ML20247M981
| ML20247M981 | |
| Person / Time | |
|---|---|
| Issue date: | 05/12/1998 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hardin C CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS |
| References | |
| NUDOCS 9805270004 | |
| Download: ML20247M981 (21) | |
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--May 12, 1998 Mr. Charles M. Hardin Executive Director.
Conference of Radiation Control Program Directors, Inc.
205 Capital Avenue l
Frankfort, KY 40601 l-f
Dear Mr. Hardin:
- As requested in your letter dated February 10,1998, I have enclosed the written manuscripts of my scheduled presentations at the ' meeting of the Conference of Radiation Control Program Directors, Inc., in Mesa, Arizona, on May 17-20,1998.
l The titles of my presentations are$
1.
Revision of 10 CFR Part 35, " Medical Uses of Byproduct Material" 2.
Guidance Consolidation Project 3.
Implementation of 10 CFR 34.20: Current issues If you need any further information, please contact Sally L. Merchant at 301-415-7874.
Sincerely, originial signed by Donald A. Cool Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety _
and Safeguards
Enclosures:
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l Mr. Charles M. Hardin Executive Director Conference of Radiation Control Program Directors, lac.
205 Capital Avenue Frankfort, KY 40601
Dear Mr. Hard:
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As requeued in your letter dated February 10,1998, I have enclosed the written manuscripts of l
my scheduled presentations at the meeting of the Conference of Rad ation Control Program l
Directors, Inc., in Mesa, Arizona, on May 17-20,1998.
The titles of my presentations are:
1.
Revision af ".0 CFR Part 35,"Madical Uses c:Syproduct Material" 2.
Guidance Consolidation Project 3.
Implementation of 10 CFR 34.20: Current issues if you need any further information, please contact Sally L. Merchant at 301-415-7874.
j Sincerely, l
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Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
Enclosures:
As stated l
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REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" Donald A. Cool, Ph. D.
U.S. Nuclear Regulatory Commission i
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l INTRODUCTION The U.S. Nuclear Regulatory Commission (NRC) examined the issues surrounding its medical use program in detail d'.:.-ing the 1993 internal senior management review; in l
- the 1996 independent external review by the National Academy of Sciences, institute of Medicine'; and in NRC's Strategic Assessment and Rebaselining Paper Number 7, l
" Materials / Medical Oversight. 2 In follow-up to the reviews, in March'1997, the Commission directed that 10 CFR Part 35: (1) be restructured into a risk-informed, more performance-based regulation that would focus on those medical procedures that pose the highest risk, from a radiation safety i
aspect, with a subsequent decrease in the oversight of low-risk activities; (2) focus on those requirements that are essential for patient safety; (3) initiate improvements in NRC's medical program, by implementing recommendations from internal staff audits, other i
rulemaking activities, and results of analyses in medical issues papers; (4) incorporate j
regulatory requirements for new treatment modalities; (5) reference, as appropriate, l
available industri guidance and standards; and (6) provide for capturing not only relevant safety-significant events, but also precur,or events. The Commission also directed the 7.taff to submit a plan to revise Part 35, associated guidance documents, and, if necessary, the Commission's 1979 Medical Use Policy Statement (MPS).
In June 1997, the Commission approved the staff's proposed plan for the revision of Part 35 and the MPS.* The staff implemented that plan by establishing a Working Group, Steering Group, and guidance consolidation team that included regional licensing and inspection staff and representatives of two Agreement States and a non-Agreement State. The Agreement State representative on the Working Group is also a member of the i
Conference of Radiation Control Directors' Suggested State Regulation Committee on Medical Regulation, which is working toward parallel development of suggested State medicairegulatiors. State participation in the process has provided an early opportunity for. State input, and should enhance development of corresponding rules in State regulations. In addition, it will provide the State staff an early opportunity to assess the
potential impacts of NRC draft language on the regulation of non-Atomic Energy Act I
materials used in medical diagnosis, treatment, or research in the States.
Please note that the material presented in the following sections is based on the staff's present proposal for revising Part 35, and should not be considered the Agency's position untilit has undergone Commission review, which is scheduled to start about June 1,1998.
SCHEDULE The schedule approved by the Commission calls for staff to provide the proposed rule, associated guidance document, and recommendatbns for revising the 1979 MPS to the Commission in May 1998.5 Following Commission approval, the proposed rule and MPS will be published in the Federal Register for a 75-day public comrnent period. During this time, three facilitated public meetings (tentatively planned for San Francisco, CA, i
Kansas City, MO, and Washington, DC) will be held to discuss the proposed rule and MPS. The staff expects to provide a final rule, associated guidance document, and the final MPS for Commission approval in f"ay 1999.
The staff has proposed that the revised Part 35 be implemented six months after publication of the final rule, except for the training and experience requirements. Since the consolidated guidance document for medical use licensees is being developed in parallel with the revised regulatory requirements in Part 35, the staff believes that a longer implementation period will not be necessary. During this time period NRC workshops might be needed for the benefit of licensees, States, and others that are affected by the revision.
The staff has proposed that licensees would have up to two years after the effective date of the final rule to comply with the proposed training requirements for authorized users, authorized medical physicists, authorized nuclear pharmacists, and Radiation Safety Officers. During this 2-year period, licensees will have the option of complying with either the current requirements in Subpart J or the revised training and experience requirements, The current Subpart J would be deleted two years after the effective date of the final rule.
As discussed below, the staff's proposed training and experience requirementsinclude an The two-year implementation period will allow time for potential examining exam.
organizations and entities to prepare their applications and for NRC to review and approve these applications. The two-year time period will also allow individuals from Agreement States time to satisfy the revised training requirements, in order to work in NRC jurisdictions.
MEDICAL POLICY STATEMENT As noted above, the Commission directed that the staff develop recommendations, l
if necessary,to revise the MPS. The staff has proposed that the MPS be revised to read
as follows:
1.
NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public.
2.
NRC will not intrude into medical judgements affecting patients, except as necessary to provide for the radiation safety of workers and the general public.
3.
NRC will, where justified by the risk to patients, regulate the radiation safety of patients primarily to assure that the use of radionuclides is in accordance with the physician's directions.
4.
NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.
The staff believes that the revised statement emphasizes both NRC's intention not to intrude into medical judgements affecting patients and the importance of byproouct material being used according to physicians' directions. In addition,it is consistentwith the Commission's directions to focus on requirem3nts for patient safety, to regulate the medical use of byproduct material based on the risk posed by the medical use, and to reference, as appropriate, available industry guidance and standards. Throughout the rulemaking process, the staff has been careful to ensure that the proposed requirements for the medical use program are consistent with the staff's revised MPS.
G6NERAL OVERVIEW OF STAFF-PROPOSED RULE The Part 35 outline below shows the staff-proposed structuraichanges to Part 35.
The staff-proposed rule has a modality-based structure that incorporates all the modality-specific requirements into the same subpart; the current Teletherapy Subpart has been expanded to codify the requirements for remote afterloaders and gamma stereotactic radiosurgery devices, which are currently regulated through license conditions; a new subpart is proposed to allow for easier licensing of new medical procedures that use byproduct material or radiation therefrom for uses that are not specifically addressed in the current Part 35; and all the requirementsfor records and reports have been removed from the administrative and technical sections and placed in separate subparts, for easier reference. As noted above in the discussion of the staff's proposed implementation schedule, Subpart J will be deleted two years after the effective date of the final rule, at which time licensees will be required to comply with the new training and experience requirements in the other subparts. The staffs proposed Appendix A provides the requirements for an examining organization or entity; examination programs; and written examinations. This appendix is needed because of the proposed revision to the training and experience requirements for an authorized user, medical physicist, authorized nuclear pharmacist, and Radiation Safety Officer that would require an individual to pass an examination given by an organization or entity approvea by the NRC or an Agreement State.
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The staff-proposed outline for the revised Part 35 is as follows:
1 Subpart A
General Information B
General Administrative Requirements C
General Technical Requirements D
Unsealed Byproduct Material-Low Dose (@@ 35.100 & 35.200 uses)
)
E Unsealed Byproduct Material-High Dose (@ 34.300 uses)
F Manual Brachytherapy (@ 35.400 uses)
G Sealed Sources for Diagnosis (@ 35.500 uses)
H Therapeutic Medical Devices ( 35.600 uses) i Reserved J
Training and Experience Requirements K
Other Medical Uses of Byproduct Material or Radiation Therefrom L
Records M
Reports N
Enforcement Appendix A - Examining Organization or Entity In addition to the structural changes and the specific changea within the subparts, the staff has proposed an overall change in regulatory philosophy. Consistent with a risk-informed, performance-based approach to medical use licensing, the amount of information needed from an applicant, to possess and use byproduct materiel, would be reduced.
Under the staff-proposed rule, an applicant for an NRC medical use license would have to submit a signed e,r-4 cation, documentation of the training and experience of the individuals named on the license, the facility diagram, and a list of instrumentation. An applicant would also have to develop, maintain, and implement procedures, e.g., for interdepartmental / interdisciplinary coordination of the radiation protection program; written directives; proper operation of instruments to measure alpha, beta, and photon-emitters; labeling and shielding; and safety procedures for remote afterloaders, teletherapy, and gamma stereotactic radiosurgery units. However, the applicant would no longer be required to rubmit these pacedures as part of the license application. Furthermore, licensees would be provided maximum flexibility in developing their procedures because most of the requirements are stated in terms of the objectives to be achieved, rather than a list of prescriptive details thai must be included.
The Groups developing the rule have ensured, to the extent possible, that the proposed rule includes all of the requirements for medical licensees. This responds to numerous concerns from stakeholder that performance-based rules often result in requirements being placed in guidance documents and license conditions. As a result, some prescriptive sections appear in the draft proposed rule where the requirements are necessaryfor safe operations. This approach was also taken with the developmentof the associated guidance documont for medical use licensees, which was developed in parallel with this rulemaking. The staff-proposed guidance document provides model procedures to assist the applicant in developing various procedu es required by the regulations, but it does not contain additional requirements. Licensees may choose to follow the specific
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- models provided in the guidance document or ' develop alternatives.to achieve the objectives.
L The staff has also proposed deleting requirements from Part 35 that are contained elsewhere in the Commission's regulations, Part 35 licensees will continue to be required.
to comply with these requirements, but staff believes that there is no need to duplicate-L requirements, unless more specific requirements are needed for medical licensees.
Examples of such requirements that were deleted from Part 35 include Ai. ARA programs,
' surveys for contamination and ambient radiation exposure rates, storage cf volatiles and -
l' gases, and possession of survey instruments.
i The' staff's proposed performance-based requirements will provide increased flexibility for the licensees in complying with the regulations. For example, the requirement for a medical institution licensee to have a Radiation Safety Committee (RSC) has been deleted in the staff's proposed rule. Instead, the proposed requirements specify the l
responsibility for and functions of the radiation safety program, including some of the i
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. functions previouslylisted as those of the RSC. This change places the responsibility for the radiation safety program of all Part 35 'censees on the licerisee management, but provides flexibility in carrying out this responsibility. A licensee may implement these
- requirements using an RSC, or other existing management committees and structures that serve similar functions.
One of the issues addressed by the staff that cuts across most of the subparts listed j
above is training and experience requirements for authorized users (AU), authorized medical physicists (AMP), authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO).
The majority of the comments received during development of the l
proposed revision addressed training and experience requirements for authorized users.-
As a result of these comments, the staffis proposing the following criteria for training and j
experience:
1.
Training and experience criteria should be risk-based and focused on radiation safety; 2.
Individuals should completa a structured educational program that consists of didactic training and practical experience; 3.
Specific references to speciality boards, by name, should be celeted; 4.
Speciality boards will be approved by the Commission or an Agreement State if the board certification process includes.all the training and experience requirements associated with the equivalent training pathway; 5.
A preceptor,when required, should certify that an individual has achieved a level of competency sufficient to function independently as an authorized user for the requested use, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer; and 6.
Individuals should demonstrate sufficient knowledge of radiation safety by passing an examination given by an organization or entity approved by the Commission or an Agreement State.
Based on the above criteria, the staff has proposed the training and experience requirements in Table 1.
Table 1. Training and experience Structured Educational Program Other Didactic (hrs)
Practical (hrs)
AUs for 40 20 Physician, preceptor, exam 35.100 uses AUs for 80 40 Physician, preceptor, exam j
35.200 uses AUs for 80 40 Physician, p<eceptor, 35.300
- exam, uses 5 cases AUs for 200 500 Physician, preceptor, exam 35.400 1 yr ACGME program, uses 2 yrs clinical experience AUs for 8
Physician, Dentist, 35.500 Podiatrist uses AUs for 200 500 Physician, preceptor, 35.600
- exam, i
uses 1 yr ACGME program, 2 yrs clinical experience RSO 200 Preceptor, exam,1 yr l
or i
AU AMP Preceptor, exam, MS, 2 l
yrs ANP 700 Preceptor, exam j
STAFF RESPONSE TO COMMISSION ITEMS FOCUS PART 35 ON PROCEDURES THAT POSE THE HIGHEST RISK The staff has focused its proposed revision to Part 35 on the medical procedures that pose the highest risk to patients, workers, and the public. For example, the staff's proposed revision expands the current Teletherapy Subpart to include other therapeutic medical devices that involve high-risk procedures. The expanded subpart would codify the requirementsfor remote afterloaders and gamma stereotactic radiosurgery units, which are currently regulated through license conditions. Some of the staffs proposed requirements for these devices are prescriptive, where warranted by the risk. The staff has also made changes in the current Part 35 requirements where warranted by the risk of the modality, e.g., requiring output measurements for manual brachytherapy sources.
Staff extensivelydiscussed the training and experience requirements for the higher-riskmodalitieswith medicalsocietiesand boards. Approximately 90 percentof thewritten comments, received in response to NRC's request for input during development of the proposed rule, were from radiation oncologists who feel very strongly that the current requirements for authorized users of brachytherapy and therapeutic medical devices should be retained because of the high risk associated with use of these modalities and because radiation safety training and clinical competence are intertwined for uses of these devices. Therefore, the staff has proposed status quo for the number of training and experience hours for authorized users of these higher-risk modalities, plus added requirementsfor an exam focused on radiation safety and for a preceptor statement that an individual has achieved a level of competency to independently function as an authorized user for the use requested.
FOR DIAGNOSTIC PROCEDURES, CONSIDER REGULATORY OVERSIGHT ALTERNATIVES CONSISTENT WITH THE LOWER OVERALL RISK As a result of the staffs review and the public comments, the requirements for training and experience for lower-risk diagnostic procedures have been revised to focus on radiation safety. Revisions have also been made to some of the current requirements, such as elimination of the requirements for assaying unit doses.
In addition, the requirement to measure molybdenum-99 concentrations has been revised to require measurement of the first eluate or extract from a generator.
ADDRESS HOW BEST TO CAPTURE NOT ONLY RELEVANT SAFETY-SIGNIFICANT ISSUES, BUT ALSO PRECURSOR EVENTS Staff considered the issue of how best to identify and capture events and circumstancesthat could lead to significant errors or systematic problems and develcped 4
alternatives for requirements in this area, which were discussed at the facilitated public
meetings last fall. After substantial staff deliberation, a precursor event was defined as a defect, exclusive of ordinary equipment failures, in equipment (hardware and /or software), byproduct material, or procedures supplied by a manufacturer or vendor that, in the opinion of the Radiation Safety Officer or authorized user, could lead to a medical event. The staff recently forwarded this definition (along with suggested rule text for reporting precursorevents) and several other proposed altematives to capture precursor events to the Commission for further direction.
CHANGE " MISADMINISTRATION" TO " MEDICAL EVENT" OR COMPARABLE TERMINOLOGY The staff-proposed revision of Part 35 uses the term " medical event," rather than the term " misadministration." The staff's criteria for determining whether there has been a medical event are based on the current Part 35 requirements,with minor changes to make the reporting threshold dose-based, where possible. In general, the staff's proposal requires licensees to report a dose that is greater than 0.05 Sv effective dose equivalent or 0.5 Sv to orcan or tissue AND represents a to,1 dnse or dosage that differs by at least
- 20 percent from the prescribed dose or dosage, or a fractionated dose that differs by at least i 50 percent from the prescribed dose for a single fraction, or a dose or dosage that i
is the wrong pharmaceutical; delivered to the wrong individual; delivered by the wrong route; delivered to a site other than the treatment site; delivered by the wrong mode; or from a leaking source. The proposed revision also addresses two areas that have caused problems in implementing the current misadministration requirements - patient intervention and wrong treatment site.
REDESIGN PART 35 TO ALLOW FOR TIMELY INCORPORATION OF NEW i
TREATMENT MODALITIES Staff has proposed a new Subpart K that addresses new medical procedures that use byproduct material or radiation therefrom fcr uses that are not specifically addressed in the current Part 35. The staff's revision will allow for easier licensing of these raw procedures because the section on license applications has been expanded to include a list of information that NRC needs for evaluating an application for a new medical procedure that uses byproduct matenal or radiation therefrom.
RE-EVALUATE AND REVISE THE QUALITY MANAGEMENT PROGRAM TO FOCUS ON REQUIREMENTS THAT ARE ESSENTIAL FOR PATIENT SAFETY The staff has deleted the Quality Management Program (QMP) as a stand-alone program in the proposed revision. The requirements for a medical licensee to establish and maintain a written QMP, to annually review the QMP, and to submit the QMP for NRC review have been deleted. The staff has retained the requirements for licensees to have
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l l written directives for high-risk procedures and to develop, maintain, and implement procedures to provide high confidence thnt the right patient receives the correct dose at the correct treatment site. This approach is consistent with the Commission direction to re-evaluate and revise the QMP prov;sions to focus on those requirements that are essential for patient safety, and with the staff's proposed revision of Statement 3 of the MPS, which states that "NRC will, where justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordar m-with the physician's directions."
CONSIDER THE VIABILITY OF USING OR REFERENCING AVAILABLE INDUSTRY GUIDANCE AND STANDARDS Staff reviewed the applicable industry guidance and standards to determine if the needed standards were available; and, if they were available, determined if they are consistentwith NRC's regulatory needs and, if so, whether they should be incorporated cr referenced in Part 35. The staff's proposed revision takes into account industry standards, where appropriate.
However, tha staff I as opted to codify the objectives to be accomplished, rather than referencing specific task group reports and industry standards in the regulation, so that licensees would have increased flexibility in demonstrating compliance.
For example, there are several different nationally and internationally recognized bodies, that publish standards for calibrations of therapeutic medical devices, that a licensee could follow to demonstrate compliance with Part 35.
CONSIDER A RULEMAKING PROCESS THAT PROVIDES MORE OPPORTUNITY FOR lNPUT FROM POTENTIALLY AFFECTED PARTIES THAN IS PROVIDED BY THE
- NORMAL NOTICE AND COMMENT RULEMAKING PROCESS The staffs program for revising Part 35 and the associated guidance document has provided more opportunity for input from potentially affected parties (the medical community and the public) than is providad by the typical notice and comment rulemaking process. Early public input was solicited through several different mechanisms: requesting public input through Federal Register notices; holding public meetings of the Working and Steering Groups developing the revised rule language; meeting with medical professional societies and boards; putting background documents, options for the more significant regulatory issues associated with the rulemaking, alternatives for revising the MPS, and a "strawman" revision of the draft proposed rule on the Internet and in the NRC's Public j
Document Room; and convening two facilitated public workshops. The Part 35 Workshop that was held in conjunction with the All Agreement States Meeting in October 1997, the Advisory Committee on the Medical Uses cf isotopes (ACMUI) meetings in September 1997 and March 1998, and the ACMUI subcommittee meetings in February 1998, were also publicly noticed. Transcripts of the workshops and the ACMUI meetings were made publicly available and NUREG documents have been prepared that summarize the public comments. The staff benefitted from the interactions and received many useful comments.
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REFERENCES 1.
National Academy of Sciences, Institute of Medicine, " Radiation in Medicine: A Need for Regulatory Reform," National Academy Press, Washington, DC,1996.
l 2.
U.S. Nuclear Regulatory Commission, "DSI 7: Materials / Medical Oversight, l
Strategic Assessment issue Paper," September 16,1996.
3.
U.S.
Nuclear Regulatory Commission, Staff Requirements Memorandum-COMSECY-96-057, " Materials / Medical Oversight (DSI 7)," March 20,1997.
4.
U.S. NuclearRegulatory Commission, Staff Requirements Memorandum "SECY-97-115, Program for Revision of 10 CFR Part 35, ' Medical Uses of Byproduct Material' and Associated Federal Register Notice," June 30,1997.
5.
U.S. Nuclear Regulatory Commission, Supplementallnformation on SECY-97-115,
" Program for Revision of 10 CFR Part 35. ' Medical Uses of Byproduct Material,' and Associated Federal Register Notice," SECY-96-131, June 20,1997.
IMPLEMENTATION OF 10 CFR 34.20:
CURRENT ISSUES Donald A Cool, PhD Nuclear Regulatory Commission LOCATION OF RADIOGRAPHY The revision of 10 CFR Part L4 introduced a number of regulatory changes affecting industrial radiography operations. There has been some confusion regarding changes affecting the activities licensees may conduct under the revised regulations at locations identified on the license.
As a result of an enforcement action, the Commission directed the staff to revise 10 CFR Part 34 to more clearly define a " permanent radiographic installation" and to ensure that the Nuclear Regulatory Commission (NRC) understands when activities are conducted in such installations and the conditions of use at the installations. In an attempt to achieve this goal, the staff revised the definition for a permanent radiographicinstallation, and added new definitions for field station and temporaryjobsite. The permanent radiographic installation definition establishes that these installations are not located at temporary jabsites. The definition for temporary jobsite indicates it means a location where radiographic operations are conducted and where licensed material may be stored other than those location (s) of use authorized on the license.
10 CFR 34.13(j) requires radiography license applicants to identify the locations of ar.d describe all field stations and permanent radiographic installations. 10 CFR 34.41(b) provides that radiographic operations conducted at locations identified on a license must be conducted in a permanent radiographic installation unless othenvise specifically authorized.
As a result of these changes, a licensee may not treat a location identified on its hcense as a temporary jobsite for purposes of conducting radiography. If a existing licensee has described a location identified on its license as only a storage location, but also wishes to perform radiography at that location, the licensee must submit a license amendment request which describes the conditions of use at the location. Radiography may only be performed in a permanent radiographic installation which has been described in the license application, unless such an amendment has been granted.
ASNT APPLICATION Section 34.43 of 10 CFR Part 34 concerning training provides that a licensee may not l
permit any individualto act as a radiographer until the individuals certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in 10 CFR Part 34, Appendix A. This section also provides that an independent organization that would like to be i
recognized as a certifying entity should twmit its request to the Director of the Office of Nuclear I
Materials Safety and Safeguards. A certifying entity may be an independent certifying organizatim which meets all of the requirements in appendix A or an Agreement State meeting the requirements in Appendix A, Parts ll and Ill. Part I of Appendix A provides the requirements for an independent certifying organization, and only applies to organizations other than the Agreemert States. Parts 11 and 111 of Appendix A provides the requirements for certification programs and written examinationsfor a certifying entity, and includes the Agreement States. Appendix A of the proposed rule does not impose new requirements on licensees.
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2 In order to be recognized as an independent certifying organization,the organization should be a national society or associationinvolved in setting national standards of practice for industrial i
radiography or non-destructivetesting. An acceptable certification program would include training in the subjects listed in 10 CFR 34.43(g), completion of a written and practical examination, and require a minimum period of on-the-job experience. The American Society for Nondestructive Testing (ASNT) submitted its request for recognitionin April 1997. A " team" review approach was followed in evaluating the submission. The team or " working group" was composed of three NRC staff members, two Agreement State representatives from certifying states, and an Agreement State representativefrom a non-certifying state. The team assembled at the NRC's headquarter offices on September 17,1997, to initiate its review. The team was tasked with (1) developing i
review criteria in order to ensure that the performance oriented elements specified in 10 CFR Part 34, Appendix A are met, (2) conducting a review and evaluation of the industrial radiography radiation safety personnel certification program, and (3) either prepare a letter notifying the American Society for NondestructiveTesting Inc. (ASNT) of program approval or prepare a request for additionalinformationto support the request. The team also developed a " check list" to assist it in evaluating the program. The team used recommendations made by the Conference of Radiation Control Program Directors' G-34 committee in developing its review criteria.
Following the working group's initial review, a request for additional information or i
clarification of severalitems was sent to ASNT in a letter dated November 17,1997. Subsequent requests dated March 9,1998, and April 14,1998, were also sent. These requests for information primarily concerned administrativeaspects of ASNT's program. ASNT respondedin letters dated January 5,1998, March 12,1998, and April 17,1998. The working group also determined that it needed additional expertise to assist in evaluating and ensuring that the examination test items were drawn from a question bank containing psychometrically valid questions. An expert in the NRC's Office of Nuclear Reactor Regulation (NRR), Division of Reactor Controls and Human Factors, Human Factors Assessment Branch assisted the working group with this task. After conducting an initial review of those portions of the application applicable to examination development, a letter dated January 22,1998, was sent requesting additional information. ASNT responded in a letter dated February 12,1998. The current objective is to complete the review and processing of the ASNT application in May 1998.
Job Performance inspections Regionalinspection staff raised a question about how to handle situations where revised 10 CFR Part 34 modified the time frequency for performing certain tas'ks, but information referencedin the license appeared to commit the licensee to a previously required frequency. In particular, in the revised regulation,10 CFR 34.43(e) provides that an inspection program of the job performance of each radiographer and radiographer assistant shall be conducted to include observationof the performance of each radiographerand radiographersassistant during an actual industrialradiographicoperation, at intervals not to exceed 6 months. In the previous regulation, 10 CFR 34.11," Issuance of specific licenses for use of sealed sources in radiography," indicated that an application for a specific license for use of sealed sources in radiography would be approved if, as provided in 10 CFR 34.11(d), the applicant has established and submits to the Commission a description of its radiographer and radiographer' assistants inspection program which must include observation of the performance of each radiographer and radiographer assistant during an actual radiographic operation at intervals not to exceed three months.
3 In responding to the question, NRC headquarters staff noted that in the statements of consideration for the final rule, the implementation section provided that licensees were required to develop and implement revised procedures needed to implement the final rule within 60 days of the effective date of the rule. The implementation section also provided that procedures requiring submittal to the NRC will not need to be submitted until the next lic6,ise renewal.
Therefore, licensees are expected to modify their operating procedures to address the new inspection frequency and then submit these procedures as part of their next renewal. Further, NRC's Office of the General Counsel (OGC) provided a previous opinion in which OGC concluded that the Commission may issue a rule pursuant to Section 187 of the Atomic Energy Act, which alters a license provision, without going through a formal license amendment proceeding. The regions were instructed to use inspection / enforcement discretion regarding such situations.
Modification of Procedures NRC has received several questions concerning when is a license amendment required.
The implementation section in the statements of consideration for the final rule, provides that for any use/ storage locations not previously identified on the license (e.g., field stations, permanent radiographic installations, and temp:rary jobsi ss exceeding 180 days), licensees must either request amendments or notify NRC, as appropriate,within 60 days of the effective date of the rule.
The license must be amended to identify field stations and permanent radiographic installations.
Written notification is expected for temporary jobsites exceeding 180 days but a license amendment is not required.
The implementation section also provides that licensees are required within 60 days of the effective date of the rule to develop and implement revised procedures needed to implement the final rule. However, procedures requiring submittal to the NRC do not need to be submitted until the next license renewal.
Drive Cable Failures 1
During Novemberthrough December 1997, the NRC received three reports of drive cable I
I failures associatedwith the Amersham QSA(Amersham)660 radiographysystem. Allthree of the failures occurred immediately behind the male connector and apoeared to be generic in nature.
Although drive cable failures have occurred periodically within the industrial radiography industry, it was uncommon for so many apparentlyidentical failures within such a brief period of time. The l
apparent genetic nature of the events, the potential for serious exposure to radiographer and the possibility that the issue went beyond NRC jurisdiction thus affecting Agreement States warranted heightened attention by Ne NRC. As a result, a Special Team Inspection was initiated on December 22,1997, and was chartered to conduct inspection follow-up of the Amersham QSA (Amersham) radiography drive cable failures involving MQS Inspection, Inc. (MOS), Calumet Testing Services,Inc., and possibly other licensees or facilities. The inspection was to also focus
)
on other drive cable failures over the past several years and determine if a generic problem existed i
and to determine the root cause of the failures. The inspection involved interaction with three
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Agreement States including close coordination of inspection activities conducted within their jurisdiction. The team is developing a NUREG, available in May 1998, which will discuss root cause analysis and recommendations.
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4 MOS reported that on November 16,1997, the drive cable on one of their Amersham Model
- 660 exposure devices had broken, separating the source assembly from the cable. On December-8,1997, MQS reported an additional incident. A record search of the Nuclear Materials Event Database (NMED) indicated that as of December 11,1997, MQS had reported a total of four drive cable failures. Calumet Testing Services Inc. (CTSI), another radiography licensee, reported an additionalcable break that occurred on November 21,1997c All these events / failures involved an
- Amersham Model 660 radiography system.
A review of the NMED data and Part 21 reports indicate that as many as.15 additional reports of cable breaks have occurred in the past. The majority of these failures have occurred in,
the States of Texas and Louisiana. These cable breaks have occurred with Amersham Model 660
.. equipment as well as with SPEC Model 150 and INC Model lR-100 radiographic exposure devices.
Triumph Controls (TCl), the manufacturer of the drive cable, is located in Pennsylvania.
Triumph is not an NRC licensee, but is a supplier of basic component equipment intended for use in devices used by NRC licensees. Triumph supplies its cable to all three radiography equipment manufacturers in 500-1000 foot lengths that are cut to the desired length by the manufacturers.
. Use of thit "off-the-sholf" component by all three mEjor radiography camera manufacturers increased the likelihood that the cable failures were of generic consequence.
1 Discussionswith all of the major radiography manufacturersindicated that the TCl-produced 5222 drive cable has been used throughout the industry since the early 1960's. However, there is no evidence to support that a systematic evaluation was performed regarding the selection of the 5222 cable for use in industrial radiography, other than the drive cable was originally designed 1
for use in the aerospace industry. Apparently, the drive cable was selected "because it worked" and no cost effective alternative has been identified, although some other cabies have been evaluated and rejected.
' Proper. maintenance and inspection of radiographic equipment is crucial to its safe operation. In particular, interviews and discussionswith representativesof the radiographyindustry indicate that proper maintenance of the drive cable is essential for ma,'ntaining cable integrity and preventing cable failures, and proper inspection of drive caoles is crucial for early detection of failure precursors. Proper maintenance of drive cables includes appropriate lubrication, cleaning, and periodicinspection. Discussions with radiography industry personnelindicate that there has been an apparent lack of emphasis on the part of the radiography industry and regulatory community on the importance of maintenance and inspection of associated equipment, including drive cables, and a perception that maintenance and inspection of associated equipment is not a crucial as maintenance and inspection of the camera. There are currently no standard procedures or recommendationsfor maintenance and inspection of drive cables. Maintenance and inspection recommendations vary greatly among radiography equipment manufacturers as well as service i
providers of radiography drive cables.
The cable may be' subjected to harsh environmental conditions such as: extreme 1
' temperatures,high humidity, salt water, corrosive chemicais, dirt, dust, and sand. The cable may.
i be subjected to harsh operationalconditions such as: impact loads at each limit of travel, excessie
. and frequent bending loads, inappropriate storage, drops, extemal impacts.
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5 On February 6,1998, Amersham submitted a report to the Commonwealth of Massachusetts addressing its review of six drive cable failures. All six of the drive cable failures were subjected to an analysis performed by Analytical Answers, Inc.(AA).Woburn, Massachusetts AA identified tha cause of the drive cable breaks as a combination of tensile overload, fatigue and corrosion fatigue. The Amersham analysis also addressed a number of operational issues and administrative factors The operationalissues focused upon observations by Amersham service personneland input from the field dealing with the manner in which drive cables are handled and transported. The administrativefactors dealt with possible reasons for the increase in the number of reported drive cable failures including enhanced NRC reporting requirements and factors resulting from the 1992 changes to 10 CFR Part 34. Amersham's assessment based upon metallurgical analyses and inspection of the returned drive cables concluded that wear and corrosion were the principal causes of the failures.
It would appear that drive cable failures have become an accepted occurrence within the radiography industry. The lack of critical review and the subsequent acceptance of drive cable failures appears to have created a mind set within a substantial portion of the industry that such cable failures are inevitable and reduced the attention to the condition of the cable, related maintenance and possibly to the early detection of cable failures.
Manufacturers, the radiography industry and regulatory agencies do not adequately emphasize the importance of observing and evaluating the condition of radiography drive cables.
As a result, opportunitiesto detect precursorevents may be missed due to incomplete or ineffectie visual examinations and/or maintenance.
7 GUIDANCE CONSOLIDATION PROJECT Donald A. Cool, Ph.D.
U. S. Nuclear Regulatory Commission During the Business Process Reengineering (BPR) effort to evaluate and improve the materials licensing process,it was determined that much of the existing licensing guidance was very old, and in some cases duplicative,or unavailablein a current er readily accessible electronic format.
As a result, NRC's Division ofIndustrial and Medical Nuclear Safety (IMNS) has undertaken an ambitious program to update and consolidate all existing Division 10 guidance documents over the next 3 years. Thereafter, guidance documents will be updated on a 3-year revision cycle. For the I
initial 3-year cycle,lMNS has scheduled the development of 20 to 24 specific use licensing guidance documents. A current list of the NUREGs planned to be developed, including expected starting dates, is provided on the following pages. Additional topics will be added as they are identified.
1 THE PROCESC:
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The schedule provides an estimate of one-year duration for completion of each of the licensing guidance documents (Final NUREGs). The guidance will be published in draft for a 90-day comment period, then revised and published in final. The scheduled first phase (to draft) has a duration of 5-months, and the second phase (to final),4 months. The duration of the second phase is expected to vary depending upon the extent of revision needed.
The process for developing the guidance NUREGs includes the use of self-managed writing teams, consisting ofindividuals from NRC's regional and Headquarters Offices, and from NRC's Agreement States. The teams will use a collaborativeprocess to consolidate existing guidance into a series of topic specific guidance NUREGs for use by both regulators and licensees / applicants.The process includes activities designed to enhance the effectiveness of the team, and includes identificatiormf the roles team members fill on the team, development of specific team " rules" for effective participation, and identifies the responsibilities of each member in completing the task.
This process has proven to be very effective in the development of the first six NUREGs.
To assist the teams in accomplishingtheir task, NMSS has provided a " Regulatory Product Development Center, (RPDC)," which is best described as a laboratory for the development of materialslicensing, inspection,and rulemaking support products. The RPDC provides a dedicated work environment, team facilitation,and document and computer support. The Teams are provided the ability to work together, both within the RPDC and in distributed locations. Using computer software (currently" Lotus Notes"), team members may participate in writing or reviewing the same document from remote locations. The RPDC is designed to support most Team needs.
DOCUMENT REVIEW:
Each document is reviewed by two teams of NRC, and when possible, Agreement State managers in lieu of the sequential process currently in use at NRC. This two-tiered management review process, which allows NRC IIcadquarters, regional, and Agreement State management i
interface during review of the document,is superior to, and less time consuming, than the previous linear method of review.
The first reviewof the document is performed by a " Pink Team." A Pink Team consists of key managers and/or highly technical staff charged with guiding the Writing Team in developing a regulatory product. A Pink Team gives guidance to a writing team prior to seeking senior management concurrence (Red Team), and provides early adjustments to the guidance. The emphasis for a Pink Team review is on technical and regulatory issues.
A Red Team is a management review team that consists of key managers from the regions and from other impacted NRC Offices. The Red Team reviews the complete document late in the development process. The emphasis of a Red Team review is on policy issues. The purpose of a Red Team is to provide parallel management revie e and concurrence on a completed product. Red Teams will consist oflieadquarters Branch Chiefs or higher, and regional Division Directors.
AGREEMENT STATE PARTICIP'ATION:
IMNS is continuing to seek Agreement State participationin development of the documents, or to serve on management review teams. In the past months, we have been fortunate to have had participation from the States of Colorado, Illinois, Mississippi, New Hampshire, North Carolina, Ohio, and Washington. Their participation has contributed immeasurably to the success of the project. Questionsor suggestions concerning this project or any of the guidance documents may be addressed to Sally L. Merchant, Proj ect Manager, at (301 ) 415-7874, E-mail address: sim2@nrc. gov.
Licensing Guidance Consolidation Projects:
(These dates may change as higher priorities are identified)
Etart Publish Part 36 Irradiator Licenses Publish in Final 7/98 11/98 Academic, Lab and Industrial Use of Small Quantities Publish in Draft 1/98 6/98 Publish in Final 9/98 1/99 Exempt Distribution (Formerly NUREG 1562)
Publish in Final 2/98 7/98 Specific Licenses of Broad Scope Published in Draft 3/98 8/98 Published in Final 11/98 5/99 Manufacturing and Distribution Publish in Draft 6/98 10/98 Publish in Final 1/99 5/99 Radiopharmacy Published in Draft 7/98 12/98 Published in Final 4/99 8/99 Ownership and Bankruptcy Filings Published in Draft 8/98 12/98 Published in Final 3/99 7/99 Well-Logging Licenses Publish in Draft 8/98 1/99 Publish in Final 4/99 9/99 General Licensing Published in Draft 10/98 2/99 Published in Final 5/99 9/99 Service Providers Publish in Draft 11/98 5/99 Publish in Final 8/99 12/99 Special Nuclear Materials Licensees of Less Than Critical Mass Publish in Draft 1/99 6/99 Publish in Final 9/99 1/00 l
t
l Administrative Procedures.
Publish in Draft
'2/99
'6/99
' Publish in Final 9/99-2/00 -
Part 20 Guidance Revision-Publish in Draft 3/99 8/99 Publish in Final 11/99 3/00 Reciprocity Published in Draft -
6/99 11/00
' Published in Final
-2/00 6/00 Source and Special Nuclear Materials Publish in Draft 8/99 1/00 l
Publish in Final 4/00 8/00 l
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