ML20303A290
| ML20303A290 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/2020 |
| From: | Brian Anderson NRC/NMSS/DMSST |
| To: | |
| TAPP, KATIE/NMSS/MSST | |
| Shared Package | |
| ML20303A288 | List: |
| References | |
| STC-20-074 | |
| Download: ML20303A290 (7) | |
Text
Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
The TER relies on dose rate and distance measurements The NRC staff believes the difficulty of performing survey measurements of dogs is that are difficult to obtain. Exubrion reported that because no different than performing surveys of previously approved animal release, such of movement during the equilibration time of the meter, it as horses or cats. As NUREG-1556, Volume 7, Appendix D does not require is hard to get a stable dose rate reading. It would be licensees to submit detailed survey procedures for licensing, NRC staff does not equally difficult holding a meter steady at the prescribed 1 believe there is a need for Exubrion to submit it in this generic application.
distance of 3.3 feet. The poor correlation of Wendt et al1 However, licensees are required to ensure adequate release surveys per 10 CFR exposure rate/weight data seems to corroborate that 20.1501 and surveys shall be retained for 3 years per 10 CFR 20.2103(a). This assertion. Exubrion should provide protocols to be added should be evaluated during inspections.
in the TER for attaining high confidence measurements to be used in guiding release decisions.
The Boards letter dated August 11, 2020 asked, in part, what happens to the radiopharmaceutical if it is not injected into the correct spot, is it then excreted? Does it Exubrion performed a study in rats to investigate this. The worst case is an travel to a different physical location within the animal intravenous injection, where the study showed the material primarily distributed to where the owner needs to be aware of a different radiation the liver with little to no excretion. For injections other than intravenous, the hazard? Is it appropriate to release the dog? NRC material remained at the injection site.
2 responded Exubrion stated that they saw no bio kinetic transfer to any other organs in a study evaluating impacts In addition, during the initial dog studies, there was an injection that accidentally of missed injection sites. This satisfies the question missed the synovial sac. In that case, subsequent imaging revealed that the regarding transfer to organs, but was an increase in injected material remained at the injection site with no biodistribution elsewhere.
excretion noted? If so, there is a risk of contamination and not just exposure that needs addressed.
Enclosure 1
Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
The TER states that Licensees should use the information gathered during the pre-screening evaluation and discussions with the owner, not Exubrions evaluation Exubrion preformed the dose assessment for four bounding categories of dog-of common dogs, to determine the typical time and human interactions and demonstrated they do not exceed public dose limits with distances the dog has with all individuals in the household. instructions. As long as the household members typical interaction patterns do not Based on the information about the interactions in the exceed the bounds of these categories, licensees will not need to perform dogs household, the licensee will determine if release is individual dose assessments. This procedure does not allow licensees to perform appropriate for each dog following treatment and provide their own dose assessments to allow release when household members 3
instructions to the household in order to have confidence interaction patterns do not fit into one of these categories.
that public dose limits will not be exceeded. This amounts to an individual dose assessment for each household The information gathered during the prescreening questionnaire should be used to member. Will the assessments be reviewed by the NRC determine which category should apply for the household. The procedure requires during inspection and what guidelines will they use for the the licensee to retain the prescreening questionnaire. Therefore, this should be review? A standard license commitment to retain every available for inspection.
household members time studies and dose assessments should be included for each treatment.
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Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
NCRP Report No. 116, Limitation of Exposure to Ionizing Radiation, recommends an equivalent dose limit for the fetus of an occupationally exposed The NRC does not have different public dose limits for pregnant women or fetuses.
individual of 50 mrem (0.5 mSv) per month during The public dose limit is 2 mrem in any one hour and 100 mrem a year. However, NUREG-1556, volume 7, Appendix D does address pregnant women and their the pregnancy. Excluding this treatment for 4 need to limit exposure to a radioactive animal. Exubrion addresses this in their households with pregnant women would seem prescreening questionnaire which has licensees question if close contact sensible if their interactions fall within those interactions with pregnant women can be minimized and discuss strategies to extended and prolonged close contact categories or minimize their dose prior to treating the dogs.
if individual assessments result in a dose of exceeding 50 mrem per month.
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Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
Under Notes to License Reviewer, the first bullet on page 18 of the TER, describes that license reviewers obtain a commitment that the licensee will not use Exubrions demonstrated that public dose limits will not be exceeded for the this procedure to release a dog whose typical maximum amount of times described in the four behavior categories described in behavior patterns, without instructions, do not fit into the application. Therefore, this procedure can only be used to release dogs when all household members fit into one of these categories. If a licensee wishes to 5 the time and distance limitations listed for one of the release a dog where a household member does not fit into one of these categories described in the procedure as these categories, more evaluation would need to be done to demonstrate public dose categories are the only ones evaluated. This bullet limits would not be exceeded. This would require a license amendment. The final is confusing, does it intend to mean that the TER provides more information on the categories.
treatment should not be performed, or that another procedure for release should be followed?
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Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
Under Notes to License Reviewer, the second bullet on page 18 of the TER, states that the licensee will not release a dog if a child is in the house under the age of 5 who does not fit into the common contact or extended duration or immediate contact This language was updated in the final version of this document. The scenarios, because the other scenario is not objective of this language is to not use this procedure to release dogs evaluated by Exubrions technical basis and the where household members behavior does not fit into one of the pre-6 typical interaction patterns could exceed the public established categories evaluated by Exubrion. If a licensee would like to dose limits. What is the other scenario that was allow release to a household where behaviors do not fit into the categories, not evaluated by Exubrion? Is the objective of this additional evaluation and procedures would be necessary. This would point meant to restrict releasing a dog into a require a license amendment.
household with children under the age of 5 where a pre-established contact scenario does not fit with what is discovered during pre-screening or is it to reject the candidate for treatment all together?
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Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
The TER describes that licensees must investigate any public exposure where limits might have been exceeded, even if it is due to individuals not following instructions, and to report those to the NRC per 10 CFR 20.2203. The Board supports this requirement; however, concern exists over the discussion of 500 mrem being an acceptable limit to protect health and safety.
The NRC removed language from the TER regarding benefits to the owner The TER concludes that Even if no instructions are and reference to other regulations other than the public dose limit. In followed, the staff determined that the highest likely addition, the NRC updated the TER to clarify that it is the individual exposure to a household member, who is a member licensees responsibility to ensure compliance with public dose limits. As of the public, would likely be below 500 mrem. As described in the TER, the NRC staff believes Exubrions proposed this dose will be received by someone who would procedure provides adequate measures to ensure public dose limits will not likely be benefitting from the exposure and is at a be exceeded when owners provide complete and accurate information.
level allowable by the NRC in other circumstances 7 where individuals benefit from the exposure, such as However, staff performed calculations to bound the worst case dose if an patient release, the staff finds the risk from this dose owner provides incomplete or inadequate information during prescreening acceptable given the licensee provides adequate or if a household member chooses to not follow instructions after the owner instructions and means to prevent the exposure.
confirms they will. The staff finds the likelihood of such a scenario to be Licensees may lower their safety focus knowing that low given the conservatisms in the calculations and assumptions used in acceptable limits from other parts of the 10 CFR the scenario and that the licensee provides adequate instructions and should still be upheld in worst case scenarios and means to prevent the exposure. Therefore, the staff finds Exubrions ignore the need to follow up or calculate doses to proposal adequate to protect the publics health and safety.
adhere to 10 CFR 20.1301. An increased dose allowed to members of the public, as a consequence of patient release, is due to the life-saving or quality of life improving treatments to a human person, not an animal. The Board objects to the conclusion that an increase in dose from a treated animal is a beneficial exposure and recommends removing any discussion of other parts of regulation or the 500 mrem limit.
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Agreement State Comment Resolution Exubrion Technical Evaluation Report Comment Response Comment No.
Licensees should not use Exubrions evaluation of typical dog behavior.
Step A3.7 of the Procedure is confusing where it Instead, licensees will need to conduct a prescreening evaluation with the states Note that only [one] category will apply for the dog owner to understand the individual dogs typical behavior, including all entire household. If all the household members do typical dog-human interactions, in order to determine the behavior of the 8 not fit into the same category, then is the most dog. The licensee will then use the prescreening information to choose the restrictive category used? How does that reconcile appropriate category for the household. The TER has been updated for with the TER where it says Exubrions evaluation of clarity on this point.
common dogs should not be relied upon?
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