Ala. Admin. Code r. 420-3-26-.13

Current through Register Vol. 43, No. 1, October 31, 2024

Section 420-3-26-.13 - Administrative Procedures

(1) Purpose and Scope. This Rule establishes the administrative procedures for the Agency as the Radiation Control Agency and describes the organization, methods of conducting business, and interpretations as required by the Alabama Administrative Procedures Act.

(2) Organization and Method of Conducting Business.

(a) Organization. The State Board of Health is designated in Code of Ala. 1975, § 22-14-4, as the State Radiation Control Agency with the State Health Officer as Director. The Director has designated the Division of Radiation Control to implement Chapter 14 of Title 22, Code of Ala. 1975. The State Health Officer as Director may delegate certain duties to the Division of Radiation Control and its Director. These duties are:

1. To inspect, process applications to register x-ray facilities, and investigate accidents, incidents, and overexposures as may be required to assure the safe use of x-ray equipment as is defined in these rules.

2. To inspect, the use of particle accelerators and radioactive material, process applications to register particle accelerators, process applications to license the use of radioactive material(s), and investigate accidents, incidents and overexposure as may be required to assure the safe use of particle accelerators or radioactive materials.

3. To conduct environmental monitoring around nuclear facilities which have a reasonable potential for releasing radioactive material into the environment.

4. To develop emergency plans for responding to any radiological emergency in accordance with Memoranda of Understanding and other Agencies.

5. To respond to, and pursuant to written delegations, issue orders necessary to protect the public health and safety during radiation emergencies, incidents or accidents.

6. To conduct limited training in the safe use of radiation.

7. To answer public inquiries, investigate complaints, and provide limited quantities of general information to the public.

8. To receive, process, and coordinate with other agencies requests for orders for the routing of radioactive material shipments.

9. To determine the compliance of a person's use of radiation as the result of an inspection, investigation, or review of submitted information. This is subject to review and appeal as provided for in this Rule.

10. To issue orders directing compliance with these rules, and when not contested issue orders to suspend, revoke, or modify a license or registration, or sources of radiation.

11. To develop contracts for programs compatible with the Act.

12. To issue orders relating to the routing of radioactive materials as provided for in this Rule.

13. To maintain an index and file of all decisions, opinions, and declaratory rulings issued by the Agency; by subject matter. Copies of these orders are available in the Division of Radiation Control's Office for public review and copying at 25¢ per page.

14. To maintain a file of all licenses, registrations, inspections, investigations and related correspondence for public inspection and copying at 25¢ per page. Certain files may be temporarily unavailable when being used by the Staff or pending determination of compliance or enforcement action. Further, information as determined pursuant to § 22-14-6(d)Code of Ala. 1975, shall not be available for public review or copying.

15. To maintain a list of all forms, statements of policy, instructions, guides, and interpretations available for public review and copying.

16. To maintain copies of all memoranda of understanding or contracts between the Agency and other agencies relating to the radiation program in Alabama, for public inspection and for copying at 25¢ per page.

17. To issue orders suspending a license if the inspection fees are not paid within 45 days of billing the licensee as provided for in the Act.

18. To notify a licensee of any proposed civil penalty as may be determined in accordance to Appendix A of this Rule 420-3-26-.13. Note, the licensee may appeal or provide mitigating information for consideration before a final order is issued.

(b) Applications for Licenses, Registration, or Notice of Registration.

1. All applications for a radioactive materials license shall meet the applicable requirements of Rule 420-3-26-.02 of these rules before being approved. To assist applicants in preparing their applications, the Agency has prepared instructions and guides which are available on request. In addition, any application for the commercial burial of low-level radioactive wastes must conform with the Agency policy statement, copies of which are available on request. Amendment requests may be submitted by letter but must otherwise meet the requirements of an application prior to approval.

2. All applications for a Notice of Registration shall meet the applicable requirements of Rule 420-3-26-.08 of these rules before being approved. Amendment requests may be submitted by letter but must otherwise meet the requirement of an application prior to approval.

3. All applications to register x-ray equipment shall meet the requirements of Rule 420-3-26-.05 of these rules prior to approval. Amendment requests may be by letter but must otherwise meet the requirements for an application prior to approval.

4. Any application may be approved in part, for those proposed activities for which adequate information was supplied. Those proposed portions for which inadequate information was supplied may be approved upon receipt of additional, sufficient information without a reapplication.

5. Any person's application or amendment request which is denied may request a hearing within 30 days of the denial of the application or amendment request in accordance with the hearing procedures of this Rule.

6. Any application or amendment request will be considered abandoned, upon failure of the applicant to supply any additional reasonable information requested to determine whether the application meets the requirements of these rules within 90 days of the written request for supplemental information. This section does not apply if the applicant files for a hearing pursuant to 5 above.

7. Except for the activities listed in 420-3-26-.02(10)(q)4, if the Agency fails to respond to an application by either issuing the appropriate license, amendment, or Notice of Registration; by requesting additional supplemental information; or by denying the request within 90 days of Agency receiving the supplemental information in writing, or the application, if supplemental information was not requested; the applicant may file a petition with the Agency requiring the approval of the request. Such petition only needs to show that the Agency has received, in writing, all of the information requested from the applicant and at least 90 days has elapsed without a request for information and no action has been taken by the Agency. The petition will be granted unless the Agency can show that prior to the filing of the petition,

(i) the Agency requested in writing sent to the last known address of the applicant, additional information which has not been received,

(ii) the Agency denied the application, or

(iii) the construction, testing, or technical studies have not been completed by the Agency.

(3) Hearings.

(a) Rule Making.

1. In conformance with Section 5 of the Administrative Procedures Act (Act 81-855), the Agency shall adopt its rules and regulations. Any notice regarding the adoption, repeal or amendment of such rules shall include:

(i) The terms or substance of the proposed action.

(ii) A description of the subject and issues involved if not included in (i).

(iii) The address where written comments or statements may be delivered and the last time and date for delivering such statements.

(iv) The date, time, and place for oral statements to be made and any conditions pertaining thereto.

(v) Who the hearing officer will be if other than the Division Director or Agency Director.

2. Petitions for Rulemaking.

(i) Any interested person may petition the Agency to issue, amend, or rescind any rule. The petition should be addressed to the Director, Division of Radiation Control, Alabama Department of Public Health, Montgomery, AL 36130.

(ii) Each petition filed under this section shall:

(I) Set forth a general solution to the problem or the substance or text of any proposed rule, or amendment or specify the rule which is to be revoked or amended;

(II) State clearly and concisely the petitioner's grounds for and interest in the action requested;

(III) Include a statement in support of the petition which shall set forth the specific issues involved, the petitioner's views or arguments with respect to those issues, relevant technical, scientific or other data involved which is reasonably available to the petitioner, and such other pertinent information as the petitioner deems necessary to support the action sought. In support of its petition, the petitioner should note any specific cases of which the petitioner is aware where the current rule is unduly burdensome, deficient, or needs to be strengthened.

(iii) If it is determined that the petition includes that information required by paragraph (ii) of this section and is complete and is probably needed, the Director of Division of Radiation Control or his designee through the Agency Secretary will cause a notice of the petition to be published in the Alabama Administrative Monthly in accordance with the rule making provisions of this Rule, within 60 days.

(iv) If it is determined by the Director of Division of Radiation Control that the petition does not include the information required by paragraph (ii) of this section, or is incomplete or is not needed to protect the health and safety or not authorized by law, the petitioner will be notified of that determination and the respects in which the petition is deficient and will be accorded an opportunity to submit additional data to correct any deficiency within 90 days of the notification to the petitioner of any deficiency, the petition may be returned to the petitioner without prejudice.

(v) No hearing or rulemaking will be held on the petition unless the Director of the Division of Radiation Control determines that sufficient reason exists, he will initiate rulemaking proceedings as provided in this Rule. In any other case he will deny the petition and will notify the petitioner with a simple statement of denial. The petitioner may appeal the denial pursuant to the appeal provisions of this Rule.

(b) Appeals.

1. All orders, determinations, or denials of the Director, Division of Radiation Control, or of any local Health Departments are appealable to the State Health Officer. All initial determinations, orders, or denials of the State Officer as Agency Director are appealable as described in this section. In addition, this Rule provides for certain informal procedures to resolve contested cases.

2. Any request to appeal an order, determination, or denial shall be filed within 30 days of receiving written notice of such order, determination or denial. Such request should be addressed to:

State Health Officer

Alabama Department of Public Health

Montgomery, Alabama 36130-1701

All appeals should:

(i) For each exception, separately numbered; state concisely, without supporting argument the single error of fact or law which is being asserted in that exception and identify with particularly the portion of the decision, determination, order or denial to which the exception is addressed. A brief in support of the exception(s) should accompany the exception(s). Within 10 days of receiving the request, the Division Staff, and any other party, shall file their response to the petition.

(ii) All documents filed under this section shall be accompanied by a certificate reflecting service upon all parties to the proceeding.

3. Within 5 business days of receiving the Staff's response the State Health Officer shall issue an order designating:

(i) The Hearing Officer and any members of a Hearing Board (such as the Radiation Advisory Board of Health);

(ii) The date, time, and place for the start of the hearing;

(iii) The issues to be resolved;

(iv) And other matters appropriate for such an order, such as contained in Section 12(2) of the Alabama Administrative Procedures Act.

4. The Hearing Officer, or Hearing Board, as appropriate, shall submit their recommendations to the State Health Officer, together with the record of the proceeding as described in Section 12(b) of the Alabama Administrative Procedures Act within 10 business days of the close of the hearing.

5. The State Health Officer after reviewing the record and the recommendations shall issue an order upholding, denying or modifying the matter being appealed within 5 business days of receiving the recommendations described in paragraph (4) above. This order will be the final order of the Agency unless the State Committee of Public Health, sua sponte, elects to review the order within 30 days of its issuance.

(c) Conduct of Hearings.

1. All adjudicatory hearings shall be conducted in accordance with 10 CFR Part 2§§ 2.705; 2.706; 2.707; 2.711; 2.712; except (f); 2.713; 2.714; 2.715; 2.716; 2.718 except (b), (h), (i),(k),(l), and (m); 2.719; 2.730; 2.731; 2.732; 2.733; 2.740; 2.741 except (e); 2.742; 2.743; 2.750; except (c); 2.753; and 2.757 as in effect July 1, 1989. All references to the Commission, Atomic Safety and Licensing Board, and Presiding Officer, are to be replaced with the Hearing Officer.

2. Documents shall be filed with the State Health Officer or the Hearing Officer in adjudication subject to this Rule, either by (1) delivery to the office of the State Health Officer, in the State Office Building, 501 Dexter Avenue, Montgomery, or (2) U.S. Mail to the State Health Officer, Alabama Department of Public Health, Montgomery, Alabama 36130-1701.

3. All documents offered for filing shall be accompanied by proof of service upon all parties to the proceeding or their attorney of record, the Hearing Officer and Hearing Board members if any.

4. Filing by U.S. Mail will be deemed to be complete as of the time of deposit in the mail with sufficient postage.

5. Parties to all adjudicatory hearings shall consist of the petitioner or appellant, the Division of Radiation Control and such others as may be admitted by the Hearing Officer.

6. Rulemaking and investigatory hearings shall be conducted in accordance with the procedures outlined in the order established in the hearing. The Hearing Officer has the authority to conduct the hearing in an orderly manner and may require the consolidation of statements and close or adjourn the hearing to another day or time in the event the hearing becomes disorderly. In these hearings the Hearing Officer, Hearing Board members, and the Division of Radiological Health may ask questions of witnesses. If appropriate, they may be placed under oath.

(4) Guidance Documents of Division of Radiation Control. From time to time the Division of Radiation Control may prepare instructions, guidance documents, suggested procedures, etc., to assist persons in complying with these rules. These documents are to provide assistance and are not binding on the Board of Health. Further, other methods may be acceptable and will be approved if the rules are otherwise met. The Board of Health's policy for minimum acceptable training, experience and equipment is to be the same as the U.S. Nuclear Regulatory Commission.

(5) The Routing of Radioactive Material Shipments.

(a) Applications for designating a route shall contain sufficient information to make the assessment and determination required by 49 CFR 171.8 in effect July 1, 1989. Copies of this regulation and the associated U.S. Department of Transportation guide "Guidelines for Selecting preferred Highway Routes for Large Quantity Shipments of Radioactive Materials" are available from the Agency.

(b) Upon receiving a routing request (10 copies) with adequate information to make the necessary assessment and determination, when designated by proper delegation of the Agency Director, the Director, Division of Radiation Control shall notify the Alabama Departments of Public Safety, Highway and Emergency Management and any counties and municipalities along the proposed alternate routes of the request.

(c) The Agency Director or the Director, Division of Radiation Control shall also cause a notice to be published in a newspaper of general circulation near the routes under consideration. Such notice shall provide for an investigation hearing to be conducted by the Agency Director or the Director, Division of Radiation Control as the Hearing Officer. Such notice shall provide for receiving written comments and shall indicate the date which comments will be received. This date may be modified at the hearing if appropriate.

(d) Within 30 days of the end written comment period, the Agency Director or the Director, Division of Radiation Control will issue an order with his decision. This order shall briefly detail the basis for the decision. This is appealable as any other initial order by the Agency Director or order or decision of the Director, Division of Radiation Control.

(6) Criteria for Determining Enforcement Action.

(a) A major continuing goal of the Agency is to assure that ionizing radiation source facilities are constructed and operated with the necessary degree of safety and reliability. Similarly, it is the responsibility of the Agency to assure a corresponding degree of management controls and safety in the licensed materials processes and programs.

The nuclear industry generally recognizes the necessity for improvements in safety as well as the economic advantages that are derived by extending the management techniques and philosophy of safety to the operations of plants and processes. It is essential that all registrants and licensees meet these high standards.

While broad sanctions are available to the Agency in the event they are necessary, the objectives of safety and reliability should generally be achievable through augmented internal management programs.

Results of Agency inspections and investigations of licensed activities have shown that registrants and licensees have not in all cases complied with regulatory requirements and it has been necessary to take specific enforcement actions commensurate with the violations. This document sets out the criteria for enforcement actions to be taken with respect to future violations of license conditions relating to health and safety, in accordance with the Alabama Regulations for Control of Radiation and Act 582, Regular Session 1963, Title 22, Chapter 14, Code of Ala. 1975, as amended.

The enforcement actions available to the Agency in the exercise of its regulatory responsibilities may be divided into the following four basic types which are applicable to specific enforcement situations:

1. Noncompliance Letters.

This is a letter describing the proposed violations and request to reply within usually thirty (30) days. In his reply, the registrant or licensee may:

(i) Deny any or all violations.

(ii) Indicate what corrective measures have been instituted and their effect.

(iii) Indicate proposed corrective actions and the date when compliance will be achieved.

2. Written Notices of Violations.

Enforcement actions may be written notices to registrants or licensees, citing the proposed violations observed during investigations, inspections, or inquiries. This is a formal notice and requires at least a written response.

3. Civil Penalties.

The Agency has authority to assess a civil penalty of radioactive material licensees in cases where the noncompliance is serious or repeated. Appendix A details how and when the civil penalties are determined and how they may be reduced.

4. Orders to Cease and Desist; and Orders for Suspension, Modification or Revocation of a License or to Suspend the Activities of a Registrant.

The Agency has authority to issue orders to "cease and desist," and orders to suspend, modify, or revoke licenses. Such orders are preceded by certain procedural requirements including a written notice of violation to the licensee or registrant providing him with an opportunity to respond as to the corrective measures being taken. In the event the licensee or registrant fails to respond to the notice or to demonstrate that satisfactory corrective action is being taken, an order to show cause may be issued requiring the licensee or registrant to show why the particular order (either of revocation, or modification or suspension) should not be made effective. In those instances where the health, safety, or interest of employees to the public so requires or willful violation of the agency's rules is involved, the notice provision may be dispensed with and, in addition, the particular order may be made immediately effective pending further order. In addition to proceeding by way of order, the Agency may also, pursuant to § 22-14-12, request the Attorney General to obtain an injunction or other court order to enjoin licensees or registrants from violating the Act or any rules or order issued thereunder.

Author:

Ala. Admin. Code r. 420-3-26-.13

Adopted effective December 31, 1983. Revised and Repromulgated effective January 31, 1990.

Filed September 1, 1982. Readopted with amendments filed October 24, 1983. Amended: Filed December 19, 1986. Amended: Filed January 19, 1990.

Statutory Authority:Code of Ala. 1975, §§ 22-14-4, 22-14-6, 22-14-7, 22-14-8, 22-14-11, 22-14-12, 22-14-13, 41-22-4, 41-22-5, 41-22-6, 41-22-7, 41-22-9, 41-22-11, 41-22-12, 41-22-13, 41-22-14, 41-22-15, 41-22-16, 41-22-17, 41-22-18, 41-22-19.