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| issue date = 09/28/2017
| issue date = 09/28/2017
| title = Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construction Permit Application for Radioisotope Production, at Meeting on September 21, 2017
| title = Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construction Permit Application for Radioisotope Production, at Meeting on September 21, 2017
| author name = Haass C C
| author name = Haass C
| author affiliation = Northwest Medical Isotopes, LLC
| author affiliation = Northwest Medical Isotopes, LLC
| addressee name = Balazik M F
| addressee name = Balazik M
| addressee affiliation = NRC/Document Control Desk, NRC/NRR/DPR
| addressee affiliation = NRC/Document Control Desk, NRC/NRR/DPR
| docket = 05000609
| docket = 05000609
Line 16: Line 16:


=Text=
=Text=
{{#Wiki_filter:....... ; ... NWMI .*:.**.-.* . .'.*.*ee*o*: . . ** .' , NORTHWEST MEDICALISOTOPES U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. Michael Balazik Research and Test Reactors Branch A Division of Policy and Rulemaking Office of Nuclear Reactor Regulation September 28, 2017 NWMI-LTR-2017-015 RE: Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50..609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construdion Permit Application for Radioisotope Production, *at Meeting on September 21, 2017  
{{#Wiki_filter:. . . .;. . NWMI
.'.*.*ee*o*: .
  . ** ~ ~.*. ~ .' , NORTHWEST MEDICALISOTOPES September 28, 2017 NWMI-LTR-2017-015 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. Michael Balazik Research and Test Reactors Branch A Division of Policy and Rulemaking Office of Nuclear Reactor Regulation RE:               Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50..609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construdion Permit Application for Radioisotope Production, *at Meeting on September 21, 2017


==References:==
==References:==
: 1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2015-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015, ''NRC Project No. 0803 -Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility" (ADAMS Accession No. ML15210All4)  
: 1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2015-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015, ''NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility" (ADAMS Accession No. ML15210All4)
: 2. Northw'est Medical Isotopes, LLC Letter NWMI-l TR-2017-012 to U.S. Nuclear Regulatory Commission, dated September 8, 2017, "Docket No. 50-609, Northwest Medical Isotopes, LLC, Transmittal of Revision 3 of Chapters 1.0 through 18.0 ofNWMI-2013-021, Construction Permit *
: 2. Northw'est Medical Isotopes, LLC Letter NWMI-l TR-2017-012 to U.S. Nuclear Regulatory Commission, dated September 8, 2017, "Docket No. 50-609, Northwest Medical Isotopes, LLC, Transmittal of Revision 3 of Chapters 1.0 through 18.0 ofNWMI-2013-021, Construction Permit
* Application for Radioisotope Production"  
            *
* Application for Radioisotope Production"


==Dear Mr. Balazik:==
==Dear Mr. Balazik:==
Northwest Medical Isotopes, LLC (NWMI) met with the Advisory Committee on Reactor Safeguards (ACRS) on September 21, 2017. Several*questions were formally asked, and NWMI is formally responding through the submission of this letter. .The formal -responses address the following topical areas of the NWMI Construction Permit Application (CPA), including construction completion dates, provisions for layup and assessment for an independent control room, aircraft impact analysis, maximum precipitation, and additional fire protection provisions.  
 
: 1. Updated Construction Completion Dates NWMI currently expects to complete construction of the Radioisotope Production Facility (RPF) by December 31, 2019 at the earliest, and December 31, 2022 at the latest
Northwest Medical Isotopes, LLC (NWMI) met with the Advisory Committee on Reactor Safeguards (ACRS) on September 21, 2017. Several*questions were formally asked, and NWMI is formally responding through the submission of this letter. .The formal -responses address the following topical areas of the NWMI Construction Permit Application (CPA), including construction completion dates, provisions for layup and assessment for an independent control room, aircraft impact analysis, maximum precipitation, and additional fire protection provisions.
* 2.
: 1. Updated Construction Completion Dates NWMI currently expects to complete construction of the Radioisotope Production Facility (RPF) by December 31, 2019 at the earliest, and December 31, 2022 at the latest                                                                                       *
Production Facility Provisions for Layup and Assessment of an Independent Control Room : *
: 2. Radiois~tope Production Facility Provisions for Layup and Assessment of an Independent Control Room :                                                                                                                 *
* The NWMI RPF has the capability to store processing liquids in multiple locations.
* The NWMI RPF has the capability to store processing liquids in multiple locations. Those locations are designed to hold the liquids safely for an indefinite period of tiine. In addition~ NWMI will *develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns*
Those locations are designed to hold the liquids safely for an indefinite period of tiine. In NWMI will *develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns* (i.e., shutdowns longer than planned periodic maintenance outages). The procedure(s) will document potential hazards or undesirable conditions that *may develop, and identify ways to prevent or mitigate those conditions.  
(i.e., shutdowns longer than planned periodic maintenance outages). The procedure(s) will document potential hazards or undesirable conditions that *may develop, and identify ways to prevent or mitigate those conditions.                                                                                                                                                                                           'f b-D l
'f b-D l  
                        ***.*******"*"'.CT:'~""'~:. __ ..>. _ *._,,.~ ....~.,.,.7, . *~~~=.,....-**7";?' .,o.
.... -*.-... -.........  
_.,....._,,,,.~~--*-**~---__,,~-*--*~--~-* ....-*.- . . -......... *-- .. .
*--.. . .. f p
                                                                                                              '""'"',.;,.~.,,;,....,...,~--=-,"~~,,,...~....~
__ .. >. _ *.  
                                                                                                                                                                                        ~
....  
                                                                                                                                                                                      ...*"~
..  
                                                                                                                                                                                          ....... ~.,~.
.,o. ... ....... A ** * /. I;\."'-Northwest Medical Isotopes, LLC I 815 NW 9th Ave, Suite 256 I Corvallis, OR 97330 ;v Mr. Michael Balazik Page2 Examples of topics the procedure(s) will address include: ** * * * * * * * *
A ** * /.
* Safe conditions for process vessels to reduce corrosion potential Chemical solutions in the RPF that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations Requirements for handling and storing in-use and spent ion exchange columiis the molybdenum-99 (9 9 Mo) production and purification, and uranium recycle and recovery subsystems
f p I;\."'-
* Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits Chemical or radioactive solutions that will be processed and disposed ofto reduce the potential for long-term chemical reactions
Northwest Medical Isotopes, LLC I 815 NW 9th Ave, Suite 256 I Corvallis, OR 97330                                                                                                       ;v
* Requirements for diainitig, flushing, and decontaminating equipment and piping Removal of moisture (e.g., drying, purging) from certain systems Required operating parameters of ventilation systems and the process vessel vent system Measurement processes (e.g., turbidity, pH, concentration) to be performed for all process *
 
* systems prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state 'or processing for safe disposal, if necessary  
Mr. Michael Balazik Page2 Examples of topics the procedure(s) will address include:
* * * * * . Operational requirements and procedural steps for safe startup followitig extended shutdowns In sUmmirry, NWMI commits to furthei assess extended' layup' provisions for the RPF. In addition, NWMI commits to further assess the need for an independent control room as part of our RPF final design. 3. Aircraft Impact Analysis NWMI will reexamine and ensure. the accuracy of its estimates for aircraft take-offs and landings at the Columbia Regional Airport and* for the surrounding heliports.*.
    **     Safe conditions for process vessels to reduce corrosion potential
All discrepancies in the data will .be resolved during the RPF final.design and will be. provided in the Operating License Application:**  
* Chemical solutions in the RPF that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations
' 4. Maximum Precipitation NWMI will resolve the discrepancy in the maximum estimated precipitation for the 24-hour and 48-hour. period during the RPF final design and provide the information in the Operating License Application.  
* Requirements for handling and storing in-use and spent ion exchange columiis i~ the molybdenum-99 (99Mo) production and purification, and uranium recycle and recovery subsystems                                                                               *
; .* 5. On-site Dedicated Fire Water Supply NWMI will during RPF final design wh.ether facility will use an on'."site dedicated , fire water supply and/or use the City of Columbia fire water supply. This determination wilfbe provided in the Operating License Application.  
* Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits
*
* Chemical or radioactive solutions that will be processed and disposed ofto reduce the potential for long-term chemical reactions                                                               *
* NWMI is.submitting.this response to the NRC in accordance with 10 CFR 50.30(b), "Oath or Affirmation,".
* Requirements for diainitig, flushing, and decontaminating equipment     and piping
and 1.0 CFR 50.4, Communications." I solemniy .declare*
* Removal of moisture (e.g., drying, purging) from certain systems
and affirm that the. foregoing information is true and correct. under the penalty of P efJ*ury. . . -. ! .
* Required operating parameters of ventilation systems and the process vessel vent system
Mr. Michael Balazik Page 3 Executed on September 28, 2017. If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com.
* Measurement processes (e.g., turbidity, pH, concentration) to be performed for all process
Sincerely, Carolyn C. Haass Chief Operating Officer cc: Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation}}
      *
* systems prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state 'or processing for safe disposal, if necessary *     *               **     *       .
* Operational requirements and procedural steps for safe startup followitig extended shutdowns In sUmmirry, NWMI commits to furthei assess extended' layup' provisions for the RPF.
In addition, NWMI commits to further assess the need for an independent control room as part of our RPF final design.
: 3. Aircraft Impact Analysis NWMI will reexamine and ensure. the accuracy of its estimates for aircraft take-offs and landings at the Columbia Regional Airport and* for the surrounding heliports.*. All discrepancies in the data will .be resolved during the RPF final.design and will be. provided in the Operating License Application:** '
: 4. Maximum Precipitation NWMI will resolve the discrepancy in the maximum estimated precipitation for the 24-hour and 48-hour.
period during the RPF final design and provide the information in the Operating License Application.
: 5. On-site Dedicated Fire Water Supply NWMI will d~termine during RPF final design wh.ether facility oper~tions will use an on'."site dedicated ,
fire water supply and/or use the City of Columbia fire water supply. This determination wilfbe provided in the Operating License Application.                                                           *
* NWMI is.submitting.this response to the NRC in accordance with 10 CFR 50.30(b), "Oath or Affirmation,". and 1.0 CFR 50.4, ~'Written Communications."
I solemniy .declare* and affirm that the. foregoing information is true and correct. under the penalty of PefJ*ury.               .             .                                                         -     .
 
Mr. Michael Balazik Page 3 Executed on September 28, 2017.
If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com.
Sincerely, c~c_~
Carolyn C. Haass Chief Operating Officer cc:   Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation}}

Latest revision as of 06:08, 24 February 2020

Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50-609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construction Permit Application for Radioisotope Production, at Meeting on September 21, 2017
ML17283A108
Person / Time
Site: Northwest Medical Isotopes
Issue date: 09/28/2017
From: Haass C
Northwest Medical Isotopes
To: Michael Balazik
Document Control Desk, Division of Policy and Rulemaking
References
NWMI-LTR-2017-015
Download: ML17283A108 (3)


Text

. . . .;. . NWMI

.'.*.*ee*o*: .

. ** ~ ~.*. ~ .' , NORTHWEST MEDICALISOTOPES September 28, 2017 NWMI-LTR-2017-015 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk 11555 Rockville Pike Washington, DC 20555 Mr. Michael Balazik Research and Test Reactors Branch A Division of Policy and Rulemaking Office of Nuclear Reactor Regulation RE: Responses to Advisory Committee on Reactor Safeguards Questions on Docket No. 50..609, Northwest Medical Isotopes, LLC, NWMl-2013-021, Construdion Permit Application for Radioisotope Production, *at Meeting on September 21, 2017

References:

1. Northwest Medical Isotopes, LLC Letter NWMI-LTR-2015-006 to U.S. Nuclear Regulatory Commission, dated July 20, 2015, NRC Project No. 0803 - Northwest Medical Isotopes, LLC, Submittal Part 2 Construction Permit Application for a Radioisotope Production Facility" (ADAMS Accession No. ML15210All4)
2. Northw'est Medical Isotopes, LLC Letter NWMI-l TR-2017-012 to U.S. Nuclear Regulatory Commission, dated September 8, 2017, "Docket No. 50-609, Northwest Medical Isotopes, LLC, Transmittal of Revision 3 of Chapters 1.0 through 18.0 ofNWMI-2013-021, Construction Permit
  • Application for Radioisotope Production"

Dear Mr. Balazik:

Northwest Medical Isotopes, LLC (NWMI) met with the Advisory Committee on Reactor Safeguards (ACRS) on September 21, 2017. Several*questions were formally asked, and NWMI is formally responding through the submission of this letter. .The formal -responses address the following topical areas of the NWMI Construction Permit Application (CPA), including construction completion dates, provisions for layup and assessment for an independent control room, aircraft impact analysis, maximum precipitation, and additional fire protection provisions.

1. Updated Construction Completion Dates NWMI currently expects to complete construction of the Radioisotope Production Facility (RPF) by December 31, 2019 at the earliest, and December 31, 2022 at the latest *
2. Radiois~tope Production Facility Provisions for Layup and Assessment of an Independent Control Room : *
  • The NWMI RPF has the capability to store processing liquids in multiple locations. Those locations are designed to hold the liquids safely for an indefinite period of tiine. In addition~ NWMI will *develop procedure(s) during detailed design that will address actions to be taken for extended plant shutdowns*

(i.e., shutdowns longer than planned periodic maintenance outages). The procedure(s) will document potential hazards or undesirable conditions that *may develop, and identify ways to prevent or mitigate those conditions. 'f b-D l

      • .*******"*"'.CT:'~""'~:. __ ..>. _ *._,,.~ ....~.,.,.7, . *~~~=.,....-**7";?' .,o.

_.,....._,,,,.~~--*-**~---__,,~-*--*~--~-* ....-*.- . . -......... *-- .. .

'""'"',.;,.~.,,;,....,...,~--=-,"~~,,,...~....~

~

...*"~

....... ~.,~.

A ** * /.

f p I;\."'-

Northwest Medical Isotopes, LLC I 815 NW 9th Ave, Suite 256 I Corvallis, OR 97330 ;v

Mr. Michael Balazik Page2 Examples of topics the procedure(s) will address include:

    • Safe conditions for process vessels to reduce corrosion potential
  • Chemical solutions in the RPF that will need to be transferred to alternate containers or vessels for extended storage, and the acceptable storage locations
  • Requirements for handling and storing in-use and spent ion exchange columiis i~ the molybdenum-99 (99Mo) production and purification, and uranium recycle and recovery subsystems *
  • Limits on storage parameters (e.g., temperature, pressure), especially if more restrictive than normal operational limits
  • Chemical or radioactive solutions that will be processed and disposed ofto reduce the potential for long-term chemical reactions *
  • Requirements for diainitig, flushing, and decontaminating equipment and piping
  • Removal of moisture (e.g., drying, purging) from certain systems
  • Required operating parameters of ventilation systems and the process vessel vent system
  • Measurement processes (e.g., turbidity, pH, concentration) to be performed for all process
  • systems prior to reuse and restart of the facility, associated acceptance criteria, and guidance for restoring the target solution or other chemicals to an acceptable state 'or processing for safe disposal, if necessary * * ** * .
  • Operational requirements and procedural steps for safe startup followitig extended shutdowns In sUmmirry, NWMI commits to furthei assess extended' layup' provisions for the RPF.

In addition, NWMI commits to further assess the need for an independent control room as part of our RPF final design.

3. Aircraft Impact Analysis NWMI will reexamine and ensure. the accuracy of its estimates for aircraft take-offs and landings at the Columbia Regional Airport and* for the surrounding heliports.*. All discrepancies in the data will .be resolved during the RPF final.design and will be. provided in the Operating License Application:** '
4. Maximum Precipitation NWMI will resolve the discrepancy in the maximum estimated precipitation for the 24-hour and 48-hour.

period during the RPF final design and provide the information in the Operating License Application.

5. On-site Dedicated Fire Water Supply NWMI will d~termine during RPF final design wh.ether facility oper~tions will use an on'."site dedicated ,

fire water supply and/or use the City of Columbia fire water supply. This determination wilfbe provided in the Operating License Application. *

  • NWMI is.submitting.this response to the NRC in accordance with 10 CFR 50.30(b), "Oath or Affirmation,". and 1.0 CFR 50.4, ~'Written Communications."

I solemniy .declare* and affirm that the. foregoing information is true and correct. under the penalty of PefJ*ury. . . - .

Mr. Michael Balazik Page 3 Executed on September 28, 2017.

If you have questions, I can be reached at (509) 430-6921 or carolyn.haass@nwmedicalisotopes.com.

Sincerely, c~c_~

Carolyn C. Haass Chief Operating Officer cc: Mr. Alexander Adams Research and Test Reactors Branch A Office of Nuclear Reactor Regulation