niowave, inc. 02/11/2015, license no. 21-35144-02 ...niowave, inc i 012 north walnut street lansing,...

11 February, 2015

NRC Region Ill Office 2443 Warrenville Road , Suite 210 Lisle, IL 60532-4352

NIOWAVE, INC I 012 North Walnut Street

Lansing, MI 48906 Phone: (5 17) 999-3475

Fax: (517) 999-3626 www.niowaveinc.com

Subj : Combined Application for a License to Produce and Possess Accelerator Produced Radionuclides for Research and Development (NRC Control No. 584728)

Good day,

Niowave has received your letter of 23 January 2015 merging two previous Niowave license applications into one combined application, referenced under NRC Control No. 584728. Enclosed with this letter is Niowave, Inc.'s reapplication for this combined license to produce specific byproduct radionuclides for research and development purposes. This reapplication includes several appendices.

Once licensed, our facility will reinforce the domestic supply of useful research, medical, and industrial isotopes. Specifically, we will support the Department of Energy's domestic Mo-99 efforts and the National Isotope Development Center efforts to coordinate isotope production and distribution.

Our enclosed application addresses all of the topics identified by the review process up to this time. Several topics remain to be fully addressed where our response is contingent upon the timing of the final disposition of the proposed license. It is our intention to address these topics as it becomes possible, and we will submit appropriate amendments. Topics that are currently underway, but not yet complete:

1. Financial Assurance. Niowave has arranged for a $225,000 Letter of Credit and Standby Trust Agreement with Horizon Bank, NA. The final documents are expected to arrive at Niowave the week of February 16, 2015. Once these arrive, we will forward these to your office.

2. Contracts with isotope distributors. Niowave is currently in negotiations with a number of isotope distributors. We expect to final ize several contracts once our initial isotope production license is approved . Niowave will submit a copy of isotope distribution contracts to the NRC as they become available.

3. Shipping procedures. The enclosed license application does not include distribution, thus shipment will not be allowed under the initial license. Proper packaging and shipping procedures for radioactive material requires a significant investment in training and administrative preparations. We are prepared to make these investments once our production processes are safely demonstrated and distribution becomes the next logical step. At that time, we intend to apply for an amendment to this current

of 2 I RECEIVED FEB 12 2015

NIOWAVE, INC I 012 North Walnut Street

Lansing, MI 48906 Phone: (517) 999-3475


application. No shipping of any produced isotopes will occur until a proper license has been approved by NRC.

4. Future Licensed Activities- Our plans for future NRC licensing are constantly evolving based on the realities of the marketplace, the timing of licensing and technical milestones we achieve, and the availability of investor funding. Our intention is to initially license production of very small research quantities of isotopes (the enclosed application). Working with the NRC, we would then increase the licensed production amounts in a phased approach. Niowave also intends to add the ability to transport produced isotopes and a radiochemistry facility to our licensed activities. As we have done previously, we intend to update the NRC and other interested parties of our plans as they become clearer moving into the future.

Founded in 2005, Niowave builds compact superconducting electron linear accelerators (linacs) for commercial applications, and is based in Lansing, Michigan. Niowave is currently the only company in the world producing complete superconducting linac systems for commercial applications. Niowave has assembled a talented and experienced team to ensure safe and efficient operation of all radiation producing equipment, as well as handling all resulting activated materials.

We look forward to working with the Commission to complete the licensing process.

Sincerely,

~~~. Dr.~ry L. Grimm President and Senior Scientist

Enclosures: Application for Accelerator Produced Radioisotopes Appendix A (Example Calculations of Activity for Isotopes of Interest and Possible Incidentally Produced Isotopes) Appendix B (Sample Accelerator Activation Form) Appendix C (Sample Safety Plan) Appendix D (Sample Radiation Safety Test Material)

of2

NRC FORM 313 U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120 EXPIRES: 05/31/2015

(03-2013) Estimated burden per response to comply with th is mandatory collection request: 4.3 hours. Submittal of the 10 CFR 30, 32, 33, 34, 35, 36, 39, and 40 application is necessary to determine that the applicant is qualified and that adequate procedures exist to

.:)e,..Y.ft 'lEo"(";. protect the public health and safety. Send comments regarding burden estimate to the Information Services

Branch (T-5 F53) , U.S. Nuclear Regulatory Commission, Washington , DC 20555-0001 , or by internet e-mail to

l¥\ APPLICATION FOR MATERIALS [email protected], and to the Desk Officer, Office of Information and Regulatory Affai rs,

~~ ' ; LICENSE NEOB-10202, (3150-0120). Office of Management and Budget, Washington , DC 20503. If a means used to

""'-t. 0., impose an information collection does not display a currently valid OMB control number, the NRC may not • + conduct or sponsor, and a person is not requi red to respond to, the information collection . ..........

INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW. *AMENDMENTS/RENEWALS THAT INCREASE THE SCOPE OF THE EXISTING LICENSE TO A NEW OR HIGHER FEE CATEGORY WILL REQUIRE A FEE.

APP LICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH: IF YOU ARE LOCATED IN:

OFFICE OF FEDERAL & STATE MATERIALS AND ILLINOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, ENVIRONMENTAL MANAGEMENT PROGRAMS SEND APPLICATIONS TO: DIVISION OF MATERIALS SAFETY AND STATE AGREEM ENTS U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICEN SING BRANCH

WASHINGTON, DC 20555-0001 U.S. NUCLEAR REGULATORY COMMISSION, REGION Ill 2443 WARRENVILLE ROAD, SUITE 210

A LL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS: LISLE, IL 60532-4352

IF YOU ARE LOCATED IN:

ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA , ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS, KENTUCKY, MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, LOUISIA NA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO, NORTH NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH DAKOTA, OKLAHOMA, OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS, CAROLINA, TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA, UTAH, WASHINGTON, OR WYOMING,

SEND APPLICATIONS TO: SEND APPLICATIONS TO:

LICENSING ASSISTANCE TEAM NUCLEAR MATERIALS LICENSING BRANCH DIVISION OF NUCLEAR MATERIALS SAFETY U.S. NUCLEAR REGULATORY COMMISSION, REGION IV U.S NUCLEAR REGULATORY COMMISSION, REGION I 1600 E. LAMAR BOULEVARD 2100 RENAISSANCE BOULEVARD, SUITE 100 ARLINGTON, TX 7601 1-4511 KING OF PRUSSIA, PA 19406-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S.NUCLEAR REGULATORY COMMISSION JURISDICTIONS.

1. TH IS IS AN APPLICATION FOR (Check appropriate item) 2 NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)

[{] A. NEW LICENSE Niowave, Inc.

D B. AMENDMENT TO LICENSE NUMBER 1012 N. Walnut Street

D C. RENEWAL OF LICENSE NUMBER Lansing, MI 48906-506 1

3. ADDRESS WH ERE LICENSED MATERIAL WILL BE USED OR POSSESSED 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

Valeriia Starovoitova

BUSINESS TELEPHONE NUMBER 1012 N. Walnut Street

BUSINESS CELLULAR TELEPHONE NUMBER

Lansing, MI 48906-506 1 (517) 999-3475 (5 17) 512-3402

BUSINESS EMAIL ADDRESS

[email protected]

SUBMIT ITEMS 5 THROUGH 11 ON 8-1/2 X 11 " PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE.

5. RADIOACTIVE MATERIAL 6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED.

a. Element and mass number; b. chemical and/or physical form ; and c. maiximum amount 7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR which wi ll be possessed at any one time.

TRAIN ING EXPERIENCE.

8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS. 9. FACILITIES AND EQUIPMENT.

10. RADIATION SAFETY PROGRAM. 11 . WASTE MANAGEMENT.

12. LICENSE FEES (Fees required only for new applications, with few exceptions•)

I 3.S. I AMOUNT

$1 0.00 I (See 10 CFR 170and Section 170.31) FEE CATEGORY ENCLOSED

13. CERTIFICATION. (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT.

THE APPLI CANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT, NAMED IN ITEM 2, CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10, CODE OF FEDERAL REGULATIONS, PARTS 30, 32, 33, 34, 35 , 36, 39, AND 40, AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF. WARNING 18 U.S. C. SECTION 1001 ACT OF JUNE 25, 1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.

CERTIFYING OFFICER-- TYPED/PRINTED NAME AND TITLE "G~ru"~ '~~~ nj')O 15 Jerry L. Holl ister, Chief Operating Officer

< ' - FOR NRC use ore..v . j, :• '-~

'M'EOFFEE .fFE&LoG 1

FEECA1EOORY r~ CHECK NUMBER COMMENTS

APPROYE08Y DATE

I' <: NRC FORM 313 (03-2013)

NRC Form 313 Accelerator Produced Radionuclides Continuation of Responses NRC Control No. 584728

Item 5: Radioactive Material

5.1. Unsealed Radioactive Material

Niowave, Inc. 2/11/2015

The materials proposed for this license are scandium 46 (Sc-46) in solid form with a maximum possession limit of 1 mCi, scandium 47 (Sc-47) in solid form with a maximum possession limit of 1 mCi, manganese 56 (Mn-56) in solid form with a maximum possession limit of 1 mCi, zinc 65 (Zn-65) in solid form with a maximum possession limit of 1 mCi, copper 67 (Cu-67) in solid form with a maximum possession limit of 1 mCi, selenium 75 (Se-75) in solid form with a maximum possession limit of 1 mCi, yttrium 88 (Y-88) in solid form with a maximum possession limit of 1 mCi, strontium 89 (Sr-89) in solid form with a maximum possession limit of 1 mCi, yttrium 90 (Y-90) in solid form with a maximum possession limit of 1 mCi, molybdenum 99 (Mo-99) in solid form with a maximum possession limit of 1 mCi, holmium 166 (Ho-166) in solid form with a maximum possession limit of 1 mCi, iridium 192 (lr-192) in solid form with a maximum possession limit of 1 mCi, and gold 198 (Au-198) in solid form with a maximum possession limit of 1 mCi. See Table 6.1 for a description of the chemical and physical form of these isotopes and a description of their use.

The special nuclear material (SNM) proposed for this license is low enriched uranium (LEU) in solid form where the U-235 enrichment is between 19.75% and 10% by weight. We will not exceed the maximum possession limits for the contained U-234, U-235, or U-238 as outlined in Table 5.1. See Figure 5.1 for how the proposed possession limit for LEU varies based on enrichment of U-235. See Table 6.1 for a description of the chemical and physical form of these isotopes and a description of their use.

Table 5.1: Propose d LEU possession 1m1ts ase on -r · b d u 23 . h 5 ennc ment. LEU U-234 U-235 U-235 U-238 U-238

U-235 LEU Activity U-234 Activity Mass Activity Mass Activity Enrichment Mass Limit Mass Limit Limit Limit Limit Limit (%) Limit (g) (mCi) Limit (g) (mCi) (g) (mCi) (g) (mCi)

10.00 23.3 1.06E-01 1.5E-02 9.37E-02 2.3 5.03E-03 21 .0 7.05E-03

11.00 21.0 1.05E-01 1.5E-02 9.35E-02 2.3 4.99E-03 18.7 6.28E-03

12.00 19.1 1.04E-01 1.5E-02 9.35E-02 2.3 4.95E-03 16.8 5.65E-03

13.00 17.5 1.04E-01 1.5E-02 9.35E-02 2.3 4.91 E-03 15.2 5.12E-03

14.00 16.2 1.03E-01 1.5E-02 9.39E-02 2.3 4.90E-03 13.9 4.68E-03

15.00 15.0 1.03E-01 1.5E-02 9.38E-02 2.3 4.86E-03 12.8 4.28E-03

16.00 13.9 1.02E-01 1.5E-02 9.34E-02 2.2 4.80E-03 11 .7 3.92E-03

17.00 13.0 1.02E-01 1.5E-02 9.36E-02 2.2 4.77E-03 10.8 3.63E-03

18.00 12.2 1.02E-01 1.5E-02 9.37E-02 2.2 4.74E-03 10.0 3.36E-03

19.00 11.5 1.02E-01 1.5E-02 9.39E-02 2.2 4.72E-03 9.3 3.13E-03

19.75 11 .0 1.02E-01 1.5E-02 9.39E-02 2.2 4.69E-03 8.8 2.97E-03

Version 2.0 Page 1 of 32


25.0

23.0

21.0

19.0

:§ 17.0 ::::> w .... 0 15.0 VI VI

~ 13.0

11.0

9.0

7.0

5.0

•• . . . . . . . .

LEU Possession Limit

·· ... . .. .. . . ... ~. .. . ..

~ .. .. .. .. • • • • 41

······ •••••• 411

~ ...


.... ~ ... .... ....

9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00 20.00

Enrichment (%)

Figure 5.1: Proposed LEU possession limit with increasing enrichment.

These isotopes will be produced using a superconducting electron linac. The electron beam will strike a high Z target to generate photon and neutron flux. When the target material is exposed to these fluxes , a photon or a neutron may be absorbed by the nucleus, thereby producing the proposed radioactive isotopes by either neutron capture, photonuclear reactions or fission. In addition to fission of LEU, we also intend to use our linacs to fission natural uranium and depleted uranium for Mo-99 production. Niowave is already licensed to possess source material (NRC license number 21 -35145-01).

The incidentally activated products will depend on many parameters, including the production reaction, the energy (and the power) of the electron beam, and the time of irradiation. Before implementing a new production scheme, we will estimate the activity of the produced isotopes as well as all incidentally produced activated products. To illustrate this process, examples of three different production routes (production of Y-88 via 89Y(y,n)88Y; production of Y-90 via 89Y(n, y)90Y; and production of Mo-99 via U-235 and U-238 (fission)) are considered in detail in Appendix A. Note that similar calculations will be done for any other isotopes we pfan to produce. Where cross sections have not been experimentally determined, we will use the latest theoretical models. We will ensure the accuracy of these models by performing a low power irradiation produce a few 1-JCi to check our simulation . Only after validating our




predictions will we proceed with high power irradiation and isotope production of higher activity.

Regardless of the isotope we are producing we will follow the same pre-irradiation, irradiation, and post-irradiation procedures. Each irradiation will start with an outline of the requirements of the final product, including specific activity of the isotope of interest and its total activity. Based on these requirements we will decide on beam parameters, time of irradiation, and production mode (neutron capture, photonuclear production method, neutron or photo-fission). We will choose an appropriate converter and the target design and will evaluate the activities of the incidentally produced isotopes as described in Appendix A. Low power irradiation will then be performed to verify predicted activity prior to each new production method. Both irradiation and postirradiation plans will also be prepared and reviewed. A flow chart outlining the preirradiation steps is shown in Figure 5.2.

During irradiation we will constantly monitor electron beam parameters (energy, current, duty cycle) to ensure they do not deviate from the prescribed values. Dose rate in the production tunnels will be constantly monitored using an ionization chamber. Air samples will be taken during or immediately after irradiation. These samples will be analyzed either with the combined alpha/beta/gamma frisker or with the ORTEC HPGe detector to determine if any generated activity has become airborne. The count rate from these samples should not exceed originally measured background values. Linac operation will be documented. If at any time during irradiation beam parameters, dose rate, or count rate exceed the expected values, the irradiation will be stopped immediately. The tunnel area will be surveyed to make sure the dose rate is below the pre-determined values. The samples will be transferred into the Radioactive Material Storage area for decay in storage and an internal audit will be performed to investigate the source of the problem. Records will be kept of all the steps and corrective actions. A flow chart outlining the irradiation steps is shown in Figure 5.3.

After irradiation a survey of the tunnel area will be done to make sure it is safe to enter and transfer the samples into the gamma-spectroscopy room. Samples will be tagged and the activity of the produced isotopes as well as incidentally produced isotopes will be measured using our gamma-spectroscopy setup. The activity of the produced radiochemicals (Y-88, Y-90, or Mo-99 in the above examples) will be measured using the HPGe detector setup, which consists of a high-energy resolution ORTEC HPGe detector, ORTEC 572-type amplifier, analog-to-digital converter, and a 928-MCB multichannel analyzer. MAESTRO software will be used for data processing . A calibration procedure will be done before every gamma-spectroscopy measurement using a set of standard gamma ray calibration sources covering energy range from 122 keV to a 1.3 MeV (Co-60, Cs-137, and Eu-152). All the spectra will be stored on the hard drive for future review. After the yields are verified, the sample will be transferred into the Radioactive Material Storage area. A flow chart outlining the post-irradiation steps is shown in Figure 5.4.




From the pre-irradiation planning to the post-irradiation handling the history of each sample will be tracked via the sample activation form -a document which will be filled out during different stages of the isotope production process (see Appendix B).

Typically, it does not make sense to irradiate a target for longer than 2-3 half-lives as the activity of the produced isotope saturates. The half-life of Y-88 is 107 days, while the half-life of Y-90 is 2.7 days. Thus, even in this example we can see how the optimum time of irradiation can be different for different products. Since our production process is in the R&D stage we do not plan to irradiate the targets for longer than 5 hours under the proposed license.



I. Pre-Irradiation

Identify an isotope for production: • Isotope of interest and its specific activity

• Amount

To develop an Irradiation Plan, determine: • production mode • converter/target design • beam parameters (energy, current)

• time of irradiation • activity of incidentally produced isotopes

Complete Niowave Form NW-APG-01

\1

Develop post-irradiation plan including: • Plans for yield verification

• Disposal plans


Prepare the linac, the converter, and the target for the irradiation.

Go to Irradiation

Figure 5.2: Pre-irradiation procedures


NRC Form 313 Accelerator Produced Radionuclides Niowave, Inc. 2/11/2015 Continuation of Responses NRC Control No. 584728

II. Irradiation

No Electron beam parameters (current/energy) remain constant?

Yes

'll

No Dose rate remains constant?

Yes

'll

Immediately stop 'V / No

the irradiation. .... Does the Airborne effluent count rate stay below the threshold value?

Survey the tunnel Yes

area. Dose rate is ll less than No Once the pre-determined irradiation time period threshold value?

has been reached, was the irradiation stopped at

No the correct time? Yes

\!I 'll

Transfer the Wait till the dose rate drops to the Yes

sample into the threshold value. Then transfer RAM Storage the sample into the RAM Storage Area for DiS. Area for DiS.

'I

Go to Post-Irradiation \ll v

Perform internal audit and investigate the source of the issue. Record all the steps and corrective actions and

retain for future reference.

Figure 5.3: Irradiation procedures.


-------------- -----------------------------..,


III. Post-Irradiation

No Survey the tunnel area. Dose rate is less than r--------fl threshold value?

Wait till the dose rate drops to the threshold value. Then transfer the sample into the RAM Storage Area for DiS.

Perform internal audit and investigate the source of the issue. Record all the

steps and corrective actions and retain for

future reference.

Version 2.0

No

Yes

Transfer the sample into the Gamma-Spec Lab. Tag it and measure the yield of the produced

isotope and incidentally produced species. Yields are within the predicted range?

Yes

\1

Transfer the sample into the RAM Storage Area. Sample to be shipped off site?

Yes

----------------------------~ " Pack and ship out the

sample according to the DoT rules.

(For Future Licensing)

Figure 5.4: Post-irradiation procedures.

Page 7 of 32

No

Keep the sample in the RAM Storage Area for DiS until its activity is below the threshold

value.


5.2. Financial Assurance and Recordkeeping for Decommissioning

5.2.1 Financial Assurance for Decommissioning Certification of financial assurance for decommissioning (FAD) in the amount of $225,000 is required by this license. A letter of credit, standby trust agreement, and all supporting documentation as required by NUREG-1757, Vol. 3, Rev. 1 will be provided to the NRC before Niowave produces any material under the proposed license.

5.2.2 Recordkeeping for Decommissioning The following records will be maintained until the license is transferred to another party, or to the NRC following the termination of the license:

• Records of spills or other unusual occurrences involving the spread of contamination, including known nuclides, quantities, forms, and concentrations. These records need not be maintained if the contamination was completely cleaned up.

• As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored. This includes any inaccessible locations which might become contaminated .

• Beginning at the issuance of the license, and updated every two years thereafter, a single document that contains:

o a list of all areas currently or formerly designated as restricted areas; o all areas (if any) outside of restricted areas where spills or unusual

occurrences involving the spread of contamination have taken place; o all areas (if any) where waste is buried; o all areas (if any) outside of restricted areas that contain material such that,

if the proposed licensed expired, would either require the area to be decontaminated prior to decommissioning, or an approval of an application for disposal to be issued.

See Table 5.2 for NRC records maintenance requirements.

a e . ecor s a1n enance T bl 5 2 NRC R d M . t R eqUiremen s

Type of Record How Long Record Must be Maintained Production While the material is possessed until after transfer or

disposal (see below) Transfer For 3 years after transfer Disposal Until NRC terminates the license Important to decommissioning Until the site is released for unrestricted use




Item 6: Purpose for Which Licensed Materials Will Be Produced

6.1. Purpose for License With a growing need for radioisotopes, non-reactor based production will become vital to maintaining a commercial supply of manmade radioactive nuclides. Niowave proposes to begin production of several specific radioisotopes for research and development, which may include distribution to authorized licensees for independent analysis.

6.2 Material Possession Limits Radionuclides will be produced by an accelerator in accordance with applicable regulations. This material will be used in accordance with Table 6.1.

a e . . 1cense T bl 6 1 L. d matena possess1on 1m1ts an . I r . d uses . Radioisotope Chemical/Physical Maximum Possession Proposed Use

Form Limit Sc-46 Unsealed solid 1 mCi Production of a

radiochemical for research and development

Sc-47 Unsealed solid 1 mCi Production of a radiochemical for research and development

Mn-56 Unsealed solid 1 mCi Production of a radiochemical for research and development

Zn-65 Unsealed solid 1 mCi Production of a radiochemical for research and development

Cu-67 Unsealed solid 1 mCi Production of a rad iochemical for research and development

Se-75 Unsealed solid 1 mCi Production of a radiochemical for research and development

Y-88 Unsealed solid 1 mCi Production of a radiochemical for research and development

Sr-89 Unsealed solid 1 mCi Production of a radiochemical for research and development

Y-90 Unsealed sol id 1 mCi Production of a radiochemical for research and development

Mo-99 Unsealed solid 1 mCi Production of a radiochemical for research and development

Ho-166 Unsealed solid 1 mCi Production of a radiochemical for research and development

lr-192 Unsealed solid 1 mCi Production of a radiochemical for research and development

Au-198 Unsealed solid 1 mCi Production of a



U-234 Unsealed solid See Table 5.1 dispersed in LEU



6.3 Contracting and Sourcing of LEU


radiochemical for research and development Target material to be transmutated into Mo-99 by accelerator induced nuclear fission Target material to be transmutated into Mo-99 by accelerator induced nuclear fission Target material to be transmutated into Mo-99 by accelerator induced nuclear fission

Niowave in engaged in active negotiations with radioisotope distributors. As contracts are finalized, these will be provided to the NRC.

Niowave is engaged in discussions with Y-12 to obtain LEU, and is prepared to buy LEU outright, including all disposal costs.



Item 7: Training and Experience of Radiation Safety Officers

7.1 Radiation Safety Officer (RSO) and Assistant Radiation Safety Officer (ARSO)

Dr. Terry Grimm (President and Senior Scientist)

Mr. Erik Maddock Dr. Valeriia Starovoitova (RSO) / .... (Applied Physics Team Lead) -... /

l Ms. Amanda Grimm

(ARSO)

Figure 7.1: An organizational chart describing the management structure, reporting paths, and the flow of the authority between executive management and the RSO.

Figure 7.1 shows an organizational chart of Niowave's radiation safety team. Niowave's Senior Scientist, Dr. Terry Grimm, is responsible for all aspects of safety at Niowave, Inc. Dr. Grimm has delegated the authority for the radiation safety program to the RSO, but maintains oversight of the program. Erik Maddock is Niowave's RSO and Amanda Grimm is the ARSO. The RSO is ultimately responsible for the radiation safety program, including any and all actions taken or not taken by the ARSO. The RSO, ARSO, and Senior Scientist are all qualified to be Authorized Users (AUs) as is Dr. Valeriia Starovoitova, Applied Physics Group Lead. The RSO will be delegated by senior management with sufficient authority, organizational freedom, and management prerogative to communicate with and direct personnel regarding NRC regulations and license provisions and to terminate unsafe activities involving licensed material.

Erik Maddock is the current Niowave, Inc. Radiation Safety Officer. He obtained his MS degree in Radiological Physics from Wayne State University's Medical Physics Graduate program. During graduate school, he worked with medical radioisotopes including Mo-99, F-18, and high specific activity brachytherapy Cs-137 and Co-60 sources. Before attending graduate school, Mr. Maddock worked in the navy submarine fleet for three years as a nuclear trained naval officer. His training includes six months of classroom instruction in radiological controls from the Navy Nuclear Power Training Command in Goose Creek, SC. After power school he completed six months of handson training covering all aspects of nuclear power plant radiation safety including spill response, decontamination, and record keeping at the MARF plant in Ballston Spa, NY. His navy training covered the following subjects: radiation protection principles, characteristics of ionizing radiation, units of radiation dose and quantities, radiation




detection instrumentation, biological hazards of exposure to radiation, and hands-on use of radioactive materials. His understanding of the radiological sciences is further confirmed by his certification from passing the Part 1 Exam for Therapeutic Medical Physics by the American Board of Radiology. His tasks at Niowave as the head RSO include providing radiation safety training to all employees, establishing written safety guidelines and rules for tests in which radiation will be produced, and conducting radiation dose surveys.

Amanda Grimm is the current Niowave, Inc. Assistant Radiation Safety Officer. She received her BSE degree in Materials Science and Engineering from the University of Michigan, Ann Arbor. During the nine months that she has been acting ARSO under instruction, she has been trained by the RSO in the following subjects:

• Radiation protection principles • Characteristics of ionizing radiation • Units of radiation dose and quantities • Radiation detection instrumentation • Biological hazards of exposure to radiation • Handling of radioactive materials relevant to accelerator activities

She also has completed a one week radiation sterilization course organized by the Association for the Advancement of Medical Instrumentation (AAMI). She has been assigned as project manager to Niowave's x-ray sterilization operations including managing all aspects of x-ray dosimetry. Specifically, Ms. Grimm has established a dose measurement system, using radiochromic films and a high dose rate ionization chamber, which will be used during sterilization R&D and routine processing. Amanda has been working extensively with international standards and FDA regulations to gain certification for Niowave's x-ray sterilization processes. She has gained the full confidence of senior management and the RSO and is now entrusted to personally supervise testing involving the creation of High Radiation Areas.

The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license. Typically, these duties and responsibilities include the following:

• Ensure that licensed material possessed by the licensee is limited to the types and quantities of licensed material listed on the license; Maintain documentation that demonstrates that the dose to individual members of the public does not exceed the limit specified in 10 CFR 20.1301; Ensure security of radioactive material; Post documents as required by 10 CF.R Parts 19.11 and 21.6; Ensure that licensed material is transported in accordance with applicable NRC and DOT requirements; Ensure that radiation exposures are ALARA;

• Oversee all activities(licensed and unlicensed) involving radioactive material, including monitoring and surveys of all areas in which radioactive material is possessed or possessed and used;

• Act as liaison with NRC and other regulatory authorities; • Provide necessary information on all aspects of radiation protection to personnel

at all levels of responsibility, pursuant to 10 CFR Parts 19 and 20, and any other applicable regulations;




• Oversee proper transfer and delivery of radioactive material , and conduct radiation surveys for all shipments of radioactive material arriving at or leaving from the institution, as well as packaging and labeling all radioactive material leaving the institution;

• Distribute and process personnel radiation monitoring equipment, determine the need for and evaluate bioassays, monitor personnel radiation exposure and bioassay records for trends and high exposures, notify individuals and their supervisors of radiation exposures approaching established limits, and recommend appropriate remedial action;

• Conduct training programs and otherwise instruct personnel in the proper procedures for handling radioactive material prior to possession or possession and use, both at periodic intervals (refresher training) , and as required by changes in procedures, equipment, or regulations;

• Supervise and coordinate the radioactive waste disposal program, including effluent monitoring and recordkeeping on waste storage and disposal records;

• Oversee the storage of radioactive material not in current use, including waste; • Perform or arrange for leak tests on all sealed sources and calibration of

radiation survey instruments; • Maintain an inventory of all radionuclides possessed under the license and limit

the quantity to the amounts authorized by the license; • Immediately terminate any unsafe condition or activity that is found to be a threat

to public health and safety or property; • Supervise decontamination and recovery operations; • Maintain other records not specifically designated above (e.g., records of

production, transfers, and surveys as required by 10 CFR 30.51 and 10 CFR 20, Subpart L, "Records") ;

• Hold periodic meetings with, and provide reports to, licensee management; • Ensure that all users are properly trained; • Perform periodic audits of the Radiation Safety Program to ensure that the

licensee is complying with: all applicable NRC regulations, the terms and conditions of the license (e.g ., leak tests, inventories, possession or possession and use limited to trained, approved users), the content and implementation of the Radiation Safety Program to achieve occupational doses and doses to members of the public that are ALARA in accordance with 10 CFR 20.1101, and the requirement that all records be properly maintained;

• Ensure that the results of audits, identification of deficiencies, and recommendations for change are documented (and maintained for at least 3 years) and provided to management for review; ensure that prompt action is taken to correct deficiencies;

• Ensure that the audit results and corrective actions are communicated to all personnel who possess or possess and use licensed material ;

• Ensure that all incidents, accidents, and personnel exposure to radiation in excess of ALARA or 10 CFR Part 20 limits are investigated and reported to NRC and other appropriate authorities, if required , within the required time limits; and




• Maintain an understanding of, and up-to-date copies of, NRC regulations, the license, and revised licensee procedures, and ensure that the license is amended whenever there are changes in licensed activities, responsible individuals, or information or commitments provided to NRC during the licensing process.

7.2 Authorized Users Four authorized users are proposed: the RSO, ARSO, Dr. Terry Grimm, the President and Senior Scientist at Niowave, and Dr. Valeriia Starovoitova, Applied Physics Group Lead. Both Dr. Grimm and Dr. Starovoitova have significant experience working with radioactive material and are qualified to be authorized users.

Dr. Terry Grimm has over 25 years of experience in accelerator research with both the Department of Energy and Department of Defense. Prior to founding Niowave, he was a senior physicist and adjunct professor at Michigan State University's National Superconducting Cyclotron Laboratory for 13 years. He received his PhD from the Massachusetts Institute of Technology in Applied Plasma Physics and Nuclear Engineering.

Dr. Starovoitova has over 10 years of experience in nuclear physics. She received her BS degree from St. Petersburg State University and her PhD from Purdue University. Prior to joining Niowave, Dr. Starovoitova served at the Idaho Accelerator Center since 2007, first as a Postdoctoral Researcher, and later as a Research Assistant Professor. During these years she was involved in several applied nuclear physics projects, in particular photonuclear production of isotopes, nuclear waste transmutation, and photon activation analysis. In 2013 she joined Niowave to head the Applied Physics department.

7.3 Servicing, Maintenance and Repair Niowave staff will be servicing and maintaining production linacs. The engineers and technicians performing maintenance in a restricted area will be radiation safety workers properly trained by the radiation safety team. Prior to starting any maintenance on components with potentially high activity, a radiation safety plan will be implemented by the RSO. See Appendix C for an example of a radiation safety plan used in accelerator operations by Niowave's radiation safety team.




Item 8: Training for Individuals Working In or Frequenting Restricted Areas

Niowave is committed to training all employees in radiation safety. Our training program has been reviewed and approved by the State of Michigan licensing authority. The training program establishes two levels of workers: radiation workers and non-radiation workers. The outline of the current radiation safety training program given to Niowave's radiation workers is given below. This training was initially structured to cover material related to safely operating radiation producing machinery, but was expanded to deal with radioactive material as the threshold energy for photonuclear activation was exceeded by accelerator output. The radioactive material curriculum was again updated to include source material when a license for possession was received from the NRC. At the start of this application process the curriculum was again updated to include neutron activated byproduct material and accelerator induced fission and currently covers the following topics:

• Radiation Safety Regulations • Types of Radiation • Ionizing Radiation • Radiation Sources • Units of Radioactivity, Exposure, and Dose • Half-life of Radioactive Materials • Biological Effects of Radiation • Sources of Exposure to Radiation • Types of Radiation Exposure • Individual Dose Limits • ALARA Principle • Dose Reduction Practices • Monitoring the External Exposure • Monitoring the Internal Exposure • Records and Reports • Safety Procedures • Accelerator-Produced Radioactivity and Radioactive Material • Security of Radioactive Material • Radiation Emergency • Niowave Building: Areas and Postings

Radiation workers at Niowave are employees who are allowed to work in restricted areas, which are environments that may have radiation levels higher than that allowed to the general public. Radiation workers are issued personal dosimeters after they successfully complete training. Non-radiation workers are classified as employees not allowed in restricted areas. Training for non-radiation workers is less comprehensive than the radiation worker training. This training focuses on signs, postings, and other indicators of restricted areas, how to avoid them and what to do if you find yourself in a restricted area. Both types of radiation safety training courses are provided every quarter there are newly hired employees. Employees that have received previous training are required to attend a refresher radiation safety training course at least once a




year. Retraining more frequent than annually will be performed as deemed necessary by the radiation safety team whenever there is a change in duties or the work environment affecting workers involved in isotope production.

Radiation safety courses are for radiation workers and are taught by the RSO, while non-radiation workers are trained by either the RSO or ARSO. See Item 7 (above) for RSO and ARSO qualifications. For radiation workers, this training takes about 3 - 4 hours, with the time roughly equally split among all topics. It includes a 15 - 20 minute tour of the restricted areas and other spaces relevant to radiation safety.

Each employee's understanding of the material is assessed through a multiple-choice test given at the end of each training course. Just as there are two levels of initial training for radiation workers and non-radiation workers, there are also two levels of tests with the radiation worker exam being far more comprehensive than the nonradiation worker exam. Passing grades are 80% for the radiation worker exam, and 70% for the non-radiation worker exam. If the employee does not correctly answer a sufficient number of test questions to pass, then the RSO reviews the material related to the incorrect answers with the employee, and an oral upgrade quiz is administered by the RSO. Oral quiz results are recorded on the previously failed paper test. Annual refresher training, the annual refresher test, and the passing grade (75%) are the same for all employees. Testing material for radiation workers, non-radiation workers, and the annual refresher will be provided with this application in Appendix D.



Item 9: Facilities and Equipment

9.1 Facilities


Licensed byproduct material will be produced at Niowave's Walnut Street Headquarters, consisting of two adjacent buildings and located in Lansing, MI. The designated storage and shipping areas are in Niowave's Electron Research and Development (NERD) facility, which is a 14,000 ft2 steel framed and walled structure, built on a concrete slab in 2012 (see Figure 9.1 ). Licensed material will be produced and stored exclusively in the NERD, (see Figure 9.2). Production will be in the tunnels and long term storage in the RAM storage area (labeled in Figure 9.5). The floor of the tunnels is 6' below grade and it is shielded as shown in Figure 9.3.

Figure 9.1: Installation of accelerator within the NERD Facility.



Spectroscopy Lab

Isotope Production and Storage Areas

NIOWAVE INC. WALNUT COMPLEX HEADQUARTERS &

N.E.R.D TESnNG FACILITY

1----100'·6.00''----l

/

rl=; I ~

" .,

~

140'·4.00''


00

..... - ~0 . NERD Faci I ity /..__,.___..=--......~....-.......____, __ __._

'~------------271 '-------------1 I I

Headquarters Building

120'

Figure 9.2: Overview of Niowave's Headquarters in Lansing, MI.

9.2 Ventilation and Air Handling Equipment Niowave intends to use our superconducting linacs only for activation of stable isotopes in solid form and for fission of source material or LEU in solid form. The proposed license will allow Niowave to demonstrate the effectiveness of our technology for radioisotope production. The proposed license will allow us to further refine and develop our equipment design and production methods. Because radiochemistry will not be occurring on site, no hot-cells or synthesis units are planned for use under the proposed license. No radioactive liquids will be produced under the proposed license. No particulates will be produced during activation and no air filtration will be necessary.




Figure 9.3: Shielded tunnels dimensions. Concrete is shown as gray and earth as brown.

Figure 9.4 is a diagram of the NERD heating and ventilation system. Ridge vents which open on overpressure are also installed in the building near the ceiling. Niowave possesses the equipment necessary to perform particulate air samples. After it has been determined what isotopes may be generated during a particular production operation, an air sample will be taken during or immediately after linac operations. This sample will be analyzed either with the ORTEC HPGe detector to determine if any generated activity has gone airborne. Since only naturally occurring airborne particulates are expected, if any activated particulates above the background value are detected, production will be halted until the source of the airborne activity is determined and eliminated. When the tunnel is safe for entry, swipe samples will be taken around the target to test for loose surface contamination from airborne particulates which have precipitated.

Once Niowave is licensed for isotope production, during the first test of the entire production system, a safety survey map will record all dose rates adjacent to the production site shielding. Included with this map will be the particulate air sampling results. This survey will be submitted to the NRC for review before production operations continue.

Air sampling will take place for the first 5 production operations. If no particulates are detected during these operations, air particulate sampling will no longer be required. Each time a new type of production operation occurs, the air particulate integrity of the




system will be verified during the first 5 operations by taking air samples. If nothing is detected during these samples, particulate samples are no longer required .

9.3 Safety Related Equipment The shielded tunnels where the linac will do the production have an interlock consisting of a mechanical switch which suspends power to the accelerator when the entrance gate is opened . There also is an emergency stop button by the operating station where the area monitor dose rate display is located. Linac operators continuously monitor the entrance to the shielded enclosure via closed circuit camera.

NERD Western

Wall NERD Loading

Dock Door

1 Intake

Figure 9.4: A cross section of the NERD facility showing the airflow thru the ventilation system as it is used in cold months. A majority the air flow is recirculated, while a minority is fresh air drawn from outside. In warmer months, cool , dry air is drawn into the building overnight, and the ventilation is

secured during warm days. There is currently no air conditioning unit installed, but there is the capability to add that in the future.

Plans are in place for an upgrade to a comprehensive interlock system before isotope production begins. This includes a warning light visible within and at the entrance of the shielded enclosure which is illuminated only when the accelerator is producing radiation. An audible warning will sound within the tunnel and all adjacent areas at least 15 seconds before the creation of a high radiation area (i.e. dose rate ;::::1 00 mrem/hr). In addition to the entrance gate interlock switch described above, there will be a time delayed arming switch located within the tunnels. Once the interlocks are armed, the delay switch will prevent radiation for 15 seconds. When radiation is being produced, operators will continuously monitor the entrance to the shielded enclosure via closed circuit camera See Figure 9.5 for an illustration of this system.


NRC Form 313 Accelerator Produced Rad ionuclides Niowave, Inc. 2/11/2015 Continuation of Responses NRC Control No. 584728

As part of the planned interlock upgrade, non-permanent shielding will be added as needed in the form of lead or concrete bricks, or poly sheeting, to keep the instantaneous dose rate at any accessible outer surface of the shielded enclosure to < 7 mrem/hr. This limit is required by Niowave's State of Michigan license for a Class A shielded enclosure. An area monitor ionization chamber will be placed in the highest radiation hotspot external to the shielding. This area monitor will trip off the linac when the dose rate reaches 6.95 mrem/hr.

Secure radioactive material storage area

-'"::"'" +ypioal:-fiAac-test posit1ons

- IIIII

Alarm will sound 15 seconds before making radiation

Shielded tunnels

Tunnel entry interlocked to accelerator power

Time delayed arming switches (operators must ensure tunnels empty) and emergency shutoffs

Figure 9.5: Overhead view with details of the linac interlock system and typicallinac locations.

9.4 Storage and Security Any incidentally activated radionuclides will be produced in the tunnel close to the converter/target holder area. As mentioned earlier they will primarily come from the stainless steel beam pipe, beryllium components, LBE converter, and lead shielding. To control non-radiation worker exposure to incidentally produced radionuclides we plan to post the tunnels as radioactive material storage areas and restrict access to radiation workers. Restricted areas will are locked up when not in use, with only the RSO, ARSO, and AUs having keys.

After irradiation, the target will be removed from the production site only after it is safe to enter the tunnel and approach the target while maintaining ALARA. At no time will the




target be removed from the tunnel if it is generating a dose rate of 2 mrem/hr at a distance of 1 em. A shielded pig may be used to achieve this limit for transport to an on-site lab which is posted as a restricted area. At that time, the target may be removed from the pig for spectrographic analysis provided it does not create a high radiation area upon removal. If it becomes impossible to maintain ALARA while still obtaining a useful amount of activity from the target, a remote handling system will be constructed to place the target and remove it from the tunnel for analysis. Any radiation worker handling the target will wear gloves, a ring dosimeter, and a whole body dosimeter during handling. If storage is necessary, the target will remain inside a shielded pig in Niowave's radiation storage area or within the tunnels until background radiation levels are less than 2 mrem/hr in the nearest unrestricted area upon its removal from the pig. Surveys of adjacent areas will be performed each time additional activity is added to the radioactive material storage area. See Figure 9.6 and Figure 9. 7 for images of a recent upgrade to the NERD Facility which added a spectroscopy lab and fully enclosed the RAM storage area. See Figure 9.8 and Figure 9.9 for images of the spectroscopy lab and RAM storage the after completion of construction .

The RAM storage area is enclosed within a lockable gate that only the AUs, RSO and ARSO have keys to. This gate is unlocked only when access to the RAM storage area is required for adding or removing from storage, performing audits or surveys, when taking inventories, and other planned evolutions necessary to maintain radiation safety. When unlocked, the RAM storage area gate is continuously monitored by a qualified radiation worker to limit access to authorized personnel only. To get to the RAM storage area gate, it is necessary to pass thru the Spectroscopy Lab, which has a door that is unlocked only when the lab is occupied. Licensed material will only be stored in the NERD facility. The NERD building is locked when not in use, and security is continuously monitored by a burglar alarm service and video cameras after hours.

Figure 9.6: Entrance to Spectroscopy Lab during last phases of construction .




Figure 9.7: Close up view of entrance with the gate to the RAM storage area visible to the left.

Figure 9.8: The interior of the Spectroscopy Lab after completion .




Figure 9.9: The view into our RAM storage area after completion of the upgrade.



Item 10: Radiation Safety Program

10.1. Audit Program No response is required.

10.2. Radiation Monitoring Accelerator produced radionuclides generate a wide spectrum of radiation . Several types of detectors are needed to ensure radiation safety. Refer to Table 10.1 for Niowave's radiation monitoring instrumentation. These instruments are shipped to their manufacturers for recalibration annually.

a e 1owave T bl 10 1 N. a 1a 10n om onng ns rumen a 1on R d. f M "t . I t t f

Detector Make & Detector Type Radiation Monitored Model Fluke 451 P (x3) Handheld survey Gammas and x-rays

meter Ludlum Model 26 Geiger-Muller Frisker Alphas, gammas and

betas Ludlum 357-9 & 45-9 Area monitor with Gammas and x-rays (x2) ionization chamber Ludlum Model 2241-4 Neutron detector Fast and thermal

neutrons Ludlum Model 3000 Alpha Detector Alpha radiation with 43-92 Alpha Probe Ortec GEM1 OP4 HPGe Detector X-ray and gamma

spectrum RADeCO H-81 OAC Air Sampler Airborne particulates

Niowave will use instruments that meet the radiation monitoring instrument specifications published in Appendix I to NUREG-1556, Vol. 21, Program-Specific Guidance About Possession License for Production of Radioactive Materials Using an Accelerator. We reserve the right to upgrade our survey instruments as necessary.

The Ludlum 357-9 area monitors are used to monitor area radiation during accelerator operation and will be used for the same during isotope production. One of these monitors is placed within the shielded tunnels in order to determine if it is safe to enter. The other will be placed external to the shielding where the highest level of radiation is expected . As described in Item 9.3, this area monitor will be interlocked to secure accelerator beam production when the reading exceeds the 7 mrem/hr action level required by our state license.

No one will approach the beam line or isotope target while doing so requires entry into a high radiation area (action level dose rate of 100 mrem/hr or greater). The area monitor in the tunnels and the handheld dosimeters will be used to verify these levels. If either detector exceeds 100 mrem/hr, access to the area is prohibited until decay or a




remotely operated shielded pig reduces the dose rate to under 100 mrem/hr. See Item 9.4 for procedures to remove the isotope target from the tunnels for analysis.

1 0.3. Material Accountability Niowave has developed and will implement and maintain written procedures for licensed material accountability and control to ensure that:

• License possession limits are not exceeded (see Item 5). • Licensed material is secured from unauthorized access or removal (see Item 9). • Licensed material is maintained under constant surveillance and control (see

Item 9) . • Records of production , transfer, and disposal of licensed material are maintained.

We will conduct physical inventories of licensed material at intervals not to exceed 6 months (see Item 5).

10.4.0ccupationa1Dose We have developed and will implement and maintain written procedures for monitoring occupational doses that meet the requirements in 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203, 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, and 10 CFR 20.2106, as applicable. No airborne release into worker breathing zones will occur during licensed operations.

1 0.5. Public Dose No effluent or air emissions will be released during licensed operations. See Item 9.2 for a full discussion on this topic.

1 0.6. Safe Handling of Radionuclides and Emergency Procedures The following procedures will be used when handling radioactive material and during emergencies. Procedures will be revised only if: the changes are reviewed and approved by the licensee management and the RSO in writing; the licensee staff is provided training in the revised procedures prior to implementation; the changes are in compliance with NRC regulations and the license; and the changes do not degrade the effectiveness of the program.

10.6.1 Handling of Radioactive Material The following instructions shall be observed when handling radioactive material:

• The RSO shall receive Senior Scientist approval prior to the commencing of any evolution requiring the handling of radioactive material.

• The RSO, ARSO, or an AU shall directly supervise all handling of radioactive material.

• The specified radiation safety supervisor will not become directly involved in the handling operations so that they may maintain oversight of the entire operation and be free to provide direction as needed.

• Two person accountability is required when handling radioactive material , with one of the two people being the RSO, ARSO, or an AU.

• A lab coat or other protective outer garment shall be worn when handling radioactive material.




• Disposable gloves shall be worn at all times when handling radioactive material. • Shoe covers shall be worn when handling radioactive material where there is a

chance of loose contamination being present on the external surface. • After each evolution requiring the handling of radioactive material, hands, shoes,

and clothing shall be frisked for contamination in a region of low background radiation before leaving the area.

• No eating, drinking, chewing, smoking (including vapor equivalent), or applying cosmetics or lip balm in any area where radioactive material is stored or used.

• No storing of food , drink, or personal effects in areas where radioactive material is stored or used.

• Personal dosimeters shall be worn in areas where licensed material is stored or used, and ring dosimeters shall be used when handling licensed material unless in the case of short lived byproduct material, at least 5 half-lives have passed after their generation

• Radioactive waste shall be disposed of in accordance with the procedures in Item 10 of this document.

• Radioactive material will be stored in clearly labeled containers. • All radioactive material will be secured when not under the constant surveillance

of qualified personnel. • A rehearsal involving no licensed material will be performed prior to any handling

evolution which is new or has not been done in the prior 60 days.

1 0.6.2 Emergency Linac Shutdown Each linac will be designed with at least one emergency shutdown button. The emergency shutdowns will be tested within 7 days of any linac test, the test will be logged in the Radiation Safety Surveys binder. The shutdown circuitry will be displayed on the linac control panel. In the event of a dangerous radiation level, a red emergency shutdown button shall be immediately pushed by any operator. Once radiation is at a safe level, the incident should be reported to the radiation safety officer.

1 0.6.3 Radioactive Spill The requested licensed materials are all non-volatile solids, but may in some cases consist of loose granules. In the case of a spill of this material, the following actions should be taken by the workers handling the material:

• Notify persons in the vicinity that the spill has occurred. • Cover the spill with a damp absorbent wipe. • Clean up the spill with damp absorbent wipes while wearing disposable gloves,

protective outerwear and shoe covers. • If the spilled material is not recoverable, fold the wipes with the clean side out

and place in a plastic waste bag. Put the disposable gloves and shoe covers into the same plastic waste bag.

• Survey the area for any additional contamination and clean up as necessary. Be sure to check any adjacent areas that contamination could possibly have spread to. Check the hands, shoes, and clothing of any workers that entered the spill area.

• Report the incident to the RSO when safe to do so.




• Allow no one to return to work in the area unless approved by the RSO or ARSO. The RSO or ARSO shall ensure that the spill and decontamination are properly documented, and shall determine what additional corrective actions need to be taken. If necessary, the NRC and state shall be informed of the spill.

10.6.4 Fire in or near Radioactive Material Most fires are small and are quickly extinguished. The following procedure should be followed in this case:

• Immediately attempt to put out the fire using the quickest appropriate method, usually a fire extinguisher. If that is not possible, or if there are any injuries requiring an ambulance, use the procedure for a major fire.

• Notify nearby personnel to abandon the area. Have one person call or otherwise immediately notify the RSO. The RSO should make the decision whether to involve the fire department.

• Survey for contamination all persons who fought the fire or who were in the vicinity when it occurred .

• Decontaminate persons as necessary by removing contaminated clothing, rinsing skin with warm water, then washing with a non-abrasive soap.

• The RSO or ARSO shall direct decontamination. • Once decontamination is complete, the RSO may approve the resumption of

work in the area. When safe, the RSO should determine if state or NRC notification is necessary.

A major fire requires the response of the local fire department, however, just because the local fire department responds to the fire does not automatically make it a major fire. If the fire results in injuries requiring ambulance response, it should be considered major until proven otherwise. Supervisory personnel, including the RSO, should use discretion when determining whether a fire is major or not. As with all things involving radiation, it is rarely wrong to take the most conservative approach. The procedure for a major fire is as follows:

• Immediately abandon the building. • Call911 . • Notify the RSO by the most expeditious means available. • Ensure injured personnel receive medical attention. Inform medical personnel if

any are possibly contaminated. • Inform emergency responders upon arrival where the radioactive materials are

stored , used and their current location. Advise them as to the best possible route to access the areas containing radioactive material. Give any precautions that would be helpful in minimizing the spread of contamination if the use of pressurized water is necessary.

• Once the emergency responders have extinguished the fire, the RSO and ARSO should take charge of decontamination. No one should return to work in the area(s) affected until cleared by the RSO.

When possible based on the firefighting efforts, the RSO or ARSO should set up a controlled area where first responders and non-injured workers can be surveyed for contamination. Decontaminate as necessary before releasing contaminated personnel.




Bioassays or internal monitoring may be necessary. The RSO or ARSO should assist emergency personnel who may need to enter restricted areas to maintain their dose ALARA. Once it is appropriate, the RSO or ARSO should supervise decontamination efforts. The RSO should determine if NRC notification is necessary.

10.7. Surveys and Leak Tests We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in Appendix M to NUREG-1556, Vol. 21.

1 0.8. Maintenance No response required.

1 0.9. Transportation No response required .

10.10. Minimization of Contamination See 5.1, Item 9, 1 0.6, 10. 7, and Item 11.



Item 11: Waste Management


Niowave plans to dispose of non-transferred radioactive materials by decay-in-storage (DIS) for the isotopes we are specifically proposing to license that have a half-life of less than 120 days. All other radioactive waste will be disposed of via transfer to an authorized, licensed recipient, such as Waste Control Specialists, LLC in Andrews, Texas.

11.1 General Waste Management Procedures The following procedures shall be observed when dealing with radioactive waste:

• All radioactivity labels must be defaced or removed before disposal into nonradioactive waste streams.

• Nonradioactive waste, including uncontaminated packaging of radioactive material, shall never be mixed with radioactive waste.

• Radioactive waste shall not be created unnecessarily. The RSO or ARSO should occasionally monitor the handling of radioactive material to ensure that needless waste is not being created. All new procedures should be scrutinized to ensure the same.

• Cost, occupational and public exposure to radiation, and any other hazards which are properties of the material (e.g. toxicity, carcinogenicity, flammability, etc.) shall be considered when choosing a disposal method.

• The full scope of waste handling procedures - from the source of the waste to the waste storage areas, and eventual disposal - will be taught to radiation workers assigned to handle waste for storage and disposal.

• All non-radiation workers wil l be instructed as to how to avoid unauthorized contact with and disposal of radioactive material.

Figure 11.1 shows Niowave's designated radioactive material storage area. This area is within a locked enclosure and is in a building monitored when not occupied by a burglar alarm and video cameras. It is not accessible to workers, and only the RSO, ARSO and AUs possess keys.

Niowave is not requesting a license to produce anything but solid isotopes at this time. The short lived isotopes will be allowed to decay in storage in accordance with the procedures submitted with this application. The long lived isotopes will not be allowed to exceed our possession limit before they are disposed of.



Locked Gate r I

Door Locked

""" when Lab Unoccupied

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Figure 11 .1: Overhead view of NERD facility showing location of secure radioactive material storage area.

11.2 DIS Procedures The following procedures shall be observed when disposing of waste via DIS:

• Only waste with a physical half-life of 120 days or less may be disposed of by DIS.

• Isotopes which are produced with a half-life longer than 65 days, but less than or equal to 120 days will be kept separately from isotopes produced which have a half-life less than or equal to 65 days.

• Waste shall be stored in suitable containers marked with the isotope(s) contained therein. The container should provide adequate shielding (if needed) and the material it is constructed from should be chemically compatible with the waste it contains.

• Full containers shall be sealed with identifiable labels. o The label shall contain the date when the container was sealed, the

longest lived radionuclide in the container, total activity, and the initials of the person (RSO, ARSO, or AU) who sealed the container.

o Each packaged isotope selected for decay-in-storage will be labelled with either: "half-life :5 65 days" or "65 days< half-life :5 120 days".




o After being sealed, the container may then be transferred to the DIS area. When large quantities are held for DIS, potential measurable radiation exists even after 10 half-lives.

• Prior to disposing as ordinary trash after 10 half-lives of the longest lived isotope within, each container shall be checked as follows:

o Remove any shielding from around the container (if necessary). o Survey the contents of the container in a low background setting. o If the survey readings are indistinguishable from background readings, the

material may be disposed of as trash after removing or defacing any radiation labels.

o If the surface reading is still above background, return the container to the DIS area and notify the RSO or ARSO.

• Before disposing in the trash, record the date when the container was sealed, the disposal date, they type of material, and which instrument was used.


NRC Form 313 Continuation of Responses

Appendix A

Example Calculations of Activity for Isotopes of Interest and Possibly Incidentally Produced Isotopes

(5 pages)


Appendix A


Example calculations of activity for isotopes of interest and possible incidentally produced isotopes

Before implementing a new production scheme we will estimate the activity of the produced isotopes as well as all incidentally produced activated products. To illustrate this process examples of three different production routes (production ofY-88 via 89Y(y,n)88Y; production of Y-90 via 89Y(n, y)90Y; and production ofMo-99 via U-235 and U-238 (fission) are considered in detail below. Note that similar calculations will be done for any other isotopes we plan to produce.

Natural yttrium consists of one stable isotope, Y-89. Yttrium ingots or foil can be purchased commercially elsewhere, for example Alfa Aesar. We are going to consider two different production modes - photonuclear reaction and neutron capture separately:

89Y(y,n) ss y

B9Y(n, y)9o y

Photoneutron production of Y -88 from Y -89

For the photonuclear production of Y-88 we are planning to use a liquid metal bremsstrahlung converter capable of dissipating high electron beam power. Lead-bismuth eutectic was chosen as a converter material due to the high atomic number of lead and bismuth and the resulting high conversion efficiency. The electron beam will pass through the niobium collimator inside a stainless steel beam pipe hitting the LBE as shown in Figure 1.

Stainless steel beam pipe

Stainless steel windows

I Niobium collimator LBE

Lead shielding

Figure 1. Photonuclear production of Y -88 setup.

We assume that about 90% of the electron beam will be incident on the LBE stream sandwiched between thin stainless steel windows. Bremsstrahlung photons generated in the LBE will cause

Page 1 of 5


Appendix A


photoneutron reactions in the yttrium target placed behind the converter. Lead shielding will be set up around the target as shown.

The production rate of the isotope depends on a number of parameters, such as the the threshold energy of the nuclear reaction E1h, the maximum energy of photons Emax, the photon flux density qJ(E), and the cross-section of a photonuclear reaction fJ(E). The production rate per target nucleus can be found as:

dN Em.,

- = J rp(E) 0 CY(E) dE 0

dt E," (1)

If the target is significantly large so that the photon flux is not uniform throughout the target, the production rate R should be calculated as:

£ max

R = J J N (F)rp(E, r) · CY(E) dEd 3r, (2)

E,11 v where N(r) is the number of target nuclides per unit volume and d 3r is the volume element of the target. The 89Y(y,n) 88Y cross-section is shown in Figure 2.

, .. ... , ....

500 pb

l 00 1ib

10 1itl

2NtV lNtV .fNIV 5Nft' 6 Nt'V

Y89 (y,n)

...-·· .. \,

I /

\

\ \ ~\

·· ... --.

Figure 2. 89Y(y,n) 88Y cross-section. ,.. ....

To accurately predict the production rate we will use MCNPX, a general purpose particle transport Monte Carlo code, developed by Los Alamos National Laboratory1

• MCNPX involves source characterization, target material and geometry specifications, and physics process management. MCNPX output tallies the physical quantities of interest. The integral (2) will be evaluated by simulating bremsstrahlung fluxes with F4 tallies (photon flux averaged over a cell) and multiplying them with ENDF/B-VII cross-sections2 utilizing the FM tally multiplier card. The FM card can be used in MCNPX to calculate any quantity of the form:

1 Pelowitz, 2008 2 Chadwick et al, 2006

Page 2 of 5


Appendix A

FM = cf rp(E)·R(E)dE ,


(3)

where <p(E) is the energy-dependent fluence (particle/cm2), R(E) is an energy-dependent

function, and Cis a constant. In particular, if the cross-section cr(E) of certain reactions is chosen to be the energy-dependent function R, and constant C is properly defined, the FM card allows calculating the production rate of the radioisotope.

The yield of the radioisotope produced in the sample after irradiation time tirr will be found from the production rate as:

(4)

where NT is the number oftarget atoms in the sample and/.. is the decay constant of the produced isotope.

MCNPX simulations will be performed to predict the activity of all the activation products generated in the target. Assuming Y-88 yield to be 1 mCi we can scale up (or down) the rest of the activities. An electron beam with energies between 15 and 40 MeV and 1 hour irradiation was used for these calculations. Results will be compiled as shown in Table 1. Every time the energy of the electron beam or irradiation time changes we will recalculate the ratios to estimate the activities of all the incidentally activated products.

Table 1. Incidentally activated products for photonuclear production of Y-88 from Y-89. One hour irradiation is assumed. Current x Time necessary to produce 1 mCi of 89Y is shown in parenthesis for different beam energies.

Reaction Produced Half- Activity immediately after irradiation isotope life

15 MeV 20MeV 30MeV 40MeV (52 mA·min) (2.7 mA·min) (0.8 mA·min) (0.6 mA·min)

(y,n) 1! 1!y 108 d 1 mCi 1 mCi 1 mCi 1 mCi (y,2n) 1!Iy 80 h - - 0.6 mCi 1.2 mCi

(y,2n) lStmy 13h - - 1.2 mCi 2.5 mCi (y,np) lS tmsr 3h - 0.001 ~Ci 0.5 mCi 1.6 mCi (y,an) 1!4mRb 20m - - 4.2 ~Ci 0.3 mCi

Production of Y -90 from Y -89 via neutron capture

For photonuclear production of Y-88 we are planning to use a beryllium, lead, or LBE neutron converter (depending on the energy of the electron beam), with the target and converter surrounded by polyethylene as a moderator as shown in Figure 3. Activity of all the incidentally activated products will be evaluated as described above.

Page 3 of 5


Appendix A

Stainless steel windows

Stainless steel beam pipe

-----...,-.... -... ---- _______ _. ·-------------

Niobium~mator I Be, Pb, or LBE Polyethylene

Figure 3. Production of Y -90 from Y -89 via neutron capture

Production ofMo-99 from uranium targets


To produce Mo-99, we plan to irradiate clad uranium targets, including natural, depleted and low-enriched uranium for isotope production. Natural and depleted uranium has been purchased and is currently stored at Niowave. We are pursuing multiple sources of LEU including the DOE ULTB Program (via Y-12).

Figure 4 shows a fuel pellet prototype clad with niobium, a refractory metal with high melting point (2468°C). Cladding will prevent release of any gaseous fission fragments. Other uranium pellet/rod dimensions will also be explored and irradiated.

Before the irradiation we will estimate the activity of Mo-99 to be produced following the same routine as described above. Instead of neutron capture or photonuclear crosssections we will use fission cross-sections3

(see Figure 5). Activities of isotopes incidentally produced from uranium and

3 http://t2.lanl.gov/tour/u235nf.gif

Figure 4. Niobium clad fuel pellet prototype. 1 -niobium capsule, 2 -niobium lid, 3 -uranium

pellet.

Page 4 of 5


Appendix A

niobium cladding will be evaluated as well.

U-235 Fission Cross Section

105

-c.a c: ~ 103

..D

c:

~ 102 u m

Cl)

: 101

0 .... u

10°

Energy (eV)

Figure 5. U-235 fission cross-section.

Page 5 of 5

Nfowave, Inc. 2/11/2015


Appendix B

Sample Accelerator Activation Form (3 pages)

NIOWAVE, INC 1012 North Walnut Street

Lansing, Ml 48906 Phone: {517) 999-3475

Fax: {517) 999-3626 www.niowaveinc.com

Form NW-APG-01 Accelerator Activation Form

PRE-IRRADIATION:

Date of activation _______ ____ __ Target# ______________ _

Description of Target. _______ _______ Irradiation time _____ _ _ ___ _

Radionuclide(s) of interest _ _ _______ Total Expected Activity (Ci) _ _____ _

Beam parameters: current _ ___ A energy _ ____ MeV

Target Element Form Mass Nuclide Expected activity (Ci)

Target evaluation: Target integrity, containment, melting, burning, disintegration, contamination, cooling, post irradiation handling.

RSO: _________ .Accelerator Engineer/operator: ________ _

Page 1 of 3

Detailed drawing of the target

Target


Lansing, Ml 48906 Phone: (517) 999-3475


description ___________________________________ _

Page 2 of 3

IRRADIATION:


Lansing, Ml 48906 Phone: (517) 999-3475


Start: _____ Stop: _____ Elapsed Time: ______ Not irradiated ____ _

POST IRRADIATION: tag number ______ _

Date Counted: Time counted: File: ----- - - - ----- -----------

Activity for nuclide(s) of interest (Ci) _______ _

RELEASE:

Date Counted: Time counted: File: - - --- - - --- - --------------

Released to ----------------

Tag number Nuclide Activity (Ci) Half Life

Released by: __________________________ _

Page 3 of 3


Appendix C

Sample Safety Plan (3 pages)

Niowave N.E.R.D. Facility Tunnels Radiation Survey Map

LJ ~ ·~~ = - 111114'( - .. / --0 = 0

t ( ~"" = A = ;::: - 1

J 1. ~cP A( \ 3i1

~ . - :::: = = = = =

Accelerator Type: Stf'fv.{[ Gse 2m y DTL Survey Instrument(s) Information

I I II l I

IJ m::::t:lt! .

= = = 0 = -~ """~

@ r?A m~ '\ I..<N4(...]. 0 p

=

0 p

l Co--nf'~ l S.~\'ON

~

I

Project Leader: ___;:C:;;.;I-'Y+...;....,.S~c.;...-_____ _

Make: F L.L)tLf Model: 45\ p- oZ'-1 e Serial No: 151 B ----------------------Model: :)-:rs - ~ Serial No: '2 G '293 5

------~=-------------

I Make: W iJ\.......U tY\

Make: Model: Serial No:--.-__________________ __ (l %V)

Background Level: I (]) ~R/hr; Beam Energy: - I Z\ ~ I5 fY\ Beam Power: 3 5 (]) \r( (All areas surveyed are at or below the background radiation level recorded unless otherwise noted on the survey map above.) Survey Notes (continue on back if needed):

~ ~C.Jt.CTf 6LOCfL {V\Ac€

fly /~ fle-l~ f1A oN ITC(Z. ( 0 1'1 I ~~ Cl'..l

L H"-f¥\ o t:"l~

Aftf'A fV'lAlN l \ 0/Z (t €(1{) I N C.. ~ 9 9 0) G) M !k:'"Yl'l / t·H t

I'M Y U)a s< (lA-o: ~r-1 ' (l_o:> P : l <!>1 "'""""/ f'lfl.-/ ___: ~ DateandTimeofSurvey: J rN oV II.\ !'llS Signature~==;.~e:....._...!£..__· ...,.~~-::....·---J'-----

Initial Sytup

Drift Tube Linac Cryo-Module Test in N.E.R.D. -November, 2014 Radiation Safety Plan

~}'he project manager and test supervisor shall review this plan prior to implementation. [{}/ ;rhe linac will be located in the northern end of the west tunnel.

~ A film dosimeter badge will be placed on the southern internal wall of the NERD in line with the mouth of

)he west tunneL

W"" Unless it is be ing used for an experimental procedure, the high dose rate area monitor ion chamber will be

placed to measure radiation representative of the area around the linac.

~-At least one hand-held rad iation monitor will available at the manned instrumentation closest to the test

site.

r£1 The gate to the tunnels will be shut and interlocked.

~If necessary, a yellow chain will be run that restricts access to the eastern half to of the NERD to prevent access by non-radiation workers to areas with dose rates at or above 2 mrem!hr.

a/ All entrances to the NERD will be locked from the outside with the exception of the door in the southwest

comer of the building.

[D/Lead walls will be staged in the tunnel to shield scattered x-rays (if necessary).

13'"' Signage including "Accelerator Test," " Restricted Area," ' 'Radiation Area," and ''High Radiation Area"

will be available at or near the test site. ~/"Accelerator Test" signs will be displayed to achieve maximum visibility in the vicinity of the test site

within the NERD.

~Restricted Area" signs will be visib le at outermost boundaries.

e-"' All radiation monitors used during the test will have their calibration checked with the check source within

24 hours of the commencement of the test. Ia The emergency shutdown switch and all interlocks will be tested within 7 days of the commencement of

the test and the schematic of the emergency shutdown circuit will be posted adjacent to the switch. Ci::V'The appropriate license sticker will be posted on the power supply control panel.

(Jl/'A signed copy of this plan will be available at the main test instrumentation site.

Testing Limits

I. 2 mrem/hr on area monitor:

a. Non-radiation workers are not allowed in the tunneL

2. 2 mrem/hr anywhere outside of tunnel within boundaries in the eastern half of NERD: a. Non-radiation workers are not allowed within the boundaries.

3. 5 mrem/hr on area monitor:

a. " Radiation Area" signs must be visible at tunnel entrance. b. lfa worker must enter the radiation area. dose rate shou ld be reduced to minimum possibly to

maintain dose ALARA.

4. 5 mrem/hr anywhere outside of tunnel within eastern half of NERD:

a. "Radiation Area" signs moved to boundary in eastern half of NERD.

b. Dose rate should be kept as low as possible for the minimum ti me necessary to accomplish test in order to maintain ALARA.

5. 100 mrem!hr on area monitor: a. The "High Radiation Area'' placed in tunnel. b. Notify RSO/ARSO.

c . No one allowed within the high radiation area.

d. If not locked or interlocked, boundaries must be pern1anently monitored by a radiation worker to

prevent access.

6. l 00 mrem/hr read where workers must be present during test: a. Stop test.

b. Notify RSO/ARSO.

During Test

I. A survey at all boundaries will be taken each time power is increased to a new sustained high. Once the

highest sustained power level is reached, the survey must be recorded on a survey map and the beam

dynamics recorded in the test log. These records shall be retained for future reference or inspection.

2. The RSO/ARSO must be on site during testing as the radiation safety supervisor unless the test supervisor has agreed to take responsibility for radiation safety at which time the RSO/ARSO shall remain on call , but may leave the test site.

3. The RSO/ARSO must refrain from becoming so involved in experimental work during the test that they

can no longer be an effective safety supervisor.

4 . No one should enter the tunnel unless they have received verbal pem1ission from the test supervisor

including assurance that the beam is off.

5. A handheld dosimeter should be used to survey the tunnels upon entry after they have been posted as a high radiation area.

6. Anyone who enters the tunnel should notify the test supervisor immediately upon their exit, and provide a verbal count of how many personnel remain in the tunnels (if any).

7. Temporary shielding should be used as needed to maintain dose to workers ALARA.

8. This plan may be deviated from with the approval of the test supervisor and RSO/ARSO.

rARSO signature and date


Appendix D

Sample Radiation Safety Test Material (17 pages)

N~e D~ --------------------------------------- --------------

Niowave Radiation Worker Safety Exam

Directions: Circle the letter of the correct answer or answers. There is only one correct answer unless otherwise indicated. Passing grade is 32/40 questions.

1. Who are the Radiation Safety Officer and Assistant Radiation Safety Officer (choose two)?

a. Terry Grimm b. Jerry Hollister c. Erik Maddock d. Mark Sinila e. Steve Klass

2. Which agency regulates radiation machines in Michigan?

a. MIOSHA- Radiation Safety Section b. Department of Environmental Quality c. Secretary of State d. Department ofNatural Resources

3. Which agency regulates nuclear reactors and radioactive material produced for commercial purposes in Michigan?

a. Bureau of Alcohol, Tobacco and Firearms b. Nuclear Regulatory Commission c. National Helium Reserve d. Environmental Protection Agency

4. What does the NRC define as "source material" (choose all that apply)?

a. Deuterium b. Thorium c. Natural Uranium d. Depleted Uranium e. Plutonium

This training was developed for use within Niowave, Inc. It is intended for use by, and applies to Niowave employees, staff, and visitors.

1

5. Which agency regulates incidentally activated beam line components?

a. MIOSHA- Radiation Safety Section b. Department of Environmental Quality c. Nuclear Regulatory Commission d. Environmental Protection Agency

6. What are the state mandated facility conditions of use for a Class A facility (choose all that apply)?

a. No dose rate or interlock restrictions b. Survey map taken during every test c. Log of accelerator operations kept for every test d. None of the above

7. What are the state mandated facility conditions of use for a Class D facility (choose all that apply)?

a. No dose rate or interlock restrictions b. Survey map taken during every test c. Log of accelerator operations kept for every test d. None of the above

8. Which statements are true about postings required by the state (choose all that apply)?

a. Notice to Employees briefly describes employer and employee radiation safety responsibilities

b. License certificate posting authorizes radiation production in that room c. Current license allows for an electron beam up to 40 MeV d. None of the

9. Where can you expect to see "Radioactive Material" signs posted within the Niowave HQ at this time?

a. Coal bunker b. Principal ' s office c. NERD tunnels d. All of the above e. None of the above


2

10. What should you do if you need to pass a "Restricted Area" sign while you are doing your job?

a. Ignore it and carry on with your work b. Immediately stop and inform the RSO/ ARSO c. Call the state inspector d. Ensure you are wearing your dosimetry badge before proceed past the sign

11. Choose the three levels of restricted areas generated by linac operations. 12. Draw a line to match the levels with their dose rate limits.

a. Extreme danger area 0-2 mremlhr b. Radiation area 2-5 mrem/hr c. High radiation area 2 - 1 0 mrem/hr d. Chemobyl area 2 - 100 mrem/hr e. Restricted area 5 - 1 00 mremlhr f. Accelerator test area 2: 1 00 mrem/hr

13. Match the radiosensitive tissue(s) to the legal dose limit in effect at Niowave. There may be more than one correct match for each dose limit.

a. In utero baby b. Hands c. Skin d. e. f. g.

1.25 rem/quarter 450 mrem/gestation period 50 mrem/month 18.75 rem/quarter 50 mrem/gestation period 7.5 rem/quarter 3.525 rem/quarter


3

Using the choices below, fill the blanks. Choices may be used multiple times.

14. __ n __ dose limits to the public are _b_ mrem in any i , 100 ---

_h_ in any week, and _f_ mrem in any _1_.

15. m ___ dose limits to the public are _b_ mrem in any _i_, and

_ e_ mrem in any _ I_ . (Both questions should be answered from the lowest to the highest doses.)

a. 1 h. mrem b. 2 1. hour c. 5 J. day d. 10 k. week e. 100 1. year f. 500 m. state g. rem n. federal

16. What does ALARA stand for?

a. As Long As Readily Apparent b. As Low As Reasonably Achievable c. Absolute Lowest Achievable Radiation Average d. None of the above

17. Niowave's ALARA policy is to limit dose to personnel to what percentage of the legal limit?

a. 1% b. 10% c. 25% d. 50%

18. Qualified Niowave personnel routinely work within a high radiation area during testing.

a. True b. False


4

19. How often do you need to undergo radiation safety training?

a. Just this once b. When hired on and annually thereafter c. When hired on and biannually thereafter d. Every quarter

20. Average total background radiation from natural and manmade sources combined lS m one year.

a. 30mrem b. 100 mrem c. 310 mrem d. 620 mrem e. 1100 mrem

21 . Infrared radiation has the ability to remove electrons from their orbital shells.

a. True b. False

22. An unstable isotope has a ___ ratio of neutrons to protons than a stable isotope of the same element.

a. Higher b. Lower c. Could be either answer

23. Beta plus decay ___ the atom number of a nucleus.

a. Increases b. Decreases

24. Imaginary radioactive element Elephantanium (El) has a half-life of 28 days. If you initially have 55 Ci of the (El), how many Becquerel of activity are left over after the passage of one week?

a. 1.71 * 1012

b. 4.62*10 1

c. 4.62*10 11

d. 3.70 * 10° e. None of the above


5

25. Your rich crazy uncle has just died and has left you his fortune on the condition that you do the following: Among his collection of rare currency, there are three radioactive coins, one an alpha emitter, one a beta emitter, and one a gamma emitter. For the next year you must keep one in a shielded vault, one in your pocket, and one in your sock against the skin of your foot. Indicate the safest choices:

_c_ into the vault, _b_ into your pocket, _a_ into your sock.

a. Alpha emitter coin b. Beta emitter coin c. Gamma emitter coin

26. Assume the quality factor of a proton beam is 5. In one hour, the dose of the beam to tank of water is measured to be 50 J/kg by calorimetry. What would the dose to your soft tissue be if you shielded the tank of water from the proton beam with your body for one minute?

a. 25,000 rem b. 25,000 Gy c. 416.7 Sv d. 416.7 rem

27. What medical treatment is most likely to save your life in the immediate aftermath of a linac accident where you were accidentally irradiated by an x-ray beam to a whole body dose of 4 Gy?

a. CPR b. Bone marrow transplant c. Stomach pump d. Chemotherapy


6

28. Lansing has suffered two terrorist attacks by the radical environmental group Donkey Liberation Army: a bioweapon and radiological dispersal device (AKA dirty bomb). Fortunately, Mayor Bemero has stocked up on antidote to the bioweapon, but the BWL let it get contaminated by the dirty bomb! Due to your vast knowledge of radiation safety, you are called on to choose where the populace of the state capitol will inject themselves with the antidote. Keeping in mind that the contamination spread by the dirty bomb will all stay in the tissue that it was initially injected into, while the antidote will spread throughout the body, what part of the body is it safest to inject the antidote into?

a. Small intestine b. Lymph nodes c. Bone marrow d. Heart

29. Assuming a Niowave linac acts like a point source after conversion to an x-ray beam and your dose rate at 1 m is 1 000 mremlhr, what is the closest you can be to the source while remaining below the public exposure limit?

a. 100m b. 50m c. 25m d. lOrn

30. FRIB has accidentally created black hole in East Lansing! The Navy plans on dropping a neutron bomb on it to keep it from destroying Spartan Stadium, but they need you to guide the bomb with the laser pointer from the Niowave conference room. A split second before the bo.mb explodes, you have the chance to sprint to a location shielded from the blast. Where would you be safest?

a. In a submersible at the bottom of Lake Lansing b. Inside a bunker with 1' thick steel walls c. Inside a bunker with 1' thick lead walls d. Inside of a bunker made with 1' thick sand bags

31. Once contamination has been detected within the NERD tunnels, what will no longer be allowed in the NERD?

a. Eating b. Drinking c. Applying makeup d. None of the above e. All of the above


7

32. Personal dosimeter film badges do what?

a. Are used to communicate with the admin office b. Measure the wearer's radiation dose c. Protect the wearer from excessive radiation exposure d. All the above e. None ofthe above

33. When handling accelerator produced byproduct material, what should a qualified radiation worker wear (choose all that apply)?

a. Disposable gloves b. Ring dosimeter c. Whole body dosimeter d. Ventilator e. Steel toed boots

34. When moving heavy source material parts, what is a worker required to wear (choose all that apply)?

a. Disposable gloves b. Ring dosimeter c. Whole body dosimeter d. Ventilator e. Steel toed boots

35. The imaginary, accelerator produced radioactive isotope Henningium has a halflife of 73 days. How long must remain in "decay-in-storage" before it can be disposed of as trash?

a. 6 months b. 1 year c. 1.5 years d. 2 years e. None of the above

36. What two phone numbers should the RSO call if a contamination emergency has occurred? NRC: 301-816-5100; MI DEQ: 517-636-6800


8

37. How is a Geiger-Meuller frisker used to determine beta radiation levels when surveying mixed beta and gamma contamination? Subtract counts/dose measured with cap on with counts/dose measured with cap off.

38. In non-emergency situations, when are contamination surveys required? In the target region after production of radioisotopes Of the beam line after exceeding activation threshold Any area where radioisotopes are handled, stored and disposed of

39. What material properties ofNiowave' s byproduct material make a spill less likely and/or less serious? Solid Granular rather than powder Non-volatile Not readily dispersible (2 out of 4 for full credit)

40. If a fire in the NERD has occurred in the radioactive waste disposal locker, and has been put out by workers using a fire extinguisher, one of the workers who put out the fire has smoke inhalation bad enough that an ambulance has been called. In this situation, what circumstance(s) would prompt the RSO to use the major fire procedure. Injured worker is also contaminated

(Extra Questions)

41. What is one step that all radiological emergency procedures share in common? Notify the RSO/ARSO.

42. You have come in early to set up for isotope production in the NERD. You think that you will be alone, but the ARSO has also arrived early and has opened the byproduct material storage vault. He appears to be performing an inventory. He is wearing the proper safety equipment, a ring dosimeter and has his dosimetry badge attached to his belt. What is wrong with this situation? No two person accountability.


9

N~e D~ ----------------------------------------- ---------------

Niowave Non-Radiation Worker Safety Exam

Directions: Circle the letter of the correct answer or answers. There is only one correct answer unless otherwise indicated. Passing grade is 14/20 questions.

1. Who is the Radiation Safety Officer?

a. Terry Grimm b. Jerry Hollister c. Erik Maddock d. Mark Dantonio

2. Who is the Assistant Radiation Safety Officer?

a. Steve Klass b. Mark Sinila c. Miley Cyrus d. Amanda Grimm

3. The largest part of our background radiation exposure comes from:

a. Photon torpedoes b. Naturally occurring sources of radiation and radioactivity in the

environment c. Nuclear weapons fallout d. Industrial radiography

4. Alpha particles are emitted from heavy metals, consist of a helium nucleus, are very penetrating, and are very dangerous due to external exposure.

a. True b. False

5. Which agency regulates radiation machines in Michigan?

a. MIOSHA- Radiation Safety Section b. Indian Gaming Commission c. Secretary of State d. Department ofNatural Resources


1

6. Which agency regulates nuclear reactors and radioactive material produced for commercial purposes in Michigan?

a. Bureau of Alcohol, Tobacco and Firearms b. Nuclear Regulatory Commission c. National Helium Reserve d. Department of Environmental Quality

7. Where are radiation producing tests conducted within the Niowave HQ?

a. NERD Facility b. Niobium vault c. Coal bunker d. Shop expansion e. Gym or High Bay

8. Where should you go for the web address to the state ' s radiation rules?

a. Notice to Employees b. The Drudge Report c. Physics Today d. Dosimetry Report

9. What will you see if you are in an unrestricted area?

a. Purple "Unrestricted Area" signs b. Everyone wearing yellow coveralls c. Large orange flashing lights d. None of the above

10. What designates a restricted area (choose all that apply)?

a. Purple tape on the floor b. Yell ow chain boundaries c. "Restricted Area" signs d. You must be wearing a personal dosimeter badge to enter e. All of the above


2

11. Personal dosimeter film badges do what?

a. Are used to communicate with the admin office b. Measure the wearer's radiation exposure c. Protect the wearer from excessive radiation exposure d. All the above

12. Where can you expect to see "Radioactive Material" signs posted within the Niowave HQ at this time?

a. Coal bunker b. Principal ' s office c. Behind NERD tunnels d. All of the above e. None of the above

13 . What should you do if you see a "Restricted Area" sign?

a. Ignore it and carry on with your work b. Immediately stop and inform the RSO/ ARSO c. Call the state inspector d. Do not proceed past the sign

14. What is a unit for radiation dose?

a. slug b. millimeter (mm) c. millirem (mrem) d. Pascal (Pa)

15. What is the legal dose limit for non-radiation workers in one hour?

a. There is no limit, but must be kept to a minimum b. Non-radiation workers are not allowed to receive and dose c. The same as for the general public (2 mrem) d. Once you pass this test, it is the same as for a badge wearing radiation

worker in one quarter (1.25 rem)

16. What does ALARA stand for?

a. As Long As Readily Apparent b. As Low As Reasonably Achievable c. Absolute Lowest Achievable Radiation Average d. None of the above


3

17. What should you do if you find yourself standing directly next to a "Radiation Area" sign while a test is going on?

a. Stop and call the RSO/ ARSO immediately b. Immediately exit the way you came, then inform the RSO/ ARSO c. Yell for help until a radiation worker moves the sign d. Do not proceed past this sign

18. Niowave ' s ALARA policy is to limit dose to personnel to what percentage of the legal limit?

a. 1% b. 10% c. 25% d. 50%

19. Qualified Niowave personnel routinely work within a high radiation area during testing.

a. True b. False

20. How often do you need to undergo radiation safety training? a. Just this once b. When hired on and annually thereafter c. When hired on and biannually thereafter d. Every quarter


4

Niowave Annual Refresher Training

Question 1: Examples of ionizing radiation include: r Alpha and omega particles, sunlight and x-rays

r Radiowaves r

X-rays, gamma-rays, and microwaves r

Alpha, beta, neutron particles and gamma-rays

Question 2: Which radiation presents the greatest danger from external exposure? r

Alpha

r Beta

r Gamma

r Delta

Question 3: The largest part of our background radiation exposure comes from r

Diagnostic x-rays r

Naturally occurring sources of radiation and radioactivity in the environment r Nuclear weapons fallout r Industrial radiography

Question 4: Small traces of many naturally occurring radioactive materials are present in the human body. These come mainly from naturally radioactive isotopes present in the food we eat and in the air we breathe. Once example is the isotope potassium-40 (K-40).

r True

r False

Question 5: Ifthe initial activity of a sample ofS-35 is 1 millicurie (halflife ~ 90 days). What is the approximate activity after 180 days?

r 500 milli Curies

r 250 micro Curies

r 500 micro Curies

r 125 micro Curies

Question 6: The units of dose equivalent are:

r Rem

r Grey (Gy) r

Curie(Ci)

r Bequerel (Bq)


Question 7: When a cell is damaged by radiation: r

It always causes death to the cell r It may repair the damage and operate normally r

It will start dividing r

There is a high probability of cancer

Question 8: If radiation causes damage to a cell, and the cell is not effectively repaired: r

The person will certainly get cancer r

The cell will continue to operate normally r

The cell will most likely die r

All future offspring of the person will carry the mutation

Question 9: If a pregnant worker does not "declare" pregnancy, her annual dose limit is:

r 50 rem

r 50mrem

r 500mrem

r 5 rem

Question 10: Which of the following statements is true?

r The general public exposure limit is 1 00 mRem/yr r

The average background radiation dose received annually by the general public IS

~ 31 OmRem/yr r

Ionizing and non-ionizing radiation are two types of radiation r

All of the above

Question 11: A film dosimeter badge is designed to: r

Measure internal radiation exposure r

Measure external radiation exposure r

Protect the wearer from excessive radiation exposure

r All the above

Question 12: Any medical administration of radioactive material must be reported to the RSO so that he or she can:

r Calculate your dose from the administration

r Make sure that you are medically able to continue work


r Ensure that the medical exposure is not recorded on your personal dosimeter

r Evaluate whether the administration is within the legal guidelines

Question 13: Working around activated materials r

Involves little or no radiation exposure r

Causes exposure to neutron radiation r

Involves only exposure to beta dose

r Involves mostly exposire to gamma and beta dose

Question 14: Residual radioactivity may be found r

In bremsstrahlung converters r

In electron beam dumps r

In activated beamline components

r All of the above

Question 15: Methods to reduce external radiation dose include: r

Minimizing time, maximizing distance and putting the source between you and shielding r

Minimizing time, maximizing distance and using available shielding r

Minimizing time, minimizing distance and using available shielding r

Calculating dose rate using diffusion theory prior to entering any radiation field

Question 16: Methods to reduce internal radiation dose include: r

Covering all wounds and cuts r

Not eating or drinking in areas containing radioactive material r

Not applying chap stick in areas containing radioactive material r

All of the above

Question 17: What do you do in the event of a radiological incident that occurs on the weekend? r

Call the RSO immediately r

Leave a written message at the RSO's desk

r Personally inform the RSO on Monday

r Call the EPA

Question 18: What is source material?

r Enriched uranium


r Technetium

r Both of the above

r None of the above

Question 19: When are you allowed to use your personal dosimeter? r During dental x-ray procedure r

While working at Niowave with radioactive materials or machines that emit radiation r During a long flight to Europe to measure your dose due to cosmic radiation r

During a collaboration trip to another accelerator facility

Question 20: How often do you need to undergo radiation safety training?

r There are no training requirements for work with radioactive material

r Every new Niowave worker has to have initial radiation safety training and annually thereafter

r Every new Niowave worker has to have initial radiation safety training and biannually thereafter

r· Every Niowave worker has to have safety training every six months

BRENDA CHAMPION 517-999-3475 NIOWAVE 1012 N. WALNUT ST LANSING MI 48906

SHIP TO:

1.0 LBS LTR

MATERIALS LICENSING BRANCH NRC REGION III OFFICE 2443 WARRENVILLE ROAD, SUITE 210

LISLE IL 60532-4352

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Reference#!: NRC I SF 11M UlS 17.1.0'1. WNlNVSO 60.0A 01/2015

niowave, inc. 02/11/2015, license no. 21-35144-02 ...niowave, inc i 012 north walnut street lansing,...

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