ML20210R742

Working Draft Entitled, Low Dose Sealed Sources, as Part of NRC Program to Revise 10CFR35 & Associated Guidance Documents

ML20210R742
Person / Time
Issue date:	08/07/1997
From:	NRC
To:
Shared Package
ML20210K626	List: ML20210K620 ML20210R737 ML20210R742 ML20210R752 ML20210R759 ML20210R770 ML20210R775
References
FRN-62FR42219, RULE-PR-35 PROC-970807-01, PROC-970807-1, NUDOCS 9709030246
Download: ML20210R742 (33)

Text

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August 7,1997 WORKING DRAFT ,

i LOW DOSE SEALED SOURCES NOTE ,

Following Commission approval of the staffs program to revise 10 CFR Part 35 and -

associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach These draft modalities are being provided to the Part 35 Working Group at a very early stage in their development because they are key to the discucsion of significant issues associated with the regulation of the medical use of byproduct material, which is an agenda item at the August 19 20 meeting of the group. It should be noted that at this point in their development that they have not undergone a thorough review, including a review to ensure that they reflect the Commbslon's direction, in fact, in some cases, the draft documer,ts contain different alternatives to regulation of a specific area. Hopefully, these differences will stimulate input and additional alternatives from the Working Group.

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O 4 STAFF LEVEL DRAFT DOCUMENTS August 7. 1997 PART 35 -MEDICAL USE OF BYPRODUCT MATERIAL Low Dose Scaled Sources Subpart A--General Information ........ ........... 3 Purpose and scope 3 Section 35.1 LDR .. ............

Section 35.2 LDR Definitions ..................3 Section 35.5 LDR Haintenance of records . . . . . . . . . . . . . 4 Section 35.6 LDR Provisions for research involving human subjects

........................4 Section 35.7.LDR FDA other Federal, and State requirements . . . 4 Section 35.8 LDR Information collection requirements: OMB approval 5 Section 35.11 LDR License required . . . . . . . . ........ 5 Section 35.12 LDR Application for license, amendment, or renewal . . 6 Section 35.13 LDR License amendments . . ...... ..... 6 Section 35.14-LDR Notifications of Personnel and Administrative Changes

................ ........ 7 Section 35.15 LDR Exemptions regarding Type A specific licenses of broad scope .......... . . ... 7 Section 35.18 LDR License issuance . . . . . . . . . . . .... 8 Section 35.19 LDR Specific exemptions .... ......... 8 Subpart B General Administrative Requirements . . . . . . . . . . . 8 Section 35.21 LDR Radiation Safety Officer . . . ........ 9 Section 35.22 LDR Radiation Safety Committee . . . . . . . . . . . 9 Sec. tion 35.23 Lbd Statements of authority and responsibilities . . 11 Section 35.25 LDR Supervision .................. 11 Section 35.31-LDR Radiation safety program changes . . . . . , , . 12 Section 35.32 LDR Quality management program . , . . . . . . . . 12 Section 35.33 LDR Licensing Event Reports ........., . 14 Section 35.49 LDR Suppliers for sealed sources or devices for medical use ...................... 16 Subpart C General Technical kequirements . . . . . . . . . . . , . 16 Section 35.51 LDR Calibration and check of survey instruments .. 16 Section 35.57 LDR Authorization for calibration and reference sources

.,...................... 17 Section 35.59 LDR Requirements for possession of sealed sources and brachytherapy sources ............. 17 Section 35.75 LDR Release of individuals containing a:k w ose.cjp August 7, 1997

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• August 7. 1997 STAFF. LEVEL DRAFT DDCUMENTS radiopharmaceuticals or permanent implants . . . 20 Sources for Brachytherapy .... .......... 21 Subpart G Section 35.400-LDR Use of sources for brachytherapyMDVE INTO SECTION 35.49 or 597 . . . . . . . . . ........ 21 Section 35.404 LDR- Release of patients or human research subjects treated with temporary implants ...... . 21 Section 35.406 LDR Brachytherapy sources inventory ........ 22 Section 35.410 LDR Safety instruction . . . . . . ........ 22 Section 35.415 LDR Safety precautions . . . . . . . .. ... 23 Section 35.420 LDR Possession of survey instrument ........ 24 Sealed Sources for Diagnosis .... 24 Subpart H .........

Section 35.500-LDR Use of sealed sources for diagnosis ...... 24 Section 35.520 Availability of survey instrument . . . . . . . . . . 25 Subpart J Training and Experience Requirements . . . . . . . ... 25 Section 35.900 LDR Radiation Safety Officer ............ 25 Section 35.901-LDR Training for experienced Radiation Safety Officer

.... ... ............. J Section 35.940 LDR Training for use of brachytherapy sources ... 26 Section 35.941 LDR Training for ophthalmic use of strontium 90 .. 27 Section 35.950-LDR Training fc' use of sealed sources for diagnosis 28 Section 35.970 LDR Training fr .,,perienced authorized users ... 29 Section 35.97blDR Recentness of training .. .......... 29 Subpart K Enforcement . , . . . . . . . . . . . . . . . . . . . . 29 Section 35.990 LDR Violations . . . . . . . ...,.....,. 29 Section 35.991 LDR Criminal penalties . . . . . ......... 30 Section 35.999 LDR Resolution of conflicting requirements during transition period ............... 30 a:lowdose.cjp August 7 1997

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i STAFF. LEVEL DRAFT DOCUMENTS August 7, 1997 Subpart A.. General Information ,

Section 35.1.LDR Purpose and scope This part prescribes requirements and provisions for the medical use of j 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 ,qublic health and safety. The requirements and  !

i provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirement 3 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. -

i Section 35.2.LDR 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 eny State with which the Coc.nission or the Atomic '

Energy Comission has entered into an offective agreement under subsection

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274b of the Atomic Energy Act of 1954, as amended. .

i 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. .

Authorfled user means a physician, dentist, or podiatrist who is:

-(1) Board certified as described in Paragraph (a) of Sections 35.940 or 35,950:

(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.

Bracitytherapy source means an individual sealed . source or a .  :

manufacturer-assembled source train that is not designed to be disassembled byithe user.

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. 4 -0 STAFF. LEVEL DRAFT DOCUMENTS August 7. 1997 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 fra byprMuct material to human beings in the practice of dentistry in accordai.c' 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.

Depleted Uranfwl means the source material uranium in which the isotope uranium 235 is less than 0.711 weight percent of the total uranium present which is used for shielding, such as in portable shields. Depleted uranium does not include special nuclear material.

Management means the chief executive officer or that person's delegate or delegates.

Medical entity means any organization of medical practice that is not defined as a medical institution.

-Nedical Institution means an organization in which several medical disciplines are practiced and that provides in patient care.

Medical use means the intentional interital or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

Nodalfty refers to the type of medical use, such as brachytherapy, high dose. rate brachytherapy, teletherapy, and diagnostic and therapeutic use of unsealed; sources, for purposes of this part, diagnostic and therapeutic use.of unsealed sources is considered a single modality. CHECK THIS WITH WRITING (ROUP 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.

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1 s s STAFF LEVEL DRAFT DOCUMENTS August 7, 1997 Podiatric use means the intentional external administration of the d radiation fre.n byproduct naterial to human beings' in the practice of podiatry in accordance with a. license issued by a State or Territory of the Wited Stctes the District of Columbia, or the Commonwealth of Puerto Rico Podiatrist means an individual licensed by a State or Territory of the

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United States, the District'of Columbia, or the Commonwealth of Pe ato Rico to practice podiatry, Prescribed dose means:

1 (3) For brachytherapy. either the total source strength ar.d 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.

Reportable Medical Dent means an oral and/or written report to the NRC involving: THE CRITERIA BELOW IS BEING EVALUATED (i) The administration of a brachytherapy dose involving the wrong individual, wrong radioisotope, wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site), or when the calculated administered dose differs from the prescribed dose by more than 20 percent of the prescribed dose:

(ii) A sealed source that is leaking:

(iii) A temporary implant, when one or more sealed sources are not removed upon completion of the procedure:

(iv) Any structural m*chanical, electrical or electronic malfunction of associatMi e tament or afterloader device and its ancillary equipment, pw supplies and computerized treatment planning systems that may effect the dose to the patient.

Sealed source means any byproduct material that is encased in a capsule designed to prevent'. leakage or escape of the byproduct material. Stents will be covered under emerging technologies. The definition of sealed

source is under review n it is applicable to emerging technology. This is l

being reviewed,_ evaluated, and discussed with SSSS.

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N F LEVEL DRAFT DOCUMENTS August 7, 1997 Wrf tten directfve means a written set of directions, dated and signed by an authorized _ user prior to'the administration of radiation,-concerning patient. or human research subject, treatment from radiation to include, i a but not limited to the following information:

For brachytherapy: THIS IS BEING EVALUATED .

1 (i) Prior to implantation: the radioisotope, the nuober 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).

Section 35.5 LDR 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 i _period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the E - required retention period. Records such as letters, drawings.

4 specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards av W tampering with and loss of records.

Secttro 35.6 LDR 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 suojects 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.

Section 35,7 LDR FDA, other. Federal,-and State requirements-

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STAFF LEVEL DRAFT DOCUMENTS August 7, 1997 Nothing in this part relieves the licensee from complying with applicable '

FDA, other Federal, and State requirements governing research involving human subjects, radioactive drugs or devices.

Section 35,8 LDR Information collection requirements: OMB approval  ;

(a) The Comission has submitted the information collection requirements contained in this part to the Office of Management and Budget (0MB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C.-3501 et seq.). OMB has approved the information collection requirements in this part under :ontrol number 3150-0010. This section will be updated upon completion of the OMB package which will reflect the revisions to Part 35.

1 (b) The approved information collection requirements contained in this part appear in Sections This section will be updated upon completion of the OMB package which will reflect the revisions to Part 35.

. (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:

In Section 35.12. Form NRC-313 is approved under control number .

3150-0120. This section will be updated upon completion of the OMB

, package which will reflect the revisions to Part 35.

_Section 35,11 LDR License required (a) A person shall not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material or depleted uranium as defined in this part,-'for medical use except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of-this section.

(b) - An individual'may receive, possess, use, or transfer byproduct material or depleted uranium as defined in this-part, in accordance with the regulations in this chapter under the supervision of an authorized user as provided in Section 35.25. unless prohibited by

. license condition. In draft final, make sure 35,25 is the correct

- reference'here, i

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August 7. 1997 i STAFF LEVEL DRAFT DOCUMENTS Section 35.12 LDR Application for license, amendment, or renewal (a) .An application for medical use sited in a medical institution may

=only be submitted by the' institution's management. An application for medical use not sited in a medical institution may be submitted by any person representing _the highest level of management responsible for the medical entity.

(b) An application for a license for medical use of byproduct mater _tal as described in Sections 35,400 and 35.600 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 3

the form. refer to the instructions in the most current versions of the appropriate Regulatory Guides for the requested modalities of use. A request for a license amendmer,t or renewal may be submitted as an original and one copy in letter format. In final draft, make sure 35.400/500 are correct references (c) For copies of regulatory guides, application forms, or to submit an application or an amendment request, refer to Section 30.6 of this chapter.

(d) An applicant that satisfies the requirements specified in 10 CFR 33.13 may apply for a Type A specific license of broad scope.

Section 35.13 LOR 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 under the license, except an individual who is:

(1) .An authorized user certified as described _ in Paragraph (a)

.of Sections 35,940 and 35.950:

(2) Identified as an authorized user on a Commission or Agreement State license that authorizes the.use of a:lowdose.Cjp 6 August 7. 1997

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byproduct material in medical use; 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 use of byproduct material in medical use.

(c)- _Before it changes Radiation Safety Officers:

(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.

Section 35.14 LDR Notifications of Personnel and Administrative Changes ,

-(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 4 individual to work as an authorized user pursuant to Section 35.13 (b)(1) through (b)(4). Correct these reference numbers on final draft (b) A licensee shall notify the Commission by letter no later than 30 days after:

(1) An authorized user or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; or

-(2) The licensee's mailing address changes.

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(c) The licensee shall. mail the documents required in this section to the appropriate address -identified in Section 30.6 of this chapter.

-Section 35.15 LDR Exemptions regarding Type. A specific licenses'of broad scope

A licensee possessing a Type A specific license of broad scope for medical

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STAFF LEVEL ORAFT DOCUMENTS' August 7, 1997 s

use-is exempt from the.following: i (a) The provisions of Section 35,13(b);

(b)- The provisions of Section 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 Section 35.14(a); and The provisions of Section 35.14(b)(1) for an authorized user.

(d)

I Section 35,18 LDR -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 Section 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.

Section 35,19eLDR . 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 ailowdose,cjp' 8- August 7.-1997

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I STAFF LEVEL DRAFT DOClMENTS August 7, 1997-Section 35.21 LDR 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) Review personnel exposure records and investigate overexposures, accidents, spills, losses, thefts, unauthorized -

receipts, uses, transfers, disposals, reportable medical events, and other deviations from approved radiation safety practice and implement corrective actions as necessary:

(2) Establish written policies and procedures for implementing the radiation safety program.

(3) Brief management on the radiation safety program, at intervals not to exceed 12 months.

(4) For medical use not at a medical institution, approve or disapprove minor changes in radiation safety procedures, pursuant to Section 35.31. (This needs to be evaluated for consistency with RSC discussion and 35.31) and (5) Assist the Radiati_on Safety Committee, if such a committee is required pursuant to Section 35,22, in the performance of its duties, Section 35.22 LDR Radiation Safety Committee A radiation safety comittee must be established to oversee the medical use of NRC regulated material, the radiation therefrom, if the licensee _is authorized for more than on modality described in this.part.

(a). The Comittee must meet the following administrative requirements:-

-(1) Membership must consist of at least-three individuals and must

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• STAFF LEVEL DRAFT DOCUMENTS August 7, 1997 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) 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.

(3) The Committee must meet at least quarterly.

(4) The licensee must prepare, and certify the accuracy, minutes of each radiation safety committee meeting. The minutes must include:

(i) The date of the meeting:

(ii) Members present and absent:

(iii) Summary of deliberations and discussions:

(5) Retain a copy of the minutes for the duration of the license.

(b) To oversee the use of licensed material, the Committee must:

(1) (1) Review, on the basis of safety and with regard to the

• raining and experience standards of this part, and approve or disapprove any individual who is to be listed as an authorized user or the Radiation Safety Officer before submitting a license application or request for amendment or renewal: or (ii) Review, pursuant to Section 35.13 (b)(1) through (b)(3), 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.

(2) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management a:lodose cjp 10 August 7, 1997

STAFF LEVEL DRAFT DOCUMENTS August 7, 1997 representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part: review for consistency with 35,31 and discussion under RSO section (3) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and (4) Review the radiation safety program with the assistance of the Radiation Safety Officer, at intervals not to exceed 12 months.

Section 35,23 LDR Statements of authority and responsibilities (a) A licensee shall provide the radiation safety officer and the radiation safety committee, when such a committee is required pursuant to Section 35.22, 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 the radiation safety committee, when such a committee is required pursuant to Section 35.22, and retain the current edition of these statements as a record until the Commission terminates the license.

Section 35,25 LDR 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 Section 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 maierial and in the licensee's written quality management program; a:10wdose.cjp 11 August 7. 1997

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I STAFF LEVEL DRAFT DOCUMENTS- August 7, 1997 (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and. quality management program 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 supervises an individual is responsible for the acts-and omissions of the supervised individual.

Section-35,31 LDR Radiation safety program changes

.(a) _ A licensee may make minor changes in radiation safety procedures that are not potentially important to safety that were described in the application for license, renewal, or amendment except for those changes in Section 35.13 of this part. 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 rsnewed or terminated. The record must include the effective date o', the change, a copy of the old and new radiation safety procedures, the ,ea rn for the change, and the signature of the Radiation Safety Officer. Review and make consistent with discussion of RSC and this issue Section 35,32 LDR Quality management program (a) Each applicant or licensee under this part, as applicable, shall

-establish and maintain a written program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The-program must

' include' written policies and procedures to meet the following specific objectives:

(1) That, prior to administration. a written directive is prepared 1

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-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 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a written revision to an existing written directive may be made for any therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiation dose.

If, because of the emergent nature af 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 immedi::tely in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.

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(2) - That, prior to each. administration, the patient's or human .

H 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 rel:ted calculations for brachytherapy 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 perform an audit of a representative sample of written directives, at intervals not to exceed 12 months, to verify

that no unintended deviation occurred.

(c) The licensee shall retain:

(1) Each written directive; and (2) A record of each administered radiation dose where a written

directive is required in paragraph (a)(1) above, in an auditable form, for th ee years after the_ date of administration.

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Section 35,33 LDR Licensing Event Reports CRITERIA, THRESHOLD LIMIT, AND THE EXTEPfT OF PATIENT NOTIFICATIONS ARE UNRESOLVED.

1 (a) For_a Reportable Medical Event:

(1) .The licensee shall notify by telephone the NRC Operations -

Center # no later than the next calendar day after discovery of the reportable. medical event.

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'(2) LThe 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 reportable medical event. The written report must. include the licensee's name: the picscribing physician' ailowdosehjp 14 August 7. 1997

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• August 7, 1997 STAFF LEVEL DRAFT DOCUMENTS nu e a brief description of the event: why the event occurred:

the effect on the individual who received the reportable medical event; what improvements are needed to prevent recurrence: _ actions taken to prevent recurrence: whether the licensee notified the individual (cr the individual's responsible relet.;vc 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 acct the requiramcats of this scction, the notification of thc individual recciting the misadministratien may la made instcad tc that individual's respcasibic relative

, cr guardien. ;, hen appropriate.

(b) Each licensee shall retain a record of each reportable medical event fcr 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, etd that individual's referring physician, if applicabic), the individual's social security number or other identification number if one has been assigned, a brief description of the reportable medical event, why it occurred, the ef fect 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 affected individuals, cr to that individual's rcspcasible relativcs or guardians.

2 The comercial telephone number of the NRC Operations Center is (301) 816-5100.

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-STAFF LEVEL DRAFT! DOCUMENTS August 7; 1997 .

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^ Section 35.49 LDR _

Suppliers for sealed sources-or devices for medical:use: .

A licensee may use for medical use only sealed sources or devices -t manufactured; labeled, packaged, and distributed in accordance with a~

-license issued pursuant to 10 CFR Part 30 and 10 CFR 32.74 or the i equivalent requirements of an Agreement State.

i 111E FOLLOWING SECTIONS ARE CURRENTLY. UNDER REVIEW AND RESEARCH - MINIMAL CHANGES HAVE BEEN MADE.

Subpart C_ General Technical Requirements Section 35.51 LDR 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 licer.dee'shall retain a record of each survey instrument

. calibration for three years. The record must-include:

' ailowdose.cjp : -16 August 7. 1997

._ e-l August 7. 1997 1 STAFF LEVEL DRAFT DOCUMENTS

-(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.

Section 35.57 LDR Authorization for calibration and reference sources a): Any person-authorized by Section 35.11 of this part for medical use of byproduct material may receive, possess and use unsealed byproduct 4

material and sealed sources, manufactured and distributed by a person '

licensed pursuaat to Section 32,74 of this chapter or equivalent Agreement State regulations, for check, calibration, and reference use, with activities not exceeding 15 millicuries each:

b) Any person authorized by Section 35.11 for medical use may receive, possess and use 999 kilograms of depleted uranium as shielding.

Sec* ion 35,59 LDR- Requirements for possession of sealed sources and l

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 4 duration of source use in' a legible form convenient to users.

(b) A licensse shall verify the source activity of brachytherapy sources prior to use, RESEARCH AND WORK ON WORDING (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 be' ore 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 Comission or an Agreement State and described in the label or brochure that accompanies the-source, a:lowdose cjp 17 August 7. 1997 e w e- ,:- m-,- -..e -

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LSTAFF. LEVEL DRAFT DOCUMENTS August 7 :1997

(c) _ To satisfy the leak test requirements of this section, the licensee.

must:. j l

-(l) 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 1 accumulate or wash the source in a soll volume of detergent 1 solution and treat the entire volume as the sample:

F (2) -Take device source test samples when the source is in the "off" 4

-position, and 3 (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, <

rf 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)- Inunediately withdraw the sealed source from use and store it in accordance with the requirements in parts 20 and 30 of this

1. chapter:-and (2) File a report within five. days of the leakage test with the Eappropriate NRC Office listed in Section-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) LA licensee need not perform a leakage test on the following sources: -

- ( 1_)__ Sources containing only byproduct material with a half-life of

.a;lowdose.cjp- 18 August 7. 1997 '

C STAFF LEVEL DRAFT DOCUMENTS August 7, 1997 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, ha.vever.-

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. THIS IS BEING EVALUATED LEAVE AT QUARTERLY OR CHANGE TO SIX HONTHS TO

-TIE IN TO LEAK TESTS? WE COULD PUT A STATEMENT IN THAT LICENSEES WILL ESTABLISH PROCEDURES TO ENSURE ACCOUNTABILITY OF ALL SOURCES -

THIS IS TRULY PERFORMANCE, BUT THIS IS A POTENTIAL HIGH RISK IF A BRACHYTHERAPY SOURCE IS LOST: NOT S0 MUCH WITH CALIBRATION / REFERENCE SOURCE.

(h) A licensee in possession of a sealed source or brachytherapy source shall measure the ambient dose rates in all areas where such sources are stored to ensure compliance with the exposure limits in 10 CFR Part 20. This does not apply to sealed sources in diagnostic devices.

(i) A licensee shall retain a record of each survey required in paragraph (h) of this section for five 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.

(1) (a)- A licensee shall dispose of sealed sources and depleted uranium in accordance with Part 20 or Section 30.41 of these regulations.

a:lowdose.cjp 19 August 7, 1997

e

• e STAFF LEVEL f> RAFT DOCUMENTS' August 7. 1997

. (b)- Alicenseelmayholdbyproductmaterialwithaphysical _

half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of Section 20.2001 of this chapter if it:

1 (1) Holds byproduct material for decay a minimum of ten.

i half-lives:

(2) Manitors byproduct material at the container surface L 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: and (3) Removes or _ obliterates all radiation labels, (c) A licensee shall retain a record of each disposal permitted under paragraph (b) of this section for five 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.

Section 35.75 LDR 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 e permanent implants containing radioactive material if ths total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).2

^

The licensee shall provide the released individual with

~

(b) instructions, including written instructions, on actions recomended to maintain doses to other individuals as low as is

. reasonably achievable if the total effective dose equivalent to 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).

a:lowdose.c,1p 20 August 7, 1997

1 STAFF LEVEL DRAF1 DOCUME F9 August 7, 1997 any other individual is likely to exceed 1 mil 11 sievert (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 ccascqucnces rationale and potential consequencesof failure to follow the guidance. THIS NEEDS TO BE EVALUATED (c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for five 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 five 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).

Subpart G Sources for Brachytherapy Section 35,400 LDR Use of sources for brachytherspyMOVE INTO SECTION 35,49 or 597 A licensee shall use sealed sources for medical uses as approved in the

) sealed source and device registry.

4

> Section 35.404 LDR 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

.teaporary implant until all source.; have been removed.

a:10wdose.cjp 21 August 7. 1997-

4 STAFF LEVEL DRAFT' DOCUMENTS-August 7, 1997- i (b) A licensee shall retain a record of patient or human research subject surveys for five years. Each record must include the date of the

-survey, identification of the patient or the human research subject.

- the doce 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.

Section 25.406 LDR Brachytherapy sources inventory (a) Promptly after removing them from a patient or a human research i

- 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 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 thuy were removed from storage the number and activity of the scurces in storage after the removal, and the initials of the individual who removed the sources from j storage; i

(2) 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 five years.

Section 35.410 LDR Safety instruction i.-

a:lowdose.cjp- 22. August 7. 1997

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l STAFF. LEVEL DRAFT DOCUMENTS: -August 7 :1997- ,

(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 five 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.

Section 35.415 LDR Safety precautions (a) for each patient or human research subject receiving implant therapy and not released from licensee control pursuant to S 35.75 of this part, a licensee shall:

4 (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy. PART 20 PUBLIC DOSE ISSUE (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: PART 20 ISSUE

- (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 PART 20 ISSUE i

(4) .

I'TeTptly after i;plaritiTis thC niatGrial. SuiVai the dG3c.

~

a:londose cjp .' 23 August 7. 1997 v .t y -

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• August 7, 1997 STAFF LEVEL DRAFT DOCUMENTS retcs in contiguous rcstricted and unicstricted arcas with a radiatica mcasurcm:nt survcy instrumcat to dcmcastrate cc piiance with the requircmcats of Part 20 cf-this ehepter, and retein for thrcc5 years a rccord af coch survey that includcs the time and d;te of the survcy, a plen cf the are; cr list af points survcyed, the mcasurcd dcsc ratc at several points cxpressed :n millirem pcr hour, the-tnstrumcat 0;cd ic makc the survcy, and the initials cf the individual whc made the survcy.

CHANGE TO ALLOW INITIAL SURVEY WITH SUBSEQUENT SURVEYS ONLY IF INITIAL PARAMETERS CHANGE (5' Provide the pat kat cr the human rcscarch subjcct with retRetica safety guidance that will help tc kcep radiatica dosc to houschcid mcmbers and the public as lcw as reasonably echievabic before releasing the ;ndiviuval if thc individual was administered a permanent implant--

(b) A licensee shall notify the Radiation Safety Officer immediately if the patient or the human research subject dies or has a medical emergency.

Section 35.420 t.0R Possession of survey instrument L

A licensee authorizej 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 THIS SECTION NEEDS TO BE REVIEWED Section 35.500 LOR Use of sealed sources for diagnosis A licensee shall use the following sealed sources in accordance with the l

manufacturer's radiation safety and handling instructions:

i a:lowdose.cjp 24 August 7, 1997

= August 7, 1997 STAFF LEVEL DRAFT DOCUMENTS (a) ;1odine 125.~ americium 241.-or gadolinium 153 as a sealed source in a device for. bone mineral analysis; and (b) lodineil25 as a sealed source in a portable imaging-device.

Section 35,520 Availability of survey instrument A l_icensee 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 Section 35,51 of this part, Subpart J Training and Experience Requirements Section 35.900 LDR Radiation Safety Officer Except as provided in Section 35.901, the licensee shall require an individual fulfilling-the responsibilities of the Radiation Safety Officer as provided in Section 35,32 to be an individual who-(a) Is certified by:

(1) Amerir.an Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology:

American-Board of Nuclear Medicine:

(3)

(4) American Board of Science in Nuclear Medicine:

(5) -Board of Pharmaceutical Specialties in Nuclear Pharmacy:

(6) American Board of Medical Physics in radiation oncology physics:

_ (7)_ Royal College of Physicians and Surgeons of Canada in nuclear medicine:

(8) American Osteopathic Board of Radiology: -

(9)- LAmerican Osteopathic. Board of Nuclear Medicine: or-(10). Other board certification that has been approved by NRC f(b) Has had classroom and laboratory training and experience as follows:

G;10wdose.cjp_ 25 August 7, 1997

.i- - , . . - ,

_ _ . . _ _ . _-~ - ._.__.___._ _ . . -_ . - _ . _ _ _ _ _ _

d STAFF LEVEL DRAFT DOCUMENTS' August 7. 1997-

-(l) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes: j (1) Radiation physics and instrumentation: )

(ii) Radiation protection: '

(iii) Mathematics pertaining to the use and measurement of radioactivity: ,

(iv) Radiation biology; and (v) Radinpharmaceutical chemistry: and (2)- One year of full time experience as a radiation safety  :

4 technologist at a medical institution under the supervision of

' the-individual identified as the Radiation Safety Of ficer on a-Commission or Agreement State license that authorizes the medical use of byproduct material: or  !

(c) De an authorized user identified on the licensee's license, o Section 35.901 LDR Training for experienced Radiation Safety Officer .

L- An; individual identified as a Radiation Safety Officer on a Commission or.

Agreement-State license before October 1. 1986 need not comply with the training requirements of Section 35.900.

'Section 35,940 LDR Training for use of brachytherapy sources Except as provided in Section 35.970, the licensee shall require the authorized user of a brachytherapy source listed in Section 35.400 for therapy to be a-physician who:

i (a) _-Is _ certified, by testing, by a medical specialty board whose

. certification process includes all of the training and experience requirements in Section 35.940(b) of this section and whose certification has been accepted by the NRC: or

-(b) is in the active practice of therapeutic radiology, has had classroom _-

and laboratory training in radioisotope. handling techniques

< ' applicable to the therapeutic use of. brachytherapy saurces.

. supervised work experience, and supervised clinica' experience as follows:

-(1) _L200 hours of classroom and laboratory training that includes:

-(i) -Radiation physics and instrumentation:

La:lowdose,cjp- _26 August 7. 1997

l ETAFF LEVEL; DRAFT DOCUMENTS August-7, 1997' .

Radiation ~ protection:_  ;

l(11) _

. (iii) Mathematics pertaining te the_use and measurement of_

radioactivity: and (iv) Radiation; biology:

" .(2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of_ an authorized user at a medical institution that includes:

-(1) Ordering, receiving, and unpacking radioactive materials-safely and performing the related radiation surveys:

l (ii) Checking survey meters for-proper operation:

(iii) Preparing implanting, and removing sealed sources:

(iv) Maintaining running _ _ inventories of material on hand:

(v) Using administrative controls to prevent the misadministration of byproduct material: and

, (vi) Using emergency procedures to control byproduct material:

.and 1

-(3) Three years of supervised clinical experience that includes one 4

year in a_ formal training program approved by the Residency Review Committee for Radiology of the Accreditation' Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical. institution that includes:

2 -(1) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications:-

(ii) Selecting the proper brachytherapy sources and dose

^

and method of administration:

_(iii) Calculating the dose; and

-(iv) . Post-administration followup and review of case

-histories in collaboration with the authorized user.

Section 35.941 LDR Training for' ophthalmic use of strontium 90 Except as provided in Section 35.970, the licensee shall-require the authorized user of only strontium 90 for_ ophthalmic radiotherapy to be a physician who is in_ the-active practice of-therapeutic radiology or

.a:10wdose.cjp- - 27 August 7. 1997

]

• ' *w,_-

7-August 7, 1997 jSTAFF.LEVELDRAFTDOCUMENTS-l ' ophthalmology, and has had classroom and laboratory training in basic-  ;

radioisotope; handling techniques applicable to the use of strcntium 90 for ophthalmic radiotherapy _and a period of supervised clinical _t'aining in ophthalmic radiotherapy as follows:

(a) . 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training that includes:

l '

.(1) Radiation physics and instrumentation:

(2) Radiation protection:

(3) Mathematics pertaining to the u'se and measurement of radioactivity: and (4) Radiation biology:

(b) Supervised clinical training in_ ophthalmic radiotherapy under the ,

supervision of an authorized user at a medical instits Jn that includes the use of strontium 90 for the ophthalmic treatment of five individuals that includes:

I (1). Examination of each individual to be treated:

(2) Calculation of the dose to be administered.

(3) Administration of the dose; and followup and review of each individual's case history.

(4) 4 Section 35,950 LDR Training for use of sealed sources for diagnosis Except as provided in Section 35,970, the licensee shall require the

t. authorized user of a sealed source in a device listed in Section 35.500 to be a physician, dentist, or podiatrist who:

(a)- _

Is certified in:, by testing, by a medical specialty board whose certification process includes all of the train _ing and experience requirements in Section 35,950(b) of this section and whose certification has.been accepted by the NRC: or_

i (b) _Has had 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic h' radioisotope handling techniques!specifically applicable to. the use - '

of;the device that includes:

, -(1)- Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation:

'(2)- Radiation biology;

-(3) Radiation protection:-and-a:10wdose,cjp- 28 August 7, 1997

e STAFF LEVEL DRAFT DOCUMENTS August 7. 1997 (4) Training in the use of the device for the uses requested.

Section 35.970 LDR Training for experienced authorized users Physicians. dentists. or podiatrists identified as authorized users for the medical, dental, or podiatric use of byproduct material on a Comission or Agreement State license issued before April 1. 1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of subptrt J.

Section 15.972 LDR Recentness of training The training and experience specified in this subpart must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

Subpart K Enforcement Section 35.990 LDR Violations (a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of--

(1) The Atomic Energy Act of 1954, as amended:

(2) Title 11 of the Energy Reorganization Act of 1974, as amended:

or (3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of--

(1) Sections 53. 57. 62. 63. 81. 82, 101, 103, 104. 107, or 109 of the Atomic Energy Act of 1954, as amended:

(ii) Section 206 of the Energy Reorganization Act:

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(1) of this section:

(iv) Any term condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this a:1 M ose. cap 29 August 7. 1997

r,; s STAFF LEVEL DRAFT DOCUMENTS August 7. 1997-section.

(2) For any violation for which a license may be revoked under section 186Lof the Atomic Energy Act of.1954, as amended.

Section 35.991 LDR- Criminal penalties (a) Section 223 of the. Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation

- of, or conspiracy to violate, any regulation issued under sections 161b. 1611. or-161o of the Act. For purposes of section 223. all.the regulations in part 35 are issued under one or more of sections 161b.

1611. or-1610. except for the sections listed in paragraph (b) of this section.

(b)- The regulations in part 35 that are not issued under subsections 161b 1611. or 161o for the purposes of section 223 are as follows:

Sections 35.1, 35.2. 35.7. 35.8. 35.12. 35.15.-35.18, 35.19. 35.57.

-35.100. 35.600. 35.901, 35.970. 35.971. 35.990, 35.991, and 35.999.

Section.35.999 LDR Resolution of conflicting requirements duririg transition period-(a). If the requirements of this part are more restrictive than the existing license condition, then the licensee shall comply with this part unless exempted by paragraph (c) of this section.

(b) Any existing license condition that is more restrictive than a requirement in this part remains in effect until there is a license amendment or renewal.

(c) If a license condition exempted a licensee from a requirement in-this part effective prior to the effective date of this part, it continues to exempt-a licensee from corresponding sections of this w t. '

i

-(d) 'If- a license condition: cites a provision of this part in effect prior to the effective date of this part, and there is no corresponding provision after the effective date-of this part, then the license- 1 condition remains in effect until there is-a license' amendment or renewal that modifics-or: removes that condition.

a:10wdose.c.1p 30 August 7. 1997