COLLEEN CAROL CASEY or HECTOR LUIS RODRIGUEZ-LUCCIONI, Ph.D MATERIALS LICENSING BRANCH

UNITED STATES NUCLEAR REGULATORY COMMISSION REGION III

2443 WARRENVILLE ROAD STE 210 LISLE, ILLINOIS 60532-4352

OFFICE: (630)-829-9841 (Casey) or (630) 829-9564 FAX: (630) 515-1078

CONVERSATION RECORD jTIME jDATE

ACTUALLY FAXED? November 17,2011

NAME OF PERSON(S) CONTACTED ORGANIZATION TELEPHONE NO.

Crint LaBrosse, RSO Plastatech Engineering Ltd. 989-754-6500 Fax: 989-754-1626

SUBJECT

license No.: 21-26714-01 Control No.: 575592

SUMMARY

We have reviewed your application dated July 6, 2011 t requesting renewal of your byproduct materials license and find that we need additional information as follows:

1. In reviewing your renewal application we noticed that you did not include a completed . Appendix B from NUREG 1556t Vol. 4, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Fixed Gauge Licenses/' October 1998.

Therefore we do not have a curren~ complete radiation safety program with which we can renew your license. 5,i'-CIA-Lc( IVlI;'( J~:J. ,( f->xc/:'~ (~ jL'

1/"'!7{IH-This document is intended for use by applicantst Icensees, and NRC staff and is also available to Agreement States. The Abstract i his report states, "When published, ~ this final report should be used in preparing peFtAle gauge license applications. NRC staff will use this final report in reviewing these applications."

Full use of this document and all of its sections that are appropriate for this license, for all of your licensing correspondence will greatly reduce your regulatory burden, simplify your license and enhance safety by providing for more comprehensive update safety procedures and al complete renewal applications. This NUREG may be located on our website at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v41

In response, please complete this Appendix in full and transmit it to us with a currently signed and dated letter, in accordance with the instructions below.

2. This NUREG contains an item that has changed since its publication but it has not been fully revised yet to reflect these changes. Item 7.1 currently gives you the

1

option of "self-appointing" your RSO internally.

We can no longer permit you to do this. NRC must amend your license before you change RSOs in the future. To change RSOs you should name the proposed RSO, provide evidence of adequate and appropriate training and experience with the fixed gauges and submit a signed and dated statement that the proposed RSO accepts the position and understands the duties and responsibilities associated with it. Your senior management representative must also sign this statement and delegate authority to the proposed RSO to operate your Radiation Safety Program.

Additional Guidance for Renewing an NRC License

Please note that using the NUREG 1556 series documents will help ensure that your licensing correspondence is prepared more completely and in a less burdensome manner.

In preparing future licensing correspondence please focus on providing the information requested in Appendix B to NUREG 1556, Volume 4, Follow the "Suggested Format" provided in this Appendix and use the suggested responses and model procedure/appendix references whenever possible, appending descriptive information as appropriate. It is strongly advisable to read the corresponding text in the front of each NUREG to ensure a complete understanding of the commitments that you make.

Please do not submit resumes, curricula vitae, college transcripts, any personal, proprietary information, blueprint diagrams, or copies of blueprint diagram and any extraneous, prescriptive information and procedures, unless we specifically request it, which is unlikely.

If you are continuing authorization for an incumbent RSO and authorized users, please only provide their names and requested authorizations. Submission of an updated, current, "Delegation of Authority" for the incumbent RSO that is dated and signed by a senior management official, is recommended. It is not necessary to submit training and experience qualifications again for incumbent authorized staff.

If you must deviate from a model procedure or suggested response, it may be possible to simply indicate what the deviation is and still use the model procedure/ suggested response as a "basic" commitment. Descriptive information may be "recycled" from previous documents only so long as it is current. complete information equivalent to the model procedure (as appropriate) and does not contain extraneous material.

It is in your best interests to only provide those commitments, statements, representations and procedures, in a clear and explicit manner, that we require to issue your license. These documents will form the basis for the license in the last condition of the license, called the "tie-down" condition.

You will realize the benefit of a reduced regulatory burden while enhancing safety and maintaining compliance and efficiency if you establish your license in this manner.

In fact, the easiest way to prepare a renewal, for example, is to take a copy of NUREG 1556, Vol. 2

4, Appendix B, to your copy machine and copy it out directly, or print Appendix B from this document on our website at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v41

It is imperative that you read the text in the front of the NUREG that corresponds to each section, in order to understand the commitments you are making or that you need to develop and submit. Simply fill in the checkmarks and blanks on the copied checklist, thereby making your license commitments, appending appropriate information as necessary.

Please do not re-type the checklist as errors and omissions may be introduced. As you need to append certain information or provide an alternative procedure, please be sure to incorporate the information in the NUREG, at a minimum, to ensure completeness.

If you wish, you may contact me at the telephone number above to discuss further on how best to go about generating the resubmittal of your renewal application. We would be happy to assist you as we are able.

Please also be reminded of the provisions in 10 CFR 30.9(a), A Completeness and accuracy of information,"..."(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission=s regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects."

In accordance with 1 0 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.

3

_ ... ----- -- ---

ACTION REQUIRED

Please submit the requested information within 14 calendar days (by December 1,2011) by referencing control number 575592 to facilitate proper handling. Upon receipt of your response we will continue our review. Address your written response to my attention at the above address. Please always include the direct telephone number (no personal cellphones, please), fax number and, if preferred, email address, of at least one or two persons who are knowledgeable in your license and can serve as points of contact.

PLEASE DIRECT ANY QUESTIONS YOU MAY HAVE TO ME AT 630-829-9841.

NAME OF PERSONS DOCUMENTING CONVERSATION SIGNATURE DATE

Hector Luis Rodriguez-Luccioni, Ph.D. November 17, 2011

Email address: Hector. Rodrjg uez-Luccioni@nrc.gov

C~I::;~ November 17, 2011

Email address: Colleen.Casey@nrc.gov

4

TRANSMISSION VERIFICATION REPORT

TIME : NAME : FAX: TEL : SER.fI :

11/17/2011 15:16 USNRC RIll 6308299782

000A7.J925774

DATE,TIME 11/17 15: 15 FAX NO. I NAME 89897541626 DURATION 1313:00:56 PAGE(S) 135 RESULT OK MODE STA~mARD

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UNITED SlATESNRC FORM 386 (Rill) NUCLEAR REGULATORY COMMISSION

REGION III 2443 Warrenville RQlld. SI.Jit9 210

Lisle, illinois 60532-4352

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FROM: (SENDER) ~4--<l:I/ediJ-~. ----­If you do not receive the complete fax transmittal, please contact the sender as soon as possible at the telephone number provided above.

NRC FORM 386 (Rill) UNITED STATES

NUCLEAR REGULATORY COMMISSION REGION III

2443 Warrenville Road. Suite 210 Lisle, Illinois 60532-4352

TELEFAX TRANSMITTAL

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MESSAGE

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NOTICE

This message is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential, or exempt from disclosure under applicable law. If the reader of this message is not the intended recipient or the employee responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the sender immediately by telephone and return the original to the above address, by U.S. Mail. Thank you.

NRC FORM 386 (Rill) (4-2Q04) PRINTED ON RECYCLED PAPER

TRANSMISSION VERIFICATION REPORT

TIME : 11/1 2011 15:25 NAME : USNRC RIll FAX: 5308299782 TEL : SER. # : 000A7.]925774

DATE,TIME 11/17 15: 23 FAX NO./NAME 89897541626 DURATION 00:01:11PAGE(S) 08 RESULT OK MODE STANDARD

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UNITEO STATES NUCLEAR REGULATORY COMMISSION

REGION III 2443 Warrenville Road, Suite 210

l.,i$le, lUinQi$ 80532-4352

TELEFAX TRANSMITTAL

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LOCATION: p f C\ . .~ .... ~ ~ec-),

FAX NUMBER: 'tit. -..t..ft.J ~_;t " i VERIFY BY CALLING SENDER OJ

FROM: (SIENDIER)

If you do not receive the complete fax transmittal, please contact the sender as soon as possible at the telephone number provided above.

MESSAGE

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NRC FORM 386 (Rill) UNITED STATES (4-~CC4;

NUCLEAR REGULATORY COMMISSION REGION III

2443 Warrenville Road. Suite 210 Lisle. Illinois 60532·4352

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FROM: (SENDER)

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MESSAGE

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NOTICE

This message is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential, or exempt from disclosure under applicable law. If the reader of this message is not the intended recipient or the employee responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the sender immediately by telephone and return the original to the above address, by U.S. Mail. Thank you.

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NRC FORM 386 (Rill) (4-2004) PRINTED ON RECYCLED PAPER

APPENDIXB

Suggested Format for Providing Information Requested in Items 5 Through 11 of NRC Form 313

Table B.1 Items 5 &6: Materials To Be Possessed and Proposed Uses

Yes No Radioisotope Manufacturer or Distributor

Model No.

Quantity Use As Listed on SSD Certificate

Specify Other Uses Not Listed on

SSD Certificate

Cobalt-60 Sealed source manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ) Specific description ofthe gauge use:

[ ) Not applicable

[ ) Uses are:

(Submit safety analysis supporting safe use)

Krypton-85 Sealed source manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ] Specific description ofthe gauge use:

[ ] Not applicable

[ ] Uses are:

(Submit safety analysis supporting safe use)

Strontium-90 Sealed source manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ] Specific description ofthe gauge use:

[ ] Not applicable

[ ] Uses are:

(Submit safety analysis supporting safe use)

Cesium-137 Sealed source manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ) Specific description ofthe gauge use:

[ ) Not applicable

[ ) Uses are:

(Submit safety analysis supporting safe use)

B-1 NUREG - 1556, Vol. 4

APPENDIXB

Yes No Radioisotope Manufacturer or Distributor

Model No.

Quantity Use As Listed on SSD Certificate

Specify Other Uses Not Listed on

SSD Certificate

Americium­241

Sealed sour.ce manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ] Specific description ofthe gauge use:

[ ] Not applicable

[ ] Uses are:

(Submit safety analysis supporting safe use)

Other Isotope (Specify):

Sealed source manufacturer or distributor and model number:

Device manufacturer or distributor and model number:

Not to exceed either the maximum activity per source or maximum activity per device as specified in Sealed Source and Device Registration Certificate

Yes [ ] Specific description ofthe gauge use:

[ ] Not applicable

[ ] Uses are:

(Submit safety analysis supporting safe use)

Financial Assurance Required and Evidence ofFinancial Assurance Provided

NUREG - 1556, Vol. 4 B-2

APPENDIXB

Table B.2 Items 7 Through 11: Training and Experience, Facilities and Equipment, Radiation Safety Program, and Waste Disposal

Item No. and Title Yes Alternative Procedures Attached

Suggested Response

7. Individual(s) [ ] Before obtaining licensed materials, the proposed RSO [ ] Responsible For will have successfully completed the training described Radiation Safety in Criteria in the section entitled "Individual(s) Program And Their Responsible for Radiation Safety Program and Their Training And Training and Experience - Radiation Safety Officer" in Experience NUREG-1556, Vol. 4, dated October 1998.

7.1 Radiation Safety Officer

ctllt#~1Hfs H Name: ___________

S"Je;&­ UC!tT70N; reU WI fftttlc 1b

L[(ft#C1l-~eJ> I PtIU7;~tf;1I

[ ] [ ]7. Individual( s) PROPOSED AUTHORIZED USERS: Responsible For Radiation Safety Before using licensed materials, authorized users will Program And Their have successfully completed the training described in Training And Criteria in the section entitled, "Authorized Users" in Experience NUREG-1556, Vol. 4, dated October 1998.

7.2 Authorized Users

8. Training for The applicant is not required to, and should not, submit Need Not Be Submitted with Individuals Who in is training program, for individuals who in the course Application the Course of of employment are likely to receive occupational doses Employment are of radiation in excess of 1 mSv (100 mrem) in a year Likely to Receive (occupationally exposed workers) and ancillary Occupational Doses personnel, to the NRC for review during the licensing of Radiation in phase. Excess of 1 mSv (l00 mrem) in a Year (Occupationally Exposed Workers) and Ancillary Personnel

have

B-3 NUREG - 1556, Vol. 4

APPENDIXB

Item No. and Title Suggested Response Yes Alternative Procedures Attached

9. Facilities and Equipment

We will ensure that the location of each fixed gauge meets the Criteria in the section entitled "Facilities and Equipment" in NUREG-1556, Vol. 4, dated October 1998.

[ ] [ ]

10. Radiation Safety Program - Audit Program

The applicant is not required to, and should not, submit its audit program to the NRC for review during the licensing phase.

Need Not Be Submitted with Application

10. Radiation Safety Program - Survey Instruments

Surveys pursuant to 10 CFR 20.1501 will be performed by a person specifically authorized by the NRC or an Agreement State to perform these surveys.

OR

We will use instruments that meet the Criteria in the section entitled" Radiation Safety Program ­Instruments," in l\ruREG-1556, Vol. 4, dated August 1998, and one ofthe following:

Each survey meter will be calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations.

OR

We will implement the model survey instrument calibration program in Appendix I to NUREG-1556, Vol. 4, dated October 1998.

[ ] [ ]

10. Radiation Safety Program - Material Receipt and Accountability

Physical inventories will be conducted at intervals not to exceed 6 months or at other intervals approved by the NRC, to account for all sealed sources and devices received and possessed under the license.

[ ] [ ]

10. Radiation Safety Program ­Occupational Dosimetry

We will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the Criteria in the section entitled "Radiation Safety Program-Occupational Dosimetry," in NUREG-1556, VoL 4, dated October 1998.

[ ] [ ]

NUREG - 1556, Vol. 4 B-4

APPENDIXB

Item No. and Title Suggested Response Yes Alternative Procedures Attached

10. Radiation Safety Program - Public Dose

The applicant is not required to submit a response to the public dose section during the licensing phase. However, during NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for individual members of the public.

Need Not Be Submitted with Application

10. Radiation Safety Program-Operating & Emergency Procedures

Ifthe gauge meets one or more of the safety conditions specified in "Discussion,"in the section entitled "Radiation Safety Program-Operating Emergency Procedures," in NUREG 1556, Vol. 4, dated August 1998 state the following:

Operating and emergency procedures will be developed, implemented, maintained, and distributed, and will meet the Criteria in the section entitled "Radiation Safety Program - Operating and Emergency Procedures," in NUREG-1556, Vol. 4, dated August 1998.

For each gauge requested that does not meet one or more of the safety conditions specified in "Discussion," in the section entitled "Radiation Safety Program-Operating Emergency Procedures," in NUREG 1556, Vol. 4, dated August 1998 provide your operating, emergency and lock-out (ifapplicable) procedures to NRC for review.

[ ]

[] Procedures Attached

[ ]

10. Radiation Safety Program - Leak Test

Leak tests will be performed at intervals approved by the NRC or an Agreement State and specified in the Sealed Source and Device Registration Certificate. Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services for other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit supplier's instructions.

OR

We will implement the model leak test program published in Appendix M to NUREG-1556, Vol. 4, dated October 1998.

[ ]

[ ]

[ ]

B-5 NUREG - 1556, Vol. 4

APPENDIXB

Item No. and Title Suggested Response Yes Alternative Procedures Attached

10. Radiation Safety Program ­Maintenance

ROUTINE MAINTENANCE We will implement and maintain procedures for routine maintenance of our fixed gauges according to each manufacturer's or distributor's written recommendations and instructions.

NON-ROUTINE MAINTENANCE OPERATIONS The gauge manufacturer, distributor or other person authorized by NRC or an Agreement State will perform non-routine operations such as installation, initial radiation survey, repair, and maintenance of components related to the radiological safety of the gauge, gauge relocation, replacement, and disposal of sealed sources, alignment, or removal of a gauge from service.

[ ]

[ ]

[] The information listed in AppendixN supporting a request to perform non-routing operations in-house is attached

10. Radiation Safety Program ­Transportation

The applicant is not required to submit its response to transportation during the licensing process; this issue will be reviewed during inspection. However, the licensee should develop, implement, and maintain transportation procedures according to NRC and DOT regulations.

Need Not Be Submitted with Application

10. Radiation Safety Program - Fixed Gauges Used at Temporary Job Sites

This is not applicable to our program. We will not use fixed gauges at temporary job sites.

OR

We will develop, implement, maintain and distribute procedures that meet the Criteria in the section entitled "Radiation Safety Program - Fixed Gauges Used at Temporary Job Sites" in NUREG-1556, Vol. 4, dated October 1998.

[] Not Applicable

[ ] [ ]

10. Radiation Safety Program ­Minimization of Contamination

The applicant is not required to submit a response to minimization of contamination if the applicant's responses meet the criteria for the following sections: Radioactive Material - Sealed Sources and Devices, Facilities and Equipment, Radiation Safety Program ­Operating and Emergency Procedures, Radiation Safety Program - Leak: Testing, and Waste Management-Gauge Transfer and Disposal.

Need Not Be Submitted with Application

NUREG - 1556, VolA B-6

APPENDIXB

Item No. and Title Suggested Response Yes Alternative Procedures Attacbed

11. Waste Management - Gauge Disposal & Transfer

The applicant is not required to submit a response to waste management during the licensing process. However, the licensee should develop, implement, and maintain gauge transfer and disposal procedures in its radiation protection program.

Need Not Be Submitted with Application

B-7 NUREG - 1556, Vol. 4