ML20005F341
| ML20005F341 | |
| Person / Time | |
|---|---|
| Issue date: | 12/29/1989 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-53FR8460, RULE-PR-2, RULE-PR-34 NUDOCS 9001160198 | |
| Download: ML20005F341 (51) | |
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[7590-01)
N DOCKET NUMBER N ^2(/
DOCKETCO PROP ED RUl.E USNP.C
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- )0 'JkN -5 P5 :34 RIN: 3150-AC12 10 CFR Parts 2 and 34 i
Safety Requirements for Industrial Radiographic Equipment
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AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule and modification of the General Statement of Policy and Procedure for NRC Enforcement.
SUMMARY
- The Nuclear Regulatory Commission is amending its regulations that apply to industrial radiography. This rule, requires licensees to use l
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only radiographic exposure devices and associated equipment that provide t
l certain additional safety features. This rule also requires radiographers to wear alarm ratemeters. These new requirements are intended to reduce f
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radiation exposures to both radiography personnel and the gener'al public from the.use of radiographic equipment. These amendments affect persons licensed to perform industrial radiography and manufacturers of radio-graphic equipment. The amendments do not affect x-ray radiography or devices incorporating naturally occurring or accelerator produced radio-
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active material because the regulation of these items is not included in the Atomic Energy Act of 1954, as am' ended.
In addition, the Commission
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_ is modifying its Enforcement Policy (10 CFR Part 2, Appendix C) to add a specific example to Supplement VI to' reflect the importance of meeting the requirements of the rule.
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[7590-01) t EFFECTIVE DATE:
(12 months 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
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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, Washington, DC 20555, telephone (301) 492-3628.
SUPPLEMENTARY INFORMATION:
CONTENTS
Background
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Radiography Related Overexposures Previous Regulatory Initiatives Public Comments Modification of Enforcement Policy Finding of No Significant Environmental I'mpact: Availability Paperwork Reduction Act Statement Regulatory Analysis Regulatory Flexibility Analysis Backfit Analysis List of Subjects Appendix A - Regulatory Flexibility Analysis t
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On March 15, 1988, the Nuclear Regulatory Commission published for public comment a proposed rule [53 FR 8460) that would require NRC licens-ees to use radiographic exposure devices that meet the criteria speci-fied in American National Standard N432, " Radiological Safety for the 2
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Design and Construction of Apparatus for Gartma Radiography," 1981 (Pub-lished as NBS Handbook 136) and a number of additional criteria that were recommended by an ad hoc equipment design safety task force. Other requirements included in the proposed rule were additional reporting i
requirements and a requirement for radiographers to wear alarm ratemeters
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with the alarm signal set at a dose-rate of 500 mR/hr.
The purpose in
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proposing these amendments to the regulations was to reduce overexposures to both radiographers and the general public by specifying certain safety related performance requirements on radiographic exposure devices and by requiring radiographers to carry a supplemental radiation alarm monitor.
The public comment period was scheduled to end on May 16, 1988, but a l
number of requests for extension were received and the comment period was extended until August 16,1988[May20,1988;53FR18096). All comments i
received were given full consideration.
Background
Industrial radiography is a technique of nondestructive testing that uses radioactive sources or x-rays to detect flaws in welds and cracks, breaks or other structural deficiencies in bridges, pipelines and manufactured articles. Most industrial radiography operations are con-ducted using gamma-ray emitting sources, although x-rays and neutrons can also be used.
The procedure for taking radiographs is similar to the procedure used for taking medical x-rays except that a radioactive source is generally used in place of an x-ray machine. The operating principle of all of the devices is similar. Most radiography operations involve projecting a radioactive source out of its shielded position within the 3
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device; howev'er, some devices, such as the 50 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 exposure device or camera (which contains a sealed gamma-ray emitting sour.ce within a radiation shield) is placed nearby. A flexible hollow tube called a " guide tube" is connected to the I
front of the device, and the other end of the guide tube (to which an l
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 j_
while the connection is being made. Lastly, a hollow tube through which the control cable moves is connected to the back of the cevice. 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 expose 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 source assembly is in its shielded position.
The source is then secured in 4
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this position and the film is retrieved for developnient. The radiographer
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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 overexposures to radiographers and occasionally to the general public occur. Accidental radiation over-exposures to both radiographers and the public have concerned both the NRC and the Agreement States because the radiation levels of the radioactive 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 radiation which are rigidly controlled and remote from the public, industrial radiography involves the use of high activity sources, sometimes in close proximity to the general public. The work which is of ten only under control of the radiographer is generally performed under production pressure and is often performed 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 radiogrpphers to perform the radiography, themselves without the direct supervision of the more highly trained and skilled radiographer). Such failures, either singly or in combination, occasionally lead to radiation overexposures.
Some of the failures of 5
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radiography licensees to follow NRC requirements have been documented in a recent NRC information notice.1 The NRC has been concerned about the number of radiation overexposures i
among radiographers for several years and has completed, has underway, or is considering, actions intended to reduce the frequency of the over-exposures. These actions include: (a) development of a training manual for radiography personnel to help ensure that they understand the need for, and the application of, good radiation protection practices, (b) develop-ment of NRC requirements to ensure that radiographers are adequately trained and are aware of their direct responsibility for safety performance,.
l (c) increased inspection of workers performing actual radiography oper-ations, (d) publication of guidance for reporting events to ensure that l
these reports include clear information concerning equipment failures l
l when appropriate, and (e) the establishrrent of safety requirements for radiographic equipment, l
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2NRC Information Notice No. 87-45: "Recent Safety Rela.ted Violations of NRC Requirements by Industrial Radiography Licensees," September 25, 1987. Single copies of this information notice may be obtained by telephane by interested persons at (301) 634-3273.
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4 Rediography Related Overexposure's i
1 NRC licensees are required to report radiation overexposures to the NRC.
Based on overexposures reported to the NRC over the decade ending in
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1984, industrial radiography has accounted for 1) more than one-half of j
the overexposures greater than 5 rems to the whole body or 75 rems to the extremities and 2) almost 60% of the overexposures 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 overexposures reported by NRC licensees.8 During the years 1979 through 1983, radiographer overexposures re-ported to the NRC and Agreement States combined accounted for 18% of all occupational overexposures, although radiographers represented only 4% of all radiation workers. Many additional incidents may have occurred which had the potential for serious o'erexposure from the high-intensity rela-v tively high-energy gamma-ray sources used but did not require reporting.
Three incidents in foreign countries where children or adults have found lost radiography sources and have died from overexposure illus-trate the extreme hazard potential involved in radiography over-exposures.
In other cases involving radiography sources, overexposures have caused acute effects such as burns and necrosis of body tissues.
i Some examples of incidents which show the extreme hazard potential are:
L (1) 1979, California: The source assembly was improperly connected 1
or become disconnected and was cranked out of the end of the guide tube and fell to the ground.
No radiation survey was made.
An individual tThe year 1984 is the most recent year for which complete exposure data has been tabulated for all NRC licensees.
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found the source and placed it in his hip pocket and carried it around for about 45 minute'. The individual suffered a severe radiation burn on s
his right buttock.
In 1985, the individual.still walked with difficulty and was under periodic medical evaluation. Ten other persons were exposed, two of whom developed radiation burns on their fingers.
(2) 1980, Texas: The source assembly was not properly connected, and the source remained in the guide tube. A proper radiation survey was not made, and the source was stored in the coiled-up guide tube in a room adjacent to a work area. One radiographer received an overexposure of 75 rems, another person received an overexposure of 198 rems and thirty-one persons received exposures ranging from 0.09 to 4 rems.
Had another radiography crew not discovered the next day that the source was missing from the device, many others could have been seriously exposed.
(3) 1984, Texas: An assistant radiographer received an over-i exposure of 7.5 rems for the calendar quarter.
Investigation showed that the radiographer did not always lock the source after each exposure as required, nor did he always'make the required radiation survey. Subse-quent investigation also revealed that the source locking mechanism was defective.
(4)~ 1984, Morocco:
A source assembly became disconnected and fell to the ground. A laborer found it and took it home. Eight members of his family died from overexposure, and several others received signifi-cant doses.
(5) 1985, Wyoming: The source assembly was not connected properly or became disconnected.
The radiography crew failed to m&he the required radiation survey, and the source was stored in the coiled-up guide tube in the back of a pickup truck for 2 days. Three radiographers received 8
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exposures of 22, 7 and 0.6 rem respectively. One unbadged employee and six members of the general public received doses believed to be less than 0.5 rem each.
5 NRC studies of radiography exposure data indicate that radiography equipment problems contribute to approximately 40% of all reported overexposures.
Equipment problems of the following types frequently play l
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 defective 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.
i (4) The source becomes stuck in the guide tube due to damage to the l
guide tube or due to fraying of the control cable.
All of these conditions could 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).
Radiographers are required by the regulations in 10 CFR 34.43(b) to perform such a survey..In many cases, towever, the radiation survey j
instrument is not use.d, 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 exposure to the public as well as to radiography personnel since the 9
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source, either on the ground or in the guide tube, has essentially no shielding.
Previous Regulatory Initiatives In an effort to reduce the rate and severity of radiography over-exposures attributable to equipment problems, the NRC published an a
Advance Notice of Proposed Rulemaking (ANPRM) on March 27, 1978, (43 FR 12718) announcing that it was undertaking the development of safety requirements for radiograph'ic exposure devices that are licensed under 10 CFR Part 34. Among the several comments received was the suggestion that the NRC delay further action on any rulemaking until completion of a related consensus performance standard. A voluntary consensus standard, National Bureau of Standards (NBS) Handbook 136, American National Standard N432, " Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography" was issued by NBS in January 1981.
The standard incorporates many of the safety design features proposed in the ANPRM; however, it is a voluntary consensus standard.
Although there was no regulatory requirement for manufacturers to adopt the recommendations of the standard, recent amendments to 10 CFR Parts 30 and 32 formalized NRC's source and device registration process and will ensure that future radiography devices that are registered with the NRC for the first time meet the requirements of the standar,d.
In March 1980 (partly as a result of a serious radiation accident that occurred in California in 1979, example 1 above), an ad hoc Radio-graphy Steering Committee composed of NRC personnel and State officials representing the Conference of Radiation Control program Directors, Inc.,
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o was formed to draft recommendations for improving ra'diography 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,3 and in 1984 the equipment safety task force presented its 4
recommendations on performance criteria for radiographic exposure devices 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.
l 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."
Some of the performance requirements expected to be incorporated in the 1
i revised standard are the same as those recommended by the equipment task l'
force. Publication of the revision of ANSI N432 as a final industry
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'NUREG/BR-0024, " Working Safely in Gamma Radiography," S. A. McGuire and C. A. Peabody, 1982. Copies of NUREG/BR-0024 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box j
37082, Washington, DC 20013-7082. Copies are also available from the i
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 KRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC 20037.
'" Radiographic Equipment Safety Performance Criteria," D. Honey (CA),
R. Ratliff (TX), R. Wascom (LA), S. Baggett, and A. Tse (NRC), April 30, 1984.
For a copy of this report, see paragraph heading For Further Information
Contact:
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standard may take several years. When issued, NRC Will consider if additional rulemaking is appropriate or necessary to incorporate the
' standard.
While American National Standard N432 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 a'ssumed that the voluntary consensus standard has had little effect on reducing the number or severity of radiography overexposures.
Further, some of the equipment improvements recommended by the Radiography i
Steering Committee are not included in the standard.
NRC studies indicate that some 40% of the overexposure incidents involved equipment problems.
Therefore regulatory action is needed at this time in order to reduce the number of radiography incidents and to prevent additional serious overexposures that are 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 overexposures, 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 radiographers wear alarm meters.
l These are radiation detection device's that provide an audible alarm at I
some preset dose or dose-rate or both.
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Audible-alarm meters are especially useful when radiographers 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 officials.
NRC Regulatory Guide 8.285, " Audible-Alarm Dosimeters", discusses a pro-gram for the appropriate use of audible-alarm meters. The term " audible-alarm dosimeters" as used in this guide refers to pocket sized radiation detectors that alarm when either a preset integrated exposure or a preset exposure rate is reached. They provide an audible warning to a radiographer when he or she is approaching an exposed source, so that actions can be taken immediately to minimize unnecessary radiation exposure. These dosi-meters are used in nuclear power plants on a relatively 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.
The steering committee recommended that audible-alarm rate meters be required in the final rule.
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' 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)275-2060 or by writing to the Superintendent of Documents, U.S.
Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.
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j Public Comments 9
The NRC received a total of 88 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 responses not relevant to the proposed rule. The number of valid responses to the proposed rule was 68. The proposed amendments involved 26 separate items, and the average responder commented on at least 10 of the items.
In addition, the American Society for Nondestructive Testing, Inc. submitted the results of a survey of 399 of its members regarding the proposed safety requirements for industrial radiographic equipment. All of the comments have been considered in preparing the final rule as described in the Analysis of Comments. document which is available for review and copying for a fee at the NRC Public Document Room located at 2120 L Street NW.,
Lower Level, Washington, DC 20037.
Most of those commenting indicated that they approved of the NRC goals for improving the safety of radiography equipment, but many expressed differences of opinion on methods of obtaining these goals.
Of the 26 items proposed, comments were equally divided on 2, opposed on 9, and in favor on 15. 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:
Twenty-four comments were received on this provision, with the comments l
l essentially divided. The main issue raised by commenters opposed to the 14 e
requirement involved the maximum allowed radiation levels specified in i
i the ANSI standard. Many felt that the added shielding required to meet the specified radiation levels would limit the portability of the devices and make them too heavy to handle. One commenter felt that meeting the radiation level requirements of the standard would not be cost effective and felt that the levels on present equipment were not a major contributor
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to exposure.
Response
The ANSI standard specifies a maximum radiation level of 50 mR/hr at 5 cm.
Part 34 specifies a maximum radiation level of 50 mR/hr at 6 inches (15 cm) for radiographic exposure devices measuring less than four (4) inches from the sealed source to the surface. The existing limit of 50 mR/hr at 6 inches (15 cm) was established when lead'was commonly used for shielding and most devices measured about 4 inches (10 cm) in radius.
Surface levels, based only on the inverse square law, ignoring buildup and multiple scattering, would then be about 300 mR/hr. With the change-over from lead to depleted uranium shielding in the mid-1960's, it was possible to meet the requirement of 50 mR/hr at 6 inches with devices that measured on the order of 2 inches (5 cm) from source to surface of the device.
Surface levels, based only on the inverse square law as stip-ulated above, would then be about 800 mR/hr.
Some commenters have stated that measured surface levels have not exceeded 350 mR/hr, but it is not clear that they have corrected these measurements for the effective center of the detector used.
Surface measurements on small packages or devices are prone to large errors and are difficult to perform correctly.
For example, a true surface reading of 800 mR/hr on a device that measures only 2 inches (5 cm) from source to surface will read about 360 mR/hr at 15
1 inch from the surface, based on the inverse square law.
Should the detector used to measure such a surface dose have an effective center of 1 inch, it would read 360 mR/hr for the surface dose rate. An additional problem concerns the size of the detector used to make the measurements.
Large area detectors are not recommended for measuring surface dose rates, particularly on small packages or devices, since they provide average readings only and are not likely to detect small voids in shielding materials.
The difficulty involved in making surface measurements is recognized in ANSI N432 in that Section 8.1.2 specifies procedures for measuring exposure rates at 50 mm and 1 m from the surface, but no proce-dure is specified for making the surface measurement.
There is also a problem involving exposure when carrying the smaller devices. The dose rate to the gonads remains the same because the dose rate at 6 inches (15 cm), which is estimated to be the distance from the surface to the gonada) area, is specified to be 50 mR/hr regardless of the size of the device. The dose rate to the thigh (measured at I cm depth and assuming that the device is carried against the thigh), however, changes from 260 mR/hr for a device with the source 4 inches from the surface, to 555 mR/hr for a devi.ce with the source 2 inches from the surface. The average of two independent studies, one in France and one in the USA, indicates that radiography devices are carried about 6.25 minutes per day or 20.8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per year. Annual doses received at the thigh are 5.4 R for the older larger devices and 11.5 R for the newer smaller devices. These considerations, no doubt, led to specification of s
the external radiation levels specified in ANSI N432.
It should be noted that these radiation levels were published in 1981, that identical levels have been part of the international standard ISO 3999 since 1977 and even 16
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i lower levels are being proposed in the European community. The fact that radiographic exposure devices that mee.t the requirements of ANSI N432, 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 e
35 and 45 peunds, 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 label to the radiographic exposure device that would identify the radionuclide in the device, its activity on the date specified, its model number and serial number and the manufacturer of the sealed source.
Comment:
Fourteen comments were received on thit provision, with twelve approving. The negative comments indicated that the upkeep of the mark-ings could be costly and that the isotope manufacturer must be respon-
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sible for providing the label to the user. One commenter proposed that the exposure device label should also include the name, address, and telephone nu,mber of its owner so that the proper persons could be con-tacted if the device became lost and then found.
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Response
In current industry practice the manufacturer provides a plate to the device user with the source changer and the new source.
It is the re-sponsibility of the user to attach the plate containing the prescribed information to the radiographic exposure device. The NRC agrees that it would be desirable to include the name, address and telephone number of the owner on the label and is including this requirement 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:
1 There were no negative comments on this provision.
Some commenters l
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.
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Comment:
No' negative responses were received on this provision.
One manufac-turer asked if this imp 1'es that no modifications may be made without i
f resubmission of desi.gns 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 dev'ce 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. However manufacturers would need NRC approval of modified designs prior to distribution of the new devices. The provision stands as origi.nally stated.
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 equipment task force mentioned previously was that the coupling should 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 provision.
Several commenters from each side indicated that the wording 19
should be changed from.' technical specifications to performance require-a 6
- ments. They. suggested that the wording be patterne'd after the wording
'used in the regulations issued by the State of Texas. Basically, these regulations. 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 will j
. en'sure compliance with t'ils performance requirement by requiring NRC j
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 l
additional or supplemental information concerning the position of the radioactive source.
It was not intended as a substitute for the use of j
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 20
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would lead indiographers to neglect the use of the s'urvey meter. Three commenters stated that the indicators on some of the devices now in use i
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 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 t.o 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 l
i of the International Radiography Standard, ISO 3999, by the French delega-tion, but there appears to be little support for this from other countries.
In view of the continued opposition and past experience with these indicators, the NRC has removed the provision.
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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 S 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.
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a' Section 34'.20(c)(3)-Automatic Securing of Source Ass'embly.
This provision provides a system to automatically secure the source assembly-in 'the shielded position each time it is cranked back into the exposure device. The provision eliminates the manual securing which is.
now required under l'34.22(a) of the current regulations. The provision helps ~ eliminate the problem of the source accidentally moving out of the o
fully shielded position after it has been cranked back into the device.
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-Comment:
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Thirty-two comments were received on this provision, seven in favor and twenty-five opposed. The majority of those opposed appeared con-l[
cerned with the additional maintenance needed to keep the automatic securing system, operating' properly.
Four'were opposed on the basis of L
cost. Three pointed out that it could easily be bypassed. One commenter 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 comnIenters.
Some of the incidents involving overexposures 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 excessive wear caused by radiographers using foot operation rather than 22
~
m hand operation in the manual securing. As for the statements regarding by passing the automatic securing and discouraging the use of survey meters, the NRC does not believe many persons will deliberately by pass or ignore such beneficial measures. Appropriate maintenance, coupled with adequate 1
QA and QC programs, which should be included in the licensee's operations, should eliminate any serious problems with this provision.. It should be noted~ also that the automatic securing reduces the workload on the radiographer by eliminating the manual securing requirement. The pro-vision remains as proposed.
Section 34.20(c)(4)-Require Safety Plugs or Covers.
The purpose of this provision is to prevent the access of water and other matter into the dev1ce where they could contribute to malfunctions and wear.
Comment:
Sixteen comments were received on this provision, all favorable.
One commenter approved on the condition that the covers or plugs were not integrated as a working, moving function of the device. Another commen-ter wanted the device to be equipped with a receptacle to hold the plugs
-or covers and keep them clean. A third commenter felt that the equipment should be required to perform satisfactorily under conditions of mud, sand, water, etc., and leave it up to the' manufacturer to determine if plugs or covers were needed to achieve this.
i 23
~
1
Response
General design. conditions' under Section 5.1 of ANSI N432 presently call. for the exposure' devices to be designe' with due regard 'for the need d
- to minimize the entry of water, mud, sand or other foreign matter into the controls or moving parts during use. The NRC feels that the use of I
appropriate plugs or covers during storage or transportation is also
- necessary but agrees that these need not be integrated into the device.
Receptacles for'the plugs or covers should be an option of the manufacturer. No change is made in the requirement.
l l
(
L Section 34,20(c)(5)-Labelling of the Source or Source Assembly.
The purpose of this provision is to help minimize overexposures that could occur if a member of the -public finds a lost source assembly.
Comment:
Twelve comments were received with eleven in favor. One commenter was concerned that the label might interfere with the operation of the lock or the guide tube..The commenter who was opposed felt that this was not practical and that we should see if it could be done successfully before making it a regulation.
Response
This provision was made part of, Texas regulations on October 1, 1987. Early attempts to use heat shrinkable plastic or soft metal sleeves werp not successful. The current method used by most manufacturers involves laser etching of the source assembly. The requirement will remain as written in the proposed rule with the understanding that laser etching or any other successful method will be acceptable.
24
s
=;
4.
Section 34.20(c)(6)-Guide Tube Crushing Tests and Ki'nking Resistance Test.
The purpose of this provision is to prevent the source assembly from hanging up in the guide tube and creating a condition that could lead to radiation overexposures. The crushing tests for control tubes as speci-fled in ANSI N432 should be used for the guide tubes.
The proposed revision to ANSI N432 has a-kinking test for such guide tubes, and the NRC would find this test acceptable for meeting the require-ments of this section.
The test referred to is described in its entirety as follows:
Place the projection sheath (guide tube) without connection, on a horizontal surface and fix one of the ends so that it does not move in any way during the test. The length of the projection sheath shall be the maximum length authorized by the manufacturer.
Form a flat closed loop, either on the right or left of the positioning axis, with the fixed end under the loop, and keep the ends crossed by means of a hoop so that the-loop cannot come undone under the action of a vertical component of elasticity and the free end can still slide without noticeable friction.
l Apply a tractive force to the free end, at a tangent to the loop, 1
reducing the diameter of the loop. The force shall be applied by means of a dynamometer in such a way that it reaches 200 N in 5 seconds. The force shall be maintained at this level for 10 seconds.
Repeat the test 10 times, undoing and redoing the loop at the same point for each test.
If the projection sheath is composed of various parts with connec-tions, restart the test including a connection in the loop.
Close the loop as above so that the connection and the crossing point are opposite each other.
25
y, tc 1
.l l
Comment:
l 5
h Ten comments were; received on this provision, eight approving, two M
opposed. Those opposing were persons in the aircraft industry who
~ bjected that.the special guide tubes they required would not withstand o
r the specif.ied tests.
Response:-
y Persons who have special requirements'should apply to the NRC under
$ 34.51 for an exemption of the-requirement. The provision is_: unchanged.
[
- Section 34.20(c)(7)-Requirement to Use Guide Tubes.
.The purpose of this provision is to ensure that the source assembly will'not be' cranked out of the camera and fall to the ground.
Comment:
- L Three comments were received, all approving.
Response
The provision is unchanged.
Section 34.20(c)(8)-Requirement for the Use of Exposure Heads.
The purpose of this provision is to prevent the source assembly'from
~ i passing out of the end of the guide tube.
Comment:
Eight comments were. received on this provision, all favorable.
26
?;,
3,- v
- c. -
5
'e 4,i Response:'
Thepr,ovisionisunchanged..
o i
. Section 34.20(c)(9)-Require Guide. Tube Exposure Head Tensile Test. -
'The purpose of this provision is-to ensure that the exposure head
- will not easily become dislodged in use.
Comment:
[
Two comments, both favorable, were received on this provision.
l m
Response
The' provision is unchanged.
LSection 34.20(c)(10)-Source Changers.
I
'The purpose of this_ provision is to prevent exposure.of. persons when making a source change.
i Comment:
Three comments were received on this provision. One commenter believed the source changer design to be adequate. One commenter believed i
that most source changers left something to be desired. One believed that source changers should not be included in this section.
1
Response
Because source changers fall within the category of associated equip-3 ment, the NRC does not believe that this provision should be relocated. The wording of the final provision has been changed, however, to require a 27 1
Si system to assure that the source is not accidentally withdrawn from the I f changer when connecting or disconnecting the drive cable to or from a source assembly.
Section 34.20(d)-Compliance of New Devices with $ 34.20 After One Year.
The purpose of.this requirement is to ensure all newly manufactured devices acquired by licensees meet the performance requirements of SL34.20(a) thru (c) after 1 year from publication of the final rule in the Federal Register..
Comment:
One commenter requested the compliance not be required for two to
.two and one-half years. Some other commenters expressed doubt that manufacturers could meet the requirements in one year. One commenter noted that there was only one type IR device for iridium sources and none for cobalt sources available in the U.S. at the present time.
Response
The requirement has been changed to require compliance after one year from the effective date of the final rule.
Section 34.20(e)-A11 Devices in Use to Comply with $ 34.20 After Five Years.
The purpose of this provision 1,s to require that all radiographic exposure devices meet all of the provisions of S 34.20 after five years or be retired from use.
28 l
)
4-
. Comment:
Twenty-seven comments were received on this provision, 2 in favor and 25 opposed. Most of the comments objecting to the provision challenged the average lifetime of 5 years for the devices, citing for the most part a 10 to 15 year lifetime. The other major objection was the cost, with one commenter citing a value of over $630,000. One commenter had reservations about setting 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 no projection device for cobalt presently available in the U.S. that meets the standard and that current devices, which cost around $15,000, would have to be replaced in 5 years.-
Response
While many of the commenters feel.that this provision poses an excessive financial burden to users and could result in premature replacement of safe and useful equipment, this view is not shared by the NRC.
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.
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 out of business. A side-effect of this depressed state of the industry has been the creation of a large market in used radiographic exposure devices.
29
i The choice of five years was based upon discuss' ions with equipment manufacturers'and upon NRC experience which indicated that the average
- lifetime of devices which project a source out of a shielded position is around five years. The NRC. recognizes, however, that the average life expectancy is dependent upon the design of the device, the amount of use, the environment at the use site, and the quality of the maintenance program.
The choice of a five year implementation period for the rule rather than a more accelerated period was made for a number of reasons. Radiography exposure device manufacturers would probably be unable to manufacture 3500 devices meeting the requirements of the rule in a much shorter time; the 5 year period avoids imposing a severe financial impact on the radiography industry, particularly on the small entities; and the number of radiography overexposures 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 radiographers, and user licensees
-i need additional time to evaluate new models as they become available to assure that they meet expectations under operational field conditions.
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 shown by the intent of one of the larger device suppliers to L
issue a notice 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 I.
with similar problems not subject to this notice are also in use in the marketplace. This provision will help to phase out of use such unser-viceable and possibly unsafe devices. While conceding that the lifet.ime 30 i
.c I
E* r..
of many devices may be as much as 10 years, the NRC believes that many of-the-devices currently ~in use need to be replac6d with devices meeting the criteriaLof the rule to protect the public health and safety. With regard-to the charge that compliance with the new rule would constitute an' excessive financial burden,.it should be pointed out 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 7 years at the date required for coup 11ance and would, therefore, also have been eligible'for a 7 year application of its depreciation allowance. This allowance would seem to' appreciably reduce the financial burden claimed by the c'mmenters.
In-o addition, the regulatory analysis for this rule indicates that the cost to the industry resulting from implementation of this provision of the rule _is of the order of $4 million on a 1989 present worth basis calculated-over the 10 year interval from 1990 to 1999. The. cost to the individual licensee resulting from implementation of this provision of the rule over the same ten year period is $3636. Annual costs over this 10 year period are therefore S400,000 for the industry and 5364 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 rule.
Section 34.21-Limit on External Radi,ation 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).
After a period of five years from the effective date of the final rule, 31
[1
,1 i
all radiograph _ic equipment _except source changers and storage containers will be required to meet the requirements of 6-34.20. 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 i
. two opposed._ The principal comments were that reduction of external radiation levels would not be cost effective and that existing levels have not proven to be a radiological health hazard.
Response
ll The issue of external radiation levels is extensively discussed in j
the response to S 34.20(a) and will not be repeated here. The final i
l version of 9 34.21 will change from that in the proposed rule to the extent that the requirements will become effective 5 years after the
- effective date of the final rule rather than 5 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 equipment.
Comment:
Sixteen comments were received, six in favor and ten opposed. The principal comments were that item one, involving source disconnects, and item two, involving inability to retract the source, were reasonable 32 I
r 73 reporting items.
However, the requirement to report'about item three, failure of any component to perform its function, was unclear, open ended,
.t.
and could lead to large volumes of required reports. Other commenters t
f believed that the costs would be prohibitive and still others commented
.that licensees would simply refuse to comply with these reporting require-ments. One commenter felt that. reporting of defective equipment should be reported under 10 CFR Part 21.
Response
These requirements are separate and distinct both in content and purpose from those contained in 10 CFR Part 21, " Reporting of Deftets and
. Noncompliance" which implements section 206 of the Energy Reorganization'.
Act of,1974, as amended. By specifying conditions for reporting defects or noncompliance of radiographic equipment under this provision any ambiguity resu1 ting from interpretation of Part 21 provisions is avoided.
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 volume of reports would be required along with the. correspondingly high costs associated with generating such reports.
Section 34.33(a)-Require Wearing of an Alarm Ratemeter.
This provision is intended to provide radiographers in the field with a duplicative or redundant device as a backup to the survey meter the radiographer is supposed to carry.
33
Comment:
j Fifty comments were received on this provision, eighteen approved, thirty-two were opposed-The principal comments of those approving the I
- provision were that the rule should specify an alarm ratemeter irtstead 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 read zero. One commenter felt that i
there should also be a requirement that the alarm should go off if the
-ratemeter is subjected to radiation saturation.
i Comments of those opposing the provision were that radiographers will rely on the alarm ratemeter and not use the survey meter, that two-man crews should be required instead,'that survey meters with audible alarms should be used instead, that alarm ratemeters do not work in noisy environments, and that they cost too much. Others believed that management 1
and regulatory agencies needed to enforce proper procedures instead of i
requiring alarm ratemeters. One commenter believed that a hearing test should be required of individuals wearing alarm ratemeters. Another com-menter believed that they were completely unnecessary for permanent facil-ities and that an exemption from this provision should be granted for such facilities.
Response
The purpose of this provision.is to provide an additional warning of possible hazardous radiation levels in the event the survey meter is defective or misread, in much the same manner that buzzers and lights provide backup warning in automobiles of l'ow or almost empty gas tanks
~
for those who ignore or misread their fuel gauge.
It is felt that as 34
)
a.,
e-d.
'I warning devices, alarm ratemeters may be able to prevent many over-exposures that have occurred as a result of improper surveys.
The NRC does not agree with the assumption that radiographers will neglect using survey meters and depend on the alarm ratemeter, nor does it agree thet the use of two-man radiography crews will eliminate the need for alarm dosimeters.- One of the most recent overexposure incidents involved a twi-man crew that was operating with a defective survey meter.
Had the crew been using alarm ratemeters, at least one of the radio-j i
graphers would have been alerted to the abnormal radiation fields present.
Survey meters with audible alarms do not provide the same redundancy that i
separate alarm ratemeters do, primarily because the alarm is connected to the survey meter output and if the survey meter fails, so does the audible l
I alarm.
In regard to radiation saturation, most of the alarm ratemeters or alarm dosimeters treet the standard for these devices, ANSI N13.27, which specifies that exposure alarms shall continue to operate in radia-j j
tion fields one thousand times higher than the highest alarm setpoint.
l Typical alarm ratemeters have upper level settings of 10R/hr or greater.
Most alarm ratemeters on the market also integrate the exposure and generally provide a chirp for every mR accumulated.
Alarm ratemeters and dosimeters are required to have a sound pres-sure level of 75 dBA at 30 cm from the device according to ANSI N13.27.
This is roughly comparable to the sound of busy street traffic. Although the alarm may not be detectable in fligh noise environments, radiographers should continue to keep such alarm ratemeters activated and continue to
' carry an operable and properly calibrated radiation survey meter regard-less of the environment.
35
In regard to the comment that alarm ratemeters are unnecessary for permanent facilities, the' NRC believes that the use of such alarm rate-meters-should not be required for permanent facilities where other alarm-1.ng.or warning devices are in routine use to warn personnelsof high radiation fields. The provision has been rewritten to include this exemption'.. It should be noted, however, that the converse 11s not accept-abl e'.
The wearing of alarm ratemeters 'at permanent facilities cannot be q
used as a substitute for other alarming or warning devices at such q
f acilities.
Section 34.33(f)(2)-Alarm Ratemeters Must Alarm at a Preset Level of i
500 mR/hr.
The purpose of this provision was to set the alarm high enough that the alarm dosimeter will not alarm unnecessarily during normal radiography operations and still provide a reliable alarm before a radiographer could get within 10 feet of a lower activity (10 C1) unshielded source.
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 on 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.
36
1,,
Response
Radiographers 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 appropriase {qns ($ 20.203(c)) and survey the-restricted area bound-ary. Also, calculations based on the inverse square law show that for a 200 C1 Iridium source the radiation field at a normal operator's position r
b (with 21-foot guide tube and 25-foot control tube) is approximately e
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 ratemeters that trigger while radiographers are conducting normal operations 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 have a problem with this provision due to the 'need to work at nuclear power facilities where higher' radiation icvels 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 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.
Modification of Enforcement Policy The C'ommission is modifying its General Statement of Policy and Procedure for NRC Enforcement Actions, 10 CFR Part 2, Appendix C (Enforcement Policy), to reflect the Commission's amendment of 10 CFR 37
1 i
Part 34'.
The. change to the Enforcement Policy is being published con-currently with the new rule.
The modification to.the Enforcement Policy is being made at this
?
time to Supplement VI, " Fuel Cycle and Materials Operations", to put t
J licensees on notice that the failure to implement the requirements for L
dosimetry and equipment by the required date may b'e considered a i
violation of significant regulatory concern. The example is to be used l'
l:
as. guidance in considering Severity Level III violations of the require-ments. The example for Severity Level III is significant because it l
represents failures associated with the use of equipment and dosimetry L
designed to minimize overexposures from radioactive materials.
Finding of No Significant Environmental Impact: Availability l.
The Commission has determined under the National Environmental l
Policy Act of 1969, as amended, and the Commission's regulations in Sub-I' part A of 10 CFR part 51, that this rule is not a major Federal action significantly affecting the quality of the human environment and, there-q
- fore, an environmental impact statement is not required.
The final rule involves engineering design modifications to indust-t rial radiography devices and requires licensees to use only radiography devices and associated equipment that provide certain additional safety features.
Radiographers are required to wear alarm ratemeters.
No requirements for significant quanti ^ ties of materials, water, electricity
[
or other forms of energy have been identified, and no environmental or radiation impacts are involved.
i 38
F-g N..
as
- [4 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 environmental 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.
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 coll'ection of information is esti-
[
mated to' average 0.34 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 in'structions, searching existing data sources, gathering.and maintaining l
l_
the data needed, and completing and reviewing the collection of informa-1
[
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.
i Nuclear Regulatory Commission, Washington, DC 20555; and to the Paper-l work Reduction Project (3150-0007), Office of Management and Budget, Washington, DC 20503.
39
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 Commission. The regulatory analysis is available for r
inspection in the NRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC.
Single copies may be obtained from Donald O.
Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3628.
Regulatory Flexibility Analysis The NRC has prepared a final regulatory flexibility analysis of the-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
~
of this document, indicates that this rule could have an economic impact 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.
Backfit Analysis 4
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 design, construct or operate a facility.
Accordingly, NRC has determined that the backfit rule 10 CFR 50.109 does not apply to this final rule, 40 l
i 4
4, 9 Therefore, a backfit analysis is' not required for _th'is final rule because 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 n
Part 2 - Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Civil penalty, Enforcement, Environmental protection, Nuclear materials, Nuclear 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 under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization 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:
PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS 1.
The authority citation for Part 2 continues to read in part as follows:
AUTHORITY:
Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201);
sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
2.
Appendix C, Supplement VI, is modified by adding example 9 to paragraph C to read as follows:
41
i g
y y
~
- j.
Appe_ndix C -- General Statement of Policy and. Procedure for NRC e;
~
Enforcement-Actions e-a e'
a fSupplement-VI -- Severity Categories
[
C.
Severity III.
l:
9.
Failure, during radiographic operations, to have present or use_ radiographic equipment,' radiation survey instruments, and/or personnel monitoring devices as required by Part 34.
[
PART 34 - LICENSES'FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS' L
1.-
The authority citation for Part 34 is revised to read as l:
follows:
L AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat.-935, 948, 953, 954,
- as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Section 34.32 also issued under sec. 206, 88 Stat.1246 (42 U.S.C.
1 5846).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); SS 34.20(a)-(e), 34.21(a) and (b), 34.22, 34.23, 34.24, 34.25(a),
(b)and(d),34.28,34.29,34.31(a)'and(b),34.32,34.33(a),(c),(d) and (f), 34.41, 34.42, 34.43(a), (b) and (c) and 34.44 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and SS 34.11(d),
34.25(c) and (d), 34.26, 34.27, 34.28(b), 34.29(c), 34.30, 34.31(c),
4
)
34.33(b) and (e) and 34.43(d) are issued under sec. 1610, 68 Stat. 950, i
as amended (42 U.S.C. 2201(o)).
42
y
- 1. ;
c a
a.
t:.:
L 2.'
A new $ 34.20 is added under the Equipment Control heading in Subpart B to read as follows:
L;,
9-34.20 Performance requirements for radiography equipment.
~
-Equipment used in industrial radiographic operations must meet the following minimum criteria:
(a) Each radiographic exposure device and all associated equipment must meet the requirements specified in American National Standard N432
" Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," 1981 (published as NBS' Handbook 136).
This publica-f tion has been approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a). This publication t
may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402 and from the American National.
- Standards Institute, Inc.,1430 Broadway, New York, New York 10018, Tele-phone (212) 642-4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Public Document Room, 2120 L Street 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.
(b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices and associated equipment.
(1) Each radiographic exposure device must have attached to it by the user, a dur.able, legible, clearly visible label bearing the--
(1) Chemical symbol and mass number of the radionuclide in the device; (ii) Activity and the date or which this activity was last measured; 43
~
~
(iii) Model number and serial number of the sealed source; (iv) Manufacturer of the sealed source; and
' (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 th'e 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 be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.
(2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device, l
This securing system may only be released by means of a deliberate opera-tion on the exposure device.
(3) The outlet fittings, lock box, and drive cable fittings on each 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:
44
v.
a.
e:
4 c
,1 5
" DANGER - RADI0 ACTIVE." - The label must not interfere with the safe opera-
)
i 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 3
l device.
(7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during radiographic operations.
l (8) The guide tube exposure head connection must be able to with-stand the tensile test for control units specified in ANSI N432.
(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, i-(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 of 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 l
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:
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'S-34.21 -Limit on levels of radiation for radiographic exposure devices and_ storage containers.
(b)_ Paragraph (a) of this section applies to all equipment manu-factured prior to (insert a date 1 year after the effective date of the finalrule).
After (insert a date 5 years after the effective date of.
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the final rule), radiographic equipment other than storage containers and source changers must meet the requirements of 5 34.20, and S 34.21 applies only to storage containers (source changers).
4 A'new heading " REPORTING" is added and a new $ 34.30 is added under that heading to read-as follows:
1 6 34.30 Re:orting 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; Division of Industrial and Medical Nuclear Safety; Medical, Academic and Commercial Use Safety Branch; l
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 safe operation of the device) to properly perform its intended function.
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(b) The' licensee 1shall include the following fnformation in'each
-reportfsubmitted under paragraph (a) of this section:
(1) A-description 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, q
(6) Corrective actions taken or planned to prevent recurrence.
(7) Qualifications'of-personnel involved in the incident.
(c) Reports.of overexposure submitted under 10 CFR 20.405 which involve failure of safety components of radiography equipment must also include the information specified in paragraph (b) of this section.
)
5.
In S 34.33 paragraph (a) is revised to read as follows, and a new paragraph (f) is added to read as follows:
5 34.33 Personnel monitoring.
(a) The licensee may.not permit any individual 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, an alarm ratemeter, and either a film badge or a thermolumine-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 milliroentgens 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.
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n (f) Each alarm ratemeter must--
(1) Be checked to ens'ure tha.t the alarm functions properly (sounds) prior to use at the start of each shift; j
(2) Be set to give an alana signal at a preset dose rate of 500 mR/hr.;
(3) Require special means to change the preset alarm function; and I
(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.
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6.
In Appendix A, Item II.C, "Use of personnel monitoring equipnent," is revised to include:
Appendix A yI C
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3.
Alarm ratemeters Dated at Rockville, MD, this d 9 day of D e = 4-s 1989.
For the Nuclear Regulatory Commission.
.d de J
C. Hoy'ie ' /
~
istant Secretary of the Commissign k
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=o to APPENDIX A TO THIS DOCUMENT -- REGULATORY, FLEXIBILITY ANALYSIS FOR AMENDMENTS TO 10 CFR PART 34 ON i
SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT P
The Nuclear Regulatory Commission is amending its regulations that i
apply to industrial radiography. These amendments impose additional safety performance standards on radiographic equipment, and radiographers are required to wear alarm ratemeters.
In addition, the amendments require reporting of failures of radiography equipment to meet safety performance standards in the field.
Industrial radiography performed in the field has been of concern to the NRC and the Agreement States for over 20 years,-in part because of its high incidence of overexposure (4 to 5 times that of other radiation workers), and in part becaun of the potential for serious consequences l
to both the public and radiographers due to the high activity of the r
radioactive sources used in this industry. Among the actions considered by the NRC to help alleviate the situation are:
(a) A training manual for radiography personnel, (b) Improved training programs for individual radiographers, (c)
Increasing inspection time observing actual radiogr phic operations.
(d) Providing additional guidance for reporting events as required by 10 CFR, and (e) Establishment of safety requirements for radiographic equipment.
The amendments in this rulemaking f all within category (e) above.
i They are designed to reduce the potential for overexposures by the 49
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o imposition of safety performance standards on radiographic exposure devices and associated equipesnt and by providing some redundancy in j
detecting exposed sources by requiring the use of alarming ratemeters.
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A total of approximately 1,100 radiography licenses are currently i
in effect, approximately one-third have been issued by the NRC and the j
other two-thirds by the Agreement States.
Based upon a recent survey of some 355 NRC radiography licensees and discussions with Agreement State personnel in California, Louisiana, and Texas (which contain most of the non-NRC radiography lic&nsees), the staff l
l has concluded that approximately 90% of all radiography licensees have i
annual receipts of less than $3.5 million, the criteric.n for defining "small entities " specified in Section 60$(b) of the Regulatory Flexibility Act of 1980.
Most of the radiography licensees are in the business of nondestruc-l tive testing in which radiography represents only a part of their total income. A few small firms work only in radiography.
In spite of their i
classification as small entities, the NRC survey cited above indicated j
that 76% of the licensees had annual receipts of over $500K and most of the remainder had annual receipts exceeding $250K.
The estimated costs to individual licensees resulting from these i
amendments consist of an initial cost of $3,636 for the purchase of radiography devices and $1,477 for purchase of alarm ratemeters, pl.us an annual cost of $1.188 for replacem'nt of devices end' alarm dosimeters, e
annual calibration of alarm dosimeters, annual maintenance costs, and reporting and labelling requirements.
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A bre'akdown in the annual cost per licensee giv'en above is at follows:
l l
Replacement of exposure devices (over
$ 404 and above the present cost) i Replacement of alarm ratemeters
$ 295 l
Calibration of alarm ratemeters 5 227 Ratemeter battery replacement 5 164 Reporting and labelling requirements
$ 98
$1188 Although the majority of the licensees fall within the category of "small entities" as defined by the NRC, the Commission believes that the initial and annual costs of the new rulemaking, which are described above, 1
should not have a significant economic impact on most of the licensees because the costs are small compared to their annual receipts.
- Further, the Commission has concluded that the benefits that would result to radio-graphers and to the general public as a result of these amendments out-l weigh the small cost to the licensees. This final rule does not duplicate or conflict with other Federal rules.
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