Radiation Guide 1.2 - Guide for the Preparation of Applications for Licenses to Use Sealed Sources in Portable Gauging Devices

1. Introduction


1.1 Purpose of Guide

The purpose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals for the use of sealed sources in portable gauging devices. Examples of portable gauging devices are a moisture-density gauge that contains a gamma-emitting sealed source, cesium-137, and a sealed neutron source, americium-241-beryllium; and a lead-in-paint analyzer that contains a cobalt-57 source.

This regulatory guide is intended to provide you, the applicant and licensee, with information that will enable you to understand specific regulatory requirements and licensing policies as they apply to portable gauging devices. The information in this guide is not a substitute for training in radiation safety or for developing and implementing an effective radiation safety program.

After you are issued a license, you must conduct your program in accordance with (1) the statements, representations and procedures contained in your application; (2) the terms and conditions of the license; and (3) the Department of Health's regulations in 12 NYCRR 38. The information you provide in your application should be clear, specific and accurate.

1.2 Applicable Regulations

The New York State Department of Health issues licenses for the use of radioactive materials under the regulations of Titles 10 NYCRR Part 16 and 12 NYCRR Part 38. The statutory authority for the rules and regulations is found in the Public Health Law, Sections 201 and 225.

1.3 As Low As Is Reasonably Achievable (ALARA)

Part 38 requires that persons who operate or permit the operation of radioactive installations shall make every effort to maintain radiation exposures and releases of radioactive material as far below the limits of Part 38 as is reasonably achievable. License applicants should give consideration to the ALARA philosophy in the development of plans for work with radioactive materials.

2. Filing An Application

You, as the applicant for a materials license, must complete DOSH Form 236 (7/06). You should complete Items 1 through 4 and 18 on the form itself. For Items 5 through 17, submit the information on supplementary pages. Each separate sheet or document submitted with the application should be identified and keyed to the item number on the application to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8 ½ x 11 inch paper to facilitate handling and review. If larger drawings are necessary, they should be folded to 8 ½ x 11inches. You should complete all items in the application in sufficient detail for the Department to determine that your equipment, facilities, training and experience, and radiation safety program are adequate to protect health and to minimize danger to life and property.

You must submit two copies of your application with attachments. Retain one copy for yourself, because the license will require that you possess and use licensed material in accordance with the statements and representations in your application and in any supplements to it.

Mail your completed application and the required fee to:

Center for Environmental Health
Bureau of Environmental Radiation Protection
Empire State Plaza-Corning Tower, Room 1201
Albany, New York 12237

Applications received without fees will not be processed and the fee is non-refundable.

3. Contents Of An Application

Indicate whether this is an application for a new license or a renewal of an existing license by checking the appropriate box at the top of the application form (DOSH 236). Also, please indicate the number of this application guide (Radiation Guide 1.2).

Item 1. - Applicants' Name and Mailing Address

If you are an individual, you should be designated as the applicant only if you are acting in a private capacity and the use of the radioactive materials is not connected with your employment with a corporation or other legal entity. Otherwise, you the applicant, should be the corporation or other legal entity applying for the license and the name of the company should be entered exactly as it appears on other legal documents.

The address specified here should be your mailing address to which correspondence should be sent. This may or may not be the same as the address at which the material will be used, as specified in Item 2.A.

Also enter your company's Federal Employers Identification Number (FEIN).

Item 2 - Locations of Use and Storage

Every radioactive source licensed by the Department must be stored in its approved permanent storage facility, unless otherwise specifically authorized. An in-State license is issued when the permanent storage facility is located within the State of New York. Applicants requesting multiple permanent storage locations in this State are required to obtain a separate license for each location. An out-of-State license shall be issued if the permanent storage facility is licensed, either by the United States Nuclear Regulatory Commission or another Agreement State.

Applicants for an in-State license must specify the permanent storage location by the street address, city and state, or other descriptive address (such as five miles east on Highway 10, Anytown, NY). A Post Office Box address is not acceptable. Please be sure to submit sufficient information for us to locate your facility and to document its location for our records. You should either submit a copy of a street map with your location marked, or hand-drawn map showing the nearest highway, nearest street intersection, and your facility's location.

As part of your application you are required to submit a description, including a plan drawing or sketch of the storage facility which you will provide for radioactive materials. (See Item 15, below.) The storage facility must be located within non-residential premises that are commercially zoned, have no prohibitions against the storage of hazardous materials, and provide adequate on-site security against unauthorized removal of licensed material. Self-storage units, commercial warehouses, or out-buildings on residential property, for example, are not considered acceptable as radioactive material storage locations. Under no circumstances shall radioactive material be stored in a residence.

Also, clearly specify whether a location is one at which operations will be conducted or whether the location is only for storage of sources and devices. If you will also conduct operations at temporary job sites, you may add "temporary job sites in New York State." (See further discussion under "Use at Temporary Job Sites", below.)

Applicants for an out-of-State license need only submit a copy of the license which authorizes permanent storage of the sources to be used in New York State.

Use at Temporary Job Sites*

For licensees requesting to use gauges at temporary job sites, a condition on your license will authorize portable gauges to be stored in the transport vehicle for short periods (not exceeding five (5) consecutive nights). The purpose of this condition is to allow company employees on overnight travel status to remain at a temporary job site for an entire work week rather than having to travel back to the permanent storage location at the end of each work day. It does not authorize an employee to store radioactive sources over night at his/her place of residence. Abuse of this condition may result in the Department taking enforcement action against your license.

Applicants requesting temporary storage at a facility other than the permanent storage facility, or requesting vehicular storage in excess of five consecutive nights, must contact the Department for prior approval. Submission of additional information in support of such a request will be required.

* "Temporary" is taken to mean a period of less than six months duration.

Item 3 - Nature of Business and Person to be Contacted about Application

Describe the type of business in which you are engaged.

Item 4 - License Information

Enter the license number of any previous or current licenses authorizing use of radioactive materials (including General Licenses) and the name of the issuing agency. If a license has ever been suspended or revoked, describe the circumstances on additional sheets.

Indicate whether this is an application for a new license or a renewal of an existing license.

Item 5 - Department of Use

Indicate what department, unit or laboratory in your organization will use radioactive materials.

Item 6 - Individual Users

Employees who will use your device under the supervision of a responsible individual named in Item 7 do not need to be designated by name.

Item 7. Radiation Safety Officer

Part 38 requires that your staff be qualified by training and experience to use radioactive material in such a manner as to protect health and minimize danger to life or property before the Department approves an application for a license. You must also provide a radiation protection program designed to ensure compliance with Part 38 and the conditions of your license; and provide a Radiation Safety Officer (RSO) who will ensure implementation of the safety program on a day-to-day basis. You must delegate authority to the RSO to take whatever actions are necessary to ensure safety, and make sure that RSO's other job duties are adjusted so that he or she has enough time to discharge RSO duties properly. For a large program with many gauges and gauge users, this may be a full-time job.

You should provide the name of the person who will be responsible for your radiation safety program (RSO) and describe that person's training and experience.

The individual responsible for your radiation safety program must be familiar with the Department's regulations (Part 38), your operating and emergency procedures and the conditions of your license. The individual must also have completed the device manufacturer's training program, and should have some additional formal training in managing a radiation safety program. If the RSO has completed the device manufacturer's program, you should submit a copy of the training certificate. If training will be completed after the application is submitted, a copy of the RSO's certificate must be submitted as soon as possible and before the license is issued.

If the RSO has received additional formal training, you should state where and when (specific dates) the training was received, the topics covered, and the name and qualifications of the instructor.

You must also ensure that your RSO is familiar with Part 38, your operating and emergency procedures, the conditions of your license, and will ensure compliance with all requirements.

Appendix I to this guide contains a model description of the duties and authority of an RSO. You should submit a copy of this appendix as your description of your RSO's functions or make any necessary changes in red ink and submit that.

Item 8 -Radioactive Material to be Possessed

8.A. Identify each radioisotope that will be used in a gauging device.

8.B. Identify the manufacturer and model number of each sealed source that will be used in a gauging device.

8.C. Specify the amount of radioactive material that will be in each sealed source.

8.D. Identify the manufacturer and model number of each gauging device in which the sealed sources will be used.

You should consult with your proposed supplier for this information to be sure that your sources and devices conform to the sealed source and device designations registered with the USNRC or an Agreement State.

NOTE: It is our practice to provide flexibility in the number of identical sealed source/device combinations you may want to possess at any one time. Therefore, it is not necessary for you to specify the number of identical sealed source/device combinations.

Item 9. Purpose for which Radioactive Materials will be used

Specify the purpose for which the gauging device you want to possess will be used. For example, a moisture-density gauge is normally used for measuring moisture and density of construction materials.

Item 10 & 11 - Training and Experience of Individual Users

The following information must be provided:

  1. A commitment that each employee will complete the device manufacturer's training program before being permitted to use a device.
  2. If you wish to have user training provided by an organization other than the device manufacturer, you must request authorization for this. Only third-party training by a provider acceptable to the Department will be authorized as an alternative to the manufacturer's training. You must contact this office concerning the third party provider you propose to use.
  3. A commitment that records documenting the above training of each employee will be maintained for three years from the date the training is completed.
  4. A commitment that employees will also receive training in applicable regulations, the conditions of your license and the Operating and Emergency Procedures required under Item 14.D of this guide. You must confirm that this training will be given before employees begin duties involving licensed materials and as annual refresher training. Records of such training must be maintained for three years.
  5. A commitment that employees will also receive required DOT training. See Appendix IV for relevant DOT requirements and confirm that this training will be provided as required and training records maintained.

You may respond to all of the above (except number 2) by stating that you will ensure training and maintain records of such for all device users, in accordance with the provisions of New York State Department of Health Radiation Guide 1.2.

ITEMs 12 & 13. Instumentation and Calibration

You do not need to have a radiation survey meter and make surveys during routine use of the device as long as you have made the commitment that personnel will wear a film badge or thermoluminescent dosimeter when using or transporting the device. If survey meters are provided, they must be calibrated annually by a qualified vendor licensed by the NRC or an Agreement State to perform such calibrations.

Indicate whether you intend to provide radiation survey meters to your employees and if so submit your commitment that all survey instruments will be appropriate to the types of radiation to be detected and will be maintained operational and calibrated annually by a qualified vendor licensed by the US NRC or an Agreement State to perform such calibrations.

Item 14 - Personnel Monitoring

Part 38 requires that personnel monitoring equipment be used by individuals entering restricted areas who receive or are likely to receive a dose in excess of the doses specified in Section 38.24.

Due to the variability of radioactive gauge usage situations and patterns, and observations that badge readings may be the only indication of poor handling procedures, the Department requires the use of whole body badges for users of most portable gauges. If you will only use lead-in-paint analyzers with sources of 10 millicuries or less you may choose not to use badges. Otherwise state the type of personnel monitoring equipment you will use, the types of radiation detected (including neutrons for gauges with neutron sources), and the frequency at which the film badges or TLDs will be changed. The changes should be made at intervals not to exceed one month for film badges and three months for TLDs.

Item 15- Facilities and Equipment

Part 38 provides that an application will be approved if, among other things, the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property. It also requires that licensed material stored in an unrestricted area be secured from unauthorized removal from the place of storage; and that licensed material in an unrestricted area and not in storage be tended under the constant surveillance and immediate control of the licensee.

15.A. Confirm that the device will always be stored in a locked enclosure such as the transport vehicle, store room, etc., in a way that will prevent access by unauthorized persons when the device is not in use. A minimum of two independent physical controls should be employed to secure the device from unauthorized removal whenever the gauge is in storage or transport. (See Appendix II, Section 4 for additional guidance on this requirement.)
15.B. Permanent storage locations must be zoned for commercial use and you must have and control exclusive access to such locations. Describe each permanent storage location.* Confirm that each storage location is properly zoned and submit diagrams showing storage arrangements, room and building layout and security mechanisms. Diagrams must indicate types of occupancy in all areas adjacent to the storage area, including above and below.

*NOTE: If you plan to store radioactive devices at more than one location, and dispatch them to temporary job sites, you will probably need a license for each fixed storage location.

15.C. Vehicle storage must be in the trunk of any passenger vehicle, blocked and braced to prevent shifting during transport. If transported in an open bed vehicle, the device must be locked in a steel cabinet, bolted to the bed of the truck. Confirm that your transport methods will meet these criteria, or describe your procedures providing same level of security.
15.D. Confirm that all devices will be in locked storage or physically watched by an authorized user at all times. It is not acceptable, for example, for a device to be chained to a post or left lying unattended at the place of use during lunch or breaks, since it would then be accessible to unauthorized persons.

Item 16 - Radiation Protection Program

You, as the licensee, are responsible for the conduct of your radiation protection program and for all actions of your employees. Your program must cover the following components at a minimum:

16.A. Leak Testing

You must perform periodic tests to determine whether or not there is any leakage from the radioactive source in each device. The leak test must be performed at six-month intervals, and the measurement of the leak-test sample must be quantitative, using instrumentation sufficiently sensitive to detect 0.005 microcurie of radioactivity.

The options for leak-testing are:

  1. Engage the services of a licensed consultant or commercial facility to take samples, evaluate the samples, and report the results to you.
  2. Use a commercial leak-test kit. You take the smear and send the smear to the licensed kit supplier, who reports the results to you.
  3. Perform the entire leak-test sequence yourself, including taking the smears and evaluating them.

For Option 1, specify the name, address, license number, and licensing agency of the consultant or commercial organization.

For Option 2, specify the kit model number and the name, address, and license number of the kit supplier. In your application, you should state that the test samples will be taken by the individual specified in Item 6 as your Radiation Safety Officer.

For Option 3, specify how the test sample will be taken and the instrumentation that will be used for measurement. An instrument capable of making quantitative measurements must be used and must be appropriate and calibrated for the nuclides of interest. Describe the instrument to be used, its calibration and its lower limit of detection and include a sample calculation for conversion of the measurement data to microcuries. You must also list under Items 8 and 9 of the application the calibration sources to be used and confirm that they are traceable to national standards to within ± 5%.

You should also specify the individual who will evaluate the samples along with his or her qualifications. The individual must have prior experience in making such quantitative measurements and this experience must be documented in your application.

16.B Maintenance

Licensees must routinely clean and maintain gauges according to the manufacturer's recommendations and instructions. For gauges with a source rod, radiation safety procedures for routine cleaning and lubrication of the source rod and shutter mechanism (e.g., to remove caked dirt, mud, asphalt, or residues from the source rod; lubricate the shutter mechanism) must consider ALARA and ensure that the gauge functions as designed and source integrity is not compromised.

Licensees must also perform daily checks of the shutter (sliding block) on gauges with a source rod, to verify that the sliding block is completely closed. Appendix II, Section 1 of this guide contains a utilization log form to be used for logging gauges in and out of storage and documenting their location. The form includes a column for recording the results of shutter checks; which must be done when a gauge is logged out, before use on each day of use, and when the gauge is logged back in, as follows:

  1. Turn the gauge over and visually verify that the tungsten sliding block is completely closed, keeping as much distance as possible between you and the base of the gauge. If any portion of the opening is uncovered, the sliding block must be cleaned and returned to the fully closed position before transporting, using, or storing the gauge. The manufacturer's instructions for cleaning the sliding block must be followed.
  2. If a radiation survey meter is available, and in good working order, radiation levels at the gauge surface shall also be checked. The exposure rate should be approximately 10-20 mrem per hour.
  3. If a sliding block is found to be partially or fully open, the Department of Health must be notified by telephone within 24 hours.

You may not perform any maintenance or repair that involves detaching the source or source rod from the device. Such work may only be performed by the device manufacturer or another company licensed to perform the work. This is true even if your gauge manufacturer's manual describes removing the rod source for maintenance, as some older manuals do.

You should state that routine cleaning and maintenance of gauges will be performed in accordance with the manufacturer's recommendations and instructions by properly trained staff, and that the source or source rod will not be removed.

You should state that daily checks of gauge shutters (sliding blocks) will be performed as described in this guide, and recorded on utilization log forms.

16 C. Transportation of Devices to Field Locations

Any vehicle used for transporting gauges shall be driven only for purposes associated with use or transport of the contained radioactive material, by a person either qualified to use the material, or accompanied by a person so qualified. No passengers shall be carried unless they are also involved in work under this license.

Transport of licensed material must be carried out in accordance with the applicable requirements of the Department of Transportation (DOT).

It is your obligation to be familiar with the applicable DOT regulations on transportation of radioactive materials. The requirements for package labeling are in Subpart E of 49 CFR Part 172 of the DOT regulations. General requirements for shipping and packing radioactive material are in Subpart I of 49 CFR Part 173 of the DOT regulations.

The audit form in Appendix III to this guide lists specific DOT package requirements, and laminated card shipping papers can be used as "permanent" papers. You should state that packaging and transport of the device will be carried out in accordance with all applicable DOT regulations.

16.D. Operating and Emergency Procedures

You must provide your personnel with written operating and emergency procedures and you must state that you will provide the procedures to each person who uses a device. Your procedures must include the following topics, and must be provided to each user in a convenient format:

  1. Use of personnel monitoring. All personnel who use the device must wear their personal dosimeters when they are close to, transporting or working with the device, or performing maintenance or cleaning it.
  2. Use of the device. The manufacturer's instruction manual for the use of the device must be provided.
  3. Storage of the device. Procedures for storage of the device when it is not in use or under the physical surveillance of a user must be provided. These must cover work-day and overnight storage.
  4. Transportation. Procedures for transporting devices to and from work sites must be provided.
  5. Emergency procedures. Steps workers are to take in the event of loss, damage or serious malfunction, including individuals to be notified, must be provided. Procedures should specify that loss, or damage that might result in contamination or exposure, must be reported immediately to the Department, and must contain current daytime and after-hours telephone numbers for the Department.

Appendix II to this guide contains model Operation, Transport and Emergency Procedures and a Utilization Log form. You must submit these as procedures to be provided to users or make any necessary changes in red ink and submit that copy for review.

16 E. Annual Audits

Section 38.17 of Part 38 requires licensees to maintain all radiation exposures as low as reasonably achievable (ALARA); and to develop, document and implement a radiation protection program appropriate to the licensed activities; and to conduct an annual audit of the program and of the performance of the RSO. You must submit a management commitment that annual audits will be conducted, describe what they will consist of and state who will conduct them. Appendix III to this guide contains an audit form that would be acceptable to the Department; and for a portable gauge license, would find it acceptable for the audit to be conducted by senior management, accompanied by the RSO.

Item 17 - Waste Management

Because of the nature of the licensed material contained in devices, your only option for disposal is to transfer the material to an authorized recipient.

Therefore, you must obtain your devices from suppliers who will agree to receive them back. You should submit evidence that the supplier of any radioactive sources to be possessed under the license will receive them back.

Item 18 - Certification

If you are an individual applicant acting in a private capacity, you are required to sign the form. Otherwise, your application must be dated and signed by the Chief Executive Officer of the corporation or legal entity applying for the license, or by a person who is authorized to sign official documents and to certify that the application contains information that is true and correct to the best of your knowledge and belief. Unsigned applications will be returned for proper signature.

Additional Documents to be Submitted

In addition to the foregoing, you must also submit:

  1. In-state applicants must send a copy of a letter sent to the Police Department in each permanent use location listed in item 2 of the application, which informs them that radioactive materials will be on the premises and instructs them on any precautions to be taken and notifications to be made in the event of a fire or emergency.
  2. In-state applicants must send a copy of a letter sent to the Fire Department in each permanent use location listed in item 2 of the application, which informs them that radioactive materials will be on the premises and includes a completed Hazardous Materials Form (F100965-001), and instructs them in any precautions to be taken and notifications to be made in the event of a fire or emergency.
  3. All applicants must provide proof that you have obtained the required Workers' Compensation and Disability Benefits coverage, or that you are not required to provide coverage under Section 57 of the Workers' Compensation Law and Section 220, subdivision 8 of the Disability Benefits Law. Such proof must be current at the time of license application.
  4. Out-of-state applicants must submit a copy of their radioactive materials license issued by the U.S. Nuclear Regulatory Commission or an Agreement State.

Amendments to a License

After you are issued a license, you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application; (2) the terms and conditions of the license; and (3) the Department's regulations.

It is your obligation to keep your license current. You should anticipate the need for a license amendment insofar as possible. If any of the information provided in your application is to be modified or changed, submit an application for a license amendment. In the meantime, you must comply with the terms and conditions of your license until it is actually amended; Department regulations do not allow you to implement changes on the basis of a submission requesting an amendment to your license.

An application for a license amendment may be prepared either on the application form or in letter form and should be submitted in duplicate to the address specified in Section 2 of this guide. Your application should identify your license by number and should clearly describe the exact nature of the changes, additions or deletions. References to previously submitted information and documents should be clear and specific and should identify the pertinent information by date, page and paragraph. For example, if you wish to change the RSO, your application for a license amendment should specify the new individual's name, training and experience. The qualifications of the new RSO should be equivalent to those specified in Item 6 of this guide.

List of Appendices

The Appendices can be found on pages 15-31 of Radiation Guide 1.2 which is available in Portable Document Format (PDF, 103KB, 31pg.)

  1. Radiation Safety Officer
  2. Procedures
  3. Annual Audit Form
  4. U.S. DOT Training Requirements