ML20148D300

Ack Receipt of 860926 Application in Response to NRC .Proposed Program Does Not Adequately Support Existing & Proposed Licensed Activities,Respond to NRC Concerns & Not in Conformance W/Nrc Policies & Min Criteria in Reg Guides

ML20148D300
Person / Time
Issue date:	12/12/1986
From:	Matson E NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Seaman S SEAMAN NUCLEAR CORP.
Shared Package
ML20148C660	List: ML20148C784 ML20148C916 ML20148D300 ML20148D500
References
NUDOCS 8801250362
Download: ML20148D300 (10)

Text

_-

.l DEC 12 6 Seaman Nuclear Corporation ATTN: Scott C. Seaman i Manager, Sales Administration 7315 South First Street Oak Creek, WI 53154

Dear Mr. Seaman:

We received and reviewed your application dated September 26, 1986, which was in response to our letter dated May 30, 1986. We find that as described: your <

proposed program does not adequately support your existing and proposed licensed activities, was not adequately responsive to some of the concerns we ,

addressed in our letter and in many cases does not conform to NRC policies and the minimum criteria expressed in the germane regulatory gtides. Therefore,  !

in order to continue our review, we need the following infonnation:

1. In our previous letter we requested that you submit a copy of the written instructions given to customers on how to operate gauges, and on radiation safety practices and a copy of the written test given to training course l participants. To date, we have received only the operator's manual for i the C-200 model gauge. Therefore, please submit the following documents: '

a. The Radiation Safety Manual;

b. The written test and the answers for the gauge users' training course; .

c. The Operator's Manuals for each NRC licensed gauge model; and

d. A list of the dates when the gauge user's training course will be i offered. '

2. Radiation Safety Officer 2

The training and experienca of the proposed radiation safety officer as ,

i described in your application dated September 26, 1986, does not meet our l l minimum criteria. We will approve Mr. Scott Seaman as RSO if he successfully corrpletes a 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> formal radiation safety or health physics course covering 4

the topics listed below and submits evidence of its completion. Alternatively,

you may propose another person as RS0 who meets the qualifications described in the "Guide for Preparation of Applications for Use of Radioactive Material in Servicing Preregistered Gauges, Measuring Devices and Sealed Sources Used in Such Devices", j l

l 8901250362 871210 l GEQ3 LIC30 i 48-12016-01 PDR I J

Seaman Nuclear Corporation 2

a. Principles and practices of radiation protection;

b. Radioactivity measurements, monitoring techniques, and the use of instruments;

c. Mathematics basic to the use and measurement of radioactivity; and

d. Biological effects of radiation.

3. Training of Course Instructors The training and experience of the instructors for the gauge user's training course, Don Scott and Harry Seaman, as described does not meet our minimum criteria. To assure that the NRC will find your user's training program adequate, these individuals must submit documentation and/or obtain additional training to show they meet the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training described in the "Guide for Preparation of Applications for the Use of Sealed Sources in Portable Gauging Devices", Items 7 and 8.

4. Training Course for Instructors As described in your application, your proposed instructor training course does not meet the criteria specified in the "Guide for Preparation of Applications for the Use of Sealed Sources in Portable Gauging Devices". In order for an individual to be approved as an instructor he/she must have a minimum of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training. Therefore, in order to assure that the NRC will find persons who complete your instructor's training course qualified as instructors, submit the following information:

a. Describe the topics to be covered. Topics should include those listed in Item 2 above, use of gauge, emergency procedures, and NRC regulations.

b. Describe the number of hours to be spent on each topic. The course should be approximately 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in length,

c. Describe the method for determining each trainee's competency.

Submit a copy of the test and the correct answers. State the passing g rade.

5. Users Training Course When we receive a copy of the written test and answers for the users' training course, we will forward a description of the training course to NRC headquarters for their coninents.

Seaman Nuclear Corporation 3 Although the NRC will review the course and provide comments, please note that the NRC does not "approve" or "disapprove" training courses. This could lead to misunderstandings on the part of persons as to whether NRC has endorsed courses and whether anyone taking the course would be guaranteed receiving a license. Such generic approvals cannot be made since many training organizations are not NRC licensees and we cannot monitor changes in instructors or curricula. We are developing an automated data system which will provide a description of safety courses available and acknowledgment of the fact that a course has been accepted as providing adequate training to users in previous licensing cases. To assure your course will be accepted as providing adequate training, we suggest you implement any coaments or recommendations provided. Comments on training of instructors are enclosed and further comments will follow at a later date.

6. Operator's Manuals We have reviewed your operator's manual for Model C-200 and have the following comments:

a. Modify the "Maintenance and Troubleshooting" section to clearly and strongly prohibit the user from attempting to remove, repair or dismantle the source holder, shutter mechanism and other radiation safe related items,

b. The section on "Shipping Instructions" on page 6-10 refers to transitional packaging. Please define this term and describe how it complies with 00T regulations and how the term is used in 00T regulations, i

c. The section on "Moisture Measurements" on page 2-4 states, "the radioactis' source in the meter emits high speed neutrons that travel at the speed of light." This is an incorrect statement of fact.

Neutrons cannot travel at the speed of light. Please correct the error,

d. Modify your emergency procedures described on page 6-6 as indicated in Item 7 of this letter.

I

e. Modify the Operator's Manuals for the other gauges to address each of I the above items.

l l

4 Seaman Nuclear Corporation 4

7. Emergency Procedures The emergency procedures described in th_ J-200 Operator's Manual are lengthy, cumbersome and attempt to cover too much information. Recognizing that this may be the only source of instruction the gauge user has during an emergency and that most gauge users do not have enough training or experience to properly assess radiation safety hazards, the emergency procedures need to be improved in the following manner:

a. Licensees should be instructed in a brief, clear, unambiguous manner to take the following steps immediately when a gauge has been damaged:

1. Do not touch or move the gauge. Stop any involved vehicle.

2. Clear and secure the area around the gauge for a distance of 15 feet. Assess the damage to this gauge.

3. Call for help, describe the situation and follow any advice.

b. Provide the gauge user with a list of persors to contact. This may be general information such as call the state authorities or the NRC, but for Seaman Nuclear Corporation you should provide the telephone number in the emergency instruction section.

Submit a copy of the modified emergency procedures and incorporate these procedures into all other Operator's Manuals and Radiation Safety Manual.

8. Source Removal Procedures

a. Modify and submit your sealed source removal procedures to include a clear, strong statement not to force the source capsules, cut the source holders or attempt to remove the source in any other way than described in the procedure.

b. Your procedures address the use of distance to attempt to reduce operator's exposures, however, it appears that you have not made provisions for the use of shielding to assure exposures are ALARA.

There appear to be several steps and areas where shielding could be used. Please describe ,< hat shielding you will add and require operators to use when performing these procedures, s

Seaman Nuclear Corporation 5

9. Sealed Source Model Number In Item 5 of your application you requested authorization for 300 millicuries of americium-241 as a sealed source Amersham Model AMN.18. NRC has no records showing that Model AMN.18 has been registered or approved by the NRC or an Agreement State. Amersham has, however, registered and NRC has approved an americium-241 sealed scurce Amersham Model AMC.18. Please indicate if this is the model number you wish to request. Alternatively, you or Amersham must i submit the necessary information required for the NRC to approve the AMN.18 I source. Refer to the "Guide for Reviews of Custom Made Sealed Sources and i Devices" for specific information. 1

10. Control and Transfer of R & D Gauges l

Your application states on page 2 that gauges in the research and development i stage will be used by Seaman Nuclear Corporation authorized and trained l personnel. This statement suggests that you will allow research gauges to be ,

used by anyone as they are authorized and trained by Seaman Nuclear  !

Corporation This may include separate companies, non-employees, or clients, i etc. Please note that it is within the purview of the NRC to determine who is I authorized to use byproduct material.

The NRC's intent for permitting research gauges to be used at temporary job sites is to allow the licensee to test and evaluate a design in actual field ,

situations prior to, but in direct support of, obtaining NRC or Agreement l State device approval and registration. It is not our intent to allow manufacturers to transfer research gauges or devices to clients or others for their use or evaluation or to circumvent the gauge licensing and registration process.  ;

i Therefore, state that research gauges will be used by Seaman Nuclear l Corporation at temporary job sites for the purpose of evaluating the gauge i design.

Confirm that Seaman Nuclear Corporation will not transfer the gauges or allow clients to use research gauges at temporary job sites unless they have a valid NRC license which authorizes possession of the custom-made research gauge,

11. R & D Gauges Establish and submit procedures to assure that research gauges are safe with respect to radiation safety aspects and that their use meets the provisions of 10 CFR Part 20. Include the following:

a. Describe how you will assure compliance with radiation levels stated in 10CFR Part 20. We recomend that you require the gauge operator to have and use a calibrated survey meter capable of detecting the

.adiations of interest.

i

1 Seaman ..uclear Corporaticn 6 .

b. Describe the operating and emergency procedures for'research gauges.

The procedures should contain the same elements in the non-rcsearch gauge procedures and additional instructions such as use a survey meter, use the gauge for the purpose of evaluating its performance, etc.

i ,

c. Describe your procedures for assuring the research gauges are used for the purpose of evaluating their performance. This should include i a commitment to establish a limit for the length of time a research gauge will be used at temporary job sites. This time frame should be long enough to evaluate the gauge but short enough to ensure that the gauge is not being used for routine work not associated with its research status.

12. Neutron Sources In support of your request to use californium-252 sealed sources up to 100 millicuries per source and americium-241 beryllium sealed sources up to 300 nillicuries, please describe the equipment and the procedures you will use to

safely handle these neutron sources. Your description should include, but not be limited to, the followint-i

a. The type, amount and locatien of shielding; i

b. Method for evaluating neutron radiation levels. We recommano you use  :

a neutron survey meter, and that the meter be calibrated annually.

Describe the manufacturer's name end model number of the meter.

I

c. Procedures and instructions handling these sources in a safe manner,

d. Frequency, location and records of area surveys to determine neutron. l beta and gamna radiation levels.

. 13. Personnel Monitoring - Extremities The description of the evaluation you performed to determine extremity exposure levels did not afford enough specific data for us to detennine its adequacy. However, you stated that you will be performing another analys }s of extremity exposures. Therefore, please describe how and when you will perform this new analysis . We recommend that personnel wh0 perform servicing which involves placing hand and fingers close to or inside the gauges wear finger TLD badges during these operations. If you choose not to follow our 1

recommendation, we will consider placing a conoition on your license requiring the use of finger badges in order to obtain the information needed to evaluate

extremity exposure levels, 4

f 4

i

-\-----v -- , ,, ,- , .. -.-..,,.m. .,.,..-_,,_,,n..,, ,.,.,..,,.,_..-,wnen,-_..-

=. .- . - - . . .- -

Seaman Nuclear Corporation 7 14 Personnel Monitoring - Extremity and Whole Body Your application states that you will use film badges to comply with personnel monitoring requirements as stated ir 10 CFR Part 20,202. Please describe what actions you are taking with regard to your personnel monitoring program to assure compliance with 10 CFR Part 20.202. Specifically, describe who wears personnel monitoring devices, and when they trust be worn. In addition to any others deemed appropriate, gauge users, service technicians and persons who frequently enter the storage area should wear monitors whenever working with or near byproduct material.

15. Leak Test Program The det,,'iption of your leak testing program was not complete or rasponsive to our letter dated May 30, 1986 and does not provide the information requested by the "Guide for the Prepar:stion of Applications for Licenses for the Use of Radioactive Materials in Leak-Testing Services." It appears from past correspondence and inspection information that you are using leak test kits and leak test analysis services from Health Physics Associates for your cwn gauges and supplying these kits to your customers. Please describe what your current practices are, and in addition to your overall description include the followir.g details:

a. Provide the name and hRC license i,sber of the firm who provides the leak test kits and performs the analysis,

b. Describe the movement of the kits and samples from the firm to Seaman Nuclear Corporation and to your customers. Who distributes the kits and who collects the uncounted samples?

c. If the kits and uncounted samples are redistributed and collected by Seaman Nuclear Corporation, describe any alterations you may make in the kits and describe how customers are notified of results. Provide the information requested in Item 10.4 of the leak test guide if you are involved in these prcredures,

d. If kits are sent directly from the supplyitig firm to your custorrers, if customers send the uncounted samples directly to the firm for analysis, and if the firm notifies custerrers of the results, please I so state.

I

e. If you are responsible for any of the followi.19 activities submit a description of each activity addressing the information requested in the guide for leak testing:

1. Distributing leak test kits; l

2. Collecting uncounted 91mples; and

3. Records and notification of ar,alysis results.

l

. . l Seaman Nuclear Corporation 8

16. Operating Procedures The "Guide for Preparation of Applications for Use of Sealed Sources in Portable Gauging Devices" states in Item 10.6 that operating and emergency procedures provided to personnel should include procedures for storage of devices when they are not in use or under the physical surveillance of a user. The operating procedures described in your application dated September 26, 1986 state that each storage container shall be locked when not under the direct surveillance of the user. It is unclear as to whether this statement indicates that the devices will be secured in storage when unattended. Placing the meter in its shipping container is not considered to be storage. The gauge in its shipping container must be placed in storage which is secure from unauthorized entry. Therefore, modify and sutwit your operating procedures to include instructions to secure the device in storage when it is not under the physical surveillance of the user.

17. Survey Program The survey program described in your application needs to be substantially supplemented to meet the acceptable procedures described in Regulatory Guide 8.21. Therefore, submit the following information:

a. Your procedures imply that only the gauge storage area will be monitored routinely. Regulatory Guide 8.21 recommends survey '

locations include areas where an individual could use a source that could produce a ganina or beta dose rate exceeding 0.5 mrad / hour at one meter. Identify these areas and confirm that they will be surveyed at least monthly,

b. Describe your procedures for surveying unrestricted areas to usure compliance with 10 CFR 20.105(b). Include in your description where surveys will be performed and the frequency at which they will be performed . Regulatory Guide 8.21, Item 1.15.2 contains a dest.. iption of the procedures that the NRC finds acceptable,

c. Regulatory Guide 8.21 recommends surveys be performed during any new operations. Incorporate this recomendation into your procedures and submit your procedures,

d. Regulatory Guide 8.21 recommends surveys be conducted when there is a significant change in the conditions that existed at the time of the most recent survey, including changes in quantity of radicactive material handled or in protective equipment or measures. Incorpora te these recomendations into your procedures and submit the procedures.

0 Seaman Nuclear Corporation 9

e. Your procedares state that the frequency of routine surveys in the storage area will be quarterly. We recommend that you modify your frequency of all routine surveys in all areas to meet the criteria established in Regulatory Guide 8.21, Table 1. Submit your modified procedures.

f. Regulatory Guide 8.21, Item 3, discusses the need for records of surveys. Confirm that records will be kept of results of surveys performed to meet 10 CFR Part 20 and Regulatory Guide 8.21. Indicate that records sill include survey results in same units used in 10 CFR Part 20, date of survey, location of survey, and signature of the person making the record.

9 Describe who will be given the responsibility of performing routine and operational surveys and who will be responsible for reviewing survey results.

h. Confirm that all surveys will include measurement of neutron radiation levels as well as beta /ganma levels.

18. ALARA Provide the following information:

a. Describe the frequency with which manegement will review the entire radiation safety program. These reviews should be performed at least annually.

b. Describe the scope of management's review of the radiation safety program. Reviews should include personnel exposure levels and

.results of area surveys.

c. NRC inspections have noted that radiation levels in the gauge and sealed source storage area are approximately 70 mR/ hour. Personnel must enter this area routinely to retrieve spare parts and other stock items. Please describe what actions you can take to lower the radiation levels in this area where personnel must frequent or to reduce the frequency or proximity of personnel to this area.

In conclusion, certain aspects of your radiation safety program as described I in your application dated September 26, 1986 do not meet our minimum I criteria. The deficiencies in your program and our minimum criteria are i described in this letter. The adequacy of your response to this letter will determine what activities we will and will not authorize on your renewed l license.

I i

1

Seaman Nuclear Corporation 10 If you have any questions or require clarification on any of the information stated above, you may contect us at (312) 790-5625.

We will continue our review of your application upon receipt of this information.

Please reply in duplicate, within 30 days, and refer to Control Number 17473.

Sincerely, Original Signed By Evelyn R. Matson Materials Licensing Section RI!!

Matson/pd 12/ /86 1