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Ohio Laws and Rules
(A) In accordance with section 3748.21 of the Revised Code, this rule does not apply to any person to the extent that the person is subject to regulation by the United States nuclear regulatory commission. Except as otherwise provided in paragraphs (B) to (E) of this rule, any facility that handles radioactive material for which a license is required by Chapter 3748. of the Revised Code and this rule shall comply with standards and requirements set forth in subpart J to 10 C.F.R. part 35 as specified in appendix A to this rule, as that appendix exited on June 9, 1997, and as if that appendix had included naturally occurring or accelerator-produced material. Standards set forth for byproduct material in appendix A and to this rule shall apply to NARM. As used in this rule, “naturally occurring radioactive material” or “NORM” means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material. As used in this rule, “technologically enhanced” means the chemical properties or physical state of natural sources of radiation have been altered or the potential exposure pathways of natural sources of radiation to humans have been altered to increase the human radiation exposure. In all cases where the “commission” or “nuclear regulatory commission” is referenced in appendix A, that term shall refer to the director, except that the term shall continue to refer to the United States nuclear regulatory commission for those activities which jurisdiction is specifically retained by the United States nuclear regulatory commission irrespective of any agreement with the state of Ohio pursuant to section 274(b) of the “Atomic Energy Act.” In all cases where “special nuclear material” is referenced, that term shall refer to quantities not sufficient to form a critical mass.
(B) The following activities are exempt from licensure, unless the director determines that the dose received by an average member of the critical group would exceed the dose limit specified in rule 3701:1-38-22(B) of the Administrative Code:
(1) The handling, distribution, or processing of:
(a) Soil containing technologically enhanced radium-226 or radium-228 with a radon emanation rate less than 0.74 becquerels per square meter per second (twenty picocuries per square meter per second), provided that the concentration of technologically enhanced radium-226 or radium-228 in the soil, averaged over any one hundred square meters, and averaged over the first fifteen centimeters of soil below the surface, does not exceed one becquerel per gram (twenty-seven picocuries per gram);
(b) Soil containing technologically enhanced radium-226 or radium-228 with a radon emanation rate equal to or greater than 0.74 becquerels per square meter per second (twenty picocuries per square meter per second) provided that the concentration of technologically enhanced radium-226 or radium-228 in the soil, averaged over any one hundred square meters, and averaged over the first fifteen centimeters of soil below the surface does not exceed 0.185 becquerel per gram (five picocuries per gram);
(c) Media, other than soil, containing technologically enhanced radium-226 or radium-228 with a radon emanation rate less than 0.74 becquerels per square meter per second (twenty picocuries per square meter per second) provided that the concentration of technologically enhanced radium-226 or radium-228 does not exceed one becquerel per gram (twenty-seven picocuries per gram);
(d) Media, other than soil, containing technologically enhanced radium-226 or radium-228 with a radon emanation rate is equal to or greater than 0.74 becquerels per square meter per second (twenty picocuries per square meter per second) provided that the concentration of technologically enhanced radium-226 or radium-228 does not exceed 0.185 becquerel per gram (five picocuries per gram);
(e) Soil containing NARM other than technologically enhanced radium-226 or radium-228 provided that the concentration of NARM averaged over any one hundred square meters, and averaged over the first fifteen centimeters of soil below the surface is five becquerels per gram (one hundred thirty-five picocuries per gram) or less;
(f) Media, other than soil, containing NARM other than technologically enhanced radium-226 or radium-228 provided that the concentration of NARM is five becquerels per gram (one hundred thirty-five picocuries per gram) or less; or
(g) Materials in the recycling process contaminated with scale or residue not otherwise exempted or other equipment containing NARM with a radiation exposure level that does not exceed 0.25 micrograys (twenty-five microrads) per hour above background at any accessible point.
(2) The manufacture, wholesale or retail commercial distribution, use, or disposal of the following products or materials, or the recycling of equipment used to produce, contain, or transport the following:
(a) Potassium or potassium compounds that have not been isotopically enriched in the radionuclide potassium-40;
(b) Fossil fuel or byproducts from fossil fuel combustion, including bottom ash, fly ash, and flue-gas emission control byproducts; or
(c) Material used for building construction, industrial processing, sandblasting, metal casings, or other NARM in which the radionuclide content has not been concentrated to a level higher than is found in its natural state, or zirconium-bearing sands and products produced from those sands provided that the radioactive constituent is consistent with the radioactive levels stated in the material safety data sheet accompanying the zirconium-bearing materials,
(3) The wholesale and retail commercial distribution, including custom blending, possession, and use of the following products or materials or the recycling of equipment or containers used to produce, contain, or transport these products as follows:
(a) Phosphate or potash fertilizer;
(b) Phosphogypsum for agricultural uses if such commercial distribution and uses meet the requirements of 40 C.F.R. 61.204, 40 C.F.R. 61.207, and 40 C.F.R.61.208 as specified in appendix D to this rule; or
(c) Materials used for building construction if the materials contain NARM that has not been concentrated to higher levels than found in its natural state. The exemptions contained in this paragraph do not apply to the manufacture of phosphate or potash fertilizer.
(4) The possession, storage, use, transportation, or commercial distribution of natural gas and natural gas products or of crude oil and crude oil products containing NARM. The exemptions contained in this paragraph do not apply to the processing of natural gas or crude oil or the manufacture of natural gas products or crude oil products containing NARM.
(5) Possession of produced waters from crude oil or natural gas production provided that the produced waters are reinjected in a well approved by the United States environmental protection agency or discharged under the authority of the United States environmental protection agency.
(6) The possession, storage, use, transportation or commercial distribution of compressed gases and compressed gas products containing NARM. The exemptions contained in this paragraph do not apply to the processing of compressed gas or compressed gas products containing NARM.
(C) Notwithstanding paragraph (A) of this rule, any facility that handles NARM for which license is required by Chapter 3748. of the Revised Code does not have to comply with the following standards or requirements as indicated:
(1) Information collection and the United States office of management and budget approval provisions of appendix A to this rule.
(2) References requiring communication to the United States nuclear regulatory commission. Instead, the required communication shall be directed to the director, Ohio department of health, P.O. Box 118, Columbus, Ohio 43266-0118. An incident or a misadministration requiring reporting shall be made by calling (614) 644-2727.
(3) References to written interpretations by the United States nuclear regulatory commission contained in appendix A, appendix B, and appendix C to this rule.
(4) References to the import or export of source, byproduct, and special nuclear material.
(5) References to any fees. Instead, fees shall be assessed and collected in accordance with rule 3701:1-38-02 of the Administrative Code.
(6) References to any enforcement, or civil or criminal penalties. Instead, enforcement activities and civil or criminal penalties shall be in accordance with Chapter 3748. of the Revised Code.
(D) Notwithstanding paragraph (A) of this rule, the requirements of appendix A are in addition to any applicable licensing requirements contained in Chapter 4773. of the Revised Code.
(E) Information provided by a licensee or applicant for a license or license renewal that constitutes a “trade secret” as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.
Appendix A Nuclear Regulatory Commission
Part 35-Medical use of byproduct material
Subpart A-General Information
Sec.
35.1 Purpose and scope.
35.2 Definitions.
35.5 Maintenance of records.
35.6 Provisions for research involving human subjects.
35.7 FDA, other Federal, and State requirements.
35.8 Information collection requirements: OMB approval.
35.11 License required.
35.12 Application for license, amendment, or renewal.
35.13 License amendments.
35.14 Notifications.
35.15 Exemptions regarding Type A specific licenses of broad scope.
35.18 License issuance.
35.19 Specific exemptions.
Subpart B-General Administrative Requirements
35.20 ALARA program.
35.21 Radiation Safety Officer.
35.22 Radiation Safety Committee.
35.23 Statements of authority and responsibilities.
35.25 Supervision.
35.29 Administrative requirements that apply to the provision of mobile nuclear medicine service.
35.31 Radiation safety program changes.
35.32 Quality management program.
35.33 Notifications, reports, and records of misadministrations.
35.49 Suppliers for sealed sources or devices for medical use.
Subpart C-General Technical Requirements
35.50 Possession, use, calibration, and check of dose calibrators.
35.51 Calibration and check of survey instruments.
35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.
35.53 Measurement of dosages of unsealed byproduct material for medical use.
35.57 Authorization for calibration and reference sources.
35.59 Requirements for possession of sealed sources and brachytherapy sources.
35.60 Syringe shields and labels.
35.61 Vial shields and labels.
35.70 Surveys for contamination and ambient radiation exposure rate.
35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
35.80 Technical requirements that apply to the provision of mobile nuclear medicine service.
35.90 Storage of volatiles and gases.
35.92 Decay-in-storage.
Subpart D-Uptake, Dilution, and Excretion
35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies.
35.120 Possession of survey instrument.
Subpart E-Imaging and Localization
35.200 Use of unsealed byproduct material for imaging and localization studies.
35.204 Permissible molybdenum-99 concentration.
35.205 Control of aerosols and gases.
35.220 Possession of survey instruments.
Subpart F-Radiopharmaceuticals for Therapy
35.300 Use of unsealed byproduct material for therapeutic administration.
35.310 Safety instruction.
35.315 Safety precautions.
35.320 Possession of survey instruments.
Subpart G-Sources for Brachytherapy
35.400 Use of sources for brachytherapy.
35.404 Release of patients or human research subjects treated with temporary implants.
35.406 Brachytherapy sources inventory.
35.410 Safety instruction.
35.415 Safety precautions.
35.420 Possession of survey instrument.
Subpart H-Sealed Sources for Diagnosis
35.500 Use of sealed sources for diagnosis.
35.520 Availability of survey instrument.
Subpart I-Teletherapy
35.600 Use of a sealed source in a teletherapy unit.
35.605 Maintenance and repair restrictions.
35.606 License amendments.
35.610 Safety instruction.
35.615 Safety precautions.
35.620 Possession of survey instrument.
35.630 Dosimetry equipment.
35.632 Full calibration measurements.
35.634 Periodic spot-checks.
35.636 Safety checks for teletherapy facilities.
35.641 Radiation surveys for teletherapy facilities.
35.643 Modification of teletherapy unit or room before beginning a treatment program.
35.645 Reports of teletherapy surveys, checks, tests, and measurements.
35.647 Five-year inspection.
Subpart J-Training and Experience Requirements
35.900 Radiation Safety Officer.
35.901 Training for experienced Radiation Safety Officer.
35.910 Training for uptake, dilution, and excretion studies.
35.920 Training for imaging and localization studies.
35.930 Training for therapeutic use of unsealed byproduct material.
35.932 Training for treatment of hyperthyroidism.
35.934 Training for treatment of thyroid carcinoma.
35.940 Training for use of brachytherapy sources.
35.941 Training for ophthalmic use of strontium-90.
35.950 Training for use of sealed sources for diagnosis.
35.960 Training for teletherapy.
35.961 Training for teletherapy physicist.
35.970 Training for experienced authorized users.
35.971 Physician training in a three month program.
35.972 Recentness of training.
35.980 Training for an authorized nuclear pharmacist.
35.981 Training for experienced nuclear pharmacists.
Subpart K-Enforcement
35.990 Violations.
35.991 Criminal penalties.
35.999 Resolution of conflicting requirements during transition period.
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Source: 51 FR 36951, Oct. 16, 1986, unless otherwise noted.
Subpart A-General Information
§ 35.1 Purpose and scope.
This part prescribes requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. 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 19, 20, 21, 30, 71, and 170 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.
§ 35.2 Definitions.
Address of use means the building or buildings that are identified on the license and where byproduct material may be received, used, or stored.
Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.
ALARA (as low as reasonably achievable) means making every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical:
(1) Consistent with the purpose for which the licensed activity is undertaken,
(2) Taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and
(3) In relation to utilization of nuclear energy in the public interest.
Area of use means a portion of an address of use that has been set aside for the purpose of receiving, using, or storing byproduct material.
Authorized nuclear pharmacist means a pharmacist who is:
(1) Board certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties;
(2) Identified as an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in the practice of nuclear pharmacy; or
(3) Identified as an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in the practice of nuclear pharmacy.
Authorized user means a physician, dentist, or podiatrist who is:
(1) Board certified by at least one of the boards listed in Paragraph (a) of §§ 35.910, 35.920, 35.930, 35.940, 35.950, or 35.960;
(2) Identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material; or
(3) Identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material.
Brachytherapy source means an individual sealed source or a manufacturerassembled source train that is not designed to be disassembled by the user.
Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.
Dental use means the intentional external administration of the radiation from byproduct material to human beings in the practice of dentistry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.
Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.
Management means the chief executive officer or that person’s delegate or delegates.
Medical Institution means an organization in which several medical disciplines are practiced.
Medical use means the intentional internal or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.
Ministerial change means a change that is made, after ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making a discretionary judgment about whether those requirements should apply in the case at hand.
Misadministration means the administration of:
(1) A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or I-131:
(i) Involving the wrong individual, or wrong radiopharmaceutical; or
(ii) When both the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage and the difference between the administered dosage and prescribed dosage exceeds 30 microcuries.
(2) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:
(i) Involving the wrong individual, wrong radiopharmaceutical, or wrong route of administration; or
(ii) When the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage.
(3) A gamma stereotactic radiosurgery radiation dose:
(i) Involving the wrong individual, or wrong treatment site; or
(ii) When the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose.
(4) A teletherapy radiation dose:
(i) Involving the wrong individual, wrong mode of treatment, or wrong treatment site;
(ii) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose;
(iii) When the calculated weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescribed dose; or
(iv) When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.
(5) A brachytherapy radiation dose:
(i) Involving the wrong individual, wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site);
(ii) Involving a sealed source that is leaking;
(iii) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or
(iv) When the calculated administered dose differs from the prescribed dose by more than 20 percent of the prescribed dose.
(6) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries of either sodium iodide I-125 or I-131, both:
(i) Involving the wrong individual, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and
(ii) When the dose to the individual exceeds 5 rems effective dose equivalent or 50 rems dose equivalent to any individual organ.
Mobile nuclear medicine service means the transportation and medical use of byproduct material.
Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.
Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
Podiatric use means the intentional external administration of the radiation from byproduct material to human beings in the practice of podiatry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.
Prescribed dosage means the quantity of radiopharmaceutical activity as documented:
(1) In a written directive; or
(2) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
Prescribed dose means:
(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;
(2) For teletherapy, the total dose and dose per fraction as documented in the written directive; or
(3) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.
Radiation Safety Officer means the individual identified as the Radiation Safety Officer on a Commission license.
Recordable event means the administration of:
(1) A radiopharmaceutical or radiation without a written directive where a written directive is required;
(2) A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;
(3) A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or I-131 when both:
(i) The administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage, and
(ii) The difference between the administered dosage and prescribed dosage exceeds 15 microcuries;
(4) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage;
(5) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15 percent or more of the weekly prescribed dose; or
(6) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose.
Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.
Teletherapy physicist means the individual identified as the teletherapy physicist on a Commission license.
Written directive means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in paragraph (6) of this definition, containing the following information:
(1) For any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or 1-131: the dosage;
(2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration;
(3) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;
(4) For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period;
(5) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or
(6) For all other brachytherapy:
(i) Prior to implantation: the radioisotope, number of sources, and source strengths; and
(ii) After implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 34120, July 25, 1991; 59 FR 61781, Dec. 2, 1994; 60 FR 48626, Sept. 20, 1995]
§ 35.5 Maintenance of records.
Each record required by this part must be legible throughout the retention period specified by each Commission 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 stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
[53 FR 19247, May 27, 1988]
§ 35.6 Provisions for research involving human subjects.
A licensee may conduct research involving human subjects using byproduct material provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before conducting such research. Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an “Institutional Review Board” in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
[59 FR 61781, Dec. 2, 1994]
§ 35.7 FDA, other Federal, and State requirements.
Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
[59 FR 61782, Dec. 2, 1994]
§ 35.8 Information collection requirements: OMB approval.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0010.
(b) The approved information collection requirements contained in this part appear in §§ 35.6, 35.12, 35.13, 35.14, 35.20, 35.21, 35.22, 35.23, 35.29, 35.31, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980, and 35.981.
(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved as follows:
(1) In § 35.12, NRC Form NRC 313 is approved under control number 3150-0120.
(2) [Reserved]
(d) OMB has assigned control number 3150-0171 for the information collection requirements contained in §§ 35.32 and 35.33.
[51 FR 36951, Oct. 16, 1986, as amended at 57 FR 41378, Sept. 10, 1992; 59 FR 61782, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997]
§ 35.11 License required.
(a) A person shall not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) or (c) of this section.
(b) An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in § 35.25, unless prohibited by license condition.
(c) An individual may prepare unsealed byproduct 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 § 35.25, unless prohibited by license condition.
[51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782, Dec. 2, 1994]
§ 35.12 Application for license, amendment, or renewal.
(a) If the application is for medical use sited in a medical institution, only the institution’s management may apply. If the application is for medical use not sited in a medical institution, any person may apply.
(b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, and 35.500 of this part must be made by filing an original and one copy of Form NRC-313, “Application for Materials License.” For guidance in completing the form, refer to the instructions in the most current versions of the appropriate Regulatory Guides. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.
(c) An application for a license for medical use of byproduct material as described in § 35.600 of this part must be made by filing an original and one copy of Form NRC-313. For guidance in completing the form, refer to the instructions in the most current version of the appropriate Regulatory Guide. A request for a license amendment or renewal may be submitted as an original and one copy in letter format.
(d) For copies of regulatory guides, application forms, or to submit an application or an amendment request, refer to § 30.6 of this chapter.
(e) An applicant that satisfies the requirements specified in 10 CFR 33.13 may apply for a Type A specific license of broad scope.
[51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782, Dec. 2, 1994]
§ 35.13 License amendments.
A licensee shall apply for and must receive a license amendment:
(a) Before it receives or uses byproduct material for a clinical procedure permitted under this part but not permitted by the license issued pursuant to this part;
(b) Before it permits anyone to work as an authorized user or authorized nuclear pharmacist under the license, except an individual who is:
(1) An authorized user certified by the organizations specified in paragraph (a) of § 35.910, § 35.920, § 35.930, § 35.940, § 35.950, or § 35.960;
(2) An authorized nuclear pharmacist certified by the organization specified in paragraph (a) of § 35.980;
(3) Identified as an authorized user or an authorized nuclear pharmacist on a Commission or Agreement State license that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively; or
(4) Identified as an authorized user or an authorized nuclear pharmacist on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy, respectively.
(c) Before it changes Radiation Safety Officers or Teletherapy Physicists;
(d) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license; and
(e) Before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license.
[51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782, Dec. 2, 1994]
§ 35.14 Notifications.
(a) A licensee shall provide to the Commission a copy of the board certification, the Commission or Agreement State license, or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user or an authorized nuclear pharmacist pursuant to § 35.13 (b)(1) through (b)(4).
(b) A licensee shall notify the Commission by letter no later than 30 days after:
(1) An authorized user, an authorized nuclear pharmacist, Radiation Safety Officer, or teletherapy physicist permanently discontinues performance of duties under the license or has a name change; or
(2) The licensee’s mailing address changes.
(c) The licensee shall mail the documents required in this section to the appropriate address identified in § 30.6 of this chapter.
[59 FR 61782, Dec. 2, 1994]
§ 35.15 Exemptions regarding Type A specific licenses of broad scope.
A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
(a) The provisions of § 35.13(b);
(b) The provisions of § 35.13(e) regarding additions to or changes in the areas of use only at the addresses specified in the license;
(c) The provisions of § 35.14(a); and
(d) The provisions of § 35.14(b)(1) for an authorized user or an authorized nuclear pharmacist.
[59 FR 61782, Dec. 2, 1994]
§ 35.18 License issuance.
The Commission shall issue a license for the medical use of byproduct material if:
(a) The applicant has filed Form NRC-313 “Application for Materials License” in accordance with the instructions in § 35.12;
(b) The applicant has paid any applicable fee as provided in part 170 of this chapter;
(c) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this chapter for the protection of the public health and safety; and
(d) The applicant meets the requirements of part 30 of this chapter.
[51 FR 36951, Oct. 16, 1986, as amended at 63 FR 31607, June 10, 1998]
§ 35.19 Specific exemptions.
The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as 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. The Commission will review requests for exemptions from training and experience requirements with the assistance of its Advisory Committee on the Medical Uses of Isotopes.
Subpart B-General Administrative Requirements
§ 35.20 ALARA program.
(a) Each licensee shall develop and implement a written radiation protection program that includes provisions for keeping doses ALARA.
(b) To satisfy the requirement of paragraph (a) of this section:
(1) At a medical institution, management, the Radiation Safety Officer, and all authorized users must participate in the program as requested by the Radiation Safety Committee.
(2) For licensees that are not medical institutions, management and all authorized users must participate in the program as requested by the Radiation Safety Officer.
(c) The program must include notice to workers of the program’s existence and workers’ responsibility to help keep dose equivalents ALARA, a review of summaries of the types and amounts of byproduct material used, occupational doses, changes in radiation safety procedures and safety measures, and continuing education and training for all personnel who work with or in the vicinity of byproduct material. The purpose of the review is to ensure that licensees make a reasonable effort to maintain individual and collective occupational doses ALARA.
§ 35.21 Radiation Safety Officer.
(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee’s byproduct material program.
(b) The Radiation Safety Officer shall:
(1) Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, misadministrations, and other deviations from approved radiation safety practice and implement corrective actions as necessary;
(2) Establish, collect in one binder or file, and implement written policy and procedures for:
(i) Authorizing the purchase of byproduct material;
(ii) Receiving and opening packages of byproduct material;
(iii) Storing byproduct material;
(iv) Keeping an inventory record of byproduct material;
(v) Using byproduct material safely;
(vi) Taking emergency action if control of byproduct material is lost;
(vii) Performing periodic radiation surveys;
(viii) Performing checks of survey instruments and other safety equipment;
(ix) Disposing of byproduct material;
(x) Training personnel who work in or frequent areas where byproduct material is used or stored;
(xi) Keeping a copy of all records and reports required by the Commission regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations.
(3) Brief management once each year on the byproduct material program;
(4) Establish personnel exposure investigational levels that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure;
(5) Establish personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence;
(6) For medical use not at a medical institution, approve or disapprove minor changes in radiation safety procedures that are not potentially important to safety with the advice and consent of management; and
(7) For medical use at a medical institution, assist the Radiation Safety Committee in the performance of its duties.
§ 35.22 Radiation Safety Committee.
Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.
(a) Each Committee must meet the following administrative requirements:
(1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.
(2) The Committee must meet at least quarterly.
(3) To establish a quorum and to conduct business, at least one-half of the Committee’s membership must be present, including the Radiation Safety Officer and the management’s representative.
(4) The minutes of each Radiation Safety Committee meeting must include:
(i) The date of the meeting;
(ii) Members present;
(iii) Members absent;
(iv) Summary of deliberations and discussions;
(v) Recommended actions and the numerical results of all ballots; and
(vi) ALARA program reviews described in § 35.20(c).
(5) The Committee must promptly provide each member with a copy of the meeting minutes, and retain one copy for the duration of the license.
(b) To oversee the use of licensed material, the Committee must:
(1) Review recommendations on ways to maintain individual and collective doses ALARA;
(2)(i) Review, on the basis of safety and with regard to the training and experience standards in subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or
(ii) Review, pursuant to § 35.13 (b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist;
(3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under § 35.31 of this part;
(4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material;
(5) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and
(6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.
[51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61782, Dec. 2, 1994]
§ 35.23 Statements of authority and responsibilities.
(a) A licensee shall provide the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, sufficient authority, organizational freedom, and management prerogative, to:
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions; and
(3) Verify implementation of corrective actions.
(b) A licensee shall establish and state in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, and retain the current edition of these statements as a record until the Commission terminates the license.
§ 35.25 Supervision.
(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by § 35.11(b) of this part shall:
(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual’s use of byproduct material and in the licensee’s written quality management program;
(2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to the use of byproduct material; and
(3) Periodically review the supervised individual’s use of byproduct material and the records kept to reflect this use.
(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11(c), shall:
(1) Instruct the supervised individual in the preparation of byproduct material for medical use and the principles of and procedures for radiation safety and in the licensee’s written quality management program, as appropriate to that individual’s use of byproduct material;
(2) Require the supervised individual to follow the instructions given pursuant to paragraph (b)(1) of this section and to comply with the regulations of this chapter and license conditions; and
(3) Require the supervising authorized nuclear pharmacist or physician who is an authorized user to periodically review the work of the supervised individual as it pertains to preparing byproduct material for medical use and the records kept to reflect that work.
(c) A licensee that supervises an individual is responsible for the acts and omissions of the supervised individual.
[51 FR 36951, Oct. 16, 1991, as amended at 56 FR 34121, July 25, 1991; 59 FR 61782, Dec. 2, 1994]
§ 35.29 Administrative requirements that apply to the provision of mobile nuclear medicine service.
(a) The Commission will license mobile nuclear medicine service only in accordance with subparts D, E and H of this part and § 31.11 of this chapter.
(b) Mobile nuclear medicine service licensees shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of byproduct material at the client’s address of use. The mobile nuclear medicine service licensee shall retain the letter for three years after the last provision of service.
(c) If a mobile nuclear medicine service provides services that the client is also authorized to provide, the client is responsible for assuring that services are conducted in accordance with the regulations in this chapter while the mobile nuclear medicine service is under the client’s direction.
(d) A mobile nuclear medicine service may not order byproduct material to be delivered directly from the manufacturer or distributor to the client’s address of use.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.31 Radiation safety program changes.
(a) A licensee may make minor changes in radiation safety procedures that are not potentially important to safety, i.e., ministerial changes, that were described in the application for license, renewal, or amendment except for those changes in §§ 35.13 and 35.606 of this part. Examples of such ministerial changes include: editing of procedures for clarity or conformance with local drafting policy or updating names, telephone numbers, and addresses; adoption of model radiation safety procedures published in NRC Regulatory Guides; replacement of equipment; reassignment of tasks among employees; or assignment of service contracts for services such as personnel dosimetry, radiation safety equipment repair or calibration, waste disposal, and safety surveys. A licensee is responsible for assuring that any change made is in compliance with the requirements of the regulations and the license.
(b) A licensee shall retain a record of each change until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical institution, the Radiation Safety Committee’s chairman and the management representative.
§ 35.32 Quality management program.
(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following specific objectives:
(1) That, prior to administration, a written directive
1is prepared for:
1 If, because of the patient’s condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient’s record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.
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 will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient’s record and a written directive is prepared within 24 hours of the oral directive.
(i) Any teletherapy radiation dose;
(ii) Any gamma stereotactic radiosurgery radiation dose;
(iii) Any brachytherapy radiation dose;
(iv) Any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131; or
(v) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-125 or I-131;
(2) That, prior to each administration, the patient’s or human research subject’s identity is verified by more than one method as the individual named in the written directive;
(3) That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
(4) That each administration is in accordance with the written directive; and
(5) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
(b) The licensee shall:
(1) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:
(i) A representative sample of patient and human research subject administrations,
(ii) All recordable events, and
(iii) All misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months;
(2) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and
(3) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.
(c) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:
(1) Assembling the relevant facts including the cause;
(2) Identifying what, if any, corrective action is required to prevent recurrence; and
(3) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.
(d) The licensee shall retain:
(1) Each written directive; and
(2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.
(e) The licensee may make modifications to the quality management program to increase the program’s efficiency provided the program’s effectiveness is not decreased. The licensee shall furnish the modification to the appropriate NRC Regional Office within 30 days after the modification has been made.
(f)(1) Each applicant for a new license, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the NRC.
(2) Each existing licensee, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 by January 27, 1992 a written certification that the quality management program has been implemented along with a copy of the program.
[56 FR 34121, July 25, 1991, as amended at 59 FR 61783, Dec. 2, 1994]
§ 35.33 Notifications, reports, and records of misadministrations.
(a) For a misadministration:
(1) The licensee shall notify by telephone the NRC Operations Center
2no later than the next calendar day after discovery of the misadministration.
2 The commercial telephone number of the NRC Operations Center is (301) 816-5100.
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadministration. The written report must include the licensee’s name; the prescribing physician’s name; a brief description of the event; why the event occurred; the effect on the individual who received the misadministration; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or the individual’s responsible relative or guardian), and if not, why not; and if there was notification, what information was provided. The report must not contain the individual’s name or any other information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual receiving the misadministration may be made instead to that individual’s responsible relative or guardian, when appropriate.
(3) The licensee shall notify the referring physician and also notify the individual receiving the misadministration of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgement, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the individual receiving the misadministration cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification.
(4) If the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual by sending either:
(i) A copy of the report that was submitted to the NRC; or
(ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.
(b) Each licensee shall retain a record of each misadministration for 5 years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration, and that individual’s referring physician, if applicable), the individual’s social security number or other identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals receiving misadministrations, or to that individual’s responsible relatives or guardians.
§ 35.49 Suppliers for sealed sources or devices for medical use.
A licensee may use for medical use only:
(a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR part 30 and 10 CFR 32.74 or the equivalent requirements of an Agreement State; or
(b) Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to 10 CFR part 30 or the equivalent requirements of an Agreement State.
[59 FR 61783, Dec. 2, 1994]
Subpart C-General Technical Requirements
§ 35.50 Possession, use, calibration, and check of dose calibrators.
(a) A licensee shall possess and use a dose calibrator to measure the activity of dosages of photon-emitting radionuclides prior to administration to each patient or human research subject.
(b) A licensee shall:
(1) Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the requirement of this paragraph, the check must be done on a frequently used setting with a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon-emitting radionuclide;
(2) Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 keV and 500 keV;
(3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over a range from the highest dosage that will be administered to a patient or human research subject to 1.1 megabecquerels (30 microcuries); and
(4) Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.
(c) A licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator.
(d) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
(e) A licensee shall retain a record of each check and test required by this section for three years unless directed otherwise. The records required in paragraphs (b)(1) through (b)(4) of this section must include:
(1) For paragraph (b)(1) of this section, the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check;
(2) For paragraph (b)(2) of this section, the model and serial number of the dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the identity of the individual performing the test.
(3) For paragraph (b)(3) of this section, the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the identity of the individual performing the test.
(4) For paragraph (b)(4) of this section, the model and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the identity of the individual performing the test.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61783, Dec. 2, 1994]
§ 35.51 Calibration and check of survey instruments.
(a) A licensee shall calibrate the survey instruments used to show compliance with this part before first use, annually, and following repair. The licensee shall:
(1) Calibrate all scales with readings up to 1000 millirem per hour with a radiation source;
(2) Calibrate two separated readings on each scale that must be calibrated; and
(3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
(b) When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.
(c) A licensee shall check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks.
(d) A licensee shall retain a record of each survey instrument calibration for three years. The record must include:
(1) A description of the calibration procedure; and
(2) The date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.52 Possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.
(a) This section does not apply to unit dosages of alpha- or beta- emitting radionuclides that are obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements.
(b) For other than unit dosages obtained pursuant to paragraph (a) of this section, a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or betaemitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. In addition, the licensee shall:
(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and
(2) Check each instrument for constancy and proper operation at the beginning of each day of use.
[59 FR 61783, Dec. 2, 1994]
§ 35.53 Measurement of dosages of unsealed byproduct material for medical use.
A licensee shall:
(a) Measure the activity of each dosage of a photon-emitting radionuclide prior to medical use.
(b) Measure, by direct measurement or by combination of measurements and calculations, the activity of each dosage of an alpha- or a beta-emitting radionuclide prior to medical use, except for unit dosages obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements;
(c) Retain a record of the measurements required by this section for three years. To satisfy this requirement, the record must contain the:
(1) Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;
(2) Patient’s or human research subject’s name, and identification number if one has been assigned;
(3) Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);
(4) Date and time of the measurement; and
(5) Initials of the individual who made the record.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61784, Dec. 2, 1994]
§ 35.57 Authorization for calibration and reference sources.
Any person authorized by § 35.11 of this part for medical use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use:
(a) Sealed sources manufactured and distributed by a person licensed pursuant to § 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each;
(b) Any byproduct material listed in §§ 35.100 or 35.200 with a half-life not longer than 100 days in individual amounts not to exceed 15 millicuries;
(c) Any byproduct material listed in §§ 35.100 or 35.200 with a half-life longer than 100 days in individual amounts not to exceed 200 microcuries each; and
(d) Technetium-99m in individual amounts not to exceed 50 millicuries.
§ 35.59 Requirements for possession of sealed sources and brachytherapy sources.
(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users.
(b) A licensee in possession of a sealed source shall:
(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 six months before transfer to the licensee; and
(2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that accompanies the source.
(c) To satisfy the leak test requirements of this section, the licensee must:
(1) Take a wipe sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or wash the source in a small volume of detergent solution and treat the entire volume as the sample;
(2) Take teletherapy and other device source test samples when the source is in the “off” position; and
(3) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample.
(d) A licensee shall retain leakage test records for five years. The records must contain the model number, and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety Officer.
(e) If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall:
(1) Immediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this chapter; and
(2) File a report within five days of the leakage test with the appropriate NRC Office listed in § 30.6 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, describing the equipment involved, the test results, and the action taken.
(f) A licensee need not perform a leakage test on the following sources:
(1) Sources containing only byproduct material with a half-life of less than 30 days;
(2) Sources containing only byproduct material as a gas;
(3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha-emitting material;
(4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or transfer; and
(5) Seeds of iridium-192 encased in nylon ribbon.
(g) A licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in its possession. The licensee shall retain each inventory record for five years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.
(h) A licensee in possession of a sealed source or brachytherapy source shall measure the ambient dose rates quarterly in all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
(i) A licensee shall retain a record of each survey required in paragraph (h) of this section for three years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the survey instrument used, and the signature of the Radiation Safety Officer.
[51 FR 36951, Oct. 16, 1986, as amended at 52 FR 31611, Aug. 21, 1987; 53 FR 19247, May 27, 1988]
§ 35.60 Syringe shields and labels.
(a) A licensee shall keep syringes that contain byproduct material to be administered in a radiation shield.
(b) To identify its contents, a licensee shall conspicuously label each syringe or syringe radiation shield that contains a syringe with a radiopharmaceutical. The label must show the radiopharmaceutical name or its abbreviation, the clinical procedure to be performed, or the patient’s or the human research subject’s name.
(c) A licensee shall require each individual who prepares a radiopharmaceutical kit to use a syringe radiation shield when preparing the kit and shall require each individual to use a syringe radiation shield when administering a radiopharmaceutical by injection unless the use of the shield is contraindicated for that patient or human research subject.
[51 FR 36951, Oct. 16, 1986, as amended at 59 FR 61784, Dec. 2, 1994]
§ 35.61 Vial shields and labels.
(a) A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
(b) To identify its contents, a licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical. The label must show the radiopharmaceutical name or its abbreviation.
§ 35.70 Surveys for contamination and ambient radiation exposure rate.
(a) A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
(b) A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored.
(c) A licensee shall conduct the surveys required by paragraphs (a) and (b) of this section so as to be able to detect dose rates as low as 0.1 millirem per hour.
(d) A licensee shall establish radiation dose rate trigger levels for the surveys required by paragraphs (a) and (b) of this section. A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds a trigger level.
(e) A licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
(f) A licensee shall conduct the surveys required by paragraph (e) of this section so as to be able to detect contamination on each wipe sample of 2000 disintegrations per minute.
(g) A licensee shall establish removable contamination trigger levels for the surveys required by paragraph (e) of this section. A licensee shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds the trigger level.
(h) A licensee shall retain a record of each survey for three years. The record must include the date of the survey, a plan of each area surveyed, the trigger level established for each area, the detected dose rate at several points in each area expressed in millirem per hour or the removable contamination in each area expressed in disintegrations per minute per 100 square centimeters, the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
(a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent 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 millisieverts (0.5 rem).
1
1 Regulatory Guide 8.39, “Release of Patients Administered Radioactive Materials,” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
(b) The licensee shall provide the released individual 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 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include:
(1) Guidance on the interruption or discontinuation of breast-feeding and
(2) Information on the consequences of failure to follow the guidance.
(c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated by:
(1) Using the retained activity rather than the activity administered,
(2) Using an occupancy factor less than 0.25 at 1 meter,
(3) Using the biological or effective half-life, or
(4) Considering the shielding by tissue.
(d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).
[62 FR 4133, Jan. 29, 1997]
§ 35.80 Technical requirements that apply to the provision of mobile nuclear medicine service.
A licensee providing mobile nuclear medicine service shall:
(a) Transport to each address of use only syringes or vials containing prepared radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits;
(b) Bring into each address of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all associated waste;
(c) Secure or keep under constant surveillance and immediate control all byproduct material when in transit or at an address of use;
(d) Check survey instruments and dose calibrators as described in §§ 35.50 and 35.51, and check all other transported equipment for proper function before medical use at each address of use;
(e) Carry a radiation detection survey meter in each vehicle that is being used to transport byproduct material, and, before leaving a client address of use, survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure that all radiopharmaceuticals and all associated waste have been removed;
(f) Retain a record of each survey required in paragraph (e) of this section for three years. The record must include the date of the survey, a plan of each area that was surveyed, the measured dose rate at several points in each area of use expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who performed the survey.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.90 Storage of volatiles and gases.
A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shipper’s radiation shield and container. A licensee shall store a multi-dose container in a fume hood after drawing the first dosage from it.
§ 35.92 Decay-in-storage.
(a) A licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of § 20.2001 of this chapter if it:
(1) Holds byproduct material for decay a minimum of ten half-lives;
(2) Monitors byproduct material at the container surface before disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding;
(3) Removes or obliterates all radiation labels; and
(4) Separates and monitors each generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level before disposal.
(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section for three years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993]
Subpart D-Uptake, Dilution, and Excretion
§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies.
A licensee may use for uptake, dilution, or excretion studies any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 35.920, or an individual under the supervision of either as specified in § 35.25.
[59 FR 61784, Dec. 2, 1994]
§ 35.120 Possession of survey instrument.
A licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour.
Subpart E-Imaging and Localization
§ 35.200 Use of unsealed byproduct material for imaging and localization studies.
A licensee may use for imaging and localization studies any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 35.920, or an individual under the supervision of either as specified in § 35.25.
[59 FR 61784, Dec. 2, 1994]
§ 35.204 Permissible molybdenum-99 concentration.
(a) A licensee may not administer to humans a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.
(b) A licensee that uses molybdenum99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate or extract.
(c) A licensee that must measure molybdenum concentration shall retain a record of each measurement for three years. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the time and date of the measurement, and the initials of the individual who made the measurement.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.205 Control of aerosols and gases.
(a) A licensee that administers radioactive aerosols or gases shall do so in a room with a system that will keep airborne concentrations low enough so as not to exceed the limits prescribed by §§ 20.1201 and 20.1301 of this chapter. The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
(b) A licensee shall administer radioactive gases only in rooms that are at negative pressure compared to surrounding rooms.
(c) Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a spill to reduce the concentration in the room low enough so as not to exceed the limits prescribed by § 20.1201 of this chapter. The calculation must be based on the highest activity of gas handled in a single container, the air volume of the room, and the measured available air exhaust rate.
(d) A licensee shall make a record of the calculations required in paragraph (c) of this section that includes the assumptions, measurements, and calculations made and shall retain the record for the duration of use of the area. A licensee shall also post the calculated time and safety measures to be instituted in case of a spill at the area of use.
(e) A licensee shall check the operation of reusable collection systems each month, and measure the ventilation rates available in areas of radioactive gas use each six months.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 27667, July 22, 1988; 59 FR 41643, Aug. 15, 1994]
§ 35.220 Possession of survey instruments.
A licensee authorized to use byproduct material for imaging and localization studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
Subpart F-Radiopharmaceuticals for Therapy
§ 35.300 Use of unsealed byproduct material for therapeutic administration.
A licensee may use for therapeutic administration any unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 35.920, or an individual under the supervision of either as specified in § 35.25.
[59 FR 61784, Dec. 2, 1994]
§ 35.310 Safety instruction.
(a) A licensee shall provide radiation safety instruction for all personnel caring for the patient or the human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with § 35.75 of this chapter. To satisfy this requirement, the instruction must describe the licensee’s procedures for:
(1) Patient or human research subject control;
(2) Visitor control;
(3) Contamination control;
(4) Waste control; and
(5) Notification of the Radiation Safety Officer in case of the patient’s or the human research subject’s death or medical emergency.
(b) A licensee shall keep for three years a list of individuals receiving instruction required by paragraph (a) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61784, Dec. 2, 1994]
§ 35.315 Safety precautions.
(a) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with § 35.75 of this chapter, a licensee shall:
(1) Provide a private room with a private sanitary facility;
(2) Post the patient’s or the human research subject’s door with a “Radioactive Materials” sign and note on the door or in the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or the human research subject’s room;
(3) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer;
(4) Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of part 20 of this chapter, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
(5) Either monitor material and items removed from the patient’s or the human research subject’s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste.
(6) [Reserved]
(7) Survey the patient’s or the human research subject’s room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient or human research subject to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters; and
(8) Measure the thyroid burden of each individual who helped prepare or administer a dosage of iodine-131 within three days after administering the dosage, and retain for the period required by § 20.1206(a) of this chapter a record of each thyroid burden measurement, its date, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements.
(b) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical emergency.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 59 FR 61784, Dec. 2, 1994; 62 FR 4133, Jan. 29, 1997]
§ 35.320 Possession of survey instruments.
A licensee authorized to use byproduct material for radiopharmaceutical therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
Subpart G-Sources for Brachytherapy
§ 35.400 Use of sources for brachytherapy.
A licensee shall use the following sources in accordance with the manufacturer’s radiation safety and handling instructions:
(a) Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
(b) Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
(c) Gold-198 as a sealed source in seeds for interstitial treatment of cancer;
(d) Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;
(e) Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and
(f) Iodine-125 as a sealed source in seeds for interstitial treatment of cancer.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
[51 FR 36951, Oct. 16, 1986, as amended at 54 FR 41821, Oct. 12, 1989]
§ 35.404 Release of patients or human research subjects treated with temporary implants.
(a) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a radiation survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed. The licensee may not release from confinement for medical care a patient or a human research subject treated by temporary implant until all sources have been removed.
(b) A licensee shall retain a record of patient or human research subject surveys for three years. Each record must include the date of the survey, the name of the patient or the human research subject, the dose rate from the patient or the human research subject expressed as millirem per hour and measured at 1 meter from the patient or the human research subject, the survey instrument used, and the initials of the individual who made the survey.
[59 FR 61785, Dec. 2, 1994]
§ 35.406 Brachytherapy sources inventory.
(a) Promptly after removing them from a patient or a human research subject, a licensee shall return brachytherapy sources to the storage area, and count the number returned to ensure that all sources taken from the storage area have been returned.
(b) A licensee shall make a record of brachytherapy source use which must include:
(1) The names of the individuals permitted to handle the sources;
(2) The number and activity of sources removed from storage, the patient’s or the human research subject’s name and room number, the time and date they were removed from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who removed the sources from storage;
(3) The number and activity of sources returned to storage, the patient’s or the human research subject’s name and room number, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage.
(c) Immediately after implanting sources in a patient or a human research subject the licensee shall make a radiation survey of the patient or the human research subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.
(d) A licensee shall retain the records required in paragraphs (b) and (c) of this section for three years.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61785, Dec. 2, 1994]
§ 35.410 Safety instruction.
(a) The licensee shall provide radiation safety instruction to all personnel caring for the patient or the human research subject undergoing implant therapy. To satisfy this requirement, the instruction must describe:
(1) Size and appearance of the brachytherapy sources;
(2) Safe handling and shielding instructions in case of a dislodged source;
(3) Procedures for patient or human research subject control;
(4) Procedures for visitor control; and
(5) Procedures for notification of the Radiation Safety Officer if the patient or the human research subject dies or has a medical emergency.
(b) A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (a) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61785, Dec. 2, 1994]
§ 35.415 Safety precautions.
(a) For each patient or human research subject receiving implant therapy and not released from licensee control pursuant to § 35.75 of this part, a licensee shall:
(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy.
(2) Post the patient’s or human research subject’s door with a “Radioactive Materials” sign and note on the door or in the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or human research subject’s room;
(3) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer; and
(4) Promptly after implanting the material, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of part 20 of this chapter, and retain for three years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirem per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
(b) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical emergency.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61785, Dec. 2, 1994; 59 FR 65244, Dec. 19, 1994; 62 FR 4133, Jan. 29, 1997]
§ 35.420 Possession of survey instrument.
A licensee authorized to use byproduct material for implant therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour.
Subpart H-Sealed Sources for Diagnosis
§ 35.500 Use of sealed sources for diagnosis.
A licensee shall use the following sealed sources in accordance with the manufacturer’s radiation safety and handling instructions:
(a) Iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis; and
(b) Iodine-125 as a sealed source in a portable imaging device.
§ 35.520 Availability of survey instrument.
A licensee authorized to use byproduct material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour. The instrument must have been calibrated in accordance with § 35.51 of this part.
Subpart I-Teletherapy
§ 35.600 Use of a sealed source in a teletherapy unit.
The regulations and provisions of this subpart govern the use of teletherapy units for medical use that contain a sealed source of cobalt-60 or cesium-137.
§ 35.605 Maintenance and repair restrictions.
Only a person specifically licensed by the Commission or an Agreement State to perform teletherapy unit maintenance and repair shall:
(a) Install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source; or
(b) Maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.
§ 35.606 License amendments.
In addition to the changes specified in § 35.13 of this part, a licensee shall apply for and must receive a license amendment before:
(a) Making any change in the treatment room shielding;
(b) Making any change in the location of the teletherapy unit within the treatment room;
(c) Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room;
(d) Relocating the teletherapy unit; or
(e) Allowing an individual not listed on the licensee’s license to perform the duties of the teletherapy physicist.
§ 35.610 Safety instruction.
(a) A licensee shall post instructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of:
(1) The procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before turning the primary beam of radiation on to begin a treatment or after a door interlock interruption;
(2) The procedure to be followed if:
(i) The operator is unable to turn the primary beam of radiation off with controls outside the treatment room or any other abnormal operation occurs; and
(ii) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the teletherapy unit or console operates abnormally.
(b) A licensee shall provide instruction in the topics identified in paragraph (a) of this section to all individuals who operate a teletherapy unit.
(c) A licensee shall retain for three years a record of individuals receiving instruction required by paragraph (b) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61785, Dec. 2, 1994]
§ 35.615 Safety precautions.
(a) A licensee shall control access to the teletherapy room by a door at each entrance.
(b) A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will:
(1) Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed;
(2) Turn the primary beam of radiation off immediately when an entrance door is opened; and
(3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console.
(c) A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light.
(d) A licensee shall install in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status.
(1) A radiation monitor must provide visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source, and must be observable by an individual entering the teletherapy room.
(2) A radiation monitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit. This backup power supply may be a battery system.
(3) A radiation monitor must be checked with a dedicated check source for proper operation each day before the teletherapy unit is used for treatment of patients or human research subjects.
(4) A licensee shall maintain a record of the check required by paragraph (d)(3) of this section for three years. The record must include the date of the check, notation that the monitor indicates when its detector is and is not exposed, and the initials of the individual who performed the check.
(5) If a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked with a dedicated check source for proper operation at the beginning of each day of use. The licensee shall keep a record as described in paragraph (d)(4) of this section.
(6) A licensee shall promptly repair or replace the radiation monitor if it is inoperable.
(e) A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient or the human research subject from the teletherapy unit console during irradiation.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988; 59 FR 61785, Dec. 2, 1994]
§ 35.620 Possession of survey instrument.
A licensee authorized to use byproduct material in a teletherapy unit shall have in its possession either a portable radiation detection survey instrument capable of detecting dose rate over the range 0.1 millirem per hour to 100 millirem per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1,000 millirem per hour.
§ 35.630 Dosimetry equipment.
(a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.
(1) The system must have been calibrated by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or
(2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee’s system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 source.
(b) The licensee shall have available for use a dosimetry system for spotcheck measurements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.
(c) The licensee shall retain a record of each calibration, intercomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM.
[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23471, May 21, 1991]
§ 35.632 Full calibration measurements.
(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:
(1) Before the first medical use of the unit; and
(2) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
(ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;
(iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and
(3) At intervals not exceeding one year.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within
13 percent for the range of field sizes and for the distance or range of distances used for medical use;
(2) The coincidence of the radiation field and the field indicated by the light beam localizing device;
(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;
(4) Timer constancy and linearity over the range of use;
(5) On-off error; and
(6) The accuracy of all distance measuring and localization devices in medical use.
(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379-396, or by Task Group 21 of the Radiation Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741-771, and Vol. 11, No. 2, 1984, p. 213. (Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20852-2738. Copies of the documents are also on file at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. A notice of any change in the material will be published in the Federal Register.)
(e) A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month for cobalt-60 or six months for cesium-137.
(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the licensee’s teletherapy physicist.
(g) A licensee shall retain a record of each calibration for the duration of use of the teletherapy unit source. The record must include the date of the calibration, the manufacturer’s name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, and assessment of timer linearity and constancy, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, and the signature of the teletherapy physicist.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 43420, Oct. 27, 1988; 57 FR 61786, Dec. 29, 1992; 59 FR 50689, Oct. 5, 1994]
§ 35.634 Periodic spot-checks.
(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:
(1) Timer constancy, and timer linearity over the range of use;
(2) On-off error;
(3) The coincidence of the radiation field and the field indicated by the light beam localizing device;
(4) The accuracy of all distance measuring and localization devices used for medical use;
(5) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b) of this part; and
(6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).
(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the teletherapy physicist. That individual need not actually perform the spotcheck measurements.
(c) A licensee shall have the teletherapy physicist review the results of each spot-check within 15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for three years.
(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month that assure proper operation of:
(1) Electrical interlocks at each teletherapy room entrance;
(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);
(3) Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility;
(4) Viewing systems;
(5) Treatment room doors from inside and outside the treatment room; and
(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(e) A licensee shall arrange for prompt repair of any system identified in paragraph (d) of this section that is not operating properly, and shall not use the teletherapy unit following door interlock malfunction until the interlock system has been repaired.
(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section for three years. The record must include the date of the spot-check, the manufacturer’s name, model number, and serial number for both the teletherapy unit and source, the manufacturer’s name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer linearity and constancy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the determined accuracy of each distance measuring or localization device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.636 Safety checks for teletherapy facilities.
(a) A licensee shall promptly check all systems listed in § 35.634(d) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by § 35.606 (a) through (d).
(b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in § 35.634(d), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(c) A licensee shall retain for three years a record of the facility checks following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer.
[51 FR 36951, Oct. 16, 1986, as amended at 53 FR 19247, May 27, 1988]
§ 35.641 Radiation surveys for teletherapy facilities.
(a) Before medical use, after each installation of a teletherapy source, and after making any change for which an amendment is required by § 35.606 (a) through (d), the licensee shall perform radiation surveys with a portable radiation measurement survey instrument calibrated in accordance with § 35.51 of this part to verify that:
(1) The maximum and average dose rates at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 10 millirem per hour and 2 millirem per hour, respectively; and
(2) With the teletherapy source in the on position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that:
(i) Radiation dose rates in restricted areas are not likely to cause any occupationally exposed individual to receive a dose in excess of the limits specified in § 20.1201 of this chapter; and
(ii) Radiation dose rates in controlled or unrestricted areas are not likely to cause any individual member of the public to receive a dose in excess of the limits specified in § 20.1301 of this chapter.
(b) If the results of the surveys required in paragraph (a) of this section indicate any radiation dose quantity per unit time in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit:
(1) Except as may be necessary to repair, replace, or test the teletherapy unit shielding or the treatment room shielding; or
(2) Until the licensee has received a specific exemption pursuant to § 20.1301 of this chapter.
(c) A licensee shall retain a record of the radiation measurements made following installation of a source for the duration of the license. The record must include the date of the measurements, the reason the survey is required, the manufacturer’s name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.
[51 FR 36951, Oct. 16, 1986, as amended at 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 63 FR 39483, July 23, 1998]
§ 35.643 Modification of teletherapy unit or room before beginning a treatment program.
(a) If the survey required by § 35.641 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in § 20.1301 of this chapter, the licensee shall, before beginning the treatment program:
(1) Either equip the unit with stops or add additional radiation shielding to ensure compliance with § 20.1301 of this chapter.
(2) Perform the survey required by § 35.641 again; and
(3) Include in the report required by § 35.645 the results of the initial survey, a description of the modific