IA-87-400, Rept of Matls Safety Regulation Study Group to Nrc
| ML20236E100 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/1986 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20236E009 | List: |
| References | |
| FOIA-87-400 NUDOCS 8707310230 | |
| Download: ML20236E100 (42) | |
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REPORT 09 THE !
MATERIALS SAFETY REGULATION STUDY GROUP l
TO THE ,
l U.S. NUCLEAR REGULATORY COMMISSION 1
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1 October, 1986 l
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l 8707310230 870728 PDR FOIA l POTTER B7-400 PDR
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II:KNo n pCMENT q
The Materials Safety Regulation Revi
, the enthusiastic and dedicated assi ew Study Group wishes to acknowledge -
.visited.
staff with whom it came in contact as well as ststance eprovided NRC by all{
in RegionsSpecifically, the Study Group would l ate officials and industries ,
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of Oklahoma and South Carolina, theinoffi employees iIII and IV,'th the states !
Ond New England Nuclear, as well as NRC c als of Kerr-McGee and Westingho '
headquarters personnel, 2 5
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6 EXECUTIVE
SUMMARY
The Materials Safety Regulation Review Study Group - (Study Group) was established by the Executive Director for operations of the U.S.' Nuclear
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Regulatory Commission in May, 1986. Under the charter of the Study Group each-of the five members independently reviewed the activities related to safety-of the licensing and inspection program for. fuel cycle and materials facilities under the jurisdiction of the U.S. Nuclear Regulatory Commission and provided-recommendations to the other members for editing -and submittal to the Executive Director for Operations.
The members of the Study Group are Edson G. Case, retired Deputy '
Director, Office of Nuclear Reactor Regulation, NRC Romas F. Engelhardt, retired Deputy Director, Office of Executive Legal Director, NRC; John M.- ,
Googin, Senior Staff Consultant, Development Division Y-12, Martin Marietta Energy Systems, Inc. Ralph G. Page, retired Chief, Uranium Fuel Licensing Branch, Office of Nuclear Materials Safety and Safeguards, NRC; and Clifford V. Smith, Jr. , C'tairman, Chancellor, University of Wisconsin-Milwaukee.
Se Study ',roup first convened in June in Washington, D.C. in the office of Nuclear Material Safety and Safeguards. At that time, the Study Group was briefed by NRC Headquarters officials on the scope of NRC fuel cycle. and materials issues facing tne agency. The Headquarters staff also informed the Study Group of studies ,::ently underway to deal with certain of the issues that the Study Group wa. ined to review. The Study Group then visited-the NRC regional offices in * :ans I, King of prussia, Pennsylvania, II--Atlanta, Georgia, III-Chicago, n ..nois and-Region IV-Dallas, Texas. S e Study Group also visited with the rtate nealth cepartment officials concerned with nuclear -
matters in the State of Oklahoma (a non-Agreement State), and the State of ,
Soutn Carolina ' (an Agreement State) . Further, the group visited'the uranium hexaflouride conversion f acility of Kerr-McGee's Sequoyah Fuels- Corporation at
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7 Sequoyah, Oklahoma 7 the fuel fabrication facility of Westinghouse Corporation in Columbia, South Carolina; and the radiopharmaceutical production facilities 1
of the New England Nuclear Company in Boston, Massachusetts. During the '
visits to the regional offices, the Study Group conferred with the regional administrator and his senior managers, the branch chiefs of the areas that the Study Group was concerned with, as well as many of the staff. Upon completion of the field visits, the Study Group met again in Washington, D.C. to discuss with headquarters personnel some of the concerns that had been raised during .l its field visits.
The recommendations and discussion, therefore, that are presented in this report are cased on our visits to the various entities mentioned before, as .
well as in depth discussion among the members of the Study Group.
It is the conclusion of the Study Group that, if the recommendations set forth herein are implemented, the NRC's regulatory program for fuel cycle and materials will be substantially improved. However, the Study Group wishes to' make clear tnat its recommendations snould not be taken to infer that the Offices of Nuclear Materials Safety and Safeguards, Inspection and Enforcement and Nuclear Regulatory Research are not performing their functions well and are not aware of some of the prob 1sams that the Study Group is highlighting, or that the public is not ceing adequately protected against hazards incident to the use of radioactive materials regulated by the NRC.
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RECOMMENDATION $1:
We recommend that the NRC reach a decision on an expedited basis concerning the scope of NBC regulatory authority for chemically hazardous substances that are used in or incident to the processing of licensed 3 material. We further recommend that upon reaching a decision regarding this -
matter the NRC promptly develop memoranda of understanding with federal and q state agencies that share regulatory responsibilities at locations where NRC l I
licensed materials are possessed or used, to assure that there are no j regulatory implementation gaps and that the overall health and safety of the I public will be fully protected. Se memoranda should specify the involved agencies authorities and responsibilities and be made available to the states and all other interested parties. Se memoranda should also be made available to the public via an appropriate explanatory press announcement concerning the l
scope of NRC responsibilities and those of the other involved governmental )
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l DISCUSSION Tne incident at the Sequoyah Fuels Corporation facility in January 1986, focused attention on the lack of clarity regarding NRC's authority and responsibility to regulate non-radiological hazardous substances such as enemically hazardous substances that are used in or incident to the processing of NRC licensed material. It also made clear the existence of a regulatory implementation gap betwe - ene responsibilities of,the NRC and those of other !
Federal and State agenc; ..
Prior to tie incicent tne only guidance available to the NRC staff regarding NRC authority and responsibility for non-radiological hazards was found in an Octeoer 10, 1984 memorandum frora the Office of the Executive Legal Lirector to the Office of Nuclear Regulatory Research. Sat memorandum l
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reacned tne conclusion enat the Atomic Energy Act provided authority for the l
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.i NRC to regulate ndn-radiological hazards when they were related to the use of source, byproduct and special nuclear materials. The content of that memorandum was not widely circulated to the NRC staff nor was it incorporated into an NRC regulation or formal staff guidance. In part, tnis nuy have been due to the ambiguous nature of the advice and to the narrow issue to which the memorandum was addressed. As a consequence, the materials licensing and inspection staffs at Headquarters and in the regions were continuing to operate under the general impression tnat NRC authority and responsibility at 1 i
mixed use facilities were limited to those matters involving radiological i safety.
1 Subsequent to the Sequoyah incident the issue of NRC authority and responsibility for non-radiological hazards at mixed use licensed facilities i
has received substantial attenticn. The Lessons Learned Group in its report ;
of May 29, 1986, to the Executive Director for Operations, highlighted this issue and the issue of the regulatory implementation gap in responsibility among the various regulatory agencies having an ic. 3 rest in the Sequoyah facility. More recently, the General Counsel transmitted to the Commission a paper, dated September 23, 1986, analyzing the jurisdictional issues associated with non-radiological hazards.
Our review and our discussions with NRC staff members, and state and licensee representatives supports our concern that there exists at present a serious regulatory implementation gap at NRC licensed facilities which possess or use non-radiological nazardous materials in connection with NRC licensed materials. For the most p a r't it is unclear whether at such facilities the NRC nas exclasive or snared 2. nority and responsibility for protecting the public healtn and safety.
The Study Group recommends tnat memoranda of understanding should be executed between- the NRC and other Federal and State agencies regarding safety responsibility at these mixed use facilities. The memoranda might be
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structured along tne lines of the existing Memorandum of Understanding between the NRC and the Mine Safety and Health Administration publisned in 45 CFR 1315 on June 14, 1980. Until the NRC clarifies the scope of its authority and the appropriate memoranda of understanding are consumated, the regulatory imple-mentation gap continues to exist and the prospects of incidents adversely ;
impacting on the public health and safety are ever present. For that reason I
we are recommending expeditious action by NRC and to clarify the scope of its regulatory authority and responsibility for these mixed-use facilities.
When the NRC acts to clarify its regulatory authority and responsibility over the mixed use facilities discussed above, it is essential that the decision be promptly implemented. Expedited efforts should be undertaken to negotiate new or revised memoranda of understanding with the necessary Federal ano State agencies to assur-
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responsibility of the NRC and these other agencies are clear and, most importantly, uncerstood by the agencies involved. It is essential that these memoranda deal in a coordinated fashion with the totality of these mixed-use i facilities to assure that tne puolic health ano safety is fully protected.
l As these memoranda are executed, they snould be broadly disseminated to !
representatives of the States, the press and tne public so that tne information is generally available regarding the nature of the shared rederal-State authority and responsibility for protecting the health and safety of the public.
Under tne present p: -dares memoranda of understanding are not widely ,
disseminated. As a cons-:ance, few are awsre of their existence or content.
This in turn has led me a: 1 af the public and their representatives to hold NRC responsible for all ; ;.:ents that occur at an NRC licensed facility regardless of wnether tney tavolved radiological or non-radiological materials-or were considered industrial accidents. We believe that the broadest public dissemination of these memoranda and sn explanation of their content will serve to educate the public regarding the shared nature of regulatory I autnority and responsibility over mixed use NRC licensed facilities.
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11 RECOMMENDATION 92:
We recommend that NRC strengthen and expedite the issuance of an emergency preparedness rule for fuel cycle and materials licensees possessing or using large quantities of hazardous radioactive materials. The rule should include performance type requirements for emergency preparedness rather than simply requiring licensees to submit brief descriptions of their emergency response capability. Both radiological and chemical releases should be considered in developing the required on-site and off-site emergency plans unless the licensee can demonstrate that an uncontrolled on-site chemical release could have no significant adverse safety effects on the licensed activities at the site.
DI SCUS SION l
The NRC has been grappling with a regulation concerning emergency preparedness at fuel cycle licensees and materials licensees possessing or using large quantities of hazardous radioactive material since 1981. The more difficult lasues appear to be related to the need for and scope of off-site emergency planning and related jurisdictional issues. The Study Group believes that the Sequoyah incident has provided an appropriate example of the magnitude of releases of nazardous materials that should be considered in the development of NRC-required emergency plans--both on-site and off-site--for these facilities. We f artner agree with the Sequoyah Lessons 14arned Group that the incident demony sted a namber of deficiencies in the pre-incident i emergency preparedness - 8 5.res at Sequoyah that should be corrected. To l avoto similar proolems :- :ner f acilities, we recommend that the emergency preparedness rule inc1;Je ericemance-type requirements covering the kinds of deficiencies enat were o.scoverea at Sequoyah. Performance-type requirements l
1 should be considered witn respect to the following: capability for detecting, assessing anc responding promptly to hazardous releases; a system to alert
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workers and affected messers of the public to such releases; public notices concerning the emergency alert system and actions the public might be asked to j taker and development of emergency plans in coordination with local au thor ities. Also, we recommend that NRC consider whether the proposed threshold for soluble uranium exposure, which requires emergency planning and l response actions, should be lowered from 2.0 milligrams of uranium.
With regard to potentially hazardous non-radiological materials used at these types of facilities, the Study Group believes that the philosophy used in power reactor safety reviews should be applied to fuel cycle facilities.
Reactor practice is to consider the effects on the licensed activities at the l
site of uncontrolled on site releases of each of the hazardous ' materials l
present, unless the licer.see can demonstrate that the potential effects are '
minimal or that'such releases are of very low probability due to demonstrated de, sign, construction and quality assurance practices. With regard to the potential of f-site effects of the uncontrolled release of hazardous non-radioative materials whien would not be present at the site but for the activities licensed by NRC, the Study Group believes that logically their effects should be considered in the off-site emergency preparedness measures required by NRC, particularly if ne other agency has assumed this responsibility.
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RECOMMENDATION 63: I We recommend that the ongoing NRC staff review of current general license policies and procedures be given a higher priority with sufficient resources to permit its completion within the next six months. Changes resulting from this staff review 'should be implemented within twelve months.
In conjunction with this review, the NRC should considers (1) prohibiting the use of general licenses for devices containing large quantities of byproduct-materials - (2) preparing criteria for distinguishing between devices l l
acceptable for general license distribution and those devices which should be ]
specifically licensed; (3) adding requirements on all licenses for i
distribution of general license devices, except those containing small
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quantities, to requir'e the manufacturer of the general license device to >
conduct periodic radiation surveys to determine whether the device is being safely used and to report unsafe conditions to NRC.
DISCUSSION l
NRC regulations permit tne distribution of byproduct materials (radioisotopes) in certain devices on a general license basis without the user of the device needing to apply for a license or needing to demonstrate any qualification to use the device safely. This general licensing depends on j safety being engineered ;-to the device and on safety determinations made by NRC in reviewing license . pilcations suomitted oy the device manufacturers.
The purpose of general .. ;- nsing is to simplify the licensing process and enereoy reduce the 11cena;n; ef fort for devices celieved to be inherently safe.
'Ihere are many thousands of suen devices presently in the public domain containing up to several curies of cesium 137, americium 241, cobalt 60, and l
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other radioactive materials. These devices are used for many purposes, including use in level gauges, thickness gauges, density gauges, static elimination devices, analytical instruments and luminous markers.
Since 1984 NRC has been conducting a study of general licensed devices.
The study to date indicates that some devices have been abandoned by general licensees, some nave been cisposed of in unauthorized ways, some have malfunctioned or been involved in accidents that possibly could have caused I
significant ractation exposures to individuals, and many could not be located l and accounted for. The study thus far has principally focused on defining the '
proolem. A next step will oe to determine what changes should be made in NRC '
regulations such as possioly limiting the distribution of general licensed devices and cetter accountability of the devices permitted to remain under general license. We believe that this study should be completed within the next six months and changes resulting from the study implemented within twelve months.
In connection with tne study we recommend that NRC prohibit the use of large quantities of byproduct materials in general licensed devices. Under tne provisions of 10 CFR 32.51(a) (2) (iii) and 10 CFR 32.24, devices are j evaluated against a limiting criterion for accidental exposure to up to 15 rems exposure to the whole oody, 200 rems to the extremities and 50 rems to other body organs. These doses seem high to us and not appropriate for limiting the accidental doses that individuals might receive from general licensed devices. Individuals working with or around such devices will not normally oe radiation wor <ers and, accordingly, we recommend that they be pronibitad from receiving emergency type doses of these magnitudes. Also, we celleve that some of tne ia.ges containing multicurie quantities of cesium ' 37 and americium 241 could ce tavolved in misuses or accidents that could cause radiation exposures muen higt.er than specified. For example, gauges that are presently general licensed may contain a much as E curies of Cesium 137. The unsnielded dose rate from this size source is on the order of 1.5 rems per
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hour at one meter 'and. about 14 rems per hour at one foot away. Accordingly,'a
. dose exceeding 15 rems to the whole body could easily occur in the event of a postulated misuse. In any event, we believe more conservative misure and accident assumptions should be made when evaluating general. license devices. I I
The Study Group was informed that present NRC licensing procedures for general license devices do not clearly distinguish between devices suitable for general licensing and those requiring a specific license. We recommend i that NRC prepare more definitive licensing criteria to provide clear guidance l to license applicants,. tne NRC licensing staff. and the public concerning the-l qualification of a device for general license distribution, including limits-on tne kinds and quantities of radioactive materials permitted in such devices.
l l l l As a final comment, the Study Group believes that periodic' radiation l surveys snould be performed' of all general licensed devices permitted in the public domain except devices containing small quantities of radioactive materials. We recommend that this me required as a condition of the specific license issued to the device manufacturer. Also, any noted unsafe conditions should me required to oe reported promptly by the devien manuf acturer to NRC.
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RECOMMENDATION $4:
We recommend that the NRC issue-a regulation requiring that individual industrial radiographer must, in addition to completing an NRC approved training program, be certified by the NBC or an Agreement. State. The regulation should further provide that failure to follow established l
procedures by an individual radiographer would constitute a baeis for suspension or revocation of the certificatix. Periodic decertification should also be required.
DISCUSSION A requirement for certification of industrial radiographer was last formally considered by the NRC in June 198 5. The Study Group believes that enere are two reasons for reconsidering such a requirements first, deficient training of radiographer may be a contributing cause in overexposure incidents and certification would improve that training, and second, establishing a requirement for NRC certification could result in improved adherence to established safety procedures by individual radiographer and thereby reduce overexposure incidents by providing NRC authority to revoke certifications if safety procedures were willfully disregarded. With regard to the improved training tnat could result from a NRC cert'ificat' ion requirement, enere was ..*..;e doubt-expressed oy those inside and outside tne NRC with whom we discus . nts issue that radiographer training would be improved if_tnied-part: *tatication were required oy NRC. The major concerns, as expresseu :: .:se who commented on the advance notice of rulemaking on enis suo]eet tsaued in 1982, were that most believed the present training program was adequate, that overexposure are not caused by poor training but rather by failure to follow well-established procedures, and that the cost of a certification would be unwarranted.
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l Tne Study Group believes tnat in previous considerations of this matter i
1 proper weight may not have been given to the capability of a certification program to improve safety by improving adherence to safety procedures.- Under the present system, a radiographer dismissed by a company for failure to follow procedures is free to take a job involving radiography with a nearby less well-intentioned competitor who may encourage disregarding safety procedures in order to increase production. A certification program would prevent or deter such abuses. Moreover, it would improve accountability for i safety by permitting NRC to take action agAinst an individual radiographer if i
warranted by the facts. When considered in combination with the improved training that would result from certification, the Study Group believes that, on balance, certification of individual radiographer should be required by N RC .
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RECOOGNDATION 65:
We recommend that NRC expand its licensing and inspectico procedures to ensure a comprehensive review of all' facets of fuel cycle and materials licensees possessing or using large quantities of hazardous or radioactive materials. The review should cover all aspects important to nuclear safety, radiation safety, process safety, and confinement of hazardous materials.
Increased emphasis should be given to conducting comprehensive assessments of such licensees' capability and performance.
DISCUSSION Increased attention snould be given by NRC to all facets important to worker safety and confinement of hazardous materials in licensee operations.
An integrated review approach is needed. Review is needed of the design, construction, quality control, calibration, maintenance and performance of all systems empfoyed for acnteving nuclear safety, radiation safety,-process safety and confinement of nazardous materials.
We were told tnat until the Sequoyah incident, NRC had confined its .
review primarily to nuclear safety, radiation safety, and confinement of raoicactive materials. Our recommendation is that in addition to these reviews, NRC should conduct comprehensive reviews of process safety systems and system for confine e-: of all hazardous materials on-site which could affect radiation safet; -;ttions at the plant.
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We recommend that NRC vigorously implement the planned program to conduct comprehensive on-site systematic safety assessments of all fuel cycle and materials licensees possessing or using large quantities of hazardous or radioactive materials.
DISCUSSION The Study Group applauds the ef fort underway in NRC to conduct on-site systematic safety assessments, e.g., review of fire safety, radiological l
contingency planning, radiation safety, process controls and process safety, maintenance and other quality controls, and licensee training programs.
Assessments will be made not only to confirm the existence of appropriate licensee operating procedures, but also to determine whether the p ocedures are followed oy the licensee to achieve an acceptable level of safety. Region I has taken a lead in this program review.
These reviews will be useful, we believe, in determining whett.er NRC regulations should be changed and, if so, in what respects, and whether existing licensing and inspection procedures should be expanded.
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RECOMMENDATION $7: j We recommend that the NRC give additional emphasis to actively encouraging states which are not now in the Agreement State.s program to join.
We further recommend that the NRC seek legislative authority to rsquire the transfer of responsibility for materials regulation to the states should the additional emphasis prove incapable of accomplishing this transfer to all j states within a reasonable period of time.
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DISCUS SION 1
For a numcer of years the Agreement State Program has been successfully administered by NRC, and before that oy the Atomic Energy Commission. As a .
consequence, there are now 27 states that have joined the Program, and a few additional states are preparing to join. Despite this success, it appears that the Prograu has reached a plateau with respect to attracting the remaining states. Accordingly, we believe that this is an appropriate time for the NRC to reevaluate its approacn to encouraging states to join the Agreement State Program.
From our discussions with NRC 9taff and representatives of Agreement and non-Agreement States, we . ave concluded that (1) there would be substantial ownefits to the NRC if - te r emaining states were to Join the Program, and (2) all states appear i.m tne capaoility or potential capaoility to effectively nanale tne . 4:ory responsibilities of the Program.
The principle bene fit accruing to the NRC in attracting more states to the Program is to reduce tne numoer of employeen necessary to continue the regulatory responsibilities that would be transferred to the states. This, in
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turn, would either reduce the total resources needed by NRC to conduct its programmatic activities or make available addit.onal staff and funds to concentrate in those regulatory areas which are considered by the NRC to be of greater importance to tne agency's primary mission of protecting the public health and safety.
During the early pnases of the implementation of the Agreement State Program, there were- substantial questions raised regarding the capability of the states to handle the Program safely. Experience to date indicates, for the most part, that these concerns were not justified. The states.that joined the Program have generally shown a willingness and capability to effectively organize their regulatory programs so as to be compatible with NRC requirements. Tnere is little reason to doubt that those states that remain outside of the Program have the capabilities to maintain an equally effective regulatory regime. Moreover, the availability to tne states of trained personnel is no longer tne serious problem it once was, and the technology available to the states to effectively perform a regulatory role has substantially advanced.
I For these reasons, we Delieve that the NRC should revitalize its I Agreement State Program and andertake actively to encourage those states which are not in the Program to join, and to join in the near future.
Implementation of this recommendation will involve the NRC staff in an i
t activist role whien is not ene role which it nas ceen accustomed to in the !
past. It would also involve the Commissioners in hich level State and Congressional contacts . . m nas not oeen done in the recent past.
l Should this effor- i.. to produce positive results within a reasonable period of time, we bel.ev inat the NRC should seek legislative authority to i
require the remaining states to ~ join the Agreement States Program and to j relieve the NRC of responsioliity for the continued regulation of the types of materials normally transferred to the states under tnis Program.
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l RECOMMENDATION $8:
1 We rocc.< mend that increased attention be given to the quality of NRC licensing reviews and inspections and the ade<.guacy of staffing for these activities. In this connection, we reconenend that NRC conduct a comprehensive study of this matter to determine whether present procedures should be strengthened and whether additional staffing may be required.
DISCUSSION Several NRC staff memoers expressed the belief that NRC has not allocated suf ficient staff resources to carry out quality licensing reviews of materials license applications or to conduct quality inspections of materials and fuel cycle licensees. Some individuals stated that their work is judged primarily from the standpoint of numoers of licensing actions taken and numbers of inspections completed, anc inadequate attention is given to the quality of their work. They suggested that this is caused in large measure by the heavy emphasis on the quantitative performance criteriE contained in performance contracts of NRC Senior Executives and the need to complete specified numbers of licensing actions and inspections to achieve an outstanding performance rating. Also, some ow11 eve enat the materials program has not received the staff resources that it needs, because NRC focuses most of its attention and allocates almost all its resources for the prevention of low probability /high consequence reactor ace::ents, and gives little attention and alloca,tes -
relatively few resources :) ene prevention of high probability / low consequence materials accidents.
We note that NRC has allocated on the order of 100 FTL's (full time equivalent staff years) to the materials regulatory program (not including fuel cycle resources). Thbse resources are about equally divided for
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licensing and inspection activities. Since there are about 7000 NRC materials licenses, this results in about 70 licenses for each allocated PTE. In our l
visit to an Agreement State (South Carolina), we were told that the State had allocated 13 staff positions for their materials program consisting of 350 materials licenses, and tnat four new positions had recently been approved, j Thus the State has allocated more than twice as many PTE's per license than NRC.
We were informed enat the frequency of conducting inspections of materials licensees is mostly determined by applying the allocated inspection f resources in tne best availaole manner rather than determined from a studied assessment of the needed frequency and effort required for effective inspection of the various categories of materials licensees. Some specific j licensees are never inspected and probably cannot be effectively inspected l unless aodicional inspection resources for the materials program are allocated.
We believe NRC should conduct a comprehensive study of the quality of ;
materials fuel cycle licensing reviews and inspections, and determine whether current procedures should be changed and whether additional resources are needed. Additional'ffE's in particular may be needed to permit mora inspection of fuel cycle activities.
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RECOOENDATION $9:
We reca== mand that the NRC use a suitable mix of performance-based l
regulations and appropriate prescriptive requirements.
l DISCUSSION The Study Group was asked to give particular attention to performance versus prescriptive regulation. Performance regulations specify regulatory l objectives broadly and permit licensees to establish their own means for achieving compliance. Prescriptive regulations, on the other hand, specify the manner in which the requirements are to be met. Stated another way, performance regulations specify "what" must ce achieved and prescriptive ,
requirements specify "how" compliance must be achieved. Present NRC regulations contain a mix of performance and prescriptive requirements. In 10 CFR 20, for example, the following are performance-type provisions:
Mane every reasonable effort to maintain radiation exposures and effluents released to unrestricted areas as low as reasonably achievable.
Conduct needed radiation surveys.
Provide personnel monitoring equipment to measure radiation doses.
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Secure radioactree materials from unauthorized removal.
l The following are exa pies of 10 CFR 20 prescriptive-type requirements:
Laoel containers of radioactive materials and post areas where these are located with a specific type of sign.
Follow prescrioed measures for receiving and monitoring packages of radioactive material.
Maintain detailed radiation exposure records.
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-- Maintain radiation doses and effluent concentrations below specified levels, and take prescribed actions if these are exceeded.
-- Dispose of radioactive wastes in accordance with prescric>ed methods and limits.
We celleve that botn performance-type and prescriptive-type requirements are needed. Ideally, performance-type requirements should be specified for j eacn subset of prescriptive-type requirements, and license applicants should oe required to describe how they will meet the performance-type requirements if tney propose not to follow ene specified prescriptive requirements.
As a general observation, we believe performance-type requirements are j more suitable for a licensee which 'is highly qualified to operate a large j nuclear program and prescriptive-type requirements are more suitable for a licensee which is minimally qualified or who operates a small nuclear j program. A suitable mix of requirements is best, we believe, for all l programs. From an inspection standpoint, it is much easier for inspectors to determine compliance with prescriptive-type requirements as compared with l
performance-type requirements. Much more tr.aining and higher qualifications ;
are needed by inspectors to determine compliance with performance-type requirements. A licensee is either doing what a prescriptive requirement specifies or is not. Inspection against a performance-type requirement !
requires tne inspector to exercise a great amount of professional judgment in i determining compliance. 1 A licensee may or - 2; - :: prefer performance-type requirements. On the i
one hand these provide t..e ..:ensee wide flexibility in the method of achieving compliance, but on :ne other nand an NRC inspector 'may take exception to the licensee's oelief that he is in compliance. Whether j l
performance-type requirements are preferable over prescriptive-type requirements may be largely dependent on whether a licensee is willing to ;
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RECO90GNDATION 010:
We recommend the NRC consider the feasibility of utilizing a broad 4
license, similar to that developed with the Air Force, for. companies that have !
l extensive and multi-location licensing programs. The successful use of such a l license could reduca resource demands on NBC and place more direct responsibility on the broad licensee to achieve and maintain safe operations.
DISCUSSION l During our discussions with the NRC staff, the Study Group was informed about a new licensing program recently undertaken with the U.S. Air Force.
Under this program, the NRC issued a single materials license to the Air Force covering the materials possessed and used at approximately 100 Air Force installations. The terms of ene license made' the Air Force responsible for monitoring and inspecting the possession and use of radioactive materials at tne various installations. The NRC maintains regulatory responsibility and control through the exercise of performance overview of the Air Force. We were informed that the program to date has worned well.
We were impressed by tne potential of this licensing for application to other NRC 11censees that possess and use licensed materials extensively and at .
multi-locations. It nas application to other Federal entities that operate in tne same fashion as t..- .- c'o r c e . It also has the potential for being a useful method for lice- : .'arge commercial firms that utilize licensed materials at many locat. .2.
The application of c. s type of licensing introduces a degree of flexibility into the NRC licensing program that is useful to both NRC and the
27 licensees. The NRC oenefits be being able to reduce licensing and inspection resources dedicated to these types of licensees. The licensee, on the other hand, would be in a cetter position to develop coordinated programs for the possession and use of licensed materials at the various locations where they are used. In addition, the licensee is responsible to a single NRC regional office for its total operation rather than to several.
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1 RECOMMENDATION 911:
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We recommend that the NRC increase significantly the amount of training I provided to its fuel cycle and satorial licensing and inspection staff as well as its management staff. Such training should include the establishment of a formal technical training program, periodic seminars and periodic meetings between Headquarters and regional office staffs.
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l DISCUSSION I During the Study Group's visits to the regional offices, questions were raised with staff concerning the adequacy of their training. The NRC ,
personnel in the regional offices visited expressed concern about what they considered to be inadequate opportunities for employee training. Both the oranen eniefs as well as employees within the branch felt that training was extremely important for them so that they could become more. technically competent anc thus coulo co a better job in the licensing and inspection process. They also believed that the whole area of professional training and development neeced to be revamped within NRC.
It was pointed out to tne Study Group that there is no formal technical training program for new picyees coming it.to the agency. Thus, it appears t
j' that 1,n many instances a e NRC employee is given a few guidelines from their supervisor and then is :.: ei loose. This causes great dif ficulties for the employees during their :n:tial inspection and licensing activities. In many instances they are dealing with counterparts on the industry side who are much more knowledgeable than they are about even NRC requirements. After considering the comments, the Study Group concluded that NRC needs to develop L_- - - _ - _ - - _ . _ - - _ - _ _ - - - - - - - _ _ . - - _ _ - - - - -- --
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29 a formal technical training program. Suen a program would be best implemented by an individual or group devoting full time to this activity. It should be mandatory that all new NRC employees go through a rigorous training program.
A technical training program should be laid out for each employee, funds should be provided for these employces to travel to attend these training programs, as well as professional meetings in which the subject matter
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discussed is in the realm of the area that they are working in.
The greatest resource that NRC has is its people. To the extent that its employees are well-trained, motivated, and feel that eney are developing professionally, the NRC will be able to do a better job. This attitude and-enis approacn to traini g is the backbone of every major successful corporation in this country. They should be of no less importance to NRC. If ;
NRC wisnes to retain and attract competent individuals to carry out the l
government's important work in this area, then it is extremely important that an adequate and comprehensive training program be instituted throughout the agency.
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RECOMMENDATION 012:
We recomunend that NRC give serious study and thought to the
- implementation of the proposed comprehensive revision of 10 CFR 20 " Standards l for Protection Against Radiation" because of its perceived complexity by the states, the industry and some of the NRC regional staff. l I
DI SCUSSION ;
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The Study Group understands the importance of, and endorses, NRC's promulgation of a proposed comprehensive revision to 10 CFR 20 " Standards for l Protection" to make NRC regulations more consistent with recommendations of the International Commission on Radiological Protection. Notwithstanding, a l great deal of concern was expressed to the Study Group concerning the perceived complexity of the proposed rule changes and the increased qualifica-tions needed by licensees to understand and achieve compliance with the new requirements. Accordingly, we recommend that the NRC provide phased imple-mentation over a period of several years before the .new requirements come fully into force.
Tne NRC staff informed us that they plan to prepare Regulatory Guides which will discuss and explain the new requirements for several different categories of licensees. Ne Study Group strongly supports the preparation of these guides and recom.e :s inat these be issued and discussed with licensees cefore the new requirez- .s come into force. In this connection, we recommend that regional ::2 tning seminars be held to discuss the guides and answer licensee questions on implementation details.
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l RECOMMENDATION $13:
We recommend that all NRC fuel cycle licensing and inspection functions, including the office of Inspection and Enforcement headquarters functions, be perfonned by a single group under one supervisor at the branch chief level at one location. We recommend that the one location be NRC headquarters. This NRC fuel cycle licensing and inspection group should be provided technical assistance from other NAC technical groups as needed; however, the licensing and inspection group should have overall safety responsibility.
DISCUSSION ,
At present the licensing activities for fuel cycle plants are carried out at NRC headquarters and the inspection activities are carried out by all five regional offices. Region I has inspection responsibility for two plants.
Region II has s:ix plants. Region III has two plants. Region IV has one plant and Regional V has three plants. During the visits of the Study Group to the four regional offices it became clear that the personnel involved in these activities varied significantly in experience and background. In one regional office a health physicist witn no previous experience in fuel cycle operations anc iacking a clear understanding of the chemical processes involved was responsible for inspecting the facility. In another regional office a senior l inspector who fully understood not only the radiological implications of the plant's activities but also understood the total chemical process inspected the plants. Since there are so f ew plants, it is the opinion of the Study Group that comDining tne ..:ensing and inspection functions would result in increased efficiencies a ..etter utilization of NRC resources as well as improvements in overal. . ; regulation and safety.
l This concept was o tsc.ssed oy the Study Group with NRC personnel at many of the regional offices, anc most indicated that some consolidation should be i
undertaken, since the NRC resources devoted to this activity were cmall. In
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our vaew and in ene view of those with wnom we discussed this issue, it makes sense to form a critical mass in one place within the o:ganization cha4ged with the responsibility for licensing and inspection of these fac.11' ties.
Inasmuch as the licensing activities are already concentrated end carried out oy NMSS headquarters, we would r ecommend that the inspection activities be consolidated within that office at headquarters.
The major point the Study Group wishes to emphasize is that it does not
, .nske sense, where so few of these complex plants are currently operating, to l
l tave the responsibility for them parcelled out' on a regional basis. There i will probably be very few, if any, of these 31 ants built in the near future.
l The availability of NRC personnvl with croad chemical engineering backgrounds l
who fully understand the complexities of fuel cycle plants, is very limited.
Accordingly, these resources should be consolidated within one organization l wnich is given the undivided responsibility for the health and safety activ-ities of sucn facilities.
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33 RE(.N TION 014:
We recommend that the development of materials regulations, guides and standards be consolidated in NMSS where the majority of the expertise and I managinent interest in such matters lies. Personnel in the Office of Nuclear Regulatory Research now involved with this effort should be transferred to the office of Nuclear Material Safety and Safeguards.
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DISCUSSION The Office of Nuclear Regulatory Research (RES) is assigned l
responsibility for developing regulations, guides and standards (regulatory l
l documents) for the possession and use of nuclear materials. It is responsible I
! for initiating the developinent of these regulatory cocuments as well as l
l , responding to requests from the Office of Nuclear Materials Safety and l Safeguards (M4SS) for tnear development.
l From our discussions with the RES staff members, it appeared that their management interest and resources are dedicated primarily to matters involving nuclear reactors and that much less of time and effort is devoted to fuel l
cycle and materials regulation. Moreover, RES nad only a limited number of staff with the requisite expertise to develop regulatory documents for l materials licensing.
Discussions witn .Mia staf f memoers bears out the fact that it is not receiving the support it;- I3 that it deems necessary to effectively perform its function. It appear; enat regulatory documents are delayed for lengthy periods of' timer are unexpectedly suspendedt or their need is disputed. This nas created celay problems for NMSS.
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We believe that ene fuel cycle and materials regulatory program warrants more attention than is presently devoted by RES. Thus, we are recommending that the responsibility for developing regulatory cocuments for fuel cycle and l s
materials be transferred from RES to NMSS. In this way the performance of the
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task rests witn the office having the most interest, expertise, and most )
importantly, the willingness to assume this additional responsibility.
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RECOMMENDATION.615:
we recommend, that af ter successful implementation of Recommendation 913, NRC transfer the balance of the Office of Inspection and Enforcement materials inspection functions to the office of Nuclear Material Safety and Safegur-4s. Personnel in the Office of Inspectioc. and Enforcement now involved with this effort should be transferred to the Office of Nuclear Material Safety and 3afeguards.
. DISCUSSION The Study Group noted that the number of personnel in the headquarters Office of Inspection and Enforcement cevoted to materials and fuel cycle inspection activities was very small. In fact, greater than 90% of the Headquarters It was.
resources appeareo devoted to nuclear reactor inspection activities.
also noted during our visits to the regional of fices, that there was a general widespread complaint about the lack of adequate and timely support and f
information from Headquarters concerning inspection matter's related to materials and fuel cycle f acilities. The most likely reason appears to be the small amount of Headquarters resources devoted to these activities.
After due consideration, it appears logical to the Study Group that those few personnel in the headquarters Office of Inspection and Enforcement dealing witn materials ano fuel cycle inspection functions should to be transferred to '
the Of fice of Nuclear Ma*.ar ;al Safety and Safeguards, where NRC then would
- ntity the responsibility for and experts concerned have consolidated into - -
with the inspection an: .
a . sing activities of materials and fuel cycle activities.
The Stucy 3: ;.p celleves that tne same considerations also appear to apply to the organization of the reactor licensing and inspection program.
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RECOMMENDATION 916:
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!' We recomunend that the NBC regional licensing and inspection staff l
responsible for materials regulation be combined in one group such that the 1
i individual NRC staff members within the group would be trained in and perform '
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DISCUS SION i
Most of the NRC materials licensing effort was decentralized to the Regions several years ago uncer the terms of an agreement between the Director, Office of Nuclear Material Safety and Safeguards and each of the f
Regional Administrators. Under this arrangement, program direction comes f rom l
Headquarters, but individual materials licenses are reviewed, issued and l
inspected from the fiel:. :ne potential advantages cited for this method of l I operation at the time .- .ss first implemented included (1) having the license reviewers physically cl.;v: to ene licensees would promote better communication and understanding between the NRC and its licensees and (2) l having tne NRC materials license reviewers physically closer to the 14fC l
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37 materials inspectors would likewise facilitate communication and under-standing, ano thersby improve moth the licensing and inspection processes. It appears that all of these advantages are being realized and that the program has been successful.
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However, the Study Group observed in its visits and discussions in the Regional Offices that only in Region I are the licensing and inspection staff members responstole for materials regulation comoined in one group such that individual staff members within the group can and do perform both licensing and inspection functions interchangeably. We believe that this organizational arrangement is far superior to those of the other Regions since it maximizes the advantages of decentralization of the materials licensing function, facilitates trade-of f s between licensing ef forts and inspection efforts on individual cases, and improves morale by permitting a wider and more equitable l
snaring of the out-of-the-of fice burdens of inspecting licensees. We recommeno that all Regions adopt ene Region I type of organization for carrying out their materials licensing and inspection responsibilities.
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- l OTHER RECOMMENDATIONS RECOMMENDATION 917 We recommend that NRC revise its regulatory guideh !Gr the format and content of license applications for fuel cycle plants to ensure an ites by item correlation between Part I (License Conditions) and Part II (Safety Demonstration). A similar license guide is needed for materials licensees possessing or using large quantities of hazardous radioactive materials. A license condition should be developed to cover each ites discussed in the demonstration part of the application.
DISCUSSION The NRC staff nas prepared and is using regulatory guides to describe a standard format and content for health and safety sections of license renewal applications for uranium fuel fabrication plants (Regulatory Guide 3.52) and I uranium hexafluoride production (Regulatory Guide 3.55) . The guides consist )
of two major parts. Part I discusses tne commitments that license applicants should make which become einding license conditions and Part II discusses supporting information s .;n demonstrates ene applicants' capability to meet' the proposed license c:...:;ons.
In our discussion of :nese guides with NRC regional office staff and in our independent review, we noted that there is no item-by-item correlation j (and such correlation is needed) between Part I (License Conditions) and Part II (Safety Demonstration) making it difficult to track license commitments and
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i backup supporting inforraation. Perhaps as a result of this confusion, we understand that at least one licensee was cited for noncompliance with a !
statement contained in Part II (Safety Demonstration) which was not intended j to be a license requirement. Irrespective of the cause of this problem, licensees and NRC inspectors would be benefited by clearly distinguishing license requirements and backup supporting information, and revising the standard format and content guides to require an item-by-item correlation of ,
statements in Part I and II. In this connection, care should be taken to assure that applicant commitments are made for all aspects of operations important to safety, including fire protection, process safety design, quality control and maintenance, and hazardous non-radioactive chemicals storage and use. )j
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A similar guice snould ce prepared for applications to possess and use large amounts of hazardous radioactive materia.ls, such as those used in manufacturing raciopnarmaceuticals.
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40 RECOMMENDATION $18 We recoemend that NRC prepare Standard Review Plans'for fuel cycle and
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materials licensees possessing or using large quantities of hazardous radioactive materials conforming to the format and content guides discussed in Recosamendation $17 above.
DISCUSSION l
Standard Review Plans are needed to provide appropriate guidance to NRC staff and license applicants concerning the scope and depth of licensing .
reviews, the adequacy of submitted information called for in the Standard Format and Content guides, and the need for independent validation of information by license reviewers or by. third parties (for example, nuclear safety assumptions and criticality calculations, ventilation system capabilities, effluent monitoring and alarm systems capabilities, financial commitments for decommissioning, and accuracy of offsite authorities' phone numbers to be called during emergencies.) The Standard Review Plans should be prepared after the Standard Format and Content guides have been revised as recommended in #17 above, s..d should be organized to permit an item-by-item correlation with those -
. :e s . Copies of the Standard Review Plans should be made available also to . -se applicants and other interested persons.
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1 41 RECOMMENDATION 019 1
l We roccamend that NRC issue major amendments to fuel. cycle and materials j licensees possessing or using large quantities of hazardous radioactive materials only after the amendments have been discussed jointly by the licensing staff and inspectors with the affected licensee. A clear understanding should be established with the licensee concerning what the new license requires at the time it is issued.
1 DISCUSSION Applications for new or major amendments to fuel cycle and materials licenses for p.ssession or use of large quantities of hazardous. radioactive materials may be quite lengthy and complex in content. Accordingly, we believe it important for the NRC licensing staff, NRC inspectors and license applicants to meet and discuss applicable requirements before these licenses or major amenoments thereto are issued. Unless this is done, a-licensee may ,
I unwittingly fail to comply with a requirement because the licensee'did not interpret it the same way NRC did. Tnese meetings should also assure that NRC licensing staff and NRC inspectors interpret license requirements alike or identify where applicable requirements should be changed to reflect the proper intent. For this process to be successful, licensees should participate fully in these meetings descr.:. ; snear understanding of wnat is. required, asking
.a questions to clarify NPJ . tentions, and requesting changes of wording to reflect proper underste... :4.
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42 RECOMMENDATION $20 1
We recomunend that NRC inspectors be given more latitude with respect to deciding when not to make a compliance issue of minor items of non-compliance when the intent and spirit of the regulatory requirements have been met.
DISCUSSION We were informed that it is the policy of some, but not all, regional offices to cite licensees for every item of noncompliance regardless of the significance of the matter and wnether or not the licensee complied with the intent and spirit of the requirements. In some instances, we were told, the inspectors cite licensees for noncompliance, but inform them that their departure from the requirement was in fact a safety improvement. We believe that citations of this type are not useful and should in most situations be avoided. Such citations are likely to discourage licensees from making appropriate improvements and unduly alarm ene public about matters unimportant to safety.
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i RECOMMr.NDATION 021
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We recommend that NRC maintain a readily available file of 1 interpretations of the regulations which should be maintained for use by the l
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DISCUSSION l
We were informed by regional office staff that they had been provided little guidance with respect to the intent and interpretation of NRC regulations and the findings necessary to support compliance or noncompliance with applicable requirements. Additional guidance is apparently needed. Two, i i
examples were cited to illustrate regulatory requirements unclear to some of the staff (1) which dose standards in 10 CFR 20.101(a) (i.e., 7.5 rems to the skin of the whole oody or 18.75 rems to the hands and forearms) should apply l An determining compliance with an exposure does to the skin of the hands and l (2) what constitutes a " permanent" radiographic installation for purpose of
- determining compliance with 10 CFR 34.29. These and other troublesome l
requirements should be discussed'in writing and appropriate guidance provided to the NRC staff. As these interpretations are given, they should be j exchanged between NRC Headquarters and the regional of fices, and a complete file of all interpretatt:. s maintained available for use by the NRC staff.
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l RECOKKENDATION 022 We recommend that communications between NBC headquarters and regional offices and between NBC and licensees be improved.
DISCUS SION I
He were informed that relatively little information is being exchanged between inspectors in the five regional offices. Although periodic interoffice meetings take place.between Branch Chiefs and .Section Chiefs, the staff which performs inspections has little opportunity to discuss common problems with their counterparts in other NRC offices. We believe that periodic meetings between the staff who perform similar types of licensing and ., l inspection worx should be held, perhaps annually, to discuss and exchange experiences on methods and approaches, problem cases, compliance trends and fixes, and interpretations of troublesome regulations.
We believe that NRC shoula also nold more regulatory workshops for its licensees. These have been held at relatively infrequent periods in the past. Topics for possibie discussion each year might include licensee management responsibilities; methods of achieving compliance with regulations and license requirements; ALARA cojectives anc programs; radiation safety methods and practicees elements of effective emergency planning; radiation safety facilities, equipment an'd instruments; radiation safety training programs; and compliance ::+nds.
Finally, we believe ena: NRC should issue larger numbers of Bulletins and Informational Notices to keep materials licensees better informed on important regulatory matters. Care should be taken that regional office staff are
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I. appropriately informed of these before mailing to licensees. We were told L that regional office staff sometimes first hear of the issuance of these from l licensees who are calling to ask questions about them.
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