ML20217L044
| ML20217L044 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1989 |
| From: | Bernero R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20217L002 | List: |
| References | |
| FRN-56FR67011, RULE-PR-31, RULE-PR-32 AD34-1-049, AD34-1-49, NUDOCS 9708190019 | |
| Download: ML20217L044 (4) | |
Text
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[. osk#*,, UNITE D STATE s Ross a NUCLE AR REGULATORY COMMISSION speis gypdg
@bg i W ASHING T ON. D. C. 206tl r
'Gooco' Shao Houston HEMORANDUH FOR: Eric S. Beckjord, Director Sheron Office of Nuclear Regulatory Research sf 8/3 FROM: Robert H. Bernero, Director Office of Nuclear Material Safety Riani and Safeguards r,i ng
SUBJECT:
NMSS PRIORITY 1TEMS l8 durj pt Our March 22, 1989 NHSS, subject as above, provided a revision memorandum of HMSS top priorityfrom researc the Director,h projects for rulemaking, research, regulatory guides and policy statements. We have again revised t lists to reflect the status of priority items and our current needs.
Significant comments on the priority items appear in enclosure 4.
The purpose of these lists was ideally to provide an aid to managers and project leaders for directing effort and monitoring progress. It is anticipated that both our offices, where confronted with a decision on allocating resources, may rely cn these lists as HMSS' expression of top priorities for Research.
/
Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated
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.i ENCLOSURE 1
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TOP FIVE RULEMAKING ACTIONS NMSS RES COMP.
PRIORITY REF NO. . TITLE EDiiTACT g PRODUCT (S) DATE5
, 1 RM 173 Anticipated Processes K. Kalman C. Pritchard Publish:
and Events and x20428 x23884 Proposed Rule 12/30/89 Unanticipated Processes (HLWM) (RES) Final Rule TBD and Events for the HLW
- Repository ,
2 .TBD Design Basis Accident 8. Thomas C. Pritchard Publish:
Dose Limit for HLW x20435 x23884 Proposed Rule TBD Repository * (HLWM) (RES) Final Rule TBD 3 #112 Storage of Spent Nuclear J. Roberts W. Pearson Proposed Action:
Fuel in NRC Approved x20608 x23764 Proposed Action Published 05-05-89(C)
Casks at Civilian ( 19915 ) (RES) Public Comment Period 06-19-89(C)
< Nuclear Power Reactor Final Action Pub 1'd 03-00-90 Sites 4 #189 Physical Fitness Program C. Brown for Tactical Response P. Ting D. V. Hopkins Publish Proposed Rule: 05-25-90 Team Members' x20360 x23784 Final Action Pub 1'd: 04-25-91 (SGTR) (RES)
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5 RM0 81 Requirements for 5. Baggett J. J. Mate Proposed Action to EDO 03-30-90 Possession of Industrial x20542 x23795 Proposed Rule Published in FR 04-40-90 Devices (IP915) (RES) Final Action to FR 05-31-91
, 2A coordinated staff paper is being prepared at this time by 79tSS and RES for EDO approval of fcroal rulemaking action.
PRIORITY ITEMS 4
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TOP REGULATORY GUIDES !
MSS RES COMP.
PRIORITY REF NO. TITLE NilTACT g PacoUCT(s) UKTE5 ,
1 T80 Standard Format and M.De111gatti C.Prichard Work plan for preparation 6/30/88(C)
Content Guide of x23403 x23884 of the guide License Application (MLW) (RES) Table of contents for RG 8/15/89 for a High-Level , Draft guide for public comment 12/31/89 Waste Repository Final guide 6/01/30 101' POLICY STATEEN1 ACI10NS 1 MA Exemptions from K.Dragonette W.Lahs Commission Policy Statement 8/19/88C ,
Regulatory Control x23437 x23774 with Options (formerly De Minimis/ (LtW) (RES) l Below Regulatory Concern) i Fed. Reg. Motice TBD ,
Workshop /Mtgs. ~ TBD '
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Enclosure 4 Revision 5=
7/Z4/59 i
BA$!$ FOR CHANGES (REVisl0NS) IN T0p FIVE PRIORITY LISTS Rulemaking Actions:
i REF N0 034 - Completed. Removed from list.
I REF NO 095 - The action on the Basic QA Rule for Medical Use of Byproduct i Naterial will be completed in September 1989 when it is published. !
No problems or impediments appear in its path. However .the ;
proposed rulemaking action on the Comprehensive QA Rule,has been put *0N HOLD' and may be revitalized at a later date. Removed from list. ,
REF N0 053 - The rulemaking action on Safety Requirements for Industrial Radiographic (quipment is soon to be completed. August 10 1989
- is the target for publication of the final rule. Removedfrom list.
"Antici REF NO 173 - The. specific meaning and use of termsEvents are neededand Unanticipated Proce to sharpen '
the definitions and usage now found in 10 CFR Part 60 (Sections 60.2, '
. 60.102, and 60,113). With such clarification, the uncertainty in their application should be reduced. This activity rates top
- priority because it has critical inf!uence on alsest all facets of '
the HLW repository program. Th!s is a new item on the list. .
REF NO 081 - This rulemaking action has significant impact on a national scale .
. due to thousands of material Itcensees (users)-and the potential for contamination of metal products via scrap metal processing.
- This is= a new item on the list.
- REF-N0 (TDB) Decision to seek a rulemaking on' the " Design Basis Accident Dose Limit for.HLW Repository" has been considered an important step '
to reduce the uncertainty in the design and operation of the HLW
- repository. Establishment of a dose limit following a design
-basis accident will clarify the expectations of design as well as :'
siting of the repository. A coordinated staff-paper is being-prepared at this time by NMS$ and RES for EDO approval of formal rulemaking. action. This is a new item on the list.
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POLICY ISSUE September 14, 1989
,_ ggggq SECY-89-289 For: The Commissioners t
From: James M. Taylor Acting Executive Director for Operations
Subject:
STAFF INITIA*IVES ON THE GENERAL LICENSE PROGRAM
Purpose:
To inform t'a Commission of the current problems with the general lir anse program and identify actions being taken to strengthen the program.
Summary: General licensees include individuals or organizations that become licensees, without contacting the U. S. Nuclear Regulatory Commission (NRC), when they receive a byproduct source or a device containing a byproduct source from a
- specific licensee.These devices include certain measuring, gauging, illumineting, and controlling devices containing byproduct material ,angir#g from microcuries to several curies.
There are approximately 30,000 general licensees in non-Agreement States using about 400,000 devices, and about twice 4
this many in Agreement States. General licensees are expected to be able to use the devices safely by following simple instructions "- without having radiological safety training or experience -- because safety is built into the devices.
Since the program has evolved over several decades and has not been re-evaluated in depth, there are questions as to whether the existing regulatory structure governing certain types of general licensees provides a degree of protection of 3 the public health and safety comparable to that of other NRC- N regulated activities. NRC rarely inspects or contacts general '
licensees. We do know that the accounting for such devices is y not adequate, that devices occasionally enter unauthorized s waste streams, that general licensees are frequently unaware of thqir obligations and responsibilities, and that the disposal of devices containing sources that exceed " Class-C" waste quantities is a problem. Because these known problems CONTACT:
John H. Austin, HMSS 492-0689 p%6 klL'lt]CC,Y )))
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l The Commissioners 2 are not viewed as being acute, NRC's handling of the g'eneral license piogram is reactive, as opposed to a more proactive program. Nonetheless, we believe the public health and safety have been adequately protected, but there is considerable room for improvement. Most, if not all, Agreement States appear to share this view.
The staff has reviewed the general license program and has worked with the Agreement States, as well as the Regional Offices to curtai1Ing,obtainandevaluateideasaboutmodifying, or even eliminating the general license program to achieve better regulation and performance. Although the staff is unable to prepare quantitative cost-benefit analyses justifying additional requirements, we have identified a number of rulemaking initiatives to improve the program and slightly curtail its scope. Four additional initiatives of other types are identified. Several additional options are identified for future consideration. The staff concluded that the general license program should be continued, but with some limitations in the scope.
Backaround: The use of byproduct, source, and special nuclear materials can be grouped into three categories for the purpose of a defining the degree of regulatory control necessary to protect public health and safety. These are: a) specific licenses covering activities that require an understanding of certain radiation protection principles and procedures in order to safely possess and use the materials; b) general licenses covering the possession and use of sources or source-device combinations that have sufficient built-in shielding and containment features to require no special training in radiation protection for safe use; and c) sources and devices that are exempt from licensing, because they represent essentially no threat to public health and safety, and for which there is no particular concern over the ultimate disposal of the devices. (Various sections of the regulations create general licenses to receive title to and own source, byproduct, and special nuclear materials without regard to quantity. However, these general licenses do not authorize acquiring, delivering, r6ceiving, possessing, using or transferring those materials, except as authorized in a specific license. Thus,-general licensees engaged in the latter activities would usually have extensive training in radiation protection principles, as required in the specific license.)
Specific licenses are issued only to individually named n persons or organizations after application to NRC or Agreement State review. General licenses go into effect without application to NRC or to an Agreement State, and,
o The Commissioners 3 except under a few specific cases, without. issuance of license documents. Under current regulations, general licenses also exist for numerous activities such as ownership, transportation, and import / export, as well as for use of regulated materials.
There are a number of exemptions in the rules. For example, 4 - small quantities of byproduct materials, which are exempt from licensing are not subject to regulatory control beyond the Commission,s initial safety findings and issuance of a specific license authorizing the manufacture and distribution' of exempted sources or devices containing sources.
for Part 40 general licenses, there are essentially no constraints on the possession, use, and distribution of source material in quantities up to 15 pounds at any one time and up to 150 pounds in one calendar year. (The only exception is that general licensees are prohibited from administering source material, or radiation therefrom, either externally or internally, to human beings.) Transfers of the "small quantities" of source material identified above are not required to be reported to NRC, so how many individuals are generally licensed or who they are is unknown. Because Part 40, which has remained essentially unchanged for several 4 decades, is based in large measure on control of what was then considered strategic material, rather than on health 4
and safety concerns, and because of inconsistencies between Part 40 and Parts 30, 31, and 32, a major rework of Part 40 is highly desirable, but will not be discussed further here.
The focus of this paper is on byproduct material contained in devices generally licensed pursuant to Section 31.5 of 10 CFR Part 31. What is now Section 31.5 was published as an immediately effective rule in January, 1959, when there were about 4,000 gauges in use. In that time frame, the general license usually covered industrial research and use.
At the end of 1960, the number of gauges generally licensed increased by about 1,000, for a total of between 5,000 and 6,000 gauges. (See Annual Report to Congress of the Atomic Energy Commission for 1959, pp 454-6; and for 1960, pp 8-10.)
There are now 400,000 devices generally licensed in non-Agreement States in a wide variety of applications, but the regulatory framework and process have changed little over the past three decades.
Under Section 31.5, general licenses are created for byproduct
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material contained in certain measuring, gauging, illuminating, and controlling devices. There are an estimated 30,000 general licensees in non-Agreement States. The quantity of byproduct material within these devices ranges from microcuries to several curies. Enclosure 1 provides a description of the e r- - + y - ., , - , g .. , ~ ., y y9-<w- - - - - -- - - - - ----,y- w-
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l types of devices used and shows a breakdown of the curie i content of various types of generally-licensed devices, j The manufacturer of products to be distributed to general licensees must apply to NRC (or to an Agreement State) for a specific license to authorize that activity. Before issuing such a specific license, NRC (or the Agreement State in which the applicant resides) conducts a safety analysis of the product design as described in the application. In general, these devices are not required to be tested under the varied conditions under which the product must perform in a safe manner, although some devices are subjected to prototype testing in accordance with standards prepared by the American National Standards Institute (ANSI). If the applicant demonstrates an ability to meet the criteria for generally distributing the devices and complies with the appropriate regulations contained in 10 CFR Parts 19, 20, 30, and 32, or equivalent Agreement State regulations, then the applicant is granted a specific license authorizing distribution of the product to general Itcensees. For purposes of this paper, the specific licensee will be called the vendor. There are 54 vendors licensed by NRC and 76 vendors licensed by Agreement States.
g The vendors are required to report all transfers of sources and devices to generally-licensed individuals, quarterly, te NRC (or to the Agreement State that issued the specific license). Such reports identify: each general licensee by name and address; an inaividual who may constitute a point of contact between NRC and the general licensee by name and/or position; the type and model number of the device transferred; and the quantity and type of byproduct material contained in the device.
General licensees are expected to be able to use the devices safely without having radiological safety training or experience, because the general license program is predicated on the fact that safety is built into the device. General licensees are required by rule to follow any minimum safet.v instructions and precautions contained on the device Itbel, are required to have certain types of maintenance performed only by someone ;uthorized by NRC or an Agreement State, and may only transfer the device as specified in the rules.
However, for many devices, there is a potential for exposures that are unacceptably high (e.g., in excess of 10 CFR Part 20 limits), if these regulatory expectations are not fulfilled.
Discussion: Following is a discussion of the known problems with the general license program, the questions being addressed in the re-evaluation of the program, and the approach being taken to sharpen and update the program.
The Commissioners 5 A. Problems ,
- 1. Loss of Control The most significant problem associated with generally-licensed devices is loss of control over them. In practice, general licensees are often unaware of the potential hazards of the devices; they do not always follow the regulations on transfer, maintenance, disposal, and record-keeping. For example, radioactivity warning labels on the devices have been allowed to become illegible because of corrosion and wear. The devices then become susceptible to loss, theft, improper transfer, hnd improper disposal. Loss or theft of the device represents the most common kind of loss or control.
Less frequently, the devices are damaged usually in fires. However, sealed sources usually remain intact even during fires and explosions. The major exception to this source invulnerability occurs when sealed sources are melted in batches of steel, either as a result of being eroded out of their mounting in the wall of the steel-melting furnace (where they are a used as level detectors) or as a result of b*ing left attached to pieces of scrapped equipment that are being melted for recycle. Such occurrences, however, would not be substantially affected by whether the devices were generally or specifically licenseo The staff does not recall any instance where generally-licensed devices have caused serious injury or death such as has occurred in industrial radiography and medical therapy, and believes the probability of such an event to be very small.
- 2. Disposal Currently, the staff issues specific licenses authorizing the distribution of radioactive devices ,
to general licensees, without explicitly addressing the ultimate disposition of the licensed materials.
This is also true for specifically-licensed devices.
We see four problems with the ultimate disposition of sources within the general license program.
First, general licensees may be totally unaware of the costs associated with disposal of the devices, at the time they purchase them. Such costs for disposal may be several times the original purchase price and have not been highlighted or understood in the transactions between the vendor and the e
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I e I The Commissioners 6
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1 general licensee. Second, general licensees often !
do not know where to dispose of unwanted sources. ;
In some cases, the vendor will not accept return of the devices, and in other cases, a specific licensee will accept them only after receiving a fee, occasionally set at a level considered to be excessive
' or prohibitive by the general licensee. Third, '
general licensees are unlikely to be familiar with packaging requirements for commercial disposali !
And, fourth, general licensees cannot dispose of devices containing quantities of licensed material that exceed the Class C level, as defined in NRC's low-level waste regulations.
As indicated in Table 1.1. of Enclosure 1, over 1000 gener611y-licensed devices contain byproduct material exceeding Part 61 Class C concentrations.
A general licensee is in a dilemma if such a source is no longer wanted or needed, since there is not, absent an imminent health and safety problem, an established process for disposing of the source.
Furthermore, it is very unlikely that general a licensees are aware, at the time they purchase the device, of this situation or the costs of disposing of the device. (See SECY-89-083, SECY-89-169, and SECY-89-196 for a broader discussion of the greater-than-Class-C [GTCC) issue.)
- 3. Quality of Devices
- During the 1960's and 1970's, there were rulecakings which authorized the distribution of various devices to general 1;'er.sess. These separate rulemakings were not nece ssarily consistent with each other. In
- the early 1960's, regulations providing detailed requirements for quality assurance programs for vendors authorized to distribute to general licensees became part of the regulations in Part 32. As additional regulations were developed for new devices, the practice of incorporating detailed quality assurance requirements in the regulations appears to have stopped in the late 1960's or early 1970's. Section 32.51 merely requires the applicant to submit " sufficient information" r 'ating to, among other things, quality control. Howe. ', the current regulations do not specify what NRC expects from vendor quality assurance programs. In these cases, quality control programs associated with applications for-distributing to general licensees have been reviewed against industrial e
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- 4. f The Commissioners 7 consensus standards such as those of the ANSI, !
including the extent to which the standards addressed quality assurance in the design and manufacture of the devices. ,
r At present, license application reviews are based entirely on claims and data supplied by the manufacturer, with some devices being tested by the vendor and approved by the Underwriters' Laboratories, for use in explosive atmospheres. Some of the problems encountered with the leaking 3M static eliminators
- might Yve been avoided if the devices had been subjected to third-party testing under the types of environments in which the devices were used. Likewise, some recent problems with a design of teitiated exit signs could have been discovered througn third party testing.
3 Presently, all Agreement States are authorized to perform sealed source and device reviews, which i could lead to varied interpretations of standards, lack of uniformity, and administrative difficulties.
However, based on NRC's onsite review of Agreement 4 States' programs, this has not been a continuing problem. Currently, when an Agreement State performs a sealed source and device review, that State submits i
to NRC a registration sheet for the source and device
- for incorporation into the National Registry. The
, NRC staff does not undertake much technical review of those sheets and the underlying analysis. Once a device is approved by NRC or an Agreement State for vendor distribution, that device can be distributed to general licensees nation-wide.
- 4. Low Regulatory Priority Budgetary constraints have limited NRC oversight of the general license program. In NRC contacts with knowledgeable individuals, one of the most frequent criticisms of the general license program is that not enough attention is being given to it, contributing to the difficulty in determining how and why to improve the program. There is a belief that NRC would have greater contact with the general licensees through a periodic inspection schedule.
However, NRC can now inspect general licensees on any .
schedule it chooses, if the resources can be justified. i General licensees are believed to be in a lower-risk l category and, therefore, because of constrained i resources, NRC typically inspects only if a problem is suspected.
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The Commissioners 8 B. Issues Beino Addressed in Re-evaluation Nearly everyone involved in the general license program holds views on what, if anything, should be done to improve it. Those views span a very wide spectrum rangingfromdoingnothingtobecomingmoreproactIve.
All these positions have some merit. Thus , the p r l.T. . y -
problem is to choose a sensible course which addresses areas where current practice is no longer judged acceptable.
- 1. Viability of General License Concept Making the choice of strategic options to improve the program necessitates balancing the additional resources required against the Incremental safety gained. Thus, the staff has reconsidered the viability of the general license concept. Clearly, some or all of the generally-licensed devices could be specifically licensed, but this would entail over one hundred full-time equivalent units (FTE) of a NRC's resources, as well as substantial impacts on the general licensees, stemming from the need to 4 apply for a specific license. Thus, one issue requiring resolution is: what is gained through specific licenses? The most significant advantage of issuing specific licenses as opposed to general licenses is the more substantive contact with the licensee through the five-year license-renewal cycle.
L. Assianment of Responsibilities Evaluation of broad strategy options for improving regulatory compliance under the general license program included thorough consideration of where to place responsibility for implementing changes and how to be sure that the desired results will be achieved. Whether to place most responsibility on the Commission and Agreement State staffs, on the vendors, or on the general licensees involved consideration of many pros and cons.
One view holds that it is easier to apply further regulations to 54 vendors than to further regulate about 30,000 general licensees, in non-Agreement States, who possest 400,000 devices. Thus, NRC could choose to place most of the responsibility for monitoring and tracking generally-licensed devices on the vendors. To be effective, this strategy would require that Agreement States take compatible
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The Commissioners 9 measures. Even if this were to occur, the vendor would be made a " middle-man" between the regulator, with the legal standing, and the general licensee. ,
The vendor could neither require the general licensee to respond to requests for information nor take enforcement action for inadequate or erroneous responses. Such an approach would vock if vendors 1 could only lease the devices to general licensees, an arrangement the staff believes unjustified.
The problems that have occurred with general licensees can all be traced to violations of existing regulations. '
Imposing new requirements on general licensees will not help unless the effort is made to assure compliance.
Wherever responsibilities are placed, there is a clear need to ensure that responsibilities are well '
understood, periodically reenforced, and complied with.
- 3. Acceptability of Devices Another issue frequently raised is whether certain devices should continue to be withia the general
. license domain. Interaction with knowledgeable individuals involved in the general license program reveals a widely-held view that there are some generally-licensed devices that should have tighter regulatory controls over them than those afforded through the general license concept. An example is a device that utilizes curie quantity americium sources.
Under the current rules, devices (including portable gauges housing curie quantity sources) must be generally licensed, if requested by a vendor, upon a demonstration that the requirements specified in the rules for a general license are met. Therefore, to require certain devices to come under a specific license would requiro a rule change.
C. Staff Approach Because of the aforementioned concerns and problems, the Office of Nuclear Material Safety and Safeguards (NMSS) has considered a large number of initiatives that could sharpen and update the general license program and process.
Further, because of the wide range of views on what more, if anything, should be done to improve the general license
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The Commissioners 10 program, this paper was subjected to a much more thorough peer review than normal. For example, a preliminary evaluation of possible options for improving the program was performed, and those results were transmitted on March 2,1989 to the Regional Of fices and all Agreement States for review and comments.
Thestaffreceived2i' responses (seeEnclosure2 fora summary), including 14 from Agreement States and one from a non-Agreement State.- Nearly all commenters urged greater oversight and regulation of the general license program. However, little specific information was offered to characterize or quantify the expected benefits of an increase in regulation.
Based on this examination and comments received, the staff concludes that the underlying concept of the generally-licensed products (i.e., build adequate safety into the device so that users need not have knowledge of radiation protection principles) has worked reasonably well, but there is room for improvement. Following is a discussion of the approach the staff is taking to improve the genaral license program. (See Enclosure 3 for a more in-depth
( discussion of the approaches and Enclosure 4 for a discussion of initiatives that might be considered in the future if the selected initiatives do not result in the anticipated improvements.)
- 1. Control To improve control of and licensee awareness of their generally-licensed devices, NMSS has already undertaken two initiatives. The first involved entering into a computer all transfers of devices and materials as reported to NRC via quarterly i transfer reports from the vendors. The second :
initiative, currently being developed by the staff, t is a proposed rulemaking that would establish a'
- reporting program in which NRC would periodically send each general licensee a request for information on the status of the devices, including information related to inventory, maintenance, and disposal.
Non-respondents would be contacted by telephone and/or field inspection. This program would become an item of compatibility for the Agreement States.
Some states might accomplish these objectives through their existing inspection programs for '
general-licensees. This practice is expected to make general licensees more aware that they have the devices and must meet.certain regulatory obligations.
It is also expected to reduce the probability that
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.The Commissioners 11 the devices will enter unauthorized disposal channels (believed to be the single largest problem associated with control and safety).
The staff is developing a pilot program to survey, through a contractor, some general licensees to
- c:rtci.c the status of their devices and the extent to which they have surplus sources that exceed GTCC concentrations.
NRC has little information on whether general licensees are assuring that all testing and servicing are being performed in accordance with the regulations and instructions. NRC's rules do not presently require reporting of information about the test results or problems being experienced with the devices. The aforementioned reporting program should obtain '
information on test results, who performed the tests, and on sny problems with the device. Such a reporting system would enhance licensees' awareness of their '
responsibilities and would enhance NRC's awareness of what is going on in the field. The latter could serve as a basis for inspections, enforcement actions, and a changes to the regulations.
Is mentioned before, the vendors are also required to report to NRC, on a quarterly basis, all transfers of devices to generally-licensed individuals. That report must identify, among other things, a point of contact between the Commission and the general licensee.
The contact point identified in those reports is frequently a ourchasing agent who may or may not be aware of the nature of the device, or be in a position 4 to ensure that the responsibilities are carried out.
The rulemaking on the reporting program would require the vendors to identify an individual in the general licensee's organization who has authority to require, for example, necessary tests to be performed and proposed annual reports to be submitted. This would increase the t. hance that the responsibilities of the general licensee would be fulfilled.
Each vendor chooses its own format with varying degrees of detail in the quarterly transfer reports.
This complicates the process of entering the information into computer storage. Specifying the format would decrease the potential for inaccurate or incomplete reports. The reporting rule should be ame W d to ast,ure a more appropriate general licensee contact and to standardize the reporting forms and requirements.
4 The Commissioners 12 Because portable devices have the potential for exposing a, wider range of people, the staff believes that greater controls should be placed on those devices to ensure proper transporting, storage and use. There is no precise way to draw a line on the
, source strength above which specific licensing
. . should be required, but the most commonly offered is one curie.
The staff intends to determine whether there should te an upper limit on the curie quantity of licensed material as one factor in deciding whether a device should be generally-licensed. Devices containing quantities of materials above such a limit and having certain other characteristics would be specifically licensed to ensure greater accountability of the licensees. Suchlicensingactionswouldinclude reviews of the applicants training, controls, and uses of the devices, as well as their disposal intentions and capabilities to finance the disposal of the devices. Because of the complexity of the issues involved, the staff believes that the rulemaking process would be the preferred way to a identify and pursue the issues.
The staff notes that there are instances where a particular type of device raises safety concerns, even though it meets the specifications in the rules for general licenses; e.g., curie quantity americium-241 gauges. The rules are based on the assumption that the general licensee will comply with all requirements. That assumption may be ideal, but is ter uous in the real world. Where generally licensed devices have greater potential for accidents, can cause high exposure or extensive contamination if
. involved in an accident, or are likely to enter unauthorized disposal channels, etc., the devices might not be good candidates for general licensing.
Therefore, the staff believes-that the rules should be amended to take into account these types of considerations, in addition to an upper bound on source size, for decisions about general licensing or specific licensing. Although NRC would not contemplate exercising this authority frequently, having it would be beneficial. Among other things, it would encourage a more conservative approach in the design of devices for general license use.
Although the problems of disposal of generally-e
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The Commissioners- 13 licensed devices surface only now and then, when they do, it becomes evident that there is a significant gap in the general license program; namely, what to do with unwanted sources. That gap can only become more significant with time, as the devices approach the end of their useful lives or the need for them wanes.
The staff has considered the possibility of requiring vendor applicants to submit a " proposed ultimate disposition plan" for the radioactive materials they want to sell to general licensees. The staff intends to fur (her explore this matter through a rulemaking.
At a minimum, the staff believes the vendors should be required to inform each general licensee, before the transaction, what the projected disposal costs are for the device.
- 2. Greater-Than-Class-C Quantities (GTCC)
The problems encountered with disposing of unwanted generally-licensed devices containing GTCC quantities of byproduct material are the same as those for specifically-licensed devices. This matter will be e addressed in the Commission paper on GTCC that is scheduled to be issued in late 1989.
- 3. Quality of Devices As previously mentioned, license application reviews are based, in most cases, entirely on claims and data supplied by the manufacturer. Staff has initiated an 1" dependent testing program to perform an audit of so+ of the generally-licensed devices,
' but that effort is small. Requiring third party testing of all types of generally-licensed devices o would have the advantage of confirming the proposed design and uses of the device and confirming the acceptable environments of use. With such information, the staff could place conditions on the vendor's specific license, authorizing distribution to general licensees, which would limit distribution to those tested uses and environments. This would better ensure that unanticipated (at the time of authorizing distribution to general licensees) uses and environments do not occur. The staff intends to initiate a rulemaking to further explore this option.
Improving the quality assurance requirements of the vendor would provide a greater degree of confidence that finished devices would be manufactured uniformly,
. - . - _- - _= -. - --
The Commissioners 14 that they would be built as designed,,would meet the specifications furnished, and would meet any conditions derived from a testing program. Such vendor programs should be tailored to the nature of the device and the-intended uses. Accordingly, rather than remaining vague on the quality assurance requirements, the
-. - staff intends to develop a proposed performance-oriented rule that would require vendors to have a quality assurance program in the design, manufacture and distribution of devices to be generally licensed.
Such a requirement should allow flexibility on how extensive the program should be, determined by the safety significance of the distribution to be authorized (e.g., in association with the manufacture of consumer producti, versus manufacturing of limited industrial products).
- 4. Quality of Licensing Review Presently, all Agreement States are authorized to perform sealed source and device reviews, which could lead to varied interpretations of standards, lack of l uniformity, and administrative difficulties. However, a based on NRC's onsite review of Agreement States' programs, this has not been a continuing problem.
Once a device is approved by NRC or an Agreement State for vendor distribution, that device can be 4 distributed to general licensees nation-wide. While a single organization performing these reviews could ensure carefully prepared standards, clear policy and feed-back to the industry, prompt changes in policy in response to field experiences, and consistent applications of policy to a wide variety of circumstances, there is no public health and safety reason to terminate the Agreement States' authority to perform these reviews.
However, to better ensure consistency and uniformity, the staff plans, within budget constraints, to enhance NRC oversight of Agreement State sealed source and device reviews.
- 5. Staff Initiatives and Resources The FY 90-91 budgets provided resources-for.those initiatives expected _to have the highest payoff in terms of enhancing safety in the general license program. This includes two FTE in FY90, and four FTE in FY91 and beyond, to maintain tracking of the generally-licensed devices, to develop a reporting requirement to enhance our awareness of possible _
problems with the devices, and to increase our followup
l' l
-9 s The Commissioners 15 inspection effort., Two additional FTE-are included beginning in FY91 to review third party testing programs and to review vendor quality assurance programs. Also, the Office of Nuclear Regulatory Research has resources available to pursue appropriate rulemakings.
Other initiatives identified within the paper, such as increasing the staff's oversight of Agreement State general license programs, and conversion of certain generally-licensed devices to specifically-licensed devices, were given consideration during the past budget cycle, but were not funded because of competing priorities. The staff will continuo its analysis of these and other initiatives and will modify its resources requests, as appropriate, during the next budget cycle.
Coordination: This paper has been reviewed by the Office of the General Counsel and there was no legal objection.
\
a
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M. Tay r ing Executive Director for Operations
Enclosures:
- 1. Devices Licensed under 10 CFR Section 31.5
- 2. Summary of Comments on Draft
- 3. Prime Candidates for Improving General License Program
- 4. Other Options DISTRIBUTION:
Commissioners OGC OIG-LSS GPA REGIONAL OFFICES EDO ACRS ACNW ASLBP ASLAP.
SECY
DEYlCES AND MATERIALS GENERALLY LICENSED UNDER 10 CFR Section 31.5 There are many different byproduct radionuclides authorized to be transferred to general licensees. The quantity of licensed material contained in devices also covers a wide range. These wide variations result from the vendors matching)the radionuclides'orproperties activity to the measurement function to(e.g., nature of Thus, be performed. decaythe andquantities specific of radionuclides in devices range from microcuries to curies and include many different radionuclides. Following is a description of some of the device types that are used under the general license. Table 1.1 lists the estimated nunber of devices and materials which have been issued to general licensees authorized by 10 CFR Section 31.5.
la Aerosol Neutralizer. In industrial applications aerosol particle sizes of ter. are measured by an optical device which "looks at" the particles while they are suspended in air. Often the particles have picked up an electrical charge which causes them to be attracted to surfaces they pass near. Adsorption of particles on surfaces would interfere with optical measurements on the particles. Kr-85 sources of 2 to 15 millicurie size are used to produce ions which will neutralize the charge on particles and thus keep them from plating out before the optical measurements can be made. The different source sizes of Kr-85 are chosen according to the s desired fitw rate through the device.
10 Beta Backscatter Gauge. Since the beta-particle mass is small compared with that of the eucleus, large deflections can occur in single collisions, particularly when beta particles of low energies are scattered by high-atomic-number elements. When the scattering material is sufficiently thick and multiple scattering occurs, a large fraction of the betas may be scattered through more than ninety degrees. This phenomenon is called backscattering, since it bounces the particles back in the direction from which they came.
The beta backscatter gauge contains a small sealed source and a radiation detector that measures how much radiation is reflected back from a material sample. The amount of radiation reflected back is dependent on the thickness of the material. These gauges differ from the industrial thickness gauges in that they contd n smaller radioactive sources (usually less than one hundred microcuries) and are also smaller dimensionally. Because they can give quick and simple measurements, they are consnonly used in quality control laboratories. These gauges are commonly used for thickness measurements on plastic, paper, steel sheets, precious metal platings, plating of circuit boards, and plastic coatings.
ENCLOSURE 1 .
4
- 3. Electron Capture Detector The detector incorporates a radioactive foil source, usually nickel-63, which emits beta particles and tonizes the carrier gas, e.g., nitrogen flowing through the detector. Under the influence of a polarizing electric. field, a constant current is set up. When an electron capturing substance passes through the chamber, the current is reduced due to the absorption of electrons by this substance. The output signal is proportional to the molecular concentration of that component.
The pulse-frequency is detected, amplified, and made the basis of the chromatography. The sensitivity and selectivity of the response of the detector are determined by the electron affinity of the substances. In the case of organic compounds, the electron affinity depends mainly on the predominant functional group in the molecule, such as halogens, esters, hydroxyls end other oxygenated groups.
4 Electrostatic Voltmeter. A small nickel-63 source is used to ionize air near the detector / probe aperture of the voltmeter. When the detector is placed near a surface bearing a static charge, current flows through the ionized air into the detector. The current drives the amplifier and feedback to reduce the electrostatic field at the detector to zero. The potential difference between s
the detector current and the feedback is translated into a voltage roading.
The device is used as a monitor in electrostatic control systems.
- 5. Fuel Densitometer Emitter. In some comercial jet aircraft, for example the Boeing 757s, each fuel tank has a 2-millicurie Am-241 density gauge which measures the attenuation of radiation by the fuel between the source and the detector. Since attenuation is proportional to the density of the fuel, a direct cAculation of density can be made from the output of the radiation detector. The output is fed into a computer which, on the basis of the fuel density, controls the fuel-air mixture to be supplied
-to the jet engines. This very simple device provides a highly reliable method of controlling the fuel-air mixture in a way which promotes fuel economy.
- 6. Gauging Devices. This category contains-a large variety of measuring devices, all of ~which work or. a similar principle in that each contains a radioactive source that is shielded in 311 direction except for a small opening which emits a beam of radiation. The beam passes through the material being measured. Some of the radiation is blocked or reflected by the material, with denser or thicker materials blocking more of the radiation. These variations can be measured by radiation detectors which can, in turn, be calibrated to measure thickness, density or weights of materials. This information is then used to control manufacturing processes, such as the thickness of steel, paper, or plastic sheeting, or of coatings on such materials.
A principal advantage of gauges is that they measure levels in a completely non-contacting manner. The nuclear gauges can also be used on the most difficult process materials (e 9., those that are corrosive, abrasive, very hot, under high pressure or viscous). There are two types of nuclear level systems - single point (on-off) and continuous.
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The-simplest of single point level control systems utilizes one or more Gleger-Muller tube detectors, a simple amplifier and a preset relay output to indicate if the process material is between the source and detec tor.- More than one single point gauge may be used to indicate level at discrete points in the container. The radionuclide source is sized to produce a field at the detector of between 0.1 and 0.5 millirem per hour with no process material in the radiation path. When the process material comes between the source and the detector, the radiation at the detector is reduced to essentially zero, enabling a reliable switching -
. actions.
Continuous systems utilize a fan-shaped radiation beam and vertical ion chamber detector. As the process material rises, increasing amounts of radiations are blocked. The detector, sensing proportionally less radiation, produces an analog signal corresponding to material leven.
- 7. Fill-level Gauges. Fill-level gauges are a special category of gauging devices. The most widespread applications include controlling the level in bottles, cans, or jars. These americium-241 fill-level gauges contain up to 100 mil 11 curies and are not suitable for dense materials or large vessels because of the relatively low energy of its photon.
- 8. In-Flight Blade Inspection Systems. The in-flight blade inspection system for helicopters consists of a 500-microcurie Sr-90 source in a housing mounted in each blade of the helicopter rotor. Typically, the helicopter that this system is used on has seven blades. The Sr-90 source is mounted on a spring-loaded bellows that holdh the source inside the hollow blade. Because each blade has a core cavity that is under vacuum, if the vacuum should be lost due to a crack in the blade, then the source " pops-up" outside the blade. A radiation detector on the fuselage sends a signal to the pilot indicating that a crack has developed in the blade and that the pilot must land innediately.
- 9. Liquid Scintillation Spectrometers. Liquid scintillators consist of organic scintillators used as the solute in liquid organic solvents. The passage of nuclear radiation through the solution first excites the solvent to a higher electronic state which quickly transfers that excitation energy to the solute before quenching can occur. The solute then returns to the electronic ground state by emitting a photon with a wavelength suitable for photomultipler-tube response. Liquid scintillation counting systems are used to measure the amount of radioactivity in samples and are predominately used by biomedical and chemical research facilities. These instruments contain microcurie quantities of cesium-137, or radium-226 to serve as internal calibration reference source.
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100 Self-Luminous Exit signs. Self-luminous exit signs contain hydrogen-3 (tritium) gas which decays by beta particle emissions. When the beta particle strikes a phosphor, the latter gives off visible light. Thus,
, the tritium is mixed with a phosphor and coated on the inside of a glass tube to serve as a light source. The exit signs are frequently installed in places where it would be difficult or expensive to wire for electrical signs. The useful life of the exit sign is about. ten years, because of radiation damage to the phosphor.
- 11. Static Eliminators / Meters. Among the most widely used of the --
radionuclioe devices, static eliminators with polonium-210 sources work by ionizing the air next to the surface of material that is being produced in sheets or rolls, so that the ionized air will conduct away the static electricity charge which builds up during the manufacturing process. The primary purpose in myt cases is to prevent the static electricity from building up a sufiicient charge to attract dust particles to the surface of products such as aluminum foil, plastic wrapping materials, photographic film and many others. In some applications, these devices are used to prevent static electricity from creating a spark hazard in an explosive atmosphere, but the most comon application is in preventing dust from adhering to surfaces of the product.
Tritium is also used in static meters to monitor hazard areas for static charge buildup, in manufacturing ond/or laboratory environments such as hospital operating rooms, fuel storage and handling areas, coating or extruding with flamable so& vents, processing of paper, plastics, textiles, and semiconductor materials. The device measures static without contacting charged objects, and checks the effectiveness of static control equipment.
The voltage on the surface being measured is induced onto an internal element of the meter. This is detected through the tritium beta-decay and a high impedance voltage measuring element.
- 12. X-Ray Fluorescence Spectrometer. X-ray fluorescence techniques use radionuclide sources of low-energy gamma, x-ray or bremsstrahlung radiation to excitc characteristic x-radiation from a target material.
The excitation process involves ejection of a K or L electron of the target followed by radioactive de-excitation of the atom when an electron from a higher shell falls into the vacancy. A photon is then emitted with energy equal to the difference in the binding energies of the two electron shells; that photon's energy is unique for each element. Calcium (Z=20) is the element of lowest atomic number conveniently measured routinely while, with special detection methods, the range can be extended down to magnesium (Z=12).
The micronmethod range down can be to used both a small for measuring fraction of a microncoating) thicknesses and for making a rapid(in the nondestructive chemical analysis, in the latter, the incident radiations excites individual constituents of an alloy or mineral or impurities in a substance (e.g., lead in gasoline) and photons from each can be counted selectively by pulse height analysis.
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TABLL 1.1
" ESTlHATED NUMBER OF GENERALLY-LICENSED DEVICES AND MATERIALS UNDER SECTION 31.5 DEVICE TYPE ISOTOPE NUMBER OF TOTAL AND DEVICES NUMBER ACTIVITY SOLD OF a
PER YEAR DEVICES
.1. AEROSOL NEUTRALIZER Kr-85(15aci) 120 9600 800 700G'
- 2. BETA BACKSCATTER Pm-147(900uCl GAUGE- T1-204(45uC1))
Sr-90(5uC1))
Cs-137(30uCi
- 3. ELECTRON CAPTURE Ni-63(15mC1) 900 8000 DETECTOR 4.- ELECTROSTATIC Ni-63(10uC1) 890 3000 VOLTMETER
Cs-137(.5-401))
Kr-B5(.5-1.2Ci Sr-90(.5-1Ci)
- 8. IN-FLIGHT BLADE Sr-90(500uti) 200 1000 INSPECTION SYSTEMS
C
- 10. SELF-LUMIN0US EXIT H-3(25Ci) 20,000 180,000 SIGNS
Am-241 10mC1)
Cm-244 30 mci) (GTCC)
Footnotes
- a. Numbers represent transfers of device and materials as reported to NRC in non-Agreement State quarterly reports. (continuedonnextpage) 5
4 The' total numbers of devices nation-wide n.ay be higher, because some Agreement State licensees are not required to submit quarterly reports to hRC.
b.- GTCC neans greater-than-Class-C quantities. (See 10 CFR Section 61.55, " Waste Classification," for the definition of Class C wastes.)
- c. Represents the number of signs sold in the past ten years, which is the useful life of exit signs. Therefore, we can expect the return of about 20,000 signs per year starting in 1990. ,,
- d. Represents the number of static eliminators sold in the last three years, which is the useful life of static eliminators. They are then replaced or returned to the vendor.
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SUMMARY
OF COMMENTS ON THE DRAFT EVALUATION OF THE GENERAL LICENSE PROGRAM On March 2,1989, the staff sent a "strawman" version of this paper to the Regional Offices, Agreement States, and other interested persons for review and comment. A total of 24 commented on the draft, including 14 Agreement States -
and one non-Agreement State. Table 4-1 shows the number and general nature of comments on the various sections of the draft evaluation of the general license program -
Among the general comments on the overall report, eight were favorable, although suggesting-changes, and four more were supportive, but gave more emphasis to their suggested changes. One(RegionIV)wasunfavorable,suggestingfurther consideration of, terminating the general license program.
There were 12 comments on the Background section, all favorable, but suggesting minor changes.
Five comments on the Initiatives section were favorable, but suggested changes; and one was unfavorable, on the basis that the statement on sealed source ' safety (page 5)-ignores the real problem of inadvertently melting the sources in scrap-reprocessing furnaces, which has happened.
-The five comments on the Issues section all dealt with suggested changes in presentation. One took issue with placing added reporting re.;onsibilities on vendors, stating that the real issue is, "Will we put enough effort into inspections to maintain adequate regulatory control?"
R Enclosure 2
4 I .
There were four general comments on the Discussion section, all of which were suppurtive, although three suggested changes in emphasis. Most of the comments dealt with the five specific areas for improvement. The Upper Bound on Source Size Permitted under General License drew the most comments --twenty-three --
all of which were v.'p.aer+ive .but suggested changes of various sorts. One cornenter (State of Kentucky) took sharp issue with the staff's view that the magnitude of the problem does not justify the expenditure of the additional resources (threeFTEforlicensingandinspection). Two were uncritically supportive.
The section on Responsibilities and Communications drew five totally supportive comments and 16 that suggested changes that were relat.ively minor in nature.
The section on Ultimate Disposition of Sources and Devices was the next most frequentlycommegtedon. It had three completely supportive comments and 13 that suggested changes. The most frequently-suggested change was for specific licensing of items whose waste disposal category would be greater-than-Class-C.
Third-Party Testing was the subject of three totally favorable comments and eight that were favorable, but with suggested changes. The changes were all different and minor in nature.
The Quality Assurance Program for vendors drew four totally favorable comments, and six that were fcvorable, but suggesting changes. Concern was expressed that the third party be truly independent, not just an agent of the manufacturer.
Other Options, on page 19 of the March 2,1989 draft of this paper, received three generally favorable comments, three that suggested changes, and one disagreeing with the proposal to create a Sealed Source and Device Section, on the basis that added effort on policy guidance for vendor licensing would be of more benefit.
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The section on Recommendations received three totally favorable endorsements and -
one that objected to the recommendation to continue generally-licensing gauges, including those portable gauges that are now generally licensed. The objection was based on the view (State of Florida) that some of these devices should 1,e .pcel.%11y licensed.
Enclosure 3. " Options That Hight Be Considered Further," drew 11 favorable '
comments, plus one that suggested a change to have inspections done by mail, and five that opposed certain of the options: one against the annual fee, two opposing the idea of terminating the general licensing program, one disagreeing with the staff's view that inspections of general licensees would require too much effort, and one stating that staff should not express a view on sale vs lease, because this is a business decision best left to the vendors.
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r TABLE 2.1
SUMMARY
OF COMMENTS ON THE DRAFT EVALUATION OF THE GENERAL LICENSE PROGRAM W
FAVORABLE FAVORABLE, BUT UNFAVORABLE SUGGESTING CHANGE OR DISAGREE Gen 3ral Conments on the cverall report 11 1111 1 LLa scc NO COMMENTS Background ut1 pt1 11 Initiatives ut1 1 i
Issues ut1 1 Discussion 1 111 Quality Assurtnce Program 1111 Mt1 1 Third-Party Testing 111 M41 111 Ultimate Disposition 111 u t1 M tf 111 Upper Bound 11 uti ut1 ut1 1111 1 Responsibilities lill uti M41 ut1 1 Other Options 111 111 1 Reconnendations 111 1 Enc 1 1 1 11 11 Enc 1 2 1 Enci 3 Annual Fee 11 1 Terminate General License Program 1 11 Sale vs Lease 1111 1 1 Inspect Gen. Licensees :1 1 Responsibilities 1 R: porting 1 End Use 1 4
PRIME CANDIDATES FOR IMPROVING GENERAL LICENSE PROGRAM 4
- 1. 00ALITY ASSURANCE PROGRAM FOR VENDORS During the 1960's and 1970's, there were rulemakings which authorized the distribution of various devices to ge39ta', licensees. These separate rulemakings were not necessarily consistent with each other. In the early 1960's, regulations providing detailed requirements for quality assurance programs for vendors authorized to distribute to general licensees became part of the regulations in Part 32. As the number of types of generally-licensed devices increased, that practice of incorporating detailed quality assurance requirements in the regulations appears to have stopped in the late 1960's or early 1970's. Section 32.5 merely requires the applicant to submit " sufficient information" relating to, among other things, quality control. In these cases, quality control programs associated with applications for distributing to general licensees have been reviewed againstindustrjalconsensusstandardssuchasthoseoftheANSI,includingthe extent to which the standards addressed quality assurance in the design and manufacture of the devices. However, the regulations are not clear or specific on whether the vendor must have NRC or Agreement State approval before distributing devices with a revised design.
Improving the quality assurance requirements on the vendor would provide a greater degree of confidence that finished devices would be manufactured uniformly, and that they would be built as designed and would meet the specifications furnished, as well as meeting any conditions derived from a testing program (to be discussed later). In 1988, numerous 3M static elimination devices were discovered to be leaking radioactive material. Some of the problems encountered with the 3M devices might have been avoided if an adequate quality assurance program had been used during the design, manufacture, and distribution of the devices. Other than the 3M case, leaking devices have not been a dominant source of the problems with the generally-licensed devices.
ENCLOSURE 3
Quality assurance programs of vendors should be tailored to the nature of the device and the intended uses. Accordingly, rather than remaining vague on the quality assurance requirements, the staff recommends further exploration of a performance-oriented rule that would require vendors to have a quality assurance program in the design, manufacture and distribution of devices to be generally licensed. Such a requirement should allow flexibility on how extensive the program should be, to be determined on the safety significance of the distribution to be authorized (e.g., in essociation with the manufacture of consumer products versus manufacturing of limited industrial product. . Of the 24 commenters on the draft of this paper, a total of 10 commented favorably on requiring a quality assurance program, and none disagreed.
As an alternative to a rule, the staff could develop a regulatory guide that describes the staff's expectations on vendors' quality assurance programs.
This approach would be less resource-intensive than a rulemaking, and has the advantage of providing greater flexibility in deciding on what is the acceptable scope and magnitude of quality assurance programs. The disadvantage is that regulatory guides do not create requirements.
4 Should there be such a requirement, the staff estimates that the continuing incremental need for NRC resources would be about three to four FTE, including both licensing reviews and inspections of vendors' quality assurance programs, starting in about FY92.
- 2. THIRC-PARTY TESTING OF GENERALLY-LICENSED DEVICES At present, license application reviews are based entirely on claims and data supplied by the manufacturer, with some devices being tested by the vendor and approved by the Underwriters' Laboratories, for use in explosive atmospheres.
Some of the problems encountered with the leaking 3M static e:iminators might have been avoided if the devices had been subjected to third party testing under the types of environments in which the devices were used. Likewise, some recent problems with a design of tritiated exit signs could have been discovered through third party testing.
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1 An advantage of third party testing would be to confirm the proposed design and uses of the device and to confirm the acceptable environments of use. With such information, the staff could place conditions on the vendor's specific license, authorizing distribution to general licensees, which would limit distribution to those tested uses and environments. This would better ensure that unanticipated (at the time of authorizing distribution to general licensees) uses and environments do not occur. Such a program could also be called upon to re-evaluate the performance of devices that are suspected of being faulty or damaged by some accident. or are returned to the manufacturer for any reason, and to evaluate whether there is need to change the criteria for the acceptability of the device, in view of health and safety concerns arising from experience.
As with on going third party testing for many products that do not contain radioactive material, costs for the testing would be borne by the manufacturer of the product.
Although the staff has initiated an independent testing program to perform an audit of some of the generally-licensed devices, that effort is relatively small, involving about 0.1 FTE and a few hundred thousand dollars. The staff recommends thatarequirements for independent testing by an impartial third party, with costs absorbed by the vendors, be further explored through a rulemaking. If there were such a rule, we estimate that the continuing incremental impact on licensing and inspections would be modest; on the order of one to two FTE, primarily for reviewing the testing programs, the qualifications of the third party, and the test results.
Of the commenters on the draft of this paper, 11 were favorable and none was unfavorable toward requiring third party testing.
- 3. ULTIMATE DISPOSITION OF BYPRODUCT SOURCES Currently, the staff issues specific licenses authorizing the distribution of radioactive devices to general licensees, without explicitly addressing the ultimate disposition of the licensed materials. This is also true for 3
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specifically-ficenseddevices. In general, the regulations require disposal of waste sources in a manner similar to that of specific licensees. The rules prohibit the transfer of a device to another general licensee, unless certain conditions exist. We see four problems with the ultimate disposition of sources within the general license program. First, general licensees may be totally unaware of the costs associated with disposal of the devices, at the time they purchase them. Such costs for disposal may be several times the original purchase price and have not been highlighted or internalized in the transactions between the vendor and the general licensee. Second, general licensees often do not know where to dispose of unwanted sources. In some cases, the vendor will not accept return of the devices and, in other cases, a specific licensee will accept them only after receiving a fee, occasionally, set at a level considered to be excessive or prohibitive by the general licensee. Third, general licensees are unlikely to be familiar with packaging requirements for commercial disposal.
And, fourth, general licensees cannot dispose of devices containing quantities of licensed material that exceed the Class C level as defined in NRC's low-level waste regulations. (See 10 CFR Section 61.55, " Waste Classification," and SECY 89-083 for a discussion of the "above Class C" disposal problem.)
a Although these problems surface only now and then, when they do, it becomes evident that there is a significant gap in the general license program, namely what to do with unwanted sources. That gap can only become more significant with time, as the devices approach the end of their useful lives or the need for them wanes.
The staff has considered the possibility of requiring vendor applicants to submit a " proposed ultimate disposition plan" for the radioactive materials they want to sell to general licensees. Options for such a plan include an.
agreement for the vendor to take the device back if it is no longer wanted, an agreement from the general licensee to retain the device until its activity could be considered " decayed away" (which in most cases is not practical), or an agreement that the general licensee will take on the responsibility of disposing of the source at a low level waste site, assuming s Jch sites will 4
l accept the material. Because there is no disposal site for wastes greater-than-Class C, it would seem appropriate to require any vendor seeking authorization to distribute materials that would come within this category to take back the material from the general licensee once it is no longer wanted. Any such take-back provision could be addressed under the financial assurance requirements for decommissioning of the vendor's facilities, to ensure that the vendor would meet its obligations.
The staff recommends further exploration.of this initiative through a rulemaking.
At a minimum, the staff believes the vendors should be required to inform each general licensee, before the transaction, what the projected disposal costs are for the device. Should there be a requirement to address the ultimate disposition of the devices, there would be modest continuing demand for resources, on the order of one FTE, because the review of the disposition plan would have to anticipate the number of devices to be sold and the costs of disposal. The incremental costs for vendors could be very substantial, if made retroactive for devices already sold, since the disposal costs for the devices have not been internalized and could in many cases run into the tens of thousands of dollars range, per device.
Considerable interest in this area was expressed by the Agreement States, during the comment period for the draft of this paper. Sixteen favorable comments were received, with no unfavorable comments, on addressing the ultimate disposition of the devices.
- 4. UPPER BOUND ON SOURCE SIZE PERMITTED UNDER GENERAL LICENSE The staff has considered whether there should be a risk-based upper limit on the quantity of material that can be obtained under-a general-license. In deciding where to draw the line, one must consider the nature of the device (e.g., sources imbedded in a large, fixed-location device), the relative radiological hazard associated with the radionuclide and the estimated number of devices to be used, the environment of use, and the potential for misuse or 5 .,
~ _ _ _ _ __.._ _ _
loss of control. These factors must be entered into the balance between the
, additional protection that might be achieved by specifically licensing the device and the resources required to license those devices.
4 This topic received the greatest number of comments during peer review of this paper. A total of 23 commenters addressed this subject, with all but one in favor of placing an upper limit on the sources allowed in generally-licensed
~
devices. Many commenters linked the cut-off to the greater-than-Clais U quantity.
One Agreement State noted that the resource impact would be small relative to the additional protection of the public health and safety afforded from specifically licensing the devices. Other comm, enters would only allow devices containing less than one curie to be generally licensed. However, little specific information was received on a cost-benefit analysis that would justify either option.
Nonetheless, the staff recommends adopting some constraints on source sizes permitted under the general license program, based on use, potential for accidents, loss of control, or disposal problems.
As previously indicated, Enclosure 1 lists the types of generally-licensed devices and indicates the quantity of radioactivity contained in the devices, as well as the total number of devices that are generally licensed. Based on that information and considering the factors just noted, the staff believes that resources cannot be justified to specifically license the following devices: static eliminators, aerosol neutralizers, beta backscatter gauges, electron capture detectors, electrostatic voltmeters, in-flight blade inspection systems, liquid scintillation spectrometers, self-luminous exit signs, X-Ray fluorescence spectrometers, calibrator sources and reference sources, and similar low-hazard devices.
The main part of any evaluation, either under a general license or a specific license, would be of the prototype sealed source and device. Little would be gained by the paper transaction involved in specific licensing. The risks associated with those devices do not justify expending hundreds of FTE to specifically license them. The remaining devices are more problematic.
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The fill level gauges and fuel densitometer emitters contain 100 mci and 50 -
. mci, respectively, of americium-241. Although the americium is used for-its
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photon-emitting property, it is also an alpha-emitter, a factor requiring additional. consideration. The fill level gauges are almost always fixed, sturdy gauges which are rarely involved in radiological incidents, even though they are sometimes used in harsh environments. The fuel densitometers are mounted in fuel tanks of aircraft. As with level gauges, they are rarely involved in radiological incidents, but the ones that"d5 occur would not be influenced by the nature of the licensing action. Based on these considerations, the staff ruled out specifically licensing them.
One remaining category, the large gauging devices, covers 16,000 devices containing curie quantities of americium-241, cobalt-60, cesium-137, krypton-85, or strontium-90.
4 There are about 6,000 general licensees possessing them. The relative numbers of devices containing these radionuclides are as follows:
Radionuclide Percent of Total Devices e
Cesium-137 53 Americium-241 12 Krypton-85 10 Strontium-90 10 l
Cobalt-60 4 Other 11 2 The staff believes that the vast majority of these gauges are used in a fixed position.' Because of the fixed position of the devices, the staff concludes
]-
that little would be gained by specifically licensing them, particularly if the However, there are some gauges !
measures discussed previously were adopted.
J that are portable, such as the-strontium-90 gauges used to measure the thickness
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of products, and the cesium-137 gauges that measure density of products. But ,
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these gauges are not in transit as extensively as are-some other portable gauges, which are specifically licensed on the grounds that they have a high
- mobility rate.-
Under the current rules, portable gauges housing curie quantity sources must be generally licensed, if. requested by a vendor, on demonstration that the requirements specified in the rules for a general licerse are met. Therefore, to require them to come under a spec'ific' license would require a rule change.
There is a certain amount of appeal to having greater controls over all portable gauges, as there is to having greater controls over devices containing greater-than-Class-C. quantities of licensed material.
Because portable devices have the potential for exposing a wider range of
- people, the staff believes that greater controls should be placed on those devices to ensure proper transporting, storage and use. There is no precise way to draw a line on the source strength above which specific licensing should be required, but the most commonly offered is one curie.
Further, the staff believes that, if vendors do not have a binding agreement to take back the sources that contain quantities greater-than-Class-C that they transferred to general licensees, then such sources should be specifically licensed to enhance accounting for them and to better ensure proper disposition of them.
4 The staff recommends exploring,.through a rulemaking, whether there should be an upper limit on the curie-quantity of licensed material that can be contained in generally-licensed devices and an upper limit of " Class-C quantity" (as defined in 10 CFR Section 61.55) for generally-licensed devices. Devices containing quantities of materials above those limits would be specifically-licensed to ensure greater accountability of the licensees. Such licensing actions would include reviews of the applicants controls and uses of the devices, as well as their disposal intentions and capabilities to finance the disposal of the devices. The staff would not apply the curie limit to exit signs. ,
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's Placing such limitations on the source size that may be generally licensed means more devices would have to be specifically licensed. These reviews would not be individually resource-intensive nor would the inspection frequency be high. In fact, the inspections could be performed by way of the annual mail survey. Therefore, we estimate that the caseload increase would require an additional five to ten FTE, assuming there would be a few thousand more specific licensees and depending on the complexity of the licensing process.
The staff notes that there are instances where a particular type of device raises safety concerns, even though it meets the specifications in the rules for general licenses. The rules are based on the assumption that the general licensee will comply with all requirements. That assumption may be ideal but is tenuous in the real world. Where generally-licensed devices have greater potential for accidents, can cause high exposure or extensive contamination if involved in an accident, or are likely to enter unauthorized disposal channels, etc., the devices might not be good candidates for general licensing. Therefore, the staff believes that the rules should be amended to take into account these types of considerations, in addition to an upper bound on source size, for.
decisions about6 general licensing or specific licensing. Such a rule change would require a fraction of an FTE. Although we would not contemplate exercising this authority frequently, having it would be beneficial. Among other things, it would encourage a more conservative approach in the design of devices for general license use.
- 5. RESPONSIBILITIES AND COMMUNICATIONS When the vendors sell the device, they must transmit to the general licensee a copy of the general license regulations contained in Section 31.5 (or an-equivalent Agreement State regulation). The vendors may also be required to provide guidance on simple maintenance tasks that the general licensee can perform (e.g. , replacement of indicator light bulbs) and the vendor may transmit a copy of the survcy report on radiation profiles around the device.
Any such instructions are reviewed during the licensing process for the vendors.
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Section 31.5 requires, in part, the general licensee: a) to ensure that all-labels affixed to the device are maintained thereon; b) to have the device leak-tested on a specified schedule; and c) to assure that all testing, installation, servicing, and removal from installation are perfort..d either in '
accordance with the instructions on the label or are performed by individuals who are specifically licensed. Further, Section 31.5 requires the general licensee to maintain records for specified periods, to show compliance with the r
afo'ement16nid.
Upon damage to or failure of the shielding or the on-off mechanism, the general licensee must, among other things, report to the appropriate Regional Administrator, or the Agreement State Director, within 30 days, the nature of.the event and the remedial actions. Section 31.5 prohibits the abandonment of the device and limits transfer or disposal of the device to individuals possessing a specific license (transfer to another general licensee is authorized only if the device remains in-use at a particular location or where the device is held in storage in tne original container). Other than the above, general licensees (who are assumed to have no knowledge or training on radiation protection principles) are pretty mucheon their own to use the device.
The recent general license reviews show that many general licensees are not aware of their responsibilities under the general license. NRC has scant information on whether general licensees are assuring that all testing and servicing are being performed in accordance with the regulations and instructions. NRC knows little about the test results or problems being
- experienced with the devices. As indicated before, the staff is developing a proposed rule to require general licensees to respond annually to NRC via a questionnaire. The questionnaire could seek information on test results, who performed the tests, and on any problems with the device. Such a reporting system would enhance licensees' awareness of their responsibilities and would
- enhance NRC's awareness of what is going on in the field. The latter could serve as a basis for inspections, enforcement actions, and changes to the regulations.
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Since we do r.ot know much about problems in the field, it is difficult to make an estimate of the resource implications of this recommendation. However, since there are about 400,000 devices under general licenses, odds are that there are some significant problems occurring that, if we were awar'e of them, would require some follow-up action. Most, if not all, Agreement States inspect general licensees. If NRC were to have a modest follow-up program based on obtaining the information just mentioned, we estimate that there would be a
~'need for two additional FTE.
As mentioned before, the vendors are also required to report to NRC, on a quarterly basis, all transfers of devices to generally-licensed individuals.
That report must identify, among other things, a point of contact between the Commission and the general licensee. The contact point identified in those reports is frequently a purchasing agent who may or may not be aware of the nature of the device, the responsibilities of the organization, or be in a position to ensure that-the responsibilities are carried out. If the contact point in those reports were to be an individual who has authority to require, for example, the necessary tests to be performed, the proposed annual reporting requirement wou)W be more meaningful, and there would be a greater chance that the responsibilities of the general licensee would be fulfilled.
With further regard to the quarterly transfer reportc, each vendor chooses its own format with varying degrees of detail. This complicates the process of entering the information into computer storage. The staff has considered whether to standardize and expand the vendor's quarterly reports. Specifying the format would decrease the potential for inaccurate or incomplete reports.
- The staff recommends initiating a rulemaking to assure a more appropriate general licensee contact and to-standardize the reporting forms and requirements. Such a rulemaking should be an item of compatibility for the Agreement States.
Resources required for maintaining a centralized list of generally-licensed devices based on standardized forms would be decreased from about 2 FTE to about 1.5 FTE. The two FTE are currently within the base budget of HMSS. All commenters addressing this section were generally favorable to these recommendations, 11 .,
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- 6. RESOURCE RAMIFICATIONS As mentioned in the paper, budgetary constraints have limited NRC oversight of the general license program. The staff proposed budget for FY91 was being prepared while this reevaluation was being completed. Some of the recommendations and their resource implication have been factored into that proposed budget, but other recommendations that evolved have not. Next is a discussion of what is (and is not) in the budget.
The HMSS base budget includes two FTE to maintain the tracking of generally-licensed devices and to interpret and follqw up on data provided in the survey of these licenses. In the past, NHSS has budgeted two FTE for entering into the computer the quarterly transfer reports from the vendors. That effort would be significantly expanded by an annual survey of general licensees, but such data-entry activities could be performed by a contractor. Thus, the two FTE in the base budget could be used primarily for evaluating the siirvey results. The recommendation to expand the scope of the annual survey to include questions on compliance with all applicable requirements placed on the general licensees would result in a broader feedback on that questionnaire. Thus, there would be an increased demand both to review and evaluate the responses, as well as to inspect any indicated problems. NMSS has reflected this in the proposed FY91 budget by incorporating two additional FTE.
The proposed FY91 budget also includes one FTE for review of vendor quality assurance program. We estimate that, if there were an effective rule providing more specific requirements for such programs, there would be a need for a total of three to four FTE to review and inspect those programs. However, the delta would not be required until FY92 or FY93, and is not included in the proposed FY91 budget.
The proposed budget also contains one FTE for review of third party testing results.- If there were a rule requiring third party testing of generally-licensed devices, then there would be a continuing need for a total of two FTE for the reviews and inspections. Again, the delta would not be needed until FY92 or FY93.
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.NRC having greater oversight of the Agreement States sealed source and device reviews would require about two FTE, which is tot budgeted. Finally, the recommendation to specifically license some devices that are now generally licensed would require ~an additional five to ten FTE, which are not budgeted. -
With the above enhancements to the program and with the formation of a Sealed Source and Device Section, that Section might be composed of about 12 FTE (about four FTE are presently budgeted for this effort in Headquarters, with an additional four FTE proposed in the FY91 budget).- Because of the magnitude of i the general license program, because of the potential for unacceptable exposures to workers and the public, and in order to focus the program, the staff recommends
- ' creating a Sealed Source and Device Section in Headquarters. Also, the enhancements
- described in this enclosure would require at least seven additional FTE in the Regions for. licensing actions and inspections. The rulemakings recommended in this paper would require approximately three FTE over a two-year period.
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I OPTIONS-THAT HIGHT BE FURTHER CONSIDERED 4
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- 1. ANNUAL FEE FOR GENERAL LICENSEES Some Agreement States charge an annual fee on general licensees, in part to defray costs of the registration program and in some cases to 4 periodically follow up with the general licensee. The Ag eement States imposing an annual fee on general licensees have observed improved accounting for the matcrials and devices obtained and used 59 der the -
general license and appear to have experienced fewer lost devices.
Annual fees on the order of $25 to $100 per general licensee are assessed by those Agreement States. Processing the fee is one way to assure better tracking of the devices. However, since the staff does not propose to '
i inspect gengral licensees as a routine matter, since the Agency's attention given to each of them will not change substantially even if the staff's recommendations are adopted, since the staff is developing a rule to require periodic contacts through the mails, and since all fees generated because of NRC actions are placed in the general fund of the U. S.
Treasury, not the llRC account, the issue of whether to assess an annual fee was dropped from further consideration.
- 2. TERMINATE GENERAL LICENSE PROGRAM Some have suggested dropping the general license program in favor of either specifically licensing the devices or exempting the devices. That view divides the universe into two bins: eithera)thedeviceshave potential risks similar to-specifically-licensed devices and other regulated activities and, therefore, should be regulated in a similar manner; or b)'the devices have had safety built into them and are not ENCLOSURE 4 1
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I suf ficiently hazardous to deserve specific licenses; therefore, they should be exempted. Although there is a certain amount of appeal to that logic, the staff believes that the resources necessary to specifically license the devices are not justified, considering the risks, but is relectant to remove all regulatory controls over them because of the potential for unacceptable exposures of workers and the public, should
, the devices not be treated in a manner anticipated by the regulations.
Therefore, this option was dropped from further consideration.
- 3. SALE VERSUS LEASE Because disposal of the devices presents a problem, some have suggested that the vendor engaging in the business venture should retain responsibility for its hazardous product until its ultimate disposal.
One way to gecomplish this is through a requirement that only lease ;
arrangements be allowed. This matter could be further explored under the
' topic of ultimate disposition of the devices.
- 4. INSPECT GENERAL LICENSEES NRC does not inspect general licensees except for cause. Changing this policy to become more proactive would require anywhere from tens of full-time equivalent units (FTE) to hundreds of FTE, depending on the frequency of inspections. Many, if not all, Agreement States inspect general licensees. Clearly, such inspections heighten general licensees' awareness of their devices and responsibilities.- However, the staff did not further consider this option, in light of the proposed rule change on annual contacts with the general licensees.
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- 5. RESPONSIBILITIES OF VENDORS Vendors engage in distributing devices to earn a profit, and the thought has been advanced that they should bear more responsibility for their products (e.g., for cleanup of contamination events, for tracking the devices, for disposal of them, and for inspecting the general licensees). The staff adopted some of these thoughts in its evaluation and believes a proper balance has been struck, considering the practicalities of implementing the possibilities.
- 6. REPORTlHG REQUIREMENTS Currently, general licensees are required to keep the results of leak tests on file for a period of one year af ter the next required leak test. Since NRC does not inspect general licensees, the Agency receives very little $nformation, directly, about the integrity of the sources in the field. However, the information available to the staff indicates that leakage of sealed sources is a rare event. This does not support a massive mail-in of these reports.
The staff believes that the recom-mendations on annual responses from general licensees, quality assurance programs, and third-party testing would ensure continued integrity of the sources and devices.
- 7. END USE OF DEV!CE Some have suggested greater restrictions on the end use of devices. For example, one school of thought would have devices that are to be locate'd near food, drugs or cosmetics subjected to greater restrictions and requirements than those being used in, for example, industrial chemicals manufacturing.
Rather than develop separate regulations tailored to the end use of a device, the staff believes that such considerations should be factored into the licensing-review process.
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