ML20247K971
| ML20247K971 | |
| Person / Time | |
|---|---|
| Issue date: | 09/18/1989 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-55FR843, REF-10CFR9.7 AC12-2-06, AC12-2-6, M890911, NUDOCS 8909220083 | |
| Download: ML20247K971 (47) | |
Text
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. UNITED STATES - IN RESPONSE, PLEASE Mg T NUCLEAR REGULATORY COMMISSION- REFER TO: M890911 g- 7 E. W ASHINGTON, D.C. 20555
% ,,,,, September 18, 1989 OFFICE OF THE -
SECRETARY l
u MEMORANDUM FOR: James-M. Taylor
' Acting Executive Director for Operations {
FROM: 6 el J. Chilk, Secretary V ,
SUBJECT:
STAFF REQUIREMENTS - AFFIRMATION / DISCUSSION AND' VOTE, 10:00 A.M., MONDAY, SEPTEMBER 11, {
i 1989, COMMISSIONERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND ,
(OPEN TO PUBLIC ATTENDANCE) I i
I. SECY-89-276 - Motion for Reconsideration Filed by Joseph J. .!
Macktal The Commission, by a 4-0 vote, approved an order responding to an August .18, 1989,. motion by Joseph J. Macktal requesting that the Commission reconsider'its decision in CLI-89-14 where in it declined to disqualify itself from deciding any future matters involving Mr. Macktal. The order denied.the motion to ,
reconsider. i (Subsequently, on September 11, 1989, the Secretary signed the Order.)
II. SECY-89-194 - Amendments to 10 CFR Part 34: Safety Requirements for Industrial Radicarachic Eauionent j The Commission, by a 4-0 vote, approved amendments to 10 CFR Part 34 which apply to industrial radiography. The amendments are intended to reduce radiation exposure to both radiography personnel and the general public from the use of radiographic equipment. The Commission also modified its enforcement policy.
to add a specific example to put licensees on notice that the failure to implement the requirements for dosimetry and equipment may be considered a violation of significant regulatory concern.
690,92hh C Tf PLE pT9.7 ' s I
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The Commission also agreed to make~the rule effective six .{
months.after publication and agreed to the attached modifications.
The rule should be modified as noted, reviewed by'the Regulatory Publication Branch ~for conformance with the requirements of the lederal Register and returned for signature and publication.
(EDO) (SECY Suspense: 10/6/89) l
Attachment:
As stated cc: Cha'irman Carr Commissioner Roberts Commissioner Rogers Commissioner Curtiss OGC GPA PDR - Advance DCS - P1-24
[7590-01).
, b m.As -
4 EFFECTIVE DATE: -(-It ;;.er.th?from date of publication). The' incorporation
.by reference of certain publications listed in the regulations is approved by the Director of.the Federal Register as of .
FOR FURTHER INFORMATION CONTACT: Dr. Donald O. Nellis, Radiation' Protec-tion' and Health Effects Branch, Division of Regulatory Applications, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, l Washington, DC 20555, telephone (301) 492-3628.'
1 l
SUPPLEMENTARY ~INFORMATION:
CONTENTS
Background
. Radiography Related Overexposure . .
Previous Regulatory Initiatives ,
I Public Comments Finding of No Significant Environmental Impact: Availability Paperwork Reduction Act' Statement l
Regulatory Analysis Regulatory Flexibility Analysis l~
Backfit Analysis List of Subjects Appendix A - Regulatory Flexibility Analysis On March 15, 1988, the Nuclear Regulatory Commission published for public comment a proposed rule [53 FR 8460] that would require NRC licen-sees to use radiographic exposure devices that meet the criteria speci-fied in American National Standard N432, " Radiological Safety for the 05/22/89 2 Enclosure A
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[7590-01]
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device; however, some devices, such as the so called "pipeliner," utilize '
a shutter to allow the radiation beam to exit from the device while the source remains in a shielded position within the device.
The general procedure used is as follows: First, a radiation sensi-tive film is positioned over the area of interest on the item to be examined. Then a radiography expot re device or camera (which contains a sealed gamma-ray emitting source within a radiation shield) is placed nearby. A flexible hollow tube called a " guide tube" is connected to the front of the device, and the other end of the guide tube (to which an exposure head is attached), is positioned opposite the film on the item to be examined. Next, on the back of the device, a " control cable" is connected to the radiation source assembly, sometimes called a " pigtail" (a short length of wire with the source fastened on one end and a connec-tor for the control cable on the other). Use of the " pigtail" allows the connection to be made without directly exposing the radiographer because the source itself remains in its shielded position within the device while the connec. ion is being made. Lastly, a hollow tube through which the control cable moves is connected to the back of the device.. The con-trol cable and its tube are then unreeled until the cranking device for operating the cable is approximately ten to twenty feet from the device.
This distance provides radiation protection for the radiographer. Next, the radioactive source is cranked or pushed from the radiographic device to the end of the guide tube. This causes the gamma-rays from the source to penetrate the item under examination and expuse the film. At the end of the desired exposure time the source is cranked back into the device.
A survey is made with a radiation detection device to ensure that the 14 .t.n u source assembly is in its shielded positio then M secured in 06/05/89 4 Enclosure A
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.this position and the. film is. retrieved for development. The radiographer L is then ready to proceed with the next exposure. In some instances, what is referred to as "real time" radiography is performed. This merely involves replacing the. film with remotely operated TV fluoroscopic equipment, solid state, or other suitable detection equipment that produces an image in real time without requiring development of a film.
Although the described procedure appears straightforward, and most radiography is performed safely, radiation overexposure to radiographer and occasionally to the. general public occur. Accidental radiation over-y exposures to both radiographer and the public have concerned both the NRC and the Agreement States because the radiation levels of the radioactive-Ii sources used in industrial radiography are sufficient to cause serious injury or death.
Industrial radiography performed in the field.is of most concern.
Unlike many other applications of ionizing radiition which are rigid?y controlled and remote from the public, industrial radiography involves the use of high activity sources, sometimes in close proximity to the general
,a=,publiegdh often only under control of the radiographer) The workg is generally performed under production pressure and is often per-formed in adverse weather and environmental conditions. Such conditions can lead to both equipment failure and failure to follow proper safety procedures (e.g., failure to perform the required radiation survey or allowing assistant radiographer to perform the radiography themselves without the direct supervision of the more highly trained and skilled radiographer). Such f ailures, either singly or in combination, occa-siona11y lead to radiation overexposure. Some of the failures of 05/22/89 5 Enclosure A
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[7590-01] t 4
radiography licensees to follow NRC requirements have been documented in a recent NRC information notice.1 P Radiography Related Overexposure / M*Cbh fy9 The NRC has been concerned about the number of radiation overexposure among radiographer for several years and has completed, has underway, or is considering, actions intended to reduce the frequency of the overexpo-sures. These actions include: (a) development of a training manual for.
radiography personnel to help ensure that they understand the need for, andtheapplicationof,goodradiationprotectionpractices,l(b)conid:r' d: f =d A r
p c. eq w 4 b
- ti:n Of :: vers' peeg- ~ te deprove trai 4 ng provided ten i divid; 1 r:di:
- r.ut u Lus
-gre;heret;5:1[ensurethat re adequately trained and are aware of
^
ed their direct responsibility for safety performance, (c) increas Q inspec-d y tion ti.Tre went uinerving workers performing act.ual radiography operations,
,y.a.% d (d) rr"4 din; :dditi:n.Y guidance for reporting events " *=Tdeed / $
_10CrognpensurImf~thatthesereportsincludeclearinformationconcern-ing equipment failures when appropriate, and (e) the establishment of safety requirements for radiographic equipment.
2NRC Information Notice No. 87-45: "Recent Safety Related Violations of NRC Requirements by Industrial Radiography Licensees," September 25, 1987. Single copies of this information notice may be obtained by telephone by interested persons at (301) 634-3273.
2NUREG/BR-0024, " Working Safely in Gamma Radiography," 5. A. McGuir nd' C. A. Peabody,1982. Copies of NUREG/B9-0024 may be purch rom the Superintendent of Documents, U.S. Government Print' ice, P.O. Box j 37082, Washington, DC 20013-7082.
National Technical Information Copies so available from the
, U.S. Department of Commerce, l g, '
5285 Port Royal Roa ngfield, VA 22161. A copy is available for inspecti opying for a fee in the NRC Public Document Room, 2120 L s NW., Lower Level, Washington, DC 20037.
06/05/89 6 Enclosure A
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[7590-01)
NRC licensees are. required to report radiatiot. overexposure to the Bw.t - we.va-~ *M %
NRC.4 g er the decade ending in 1984 4 industrial radiography h i' accounted for 1) more than one-half of the overexposure "apa"t^d h all Z lic a
- M greater than 5 rems to the whole body or 75 rems to the extremities and 2) almost 60% of the overexposure. greater than 25 rems to the whole body and 375 rems to the extremities. Over this same period, radiography accounted for almost 25% of all overexposure reported by NRC licensees.X:
During the years 1979 through 198 radiographer overexposure reported to the NRC and Agreement States combined accounted for 18% of all occupa-tionaloverexposures,althoughradiographersrepresen(tonly 4% of all rad-iation workers. -It i; hii:=d thehany ncidents N Iccurred M d not require reportinhdwhich had the potential for serious over-exposure from the high-intensity relatively high-energy gamma-ray sources usedd ijg .
Three incidents in foreign countries where phildren or adults have found lost radiography sources and have died from overexposure illu-strate the extreme hazard potential involved in radiography overexpo-sures. In other cases involving radiography sources, overexposure have caused acute effects such as burns and necrosis of body tissues. Some examples of incidents which show the extreme hazard potential are:
(1) 1979, California: The source assembly was improperly connected or became disconnected and was cranked out of the end of the guide tube and fell to the ground. No radiation survey was made. An individual 1 XThe year 1984 is the most recent year for which complete exposure data has been tabulated for all NRC licensees.
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. exposures of 22, 7 and 0.6 rem respectively. One unbadged employee and six members offthe~ general public received doses believed to be'less than 0.5 rem each, pc :
Mtudiesofrtdiographyexposuredataindicatethatradiography
)(
equipment problems contribute to approximately.40% of all reported j overexposure. Equipment problems of the following types' frequently play-a contributing role:
(1) The source moves out of the shielded position after being cranked back into the device and before being locked, or the locking
. device is defectiv'e and fails to retain the source in the proper position.
(2) The source assembly is not properly connected or becomes dis-connected, so that while it may be cranked out of its shielded position in the device, it'cannot be retracted and remains-in the guide tube.
(3) The source assembly is not properly connected or becomes dis-connected and is cranked out through the end of the guide tube and drops to the ground.
(4) The source becomes stuck in the guide tube due to damage to.the guide tube or due to-fraying of the control cable.
All of these conditions c'ould be recognized by performing a radia-tion survey after each radiographic exposure (to verify that the source is properly returned to its shielded position within the radiography device). Radiogr'aphers are required by the regulations in 10 CFR 34.43(b) to perform sucn a survey. In many cases, however, the radiation survey instrument is not used, is used incorrectly, or is defective. In Item (1) above, any overexposure would typically involve only the radiograph-ers. In the remaining three items there is considerable potential for l exposure to the public as well as to radiography personnel since the 05/22/89 9 Enclosure A
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i was ' formed to draft recommendations 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: Training and Certification, Radiographic Equipment Design Safety, Inspection, and Collection and Analysis of Incident Data.
In 1982, the NRC published a training manual for industrial. radio-graphers,2 and in 1984 the equipment safety task force presented its recommendations on performance criteria for radiographic exposure devicesI J to the Radiography Steering Committee and urged that the recommendations be added to the rules as soon as possible. These recommendations include many of the performance criteria specified in the consensus standard-together with additional criteria.
The voluntary consensus standard ANSI N432, issued in 1981, is currently under review for possible revision. The revision is expected to incorporate many of the performance requirements in the international standard, ISO 3999, " Apparatus for Gamma Radiography Specification."
Sone of the performance requirements expected to be incorporated in the revised standard are the same as those recommended by the equipment t'ask force. Publication of the revision of ANSI N432 as a final industry 3 REG /BR-0024, " Working Safely in Gamma Radiography," 5. A. McGuire and
. A. Peabody, 1982. Copies of NUREG/BR-0024 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies are also available from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161. A copy is available for inspection or copying for a fee in the NRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC 20037.
4" Radiographic Equipment Safety Performance Criteria," D. Honey (CA),
I R. Ratliff (TX), R. Wascom (LA), S. Baggett, and A. Tse (NRC), April 30, l 1984. For a copy of this report see paragraph heading For Further l Information
Contact:
l I
06/05/89 11 Enclosure A l
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. standard may take sev'eral years. When issued, NRC will consider if additional rulemaking is appropriate or necessary to incorpo' rate the standard.
I Y
While th: ; 9 -t:ry :On::n:a eteudm w American National Standard N432 Y>
has been available since 1981, it does not appear that all manufacturers are actually using the consensus standard nor does it appear that'its provisions have been uniformly or completely implemented by radiography equipment manufacturers. Also, some of the equipment currently in use may have been manufactured prior to publication of the standard and may not meet its provisions. As a result, it is assumed that the voluntary consensus standard has had little effect on reducing the number or sever-ity of radiography overexposure. Further, some of the equipment improve-ments recommended by the Radiography Steering Committee are not included in the standard. .
-It 5:: bec" st:ted 0:rli;r th:INRCstudiesindicate[thatsome40%
en -
i ofthefncidentsinvolvedequipmentproblems. Therefore3it .; f;11 th:t*
regulatory action is needed at this time in order to reduce the number of radiography incidents cc:gr-in[and pc::iMf to prevent additional serious overexposure that are ;;tenti:ll.Y, possible given the high radiation
) output of the sources used in this industry.
The Radiography Steering Committee also suggested that one means of reducing radiographer overexposure caused by the failure to detect the return of the source to its properly shielded position in the radiographic exposure device, would be to require that radiographer wear alarm meters, j These are radiation detection devices that provide an audible alarm at some preset dose or dose rate or both.
05/22/89 12 Enclosure A
i [7590-01) 1.
Audible-alarm meters are especially useful when radiographer cannot hold survey meters because they need both hands to perform a job or when they cannot continually look at the survey meter because the operation they are performing requires them to look elsewhere. Alarm meters are not to be substituted for a radiation survey meter but are to be considered a complementary warning device. The use of audible-alarm meters is now a requirement for radiographer trainees in Canada and has proved useful according to Canadian'nfficials.
NRC Regulatory, Guide 8.285 "Atdible-Alarm Dosimeters" discusses a pro-gram for the appropriate use of audible-alarm meters. The term " audible-alarm' dosimeters" as used in this guide refer.= to pocket sized radiation detectors that alarm when either a preset integrated exposure or a preset exposure rate is reached. E qui-h; h m bdic:ted th:M se dosimeters are used in nuclear power plants on a rel.atively widespread basis. Few, however, are used in the radiography industry in the United States. Alarm meters are considered reliable and hold up well with proper use.
provide an audible warning to a radiographer when he or she is approach-ing an exposed source, so that actions can be taken immediately to mini-(mizeunnecessaryradiationexposure.[Thesteeringcommitteerecommended that the u:g. ca. y
. audible-alarm meters be c"&pe rte in the final rule.
l 5 Regulatory Guide 8.28 is available for inspection at the Commission's Public Document Room, 2120 L Street NW. Lower Level, Washington, DC 20037. Copies of the Regulatory Guide may be purchased by calling (202)275-2050 or by writing to the Superintendent of Documents, U.S.
Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.
06/05/89 13 Enclosure A
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Public Comments The NRC received a total of eighty-eight public responses to the proposed rule.
Some of the responses were duplicates, some were requests for an extension of the comment period, and some were not relevant to the proposed rule. The number of valid responses to the proposed rule was sixty-eight. The proposed amendments involved twenty-six separate items and the average responder commented on at least ten of the items.
- de W C.I < A A ,,
b awf Up L All of the comments have been consideredq .
d h r;: 5::.- i.;; b=i [in y ;,y them L J A ,
S.kM%
q ,z,e. sa A AAnalysis of Comments document which is available for review and copying A L. for a fee at the NRC Public Document Room located at 2120 L Street NW, Lower Level, Washington, DC 20037.
reLs9[y Dj" g Most of those commenting indicated that they approved of the NRC-M*rr" *7M goals for improving the safety of radiography equipment but many expressed-differences of opinion on methods of obtaining these goals.
Of the twenty-six items proposed, comments were equally divided on two, opposed on nine, and in favor on fifteen. The principal comments and the NRC response for each of the proposed items are given below.
Section 34.20(a) Radiographic Equipment Must Meet the Requirements of ANSI N432.
Comment:
- c. M Twenty-four -espe"re ?were received on this provision, with the comments essentially divided. The main issue raised by commenters opposed to the requirement involved the maximum allowed radiation levels specified in the ANSI stancard. Many felt that the added shielding required to meet 06/05/89 14 Enclosure A
- s. [7590-01) ]
j 1
lower levels are being proposed in the European community. The fact that 1
radiographic exposure devices that meet the requirements of ANSI N432, I including the external radiation levels specified, are now on the market, !
seems to refute the contention that such devices would be too. heavy to handle. Most portable exposure devices now on the market weigh between 4
i 35 and 45 pounds' including those that meet the external radiation levels of the standard. It should also be mentioned that these radiation levels can be attained by use of lower strength radiation sources although this alternative would imply additional costs because of more frequent source replacements. The provision in the final rule accordingly remains the same as in the proposed rule.
Section 34.20(b)(1)-Exposure Device Label.
This provision requires the user to attach a labe.1 to the radiographic exposure device that would identify the radionuc]ide in the device, its activity on the date specified, its model number and serial number and the manufacturer of the sealed source. Th::: :;,; 3;;;i'irat4:n cre A
""" ir. 5 :ticr. 4.2 of ANSI N432 Lui ,1; is r,et cle:r th t they censtil
_tute : requireinat ir, the stenderd. lle e.er the stard;rd d::: previd: 3-that the devi:: hr. : e ivcot.*vu ivi aLLecning 1.nis iobci.
l l Comment:
i i Fourteen comments were received on this provision, with twelve
- approving. The negative comments indicated that the upkeep of the mark-1
- j. ings could be costly ano that the isotope manufacturer must be respon-sible for providing the label to the user. One commenter proposed that the exposure device label should also include the name, address, and 05/22/89 17 Enclosure A l
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4 telephone number of its owner so that the proper persons could be con--
tacted if the device became lost and then found.
Response
In current industry practice the manufacturer provides a plate to the
$nor tL device user with the changer and the new source. It is the responsibility )(
of the user to attach the plate containing the prescribed information to the radiographic exposure' device. The NRC agrees that it would be desir-able to include the 'name, address ahtelephone number of the owner on the label and is. including this requihent in the final rule. It is the responsibility of the user to keep this'information current. No other changes are being made to the proposed rule in regard to this provision.
Section 34.20(b)(2)-Exposure Devices Intended as Type B Transport Containers to Meet Part 71 Requirements.
Comment:
There were no negative comments on this provision. Some commenters mentioned that their devices already met this requirement.
Response
No change is to be made in this provision.
Section 34.20(b)(3)-Modification of Exposure Devices and Associated Equipment is Prohibited.
05/22/89 18 Enclosure A
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Comment:
No negative responses were received on this provision. One manufac-turer asked if this implies that no modifications may be made without resubmission of designs to the proper NRC or Agreement State authority.
Response
The purpose.of this provision is to prohibit modifications by users that could compromise the safety of the device. One example would be the use of a source assembly different from that approved by the device manu-facturer, and which does not meet the QA and QC requirements of the speci-fied source assembly. This provision is not intended to impose design restrictions on manufacturers.A The provision stands as originally stated.
W ' # ' "' ""& 'S ~'I' *'t r~% dM &
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Section 34.20(c)(1)-Source Assembly - Control Cable Connection.
The purpose of this provision was to require a coupling between the source assembly and the control cable such that the possibility of an unintentional disconnect could not occur. The recommendation of the equipmenttaskforcementjonedpreviourlywasthatthecouplingshould require the application of motion in two planes and a positive force in one of these planes to complete the connection.
Comment:
Twenty-two comments were received, fifteen for and seven against the o provision. Several commentors from each side indicated that the wording should be changed from technical specifications to performance require-ments. They suggested that the wording be patterned after the wording used in the regulations issued by the State of Texas. Basically these 1
06/05/89 19 Enclosure A i
. [7590-01) require that the connection shall be designed in such manner that the source assembly will not become disconnected if cranked outside of the guide tube. Most commenters felt that the technical specifications listed
'in the present wording could prevent designers from developing a connector that would provide the best performance possible.
Response
This suggestion was adopted and the wording of the provision has been changed to reflect the performance requirement approach used by the State of Texas. Also, NRC's source and device registration process vile 54 re-/I '**O Aj / requir NRC approval before the newly designed connectors could be used.
Section 34.20(c)(2)-Require a Readily Visible Source Position Indicator.
The purpose of this provision was to provide the radiographer with additional or supplemental information concerning the position of the radioactive source. It was not intended as a substitute for the use of a survey meter but rather to provide supplementary information much as does a warning light on the gas gauge of an automobile.
Comment:
Forty-two comments were received on this provision, four approved and thirty-eight opposed the provision. Most of those commenting against it felt that the indicator would not be foolproof, could easily fail, and would lead radiographer to neglect the use of the survey meter. Three commenters stated that the indicators on some of the devices now in use are not completely reliable and have not proven to be fail-safe. Three indicated that they did not think it would increase safety. Others pointed l
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i out that most indicators only indicated the position of the source assembly and would not be of use if the source separated from the assembly. Two of those approving the provision noted that the position indicator should only be relied upon as a guide.
Response
This particular item has long been controversial. At a 1978 NRC meeting convened to discuss the design of radiographic exposure devices, it was generally agreed that it was not possible to design a position indicator that could not fail. It was also pointed out at this meeting that source position indicators consisting of red and green lights were installed on some devices as early as 1958. These failed so frequently that the NRC asked manufacturers to remove them. Also, a provision for such an indicator has been proposed for inclusion in the next revision of the International Radiography Standard, ISO 3999, by the Fre:-P.h delega-tior)jbut there appears to be little support for this from other countries. g In view of the continued opposition and past experience with these indicators the NRC has removed'the provision.
Note: Proposed paragraph S 34.20(c)(2) has been deleted. It should be noted that proposed rule paragraphs S 34.20(c)(3) through 5 34.20(c)(10) as discussed below, are designated as paragraphs S 34.20(c)(2) through S 34.20(c)(9) in the text of the final rule.
Section 34.20(c)(3)-Automatic Securing of Source Assembly.
This provision provides a system to automatically secure the source assembly in the shielded position each time it is cranked back into the 05/22/89 21 Enclosure A 1
l l
[7590-01] 1 exposure device. The provision eliminates the manual securing which is now required under S 34.22(a) of the current regulations. The provision ;
l helps eliminate the problem of the source accidentally moving out of the i fully shielded position af ter it has been cranked back into the device.
Comment:
Thirty-two comments were received on this provision,'seven in favor I and twenty-five opposed. The majority of those opposed appeared con-cerned with the additional maintenance needed to keep the automatic securing system operating properly. Four were opposed on the basis of cost. Three pointed out that it could easily be bypassed. One mmmenter pointed out that existing devices with this provision have failed, and two indicated that the source could be locked outside the device instead of inside. Several also expressed concern -that the provision would discourage the use of the survey meter. One commenter would like to include the option of unsecuring the source remotely.
Response
The NRC does not agree that the automatic securing provision will cause all the problems raised by commenters. Some of the incidents involving overexposure caused by the source slipping out of its shielded position, are due to failure of the radiographer to manually secure the source after each exposure as required by current regulations, or due to I
excessive wear caused by radiographer using foot operation rather than hand operation in the manual securing. As for the statements regarding rh by-passing the automatic securing discouraging the use of survey meters,
[
the NRC does not believe that many persons will deliberately by-pass or ignore such beneficial measures. Appropriate maintenance, coupled with 06/05/89 22 Enclosure A
. [7590-01 S 34.20(a)' thru (c) after one year from publication of the final rule in
'[ ~
the Federal Register.
Comment:
'One commenter requested the compliance not be required for two to c two and one half years. Some other commenters expressed doubt that
'i '
manufacturers could meet the requirements in one year. One commenter-notedthattherewasonlyonetypeIRdeviceforkridiumsourcesand y none for obalt sources available in the U. S. at the present time.
Response
I The requirement has been changed to require compliance after one year l from the effective date of the final rule.
Section 34.20(e)-All Devices in Use to Comply with S 34.20 After Five Years.
The purpose of this provision is to require that all radiographic exposure devices meet all of the provisions of S 34.20 after five years or be retired from use. The choice of five years was. based upon discussions m
[withequipmentmanufacturersanduponNRCexperiencewhichindicated i
that the average lifetime of devices which prof.::t a source out of a at shielded position is around five years. The NRC recognizes, however, that i
[p the average life expectancy is dependent upon the design of the device, i the amount of use, the environment at the use site, and the quality of .-
g the maintenance program. The choice of a five year implementation period for the rule rather than a more accelerated period was made for a I
' number of reasons. Radiography exposure device manufacturers would l ,
probably be unable to manufacture 3500 devices meeting the requirements ,
\
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.: [7590-01]
of the rule-in a much shorter time; the five year period avoids imposing a severe financial impact on the radiography industry, particularly on the small entities; and the number of radiography overexposure occurring per year does not appear to justify a shorter implementation period.
In addition, the gradual use of new models is advisable since additional training'will be-required for radiographer, and user licensees need additional time to evaluate new models as they become available to l
assure that they meet expectations under operational field conditions.
u<@pWf u5 h Comment:
cJ Twenty-seven comments were received on this provision, two in favor and twenty-five opposed. Most of the comments objecting to the provision challenged the average lifetime of five years for the devices, citing for the most part a ten to fifteen year lifetime. The other major objection was the. cost, with one commenter citing a value of over $630,000. One connenter had reservations about st%ing a time limit for compliance especially when working models for some of the provisions have yet to be developed and tested. Another stated that there is ao projection device for cobalt b t meets the stand b hresently available in the U.S and i A - -
i that current devices, which cost around $15,000, would have to be replaced in five years.
Response
The NRC is aware that retrofitting of existing radiographic expo-sure devices to meet the requirements of the rule is not practical and that meeting the requirements of the rule involves the purchase of new equipment that meets all the requirements.
06/05/89 29 Enclosure A l l
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7
[7590-01)
-o The NRC is aware that the radiography industry is in'a period of recession and that, as a result. many smaller radiography firms have gone ou't of business. A side-effect o :.ais depressed state c' the industry has been the creation of a large market in used radiographic exposure
' devices.
The NRC is concerned that many of the devices now in use by- the industry may be from 10 to 20 years old. The devices may no longer be in production and replacement parts may not be available. Emphasis of this point is stewn by the intent of one of the larger device suppliers to issue a notit phasing out of service, over a period of 3 years beginning in 1989, certain of the devices it normally services because of unavaila-bility of replacement parts. The NRC believes that many other devices with similar problems not subject to this notice are also in use in the market place. This provision will help to phase out of use such unser- h viceable and possibly unsafe devic
- le many of the commenters *%. ,, py
[ feel that this provision poses ar[inancial burden M yMrs and could er /
result in premature replacement of safe' and-useful equipment, this view QsnotsharedbytheNRC While conceding that the lifetime of many devices may be as much as 10 years, the NRC believes that many of the devices currently in use d Qeyp] w th devices meeting the criteria of the ruleg With regard to the charge that compliance with the ep*=
- newrulewouldconstituteakfinancialburden,itshouldbepointedout
, that all equipment in use at the time of publication of the proposed rule will have been in service for a period of more than seven years at the date required for compliance, and would therefore also have been eligible for a seven year application of its depreciation allowance. This allow-ance would seem to appreciably reduce the financial burden claimed by the 06/05/89 30 Enclosure A L_________________
f I,
, .[7590-01) commenters. In addition, the regulatory analysis for this rule indicates that the cost to the industry resulting from implementation of this provi-sion of the rule is of the order of $4 million dollars on a 1989 present worth basis calculated over the ten year interval from 1990 to 1999. The cost to the individual licensee resulting from implementation of this pro-vision of the rule over the same ten year period is $3636. lonual costs over this ten year period are therefore $400,000 for the industry and
$364 for individual licensees. In view of these arguments, the provision remains as proposed except that the five year period will begin after the effective date of the final rui p hich iii 6 m,e p ..-- efter pei moi..m.
'- thi r;&=1 %;;i:t:r
- Section 34.21-Limit on External Radiation Levels.
The purpose of this provision is to. allow equipment received prior to one year after the effective date of the rule to meet the existing radiation levels of the present S 34.21 now redesignated S 34.21(a).
Afteraperiodoffiveyearsfromtheeffectivedateofthefinalruleg all radiographic equipment except source changers and storage containers will be required to meet the requirements of S 34.20. Source changers and storage containers continue to be regulated under S 34.21(a).
Comment:
Five comments were received on this provision, three approving and two opposed. The principal comments were that reduction of external l
radiation levels would not be cost effective and that existing levels have not proven to be a radiological health hazard.
06/05/89 31 Enclosure A
1 1 i*
lc. ? .
[7590-01]
l Response:
l The issue of external radiation levels is extensively. discussed in the response to S 34.20(a) and will not be repeated here. The final version of S 34.21 will change from that in the proposed rule to the
.p m A A u . elkra fn p alt. N. d4e k dk .1 % k r.tw L extentthatff!r: ynr: :ft:r th: effertf/: d:*,: uii; be .;d i;,pe;; ef"-
five years after publication of the final rule.
Section 34.30-Reporting Requirements.
The purpose of this provision is to provide the NRC with information on problems experienced with radiographic equip ese requirements ]
e separate and distinct both in content and purpose from those contained in 10 CFR Part 21, " Reporting cf Defects and Noncompliance" which imple-ments section 206 of the Energy Reorganization Act of 1974, as amended.
By specifying conditions for reporting defects or noncompliance of radio-graphic equipment under this provision any ambiguity resulting from interpretation of Part 21 provisions is avoided.
C
~
~
-mb qu Ao Comment >
Sixteen comments were received, six in favor and ten opposed. The principal comments were tnat item one, involving source disconnects, and item two, involving inability p .v.
to g ract,thg
-- source, were reasonable reporting items. However y
3 1 tem three, a..wh ig .ww. i.e.g e. failure of X any component to perform its functiogwas unclear, open ended, and could y lead to large volumes of required reports. Other commenters believed that the costs would be prohibitive and still others commented that licensees would simply refuse to comply with these reporting requirements. One 1
commenter felt that reporting of defective equipment should be reported under 10 CFR Part 21.
06/05/69 32 Enclosure A l
,. -c
,, g . - ,
[7590-01)
Response
The NRC agrees that item three was ambiguous and has rewritten it to apply only to components critical to safe operation of the device.
The NRC does not agree with those commenters who believed that a large l
volume of reports would be required along with the correspondingly high costs associated with generating such reports.
l Section 34.33(a)-Require Wearing of an Alarm Ratemeter.
This provision is intended to provide radiographer in the field with a duplicative or redundant device as a backup to the survey meter the radiographer is supposed to carry Its purpose is to provide anm additional warning of possible hazardous radiation levels in the event g
the survey meter is defective or misread, in much the same manner that -
V g3 W
buzzers and lights provide backup warning in automobi.les of low or (
almost empty gas tanks for those who ignore or piisread their fuel gauge.
It is felt that as warning devices, alarm ratemeters may be able to I
prevent many overexposure that have occurred as a result of improper veys.
Comment:
Fifty comments were received on this provision, eighteen approved, thirty-two were opposed. The principal comments of those approving the provision were that the rule should specify an alarm ratemeter instead of dosimeter, that state-of-the-art chirpers should be allowed, that the trigger level of 500 mR/hr was too high (this is addressed in 6 34.33(f))
and that they can malfunction and rcad zero. One commenter felt that there should also be a requirement that the alarm should go off if the ratemeter is subjecttd to radiation satcration.
06/05/89 33 Enclosure A l
- e
- 9'; *
.- [7590-01]
Comment:
Thirteen comments were received on this; requirement. All thirteen were opposed. The principal comments were that the trigger level was too high for. most working conditions and that the trigger _ level was too high to check conveniently or, a daily basis' without' the use of a large check -
source.that would require a specific license. One commenter pointed out
-that around power facilities 500 mR/hr was too' low and recommended a trigger level of 100-200 mR/hr above the ambient background rate.
Osap u .
hitir A p(
Radiographer routinely work with radioactive sources whose activ-ities are sufficient to create high radiation areas {>100mR/hr) and radio-graphers are required to post the boundaries of the high radiation areas with appropriate signs (S 20.203(c)) and survey the rettricted area bound-ary. Also, calculations based on the inverse square law show that for a 200 Ci Iridium source the ri iiation field at a normal operator's position (with 21 foot guide tube and 25 foot control tube) is approximately 430 mR/hr. Trigger levels of much less than the 500 mR/hr specified would then trigger an alarm under normal radiography exposures. Also, alarm rateetters that trigger while radiographer are conducting normal opera-tions would prove annoying and would likely be turned off. In view of these conditions, the trigger level should be set at 500 mR/hr. Those licensees that hav( a problem with this provision due to the need to work at nuclear power facilities where higher radiation levels may exist, may apply for an exemption under S 34.51.
!- With regard to the requirement to check the dosimeter alarm at '
500 mR/hr on a daily basis, the provision has been rewritten to require a 05/22/89 36 Enclosure A
'[7590-01]
?. 7 ]
- calibration on an annual basis instead. The' requirement for a daily .
check on the alarm remains unchanged. This can be provided by an-electronic check point that corresponds' approximately to the response of a 500 mR/hr field.
Finding of No Significant Environment Impact: Availability The Comission has determined under the National Environmental Policy Act of 1969, as amended, and the Comission)s regulations in Sub-part A of 10 CFR Part 51, that this rule is not a major Federal action significantly affecting the quality Jf the human' environment and there-fore an environmental impact statement is not required.
The final rule involves engineering design' modifications to indust-rial radiography devices and requires licensees to use only radiography devices and associated equipment that provide certain additional safety features. Radiographer are required to wear alarm ratemeters. No requirements for significant quantities of materials, water, electricity
.or other forms of energy have been identified and no environmental or radiation impacts are involved.
The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC.
Single copies of the environm: ental assessment and the finding of no significant impact are available from Dr. Donald O. Nellis, Radiation Protection and Health Effects Branch, Division of Regulatory Applications, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301 492-3628.
K 06/05/89 37 Enclosure A n - - _ _ _ . ___- ______________-_ -_ _ __ _ _ _
E -
[7590-01]
Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
{
These requirements were approved by the Office of Management and Budget, approval number 3150-0007.
Public reporting burden for this collection of information .is esti-O.
mated to average j 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> per response, including the time for reviewing g instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of informa-tion. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Records and Reports Management Branch (P-530), U.S.
Nuclear Regulatory Commission, Washingtor), DC 20555; and to the Paper-work Reduction Project (3150-0007), Office of Management and Budget, Washington, DC 20503 Regulatory Analysis The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Coramission. The regulatory analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW, Lower i
Level, Washington, DC. Single copies may be obtained from Donald O.
Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commissien, Washington, DC 20555, telephone (301) 92-3628.
[
l 06/05/89 38 Enclosure A
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __________________________________________-.--________________________________________________J
.- [7590-01) l
. 1 Regulatory Flexibility Analysis
'i The NRC has prepared a final regulatory flexibility analysis of the i impact of this rule on small entities as required by Section 604 of the
._ Regulatory Flexibility Act. The analysis, which'is set out in Appendix A I of this document, indicates that this rule could have an economic impact l
of about $5,113 initially, and $1,188 annually on each radiography licen-see, 90% or more of which are considered to be small entities. These costs are not considered to be overly burdensome in light of the possible benefits derived. 37,6cId p b p : S --
/
,- Modification of Enforcement Policy The Commission is modifying its General Statement of Policy and Procedure for NRC Enforcement Actions, 10 CFR Part 2, Appendix'C l (Enforcement Policy) to reflect the Commission's amendment of 10,CFR Part 34. The change to the Enforcement Policy is being published concurrently with the new rule.
The modification to the Enforcement Policy is being made at this l- time to Supplement VI " Fuel Cycle and Materials Operations" to put licensees on notice that the failure to implement the requirements for dosimetry and equipment by the required date may be considered a violation of significant regulatory concern. The example is to be used as guidance in considering Severity Level III violations of the regt.i rements. The example for Severity Level III is significant because it represents Pailures associated with the use of equipment and dosimetry designed to minimize overexposure from radioactive materials.
(
06/05/89 39 Enclosure A
('o -
'[7590-01]-
Backfit' Analysis This final rule does not modify or add to systems, structures, com-ponents, or design of a facility; the design approval or manufacturing license for a facility; .or the procedures or organization required to l
L design, construct or operate a facility. Accordingly, NRC has determined that the backfit rule 10 CFR 50.109 does not apply to this final rulg end} [
erefore,qa backfit. analysis is not required for this final rule because X-these amendments' do not involve provisions which. impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Part 2 and 10 CFR Part 34 Part 2 - Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Civil penalty, Enforcement, Envi.ronmental protection, Nuclear materials, Nu: lear power plants and reactors, Penalty, Sex discrimination, Source. material, Special nuclear material, Violations, Waste treatment and disposal.
Part 34 - Byproduct material, Incorporation by reference, Packaging and containers, Penalty, Radiation protection, Radiography, Reporting and recordkeeping requirements, Scientific equipment, Security measures.
For the reasons set out in the preamble and unoer the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorg eization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CfR Part 2 and 10 CFR Part 34:
06/05/89 40 Enclosure A
o5 ,
'[7590-01) 1 NW. , Lower Level, Washington, DC 20555. ' A copy of the document is also on
~
file at the Office of the Federal Register,1100 L Street NW. , Room 8301, Washington, DC 20408. :l (b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices and associated equipment.
f (1) Each radiographic exposure device must have attached to it by the user, a durable, legible, clearly visible label bearing the- -
(i) Chemical symbol and mass number of the radionuclides in the device;
'(ii) Activity and the date on which this activity was last measured; (iii) Model number and serial number of the sealed sourcQM y (iv) Manufacturer
'thesealedsourcha y (v) Licensee's name, address, and telephone number.
(2) Radiographic exposure devices intended for use as Type B tran-sport containers must meet the applicable requirements of 10 CFR Part 71.
(3) Modification of any exposure devices and associated equipment is prohibited, unless the design of 'any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.
(c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the following requirements apply to radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation.
(1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must 06/05/89 43 Enclosure A L_ ______ _ - _ - - - - - - - - -
O L.4- -
[7590-01]-
144IIbe such that it cannot be unintentionally disconnected under normal y(
and reasonably foreseeable bnormal conditions.
(2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device.
_This securing system may only be released by means of a deliberate opera-l tion on the exposure device.
(3) The outlet fittings, lock box, and drive cable fittings on' ench radiographic exposure device must be equipped with safety plugs or covers which.must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.
(4) Each sealed source or source assembly must have attached to it or engraved in it, a durable, legible, visible label with the words:
" DANGER - RADI0 ACTIVE." The label must not interfere with the safe opera-tion of the exposure device or associated equipment. .
(5) The guide tube must have passed the crushing tests for the con-trol tube as specified in ANSI N432 and a kinking resistance test that closely approximates the kinking forces likely to be encountered during use.
(6) Guide tubes must be used when moving the source out of the device.
(7) An exposure head or similar device designed to prevent the source assembly from passing out of the and of the guide tube must be attached to the outermost end of the guide tube during radiographic operations.
(8) The guide tube exposure head connection must be able to with-stand the tensile test for control units specified in ANSI N432.
06/05/89 44 Enclosure A I
l:
12 -4 L+N'~ .
.. . [7590-01]
(9) Source changers must provide a system for assuring that the source will not be accidentally withdrawn from the changer when connect-ing or disconnecting the drive cable to or from a source assembly.
(d) All newly manufactured radiographic exposure devices and asso-L ciated equipment acquired by licensees after (insert a date 1 year from the effective date of the final rule) must comply with the requirements o'f this section.
(e) All radiographic exposure devices and associated equipment in use after (insert a date 5 years from the effective date of the final rule) must comply with the requirements of this section.
- 3. In S 34.21 the existing paragraph is designated as paragraph (a) and a new paragraph (b) is added to read as follows:
S 34.21 Limit on levels of radiation for radiographic exposure devices and storage containers. ,
a a a a m (b) Paragraph (a)ofthissectionappliestoall;x;;tinhYequipment /
m..kbd
-ere4"ed* prior to (insert a date 1 year after the ef4ective k date of the 2d p5" 5 final rule). Jis jn t
fter (insert the/ effective date of the final )(
rule),
34.21 applies only to storace containers (source changers}3eetF#~
( p w 4s.~ L y.a. %.: a-a Q
-ell ;ther radiographic equipmentjmust meet the requirements of S 34.20]
- 4. A new heading " REPORTING" is added and a new $ 34.30 is added under that heading to read as follows:
S 34.30 Reporting requirements.
(a) In addition to the reporting requirements specified under other sections of this chapter, each licensee shall provide a written report to the U.S. Nuclear Regulatory Commission; Oivision of Industrial and Medical 06/05/89 45 Enclosure A
'a,
+ C ' .
.e - 1 [7590-01]
O Nuclear Safety; Medical, Academic and Commercial Use Safety Branch; Washington, DC 20555, with a copy to the Director, Office for Analysis and Evaluation of Operational Data, U.S. Nuclear Regulatory Commission, Washington, DC 20555, within 30 days of the occurrence of any of the following incidents involving radiographic equipment:
(1) Unintentional disconnection of the source assembly from the control cable.
(2) Inability to retract the source assembly to its fully shielded position and secure it in this position.
(3) Failure of any component (critical to stfe operation of the device) to properly perform its intended functiog and-9f:S :;;.ld #
p:te;.tielly ::uce 2 -adiatier 5:::rd, 2nd "i:5 i: n:t : rr::t:51: ::; ;,;.-[
af the 'c-ar-e' e -n"+4na - inten:n:: pre;;rr ethae thea by repl:::::nt. *
(b) The licensea shall include the following ir> formation in each report submitted under paragraph (a) of th_is section:
(1) A desc. ption of the equipment problem.
(2) Cause of each incident, if known.
(3) Manufacturer and model number of equipment involved in the incident.
(4) Place, time and date of the incident.
(5) Actions taken to establish normal operations.
(6) Corrective actions taken or planned to prevent recurrence.
(7) Qualifications of personnel involved in ncident.
K (c) Reports of overexposure submitted under 10 CFR 20.405 which involve failure of safety components of radiography eouipment must also include the information specified in paragraph (b) of this section.
06/05/89 46 Enclosure A L - _- - ____-__---_-- . _ . - - _ - - _ _ _ - _ - -
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[7590-01]
- 5. In S 34.33 paragraph (a) is revised to read as follows and a new paragraph (f).is added to read as follows:
$ 34.33 Personnel monitoring.
(a) .The licensee may not permit any in'dividual to act as a radio-grapher or a radiographer's assistant unless, at all times during radio-graphic operations, each such individual wears a direct. reading pocket dosimeter,analarmratemetergndeitherafilmbadgeorathermolumine- y scent' dosimeter (TLD) except that for permanent radiography facilities where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required. Pocket dosimeters must have a range from zero to at least 200 milliroentgen and must be.
recharged at the start of each shift. Each film badge and TLD must be assigned to and worn by only one individual.
m a
- a m (f) Each alarm ratemeter must-- .
(1) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift; l
(2) Be set to give an alarm signal at a preset dose rate 500 mR/hr.
l (3) Require special means to change the preset alarm function; and (4) Be calibrated at periods not to exceed one year for correct response to radiation: Acceptable ratemeters must alarm within plus or minus 20 percent of the true radiation dose rate.
- 6. In Appendix A, Item II.C, "Use of personnel monitoring equipment," is revised,to include:
Appendix A II ***
06/05/89 47 Enclosure A L __ _ _ _ _ _ _ _ - _ - - _ - _ _ - _ _ _ _ _ - - _ _ _ - - - - - - - - - - - - - - - - - - - --- -- --