16 Del. Admin. Code § 4465-K-8.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-K-8.0 - Procedure for Administrative Action by Agency

8.1 If the Agency determines that condition(s) exist(s) in a registered facility which represent(s) a threat to life or a serious risk of damage to health, safety and welfare of the workers or public, or if serious violations, repeat violations, or general disregard of accepted radiation practice are found to exist, administrative action is required.

8.2 Compliance Conference. A meeting held by the Agency with management of a licensee, registrant, or other license, certificate or registration holder to discuss the following:

8.2.1 safety, safeguards, or environmental problems;

8.2.2 compliance with regulatory, license condition, or registration condition requirements;

8.2.3 proposed corrective measures including, but not limited to, schedules for implementation; and

8.2.4 enforcement options available to the agency.

8.3 Suspension of Certificate, License or Registration

8.3.1 Conditions for Suspension of Certificate, License or Registration

8.3.1.1 If some condition(s) is/are determined to exist in a registered facility which present(s) an imminent radiation hazard to human health, the Agency may cease operations of the source of radiation without a hearing or written notice until such time the conditions have been corrected.

8.3.1.2 Further enforcement action shall be taken in accordance with the regulations.

8.3.1.3 Such an imminent radiation hazard shall include, but is not limited to, any one of the following:

*	The existence of three (3) or more Severity Level 1 items.

*	Failure to correct any Severity Level 1 item within thirty (30) days.

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

*	The absence of a Radiation Safety Officer.

8.3.2 The suspension shall be effective upon receipt of written notice by the Radiation Safety Officer or the person in charge of the radiation facility or their agent.

8.3.2.1 A suspension statement recorded on the inspection report by the Agency constitutes a written notice.

8.3.2.2 Service of a written notice of suspension by the Agency stating the reason(s) for the suspension must be made by the close of the following business day.

8.3.2.3 The certificate, license or registration shall not be suspended for a period longer than necessary to correct the hazardous conditions, unless mutually agreed upon.

8.4 Right of Appeal of Suspension

8.4.1 The owner/manager of the registered facility may submit in writing an appeal to the Authority on Radiation Protection for reconsideration of a decision by the Agency.

8.4.2 The notice of appeal shall be sent via certified mail to the Authority on Radiation Protection and to the Agency. An appeal shall not automatically stay the decision of the Agency.

8.4.3 After review for potential radiation hazard to the public, the suspended or revoked license or registration may be stayed on the order of the Program Administrator for Radiation Control.

8.4.4 If a notice of appeal is not filed within thirty (30) days, the license or registration suspension or revocation recommendation shall be upheld and other enforcement action taken in accordance with the this regulation, section 9.4. If the notice of appeal is timely filed, the Authority on Radiation Protection shall hold a hearing at its earliest opportunity.

8.5 Reinstatement of Certificate, License or Registration:

8.5.1 In consultation with the Authority on Radiation Protection, if a follow-up inspection by a representative of the Agency shows the imminent radiation hazard(s) to human health no longer exist(s), the suspension shall be lifted immediately and the certificate, license or registration returned.

8.5.2 If there is no evidence that the imminent radiation hazard(s) has/have been corrected, the suspension will remain in effect until the condition(s) has been corrected.

8.5.3 The owner/manager of the registered facility may request, in writing, a hearing before the Authority on Radiation Protection at any time during the period of suspension, for the purpose of demonstrating that the imminent radiation hazard(s) no longer exist.

8.5.4 The request for hearing shall not stay the suspension.

8.5.5 A record of all proceedings shall be made in accordance with Compliance Procedures.

8.6 Exemption Requests

8.6.1 All requests for exemptions must be filed with the Agency for review. If a determination cannot be made by the Agency, the exemption request must be referred to the Authority.

8.6.2 Agency may grant, an exemption if based on national standards.

8.6.3 Shall hear an appeal by the applicant within ten (10) days following the denial of an exemption request by the Agency. If an exemption is granted; record of the action shall become a part of the permanent record of the facility.

8.6.4 An exemption is not transferable.

16 Del. Admin. Code § 4465-K-8.0

16 DE Reg. 1274( 6/1/2013) (Final)