ML21011A218
| ML21011A218 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/2021 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Kimchy Y Check-Cap, Ltd |
| Irene Wu, NMSS/MSST | |
| References | |
| Download: ML21011A218 (3) | |
Text
January 27, 2021 Yoav Kimchy, Ph.D.
Founder and Chief Technology Officer Check-Cap Ltd.
29 Abba Hushi Ave.
PO Box 1271 Isfiya 3009000, Israel
SUBJECT:
APPLICABILITY OF TITLE 10 OF THE CODE OF FEDERAL REGULATIONS 20.2003(B) TO SANITARY SEWERAGE DISPOSAL FOR C-SCAN SYSTEM
Dear Dr. Kimchy:
By letter dated March 15, 2020 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML21007A278), Check-Cap Ltd. (Check-Cap) submitted a request to the U.S. Nuclear Regulatory Commission (NRC) seeking an interpretation of NRCs regulations.
Check-Caps request asked whether Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applies to the disposal of the colon-imaging capsule from the C-Scan (C-Scan) system in excreta. The provision in 10 CFR 20.2003(b) allows for the excreta from individuals undergoing medical diagnosis or therapy with radioactive material to be discharged into the sanitary sewerage. The NRC staff has reviewed the information provided by Check-Cap and has determined that the capsule is not excreta of the form identified under 10 CFR 20.2003(b) that can be disposed of in the sanitary sewerage.
When 10 CFR 20.2003(b) was promulgated, ingested sealed sources were not envisioned as potential excreta. While the NRC does not define excreta in its regulations, the NRC staff referenced several medical dictionaries, including the Stedmans Medical Dictionary. Based on the definitions of excreta, excrement, excretion, and feces in these medical dictionaries, the NRC staff does not consider the C-Scan capsule to be excreta because it is neither undigested residue of food, a waste product of metabolism, nor the product of a tissue or organ that is waste material to be eliminated from the body.
In addition to evaluating the question posed by Check-Cap, the NRC staff researched the statements of consideration related to the promulgation and revision of 10 CFR Part 20 and evaluated the prospects associated with disposing of the capsule in the sanitary sewer system.
The statements of consideration for the final rule revising 10 CFR Part 20 discussed the disposal of insoluble material in sanitary sewerage. In the final rule (56 FR 23360; May 21, 1991), the Commission modified the conditions for disposal of radioactive wastes into sanitary sewer systems so that dispersible biological materials may continue to be disposed of by release to sanitary sewers. However, the revised rule no longer permitted the disposal of nonbiological insoluble materials, such as flakes of metallic foil containing americium-241, because of the potential for re-concentration and accumulation of these materials in the sanitary sewer system, sewage treatment plants, and sewage sludge. Because the capsule would be nonbiological insoluble material, the NRC does not consider the capsule suitable for sanitary sewerage disposal.
Additionally, the NRC staff has additional concerns about the disposal of the capsule in a sanitary sewerage. Given the size of the capsule, it is anticipated that these sealed sources
Y. Kimchy 2 would be collected on screens and filters as part of the pretreatment process at a wastewater treatment plant.1 These screens and filters are then cleaned and the materials that do not pass through are removed and typically sent to a municipal landfill. The capsules may then be flagged by radiation detectors at the wastewater treatment plant and/or landfill, possibly creating orphan sources that would need to be collected and disposed of consistent with 10 CFR Part 20, Subpart K, Waste Disposal. If this occurs, the NRC staff is concerned that the ultimate disposal responsibility would then be passed from a licensee (e.g., a physician or clinic) to a non-licensee (e.g., municipal sanitary sewerage facility or landfill). Finally, these capsules may raise concern if found in the public, such as at a wastewater treatment plant or a landfill, because these capsules would have to be labeled pursuant to 10 CFR 20.1904, Labeling containers.
If you have any questions regarding this letter, please contact me at 301-415-5422, or via e-mail at Christian.Einberg@nrc.gov.
Sincerely, Signed by Einberg, Christian
, on 01/27/21 Christian Einberg, Branch Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Cc: Amy Roma, Hogan Lovells Sachin Desai, Hogan Lovells 1
U.S. Environmental Protection Agency, Wastewater Technology Fact Sheet: Screening and Grit Removal, June 2003, https://www3.epa.gov/npdes/pubs/final_sgrit_removal.pdf.
Y. Kimchy 2
SUBJECT:
APPLICABILITY OF TITLE 10 OF THE CODE OF FEDERAL REGULATIONS 20.2003(B) TO SANITARY SEWERAGE DISPOSAL FOR C-SCAN SYSTEM DATED: JANUARY 27, 2021 DISTRIBUTION:
Public VHolahan, NMSS ASchwartzman, NMSS Amy Roma, Hogan Lovells amy.roma@hoganlovells.com Sachin Desai, Hogan Lovells sachin.desai@hoganlovells.com ADAMS Accession Number: ML21011A218 OFFICE NMSS/MSST NMSS/MSST NMSS/DUWP OGC/NLO NMSS/MSST NAME IWu LDimmick CMcKenney IIrvin CEinberg DATE 1/12/2021 1/12/2021 1/13/2021 1/26/2021 1/27/2021 OFFICIAL RECORD COPY