ML20198K019
| ML20198K019 | |
| Person / Time | |
|---|---|
| Issue date: | 05/10/1996 |
| From: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Glenn J NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-077, AF70-1-77, NUDOCS 9801140292 | |
| Download: ML20198K019 (2) | |
Text
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[gn Asa k UNITED STATES - ~ ! [
p NUCLEAR REGULATORY COMMIS810N WASHINGTON, o.C. 30006 4001 May 10. 1996 t
MEMORANDUM TO: John E. Glenn, Chief Radiation Protection and Health Effects Branch Division Regulatory Applica ions,JtES FRON: arr W. CNC h=
Medical, Academic and Connercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
- COMMENTS ON THE DRAFT SAFETY REPORT, ENVIRONMENTAL ASSESSMENT, AND COST BENEFIT ANALYSIS ASSOCIATED WITH THE TRI-MED PETITION FOR RULEMAKING The staff has reviewed the three draft documents associated with the Tri-Med setition for rulemaking. Copies of the documents are attached and include landwr'itten comments (Attachments 1-3).
The following comments are highlighted for your attention:
1.- The analyses are based upon the Tri-Hed product and method of analysis.
Introduction of a new product or methodology may require a new set of analyses unless the current analyses are broadened. Several ooints of discussion are marked with an asterisk, indicating example analyses that
-may need to change with developments beyond the Tri-Med product and
-methodology.
In lieu of a completely new set of future analyses, it may be plausible to expand the current analysis by multiplying the current dose assessments by a factor (e.g.,100 or 1000) that would result ir, an expanded dose which is still significantly under all Federal regulatory l imit s .' A statement regarding anticipated developments should be clearly indicated. However, this ap? roach should be reviewed with the Office of the General Counsel (0GC) for consistency with requirements for environmental assessments (EAs) under the National Environmental Policy Act (NEFA).
2.- Consistent with NEPA requirements, the EA and the associated analyses in lthe safety? report need to be within all applicable Federal limits
_ (including the U.' S. Environmental Protection Agency and Occupational t' Safety Health Administration limits), state as such, and cite the limit (s). .
+
Contact:
' Susanne R. Woods, NHSS (301);415-7267 .
30 MFR32SS2: .PDR s vvw .
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John E. Glenn May 10, 1996
- 3. The environmental justice discussion is based solely on the finding of no significant impact; however, current NRC and/or NMSS policy and procedures should be reviewed regarding requirements to complete the actual environmental justice analyses for rulemaking efforts.
- 4. The accuracy of the approach used in many of the dose calculations is important to emphasize. While changing the approach may result in a dose that does not exceed Federal limits, the approach will likely serve as a model for future EAs and dose comparisons completed in association '
with this issue.
- 5. The rate of the C-14-urea etpsule use, at 600,000 capsules per year, may be an underestimate (see comments in draft safety report, page 8).
- 6. The estimated number of capsules (150) used for shipping and inventory quantities associated with various dose calculations may be an underestimate. The analysis assumes that the complete stock inventory is depleted before a new shipment arrives. However, the overall inventory is influenced by such things as product shelf-life and cost-effective purchasing (see comments in draft safety report, page 10).
- 7. There are available references that should be included in such discussions as that of the expected dose to the patient (draft safety report, page 20) [e.g. Stubbs and Marshall,1993 (Attachment 4)).
- 8. The term ' bound" is used inconsistently throughout the documents and should be clearly defined.
- 9. The specific type of dose determined (e.g., EDE, TEDE, CEDE) in many of the dose calculations should be specified.
Attachments: 1. Draft Safety Report, 3/96
- 2. Draft EA, 3/25/96
- 3. Draft Analysis of Cost and Benefits, 3/25/96
- 4. 1993 JNM article (Stubbs and Marshall)
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