In the Handbook, Appendix A, Table A.1, the reporting requirements for 10 CFR 37.81(e) and (f) are combined as one item. However, the reporting requirements for 37.81(e) and 37.81(f) have minor differences. 10 CFR 37.81(e) requires notification to the NRCs Operations Center and the LLEA upon recovery of lost or missing category 1 quantities of radioactive materials, while 37.81(f) only requires notification to the NRCs Operations Center upon recovery of lost or missing category 2 quantities of radioactive materials. These reporting requirements should be separated in the Handbook for clarity.
Reference:
OAS Letter, dated February 3, 2023 (ML23059A432)
Yes These line items were separated in the chart.
28 Texas Appendix A 49 CFR 171.15(b)(1) requires that a report be made to the National Response Center if a person is killed or receives an injury requiring admittance to a hospital, as a direct result of the radioactive material.
We want to make sure that all that is to be reported are the events where the hazardous materials is what caused the incident and not the fact that it was involved in the accident.
Yes Added a section titled Transportation to the handbook to add clarity.