ML20244D191

Draft Value/Impact Assessment of Reg Guide Fc 403-4, Guidelines for Preparation of Applications for Licenses for Use.... Proposed Reg Guide Should Be Issued

ML20244D191
Person / Time
Issue date:	01/31/1985
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
Shared Package
ML20101U760	List: ML20244D191
References
TASK-FC-403-4, TASK-RE REGGD-10.XXX, NUDOCS 8502080016
Download: ML20244D191 (16)

Text

• 1. 0FF}C OFNCLEAlfidG [.ATORY RESEARCH Anuary 1985 W.

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[ DRAFT REGULATORY GUIDE AND VALUE/ IMPACT STATEMENT Ta 3

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1. A.1 GUIDE FOR THE PREPARATION"0F APPLICATIONS FOR LICEtlSES. FOS.THE USE OF PANORAMICDRYf0VRCE SELF-CONTAINED WET 60VRCgSTORAGE IRRADIA STORAGE IRRADIATORS, AND C. PANORAMIC 50hR,QESTORAGEIRRADIATORS N;*; .

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'This regulatory guide and the associated value/ impact statement are being issued in draft form to involve the pubile in the early stages of the development of a regulatory positten in this area. They have not received complete staf f . review and do not represent an of ficial NRC staff pnsition.

Public comments are being solicited on both drafts, the guide (including any implementation schecule) and the value/ impact statement. Comments on the value/ impact statement should be accompanied by supporting Comments on both draf ts should be sent to the Secretary of the Commission, U.S. Nuclear Raouletory data.

Commission. Washington, D.C. 20555 Attention: Docketing and Service Branch, by April 1, 1985.

l-Requests f or single copies of draf t guides (which may be reproduced) or for placement on an automatic j distribution list for single copies of future draft guides in specific divisions should be made in iA l

writing to the U.S. Nuclear Regulatory Commission, washington, D.C. 20555. Attention: Director, Division of Technical Information and Document Control OGb 9 lb@28/h/W B

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. TABLE OF CONTENTS w

S ction Page

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . I 1.1 - Purpose of Guide . . . . . . . . . ... . . . . . . . . . . I 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 I - License Information . . ......... ...... 4 Item 2 - Name and Mailing Address of Applicant . ........ 4 Item 3 - Locations of Use. . . . . . . . . . . . . . . . . . . . 4 .

Item 4 - Person To Be Contacted About Application. . . . . . . . 4

.. Item 5 - Material To Be Possessed. . . . . . . . . . . . . . . . 5 Item 6 - Purpose for Which Licensed Material Will Be Used. . . . 5 Item 7 - Individuals Responsible for Radiation Safety ~

program--Their Training and Experience . . . . . . . . . 5 Item 8 - Training Provided to Other Users. . . . . . . . . . . . 7 Item 9 - Facilities and Equipment. ............... 7 9.1 - Basic Facility Design and Construction . . . . . 8 9.2 - Other Safety Considerations . . . . . . . . . . . 10 Item 10- Radiation Protection Program. ............. 11 10.1 - Personnel Monitoring Equipment . ........ 11 10.2 - Radiation Detection Instruments. . . . . . . . . 12 10.3 - Leak-Testing . . . . . . . . . . . . . . . . . . 13 10.4 - Operating and Emergency Procedures . . . . . . . 14 10.5 - Hospital Arrangements. . . . . . . . . . . . . . 15 Item 11- Waste Management. ................... 15 Item 12- License Fees. . . . . . . . . . . . . . . . . . . . . .

15 Item 13- Ce rti fication . . . . . . . . . . . . . . . . . . . . . 16

4. AMEN 0MENTS TO A LICENSE. . . . . . . . . . . . . . . . . . . . . 16

5. RENEWAL OF A LICENSE . . . . . . . . . . . . . . . . . . . . . . 17 Appendix A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Draft Value/ Impact Statement. .................... 21 L

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1. _ INTRODUCTION 1.3 PURPOSE OF GUIDE

• The purpose of this regulatory guide is to provide assistance to applican 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 source-storage irradiators.

This regulatory guide is intended to provide you, the applicant and licensee, with information that will enable you to understand specific reg tory requirements and licensing policies as they apply to gamma irradiators .

The information in this regulatory guide is not a substitute for training in radiation safety and for developing and implementing an effective radiation safety program. j After you are issued a license, you must conduct your program in accordanc 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.

1.2 APPLICABLE REGULATIONS I NRC regulations applicable to frradiators are in 10 CFF. Part 19 " Notices ,

Instructions and Reports to Workers; Inspections"; 10 CFR Part 20, " Standard for Protection Against Radiation"; 10 CFR Part 21, " Reporting of Defects and Noncompliance"; 10 CFR Part 30, "Ru k:

sI.G eeral Applicability to Domestic Licensing of Byproduct Material"; h Cik W. 71, " Packaging and Transportation of Radioactive Material"; and 10 CFR Part 170, " Fees for Facilities and Mate-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.

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3. CONTENTS OF AN APPLICATION i 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.

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.

The address specified here should be your mailing address for correspon-

~dence. .This may or may not be the same as the address at which the material.

will be used, as specified in Item 3.

Item 3 - LOCATIONS OF USE You should specify each locatf 7 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.

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. ,

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g 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 l 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 gecified above is available from the supplier of the irradiator.

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 l will be done in accordance with the Food and Drug Administration's regulatory requirements. ,

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Item 7 - INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM--THEIR TRAINING l AND EXPERIENCE 1

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Paragraph 30.33(a)(3) of 10 CFR Part 30 specifies that you must be qualified i 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 l l

before an application for a license is approved. l You need to include a commitment that, whenever the irradiator is in l operation, a " responsible individual" will be on duty and immediately available l 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

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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 (R50), 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 individual").

1. The name of each individual.

2. Specific dates each individual's training was. completed and where and

• - by whom the training was conducted. As a minimum, any " responsible individual" should have successfully completed a training course of approximately 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 materials.

'a 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.

3. Specific dates of each individual's actual experience.in irradiator As a minimum, each use, the type of irradiator usect, and its location.

"re:;ponsible individual" should have at least 3 months (full-time equivalent) of actual experience in the use of the same type irradiator specified in the The 3 months of application and in operations associated with irradiator use.

experience may include some preoperational involvement while the irradiator is being constructed if the individual works with the personnel of the firm p

constructing the,irradiator and learns about the irradiator, its safety systems, The actual experience in irradiator operations and how the irradiator functions.

af ter the irradiator goes into operation should be for a minimum of 4 weeks,.

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ps .- JItem 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 materials, (2) the use of radiation detection instruments, (3) your operating and emergency procedures, and (4) the design and operation of the irradiator.

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 o

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 al1 aspects of the training program.

2. Copies of the examination, the correct answers, the passing grade, i

and a discussion of additional instruction for individuals who are found to be deficient.

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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- t ing in the actual operation and use of the irradiator. The on-the-job training i 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 will be maintained for a period of 3 years.

' Item 9 - FACILITIES AND EQUIPMENT 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. I are adequate to protect health and minimize danger to life or property. There-I fore, you should provide information concerning your equipment and facilities.

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. '9.1 Basic Facility Design and Construction include a sketch or drawing of the irradiator facility and its surround-

~1ngs, 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 l

1/4 inch = 1 foot.

2. The type, thickness, and density of shielding materials on all sides, including the floor and roof.

3. The locations of entrances and other points of access into the a irradiator room and locations of control devices, alarms, and signals.

4. A description of the nature of the areas adjatant 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 _ vel 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 contro1' device that causes radiation to be reduced so that an individual could not receive a dose of more than 100 mrem in an hour.

• Prevent source operation if the resviting radiation level could result in a dose to an individual in excess of 100 mrem in an hour.

• Ensure that the entry control devices will not prevent an individual from leaving the area.

• Have additional control devices that will reduce the radiation level l

I in case the primary entry control devices fail so that an 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 une other individual aware of the attempted entry. .

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• Have' additional control' devices that will reduce the radiation level so that, if the shielding fatis, an individual will not receive a dose of more than 100 mrem in an hour. The devices must generate j visible and audible alarm signals. However, this requirement does not apply to irradiators with permanent structural components with no credible probability of failure. i

• Have devices that will automatically generate visible and audible-alarm signals to alert personnel before the source can be put into operation and that will allow an individual enough time to operate a control device to prevent source operation.

• Have administrative procedures and devices to ensure 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

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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.

In preparing the annotated sketch or drawing and the description of the con'.rol 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 shielded room where the sealed sources are located thould not exceed 2 milliroentgen pe; hour-when the sealed sources are exposed. The design must take into account potential

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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.

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

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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, 'I treatment, monitoring, and makeup systems.

b. The pool should be watertight.

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.

e. The pool should be equipped with a system capable of keeping the water clean; the level of conductivity should not exceed 10 microsiemens 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. (.

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h. A means should be provided to prevent the migration of pool water into municioal water supply systems.

2. If in-air irradiation is to be performed, the facility should have a ventilation system to keep ozone, nf trogen 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 concentra ions 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.

A 4 The irradiation room should be provided with an automatic fire extinguishing system.

5. Product carriers, packages, and totes should be designed and maintained so that they cannot interfere with the source holder or source elevating and lowering nechanisms.

b Item 10 - RADIATION PROTECTION PROGRAM You, as the licensee, are responsible for the conduct of the irradiator program and all actions of your employees.

10.1 Personnel Monitoring Eouiement

• Section 20.202 of 10 CFR Part 20 requires that personnel monitoring equipment be used by individuals entering restricted areas who receive or are I

1 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,

• Adopted by the American Conference of Governmental Industrial Hygienists (ACGIH), P.O. Box 1937, Cincinnati, Ohio 45201. The threshold limit values *

1. are reassessed and published annually by ACGIH; you should use the most recent edition of these values.

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or gonads; 18-2/', rems to the hands and forearms or feet and ankles; and

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. 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

,1 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.

. 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 I-instrumentation.

State that you will have available for use at all times a calibrated, operable survey meter that can measure up to I roentgen per hour. You do not need to name the manufacturer or the model number of the survey meter.

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 20*4 of thi actual values ever 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 number. If the perss, or firm is not a licensee, provide a copy of the procedure used for instrument calibration for, NRC review.

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p; Note: A person or firm in a non-Agreement State who uses radium for

g instrument calibration would not be an NRC licensee 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 inform.ation about survey instrument calibration, refer to ANSI N323-1978, " Radiation Protection Instrumentation Test and Calibration."*

10.3 Leak-Testing As'a licensee, you must perform such tests as the NRC deems appropriate

-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.

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

r. -source leak should be assumed and you should take steps to identify the specific q 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.

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.

• Copier may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018.

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' 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.

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.

- 10.4 Operating 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 It is not necessary to procedures to each. person who uses the irradiator. However, submit the detailed operating and emergency procedures to the NRC.

I 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 personnel 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 sta.te 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.

Take into Emergencies that can occur and actions to be taken.

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account any situation that can cause an emergency shutdown, such as a' trip of l^

the emergency system in the irradiation room, violation of any entry point The individual responsible for into the irradiation room, source jams, etc.

l- the irradiator program must be notified of any einergency.

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5. Associated irradiatcr operations. If personnel perform associated i frradiator 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.

10.5 Hospita1' Arrangements 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

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from the hospital's management is preferable.

Item 11 - WAST 6 MANAGEMENT Section 20.301 of 10 CFR Part 20 specifies the general requirements for disposal of licensed material, i.e., the sealed sources. Becausc 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 authorized to dispose of your licensed material.

' 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-E mine the amount of tne fee that must accompany your application. Applications 15 I

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All application fees may p

• for which no fee is received may be returned to you. ,t, be charged irrespective of the NRC's disposition of your application or your withdrawal of the application. i i

Item 13 - CERTIFICATION -

If you are an individual applicant acting in a private capacity, you Otherwise, your application should be yourself are required to sign the form.

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.

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4. AMENDMENTS TO A LICENSE After you are issued a license, you must conduct yourd program in your in accordan

.with (1) the statements, representations, and procedures containe application, (2) the terms and conditions of the license, and (3) the Nucle Regulatory Commission's regulations. You should anticipate It -is your obligation to keep your license current.

If any of the informa-the need for a license amendment insofar as possible.

tion provided in your application is to be modified or changed, submit an In the meantime, you must comply with application for a license amendment. NRC the terms 'and conditions of your license until it is actually amended; regulations do not allow you to implement changes on the basis of a su requesting an amendment to your 1.icense.

An application for a license amendment may be prepared either on th tion form (NRC Form 313) or in letter form and should be submitted " in dupl to the address specified in this guide in Section 2, " Filing An Application.

Your application should identify your license by number and References should clearl describe the exact nature of the changes, additions, or deletions. fic to previously submitted information and documents should be clear and and should identify the pertinent information by date, page, and paragraph.

For example, if you wish to change the " responsible individual," your ap for a license amendment should specify the new i:'dividual's name, traini experience.

The qualifications of the new individual should be equivalent to those specified in Item 7 of this guide. .

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