ML20236P467
| ML20236P467 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1987 |
| From: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| TASK-PINV, TASK-SE SECY-87-189, NUDOCS 8708120379 | |
| Download: ML20236P467 (122) | |
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EYh.
POLICY ISSUE July 29, 1987 SECY-87-189 For:
The Commissioners From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
NRC STAFF ANALYSIS OF THE RECOMMENDATIONS CF THE MATERIALS SAFETY REGULATION REVIEW STUDY GROUP
Purpose:
To obtain Commission approval for staff use of the Materials Safety Regulation Review Study Group Report (MSRRSG), and to obtain Commission approval of staff proposals to implement the recommendations of the report. Also, in related matters, l
to inform the Commission of the results of team assessments l
at fuel cycle facilities.and the staff's proposed response l
to recommendations contained in House Report 100-167, issued by the House Committee on Government Operations.
Background:
The Materials Safety Regulation Review Study Group was established by the Executive Director for Operations in May 1986.
Under the charter of the MSRRSG, each of the five members ir. dependently reviewed the activities related to safety within the licensing and inspection program for fuel cycle and materials facilities under the jurisdiction of the Commission.
Following a series of meetings and site and state visits, a summary group report was provided to the NRC on October 24, 1986 by the Chairperson, Dr. Clifford V. Smith, Jr.
The report contained a total of 22 recommendations.
In the Staff Requirements Memorandum dated December 8,1986, the Ccmmission directed that the staff obtain public comments on the MSRRSG report, and that the staff obtain Commission approval prior to implementing any MSRRSG recommendations.
The staff understood that the purpose of this restriction was to overcome any procedural difficulty that might exist CONTACT:
Donald A. Cool, NMSS 42-74283 8708120379 070729 PDR SECY ppa 87-109 t
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4
+.
The Commissioners 2
s relating to conformance with the Federal Advisory Committee Act while public comments on the MSRRSG report were being obtained. The report was published for public comment in l
the Federal Register on December 17, 1986 (51 FR 45122).
The staff proviaed a summary of the public comments and the s
staff's plans for review and assessment to the Commission on April 7,1987 (SECY-87-94), noting that comments were b
received in 49 letters from individuals, licensees, citizen activist groups, and members of licensee organizations expressing their own personal views. The letters contained j
207 comments on the MSRRSG recommendations plus one comment on the applicability of the Federal Advisory Committee Act and three recommendations on matters not covered by the MSRRSG. The staff has now completed its review and assessment.
Discussion:
Over ttia last several years, and particularly after the January'4,1986 accident ct the Sequoyah Fuels Corporation uranium hexafluoride conversion facility, the staff had been working on numerous suggestions and recommendations for improving the regulation nuclear materials. Many of the recceendations made by the MSRR3G were not unique, and were already in various stages of consideration or implementation.
The recommendations of the FSRRSG can be categorized into two broao groups. The first group consists of recommendations 4
related to radiation and industrial safety concerns, for example, nonradiological hazards, emergency preparedness, and radiography safety.
In general, the staff is in agreement with these recommendations and was taking action that is consistent with the MSRRSG approach. The staff plans to continue with these actions, and to coordinate these activ1tks with the Agreement States as appropriate.
The second group consists of recommendations related to administrative aspects of NRC operaticns, including organizational changes, training, procedures, and schedules.
The issues raised by some of these recommendations have already been addressed by the Commission as a part of the recent reorganization. The staff will pursue a number of these administrative improvements in the context of the new organization. However, the staff does not plan to pursue further major organizational changes as recommended by the MSRRSG.
A summary of the MSRRSG recommendations, the public comments received, and the staff's position on each recommendation is provided in Enclosure 1. provides a detailed analysis of the recommendations and public comments, and is I
designed to be a free-standing public document which describes j
the staff's response to the MSRRSG recommendations.
4 The Commissioners 3
During the same period of time that the MSRRSG report was being prepared and evaluated, the staff undertook an indepen e action to assess operational safety at each of the 12 n.usor fuel facilities licensed by the NRC. These facilities included the two facilities producing uranium hexafluoride, the seven facilities producing commercial nuclear reactor fuel, and the three facilities producing naval reactor fuel.
The assessments were conducted between early 1986 and March 1987 using a multidisciplinary team approach involving NRC personnel from the responsible Region as well as Headquarters personnel. The Regional personnel included not only those normally inspecting radiation, criticality safety, and emergency preparedness programs at fuel facilities, but also experts from reactor inspection groups with fire protection and operations engineering experience.
Furthermore, because certain occupational safety and environmental protection responsibilities are within the purview of the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA), these two agencies were invited to participate as part of the NRC teams in most of the assessments. The Federal Emergency Management Agency (FEMA) also participated in two of the assessments in the area of emergency preparedness.
The most important safety issues identified as needing attention by licensees were in the areas of fire protection, chemical hazards identification and mitigation, management controls or quality assurance, safety-related instrumentation and maintenance, and emergency preparedness. A summary of the results of the operational safety assessments is included as Enclosure 3.
These findings contributed to and support the staff position on the MSRRSG recommendations.
The significant safety issues coverea by the MSRRSG were already being addressed as part of ongoing staff activities.
The staff has integrated all of its proposed regulatory improvements into the Five-Year Plan /FY 1989 budget formulation process, which also includes progratsatic objectives and improvements based on thc NRC strategic plan, the Lessons Learned Report from the Sequoyah Fuels Corporation acciaent, the medical improvements program, and the results of operational safety assessments at the major fuel facilities.
l
t 4
The Commissioners 4
The staff estimated that approximately 15 FTE's per year would be needed for implementing the MSRRSG recommendations.
Adequate resources for this work were included in the budget submitted to the Commission on July 6, 1987. The final staff program for regulatory improvements will be in accordance with the resources and priorities approved in the budget process.
On June 18, 1987, the U.S. House of Representatives' Committee on Government Operations published a report titled, "NRC's Regulation of Fuel Cycle Facilities: A Paper Tiger" (Enclosure 4). The Office of Governmental and Public Affairs provided the report and a House press release to the Commissioners on June 24 and June 25, respectively, and stated that a follow-up letter to NRC was being prepared to request NRC comments on the report.
The report concluded with 18 recommendations for improving the regulation of fuel cycle facilities. Most of the recommendations dealt with regulatory matters similar to those covered by the Lessons Learned Group from the Sequoyah Fuels Corporation accident and the Materials Safety Regulation Review Study Group. is the staff's 3roposed response indicating agreement with most of t1e 18 committee i.
recommendations. The report contains recommendations which i
are more specific to fuel cycle facilities. The MSRRSG report covers additional issues in the broad area of materials regulation. While the House report goes further in some of its recommendations covering specific issues such as emergency response than dces the MSP.RSG report, the staff believes that the recommendations in both reports are compatible and complementary. The responses to the House report are consistent with the responses to the MSRRSG recommendations.
Recommendations:
That the Commission:
Approve the use of the MSRRSG recommendations in considering improvements to the fuel cycle and materials program, new that the process of public review of the report i
is complete.
Aporove the staff responses to the 22 specific MSRRSG recommendations as provided in Enclosure 2.
Approve the staff plans to implement these recommendations as contained in the responses subject to the resources provided during the budget process.
a-___-_________-
4 The Commissioners 5
Note that the staff has drafted responses to the recommendations contained in House Report 100-167.
If requested by Congress or at the Commission's initiative, the staff can prepare a response to the House Committee on Government Operations based upon the draft responses contained in Enclosure 5.
Note that the Office of the General Counsel has reviewed this paper and has no legal objection.
l
(
ictor Stell, fr.
Executive Director for Operations
Enclosures:
1.
Summary of Staff Analysis of MSRRSG Recommendations 2.
Detailed Staff Analysis of MSRRSG Recommendations 3.
Results of Operational Safety Assessments at the Major Fuel Facilities
'4.
House Report 100-167 5.
Staff Response to Recommendations in House Report 100-167 Commissioners comments or consent should be provided directly to the Office of the Secretary by c.o.b. Monday, August 17, 1987.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Monday, August 10, 1987, with an infor-t mation copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical-review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC (H Street)
OI OIA GPA REGIONAL OFFICES
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l PROPOSED ACTIONS TO IMPLEMENT RECOMMENDATIONS OF THE MATERIALS SAFETY REGULATION REVIEW STUDY GROUP t
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EXECUTIVE
SUMMARY
The Materials Safety Regulation Review Study Group (MSkkSG) was established by the Executive Director for Operations of the U.S. Nuclear Regulatory Commission in May-1986. _ Under the charter of the Stua; Group each of the five members independently reviewed the activities related to safety within the licensing and inspection program for fuel cycle and materials facilities under the juris-diction of the Commission and provided recommendations to the other members for editing and submittal to the Executive Director for Operations.
The members of the Study Group were Edson G. Case, retired Deputy Director, Office of Nuclear Reactor Regulation, NRC; Thomas F. Engelhardt, retired Deputy Director, Office of Executive Legal Director, NRC; John M. Googin, Senior Staff Consultant, Development Division, Y-12 Plant, Martin Marietta Energy Systems, Inc.; Ralph G. Page, retired Chief, Uranium Fuel Licensing Branch, Office of Nuclear Materials Safety and Safeguards, NRC; and as Chairman of the Study Group, Clifford V. Smith, Jr., former Director of the NRC's Office of Nuclear Materials Safety and Safeguards, and currently Chancellor, University of Wisconsin-Milwaukee.
i The Study Group first convened in June, 1986, 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 the Agbncy.
The Headquarters staff also informed the Study Group of studies currently underway to deal with certain of the issues that-the Study Group was asked to review.
The Study Group then visited the NRC Regional offices in Regions I, King of Prussia, Pennsylvania; Region II, Atlanta, Georgia: Region III, Chicago Illinois; and Region IV, Dallas, Texas.
The Study Group also visited with the state health department officials con-carned with nuclear matters it, the State of Oklahoma (a non-Agreement State),
and the State of South Carolit1 (an Agreement State).
Further, the group visited the uranium hexaflourMe conversion facility of Kerr-McGee's Sequoyah 1
l l
I Fuels Corporation at Sequoyah, Oklahoma; the fuel fabrication plant of Westinghouse Corporation in Columbia, South Carolina; and the radiopharmaceu-l tici production facilities of the New England Nuclear Company in Boston, Mas 2chusetts.
During the visits to the Regional offices, the Study Group conferred with the Regional Administrator and his senior manager::, 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 its field visits.
The MSRRSG recommendations and discussions presented in this report are based on these visits, as well as on the in-depth discussion among the members of the Study Group.
Since the MSRRSG obtained its information from the Headquarters staff, from licensees. and from Regional office personnel, all of whom are involved in constant communication and cooperative actions on matters of common interest, it was to be expected that the recommendations of the Study Group would deal with matters that had often been discussed before.
In many cases, the MSRRSG referred to work already in progress to implement the course of action they recommended, and urged that it be completed expeditiously.
The MSRRSG report was published in its entirety in the Federal Register (51 FR 45122, December 17, 1986) with a request for public review of the report and comment on its contents and reco. emendations. Comments were received in 49 letters from individuals, licensees, citizen activist groups, and members of licensee organizations expressing ~their own personal views.
The letters con-tained 207 comments on the MSRRSG recommendations plus one comment on applica-bility of the Federal Advisory, Committee Act and three recommendations on matters not covered by the MSRRSG.
The NRC staff has analyzed the MSRRSG recommendations and the public comments on them, evaluating potential benefits of implementing each recommendation against the cost in staff and licensee time and resources.
The public comments did not identify any concerns that the staff had not considered, but in response to the comments, the staff revised its previous plans so as to provide increased emphasis on training for licensee personnel as well as the NRC staff and to encourage greater involvement of Regional and licensee personnel in licensing I
2
4 reviews and discussions.
The staff also collected and reviewed information on j
actions that were already in progress to deal with aspects of most of the issues that were covered by the recommendations.
After extensive discussion and analysis of alternatives by members of the various staff groups involved in implementing the recommendations, an analysis and a staff position were devel-oped for each of the 22 MSRRSG recom:nendations.
With regard to the MSRRSG recommendations,-the staff position is that additional effort, above presently budgeted levels, would yield significant improvements, especially in exploring the feasibility of initiating a program of certification of radiographer to be conducted under the auspices of the American Society of Nondestructive Testing-(Recommendation No. 4), broadening the scope of inspections (Recommendation No. 5), and providing more training and guidance for the staff and for Agreement State and licensee personnel (Recommendation No. 11).
The 22 recommendations of the MSRRSG, the public reactions, and the staff position ar2 summarized in Table S.I.
The detailed discussion and analysis of each recom-
-mendation, a summary of public comments, and a statement of the staff's position are given in the main body of the report.
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PROPOSED ACTIONS TO IMPLEMENT RECOMMENDATIONS OF THE MATERIALS SAFETY REGULATION REVIEW STUDY GROUP
- 1. 0 RECOMMENDATION:
That the NRC reach a decision, on an expedited basis, concerning the scope of NRC regulatory authority for chemically hazardous substances that are used in or incident to the processing of licensed material.
They further recommended that upon reaching a decision regarding this matter, the NRC shculd promptly develop memoranda of understanding with federal and state agencies that share regulatory responsibilities at locations where NRC-licensed materials are possessed or used, to assure that there are no regulatory implementation gaps and that the overall health and safety of the public will be fully protected.
The memoranda should specify the authorities and responsibilities of the involved agencies and should be made available to the states and all other interested parties.
The l
memoranda should also be made available to the public via an appropriate explana-tory press announcement concerning the scope of NRC responsibilities and those of the oth e involved governmental agencies.
1.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
i The Study Group noted the lack of clarity regarding NRC's authority and responsibility to regulate non-radiological hazardeus substances such as chemically hazardous substances that are used in or incident to the processing j
of NRC-licensed material and also noted the existence of a regulatory implemen-tation gap between the responsibilities of the NRC and those of other federal and state agencies.
The MSRRSG found that the only guidance available to the NRC staff regarding
' the NRC authority and responsibility for non-radiological hazards was in an October 10, 1984 memorandum from the Office of the Executive Legal Director to the Office of Nuclear Regulatory Research.
That memorandum reached the con-i clusion that the Atomic Energy Act provided authority for the NRC to regulate the toxic hazards of uranium; however, it was not widely circulated to the NRC staff nor was it incorporated into an NRC regulation or formal staff guidance.
7
i The Study Group found that the materials licensing and inspection staffs at Headquarters and in the Regions are operating under the general impression that NRC authority and responsibility at mixed use facilities are limited to matters
]
involving radiological safety.
)
The Sequoyah lessons Learned Group, in its report of May 29, 1986 to the
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)
Executive Director for Operations, highlighted the non-radiological hazards issue and the regulatory implementation gap in responsibility among the various
.l regulatory agencies having an interest in the Sequoyah facility.
More recently, the General Counsel transmitted to the Commission a paper, dated l
Septembe.r 23, 1986, analyzing the jurisdictional issues associated with non radiological hazards.
The Study Group concluded that when the NRC acts to clarify its regulatory authority and responsibility over non-radiological hazards, new or revised memoranda of understanding should be developed with other involved federal and state agencies to assure that the scope and limits of authority and respon-sibility of the NRC and these other agencies are clear and, most importantly, understood by the agencies involved.
The Study Group also noted that, under the present procedures, memoranda of understanding are not widely disseminated.
As a consequence, few are aware of their existence or content.
Therefore, the new memoranda of understanding should be broadly disseminated to representatives of the states, the press and the public.
- 1. 2
SUMMARY
OF PUBLIC COMMENTS Among the 49 public comment let.ters,11 expressed support for implementation of Recommendation No. 1, and four voiced opposition.
Those supporting the recom-mendation mainly stressed their desire to improve the regulation of areas they considered to be inadequately covered at present.
Those opposed generally agreed that NRC should clearly define its area of regulatory responsibility, but also urged that their responsibility should be limited to radiological safety and health and should not include new responsibilities for non-radiological hazards.
These commenters pointed out that the proper expertise for 8
e regulating these' areas resides in EPA and OSHA.
Regulation of non radiological
' hazards, they said, is not presently within NRC's area of technical competence; and if the Commission were to staff up to cover new respons.ibilities in this area, it would duplicate staff functions that are already available in the other agencies.
1.3 STAFF ANALYSIS AND POSITION The staff has considered several options regarding the Commission's jurisdiction over non-radiological hazards' under its regulatory authority granted by the-Atomic Energy Act of 1954, as amended.
As a first option, the Commission could adhere to its long standing interpretation of its jurisdiction as limited to i
the physical hazards of radiation arising from use of licensed facilities and materials.
Alternatively, the Commission could confine its jurisdiction to nuclear materials, as defined in the Atomic Energy Act, but adopt a more expan-sive definition of public health cnd safety to include non radiological health hazards from licensable materials or facilities.
The staff has pursued the second option, especially for cases where an exercise of NRC authority is needed to address a serious safety matter that is not being addressed by any other agency.
For the purpose of defining the staff's regulatory roles, the hazards that may be associated with facilities which handle source, byproduct, and special nuclear material can be grouped into four categories:
1.
radiation risk produced bi radioactive materials 2.
chemical risk produced by radioactive materials 3.
plant conditions which may directly or indirectly affect the radiation risk, e.g., those which might produce a fire or explosion.
4.
plant conditions whith~ result-in an occupational or public risk but do not significantly affect licensed radioactive material, e.g., chronic exposure to toxic non-radioactive chemicals.
The staff has required, and will continue to require, that the first three categories be covered through the licensing and inspection process.
Both NRC and the Occupational Safety and Health Administration (OSHA) have jurisdiction over occupational health and safety onsite.
NRC has jurisdiction with respect to the hazard of working with the radioactive matr. rials.
OSHA 9
1
i establishes standards for other working conditions in plants, including working with hazardous chemicals as defined in 29 CFR 1910.1200.
OSHA regulations include process controls, work practices, exposure limits, safety training, and require a materials safety data sheet for each hazardous chemical used in the facility.
Similarly, the Environmental Protection Agency establishes standards for releases of chemicals to the environment, including airborne and waterborne releases as well as solid waste disposal.
The Emergency Planning and Comunity Right-To-Know Act of 1986, Title III of the Superfund Amendments and Reauthorization Act of 1986 (Public Law 99-499) establishes a complete and comprehensive offsite emergency preparedness and response program for hazardous and toxic chemicals under the direction of E'PA and FEMA.
It will apply to all NRC and Agreement State licensees who possess a hazardous chemical in the threshold quantity established by EPA.
Although OSHA and EPA have responsibility and authority for the fourth category of hazards (chemical and other non-radiological hazards), the NRC nevertheless plans to exercise some leadership with regard to this category.
This is consistent with the conclusions of the General Counsel in his memorandum of September 23, 1986 regarding regulatory jurisdiction.
For example, as NRC conducts multidisciplinary team assessments of operational safety at NRC-licensed-facilities, OSHA and EPA will be invited to participate.
Similarly when NRC inspectors %ntify problems in other agencies' regulatory jurisdiction during our inspections, NRC will continue to inform the responsible agency so that action can be taken as appropriate.
NRC plans to provide more broad training for NRC licensing and inspection staff to enable them to better identify potential problems outside NRC's direct regulatory jurisdiction in an effort to improve their effectiveness irhmaking such referrals.
The NRC also plans to continue to share information and explore opportunities for further cooperation with EPA in this area; for example, through the NRC/ EPA Interface Council.
The staff will monitor the effectiveness of existing arrangements, and plans to work with OSHA and EPA to develop and document, through mechanisms such as a memorandum of understanding, a clearer statement of the respective roles of each agency.
10
)
- 2. 0 RECOMMENDATION:
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
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to submit brief descriptions of their emergency resconse capability.
Both radiological and chemical releases should be considered in developing the j
required on site and off site emergency plans unless the licensee can demon-strate that an uncontrolled on-site chemical release could have no significant adverse safety effects on the licensed activities at the site.
2.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The Study Group believed that the more difficult issues of emergency
{
preparedness ara related to the need for and scope of off-site emergency planning and related jurisdictional issues.
They agreed with the Sequoyah Lessons Learned Group that the Sequoyah incident demonstrated a number of deficiencies in the pre-incident emergency preparedness measures at Sequoyah and that these should be corrected.
They recommended that performance-type requirements be considered with respect to the following:
capability for detecting, assessing, and responding promptly to hazardous releases; a system to alert workers and affected members of the public to such releases; public notices concerning the emergency alert system and actions the public might be asked to take; and development of
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emergency plans in coordination with local authorities.
Also, they recommended j
that NRC consider whether the proposed threshold for soluble uranium exposure,
{
which requires emergency planning and response actions, should be lowered from 2.0 milligrams of uranium.
T5e Study Group noted that reactor licensing practice is to consider the effects on the licensed activities at the site if thers should be uncontrolled on-site releases of each of the heTardous materials present, unless the licensee can demonstrate that the potential effects are minimal or that such releases are of very low probability due to demonstrated design, construction and quality 1
11
assurance practices.
The Study Group believes that off-site effects of uncon-trolled releases of non radioactive chemicals should be considered in the off site emergency preparedness measures required by NRC, particularly if no other agency has assumed this responsibility.
2.2
SUMMARY
OF pUBLIC COMMENTS Public comments were divided, with seven in favor of Recommendation No. 2, and five opposed.
Those in favor of the recommendation commented mainly on two aspects:
emergency preparedness should be improved to provide better protec-tion for the public, and materials licensees who may possess large quantities of radioactive material should be required to develop emergency preparedness plans.
Two comments specifically supported the idea of reducing the soluble uranium exposure threshold, as mentioned by the Study Group in their discus-sion of the recommendations, and one opposed the reduction.
The comments in opposition to the recommendation noted the following points:
Criteria and performance standards for emergency preparedness already exist in the Standard Format (NUREG-0762) and the Standard Review Plan (Draft, June 1981).
The ACRS reviewed a proposed emergency preparedness rule on June 19, 1985, and recommended that it not be promulgated, on the basis that potential accidents were probably adequately covered by existing contingency plan requirements of the NRC.
NUREG-1140, "A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees," says the risk is small and involves only small doses to few people.
L Reactor-type regulation is not appropriate for fuel cycle facilities.
+
Licensees' problems of dealing with local and other agencies were not takin into account.
They may not be able to obtain cooperation on emergency response planning.
12 t
2.3' STAFF ANALYSIS AND POSITION On June 3, 1981, the Commission published in the Federal Register (46 FR 29712) an Advance Notice of Proposed Rulemaking (ANPRM) on emergency preparedness for certain fuel cycle and other radioactive material licensees.
In the ANPRM, the Commission proposed to codify, with some modifications, the radiological emergency requirements set forth in the orders.
There were 18 public comment letters received in response to the ANPRM; the main comment was that there is no neec for the regulations.
In response, the staff conservatively analyzed possible accident scenarios and found that, while the proposed emergency pre-paredness regulations are not cost effective, nevertheless, they would bolster the protection provided by engineered safety features and thereby mitigate the consequences of an accident should it occur.
In March-1986, the staff submitted the proposed rule (SECY-86-99, " Proposed Rule on Emergency Preparedness for Fuel Cycle and other Radioactive Material Licensees") for Commission consideration, with a statement that staff ricom-mendations would be provided when the analysis of the " regulatory gap" issue was completed.
On October 28, 1986, the Commission provided the following direction to the staff:
"The proposed rule should be revised to address more directly the need to j
consider and plan for any serious non-radiological hazards to the public, I
and to reflect the lessons learned from the Sequoyah fuel accident."
.s The redrafted rule was returned to the Commission for review and approval on January 30, 1987.
The proposed rule was approved by the Commission in March 1987 and has been published in the Federal Register for comment (52 FR 12921).
Consistent with Commission guidance, the staff proposes to expeditiously pursue final rulemaking on emergency preparedness, to address non-radiological hazards and incorporate the lessons learned from the Sequoyah Fuels accident.
The 13
Staff notes that the Final Rule on Emergency Preparedness for Fuel Cycle and other Material Licensees establishes a schedule for licensee compliance, and will ensure adequate licensee preparedness to handle emergencies.
In addition to the implementation of the individual recommendations that have been made to improve the NRC response to fuel cycle and material licensee emergencies, the staff will continue its training and assessments to assure preparedness to respond to emergencies threatening the public health and safety.
Development of a regulatory guide is planned to provide information on complying with the new emergency preparedness regulation.
Guidance will be provided to assist inspectors in evaluating licensees' emergency preparedness plans.
Close coordination with Agreement States will be required to assure that incorporation of the new emergency preparedness regulation into their programs will be accomplished effectively ~.
The staff's position is that continuation of this plan will provide the most expeditious means of implementing the MSRRSG's recommendation number 2.
E e9 l
l 1
14
l
- 3. 0 RECOMMENDATION:
l 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 I
)
review, the NRC should consider:
(1) prohibiting the use of general licenses for devices containing large quantities of byproduct materials; (2) preparing
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criteria for distinguishing b'etween devices acceptable for general license l
distribution and those devices which should be specifically licensed; (3) add-ing requirements on all licenses for distribution of generally licensed devices, l
except those containing small quantities, to require the manufacturer of the generally license device to conduct periodic radiation surveys to determine
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whether the device is being safely used and to report unsafe conditions to NRC.
j 1
3.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
l Since 1984, NRC has been conducting a study of generally licensed devices.
I The study to date indicates that some devices have been abandoned by general f
licensees, some have been disposed of in unauthorized ways, some have mal-functioned or been involved in accidents that possibly could have caused significant radiation exposures to individuals, and many could not be located and accounted for.
The study thus far has principally focused en defining the problem.
A next step will be to determine what changes should be made in NRC regulations such as possibly limiting the distribution of generally licensed devices and better accountability of the devices permitted to remain l
under general license.
We beli, eve that this study should be completed within the next six months and changes resulting from the study implemented within twelve months.
i In connection with the study, the Study Group recommended that NRC prohibit the use of large quantities of byproduct materials in generally licensed devices.
They noted that gauges that are presently generally licensed may contain as much as 5 curies of cesium 137.
The unshielded dose rate from this size source is on the order of 1.5 rems per 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.
15 i
l 1
The Study Group was informed that present NRC licensing procedures for i
i generally licensed devices do not clearly distinguish between devices suitable for general licensing and those requiring a specific license.
They recommended that NRC prepare more definitive licensing criteria to provide clear guidance to license applicants, the NRC licensing staff, and the public concerning the qualification of a device for general distribution, including limits on the 3
kinds and quantities of radioactive materials permitted in such devices.
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The Study Group also believed that periodic radiation surveys should be performed of all generally licensed devices permitted in the public domain except devices containing small qualities of radioactive materials.
They recommended that this be required as a condition of the specific license issued to the device manufacturer.
Also, any noted unsafe conditions should be required to be reported promptly by the device manufacturer to NRC.
3.2
SUMMARY
OF PUBLIC COMMENTS Recommendation No. 3 drew 14 favorable comments and 9 expressing opposition.
Those supporting the recommendation generally commented on the hazards to the public when devices issued under a general license become lost, abandoned, or otherwise removed from regulatory scrutiny, especially if cesium-137 is involved.
Several commented on the need to define "large quantities" and "small quantities." At least one manufacturer of devices said that they had been performing radiation surveys at customers' sites for many years and urged that such surveys be required; but most other manufacturers strenuously objected to this idea, most often pointing to the cost of performing this service and their powerlessness to take any enfor, cement action.
Several commenters suggested that the quantity of radioactivity in a device is not an appropriate criterion, since the factors important to public health and safety are the potential radiation dose to the public in the event of an accident and the design and construction of the device in ways which mitigate the effects of accidents.
- 3. 3 STAFF ANALYSIS AND POSITION The staff has long recognized the need to examine its regulations for generally licensed devices and is now completing a study begun in 1984, which has 16
I identified several areas of safety concern about the use under general licenses of radioactive material and devices containing radioactive material.
Inade-quate accountability of the devices and users' lack of awareness of regulatory requirements are the main areas of concern.
An estimated 200,000 devices are used throughout the country under the general license provisions.
These devices may contain a few tenths of a microcurie of beta / gamma emitters or up to curie quantities of beta / gamma / neutron emitters and thus possess diverse radiologic risks.
The staff'has found that users of generally licensed devices frequently are unaware of the regulations concerning transfers, disposal, and recordkeeping.
Thus these devices are susceptible to loss, improper transfers, and improper disposal.
As corrective action, the staff is considering several changes in the current regulatory program for general licenses.
One alternative is to require vendors to communicate more effectively with their customers about regulatory requirements.
This could increase awareness of and compliance with the requirements.
Another alternative is a computerized, nationwide registry which would track all devices and users of the devices.
The registry would j
enable the NRC to periodically check the status of the devices.
This should help alleviate the accountability problems and would also serve to remind users j
of their regulatory responsibilities.
Additional possible improvements include standardizing reports of transfers from the vendors to facilitate complete and accurate, periodic reporting, and assuring that manufacturers distribute devices in accordance with the regulations.
Substantial resources have been expended on the general license study.
Rulemaking was initiated in 1986",'but temporarily held in abeyance while additional supporting technical work was performed.
The supporting technical work covered additional types of generally licensed devices.
The staff is now completing tha technical work and will initiate rulemaking in the near future (SECY-87-167).
However, because of the technical complexity of the work, the major policy issues, and the large number of general licensees affected, the staff anticipates that it will take two years to complete the rulemaking.
17
The proposed rulemaking would clarify some confusing sections of the present regulation to improve compliance.
The apprnach being considered by the staff may involve a user and device registration provision.
In addition, the l
proposed rule may require periodic reporting by general licensees that possess the more potentially hazardous sources to confirm that they have the devices, and that the devices are being used and maintained according to the requirements set out in the regult.tions.
The staff's position is that implementation of this plan will respond to the MSRRSG's Rece:nmendation No. 3.
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_ - _ _ _ - ~
- 4. 0 RECO'MENDATION:
M 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 NRC or an Agreement State.
The regulation should further provide that failure to follow established procedures by an individual radiographer would constitute a basis for suspension or revocation of the certification.
Periodic decertification should also be required.
4.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The Study Group believed that there are two reasons for reconsidering a requirement for > ' ratification of industrial radiographer?.; first, deficient training of radiographer may be a contributing cause in overexposure inci-dents 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 i
l safety procedures are willfully disregarded.
Little doubt was expressed by those inside and outside the NRC with whom the group discussed this issue that radiographer training would be improved if third party certifications were required by NRC.
The Study Group believed that, in previous considerations of this matter, proper weight may not have been given to the capability of a certification program to l
improve safety by improving adherence to safety procecures.
Under the present 1
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.
- 4. 2
SUMMARY
OF PUBLIC COMMENTS This recommendation drew the most public comment; six in support of the recommendation plus three more generally favorable but with some reservations, and 18 opposed.
It was noted that the Agreement State of Texac has already implemented a testing program for industrial radiographer.
Most organizations 19
which employ radiographer were concerned about the cost and time that would be required if they had to obtain NRC certification, and they generally preferred to handle radiographer training and appraisal of competence themselves.
One commenter pointed out that if an Agreement State provided the certification of a radiographer, arrangements would have to be made for other states to accept the certification and that some clearinghouse for information on current certi-fications, and especially on revoked certifications, would have to be maintained up to date at all times.
Many expressed apprehensions about the administration and cost of such a program.
- 4. 3 STAFF ANALYSIS AND POSITION There were serious personnel overexposure in the radiography industry in the 1970's; and the staff informed the Commission in SECY-80-324, dated July 9, 1980, of several proposals to improve radiography safety.
The proposals included certification of radiographer.
An Advance Notice of Proposed Rulemaking (ANPR) indicating that NRC was considering radiographer certification was published in the Federal Register on May 10, 1982.
Because of interest in the rulemaking, several public hearings were held.
Based upon uncertainty in the amount of safety improvement which could be achieved, the number of negative public com-ments received, and anticipated problems witn administering the program, the staff recommended and received Commission approval of withdrawal of the ANPR (see SECY-85-221, dated July 17, 1985).
The staff still maintains an active program to increase radiation safety in industrial radiography.
One of the most important aspects' of the current pro' gram is the proposed rulemaking to improve radiography equipment.The rulemaking is intended to imprvi the reliability and safety of radiographic o
equipment, and may propose the use of audible alarming dosimeters by radiographic personnel.
Until recently, many radiography inspections concentrated on the radiographer's base location and records.
Inspection and Enforcement Manual Chapter 2800 was 20
I I
recently revised to spe~cify that the Regions should conduct 25 percent of their radiography inspections at temporary job sites.
This increase in " hands-on
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inspection" will allow the staff to ccserve radiographic operations conducted in the field on a frequent basis, more completely evaluate a licensee's in-house l
audit program, and allow us to examine more closely radiographer' safety practices.
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Also, the staff has recently agreed to provide funding to the State of Texas for preparation of questions and answers on radiation safety in radiography.
Texas is preparing the " question bank" because it is currently proceeding with rulemaking to require individuals performing radiography in the State to pass a State-administered examination on radiation safety (i.e., certification).
The validated test questions are anticipated to be available from Texas in early 1988.
NRC intends to use this " question bank" to prepare a NUREG or similar document for use by its licensees when preparing examinations for radiograpners.
The standardization of examinations may improve the quality and consistency of the written examinations currently presented; however, this is not viewed as a formal program of certification of radiograprers.
The issue of providing formal certification for radiographer is being reconsidered in connection with the work of a special Task Group of the American Society for Nondestructive Testing, Inc. (ASNT).
The Task Group was established to identify specific actions ASNT should take to provide enhanced or new training and certification as industrial radiation safety services to the Society's members and the industry served.
The NRC staff has been invited to send a representative to serve on the Task Group.
This third party certifi-cation is an idea which the staff has considered to be potentially advantageous, if an effective program can be developed.
The staff will also monitor the Texas certification program cs're' fully to determine its applicability to NRC licensing.
Although the Commission decided not to pursue radiography certification as a regulatory requirement, the staff believes that the actians by the ASNT Task Group will address the MSRRSG's Recommendation No. 4.
The staff believes that the possible adoption of a plan for radiographer certification by ASNT shows 1
promise of improving performance.
The NRC staff will work closely with ASNT on this effort.
l 21
- 5. 0 RECOMMENDATI0ti:
That NRC expand its licensing and inspection procedures to ensure a comprehensive review of all facets of fuel cycle and materials licensees possessing or using large quantities cf hazardous or radioactive materials.
The review should cover all aspects important to nuclear safety, rediation safety, process safety, and confinement of hazardous materials.
Increased emphasis should be given to conducting comprehensive assessments of such licensees' capability and performance.
5.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The MSRRSG was told that until the Sequoyah incident, NRC had confined its review primarily to nuclear safety, radiation safety, and confinement of radio-active materials.
Their recommendation was that in addition to there reviews, NRC should conduct comprehensive reviews of the design, construction, quality control, calibration, maintenance and performance of all systems employed for achieving nuclear safety, radiation safety, process safety and confinement of hazardous materials.
5.2
SUMMARY
OF PUBLIC COMMENTS Public comments on Recommendation No. 5 were four in favor and four opposed.
Those in favor of the recommendation generally saw it as a means of improving the protection of the public from the hazards which they feared might arise from a licensee's facilities and operations.
Those against were concerned about cost of more comprehensive licensing and inspection procedures and the additional training and technicaT competence required for NRC to bc able to provide them.
I 22
5.3 STAFF ANALYSIS AND POSITION The staff believes that the response to this recommendation should be coordinated with the activities to implement Recommendations No. I and No. 6.
The team inspections covered by TI 2600/1 provide a more comprehensive assess-ment of all types of radiological and non-radiological hazards.
The staff's
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position is that license renewal reviews can be made more comprehensive,
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especially in areas identified by the team assessments as requiring additional review.
The staff's position also covers revising the priorities of inspection scheduling as indicated by experience with team operational safety assessments to be necessary so that attention and timely inspection will be provided in areas where hazards are being found.
Further actions may be shown to be I
desirable when staff has the benefit of the analyses of licensee performance indicators.
l 4
.s I
c' 23
6.0 _ RECOMMENDATION:
That NRC vigorously implement the planned program to cenduct comprehensive on site systematic safety assessments of all fuel cycle and materials licensees possessing or using large quantities of hazardous or radioactive materials.
6.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The Study Group applauded the effort unuerway in NRC to conduct on-site j
systematic safety assessments, e.g., review of fire safety, radiological contingency planning, radiation safety, process controls and process safety, maintenance and other quality controls, and licensee training programs.
Region I has taken a lead in this program review.
- 6. 2
SUMMARY
OF PUBLIC COMMENTS One public comment on this recommendation was favorable, just on general principles, and three warc opposad.
Two opposed the recommendation because their experiences with " comprehensive on-site systematic safety assessments" of their facilities were not good.
One pointed out that the team was poorly organized and inadequately prepared for the task, that the process was hastily performed, and that the reports were poor.
The other complained that the results of.the assessments had not been reported to them six months later.
6.3 STAFF ANALYSIS AND POSITION Experience is being gained in ttle performance of multidisciplinary team assessments of licensees' facilities.
The results of the trial team assess-ments indicate that they can be applied more broadly in other site inspections.
The staff now beiieves that te'am inspections are profitable for improved regulation and that they should be continued and strengthened to provide an additional stimulus for more comprehensive licensing reviews.
The present inspection Temporary Instruction 2600/1 calls for the Regional office to set up teams of four to six inspectors with the proper expertise to cover broad-scope inspections.
Team assessments should include Headquarters 24
. specialists, OSHA and EPA participants, and representatives from other Regional l
offices, as appropriate.
The TI was made applicable only to 12 fuel cycle facilities, with the findings to be reported promptly to Headquarters as well as to the Regional office.
The multidisciplinary team assessment concept will be expanded to other types of large, complex facilities, such as radiopharma-ceutical manufacturers, in addition to the 12 fuel cycle facilities.
The
. development and use of performance indicators will be correlated with infor-mation from team assessments to reinforce the information base applicable to a broader scope of potential hazards.
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- 7. 0 _ RECOMMENDATION:
That the NRC give additional emphasis to actively encouraging states which are not now in the Agreement States Program to join.
We further recommend that the NRC seek legislative authority to require the transfer of responsibility for materials regulation to the states should the additional emphasis prove incap-able of accomplishing this transfer to all states within a reasonable period of time.
7.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
From discussions with NRC staff and representatives of Agreement and non-Agreement States, the Study Group concluded that (1) there would oe sub-stantial benefits to the NRC if these remaining states were to join the Program, and (2) all states appear to have the capability or potential capability to effectively handle the regulatory r, responsibilities of the Program.
The principal benefit accruing to the NRC in attracting more states to the Program is to reduce the number of employees necessary to continue the regu-latory responsibilities that would be transferred to the states.
This,.in turn, would e'ther reduce the total resources needed by NRC to conduct its i
programmatic activities or make available additional staff and funds to con-centrate in those regulatory areas which are considered by the NRC to be of greater importance to the Agency's primary mission of protecting the public health and safety.
Shouldthiseffortfailtopro%ucepositiveresultswithinareas'onableperiod of time, the Study Group believes that the NRC should seek legislative authority to require the remaining states to join the Agreement States Program and to relieve the NRC of responsibility for the continued regulation of the types of materials normally transferred to the states under this Program.
- 7. 2
SUMMARY
OF PUBLIC COMMENTS This recommendation drew four favorable comments plus seven more that were generally favorable, but with some recarvations, and nine comments expressing 26
opposition.
The favorable comments came from licensees who had good experiences in dealing with their states on other regulatory matters and were confidont of the state's ability to take on nuclear regulation successfully Those who expressed reservations about endorsing the recommendation were generally con-cerned about forcing all states tc become Agreement States, whether they wante~d to or not.
Those against the recommendation expressed concerns about compati-bility and consistency of Agreement State regulatory programs, about the size of Agreement State fees, and about the possibility that Agreement State programs will be more subject to local political pressures.
- 7. 3 STAFF ANALYSIS AND POSITION For many years the Commission's posture with respect to new Agreement States has been to be responsive to State inquiries ar.d to work actively with those l
States who have indicated a desire to seek Agreements.
The recent Low-Level Radioactive Waste Policy Amendments Act of 1985 has stimulated new interest in the program.
(The recent Agreement with Illinois is an excellent example.)
The staff's proposed Strategic Plan includes a goal to bring more States into the program.
If it is approved by the Commission, GPA will be responsible for developing an operating plan to satisfy this goal.
The staff, however, does not support the recommendation to force States to assume regulatory authority for licensees covered under such Agreements.
This is contrary to the intent and purpose of Section 274 " Cooperation with States" (emphasis added) and would fundamentally alter the present cooperative relationship of NRC with the States.
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8.0 RECOMMENDATION
That increased attention be given to the quality of NRC licensing reviews and inspections and the adequacy of staffing for these activities.
In this connec-tion, the MSRRSG recommended that NRC conduct a comprehensive study of this matter to determine whether present procedures should be strengthened and whether ac11tional staffing may be required.
8.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
Several NRC staff members expressed the belief that NRC has not allocated sufficient 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 numbers of licensing actions taken and' numbers of inspections completed; and, also, some believe that the materials program has not received the staff resources that it needs, because NRC focuses most of its attention and allocates most of its available resources to the prevention of low probability /high consequence reactor accidents, applyir.g relatively few resources to the prevention of high probability / low consequence material accidents.
The Study Group noted that NRC has allocated major effort to the materials regulatory program and that these resources are about equally divided for licensing and inspection activities.
In their visit to an Agreement State auth Carolina), the Study Group found that the State has allocated more than twice as much effort per,1,icense as NRC.
The MSRRSG Was informed that the frequency of conducting inspections of materials licensees has not been determined from a studied assessment of the needed frequency and effort required for effective inspection of the various categories of materials licensees, but, rather, by applying the allocated inspection resources in the best available manner.
Some specific licensees are never inspected and probably cannot be effectively inspected unless additional inspection resources for the materials program are allocated.
28
l The Study Group believed that NRC should conduct a comprehensive study of the quality of materials and fuel cycle licensing reviews and inspections, whether current procedures should be changed, and determine whether additional l
resources are needed.
Additional FTE's, in particular, may be needed to permit more inspection of fuel cycle activities.
8.2
SUMMARY
OF PUBLIC COMMENTS Recommendation No. 8 drev eight supporting comments and one which expressed the view that the present program is excellent, implying that no improvement is required.
Another said that they considered improvement in timeliness of reviews to be needed more than improvement in quality; and they suggested the adoption of time limits for staff actions on reviews.
8.3 STAFF ANALYSIS AND POSITION This recommendation is related to several other programmatic activities under which the staff is reexamining its licensing and inspection programs and priorities.
Operations Branches have been established in all of the Divisions of NMSS.
In the Division of. Fuel Cycle, Medical, Academic, and Commercial Use Safety, the Operations Branch plans to collaborate with the Regional staff in developing improved methods of quality assurance in licensing and inspection activities.
Other objectives under. development include the following:
Expanding the scope of reviews and inspections into new technical areas, such as quality assurance in the activities of medical licensees.
Increasing the detail of licensing reviews and inspections such as those in the field of radiography, and applying internal quality assurance in the performance of these regulatory functions.
Emphasizing operational safety team assessments in other materials license categories, similar to what is being done in the team operational safety assessments of major fuel cycle facilities.
29
4 Updating and improving review plans and inspection procedures as is being done in connection with scheduling team operational safety assessments prior to license renewals for major fuel cycle facilities.
Improving the training for. reviewers and inspectors.
+
The staff's position is that the implementation of these plans will achieve the objective of.the MSRRSG's Recommendation No. 8.
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9.0 RECOMMENDATION
That the.NRC use a suitable mix of performance-based regulations and appropriate prescriptive requirements.
9.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
Performance regulations specify "what" must be achieved and prescriptive requirements specify "how" compliance must be achieved.
Present NRC regu-lations contain a mix of-performance and prescriptive requirements.
As a general observation, the Study Group believed performance-type requirements are more suitable for a licensee which is highly qualified to operate a large nuclear program and prescriptive-type requirements are more suitable for a licenset which is minimally qualifia.d or who operates a small nuclear program.
A suitable mix of requirements is best, they stated, for all programs.
From an
. inspection stardpoint, it is much easier for inspectors to determine compliance with prescriptive-type requirements as compared with perforamnce-type require-Much more training and higher qualifications are needed by inspectors ments.
to determine compliance with performance-type requirements.
- 9. 2
SUMMARY
OF PUBLIC COMMENTS Pubic comments were evenly divided, three in support of the recommendation and three opposed.
Those opposed were urging the use of performance-based regula-tions.
One suggested that the prescriptive regulations be reserved far rmaller licensees with less sophisticated. programs.
However, the possibility of increased use of performance-type requirements gave rise to some concerns, suon as the possibility of inconsistent interpretations from different Regional 4
offices.
Also, the increased importance of the inspector's " professional judg-ment" would require an increase in inspector training for which the NRC may not be able or willing to provide.
One commenter,'however, stated that the possible
{
problems of interpretation of performance-type requirements would be offset by the appeal routes available to the licensee.
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- 9. 3 STAFF ANAlfSIS AND POSITION As discussed by the MSRRSG, the NRC regulatory approacn already includes a mix of prescriptive and performance requirements.
Maintaining the appropriate mix is e continuing effort based on feedback from AE00 analyses of events, inspec-tion findings and other reports of operational data.
The regulations that apply to certain licensees, such as radiographer and medical licensees, con-tain more prescriptive requirements.
Others, such as the broad licenses and the fuel cycle facilities licenses, contain more performance requirements.
The staff anticipates that the results of the team inspections of licensees' sites and the AE00 evaluation of new performance indicators may show the need for additional requirements which could affect the present mix of prescriptive-and performance-based regulations.
The staff believes we should have performance requirements to the extent practicable and use prescriptive requirements where necessary.
The proposed medical rule on QA and the new rule being developed for general licenses are examples of the application of more prescriptive requirements where a need has been recognized.
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l 10.0 RECOMMENDATION:
l That the NRC consider the feasibility of utilizing a broad license, similar to that developed with the Air Force, for companies that have extensive and multi-location licensing programs.
The successful use of such a license could reduce resource demands on NRC and place more direct responsibility on the broad licensee to achieve and maintain safe operations.
10.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
Under a new licensing program recently undertaken with the U.S. Air Force, 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 the license made the Air Force responsible for monitoring and inspecting the possession and use of radioactive materials at the various installations.
The NRC maintains regulatory responsibility and control through the exercise of performance overview of the Air Force.
The Study Group was informed that the program to date has worked well.
The Study Group was impressed by the potential for application of this type of licensing to other NRC licensees that possess and use licensed materials exten-sively and at multi-locations.
It has application to other Federal entities that operate in the same fashion as.the Air Force.
It also has the potential for being a useful method of licensing large commercial firms that utilize licensed materials at many locations.
10.2
SUMMARY
OF PUBLIC COMMENTS..
Recommendation No. 10 drew two comments supporting the recommendation, plus three more that were favorable but with some reservations, and four that were opposed.
Those supporting the recommendation pointed out that a broad license covering operations at many locations would reduce the number of individual amendments, renewals and other actions needed to make changes that affect many locations and ~ hat it would permit a multi-location corporation to have one c
uniform comprehensive corporate program for all facilities.
The need for a reciprocity program with Agreement States was pointed out as an important 33
l factor in making the implementation of the recommendation work.
An intervenor group pointed out that handling multi-location operations under a broad national license would make it extremely difficult, if not impossible, for local neighborhood intervenor groups concerned with a single location to participate in the licensing proceedings.
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10.3 STAFF ANALYSIS AND POSITION 1
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i NMSS has a long-standing policy to encourage the issuanca of broad licenses where appropriate.
Title 10 CFR Part 33, published in 1968, specifically addresses the requirements for the issuance of broad licenses to applicants with the organizational capability to safely manage a broad spectrum of uses of byproduct material.
It was published with the specific objective of obtaining broad licenses where feasible.
Over 200 broad licenses have been issued to most major universities, medical institutions, and large private companies.
Two military broad licenses have recently been pursued.
In 1985, the U.S. Air Force was issued a broad license, allowing the consolidation of almost 100 individual licenses.
A broad license was issued to the U.S. Navy in 1987, consolidating almost 200 licenses.
(The U.S. Army has not pursued the option of obtaining a broad license, despite urging from the NRC staff.)
The staff believes that the opportur.ities for additional broad licenses have been, for the most part, fully pursued, and that the potential for additional resource savings would be mihimal.
However, the staff will continue to pursue opportunities as they are identified.
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11.0 RECOMMENDATION:
That the NRC increase significantly the amount of training provided to its fuel cycle and material 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.
11.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The NRC personnel in the Regional offices visited by the MSRRSG expressed concern about what they considered to be inadequate opportunities for employee training.
Both the branch chiefs as well as employees within the branch felt that training was extremely important for them so that they could become more technically competent and thus could do a better job in the licensing and inspection process.
They also believed that the whole area of professional training and development needed to be revamped within NRC.
It was pointed out to the Study Group that there is no formal technical l
training program for new employees coming into the Agency.
In many instances, new Agency employees are dealing with counterparts on the industry side who are much more knowledgeable than they, even about NRC requirements.
A formal technical training 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.
The Study Group believes that a technical training program should be laid out for each employee, funds should be provided for these empl.oyees to travel to attend these training programs, as well as professional meetings in which the subject matter is in l
the area 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 they are developing professionally, the NRC will be able to do a better job.
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11.2
SUMMARY
OF PUBLIC COMMENTS
'All 10 public comments supported the recommendation.
Some urged the broadening of the program to include Agreement States staff members.
11.3 STAFF ANALYSIS AND POSITION In the past' year, NRC has focused attention on changes that may be implemented to upgrade the fuel cycle and materials safety licensing programs.
Based on various recommendations already under consideration by the NMSS staff, plans were being developed for increasing the training for NMSS technical staff members.
The recommendation of the MSRRSG suggests that this be broadened to include inspection training.
The staff established a working group to review our technical training programs, and the group agreed that improvements are needed.
The staff is pursuing training improvements within budget constraints.
The staff will focus its efforts on:
(1) identifying a core group of training courses which should be completed by all licensing personnel or inspectors in a given program area, (2) developing needed courses where none are currently
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available, (3) upgrading the resources of the NRC Technical Training Center to support the fuel cycle and materials programs, (4) encouraging on-the-job j
training opportunities such as in-ho.use seminars, site visits, or rotational assignments, and (5) developing training manuals.
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~12.0 RECOMMENDATION:
That_ NRC-give serious. study and thought to the implementation of the proposed comprehensive _ revision of 10 CFR 20, " Standards of Protection Against Radiation,"
because of its perceived complexity by the states, the industry and some of the NRC Regional staff.
12.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
A great deal of concern was expressed to the Study Group concerning the i
perceived complexity of the proposed rule changes and the increased qualifi-cations needed by licensees to understand and achieve compliance with the new requirements.
Accordingly, they recommended that the NRC provide phased j
implementation over the period of several years before the new requirements l
come fully into. force.
The'NRC staff informed the Study Group that.they plan to prepare Regulatory Guides which will discuss and explain the new requirements for several differ-ent categories of licensees.
The Study Group strongly supports the preparation of these guides and recommends that these be issued and discussed with l'icensees
-before the new requirements come into force.
In this connection, they recom-mended that Regional' training seminars be held to discuss the guides and answer I
1 licensee questions on implementation. details, 1
t 12.2 '
SUMMARY
OF PUBLIC COMMENTS Public comments on Recommendation..No.12 included one that was in favor of the recommendation, two that were favorable with some reservations, and four that were opposed.
Those in favor generally supported upgrading the standards but.
had some concern about the difficulty of providing information and training, and of achieving a better understanding of the new regulations.
Those opposed feared the increase in complexity if the regulations.
One suggested that the revised 10 CFR Part 20 be completely rewritten and clarified so that it can be understood without the need for supplemental material.
12.3 STAFF ANALYSIS AND POSITION The revision of 10 CFR Part 20 was undertaken by the NRC staff to bring the basic regulations of the NRC into line with the current philosophy and tech-nology of the radiation protection community.
Implementation of the revision of 10 CFR Part 20 will enable the NRC to comply with the recently issued Radiation Protection Guidance to Federal Agencies for Occupational Exposure-approved by President Ruagan.
The revision is based upon the recommendations of the InternatO;nal Commission on Radiological Protection, and incorporates up-to-date scientific information on radiation, radionuclides, and radiation ri s k.
10 CFR Part 20 must be a soundly-based technical document since it provides the foundation on which other regulations are built.
In order for the NRC to properly exercise its regulatory responsibility and assure the safe use of radiation and radioactive materials, the basic regulations must be maintained current.
The NRC staff therefcre recommends that the current rulemaking be continued and completed.
The staff recognizes-that portions of the proposed rule are complex and difficult to understand for those who do not have a strong background in radiation protection and have not kept up to date with current developments in radiation protection theory.
The staff considers it esscatial to bridge I
the gap in information and understanding with a series of guides.
These guides would explain to categories of licensees, such as radiography and nuclear medicine, how 10 CFR Part 20 applies to their operations and what must be done to comply with the revised rule.
The staff's position is that the planned development of these guides should be continuN.
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j 13.0 RECOMMENDATION:
i That all NRC fuel cycle licensing and inspection functions, including the Office of Inspection and Enforcement Headquarters functions, be performed by a single group under one supervisor at the branch chief level at one location.
The MSRRSG recommended that the one location be NRC Headquarters.
This NRC fuel cycle licensing and inspection group should be provided technical assist-ance from other NRC technical groups as needed; however, the licensing and inspection group should have overall safety responsibility.
13.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
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 six plants, Region III has two plants.
Region-IV has one plant and Region V has three plants.
During the visits of the Study Group to four Regional offices, it became clear that the personnel involved in these activi-ties varied significantly in experience and background.
Since there are so few fuel cycle plants, it was the opinion of the Study Group that the Regional office inspection activities should be consolidated with the licensing activi-ties at Headquarters.
The availabil.ity of NRC personnel with broad chemical engineering backgrounds who fully understand the complexities of fuel cycle plants is very limited.
Accordingly, these resources should be consolidated within one organization which is given the undivided responsibility for the health and safety activities ofss.uch facilities.
13.2
SUMMARY
OF PUBLIC COMMENTS All six public comments were favorable, noting the opportunity to improve regulatory consistency and to make the specific expertise of certain individuals available as resources to others.
39
13.3 STAFF ANALYSIS AND POSITION The April 1987 reorganization of the NRC Headquarters staff combined the fuel cycle and materials licensing and inspection policy functions within NMSS.
The Regional office fuel cycle inspection functions were not combined with the Headquarters staff, as recommended by the MSRRSG, because this would reduce the valuable interactions between Regional fuel cycle inspectors with licensees and NRC inspectors in the materials and reactor programs.
The staff's position is that, at this time, centralization of regional inspection functions is not needed.
The recent Headquarters reorganization is expected to yield benefits in making more broadly available any needed expertise.
The staff believes these that the recent reorganization will be adequate to address MSRRSG Recommendation No. 13.
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10 0 RECOMMENDATION:
That the development of materials regulations, guides and standards be consolidated in NMSS where the majority of the expertise and management 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 j
Nuclear Material Safety and Safeguards.
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14.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The Office of Nuclear Regulatory Research (RES) is assigned responsibility for developing regulations, guides, and standards (regulatory documents) for the possession and use of nuclear materials.
From 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 time and effort is devoted to fuel cycle and materials regulation.
Moreover, RES had only a limited number of staff with the requisite expertise to develop regulatory documents for materials licensing.
The Study Group believed that the fuel cycle and materials regulatory program warrants more attention than is presently devoted by RES.
Thus, they recom-mended that the responsibility for developing regulatory documents for fuel cycle and materials be transferred f. rom RES to NMSS.
In this way the perfor-mance of the task rests with the office having the most interest, expertise, and most importantly, the willingness to assume this additional responsibility.
14.2
SUMMARY
OF PUBLIC COMMENTS..
Two public comments supported this recommendation and one opposed it.
One stated that consolidation would result in a more cohesive regulatory struc-ture, but another perceived advantages in keeping a separation between the j
l development of standards and the enforcement of standards.
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1 14.3 STAFF ANALYSIS AND POSITION In the April 1987 reorganization of NRC Headquarters functions, emphasis was I
placed on consolidating closely related activities.
The Commission decided that the preparation of regulations, guides and standards is a function of the Office of Nuclear Regulatory Research, with provisions for technical assistance and collaboration from the offices responsible for the functions of licensing and inspection.
Whether or not the Commission wants to consider further the MSRRSG recommendation will depend on the success of this assignment of responsibilities under the 1987 reorganization.
The staff agrees that more effort is needed on development of materials regulation, guides, and standards, as part of the overall effort to improve materials licensing and regulation.
The Office of Nuclear Material Safety and Safeguards is committed to provide technical assistance and cooperation to the Office of Nuclear Regulatory Research in developing regulations, guides, and standards.
The staff's position is that this commitment should
)
I continue to be emphasized.
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15.0 RECOMMENDATION:
That after successful implementation of Recommendation No. 13, NRC transfer the balance of the Office of Inspection and Enforcement materials inspection func-tions to the Office of Nuclear Material Safety and Safeguards.
Personnel in the Office of Inspection and Enforcement now involved with this effort should be transferred to the Office of Nuclear Material Safety and Safeguards.
15.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
It was noted during Study Group visits to the Regional offices, that there was a general widespread complaint about the lack of adequate and timely support and information from Headquarters concerning inspection matters related to materials and fuel cycle facilities.
The most likely reason appears to be the small amount of Headquarters resources devoted to these activities.
By transferring those few personnel in the Headquarters Office of Inspection and Enforcement dealing with materials and fuel cycle inspection functions to the Office of Nuclear Material Safety and Safeguards, NRC would consolidate into one entity the responsibility for and experts concerned with the inspec-tion and licensing activities of materials and fuel cycle activities.
The Study Group believes that the same considerations also appear to apply to the organization of the reactor licensing and inspection program.
l 15.2
SUMMARY
OF PUBLIC COMMENTS There were two public comments. sin favor of this recommendation and-one opposed.
The opposition reflected the view that lack of adequate and timely support for fuel cycle and materials regulation is a management problem which may not necessarily be corrected by reassignment of activities.
15.3 STAFF ANALYSIS AND POSITION 1
The recent NRC reorganization provided for consolidation of Headquarters i
inspection functions relating to fuel cycle and material safety within NMSS.
43
'It did t include consolidat#on of the functions performed by inspectors in the Regional offices.
The staff believes that this did, in fact, implement MSRRSG Recommendation No. 15;~no further: changes are recommended.
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16.0 RECOMMENDATION:
That the NRC Regional licensing and inspection staff responsible for materials regulation be combined in one group such that the individual NRC staff members within the group would be trained in and perform both licensing and inspection functions.
16.1 - CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
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 respon-sible for materials regulation combined in one group such that individual staff members within the group can and do perform both licensing and inspection functions interchangeably.
They believed 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-offs between licensing efforts and inspection efforts on individual cases, and
-improves morale by permitting a wider and more equitable sharing of the out-of-the-office burdens of inspecting licensees.
The Study Group recommended that all Regions adopt the Region I type of organization for carrying out their materials licensing and inspection responsibilities.
16.2
SUMMARY
OF PUBLIC COMMENTS All four public comments supported this recommendation, with two expressing the hope for improved communication not only between licensing and inspection staffs, but also between regulatory and licensee staffs.
16.3 STAFF ANALYSIS AND POSITION t
,t While the staff recognizes that there are potential benefits from having one group perform the functions of materials licensing and inspection, the staff is also aware of differences in licensing and inspection workloads and respon-sibilities in the regional offices.
The potential benefits of combining licensing.and inspection functions will vary from Region to Region.
Therefore, the staff does not recommend a move toward standardization of Regional office 45
l organizations and training activities.
However, the staff notes that Region 1
II has now consolidated these functions in one group and it believes that the Regions should evaluate this recommendation in light of their resources, case j
workloads-and efficiency in operations.
The staff supports the goal of improved
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comr.1unications between Re'gions and between the Regions and Headquarters.
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17.0 RECOMMENDATION:
That NRC revise its regulatory ~ guides for the format and content of license applications for fuel cycle plants to ensure an item-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
~hould be developed to cover each item discussed in the demonstration part of s
the application.
17.1. CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The NRC staff has prepared and is using regulatory guides to describe a ctandard format and content for health and safety sections of license renewal applica-tions.
The guides consist of two major parts.
Part I discusses the commitments that license applicants should make which become binding license conditions and Part II discusses supporting information which demonstrates the applicants' capability to meet the proposed license conditions.
In discussion of these guides with NRC Regional office staff and in their independent review, the MSRRSG noted that there is no item-by-item correlation (and such correlation is needed) between Part I (License Conditions) and Part II (Safety Demonstration), making it. difficult to track license commitments and backup supporting information.
Licensees and NRC inspectors would be bene-fitted 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.
A similar guide should be prepared for applications to possess and use large I
amounts of hazardous radioactive materials, such as those used in manufacturing radiopharmaceuticals.
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l 17.2
SUMMARY
OF PUBLIC COMMENTS Public comments were two for and two against this recommendation.
Those opposed expressed the fear that this approach would lead to additional prescriptive-type requirements on licensees and to a proliferation of license conditions.
17.3 STAFF ANALYSIS AND POSITION This recommendation pertains to fuel cycle facilities; and the staff agrees that for fuel cycle facility licenses there would be some benefit to having an item-by-item correlation between Part I and Part II of the Standard Format and Content guides.
As revisions are made to Standard Format and Content guides, consideration will be given to increasing the correlation between Part I and Part II, where such correlation is clearly beneficial.
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18.0 RECOMMENDATION:
That NRC prepare Standard Review Plans for fuel cycle and materials licensees possessing or using large quantities of hazardous radioactive materials con-forming to the format and content guides discussed in Recommendation No.17 above.
18.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
Standard Review Plans are needed to provide appropriate guidance to NRC staff and license applicants.
The Standard Review Plans should be prepared after the Standard Format and Content guides have been revised as recommended in No. 17 above and should be organized to permit an item-by-item correlation with those guides.
Copies of the Standard Review Plans should be made available also to license applicants and other interested persons.
18.2
SUMMARY
OF PUBLIC COMMENTS This recommendation drew two comments that were mildly supportive, although one expressed some reservations about the vagueness of the term "large quantities of radioactive materials."
18.3 STAFF ANALYSIS AND POSITION The material licensing group now has a nearly comple;e set of 15 Standard Review Plans (SRP's) for their licenses and plans to continue expeditiously to develop the remaining two plans to complete the set.
In fuel cycle licensing, the staff agrees that more Standard Review Plans are needed and that they should be correlated with the Standard Fnemat and Content (SFC) guides.
Some SRP's have been in use for a long time ar,J are updated and improved from time to time.
Others are being developed.
The staff agrees that this effort should continue and that the SRP's should be correlated with the SFC guides to the extent that is helpful and that both should be made available to license applicants and interested persons as suggested.
O
i 19.0 RECOMMENDATION:
That NRC issue major amendments to fuel cycle and materials 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.
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19.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
Applications for new or major amendments to fuel cycle and materials licenses for possession or use of large quantities of hazardous radioactive materials may be quite lengthy and complex in content.
Accordingly, the MSRRSG believed it important for the NRC licensing staff, NRC inspectors, and license appli-cants to meet and discuss applicable requirements before these licenses or major amendments thereto are issued.
Unless this is done, a licensee may unwittingly fail to comply with a requirement because the licensee did not interpret it the same way NRC did.
These meetings should,also assure that NRC licensing staff and NRC inspectors interpret license requirements alike or identify where applicable where requirements should be changed to reflect the proper intent.
For this process to be successful, licensee!. should participate fully in these meetings describing their understanding of what is required, asking questions to clarify NRC intentions, and requesting changes of wording to reflect prcper understandings.
19.2
SUMMARY
OF PUBLIC COMMENT 5..
All six public comments were in favor of this recommendation, one noting that "it is not unusual to find confusion among the NRC licensing staff, the NRC inspection staff, and our staff regarding the interpretation of licensing requirements." Another suggested that NRC " hire a couple of writers (preferably ex-newsmen) to draft your stuff."
50
19.3 STAFF ANALYSIS AND POSITION The general practice of the ' licensing staff has been to meet with licensees concerning major amendment applications.
Inspectors will be included in these meetings if they are able to attend.
Practical problems of case work load and travel times, however, will limit the degree which this recommendation regarding meeting can be implemented.
However, the standard practice, which will be continued, is to consult with the Regions on major amendments tc fuel cycle licensees.
Noting the public comments aboet the need for closer coordination between license reviewers, inspectors, and licensee staffs, the staff's position favors increased emphasis on improving communications and continuing to encourage inspectors to attend meetings that are scheduled with licensees.
)
51
i 20.0 RECOMMENDATION:
.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.
20.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The MSRRSG was 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 whether or not the licensee complied with the 1
intent and spirit of the requirements.
In some instances, they were told, the inspectors cite licensees for noncompliance, but inform the'm that their depart-ure from the requirement was in fact a safety improvement.
The Study Group believes that citations of this type are not useful and should in most situa-tions be avoided.
Such citations are likely to discourage licensees from making appropriate improvements and unduly alarm the public about matters unimportant to safety.
20.2
SUMMARY
OF PUBLIC COMMENTS Six public comments favored the recommendation; three were opposed.
Those in favor were from licensees, those in opposition were from interveners who feared the loss of information on ilcensees' performance if minor items are not cited for non-compliance.
They tended toward the view that "there ate no minor items when dealing with a nuclear facility."
.s 20.3 STAFF ANALYSIS AND POSITION
, The staff agrees that a well-trained inspector should use good judgement in
' identifying violations which are truly insignificant.
However, the staff believes it is exceedingly rare that " inspectors cite licensees for non-compliance, but inform them that their departure from the requirement was in fact a safety improvement."
It would be poor regulatory policy to instruct inspectors that violations of license requirements should be ignored if they 52
seem minor.
Rather, all items of noncompliance should be noted 'and resolved in some manner, although the staff agrees.that emphasis should be placed on matters important to safety.
Where an inspector finds that a regulatory requirement' compromises safety, or conflicts with good practice, the specific issue should be brour,nt to the attention of appropriate staff so that cor-rections can be madra in the regulatory process.
The staff believes that MSRRSG Recommer.dation No. 20 will be best addressed by improved training of inspectors.
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21.0 RECOMMENDATION:
.That NRC maintain a readily available file of interpretations of the regulations which should be maintained for use by the NRC staff.
21.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATIONS:
The Study Group was 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.
As interpretations are given, they should be exchanged between NRC Headquarters and the Regional offices, and a complete file'of all interpretations maintained available for use by the HRC staff.
21.2
SUMMARY
OF pUBLIC COMMENT _S All eight public comments were in favor of the recommendation, and all urged that the file be made available to licensees as well.
21.3 STAFF ANALYSIS AND POSITION Official interpretations of NRC regu,lations are published in 10 CFR Part 8.
In addition,-there are various sources of information within NRC related to interpretation of regulations, staff technical positions, and interpretations of regulatory requirements.
These have not been centralized in a single file due to both practical and prog ymmatic considerations.
The staff recognizes the potential usefulness of a readily accessible, authoritative source of information and guidance to augment the official regulations and regulatory documents.
A7though many additional documents are available to provide guidance, interpretation of regulations, and statements of policies and positions, resource have not been available to develop and organize a system for providing access to a centralized file of this information, j
54
The staff believes that the current system provides adequate and reasonable information for use on a day-to-day basis, but also acknowledges that a more comprehensive, organized, and centralized system, along the lines recommended by the MSRRSG, would be beneficial.
Accordingly, the staff will explore the development of s_ h a system.
l l
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22.0 RECOMMENDATION:
That communications between NRC Headquarters and Regional offices and between NRC and licensees be improved.
22.1 CONDENSED MSRRSG DISCUSSION OF RECOMMENDATION:
The Study Group was 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 Leaders, the staff which performs inspections has little opportunity to discuss common prob-lems with their counterparts in other NRC offices.
The Study Group believed that periodic meetings between the staff who perform similar types of licensing and inspection work 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.
They also believed that NRC should also hold more regulatory workshops for its licensees.
- Finally, they believed that NRC should issue larger numbers of Bulletins and Information Notices to keep materials licensees better informed on important regulatory matters.
Care should bc taken that Regional office staff are appropriately.
informed of these beiere mailing to licensees.
The Study Group was told that Regional office staff sometimes first hear of the issuance of thase from licensees who are calling to ask questions about them.
22.2
SUMMARY
OF PUBLIC COMMENTS Ninepuo'liccommentsfavoredttE.recommendationandoneopposeditonthe grounds that additional meetings would be costly and burdensome, especially for medical licensees.
22.3 STAFF ANALYSIS AND POSITION 1
(
NMSS reali?ed the importance of assuring consistency when it decentralized the vast majority of its 9,000 byproduct material licenses.
It was at this time that HMSS developed the National Program Review (NPR).
NPR is an ongoing 56
--J
oversight process, developed by NMSS and the Regions, to assure the technical I
adequacy, consistency, timeliness, and efficiency of its decentralized programs.
It includes the following elements:
Encourage frequent telephone contact at working levels.
~
Arrange periodic (monthly or so) conference calls to discuss generic issues.
Conduct License Reviewer Workshops (staff-level technical discussions).
Participate in Interoffice Working Group meetings.
Issue Policy and Guidance Directives.
Conduct Executive Management Seminars (executive policy discussions).
Review a small percentage of completed licensing actions.
Use standardized paragraphs, deficiency letter formats, requests for additional information (as appropriate).
i Encourage license reviewer / inspector interaction.
The staff believes that these elements comprise an adequate program for improving communications with the Regions and that they should be given emphasis in implementing the MSRRSG Recommendation No. 22.
Emphasis will also be given to increasing the involvement of license reviewers and inspectors in meetings and conference calls, k
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23.0 FEDERAL ADVISORY COMMITTEE ACT In the Federal Register Notice which published the Material Safety Regulation Review Study Group's report for public review and comment, it was noted that the public is invited also to " comment on the circumstances of the preparation and receipt of the report as they are affected by the requirements of the Federal Advisory Committee Act."
Only one public comment addressed this point and it stated, "The Federal Advisory Committee Act does not apply to the Study Group, as it is not an advisory committee under the Act, as interpreted by the Courts...."'
Other public comments dealt with the make-up of the MSRRSG:
"With all due respect to the five member study group, it is felt that considerations with respect to regulation amendments effecting any industrial occupation should have an input from individuals whom have functioned in that occupation."
"I would like to have seen a world reknown radiation expert such as Dr. Rosalie Bertell from the International Institute of Concern for Public Health, who is not indebted to the NRC or the nuclear industry, included in the review panel.
A little balance is called for here."
"The panel chosen to review the regulatory program consisted of 5 (seemingly) very Pro-kuclear experts.
To have a balanced panel, one would think that a representative of the Union of Concerned Scientists (or some similar " cautions group) would have been included."
"The Study Group was made up of essentially ex-regulators.
There is a definite need for a much broader based experienced group sto participate in such a review.
Experienced personnel from industry and professional societies should have been included."
"It was interesting to note that of the five persons paid to examine your licensing and inspection program all but Dr. Googin were former NRC employees and not licensees who are most affected."
58
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"As for the Study Group Report itself, OCRE believes that it is excellent.
The Study Group has identified a number of areas where improvement is needed in the regulation of materials licensees.
The NRC should implement its recommendations without delay."
"The Study Group has exemplary qualifications and obviously went to great lengths to meet the health and safety needs of the public in regard to radiation sources in the most efficient and effective manner."
The staff has reviewed all public comments and the advice of the Office of General Counsel concerning the Study Group and its recommendations.
The staff also considered the reorganization, the effects of implementing planned programs,'and the comparison with recommendations made by other groups.
The MSRRSG recommendations are similar to those of other groups, and the staff's position is that they should be considered in actions taken by the NRC to improve its performance.
e en i
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24.0 OTHER ISSUES RAISED BY THE PUBLIC In addition to the recommendations of the MSRRSG, the public comments dealt with other issues perceived by them to be important.
Three specific recom-mendations on other matters were made by the members of the public:
That NRC should develop guidance on the safety and conditions under which raffinate from UFs facilities may be used as fertilizer, l
That NRC should seek authority for the regula;ory oversight of DOE facilities; and That NRC should seek authority for the regulatory oversight of users of naturally-occurring and accelerator produced radioactive material.
Each of these items had been brought to the attention of the staff previously and had been considered for regulatory action.
The risk to public health and safety and to the environment from using raffinate from UFs operations as fertilizer for certain limited applications was assessed in the Environmental Impact Appraisal for the Sequoyah UFe plant and found to be inconsequential.
Specific license conditions for the Sequoyah Plant were imposed by the staff, authorizing the use of raffinate as. fertilizer only on land controlled by the licensee and not on agricultural products for human use.
Application of raffinate fertilizer to hay which could be sold for cattle feed was authorized with strict provisions for analysis and control of the level of uranium in the hay to assure that it does not exceed the permissible concentration.
With respect to regulating DOE facilities, the staff notes that the Energy Reorganization Act of 1974 separated the Nuclear Regulatory Commission and its functions from the former Atomic Energy Commission and gave the NRC full responsibility for all the licensing and related regulatory functions that had been assigned to the Atomic Energy Commission by the Atomic Energy Act of 1954, as amended.
The Atomic Energy Act of 1954, as amended, specifically excluded the facilities and operations of the Atomic Energy Commission from licensing and regulation by the Nuclear Regulatory Commission.
The Energy Reorganization 00
Act continued this exclusion with certain limited exceptions that are identified in Section 202.
The Nuclear Waste Policy Act of 1982 also specifies that cer-tain nuclear waste disposal facilities of the Department of Energy are subject to licensing and regulation by the NRC.
As it stands now, the law specifically.
excludes all other DOE facilities from licensing and regulation by the NRC.
With respect to the issue of NRC regulation of naturally occurring and accelerator produced radioactive material (NARM), the staff has published two reports on this matter (NUREG's 0310 and 0976) and the' Commission considered the question in 1978 (SECY 78-211 and 667).
In accordance with Commission instructions, NRC staff has been assisting the States in developing voluntary standards for regulating NARM and model regulatory programs.
There are presently no staff plans to recommend seeking legislation to enable NRC regulation of NARM.
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July 1, 1987 MEMORANDUM FOR:
Victor Stello, Jr.
Executive Director for Operations FROM:
Hugh L. Thompson, Jr., Director l
Office of Nuclear Material Safety and Safeguards
SUBJECT:
RESULTS OF OPERATIONAL SAFETY ASSESSMENTS AT THE MAJOR FUEL FACILITIES As a result of the accident involving catastrophic failure of a UF cylinder which allowed a major release of uranium hexafluoride at the Kerr kcGee Sequoyah Fuels Corporation in Gore, Oklahoma on January 4,1986, it was decided to conduct operational safety assessmen.ts. at each of the 12 major fuel cycle facilities licensed by the NRC.
These facilities include the 2 UF, production facilities, the 7 facilities producing commercial nuclear Feactor fuel and the 3 facilities producing naval reactor fuel.
These facilities are:
UNC, Inc., Uncasv111e, Connecticut Combustion Engineering, Hematite, Missouri Combustion Engineering, Windsor, Connecticut Babcock and Wilcox, Lynchburg, Virginia - Navy. plant Babcock and Wilcox, Lynchburg, Virginia - commercial plant General Electric, Wilmington, North Carolina Westinghouse, Columbia, South Carolina Nuclear Fuel Services, Erwin, Tennessee Allied Corporation, Metropolis, Illinois Sequoyah Fuels Corporation, Gore, Oklahoma Advanced Nuclear Fuels, Richland, Washington GA Technologies, Inc., San Diego, California Following the team assessments at Sequoyah Fuels Corporation (SFC) and Allied Corporation in early 1986, the remaining 10 one-week assessments were conducted between August 1986 and March 1987 using a multidisciplinary team approach involving NRC personnel from the responsible Region as well as Headquarters IE and NMSS personnel.
The Regional personnel included not only those normally inspecting radiation and criticality safety and emergency preparedness programs at fuel facilities, but also experts from reactor inspection groups with fire protection and operations engineering expertise.
The release of uranium hexafluoride at SFC resulted in the production of airborne hydrofluoric acid. due to reaction with airborne moisture and this acutely toxic chemical was the cause of the death of a worker.
Assessment of chemical hazerd protection was also included in the team assessments.
This was done with some assistance from chemical safety experts from Oak Ridge National Laboratory.
Victor Stello, Jr..
2 Furthermore, because chemical safety has not been regulated by the NRC, but is more the responsibility of Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA).
These 2 Agencies were invited to participate, as part of the NRC teams, in most of the assessments.
EPA and OSHA participated in 5 of the assessments.
In addition, the Federal Emergency Manage-ment Agency participated in 2 of the assessments in the area of emergency preparedness.
Thus these assessments attempted to provide a review of the effectiveness of the fuel facility overall safety programs.
A total of approxi-mately 6 FTE's of effort was used in preparing for, conducting, and reporting of these 12 assessments.
Major areas of assessment were as follows:
Management Controls of Safety P ograms Nuclear Criticality Safety Radiation Safety Emergency Preparedness Fire Protection Chemical and other Hazards Identification.and Mitigation Safety-Related Instrumentation and Maintenance '
Reports of the assessments were issued to the licensees, identifying the findings as weaknesses, or recommendations for corrective action and in a few cases, as violations.
The licensees were requested to respond to the reports and inform the NRC of actions they planned to take.
As would be expected, in areas such as radiation and criticality safety where NRC regulations or licenses provide requirements and which have been inspected routinely, the performance of the licensees was generally better than in areas such as fire prevention or chemical and other hazards identification and mitigation, areas in which NRC has not emphasized in license requirements or inspections in the past.
Following completion of the 12 assessments, a meeting was held in Headquarters at the end of March at the Division Director level among IE, NMSS, AEOD, and Regions I, II, III, IV, and V to exchange information and reach agreement on how to factor the assessment results into the licensing and inspection programs.
All agreed the team assessments were useful to the NRC and the licensees in identi-fying several significant operational safety issues that should be pursued further in our regulation of these facilities.
There was particular agreement that the multidisciplinary team approach was successful due to the ability to combine the efforts of experts in several safety areas.
It is a useful method for NRC to use further.
The most important safety issues identified as needing attention by licensees were in the areas of fire protection, chemical hazards identification and mitigation, management controls or quality assurance, safety-related instrumen-tation and maintenance and emergency preparedness.
The following paragraphs briefly summarize the assessment findings and pTanned actions in these areas, and provide some additional information and actions planned relative to the general area of operational safety at NRC-licensed fuel facilities.
d Victor' Stello, Jr.
3 Fire Protection For nuclear fuel facilities in general, probably the most important type of hypothetical event that could result in release of fuel material is a fire.
This is primarily because the processes involving nuclear fuel processing involve the use of flammable chemical solvents and flammable gases such as hydrogen, as well as elevated processing temperatures.
NRC has not provided detailed regulations or emphasized fire protection in inspection programs, but has reviewed licensee use of the local building codes and insurability.
During the assessments, signif-icant deficiencies from acceptable fire protection practice and programs were noted in nearly all the facilities.
Although not all facilities had the same ones, typica? deficiencies included lack of program definition and management assignment, lack of fire hazards analyses, lack of technical expertise, inadequate fire fighting and protection equipment, inadequate training, and inadequate fire prevention and preffre planning.
It was concluded that NMSS would develop licensing criteria for these facilities to ensure that the necessary upgrading of licensee fire protection programs -in this area occurs.
Although 10 CFR 50 Appendix R is not applicable to and should not be a'pplied to these facilities, the staff plans over the next 6 months to prepare standard license requirements as appropriate to these facilities.
As an interim measure, the Regions will pursue with licensee management the correction of the specific deficiencies identified at each facility.
Following inclusion of requirements for fire protection programs in licenses, routine inspections will cover this area.
Management Controls or Quality Assurance The licenses for these facilities currently contain requirements for management controls in the areas of radiological safety and nuclear criticality safety, as well as emergency preparedness.
There were some deficiencies at several of the facilities. and these are being pursued.
However, one of the key lessons from the Sequoyah accident was that the management had become almost totally uninvolved in the management of the ' safety aspects of the facility.
Consequently, the NRC Order modifying the license issued to SFC specified a quality assurance program covering all aspects of facility operations, including facility design and construction, procedures, maintenance, and training, with audits and feedback m chanisms.
Similarly, the staff is working with Allied Corporation to achieve an up-to-date and complete quality assurance program for that facility.
It has been concluded that this approach should be taken for all the fuel facilities.
Again, the staff will pursue this through the licensing process.
Chemical and 7ther Hazards Identification and Mitigation Strictly speaking, NRC has not in the past regulated chemical hazards at NRC licensed facilities, nor are we proposing to do so now.
In the NRC response to the issue of emergency preparedness for chemical releases, the Commission decided that emergency planning for hazardous chemical release at such facilities should be conducted in accordance with the recently enacted Emergency Planning and Community Right-to-Know Act of 1986, part of Public Law 99-499.
This is part of the rulemaking package that was issued for public comment on April 20, 1987.
i
Victor Stello, Jr.
4 With regard to onsite chemical hazards, the Chairman's letter of January 13, 1987 to Congressman Synar, Chairman, Subcommittee on Environment, Energy and Natural Resources, Committee on Government Operations, stated:
"Both NRC and OSHA have jurisdiction over occupational health and safety onsite.
NRC has jurisdiction with respect to the hazard of working with the radioactive materials.
OSHA establishes standards for other working conditions in plants, including working with hazardous chemicals as defined in 29 CFR 1910.1200.
OSHA regulations include process controls, work practices, exposure limits, safety training, and require a materials safety data sheet for each hazardous chemical used in the facility.
The jurisdictions of the two agencies are complementary and leave no regulatory gap. (In some jurisdictions the State may regulate occupational safety under an agreement with OSHA.) Accordingly, no additional legislation is necessary for occupational health and safety purposes in NRC licensed facilities."
For discussion purposes, there are 4 kinds of hazards that may be associated with the nuclear fuel facilities:
1.
radiation hazards of radioactive materials 2.
chemical hazards of radioactive materials 3.
radiation hazards caused by fires or explosions, or by chemicals, such as loss of containment integrity or concentration of fissionable materials by precipitation, etc.
4.
chemical hazards of chemicals Based on the Agency expertise and the cited letter to Congressman Synar, the i
staff plans to continue to carry out NRC responsibility for the first three hazards above. We will continue to require, through the licensing process, that the first three hazards be covered in safety evaluations and other reviews, as well as inspections.
Although OSHA and EPA have responsibility and authority for onsite and offsite chemical hazards associated with these facilities, the staff nevertheless plans i
to exercise some leadership with regard to hazard number 4 We plan to continue i
to cooperate with other Federal and State agencies in the exercising of their responsibilities in this regard.
For. example, as we conduct NRC team assessments of operational safety at NRC-licensed facilities, we will cooperate by informing OSHA and EPA of those opportunities for a coordinated approach that can be I
mutually beneficial without duplication of effort.
Similarly when we see problems in other agencies' regulatory jurisdiction during our inspections, we will continue to inform them so that action can be taken as appropriate.
We plan to provide some training to NRC inspectors in fundamentals of fire safety and i
chemical hazards-to improve our effectiveness in making such referrals. Subsequent to one of the recent safety assessments that OSHA personnel participated in, OSHA issued citations against violations of 29 CFR safety requirements.
We also plan to continue to share information with EPA in this area; for example, through the NRC/ EPA Interface Council.
Victor Stello, Jr.
5 Safety-Related Instrumentation and Maintenance Fuel facilities do not have a great deal of safety-related instrumentation and interlocks, unlike reactors.
However, the team assessments found a wide varia-tion in licensee programs for testing of process instrumentation and control equipment, such as interlocks on UF cylinder heating systems, or emergency diesels.
Itwasconcludedthatregbirementsforthosefewcriticalsystens should be called out in the licenses as required maintenance and testing.
The staff plans to consider this as an ongoing licensing renewal issue.
Emergency Preparedness The assessment teams found deficiencies in emergency preparedness, including coordination with and training of offsite agencies, composition of site emergency response organization, conduct of drills and audits of emergency plans, and inconsistencies of the licensee plans with the 1981,0rder'.
Following completion of the emergency preparedness rulemaking, the. staff will take actions required for implementation.
As an interim measure, the staff is addressing the noted deficiencies on a case-by-case basis with the licensees.
Need for Regulations in the Above Areas The staff has concluded that the deficiencies identified by the operational l
safety team assessments are amenable to correction through case-by-case followup on report findings by the Regions, coupled with amendments and renewals of facility licenses.
The staff does not believe at this time that new regulations are required other than the ongoing rulemaking on emergency preparedness; however, i
this issue could be revisited as we gain experience with the licensee followup actions.
Emphasis and Form of Future Inspection Programs Based on the agreement by Regional and Headquarters staff on the usefulness of the team assessment approach to identifying safety deficiencies requiring licensee corrective actions in several technical areas, the staff plans to use team inspections as an adjunct to the licensing renewal process.
These facilities are currently subject to a five-year license renewal.
To achieve an immediate effect, the findings from the recent assessments are being addressed in imminent licensing renewals for the fuel facilities.
In the future, team assessments would be conducted about 1 year prior to expiration of licenses, to help identify important safety issues for resolution by licensees prior to renewal. Apart from the team assessments at fuel facilities, Region I also used this approach at some of the major materials licensees, including 2 major facilities involved in producing and distributing radiopharmaceuticals.
These facilities involve chemical processing of substantial quantities of radioactive materials. 'The results of these assessments were similar to those for fuel facilities, and are being considered by Region I in the license renewal process.
______________-_J
Victor Stello, Jr.
6
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The staff plans to also augment-the routine fuel facility inspection program as thG various licensing actions are taken.
As an interim measure, the NRC Inspection Manual will be revised based on the lessons from these assessments to require specific followup on the team assessment results, as well as to continue the radiological and criticality safety inspections.
Public Seminar With Licensees Upon receipt of responses from the licensees to the assessment findings, the staff is considering holding a meeting with the licensees, that would be open to the public, to discuss the results and NRC plans to implement them in the licensing and inspection process.
Staffing Implications Staffing resources of approximately 6FTEts are r.etded to accomplish the additional licensing requirements in Headquarters and additiona'l Regional inspections and assessments are reflected in both this report and the report on the recommenda-tions of the Materials Safety Regulations Review Study Group.
These resource needs are being considered as part of the NMSS/ Region FY 88/89 Budget Formulation Process.
Summa ry:
The results of the team operational safety assessments were useful in identifying actions needed to obtain improved operational safety performance and will continue to be used as an effective tool in the NRC regulatory program for the fuel facilities.
(Sqned) Robert R. Bernero Hugh L. Thompson, Jr., Director 3
Office of Nuclear Materials Safety
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4 1
ENCLOSURE 5 i
~ :- - _-__.- -
NRC RESPONSES TO RECOMMENDATIONS OF THE HOUSE COMMITTEE CN GOVERNMENT OPERATICNS IN THE REPORT "NRC'S REGULATION OF FUEL CYCLE FACILITIES: A PAPER TIGER" This response describes programs and plans covering the 18 recommendations included in the House Committee on Government Operations Report.
RECOMMENDATION 1:
NRC should determine, and publicly clarify, its legal authority to regulate all chemical hazards which could affect, either directly or indirectly, the safe use of licensed radioactive material.
For example, in the case of a UF conversion plant, 6
NRC should determine whether it has authority over all aspects of the production of UF since W is both chemically toxic 6
6 and radioactive.
The Commission also should clarify its authority over areas of the plant where there are nonradio-logical chemicals (such as fluorine storage tanks) if those areas pose hazards to the safe production and use of UF
- 6 RECOMMENDATION 2:
If the Commission feels that it does not have authority to regulate all chemical hazards at the facilities which it licenses, it should determine whether other Federal agencies have such authority.
In that event NRC should develop definitive cooperative agreements with those agencies to clarify the divisions of authority and the procedures to be followed to assure that all agency requirements and respon-sibilities regarding chemical hazards or releases at NRC-licensed facilities are met.
j 2
RECOMMENDATION 3:
If NRC feels that no Federal agencies have adequate regulatory authority over chemical hazards and operations at NRC-licensed facilities, the Commission should recommend to Congress whether NRC or some other Federal agency should be granted such authority.
NRC Response Recommendations 1, 2, and 3 all relate to regulatory jurisdiction over non-radiological hazards at NRC-licensed nuclear fuel cycle facilities.
We agree with the objectives of these recommendations.
With regard to authorities for chemical hazards, the NRC Chairman's letter of January 13, 1987 to Congressman Synar, Chairman, Subcommittee on Environment, Energy and Natural Resources, Committee on Government Operations, provided clarification as follows:
"Both NRC and OSHA have jurisdiction over occupational health and safety onsite.
NRC has jurisdiction with respect to the hazard of working with the radioactive materials.
OSHA establishes standards for other working conditions in plants, including working with hazardous chemicals as defined in 29 CFR 1910.1200.
OSHA regulations include process controls, work practices, exposure limits, safety training, and require a materials safety data sheet for each hazardous chemical used in the t'acility.
The juris-l-
dictions of the two agencies are complementary and leave no regulatory gap.
(In some jurisdictions the State may regulate occupational' safety under an agreement with OSHA.) Accordingly, no additional legislation is necessary for occupational health and safety purposes in NRC-licensed facilities."
For the purpose of defining regulatory roles, the hazards that may be associated with the nuclear fuel facilities can be grouped into four categories:
1.
radiation' risk produced by radioactive materials 2.
chemical risk produced by radioactive materials L_ _ _ _
3 3.
plant conditions which may directly or indirectly affect the radiation risk, e.g., those which might produce a fire or explosion.
4.
plant conditions.which result in an occupational or public risk but do not affect significantly licensed radioactive material, e.g.,
chronic exposure to toxic non-radioactive chemicals.
The staff has required, and will continue to require, that the first three categories be covered through the licensing and inspection process.
Although OSHA and EPA have responsibility and authority for regulating chemical and other non-radiological hazards, the NRC nevertheless plans to exercise leadership in this area. This is consistent with the conclusions of the General Counsel in his memorandum of September 23, 1986 regarding regulatory jurisdiction.
For example, as NRC conducts multidisciplinary team assessments of operational safety at NRC-licensed facilities, OSHA and EPA will be invited to participate.
Similarly, when NRC inspectors identify problems that are within other agencies' regulatory jurisdiction, NRC will inform the responsible agency so that action can be taken as appropriate.
NRC also plans to provide more training for its licensing and inspection staff to enable them to better identify potential problems outside NRC's direct regulatory jurisdiction in an. effort to improve their effectiveness in making such referrals.
The NRC also plans to continue to share information and explore opportunities for further cooperation and coordination with EPA in this area; for example, through the NRC/ EPA Interface Council.
The staff _will monitor the effectiveness of existing arrangements, and plans to work with OSHA and EPA to develop and document, through mechanisms such as a memorandum of understanding, a clearer statement of the respective roles of each agency.
A copy of the NRC letter referred to above is attached.
4 RECOMMENDATION 4:.
NRC should identify. and provide licensing guidance and reviews for all aspects of licensed facilities which could affect the safe use of licensed radioactive material.
NRC Response The staff agrees with the objectives of this recommendation.
The NRC has t' proximately 9,000 fuel cycle and material licenses, which fall into about 100 categories.
The NRC staff has developed about 20 licensing guides and 20 review plans which cover the vast majority of all licensees.
There are an additional 40 regulatory guides which cover specific aspects of fuel cycle and material safety.
Although the staff has developed extensive guidance, we recognize the need to develop more guidance in certain areas and update old guidance documents.
For example, further guidance will be necessary in the area of fire protection and emergency preparedness.
The staff will continue to develop additional documents as permitted by available resources.
O 5
RECOMMENDATION 5:
NRC should require license reviewers to have qualifications and training for all aspects of licensed facilities which affect the safe use of licensed radioactive material.
l NRC Response We agree with this recommendation.
The task of recruiting and maintaining a staff with the necessary qualifications to evaluate license applications receives continuing emphasis in the NRC.
In recruiting, we seek individuals with strong academic and professional backgrounds in specialized technical skills.
Training is provided to enhance the skills required to conduct license reviews, to gain qualifications in important technical disciplines, and to provide new information or qualifications in the staff's present areas of expertise.
To date, we have sought to assure appropriate coverage of all types of risks affecting the safe use of radioactive material in licensed operations and facilities by having our license reviews conducted by groups of individuals comprising a spectrum of special skills.
The NRC is increasing its training effort for the fuel cycle and materials licensing and inspection staff.
The objective is not only to assure technical proficiency in specialized skills such as nuclear criticality but also to broaden technical perspectives so ~that all issues which might impact radio-logical and nuclear safety are identified and properly addressed.
I
l 6
RECOWENDATION 6:
NRC should amend its regulations to require that licensees submit license renewal applications far enough in advance of the expiration date of the license to allow NRC sufficient time to adequately review the renewal application before the license expires.
NRC should make every effort to eliminate any unnecessary delays in reviewing license renewal applications.
NRC Resoonse We agree with minimizing delays in license renewals.
In the past, some fuel cycle license renewal applications have not always been initially adequate to respond to current regulatory concerns of the Agency, and therefore they require revisions. Actions to reduce the time required for license renewal include issuing Standard Format and Content Guides for improving licensee understanding of what NRC expects.
Furthermore, NRC plans to conduct operational safety team assessments about one year prior to license rerewal, thereby permitting earlier identification of new issues to be covered in license renewal applications.
In addition, improved tracking of significant license actions is underway.
The staff will censider further actions that may be appropriate to reduce or minimize delays in the license renewal process.
1 i
RECOPEt!DATION 7:
'In the event that NRC attaches conditions to its renewal of a license requiring the licensee to take certain actions, the Commission should follow up to ensure by means of a safety evaluation inspection and report that the actions have been carried out.
NRC Response We agree with this recommendation. Our experience indicates that follow up is needed to ensure compliance with new license conditions or other requirements that are imposed.
Normally, compliance with new license conditions would be checked in the first rcutine inspection following their imposition.
- However, in some circumstances, the staff will scheaule a special inspection to ensure prompt compliance with new requirements. An example occurred in connection with the recent license amendment covering operations of a new facility to covert depleted UF to UF within the' controlled areas of the Sequoyah site.
In this 6
4 case, NRC conducted a preoperational inspection prior to issuing the amendment and then followed up with a start-up inspection to ensure that items found on the first inspection were taken care of and that the licensee was in compliance with the license a.mendment conditions which had been imposed.
There are occasions when the NRC adds new requirements for all licensees of a certain type. When this happens, it is the Commission's practice to issue special instructions to the Regions requiring them to conduct follow-up actions to ensure that licensees have complied with the new requirements.
8.
RECOMMENDATION 8:
NRC should consider conducting a plant-wide inspection to verify that a licensee actually is carrying out license requirements and agreements before approving renewal of a license.
RECOMMENDATION 9:
NRC should revise its inspection program to ensure that.
inspections cover al'1 areas of licensed facilities which would affect the safe use of license radioactive material.
Inspectors should focus heay11y on plant operations, procedures, equipment, employee training, and emergency response.
RECOMMENDATION 10:
NRC inspections of fuel cycle facilities should utilize individuals having qualifications.and training in all areas of the facilities which affect environmental safety and health, not just those involving radiological hazards.
If necessary, NRC should consider use of inspection
" teams" to insure that such qualifications and training are represented on the team.
RECOMMENDATION 11:
NRC should consider conducting joint inspections with representatives from other agencies at licensed facilities when those facilities are subject to the jurisdictions of other agencies.
NRC response Recommendations 8, 9, 10, and 11 all relate to changes in the inspection program for fuel cycle facilities that woulc' broaden the scope of review to include all areas of licensed facilities which affect the safe use of licensed material. We agree with the objectives of these recommendations.
o
a.
9 Following the Sequoyah Fuels Corporation accident, the NRC conducted plant-wide inspections of its major fuel cycle facilities using multidisciplinary assessment teams.
These facilities were:
UNC, Inc., Uncasville, Connecticut Cembustion Engineering, Hematite, Missouri Combustion Engineering, Windsor, Connecticut Babcock and Wilcox, Lynchburg, Virginia - Navy plant Babcock and Wilcox, Lynchburg, Virginia - commercial plant General Electric, Wilmington, North Carolina Westinghouse, Columbia, South Carolina Nuclear Fuel Services, Erwin, Tennessee Allied Corporation, Metropolis, Illinois Sequoyah Fuels Corporation, Gore, Oklahoma Advanced Nuclear Fuels, Richland, Washington GA Technologies, Inc., San Diego, California The mult1 disciplinary assessment teams consisted of about ten members each and included members with specialized skills in radiation safety, criticality safety, fire protection, emergency preparedness, management controls, environmental protection, and chemical process safety.
OSHA and EPA representatives were invited to participate in the assessments and did in some, though not all, of the assessments.
1 The fuel facility operational team assessments focused on areas of licensed facilities which could affect the safe use of licensed radioactive material such as plant operations, procedures, equipment, training, and emergency response as well as other areas such as nuclear criticality control, non-radiological hazards, and fire protection.
Future plans call for similar assessments about one year prior to license renewal to identify issues that need to be addressed in the licensing process.
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10 RECOMMENDATION 12:
The Radiological Contingency Plans of fuel cycle facilities should be reviewed and revised as necessary in order to correct the inadequacies discovered as a result of the Sequoyah accident and to assure that nonradiological' hazards are adequately addressed.
NRC Response We agree with this recommendation.
The NRC-has conducted team assessments at all its major fuel cycle facilities.
including the licensees' Radiological Contingency Plans (RCP's).
Inadequacies found in contingency planning are being corrected as a result of the lessons
-learned from the Sequoyah accident.
Requirements for nonradiological hazards are covered by the proposed rule on emergency preparedness published by the NRC in April 1987.
Independent of NRC regulatory control, licensees are also required to comply with the EPA Emergency Preparedness and Community Right-To-Know Act of 1986, Title III of the Superfund Amendments and Reauthorization Act of 1986 (Public Law 99-499), which provide requirements for non-radiological hazards.
e 11 RECOMMENDATION 13: The revised fuel cycle facility emergency response plans should, among other things:
(a)
Fully describe the notification requirements and other responsibilities that licensees have for all federal and state agencies in emergencies; (b) Require employee training in, and annual updates of, the plan; (c) Require periodic emergency drills and exercises involving offsite emergency persernel and nearby residents, as well as headquarters and regional officials from NRC; and (d) Provide for licensee and NRC evaluations of all emergency drills.
NRC Response
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We agree with most of this recommendation, but do not agree with routine participation of nearby residents or NRC personnel in periodic emergency drills.
(a) The proposed emergency preparedness rule published in April 1987 includes notification reoufrements for offsite response organizations, including other federal and state agencies.
The fifty States have different agencies and different reporting requirements.
The emergency preparedness rule includes a requirement that the licensee obtain comments on the Radiological Contingency Plan from the state and that these comments be provided to the NRC.
It is anticipated that comments will be provided on the appropriate notifications by state and local agencies and groups during the comment period.
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(b) Requirements for employee training and annual updates of licensee Radiological Contingency Plan are provided (see NUREG-0810 Sections 7.2 and 7.4, respectively).
These requirements would be continued by the proposed rule on emergency preparedness for fuel cycle facilities.
(c)
Licensees are currently required to have periodic exercises (every five years) that include respondents from offsite organizations that need to provide onsite response, such as fire departments and emergency services.
The staff has not required participation in exercises by nearby residents for nuclear power reactors, and does not believe that this participation would be necessary for neighbors of fuel cycle facility plants.
Radiological emergencies at these fuel facilities would involve small doses.
The potential radiological risks are lower than from industrial accidents or l
chemical releases.
The normally available capability of local governments to respond to industrial emergencies would therefore provide adequate response for local residents. As noted earlier, most NRC licensees are required to comply the EPA Emergency Preparedness and Community Right-To-Know Act of 1986 to have emergency planning that also covers potential release of hazardous chemicals.
RoJtine participation by 'Se staff in the licensees' exercises is not viewed as an efficient use of limited NRC resources. A review of the exercises is part of the inspection process and provides assurance that these training exercises are conducted and any lessons learned incorporated.
The NRC Headquarters and Regional staffs also conduct periodic training anc exercises.
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i (d)
Licensees are required to evaluate all emergency drills [NUREG-0810, Section 7.3(A)].
NRC evaluation is accomplished during inspections of the licensee's emergency preparedness activities.
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.l RECOMMENDATION 14:
Before approving revised fuel cycle facility emergency response plans, NRC should take part in, and monitor, test implementations of the plans.
NRC Response We agree with the intent of this recommendation to assure that adequate emergency response plans are implemented for fuel cycle facilities.
We believe, however, that direct NRC participation in licensees' exercises is not the only mechanism for assuring appropriate planning.
There are more efficient and less resource intensive' ways to accomplish the objectives.
Inspections, and particularly the operational team assessments, have enabled the NRC to identify weaknesses in licensee programs and direct licensees to incorporate corrections as necessary.
The NRC staff believes' that this approach should be continued, and that it will provide an appropriate monitoring and evaluation of licensee emergency preparedness plans.
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O 14 RECOMMENDATION 15:
Fuel cycle emergency plans should be reviewed by the same NRC officials who review nuclear power plant emergency plans as well as by the officials responsible for licensing and regulating fuel cycle facilities.
NRC Response We agree that there is a certain commonality of approach to emergency response for nuclear power plants and fuel cycle facilities.
However, because the Radiological Certingency Plans submitted by fuel cycle licensees are significantly different in scope, in the nature of the emergencies, and in the content of the \\
l plans from the Emergency Plans submitted by nuclear power plants, we have I
emphasized review by the fuel cycle licensing and inspection staff where the required fuel cycle experience and specialized technical competence are established.
The plans are also to be reviewed by the NRC Regional Offices which are in close contact with state and local authorities and are involved in emergency planning at both nuclear power plants and fuel facilities.
Those generic aspects of emergency planning and response necessary to provide coordination of similar functions, such as regulation development and guidance and training of NRC emergency response personnel, are done in conjunction with nuclear power plant emergency planning specialists and the staff of the Office of Analysis and Evaluation of Operational Data.
Increased Regional Office involvement in the review of Radiological Contingency Plans, coordinating them with other agencies and state and local officials as appropriate, is planned to assure consistency and cooperation.
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15 RECOMMENDATION ~16: NRC's Headquarters Operations Center should have on hand, or have immediate access to,. copies of all emergency response plans for, licensed facilities.
NRC Response We agree with this recommendation.
The Radiological _ Contingency Plans for all licensees that are required to submit and maintain such plans are kept ori file in the NRC Operations Center and are immediately available in the event of an emersancy.
The Licensing Assistant in
-the Division of Fuel Cycle, Medical, Academic, and Commercial Use Safety forwards all revisions to the Headquarters Operations Center as soon as they are received so that the plans can be kept up-to-date.
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16 RECOMMENDATION 17:
In the event of an emergency at a licensed facility, NRC should set up one or more 24-hour " hot lines" (rumor control centers) to provide information to local residents, news media, and others.
NRC Response We agree _with the objectives of this recommendation.
Pubite Affairs Officers in NRC Headquarters and in the Regions currently perform the function of rumor control for the Agency. A Public Affairs Officer would also normally be included in the NRC response team dispatched to the site in an emergency. All are available to answer telephone inquiries from members:of the public and press.
However, we agree that a state. or local central line, similar to that used for reactor sites, would also be desirable.
The staff intends to incorporate the recommendation for state and local rumor control arrangements into a Regulatory Guide that will provide guidance on ways accep-table to the staff for compliance with the requirements established by regula-tion.
The possibility of including an 800 number for toll-free calls.is being i
censidered.
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RECOMMENDATION 18:
NRC should propose, as soon as possible, a rule on emergency preparedness for fuel cycle facilities which would strengthen preparedness requirements and reflect some of the lessons learned from the Sequoyah accident. At a minimum the rule should require that state and local officials and nearby residents be actively involved in emergency planning and periodic emergency drills for licensed facilities.
NRC Response We agree with the objectives of this recommendation.
A proposed rule to accomplish this purpose was published in the Federal Register on April 20, 1987 (52 FR 12921). The public comment period expired on July 20, 1987.
Final action on the rule is currently scheduled for March 1988.
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8 NUCLEAR REGULATORY COMMISSION o
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January 13, 1987 Sniezek
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The Honorable Mike Synar, Chairman Keppler Subcommittee on Environment. Energy and ED016f 7 Natural Resources Committee on Government Operations United States House of Representatives Washington, D. C.
20515
Dear Mr. Chairman:
On June 23, 1986 the NRC provided answers to several questions regarding the Commission's response to the accident at.the Sequoyah Fuels Company plant at Gore Oklahoma.
The answer to Question 4 related that the NRC was continuing its analysis of its authority to respond to incidents involving the release of hazardous chemicals at a. licensee's site, but which did not involve NRC licensed material, and would advise the Congress whether additional legislation is needed.
The Commissdon has l
essentially completed its review of this area of regulatory I
concern.
The Commission's need to separately address emergency planning and response for offsite releases of hazardous nonnuclear chemicals has been overtaken by the enactment of the Emergency Planning and Community Right-To-Know Act of 1986, Title III of the Superfund Amendments and Reauthorization Act of 1986 (Public Law 99-499).
This new law establishes a complete and comprehensive offsite emergency preparedness and response program for hazardous and toxic chemicals under the direction of EPA and FEMA.
It will apply to all NRC and Agreement State licensees who possess a hazardous chemical in the threshold quantity established by EPA.
The Commission, therefore, does not see a need for any additional legislation to address ncnnuclear hazardous chemicals for its licensees.
Both NRC and OSHA have jurisdiction over occupational health and safety onsite.
NRC has jurisdiction with respect to the hazard of working with the radioactive materials.
OSHA establishes.
standards for other working conditions in plants, including working with hazardous chemicals as defined in 29 CFR 1910.1200.
OSHA regulations include process controls, work practices, exposure limits, safety training, and require a material safety data sheet for each hazardous chemical used in the facility.
The jurisdictions of the two agencies are complementary and leave no regulatory gap.
(In some jurisdictions the State may
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regulate occupational safety under an agreement with 0,SHA.)
Accordingly, no additional legislation is necessary for occupational health and safety purposes in NRC licensed i
facilities.
The Commission appreciates your interest in these matters.
Sincerely, Lando W.
ch, Jr.
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