216-RICR-40-20-7
216-RICR-40-20-7. Licensing of Radioactive Material (version Adoption, 01/01/2019 to 01/04/2022)
7.1 Authority
A. This Part is promulgated
pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3 -5 .
B. This Part provides for the
licensing of radioactive material. No person shall receive, possess,
use, transfer, own or acquire radioactive material except as
authorized in a specific or general license issued pursuant to this
Part or as otherwise provided in this Part.
C. This Part establishes
general licenses for the possession and use of radioactive material
and a general license for ownership of radioactive material. The
general licenses provided in this Part are subject to the provisions
of §§ 7.4.3, 7.6.2, 7.6.3, 7.6.9, 7.8.5 and 7.12.1 of this Part,
and Parts 1 and 2 of this Subchapter unless indicated otherwise in
the specific provision of the general license.
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:
1. Persons generally licensed
under this Part, 10 C.F.R. Part 31 or equivalent regulations of
another Agreement State (as defined by 10 C.F.R. § 40.4).
2. Persons licensed under Part
9 of this Subchapter.
E. This Part prescribes
requirements for the issuance of specific licenses to persons who
introduce radioactive material into a product or material owned by or
in the possession of a licensee or another, and regulations governing
holders of such licenses.
F. This Part
prescribes requirements for the issuance of specific licenses of
broad scope for radioactive material (“broad licenses”) .
G. This Part prescribes
certain requirements governing holders of licenses to manufacture or
distribute items containing radioactive material.
H. The requirements of this
Part are in addition to, and not in substitution for, other
applicable requirements of this Subchapter.
1. All licensees are subject
to the requirements of Parts 1 and 2 of this Subchapter.
2. Licensees engaged in use of
radionuclides in the healing arts are subject to the requirements of
Part 9 of this Subchapter.
3. Licensees engaged in
industrial radiographic operations are subject to the requirements of
Part 10 of this Subchapter.
4. Licensees engaged in
wireline and/or subsurface tracer studies are subject to the
requirements of Part 11 of this Subchapter.
I. In any
conflict between the requirements in this Part and a specific
requirement in another Part of the regulations in this Subchapter,
the specific requirement governs.
7.2 Incorporated Material
7.2.1 General Provisions
for Radioactive Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 30 (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. Notwithstanding the
provisions of § 7.2.1(A) of this Part, §§ 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 of 10
C.F.R. Part 30 are not incorporated by reference.
7.2.2 General Licenses for
Radioactive Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 31 (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. Notwithstanding the
provisions of § 7.2.2(A) of this Part, §§ 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 of 10
C.F.R. Part 31 are not incorporated by reference.
7.2.3 Specific Licenses to
Manufacture or Transfer Certain Items Containing Radioactive Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 32 (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. Notwithstanding the
provisions of § 7.2.3(A) of this Part, §§ 32.1, 32.8, 32.11,
32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 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 of 10
C.F.R. Part 32 are not incorporated by reference.
7.2.4 Specific Domestic
Licenses of Broad Scope for Radioactive Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 33 (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. Notwithstanding the
provisions of § 7.2.4(A) of this Part, §§ 33.1, 33.8, 33.12,
33.16, 33.21 and 33.23 of 10
C.F.R. Part 33 are not incorporated by reference.
7.2.5 Licensing of Source
Material
A. Except as provided in this
Part, the requirements of 10
C.F.R. Part 40 (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. Notwithstanding the
provisions of § 7.2.5(A) of this Part, §§ 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,
40.12(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), (f), 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, 40.60, 40.62, 40.63, 40.64, 40.65,
40.66, 40.67, 40.71, 40.81 and 40.82 of 10
C.F.R. Part 40 are not incorporated by reference.
7.2.6 Licensing of Special
Nuclear Material
A. Except as provided in this
Part, the requirements of
10 C.F.R. Part 70 (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. Notwithstanding the
provisions of § 7.2.6(A) of this Part, §§ 70.1, 70.2, 70.3, 70.4
(paragraph 2 in the definition of Commencement of Construction and
paragraph 9ii in the definition of Construction only), 70.5, 70.6,
70.7, 70.8, 70.9, 70.10, 70.13, 70.14, 70.17, 70.18, 70.20, 70.20a,
70.20b, 70.21, 70.22, 70.23(a)(1), (a)(5) through (a)(12) and (b),
70.24, 70.25(a)(1), (c), (d), and (f), 70.31(c), (d) and (e),
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), 70.33, 70.35, 70.37,
70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53,
70.54, 70.55, 70.56, 70.57, 70.58, 70.59, 70.60, 70.61, 70.62, 70.64,
70.65, 70.66, 70.72, 70.73, 70.74, 70.76, 70.81 and 70.82, 70.91,
70.92 and Appendix A to 10 C.F.R. Part 70 are not incorporated by
reference.
7.2.7 Effect of
incorporation of 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70
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:
1. Any reference to NRC or
Commission shall be deemed to be a reference to the Agency.
2. Any reference to NRC or
agreement state shall be deemed to be a reference to the Agency, NRC
or agreement state.
3. Any reference to byproduct
material shall be deemed to be a reference to radioactive material.
4. Any reference to special
nuclear material shall be deemed to be a reference to special nuclear
material in quantities not sufficient to form a critical mass.
5. Any reference to “NRC
Form 313, Application for Material License" shall be deemed to
be a reference to Agency Form MAT-1, Application for Material
License.
6. Any reference to “NRC
Form 244, Registration Certificate - Use of Depleted Uranium Under
General License" shall be deemed to be a reference to Agency
Form GEN-1 "Registration Certificate - Use of Depleted Uranium
Under General License".
7. Any reference to “NRC
Form 483, Registration Certificate - In Vitro Testing with Byproduct
Material Under General License" shall be deemed to be a
reference to Agency Form GEN-3, Certificate - In-Vitro Testing with
Radioactive Material Under General License.
8. Any notifications, reports
or correspondence referenced in the incorporated sections of 10
C.F.R. Parts 30, 31, 32, 33, 40 and 70 be directed to the Agency
using Agency contact information specified in § 1.4 of this
Subchapter.
7.3 Definitions
A. In addition to the
definitions contained in 10 C.F.R. § 30.4, 10 C.F.R. § 32.2, 10
C.F.R. § 40.4 and 10 C.F.R. § 70.4, 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.
3. “NARM” means any
naturally occurring or accelerator-produced radioactive material. It
does not include byproduct, source, or special nuclear material.
4. “Offshore waters” means
that area of land and water, beyond Rhode Island’s Submerged Lands
Act jurisdiction, on or above the U.S. Outer Continental Shelf.
5. “Radioactive material”
means any material (solid, liquid, or gas) which emits radiation
spontaneously.
6. “Special nuclear material
in quantities not sufficient to form a critical mass” means uranium
enriched in the isotope U-235 in quantities not exceeding 350 grams
of contained U-235; uranium-233 in quantities not exceeding 200
grams; plutonium in quantities not exceeding 200 grams; or any
combination of them in accordance with the following formula: For
each kind of special nuclear material, determine the ratio between
the quantity of that special nuclear material and the quantity
specified above for the same kind of special nuclear material. The
sum of such ratios for all of the kinds of special nuclear material
in combination shall not exceed "1" (i.e., unity). For
example, the following quantities in combination would not exceed the
limitation and are within the formula: (175 (grams contained
U-235)/350) + (50 (grams U-233)/200) + (50 (grams Pu)/200) = 1.
7.4 Exemptions
7.4.1 Persons Using Sources
of Radiation Under Certain Department of Energy and Nuclear
Regulatory Commission Contracts
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:
1. The performance of work for
the DOE at a United States Government-owned or controlled site,
including the transportation of sources of radiation to or from such
site and the performance of contract services during temporary
interruptions of such transportation;
2. Research in, or
development, manufacture, storage, testing or transportation of,
atomic weapons or components thereof; or
3. The use or operation of
nuclear reactors or other nuclear devices in a United States
Government-owned vehicle or vessel.
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:
1. The exemption of the prime
contractor or subcontractor is authorized by law; and
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.
7.4.2 Carriers
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.
7.4.3 Exempt Concentrations
For the purpose of this Part,
exempt concentrations are defined by 10 C.F.R. § 30.14 and 10 C.F.R.
§ 30.70, Schedule A [§ 7.9.1 of this Part].
7.4.4 Exempt Quantities
For the purpose of this Part,
exempt quantities are defined by 10 C.F.R. § 30.18 and 10 C.F.R. §
30.71, Schedule B [§ 7.9.2 of this Part].
7.4.5 Certain Items
Containing Radioactive Material
For the purpose of this Part,
exemptions for certain items containing radioactive material are
defined by 10 C.F.R. § 30.15.
7.4.6 Self-luminous
Products Containing Tritium, Krypton-85, or Promethium-147
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.
7.4.7 Gas and Aerosol
Detectors Containing Radioactive Material
For the purpose of this Part,
exemptions for gas and aerosol detectors containing radioactive
material are defined by 10 C.F.R. § 30.20.
7.4.8 Radioactive Drug:
Capsules Containing C-14 Urea for "in vivo" Diagnostic Use
for Humans
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).
7.4.9 Certain Industrial
Devices
For the purpose of this Part,
exemptions for certain industrial devices are defined by 10 C.F.R. §
30.22.
7.4.10 Unimportant
Quantities of Source Material
For the purpose of this Part,
unimportant quantities of source material are defined by 10 C.F.R. §
40.13, excluding § 40.13(c)(5)(iv).
7.5 Licenses
A. Licenses for radioactive
materials are of two types: general and specific.
1. The Agency issues a
specific license to a named person who has filed an application for
the license under the provisions of this Subchapter.
2. A general license is
provided by regulation, grants authority to a person for certain
activities involving radioactive material, and is effective without
the filing of an application with the Agency or the issuance of a
licensing document to a particular person. However, registration with
the Agency may be required by the particular general license.
B. Types of specific licenses
of broad scope:
1. A "Type A specific
license of broad scope" is a specific license authorizing
receipt, acquisition, ownership, possession, use and transfer of any
chemical or physical form of the radioactive material specified in
the license, but not exceeding quantities specified in the license,
for any authorized purpose. The quantities specified are usually in
the multicurie range.
2. A "Type B specific
license of broad scope" is a specific license authorizing
receipt, acquisition, ownership, possession, use and transfer of any
chemical or physical form of radioactive material specified in the
table referenced in § 7.9.6 of this Part, for any authorized
purpose. The possession limit for a Type B broad license, if only one
radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in Column I of the table referenced in § 7.9.6 of
this Part. If two or more radionuclides are possessed thereunder, the
possession limit for each is determined as follows: For each
radionuclide, determine the ratio of the quantity possessed to the
applicable quantity specified in Column I of the table referenced in
§ 7.9.6 of this Part, for that radionuclide. The sum of the ratios
for all radionuclides possessed under the license shall not exceed
unity.
3. A "Type C specific
license of broad scope" is a specific license authorizing
receipt, acquisition, ownership, possession, use and transfer of any
chemical or physical form of radioactive material specified in the
table referenced in § 7.9.6 of this Part, for any authorized
purpose. The possession limit for a Type C broad license, if only one
radionuclide is possessed thereunder, is the quantity specified for
that radionuclide in Column II of the table referenced in § 7.9.6 of
this Part. If two or more radionuclides are possessed thereunder, the
possession limit is determined for each as follows: For each
radionuclide determine the ratio of the quantity possessed to the
applicable quantity specified in Column II of the table referenced in
§ 7.9.6 of this Part, for that radionuclide. The sum of the ratios
for all radionuclides possessed under the license shall not exceed
unity.
7.6 Specific Licenses
7.6.1 Application for
Specific Licenses
A. Applications for specific
licenses shall be filed in duplicate on a form prescribed by the
Agency, and shall include a designated e-mail address for receipt of
official Agency correspondence in electronic format.
B. The Agency may at any time
after the filing of the original application, and before the
expiration of the license, require further statements in order to
enable the Agency to determine whether the application should be
granted or denied or whether a license should be modified or revoked.
C. Each application shall be
signed by the applicant or licensee or a person duly authorized to
act on their behalf.
D. An application for a
license may include a request for a license authorizing one or more
activities.
E. In the application, the
applicant shall submit the required information to the Agency without
reference to previously submitted documents unless permission has
been obtained from the Agency, in advance, to incorporate by
reference information contained in previous applications, statements,
or reports filed with the Agency. All references shall be clear and
specific and shall contain all of the information needed for a
particular item on the application.
F. Applications and documents
submitted to the Agency may be made available for public inspection
except that the Agency may withhold any document or part thereof from
public inspection if disclosure of its content is not required in the
public interest and would adversely affect the interest of a person
concerned.
G. Specific License to Use
Radioactive Material in the Form of a Sealed Source or in a Device
That Contains the Sealed Source. For the purposes of this Part,
requirements for a specific license to use radioactive material in
the form of a sealed source or in a device that contains the sealed
source are defined by 10 C.F.R. § 30.32(g).
H. Consideration of the Need
for an Emergency Plan for Responding to a Release of Radioactive
Materials. For the purpose of this Part, requirements for
consideration of the need for an emergency plan for responding to a
release of radioactive materials are defined by 10 C.F.R. §
30.32(i).
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:
1. A request for authorization
for the production of PET radionuclides or evidence of an existing
license issued under this Part, or equivalent regulations of the U.S.
Nuclear Regulatory Commission or another Agreement State, for a PET
radionuclide production facility within its consortium from which it
receives PET radionuclides.
2. Evidence that the applicant
is qualified to produce radioactive drugs for medical use by meeting
one of the criteria in § 7.6.16(B) of this Part.
3. Identification of
individual(s) authorized to prepare the PET radioactive drugs if the
applicant is a pharmacy, and documentation that each individual meets
the requirements of an Authorized Nuclear Pharmacist as specified in
10 C.F.R. § 32.72(b)(2) and § 7.6.16(C) of this Part.
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.
7.6.2 General Requirements
for Issuance of Specific Licenses
A. For the purposes of this
Part, general requirements for issuance of specific licenses are
defined by 10 C.F.R. §§ 30.33, 40.32 and 70.31.
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:
1. Each initial application
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.
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.
7.6.3 Terms and Conditions
of Licenses
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 10 C.F.R. § 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)].
7.6.4 Financial Assurance
and Recordkeeping for Decommissioning
A. For the purpose of this
Part, requirements for financial assurance and recordkeeping for
decommissioning for a specific license authorizing the possession and
use of unsealed radioactive material are defined by 10 C.F.R. §
30.35.
B. For the purpose of this
Part, requirements for financial assurance and recordkeeping for
decommissioning for licenses authorizing the receipt, possession and
use of source material are defined by 10 C.F.R. §§ 40.36 (a), (b),
(d) and (f).
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).
7.6.5 Expiration and
Termination of Licenses and Decommissioning of Sites and Separate
Buildings or Outdoor Areas
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.
7.6.6 Renewal of Specific
Licenses
A. Applications for renewal of
specific licenses shall be filed in accordance with § 7.5.2 of this
Part.
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.
7.6.7 Amendment of Licenses
For the purpose of this Part,
requirements for amendment of licenses are defined by 10 C.F.R. §§
30.38, 40.44 and 70.34.
7.6.8 Agency Action on
Applications to Renew or Amend
In considering an application
to renew or amend a license, the Agency will apply the criteria set
forth in §§ 7.6.2, 7.5 or 7.6 of this Part as applicable.
7.6.9 Transfer of
Radioactive Material
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)].
7.6.10 Requirements for a
Specific License of Broad Scope
A. A person may file an
application for specific license of broad scope in accordance with
the provisions of § 7.6.1 of this Part.
B. For the purpose of this
Part, requirements for the issuance of a Type A specific license of
broad scope are defined by 10 C.F.R. § 32.13.
C. For the purpose of this
Part, requirements for the issuance of a Type B specific license of
broad scope are defined by 10 C.F.R. § 32.14.
D. For the purpose of this
Part, requirements for the issuance of a Type C
specific license of broad scope are defined by 10 C.F.R. §
32.15.
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.
7.6.11 Requirements for
License to Manufacture or Initially Transfer Devices to Persons
Generally Licensed Under § 7.7.1
A. For the purpose of this
Part, requirements for a license to manufacture or initially transfer
devices to persons generally licensed under § 7.7.1 of this Part are
defined by 10 C.F.R. § 32.51.
B. For the purpose of this
Part, license conditions for person licensed under § 7.6.11(A) of
this Part are defined by 10 C.F.R. § 32.51(a).
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.
7.6.12 Requirements for
License to Manufacture, Assemble, Repair or Initially Transfer
Luminous Safety Devices for Use in Aircraft
A. For the purpose of this
Part, requirements for a license to manufacture, assemble, repair or
initially transfer luminous safety devices for use in aircraft are
defined by 10 C.F.R. § 32.53.
B. For the purpose of this
Part, requirements for labeling of devices licensed under §
7.6.12(A) of this Part are defined by 10 C.F.R. § 32.54.
C. For the purpose of this
Part, requirements for quality assurance and prohibition of transfer
of devices licensed under § 7.6.12(A) of this Part are defined by 10
C.F.R. § 32.55.
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.
7.6.13 Requirements for
License to Manufacture or Initially Transfer Calibration or Reference
Sources Containing Americium-241, Plutonium or Radium-226
A. For the purpose of this
Part, requirements for a license to manufacture or initially transfer
calibration or reference sources containing americium-241 or
radium-226 are defined by 10 C.F.R. § 32.57.
1. For the purpose of this
Part, requirements for labeling of devices licensed under §
7.6.13(A) of this Part are defined by 10 C.F.R. § 32.58.
2. For the purpose of this
Part, requirements for leak testing of each source licensed under §
7.6.13(A) of this Part are defined by 10 C.F.R. § 32.59.
B. 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.
7.6.14 Requirements for
License to Manufacture or Initially Transfer Ice Detection Devices
Containing Strontium-90
A. For the purpose of this
Part, requirements for a license to manufacture or initially transfer
ice detection devices containing strontium-90 are defined by 10
C.F.R. § 32.61.
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.
7.6.15 Requirements for
License to Manufacture and Distribute Radioactive Material for
Certain in-vitro Clinical or Laboratory Testing Under General License
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.
7.6.16 Requirements for
License to Manufacture, Prepare, or Transfer for Commercial
Distribution of Radioactive Drugs Containing Radioactive Material for
Medical Use Under Part 9
A. For the purpose of this
Part, requirements for a license to manufacture, prepare, or transfer
for commercial distribution of radioactive drugs containing
radioactive material for medical use under Part 9 of this Subchapter
are defined by 10 C.F.R. § 32.72.
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 of the following:
1. Registered with the U.S.
Food and Drug Administration (FDA) as the owner or operator of a drug
establishment that engages in the manufacture, preparation,
propagation, compounding, or processing of a drug under 21 C.F.R. §
207.20(a);
2. Licensed as a drug
manufacturer and/or pharmacy in accordance with Pharmacists,
Pharmacies and Manufacturers, Wholesalers and Distributors
[Subchapter 15 Part 1 of this Chapter]; or
3. Licensed as a positron
emission tomography (PET) drug production facility pursuant to this
Part.
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 Pharmacists, Pharmacies and
Manufacturers, Wholesalers and Distributors [Subchapter 15 Part 1 of
this Chapter].
7.6.17 Requirements for
License to Manufacture and Distribute Sources or Devices Containing
Radioactive Material for Medical Use
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.
7.6.18 Requirements for
License to Manufacture and Distribute Industrial Products Containing
Depleted Uranium for Mass-Volume Applications
A. For the purpose of this
Part, requirements for a license to manufacture and distribute
industrial products containing depleted uranium for mass-volume
applications are defined by 10 C.F.R. § 40.34.
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.
7.6.19 Requirements for
License to initially transfer source material for use under the
'small quantities of source material' general license
A. For the purpose of this
Part, requirements for a license to initially transfer source
material for use under the “small quantities of source material”
general license are defined by 10 C.F.R. § 40.54.
B. For the purpose of this
Part, requirements for quality control, labeling, safety
instructions, and records and reports for licenses issued pursuant to
§ 7.6.19(A) of this Part are defined by 10 C.F.R. § 40.56.
7.7 General Licenses
7.7.1 General License for
Certain Detecting, Measuring, Gauging, or Controlling Devices and
Certain Devices for Producing Light or an Ionized Atmosphere
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.
7.7.2 General License to
Install Devices Generally Licensed in § 7.5.11
For the purpose of this Part,
requirements for a general license to install devices generally
licensed in § 7.5.11 of this Part are defined by 10 C.F.R. § 31.6.
7.7.3 General License for
Luminous Safety Devices for Use in Aircraft
For the purpose of this Part,
requirements for a general license for luminous safety devices for
use in aircraft are defined by 10 C.F.R. § 31.7.
7.7.4 General License for
Calibration or Reference Sources
A. For the
purpose of this Part, requirements for a general license for
americium-241 and radium-226 in the form of calibration or reference
sources are defined by 10 C . F . R .
§ 31.8.
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.
7.7.5 General License to
Own Radioactive Material
A. A general
license is hereby issued to own radioactive material without regard
to quantity. Notwithstanding any other provisions of this Part, a
general licensee not authorized to manufacture, produce, transfer,
receive, possess, use, import, or export radioactive material except
as authorized by a specific license.
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.
7.7.6 General License for
Strontium 90 in Ice Detection Devices
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.
7.7.7 General License for
Use of Radioactive Material for Certain in vitro Clinical or
Laboratory Testing
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.
7.7.8 General License for
Use of Radioactive Material for Certain in vitro Clinical or
Laboratory Testing
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.
7.7.9 General License for
Small Quantities of Source Material
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.
7.7.10 General License for
Use of Certain Industrial Products or Devices
For the purpose of this Part,
requirements for a general license for use of certain industrial
products or devices are defined by 10 C.F.R. § 40.25.
7.8 Serialization of Nationally
Tracked Sources, Sealed Source & Device Registry, Records and
Reports
7.8.1 Records
A. 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.
7.8.2 Right to Cause the
Withholding or Recall of Radioactive Material
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.
7.8.3 Serialization of
Nationally Tracked Sources
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.
7.8.4 Sealed Source and
Device Registry
A. 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.
7.8.5 Modification,
Revocation, and Termination of Licenses
A. 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 and 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; and
2. 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 and 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.
7.9 Schedules
7.9.1 Exempt Concentrations
For the purpose of this Part,
the schedule of exempt concentrations is defined by 10 C.F.R. §
30.70, Schedule A.
7.9.2 Exempt Quantities
For the purpose of this Part,
the schedule of exempt quantities is defined by 10 C.F.R. § 30.71,
Schedule B.
7.9.3 Quantities of
Radioactive Materials Requiring Consideration of the Need for an
Emergency Plan for Responding to a Release
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.
7.9.4 Schedule C:
Quantities of Licensed Material Requiring Labeling
For the purpose of this Part,
quantities of licensed material requiring labeling are defined by
Appendix B to 10 C.F.R. Part 30.
7.9.5 Decommissioning
Funding Criteria
A. For the purpose of this
Part, criteria relating to use of financial tests and parent company
guarantees for providing reasonable assurance of funds for
decommissioning are defined by Appendix A to 10 C.F.R. Part 30.
B. For the purpose of this
Part, criteria
relating to use of financial tests and self guarantees for providing
reasonable assurance of funds for decommissioning are defined by
Appendix C to 10 C.F.R. Part 30.
C. 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
commercial companies that have no outstanding rated bonds are defined
by Appendix D 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.
7.9.6 Limits for a Specific
License of Broad Scope
A. For the purpose of this
Part, limits for a specific license of broad scope are defined by 10
C.F.R. § 33.100, Schedule C.
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
7.10 Reciprocal Recognition of
Licenses
7.10.1 Specific Radioactive
Material Licenses
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 and eighty (180) days in any calendar
year provided that:
1. The licensing document does
not limit the activity authorized by such document to specified
installations or locations;
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:
a. Informs the Agency by
telephone, facsimile, an Agency Form MAT-9N, or a letter of initial
activities or revisions to the information submitted on the initial
Agency Form MAT-9i;
b. Receives oral or written
authorization for the activity from the Agency; and
c. Within three (3) days after
the notification, files an Agency Form MAT-9N, a copy of the
pertinent licensing document, and the appropriate fee as prescribed
in § 15.5.4 of this Subchapter.
3. The out-of-state licensee
complies with all applicable regulations of the Agency and with all
the terms and conditions of his licensing document, except any such
terms and conditions which may be inconsistent with applicable
regulations of the Agency;
4. The out-of-state licensee
supplies such other information as the Agency may request; and
5. The out-of-state licensee
shall not transfer or dispose of radioactive material possessed or
used under the general license provided in § 7.10.1(A) of this Part
except by transfer to a person specifically licensed by the Agency,
another Agreement State or by the U.S. Nuclear Regulatory Commission
to receive such material.
6. The out-of-state licensee
files an amended Agency Form MAT-9N with the Agency to request
approval for changes in work locations, radioactive material, or work
activities different from the information contained on the initial
MAT-9N.
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:
1. Such person shall file a
report with the Agency within thirty (30) days after the end of each
calendar quarter in which any device is transferred to or installed
in Rhode Island. Each such report shall identify each general
licensee to whom such device is transferred by name and address, the
type of device transferred, and the quantity and type of radioactive
material contained in the device;
2. The device has been
manufactured, labeled, installed, and serviced in accordance with
applicable provisions of the specific license issued to such person
by the U.S. Nuclear Regulatory Commission or an Agreement State;
3. Such person shall assure
that any labels required to be affixed to the device under
regulations of the authority which licensed manufacture of the device
bear a statement that "Removal of this label is prohibited;"
and
4. The holder of the specific
license shall furnish to each general licensee to whom he transfers
such device or on whose premises he installs such device a copy of
the general license contained in § 7.7.1 of this Part.
C. The Agency may withdraw,
limit, or qualify its acceptance of any specific license or
equivalent licensing document issued by another agency, or any
product distributed pursuant to such licensing document, upon
determining that such action is necessary in order to prevent undue
hazard to public health and safety or property.
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.
7.10.2 Generally Licensed
Devices
A. Reciprocity requests
involving generally licensed devices registered pursuant to § 7.7.1
of this Part or the equivalent regulations of the U.S. Nuclear
Regulatory Commission or another Agreement State shall be handled in
accordance with the procedures contained in § 7.10.1 of this Part.
Applicants for reciprocity shall submit evidence of current
registration pursuant to § 7.7.1 of this Part (or the equivalent
regulations of the U.S. Nuclear Regulatory Commission or another
Agreement State) in lieu of a specific radioactive materials license.
B. Reciprocity requests
involving other generally licensed devices shall also be handled in
accordance with the procedures contained in § 7.10.1 of this Part.
In lieu of a specific radioactive materials license, applicants for
reciprocity shall submit a copy of the general license authorization
for the device and documentation that they are authorized to possess
the device under a general license pursuant to the regulations of the
U.S. Nuclear Regulatory Commission or another Agreement State that
are applicable to the jurisdiction where the reciprocity request
originated.