216-RICR-40-20-7
D. This Part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing radioactive material for sale or distribution to:
H. The requirements of this Part are in addition to, and not in substitution for, other applicable requirements of this Subchapter.
B. Notwithstanding the provisions of § 7.2.1(A) of this Part, 10 C.F.R. §§ 30.1, 30.2, 30.3, 30.4 (paragraph 2 of the definition of "Commencement of Construction" and paragraph 9ii of the definition of "Construction" only), 30.5, 30.6, 30.8, 30.9, 30.12, 30.21(c), 30.31, 30.32(e), 30.34(d), (e)(1) and (3), 30.37, 30.39, 30.41(b)(6), 30.52, 30.53, 30.55, 30.61, 30.63 and 30.64 are not incorporated by reference.
B. Notwithstanding the provisions of § 7.2.2(A) of this Part, 10 C.F.R. §§ 31.1, 31.2, 31.4, 31.9, 31.13, 31.14, 31.15, 31.16, 31.17, 31.18, 31.19, 31.21, 31.22 and 31.23 are not incorporated by reference.
B. Notwithstanding the provisions of § 7.2.3(A) of this Part, 10 C.F.R. §§ 32.1, 32.8, 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.21(a), 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29, 32.30, 32.31, 32.32, 32.40, 32.201, 32.210, 32.211, 32.301 and 32.303 are not incorporated by reference.
B. Notwithstanding the provisions of § 7.2.4(A) of this Part, 10 C.F.R. §§ 33.1, 33.8, 33.12, 33.16, 33.21 and 33.23 are not incorporated by reference.
B. Notwithstanding the provisions of § 7.2.5(A) of this Part, 10 C.F.R. §§ 40.1, 40.2, 40.4 (definition of "Reconciliation", paragraph 2 in the definition of Commencement of Construction and paragraph 9ii in the definition of Construction and definition of "Foreign obligations only), 40.5, 40.6, 40.7, 40.8, 40.9, 40.10, 40.11, 40.12, 40.13(c)(5)(iv), 40.14, 40.20, 40.21, 40.23, 40.26, 40.27, 40.28, 40.31, 40.32(d), (e), and (g), 40.33, 40.36(c), (e), and (g), 40.38, 40.41(d), (e)(1) and (3)(g) and (h), 40.43, 40.45, 40.51(b)(6), 40.52, 40.53, 40.56, 40.62, 40.63, 40.64, 40.65, 40.66, 40.67, 40.71, 40.81 and 40.82 are not incorporated by reference.
C. Except as provided in this Part, the requirements of 10 C.F.R. § 150.11(b) (2019) 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.
A. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70 the following words and phrases shall be substituted for the language in 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70 as follows:
A. In addition to the definitions contained in 10 C.F.R. §§ 30.4, 32.2, 40.4 and § 70.4, whenever used in this Part, the following terms shall be construed as follows:
A. Any prime contractor or subcontractor of the U.S. Department of Energy (DOE) or the U.S. Nuclear Regulatory Commission (NRC) operating within the State of Rhode Island is exempt from the requirements for a license set forth in this Subchapter to the extent that such prime contractor or subcontractor under his contract manufactures, produces, transfers, receives, acquires, owns, possesses, or uses sources of radiation:
B. In addition to the foregoing exemptions, any prime contractor or subcontractor of the DOE or the NRC is exempt from the requirements for a license set forth in this Subchapter to the extent that such prime contractor or subcontractor manufacturers, produces, transfers, receives, acquires, owns, possesses, or uses sources of radiation under his prime contract or subcontract when the State of Rhode Island and the NRC jointly determine that:
2. Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the requirements in this Part to the extent that they transport or store radioactive material in the regular course of carriage for another or storage incident thereto.
For the purpose of this Part, exempt concentrations are defined by 10 C.F.R. §§ 30.14 and 30.70, Schedule A [§ 7.9.1 of this Part].
For the purpose of this Part, exempt quantities are defined by 10 C.F.R. §§ 30.18 and 30.71, Schedule B [§ 7.9.2 of this Part].
For the purpose of this Part, exemptions for certain items containing radioactive material are defined by 10 C.F.R. § 30.15.
For the purpose of this Part, exemptions for self-luminous products containing tritium, Krypton-85, or Promethium-147 are defined by 10 C.F.R. § 30.19.
For the purpose of this Part, exemptions for gas and aerosol detectors containing radioactive material are defined by 10 C.F.R. § 30.20.
For the purpose of this Part, exemptions for capsules containing C-14 urea for "in vivo" diagnostic use for humans are defined by 10 C.F.R. § 30.21, excluding 10 C.F.R. § 30.21(c).
For the purpose of this Part, exemptions for certain industrial devices are defined by 10 C.F.R. § 30.22.
A. Licenses for radioactive materials are of two (2) types: general and specific.
B. Types of specific licenses of broad scope:
I. Production of PET Radioactive Drugs for Noncommercial Transfer. An application from a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part 9 of this Subchapter shall include:
4. Information identified in 10 C.F.R. § 32.72(a)(3) on the PET drugs to be noncommercially transferred to members of its consortium.
B. Use of Radioactive Material at Property Not Owned by Applicant. In addition to the requirements set forth in § 7.6.2(A) of this Part and/or Part 9 of this Subchapter, a specific license for use of radioactive material where the proposed location of use is not owned by the applicant will be issued under the following conditions:
2. Each amendment request for an additional location of use shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.
For the purpose of this Part, terms and conditions of licenses are defined by 10 C.F.R. §§ 30.34 [excluding §§ 30.34(d), (e)(1), & (e)(3)], 40.41 [excluding §§ 40.41(d), (e)(1) and (3) and (g)] and § 70.32 [excluding §§ 70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k)].
C. For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for licenses authorizing the receipt, possession and use of special nuclear material in quantities not sufficient to form a critical mass are defined by 10 C.F.R. §§ 70.25(a)(2), (b), (e) and (g).
For the purpose of this Part, requirements for expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas are defined by 10 C.F.R. §§ 30.36, 40.42 and 70.38.
B. In any case in which a licensee, not less than thirty (30) days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the Agency.
B. A licensee shall notify the Agency by letter no later than thirty (30) days after:
4. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used.
In considering an application to renew or amend a license, the Agency will apply the criteria set forth in §§ 7.5 or 7.6 of this Part as applicable.
For the purpose of this Part, requirements for transfer of radioactive material are defined by 10 C.F.R. §§ 30.41 [excluding § 30.41(b)(6)], 40.51 [excluding § 40.51(b)(6)] and 70.42 [excluding § 70.42(b)(6)].
E. An application filed pursuant to this Part for a specific license other than one of broad scope will be considered by the Agency as an application for a specific license of broad scope under this Part if the requirements of the applicable sections of this Part are satisfied.
C. For the purpose of this Part, requirements for material transfer reports and records for a person licensed under § 7.6.11(A) of this Part are defined by 10 C.F.R. § 32.52.
D. For the purpose of this Part, requirements for material transfer reports for persons licensed under § 7.6.12(A) of this Part are defined by 10 C.F.R. § 32.56.
D. For the purpose of this Part, requirements for a license to manufacture or initially transfer calibration or reference sources containing plutonium are defined by 10 C.F.R. § 70.39.
B. For the purpose of this Part, requirements for quality assurance and prohibition of transfer of devices licensed under § 7.6.14(A) of this Part are defined by 10 C.F.R. § 32.62.
For the purpose of this Part, requirements for a license to manufacture and distribute radioactive material for certain in vitro clinical or laboratory testing under general license are defined by 10 C.F.R. § 32.71.
B. In addition to the requirements in § 7.6.16(A) of this Part, the applicant shall submit evidence that the applicant is at least one (1) of the following:
C. In addition to the provisions of 10 C.F.R. § 32.72(b)(4), an individual may function as an authorized nuclear pharmacist only if they are licensed as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
For the purpose of this Part, requirements for a license to manufacture and distribute sources or devices containing radioactive material for medical use are defined by 10 C.F.R. § 32.74.
B. For the purpose of this Part, conditions of specific licenses issued pursuant to § 7.6.18(A) of this Part are defined by 10 C.F.R. § 40.35.
For the purpose of this Part, requirements for a general license for certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere are defined by 10 C.F.R. § 31.5.
For the purpose of this Part, requirements for a general license to install devices generally licensed in § 7.7.1 of this Part are defined by 10 C.F.R. § 31.6.
For the purpose of this Part, requirements for a general license for l uminous safety devices for use in aircraft are defined by 10 C.F.R. § 31.7.
B. For the purpose of this Part, requirements for a general license for plutonium in the form of calibration or reference sources are defined by 10 C.F.R. § 70.19.
B. A general license is hereby issued to own special nuclear material in quantities not sufficient to form a critical mass. Notwithstanding any other provisions of this Part, a general licensee under this section is not authorized to acquire, deliver, receive, possess, use or transfer special nuclear material in quantities not sufficient to form a critical mass, except as authorized in a specific license.
For the purpose of this Part, requirements for a general license for Strontium 90 in ice detection devices are defined by 10 C.F.R. § 31.10.
For the purpose of this Part, requirements for a general license for use of radioactive material for certain in vitro clinical or laboratory testing are defined by 10 C.F.R. § 31.11.
For the purpose of this Part, requirements for a general license for certain items and self-luminous products containing Radium-226 are defined by 10 C.F.R. § 31.12.
For the purpose of this Part, requirements for a general license for small quantities of source material are defined by 10 C.F.R. § 40.22.
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.
For the purpose of this Part, the right to cause the withholding or recall of radioactive material defined by 10 C.F.R. § 30.62.
Each 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.
B. Inactivation of Certificates of Registration of Sealed Sources and Devices
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.
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:
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:
For the purpose of this Part, the schedule of exempt concentrations is defined by 10 C.F.R. § 30.70, Schedule A.
For the purpose of this Part, the schedule of exempt quantities is defined by 10 C.F.R. § 30.71, Schedule B.
For the purpose of this Part, quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release are defined by 10 C.F.R. § 30.72.
For the purpose of this Part, quantities of licensed material requiring labeling are defined by Appendix B to 10 C.F.R. Part 30.
D. For the purpose of this Part, criteria relating to use of financial tests and self-guarantee for providing reasonable assurance of funds for decommissioning by nonprofit colleges, universities, and hospitals are defined by Appendix E to 10 C.F.R. Part 30.
B. In addition to the values referenced in § 7.9.6(A) of this Part, the following table of limits for a specific license of broad scope is also applicable to this Part:
| Radioactive Material | Col. I curies | Col. II curies |
| Beryllium-7 | 10 | 0.1 |
| Cobalt-57 | 10 | 0.1 |
| Radium-226 | 0.01 | 0.0001 |
| Scandium-46 | 1 | 0.01 |
| Sodium-22 | 0.1 | 0.001 |
A. Subject to this Subchapter, and the limitations contained in § 7.10.1(D) of this Part, any person who holds a specific license from the U.S. Nuclear Regulatory Commission or any Agreement State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within Rhode Island, except for areas under exclusive federal jurisdiction, for a period not in excess of one hundred eighty (180) days in any calendar year provided that:
2. The out-of-State licensee submits Agency Form MAT-9i, a copy of the pertinent licensing document, and the appropriate fee as prescribed in § 15.5.4 of this Subchapter to the Agency at least three (3) days prior to engaging in such activity for the first time in a calendar year. If a submittal cannot be filed three (3) days before engaging in activities under reciprocity, because of an emergency or other reason, the Agency may waive the three (3) day time requirement provided the licensee:
B. Notwithstanding the provisions of § 7.10.1(A) of this Part, any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in § 7.7.1 of this Part within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in Rhode Island, except for areas under exclusive federal jurisdiction, provided that:
D. The Agency will not accept any applications for reciprocity under this Part with respect to activities authorized pursuant to regulations that are equivalent to Part 9 of this Subchapter entitled “Medical Use of Radioactive Material.” These activities will only be authorized under the provision of a specific license issued by the Agency.