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{{#Wiki_filter:Attachment 1 | {{#Wiki_filter:Attachment 1 Regulatory Evaluation Summary Reporting of Medical Treatment of a Contaminated Individual 1.0 Overview of the Issue The purpose of the proposed regulatory initiative is to address situations involving the following NRC regulations: | ||
10CFR70.50 Reporting requirements (b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours after the discovery of any of the following events involving licensed material: | |||
of the Issue The purpose of the proposed regulatory initiative is to address situations involving the following NRC regulations: | |||
10CFR70.50 | |||
-four hour report. Each licensee shall notify the NRC within 24 hours after the discovery of any of the following events involving licensed material: | |||
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. | (3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. | ||
10CFR40.60 | 10CFR40.60 Reporting requirements (b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours after the discovery of any of the following events involving licensed material: | ||
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. | (3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. | ||
Specifically, the industry is seeking clarification in the interpretation of the following: | Specifically, the industry is seeking clarification in the interpretation of the following: | ||
* medical treatment | |||
* medical facility (onsite vs. offsite) | |||
* with spreadable radioactive contamination In addition the industry is seeking a regulatory framework that will ensure consistent interpretation. | |||
Statement 2.1 | 2.0 Purpose Statement 2.1 Medical Treatment The industry interprets the definition medical treatment to align with OSHA guidelines. As stated in OSHA regulation 29 CFR 1904.7(b)(5) medical treatment does not include: | ||
: 1. A visit to a physician or other licensed health care professional (e.g., nurse) solely for observation or counseling, or | : 1. A visit to a physician or other licensed health care professional (e.g., nurse) solely for observation or counseling, or | ||
: 2. The conduct of diagnostic procedures, such as x | : 2. The conduct of diagnostic procedures, such as x-rays and blood tests, including the administration of prescription medications used solely for diagnostic purposes (e.g., eye drops to dilate pupils); or | ||
-rays and blood tests, including the administration of prescription medications used solely for diagnostic purposes (e.g., eye drops to dilate pupils); or | : 3. First aid [further clarified in 29 CFR 1904.7 (b)(5) (ii) | ||
: 3. First aid | NOTE: This interpretation would not remove the requirement to notify the NRC for offsite medical treatment of an individual who has spreadable contamination on their clothing or body. The industry recognizes the importance of informing the NRC of any interaction of a contaminated individual with the general public. | ||
NOTE: This interpretation would not remove the requirement to notify the NRC for offsite medical treatment of an individual who has spreadable contamination on their clothing or body. The industry recognizes the importance of informing the NRC of any interaction of a | Page 1 of 3 | ||
Attachment 1 2.2 Medical Facility The NRCs interpretation requires the industry to provide a 24 hour report to the NRC regardless of whether the medical treatment facility is located offsite or on the licensee property. | |||
This interpretation is inconsistent with the reporting requirement for 10 CFR 50 licensees (see below) which requires reporting (within 8 hours) only if the facility is located offsite. 10CFR50.72 | For facilities with medical treatment capabilities (as discussed above) onsite and with processes in place for managing potential contamination this interpretation has led to the reporting of multiple low significance incidents necessitating the commitment of significant resources to event notifications followed by written reports. | ||
If not reported under paragraphs (a), (b)(1) or (b)(2) of this section, the licensee shall notify the NRC as soon as practical and in all cases within eight hours of the occurrence of any of the following: | This interpretation is inconsistent with the reporting requirement for 10 CFR 50 licensees (see below) which requires reporting (within 8 hours) only if the facility is located offsite. | ||
10CFR50.72 Immediate notification requirements for operating nuclear power reactors (3) Eight-hour reports. If not reported under paragraphs (a), (b)(1) or (b)(2) of this section, the licensee shall notify the NRC as soon as practical and in all cases within eight hours of the occurrence of any of the following: | |||
xii) Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment. | xii) Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment. | ||
The industry seeks to change the interpretation of | The industry seeks to change the interpretation of medical facility so that reporting would apply only to offsite medical facilities. | ||
2.3 | 2.3 With Spreadable Radioactive Contamination The interpretation of the term with spreadable radioactive contamination appears to be inconsistent. For example a Notice of Violation (Inspection Report Number 70-143/2014-003) was issued based upon a regional interpretation that the contamination on the skin of a person is not fixed, but spreadable due to the process during which the external layers of skin die and fall off. | ||
. For example a Notice of Violation (Inspection Report Number 70 | This interpretation is inconsistent with standard health physics professional practices which recognize that spreadable/removable contamination is characterized by the ability to physically transfer the material via contact with another medium. | ||
-143/2014-003) was issued based upon a regional interpretation that | This reality is central to the internationally recognized technique by which contamination is determined to be fixed/non-transferable or loose/spreadable. The surface of the contaminated material is rubbed with a medium such as cloth or filter paper. If the contamination is detected on the medium, the contamination is considered loose/spreadable. | ||
Page 2 of 3 | |||
This reality is central to the internationally recognized technique by which contamination is determined to be | |||
Page | |||
Attachment 1 3.0 Implementation Challenges 3.1 Anticipated Improvements The development of Notification Reports to the NRC is, rightly, a very serious issue and involves a significant amount of licensee time and resources. Licensees typically commit at least 60 person-hours directly in generating the notification and nominal costs of $100,000 per notification are not uncommon. Included in these estimates are the time and resources required to: | |||
Improvements The development of Notification Reports to the NRC is, rightly, a very serious issue and involves a significant amount of licensee time and resources. | * develop the initial written notification and associated 30 day follow-up report | ||
Licensees typically commit at least 60 person | |||
-hours directly in generating the notification and nominal costs of $100,000 per notification are not uncommon. | |||
Included in these estimates are the time and resources required to: | |||
* develop the initial written notification and associated 30 day follow | |||
-up report | |||
* perform subsequent investigations | * perform subsequent investigations | ||
* enter the incident into a corrective action system | * enter the incident into a corrective action system | ||
| Line 62: | Line 50: | ||
* perform management reviews of each action | * perform management reviews of each action | ||
* revise procedures, as needed | * revise procedures, as needed | ||
* develop material and train/re | * develop material and train/re-train staff, as needed Additional costs can include associated NRC inspection charges for closing the issue and licensee developed media support for addressing perceived negative public perception associated with the notification. | ||
-train staff, as needed Additional costs can include associated NRC inspection charges for closing the issue and licensee developed media support for addressing perceived negative public perception associated with the notification. | The proposed resolutions will not negatively impact the health and safety of workers, the public, or the environment and is certainly consistent with the focus of addressing the cumulative impact of regulatory requirements. | ||
The proposed resolutions will not negatively impact the health and safety of workers, the public, or the environment and is certainly consistent with the focus of addressing the cumulative impact of regulatory requirements. | 3.2 Anticipated Challenges There are no readily apparent challenges from the industry perspective. Revisions to procedures and training material will be required but the benefits gained will overshadow the effort involved. | ||
From a regulatory perspective the development of the appropriate guidance document must be considered. | |||
4.0 Interactions Note: information contained within this section is preliminary and may change as the project progresses. | |||
Challenges There are no readily apparent challenges from the industry perspective. | The Nuclear Energy Institute (NEI) will serve as the industry point of contact for this issue. | ||
Revisions to procedures and training material will be required but the benefits gained will overshadow the effort involved. | NEI will solicit and coordinate industry input into the development and review of materials. | ||
From a regulatory perspective the development of the appropriate guidance document must be considered. | Page 3 of 3}} | ||
Note: information contained within this section is preliminary and may change as the project progresses. | |||
The Nuclear Energy Institute (NEI) will serve as the industry point of contact for this issue. NEI will solicit and coordinate industry input into the development and review of materials.}} | |||
Latest revision as of 08:24, 31 October 2019
| ML15217A490 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 07/27/2015 |
| From: | Nuclear Energy Institute |
| To: | Division of Fuel Cycle Safety, Safeguards, and Environmental Review |
| Liu T | |
| Shared Package | |
| ML15217A487 | List: |
| References | |
| Download: ML15217A490 (3) | |
Text
Attachment 1 Regulatory Evaluation Summary Reporting of Medical Treatment of a Contaminated Individual 1.0 Overview of the Issue The purpose of the proposed regulatory initiative is to address situations involving the following NRC regulations:
10CFR70.50 Reporting requirements (b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
10CFR40.60 Reporting requirements (b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:
(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
Specifically, the industry is seeking clarification in the interpretation of the following:
- medical treatment
- medical facility (onsite vs. offsite)
- with spreadable radioactive contamination In addition the industry is seeking a regulatory framework that will ensure consistent interpretation.
2.0 Purpose Statement 2.1 Medical Treatment The industry interprets the definition medical treatment to align with OSHA guidelines. As stated in OSHA regulation 29 CFR 1904.7(b)(5) medical treatment does not include:
- 1. A visit to a physician or other licensed health care professional (e.g., nurse) solely for observation or counseling, or
- 2. The conduct of diagnostic procedures, such as x-rays and blood tests, including the administration of prescription medications used solely for diagnostic purposes (e.g., eye drops to dilate pupils); or
- 3. First aid [further clarified in 29 CFR 1904.7 (b)(5) (ii)
NOTE: This interpretation would not remove the requirement to notify the NRC for offsite medical treatment of an individual who has spreadable contamination on their clothing or body. The industry recognizes the importance of informing the NRC of any interaction of a contaminated individual with the general public.
Page 1 of 3
Attachment 1 2.2 Medical Facility The NRCs interpretation requires the industry to provide a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> report to the NRC regardless of whether the medical treatment facility is located offsite or on the licensee property.
For facilities with medical treatment capabilities (as discussed above) onsite and with processes in place for managing potential contamination this interpretation has led to the reporting of multiple low significance incidents necessitating the commitment of significant resources to event notifications followed by written reports.
This interpretation is inconsistent with the reporting requirement for 10 CFR 50 licensees (see below) which requires reporting (within 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />) only if the facility is located offsite.
10CFR50.72 Immediate notification requirements for operating nuclear power reactors (3) Eight-hour reports. If not reported under paragraphs (a), (b)(1) or (b)(2) of this section, the licensee shall notify the NRC as soon as practical and in all cases within eight hours of the occurrence of any of the following:
xii) Any event requiring the transport of a radioactively contaminated person to an offsite medical facility for treatment.
The industry seeks to change the interpretation of medical facility so that reporting would apply only to offsite medical facilities.
2.3 With Spreadable Radioactive Contamination The interpretation of the term with spreadable radioactive contamination appears to be inconsistent. For example a Notice of Violation (Inspection Report Number 70-143/2014-003) was issued based upon a regional interpretation that the contamination on the skin of a person is not fixed, but spreadable due to the process during which the external layers of skin die and fall off.
This interpretation is inconsistent with standard health physics professional practices which recognize that spreadable/removable contamination is characterized by the ability to physically transfer the material via contact with another medium.
This reality is central to the internationally recognized technique by which contamination is determined to be fixed/non-transferable or loose/spreadable. The surface of the contaminated material is rubbed with a medium such as cloth or filter paper. If the contamination is detected on the medium, the contamination is considered loose/spreadable.
Page 2 of 3
Attachment 1 3.0 Implementation Challenges 3.1 Anticipated Improvements The development of Notification Reports to the NRC is, rightly, a very serious issue and involves a significant amount of licensee time and resources. Licensees typically commit at least 60 person-hours directly in generating the notification and nominal costs of $100,000 per notification are not uncommon. Included in these estimates are the time and resources required to:
- develop the initial written notification and associated 30 day follow-up report
- perform subsequent investigations
- enter the incident into a corrective action system
- implement the corrective action, as needed
- perform management reviews of each action
- revise procedures, as needed
- develop material and train/re-train staff, as needed Additional costs can include associated NRC inspection charges for closing the issue and licensee developed media support for addressing perceived negative public perception associated with the notification.
The proposed resolutions will not negatively impact the health and safety of workers, the public, or the environment and is certainly consistent with the focus of addressing the cumulative impact of regulatory requirements.
3.2 Anticipated Challenges There are no readily apparent challenges from the industry perspective. Revisions to procedures and training material will be required but the benefits gained will overshadow the effort involved.
From a regulatory perspective the development of the appropriate guidance document must be considered.
4.0 Interactions Note: information contained within this section is preliminary and may change as the project progresses.
The Nuclear Energy Institute (NEI) will serve as the industry point of contact for this issue.
NEI will solicit and coordinate industry input into the development and review of materials.
Page 3 of 3