TITLE 16

Health and Safety

Safety

CHAPTER 74. RADIATION CONTROL


It is the policy of this State in furtherance of its responsibilities to protect the public health and safety to:

(1) Institute and maintain a regulatory program for sources of ionizing radiation so as to provide for (i) compatibility with the standards and regulatory programs of the federal government, (ii) a single, effective system of regulation within the State, and (iii) a system consonant insofar as possible with those of other states;

(2) Institute and maintain a program to permit development and utilization of sources of ionizing radiation for peaceful purposes consistent with the health and safety of the public; and

(3) Encourage the constructive uses of radiation, and to prohibit and prevent exposure to ionizing radiation in amounts which are or may be detrimental to health.

16 Del. C. 1953, § 7401; 56 Del. Laws, c. 266, § 1; 67 Del. Laws, c. 192, § 1.;

It is the purpose of this chapter to effectuate the policies set forth in § 7401 of this title by providing a program to:

(1) Effectively regulate sources of ionizing radiation for the protection of occupational and public health and safety;

(2) Promote an orderly regulatory pattern within the State, among the states and between the federal government and the State and facilitate intergovernmental cooperation with respect to use and regulation of sources of ionizing radiation to the end that duplication of regulation may be minimized;

(3) Define regulatory responsibilities with respect to radioactive material; and

(4) Permit maximum utilization of sources of ionizing radiation consistent with the health and safety of the public.

(5) [Repealed.]

16 Del. C. 1953, § 7402; 56 Del. Laws, c. 266, § 1; 67 Del. Laws, c. 192, §§ 2, 3; 78 Del. Laws, c. 336, § 1.;

As used in this chapter:

(1) "Authority" means the Authority on Radiation Protection created by § 7404 of this title.

(2) "Ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles, but not sound or radio waves or visible, infrared or ultraviolet light.

(3) "Person," in addition to the definitions contained in § 302 of Title 1, means any 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, other than the United States Nuclear Regulatory Commission or any successor thereto and other than federal government agencies licensed by the United States Nuclear Regulatory Commission or any successor thereto.

(4) "Radioactive material" means any material (solid, liquid or gas) which emits ionizing radiation spontaneously.

(5) "Users of ionizing radiation" means persons who supervise the application of ionizing radiation and/or apply ionizing radiation to human beings for diagnostic and/or therapeutic purposes.

16 Del. C. 1953, § 7403; 56 Del. Laws, c. 266, § 1; 60 Del. Laws, c. 698, § 1; 67 Del. Laws, c. 192, § 4; 76 Del. Laws, c. 249, § 1; 78 Del. Laws, c. 336, § 1.;

(a) There is created an Authority on Radiation Protection which shall be governed in accordance with Authority bylaws, established to ensure integrity, accountability and transparency regarding decisions of the Authority which impact the citizens of Delaware. The Authority shall consist of the following members:

(1) The Secretary of the Department of Health and Social Services or the Secretary's duly authorized designee;

(2) The Secretary of the Department of Natural Resources and Environmental Control or the Secretary's duly authorized designee;

(3) The Lead Administrator of the Office of Radiation Control in the Division of Public Health, Department of Health and Social Services and 12 other persons who shall be appointees of the Governor to include:

a. One appointee shall be from the Medical Society of Delaware;

b. One appointee shall be from the Delaware State Osteopathic Association;

c. One appointee shall be from the Dental Society of Delaware;

d. One appointee shall be a qualified member from the staff or faculty of the University of Delaware or Delaware State University;

e. One appointee shall be a nonmedical member from industry; and

f. The remaining 7 shall be appointed members of the public who need not fall into any of the other categories for membership on the Authority, but who have an interest in radiation protection. Each nonpublic member shall have had training in 1 or more of the following fields: radiology, nuclear medicine, radiation oncology, radiation physics, health physics or related sciences with specialization in ionizing radiation, provided however, that not more than 2 persons shall be specialists in any 1 of the above-named fields. Each county shall be represented by at least 2 members. Each of the 15 members shall have 1 vote.

(b) Authority members appointed by the Governor shall be appointed for a term of 3 years. Each Authority member shall hold over after the expiration of the member's term until the member's successor has been appointed and has taken office. Vacancies shall be filled for the unexpired term.

(c) The Secretary of Health and Social Services or the Secretary's duly authorized designee shall be Secretary of the Authority, and shall provide staffing and facilities required to enable the Office of Radiation Control to deliver core services as defined by the Delaware Radiation Control Regulations, as promulgated or amended by the Authority. The Office of Radiation Control in the Department of Health and Social Services shall be the administrative agent for the Authority. The Office of Radiation Control in the Department of Health and Social Services shall make such inspections, conduct such investigations, collect fees or administrative penalties established or levied by the Authority, administer such revenue through the General Fund, and do such other acts as may be necessary to carry out this chapter within the limits of the appropriation made for this purpose. The administrative agent shall have all of the powers conferred by law upon the Authority except adopting the rules and regulations provided for in this chapter, subject, however, to the general direction of the Authority.

(d) [Repealed.]

(e) The Authority shall elect a Chairperson to serve for at least 1 year from those members appointed by the Governor. The Chairperson shall lead biennial review of the Authority bylaws, chair public hearings and issue approval of regulations amended or promulgated by the Authority. A majority of the Authority shall constitute a quorum to transact its business.

(f) The Authority shall hold at least 4 regular meetings each calendar year and such special meetings as it deems necessary.

(g) The Authority shall establish and provide biennial review of the Authority bylaws.

(h) The Authority shall review policies and programs relating to control of ionizing radiation and make recommendations thereon to the agencies of the State.

(i) The Authority may aid the Department of Health and Social Services in the employment, training of and prescribing of the power and duties of such individuals as may be necessary to carry out this chapter.

16 Del. C. 1953, § 7404; 56 Del. Laws, c. 266, § 1; 57 Del. Laws, c. 591, §§ 16, 17; 60 Del. Laws, c. 698, § 2; 64 Del. Laws, c. 302, §§ 1, 2; 67 Del. Laws, c. 192, § 5; 69 Del. Laws, c. 67, § 2; 70 Del. Laws, c. 149, § 198; 70 Del. Laws, c. 186, § 1; 76 Del. Laws, c. 249, § 2; 78 Del. Laws, c. 336, § 1.;

(a) The Authority shall adopt rules and regulations as may be necessary for the control of sources of ionizing radiation. Prior to adoption of any rule or regulation, the Authority shall publish or otherwise circulate notice of its intended action and afford interested parties an opportunity, at a public hearing, to submit data and views orally or in writing. Such rules and regulations may provide, subject to subsection (c) of this section, for the establishment of fees by the Authority to fund the issuance of licenses, certifications or registrations, and other activities deemed appropriate to meet the requirements of this statute. No code, rule, regulation or amendment or repeal thereof shall be effective until 60 days after adoption thereof.

(b) Any fee established by the Authority shall not be effective until enacted into law by an act of the General Assembly.

(c) Fees are established for issuance of annual registration permits to radiation machine facilities located within the State, according to the fee schedule below, with appropriated revenue to be used for fee-supported program enhancements, consistent with state budgetary procedures.

Category I: Facilities with a total of 5 or more of the medical modalities or nonmedical modalities listed below: $1370.

Category II: Facilities with a total of 3 or 4 of the medical modalities or nonmedical modalities listed below: $1030.

Category III: Facilities with 2 of the medical modalities listed below: $690.

Category IV: Facilities with 1 of the medical modalities listed below, and an annual patient workload of 750 examinations or more: $275.

Category V: Facilities with 1 of the medical modalities listed below, and an annual patient workload of less than 750 examinations, and all other radiation installations with 1 or 2 of the nonmedical modalities listed below except as listed under Category VI: $140.

Category VI: Dental, podiatric, bone densitometry or veterinary installations: $75.

For purposes of the fee schedule set out above, the following definitions shall apply:

"Medical modalities" shall mean radiography, fluoroscopy, computed tomography, angiography, stereotactic breast biopsy systems, and radiation therapy, utilized in humans.

"Nonmedical modalities" shall mean radiography, fluoroscopy, analytical equipment (including electron microscopes, fluorescence analysis and X-ray diffraction equipment), computed tomography, and particle accelerators, not utilized on humans.

16 Del. C. 1953, § 7405; 56 Del. Laws, c. 266, § 1; 60 Del. Laws, c. 698, § 3; 76 Del. Laws, c. 249, § 2; 78 Del. Laws, c. 336, § 1.;

(a) The Authority shall promulgate rules and regulations for regulation of radiation sources and devices or equipment utilizing such sources and for the registration or exemption of such sources, devices or equipment. Such rules or regulations shall provide for the amendment, suspension or revocation of such licenses or registration.

(b) The Authority may require licensing or certification of users of ionizing radiation.

(c) The Authority may provide for recognition of other state or federal licenses or registrations.

16 Del. C. 1953, § 7406; 56 Del. Laws, c. 266, § 1; 60 Del. Laws, c. 698, § 4; 67 Del. Laws, c. 192, § 6; 78 Del. Laws, c. 336, § 1.;

The Authority or its duly authorized representatives shall have the power to enter at all reasonable times upon any private or public property for the purpose of determining whether or not there is compliance with or violations of this chapter and rules and regulations issued thereunder, except that entry into areas under the jurisdiction of the federal government shall be effected only with the concurrence of the federal government or its duly authorized designated representative.

16 Del. C. 1953, § 7407; 56 Del. Laws, c. 266, § 1.;

(a) The Authority or its duly authorized representatives shall require each person who possesses or uses a source of ionizing radiation to maintain records relating to its receipt, storage, transfer or disposal and such other records as the Authority may require subject to such exemptions as may be provided by rules or regulations.

(b) The Authority or its duly authorized representatives shall require each person who possesses or uses a source of ionizing radiation to maintain appropriate records showing the radiation exposure of all individuals for whom personnel monitoring is required by the rules and regulations of the Authority. Copies of these records and those required to be kept by this section shall be submitted to the Administrative Agent or Authority on request.

16 Del. C. 1953, § 7408; 56 Del. Laws, c. 266, § 1; 78 Del. Laws, c. 336, § 1.;

(a) The Governor, upon the recommendation of the Authority, may enter into agreements with the federal government providing for discontinuance of certain of the federal government's responsibilities with respect to sources of ionizing radiation and the assumption thereof by this State.

(b) In the event that the Governor enters into an agreement with the federal government all federal licenses which are valid on the effective date of such agreement shall have the force and effect of a state license or registration issued by the Authority. Such licenses shall be deemed to expire on a date which shall be the earlier of (1) the date of expiration specified in the federal license or (2) 90 days from receipt from the Authority of notice that the federal license will no longer be recognized by the Authority.

16 Del. C. 1953, § 7409; 56 Del. Laws, c. 266, § 1.;

(a) Subject to the approval of the Governor, the Authority may enter into agreements with the federal government, other states or interstate agencies for inspections or other functions relating to control of sources of ionizing radiation.

(b) The Authority or its duly authorized representatives may institute training programs for the purpose of qualifying personnel to carry out this chapter and may make personnel available for participation in any program or programs of the federal government, other states or interstate agencies.

16 Del. C. 1953, § 7410; 56 Del. Laws, c. 266, § 1; 78 Del. Laws, c. 336, § 1.;

Ordinances, resolutions or regulations of a governing body or of any other governmental unit relating to radioactive materials shall not be superseded by this chapter if they are consistent with this chapter and rules and regulations hereunder.

16 Del. C. 1953, § 7411; 56 Del. Laws, c. 266, § 1; 78 Del. Laws, c. 336, § 1.;

(a) In any proceeding under this chapter (1) for the issuance or modification of rules and regulations relating to control of sources of ionizing radiation, or (2) for granting, suspending, revoking or amending any license or registration, or (3) for determining compliance with, or granting exceptions from, rules and regulations of the Authority, the Authority shall afford an opportunity for a hearing on the record upon the request of any person who may be affected by the action of the Authority and shall admit any such person as a party to such proceeding.

(b) Whenever the Administrative Agent finds that an emergency exists requiring immediate action to protect the public health and safety, the Administrative Agent may, without notice or hearing, issue a regulation or order reciting the existence of such emergency and requiring that such action be taken as is necessary to meet the emergency. Such regulation or order may be effective immediately. Any person to whom such regulation or order is directed shall comply therewith immediately, but on application to the Authority shall be afforded a hearing within 30 days. On the basis of such hearing, the emergency regulation or order shall be continued, modified or revoked within 30 days after such hearing.

(c) Any final order entered in any proceeding by the Authority or the Administrative Agent shall be subject to judicial review by the Superior Court of this State.

16 Del. C. 1953, § 7412; 56 Del. Laws, c. 266, § 1.;

Whenever, in the judgment of the Authority, any person has engaged in or is about to engage in 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, the Authority may request the Attorney General to make application to the Court of Chancery for an order enjoining such acts or practices or for an order directing compliance and, upon a showing by the Authority that such person has engaged or is about to engage in any such acts or practices, a permanent or temporary injunction, restraining order or other order may be granted.

16 Del. C. 1953, § 7413; 56 Del. Laws, c. 266, § 1.;

It is unlawful for any person to use, manufacture, produce, transport, transfer, receive, acquire, own or possess any source of ionizing radiation unless licensed by, the Nuclear Regulatory Commission and registered with or specifically exempted by the Authority in accordance with this chapter.

16 Del. C. 1953, § 7414; 56 Del. Laws, c. 266, § 1; 78 Del. Laws, c. 336, § 1.;

The Authority may, in the event of an emergency, order the impounding of sources of ionizing radiation, with the approval of the Nuclear Regulatory Commission when deemed necessary, in the possession of any person who is not equipped to observe or fails to observe the provisions of this chapter or any rules or regulations issued thereunder.

16 Del. C. 1953, § 7415; 56 Del. Laws, c. 266, § 1; 76 Del. Laws, c. 249, § 1; 78 Del. Laws, c. 336, § 1.;

Whoever violates any of this chapter or rules, regulations or orders of the Authority shall be assessed an administrative penalty in an amount not to exceed $500 for a first offense, an amount not to exceed $750 for any subsequent offense. Each violation shall be considered a separate offense.

16 Del. C. 1953, § 7416; 56 Del. Laws, c. 266, § 1; 76 Del. Laws, c. 249, § 3.;

(a) No facility for the permanent deposit, storage, reprocessing or disposal of spent nuclear fuel elements, or for the permanent deposit, storage, reprocessing or disposal of high- or low-level radioactive waste material, shall be constructed or established in this State unless the Authority on Radiation Protection in consultation with the U.S. Nuclear Regulatory Commission first finds that such facility promotes the general good of the State and approves, after a public hearing, a petition for the approval of such facility.

(b) No high-level waste material shall be held in temporary storage for longer than 5 years.

(c) No low-level radioactive waste material shall be held in temporary storage for longer than 10 years.

(d) Whenever the Authority on Radiation Protection finds that the continued presence of a facility for the deposit, storage, reprocessing or disposal of materials in subsection (a) of this section is injurious to the public welfare, the Authority in consultation with the U.S. Nuclear Regulatory Commission shall issue its order shutting the facility and requiring immediate removal of such material as follows.

61 Del. Laws, c. 432, § 1; 67 Del. Laws, c. 192, § 7; 70 Del. Laws, c. 145, § 1; 78 Del. Laws, c. 336, § 1.;

The Authority on Radiation Protection shall not permit the deposit in Delaware, for any period of time, of any radioactive waste material set forth in § 7417(a) of this title originating in any other state.

61 Del. Laws, c. 432, § 1; 67 Del. Laws, c. 192, § 8.;