ML20210J722
| ML20210J722 | |
| Person / Time | |
|---|---|
| Site: | 07003025 |
| Issue date: | 05/30/1985 |
| From: | Adam W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Janzow E FRONTIER TECHNOLOGY CORP. |
| Shared Package | |
| ML20210J508 | List: |
| References | |
| 78333, NUDOCS 8604030543 | |
| Download: ML20210J722 (7) | |
Text
r FA MAY 3 01985 Frontier Technology Corp.
ATTN: Edward F. Janzow, Ph.D.
President 1641 Burnett Drive Xenia, OH 45385 Control No. 78333 Gentlemen:
We have reviewed your application dated February 15, 1985 requesting an NRC license for manufacturing and distribution and find that we will need additional information as follows:
1.
For those services you wish to supply to other ifcensees, please submit f
the following:
A.
With regard to leak testing:
a.
Specify the kinds of sealed sources and/or sources in devices which you intend to leak test.
Please include isotope and curie amount, as appropriate.
b.
For sources in devices specify the kind (s) of devices you will leak test.
For example, (a) chromatography, (b) density gauges, (c) explosive detectors, (d) portable moisture-fixed inplant gauges such as density gauges, level gauges, weight or bulk measuring gauges, moisture, thickness, etc.; and (e) others as appropriate to your proposed leak testing program.
c.
Provide a sample of your leak test kit including a copy of the instructions that will accompany the kit.
These instructions l
j may include:
l Procedures for performing the wipe testing including materials l
to be used and methods of handling samples to prevent or minimize exposure to hands and whole body of your personnel.
l Surveys to be performed such as those to ensure devices are in the " safe", " store", or "off" position prior to taking wipe samples from designated areas of source housing, shutters, etc.
Surveys to be performed on wipe or leak test samples to check I
for gross contamination prior to removal from site.
I B604030543 850722 l
A
Frontier Technology Corp.
2 MAY 3 01985 Any specific instructions provided by source and device manufacturers as to recommended methods and areas to be wiped.
Emergency procedures to be followed in the case of accidents such as grossly contaminated leak test samples, leaking sources, device damage by fire, etc.
d.
Please provide copies of, descriptions of or facsimiles of the type (s) of records you will maintain with regard to the leak test samples. These records should include:
Source and/or device identification.
(manufacturer, model no.,
serial no., isotope quantity, etc.)
Customer's identification (name, address, person (s) to contact, etc.)
Radiation survey measurements, as appropriate.
Date of test and date of next scheduled test.
Information on test method (s), e.g., type of wipe such as dry filter paper, wet cloth swipe, etc., and area (s) wiped.
Leak test results expressed in uct/ area wiped of alpha, beta or gama radiation.
Identification of individual performing the test.
Included with the above should be a copy of or facsimile of the leak test certificate you will supply to your customers.
Confirm that the procedures and instrumentation you have specified l-e.
in your. application for leak testing your own sealed sources l
will also be employed for collection and analysis of client leak test samples.
8.
With regard to survey instrument calibration:
l a.
Please provide a copy of, description of, or facsimile of the i
type certificate for instrument calibration you will provide to I
your customer with each calibrated instrument. Certificates should contain the following information:
Identification of customer by:
Name Address Person to be contacted.
L
7 Frontier Technology Corp.
3 MAY 5 01985 Identification of the instrument by:
Manufacturer Type Model No.
Serial No.
Calibration data such as:
Scales versus exposure rates (mr/hr) versus instrument readings (mr/hr).
Any specific comments on calibration or calibration data.
Identification of calibration soruces by:
Nuclide Exposure rates at specified distances include calibration accuracy.
Identification of individual performing the calibration.
Date of calibration.
b.
Please confirm that the sources and procedures you have specified in your application for calibration of your own survey instruments will also be employed for calibration of client survey instruments.
C.
With regard to servicing of. gauges:
a.
Please identify by manufacturer and model number each device on which services will be performed and the specific services to be performed on each device, b.
Please provide step-by-step procedures for the performance of the requested services.
These procedures should include such safety measures as:
Instructions for securing the source in a shielded condition during mounting, servicing, or the relocation of the device.
Surveys to be performed such as around shielded container, to insure acceptable radiation levels.
Proper mounting and/or relocation procedures.
a
r Frontier Technology Corp.
4 MAY 3 01985 Final survey of source following installation, etc., including leak testing; and instruction for completion of survey and leak test reports to be provided to your customers.
Determination of customer's need for personnel monitoring based on the radiation profile and occupancy evaluation in accordance with the requirements of Section 20.202, 10 CFR 20.
Determination of need for, along with procedures for the use of, appropriate caution signs, labels, signals and controls appropriate to the installation which will assure customer compliance wf th the requirements of Section 20.203, 10 CFR 20, as appropriate.
2.
Please supplement and resubmit-your contamination survey program to include:
a.
A description of your method of maintaining a record of the results of all surveys, b.
What actions will be taken when removable contamination ' limits are
~
exceeded.
c.
When radiation area surveys will be performed and what radiation levels would require corrective action.
3.
Item 10.10.1.A. of your application appears to exempt certain packages containing licensed material from safe opening procedures. There are no exemptions from safe opening. procedures in 10 CFR 20.205. Basically, 10 CFR 20.205 is divided into four parts:
Paragraph (b) refers ~ to monitoring for surface contamination upon a.
receipt of packages containing licensed material.
This contains *he exemption quoted in Item 10.10.1.A. of your application.
b.
Paragraph (d) refers to procedures for safely opening packages licensed material.
There are no exemptions in containing(d).
j Paragraph Your application contains a method that is acceptable for implementing the regulation in 10 CFR 20.205(d), which applies to all_ packages containing ifcensed material. However, you cannot use the exemptions in 10 CFR 20.205(b),
which apply to receiving packages, as a substitute for the procedures you have submitted in 10.10.1.8. which apply to opening packages.
l I
a
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Frontier Technology Corp.
5 g(qy 3 0 jg86 4.
Please supplement and resubmit Section 10.3 (Personnel Monitoring) of your application to include:
a.
Your criteria for issuance of extremity monitors, b.
Identification of the radionuclides of interest for bioassay purposes and action levels at which corrective actions would be taken.
5.
Please supply a copy of general instructions to be followed by laboratory personnel while working with radioactive materials.
These instructions should:
a.
Outline control procedures for obtaining permission to use radioactive materials at your institution.
b.
Explain what laboratory apparel to wear and what safety equipment to use (e.., use of laboratory coats, gloves, and remote pipetting devices.
Prescribe limitations and conditions on handling liquid or loose c.
(unencapsulated cr dispersible) radioactive materials and what laborate
- quipment to use in working with them.
For example, explain
'An materials and operations should be confined to radiochem..
hoods or gloveboxes and explain what shielding or remote hanas. 3, equipment is to be used when hard beta-or gamma-emitting materials are handled.
d.
Instruct the user about routine survey and monitoring procedures for each contamination control zone.
Instruct the user about movement of materials between rooms, halls, e.
or in corridors, if applicable.
f.
Explain requirements for storage of materials and labeling of containers and how areas will be identified where radioactive materials are used.
Explain where and how contaminated articles and glassware are to be handled and stored.
g.
Specify personnel monitoring devices to be used, where to obtain them, and instructions given on recording exposure results or properly turning in personnel monitoring devices for processing at appropriate intervals.
h.
Instruct the user in waste disposal procedures to follow in the laboratory, including limitations for disposal of liquid or solid wastes by the user and procedures to use for waste storage within each laboratory.
i.
Explain what records are to be kept for the use and disposal of materials.
j.
Describe contamination control procedures, including restrictions against smoking and consumption of food and beverages.
L
r Frontier Technology Corp.
6 MAY 3 01985 6.
With regard to product packaging and shielding, please submit for each sealed source or device to be distributed:
Radinnuclide, chemical / physical form; sealed source or device model number A description of the packaging Maximum activity per type of container Type and thickness of shielding Maximum radiation level at surface of each shielded container when filled with maximum activity 7.
For each sealed source or device to be distributed, either:
a.
Submit evidence of current registration with the NRC or an Agreement State, or b.
Request an evaluation of each sealed source / device in accordance with the enclosed guide.
8.
If you intend to have a source return program, please submit copies of detailed instructions (including labels and shipping documents) provided to customers. As a miniinum, these must:
a.
Establish customer's respons,ihility/ liability as shipper b.
Step-by-step instructions to complete each form / label c.
Discuss customer's responsibilities for:
1.
Survey / wipe test packages 2.
Security seal 3.
Dose rate Ifmits for label 4.
Action levels for wipe test results 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 78333.
Sincerely, l
Original Signed By William J. Adam, Ph.D.
Materials Licensing Section
Enclosure:
Standard Format and Content of Applications for Health l
and Safety Review and Registration of Devices Containing Radioactive Materials RIII AYnt 05/28/85 I
)
e a
w.
a s
s (3)
Procedures:
-Severe thunderstorms or high wind warning.
Prepare to stop outside operations.
If threatening storm clouds are sighted and appear to be approaching the site, shut down outside operations and proceed inside until weather has passed.
Place vulnerable radioactive material in storage.
Tornado watch.
Conditions are right for tornado activity,taybut none have been sighted.
One person should s
in range of a weather radio and/7r a radio tuned to a local radio station for weather upcates.
Minimize vulnerable radioactive materials in use.
Frequently check outside for the approach of violent weather.
Tornado warning.
Tornado sighted in vicinity.
If the warning is for site area, suspend operations, move vulnerable radioactive materials to storage.
Leave production area and take cover.
In no case should a person endanger his own safety.
B.
Immediate Action Following Tornado (1)
Inspect building from outside for breach of roof or walls in restricted areas.
If none is found further action is not needed.
If breach has occurred, proceed as below.
(2)
If possible without undue risk of contamination and/or radiation exposure, enter building and obtain protect-ive equipment and survey instruments from support area.
Otherwise,localnotify persons on call list, USNRC, Request Region
- III, and F2re and Police authorities.
loan of instruments and protective fcom off-site organizations and/or request assist. gear ance from such
)
organizations.
(3)
Survey areas outside building f or conta'nination and for radiation.
Post any areas found.
if possible.
Tem (4)
Close building breaches erials such as plywood, plastic sheeting,porary mat-or canvas may be used at this stage.
C.
Subsequent Actions
- Requires presence of
- RSO, Associate
- RSO, or other persons knowledgeable in radiological hazard control.
(1)
Subsequent actions will depend upon conditions.
General ar.proach is as follows:
First, take actions to prevent spread of contamination outside of building.
Locate contaminated areas, post, gut up temporary barrier, cover.
decond, take actions to prevent release of materials from building.
Close breaches.
- Third, decontaminate outside areas being sure that all radioactive materials are placed in secure containers.
Fourth, re-enter building and assess conditions.
Fifth, secure radioactive materials inside building.
begin decontamination,localcleanupEhoritiesrepair.
Sixth and Keep USNRC,t of Region III and au informed (2) as to exten radioacEive releases, if any, and status of operations.
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