ML003739426

Draft Regulatory Guide DG-0003, Guide for the Preparation of Applications for Licenses for Non-Self Contained Irradiators

ML003739426
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Issue date:	01/31/1994
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U.S. NUCLEAR REGULATORY COMMISSION January 1994 OFFICE OF NUCLEAR REGULATORY RESEARCH Division 10 Task DG-0003 DRAFT REGULATORY GUIDE

Contact:

S. A. McGuire (301) 492-3757 DRAFT REGULATORY GUIDE DG-0003 GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSES FOR NON-SELF-CONTAINED IRRADIATORS This regulatory guide is being issued in draft form to involve the public in the early stages of the develop ment of a regulatory position in this area. It has not received complete staff review and does not represent an official NRC staff position.

Public comments are being solicited on the draft guide (including any implementation schedule) and ated regulatory analysis or value/impact statement. Comments should be accompanied by appropriate its associ supporting data. Written comments may be submitted to the Regulatory Publications Branch, DFIPS, Office of Administra tion, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Copies of comments received may be examined at the NRC Public Document Room, 2120 L Street NW., Washington, DC. Comments will be most helpful if received by October 1, 1994.

Requests for single copies of draft guides (which may be reproduced) or for placement on an automatic distri bution list for single copies of future draft guides in specific divisions should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Office of Administration, Distribution and Mail Services Section.

TABLE OF CONTENTS Section Page

1. INTRODUCTION ....... ..... ........................... I

2. FILING AN APPLICATION ...................... 2

3. CONTENTS OF AN APPLICATION ....... ................... 6 Item I License Information ............ 6 Item 2 Name and Mailing Address of Applicant . . . 6 Item 3 Address(es) Where Licensed Material Will Be Used or Possessed 6 Item 4 Name of Person To Be Contacted about this Application 7 Item 5 Radioactive Material . . . . . . . . . . . . . . . . .. 7 Item 6 Purpose(s) for Which Licensed Material Will be Used . . 8 Item 7 Individual(s) Responsible for Radiation Safety Program and their Training and Experience ........... 11 7.1 Radiation Safety Officer (RSO) .... ...........

7.2 Organizational Structure and Authorities and Responsibilities of Management .... ........... 13 Item 8 Training for Individuals Working in or Frequenting Restricted Areas ...... ................... 14 8.1 Initial Training for Irradiator Operators ..... 14 8.2 Safety Reviews for Operators ............. 16 8.3 Training for Other Individuals Who Must Respond to Alarms ...... . . 16 8.4 Training for Other Individuals Permitted Unescorted" Access to Restricted Areas .................. 17 Item 9 Facilities and Equipment ..... .............. 17 9.1 General Description of the Facility and Site ... ... 17 9.2 Access Control ....... .................... 18 9.3 Shielding . . . . . . . . . . . . . . . . . . . . . . 19 9.4 Fire Protection . . . . . . . . . . . . . . . . . . . 20 9.5 Radiation Monitors ...... ................... 21 9.6 Irradiator Pools ......... ................. 21 9.7 Source Rack Protection ..... ................. 22 9.8 Power Failures ....... ................... 22 Item 10 Radiation Safety Programs ........... 23 10.1 Operating and Emergency Procedures ......... 23 10.2 Inspection and Maintenance .... ........... 26 10.3 Radiation Detection Instrument Calibrations . 27 10.4 Pool Water Purity ............... 28 10.5 Loading and Unloading Sources ......... 29 10.6 Annual Review of Radiation Protection Program 30 10.7 Financial Assurance and Recordkeeping for Decommissioning ................ 30 iii

TABLE OF CONTENTS Section Page Item 11 Was- Management 31 Item 12 Licu a Fees 31 Item 13 Certification 32

4. AMENDMENTS TO A LICENSE 32

5. RENEWAL OF A LICENSE . . . 33

6. TERMINATION OF A LICENSE . 34

7. IMPLEMENTATION ........ 34 APPENDICES A. NRC Form 313 ........... ........................... A-1 B. Responsibilities of the Radiation Safety Officer ............ B-1 C. Incidents at Large Irradiators ...... .................. C-1 iv

1. INTRODUCTION PURPOSE OF THIS GUIDE This draft regulatory guide is being developed to provide guidance to applicants and licensees on preparing applications for new licenses, license amendments, and license renewals to possess radioactive material in non-self contained irradiators, specifically panoramic dry-source-storage irradiators (Category II), underwater irradiators (Category III), and panoramic wet source-storage irradiators (Category IV). This type of license is provided for in the Nuclear Regulatory Commission's (NRC's) regulations in Title 10, Chapter I, Code of Federal Regulations, Part 36, "Licenses and Radiation Safety Requirements for Irradiators."

This guide does not cover self-contained dry-source-storage irradiators (Category I). Applications for this type of irradiator are discussed in Revi sion I to Regulatory Guide 10.9, "Guide for the Preparation of Applications for Licenses for the Use of Self-Contained Dry Source-Storage Irradiators,"

December 1988.

This guide identifies the information needed to complete NRC Form 313 for applications for a license for a non-self-contained irradiator.

(NRC Form 313 is shown in Appendix A.) The guide is based on the new 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators," which became effective on July 1, 1993, and the revised 10 CFR Part 20, "Standards for Protection Against Radiation," which must be implemented no later than January 1, 1994. Even though the information provided in this guide does not consti tute regulatory requirements, applicants should address all the items on NRC Form 313 and should either follow the specific guidance in this guide or provide responses to the items adequate to assure safe operation of the irradiator and compliance with applicable regulations.

This regulatory guide is being issued in draft form to involve the public in the early stages of the development of this regulatory guide.

It has not received complete staff review and does not represent an official NRC staff position. Regulatory guides are issued to describe and make available to the public methods acceptable to the NRC staff for implementing specific parts of the Commission's regulations, to delineate techniques used by the staff in evaluating specific problems or postulated problems, or to provide guidance to applicants. Regulatory guides are not substitutes for regulations, and compliance with them is not required.

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After a license is issued, the lic ýsee must conduct its program in accordance with: (1) the statements, representations, and procedures con tained in the application and correspondence with NRC, (2) the terms and con ditions of the license, and (3) the NRC's regulations. Section 30.9 of 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," requires that the information provided in the application be com be plete and accurate in all material respects. Information is considered to the material if it is likely to change or affect an agency decision on issuing license.

The information collections discussed in this drift regulatory guide are covered by NRC Form 313, "Application for Material License," which was approved by the Office of Management and Budget, approval number 3150-0120.

APPLICABLE REGULATIONS 19, NRC regulations applicable to irradiator operations are 10 CFR Part "Notices, Instructions and Reports to Workers: Inspection and Investiga CFR tions"; 10 CFR Part 20, "Standards for Protection Against Radiation"; 10 of Part 21, "Renorting of Defects and Noncompliance"; 10 CFR Part 30, "Rules General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators";

CFR Part Part 71, "Packaging and Transportation of Radioactive Material"; 10 Other 170, "Fees for Facilities, Materials, Import and Export Licenses, and and 10 Regulatory Services Under the Atomic Energy Act of 1954, as Amended";

CFR Part 171, "Annual Fees for Reactor Operating Licenses, and Fuel Cycle Compli Licenses and Materials Licenses, Including Holders of Certificates of ance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC."

2. FILING AN APPLICATION WHERE TO FILE State To possess or use licensed material on Federal property or in any the subject to NRC jurisdiction, an applicant is to file an application with or NRC Regional Office for the State in which the material will be possessed used. The five Regional Offices and their respective areas for licensing purposes are given in Figure 1.

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NRC REGIONAL OFFICES REGION V REGION III

• Regional Office N Technical Training Center A Uranium Recovery Field Office

• Headquarters Note: Alaska and Hawaii are included in Region V.

Region Addres, Telephone I 475 Allendale Road, King of Prussia, PA 19406-1415 215-337-5000 II 101 Marietta St., Suite 2900, Atlanta, GA 30323 404-331-4503 III 799 Roosevelt Road, Glen Ellyn, IL 60137 IV 708-790-5500 611 Ryan Plaza Drive, Suite 400, Arlington, TX 76011-8064 817-860-8100 V 1450 Maria Lane, Walnut Creek, CA 94596 510-975-0200 Figure 1. NRC Regional Offices 3

Twenty-nine states, called Agreement States (see Figure 2), to date have entered into agreements with the NRC that give them the authority to license byproduct, source, or special nuclear materials used or possessed within their borders. A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional Offices or from the Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A non-Federal organization that wishes to possess or use licensed material in one of these Agreement States should contact the responsible officials in that State for guidance on pre paring an application; these applications should be filed with the State officials and not with the NRC.

HOW TO FILE To apply for an irradiator license, complete NRC Form 313, "Application for Material License" (shown in Appendix A to this guide). Complete Items 1 through 4 and 12 and 13 on the form itself. For Items 5 through 11, submit the information on supplementary pages. Each separate sheet or document sub mitted with the application should be identified and keyed to the item number on the application to which it refers.

Complete all items in the application in sufficient detail for the NRC to determine that equipment, facilities, training and experience, and radiation safety program are adequate to protect health and minimize danger to life and property.

All license applications will be available for review by the general public in NRC Public Document Rooms. Do not submit proprietary information unless it is absolutely necessary. If it is necessary to submit propriety informatior. follow the procedure in Section 2.790 of 10 CFR Part 2, "Rules of Practice fot Domestic Licensing Proceedings and Issuance of Orders." Failure to follow this procedure may result in disclosure of the proprietary informa tion to the public or substantial delays in processing the application.

Personal information about employees should not be submitted unless it is necessary. For example, the training and experience of employees should be submitted to demonstrate their ability to manage radiation safety programs or to work safely with radioactive materials. Home addresses, home telephone numbers, dates of birth, social security numbers, and radiation dose information should not be submitted unless specifically requested by NRC.

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July 1993 AGREEMENT STATE PROGRAM

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C-F CD

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a1 U 29 AGREEMENT STATES (approximately 15,000 licenses)

Dl 21 NON-AGREEMENT STATES (approximately 7,000 licenses)

All applications should be filed in duplicate. An additional copy should be retained for future reference.

3. CONTENTS OF AN APPLICATION This portion of the guide explains, item by item, the information requested on NRC Form 313. Some of the information requested may not be appropriate for all types of irradiators. For example, information on irradiator pools is not relevant to dry-source-storage irradiators, and some information on access control is not relevant to underwater irradiators. If the information requested is not relevant, write "not applicable" for that item. Any applicable sections of the regulations are noted in brackets by the appropriate item.

Item 1 - LICENSE INFORMATION For a new license, check box A. For an amendment to an existing license, check box B. For a renewal of an existing license, check box C. If box B or C is checked, enter the license number.

Item 2 - NAME AND MAILING ADDRESS OF APPLICANT The legal name of the corporation or other legal entity applying for the license should be provided. The address specified here should be the complete mailing address for correspondence and may contain a Post Office box number, a department name, a mailing code, or other information that will assist in getting mail to the applicant. This may or may not be the same as the address at which licensed material will be used, as specified in Item 3. In general, an "attention" line should be included in the address, but that line should specify a title rather than a particular person's name.

Item 3 - ADDRESS(ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED State the location of use, specifying the street address (including building name and other locating information, if appropriate), city, and State or other descriptive address (such as 5 miles east on Highway 10, Any Town, State) to allow the NRC to easily locate the irradiator. A Post Office box 6

address is not acceptable. If more than one irradiator will be authorized on one license, the application should specify the location of each irradiator.

Item 4 - NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION Provide the name of the individual who can answer questions about the application. The NRC will contact this individual if it has questions about the application. Include his or her telephone number. If the contact person changes, notify the NRC. Notification of a contact change is for information only and is not an application for a license amendment.

The individual named in Item 4 may or may not be the individual who signs the application in Item 13 on behalf of the applicant and who has the autho rity to make and back up commitments made to the NRC. Any commitments made by the applicant should be signed by the individual named in Item 13 since only that individual is considered by NRC to have the authority to make commitments on behalf of the applicant.

Item 5 - RADIOACTIVE MATERIAL For each type of radioactive material to be used, specify:

1. The radionuclide to be possessed (e.g., cobalt-60).

2. The manufacturer's name and specific model number of each sealed source in the irradiator.

3. The maximum amount of radioactive material in any one sealed source, which may be expressed in becquerels or curies. (The use of either becquerels or curies is permitted, but for consistency, only one type should be used throughout the application.)

4. The maximum amount of radioactive material to be possessed at any one time, which may be expressed in becquerels or curies, as noted above.

The maximum amount should include a margin to allow for source reloading and exchange.

5. The number of the certificate of registration issued under 10 CFR 32.210 by NRC or an Agreement State for each model of sealed source. If a model does not have a certificate of registration, the applicant or the source manufacturer must submit information on the source as required by 10 CFR 30.32(g) and 32.210.

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Discussion In general, the use of cesium-137 chloride is not acceptable in pool irradiators or dry-source-storage irradiators that load or unload sources under water at the irradiator because it does not meet the requirements of 10 CFR 36.21(a)(3). Cesium-137 chloride is generally acceptable for exclusively dry-use irradiators.

Item 6 - PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED Specify the purpose for which the irradiator will be used. An example of an adequate response for a panoramic irradiator is, "Irradiation of products or food. There will be no irradiation of explosives and no irradiation of more than small quantities of flammable materials with a flash point below 60 0 C (140°F) without specific written authorization from NRC."

Discussion Applicants should note that, in addition to NRC approval to operate an irradiator, they must follow the regulations of other Federal agencies that regulate the irradiation of medical products and food.

Prior written authorization from NRC is required by 10 CFR 36.69(b) before irradiation of more than small quantities of flammable materials with a flash point below 60°C (140°F). As defined in the National Fire Code NFPA 30, "Flammable and Combustible Liquids Code," published by the National Fire Pro tection Association, 1 the flash point is "the minimum temperature at which a liquid gives off vapor in sufficient concentration to form an ignitible mix ture with air near the surface of the liquid.... " According to the NFPA 30

.lassification system, Class I and Class II liquids have flash points below 50°C (140 0 F). The flash points of many substances are tabulated in National Fire Code NFPA 325M, "Fire Hazard Properties of Flammable Liquids, Gases, and Volatile Solids."' Flash points are also specified on the Material Safety Data Sheets for industrial chemicals, when applicable. Examples of common 0 0 flammable liquids with a flash point below 60 C (140 F) are acetone, benzene,

'Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9146, Quincy, MA 02269-9959 (telephone 1-800-344-3555).

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most alcohols, number two fuel oil, gasoline, kerosene, toluene, and turpentine.

If the flash point of a flammable liquid is exceeded, the concentration of the vapor in air can exceed the flammable limit and the potential for an explosion can exist. The NRC's concern with irradiating flammable liquids is the possibility of explosion more than the possibility of fire.

The NRC considers that compliance with the requirements in 10 CFR 36.21, 36.27, 36.35, 36.39(h), 36.41(h), and 36.53(b)(7) will provide adequate pro tection against radiological impacts arising from a fire. NRC's regulations in 10 CFR 36.27 require heat and smoke detectors in the radiation room that, if a fire is detected, will automatically cause the source to become fully shielded and will activate an alarm. Also, 10 CFR 36.27(b) requires a fire extinguishing system; 10 CFR 36.39(h) requires an evaluation of the design of the fire protection and extinguishing systems; 10 CFR 36.41(h) requires tests of the installed detection and extinguishing systems; 10 CFR 36.21 requires that the sources be built to withstand a temperature of 600°C (1112°F) for 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> followed by the thermal shock of being cooled to 20%C within 15 seconds; 10 CFR 36.35 requires a barrier to protect the source rack; and 10 CFR 36.53(b)(7) requires an emergency procedure for fires and explosions.

With these requirements, the NRC considers that a fire is likely to be controlled without presenting a threat to the integrity of the sources.

With an energetic explosion, however, it is necessary to consider the possibility of direct damage to the source encapsulation or to the source rack such that the rack could not be lowered to the shielded position.

Concerns for preventing an energetic explosion thus can be used to establish a definition for the term "small quantity" of flammable material as used in 10 CFR 36.69(b). A "small quantity" of flammable material can be defined as a quantity of flammable material that, when dispersed evenly throughout the radiation room with no loss to ventilation, would have a

concentration below the lower flammable limit concentration. Although local concentrations could exceed the average room concentration, the movement of air into and out of the radiation room provides a margin of safety that is not given credit in the definition of "small quantity." In addition, no credit is taken for the time required to vaporize all the material, which also adds to the margin of safety. Further, small pockets of flammable vapor will contain quantities of energy too small to provide a driving force sufficient to signi ficantly damage the irradiator. Because of these factors, the definition of 9

safe small quantity is considered to be sufficiently conservative to ensure operation of an irradiator.

is An example of determining a small quantity of flammable material isopropyl alcohol illustrated here. This example considers the irradiation of 3 states that the in a radiation room whose total volume is 100 m . NFPA 325M the specific lower flammable limit for isopropyl alcohol is 2% by volume, to that of air is gravity of the liquid is 0.8, and the vapor density relative 3 alcohol in 2.1. The density of air is 1.293 kg/n . The volume of isopropyl 3 which is equal to the room at the lower flammable limit will be 2% of 100 m ,

3 to air) =

2 i 3. The weight will be 2 m x 1.293 kg/m x 2.1 (density relative 3

liquid isopropyl 5.43 kg. With a specific gravity of 0.8, the volume of the 70% isopropyl alcohol would be 6.79 liters. If the liquid mixture were be 6.79/0.7 = 9.7 alcohol and 30% water, the volume of a small quantity would 3 , a volume less than liters. Thus, in a radiation room with a volume of 100 m radiation 9.7 liters of 70% pure isopropyl alcohol (exposed to the direct limit could not beam) can be considered a small quantity because the flammable no ventilation.

be reached over any significant volume even if there were material, If the applicant will irradiate small quantities of flammable that the above the licensee's records should be sufficient to demonstrate the licensee criterion for small quantities has been met, including how room at one time.

limited the quantity of flammable material in the radiation time would If the quantity to be exposed to the direct beam at any one the concentration exceed a small quantity, it is necessary to consider whether flammable limit. If of flammable vapor in the room air could exceed the lower radiation sources product movement through the irradiator stopped and the of the irradi could not be returned to the shielded position, the temperature material would ated product would rise, the vapor pressure of the flammable leak and release increase, and that pressure might cause the containers to insufficient, the flammable vapor into the room air. If ventilation were limit and a flammable vapor concentration might exceed the lower flammable spark could cause the mixture to explode.

quantities In order to obtain NRC approval to irradiate more than small it is unlikely that of flammable material, the applicant must demonstrate that volume of the the concentration of flammable vapor in air in a significant two methods to do room would exceed the lower flammable limit. There are would be this. The first method is to demonstrate that no single failure radiation room and likely to cause the product to become immobilized in the position. Such a prevent the sources from being returned to the shielded 10

situation theoretically might arise if the product carriers became jammed and pushed into the source rack preventing its return to the shielded position.

The second method is to demonstrate that even if the product became immo bilized and the source rack could not be returned to the shielded position, the ventilation system would be adequate to prevent the concentration of flam mable vapor in a significant volume of the room air from reaching the lower flammable limit.

If an applicant is applying for authorization to irradiate more than a small quantity of flammable material, the application should include the name of the flammable material that has a flash point below 60°C (140 0 F), its flash point, its flammable limit as percent by volume in air, its specific gravity as a liquid, its vapor density relative to that of air, the maximum quantity to be in the direct radiation beam in the radiation room at any one time, and a description of the packaging for the product.

In addition, the application should either (1) describe why a single failure is unlikely to cause immobilization of the product being irradiated with the simultaneous inability to return the sources to the shielded position or (2) describe why the ventilation system will prevent the concentration of vapor in air from exceeding the lower flammable limit in a significant volume of the room if the product is immobilized and the sources cannot be returned to the shielded position. If this second approach is taken, the applicant should also provide a procedure to return the source to the shielded position and remove the product from the radiation room if the ventilation system fails. The procedure should also identify the means to detect ventilation system failure.

Item 7 - INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE 7.1 Radiation Safety Officer (RSO) [10 CFR 30.33(a)(3) and 36.13(d)]

Specify the name, training, and experience of the individual who will be responsible for the radiation safety program (the RSO).

An individual may be designated as an alternate RSO. If an alternate RSO is designated, specify the name, training, and experience of that person. If an alternate RSO is designated, describe how any confusion will be avoided about which of these individuals has ultimate responsibility for the radiation protection program. Even if there is an alternate RSO, the designated RSO 11

remains ultimately responsible for the day-to-day operation of the radiation program.

If an RSO is to be replaced, the name, training, and experience of the new F should be submitted to NRC in a license amendment before the new individual assumes the position. If the replacement is sudden, the NRC Regional Office should be contacted with the information as soon as it is known that the RSO will be changed. While the amendment request is being reviewed by NRC, the proposed RSO may assume the responsibilities of the RSO position.

Describe the provisions for contacting the RSO in case a problem needing is the attention of the RSO arises while he or she is not at the facility or not in the area.

Discussion If the RSO has had neither previous formal training in health physics nor complete certification by the American Board of Health Physics, the RSO should has a radiation safety course. Training consisting of approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> typically been considered acceptable by the NRC staff when the training covers interac the following topics: (1) radioactivity and radioactive decay, (2) radi tions of radiation with matter, (3) biological effects of radiation, (4) dosime ation detection using radiation detection instruments and personnel ters, (5) basic radiation protection principles and good safety practices regu (including time, distance, and shielding), and (6) radiation protection the lations. The course should include a written test or evaluation of individual's comprehension of these topics.

In addition to the above general course, if the RSO has not had prior equiva experience working at an irradiator, he or she should have spent the lent of at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in self-study or directed study on information directly applicable to radiation safety at irradiators, including applicable safety regulations (10 CFR Parts 20 and 36) and reports or studies describing events, problems at irradiators. Information on irradiator accidents, unusual and violations of NRC regulations can be found in the NRC report NUREG-1345, Jr., March "Review of Events at Large Pool-type Irradiators," E. A. Trager, 12

1989.2 There should be an evaluation of the individual's comprehension of this information. The license application should list the documents studied or to be studied in the description of the training of the proposed RSO and should describe how the applicant will evaluate the individual's comprehension of the information studied.

The RSO should have at least 3 months (full-time equivalent) of experience at the applicant's irradiator or at another irradiator of a similar type. The 3 months of experience may include preoperational involvement, such as acceptance testing, while the irradiator is being constructed.

7.2 Organizational Structure and Authorities and Responsibilities of Management (10 CFR 30.33(a)(3) and 36.13(d)]

Describe the organizational structure for managing the irradiator, speci fically the radiation safety responsibilities and authorities of the RSO and those other management personnel who have important radiation safety respon sibilities and authorities. In particular, the application should describe who has the authority to stop unsafe operations. Appendix B provides a list of the RSO's responsibilities that is acceptable to the NRC staff; applicants may incorporate this list in their applications.

Discussion The RSO should have independent authority to stop operations that he or she considers unsafe and to conduct tests or measurements considered to be necessary. The RSO should be relatively independent of production responsi bilities, to the extent practical, considering the size of the staff at the irradiator. The RSO should report directly to the irradiator manager. The RSO should have sufficient time and commitment from management to fulfill the responsibilities listed in Appendix B.

2Copies of NUREG-1345 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082 (telephone (202)512-2249). Copies are also available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161.

A copy is also available for inspection and copying for a fee in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

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Item 8 - TRAINING FOR INDIVIDUALS WORKING IN OR FREOUENTING RESTRICTED AREAS 8.1 Initial Training for Irradiator Operators [10 CFR 19.12, 36.13(b),

and 36.51]

Describe the training provided to individuals to qualify them to be irradiator operators, including:

(1) Classroom training; (2) On-the-job or simulator training; (3) Means employed by the applicant to test each individual's under standing of the Commission's regulations and licensing requirements and the irradiator operating and emergency procedures, and (4) Minimum training and experience of personnel who may provide training.

Discussion The training required to qualify an individual to be an irradiator operator is described in 10 CFR 36.51. The training described in 10 CFR 36.51(a) 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 for panoramic irradiators and approximately 20 to 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> for underwater irradiators. Up to 50% of that time may be self-study or reading time instead of classroom lecture time.

The written test described in 10 CFR 36.51(b) should cover the range of topics addressed in the training. The on-the-job training described in 10 CFR 36.51(c) should be under the supervision of an experienced operator and should last at least I month full-time (170 hours0.00197 days <br />0.0472 hours <br />2.810847e-4 weeks <br />6.4685e-5 months <br />). If an approved operator does not operate the irradiator for more than a year, his or her performance during operation should (1) be audited for at least a day before he or she is per mitted to operate the irradiator independently and (2) receive a safety review as described in 10 CFR 36.51(d).

The requirements in 10 CFR 36.51(a), (b), and (c) are those required for an individual to become qualified initially as an irradiator operator. They do not apply to individuals qualified to be operators before July 1, 1993, the effective date of 10 CFR Part 36. The safety review and evaluation requirements of 10 CFR 36.51(d) and (e), however, apply to all operators.

Current licensees should conduct a safety review to discuss the new Part 36 14

regulations and any changes in procedures that have occurred as a result, and conduct a safety review annually thereafter.

The subjects, required by 10 CFR 36.51, that individuals must be trained in to become an irradiator operator are:

(1) The fundamentals of radiation protection as they apply to irradiators. The goal here is to provide the individual with the necessary foundation to perform his or her task safely and to help the individual worker understand the basis for the safety requirements and procedures that will be taught.

(2) The requirements of Parts 19 and 36 of NRC regulations. The operator is not expected to be an expert on NRC regulations or to be able to determine whether a given procedure is adequate to meet NRC regulations. Instead, operators should be instructed on NRC requirements that are directly applicable to their responsibilities.

(3) The operation of the irradiator. The objective is to help the person understand the operating and emergency procedures, not to make the individual an engineer.

(4) Licensee operating and emergency procedures that the individual will perform. This is the most important part of the training because the safe operation of the irradiator depends on these procedures being followed cor rectly. The objective is that the operator is able to correctly perform the procedures that he or she will be expected to perform. The training does not have to include procedures that the individual will not perform. For example, if the individual will not perform leak tests, the individual need not be trained in the procedure.

(5) Case histories of accidents and problems involving irradiators. The individual should be taught about situations that could lead to trouble.

Instruction material on accidents is often difficult to obtain. However, NUREG-1345, "Review of Events at Large Pool-Type Irradiators," should provide some relevant information. Also, descriptions of events from NRC information notices on irradiators, which are reproduced in Appendix C to this guide, can be used as a source of information. Other sources of information should also be sought.

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8.2 Safety Reviews for Operators [10 CFR 36.51(d)]

Describe the safety reviews that will be provided to operators to meet the requirements of 10 CFR 36.51(d). Describe who will conduct these reviews and their training and experience. Describe how drills will be conducted.

Discussion The safety reviews described in 10 CFR 36.51(d) should be about 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per year for panoramic wet-source-storage irradiators and 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> per year for dry-source-storage and underwater irradiators. Safety reviews may be con ducted once per year or throughout the year on an as-necessary (or an as appropriate basis), as long as the time spent totals 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> or more per year.

The regulation requires that each operator have a brief written test on the information presented. The word "inspections" in 10 CFR 36.51(d)(4) means the "evaluations" performed under 10 CFR 36.51(e).

The "drill" in 10 CFR 36.51(d)(6) means actually going through a proce dure using the actual equipment in as realistic a manner as practical, but not necessarily with total realism if that would be difficult. For example, for a drill on the response to a fire alarm it is not necessary that the alarm actually sound if sounding the alarm would be difficult or disruptive. The operator could be told that the alarm had sounded and asked to do what he would do in that situation. In a drill it is also acceptable to correct errors as they occur rather than waiting until the drill is over. Not all operators must be put through the drill. It is acceptable to have one opera tor go through the drill and have other operators either watch the drill or be asked to critique or comment on the actions as they occur.

If a senior operator (who might also serve as the RSO, for example) con ducts the safety reviews for other operators and prepares the written test for other operators, the preparation of the test and its answers may be considered demonstration that the testing requirement in 10 CFR 36.51(d) has been met by the senior operator.

8.3 Training for Other Individuals Who Must Respond to Alarms

[10 CFR 19.12 and 36.51(g)]

Describe the training and testing to be given to employees other than irradiator operators who must be prepared to respond to alarms as described in 16

10 CFR 36.51(g). Describe the annual refresher training. Identify who (by category of worker) will be given the training.

If the individuals who will respond to alarms are not facility employees (for example, a local fire department), describe any training or orientation that will be offered. (Testing of nonemployees is not expected.)

Discussion The training and testing should be sufficient to determine that the person knows what to do in case of an alarm. The preferred type of testing is a drill in which the person being tested responds to an alarm while being observed by an evaluator. Drills should be repeated until the evaluator is satisfied with the response. After initial training, there should be annual refresher training and testing.

8.4 Training for Other Individuals Permitted Unescorted Access to Restricted Areas [10 CFR 19.12]

According to 10 CFR 19.12, all individuals who work in or frequent restricted areas must receive appropriate instruction on radiation safety.

Describe the training to be provided to meet this requirement.

Item 9 - FACILITIES AND EOUIPMENT 9.1 General Description of the Facility and Site [10 CFR 30.33(a)(2) and 36.13(e), and 36.39(j)]

Describe the irradiator (in general, not duplicating more detailed information provided in other sections). Include diagrams, sketches, and photographs, as appropriate, to show locations of safety-related equipment and features mentioned in Part 36. In addition, sketch and describe the uses of property adjacent to the facility. Provide a schedule for constructing the irradiator in case the NRC wants to schedule an inspection of the construction.

Special seismic requirements are contained in 10 CFR 36.39(j) for irradiators located in seismic areas. For a license application to operate a panoramic irradiator whose construction will start after July 1, 1993, discuss whether the facility is in a seismic area as defined in 10 CFR 36.2.

17

Discussion U.S.

Maps of the United States showing seismic areas are published by the Estimates of Geological Survey (see S. T. Algermissen et al., "Probabilistic 3)

Maximum Acceleration and Velocity in Rock in the Contiguous United States."

[10 CFR 36.13(e), 36.23, 36.31(a), 36.39(g), and 9.2 Access Control 36.41(g)]

respect to the Describe the access control system and how it works with as appropriate.

requirements of 10 CFR 36.23. Include drawings or sketches who will be made For panoramic irradiators, describe the alarm systems and controlling source aware of alarms. Describe the lock and key system for 10 CFR 36.31(a).

movement and discuss how it meets the requirements of to allow the It is important for the description to be in enough detail access control system NRC license reviewer to determine that the design of the An acceptable way is adequate to meet all the requirements of 10 CFR 36.23.

or paragraph-by to do this is to quote the section, sentence-by-sentence paragraph, and provide the relevant description underneath.

Discussion barrier The requirement in 10 CFR 36.23 for a door or other physical irradiator, applies to each entrance of the radiation room of a panoramic for product entrance whether intended for personnel access or intended solely could meet the require or exit. Panoramic irradiators with a conveyor system carriers that a ment by providing such small clearances around the product would require person could not squeeze through or by using barriers that be considered a unusual exertion to bypass. A photoelectric system cannot must prevent physical barrier. The requirement is that the door or barrier a deliberate or deter inadvertent entry by a person, not that it need prevent requirement is to mined effort to bypass the barrier. The purpose of this 3 United States Department of the Interior, Geological Survey, Open-File Report U.S. Geologi 82-1033, 1982. This report may be purchased for $24.50 from:

Colorado 80224.

cal Survey, Books and Report Sales, Box 25425, Denver, possible as new Prepayment is required. Minor updates of this report are information becomes available.

18

prevent someone from carelessly, inattentively, or accidentally entering the radiation room while the source is exposed.

This section also requires an independent backup access control system on panoramic irradiators. The purpose of the backup system is to provide a redundant means of preventing a person from being accidentally exposed to the source. In case of a failure of the interlocks on the door or barrier com bined with a failure to follow operating procedures, the backup system should warn the person entering the radiation room of the danger and automatically cause the sources to return to their shielded position.

The backup system could use photoelectric cells in an entrance maze, pressure mats on the floor, or similar means to detect a person entering the radiation room while the source is exposed. The system must also alert another person of the entry.

That person must be prepared to render or summon assistance.

According to 10 CFR 3 6.23(g), the radiation room of a panoramic irradia tor must be posted as a "high radiation area." However, 10 CFR 2 0 .1902(c) requires that the area be posted as a "very high radiation area." There has been an oversight in not adopting in 10 CFR Part 36 the new "very high radia tion area" concept that is contained in 10 CFR Part

20. The NRC plans to change 10 CFR 36.23(g) to require posting as a "very high radiation area." In the meantime, the preferred posting is "very high radiation area," and irradi ators posted in this manner will not be subject to enforcement action under 10 CFR 36.23(g).

9.3 Shielding [10 CFR 36.25, 36.39(a), 36.39(j), and 36.41(a)]

For panoramic irradiators, describe the shielding to be used and its composition. A diagram should show the configuration of shielding walls and indicate the thickness of each. Penetrations in the shield wall should be indicated. If any accessible areas outside the shield are expected to have a dose rate exceeding 0.02 millisievert (2 millirems) per hour, identify the areas and tell how access to those areas will be controlled.

Explain how compliance with the 100 mrem/year dose limit for the public in 10 CFR 20.1301(a)(1) will be achieved. For panoramic irradiators whose construction will start after July 1, 1993, identify building code requirements to which shielding walls will be built and inspections of the construction that will be performed by local authorities. For requests to possess more than 2 x 1017 becquerels (5,000,000 curies) in a panoramic irradiator, describe how cooling of the shielding walls will be accomplished (see 10 CFR 36.39(a)). If the 19

applicable" for this irraciator is an underwater irradiator, state "Not section.

Discussion integrity in the The intent of Part 36 is that shield walls retain their designed to meet the seismif event of an earthquake by requiring that they be sources. For irra requirements of local building codes or other appropriate 1993, and that are not located diators whose construction starts after July 1, it is acceptable that shielding in seismic areas (as defined in 10 CFR 36.2),

for reinforced concrete, meet generally accepted building code requirements ACI 318-89, "Building Code for example, American Concrete Institute Standard Concrete.4 Requirements for Reinforced to specify requirements In seismic areas, local building codes are likely how to tie reinforcing bars for such things as spacing of reinforcing bars, bars, and requirements for together, preferred arrangements for reinforcing building codes do not con joining reinforcing bars to floor slabs. If local could include Chapter tain seismic requirements, "other appropriate sources" of the American Concrete Insti 21, "Special Provisions for Seismic Design,"

for Reinforced tute Standard ACI 318-89, "Building Code Requirements Concrete."

9.4 Fire Protection [10 CFR 36.27, 36.39(h), and 36.41(h)]

location of the heat and For panoramic irradiators, describe the type and radiation room. Use dia smoke detectors to be used to detect a fire in the smoke detectors should be grams and sketches, as appropriate. (The heat and necessarily have to be located able to promptly detect a fire, but they do not to alert personnel capable of within the radiation room.) Describe the alarms will automatically become summoning assistance. Describe how the sources how the heat and smoke detectors fully shielded if fire is detected. Describe will be tested.

write "Not applicable" If the irradiator is an underwater irradiator, requirements for underwater because 10 CFR 36.27 contains no fire protection 4This standard is available for purchase from the American Concrete Institute, 48219.

Box 19150, Redford Station, Detroit, Michigan 20

irradiators, since the sources are always underwater and not subject to damage by fire.

For panoramic irradiators, describe the fire extinguishing system that is capable of extinguishing the fire without personnel entering the room.

Describe how flooding into unrestricted areas will be avoided. Identify the location of shut-off valves. If the fire detection or extinguishing systems are built to meet fire protection codes, those codes should be identified.

Describe the acceptance testing of the systems.

Irradiator applicants who wish to apply for an exemption from the requirement for a fire suppression system should provide the following infor mation: (1) the maximum quantity of combustible materials that may be in the room, (2) the procedures used to ensure that the maximum quantity of combusti ble materials will not be exceeded, (3) the reasons a fire will not prevent the sources from returning to the shielded position, and (4) evidence of approval by local fire officials. This exemption is likely to be more appro priate for research facilities, rather than large commercial irradiation facilities that may have large volumes of cardboard boxes as well as other combustible materials.

9.5 Radiation Monitors [10 CFR 36.23(c), 36.29, 36.39(e), 36.41(e), and 36.59(b)]

Describe the location and type of monitors used to meet the requirements of 10 CFR 36.23(c), 36.29, and 36.59(b). Describe the location and types of alarms and who will be alerted by the alarms. Use diagrams and sketches, as appropriate. Discuss the alarm set-points or the methods for establishing the alarm set-points. In general, G-M detectors are considered to have adequate sensitivity. For irradiators whose construction begins after July 1, 1993, describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and sensitivity and the acceptance testing that will be performed to meet 10 CFR 36.41(e).

9.6 Irradiator Pools [10 CFR 36.33, 36.39(c), and 36.41(c)]

Describe the pool lining. For irradiators without a stainless steel liner that were initially licensed after July 1, 1993, explain why the pool has a low likelihood of substantial leakage and how decontamination could be 21

accomplished if necessary. For irradiators first licensed prior to July 1, 1993, write "Not applicable."

Describe the high and low water-level indicators and their locations.

Describe the purification system for the pool; explain why the purification system is considered capable of maintaining pool water conductivity less than 20 microsiemens per centimeter. Describe the means to replenish pool water.

Describe the barrier used during normal operation to prevent personnel from falling into the pool. Describe how high radiation doses from radiation streaming will be avoided when using long-handled tools or poles. Use sketches if appropriate.

For irradiators first licensed after July 1, 1993, if the pool has outlets more than 0.5 meters below the surface that could allow water to drain out of the pool, describe the means of preventing inadvertent excessive loss of pool water. (Outlets in this context do not include transfer tubes between adjacent pools because the transfer tubes do not provide a means to allow water to drain out of the pools.)

For irradiators whose construction started after July 1, 1993, describe how the pool design ensures its integrity as required by 10 CFR 36.39(c),

how the design of the water purification system is adequate, and how the inspections and tests to be done meet the requirements of 10 CFR 36.41(c) and (d).

9.7 Source Rack Protection [10 CFR 36.35]

If the product moves on a product conveyer system, describe the source rack protection to be provided to prevent products and product carriers from hitting or touching the source rack or mechanism that moves the rack. Provide diagrams or sketches if appropriate.

9.8 Power Failures [10 CFR 36.37, 36.39(i), and 36.41(i)]

For panoramic irradiators, describe how the source rack will be lowered if offsite power is lost for longer than 10 seconds. Describe how loss of power will affect the lock on the doors in the radiation room for a panoramic irradiator. For irradiators whose construction begins after July 1, 1993, to meet 10 CFR 36.39(i), describe the automatic return of the source rack to the fully shielded position in the event of a power failure, and describe the testing of that function to meet 10 CFR 36.41(i).

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Item 10 - RADIATION SAFETY PROGRAM 10.1 Operating and Emergency Procedures [10 CFR 36.13(c) and 36.53]

An applicant may submit an outline or summary of its written operating and emergency procedures. This outline should allow licensees the flexibility to change procedures in ways that do not affect safety without the need for a license amendment.

The outlines or summaries of the written operating and emergency proce dures should have enough detail to allow the NRC license reviewer to determine that following the steps outlined will ensure compliance with NRC regulations.

10.1.1 Operating Procedures As described in 10 CFR 36.53, operating procedures are required for the following topics:

1. Operation of the irradiator, including entering and leaving the radiation room. The description should be in enough detail to show how com pliance with 10 CFR 36.67, "Entering and Leaving the Radiation Room," will be achieved and should include a description of the initial entry and survey after an irradiation. Describe how access to keys by individuals who have not been qualified to be operators will be prevented, as required by 10 CFR 36.31(a). At a panoramic irradiator when product movement is occurring, 10 CFR 36.65 requires the presence of an irradiator operator and another person who is trained on how to respond and prepared to render or summon assistance if the access alarm sounds. For static irradiations, a person who is trained to respond to alarms must be onsite. In 10 CFR 36.65, the term "onsite" is intended to give flexibility to licensees. For example, for a research irradiator at a university, the onsite person could be a guard located on campus but not in the building containing the irradiator provided the guard would hear the alarm and was trained as required by 10 CFR 36.51(g).

The guard would not have to be trained as an irradiator operator.

2. Use of personnel dosimeters. The description should include the categories of personnel who must wear dosimeters; the locations in the facil ity they must be worn; and how the requirements of 10 CFR 36.55, "Personnel Monitoring," will be met. The use of personnel dosimeters should begin before opening shipping casks containing sources.

23

3. Surveying the shielding of panoramic irradiators. The description should include how the surveys required by 10 CFR 36.57(a) will be done, including the types of instruments to be used. The initial survey should be considerably more thorough than subsequent surveys and should be performed by a well-qualified individual, such as the radiation safety officer or a health physics consultant. The initial survey should emphasize accessible areas, especially frequently occupied areas, areas around penetrations, and entrances to the radiation room, but should also include some locations not easily accessible. If the measured radiation dose rates are not distinguishable from normal background, the survey may indicate "background," rather than a numeri cal value. (Because of statistical fluctuations in the dose rate, the survey meter readings will fluctuate. Establish a range of dose rates to represent the natural background radiation dose rate. Readings within the range may be entered as background on survey records.) Describe the actions to be taken if radiation levels exceed the limits specified in 10 CFR 36.25.

4. Monitoring pool water for contamination before the pool water is released to unrestricted areas. The description should include the types of instruments to be used, their estimated sensitivities, methods and frequency of calibration, and how the requirements of 10 CFR 36.59(b) will be met. In addition, this procedure or another procedure should describe the surveys of other potentially contaminated liquids, sediments from pool vacuuming, and

-esins whose monitoring is required by 10 CFR 36.57(d) or (e). In general, the sensitivity required can be obtained with a thin-window G-M probe; sodium iodide detectors are generally not necessary. If water from the irradiator pool or resins is monitored in a low background area (less than 0.5 micro sievert or 0.05 millirem per hour) and no radiation above background is mea sured, the material may be considered nonradioactive and released without restriction. For this item, write "Not applicable" for dry-source-storage irradiators.

5. Leak testinq of sources. If the applicant will perform its own leak testing for dry-source-storage irradiators, describe the leak testing proce dure, including (1) the instruments to be used and their calibration method and frequency, (2) the methods of performing the analyses, and (3) the perti nent training of the individual who analyzes the samples. Describe how the sample will be collected and analyzed. The wipe should be taken on the acces sible surface closest to the source, not wiping the source itself. The value 24

of 200 becquerels (0.005 microcurie) applies to each source individually and is an action level that means that the contamination should be investigated, not that there necessarily is a leaking source. In general, the sensitivity required can be obtained with a thin-window G-M probe; sodium iodide detectors are generally not necessary.

If the licensee will not perform the leak testing, identify who will perform the leak test and either provide their license number or provide the procedures they will use.

This procedure applies to dry-source-storage irradiators only; for pool irradiators write "Not applicable."

6. Inspection and maintenance checks required by 10 CFR 36.61. Do not describe the inspection and maintenance procedures here. Instead, describe these procedures under Item 10.2 below.

7. Loading. unloading, and repositioning sources (if the operations will be performed by the licensee). All radiation safety aspects should be described, including contamination surveys of the shipping cask, radiation monitoring during operations, and recording the location of each individual source placed in the source rack. If the loading, unloading, or repositioning will not be performed by the licensee, identify who will perform these services.

8. Inspection of movable shielding required by 10 CFR 36.23(h), if applicable.

10.1.2 Emergency or Abnormal Event Procedures The emergency and abnormal event procedures listed below should include who will be notified of the event, whether NRC will be notified, the role of the RSO, and what records of the event will be kept. The procedures should include the initial actions to be taken immediately after discovering the emergency or abnormal event. The procedures generally should not include postemergency corrective actions and repairs, since there will be time to carefully consider such actions on a case-by-case basis after the situation is under control. Describe procedures for each of the following.

1. Sources stuck in the unshielded position.

25

2. Personnel overexposures.

3. A radiation alarm from the product exit portal monitor or pool monitor.

4. Detection of leaking sources, pool contamination, or an alarm caused by contamination of pool water. The description should include who will be notified and how the requirements of 10 CFR 36.59(c) will be met.

5. A low or high water-level indication, an abnormal water loss, or leakage from the source storage pool. (The procedure should address all three of these conditions, but should generally include only the initial emergency response, not subsequent actions or postemergency repairs.)

6. A prolonged loss of electrical power (more than 10 seconds). Be sure to include entry procedures.

7. A fire alarm or explosion in the radiation room.

8. An alarm indicating unauthorized entry into the radiation room, area around the pool, or another alarmed area.

9. Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility.

10. Jamming of the automatic conveyor systems.

10.2 Inspection and Maintenance [10 CFR 36.13(h), 36.53(a)(6), and 36.61]

Describe the inspection and maintenance checks required by 10 CFR 36.61, including the frequency of the checks. The required checks are:

1. Operability of each aspect of the access control system required by 10 CFR 36.23.

26

2. Functioning of the source position indicator as required by 10 CFR 36.31(b).

3. Operability of the radiation monitor for radioactive contamination in pool water required by 10 CFR 36.59(b), using a radiation check source, if applicable.

4. Operability of the over-pool radiation monitor at underwater irradiators as required by 10 CFR 36.29(b).

5. Operability of the product exit monitor required by 10 CFR 36.29(a).

6. Operability of the emergency source return control required by 10 CFR 36.31(c).

7. Leak-tightness of systems through which pool water circulates

- (visual inspection).

8. Operability of the heat and smoke detectors and extinguisher system required by 10 CFR 36.27 (but without turning extinguishers on).

9. Operability of the means of pool water replenishment required by 10 CFR 36.33(c).

10. Operability of the indicators of high and low pool-water levels required by 10 CFR 36.33(d).

11. Operability of the intrusion alarm required by 10 CFR 36.23(i), if applicable.

12. Functioning and wear of the system, mechanisms, and cables used to raise and lower sources.

13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 10 CFR 36.35.

14. Amount of water added to the pool to determine whether the pool is leaking.

15. Electrical wiring on required safety systems for radiation damage.

16. Pool water conductivity measurements as required by 10 CFR 36.63.

10.3 Radiation Detection Instrument Calibrations [10 CFR 36.55(b), and 36.57(c)]

Specify how survey instruments and pocket dosimeters (if used) will be calibrated or provide the name, address, and the NRC or Agreement State license number of the organization that will provide the service (and that is licensed to perform this activity.)

27

Discussion It may be that a calibration service company does not have a license, perhaps because it is located in a non-Agreement State and uses radium, a radioactive material not regulated by the NRC. It is also possible that a service company has a license, but the license does not specifically authorize it to provide instrument calibration services to other licensees. In these cases, submit a description of the radioactive sources and the procedures used by the company for calibrating survey instruments.

Applicants who plan to calibrate their own radiation survey instruments manu should describe the radiation source to be used (radionuclide, activity, facturer, and model number) and the written procedures for calibrating the survey instruments. The training and experience of the individual who will calibrate the instruments should also be described. As a minimum, the written procedures should specify that:

1. Calibration will be performed at least annually with radionuclide sources at distances sufficient to approximate point sources.

2. Survey instruments will be calibrated at two points on each scale or range that the instrument offers or one point per decade for digital instru ments, up to 0.01 sievert (1 rem) per hour. (Calibration is likely to require at least the following activities of typical radionuclide sources: 3000 gigabecquerels (80 millicuries) of cesium-137, 700 gigabecquerels (20 milli curies) of cobalt-60, or 1000 gigabecquerels (30 millicuries) of radium-226.)

3. Survey instruments will be adjusted to provide readings on all calibrated scales or ranges within 20% of true value.

If pocket dosimeters are to be used, describe the response checks to be performed and the range of the dosimeters. An annual response check with a response within +30% of the true dose is acceptable. High-range pocket dosi meters are not required since the purpose of these dosimeters is essentially to demonstrate that little or no dose was received.

10.4 Pool Water Purity [10 CFR 36.33(e), 36.39(d), 36.41(d), and 36.63]

Describe the equipment to maintain pool water purity and clarity, the frequency of measurements of purity, and the criterion to be used for acceptable purity (e.g., 20 microsiemens per centimeter or equivalent). If 28

conductivity meters are to be used, describe the method and frequency of calibration.

Describe what actions will be taken to lower pool water conductivity if the conductivity rises above 20 microsiemens per centimeter.

For dry-source-storage irradiators, write "Not applicable."

Discussion The purpose of keeping the water clean is not only to keep the water clear, but also to reduce corrosion of the sources. Clear water is desirable so that the sources and source rack can be visually inspected to check their condition and to retrieve any items that may drop into the pool. The proba bility of corrosion can be reduced by controlling impurity levels. The requirements in 10 CFR 36.63 are written in terms of conductivity (20 micro siemens per centimeter) because conductivity, an indicator of impurity levels, is most easily measured and most commonly used as a measure of water purity.

Chlorides are one of the most aggressive impurities in promoting corrosion of stainless steel, and chloride concentrations should be controlled to 3 parts per million or less. Water with a conductivity of less than 20 microsiemens per centimeter will normally have a chloride concentration of less than 3 parts per million. However, in some situations high water conductivities may be caused by impurities other than chlorides. In such situations, if it can be shown that those impurities at the concentrations present do not promote corrosion, it may be more appropriate to base purity control on measurements of chloride concentrations rather than conductivity so that a conductivity much higher than 20 microsiemens per centimeter could be permitted. If the applicant elects to control impurities on the basis of chloride concentra tions, the applicant should apply for an exemption to 10 CFR 36.63. Requests for exemptions that commit to maintaining chloride concentrations to less than 3 parts per million are likely to be granted.

10.5 Loading and Unloadinq Sources [10 CFR 36.13(g)]

If the applicant's own personnel will load and unload sources, describe the qualifications and training of the personnel and the procedures to be used. If the applicant will contract for source loading and unloading, identify the organizations that will be used.

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10.6 Annual Review of the Radiation Protection Program [10 CFR 20.1101(c)]

Describe the annual review of the content and implementation of the radiation protection program that is described in this Item 10. Describe how the review will be conducted and who (by position) will conduct the reviews.

Describe who will review the results of the review and any recommendations made in the review.

Discussion The annual review should include (1) a review of the adequacy of the operating and emergency procedures listed in 10 CFR 36.53, (2) a review of the results of the inspection and maintenance checks listed in 10 CFR 36.61, (3) a review of personnel monitoring results, (4) a review of radiation survey and monitoring results, and (5) a review of the adequacy of the training of workers. Ideally, the person who conducts the review should be knowledgeable in radiation protection but independent of the day-to-day operation of the radiation protection program.

10.7 Financial Assurance and Recordkeepinu for Decommissioning [10 CFR 30.35]

Irradiator applicants are required by 10 CFR 30.35(b) to submit either (1) a certification that financial assurance for decommissioning has been provided in the amount of $75,000 or (2) a decommissioning funding plan that contains a cost estimate for decommissioning (generally to justify a cost of less than $75,000) plus a certification that financial assurance for decommis sioning has been provided in an amount equal to the cost estimate. For infor mation on financial assurance mechanisms, the applicant should consult Regula tory Guide 3.66, "Standard Format and Content of Financial Assurance Mecha nisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72."

For license renewal applications in which the applicant has previously provided financial assurance of $75,000, write "Certification for financial assurance was submitted previously." For license renewal applications in which the applicant previously submitted a decommissioning funding plan with a cost estimate less than $75,000, the cost estimate should be updated and financial assurance should be provided for the new cost amount.

30

Applicants should list the records that will be maintained to comply with 10 CFR 30.35(g) and should specify the location where the records will be kept. No records are required by 10 CFR 30.35(g)(1) and (2) if no spills or contamination have occurred. Records are required for 10 CFR 30.35(g)(3) only if a decommissioning funding plan to justify an amount other than $75,000 was submitted.

Item 11 - WASTE MANAGEMENT The general requirements for disposal of licensed radioactive material are contained in 10 CFR 20.2001 through 20.2007. Because of the nature of the licensed material contained in irradiators, the only option for disposal is to transfer the material to an authorized recipient as specified in 10 CFR 20.2001(a)(1). This states, in part, that sealed sources will be shipped only to authorized recipients and transport must be in accordance with 10 CFR Part 71. The transfer should be done as soon as practical after there is no further use for the sources.

Authorized recipients are the original supplier of the irradiator sealed sources, a commercial firm licensed by the NRC or by an Agreement State to accept radioactive waste from other persons, and another specific licensee authorized to possess the licensed material. No one else is authorized to dispose of licensed material.

Item 12 - LICENSE FEES An application fee paid in full is required by 10 CFR 170.12(a) for most irradiator licenses, including applications for license amendments and renew als. (Note that construction of the irradiator may not begin before submit ting the license application and fee to the NRC (10 CFR 36.15)). Refer to 10 CFR 170.31, "Schedule of Fees for Materials Licenses and other Regulatory Services, Including Inspections, and Import and Export Licenses," to determine the amount of the fee that must accompany the application. Review of the application will not begin until the full fee has been received. All appli cation fees may be charged irrespective of the NRC's disposition of the appli cation or the withdrawal of the application. (Note that in addition to the application fee, annual fees will be assessed as described in 10 CFR 171.16.)

31

Item 13 - CERTIFICATION An 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 it contains information that is true and correct to the best of his or her knowledge and belief. Unsigned applications will be returned for proper signature.

Correspondence to the NRC from the applicant should be signed by the certifying official named in Item 13. The NRC will send correspondence to that official. Commitments made by the applicant must be signed by the official listed in Item 13.

4. AMENDMENTS TO A LICENSE After a license is issued, the program must be conducted in accordance with (1) the statements and representations contained in the application and any other correspondence with the NRC, (2) the terms and conditions of the license, and (3) the NRC's regulations. Operating and emergency procedures may be modified in accordance with 10 CFR 36.53(c) without amending the license.

It is the obligation of licensees to keep their licenses current. It is important to anticipate the need for a license amendment insofar as possible.

If any of the information provided in the application is to be modified or changed, except for changes made in procedures in accordance with 10 CFR 36.53(c), submit an application for a license amendment. The terms and conditions of the license must be complied with until the license is actually amended; changes may not be implemented based on a submission requesting an amendment to the license.

An application for a license amendment may be submitted either on the application form (NRC Form 313) or in letter form. It should be submitted in duplicate to the Regional Office at the address specified in Section 2 of this guide, "Filing an Application." The application should identify the license by number and should clearly describe the exact nature of the changes, addi tions, or deletions. References to previously submitted information and docu ments should be clear and specific and should identify the pertinent informa tion by date, page, and paragraph. Amendments may be in the form of page changes to the original application. Include the appropriate fee for a license amendment with the application. The NRC will not accept an 32

application or an application for a license amendment for filing or processing before the proper fee is paid in accordance with 10 CFR 170.12.

5. RENEWAL OF A LICENSE Licenses are generally issued for a period of 5 years.

An application for renewal must be sent to the Regional Office at the address specified in Section 2 of this guide, "Filing an Application."

An entirely new application for renewal may be submitted as if it were an application for a new license without referring to previously submitted information.

(This approach is preferable for the first renewal after July 1, 1993, the effective date of Part 36.)

As an alternative, applicants may:

1. Review the current license to determine whether the information concerning the sealed sources and the irradiator accurately represents the 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 submitted in the past to determine whether the information in them is up to date and accurately represents the facilities, equipment, personnel, radiation safety procedures, locations of use, and so on. The documents that represent the current program should be identified by date. Any out-of-date or superseded documents should also be identified.

Identify any changes that should be made in the documents to reflect the current program.

3. Review NRC regulations to ensure that any changes in the regulations are appropriately covered in the program description.

4. After this review is completed, submit a letter to the NRC in duplicate, with the proper fee, requesting renewal of the license and providing the information specified in Items 1, 2, and 3, as necessary.

5. Include the name and telephone number of the person to be contacted about the renewal application and include the current mailing address if it is not indicated correctly on the license.

33

Discussion 30 days before If an application for license renewal is filed at least for license renewal the expiration date of the license and the appropriate fee remain in effect is included, 10 CFR 30.37(b) provides for the license to However, if an applica until the NRC takes final action on the application.

date and the NRC cannot tion is filed less than 30 days before the expiration process it before that date, the license will expire.

application for It is important that the appropriate fee accompany the by a representa license renewal and that the application is dated and signed to sign official tive of the corporation or legal entity who is authorized is true and correct to document and certify that it contains information that with 10 CFR 170.12, the best 1f his or her knowledge or belief. In accordance before the the NRC will not accept an application for filing or processing for proper proper fee is paid. Unsigned applications will be returned signature.

6. TERMINATION OF A LICENSE licensee notify To terminate a license, 10 CFR 30.36(b) requires that a This notification the NRC promptly and request termination of the license.

of Disposition of must include: (1) a completed form NRC-314, "Certificate of properly and (2)

Materials," certifying that all sources have been disposed where the licensed the results of a final radiation survey of the premises must be sent to the NRC activities were carried out. This termination report loose contamination at before the expiration date of the license. If there is plan as the irradiator, it will also be necessary to submit a decommissioning described in 10 CFR 30.36(c)(2).

of properly If all the licensed radioactive material cannot be disposed for storage only of before the expiration date, a request for license renewal The renewal is neces the radioactive material must be provided to the NRC.

possession of sary to avoid violating NRC's regulations that do not allow licensable material without a valid license.

7. IMPLEMENTATION applicants The purpose of this section is to provide information to guide..

regarding the NRC staff's plans for using this regulatory 34

This draft guide has been distributed for comment to encourage public participation in its development. Except in those cases in which an applicant proposes an acceptable alternative method for complying with specified por tions of the Commission's regulations, the method to be described in the active guide reflecting public comments will be used in the evaluation of applications for new licenses or license renewals for non-self-contained irradiators.

35

APPENDIX A NRC FORM 313 U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OHS NO. 31504120 (84M EXPIRES s4--U 10 CFR30. 32. 33 ESTIMATED BURDEN PER RESPONSE TO COLY WITH TIS 34.33.3940 INFORMATION COLLEcTION REQUEST 9 HOURS SUBMe1TAL OF THE APPLICATION CqJAUF"ED ANDIS NECESSARY THAT ADEQUATE TO DETERnME THATEoST THE APPLCANT IS PROCEDURES To PROTECT THE PUBLIC HEALTH AND SAFETY FORWARD COMMENTS APPLICATION FOR MATERIAL LICENSE REGARDING BURDEN ESTIMATE ToTHE INFORMATION ANDRECORDS MANAGEMENT BRANCH(MNEB 7714) US NUCLEMArREGULATORY COMMISSION. WASHINGTON -DC 2s555oM. AND TO THE PAPERWORK REDUCTION PROJECT (31560025). OFFICE OF

______________________________________ MANAGEMENT ANDBUDGETWAsHINGTON, DC 60 INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION.

SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.

APPLICATION FOR DISTRIBUTION OF EXEMPT PROOUCTS FILE APPLICATIONS WITH: F YOU ARE LOCATED IN:

DIVISION OF INDUSTRIAL AND MEDICAL NUCLEAR SAFETY OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS lU55. O MICHIGANN INDIANA. IOWA. MINNESOTAT OHI:. Of WISCONSIN, U.S. NUCLEAR REGULATORY COMMISSION SEND APPLlCATNs To:

WASHINGTON. DC 205554=01 MATERIALS LICENSING SECTION ALL OTHER PERSONS FILE APPLICATIONS As FoLLows: U.S. NUCLEAR REGULATORY COMMISSION. REGION IN 799 ROOSEVELT ROAD IF YOU ARE LOCATED IN: GLEN ELLYN. IL 80137-5927 CONNECTICUT. DEI.AWARE. DISTRICT OF COLUMBIA. MAINE. MARYLAND, ARKANSAS, COLORADO IAHO. , KANSAS. LOUISIANA.MONTANA, NEBRASKA. NEW MASSACHUSETTS, NEW HAMPSHIRE. NEW JERSEY, NEW YORK. PENNSYLVANIA. MEX'CO. NORTH DAKOTA. OKLAHOMA. SOUTHDAKOTA. TEXAS. UTAH, OR WYOMING.

RHODE ISLAND. OR VERMONT. SEND APPLICATIONMS ToSE APPLICATIONS TO:

LICENSINGASSISTANT SECT1ON NUCLEAR MATERIALS SAFETY BRANCH NUCLEAR MATERIALS LICENSING SECTN U.S. NUCLEAR REGULATORY COMMISSION, REGION I U.S. NUCLEAR REGULATORY COMMISSION. REGION IV 475 ALLENDALE ROAD 611 RYAN PLAZA DRIVE. SUITE 400 KINGOF PRUSSIA, PA 19406-1415 ARLINGTON. Tx 7?5011-804 ALABAMA. FLORIDA. GEORGIA. KENTUCKY. MISSISPPI, NORTH CAROLINA. PUERTO ALASKA.ARIZONA. CALIFORNI HAWAII. NEVADA.OREGON. WASHINGTON. AND U.S.

RICO,SOUTH CAROLINA. TENNESSEE. VIRGINIA. VRGIN ISLANDS. OR WEST VIRGINA. TERRITORIES AND POSSESSIONS INTHE PACIFIC, S APPLICATIONS TO:

SEND APPLICATIONS TO: ._

NUCLEAR MATERIALS LICENSING SECTION RADIOACTIVE MATERIALS SAFETY BRANCH U.S NUCLEAR REGULATORY COMMSSION. REGION u U.S. NUCLEAR REGULATORY COMMISSION, REGION V 101MAMIETTA STREET. MN. SUITE 2900 1450 MARIA LANE ATLANTA. GA 30325.0199 WALNUT CREEK CA 945W,0-536 PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WIS To POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S.NUCLEAR REGULATORY COMMISSON JURISOICTIONS

1. THIS IS AN APPLICATION FOR (Chowk eRpwaft im,) 2. NAME ANDMAILINGACORESS OF APPLICANT aidde Zw ode)

NEW LICENSE A.

SB. AMENDMENT TO LICENSE NUIMBER_____________

C.RENEWAL OF LICENSE NUMBER_______________

3. ADORESS(ES) WHERE LCENSED MATERIAL WILL BE USED OR POSSESSED 4. NAMEOF PERSON TO BE CONTACTED ABOUT THIS APPI*CATION "TELEPHONENUMBER SUBMIT ITEMS 5 TIROUGH 11 ON 8-Ir2 X I PAPER THE TYPE ANDSCOPE OF INFORMATION TO BE PROVIDED IS D R IN THE LICENSE APPLICATION GUIDE.

S. RADIOACTIVE MATERIAL a Element andlmas number. b. cheamcaIandIo plmywc ftrm. anl c. mamnmumamount &. PURPOSECS)FORWHICH LICENSED MATERIAL WILL BE USED.

vollcl, val be possessed at any on.ae.

7. INDMOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR "TRAINING EXPERIENCE. & TRAINING FOR INDIIUALS WORIGN IN OR FREGUENTING RESTRICTED ^REAS

9. FACNITIESAND EQUIPMENT. 10. RADIATION SAFETY PROGRAM.

12. ICEN FEES (Se 10 CFR 170 d Socon 170.31)

IiCRIFAIN1U.

11. CEWASTE MANAGEMNT.

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AE UPONTHE APPLICANT.

THEAPPLICANT AND ANYOFFKIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT. NAMED IN ffEM Z CERTIFY THAT THIS APPLICATION IS PREPARED w CONFORMITY WITH TITLE10. CODE OF FEDERAL REGULATIONS, PARTS 30,3 3233-34-35.36.3B AND 40. AND THAT ALL INFORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIRKNOWLEDGE AND BELIEF.

WARNING 18 U.S.C. SECTION¶1 ACT OF'JUNE 25.194862 STAT.749 MAKESIT A CMIN4AL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION D ANY DEPARTMENT OR AGENCY OF THE UNITEDSTATES AS TO ANY MATTERWITHIN ITSJURISDITION.

CER-.F'ING OFFICER - TYPEDPRINTED NAME AND TITLE SIGNATURE DATE FOR NRC USE ONLY TYPE OF FEE FEE LOG FEE CATEGORY IAMOIUNT RECEIVED CHECK NUMBER COMMENTS APPROVED BY DATE INRC FORM 313 (8-9)

PRINTED ON RECYCLED.

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APPENDIX B RESPONSIBILITIES OF THE RADIATION SAFETY OFFICER The Radiation Safety Officer (RSO) is responsible for radiation safety program and ensuring that radiation safety implementing the activities are performed in accordance with approved procedures and regulatory requirements in the daily operation of the irradiator.

The RSO's duties and responsibilities include:

"* Investigating overexposures and implementing corrective actions as necessary;

"* Establishing, collecting in one binder or file, and implementing written policy and procedures for:

Assuring that an irradiator whose construction begins after July 1, 1993, is designed in accordance with NRC requirements, its construction is monitored, and the features and systems specified in 10 CFR 36.41 are tested and found to be acceptable before loading sources; Authorizing the purchase of byproduct material (e.g., new irradiator sources);

Receiving and opening packages of byproduct material (e.g.,

casks containing irradiator sources);

• Storing byproduct material; Keeping an inventory of byproduct material (e.g., location of each irradiator source (identified by its serial number) within the source rack);

Using byproduct material safely (e.g., detailed operating procedures);

Taking emergency action (e.g., detailed emergency procedures);

Making those changes to operating and emergency procedures that do not need Commission approval (in accordance with the requirements of 10 CFR 35.53(b));

Performing inspection and maintenance checks; Performing periodic surveys; Performing checks and calibrations of radiation detection instruments and water quality devices (e.g., conductivity meters);

Disposing of byproduct material (e.g., by transfer to authorized recipient);

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Training personnel, including irradiator operators, those permitted unescorted access to the radiation room or the area around the pool of an underwater irradiator, and those who must be prepared to respond to alarms; Keeping copies of all records required by NRC regulations, the license and all amendments, and the written policy and proce dures required by the regulations and the conditions of the license.

Establish personnel exposure investigational levels that, when exceeded, will initiate an investigation by the RSO of the cause of the exposure and consideration of actions that might be taken to reduce the probability of recurrence; At least annually, review the radiation protection program content and implementation, and then brief management on the results of the review and any needed improvements.

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APPENDIX C INCIDENTS AT LARGE IRRADIATORS The incidents described here are examples of dangerous dangerous incidents that have occurred at irradiators. or potentially here so that irradiator licensees can learn to avoid the They are described problems that others have had. The descriptions are taken from NRC Information Notice No. 91-14, "Recent Safety-Related Incidents at Large Irradiators,"

March 5, 1991.

1. Fatality Caused by Source Rack Jam. Bypassed Interlocks, and Faulty Survey Meter At a 340,000-Curie Co-60 irradiator in Israel, causing the product transport mechanism to stop, the a "source-down" product jam occurred, come on, and the gamma alarm to sound. The sounding of signal to the gamma alarm was considered unusual. Acting against operating and safety operator did not notify his supervisor and instead handledinstructions, the his own. He turned the alarm system off by disconnecting the situation on defeated the door interlock by cycling the power switch, the console cables, and entered the radiation room. He did not check the survey unlocked the door, before entering the radiation room, and consequently he meter he carried was unaware that the meter was not operational.

Seeing torn cartons, but unable to see that the source rack because it was resting on the edge of a carton, the remained up operator got a cart and began removing the damaged cartons. After about a minute, burning sensation in his eyes and left the room. The operator he began to feel a his film badge, but the whole body dose for the 1 1/2 to was not wearing the radiation room was estimated to be about 1,000 to 1,500 2 minutes he was in rack was later released and lowered to the pool under the rads. The source supplier, and no further overexposures were reported. direction of the The operator died from acute radiation syndrome effects 36 days after the accident.

2. Fatality and Injuries After Sources Fall out of Rack and Interlocks Bypassed At an 18,000-Curie Co-60 irradiator in El Salvador, the source transit alarm alerted the night shift operator sounding of the source was neither fully up nor fully down as a result of (Worker A) that the which should have caused the source rack to be automatically a fault condition, pool. He followed the reset procedure at the control panel, lowered to the success in stopping the alarm and releasing the door. He but he had no source rack by detaching the normal regulated air supply tried to free the pressure to force the source rack into the fully raised and applying higher position (a procedure not recommended by the supplier). This attempt also failed.

eventually able to stop the alarm, but the general failure The worker was "source-up" light remained on. He then manipulated the light and the microswitch system to produce a "source-down" light.

Worker A disabled the door interlock system by rapidly cycling buttons on the radiation monitor panel, while turning the the switch (another procedure not recommended by the supplier), key in the door thus simulating C-i

by the the detection of normal background radiation in the radiation room off the power fixed monitor and succeeded in opening the door. He then shut that, as with supply to the facility and entered the radiation room believing Without unpowered x-ray equipment, there would be no continuing radiation. instrument, he first checking the radiation levels with a portable radiation At this point he began to remove the deformed product boxes that had jammed.by the slack cable noticed that the descent of the source rack was prevented he left the of the hoist mechanism. Unable to free the rack by himself,the failure light radiation room and turned the power back on, noticing that that no alarm was was "on" and the "source-down" light was intermittent, but sounding.

rack. They Worker A then enlisted Workers B and C to help free the source assuring After had no experience or knowledge of the irradiation facility.turned off, the Workers B and C that there was no risk as the machine was three men entered the radiation room and began removingrack. the jammed product As the product boxes, while standing directly in front of the source of the boxes were removed and the source rack was lowered to the surface Cerenkov radiation.

water, the workers noticed the blue glow in the pool from source rack, he Worker A was surprised at this and after fully lowering the room, Worker A told the others to exit quickly. When leaving the radiation monitor was questioned by Worker B as to the use of the portable radiation He explained that the that was located some distance from the irradiator. that it had not instrument was for radiation detection and measurement, but been necessary to use it.

and was Worker A became ill minutes after leaving the radiation room went to the became ill and also taken to the hospital. Workers B and C later days because hospital. The company was unaware of the accident for several It was later the workers were incorrectly diagnosed as having food poisoning.

had fallen from the source rack discovered that some of the source pencils radiation room.

into the pool and that one of the pencils had fallen into the before the circumstances of the At least four more persons were overexposed accident were fully realized.

legs and Worker A was hospitalized for extensive radiation burns to his His right leg feet and gastrointestinal and hematopoietic radiation syndrome.

accident, Worker A died as a result of was amputated and, 197 days after the acute radiation for symptoms of his radiation exposure. Worker B was treated he was trans exposure and severe burns. After the amputation of both legs, Worker C ferred to a rehabilitation facility 221 days after the accident.

exposure and remained on sick leave suffered less severe symptoms of radiation to these workers from work for 199 days after the accident. Long-term effects A more detailed description may include eye damage from radiation exposure.

of the incident can be found in the IAEA publication STI/PUB/847.*

Prevents

3. Faulty Cable Brake Causes Exposed Source, but Good Survey Overexposure an unaccept An irradiator operator noticed that the product had received position and, with the source ably low dose. He shut down cell operations IAEA, Vienna, 1990.

• STI/PUB/847, "The Radiological Accident in San Salvador,"

from UNIPUB, 4611-F Copies can be obtained for reference and training tools Assembly Drive, Lanham, MD 20706-4391.

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monitor indicating that the sources were down and the in-cell radiation monitor showing radiation levels at zero, he entered the radiation survey instrument. He noticed elevated radiation cell with a portable mR/hr on the survey instrument and aborted his attempt levels between 1-2 to enter operator restricted the area and notified supervisory personnel. the cell. The tion into the cause of the elevated radiation readings Investiga the source racks was not fully down and that the top of revealed that one of 1/2 feet from the top of the pool. An inspection of the the rack was about I cated that the cable brake had failed to stop the winch, winch mechanism indi completely unwind. As a result, the source rack was raised allowing the cable to with the continuing rotation of the winch mechanism. instead of lowered manually lowered into the pool. The source rack was then It was determined that radiation exposure caused deterioration of the wiring in the Geiger-Muller tube of the cell moni tor, which caused this system to fail to warn of the elevated in the radiation room. The necessary repairs were made radiation levels to the control panel and the cell monitor, and procedures were instituted to systems of the facility. The operator followed safety upgrade the safety and operating proce dures during the incident and avoided overexposure by correctly using the portable survey instrument.

4. Violations Result in NRC Fines During an inspection and subsequent investigation at an identified the following violations: (1) failing to promptly irradiator, NRC repair the lock on the personnel-access door to the irradiator and effectively fying a procedure without first obtaining NRC approval cell, (2) modi (i.e., replacing a safety component in the irradiator start-up system) as license, and (3) deliberately bypassing administrative required in the procedures and safety interlocks and physical barriers to gain entry to the irradiator climbing over the irradiator cell access door. An NRC cell by determined that senior licensee management knew of the investigation also incomplete and inaccurate statements to the NRC during violations and made an enforcement con ference and the subsequent investigations into the circumstances violations. The potential for extremely high radiation of these licensee's lack of candor with NRC raised questions about exposures and the willingness of the licensee to comply with NRC requirements. the ability and these violations of the safety requirements to be serious NRC considered penalty against the licensee. Senior management involved and proposed a civil no longer associated with the facility. The licensee in this incident are has instituted a quality assurance program and additional training requirements.

5. Fines for Deliberate Interlock Bypass A licensee deliberately bypassed the radiation and substituted an administrative procedure for the monitor interlock systems engineered safeguard pro vided by the radiation monitor interlock. The substituted dure was implemented without NRC review, approval, and cell entry proce incorporation in the license. The alternative procedures did not constitute device that functioned automatically to prevent inadvertent an entry control comply with NRC access control requirements. entry and did not In addition, the licensee installed jumper cables to bypass ventilation system interlocks, designed to automatically protect individuals from noxious which were gases produced as a result of irradiation.

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could result if Because of the extremely high radiation exposures that this incident was a interlocks are not operational, the NRC concluded that The licensee was not allowed very serious violation of safety requirements. fully operational.

to operate the irradiator until all safety systems were safety-related This violation of NRC requirements, along with other civil penalty.

violations, resulted in NRC proposing a substantial

6. Cesium-13 7 Source Leaks the pool water at Radia A leaking cesium-137 source capsule contaminatedand it remained undetected ti. Sterilizers, Inc.'s plant in Decatur, Georgia, did not use the pool water fov an extended period of time because the licensee The contamination !'o monitoring system associated with the demineralizer.discrete samples and ::

blem was finally discovered when the licensee tookactivation of the radib; an formed radiation surveys of the pool water after locked the sources in level monitoring system, which had automaticallyradiation levels while the safe-storage position because of the excessive sources were -n the stored position.

pool water monitoring Failure to continuously use the demineralizer and of the operations.

u-derstanding system was contrary to the licensing agency's pool water contamination Had the demineralizer been operated continuously, the licensee to begin possibly could have been detected earlier, enabling mitigating the contamination.

7. Crane Brake Fails While Lowering Shipping Cask at a licensed facility A contractor who provided lifting-crane services pool to a mezzanine area, was moving a shipping cask from the source storage 19 feet. The cask when the cask made an uncontrolled descent of approximately the surface, only after an stopped its descent approximately 5 feet below were injured and there was no operator activated a manual brake. No personnelfacility or equipment as a damage to, or contamination of, the licensee's not been secured quickly, it result of this event. However, had the caskin the pool or the pool itself.

could have damaged the radioactive sources of the crane This incident was a result of improper brake adjustment and recertified for normal hoist. The crane brake was subsequently repaired Safety and Health Adminis operations in accordance with current Occupational and adjustment, as well as tration regulations. Braking system inspection procedures before crane functional load testing, are now established daily operation.

8. Faulty Welds Cause Pool Leakage several weeks that was A licensee experienced a loss of pool water for evaporative losses. The from approximately three times higher than expected and quantity of the water licensee performed tests to determine the nature to determine compliance with loss and began daily assays of the pool water a leak in the irradiator release limits for unrestricted areas. Suspectingliner and found localized pool, the licensee inspected the stainless steel caustic stress corrosion in many welds.

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Apparently, welds made during construction of the facility in 1968 were not in accordance with industry standards. Thus, these faulty welds subject to caustic stress corrosion, which resulted in the recent poolwere water losses.

9. Hose Rupture Releases Contaminated Water While the licensee was attempting to decontaminate pool water been contaminated by a leaking source, a hose on a filtration systemthat had Contaminated pool water was then pumped onto the facility floor and ruptured.

outside into the surrounding soil. The licensee failed to report theleaked to NRC and made deliberate efforts to prevent NRC's discovery of this incident incident.

Subsequently, the licensee was indicted by a Federal Court. A conviction resulted in a fine for' the company and 2 years probation for a management employee. Licensee failure to make required reports prevents the NRC performing its radiological health and safety function and from making from timely assessment of the nature and severity of an incident. a

10. Licensee Bypassed Access Control Interlocks and Lied to NRC A licensee deliberately bypassed the safety interlock systems. The subsequently learned that licensee personnel had willfully violated NRC ments, and that senior licensee management knew, or should have known, require these violations. When NRC attempted to inspect and investigate these of pected violations, senior licensee management knowingly provided false sus mation to the NRC. Subsequent enforcement action included suspension infor of the license.

11. Line Rupture Causes Loss of Pool Water A water line fractured in the pool circulation system, which the loss of 5 feet of pool water. The line break led to a loss of resulted in shielding water because the intake and outlet pipes were misaligned during maintenance.

The pipe break appears to have occurred because the pipe was made of chloride, designed for cold water, rather than for the heated water polyvinyl tempera tures typical for the irradiator. The piping was replaced with polypropylene pipe.

12. Frozen Valve Causes Source Rack To Jam in Up Position A night shift operator noticed that the travel time for the source to reach the fully unshielded position was excessive. After completing phase of irradiation, the source would not retract to the fully shielded the next tion, even using emergency equipment. The operator discovered that posi the noid valve, which was supposed to retract the source to a shielded position, sole was frozen by weather conditions. The frozen valve was in a room above irradiator facility. The operator went there and turned on a room heaterthe thaw out the valve so that it would operate. The operator violated to requirements to (1) notify the Radiation Safety Officer (RSO) that the license source C-5

had not returned to its shielded position because of the frozen valve and (2) obtain RSO permission to enter and heat the room housing the valve.

13. Frayed Cable Causes Source Rack Jam A licensee had identified a frayed lift cable a few days previously, but instead of immediately replacing the cable, the licensee decided to wait for less scheduled maintenance. The cable jammed and froze the source rack in a than fully shielded position. Employees cut the cables and let the source rack free-fall into the pool. The incident could have been prevented by fray replacing the frayed cable immediately and selecting cable material with resistant qualities.

14. Bent Shroud Prevents Source Rack from Being Lowered A source rack became stuck in the exposed position. Conveyors stopped, the source-down light came on, but cell radiation levels remained high.

Cable-slack data indicated that the rack was stuck about 5-1/2 feet down from its full-up position. The RSO attempted some raising and lowering maneuvers, pro but the rack then stuck in a full-up position. The RSO, able to run the The duct containers out of the cell, saw some were misaligned on the carrier.

RSO notified a State inspector, who arrived in the afternoon. It was deter mined that the rack cable was off its pulley. The bottom of a splice in the cable was resting on the lip of the tube leading to the cell. After the cable was set on its pulley, the cable was guided through the tube and the rack was lowered, but it caught again.

A borrowed radiation-resistant camera arrived the next morning. An adequate view of the rack was obtained by midnight. Apparently the stationary aluminum shroud between product containers and rack had been deflected and caught on the rack frame. The rack was carefully raised and dropped to break the jam. On the second try, the rack broke free and dropped into the pool.

Analysis revealed that a product container had probably tipped onto the sr -oud, causing interference with the rack.

This incident was apparently caused by inadequate design of the shroud.

This led to the shroud deforming, which interfered with rack motion. Inade quate maintenance contributed to the problem. The cable should have been replaced instead of spliced. A few months later, the entire source hoist mechanism failed and had to be replaced. This failure occurred when the source rack was submerged.

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REGULATORY ANALYSIS A separate regulatory analysis was not prepared for this draft guide. The regulatory analysis prepared regulatory for the proposed 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators," is entitled "Regulatory Analysis and Environmental Assessment of NRCRegulations on Licenses and Radiation Safety Requirements for Large Irradiators," and is dated February 1989. This regulatory analysis for the rule provides the regulatory basis for this regulatory guide, and it examines the costs and benefits of the rule as implemented by the guide. A copy of the regulatory analysis is available for inspection or copying for a fee at the NRC Public Document Room, 2120 L Street NW., Washington, DC.

RA-1

Federal Recycling Program FIRST CLASS MAIL POSTAGE AND FEES PAID

-NITED STATES USNRC NUCLEAR REGULATORY COMMISSION PERMIT NO. G-67 WASHINGTON, D.C. 20555-0001 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300