PART B
REGISTRATION OF RADIATION SOURCE FACILITIES AND SERVICES

Sec. B.1 Purpose and Scope

1. This Part provides for the registration of ionizing radiation source facilities and for the registration of persons providing radiation source installation, servicing, and/or services.
2. In addition to the requirements of this Part, all registrants are subject to the applicable provisions of the General Provisions (Part A), Standards for Protection (Part D), and Notices, Instructions and Reports (Part J) and Compliance Procedures (Part K) of the regulations. In addition, some registrants are subject to provisions of the regulations for Industrial Radiography (Part E), Healing Arts (Part F), Analytical Equipment (Part H) or Particle Accelerators (Part I) and Therapeutic Radiation Machines (Part X).

Sec. B.2 Definitions

“Facility” means the location, building, vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.

“Manager” means the individual working at the facility who is authorized by the owner to sign the application form as the applicant.

“Owner” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

“Radiation source” see source of radiation.

“Source of radiation” means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

“Storage” means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable and shall be tagged by the Agency.

Sec. B.3 Exemptions

1. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this Part, provided that the equivalent dose averaged over an area of 10 square centimeters does not exceed 5 µSv (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.
2. Radiation sources while in transit or storage incident thereto are exempt from the requirements of this Part.
3. Domestic television receivers are exempt from the requirements of this Part.

General Regulatory Provisions

Sec. B.4 Shielding Plan Review

1. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation sources shall be submitted to the Agency for review and approval. The required information is denoted in Appendices A and B of this Part and Part X, Appendix A, for radiation therapeutic sources.
2. The Agency may require the applicant to utilize the services of a qualified expert who is registered with the Agency [B.6 (d)(iii)] to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding requirements on Form R15A or equivalent.
3. The issuance of a certificate of approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in D.201, D.207, D.208, and D.301 of the regulations.
4. After installation of a radiation source, the registrant shall maintain for inspection by the Agency:
   1. The maximum rated technique factors of each source;
   2. A scale drawing of the room in which a stationary radiation source system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:
      1. The results of a survey for radiation levels present at the operator’s position and at pertinent points outside the room at specified test conditions; or
      2. The type and thickness of materials, or lead equivalency, of each protective barrier.

Sec. B.5 Registration of Radiation Source Facility

1. Each person having a radioactive material shall:
   1. Apply for registration of such facility with the Agency prior to the receipt, possession, use, transfer, ownership or acquisition of the radioactive material. Application for registration shall be completed on forms furnished by the Agency.
   2. Designate on the application form an individual to be responsible for radiation protection, address of the facility, and for the radioactive material; element name, atomic mass, chemical or physical form and maximum amount to be possessed at any one time.
2. Each person having a radiation machine facility shall:
   1. Apply for registration of such facility with the Agency prior to the operation of a radiation source facility. Application for registration shall be completed on forms furnished by the Agency and shall contain all the information required by the form and accompanying instructions;
   2. Designate on the application form (see Part K.1.b) an individual to be responsible for radiation protection;
3. Prohibit any person from furnishing radiation source servicing or services as described in B.6.d. to his radiation source facility until such person provides evidence that he has been registered with the Agency as a provider of services in accordance with B.6.

Sec. B.6 Application for Registration of Servicing and Services

1. Each person who is engaged in the business of installing or offering to install radiation sources or is engaged in the business of furnishing or offering to furnish radiation source servicing or services in this State shall apply for registration of such services with the Agency.
2. Application for registration shall be completed on forms furnished by the Agency and shall contain all information required by the Agency as indicated on the forms and accompanying instructions.
3. Each person applying for registration under this Part shall specify:
   1. That he has read and understands the requirements of this and other applicable Parts;
   2. The services for which he is applying for registration;
   3. The training and experience that qualify him to discharge the services for which he is applying for registration;
   4. The type of measurement instruments to be used, frequency of calibration, and source of calibration; and
   5. The type of personnel dosimeters supplied, frequency of reading, and replacement or exchange schedule.
4. For the purpose of B.6., services may include but shall not be limited to:
   1. Installation and/or servicing of radiation sources and associated radiation source components;
   2. Calibration of radiation source or radiation measurement instruments or devices;
   3. Radiation protection or health physics consultations or surveys; and
   4. Personnel dosimetry services.
   5. Leak test of sealed sources.
   6. Radon testing/mitigation.
5. No individual shall perform services which are not specifically stated for that individual on the notice of registration issued by the Agency.

Sec. B.7 Issuance of Notice of Registration

1. Upon a determination that an applicant meets the requirements of the regulations, the Agency shall issue a notice of registration.
2. The Agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant’s receipt, possession, use, and transfer of ownership responsibility of (Form R25) radiation sources as it deems appropriate or necessary.

Sec. B.8 Expiration of Notice of Registration

Except as provided by B.9.b., each notice of registration shall expire at the end of the specified day in the month and year stated therein.

Sec. B.9 Renewal of Notice of Registration

1. Application for renewal of registration shall be filed in accordance with B.5 or B.6.
2. In any case in which a registrant not less than 30 days prior to the expiration of his existing notice of registration has filed an application in proper form for renewal, such existing notice of registration shall not expire until the application status has been finally determined by the Agency.

Sec. B.10 Report of Changes

The registrant shall notify the Agency in writing before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate.

Sec. B.11 Approval Not Implied

No person, in any advertisement, shall refer to the fact that he or his facility is registered with the Agency pursuant to the provisions of B.5 or B.6, and no person shall state or imply that any activity under such registration has been approved by the Agency.

Sec. B.12 Assembler and/or Transfer Obligation[1]

1. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation sources in this State shall notify the Agency within 15 days of:
   1. The name and address of persons who have received these sources;
   2. The manufacturer, model, and serial number of each radiation sources transferred; and
   3. The date of transfer of each radiation source.
2. No person shall make, sell, lease, transfer, lend, assemble, or install radiation sources or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of the regulations.

Sec. B.13 Reciprocal Recognition of Out-of-State Radiation Sources

1. Whenever any radiation source is to be brought into the State, for any temporary use, the person proposing to bring such source into the State shall give written notice to the Agency at least 2 working days before such machine is to be used in the State. The notice shall include:
   1. The number(s) and type(s) of radiation source(s);
   2. The nature, start date, duration, and scope of use;
   3. The exact location(s) where the radiation source is to be used; and
   4. The name(s) of the Delaware licensed practitioner(s) and their professional license number(s) if the sources are used to irradiate human beings;
   5. A copy of the person’s home state registration or equivalent document; and
   6. A copy of the person’s home state registration or equivalent document; and
   7. The name(s) and address(es) where the source user(s) can be reached while in the state.
2. If, for a specific case, the 2 working-day period would impose an undue hardship on the person, upon application to the Agency, permission to proceed sooner may be granted.
3. The person referred to in B.13.a. shall:
   1. Comply with all applicable regulations of the Agency;
   2. Supply the Agency with such other information as the Agency may reasonably request; and
   3. Not operate within the state on a temporary basis in excess of 30 calendar days. Permission to operate for 30 days or more may be granted by the Agency in 30 day intervals up to 180 days.

APPENDIX A

INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS

In order for the Agency to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information must be submitted.

1. The plans showing, as a minimum, the following:
   1. The normal location of the system’s radiation port; the port’s travel and traverse limits; general direction(s) of the useful beam; location of any windows and doors or other openings; the location of the operator’s booth and the location of the control panel;
   2. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, ceiling of the room(s) concerned;
   3. The dimensions of the room(s) concerned;
   4. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show the distance to the closest area(s) where it is likely that individuals may be present;
   5. The make and model of the equipment, the maximum technique factors and the energy waveform (single phase, three phase, etc.);
   6. The type of examination(s) or treatment(s) which will be performed with the equipment.
2. Information on the anticipated workload of the system(s) in mA-minutes per week.
3. A report showing all basic assumptions used in the development of the shielding specifications.

APPENDIX B

DESIGN REQUIREMENTS FOR AN OPERATOR’S BOOTH

1. Space requirements:
   1. The operator shall be allotted not less than 0.70 m² (7.5 square feet) of unobstructed floor space in the booth;
   2. The operator’s booth may be an geometric configuration with no dimension of less than 0.6 m (2 feet);
   3. The space shall be allotted excluding an encumbrance by the x-ray control panel, such as overhang, cables or other similar encroachments;
   4. The booth shall be located or constructed such that unattended direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator’s position in the booth.
2. Structural Requirements:
   1. The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;
   2. When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;
   3. Shielding shall be provided to meet the requirements of Part D of these regulations.
3. Radiation Exposure Control Placement:
   The radiation exposure control for the system shall be fixed within the booth and:
   1. Shall be at least 1.0 m (40 inches) from any point subject to direct scatter, leakage or primary beam radiation;
   2. Shall allow the operator to use the majority of the available viewing windows.
4. Viewing System Requirements:
   1. Each booth shall have at least one viewing device which will:
      1. Be so placed that the operator can view the patient during any exposure;
      2. Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then outside that door there shall be an "x-ray on" warning sign that will be lighted anytime the rotor of the x-ray tube is activated. Alternatively, interlock shall be present such that exposures are prevented unless the door is closed.
   2. When the viewing system is a window, the following requirements also apply:
      1. The window shall have a viewing area of at least 0.09 m² (1 square foot);
      2. Regardless of size or shape, at least 0.09 m² (1 square foot) of the window area must be centered no less than 0.6 m (2 feet) from the open edge of the booth and no less than 1.5 m (5.0 feet) from the floor;
      3. The window shall have at least the same lead equivalence as that required in the booth’s wall in which it is mounted.
   3. When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of Appendix B4.(a).
   4. When the viewing system is by electronic means:
      1. The camera shall be so located as to accomplish the general requirements of Appendix B4.(a);
      2. There shall be an alternative viewing system as a backup for the primary system.