16 DE Admin. Code 4465. Delaware Radiation Control Regulations

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Delaware Administrative Code › Title 16 Health and Safety › Department of Health and Social Services › 4000 Division of Public Health › 4400 Health Systems Protection (HSP) › 16 DE Admin. Code 4465

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

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Type of Radiation | Quality Factor (Q) | Absorbed Dose Equal to a Unit Dose Equivalent a/

X, gamma, or beta radiation and high-speed electrons | 1 | 1

Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge | 20 | 0.05

Neutrons of unknown energy | 10 | 0.1

High-energy protons | 10 | 0.1

a/ Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.

Neutron Energy (MeV) | Quality Factor a/ (Q) | Fluence per Unit Dose Equivalent b/ (Neutrons cm -2 rem -1 ) | Fluence per Unit Dose Equivalent b/ (Neutrons cm -2 Sv -1 )

(thermal) | 2.5E-8 | 2 | 980E+6 | 980E+8

1E-7 | 2 | 980E+6 | 980E+8

1E-6 | 2 | 810E+6 | 810E+8

1E-5 | 2 | 810E+6 | 810E+8

1E-4 | 2 | 840E+6 | 840E+8

1E-3 | 2 | 980E+6 | 980E+8

1E-2 | 2.5 | 1010E+6 | 1010E+8

1E-1 | 7.5 | 170E+6 | 170E+8

5E-1 | 11 | 39E+6 | 39E+8

1 | 11 | 27E+6 | 27E+8

2.5 | 9 | 29E+6 | 29E+8

5 | 8 | 23E+6 | 23E+8

7 | 7 | 24E+6 | 24E+8

10 | 6.5 | 24E+6 | 24E+8

14 | 7.5 | 17E+6 | 17E+8

20 | 8 | 16E+6 | 16E+8

40 | 7 | 14E+6 | 14E+8

60 | 5.5 | 16E+6 | 16E+8

1E+2 | 4 | 20E+6 | 20E+8

2E+2 | 3.5 | 19E+6 | 19E+8

3E+2 | 3.5 | 16E+6 | 16E+8

4E+2 | 3.5 | 14E+6 | 14E+8

a/ Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

b/ Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

Dental panoramic or cephalometric X-ray

Dental Cone Beam Computed Tomography (CT)

Stationary radiographic or fluoroscopic X-ray

Mobile x-ray machine used routinely in 1 location

Computed Tomography (CT) scanner

Mammography

Linear Accelerator or other therapy machine

Dental intraoral (eg. bitewing, periapicals)

Bone densitometry

Podiatry

Mini C-Arm (eg. Orthopedic)

The existence of 3 or more Severity Level 1 items.

Failure to correct any Severity Level 1 item within 30 days.

The absence of a licensed practitioner in a healing arts facility.

The absence of a radiation safety officer.

Severity Level 1 | Severity Level 2

ear Accelerator or other therapy machine

Dental intraoral (eg. bitewing, periapicals)

Bone densitometry

Podiatry

Mini C-Arm (eg. Orthopedic)

The existence of 3 or more Severity Level 1 items.

Failure to correct any Severity Level 1 item within 30 days.

The absence of a licensed practitioner in a healing arts facility.

The absence of a radiation safety officer.

Severity Level 1 | Severity Level 2

1. | Operating without a permit | 1. | Registration Form

2. | Personnel Overexposure | 2. | Notice to Employees

3. | Radiation Levels Excessive | 3. | Safety Procedures

4. | Personnel Monitoring | 4. | Personnel Monitoring Records

Severity Level 1 | Severity Level 2

1. | Patient exposure (ESE) | 12.

2. | Tube support | 13. | Maintenance of x-ray system records

3. | Technique indicators | 14. | Speed of film/screen

4. | Multiple tube indication | 15. | Technique chart

5. | Gonadal shielding | 16. | Warning label

6. | Operator apron/barrier | 17. | Patient dose of 1 gray (100 rads) or more not reported to the Agency

Severity Level 1 | Severity Level 2

1. | Location of x-ray controls | 1. | Visual/audio signal

2. | Position indicating device | 2. | Adjustment of X-ray field

3. | Beam Collimation | 3. | Indication of field size, upon adjustments,

4. | Filtration deficiency of 0.2+ mm | 4. | Means to limit source to skin distance

5. | Variation in timer linearity of 15% or more | 5. | Filtration deficiency of 0.2 mm or less

6. | Variation in exposure reproducibility of 15% or more | 6. | Variation in timer reproducibility linearity more that 10% but less than 15%

7. | Total misalignment of X-ray/light field edges of 5% or more | 7. | Variation in exposure reproducibility more than 5% but less than 10%

8. | Total misalignment of X-ray beam/image receptor centers of 5% or more ) | 8. | Total misalignment of light/X-ray field edges more than 2% but less than 5%

9. | Discorrespondence of indicated X-ray field with beam limited X-ray field of 5% or more | 9

15%

7. | Total misalignment of X-ray/light field edges of 5% or more | 7. | Variation in exposure reproducibility more than 5% but less than 10%

8. | Total misalignment of X-ray beam/image receptor centers of 5% or more ) | 8. | Total misalignment of light/X-ray field edges more than 2% but less than 5%

9. | Discorrespondence of indicated X-ray field with beam limited X-ray field of 5% or more | 9. | Total misalignment of X-ray beam/image receptor centers more than 2% but less than 5%

10. | Discorrespondence of indicated X-ray with beam limited X-ray field more than 2% but less than 5%

Severity Level 1 | Severity Level 2

1. | Activation of X-ray production | 1. | Posting of exposure rate measurements

2. | Annual exposure rate measurement | 2. | Measurement records and posting of same

3. | Exposure rate | 3. | Adjustment of field

4. | Useful beam protective barrier | 4. | Means of field adjustment

5. | Limitation of X-ray field to image receptor | 5. | Indication of kV and mA

6. | Minimum field at maximum SID | 6. | Means to indicate that beam is perpendicular to image receptor

7. | High level control exposure rate limit | 7. | Audible signal to reset

8. | Timing device | 8. | Minimum source to skin distance

9. | Control of scattered radiation | 9. | Exposure rate due to transmission through primary barrier

10. | Failure to report patient dose of 1+ gray to the Agency

Severity Level 1 | Severity Level 2

1. > 2 mR/hr. | Failure to maintain radiation level from device < 4" in diameter below maximum allowable limit of 50 mR/hr. at 6" | < 2 mR/hr.

2. > 2 mR/hr. | Failure to maintain radiation level from device > 4" diameter below maximum allowable limit of 200 mR/hr. at surface | < 2 mR/hr.

3. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 200 mR/hr. at the surface | < 2 mR/hr.

4. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 10 mR/hr. at a distance of 1 meter | < 2 mR/hr.

Locking of Source

diameter below maximum allowable limit of 200 mR/hr. at surface | < 2 mR/hr.

3. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 200 mR/hr. at the surface | < 2 mR/hr.

4. > 2 mR/hr. | Failure to maintain radiation level from storage container below maximum allowable limit of 10 mR/hr. at a distance of 1 meter | < 2 mR/hr.

Locking of Source

5. | Radiation Source Storage Container was found unlocked and not under the direct surveillance of authorized individual

6. | Exposure device and/or storage container was not locked during transit or prior to unit being made secure

7. | Device was not physically secured to prevent tampering or removal

Severity Level 1 | Severity Level 2

1. | Failure to adequately maintain survey instruments | 1. | Failure to possess calibrated back up instrument

2. | Survey meter not capable of detecting 2-1000 mR/hr. | 2. | Failure to conduct quarterly calibrations

3. | Failure to calibrate unit after servicing

4. | Failure to achieve accuracy of (+ 20%)

5. | Failure to calibrate each scale using 2 points other than zero

6. | Failure to maintain calibration records for 2 years

Severity Level 1 | Severity Level 2

1. | Service to sealed source not conducted by authorized individual | 1. | Failure to conduct leak test within 6 month interval

2. | Failure to immediately withdraw contaminated unit from service to effect decontamination/repair | 2. | Leak test procedure not capable of detecting unit 0.005 uCi of removable contamination

3. | Failure to properly label unsecured source | 3. | Failure to record test results in microcuries

4. | Failure to notify agency within 5 days of receiving test results

Severity Level 1 | Severity Level 2

1. | Failure to perform quarterly operational safety maintenance and inspection | 1. | Failure to conduct quarterly inventory

2. | Failure to withdraw defective unit from service | 2. | Failure to maintain utilization log

unsecured source | 3. | Failure to record test results in microcuries

4. | Failure to notify agency within 5 days of receiving test results

Severity Level 1 | Severity Level 2

1. | Failure to perform quarterly operational safety maintenance and inspection | 1. | Failure to conduct quarterly inventory

2. | Failure to withdraw defective unit from service | 2. | Failure to maintain utilization log

3. | Failure to conduct and record alarm tests at the beginning of each period of use | 3. | Failure to log required information

4. | Failure to properly document quarterly inspection and maintenance of radiation devices

5. | Failure to record and maintain test results

Severity Level 1 | Severity Level 2

1. | Individual is not qualified Industrial Radiographer | 1. | Failure to maintain training and test records

2. | Individual is not a qualified radiographer's assistant trainee | 2. | Failure to record dosimetry data

3. | Qualified operator(s) not wearing personal monitoring devices

4. | Operating and Emergency procedures do not meet the requirements

Severity Level 1 | Severity Level 2

1. | Failure of qualified operators to maintain direct surveillance | 1. | Failure to post required information

2. | Failure to have calibrated and operable survey instrument available | 2. | Failure to maintain survey records for 2 years

3. | Failure to conduct physical radiation survey

4. | Failure to maintain records at temporary job site

Severity Level 1 | Severity Level 2

1. | Failure to meet requirements for enclosed radiography | 1. | Failure to maintain evaluation records for 2 years

2. | Failure to meet exemption requirements and maintain unit

Severity Level 1 | Severity Level 2

1. | Failure to provide safety device | 1. | Failure to label equipment

2. | Failure to provide warning devices | 2. | Failure to have appropriate warning lights

3. | Failure to install shutter | 3. | Failure to provide protective cabinet to prevent leakage

4. | Failure to construct tube housing in manner which ensures compliance | 4

quirements and maintain unit

Severity Level 1 | Severity Level 2

1. | Failure to provide safety device | 1. | Failure to label equipment

2. | Failure to provide warning devices | 2. | Failure to have appropriate warning lights

3. | Failure to install shutter | 3. | Failure to provide protective cabinet to prevent leakage

4. | Failure to construct tube housing in manner which ensures compliance | 4. | Failure to conduct Radiation Surveys

5. | Failure to obtain radiation safety officer's approval for by-passing safety device | 5. | Failure to document survey record

6. | Failure to provide and/or ensure the use of extremity dosimeters | 6. | Failure to post area

7. | Failure to instruct and/or ensure operator competence | 7. | Failure to secure unused ports

Severity Level 1 | Severity Level 2

1. | Operator did not receive radiation safety instruction or could not demonstrate understanding of radiation safety | 1. | Operator had not received copies

2. | Operator unable to demonstrate competency in the use of the accelerator | 2. | Radiation Safety Committee/Radiation Safety Officer is not authorized to terminate operations

Severity Level 1 | Severity Level 2

1. | HRA not provided with Interlock | 1. | Instrumentation and controls are not clearly identified

2. | Interlock does not require manual reset | 2. | Scram buttons do not require manual reset

3. | Safety interlocks not independently wired | 3. | Not all HRA entrances are equipped with warning lights

4. | All safety interlocks are not fail safe | 4. | Not all HRA are equipped with audible warning devices which activate for 15 seconds

5. | Scram buttons not located in HRA | 5. | HRA barriers/pathways are not identified

Severity Level 1 | Severity Level 2

1. | Particle accelerator not unsecured from unauthorized use

2. | Bypass of safety interlock not authorized by radiation safety officer and/or Radiation Safety Committee or not recorded and posted | 2. | Safety interlocks are used as routine "off" switch

ivate for 15 seconds

5. | Scram buttons not located in HRA | 5. | HRA barriers/pathways are not identified

Severity Level 1 | Severity Level 2

1. | Particle accelerator not unsecured from unauthorized use

2. | Bypass of safety interlock not authorized by radiation safety officer and/or Radiation Safety Committee or not recorded and posted | 2. | Safety interlocks are used as routine "off" switch

3. | Electrical circuit diagram not maintained and available

4. | Current operating and emergency procedures are not kept at control panel

5. | Record of quarterly safety device operability check are not available

Severity Level 1 | Severity Level 2

1. | Radiation protection survey not performed and/or documented by an approved person following operation or facility changes | 1. | Portable monitoring equipment not available, operable and calibrated

2. | Radiation levels not continuously monitored in all HRAs | 2. | All area monitors are not calibrated annually

3. | Periodic surveys of airborne particulates are not performed

4. | Periodic Smear Surveys are not conducted for contamination

5. | All area surveys are not performed according to proper written procedures

6. | Current records of all surveys and tests were not available at facility

Severity Level 1

1 . | Means are not provided to ensure compliance with Part D airborne concentrations

2. | Airborne concentrations in excess of Part D limits were discharged to an uncontrolled area

Severity Level 1 | Severity Level 2

2. | Facility radiation permit/document not posted

3. | Radiation operating procedures not posted

4. | Notice of violation for radiological working conditions not posted

5. | Notice to employees, Agency Form X not posted

6. | Violations not posted within 5 days nor remain posted for at least 5 days

7. | Documents do not appear in sufficient number of conspicuous places

Severity Level 1 | Severity Level 2

1. | Workers were not instructed to report any conditions that could cause unnecessary exposure to radiation | 1

on for radiological working conditions not posted

5. | Notice to employees, Agency Form X not posted

6. | Violations not posted within 5 days nor remain posted for at least 5 days

7. | Documents do not appear in sufficient number of conspicuous places

Severity Level 1 | Severity Level 2

1. | Workers were not instructed to report any conditions that could cause unnecessary exposure to radiation | 1. | Workers were not kept informed of radiation sources

2. | Workers were not instructed about warnings for unusual occurrence or malfunction that may involve exposure to radiation | 2. | Workers were not instructed of health protection problems associated with radiation exposure

3. | Workers were not advised of radiation exposure reports | 3. | Workers were not instructed to observe applicable parts of DRCR

Severity Level 1 | Severity Level 2

1. | Written report of specified Radiation exposure data are not given to the worker | 1. | Workers are not advised annually of their radiation exposure

2. | Workers are not furnished a radiation exposure report within 30 days after the licensee becomes informed of exposure or termination of employment | 2. | As required pursuant to Part D, Sections 46.0, 47.0 and 48.0 exposed individuals are not provided a report of their radiation exposure

Severity Level 1

1. | Agency not afforded opportunity to inspect equipment and activities

2. | Agency not permitted to consult with workers privately

3. | Worker authorized representative not given opportunity to accompany agency during inspection of physical working conditions

4. | Worker representative does not meet qualifications set forth in routine radiation

5. | Different facility/worker representatives not permitted to accompany agency on inspection

6. | Mutually agreed upon "outside" individual(s) was not permitted to accompany agency inspectors

7. | Worker(s) was not allowed to privately consult with the Agency inspector about perceived radiological condition

4. | Worker representative does not meet qualifications set forth in routine radiation

5. | Different facility/worker representatives not permitted to accompany agency on inspection

6. | Mutually agreed upon "outside" individual(s) was not permitted to accompany agency inspectors

7. | Worker(s) was not allowed to privately consult with the Agency inspector about perceived radiological condition

8. | A worker has been discharged or discriminated against for filing a radiological complaint on behalf of himself or others

Severity Level 1 | Severity Level 2

1. | All non-compliance with the requirements of Part X are Severity Level 1 violations.

Part A General Provisions

1.0 Purpose and Scope

Except as otherwise specifically provided, this regulation applies to all persons who receive, possess, use, transfer, own, or acquire any source of ionizing radiation. However, nothing in this regulation except for registration of radiation machine facilities/sources as specified in Regulation 4465 Part B shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission. See 4465 Parts C & G of this regulation which pertain to radioactive materials licensing and federal oversight.

2.0 Definitions

As used in this regulation, these terms have the definitions set forth below. Additional definitions used only in a certain Part will be found in that Part.

" A1 " means the maximum activity of special form radioactive material permitted in a Type A package. "A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

" Absorbed dose " means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad

tive material, permitted in a Type A package. These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

" Absorbed dose " means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

" Accelerator " means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

" Accelerator-produced material " means any material made radioactive by a particle accelerator.

" Activity " means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“ Address of use ” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

" Adult " means an individual 18 or more years of age.

“ Agency ” means the Division of Public Health, Delaware Department of Health and Social Services.

" Agreement state " means any state with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

" Airborne radioactive material " means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

" Airborne radioactivity area " means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of this regulation; or

borne radioactive material " means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

" Airborne radioactivity area " means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of this regulation; or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC-hours.

" Airline respirator " (see "Supplied-air respirator (SAR)").

" Air-purifying respirator " means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

" ARRT " means the American Registry of Radiologic Technologists.

“ As low as is reasonably achievable " (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

" Assigned Protection Factor (APF) " means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF

sed or registered sources of radiation in the public interest.

" Atmosphere-supplying respirator " means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“ Authorized user ” means a practitioner of the healing arts who is identified as an authorized user on an agency, agreement state, licensing state or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

" Background radiation " means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

" Becquerel " (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

" Bioassay " means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this regulation, "radiobioassay" is an equivalent term

or transformation per second (dps or tps).

" Brachytherapy " means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

" Byproduct material " means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

" Calendar quarter " means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

" Calibration " means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

" CBRPA " means Certification Board for Radiology Practitioner Assistants.

" CFR " means Code of Federal Regulations.

“ Chiropractic ” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code , Chapter 7 , Board of Chiropractic, as amended

th of a source of radiation relative to a standard.

" CBRPA " means Certification Board for Radiology Practitioner Assistants.

" CFR " means Code of Federal Regulations.

" Collective dose " means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

" Committed dose equivalent " (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

" Committed effective dose equivalent " (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (H E,50 = Σ w T H T,50 ).

“ Controlled area ” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“ Critical group ” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

" Curie " means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

" Deep dose equivalent " (H d ), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm 2 )

licable set of circumstances.

" Deep dose equivalent " (H d ), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm 2 ).

" Demand respirator " means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“ Dentist ” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

" Department of Energy " means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq ., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

" Depleted uranium " means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“ Discrete source ” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities

leted uranium " means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“ Discrete source ” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

" Disposable respirator " means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

" Distinguishable from background " means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

" Dose " is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of this regulation, "radiation dose" is an equivalent term.

" Dose equivalent (HT) " means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

" Dose limits " means the permissible upper bounds of radiation doses established in accordance with this regulation. For purposes of this regulation, "limits" is an equivalent term

Dose equivalent (HT) " means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

" Dose limits " means the permissible upper bounds of radiation doses established in accordance with this regulation. For purposes of this regulation, "limits" is an equivalent term.

" Effective dose equivalent (HE) " means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

" Embryo/fetus " means the developing human organism from conception until the time of birth.

" Exposure " generally means being exposed to ionizing radiation or to radioactive material;

" Exposure rate " means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

" Exposure units " specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Part A, Section 9.0 of this Part for Units of Exposure and Dose.

" External dose " means that portion of the dose equivalent received from any source of radiation outside the body.

" Extremity " means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“ Facility ” means the location, building vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

" Filtering facepiece (dust mask) " means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

" Fit factor " means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn

art of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

" Fit Test " means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

" Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities " means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

" Generally applicable environmental radiation standards " means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

" Gray " (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

" Hazardous waste " means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“ Healing arts ” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing

gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

" Hazardous waste " means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“ Healing arts ” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

“ Healing arts screening ” means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.

" Helmet " means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

" High radiation area " means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

" Hood " means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

" Human use " means the internal or external administration of radiation or radioactive material to human beings.

" Individual " means any human being.

" Individual monitoring " means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(2) Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. [See the definition of DAC-hours in 4465 Part D of this regulation.]

ividual monitoring " means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(3) Dose equivalent by the use of survey data.

" Individual monitoring devices " means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

" Inspection " means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

" Instrument traceability " (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

" Interlock " means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

" Internal dose " means that portion of the dose equivalent received from radioactive material taken into the body.

" JRCECT " means Joint Review Committee on Education in Cardiovascular Technology

international program.

" Interlock " means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

" Internal dose " means that portion of the dose equivalent received from radioactive material taken into the body.

" JRCECT " means Joint Review Committee on Education in Cardiovascular Technology.

" JRCERT " means Joint Review Committee on Education in Radiologic Technology.

“ JRCNMT ” means Joint Review Committee on Nuclear Medicine Technology.

" Lens dose equivalent (LDE) " means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm 2 ).

" License " means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.

" Licensed practitioner " means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

" Licensed [or registered] material " means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

" Licensee " means the holder of a license.

" Limits " [See "Dose limits"].

" Loose-fitting facepiece " means a respiratory inlet covering that is designed to form a partial seal with the face.

" Lost or missing source of radiation " means licensed [or registered] source of radiation whose location is unknown

r disposed of under a general or specific license [or registration] issued by the Agency.

" Licensee " means the holder of a license.

" Limits " [See "Dose limits"].

" Loose-fitting facepiece " means a respiratory inlet covering that is designed to form a partial seal with the face.

" Lost or missing source of radiation " means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

" Major processor " means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.

" Member of the public " means any individual except when that individual is receiving an occupational dose.

" Minor " means an individual less than 18 years of age.

“ Misadministration ” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, subsection 5.2 of this regulation.

" Monitoring " means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this regulation, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

" Natural radioactivity " means radioactivity of naturally occurring nuclides.

" Negative pressure respirator (tight fitting) " means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

" NORM " means any naturally occurring radioactive material

iation protection monitoring" are equivalent terms.

" Natural radioactivity " means radioactivity of naturally occurring nuclides.

" NORM " means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

" NRC " means the US Nuclear Regulatory Commission or its duly authorized representatives.

“ Notice of Violation ” means a written statement of 1 or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

(1) Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

(2) Corrective steps to be taken to prevent recurrence; and

(3) The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

" Occupational dose " means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“ Office of Engineering ” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms

and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“ Office of Radiation Control ” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

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

" Package " means the packaging together with its radioactive contents as presented for transport.

" Particle accelerator " [See "Accelerator"].

" Person " means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

" Personnel monitoring equipment " [See "Individual monitoring devices"].

" Physician " means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“ Podiatrist ” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

" Positive pressure respirator " means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator

ine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“ Podiatrist ” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

" Positive pressure respirator " means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

" Powered air-purifying respirator (PAPR) " means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

" Pressure demand respirator " means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“ Principal supervisor ” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

" Protective apron " means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

" Public dose " means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

ve material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

“ Qualified expert ” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of this regulation, as amended.

" Qualified medical physicist (QMP) " means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

" Qualitative fit test (QLFT) " means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

" Quality factor " (Q) means the modifying factor, listed in Tables I and II of Part A, Section 13.0, that is used to derive dose equivalent from absorbed dose

lation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

" Qualitative fit test (QLFT) " means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

" Quality factor " (Q) means the modifying factor, listed in Tables I and II of Part A, Section 13.0, that is used to derive dose equivalent from absorbed dose.

" Quantitative fit test (QNFT) " means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

" Rad " means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

" Radiation " means alpha particles, beta particles, gamma rays, X-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of this regulation, ionizing radiation is an equivalent term. Radiation, as used in this regulation, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

" Radiation area " means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

" Radiation dose " [See "Dose"].

" Radiation machine " means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

“ Radiation safety officer ” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned

with radioactive material as the only source of radiation.

" Radiation technician " means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

" Radiation technologist " means any individual who has successfully completed a JRCERT or JRCNMT approved program in radiation technology and has passed a national certification examination in his or her field of specialization.

" Radiation technology " means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

" Radioactive material " means any solid, liquid or gas which emits radiation spontaneously.

" Radioactivity " means the transformation of unstable atomic nuclei by the emission of radiation.

" Radiobioassay " [See "Bioassay"].

" Radiologist " means a physician specializing in radiology certified by or board-eligible for the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Radiologists, or the Royal College of Physicians and Surgeons of Canada.

" Radiologist assistant " or " RA " means a radiation technologist who has successfully completed an ARRT recognized program for radiologist assistants and has passed the ARRT registered radiologist assistant examination or the CBRPA radiology practitioner assistant examination.

" Registrant " means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this regulation and the Act.

" Registration " means registration with the Agency in accordance with the regulations adopted by the Agency

nts and has passed the ARRT registered radiologist assistant examination or the CBRPA radiology practitioner assistant examination.

" Registrant " means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this regulation and the Act.

" Registration " means registration with the Agency in accordance with the regulations adopted by the Agency.

" Regulations of the Department of Transportation " means the regulations in 49 CFR Parts 100-189, as amended.

" Rem " means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

" Research and development " means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.

" Residual radioactivity " means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of this regulation.

" Restricted area " means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation

result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of this regulation.

" Restricted area " means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

" Roentgen " means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A, subsection 9.1).

" Sealed source " means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

" Sealed Source and Device Registry (SSD) " means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

" Self-contained breathing apparatus (SCBA) " means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

" Shallow dose equivalent " (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm 2 ) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

" SI " means the abbreviation for Standard Internationale, the International Metric System of Measurement.

" Sievert " means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

" Source material " means:

kin receiving the highest exposure.

" SI " means the abbreviation for Standard Internationale, the International Metric System of Measurement.

" Source material " means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or

(2) Ores that contain by weight 1/20 of 1.0% (0.05%) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

" Source material milling " means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

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

" Source traceability " means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

" Special form radioactive material " means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least 1 dimension not less than 5 millimeters (0.2 inch); and

dards and Technology or other equivalent national or international program.

" Special form radioactive material " means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least 1 dimension not less than 5 millimeters (0.2 inch); and

(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

" Special nuclear material " means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

" Special nuclear material in quantities not sufficient to form a critical mass " means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1

ies not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

“ Standard Internationale (SI) ” means the international metric systems of measurement.

“ State Radiation Control Act ” or “ the Act ” means Title 16 Delaware Code , Chapter 74 , Radiation Control, as amended.

" Supplied-air respirator (SAR) " means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

" Survey " means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

" Test " means the process of verifying compliance with an applicable regulation.

" These regulations " means all parts of The Delaware Radiation Control Regulations 4465, as amended.

" Tight-fitting facepiece " means a respiratory inlet covering that forms a complete seal with the face.

" Total effective dose equivalent " (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

" Total organ dose equivalent " (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in Part D, subsection 39.1.6 of this regulation.

" Traceable to a National Standard " [See "Instrument traceability" or "Source traceability"]

or external exposures and the committed effective dose equivalent for internal exposures.

" Traceable to a National Standard " [See "Instrument traceability" or "Source traceability"].

" Unrefined and unprocessed ore " means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

" Unrestricted area " means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of this regulation, "uncontrolled area" is an equivalent term.

" User seal check (fit check) " means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

" Very high radiation area " means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.

“ Veterinarian ” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code , Chapter 33 , Veterinarians, as amended.

ee in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code , Chapter 33 , Veterinarians, as amended.

" Waste " means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

" Waste handling licensees " mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

" Week " means 7 consecutive days starting on Sunday.

" Whole body " means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

" Worker " means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

" Working level " (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

" Working level month " (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month

tial alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

" Working level month " (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

" Year " means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

22 DE Reg. 401 (11/01/18)

23 DE Reg. 306 (10/01/19)

28 DE Reg. 312 (10/01/24)

3.0 Exemptions from the Regulatory Requirements

3.1 Exemptions. An exemption may be granted by the Agency if, based on documented and publicly available information, the Agency has verified that the proposed exempted practice or equipment does not pose any danger to the applicant, his employees or any others coming into contact with the exempted practice or equipment. An exemption request that deviates from accepted standards as specified in the regulations, such that the safe use of said practice or equipment cannot be supported by extraneous documented and publicly available information must be referred to the Authority on Radiation Protection for consideration.

3.1.1 General Provision. The Agency as the Agent for the Authority on Radiation Protection may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of the regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

3.1.2 Department of Energy Contractors and Nuclear Regulatory Commission Contractors

ision. The Agency as the Agent for the Authority on Radiation Protection may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of the regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

3.1.2 Department of Energy Contractors and Nuclear Regulatory Commission Contractors. Any Department of Energy contractor or subcontractor and any Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from the regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:

3.1.2.1 Prime contractors performing work for the Department of Energy at U.S. Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

3.1.2.2 Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;

3.1.2.3 Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

3.1.2.4 Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the State and the Nuclear Regulatory Commission jointly determine:

3.1.2.4.1 That the exemption of the prime contractor or subcontractor is authorized by law; and

3.1.2.4.2 That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

4.0 General Regulatory Requirements

4.1 Records

the State and the Nuclear Regulatory Commission jointly determine:

3.1.2.4.1 That the exemption of the prime contractor or subcontractor is authorized by law; and

3.1.2.4.2 That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

4.0 General Regulatory Requirements

4.1 Records. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in the regulations.

4.2 Inspections

4.2.1 Each licensee and registrant shall afford the Agency at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

4.2.2 Each licensee and registrant shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to the regulations.

4.3 Tests. Each licensee and registrant shall perform upon instructions from the Agency, or shall permit the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary including, but not limited to, tests of:

4.3.1 Sources of radiation;

4.3.2 Facilities wherein sources of radiation are used or stored;

4.3.3 Radiation detection and monitoring instruments; and

4.3.4 Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

5.0 Additional Regulatory Requirements

The Authority through the Agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in the regulations as it deems appropriate or necessary to minimize danger to public health and safety or property.

6.0 Enforcement Requirements

6.1 Violations

censed or registered sources of radiation.

5.0 Additional Regulatory Requirements

6.0 Enforcement Requirements

6.1 Violations. An injunction or other court order may be obtained prohibiting any violation of any provision of the State Radiation Control Act, as amended or any regulation or order issued thereunder. The Authority may request the Attorney General to make application to the Court of Chancery for an order enjoining any acts or practices which constitute or will constitute a violation of any provision of this chapter or any rule, regulation or order issued thereunder.

6.2 Impounding. Sources of radiation shall be subject to impoundment pursuant to Title 16 Delaware Code , Section 7415 of the State Radiation Control Act, as amended.

6.3 Prohibited Uses

6.3.1 A hand-held fluoroscopic screen shall not be used with X-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.

6.3.2 A shoe-fitting fluoroscopic device shall not be used.

6.3.3 A closed end PID (conical position indicating device) shall not be used.

6.3.4 A source of radiation shall not be abandoned.

6.4 Penalties. In addition to any other remedies available to the Authority – the Authority may assess an administrative penalty in an amount not to exceed $500 for a first offense, an amount not to exceed $750 for a subsequent offense. Each violation of this chapter or rules, regulations or orders shall be considered a separate offense

be used.

6.3.4 A source of radiation shall not be abandoned.

7.0 Interpretations

Except as specifically authorized by the Agency in writing, no interpretation of the regulations by an officer or employee of the Agency other than a written interpretation by the Authority on Radiation Protection will be recognized to be binding upon the Agency.

8.0 Communications

All communications and reports concerning the regulations, and applications filed thereunder, should be addressed to the Agency at its Office of Radiation Control, Division of Public Health, 417 Federal Street, Dover, DE 19901.

9.0 Units of Exposure and Dose

9.1 As used in these regulations, the unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58E-4 coulomb per kilogram of air.

9.2 As used in these regulations, the units of dose are:

9.2.1 Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

9.2.2 Rad is the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram. (0.01 Gy)

9.2.3 Rem is the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

9.2.4 Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor

(0.01 Gy)

9.2.4 Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

9.3 As used in this regulation, the quality factors for converting absorbed dose to dose equivalent are shown in Table I:

9.4 If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in Part A, subsection 9.3, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

10.0 Units of Activity

10.1 For purposes of this regulation, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time.

10.2 One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

10.3 One curie (Ci) = 3.7E+10 disintegrations or transformations per second (dps or tps) = 3.7E+10 becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (dpm or tpm).

17 DE Reg

(Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time.

10.2 One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

10.3 One curie (Ci) = 3.7E+10 disintegrations or transformations per second (dps or tps) = 3.7E+10 becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (dpm or tpm).

17 DE Reg. 983 (04/01/14)

Part B Registration of Radiation Source Facilities and Services

1.0 Purpose and Scope

This Part provides for:

1.1 The registration of ionizing radiation source facilities, and

1.2 The registration of persons providing ionizing radiation source installation, servicing, and/or other services listed in this Part.

1.3 In addition to the requirements of this Part, all registrants are subject to the applicable provisions of the General Provisions (4465, Part A), Standards for Protection (4465, Part D), and Notices, Instructions and Reports (4465, Part J) and Compliance Procedures (4465, Part K). In addition, some registrants are subject to provisions of the regulations for Industrial Radiography (4465, Part E), Diagnostic X-Rays and Imaging Systems in the Healing Arts (4465, Part F), Analytical Equipment (4465, Part H) or Particle Accelerators (4465, Part I) and Therapeutic Radiation Machines (4465, Part X).

2.0 Definitions

“ Agency ” means the Division of Public Health, Delaware Department of Health and Social Services.

“ Certificate of Approval to Construct ” means a document stipulating that work will be done in accordance to the plans and specifications as approved by the Office of Engineering. If at any point after the issuance of a certificate of Approval To Construct there are any changes made to the plans, the Office of Engineering must be immediately notified for them to take appropriate action

Services.

“ Certificate of Approval to Operate ” means a document indicating that requirements for operation of a new radiation machine facility have been approved by the Office of Radiation Control, following a pre-operational, on-site inspection.

“ CFR ” means Code of Federal Regulations.

“ Chiropractic ” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per 24 Del.C. Ch. 7 , Board of Chiropractic, as amended.

“ Dentist ” shall mean a person who is qualified to practice dentistry as prescribed in 24 Del.C. Ch. 11 , Dentistry and Dental Hygiene, as amended.

“ Facility ” means the location, building, vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

“ Healing arts ” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, veterinary medicine or nursing.

“ kVP ” or Peak Tube Potential, means the maximum value of the potential difference across the X-ray tube during an exposure. This value is usually included in manufacturer’s technical specification for an X-ray device.

an X-ray device.

" Licensed practitioner " means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients, in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

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

“ Office of Engineering ” means the office in the Delaware Division of Public Health which reviews radiation shielding plans, and issues approval for construction of new radiation machine facilities or rooms.

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

" Physician " means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to 24 Del.C. Ch. 17 , Medical Practice Act, as amended.

“ Podiatrist ” means a person who is qualified to practice podiatry and is licensed under 24 Del.C. Ch. 5 , Podiatry, as amended.

“ Principal supervisor ” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts

d certified to practice medicine pursuant to 24 Del.C. Ch. 17 , Medical Practice Act, as amended.

“ Podiatrist ” means a person who is qualified to practice podiatry and is licensed under 24 Del.C. Ch. 5 , Podiatry, as amended.

“ Principal supervisor ” means the licensed practitioner responsible for initiating use of X-ray equipment or other device generating ionizing radiation in the healing arts.

" Qualified medical physicist (QMP )" means an individual who meets each of the following credentials:

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“ Radiation source ” see source of radiation

ification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

“ Radiation source ” see source of radiation.

“ Radiation safety officer ” or RSO for a radiation machine facility means an individual assigned to perform radiation safety duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

“ Radiation service provider ” means company or person who provides radiation services to registered radiation source facilities in Delaware, see Section 9.0 of this Part.

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

“ Veterinarian ” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per 24 Del.C. Ch. 33 , Veterinarians, as amended.

22 DE Reg. 401 (11/01/18)

23 DE Reg. 306 (10/01/19)

28 DE Reg. 312 (10/01/24)

3.0 Prohibitions

All registration permit-holders shall prohibit any person or company from furnishing radiation machine servicing or services to their radiation machine facility until such person provides evidence of registration with the Agency as a provider of services in accordance with Section, 9.0 of this Part.

28 DE Reg. 312 (10/01/24)

28 DE Reg

Reg. 306 (10/01/19)

28 DE Reg. 312 (10/01/24)

3.0 Prohibitions

28 DE Reg. 312 (10/01/24)

28 DE Reg. 667 (03/01/25)

4.0 Exemptions

4.1 Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this regulation, 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.

4.2 Radiation machines in transit or in storage incident to transit are exempt from the requirements of this Part. This exemption does not apply to the providers of radiation machines for mobile services.

4.3 Domestic television receivers, computer monitors, and electron microscopes are exempt from the registration and notification requirements of this regulation.

5.0 Shielding Plan Review

5.1 Radiation machine facilities proposed for construction, renovation, or equipment installation after the effective date of this regulation that are designed to house X-ray machines with the potential to generate radiation dose to members of the public equal to or greater than 100 millirem per year, or expose a member of the public to an exposure rate equal to or greater than 2 milliroentgen per hour shall be required to submit a radiation shielding plan prepared by a qualified expert who is registered with the Office of Radiation Control as a radiation service provider (see Section 9.0 of this part)

erate radiation dose to members of the public equal to or greater than 100 millirem per year, or expose a member of the public to an exposure rate equal to or greater than 2 milliroentgen per hour shall be required to submit a radiation shielding plan prepared by a qualified expert who is registered with the Office of Radiation Control as a radiation service provider (see Section 9.0 of this part). Radiation machine facilities or rooms which require a shielding plan include the following modalities:

5.2 New radiation machine facilities or rooms designed to house only X-ray machines that operate at maximum energy less than or equal to 70 kVP shall be exempt from the radiation shielding plan requirement; such devices include but are not limited to the following modalities:

5.2.1 Radiation machine facilities or rooms which generally do not require a shielding plan include the following modalities:

5.3 Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations utilizing ionizing radiation sources with maximum energy greater than 70 kVP shall be submitted to the Division of Public Health Office of Engineering for review and approval. The required information is listed in Appendices A and B of this Part and Regulation 4465 Part X, Appendix A, for radiation therapeutic sources.

5.4 The Agency shall require the applicant to utilize the services of a qualified expert who is registered with the Agency [see Section 9.0 of this Part] to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding information on Form R15A or equivalent to the Office of Engineering, Division of Public Health, which will review the shielding plan and if determined acceptable, will issue a Certificate of Approval to Construct letter to the applicant

[see Section 9.0 of this Part] to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding information on Form R15A or equivalent to the Office of Engineering, Division of Public Health, which will review the shielding plan and if determined acceptable, will issue a Certificate of Approval to Construct letter to the applicant.

5.5 The issuance of a Certificate of Approval to Construct by the Office of Engineering for radiation shielding 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 Regulations 4465 Part D, Sections 6.0, 11.0, 12.0, and 13.0 of these regulations.

5.6 The Office of Radiation Control, Division of Public Health shall conduct a pre-operational, on-site inspection to evaluate shielding and/or operating conditions prior to issuance of the radiation machine registration permit and Certificate of Approval to Operate.

5.7 The Certificate of Approval to Operate issued by the Office of Radiation Control reflects regulatory compliance at the time of the pre-operational inspection of a new facility, and does not imply or certify the facility beyond the scope of that specific inspection.

5.8 After installation of any radiation machine, the registrant shall maintain for inspection by the Agency:

5.8.1 The maximum rated technique factors of each machine;

5.8.2 A scale drawing of the room in which a stationary radiation machine 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

8 After installation of any radiation machine, the registrant shall maintain for inspection by the Agency:

5.8.1 The maximum rated technique factors of each machine;

5.8.2.1 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

5.8.2.2 The type and thickness of materials, or lead equivalency, of each protective barrier.

5.9 Radiation machine facilities that initiated design, construction or installation of dental panoramic, cephalometric, or cone beam CT devices prior to the effective date of this regulation shall maintain records of radiation surveys of exposure rate (milliroentgen per hour) levels present in uncontrolled public areas (ie. corridors or alcoves) where members of the public or employees may be present in the facility. If such surveys indicate an exposure rate equal to or greater than 2 millroentgen per hour is possible in uncontrolled public areas while X-ray equipment is in operation the facility shall provide administrative controls to limit the dose to members of the public with a visible barrier to delineate the controlled area.

22 DE Reg. 401 (11/01/18)

6.0 Registration of Radiation Source Facility

6.1 Each owner of a radioactive material facility shall:

6.1.1 Apply for registration of such facility with the Agency prior to the receipt, possession, use, sale, transfer, ownership or acquisition of the radioactive material. Application for registration shall be completed on forms furnished by the Agency

he controlled area.

22 DE Reg. 401 (11/01/18)

6.0 Registration of Radiation Source Facility

6.1 Each owner of a radioactive material facility shall:

6.1.2 Designate on the application form an individual to be responsible for radiation protection, duties; (radiation safety officer), 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.

6.2 Each owner of a radiation machine facility shall:

6.2.1 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;

6.2.2 Designate on the application form an individual to be responsible for radiation protection duties; (radiation safety officer); per Appendix C of this Part.

6.2.3 A licensed practitioner responsible for directing the operation of radiation machines shall be designated on each healing arts X-ray facility application, specifying their Delaware license number and phone number. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility has more than 1 licensed practitioner (for example, hospitals, large clinics, or multi-practitioner practices), except where prohibited by state law

aling arts X-ray facility application, specifying their Delaware license number and phone number. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility has more than 1 licensed practitioner (for example, hospitals, large clinics, or multi-practitioner practices), except where prohibited by state law.

6.2.4 Prohibit any person from furnishing radiation source servicing or services as described in subsection 9.4 of this Part to their radiation source facility, until such person provides evidence that they have been registered with the Agency as a radiation service provider in accordance with Section 9.0 of this Part.

6.2.5 In any facility regulated by or requiring registration under these regulations, the registration permit-holder shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine. The facility registration permit-holder shall document evaluation of the qualifications of each individual permitted to operate any radiation machine at the facility. Each operator shall meet all radiation safety training and experience requirements of the respective State of Delaware professional licensure board, as applicable, and any applicable requirements of these regulations (4465 Part B), and 4466 Radiation Technologist/Technician Certification Regulations.

7.0 Registration of Mobile Service Operations

7.1 In addition to the requirements of Section 6.0 of this Part, the applicant shall submit the following information:

7.1.1 An established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.

7.1.2 A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures

e applicant shall submit the following information:

7.1.1 An established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.

7.1.2 A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and

7.1.3 A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.

22 DE Reg. 401 (11/01/18)

8.0 Registration of Healing Arts Screening and Medical Research

8.1 In addition to the requirements of 6.0 of this Part each applicant shall apply for and receive authorization for healing arts screening before initiating a screening program. The information and evaluation in Appendix E of this part shall be submitted with the application.

8.2 In addition to the requirements of 6.0 of this Part, any research using radiation machines on humans shall be approved by an Institutional Review Board (IRB) as required by Title 45, CFR, Part 46 and Title 21, CFR, Part 56, as amended.

9.0 Application for Registration of Radiation Service Providers

9.1 Each person or company who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State shall apply for registration of such services with the Agency, and receive Agency approval prior to furnishing or offering to furnish any such services.

9.2 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

ation machine servicing or services in this State shall apply for registration of such services with the Agency, and receive Agency approval prior to furnishing or offering to furnish any such services.

9.2 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.

9.3 Each Radiation Service Provider applying for registration under this regulation shall specify:

9.3.1 That they have read and understand the requirements of this and other applicable regulations;

9.3.2 The education and training that qualify them to discharge the services for which they are applying for registration.

9.4 For the purpose of section 9.0, services may include but shall not be limited to:

9.4.1 Installation and/or servicing of radiation sources and associated radiation source components;

9.4.2 Calibration of radiation source or radiation measurement instruments or devices;

9.4.3 Radiation protection or health physics consultations or surveys;

9.4.4 Personnel dosimetry services;

9.4.5 Radiation Shielding Plans for X-Ray Rooms; or

9.4.6 Practice as a Qualified Medical Physicist.

9.5 No individual working as a Radiation Service Provider shall perform services which are not specifically authorized for that individual by the Agency.

10.0 Issuance of Notice of Registration

10.1 Upon a determination that an applicant meets the requirements of the regulations, the Agency shall issue a notice of registration, which shall be displayed by the registrant in public view.

10.2 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, sale and/or transfer of ownership responsibility of radiation sources as it deems appropriate or necessary

be displayed by the registrant in public view.

11.0 Expiration of Notice of Registration

Except as provided in Section 12.0 below, each notice of registration shall expire at the end of the specified day in the month and year stated therein.

12.0 Renewal of Notice of Registration

12.1 Application for renewal of registration shall be filed in accordance with Sections 6.0, 7.0 and/or 9.0 of this Part.

12.2 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.

13.0 Report of Changes

The registrant shall notify the Agency in writing on forms furnished by the Agency before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate. The Agency shall incorporate such changes and issue a corrected registration if necessary.

14.0 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 Sections 6.0 or 9.0, and no person shall state or imply that any activity under such registration has been approved by the Agency

er accurate. The Agency shall incorporate such changes and issue a corrected registration if necessary.

14.0 Approval Not Implied

15.0 Assembler and/or Transfer Obligation

15.1 Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation sources in this State shall notify the Agency within 15 days of:

15.1.1 The name and address of persons who have received these sources;

15.1.2 The manufacturer, model, and serial number of each radiation source transferred; and

15.1.3 The date of transfer of each radiation source.

15.1.4 In the case of diagnostic X-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic X-ray standard (21 CFR 1020.30(d)) shall be submitted to the Agency following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

15.2 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 these regulations.

16.0 Reciprocal Recognition of Out-of-State Radiation Sources

16.1 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 submit a complete, prescribed application form to the Agency and must receive Agency approval at least 2 working days before such machine is to be brought into the State. The applicant must receive Agency approval prior to use

e Radiation Sources

16.1.1 The number(s) and type(s) of radiation source(s);

16.1.2 The nature, start date, duration, and scope of use;

16.1.3 The exact location(s) where the radiation source is to be used; and

16.1.4 The name(s) of the Delaware licensed practitioner(s) and their professional license number(s) if the sources are used to irradiate human beings;

16.1.5 A copy of the person's home state registration license or equivalent document; and

16.1.6 The name(s) and address(es) where the source user(s) can be reached while in the state.

16.2 The person proposing to bring such out-of-state source into Delaware referred to in subsection 16.1 shall:

16.2.1 Comply with all applicable regulations of the Agency;

16.2.2 Supply the Agency with such other information as the Agency may reasonably request; and

16.2.3 Not operate within the state on a temporary basis in excess of 90 days. Permission to operate for more than 90 days may be granted by the Agency up to 180 days per year.

17 DE Reg. 983 (04/01/14)

22 DE Reg. 401 (11/01/18)

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 to the Office of Engineering in the Division of Public Health. The Agency may require a pre-operational inspection be conducted by the Office of Radiation Control to assure that design and operational safety requirements are met prior to approval of the radiation machine registration permit.

1. The plans showing, as a minimum, the following:

nstallation, the following information must be submitted to the Office of Engineering in the Division of Public Health. The Agency may require a pre-operational inspection be conducted by the Office of Radiation Control to assure that design and operational safety requirements are met prior to approval of the radiation machine registration permit.

1. The plans showing, as a minimum, the following:

(a) The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;

(b) The structural composition and thickness or lead equivalence of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

(d) 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 distance to the closest area(s) where it is likely that individuals may be present;

(e) The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);

(f) 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.

17 DE Reg. 983 (04/01/14)

1. Space Requirements:

(a) The operator shall be allotted not less than 0.70 m 2 (7.5 square feet) of unobstructed floor space in the booth;

(b) The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);

(c) The space shall be allotted excluding any encumbrance by the X‑ray control panel, such as overhang, cables, or other similar encroachments;

4/01/14)

1. Space Requirements:

(a) The operator shall be allotted not less than 0.70 m 2 (7.5 square feet) of unobstructed floor space in the booth;

(b) The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);

(c) The space shall be allotted excluding any encumbrance by the X‑ray control panel, such as overhang, cables, or other similar encroachments;

(d) The booth shall be located or constructed such that unattenuated 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:

(a) The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;

(b) 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. Radiation Exposure Control Placement:

The radiation exposure control for the system shall be fixed within the booth and:

(a) Shall be at least 1.0 m (40 inches) from any point subject to direct scatter, leakage or primary beam radiation;

(b) Shall allow the operator to use the majority of the available viewing windows.

4. Viewing System Requirements:

(a) Each booth shall have at least 1 viewing device which will:

(1) Be so placed that the operator can view the patient during any exposure; and

(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, an interlock shall be present such that exposures are prevented unless the door is closed.

he 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, an interlock shall be present such that exposures are prevented unless the door is closed.

(b) 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 m 2 (1 square foot);

(2) Regardless of size or shape, at least 0.09 m 2 (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.

(c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of Appendix B4.(a).

(d) 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); and

(2) There shall be an alternate viewing system as a backup for the primary system.

17 DE Reg. 983 (04/01/14)

The applicant or registration permit-holder, shall require each individual assigned to fulfill responsibilities and duties as Radiation Safety Officer (RSO) to be an individual who has training and experience in the safe and effective use of radiation machines and the potential radiation hazards and emergency precautions applicable to the type(s) of activity or facility for which the individual is seeking to perform RSO duties, to include:

I. Establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and to review them periodically to ensure that the procedures are current and conform with these regulations;

ds and emergency precautions applicable to the type(s) of activity or facility for which the individual is seeking to perform RSO duties, to include:

II. Ensuring that individual monitoring devices are properly used by occupationally exposed personnel as required by the regulations, that records are kept of the monitoring results, and that timely notifications are made as required by 4465 Part D;

III. Investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by these regulations and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence;

IV. Having a thorough knowledge of management policies, administrative procedures and records of the registration permit-holder and keeping management informed on a periodic basis of the performance of the registrant’s radiation protection program, if applicable;

V. Assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions;

VI. Maintaining records as required by these regulations; and

VII. Ensuring that personnel are adequately trained and complying with these regulations, the conditions of the certificate of registration, and the operating and safety procedures of the registered permit-holder.

17 DE Reg. 983 (04/01/14)

All persons performing radiation machine assembly, installation or repair shall meet the general requirements in subparagraph 1. of this paragraph and 1 or more of the specialized requirements in subparagraph 2. of this paragraph.

1. General requirements include:

s of the certificate of registration, and the operating and safety procedures of the registered permit-holder.

17 DE Reg. 983 (04/01/14)

1. General requirements include:

(a) Experience or education providing familiarity with the type(s) of equipment to be serviced, to include radiation safety;

(b) Knowledge of protective measures to reduce potentially hazardous conditions; and

2. Specialized requirements include:

(a) One year of formal training (may be satisfied by factory school, military technical training school, or other courses in radiation machine assembly, installation or repair techniques) or an associate's degree in biomedical equipment repair;

(b) A bachelor's degree in electrical engineering with specialized training in radiation producing devices; or

17 DE Reg. 983 (04/01/14)

The following information must be submitted by persons proposing to conduct healing arts screening. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation.

1. Administrative controls to include the following:

(a) The name and address of the applicant and, where applicable, the names and addresses of agents within the state;

(b) The diseases or conditions for which the X‑ray examinations are to be used in diagnoses;

(d) A description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;

applicable, the names and addresses of agents within the state;

(b) The diseases or conditions for which the X‑ray examinations are to be used in diagnoses;

(d) A description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;

(e) An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the X‑ray examination; and

(f) For mobile screening operations, location(s) where radiation machines are used and maintained.

2. Operating procedures for all X-ray systems (except bone densitometers) to include the following:

(a) An evaluation of the X-ray systems to be used in the screening program. The evaluation shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics. The evaluation shall show that such systems do satisfy all requirements of this section;

(b) A description of the diagnostic imaging quality control program; and

3. Operating procedures for bone densitometers to include the manufacturer's evaluation of the system to be used in the screening program. The evaluation shall show that such systems satisfy all requirements of this section.

4. Training data to include the following:

(a) The qualifications of each individual who will be operating the X‑ray systems;

(b) The qualifications of the individual who will be supervising the operators of the X‑ray systems. The extent of supervision and the method of work performance evaluation shall be specified; and

5. Records to include the following:

ons of each individual who will be operating the X‑ray systems;

(b) The qualifications of the individual who will be supervising the operators of the X‑ray systems. The extent of supervision and the method of work performance evaluation shall be specified; and

5. Records to include the following:

(a) A description of the procedures to be used in advising the individuals screened, and their private practitioners of the healing arts, of the results of the screening procedure and any further medical needs indicated; and

(b) A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the X‑ray examinations.

17 DE Reg. 983 (04/01/14)

1.0 Purpose and Scope

This part provides for the licensing of radioactive material, for purposes of protecting the public health and safety. No person shall receive, possess, use, transfer, sell, own or acquire radioactive material except as authorized in a specific or general license per the U.S. Nuclear Regulatory Commission (NRC), in accordance with Title 10 – Code of Federal Regulations. Primary radioactive material licensing and enforcement authority was transferred to the NRC in 2007, pursuant to the Federal Energy Policy Act of 2005. However, radioactive material facilities must be registered with the State of Delaware in accordance with Regulation 4465, Part B of these regulations.

22 DE Reg. 401 (11/01/18)

1.0 Purpose & General Provisions

1.1 Part D establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Agency. This regulation are issued pursuant to the Title 16, Delaware Code , Chapter 74 Radiation Control

elaware in accordance with Regulation 4465, Part B of these regulations.

22 DE Reg. 401 (11/01/18)

1.0 Purpose & General Provisions

1.2 The requirements of Part D are designed to control the receipt, possession, use, sale, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part D. However, nothing in Part D shall be construed as limiting actions that may be necessary to protect health and safety.

22 DE Reg. 401 (11/01/18)

2.0 Scope

Except as specifically provided in other Parts of this regulation, Part D applies to persons licensed or registered by the Agency to receive, possess, use, sell, transfer, or dispose of sources of radiation. The limits in Part D do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with the providers ALARA license conditions, or to voluntary participation in medical research programs.

3.0 Definitions

As used in Part D:

" A1 " means the maximum activity of special form radioactive material permitted in a Type A package.

" A2 " means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.

These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations

ity of special form radioactive material permitted in a Type A package.

" A2 " means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.

These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

“ Absorbed dose ” means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

“ Accelerator ” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, " particle accelerator " is an equivalent term.

“ Accelerator-produced material ” means any material made radioactive by a particle accelerator.

“ Activity ” means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“ Address of use ” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

" Adult " means an individual 18 or more years of age.

“ Agency ” means the Division of Public Health, Delaware Department of Health and Social Services.

“ Agreement state ” means any state with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

“ Airborne radioactive material ” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

“ Airborne radioactivity area ” means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

ered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

“ Airborne radioactive material ” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

“ Airborne radioactivity area ” means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of these regulations; or

“ Airline respirator ” (see " Supplied-air respirator (SAR) ").

“ Air-purifying respirator ” means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

“ Annual limit on intake (ALI) ” means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent to 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B of this regulation

r ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent to 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B of this regulation.

“ As low as is reasonably achievable ” (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

“ Assigned protection factor (APF) ” means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

“ Atmosphere-supplying respirator ” means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“ Authorized user ” means a practitioner of the healing arts who is identified as an authorized user on an Agency, agreement state, licensing state or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material

from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“ Background radiation ” means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. " Background radiation " does not include sources of radiation from radioactive materials regulated by the Agency.

" Becquerel " (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

" Byproduct material " means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

ch radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

" Byproduct material " means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

urce material, that—

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

“ Calendar quarter ” means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

“ Calibration ” means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

“ CFR ” means Code of Federal Regulations.

“ Class (or lung class or inhalation class) ” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days

amended.

“ Collective dose ” means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

“ Committed dose equivalent ” (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

“ Committed effective dose equivalent ” (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (H E,50 = Σ w T H T,50 ).

“ Constraint (dose constraint) ” means a value above which specified licensee actions are required.

“ Controlled area ” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“ Critical group ” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

“ Curie ” means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

“ Declared pregnant woman ” means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant

radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

“ Deep dose equivalent ” (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

“ Demand respirator ” means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“ Dentist ” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code , Chapter 11, Dentistry and Dental Hygiene, as amended.

“ Department of Energy ” means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq ., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

gy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

“ Derived air concentration (DAC) ” means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of 1 ALI. DAC values are given in Appendix B of this regulation.

“ Discrete Source ” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

" Dose " is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, " radiation dose " is an equivalent term

s, in similar materials using adequate measurement technology, survey, and statistical techniques.

" Dose " is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, " radiation dose " is an equivalent term.

" Dose limits " means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of this regulation, " limits " is an equivalent term.

" Embryo/fetus " means the developing human organism from conception until the time of birth.

" Exposure " generally means being exposed to ionizing radiation or to radioactive material.

" Exposure rate " means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

" Exposure units " specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section 9.1 of Part A for Units of Exposure and Dose.

" External dose " means that portion of the dose equivalent received from any source of radiation outside the body.

“ External source ” means all ionizing radiation sources that could present exposure or external dose to an individual.

" Extremity " means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“ Facility ” means the location, building vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used

on outside the body.

“ External source ” means all ionizing radiation sources that could present exposure or external dose to an individual.

" Extremity " means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“ Facility ” means the location, building vehicle, or complex under 1 administrative control, at which 1 or more radiation sources are installed, located and/or used.

" Fit test " means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

" Gray " (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad)

amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

" Gray " (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

" Hazardous waste " means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“ Healing arts ” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

" Helmet " means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

" Hood " means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

" Human use " means the internal or external administration of radiation or radioactive material to human beings.

" Individual " means any human being.

" Individual monitoring " means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

completely covers the head and neck and may also cover portions of the shoulders and torso.

" Human use " means the internal or external administration of radiation or radioactive material to human beings.

" Individual " means any human being.

" Individual monitoring " means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(3) Dose equivalent by the use of survey data.

" Individual monitoring devices " means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, " personnel dosimeter " and " dosimeter " are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

" Interlock " means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur

laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

" Interlock " means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

" Internal dose " means that portion of the dose equivalent received from radioactive material taken into the body.

" JRCERT " means Joint Review Committee on Education in Radiologic Technology.

“ JRCNMT ” means Joint Review Committee on Nuclear Medicine Technology.

" Lens dose equivalent (LDE) " means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

" License " means a license issued by the US Nuclear Regulatory Commission, agreement state, or the Agency, in accordance with applicable federal or state regulations, as amended.

" Licensed practitioner " means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, advanced practice registered nurses (APRNs) and physicians assistants (PAs) may order diagnostic or supportive X-ray procedures for patients in accordance with Title 24, Delaware Code . APRNs and PAs who supervise, perform, view, or interpret X-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code .

" Licensed [or registered] material " means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

" Licensee " means the holder of a license.

" Limits " [See " dose limits "].

" Loose-fitting facepiece " means a respiratory inlet covering that is designed to form a partial seal with the face

are Code .

" Licensed [or registered] material " means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

" Licensee " means the holder of a license.

" Limits " [See " dose limits "].

" Loose-fitting facepiece " means a respiratory inlet covering that is designed to form a partial seal with the face.

" Member of the public " means any individual except when that individual is receiving an occupational dose.

" Minor " means an individual less than 18 years of age.

“ Misadministration ” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.

" Monitoring " means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, " radiation monitoring " and " radiation protection monitoring " are equivalent terms.

" Natural radioactivity " means radioactivity of naturally occurring nuclides

adiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, " radiation monitoring " and " radiation protection monitoring " are equivalent terms.

" Natural radioactivity " means radioactivity of naturally occurring nuclides.

" NORM " means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

" NRC " means the US Nuclear Regulatory Commission or its duly authorized representatives.

“ Notice of violation ” means a written statement of 1 or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

Corrective steps to be taken to prevent recurrence; and

The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

" Occupational dose " means the dose received by an individual in the course of employment, education or training, in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S

registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

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

" Package " means the packaging together with its radioactive contents as presented for transport.

" Particle accelerator " [See " accelerator "].

" Person " means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

" Personnel monitoring equipment " [See " individual monitoring devices "]

ation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

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