Section 216-RICR-40-20-7.8 - Serialization of Nationally Tracked Sources, Sealed Source & Device Registry, Records and Reports7.8.1RecordsA. For the purpose of this Part, recordkeeping requirements are defined by 10 C.F.R. §§ 30.51, 40.61 and 70.51 [excluding 10 C.F.R. §§ 70.51(c), (d) and (e)]. B. Each record required by this Part must be legible throughout the retention period specified by each Agency Regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.7.8.2Right to Cause the Withholding or Recall of Radioactive MaterialFor the purpose of this Part, the right to cause the withholding or recall of radioactive material defined by 10 C.F.R. § 30.62.
7.8.3Serialization of Nationally Tracked SourcesEach licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.
7.8.4Sealed Source and Device RegistryA. Registration of Product Information. The Agency does not currently administer a sealed source and device registration program. Any manufacturer or initial distributor of a sealed source or device containing a sealed source who is subject to this Part shall submit a request for evaluation of radiation safety information about its product and for its registration to the Nuclear Regulatory Commission pursuant to 10 C.F.R. § 32.210.B. Inactivation of Certificates of Registration of Sealed Sources and Devices 1. A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Agency shall request inactivation of the registration certificate. Such a request must be made to the Agency and must normally be made no later than two (2) years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two (2) years after that transfer, the certificate holder shall request inactivation of the certificate within ninety (90) days of this determination and briefly describe the circumstances of the delay.2. If a distribution license is to be terminated in accordance with this Part, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Agency will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.3. A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.7.8.5Modification, Revocation, and Termination of LicensesA. The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of Rules, Regulations, and orders issued by the Agency. B. Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any Rule, Regulation, or order of the Agency.C. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.D. The Agency may terminate a specific license upon request submitted by the licensee to the Agency in writing.E. Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty (120) days, in an unsealed form, shall forward the following records to the Agency: 1. Records of disposal of licensed material made under §§1.15.2, 1.15.3, 1.15.4 and 1.15.5 of this Subchapter; and2. Records required by §1.16.3 of this Subchapter.F. If licensed activities are transferred or assigned in accordance with §7.6.3 of this Part, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty (120) days, in an unsealed form, shall forward the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated: 1. Records of disposal of licensed material made under §§1.15.2, 1.15.3, 1.15.4 and 1.15.5 of this Subchapter; and 2. Records required by §1.16.3 of this Subchapter.G. Prior to license termination, each licensee shall forward the records required by §7.6.4 of this Part to the Agency.216 R.I. Code R. § 216-RICR-40-20-7.8
Adopted effective 1/1/2019
Amended effective 5/25/2022