ML20137Z335
| ML20137Z335 | |
| Person / Time | |
|---|---|
| Issue date: | 12/27/1984 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20137Z331 | List: |
| References | |
| RTR-NUREG-CP-0073, RTR-NUREG-CP-73 NUDOCS 8603130020 | |
| Download: ML20137Z335 (29) | |
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DEC 2 71984 BSinger JEverett, RIV RECunningham BThomas, RV DRChapell NMSS r/f EAHeumann rr rentral File FCMC r/f Daussteer TDorian MDiORANDUM FOR: Regional Administrators (riart JPotter, RII Branch Chiefs Division of Fuel Cycle and Material Safsty FROM:
Richard E. Cunningham, Dimeter Division of Fuel Cycle and Hater tal Safety
SUBJECT:
POLICY AND GUIDANCE DIRECID:' FC 84-23; STANDARD REVIEW PLAN (SRP) FOR APPLICATIONS FOR LICENSES FOR THE USE OF PANORAMIC DRY SOURCE-STORAGE IRRADIATORS. SELF-CONTAINED WET SOURCE-5TORAGE IARADIATORS, AND PANORAMIC WET SOURCE-STORAGE IRRADIATORS Enclosed is the Standard Review Plan (MP) for applications to possess and use sealed sources and devices in three types of irradiators. The Regulatory Guide for use of Irradiator Applicants is being printed and wi'1 he distributed to licensees by REF. We will forward copies to your staff as soon as they a m available.
The SRP and the Regulatory Gu'ide wem pr.7pmd to support material licensing functions transferred to the f.egional offices on April 2,1984.
Draft copias of both documents were made available to your staff during training and for use in the licensing process until final approvals were obtained. Comments received during training wem considered during the revision process.
The enclosed SRP has been reviewed by ELD and no legal ob.fections wem noted. We plan to review and revise the SRP and the related Regulatory Guide in approximately one year using the cournents received from your staff based on the use of these documents during the licensing ~ process. Your staff is encouraged to consnent, particularly on how their utility might be improved. Consnents or reconenended changes should be sent by July 1985.
Originti Sicnod by D. E. Chys11
" Richard E. Cunningha.n, Director Division of Fuel Cycle and Material Safety
Enclosure:
As stated e6o313oo20 e60305 PDR NUREG CP-OO73 C PDR
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STANDARD REVIEW PLAN FOR APPLICATIONS FOR LICENSES FOR THE USE OF PANORAMIC DRY SOURCE-STORAGE IRRADIATORS, SELF-CONTAINED WET SOURCE-STORAGE IRRADIATORS, AND PANORAMIC WET SOURCE-STORAGE IRRADIATORS
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December 1984 f
This Standard Review Plan is for use with Draft Regulatory Guide FC 403-4, issued January 1985.
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U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards
a STANDARD REVIEW PLAN FOR APPLICATIONS l
FOR LICENSES FOR THE USE OF
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PANORAMIC DRY SOURCE-STORAGE IRRADIATORS, SELF-CONTAINED WET SOURCE-STORAGE IRRADIATORS, AND PANORAMIC WET SOURCE-STORAGE IRRADIATORS TABLE OF CONTENTS Section Pace 1.
INTRODUCTION..........................
1 1.1 - Purpose of Guide........
1 1.2 - Applicable Regulations..................
I 1.3 - As Low As Is Reasonably Achievable (ALARA) Philosophy 2
2.
FILING AN APPLICATION......................
2 3.
CONTENTS OF AN APPLICATION.
4 Item 1 - License Information.........
4 Item 2 - Name and Mailing Address of Applicant.
4 Item 3 - Locations of Use....................
5 Item 4 - Person To Be Contacted About Application..
5 Item 5 - Material To Be Possessed.......
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Item 6 - Purpose for Which Licensed Material Will Be Used.
6 Item 7 - Individuals Responsible for Radiation Safety sea; Program--Their Training and Experience 7
Item 8 - Training Provided to Other Users............
9 Item 9 - Facilities and Equipment.
12 9.1 - Basic Facility Design and Construction 12 9.2 - Other Safety Considerations...........
14 Item 10- Radiation Protection Program.
16 10.1 - Personnel Monitoring Equipment.
16 10.2 - Radiation Detection Instruments.........
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10.3 - Leak-Testing........
18 10.4 - Operating and Emergency Procedures.......
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10.5 - Hospital Arrangements..............
22 1
l Item 11-Waste Management.
22 Item 12-License Fees......................
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Item 13-Certification............
23 4.
AMENDMENTS TO A LICENSE.....................
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5.
RENEWAL OF A LICENSE......................
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STANDARD REVIEW PLAN FOR APPLICATIONS FOR LICENSES FOR THE USE OF PANORAMIC ORY SOURCE-STORAGE IRRADIATORS, SELF-CONTAINED WET SOURCE-STORAGE IRRADIATORS, AND PANORAMIC WET SOURCE-STORAGE IRRADIATORS 1.
INTRODUCTION 1.1 PURPOSE OF GUIDE The purpose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals for the use of sealed sources and devices for gamma irradiation in panoramic dry source-storage irradiators, self-contained wet source-storage irradiators, and panoramic wet sourca-storage irradiators.
This regulatory guide is intended to provide you, the applicant and licensee, with information that will enable you to understand specific regula-tory requirements and licensing policies as they apply to gamma irradiators.
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The information in' this regulatory guide is not a substitute for training in ru radiation safety and for developing and implementing an effective radiation safety program.
After you are issued a license, you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application, (2) the terms and conditions of the license, and (3) the Nuclear Regulatory Commission's (NRC's) regulations.
The information you provide in your application should be clear, specific, and accurate.
Reviewers This standard review plan provides you, the reviewer on NRC's technical staff, with guidance in the exercise of discretion in the licensing process.
- 1. 2 APPLICABLE REGULATIONS NRC regulations applicable to irradiators are in 10 CFR Part 19, " Notices, Instructions and Reports to Workers; Inspections"; 10 CFR Part 20, " Standards 1
for Protection Against Radiation"; 10 CFR Part 21, " Reporting of Defects and
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Noncompliance"; 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR Part 71, " Packaging and Transportation of Radioactive Material"; ano 10 CFR Part 170, " Fees for Facilities and Mate-
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rials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended."
It is your responsibility as an applicant and as a licensee to have copies of, to read, and to abide by each regulation.
As a licensee, you are subject to all applicable provisions of the regulations as they pertain to gamma irradiators.
This regulatory guide identifies the information needed to complete NRC Form 313 when applying for a license to use sealed sources and devices for gamma irradiation.
The information collection requirements in NRC Form 313 have been cleared under OMB Clearance No. 3150-0120.
- 1. 3 AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY Paragraph 20.1(c) of 10 CFR Part 20 states "... persons engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in effluents to unrestricted areas, as low as is reasonably achievable." Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achiev-able," provides the NRC staff position on this important subject.
As an applicant, you should consider the ALARA philosophy as described in Regulatory Guide 8.10 in the development of plans for work with licensed radioactive materials.
2.
FILING AN APPLICATION You, as the applicant for a materials license, should complete NRC Form 313 (see Appendix A to this guide).
You should complete Items 1 through 4, 12, and 13 on the form itself.
For Items 5 through 11, you should submit the information on supplementary pages.
Each separate sheet or document submitted with the application should be identified and keyed to the item number on the 2
s application to which it refers.
All typed pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review.
If larger drawings are necessary, they should be folded to 8-1/2 x 11 inches.
You should complete all items in the application in sufficient detail for the NRC to determine that your equipment, facilities, training and experience, and radiation ~ safety program are adequate to protect health and to minimize danger to life and property.
You should file your application in duplicate.
Retain one copy for yourself because the license will require that you possess and use licensed material in accordance with the statements and representations in your appli-cation and in any supplements to it.
Federal agencies should file applications with the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle and Material Safety, Washington, DC 20555.
If you are located in an Agreement State, you should file applications with the NRC only if you wish to possess and use licensed material in States subject to its jurisdiction.
All other persons should file applications with the NRC Regional Office for the State in which they are located.
If you are located in Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, A
Rhode Island, or Vermont, send your applications to the U.S. Nuclear Regulatory Commission, Region I, Nu:: lear Material Section B, 631 Park Avenue, King of Prussia, PA 19406.
If you are located in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee, Virginia, Virgin Islands, or West Virginia, send your applications to the U.S. Nuclear Regula-tory Commission, Region II, Material Radiation Protection Section, 101 Marietta Street, Suite 2900, Atlanta, GA 30323.
If you are located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wisconsin, send your applications to the U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 799 Roosevelt Road, Glen Ellyn, IL 60137.
If you are located in Arkansas, Colorado, Idaho, Kansas, Louisiana, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas, Utah, or Wyoming, send your applictions to the U.S. Nuclear Regulatory 3
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Commission, Region IV, Material Radiation Protection Section, 611 Ryan Plaza 1
Orive, Suite 1000, Arlington, TX 76011.
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If you are located in Alaska. Arizona, California, Hawaii, Nevada, Oregon, Washington, or U.S. territories and possessions in the Pacific, send your applications to the U.S. Nuclear Regulatory Commission, Region V, Material Radiation Protection Section, 1450 Maria Lane, Suite 210, Walnut Creek, CA 94596.
3.
CONTENTS OF AN APPLICATION The following comments apply to the indicated items of NRC Form 313.
Item 1 - LICENSE INFORMATION For a new license, check subitem A.
For an amendment to an existing license, check subitem B.
For a renewal of an existing license, check subitem C.
Reviewers This item is for information only.
No review is necessary.
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'w, Item 2 - NAME AND MAILING ADDRESS OF APPLICANT If you are an individual, you should be designated as the applicant only if you are acting in a private capacity and the use of the radioactive material is not connected with your employment with a corporation or other legal entity.
Otherwise, you, the applicant, should be the corporation or other legal entity applying for the license.
Reviewers Individuals may request licenses only if they act for themselves and not for or within a legal entity.
Other-wise, the applicant must be a legal entity such as a corporation, college, university, medical institution, or research institution.
An individual, division, or department within a legal entity may not be a licensee.
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s The address specified here should be your mailing address for correspon-k dence.
This may or may not be the same as the address at which the material will be used, as specified in Item 3.
Reviewers The applicant's mailing address needs no review.
Item 3 - LOCATIONS OF USE You should specify each location of use by the street address, city, and State or other descriptive address (such as 5 miles east on Highway 10, Anytown, State) to allow us to easily locate your facility.
A Post Office Box address is not acceptable.
Reviewers The location where the irradiator will be used should be clearly identified.
A street address or designation of a particular building on a college or university campus is adequate identification.
A Post Office Box or similar designation is not acceptable.
The lack of a clear and specific location is a deficiency; request clarifica-tion from the applicant.
Item 4 - PERSON TO BE CONTACTED ABOUT APPLICATION You should name the individual who knows your proposed program and can answer questions about the application, and you should note his or her telephone number.
If the contact changes, the NRC should be notified.
Notification of a contact change is for information only and would not be considered an appli-cation for a license amendment.
Reviewers This item is for information only and does not need review.
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Item 5 - MATERIAL TO BE POSSESSED 1.
Identify the radioisotope that will be in each sealed source in the irradiator.
2.
Identify the manufacturer and model number of each sealed source in the irradiator.
3.
Specify the total amount of radioactive material that you will possess at any one time and the maximum amount of radioactive material that will be in any single sealed source.
4.
Identify the manufacturer and model number of the irradiator.
The information specified above is available from the supplier of the irradiator.
Reviewers Check the informaticn above in the Sealed Source and Device Registry to determine that each sealed source and irradiator has been reviewed and authorized for distribu-tion. If.a sealed source /irradiator combination has not been authorized for distribution, inform the applicant that possession and use of the irradiator cannot be author-ized until there has been a review by the NRC or an Agree-ment State, as appropriate.
Also inform the applicant that reapplication may be made when the proposed distrib-utor gives assurance that the appropriate regulatory agency has completed review and that the sealed source /
irradiator combination is acceptable for distribution.
If the irradiator is custom designed, you should review the irradiator as indicated in Item 9.
Item 6 - PURPOSE FOR WHICH LICENSED MATERIAL WILL BE USED Specify the purpose for which the irradiator will be used.
For purposes of public health and safety, you should include a statement that explosives, flammables, and corrosives will not be irradiated. If you plan to irradiate food, you should state that distribution for consumption in the United States 6
will be done in accordance with the Food and Drug Administration's regulatory requirements 7 Reviewers The usual uses are irradiation of medical products, plastic-impregnated wood, and other inanimate objects.
An application for irradiating food is acceptable if it includes a statement that distribution in the United States will be in accordance with FDA regulations.
Be sure the applicant includes the statement about not irradiating explosives, flammables, or corrosives.
If it does not do so, ask the applicant to correct the deficiency by providing this statement.
Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM--THEIR TRAINING AND EXPERIENCE Paragraph 30.33(a)(3) of 10 CFR Part 30 specifies that you must be qualified by training and experience to use the material for the purpose requested in such a manner as to protect health and minimize danger to life or property before an application for a license is approved.
You need to include a commitment that, whenever the irradiator is in operation, a " responsible individual" will be on duty and immediately available in the irradiator facility.
This commitment is necessary to ensure that there will always be a trained individual who is in a management or supervisory capacity on duty who can take appropriate steps in the event of an emergency or other situation that requires corrective action.
The title of the individual is not important.
Whether the person is called the radiation safety officer (RS0), radiation protection officer (RPO), supervisor, etc, is not critical.
It is important that the persons responsible for the program be specifically named.
You should provide the following information about the individual or individuals who will be responsible for your radiation safety program
(" responsible individu&l").
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Reviewers i
If the commitment for the presence of a " responsible
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individual" whenever the irradiator is in operation is not made, ask the applicant to correct the deficiency by making the commitment.
1.
The name of each individual.
Reviewers The title of the individual is not important.
The person may be called the radiation safety officer (R50), radia-tion protection officer (RPO), supervisor, etc.
It is important that the persons responsible for the program be specifically named.
If the persons responsible for the program are not named, ask the applicant to correct the deficiency by providing the information.
2.
Specific dates each individual's training was completed and where
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and by wnom the training was conducted.
As a minimum, any " responsible W
individual" should have successfully completed a training course of approx-imately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in the following topics:
Principles and fundamentals of radiation protection and good safety practices related to the use of radioactive material.
Radioactivity measurements, use of radiation detection and measuring instruments, and monitoring techniques.
Mathematics and calculations basic to the use and measurement of radioactivity.
Biological effects of radiation.
Reviewers If the specific information requested above is not provided, as. the applicant to correct the deficiency by providing the information.
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3.
Specific dates of each individual's actual experience in irradiator
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use, the type of irradiator used, and its location.
As a minimum, each
" responsible individual" should have at least 3 months (full-time equivalent) of actual experience in the use of the same type irradiator specified in the application and in operations associated with irradiator use.
The 3 months of experience may include some preoperational involvement while the irradiator is being constructed if the individual works with the personnel of the firm constructing the irradiator and learns about the irradiator, its safety systems, and how the irradiator functions.
The actual experience in irradiator operations after the irradiator goes into operation should be for a minimum of 4 weeks.
Reviewers A minimum of 3 months of exper nce in irradiator opera-tions is needed.
The 3 months of experience may include some preoperational involvement while the irradiator is being constructed if the individual works with the person-nel of the firm constructing the irradiator and learns about the irradiator safety systems and how the irradiator
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functions.
If the total time does not meet the 3-month criterion, including at least 4 weeks in actual irradiator operations, ask the applicant to correct this deficiency by providing additional information on the individual's experience in irradiator operations or by specifying a different " responsible individual" who has the appropriate training and experience.
Item 8 - TRAINING PROVIDED TO OTHER USERS Individuals who will operate the irradiator under the supervision of a
" responsible individual" (described in Item 7) do not need to be designated by name. The following information should be provided:
1.
An outline of the training program, including the topics that will be covered and the time that will be spent on each topic.
Examples of topics to be included in the training program are (1) the principles and fundamentals of radiation safety and good safety practices related to the use of radioactive 9
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materials, (2) the use of radiation detection instruments, (3) your operating i
and emergency procedures, and (4) the design and operation of the irradiator.
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This training should be approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in length.
The training program should include an examination to test the understanding and knowledge of the individuals who have completed the training program.
The examination should have approximately 50 questions that cover all aspects of the training program.
2.
Copies of the examination, the correct answers, the passing grade, and a discussion of additional instruction for individuals who are found to be deficient.
3.
A discussion of the on-the-job training that will be given to individ-uals.
This training should consist of a minimum of 1 month of on-the-job train-ing in the actual operation and use of the irradiator.
The on-the-job training should be conducted by a " responsible individual" specified in Item 7.
4.
The name of the course instructor.
If this person is not a "respon-sible individual" specified in Item 7, submit this person's qualifications.
The minimal qualifications for a course instructor should be the same as those for a responsible individual specified in Item 7.
5.
A commitment that records documenting the training of each individual
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will be maintained for a period of 3 years.
e Reviewers To provide for flexibility with respect to individuals who may use the irradiator but who are not responsible individuals, these individuals need not be named.
The applicant must make a commitment in the application that, before an individual is designated as a user of the irradiator, that person will have received approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training in radiation and radiation safety principles and a minimum of 1 month (full-time equivalent) of training in the actual use of the irradiator.
Review the training program outline to determine that the subject matter reasonably covers the principles of radia-tion and radiation safety and other topics specified above and that the training will be about 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in length.
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If the application lacks a training program outline or if the program outline lacks specificity concerning the topics to be covered in the formal training or concerning the time to be spent on each topic, ask the applicant to correct this deficiency by providing the needed informa-tion.
Review the examination and answers to determine that the principles of radiation and radiation safety are reason-ably covered and that the answers to the questions are correct. Unless there are multiple errors, do not note a deficiency. However, if there are one or two incorrect items, bring them to the attention of the applicant at the time of license issuance or as a matter that requires no response in the deficiency letter.
The applicant should discuss the on-tha-job training that will be given.
The on-the-job training should provide prospective irradiator operators with an understanding E-of all the safety systems of the irradiator, the functions of the irradiator, and the actual operation of the irra-diator.
Responsible individuals should be present during on-the-job training.
If there is not a commitment for and description of on-the-job training, ask the applicant to correct the deficiency by providing this information.
The formal training may be provided by an outside firm or may be conducted "inhouse." The major consideration is that the individuals conducting the course have a broad background in radiation and radiation safety.
It is unacceptable for an individual who has had only the 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training specified for a " responsible individual" to conduct the training.
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Item 9 - FACILITIES AND EQUIPMENT k
Paragraph 30.33(a)(2) of 10 CFR Part 30 states that an application will be approved if, among other things, the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property. Therefore, you should provide information concerning your equipment and facilities.
9.1 Basic Facility Design and Construction Include a sketch or drawing of the irradiator facility and its surround-ings, together with an accompanying narrative, and provide the following information:
1.
The scale to which the sketch or drawing is made (the same scale should be used for all sketches and drawings).
The recommended scale is 1/4 inch = 1 foot.
2.
The type, thickness, and density of shielding materials on all sides, including the floor and roof.
E" 3.
The locations of entrances and other points of access into the irradiator room and locations of control devices, alarms, and signals.
4.
A description of the nature of the areas adjacent to the facility and the distance to these areas.
5.
A description of the safety systems, including control devices, alarms, and signals.
Explain how the regulatory requirements of each subitem in paragraph 20.203(c)(6) of 10 CFR Part 20 are met.
In order to meet these requirements, the safety systems and the radiation control program must:
Have an entry control device that functions automatically to prevent an individual from entering when the radiation level is above the normal shielded level.
The control device must be a physical barrier such as a door.
Permit entry only after actuation of a control device that causes radiation to be reduced so that an individual could not receive a dose of more than 100 mrem in an hour.
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Prevent source operation if the resulting radiation level could result
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Ensure that the entry control devices will not prevent an individual in a dose to an individual in excess of 100 mrem in an hour.
from leaving the area.
Have additional control devices that will reduce the radiation level in case the primary entry control devices fail so that en individual could not receive a dose of more than 100 mrem in an hour.
The devices must generate audible and visible alarm signals to warn individuals attempting to enter and must make at least one other individual aware of the attempted entry.
Have additional control devices that will reduce the radiation level so that, if the shielding fails, an individual will not receive a dose of more than 100 mrem in an hour.
The devices must generate visible and audible alarm signals.
However, this requirement does not apply to irradiators with permanent structural components with no credible probability of failure.
Have devices that will automatically generate visible and audible alarm signals to alert personnel before the source can be put into
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operation and that will allow an individual enough time to operate a control device to prevent source operation.
Have administrative procedures and devices t.o en:,ure that no indi-vidual is in the irradiation area when the source is taken from the shielded position to the exposed position.
Require a physical radiation survey before an individual enters the irradiation area to ensure that the radiation is below the level that could cause the individual to receive a dose of more than 100 mrem in an hour.
Require testing of the control devices each day in which operations are not continued from the previous day.
Records of these required tests should be maintained for 2 years from the date of performance of each test.
Have control devices and administrative procedures that protect and warn against inadvertent entry into the entry and exit portals used for transporting materials to and from the irradiation area.
Have a detector at each exit portal to signal the presence of loose radiation sources and a control system to prevent the loose sources from being carried out of the area.
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In preparing the annotated sketch or drawing and the description of the
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control devices, alarms, and signals, you should ensure that the design of the facility satisfies the following safety conditions:
1.
The radiation level in the area immediately outside the shieldad room where the sealed sources are located should not exceed 2 milliroentgens per hour when the sealed sources are exposed.
The design must take into account potential increases in the amount of radioactive material that could be used in the irradiator.
2.
All entrances, points of access, and exits to and from the area in which the sealed sources are located should have control devices, alarms, and signals that comply with the requirements in paragraph 20.203(c)(6) of 10 CFR Part 20.
3.
All areas in which control and interlock systems are required, including roof areas, should be locked and secured against unauthorized access when authorized personnel are not present.
Reviewers If any point specified above is not addressea or does not clearly specify how the regulatory requirements will be met, ask the applicant to correct the deficiency by providing the information.
9.2 Other Safety Considerations In addition to the items specified in Item 9.1, consider the safety features identified below as applicable to the design of the irradiator facility.
List those features that will be in the irradiator design and provide a brief description of the design criteria for each.
For features that are not included, submit a brief statement of why they are not included.
1.
If the facility has a water storage pool:
a.
The pool construction should provide for water circulation, treatment, monitoring, and makeup systems.
b.
The pool should be watertight.
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c.
Permanent pool components should be made of material that reduces the possibility of corrosion that could cause leakage of radioactive material from the sealed sources.
d.
A means should be provided to automatically replenish water losses from normal evaporation.
The pool should be equipped with a system capable of keeping e.
the water clean; the level of conductivity should not exceed 10 microstemens per centimeter.
f.
The means used to monitor storage pool water should be capable of detecting any leakage of radioactivity from the sources in the water.
g.
There should be no penetration (e.g., pipes or plugged holes) through the bottom of the pool..There should be no penetration through the walls of the pool more than 12 inches (30 cm) below normal water level, h.
A means should be provided to prevent the migration of pool water into municipal water supply systems.
2.
If in-air irradiation is to be performed, the facility should have a ventilation system to keep ozone, nitrogen oxides, and other noxious gases below values listed in the " Threshold Limit Values for Chemical Substances in Workroom Air"* so that employees are not exposed to concentrations in excess of the threshold limit values.
3.
The facility should have heat-and smoke-sensing devices to detect combustion in the irradiator room, and these devices should have audible and visible alarms.
The sensing system should be designed so that the sources will be automatically placed in the fully shielded position if either the heat-or smoke-sensing device is activated.
4.
The irradiation room should be provided with an automatic fire extinguishing system.
" Adopted by the American Conference of Governmental Industrial Hygienists (ACGIH), P.O. Box 1937, Cincinnati, Ohio 45201.
The threshold limit values are reassessed and published annually by ACGIH; you should use the most recent edition of these values.
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5.
Product carriers, packages, and totes should be designed and maintained so tha't they cannot interfere with the source holder or source elevating and lowering mechanisms.
Reviewers The application should have a commitment to the design and use of safety features in the irradiator facility.
If any of the listed features is not addressed, ask the applicant to explain the omission or the alternative to the feature.
However, consider the type of irradiator system and the
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feattres of the particular irradiator system beforc-you ask the applicant for additional information.
Item 10 - RADIATION PROTECTION PROGRAM You, as the licensee, are responsible for the conduct of the irradiator program and all actions of your employees.
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10.1 Personnel Monitoring Equipment
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Section 20.202 of 10 CFR Part 20 requires that personnel monitoring equipment be used by individuals entering restricted areas who receive or are likely to receive a dose in excess of 25% of the dose specified in para-graph 20.101(a) of 10 CFR Part 20.
The specified doses per calendar quarter are 1-1/4 rems to the whole body, head and trunk, active blood-forming organs, or gonads; 18-3/4 rems to the hands and forearms or feet and ankles; and 7-1/2 rems to the skin of the whole body.
Individuals under 18 years of age need to use personnel monitoring equipment if they receive or are likely to receive a dose in excess of 5% of the specified calendar quarter doses in paragraph 20.101(a). In addition, any individual who enters a high radiation area must use personnel monitoring equipment.
All your personnel should wear either a film badge or a thermoluminescent dosimeter (TLD) when they use the irradiator.
State the type of personnel monitoring equipment you will use and the frequency at which the film badges or TLDs will be changed.
The frequency of change should be at intervals not to exceed 1 month for film badges and 3 months for TLDs.
16 4
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Reviewers
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The lack of a commitment for personnel monitoring is a deficiency.
Inform the applicant of the need for this commitment.
10.2 Radiation Detection Instruments Paragraph 20.201(b) of 10 CFR Part 20 specifies that you, as the licensee, must make such surveys as are necessary to evaluate the extent of radiation hazards that may be present and to comply with regulatory requirements.
In order to perform appropriate surveys, you need to have operable, calibrated instrumentation.
State that you will have available for use at all times a calibrated, operable survey meter that can measure up to 1 roentgen per hour.
You do not need to name the manufacturer or the model number of the survey meter.
Reviewers The lack of a commitment for an operable, calibrated sur-
[
vey meter is a deficiency.
Inform the applicant of the need for a radiation survey meter that can measure up to 1 roentgen per hour.
In order to perform appropriate surveys, the instruments must be operable and calibrated with an appropriate radiation source.
State that the instruments will (1) be calibrated so that the readings are 120% of the actual. values over the range of the instrument, (2) have a calibration chart or graph that shows the results of the calibration, the date of the last calibration, and the due date for the next calibration affixed to the survey meter, and (3) be calibrated at intervals not to exceed 12 months and after servicing.
Also state that calibration records will be kept for a minimum of 2 years after each calibration and identify who will calibrate the instruments.
If a person or firm outside your organization will perform the calibration, identify each person or firm by name and NRC or Agreement State license numoer.
If the person or firm is not a licensee, provide a copy of the procedure used for instrument calibration for NRC review.
17
)
Note:
A person or firm in a non-Agreement State who uses radium for instrument calibration would not be an NRC licersee because NRC does not have authority to license naturally occurring radioisotopes such as radium.
If you use such a calibration service, you must provide the NRC with a copy of the procedures used.
For detailed information about survey instrument calibration, refer to ANSI N323-1978, " Radiation Protection Instrumentation Test and Calibration."*
Reviewers It is not necessary to obtain detailed information from an applicant about instrument calibration.
Information on the actual procedures or the source to be used by the applicant for its own calibrations is not necessary.
A commitment by the applicant as indicated in the guide is 4
all that is needed.
If an outside firm is specified, check to determine that NRC or an Agreement State has reviewed the calibration procedure.
A statement that the instrument manufacturer will do the calibration is accep-
/~
table without any further check.- If the calibration firm 1
k,_,J is not a licensee, obtain all necessary information from the applicant and review the information, i
If the applicant only states " instruments will be cali-brated by a firm licensed by NRC or an Agreement State" or " instruments will be calibrated by XYZ Company or equiv-alent," such statements should be considered deficient.
Inform the applicant that the name, address, and license number of each firm other than the instrument manufacturer is needed.
10.3 Leak-Testi g 1
As a licensee, you must perform such tests as the NRC deems appropriate 1
pursuant to S 30.53, " Tests," of 10 CFR Part 30.
The NRC requires tests to determine whether or not there is any leakage from sealed sources.
^ Copies may be obtained from the American National 5tandards Institute, 1430 Broadway, New York, NY 10018.
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An acceptable method of leak-testing for wet source-storage irradiators
(
that have an ion exchange system is to monitor the ion exchange resin filter bed at least once a week.
The measurement does not need to be quantitative, and your survey instrument may be used.
If any radioactivity is detected, a source leak should be assumed and you should take steps to identify the specific source that may be leaking.
You should submit your procedure for identifying the leaking source and the action you will take to remove the source from use.
Another acceptable method is to equip the ion exchange resin filter bed with a continuous radiation monitoring device with an alarm that will sound if any radioactivity is detected.
You should then identify the specific source that may be leaking.
You should submit your procedure for identifying the leaking source and the action you will take to remove the source from use.
Reviewers For irradiation facilities that have an ion-exchange system, the weekly survey or continuous monitoring of the ion-exchange resin is a satisfactory test for leakage.
The survey need not be quantitative.
However, if radio-activity is detected, there should be a procedure for determining the source that is leaking and a commitment to remove the source from use.
For panoramic dry source-storage irradiators, an acceptable method for checking for leakage is (1) wiping accessible surfaces around the sealed source rack and measuring the leak-test sample or (2) actually wiping each sealed source and measuring the leak-test sample.
The leak tests should be quantitative and sufficiently sensitive to detect 0.05 microcurie of radioactiv-ity.
The tests should be performed at intervals not to exceed 6 months, and records of the tests should be maintained for 3 years.
You should specify the type of leak test that will be performed and the means to determine the specific leaking source if more than 0.05 microcurie of radioactivity is found on a leak-test sample.
If the wipe-test method is used, specify the following:
1.
The leak-test method used.
2.
Instrumentation used for measurement.
19
3.
The identity of the individual or firm performing the test.
If a commercial firm or consultant will perform the test, specify the name and the NRC or Agreement State license number of the commercial firm or consultant.
Reviewers Any of the options for collecting the leak-test sample is acceptable.
The measurement should be performed with an instrument capable of making a quantitative measurement.
A hand-held survey meter is not acceptable.
If the applicant proposes to do the leak-testing, review the methods for collecting and measuring the leak-test sample.
If a consultant or outside firm will perform the leak test, check to determine that it is specifically licensed to perform leak-testing on sealed sources in irradiators.
(O If the consultant or outside firm is not specifically licensed to perform leak tests on sealed sources in irrad-iators, ask the applicant to provide complete information about the leak-test method, measurement of the leak-test sample, and the name and qualifications of the individual who will perform the leak tests. Review the information to determine that the leak-test procedure is one of the acceptable methods, that the measurement will be quantita-tive, and that the individual who will perform the test has training and experience in performing it. If any of this information is not provided, ask the applicant to correct the deficiency by providing the information.
10.4 Ooerating and Emergency Procedures You should provide your personnel with written operating and emergency procedures, and you should state to the NRC that you will provide copies of the procedures to each person who uses the irradiator.
It is not necessary to 20
i submit the detailed operating and emergency procedures to the NRC.
- However,
{
you should list the topics covered in your procedures, and you should state that your procedures include instructions in the following topics:
1.
Use of personnel monitoring equipment.
All persorinel engaged in irradiator operations should wear their personal dosimeters while working around the irradiator.
2.
Irradiator startup and shutdown.
In the step-by-step procedures for these operations, clearly state the precautions to be taken before startup such as ensuring that the entry controls, alarms, and signals are in operating condition, that no one is in the irradiation room, that the survey meter is in operating condition, and that the product conveyor system, totes, and packages are in satisfactory condition.
3.
Performance of radiation surveys to ensure compliance with the provisions of paragraph 20.203(c)(6) of 10 CFR Part 20.
4.
Emergencies that can occur and actions to be taken.
Take into account any situation that can cause an emergency shutdown, such as a trip of the emergency system in the irradiation room, violation of any entry point
[.,
into the irradiation room, source jams, etc.
The individual responsible for U
the irradiator program must be notified of any emergency.
5.
Associated irradiator operations.
If personnel perform associated irradiator operations (for example, maintenance, leak-testing, instrument calibration), include appendices that contain the step-by-step procedures for performing the associated operations and the performance standards for these operations.
Reviewers The applicant need not submit the operating and emergency procedures provided to personnel.
Check the application for a commitment that each item specified for inclusion in the operating and emergency procedures will be covered in the procedures given to personnel.
If any of the specified items are not included in the commit.nent, inform the applicant of the deficiency and obtain the necessary commitment.
21
10.5 Hosoital Arrangements k
You should make arrangements in advance with a local hospital to accept an individual for treatment in the event of an accident or injury resulting from irradiator operation.
The hospital's acceptance is particularly impor-tant if an individual has received a radiation exposure.
Include a copy of the hospital's commitment to accept an individual for treatment.
A letter from the hospital's management is preferable.
Reviewers If this commitment is not included with the application, inform the applicant of the need for a written commitment from a local hospital in order to correct this deficiency.
Item 11 - WASTE MANAGEMENT Section 20.301 of 10 CFR Part 20 specifies the general requirements for disposal of licensed material, i.e., the sealed sources.
Because of the
~
nature of the licensed material contained in irradiators, your only option for
'/
disposal is to transfer the material to an authorized recipient as specified in paragraph 20.301(a).
You should state that disposal will be in accordance with paragraph 20.301(a) of 10 CFR Part 20.
Authorized recipients are the original supplier of the irradiator and source, a commercial firm licensed by the NRC or by an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material.
No one else is authori:ed to dispose of your licensed material.
Reviewers The major consideration is proper disposition of the sealed sources. The only allowable method for disposal is to transfer the sources to another licensee authorized to possess them.
If the applicant proposes to return the sources to the original supplier, no further check needs to be made.
The applicant must recognize that any person 22
to whom sources might be transferred needs to be specifi-cally licensed to possess the particular sealed sources.
There is no need for clarification so long as the appli-cant specifies transfer of the sealed sources to another specific licensee authorized to possess them.
If the application does not address disposal, ask the applicant to correct this deficiency by providing a commitment that any transfer of licensed material will be to a properly authorized specific licensee as specified in para-graph 20.301(a).
Item 12 - LICENSE FEES An application fee paid in full is required by paragraph 170.12(a) of 10 CFR Part 170 for most types of licenses, including applications for license amendments and renewals.
You should refer to S 170.31, " Schedule of Fees for Materials Licenses and Other Regulatory Services," of 10 CFR Part 170 to deter-mine the amount of the fee that must accompany your application.
Applications for which no fee is received may be returned to you.
All application fees may be charged irrespective of the NRC's disposition of your applicaticn or your withdrawal of the application.
Item 13 - CERTIFICATION If you are an individual applicant acting in a private capacity, you yourself are required to sign the form.
Otherwise, your application should be dated and signed by a representative of the corporation or legal entity who is authorized to sign official documents and to certify that the application contains information that is true and correct to the best of your knowledge and belief.
Unsigned applications will be returned for proper signature.
4.
AMENDMENTS TO A LICENSE Af ter you are issued a license, you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application, (2) the terms and conditions of the license, and (3) the Nuclear Regulatory Commission's regulations.
23
It is your obligation to keep your license current.
You should anticipate the need for a license amendment insofar as possible.
If any of the informa-tion provided in your application is to be modified or changed, submit an application for a license amendment.
In the meantime, you must comply with the terms and conditions of your license until it is actually amended; NRC regulations do not allow you to implement changes on the basis of a submission requesting an amendment to your license.
An application for a license amendment may be prepared either on the applica-tion form (NRC Form 313) or in letter form and should be submitted in duplicate to the address specified in this guide in Section 2, " Filing An Application."
Your application should identify your license by number and should clearly describe the exact nature of the changes, additions, or deletions.
References to previously submitted information and documents should be clear and specific and should identify the pertinent information by date, page, and paragraph.
For example, if you wish to change the " responsible individual," your applica-tion for a license amendment should specify the new individual's name, training, and experience.
The qualifications of the new individual should be equivalent to those specified in Item 7 of this guide.
You must send the appropriate fee for license amendment with your applica-
/
tion.
The NRC will not accept an application for filing or processing before the proper fee is paid in accordance with S 170.12 of 10 CFR Part 170.
Reviewers Review any application for a license amendment in accor-dance with the criteria for review of a new application.
Check to see that the information provided by the licensee includes all changes that need to be made in previously submitted documents.
If the licensee does not provide all the documentation needed, ask it to correct the defi-ciency by providing the appropriately amended documents.
5.
RENEWAL OF A LICENSE Licenses are issued for a period of up to 5 years.
You must send an application for renewal to the address specified in this guide in Section 2,
" Filing An Application." You may submit an entirely new application for renewal 24 n~-
l as if it were an application for a new license without referring to previously l
submitted information.
1 As an alternative, you may:
1.
Review your current license to determine whether the information concerning the sealed sources and the irradiator accurately represents your current and anticipated program.
Identify any additions, deletions, or other changes and then prepare information appropriate for the required additions or changes.
2.
Review the documents you have submitted in the past to determine whether the information in ther's is up to date and accurately represents your facilities, equipment, personnel, radiation safety precedures, locations of use, and so on.
The documents ycu consider to represent your current program should be identified by date.
Any out-of-date or superseded documents should also be identified, and changes should be made in the documents as necessary to reflect your current program.
3.
Review NRC regulations to ensure that any changes in the regulations are appropriately covered in your program description.
4.
If you have not made a commitment that a " responsible individual" V
who has the minimal training and experience outlined in Item 7 will be on duty and immediately available in the irradiator facility whenever the irradiator is in operation, include this cc=it.?.cnt in your application for license renewal.
5.
After you have completed your review, submit a letter to the NRC in duplicate, with the proper fee, requesting renewal of your license and providing the information specified in Items 1, 2, 3, and 4, as necessary.
6.
Include the name and telephone number of the person to be contacted about your renewal application and include your current mailing address if it is not indicated correctly on your license.
If you file your application for license renewal at least 30 days before the expiration date of your license and include the appropriate fee for license renewal, your license will automatically remain in effect until the NRC takes final action on your application.
However, if you file an application less than 30 days before the expiration date and the NRC cannot process it before that date, you would be without a valid license when your license expires.
25
It is important that the appropriate fee accompany your application for
(
In accordance with S 170.12 of 10 CFR Part 170, the NRC will not accept an application for filing or processing before the proper fee is paid.
If you do not wish to renew your license, you must dispose of all licensed radioactive material you possess in a manner authorized by 10 CFR Part 20.
Complete NRC Form 314, " Certificate of Disposition of Materials," and send it to the NRC before the expiration date of your license with a request that your license be terminated.
If you cannot dispose of all the licensed radioactive material in your possession before the expiration date, you must request a license renewal for storage only of the radioactive material.
The renewal is necessary to avoid violating NRC's regulations that do not allow you to possess licensable material without a valid license.
Reviewers The review of a renewal application should be straight-forward if the licensee has kept its license up to date.
Check the inspection history of the licensee to determine
'2 whether additional information on a particular aspect of the program is needed.
An application for a license re-newal should not be used as an occasion to solicit infor-mation from a licensee unless it it absolutely necessary.
The license renewal process should be carried out expedi-tiously.
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