Packaging and Transportation of Radioactive Material (216-RICR-40-20-12)
A. This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B. This Part establishes requirements for packaging, preparation for shipment, and transportation of licensed material.
C. The packaging and transportation of licensed material are also subject to the requirements of other agencies (e.g., the U.S. Department of Transportation, the U.S. Nuclear Regulatory Commission and the U.S. Postal Service) having jurisdiction over means of transport. The requirements of this Part are in addition to, and not in substitution for, other requirements.
D. This Part applies to any licensee authorized by specific or general license issued by the Agency to receive, possess, use or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Agency license, or transports that material on public highways. No provision of this Part authorizes possession of licensed material.
12.2 Incorporated Material
A. Except as provided in this Part, the requirements of 10 C.F.R. Part 71 (2018) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B. Postal Service Manual (Domestic Mail Manual), section 124, is incorporated by reference at 39 C.F.R. § 111.1 (2018).
C. Notwithstanding the provisions of § 12.2(A) of this Part, §§ 71.0, 71.1, 71.2, 71.3, 71.8, 71.9, 71.10, 71.11, 71.12, 71.14(b), 71.16, 71.18, 71.19, 71.24, 71.25, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.53, 71.55, 71.57, 71.59, 71.61, 71.63, 71.64, 71.65, 71.70, 71.71, 71.73, 71.74, 71.75, 71.77, 71.85(a) (b) & (c), 71.91(b), 71.93, 71.95, 71.101(c)(2), (d) and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125 are not incorporated by reference.
D. Effect of incorporation of 10 C.F.R. Part 71. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 71, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 71 as follows:
1. Where the words “NRC”, “Commission”, “Nuclear Regulatory Commission”, “United States Nuclear Regulatory Commission” or “Administrator of the appropriate Regional Office” appear in 10 C.F.R. Part 71, substitute the words Agency except when used in 10 C.F.R. § 71.5(b), 71.10, 71.17(c)(3), and (e), 71.85(c), 71.88(a)(4), 71.93(c), 71.95, 71.97(c), (c)(3)(iii), and (f).
2. The terms “certificate of compliance, compliance holder or applicant” apply to the NRC as they are the sole authority for issuing a package Certificate of Compliance.
3. Form RCA-1, “Notice to Employees”, must be posted instead of NRC Form 3 that is specified in 10 C.F.R. Part 71.
A. In addition to the definitions contained in 10 C.F.R. § 71.4, whenever used in this Part, the following terms shall be construed as follows:
1. “Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control".
2. “Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation - Radiation Control Program, Rhode Island Department of Health.
12.4 General Provisions
12.4.1 Requirement for License
No person shall transport radioactive material or deliver radioactive material to a carrier for transport except as authorized in a general or specific license issued by the Agency or as exempted in § 12.5 of this Part.
12.4.2 Transportation of Licensed Material
For the purpose of this Part, requirements for transportation of licensed material are defined by 10 C.F.R. § 71.5.
12.5.1 Exemption of Physicians
For the purpose of this Part, requirements for exemption of physicians are defined by 10 C.F.R. § 71.13.
12.5.2 Exemption for Low-Level Materials
For the purpose of this Part, requirements for exemption for low-level materials are defined by 10 C.F.R. § 71.14(a).
12.5.3 Exemption from Classification as Fissile Material
For the purpose of this Part, requirements for exemption from classification as fissile material are defined by 10 C.F.R. § 71.15.
12.6 General Licenses
12.6.1 NRC-Approved Package
For the purpose of this Part, requirements for a general license for a NRC-approved package are defined by 10 C.F.R. § 71.17.
12.6.2 General license: Use of foreign approved package
For the purpose of this Part, requirements for a general license for use of a foreign approved package are defined by 10 C.F.R. § 71.21.
12.6.3 Fissile Material
For the purpose of this Part, requirements for a general license for fissile material are defined by 10 C.F.R. § 71.22.
12.6.4 Plutonium-Beryllium Special Form Material
For the purpose of this Part, requirements for a general license for plutonium-beryllium special form material are defined by 10 C.F.R. § 71.23.
12.7 External Radiation Standards for All Packages
For the purpose of this Part, requirements for external radiation standards for all packages are defined by 10 C.F.R. § 71.47.
12.8 Operating Controls and Procedures
12.8.1 Applicability of Operating Controls and Procedures
For the purpose of this Part, requirements for applicability of operating controls and procedures are defined by 10 C.F.R. § 71.81.
12.8.2 Assumptions as to Unknown Properties
For the purpose of this Part, requirements for assumptions as to unknown properties are defined by 10 C.F.R. § 71.83.
12.8.3 Preliminary Determinations
For the purpose of this Part, requirements for preliminary determinations are defined by 10 C.F.R. § 71.85(d).
12.8.4 Routine Determinations
For the purpose of this Part, requirements for routine determinations are defined by 10 C.F.R. § 71.87.
12.8.5 Air Transport of Plutonium
For the purpose of this Part, requirements for air transport of plutonium are defined by 10 C.F.R. § 71.88.
12.8.6 Opening Instructions
For the purpose of this Part, requirements for opening instructions are defined by 10 C.F.R. § 71.89.
12.8.7 Shipment Records
For the purpose of this Part, requirements for shipment records are defined by 10 C.F.R. §§ 71.91(a), (c) & (d).
12.8.8 Shipment Records
A. The licensee, after requesting the certificate holder's input, shall submit a written report to the Agency of:
1. Instances in which there is significant reduction in the effectiveness of any NRC-approved Type B or Type AF packaging during use;
2. Details of any defects with safety significance in any NRC-approved Type B or fissile material packaging after first use;
3. Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.
B. The licensee shall submit a written report to the Agency of instances in which the conditions in the certificate of compliance were not followed during a shipment.
C. Each licensee shall submit a written report required by §§ 12.8.8(A) or (B) of this Part within sixty (60) days of the event or discovery of the event. The licensee shall also provide a copy of each report submitted to the Agency to the applicable certificate holder. Written reports prepared under other regulations may be submitted to fulfill this requirement if the reports contain all the necessary information, and the appropriate distribution is made. These written reports must include the following:
1. A brief abstract describing the major occurrences during the event, including all component or system failures that contributed to the event and significant corrective action taken or planned to prevent recurrence.
2. A clear, specific, narrative description of the event that occurred so that knowledgeable readers conversant with the requirements of 10 C.F.R. Part 71, but not familiar with the design of the packaging, can understand the complete event. The narrative description must include the following specific information as appropriate for the particular event:
a. Status of components or systems that were inoperable at the start of the event and that contributed to the event;
b. Dates and approximate times of occurrences;
c. The cause of each component or system failure or personnel error, if known;
d. The failure mode, mechanism, and effect of each failed component, if known;
e. A list of systems or secondary functions that were also affected for failures of components with multiple functions;
f. The method of discovery of each component or system failure or procedural error;
g. For each human performance-related root cause, a discussion of the cause(s) and circumstances;
h. The manufacturer and model number (or other identification) of each component that failed during the event; and
i. For events occurring during use of a packaging, the quantities and chemical and physical form(s) of the package contents.
3. An assessment of the safety consequences and implications of the event. This assessment must include the availability of other systems or components that could have performed the same function as the components and systems that failed during the event.
4. A description of any corrective actions planned as a result of the event, including the means employed to repair any defects, and actions taken to reduce the probability of similar events occurring in the future.
5. Reference to any previous similar events involving the same packaging that are known to the licensee or certificate holder.
6. The name and telephone number of a person within the licensee's organization who is knowledgeable about the event and can provide additional information.
7. The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
D. The reports submitted by licensees and/or certificate holders under § 12.8.8 of this Part must be of sufficient quality to permit reproduction and micrographic processing.
12.8.9 Advance Notification of Shipment of Irradiated Reactor Fuel and Nuclear Waste
For the purpose of this Part, requirements for advance notification of shipment of irradiated reactor fuel and nuclear waste are defined by 10 C.F.R. § 71.97.
12.9 Quality Assurance
12.9.1 Quality Assurance Requirements
For the purpose of this Part, quality assurance requirements are defined by 10 C.F.R. §§ 71.101(a), (b), (c)(1), (f) & (g).
12.9.2 Quality Assurance Organization
For the purpose of this Part, quality assurance organization requirements are defined by 10 C.F.R. § 71.103.
12.9.3 Quality Assurance Program
For the purpose of this Part, quality assurance program requirements are defined by 10 C.F.R. § 71.105.
12.9.4 Changes to Quality Assurance Program
For the purpose of this Part, requirements for changes to a quality assurance program are defined by 10 C.F.R. § 71.106.
12.9.5 Handling, Storage, and Shipping Control
For the purpose of this Part, requirements for handling, storage, and shipping control are defined by 10 C.F.R. § 71.127.
12.9.6 Inspection, Test, and Operating Status
For the purpose of this Part, requirements for inspection, test, and operating status are defined by 10 C.F.R. § 71.129.
12.9.7 Nonconforming Materials, Parts, or Components
For the purpose of this Part, requirements for nonconforming materials, parts, or components are defined by 10 C.F.R. § 71.131.
For the purpose of this Part, corrective action requirements are defined by 10 C.F.R. § 71.133.
12.9.9 Quality Assurance Records
For the purpose of this Part, requirements for quality assurance records are defined by 10 C.F.R. § 71.135.
For the purpose of this Part, requirements for audits are defined by 10 C.F.R. § 71.137.
12.10 Determination of A1 and A2
For the purpose of this Part, requirements for determination of A1 and A2 are defined by Appendix A to 10 C.F.R. Part 71.
|Title||216||Rhode Island Department of Health|
|Chapter||40||Professional Licensing and Facility Regulation|
|Part||12||Packaging and Transportation of Radioactive Material (216-RICR-40-20-12)|
|Type of Filing||Adoption|
Regulation Authority :
R.I. Gen. Laws § 23-1.3-5
Purpose and Reason :
In accordance with the Administrative Procedures Act, R.I. Gen. Laws Section 42-35-3(a)(1), the following is a concise statement regarding this rulemaking for Packaging and Transportation of Radioactive Material (216-RICR-40-20-12). This amendment to the regulations reorganizes existing radiation control regulations into distinct Parts in order to make them more accessible to the regulated community and the general public, and to reduce the volume of said regulations by utilizing incorporation by reference of applicable portions of Titles 10 and 21 of the Code of Federal Regulations (C.F.R.). In response to public comment, §§ 12.2, 12.6.2, and 12.8.9 were revised to correct citations to the Code of Federal Regulations. In the development of this rule, consideration was given to: 1) alternative approaches; 2) overlap or duplication with other statutory and regulatory provisions; and 3) significant economic impact on small business. No alternative approach, duplication, or overlap was identified based on available information. RIDOH has determined that the benefits of this rule justify its costs.