reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-63.III.RHA 3.57 - [Appendix F] Radiological Criteria for License Termination

Current through Register Vol. 48, No. 6, June 28, 2024
3.57.1
				General Provisions and Scope
3.57.1.1 The criteria
				in this appendix apply to the decommissioning of facilities licensed under
				Regulation Regulation
				61-63, Title A, as well as other
				facilities subject to the Department's jurisdiction under the Atomic Energy and
				Radiation Control Act, Section
				13-7-10 of the 1976 S.C.
				Code, as amended. For low-level waste disposal facilities, the criteria apply only
				to ancillary surface facilities that support radioactive waste disposal activities.
				The criteria do not apply to uranium and thorium recovery facilities already subject
				to Appendix A to 10 CFR part 40 or to uranium solution extraction
				facilities.
3.57.1.2 The criteria in
				this appendix do not apply to sites which:
3.57.1.2.1 Have been decommissioned prior to the
				effective date of the rule in accordance with criteria identified in the Site
				Decommissioning Management Plan (SDMP) Action Plan;
3.57.1.2.2 Have previously submitted and received
				Department approval on a license termination plan (LTP) or decommissioning plan that
				is compatible with the SDMP Action Plan criteria; or
3.57.1.2.3 Submit a sufficient LTP or
				decommissioning plan before August 20, 1998 and such LTP or decommissioning plan is
				approved by the Department before August 20, 1999 and in accordance with the
				criteria identified in the SDMP Action Plan, except that if an EIS is required in
				the submittal, there will be a provision for day-to-day extension.
3.57.1.3 After a site has been
				decommissioned and the license terminated in accordance with the criteria in this
				appendix, the Department will require additional cleanup only if, based on new
				information, it determines that the criteria of this appendix were not met and
				residual radioactivity remaining at the site could result in significant threat to
				public health and safety.
3.57.1.4 When
				calculating TEDE to the average member of the critical group the licensee shall
				determine the peak annual TEDE dose expected within the first 1000 years after
				decommissioning.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-63.III.RHA 3.58 - [Appendix G] Nationally Tracked Sources - Serialization and Reports of Transactions

Current through Register Vol. 48, No. 6, June 28, 2024
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 must be composed only of alpha-numeric
				  characters. Each licensee who manufactures, transfers, receives, disassembles,
				  or disposes of a nationally tracked source shall complete and submit a National
				  Source Tracking Transaction Report to the National Source Tracking System as
				  specified in paragraphs 3.58.1 through 3.58.5 of this section for each type of
				  transaction.
3.58.1 Each licensee who
				manufactures a nationally tracked source shall complete and submit a National
				Source Tracking Transaction Report. The report must include the following
				information:
3.58.1.1 The name, address, and
				license number of the reporting licensee;
3.58.1.2 The name of the individual preparing
				the report;
3.58.1.3 The
				manufacturer, model, and serial number of the source;
3.58.1.4 The radioactive material in the
				source;
3.58.1.5 The initial source
				strength in becquerels (curies) at the time of manufacture; and
3.58.1.6 The manufacture date of the source.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.1 - Purpose and Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This part contains the requirements and provisions for the
					 medical use of radioactive material and for issuance of specific licenses
					 authorizing the medical use of this material. These requirements and provisions
					 provide for the radiation safety of workers, the general public, patients, and human
					 research subjects. The requirements and provisions of this part are in addition to,
					 and not in substitution for, others_in this chapter. The requirements and provisions
					 of parts I, II, III and VI of this chapter apply to applicants and licensees subject
					 to this part unless specifically exempted.
The Department provides that licensees will have up to 2 years
					 after the effective date of the final rule to comply with the training requirements
					 for authorized users, authorized medical physicists, authorized nuclear pharmacists,
					 and Radiation Safety Officers. During this 2-year period, licensees will have the
					 option of complying with either requirements of Subpart J or the requirements in
					 Subparts B and D-H of this Part.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.2 - Definitions

Current through Register Vol. 48, No. 6, June 28, 2024
4.2.1 "Address of use" means the building or
				  buildings that are identified on the license and where radioactive material may be
				  received, prepared, used, or stored.
4.2.2 "Agreement State" means any State with which
				  the Nuclear Regulatory Commission (hereafter referred to as NRC) or the Atomic
				  Energy Commission has entered into an effective agreement under subsection 274b of
				  the Atomic Energy Act of 1954, as amended.
4.2.3 "Area of use" means a portion of an address
				  of use that has been set aside for the purpose of receiving, preparing, using, or
				  storing radioactive material.
4.2.4
				  "
Associate Radiation Safety Officer
" means an individual who-
4.2.4.1 Meets the requirements in RHA 4.20 and RHA
				  4.24; and
4.2.4.2 Is currently identified
				  as an Associate Radiation Safety Officer for the types of use of radioactive
				  material for which the individual has been assigned duties and tasks by the
				  Radiation Safety Officer on-
4.2.4.2.1 A specific
				  medical use license issued by the Nuclear Regulatory Commission or an Agreement
				  State; or
4.2.4.2.2 A medical use permit
				  issued by a Nuclear Regulatory Commission master material
				  licensee.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.3 - Maintenance of Records

Current through Register Vol. 48, No. 6, June 28, 2024
Each record required by this part must be legible throughout the
					 specified retention period. The record may be the original, a reproduced copy, or a
					 microform if the copy or microform is authenticated by authorized personnel and 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, and specifications must include all
					 pertinent information such as stamps, initials, and signatures. The licensee shall
					 maintain adequate safeguards against tampering with and loss of
					 records.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.4 - Provisions for the Protection of Human Research Subjects

Current through Register Vol. 48, No. 6, June 28, 2024
4.4.1 A
				  licensee may conduct research involving human research subjects only if it uses the
				  radioactive materials specified on its license for the uses authorized on its
				  license.
4.4.2 If the research is
				  conducted, funded, supported, or regulated by another Federal agency that has
				  implemented the Federal Policy for the Protection of Human Subjects (Federal
				  Policy), the licensee shall, before conducting research--
4.4.2.1 Obtain review and approval of the research
				  from an "Institutional Review Board," as defined and described in the Federal
				  Policy; and
4.4.2.2 Obtain "informed
				  consent," as defined and described in the Federal Policy, from the human research
				  subject.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.5 - FDA, Other Federal, and State Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
Nothing in this part relieves the licensee from complying with
					 applicable FDA, other Federal, and State requirements governing radioactive drugs or
					 devices.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.6 - License Required

Current through Register Vol. 48, No. 6, June 28, 2024
4.6.1 A person may
				  manufacture, produce, acquire, receive, possess, prepare, use, or transfer byproduct
				  material for medical use only in accordance with a specific license issued by the
				  NRC or an Agreement State, or as allowed in RHA 4.6.2.1 or 4.6.2.2 of this
				  section.
4.6.2 A specific license is not
				  needed for an individual who--
4.6.2.1 Receives,
				  possesses, uses, or transfers radioactive material in accordance with the
				  regulations in this chapter under the supervision of an authorized user as provided
				  in RHA 4.15, unless prohibited by license condition; or
4.6.2.2 Prepares unsealed radioactive material for
				  medical use in accordance with the regulations in this chapter under the supervision
				  of an authorized nuclear pharmacist or authorized user as provided in RHA 4.15,
				  unless prohibited by license condition.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.7 - Application for License, Amendment, or Renewal

Current through Register Vol. 48, No. 6, June 28, 2024
4.7.1 An application
				  must be signed by the applicant's or licensee's management.
4.7.2 An application for a license for medical use
				  of radioactive material as described in RHA 4.35, 4.37, 4.40, 4.46, 4.56, 4.58 and
				  4.88 must be made by--
4.7.2.1 Filing an original
				  of DHEC Form 0813, "Application for Radioactive Material License," that includes the
				  facility diagram, equipment, and training and experience qualifications of the
				  Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s),
				  authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear
				  pharmacist(s); and
4.7.2.2 Submitting
				  procedures required by RHA 4.61, 4.67, 4.68 and 4.69, as
				  applicable.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.8 - License Amendments

Current through Register Vol. 48, No. 6, June 28, 2024
A licensee shall apply for and must receive a license
					 amendment-
4.8.1 Before it receives,
				  prepares, or uses radioactive material for a type of use that is permitted under
				  this part, but that is not authorized on the licensee's current license issued under
				  this part;
4.8.2 Before it permits anyone
				  to work as an authorized user, authorized medical physicist, ophthalmic physicist,
				  or authorized nuclear pharmacist under the license, except-
4.8.2.1 For an authorized user, an individual who
				  meets the requirements in RHA 4.24, 4.36.1, 4.39.1, 4.43.1, 4.44.1.1, 4.45.1.1,
				  4.54.1.1, 4.57.1.1, and 4.74.1.1;
4.8.2.2 For an authorized nuclear pharmacist, an
				  individual who meets the requirements in RHA 4.22.1 and RHA 4.24;
4.8.2.3 For an authorized medical physicist, an
				  individual who meets the requirements in RHA 4.21.1 and RHA 4.24;
4.8.2.4 An individual who is identified as an
				  authorized user, an authorized nuclear pharmacist, authorized medical physicist, or
				  an ophthalmic physicist-
4.8.2.4.1 On an NRC or
				  Agreement State license or other equivalent permit or license recognized by the
				  Department that authorizes the use of radioactive material in medical use or in the
				  practice of nuclear pharmacy;
4.8.2.4.2
				  On a license issued by an NRC or Agreement State specific license of broad scope
				  that is authorized to permit the use of radioactive material in medical use or in
				  the practice of nuclear pharmacy;
4.8.2.4.3 On a license issued by an NRC master
				  material licensee that is authorized to permit the use of radioactive material in
				  medical use or in the practice of nuclear pharmacy; or
4.8.2.4.4 By a commercial nuclear pharmacy that
				  has been authorized to identify authorized nuclear
				  pharmacists.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.9 - Notifications

Current through Register Vol. 48, No. 6, June 28, 2024
4.9.1 A licensee shall
				  provide the Department, no later than 30 days after the date that the licensee
				  permits an individual to work under the provisions of RHA 4.8.2 as an authorized
				  user, authorized medical physicist, ophthalmic physicist, or authorized nuclear
				  pharmacist-
4.9.1.1 A copy of the board
				  certification and, as appropriate, verification of completion of:
4.9.1.1.1 Training for the authorized medical
				  physicist under RHA 2.21.4;
4.9.1.1.2
				  Any additional case experience required in RHA 4.43.2.2.7 for an authorized user
				  under RHA 4.40; or
4.9.1.1.3 Device
				  specific training in RHA 4.74.1.5 for the authorized user under RHA 4.58;
				  or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.10 - Exemptions Regarding "Type A" Specific Licenses of Broad Scope

Current through Register Vol. 48, No. 6, June 28, 2024
A licensee possessing a Type A specific license of broad scope
					 for medical use, issued under Part II of this chapter, is exempt from--
4.10.1 The provisions of RHA 4.7.4 regarding the
				  need to file an amendment to the license for medical use of radioactive material, as
				  described in RHA 4.88;
4.10.2 The
				  provisions of RHA 4.8.2;
4.10.3 The
				  provisions of RHA 4.8.6 regarding additions to or changes in the areas of use at the
				  addresses identified in the application or on the license;
4.10.4 The provisions of RHA 4.9.1;
4.10.5 The provisions of RHA 4.9.2.1.1 for an
				  authorized user, an authorized nuclear pharmacist, authorized medical physicist, or
				  an ophthalmic physicist;
4.10.6 The
				  provisions of RHA 4.9.2.4 regarding additions to or changes in the areas of use
				  identified in the application or on the license where radioactive material is used
				  in accordance with either RHA 4.35 or 4.37.
4.10.7 The provisions of RHA 4.19.1.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.11 - License Issuance

Current through Register Vol. 48, No. 6, June 28, 2024
4.11.1 The Department
				  shall issue a license for the medical use of radioactive material if--
4.11.1.1 The applicant has filed DHEC Form 0813
				  "Application for Radioactive Material License" in accordance with the instructions
				  in
				  RHA 4.7;
4.11.1.2 The Department finds the applicant
				  equipped and committed to observe the safety standards established by the Department
				  in this Part for the protection of the public health and safety; and
4.11.1.3 The applicant meets the requirements of
				  Part II of this chapter.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart A - GENERAL INFORMATION › Section 61-63.IV.A.RHA 4.12 - Specific Exemptions

Current through Register Vol. 48, No. 6, June 28, 2024
The Department may, upon application of any interested person or
					 upon its own initiative, grant exemptions from the regulations in this part that it
					 determines are authorized by law and will not endanger life or property or the
					 common defense and security and are otherwise in the public
					 interest.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.13 - Authority and Responsibilities for the Radiation Protection Program

Current through Register Vol. 48, No. 6, June 28, 2024
4.13.1 In addition to the radiation protection
				  program requirements of RHA 3.4, a licensee's management shall approve in writing--
4.13.1.1 Requests for a license application,
				  renewal, or amendment before submittal to the Department;
4.13.1.2 Any individual before allowing that
				  individual to work as an authorized user, authorized nuclear pharmacist, or
				  authorized medical physicist; and
4.13.1.3 Radiation protection program changes that
				  do not require a license amendment and are permitted under
				  RHA 4.14;
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.14 - Radiation Protection Program Changes

Current through Register Vol. 48, No. 6, June 28, 2024
4.14.1 A licensee may
				  revise its radiation protection program without Department approval if--
4.14.1.1 The revision does not require a license
				  amendment under RHA 4.8;
4.14.1.2 The
				  revision is in compliance with the regulations and the license;
4.14.1.3 The revision has been reviewed and
				  approved by the Radiation Safety Officer and licensee management; and
4.14.1.4 The affected individuals are instructed
				  on the revised program before the changes are implemented.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.15 - Supervision

Current through Register Vol. 48, No. 6, June 28, 2024
4.15.1 A licensee that permits the receipt,
				  possession, use, or transfer of radioactive material by an individual under the
				  supervision of an authorized user, as allowed by RHA 4.6.2.1, shall--
4.15.1.1 In addition to the requirements in RHA
				  6.4 of this chapter, instruct the supervised individual in the licensee's written
				  radiation protection procedures, written directive procedures, regulations of this
				  chapter, and license conditions with respect to the use of radioactive material;
				  and
4.15.1.2 Require the supervised
				  individual to follow the instructions of the supervising authorized user for medical
				  uses of radioactive material, written radiation protection procedures established by
				  the licensee, written directive procedures, regulations of this Part and license
				  conditions with respect to the medical use of radioactive
				  material.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.17 - Written Directives

Current through Register Vol. 48, No. 6, June 28, 2024
4.17.1 A written
				  directive must be dated and signed by an authorized user before the administration
				  of I-131 sodium iodide greater than 1.11 Megabequerels (MBq) (30 microcuries (uCi)),
				  any therapeutic dosage of unsealed radioactive material or any therapeutic dose of
				  radiation from radioactive material.
4.17.1.1 If,
				  because of the emergent nature of the patient's condition, a delay in order to
				  provide a written directive would jeopardize the patient's health, an oral directive
				  is acceptable. The information contained in the oral directive must be documented as
				  soon as possible in writing in the patient's record. A written directive must be
				  prepared within 48 hours of the oral directive.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.18 - Procedures for Administrations Requiring a Written Directive

Current through Register Vol. 48, No. 6, June 28, 2024
4.18.1 For any
				  administration requiring a written directive, the licensee shall develop, implement,
				  and maintain written procedures to provide high confidence that:
4.18.1.1 The patient's or human research subject's
				  identity is verified before each administration; and
4.18.1.2 Each administration is in accordance with
				  the written directive.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.19 - Suppliers for Sealed Sources or Devices for Medical Use

Current through Register Vol. 48, No. 6, June 28, 2024
For medical use, a licensee may only use--
4.19.1 Sealed sources or devices manufactured,
				  labeled, packaged, and distributed in accordance with a license issued under Part II
				  of these regulations and RHA 2.7.7 or equivalent requirements of NRC regulations (
				  10 CFR Part 30 and
				  10
				  CFR 32.74 );
4.19.2 Sealed sources or devices noncommercially
				  transferred from a Part IV licensee or an Agreement State or NRC medical use
				  licensee.
4.19.3 Teletherapy sources
				  manufactured and distributed in accordance with a license issued under Part II of
				  these regulations or the equivalent requirements of NRC regulations ( 10 CFR Part 30
				  ).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.20 - Training for Radiation Safety Officers and Associate Radiation Safety Officer

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require an individual fulfilling the responsibilities of the Radiation Safety
					 Officer or an individual assigned duties and tasks as an Associate Radiation
					 Safety Officer as provided in
					 RHA 4.13 to be an individual
					 who-
4.20.1 Is certified by a
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State and who meets the requirements in
				  paragraphs 4.20.4 and 4.20.5 of this section. The names of board certifications
				  that have been recognized by the Nuclear Regulatory Commission or an Agreement
				  State are posted on the NRC's Medical Uses Licensee Toolkit web page.
4.20.1.1 To have its certification process
				  recognized, a specialty board shall require all candidates for certification
				  to:
4.20.1.1.1 Hold a bachelor's or graduate
				  degree from an accredited college or university in physical science or
				  engineering or biological science with a minimum of 20 college credits in
				  physical science;
4.20.1.1.2 Have 5
				  or more years of professional experience in health physics (graduate training
				  may be substituted for no more than 2 years of the required experience)
				  including at least 3 years in applied health physics; and
4.20.1.1.3 Pass an examination administered
				  by diplomats of the specialty board, which evaluates knowledge and competence
				  in radiation physics and instrumentation, radiation protection, mathematics
				  pertaining to the use and measurement of radioactivity, radiation biology, and
				  radiation dosimetry; or
4.20.1.2.1
				  Hold a master's or doctor's degree in physics, medical physics, other physical
				  science, engineering, or applied mathematics from an accredited college or
				  university;
4.20.1.2.2 Have 2 years
				  of full-time practical training and/or supervised experience in medical
				  physics:
4.20.1.2.2.1 Under the supervision
				  of a medical physicist who is certified in medical physics by a specialty board
				  recognized by the Nuclear Regulatory Commission or an Agreement State;
				  or
4.20.1.2.2.2 In clinical nuclear
				  medicine facilities providing diagnostic or therapeutic services under the
				  direction of physicians who meet the requirements for authorized users in
				  RHA 4.23, 4.39 or RHA 4.43;
				  and
4.20.1.2.3 Pass an
				  examination, administered by diplomats of the specialty board, that assesses
				  knowledge and competence in clinical diagnostic radiological or nuclear
				  medicine physics and in radiation safety; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.21 - Training for an Authorized Medical Physicist

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require the authorized medical physicist to be an individual who-
4.21.1 Is certified by a specialty board whose
				  certification process has been recognized by the Nuclear Regulatory Commission or an
				  Agreement State and who meets the requirements in paragraph 4.21.4 of this section.
				  The names of board certifications that have been recognized by the Nuclear
				  Regulatory Commission or an Agreement State are posted on the NRC's Medical Uses
				  Licensee Toolkit web page. To have its certification process recognized, a specialty
				  board shall require all candidates for certification to:
4.21.1.1 Hold a master's or doctor's degree in
				  physics, medical physics, other physical science, engineering, or applied
				  mathematics from an accredited college or university.
4.21.1.2 Have 2 years of full-time practical
				  training and/or supervised experience in medical physics-
4.21.1.2.1 Under the supervision of a medical
				  physicist who is certified in medical physics by a specialty board whose
				  certification process has been recognized under this section by the Nuclear
				  Regulatory Commission or an Agreement State; or
4.21.1.2.2 In clinical radiation facilities
				  providing high-energy, external beam therapy (photons and electrons with energies
				  greater than or equal to 1 million electron volts) and brachytherapy services under
				  the direction of physicians who meet the requirements for authorized users in
				  RHA 4.23, 4.54 or 4.74;
				  and
4.21.1.3 Pass an
				  examination, administered by diplomats of the specialty board, that assesses
				  knowledge and competence in clinical radiation therapy, radiation safety,
				  calibration, quality assurance, and treatment planning for external beam therapy,
				  brachytherapy, and stereotactic radiosurgery; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.22 - Training for an Authorized Nuclear Pharmacist

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require the authorized nuclear pharmacist to be a pharmacist who--
4.22.1 Is certified by a specialty board
				  whose certification process has been recognized by the Nuclear Regulatory
				  Commission or an Agreement State. The names of board certifications that have
				  been recognized by the Nuclear Regulatory Commission or an Agreement State are
				  posted on the NRC's Medical Uses Licensee Toolkit webpage. To have its
				  certification process recognized, a specialty board shall require all
				  candidates for certification to:
4.22.1.1
				  Have graduated from a pharmacy program accredited by the Accreditation Council
				  for Pharmacy Education (ACPE) or have passed the Foreign Pharmacy Graduate
				  Examination Committee (FPGEC) examination.
4.22.1.2 Hold a current, active license to
				  practice pharmacy;
4.22.1.3 Provide
				  evidence of having acquired at least 4000 hours of training/experience in
				  nuclear pharmacy practice. Academic training may be substituted for no more
				  than 2000 hours of the required training and experience; and
4.22.1.4 Pass an examination in nuclear
				  pharmacy administered by diplomats of the specialty board, that assesses
				  knowledge and competency in procurement, compounding, quality assurance,
				  dispensing, distribution, health and safety, radiation safety, provision of
				  information and consultation, monitoring patient outcomes, research and
				  development; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 61-63.IV.B.RHA 4.24 - Recentness of Training

Current through Register Vol. 48, No. 6, June 28, 2024
The training and experience specified in Subparts B, D, E, F, G,
					 and H of this part must have been obtained within the 7 years preceding the date of
					 application or the individual must have had related continuing education and
					 experience since the required training and experience was
					 completed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.25 - Possession, Use, and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material

Current through Register Vol. 48, No. 6, June 28, 2024
4.25.1 For direct
				  measurements performed in accordance with
				  RHA 4.27, a licensee shall
				  possess and use instrumentation to measure the activity of unsealed radioactive
				  material before it is administered to each patient or human research
				  subject.
4.25.2 A licensee shall
				  calibrate the instrumentation required in RHA 4.25.1 in accordance with nationally
				  recognized standards or the manufacturer's instructions.
4.25.3 A licensee shall retain a record of each
				  instrument calibration required by this section in accordance with RHA
				  4.93.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.26 - Calibration of Survey Instruments

Current through Register Vol. 48, No. 6, June 28, 2024
4.26.1 A licensee
				  shall calibrate the survey instruments used to show compliance with this part and
				  Part III before first use, annually, and following a repair that affects the
				  calibration. A licensee shall--
4.26.1.1 Calibrate
				  all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation
				  source;
4.26.1.2 Calibrate two separated
				  readings on each scale or decade that will be used to show compliance; and
4.26.1.3 Conspicuously note on the instrument the
				  date of calibration.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.27 - Determination of Dosages of Unsealed Byproduct Material for Medical Use

Current through Register Vol. 48, No. 6, June 28, 2024
4.27.1 A licensee shall determine and record the
				  activity of each dosage before medical use.
4.27.2 For a unit dosage, this determination must
				  be made by--
4.27.2.1 Direct measurement of
				  radioactivity; or
4.27.2.2 A decay
				  correction, based on the activity or activity concentration determined by--
4.27.2.2.1 A manufacturer or preparer licensed
				  under RHA 2.7.5 or equivalent NRC requirements;
4.27.2.2.2 An NRC or Agreement State licensee for
				  use in research in accordance with a Radioactive Drug Research Committee-approved
				  protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
4.27.2.2.3 A PET radioactive drug producer
				  licensed under Part 2 of this Regulation or equivalent Agreement State
				  requirements.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.28 - Authorization for Calibration, Transmission, and Reference Sources

Current through Register Vol. 48, No. 6, June 28, 2024
Any person authorized by RHA 4.6 for medical use of radioactive
					 material may receive, possess, and use any of the following radioactive material for
					 check, calibration, transmission, and reference use.
4.28.1 Sealed sources, not exceeding 1.11 GBq (30
				  mCi) each, manufactured and distributed by a person licensed under RHA 2.7.7 of this
				  chapter or equivalent NRC or Agreement State regulations.
4.28.2 Sealed sources, not exceeding 1.11 GBq (30
				  mCi) each, redistributed by a licensee authorized to redistribute the sealed sources
				  manufactured and distributed by a person licensed under RHA 2.7.7 of this chapter or
				  equivalent Nuclear Regulatory Commission or Agreement State regulations, providing
				  the redistributed sealed sources are in the original packaging and shielding and are
				  accompanied by the manufacturer's approved instructions.
4.28.3 Any radioactive material with a half-life
				  not longer than 120 days in individual amounts not to exceed 0.56 GBq (15
				  mCi).
4.28.4 Any radioactive material
				  with a half-life longer than 120 days in individual amounts not to exceed the
				  smaller of 7.4 MBq (200 uCi) or 1000 times the quantities in Appendix C, RHA 3.54,
				  of Part III of these regulations.
4.28.5
				  Technetium-99m in amounts as needed.
4.28.6 Radioactive material in sealed sources
				  authorized by this provision shall not be:
4.28.6.1 Used for medical use as defined in RHA
				  4.2 except in accordance with the requirements in RHA 4.56 or
4.28.6.2 Combined (i.e., bundled or aggregated) to
				  create an activity greater than the maximum activity of any single sealed source
				  authorized under this section.
4.28.6.3
				  A licensee using calibration, transmission, and reference sources in accordance with
				  the requirements in this section need not list these sources on a specific medical
				  use license.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.29 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Register Vol. 48, No. 6, June 28, 2024
4.29.1 A licensee in possession of any sealed
				  source or brachytherapy source shall follow the radiation safety and handling
				  instructions supplied by the manufacturer.
4.29.2 A licensee in possession of a sealed source
				  shall--
4.29.2.1 Test the source for leakage before
				  its first use unless the licensee has a certificate from the supplier indicating
				  that the source was tested within 6 months before transfer to the licensee;
				  and
4.29.2.2 Test the source for leakage
				  at the intervals not to exceed 6 months or at other intervals approved by the NRC or
				  an Agreement State in the Sealed Source and Device Registry.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.30 - Labeling of Vials and Syringes

Current through Register Vol. 48, No. 6, June 28, 2024
Each syringe and vial that contains unsealed radioactive
					 material must be labeled to identify the radioactive drug. Each syringe shield and
					 vial shield must also be labeled unless the label on the syringe or vial is visible
					 when shielded.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.31 - Surveys of Ambient Radiation Exposure Rate

Current through Register Vol. 48, No. 6, June 28, 2024
4.31.1 In addition to
				  the surveys required by Part III of this chapter, a licensee shall survey with a
				  radiation detection survey instrument at the end of each day of use. A licensee
				  shall survey all areas where unsealed radioactive material requiring a written
				  directive was prepared for use or administered.
4.31.2 A licensee does not need to perform the
				  surveys required by RHA 4.31.1 in an area(s) where patients or human research
				  subjects are confined when they cannot be released under
				  RHA 4.32.
4.31.3 A licensee shall retain a record of each
				  survey in accordance with RHA 4.97.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.32 - Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material

Current through Register Vol. 48, No. 6, June 28, 2024
4.32.1 A licensee may
				  authorize the release from its control of any individual who has been administered
				  unsealed radioactive material or implants containing radioactive material if the
				  total_effective dose equivalent to any other individual from exposure to the
				  released individual is not likely to exceed 5 mSv (0.5 rem). [FN1]
4.32.2 A licensee shall provide the released
				  individual, or the individual's parent or guardian, with instructions, including
				  written instructions, on actions recommended to maintain doses to other individuals
				  as low as is reasonably achievable if the total effective dose equivalent to any
				  other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose
				  equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there
				  were no interruption of breast-feeding, the instructions must also include--
4.32.2.1 Guidance on the interruption or
				  discontinuation of breast-feeding; and
4.32.2.2 Information on the potential
				  consequences, if any, of failure to follow the guidance.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.33 - Provision of Mobile Medical Services

Current through Register Vol. 48, No. 6, June 28, 2024
4.33.1 A licensee
				  providing mobile medical service shall--
4.33.1.1
				  Obtain a letter signed by the management of each client for which services are
				  rendered that permits the use of radioactive material at the client's address and
				  clearly delineates the authority and responsibility of the licensee and the
				  client;
4.33.1.2 Check instruments used
				  to measure the activity of unsealed radioactive material for proper function before
				  medical use at each client's address or on each day of use, whichever is more
				  frequent. At a minimum, the check for proper function required by this paragraph
				  must include a constancy check;
4.33.1.3
				  Check survey instruments for proper operation with a dedicated check source before
				  use at each client's address; and
4.33.1.4 Before leaving a client's address, survey
				  all areas of use to ensure compliance with the requirements in Part III of these
				  regulations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 61-63.IV.C.RHA 4.34 - Decay-in-Storage

Current through Register Vol. 48, No. 6, June 28, 2024
4.34.1 A licensee may
				  hold radioactive material with a physical half-life of less than or equal to 120
				  days for decay-in-storage before disposal without regard to its radioactivity if
				  it--
4.34.1.1 Monitors radioactive material at the
				  surface before disposal and determines that its radioactivity cannot be
				  distinguished from the background radiation level with an appropriate radiation
				  detection survey meter set on its most sensitive scale and with no interposed
				  shielding; and
4.34.1.2 Removes or
				  obliterates all radiation labels, except for radiation labels on materials that are
				  within containers and that will be managed as biomedical waste after they have been
				  released from the licensee.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED › Section 61-63.IV.D.RHA 4.35 - Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is not Required

Current through Register Vol. 48, No. 6, June 28, 2024
Except for quantities that require a written directive under RHA
					 4.17.2, a licensee may use any unsealed byproduct material prepared for medical use
					 for uptake, dilution, or excretion studies that is--
4.35.1 Obtained from:
4.35.1.1 A manufacturer or preparer licensed under
				  RHA 2.7.5 or equivalent Agreement State requirements; or
4.35.1.2 A PET radioactive drug producer licensed
				  under Part 2 of this Regulation or equivalent Agreement State requirements;
				  or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED › Section 61-63.IV.D.RHA 4.36 - Training for Uptake, Dilution, and Excretion Studies

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in RHA 4.23, the licensee shall require an
					 authorized user of unsealed radioactive material for the uses authorized under
					 RHA 4.35 to be a physician
					 who-
4.36.1 Is certified by a medical
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State. The names of board certifications that
				  have been recognized by the NRC or an Agreement State are posted on the NRC's
				  Medical Uses Licensee Toolkit web page. To have its certification process
				  recognized, a specialty board shall require all candidates for certification to:
4.36.1.1 Complete 60 hours of training and
				  experience in basic radionuclide handling techniques and radiation safety applicable
				  to the medical use of unsealed radioactive material for uptake, dilution, and
				  excretion studies that includes the topics listed in paragraphs 4.36.3 through
				  4.36.3.2.6 of this section; and
4.36.1.2
				  Pass an examination, administered by diplomats of the specialty board, that assesses
				  knowledge and competence in radiation safety, radionuclide handling, and quality
				  control; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED › Section 61-63.IV.D.RHA 4.37 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive is not Required

Current through Register Vol. 48, No. 6, June 28, 2024
Except for quantities that require a written directive under RHA
					 4.17.2, a licensee may use any unsealed byproduct material prepared for medical use
					 for imaging and localization studies that is--
4.37.1 Obtained from:
4.37.1.1 A manufacturer or preparer licensed under
				  RHA 2.7.5 or equivalent Agreement State requirements; or
4.37.1.2 A PET radioactive drug producer licensed
				  under Part 2 of this Regulation or equivalent Agreement State requirements;
				  or