ML20206E801
| ML20206E801 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/1985 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Minogue R NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 8606240012 | |
| Download: ML20206E801 (57) | |
Text
_
f bb ante MEM0PANDUM FOR:
Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM:
William J. Dircks Executive Director for Operations
SUBJECT:
CONTROL 0F NRC RULEMAKING l
By memorandum of February 13, 1984, " Control of NRC Rulemaking by Offices Reporting to the EDO," Offices were directed that effective April 1, 1984, (1) all offices under ED0 purview must obtain my approval to begin and/or continue a specific rulemaking, (2) resources were not to be expended on rule.
makings that have not been approved, and (3) RES would independently review rulemaking proposals forwarded for my approval and make recommendations to me concerning whether or not and how to proceed with the rulemakings.
In accordance with my directive, the following proposal concerning rulemaking has been forwarded for my approval.
Proposal to initiate rulemaking concerning safety requirements for industrial radiographic devices.
(Sponsored by RES _ memorandum, Minogue to ED0 dated November 12,1985.)
I approve initiation of this rulemaking and offer the following comments.
Consideration should be given to making the rule more performance-oriented and preparing a regulatory guide that explains in detail what the staff considers to be an acceptable radiography device for complying with the rule. To the extent that industry standards are appropriate, they could be endorsed in the guide and supplemented as appropriate with regulatory (staff) positions.
Given that most (90 percent) radiography overexposures involve existing devices and considering the longevity of such devices, backfitting of the new requirements seems appropriate to address the overexposures in the near time frame. The NRC Regulatory Agenda (NUREG-0936) should be modified to reflect the status of this rulemaking.
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I hh f!OV 121985 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM:
Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING:
RES REVIEW 0F NEW PROPOSED RES-SPONSORED RULEMAKING Based on our review of the new proposed RES-sponsored rulemaking entitled,
" Safety Requirements for Industrial Radiographic Exposure Devices," RES recomends that NRC should begin this specific rulemaking. This recommendation in draft form has been coordinated with NMSS and SP.
The basis for our recommendation is as follows:
Radiation exposures involving radiographers have been a concern of the NRC and the Agreement States for several years. Although radiography overexposures occur at a rate that is double the rate of radiation workers in other fields, the principal concern involves the potential for serious overexposures from radiography devices that contain radioactive sources strong enough to pose serious health hazards to both radiographers and to the general public.
(In general, it is not meaningful to specify an average dose received as a result of a radiography overexposure because the dose could vary from a few millirems to a dose sufficient to produce radiation sickness and even death).
Roughly 90% of the radiography overexposures involve the use of portable i
crank-out type radiography devices where the chief contributing factor tc the l
overexposures involves the connection between the drive or control cable and the radioactive source assembly. Several of the radiography devices now in l
use allow the source assembly to be driven from the device without a positive l
connection having been made, with the result that, when the control cable is retracted, the source assembly remains outside the device, generally in the guide tube.
Present regulations require a radiation survey to be made at the l
end of each radiographic exposure, and this survey would normally detect the presence of the source assembly in the guide tebe. The number of overexposures resulting from this kind of hident however indicates that these radiation surveys often are not made and that in some instances the guide tube containing the source assembly is disconnected from the device, coiled up and put in storage. A recent example of this type of incident
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occurred the first week in August 1985 in Wyoming where 3 radiographers received overexposures and at least 3 members of the general public received doses of approximately 0.5 rem each.
The purpose of the rulemaking being proposed here is to reduce the number of such radiography overexposures by establishing performance standards for radiography devices that will require a positive drive cable-to-source assembly connection before the source can be driven from its shielded position in the radiography device.
It is anticipated that such performance standards will reduce the number of overexposures by more than one half. Other performance standards under consideration involve a source position indicator on the device and an interlock that will prevent the removal of the drive cable from the device until the radioactive source is properly retracted into its fully shielded position inside the radiography device. Consensus standards that include such performance standards are available for consideration in this rulemaking and these should minimize the costs of the rulemaking. The benefits to be derived from a reduction in potential overexposures by the incorporation of such consensus standards in the regulations are difficult to evaluate on a monetary basis. Based on the work of the Task Force on Equipment Performance Criteria of the Radiography Steering Committee the costs to the radiography industry of any additional requirements likely to result from the rulemaking will probabl,/ be small.
The complete RES review package has been sent to OED0 (Attention: DEDR0GR)and to the Directors, NMSS and SP.
Robert B. Minogue, Director Office of Nuclear Regulatory Research i
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MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM:
Robert B. Minogue, Director Office of Nuclear Regulatory R? search
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F NEW PROPOSED RES-SPONSORED RULEMAKING 4
Based on our review of the new proposed RES-sponsored rulemaking entitled,
" Safety Requirements for Industrial Radiographic Exposure Devices," RES recommends that NRC should begin this specific rulemaking. This recommendation in draft form has been coordinated with NMSS and SP.
The basis for our recommendation is as follows:
Radiation exposures involving radiographers have been a concern of the NRC and the Agreement States for several years. Although radiography overexposures occur at a rate that is double the rate of radiation workers in other fields, the principal concern involves the potential for serious overexposures from radiography devices that contain radioactive sources strong enough to pose serious health hazards to both radiogrephers and to the general public.
(In general, it is not meaningful to specify an average dose received as a result of a radiography overexposure because the dose could vary from a i
few millirems to a dose sufficient to produce radiation sickness and even death).
Roughly 90% of the radiography overexposures involve the use of portable crank-out type radiography devices where the chief contributing factor to the l
overexposures involves the connection between the drive or control cable and the radioactive source assembly. Several of the radiography devices now in use allow the source assemb.ly to be driven from the device without a positive connection having been made,'with the result that, when the control cable is i
retracted, the source assembly remains outside the device, generally in the guide tube. Present regulations require a radiation survey to be made at the end of each radiographic exposure, and this survey would normally detect the presence of the source assembly in the guide tube. The number of overexposures resulting from this kind of incident however indicates that these radiation surveys often are not made and that in some instances the guide tube containing the source assembly is disconnected from the device, l
coiled up and put in storage. A recent example of this type of incident OFC:
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occurred the first week in August 1985 in Wyoming where 3 radiographers received overexposures and at least 3 members of the general public received doses of approximately 0.5 rem each.
The purpose of the rulemaking being proposed here is to reduce the number of such radiography overexposures by establishing performance standards for radiography devices that will require a positive drive cable-to-source assembly connection before the source can be driven from its shielded position in the radiography device.
It is anticipated that such performance standards will reduce the number of overexposures by more than one half. Other performance standards under consideration involve a source position indicator on the device and an interlock that will prevent the removal of the drive cable from the device until the radioactive source is properly retracted into its fully shielded position inside the radiography device. Consensus standards that include such performance standards are available for consideration in this rulemaking and these should minimize the costs of the rulemaking. The benefits to be derived from a reduction in potential overexposures by the incorporation of such consensus standards in the regulations are difficult to evaluate on a monetary. basis. Based on the work of the Task Force on Equipment Performance Criteria of the Radiography Steering Committee the costs to the radiography industry of any additional requirements likely to result from the rulemaking will probably be small.
The complete RES review package has been sent to OED0 (Attention: DEDR0GR)and to the Directors, NMSS and SP.
Oristaalafaned by:
ROBERT B. MIN 0GUE Robert B. Minogue, Director Office of Nuclear Regulatory Research I
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occurred the first week in August 1985 in Wyoming where 3 rad graphers received overexposures and at least 3 members of the genera public received doses of approximately 0.5 rem each.
The purpose of the rule being proposed here is to red e the number of such radiography overexposures by adopting performa e standards for radiography devices that will require a positive d ive cable-to-source assembly connection before the source can be dri n from its shielded position in the radiography device.
It is anticipated at such performance standards will reduce the number of overexposures by m e than one half. Other performance standards under consideration i olve a source position indicator on the device and an interlock that will event the removal of the drive cable from the device until the radioac ve source is properly retracted into its fully shielded position inside the radiography device. Consensus standards which include most of the rformance standards under consideration are available f~or incorporation by eference into the regulations so that costs to the NRC in developing t 's rulemaking should be small.
It is difficult to provide a monetary igure for the benefits derived from mitigation of the overexposur discussed but it is felt that the costs of meeting the proposed perfo nce standards would have a minimal impact on individual licensees.
The complete RES review ackage has been sent to OEDO (Attention: DEDROGR)and to the Directors, NMS and SP.
Robert B. Minogue, Director Office of Nuclear Regulatory Research e
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F. P. GILLESPIE CHAIRMAN, RIRB FROM:
G. A. Arlotto, Member, RIRB TITLE OF RULEMAKING: Safety Requirements for Industrial Radiographic Exposure Devices AGREE WITH REC 0W4ENDATIONS IN RES RULEMAKING REVIEW
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W. M. Morrison, Member, RIRB TITLE OF RULEMAKING:
Safety Requirements for Industrial Radiographic Exposure Devices REQUEST RIRB AGREE WITH RECOMMENDATIONS
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I have the following concerns with the subject rulemaking package:
1.
The proposal is to include in NRC regulations performance standards for the subject equipment that "in general correspond to the provisions of the industry standa.rd, NBS Handbook 136, with certain additional provisions." This proposal appears to violate the policy guidance provided to federal agencies in OMB circular #A-119 in that the voluntary consensus standard from which most of the rulemaking provisions will be taken will not be adopted and used.
2.
Throughout the RIRB package, NBS Handbook 136 is referred to as an
" industry standard."
It is not an industry standard; rather, it is a voluntary consensus standard designated as American National Standard N432. NRC had'a representative on both the subcommittee which drafted this standard, Subcommittee N43-3.5, and the i
consensus balloting committee, N43. By my tally, in addition to an NRC representative N43 has seven other governmental representatives, twelve professional society representatives, two labor representatives, i
and two insurance company representatives out of a total of twenty-nine representatives.
I would hardly characterize this as an industry group.
(continue comments next page)
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W M. MORRISON MIMBER,RIRB MARCH 29, 1985 DATE
Safety Requirements for Industrial Radiographic Exposure Devices W. M. Morrison Comments March 29,1985 t
3.
In the preliminary regulatory analysis, alternate 2, which was rejected, was to endorse the " industry standard." The reason given is that "The industry standard stipulates that it provides guidance for the design and construction of radiography devices although The staff many of the recommendations are performance standards.
feels that the radiography manufacturing industry is better equipped than the NRC in the area of design and construction standards and that the NRC should not include these as part of its regulations.
For this reason alternate 2 is rejected and alterna-tive 3 is chosen."
I do not agree the N432 (NBS Handbook 136) is a desi_gn and construction standard. As stated in the abstract of the standard "it establishes the criteria to be used in the proper design and construction of various components to ensure a high degree of radiation safety at all times.
4.
As noted above the preliminary regulatory analysis does include an alternative for endorsing the N432 standard in NRC regulations.
It does not include the alternative which is the one most commonly used by NRC; namely, endorsement of the standard by a regulatory guide.
Enclosure E, page 1 notes that "the draft proposed rule has been 5.
reviewed and concurrence received from the user offices NMSS and SP."
If that is the case', the draft proposed rule should have been included in the RIRB package for review by RIRB members.
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APR 05 W Responses by c.o.b.
will be appreciated. RAMRB will use the voting sheets to assemble the complete RES review package for eventual transmittal to the OEDO and the Director of the user office.
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PRELIMINARY DRAFT PROPOSED RULE 4
Safety Requirements for Industrial Radiographic Exposure Devices 10 CFR Par't 34
SUMMARY
- The Nuclear Regulatory. Commission is proposing to amend its regulations that apply to industrial radiography to establish performance standards for industrial radiography devices. The ' proposed amendments, which will affect $34.21 and $34.22, are intended to aid in reducing the incidence i
of radiography over-exposures..The proposed amendments will be based on the recommendations of the equipment task force to the ad hoc Radiography Steering Committee which indicates that 25-35%~of NRC radiography overexposures ar.e related to equipment problems. Since many of the recommended performance standards are included in the ANSI.c'onsensus standard, NBS Handbook 136, "American National Standard N432.. Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", it is anticipated that the proposed ~ rule will adopt the consensus standard by reference. A regulatory i
guide will be developed simultaneously to the rule and will incorporate the i
l consensus standard recommendations and such other performance requirements that l
may be recommended by the radiography steering committee.
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J PRELIMINARY REGULATORY ANALYSIS FOR PART 34 PROPOSED AMENDMENTS SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EXPOSURE DEVICES 1.
Statement of the Problem A. total of approximately 1100 licenses have been issued to firms who are engaged in industrial radiography.
Two thirds of these licenses have been issued by Agreement States and one third by the Nuclear Regulatory Commission.
The firms employ an estimated 5000 radiographers on a full or part time basis but it is estimated that another 5000 radiography supervisors are also actively engaged for a few weeks of the. year' An estimated 2000 radiographic exposure devices (manufactured by fewer than 6 companies) are in use, producing tens-of-millions of radiographic pictures per year and utilizing in excess of $20 million j
worth of radiographic film per' year.
l Radiation exposures to radiographers have been a concern of the NRC and Agreement States for some time.
Radiography incidents involving overexposure l
occur at a rate which is double that of radiation workers in other fields.
In 1979 for example, radiation exposures of greater than 5 rem per year occurred at a rate of 4 per thousand for radiography workers, 2.3 per thous'and for well logging workers, 2.0 per thousand for light water reactor workers and 1.5 per thousand for all radiation workers.
In addition, NRC' overexposure data from 1971 to 1983 show that there were 56 radiography.overexposures greater than 5 rem and from 1975 tio 1982 there were 23 radiography ~overexposures greater than 25~ rem.
Texas data from 1977 to 1983 show 95 radiography overexposures l
greater than 5 rem, of which 15 were greater than 25 rem.
Another relevant point is that 1979 exposure data show that radiographers received 16% of all overexposures despite the' fact that. radiographers represent only 4% of all radiation workers A major consideration in radiography incidents is the potential for.
serious overexposures.
Radiographic devices commonly contain radioactive sources of sufficient size to pose serious potential safety hazards to both radiographers and the public in the event of. improper use or equipment malfunction. The determination of the monetary value of the benefits gained in the reduction of radiography incidents and their concomitant hazards is very difficult, particular,1y if such incidents have major consequences such as the loss of 8 lives in an incident in Morocco in 1984.
1 ENCLOSURE B
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The NRC exposure data indicate that equipment problems contribute to between 25-35% of all the reported overexposure events.
The Texas data indi-cate a much lower incidence of equipment problems (21%) but exhibit such a high s
incidence of " unknown" exposures (65%) compared to NRC " unknown" exposures (15%) that it is probable that additional equipment problems were contributors i
to some of these " unknowns".
In 1978 the NRC published an Advance Notice of Proposed Rulemaking (43FR 12718) to announce that it was undertaking the development of design requirements for radiographic exposure devices licensed under 10 CFR Part 34, in order to reduce the radiation exposures caused by equipment failure.
Among t
the many comments received concerning this A,NPR was the suggestion that the I
NRC delay further action pending the completion of a consensu.s standard in this area.
The standard, NBS Handbook 136, "American National Standard,
)
Radiological Safety for the Design and Contruction.of Apparatus for Gamma l
Radiography" was 'ublished in January, 1981.
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In March,1980, an ad hoc Radiography Steering Comittee composed of both NRC and State representatives, was formed to draft recomendations for improving radiography safety.
Four task forces were subsequently established by the Steering Committee to address various aspects of the problem. These task force assignments were: Radiographic Equipment Design Safety; Training and Certification; Inspection; and Collection and Analysis of. Incident Data.
The proposed amendments discussed in this regulatory analysis relate to the first of these assignments ---Radiographic Equipment Design Safety.
These amendments would have an. effect on two classes of licensees ---radiogr'aphic j
equipment manufacturers and industrial radiography companies.
Apart from the existing regulations governing radiographic operations found in 10 CFR Part 34, another proposed rule has been published for comment (49 FR 39168) which would j
require an additional device survey at the time a device is put into storage 3
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and would also require performance evaluations of radiographers and radio-graphers' assistants at intervals not exceeding 3 months.
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02/19/85 2
1 ENCLOSURE B
The proposed arendments to the present regulations are required primarily to provide a ceans of reducing the incidence of overexposure among
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radiographers.
Although the consensus standard mentioned above was published in 1981, there is no indication that it has had appreciable effect on reducing either the rate or magnitude of radiographer overexposures.
Also, in light of the very competitive nature of the radiography industry it is not clear that
- all manufacturers are using the consensus standard.
Failure to take some action at this time would allow the present rate of radiographer overexposures to continue and possibly to increase.
2.
Objectives The objectives of the proposed am,endments are to specify safety perform-ance criteria for radiography devices and thereby reduce overexposures in those areas where the task force has identified problems and suggested solu-tions.
Performance criteria cover specific areas where pioblems have occurred in the past.
For the most part, these criteria are generally consistent with the provisions of the consensus standard, HBS Handbook 136. The advantage of including such performance standards in the regulitions is that industrial firms will.be required by regulation to meet the standards rather than volun-teering to do so as desired which is the case at present with the voluntary consensus standard.
3.
Alternatives Four alternatives were considered:
(1)
Take no action 'at this time.
(2)
Adopt the consensus standard, NBS Handbook 136, by including its provisions in the NRC regulations.
(3)
Propose new regulatory requirements in the fonn of perfonnance standards and simultaneously endorse the consen. sus standard, NBS Handbook 136, by a regulatory guide issued in support of the amended regulation.
(4)
Endorse the consensus' standard by reference in the NRC regulations and include such other requirements as recommended by the Radiography Steering Comittee and simultaneously develop a regulatory guide incorporating the consensus standard and such other performance standards as are recomended.
02/19/85 3
ENCLOSURE B
~
4 Consequences Alternative 1.
Take no action at this time This alternative would probably result in no change in the status quo.
The number of radiographer overexposures would probably remain the same.
This alternative would also allo.w manufacturers to implement the new consensus standard,'NBS Handbook 136, in the design of new equipment which conceivably could improve the overexposure record.
This alternative would ent, ail no costs to the NRC and only those costs to industry that were voluntarily accepted in the adoption of the consensus standard.
Alternativi 2.
Endorse the consensus standard Implementation of the consensus standard by incorporation in the regula-tions could improve the safety of radiography devices and reduce the number of overexposures.
Costs to the NRC would entail only the usual costs of rulemaking which are expected to be small.
Costs to industry are estimated at approximately $250,000 per year with benefits principally in the reduction'of exposures and litigation estimated at around $600,000 per year.
Adoption of this alternative will not have any adverse effects on NRC policies and would be expected to have only a minimal impact on applications for licenses to manufacture radiography devices.
There are no identifiable constraints to the adoption of this alternative.
Alternative 3.
Endorse the consensus standard, NBS Handbook 136, by a regulatory guide issued in support of the amended regulation.
This alternative would propos.e the amendment of the present regulations i
to include certain performance standards, followed by the issuance of o regulatory guide endorsing the consensus standard, NBS Handbook 136, as a method of meeting the performance standards.
The costs to both industry and to the NRC are expected to be essentially the same as those of Alternative 2 with the addition of the costs of issuing a regulatory guide adding to the costs to the NRC.
4 l
02/19/85 4
ENCLOSURE B
Alternative 4.
Endorse the consensus standard by reference and develop a regulatory guide.
This alternative would endorse the consensus standard by reference in the regulations and include such other performance standards as recomended by the Radiography Steering Comittee and simultaneously develop a regulatory guide incorporating the consensus standard's recommendations and such other perfomance standards that are imposed by the regulation.
The costs of implementing the recommended perfomance standards were developed through discussions with major equipment manufacturers coupled with the judgment of task force members. These costs are estimated to be in the range of $220-$300K per year or approximately $230e/r year per -
licensee.
As inucated earlier, benefits derived on the basis of avoidance or mitigation of overexposures are difficult to establish especially in tenns of monetary units.
In spite of this the adoption of this alternative should have only a minimal etfect on licensees and should not have any adverse effects on NRC policies.
No constraintes to the adoption of this alternative have been identified.
5.
Decision Rationale The staff has proposed that alternative 4 be adopted. Alternative 1 is rejected because the objective of this action is to reduce the incidence of radiographer overexposures and this alternative appears to offer no hope of accomplishing this. Alternative 2 is rejected also.
It does not address certain performance requirements identified by the equipment task force and the inclusion of all of the consensus standard's provisions in the regulation would render the l
rule change unweildy. While alternative 3 provides an alternative to the last stated objection it is rejected also since it does not address those performance standards identified by the equipment task force. Alternative 4 affords an opportunity to address those performance standards recomended by the equipment task force as well.as adopting the requirements of the consensus standard.
5 ENCLOSURE B
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Implementation The staff proposes to implement the requirement by submitting a copy 4
of the proposed regulation which endorses the consensus standard by reference to the Comission for its approval.
At the same time it will publish a regulatory guide in support of the proposed regulation which will incorporate the consensus standard and such other performance standards that are recomended by the Radiography Steering Committee.
Following receipt of Comission approval, the proposed regulation will be published in the Federal Register with a request for coments from interested persons.
Following an analysis of the coments received, the proposed rule will either be withdrawn or amended to reflect the substance of the comments received and then published in final form prior to codification as-part of the NRC regulations.
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The proposed action will provide amendments to 10 CFR Part 34, " Licenses i
for Radiography and Radiation Safety Requirements for Radiographic Operations".
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ENCLOSURE B l
~
Draft RES Recommendations to EDO Re:
New Proposed Rule on Safety Requirements for Industrial Radiographic Exposure Devices 10 CFR Part 34 The proposed rule, discussed in enclosures A and B, was developed out of recommendations of the Task Force on Equipment Performance Criteria of the NRC Steering Committee'on Radiography Safety.
RES recommends that the rule be initiated at this time as a means of reducing the number of radiography overexposures.
4 4
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ENCLOSURE C
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DRAFT REGULATORY AGENDA TITLE:
i Safety Requirements for Industrial Radiographic Exposure Devices
~
CFR CITATION:
10 CFR 34 ABSTRACT:
The prop'osed rule would amend the present regulations to establish performance standards for industrial radiography exposure devices.
0verexposuresofradiographers(andoccasionallythegeneralpublic)are more than. double that of other radiation workers and have been a concern to the NRC for'some time. Approximately 25-35% of the radiography overexposures are associated with' equi.pment malfunction. The issue of safety requirements for these devices is a primary concern since the devices use relatively high intensity, high energy gama-ray emitting
' sources with.the potential for serious overexposures.. Although a consensus standard for radiographic exposure devices was published in
~
1981, (Amer Nat.'1 Std. N432) it is not clear that all manufacturers 'are The a.lternatives considered were: taking no adopting the-standard.
action at_this time. ^ adopting 'the consensus standard in the regulations, endorsing the consensus standard by a regulatory guide, and endorsingg consensus standard by reference in the regulations along with such other perfomace standards deemed necessary and simultaneously i_ssuing a regulatory guide in support of the proposed regulation. The last alternative was selected.
The proposed rule would require licensees to modify radiographic devices to meet the performance standards through design changes and quality control procedures.
Costs of incorporating the proposed standards are estimated to be of the order of $250,000. per year or approximately $230hyear per licensee. Detennination of the monetary value of the benefits gained are difficult but in view of the potential hazards ' involved in radiography incidents the safety benefits far outweigh the costs involved.
NRC resources required for processing this rule to final publication are estimated to be 0.4 person-years.
TIMETABLE:
1 NPRM 1/3/86 LEGAL AUTHORITY:
42 USC 2111; 42 USC 2201; 42 USC 2232; 42 USC 2233 EFFECTS ON SMALL BUSINESS AND OTHER ENITIES:
Yes AGENCY CONTACT:
Donald O. Nellis Office of Nuclear Regulatory Research Washington, DC 20555 301 427-4588 e
e Enclosure D
~
Assessment of Compliance by RES With Procedures and Guidance for Rulemaking 10 CFR Part 34 Draft recommendations to initiate work on the proposed rule have been coordinated 'with user offices and their concurrence on the recomeadations was obtained.
The draft regulatory analysis (Enclosure B) outlines the problem and the cbjectives of the proposed rulemaking.
To the best of our knowledge, this proposed new rulemaking is in compliance with NRC ~ procedures and guidance for rulemaking.
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ENCLOSURE E
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UNITED STATES
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- NUCLEAM REGULATORY COMMIS$10N j
p' wAsMimcfoN.OA sosse k***a*
August 22, 1985 cenet or twa sconarant l
s
' William J. Dircks, Executive Director MEMORANDUM FORI operations FROMt f
amuel J. Chilk, Secretary STAFF REQUIREMENTS -- SBCY-85-221 -
SUBJECTS CERTIFICATION OF MAD 10GRAPHERS
--.~.
The commission by a vote of 5-0 approved the ses.ff's request to withdraw the advance notice of proposed rulemaking The Commission also regardinc certification of radiographers.
approved the draft letter for submittel to Congress (Enclosure 4 of SBCY.85.-221).
i The Commission requests that the staff add to the withdrawai notice the statement that "The Commission will reconsider the need for ruleraaking in the future if improvements are not forthcoming."
Please revise the withdrawal notice accordingly.
(NMS$) (SRCY SUSPENSE:
9/6/95)
The Commission directs that the staff provide aggressive action to implement the.altgenatives referred to in the staff paper to improve radiation safety 'in the industrial i
rcdiography area and report to the Connission on staff's progre'sa in iwPlementing this directive.
(NMSS) (SECY SUSPENSE 11/1/85)
.The cosimission further requests that the staff explore with OPE and the Ad Hoc Radiography Steering Committee OPE's recommendation in ite July 3, 1985 memo'randum on the role of the radiation safety officer and report back to the Cossaission.
(NMsS) (SECT SUSPEN53s 11/1/55) con chairman Palladino Comunissioner Roberte Comunissioner Asselstina Commaissioner ternthal connaissioner toch OGC OPE
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August 16, 1985 PkELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE -- PNO-IV-85-39E This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by NRC staff on this date.
FACILITY: Western Stress Company Licensee Emergency Classification:
Evanston, Wyoming Notification of Unusual Event Docket: 30-22259 Alert Site Area Emergency General Emergency X Not Applicable
SUBJECT:
APPARENT OVEREXPOSURE OF TWO RADIOGRAPHERS (FINAL UPDATE)
Regicn IV was notified by telephone on August 5, 1985, that three radiographers had received whole body exposures of 27 R, 9 R, and 0.6R during an incident that began on August 1, 1985, near Table Rock, Wyoming. A special inspection was conducted August 7-9, 1985. Enforcement action is being processed. On August,13, 1985, Region IV was advised by Western Stress canagement that the radiography truck containing the exposed source had also been used on another job in Wyoming on August 2,1985. A Region IV inspector was dispatched to assess the adequacy of Itcensee actions to define exposures received by both employees and members of the public and to evaluate blood test results for the two employees with highest reported exposures.
Preliminary evaluations show as many as six members of the public who may have received exposure; but best estimates are that all were less than 500 mrem.
One unbadged employee also may have received up to 500 mrem. Results of initial blood tests show that white blood' counts for the two highest exposed personnel were normal. A consultant to the licensee has participated in evaluation of exposures to unbadged personnel.
E et The licensee has committed to discontinue radiographic work until the NRC has ovaluated corrective actions.
7.
Region IV does not plan to issue a press release. Media interest is not ovident. The licensee does not plan to issue a press release.
3 g
The State of Wyoming has been informed.
if, This information is current as of 8:00 a.m., August 16, 1985.
?
2 CONTACf:
R. J. Everett, 728-8187; R. E. Hall 728-8182.
DISTRIBUTION:
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Licensee:
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BACKGROUND INFORMATION FOR REGION IV f
PRESENTATION AT 2 P.M., OCTOBER 1, 1985 COMMISSION MEETING ISSUE TO BE RAISED: Lack of written guidance about how to handle cases in which members of the general public were exposed to radiation.
PROMPTING EVENT:
Western Stress Company - Overexposure Event (PNO-IV-85-39 and updates A - E)
BACKGROUND ON OVEaEXPOSURE EVENT:
i o Western Stress Co. holds License No. 49-23490-01 issued November 28, 1984 L
authorizing radiography.
An. initial inspection conducted' on May 22-23, 1985 revealed 8 items of o
noncompliance related to failure to follow written procedures, failure to comply with DOT and NRC regulations regarding transportation of radioactive materials; and failure to obtain prior dose for person entering restricted area.
o On August 5,1985 the licensee notified Region IV of an overexposure incident that began on August 1,1985 near Table Rock, Wyoming.
o Three individuals received exposures.
(
WHOLE BODY EXPOSURE Individual Original Estimate Revised Estimate 27R 22R 1
2
~9R 7R
'3 0.6R 0.6R o From reenactment of the incident the hand dose to one individual was estimated to be 93 Rem.
o Cause of overexposures:
28 curie Ir-192 source was disconnected from the drive cable and remained at the end of the guide tube for about 2 days.
As of August 5, 1985, the source h6d been returned tc the 1,1censee's facility and is properly shielded (PNO-IV-85-39).
Anearlyreport(PNO-IV-85-39and39A)indicatedthattheguidetubewiththe o
exposed source was returned to the licensee's facility and reused before discovery of the exposed source.
J SEP 2 61985 2-On August 13, it was learned (PNO-IV-85-390 and -39E) that:
o (1) The radiography truck with the exposed source was used at another job in Wyoming, (2) 6 members of the public may have received radiation exposures but each is estimated as <500 mrem and (3) one unbadged empicyee may have received up to 500 mrem.
The licensee has committed to discontinuance of radiography work until NRC o
approves resumption.
Region IV held an Enforcement Conference with the licensee on August 21.
o Certain matters have been referred to 01.
o Escalated enforcement action is pending; details no't available as of o
September 25.
Although there is no written guidance on the subject, the NRC NOTE ON ISSUE:
staff has used its judgment in allaying concerns of the public; requiring notification. Examples: TMI, J. C. Haynes, Nuclear Pharmacy, Inc.
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UNITED STATES k
NUCLEAR REGULATORY COMMisslON wASwiscTow. o.c. rosss
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JUN.10 M Ref: SA/JOL MEMORANDUM FOR: Leonard I. Cobb, Chief Safeguards and Materials Program Branch, IE FROM:
Joel 0. Lubenau Senior Project Manager State Agreements Program Office of State Programs
SUBJECT:
INFORMATION ON THE MOROCCAN RADIOGRAPHY INCIDEHT Per our discussion on June 3,1985 I met with Ann Gore, IP to draf t a report on the Moroccan radiography incident that could be' distributed to.
6-interested parties, e.g., Steering Comittee members, Agreement States and radiography licensees. The attached draft has been found to be acceptableforthispurposebyIPstaff(enclosure).
In preparing an IE notice, you may wish to elaborate on the last paragraph since it's apparent from the stated facts that precautionary radiation surveys of the type prescribed under NRC regulations, if made, would have disclosed the problem.
O oel 0. Lubenau enior Project Manager State Agreements Program Office of State Programs
Enclosure:
As stated cc:
A. Gore, IP, w/ enc 1.
D. Chape11, FC, w/ enc 1.
Industrial Radiography Steering Committee Members, w/ enc 1.
R. Goldsmith, OPE, w/ enc 1.
N. Thomasson, OPE, w/ enc 1.
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Lost Iridium Source - Morocco
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'f In March 1984, a serious radiation incident occurred in Morocco as reported in an official press release from the Ministry of the Interior.
In the course of this accident, eight persons died from overexposure. Other personsalsoreceivedsignificantdosesthatrequiredmedic,a,1atte/ntion.
Three who were severely injured and hospitalized at the Institut Curie in Paris were released in apparently satisfactory condition after treatment.
~._
o The accident had its origin at a fossil-fuelled power plant under y
construction in Mohammedia, where iridium-19' sources were being used to 2
radiograph welds.
In March 1984, one of these scyrces, approximately 30 curies at the time, apparently broke off from its take-up reel hook and Was e
not properly returned to its shielded container. Subsequently, the guide tube wasdisconnectedfromthecameraand,thesoufc,elventuallydroppedtothe ground below,'where a passing labourer noticed the tiny metal cylinder and took'it hcme. Although it is not cle.arly known if t,he problem originated with.
a distcr.nect t.etween the scurce pigtail and drive cable or a break occurred in the pigtail-source system, there are indications that the latter r.ey have '
3 cccurred.
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Hu?',vf?,M*,*,' ",7 ' ION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-85-49 Date:
0 June 17, 1985 764 b-
' *.- y ~;tf rication constitutes (ARLY notics of events of POS$18LE safety or p.h u r.
.'unilIcance.
d is baslually all that is known t,y the staff en tiilw datu.The informatl n e n.. *
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I.mi! y 3et Testing service
. N. Griffith Sivd.
Licensee Emergency Classification:
r tftth. Indiana Notificatfon of an Unusual Event Alert
'.icense No. 13-16347-01
-51te Area Energency General Emergency
_a_Not Applicab e Subjec'.:
DISCONNCcito RADIOGNAPHY 5OURCE On &v Ib,1985, at approximately 9:45 a.m. (CDT),' the licensee contacted the Headquarte 1 ':'!) p.m. on June 14,198b.Dny '.ifilcer Lu ropnrt a r.1efingr.11 thy source dir.conneet that I'm'at approximately 10:1b e.m.gion 111 (Chicago) was notified of the event on June 1S, Re (CDT).
The event involved one radiographer who at the coclusion of radiouraphic operations was dismantling the ' source guide tube and noticed the saurca had disconnected inside the guide tube.
esposed for about 2 seconds to a 60 curie iridium-192 hource at an estimated distanc 3 inches.
the worker's film badge was processep famediately which reported a whole bo@
exposure of 1660 millfrem.
- exposure of J res at J inchen per second. Calculated exposure rates for 60 curies or iridfue show
! The radfugrapher will have followup blood' testa performed as we hands.
the licensee's con 6ultant will perform a reenactment of the event on June 17. 1985 and will report the results to Region III.
consultant report in received.
Reglun ill will perform a special inspection when the
' Region !!! has not issued a press release.
Media interest is not expected.
The licensee has not issued a press release.
The State of Indiana will be notified.
- This inforwation is curront ar, of 11
- 00 a.m. (cot), June 11. 1988 i
CONTACT:
. J. Sreniawski
. Axelson C'W-FTS 388-5611 TS 388-5612 /
CY: MIN 0GUE/ROSS CCLLCn/CGHTI l
BURDA ARLOTT0/SHA0 iOlblRjuUl10N:
MARCUS GILLESPIE/ERNST BASSETT/MORRISON B. BROOKS l H. St.
MN88 Phillips_
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_.V Licensee (Corporate Office)
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FILE MARINO ARLOTT0/SHA0 PODOLAK GILLESPIE/ERNST BASSETT/MORRISON B. BROOKS Septe:$st 27,19C4 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE -- PHO-IV-E4-19 This preliminary notification constitutes EARLY notice of events of POSSIDLE safety cr public interest significance. The infomation is as initic11y received without verification or evaluation, and is basically all that is known by MRC staff on this date.
FACILI1h Capitol X-Ray Services. Inc.
Licensee Ersrgency C1cssificotton:
2133 South 49th West Avenue Notification of Unususi Evont
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Tulsa, Oklahome 74107 Alert i
License: 35-11114-01 Site Area Eracreency Gcnerci Eccrg:,ncy
~~Y~ Not A;:plicable
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SUSJECT: APPARENT EXTREMITY OVEREXPOSURE OF RA010GRAPHER S
'h On September 25, 1934, the licenses contacted Region IV concerning a
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potential for a whole body overexpasure and a calcula+,ad overexposure to tho rigiit hand of a radiographer of 150 rem in Tulsa, Oklaiwas. The incident cccurred on Septembar 25,1984, at 3:25 a.m.
On September 27, 1934, the licensee infonned Region IV that the film badge vendor reported a racding of 730 r,1111rcm for the whole bcdy exposure and their prelimingy investigation j
of the hand exposure indicated a possible dcse of about 65 rcia.
3 Re ion IV has not issued a press release. Media interest is not cxp:sted.
g Th licensee has not issued a press release.
g The information is current as of 10:30 em, date September 27, 1984.
5 COMTACT:
R. J. Everett. 728-8187 C. A. Hooker. 728-8146 E
h DISTRIBUTION:
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,n NUCLEAR REGULATORY COMMISSION f
- I WASHINGTON, D. C. 20555
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MEMORANDUM FOR:
Don Chapell, Chaiman Steering Committee on Radiography Safety FROM:
Anthony N. Tse, Chaiman Task Force on Equipment Performance Criteria Steering Committee on Radiography Safety
SUBJECT:
TASK FORCE REPORT Enclosed is our Task Force Report on Equipment Safety Performance Criteria, as requested by yotr in the January 27, 1984 Baton Rouge, LA Steering Comittee meeting. Should you need any additional infomation, please contact any task force member.
If there are any major areas of concern, the task force group will be available at the~ next steering comittee meeting to discuss these concerns.
If I can be of any assistance, please contact me at 443-7902.
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Antonyk.se, Chairman Task Force on Equipment Perfomance Criteria
. Steering Comittee on Radiography Safety
Enclosure:
Task Force Report cc:
(w/ encl.)-SteeringCommitteeMembers S.Baggett,NMSS/NRC(TFMember)
N. Bassin, M4SS/NRC K. Black, AEOD/NRC L. Cobb, IE/NRC J. Klucsik, ELD /NRC D. Honey,CA(TFMember)
J. Lubenau, SP/NRC M. Neuwag IL R. Ratliff TX (TF Member)
R. Wascom, LA (TF Member)
I.
O RADIOGRAPHIC EQUIPMENT SAFETY PERFORMANCE CRITERIA April 30, 1984 Prepared by Task Force on Equipment Safety Performance
~
Criteria Chairman A. Tse, NRC Members S. Baggett, NRC D. Honey, California R. Ratliff, Texas R. Wascom, Louisiana e
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TABLE'0F CONTENTS Executive Summary............................
1 Purpo se and Scope............................
2 Section 1 The Industrial Radiography Industry...
4 Section 2 Causes of Accidental Overexposure..............
6 Section 3 Radiation Survey Requirements and Equipment Safety Performance Criteria............
9 Section 4 Specific Equipment Safety Performance Criteria........
11 4.1 Connectors.......................
11 4.2 Locking and Securing Mechanisms 13 4.3 Indicators and Labels.................
14 Section 5 Cost-Benefit Analysis....................
16 Section 6 Conclusions and Recommendations...............
20 Section 7 Implementation 2r G
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EXECUTIVE
SUMMARY
In 1979 the NRC established an industrial radiography steering committee to investigate the cause of accidental overexposures and injuries to industrial i
radiographers and to develop the requirements to reduce these accidents. The Steering Committee includes representatives from three agreement states who have knowledge of actual field operation practices of. industrial radiographers.
In a meeting of the Steering Committee held on January 27, 1984, in Baton Rouge, LA, four separate Task Forces were formed'to research the areas the committee had identified where improvements could result in reduction of overexposures to industrial ralliographers. The 'four areas are:
(1) equipment changes that could help eliminate equipment failures; (2) training and testing of radiographers to evaluate the effectiveness of their training; (3) establishing a uniform data collection format for incidents to allow detection of trends; and (4) improved inspection requirements to confirm that field operations are conducted properly.
This Task Force examined equipment safety performance criteria. The methodology used was to have each task force me,mber write out his suggestions on areas of improving equipment performance, including specific details, costs and benefits.
These were discussed at the first task force meeting held in Boston, MA, on March 7, 1984. At this meeting all suggestions were discussed and each member assigned a' specific task to research and complete prior to the second meeting which was held in April 2-6, 1984 in San Francisco, CA.
At the January steering committee meeting and at the two specific task force meetings the members visited four of the five industrial radiography manufac-i turing licensee's facilities. This allowed members to see the various equipment designs, as well as, to get input from the manufacturers as to what equipment changes could be made to improve safety performance as well as the approximate cost of the changes. This also allowed the task force members to obtain additional information on common equipment failures reported to the manufacturers as well as data on the number of radiograp!.ers presently working and the number of cameras in use.
1
i Based on the past experience of task force members, the information gained from research of data and interviews with source manufacturers, the Task Force made the following general conclusion:
Overexposure and accidents in industrial radiography are the result of a combination of equipment malfunctions and human error.
Equipment malfunction rate can be reduced by improving certain safety performance criteria, testing procedures and quality assurance requirements.
However, human error rate is more difficult to reduce and additional survey requirements may not reduce overexposures. The combination of improved equipment safety performance and continuance of the present radiation survey requirements should provide the greatest reduction in overexposures and accidents.
The Task Force considered numerous possible improved safety performance require-ments and the cost-benefit of each requirement. The Task Force recommends that certain equipment safety performance criteria should be incorporated into NRC and Agreement State regulations.
PURPOSE AND SCOPE This Task Force was assigned to consider the possibility of improving industrial radiography safety through certain safety-related performance criteria for j
radiographic exposure devices. The Task Force is to make recommendations along with their, justifications for consideration by the full Steering Committee. A report is to be completed and forwarded to the Steering Committee by April 30, 1984, for future consideration. The purpose of the task is to consider whether accidental overexposures o'r injuries received by radiographers, radiographer assistants, and members of the public can be reduced by imposing safety perfor-mance criteria on exposure devices.
In addition, the Task Force must consider the justification for recommending any criteria to be imposed by evaluating the benefits derived by the criteria vs. the cost to the industry for complying with the criteria.
}
2
The scope mandated by the Steering Committee is limited to portable and mobile radiographic exposure devices that use a crank-out mechanism to move a source from the shielded to the unshielded position. The task does not include consideration or items such as fixed radiographic exposure devices, source changers, radiation detection and warning instruments, inspection and maintea nance of radiographic equipment or modifying radiation shielding to minimize external radiation levels.
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SECTION 1
.THE INDUSTRIAL RADIOGRAPHY INDUSTRY
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The U.S.' Nuclear Regulatory Commission reports that a total of 1,116 licenses have been issued to firms which authorize industrial radiography.
These licenses are distributed between Agreement States and the NRC on a 2 to 1 ratio respectively.
Licensed firms employ an estimated 5000 radiographers on a full or part time basis. These radiographers utilize an estimated 2000 radiographic exposure devices to produce tens-of-millions of radiographs per i
year and expend in excess of $20 million for film.
In addition to film, radiographic firms have initial investments in equipment
~
totaling $100 million (radiographic equipment ~ $10 M, trucks ~ $90 M).
Annual expense to maintain and replace equipment is estimated at $25 million/ year j
(Radiographic equipment ~ $5M/yr, trucks ~ $20 M/yr).
l The accident experience for industrial radiography can be assessed on the basis of past experience. This experience was reviewed with representatives from California, Louisiana and Texas, which accounts for 1/3 of the total licensees.
This data indicates 22 accidents-involving injury over the last m.6G, /
decade for these states. ' Injury is defined as a hand burn and /or whole body exposures in excess of 25 rem.
Further we estimate 2 catastrophies (one in California in 1978 and the other in Texas in 1980), per decade for the U.S.
We also believe that there are an average of 25. accidents.per year involving f
~
serious overexposure greater.than 10 rem whole body equivalent.
+
The estimated cost of these injuries, accidents and overexposures is $1.5 million per year. This% stimate is: based on $1;1000Per person ren (whole body) and a total'of $11 million for the two catastrophies (one occurred in Texas in 1980 costing ~ $1M and the California accident is still under litigation, but the damage' award is expected to be $10M).
4
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This history of accidental overexposures and injuries discloses a risk to radio-graphers greater than the risk to any other group of radiation workers who use byproduct material.
Accidents are frequently coupled with a failure of the radiographer to perform proper surveys.
However, further efforts to improve system safety must emphasize improvements in equipment design criteria conjunctively with human performance to maximize effectiveness.
es-1
/ k' Several equipment manufacturers have moved forward to implement some of the equipment safety performance features, including pigtail labeling, which are currently under consideration by the Steering Committee.
Regulations should now be adopted-to provide direction for this process to assure that improvements in equipment safety performance are uniform, complete, timely, and effective.
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SECTION 2 CAUSES OF ACCIDENTAL OVEREXPOSURE Causes of overexposures from accidents in the radiographic industry may be divided into two categories:
1.
Those caused by equipment design or equipment failure with or without human error or omission.
(Example - a source is disconnected from the pigtail and left in the guide tube and the radiographer fails to perform a proper survey); and 2.
Those caused solely by human errors without equipment failure.
(Example - a radiographer forgets that the source is outside the camera and walks into the radiation field).
The overexposures from the first category are 'due to equipment design or equip-ment failure, and therefore, these overexposures may be avoided by requiring additional safety performance criteria to improve. radiographic exposure devices.
The overexposures that are due solely to human errors cannot be reduced by requiring more stringent performance criteria for the exposure device.
- However, these overexposures may be reduced by using warning instruments, such as pocket alarms, chirpers, radiation warning lights or horns. This type of overexposure will not be further discussed here because radiation detection or warning instrumentation is'outside the scope of this Task Force.
Table 2.1 summarizes each failure mode considered by the Task Force. The most important failure modes are the ones that occur frequently and that are unlikely to be known by the radiographer.
6
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TABLE 2.1 CAUSES AND POSSIBLE SOLUTIONS FOR EQUIPMENT FAILURE Likelihood of Known or Unknown Possible Failure Mode Cause Occurrence to Radiographers Solution (s)
(w/o survey) r 1.
Pigtail in guide Pigtall is not Frequent Unknown to radio-Require that the pig-I tail cannot be driven tube; does not properly con-graphers.
return to nected to drive out of shielded posi-shielded posi-cable.
tion unless the con-nection with the drive t j or,,
cable is made properly.
4 2.
Source stays Sealed sourcs Not frequent Unknown to radio-Require each component in guide tube, separates from graphers.
of the pigtail to be while the rest the pigtall.
tested to 200 pounds tensile force without of the pigtail failure, prior to returns to distribution.
shielded position.
Require positive position indicator.
3.
Source moves out The handle has Frequent Unknown to radio-Require an automatic l
of shleided been turned graphers.
locking device to secure j
position before forward a little the source as soon as the source returns to i
the source is due to some Iocked.
external force the fully shielded position l
such as dropping of the controls.
Require a mechanism to I
secure the drive cable in place at the crank control.
4.
Pigtail moves The stopping Not frequent Unknown to radio-Require positive stop-through the back mechanism graphers.
ping device to block of camera.
failed.
the pigtall from moving through back.
7
TABLE 2.1 (Continued)
Likelihood of Known or Unknown Possible Failure Mode Cause Occurrence to Radiographers Solution (s)
(w/o survey) 5.
Pigtail and The connector Frequent when Most likely Require positive force source fall disconnected guide tube falls unknown.
to be applied before 1
from the because of off or source the pigtail can be camera.
failure to driven through disconnected.
j properly connect the end of the the guide tube guide tube.
Require secured end cap or the use.of an on guide tube.
+
open ended guide tube.
Required the guide tube to be j
interlocked with the source in the shielded position.
6.
Source is left Broken drive cable Not frequent Unknown to radio-Require source to be in guide tube.
- grapher, automatically locked in the shielded position.
Enforce the inspection and maintenance proce-dures.
7.
Source is not The locking ball Not frequent The radiographer Require the ball to be in the fully shifts.its may not know.
tested to at least 200 Ib. tensile force.
shielded position.
position.
8.
Source is stuck The source or Not frequent The radiographer Require smooth pathway in guide tube.
drive cable is thould know.
at the junction between stuck in the the camera and the guide tube.
guide tube.
Require safety perform-ance criteria for guide tube.
8
j SECTION 3 RADIATION SURVEY REQUIREMENTS AND EQUIPMENT SAFETY PERFORMANCE CRITERIA Currently the regulations for industrial radiography contain adequate survey and record keeping requirements.
However, industrial radiographers continue to receive overexposures because of source disconnects, failure-to-connect or failure of sources to fully retract into the exposure device and the failure to perform a proper survey.
4 The survey requirement is very important. Unfortunately, many radiographers either do not perform this survey or do it incorrectly. When equipment failure couples with human error in not doing the surveys the result is large, often injurious,overexposures. Radiographers usually fail to perform surveys because of one or more of the following reasons:
(1) the work tends to be i
monotonous and repetitive; (2) the radiographer is rushed in performing his work; (3) th... die;-sphe ef; eat M h;;q ;,,d e ',.;;rd t; h.ndi 1 (4) the working conditions are often difficult and the use of survey meters is impractical; (S) the radiographer may not be motivated by management to work safely 0.' perform surveys; or (6)' the survey meter may be damaged or never taken to the job. site.
Even when an operable and calibrated meter is available and the radiographer uses it, a source disconnect can result in an overexposure during the process
~
of returning the disconnected source to.the exposure device.
Therefore, the existing requirements for survey 3 while very important, will not always result in safe radiography operations. The combination of human error or omission plus the possible failure of the radiograpnic equipment or survey meter increases the risk of accidents.
Radiation surveys would detect a source disconnect, but could not prevent the disconnects as more stringent safety performance criteria can.
9
Equipment failure rate can be reduced by improving performance criteria, quality assurances and testing procedures.
As the safety performance criteria is improved, this lessens the risk of overexposure even if the rate of human errors -
remains the same.
me O
O 4
e e
6 e
10 O
)
SECTION 4 SPECIFIC EQUIPMENT SAFETY PERFORMANCE CRITERIA 4.1 Criteria Related to Connectors The remotely controlled crank-out type exposure device is involved in the majority of excessive exposures.
Based on past experience, it is estimated that 90% of incidents involve the use of the crank-out type exposure device.
While it is not known how many of these are the result of disconnects or failure to properly connect, it is recognized that disconnects are involved in a significant portion of the overexposure incidents. The incidents involving disconnects arr probably second only to the ones that are the result of failure to return the source to the fully shielded position.
Pigtail connectors that do not require a positive force in at least one plane are known to disconnect if the pigtail assembly falls outside the guide tube.
Also exposure devices that allow the source assembly to be driven from the shielded position without making the proper connection are subject to the failure-to-connect accident.
In either case, if the disconnect goes unnoticed the radiographer may come in contact with the source.
If the disconnect is noticed, an overexposure may occur during the process of returning the disconnected source to the exposure device.
Therefore, it is safe to conclude that if the number of disconnects could be reduced, the number of overexposures could also be reduced.
The following criteria related to source connectors should reduce the number of disconnects.
11
.,n
,, _,, - -, -, - - - -. - - ~
.r,-
e,----
--~~-
,m
1.
The pigtail drive cable connecting procedure should require motion in at least two planes including a positive force in at least one plane that is different from the normal operating forces. This would prevent disconnects when the source is free from the guide tube.
~
t 2.
The source assembly cannot be removed from the shielded position unless the drive cable is properly connected to the pigtail.
This will require modification of lock box design for some equipment. This would prevent the failure-to-connect accident.
3.
The source assembly cannot be driven out of the shielded position unless the guide tube is properly connected to the exposure device. The task force cont 1dered the situation that, if the guide tube is not connected properly to the exposure device, the pigtail could be driven out of the shielded position without the guide tube.
However, if item one is required, the pigtail will not separate from the drive cable when outside the guide tube.
Additionally, the probability of the pigtail becoming free of the guide tube is very low and, if this event did occur, the radiographer would still be able to return the source to the shielded position. We therefore concluded that this requirement is unnecessary.
4 4.
Each component of the pigtail assembly and each component of the drive cable shall be tested to 200 pounds tensile force without failure, prior to distribution.
This would prevent pigtail components from shifting or t
I pulling off.'
I 5.
Require the guide tube and crank-out assembly be able to withstand kinking and crushing forces likely to be encountered, and that the licensee be prohibited from modifying controls or guide tubes in any manner that would degrade the safety or quality. The guide tube shall also be constructed l
so that the end-cap is securely attached.
This would lessen hanging up of I
the source in the guide tube as well as prevent the source from being pushed through the ena-cap.
12
-w
~ ~ - -
,,,-_n._.,
4.2 Criteria Related to Locking and Securing Mechanisms Failure to properly connect the source pigtail accounts for a part of accidents involving injury and overexposure resulting from failure to return the source to the fully shielded position. Other important failure modes that could produce accidental injuries and/or overexposures are:
accidental ejection of the properly connected source pigtail from the fully shielded position; locking on the drive cable while the source is not in the fully shielded position; and loss of source pigtail after disconnecting the drive cable.
Incorporation of safety performance criteria in lock box function would, in the judgement of the Task Force, reduce the frequency of the accidents.
However, specific designs to implement these criteria will require careful review to assure that additional exposure in normal operations will not result.
1.
The locking mechanism must be designed such that the drive cable cannot be disconnected unless the pigtail is secured in the shi.elded position.
l This would reduce the loss of sources after removal of the drive cable.
2.
The outlet nipple, lock box, and drive cable fittings must be equipped with safe'ty plugs or covers which will protect the source assembly from damage and from foreign matter during storage or transportation.
The securing mechanism (the lock box or the crank control) must be designed 3.
such that during radiographic operations the pigtail must be automatically secured in the shielded position each time the source is returned to that position. This would prevent accidental movement of the source from the fully shielded position during these operations.
4.
The exposure device must have a tamper resistant lock box which can be removed from the device only using specific tools and a lock that can be unlocked only with a key. This feature could discourage unauthorized I
manipulation, on the lock box.
t 13
5.
The lock must not operate unless the source assembly is in the fully shielded position. This would prevent locking of the source in a r
position outside the fully shielded position.
6.
Removal of the source asssmbly through the back of the radiographic exposure device must not be possible even when the device is unlocked.
4.3 Criteria Related to Indicators and Labels 1.
An indicator could be used on the device to indicate that the source is in the properly shielded position. Ths majority of radiography accidents involve the inability of the equipment or radiographer to indicate whether the sourse is in the properly shielded position or not. This mechanism can be either by direct or indirect measurements. The mechanism for showing the position of the source assembly must be designed and constructed such that it~is highly unlikely to falsely indicate the position of the source assembly.
l The Task Force has mixed feelings on this criteria. Our group presents the criteria because it indicates to the radiographer the position of l
l.
the source or pigtail. On the other hand 1t was felt that this would require an increase in mechanical complexity to make such a mechanism and could cause additional exposure due to change in operating procedures and the mechanism's failure rate could be high.
A label could be used on the crank-out mechanism to indicate the direction 2.
of " Expose" or " Retract". Radiographers must work at a rapid pace. This continued pr.ca has caused some confusion as to the direction to turn the crank to " Expose" or " Retract" the source.
From NRC incident reports, it was determined that confusion of this type accounts for about 2% of the reported overexposures.
A label of this type would eliminate the over-exposures resulting from confusion between the " Exposure" and " Retract" direction of movement.
14 i
We also looked into the 'use of an indicator that tells the location of the cable and therefore tells the user if the source is out and at what distance. The c.urrent use of the flex cable and drive gear combination allows for slipping leading to errors in the distance indicator.
It is
~
felt that this could give a false indication of the position of the source and 'would not provide an additional protective function.
Therefore, this type of indicator is not recommended.
3.
A label could be required on the pigtail to warn persons that this item is dangerous and radioactive. There have been incidents in which several imembers of the general public were unnecessarily exposed and a case in which a raciographer assistant picked up a disconnected source and was overexposed.' This resulted in not only overexposure and injury, but a monetary restitution. The addition of a label on the pigtail would have lessened and in some cases prevented the overexposure and injury. The Task Force recommends that the pigtail be labeled with, at a minimum, the words " Danger" and " Radioactive". The small cost of applying this label to give the finder some warning would be very cost effective.
6 9
0 6
15
SECTION 5 I
COST - BENEFIT ANALYSIS Costs fo'r incorporating safety performance criteria of radiographic equipment are summarized in Table 5.1.
Those costs were developed through discussion with major equipment manufacturers and the judgment of the Task Force.
Several manufacturers have implemented some of the safety performance criteria under consideration.
Implementation of features involving the lock box as a unit (criteria e through g) may reduce the lock box cost to $40,000 per year instead of $60,000 per year (based on a manufacturer's estimate of $200 per lock box).
The overall cott}for implementation was estimated 'at $220,000~- 300,000 per year.
~
Benefit is derived from avoidance or mitigation of injury' and overexposure which result from accidents. The societal costs of injuries and overexposures
- ere converted to dollars to permit comparison with the cost to the radiographic w
industry of implementation of equipment safety performance criteria.
Accident costs were estimated on the basis of the expected damage award in the 1978 California accident and the $1000 per person-ren used by the nuclear power industry.
Safety performance criteria were assigned mitigation or protection factors shown in Table 5.2.
These factors were estimated by the Task Force as a judgement of the effectiveness of safety features in mitigating the severity of or providing protection against accidents. The overall benefit' derived from implementation of task' force recommendations wasLestimated at $680,000 l
l per year.
i Benefit derived vs. cost to implement are summarized in Table 5.3.
l 4
16
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--,,-m---w-
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a TABLE 5.1 COSTS FOR INCORPORATING PERFORMANCE CRITERIA l
J No. of Replacement No. of Total Cost Peformance Cost Range Exposure Frequency Units Range Criteria
- Per Unit ($)
Devices Per Year Per Year
($/Yr) a.
Source Pigtail
.5 2000 2.5 5000
$ 3,000 label b.
Connector 35 2000 2.5 5000 175,000 4
c.
Lock operable 100-200 2000 0.1 200 20,000-40,000 i
only with source shleided i
d.
Control remov-50-100 2000 0.1 200 10,000-20,000 able only with i
source secured in the shielded position j
e.
Control opera-50-100 2000 0.1.
200 10,000-20,000 j
tion possible only with source connected f.
Visible Indicator 50-100 2000 0.1 200 10,000-20,000 i
to show source in shielded positicn i
g.
Automatic source 50-100 2000 0.1 200 10,000-20,000 assembly trap
{
mechanism I
Total (if lock box criteria implemented separately) 240,000-300,000 Total (if lock box criteria implemented as a unit) 220,000-300,000 j
Cost Range 220,000-300,000
\\
- The following performance criteria are already in use, thus, minimum cost is involved:
}
1.
Pull test of pigtail assembly and drive cable assembly.
2.
Guide tube performance criteria.
3.
Safety plugs for outlet nipple, lock box, and drive cable fittings.
4.
Source assembly cannot be moved through the back of the device.
5.
Controls to be marked to indicate the direction of cable movement.
17 l
TA8LE 5.2 BENEFIT FOR INCORPORATING PERFORMANCE CRITERIA t'
MITIGATION OR INJURY / EXPOSURE PERFORMANCE CONSEQUENCE.
PROTECTION REDUCTION CRITERIA EVENTS
- COST ($/YR)
FACTOR
($/YR) i I
a.
Source pigtail X
1.1M 0.1 110,000 b.
Connector X,Y,Z 1.5M 0.2 300,000 c.
Lock operable Y, Z 6.4M 0.05 20,000 only with source shielded d.
Control remov-X,Y,Z 1.5M 0.05 75,000 able only with 4
source secured in the shielded position e.
Control opera-X,Y,Z I.5M 0.1 150,000 tion possible only with source connected f.
Visible Indicator Y, Z 0.4M 0.01 4,000 to show source in shielded position g.
Automatic source Y, Z 0.4M 0.05 20,000 assembly trap mechanism TOTAL 680,000
- Events for consequences in terms of cost ($/yr):
X - catastrophic event, $11M/10 yrs = $1.1M/yr.
Y - handburn/ injury event, 4 events /yr** x 25 res/ event x $1,000/rea = $100,000/yr.
Z - serious overexposure event, 25 events /yr x 10 res/ event x $1,000/rea = $300,000/yr.
- 4 events per year is estimated for the U.S. (based on 22 events /10 yrs for Ca, La, and Tx which includes events of HRC licensees operating in these states).
~
18
[
TABLE 5.3 COST vs. BENEFIT Performance Costs Benefit Criteria
($/yr)
(5/yr) a.
Pigtail Label
$ 3,000
$110,000 b.
Connector
$175,000
$300,000 c.-g.
Lock Box
$ 40,000 - $120,000
$270,000 TOTAL
$220,000 - $300,000
$680,000 O
D 19
SECTION 6 CONCLUSIONS AND RECOMMENDATIONS The Task' Force considered the effectiveness of equipment safety performance criteria for reducing accidental overexposures.
It also considered the justi-fication for improving these criteria based on the cost-benefit analysis. The Task Force conc 1'ded that the following recommendations should be implemented u
by the NRC and the Agreement States:
1.
The pigtail cannot be disconnected from the drive cable unless a positive force is applied and motion in two planes is required.
2.
The pigtail cannot be driven out of the fully shielded position unless the drive cable is properly connected to the pigtail.
3.
Components of pigtail and drive cable must be tested to 200 pounds tensile force prior to distribution.
/
4.
Guide tube must be able to withstand kinking and crushing force.
5.
The drive cable cannot be disconnected from the pigtail unless the pigtail is secured in the shielded position.
6.
. Safety plugs should be required to protect outlet nipples, lock box and drive cable fittings.
7.
The pigtail must be secured automatically in the fully shielded position each time the pigtail is returned to that position.
8.
A tamper resistant lock box and a keyed lock must be used.
20
~
v/9.
The lock must not operate unless the pigtail is in the fully shielded position.
i;/.
10 The pigtail must not be able to move through the back of the device.
11.
An indicator may be useful on the device to indicate that the pigtail is in the proper shielded pos.ition.
gj/12. A label should be required on the crank-out unit to indicate the direction of drive cable movement.
13.
A label should be required on the pigtail to warn persons that t.his item is danget.ous' and radioactive.
Overexposures and accidents in industrial radiography result from a combination of equipment malfunction and human error.
The combination of improved equipment safety performance criteria and continuance of the present radiation survey requirements should provide the great.est reduction in overexposures.
e 9
l l
l 21
A
- a p.
SECTION 7 IMPLEMENTATION The task force recommendations should be added to the rules as soon as possible.
This should proceed by first drafting a proposed rule change and then distribute it to the Agreement States for comments.
After analysis of comments, the proposed rule should be published for public comments. These comments should be considered in the final rulemaking proceedings.
It may also be desirable to issue an information bulletin to the source manufacturers and users to recommend that source labeling and improved connectors be-pursued prior to the rule making process on a voluntary basis.
Once the rules are adopted by the NRC they should become items of compatibility for the Agreement States.
There should not be any retrofit'of equipment except the change in drive cable connectors to be compatible with the new pigtail connector. The rule should require that all sources manufactured after the effective date of the rules must be labeled and have the new connector.
In addition, all new cameras manufactured after one year from,the effective date of the rules would be required to meet all the new safety design criteria.
Presently'used cameras could be retrofitted but it would not be a requirement.
Thus, we expect that the ones not retrofitted would remain in use no longer than ten years.
If a manufacturer does request authorization to retrofit his l
presently manufactured cameras, he would have to submit the details necessary to perform a device safety evaluation.
l The effectiveness of the new requirements must be evaluated on a roJtine basis.
j l
This is best accomplished by establishing a uniform incident reporting form that can be tabulated by the NRC so the data can be analyzed to see the incident trends.
22 1
m USER OFFICE CONCURRENCE e
i I
l
[
l I
- nueo,
[e UNITED STATES g
NUCLEAR REGULATORY COMMISSION g
j WASHINGTON, D. C. 20555 1.,*..../
MAR S 1985 MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle & Material Safety, NMSS FF0M:
Karl R. Goller, Director Division of Radiation Programs & Earth Sciences, RES
SUBJECT:
INITIATION OF NEW RULEMAKING ACTION SPONSORED BY RES ---
10 CFR PART 34: SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EXPOSURE DEVICES The purposes of this memorandum are: (1) to request your concurrence in draft recomendations from the Director, Office of' Nuclear Regulatory Research, to the ED0 regarding the advisability of initiating a new rulemaking action, and (2) to obtain your approval on the associated Task Control Form.
The draft recomendations are included as Enclosure C in the enclosed Task Control Form Package.
I concur in the recomendations and would like to dispatch the transmittC memorandum (Enclosure F) to the RES Director for his signature within two weeks. Since your office is identified as a user office of the proposed rule, I would like your concurrence in initiating this rulemaking before I do this.
For your convenience, provision is made below to indicate the position you are taking regarding these recommendations, and for your signature.
The Task Control Fom for this effort which you are also requested to sign is included as Enclosure G in the Task Control Form Package. This package contains several other documents that provide useful information regarding the proposed rule. Any coments that you would like to provide on these documents would be welcome at this time.
A Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosure:
Task Coptrol Form Package oncur without coments.
D Concur with coments provided.
O Major coments provided which must
- gjE, be resolved before I will concur.
g Richa d unningham, Dir., DFCMS/NMSS Date Enclosure F
/
'o UNITED STATES A
f)M 8
~,,
NUCLEAR REGULATORY COMMISSION l/'
bb o
t, cAswiscTON, D. C. 20555 z
\\...../
MAR 8 G '-
MEMORANDUM FOR:
G. Wayne !. err, Director Office of State Programs FROM:
Karl R. Galler, Director Division of Radiation Programs & Earth Sciences, RES
SUBJECT:
INITIATION OF NEW RULEMAKING ACTION SPONSORED BY RES ---
10 CFR PART 34: SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EXPOSURE DEVICES The purposes of this memorandum are: (1) to request your concurrence in draft recomendations from the Director, Office of Nuclear Regulatory Research, to the EDO regarding the advisability of initiating a new rulemaking action, and (2) to obtain your approval on the associated Task Control Form.
The draft recomendations are included as Enclosure C in the enclosed Task Control Form Package.
I concur in the recommendations and would like to dispatch the transmittal memorandum (Enclosure F) to the RES Director for his signature within two weeks. Since your office is identified as a user office of the proposed rule, I would like your concurrence in initiating this rulemaking before I do this.
For your convenience, provision is made below to indicate the position you are taking regarding these recommendations, and for your signature.
The Task Control Form for this effort which you are also requested to sign is included as Enclosure G in the Task Control Form Package. This package contains several other documents that provide useful information regarding the proposed rule. Any coments that you would like to provide on these documents would be welcome, at this time.
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosure:
Task Control Form Package D Concur without coments.
r with coments provided.
O Major coments provided which must be resolved before I will concur.
p G. W ne r
1r., OSP Date Enclosure F
>>emt j.
d*" %
UNITED STATES p
NUCLEAR REGULATORY COMMISSION f
)M WASHINGTON. D. C. 20555 s,...../
MAR 2 01985 Ref: SA/J0L MEMORANDUM FOR: Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES FROM:
G. Wayne Kerr, Director Office of State Programs
SUBJECT:
INITIATION OF NEW RULEMAKING ACTION FOR INDUSTRIAL RADIOGRAPHY EXPOSURE DEVICES Thank you for the opportunity to review and coment on the draft recommendations to ED0 and associated Task Control Form concerning new rulemaking action for industrial radiography exposure devices.
We have two major comments on the proposed rulemaking action. One centers on the timing of it in conjunction with a research program to explore changes in radiographic equipment. Comissioner Asselstine suggested such a research program at the Steering Comittee meeting in Baton Rouge, January 23-24, 1985 and the Comittee agreed it would be worthwhile pursuing.
OSP would support a research program to find ways to make radiographic equipment safer if this is needed to show that suggested improvements are practicable. Such an effort should include provisions for manufacture of prototype designs and opportunities for field tests, if needed. The results of such a program could enhance the regulatory basis for proposed rulemaking on the subject of radiation safety performance standards for radiographic equipment.
If NRC does embark upon a research program to improve radiographic equipment, we believe it would be appropriate for the Steering Comittee to exercise some oversight over the effort. This will ensure the fullest utilization.of the special experience and knowledge of NRC and State staffs who have'a working familiarity with radiography radiation safety problems.
In a related matter, we have some concerns over how well the steering comittee is informed on radiography equipment safety standards that 4
have been developed internationally. At the last steering comittee meeting, a brief discussion was held on ISO 3999 (enclosure 1) which was brought to OSP's attention by Don Honey, California. After some effort, SP obtained a copy from the NBS library (NRC's library had no copy).
Don Nellis has been very helpful in trying to develop background information on this standard. Our concerns are:
850512 Enclosure F
= - -
-2 o
The United States voted against the standard on technical grounds (see p.2 of enclosure 2). What were the technical reasons for doing so?
o Who represents and votes for the United States?
o Does NRC have input? If not, shouldn't it?
o In view of the Steering Comittee's functions shouldn't it have an awareness of, if not a contributing role in, the development of international standards for radiography radiation safety?
According to Mr. Nellis, Tech / Ops claims it manufactures a radiography camera, Model 900, that meets the ISO standard. An NRC registration certificate was issued May 14, 1981 for this unit (enclosure 2). The device seems to incorporate many of the features that have been discussed by the Steering Committee as potentially desirable from a
~
. radiation safety viewpoint. We believe that NRC through the Steering Comittee needs to carefully review and evaluate what is currently required and is being implemented internationally before imposing new requirements through rulemaking. Perhaps this could be done as part of the aforementioned research program.
OSP has no objection to proceeding with a rulemaking now to codify radiation safety requirements that staff currently agree are necessary and which are presently imposed through the sealed source and device registration process.
If a research effort shows that additional requirements, such as those specified in ISO 3999 or incorporated into the Tech / Ops device can be shown to be both feasible and likely to contribute significantly to safety, we would support a subsequent rulemaking to amend the regulations to incorporate these additional requirements.
Other technical and editorial coments have been included as marginal notes on the enclosures to ' our memo which are returned (enclosure 3).
y UGY G. Wayne KePr, Director Office of State Programs i
i
Enclosure:
As stated i
i cc: w/ enc 1. I and 2 J. G. Davis, NMSS' J. Taylor, IE J. Heltemes, Jr., AEOD G. Cunningham, ELD i
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