ML20059H789
| ML20059H789 | |
| Person / Time | |
|---|---|
| Issue date: | 11/23/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| FRN-59FR9429 AE07-1-043, AE7-1, AE7-1-43, SECY-93-317, NUDOCS 9401310158 | |
| Download: ML20059H789 (193) | |
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RULEMAKING ISSUE November 23, 1993 (Notation Vote) secy-93-317 FOR:
The Commissioners FROM:
James M. Taylor, Executive Director for Operations
SUBJECT:
PROPOSED RULEMAKING - REVISION TO PART 34, LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS PURPOSE:
To obtain Commission approval of the proposed revision.
BACKGROUND:
By a Staff Requirements Memorandum, dated April 25, 1991, the Commission directed the staff to revise Part 34 to clarify the requirements in Section 34.27, making Part 34 more consistent with the approach taken in Part E of the
" Suggested State Regulations for Control of Radiation" (SSRCR), developed by the Conference of Radiation Control Program Directors (CRCPD) Inc., and Part 31 of the Texas regulations for the Control of Radiation. The staff was encouraged to work closely with the States, in particular, those States that have taken an active role in radiography issues.
The staff solicited recommendations on radiography issues from the Agreement States at the October 1991 All-Agreement States meeting, as well as from NRC regional offices, radiography equipment manufacturers, and radiography licensees. Also, an Agreement State workshop was held on November 18, 1992, in Dallas, Texas, to discuss the recommendations received from the Agreement States and licensees. The staff held separate discussions with the Agreement States and members of the public at the May 1991 CRCPD Annual Meeting in Wichita, Kansas, and at a workshop on mandatory radiographer certification on May 27-28, 1992 in Mobile, Alabama.
A petition for rulemaking was filed by the International Union of Operating Engineers (IU0E), Local No. 2, in October 1992, requesting that Part 34 be revised to require a minimum of two radiographic personnel when performing operations with radioactive material at temporary jobsites.
CONTACT:
NOTE:
TO BE MADE PUBLICLY AVAILABLE Cheryl A. Trottier, RES 492-3640 WHEN THE FINAL SRM IS MADE nyArtagtg
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9401310158 931123 PDR SECY 93-317 PDR 4
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e The Commissioners 2
DISCUSSION:
i In an effort to make Part 34 more comprehendible and to facilitate compliance, the format of the rule has been revised to categorize the safety requirements into subparts. This organization follows the same general format used in 10 CFR Part 39 which addresses radiation safety requirements for well logging. provides the current and proposed rule in a 2-column format for ease of review in comparing the proposed requirements with the existing rule.
The proposed revision to Part 34 contains a number of changes which would make NRC requirements more consistent with Agreement State regulations.
These are discussed in detail in the Federal Register Notice (Enclosure 2).
The major modifications to Part 34 are discussed below.
The first major change is based, in part, on the SSRCR and on comments received on the IUDE petition.
The proposed rule requires at least two radiographers or a radiographer and an individual who has met, as a minimum, the requirements to be a radiographer's assistant to be present any time radiograph'c operations occur outside of a permanent radiographic installation.
The staff believes that by requiring at least two qualified individuals to always be present when radiographic operations are being conducted, there will be a significant increase in assurance that operational safety measures and emergency procedures will be implemented effectively.
The expectation is that violations that involve failures to perform adequate radiation surveys, failures to adequately post and monitor the restricted area, and failures to lock and secure the camera when not in use will become less frequent.
Furthermore, if an incapacitating injury to a radiographer should occur at a remote location, the presence of a second individual could be an important factor in preventing unnecessary radiation exposures.
The use of at least two qualified individuals is already implicitly required under current NRC regulations for any situation where a single radiographer could not maintain direct surveillance of the operation to protect against unauthorized entry into a high radiation area. Most licensees use radiographers' assistants to fulfill this function.
This proposed rule may require licensees to hire additional employees for those jobs where they are not currently providing additional qualified staff to maintain adequate 3
Other options would be changes in staff assignments or work
{
surveillance.
schedules to accommodate the new requirement. However, because of the potential for high costs to some licensees, the proposed rule includes a discussion of the use of the exemption provision to allow some flexibility for special circumstances.
Furthermore, the Federal Register Notice requests proposals for alternatives to the two-person requirement and also requests specific comment on tiie costs identified in the draft Regulatory Analysis.
As the draft Regulatory Analysis (Enclosure 3) indicates, the estimated cost for the adoption of this provision in the proposed rule may be quite high.
While a number of Agreement States have already adopted similar requirements, the staff has not been able to determine the actual costs associated with these provisions.
However, the estimates used in the draft Regulatory
s.
The Commissioners 3
Analysis are believed to reasonably reflect the potential burden on licensees and are based on information supplied by the regions as to the percentage of licensees not currently using two individuals. The Federal Register Notice specifically solicits input from small entities on the potential impact of adopting these requirements and on how the proposed requirements could be modified to lessen any impact, i
This action would constitute a partial granting of the IU0E petition.
Although the IU0E petition ircluded a provision that the second individual t
could be a radiographer or a trainee, the staff has not adopted this provision in the proposed rule.
The term " trainee" is used by the State of Texas and means an individual who has received a specific 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> training program.
This is the same training required to become a radiographer. A number of commenters on the petition indicated that in many cases the trainee is an unskilled individual who may or may not achieve radiographer status and, therefore, expending resources on 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training may not be financially feasible for them. The proposed rule language retains the use of the term radiographer's assistant and permits use of a radiographer and an individual who meets, at least, the requirements of a radiographer's assistant to fulfill the requirement for two individuals.
By describing the second individual in such a manner an Agreement State could use a " trainee" to fulfill the requirement for the second person.
The second major modification addressed in the proposed rule would require i
mandatory certification for radiographers.
In March 1991, the Commission issued a revision to Part 34 to allow licensees to provide evidence of radiographer certification by the American Society for Nondestructive Testing-(ASNT) in lieu of submitting descriptions of a radiation safety training program, however, only 300 radiographers have applied for certification since l
this program was initiated.
The intent of establishing mandatory certification is to set up consistent standards by independent certifying i
organization (although ASNT is the only one at this time) and Agreement States.
The proposed rule includes an Appendix A which would specify the requirements for both independent organizations and Agreement States to become i
certifying entities.
Since radiography is a mobile industry where radiographers frequently work in multiple States during a given ' year, moving in and out of NRC jurisdiction, a national certification program should bring some uniformity to the field and assist in upgrading the training program for these individuals.
The State of Texas, for example, has required a state administered examination of radiographers since 1988. Data on overexposures in Texas indicates that overexposures have dropped since these requirements were instituted (although other safety enhancements issues at the same time have also contributed to the improvement in safety).
A third major modification in the proposed rule involves requirements for a i
Radiation Safety Officer (RS0) and was adopted from the Texas regulations.
The RSO is the key licensee individual charged with the responsibility to l
ensure that the requirements in the license are followed.
The proposed rule 1
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The Commissioners 4
specifies the qualifications and duties of the RSO.
Currently, applicants are only requested to specify the name of an individual to act as the RSO in the license application.
No duties are specified for this individual.
By listing the specific duties of the RSO, and requiring additional training for this position, there will be an individual qualified to provide the appropriate attention to radiation safety.
A fourth major change involves a requirement to provide additional training for radiographers' assistants. Under the current regulation, radiographers' assistants are only required to receive copies of the licensees' operating and emergency procedures and to be tested in their knowledge and understanding of those procedures and use of the licensee's equipment.
Under the proposed rule, they would be required to receive additional training in Parts 19, 20, 34, portions of Parts 30 and 71, and applicable DOT regulations.
This additional training is needed to ensure that radiographers' assistants are thoroughly knowledgeable of NRC requirements. There have been a number of cases where radiographers' assistants have been overexposed because they failed to comply with NRC requirements.
A fifth major change involves the definition of a permanent radiographic installation.
In the past, there has been some confusion as to what the NRC intended in requiring a permanent radiographic installation to have special access control devices.
The proposed rule removes the ambiguous language in the definition of a permanent radiographic installation, and requires licensees to describe all permanent radiographic installations in their license application and install alarms or access control devices.
Prior to submitting the proposed rule to the Commission, the staff provided the draft rule to the Agreement States for their review and comment.
Responses were received from about half of the Agreement States. Many had no comments and agreed with the proposed rule. The major comments are summarized below:
1)
Regarding the two-person rule, of the 19 States which responded, 5 already have requirements for a two-person crew, and one has proposed adding the requirement. Of the States who currently require a two-person requirement, none was aware of significant hardships on licensees resulting from the additional costs. However, one State suggested including a provision that would permit licensees to request an exemption from the requirement with adequate compensatory measures.
This recommendation has been addressed in the Statement of l
Considerations.
I j
2)
Several States questioned what information would be required for the l
special training for RS0s. The staff has changed the wording of the proposed requirements to clarify what inf3rmation should be addressed in the specialized training.
3)
One State recommended dropping the use of alarm ratemeters, as the State believes they encourage radiographers to rely on the ratemeter and not
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The Commissioners 5
use the survey meter to confirm that the source is secured. The staff did not adopt this recommendation on the basis that the alarm ratemeter has proven to be effective in warning radiographers when they have failed to verify source location with a survey meter.
4)
Several States objected to the proposed allowance for an individual to return to work once his/her pocket dosimeter has been found to be off-scale for reasons other than radiation exposure (i.e., the pocket dosimeter was dropped). There may be cases where an unreasonable burden would result by preventing a radiographer from returning to work when a determination can be made that no overexposure occurred, so the staff has not changed the proposed rule.
RESOURCES:
The staff believes that the resources required to implement this proposed rule would not involve any resource adjustments to the NRC-Five-Year Plan. NRC's industrial radiography licensing and' inspection programs should remain essentially the same. While NRC's radiography licensees would be expected to revise their procedures to implement the revised or new requirements,
'i licensees would be permitted to wait until their next renewal to submit the revised procedures to NRC for review.
In the interim, NRC inspection staff would confirm, as part of its regular inspection activity, that licensees had implemented the revised regulatory requirements.
There may be a slight increase in time required to conduct license reviews and inspections; however, the staff believes that the resources required should be minor and can be accounted for.within existing resource allocations.
RECOMMENDATION:
That the Commission:
1.
Approve the Notice of Proposed Rulemaking for publication (Enclosure 2) for a 90-day public comment period.
2.
Note:
That the rulemaking would be published in the Federal Register for a.
a 90-day public comment period; b.
That a draft Regulatory Analysis will be available in the Public Document Room (Enclosure 3);
The staff has prepared an environmental assessment (Enclosure 4).
c.
The assessment concludes that the action will not significantly affect the quality of the human environment; d.
That in accordance with the Regulatory Flexibility Act, an initial.
regulatory flexibility analysis has been prepared, the summary of which can be found in Appendix A to the notice..The analysis indicates that this rule could have an economic impact on radiography licensees. Approximately 90% of these licensees are considered to be "small entities." The estimated costs are not
The Commissioners 6
considered to be overly burdensome in light of the resultant benefits derived. The draft analysis will be made available for comment and a. copy will be sent to the Chief Counsel for Advocacy of the Small Business Administration.
e.
That the proposed rule contains information collection requirements that are subject to review by OMB.
Upon Commission approval, formal request for OMB review and clearance will be initiated; j
f.
That the Agreement States have been provided with a copy of the proposed rule during the office concurrence process and their i
comments have been considered in developing the proposed rule; g.
A public announcement will be issued (Enclosure 5);
h.
The appropriate Congressional committees will be informed (Enclosure 6); and i.
Copies of the Federal Register Notice of proposed rulemaking will be distributed to all Part 34 licensees. The notice will be sent to other interested parties upon request.
_/
- 4 J mes M. T(ylor xecutive Director for Operations
Enclosures:
1.
Comparative Rule Text 2.
Federal Register Notice 3.
Draft Regulatory Analysis 4.
Draft Environmental Assessment 5.
Draft Public Announcement 6.
Draft Congressional Letters
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Commissioners' comments or' consent should be provided.directly to the Office of the Secretary by COB Wednesday, December 8, 1993.
Commission Staff Office comments, if any, should be submitted l
to the Commissioners NLT Wednesday, December 1, 1993, with an information copy to the Office of the Secretary.
.If;the_ paper His of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC-OCAA OIG OPA OCA OPP 5
EDO SECY 4
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ENCLOSURE 1 COMPARATIVE RULE TEXT
r CURRENT RULE PROPOSED RULE PART 34'-- LICENSES FOR RADIOGRAPHY PART 34 -- LICENSES AND RADIATION AND RADIATION SAFETY SAFETY REQUIREMENTS REQUIREMENTS FOR RADIOGRAPHIC FOR RADIOGRAPHIC OPERATIONS OPERATIONS Subpart A -- General Provisions Sec.
Sec.
34.1 Purpose and scope.
34.1 Purpose and scope.
34.2 Definitions.
34.3 Definitions.
34.3 Applications for specific See s 34.11.
licenses.
34.5 Interpretations.
34.4 Maintenance of records.
See s 34.87.
34.8 Information collection 34.8 Information collection requirements: OMB approval.
requirements: OMB approval.
Subpart A -- Specific Licensing Subpart B -- Specific Licensing Requirements Requirements See s 3',3.
34.11 Application for a specific license.
34.11 Issuance of specific licenses 34.13 Specific license for for use of sealed sources 1.n radiography.
radiography.
Subpart B -- Radiation Safety Requirements Equipment Control Subpart C -- Equipment 34.20 Performance requirements for 34.20 Performance requirements for radiography equipment.
radiography equipment.
34.21 Limits on levels of radiation 34.21 Limits on levels of radiation for radiographic exposure devices for radiographic exposure devices, and storage containers.
storage containers, and source changers.
34.22 Locking of radiographic 34.23 Locking and relocation of exposure devices,. storage radiographic exposure devices:
containers, and source changers.
I
I storage containers, and' source changers.
34.23 Storage precautions.
See s 34.35.
34.24 Radiation survey instruments.
34.25 Radiation survey instruments.
34.25 Leak testing, repair, tagging, 34.27 Leak testing and replacement.
opening, modification and of sealed sources.
replacement of sealed sources.
34.26 Quarterly inventory.
34.29 Quarterly inventory.
34.27 Utilization logs.
See s 34.71.
34.28 Inspection and maintenance of 34.31 Inspection and maintenance of radiographic exposure devices, radiographic exposure devices, storage containers, and source storage containers, associated changers.
equipment, and' source changers.
34.29 Permanent radiographic 34.33 Permanent radiographic installations.
installations.
See 1 34.23.
34.35 Labels, storage, and transportation precautions.
Reporting 34.30 Reporting requirements.
See Subpart F, 9 34.101.
Personal Radiation Safety Subpart D -- Radiation Safety Requirements for Radiographers and Requirements Radiographers' Assistants 34.41 Conducting radiographic operations 34.42 Radiation Safety Officer.
34.31 Training.
34.43 Training.
34.32 Operating and emergency 34.45 Operating and emergency procedures, procedures.
See s 34.44.
34.46 Supervision of radiographer's assistants 2
1 34.33. Personnel monitoring.
34.47 Personnel monitoring.
Precautionary Procedures in
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Radiographic Operations 34.41 Security.
See 5 34.51.
34.42' Posting.
See 9 34.53, 34.43
'diation surveys.
34.49 Radiation surveys.
Set 5 34.41.
34.51 Surveillance.
See 5 34.42.
34.53 Posting.
'l 34.44 Supervisionlof radiographers' See 534.46 assistants.
Exemptions 34.51 Applications for exemptions.
See Subpart G, 9 34.111.
34.61 Violations.
See 5 34.121.
34.63 Criminal penalties.
See 5 34.123.
Appendix A See 5 34.43(f).
Subpart E -- Records 34.61 Records of specific license for radiography.
s 34.63 Records of receipt and transfer of sealed sources.
See s 34.24.
34.65 Records of radiation survey instruments.
See 1 34.25(c).
34.67 Records of leak testing and replacement of sealed sources.
See 5 34.26.
34.69 Records of quarterly inventory.
See 5 34.27.
34.71 Utilization logs.
See s 34.28(b).
34.73 Records of inspection and maintenance of radiographic exposure devices, storage containers,
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associated equipment, and source changers.
See 5 34.29(c).
34.75 Records of alarm system checks at permanent radiographic installations.
See 5 34.31(c).
34.79 Records of training.
See 5 34.32.
34.81 Copies of operating and emergency procedures.
See 5 34.33(b and e).
34.83 Records of personnel monitoring.
See 5 34.43(d).
34.85 Records of radiation surveys.
See 5 34.4.
34.87 Form of records.
i 34.89 Documents and records required at field stations and permanent installations.
34.91 Documents and records required at temporary jobsites and use or storage locations exceeding 180 days.
Subpart F -- Notifications See 5 34.30.
34.101 Notifications.
Subpart G -- Exemptions See 5 34.51.
34.111 Applications for exemptions.
Subpart H -- Violations.
See 5 34.61 34.121 Violations.
See 5 34.63 34.123 Criminal penalties.
Authority: Secs. 81, 161, 182, 183,
_ Authority: Secs. 81, 161, 182, 68 Stat. 935, 948, 953, 954, as 183, 68 Stat. 935, 948, 953, 954, as-amended (42 U.S.C. 2111, 2201, 2232, amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as 2233); sec. 201, 88 Stat. 1242, as amended (42.U.S.C. 5841).
amended (42 U.S.C. 5841).
Section 34.32 also issued under sec. 206, 88 Stat. 1246 (42 U.S.C.
4
e 5846).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); Section 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 Section 34.11(d), 34.25 (c) and (d), 34.26, 34.27, 34.28(b),
34 29(c), 34.30, 34.31(c), 34.33 (b)
'e) and 34.43(d) are issued sec. 1610, 68 Stat. 950, as am...ed (42 U.S.C. 2201(o)).
i Subpart A -- General Provisions.
Section 34.;
.se and scope.
Section 34.1 Purpose and scope.
This part prescribes requirements This part prescribes requirements for the issuance of licenses for the for the issuance of licenses for the use of sealed sources containing use of sealed sources containing byproduct material and radiation byproduct material and-radiation safety requirements for persons safety requirements for persons using such sealed sources in using these sealed sources in radiography-The provisions and industrial radiography. The requirement
' this part are in provisions and requirements of this addition to, ad not in substitution part are in addition to, and not in-for, other requirements of this substitution for, other requirements chapter.
In particular, the of this chapter.
In particular, the provisions of Part 30 of this requirements and provisions of Parts chapter apply to applications and 19, 20, 21, 30, 71, 150, 170, and i
licenses subject to this part.
171 of this chapter apply to j
Nothing in this part shall apply to applications and licenses subject to uses of byproduct material for this part. This rule.does not apply medical diagnosis or therapy.
to medical uses of byproduct material.
Section 34.2 Definitions.
Section 34.3 Definitions.
As used in this part:
-As used in this part:
ALARA (acronym for as low as reasonably achievable) means making every reasonable effort to maintain exposures to radiation as far below the dose limits specified in Part 20 5
4 l
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as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the-economics of improvements in relation to benefits to'the public health and safety, and other-societal and socioeconomic considerations, and in relation to utilization of nuclear energy'and licensed materials in the public interest.
Annual' safety review means a review conducted or provided by the licensee for its employees on radiation safety aspects of radiography.
The review may include, as appropriate, the results of internal inspections, new procedures ar equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions.
Associated equipment means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the source, (e.g., guide tube, control tube, control (crank-out device),
removable source stop, "J." tube).
Becquerel (Bq) means one disintegration per second.
Certifying ~ entity means an independent certifying organization or an Agreement State meeting the requirements _in Appendix A, Parts II and III.
Co111mator means a device used to limit the size, shape, and direction of the primary radiation beam.
Control tube means a protective sheath for guiding the control cable.
The control tube connects the control drive mechanism to the radiographic exposure device.
Exposure head means a device that locates the gamma radiography 6
e
sealed source in the selected working position.
(An exposure head is also known as a source stop.)
Field examination means a demonstration through practical application of the safety rules and principles in radiography including use of all appropriate equipment and procedures.
Field station means a facility where licensed material may be stored or used and from which equipment is dispatched.
Gray means the SI unit of absorbed dose.
One gray is equal to an absorbed dose of 1 Joule / kilogram.
It is also equal to 100 rads.
Independent certifying organization means an independent organization that meets the criteria
Permanent radiographic of Appendix A of this part.
installation means a shielded Permanent radiographic installation or structure designed installation means an enclosed or intended for radiography and in shielded room, cell, or vault, not i
which radiography is regularly located at a temporary jobsite, in performed.
which radiography is. performed.
Projection sheath (guide tube) means a flexible or rigid tube 1
(i.e., "J" tube) for guiding the source assembly and the attached control cable from the radiographic exposure device to the exposure head.
or working position.
Radiation Safety Officer means an individual named by the licensee who has knowledge of, responsibility for, and authority to ensure compliance with appropriate i
radiation protection rules, standards, and practices on behalf of the licensee and who meets the i
Radiographer means any re;airements of 5 34.42.
individual who performs or who, in Radiographer means any attendance at the site where the individual who meets the sealed source or sources are being requirements of 34.43, is in used, personally supervises attendance at the site where the radiographic operations and who is sealed source or sources are being responsible to the licensee for used, personally supervises assuring compliance with the radiographic operations and who is requirements of the Commission's responsible to the licensee for regulations and the conditions 7
of the license; ensuring compliance with the requirements of the Commission's regulations and the conditions of the license.
Radiographer certification means written approval _ received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety training, testing, and experience
Radiographer's assistant means
- criteria, any individual who under the Radiographer's assistant means personal supervision of a any individual, who under the radiographer, uses radiographic personal supervision of a exposure devices, sealed sources or radiographer, uses radiographic related handling tools, or radiation exposure devices, sealed sources or survey instruments in radiography; related handling tools, or radiation
Radiographic exposure survey instruments in radiography, device means any instrument Radiographic exposure device containing a sealed source fastened (also called a camera or a or contained therein, in which the projector) means any instrument sealed source or shielding thereof containing a sealed source fastened may be moved, or otherwise changed, or contained therein, in which the from a shielded to unshielded sealed source or shielding thereof position for purposes of making a may be moved, or otherwise changed, radiographic exposure; from a shielded to unshielded position for purposes of making a radiographic exposure.
Radiographic operations means.
all activities associated with the presence of radioactive sources in a radiographic exposure device during transport and use of the device, to include surveys to confirm the.
adequacy of boundaries, setting up equipment and any activity inside
Radiography means the restricted area boundaries.
i examination of the structure of
-Radiography means the materials by nondestructive methods, examination of the structure of utilizing sealed sources of materials by nondestructive methods, byproduct materials; utilizing sealed sources of byproduct materials.
S-tube means a tube (typically made of a hard metal, such as, titanium) through which the radioactive source travels in a
Sealed source means any radiographic exposure device.
byproduct material that is encased Sealed source means any in a capsule designed to prevent byproduct material that is encased leakage or escape of the byproduct in a cap:;ule designed to prevent material; leakage or escape of the byproduct' material.
8 m-r-
)
Shielded position means the location within the radiographic 1
exposure device or source changer where the sealed source is secured and-restricted from movement. (In-this position the radiation exposure will be at a minimum.
This position incorporates maximum shielding for the radioactive source.)
Sievert means the SI unit of any of the quantities expressed as dose equivalent.
The absorbed dose in grays multiplied by the quality factor is equal to the dose equivalent in Sieverts.
For comparison 1 Sv - 100 rems.
Source assembly means an assembly that consists of the sealed source and a connector that attaches the source to the control cable.
The source assembly may also include a stop ball used to secure the source in the shielded position.
Source changer means a Source changer means a device device designed and used for designed and used for replacement of replacement of sealed sources in sealed sources in radiographic-radiographic exposure devices, exposure devices, including those including those also used for also used for transporting and' transporting and storage of sealed storage of sealed sources.
sources;
Storage area means any Storage area means any location, facility, or vehicle which location, facility, or vehicle which is used to store, to transport, or is used to store or to secure a to secure a radiographic exposure radiographic exposure device, a device, a storage container, or a storage container, or a sealed sealed source when it is not in use source when it is not in use and and which is locked or has a which is locked or has a physical F
physical barrier to prevent barrier to prevent accidental accidental exposure, tampering with, exposure, tampering with, or or unauthorized removal of the unauthorized removal of the device, device, container, or source.
container, or source.
Storage container means a Storage container means.a device in which sealed sources are device in which sealed sources are transported or stored.
stored.
Temporary jobsite means a place where radiographic operations are conducted other than the location (s) of use authorized on the license.
9
f Section 34.5 Interpretations.
l Except as specifically authorized by the Commission in writing,-no interpretation'of the meaning of the regulations-in this part.by any officer or employee of-l the Commission, other than a written-i interpretation by the General.
Counsel, will be recognized to be binding upon the Commission.
Section 34.3 Applications for See 9 34.11.
f specific licenses.
A person may file an application for specific license for use of sealed sources in radiography in duplicate on NRC Form 313,
Application for Material
+
License, in accordance with the provisions of Section 30.32 of this chapter.
Section 34.4 Maintenance of records.
See 9 34.87.
Each record required by this.
part must be legible throughout the retention period specified by each Commission regulation.
The record 3
may be the original of a reproduced t
copy of a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period.
The record may also be
. stored in electronic media with'the j
capability for producing legible, accurate, and complete records during the required retention period.
Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
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Section 34.8 Information collection Section 34.8 Information collection requirements: OMB approval.
requirements: OMB approval.
(a) The Nuclear Regulatory (a) The Nuclear Regulatory Commission has submitted the Commission has submitted the information collection requirements information collection requirements contained in this part to the Office contained in this part to the Office of Management and Budget (OMB) for of Management and Budget (OMB) for approval as required by the approval as required by the Paperwork Reduction Act of 1980 (44 Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has U.S.C. 3501 et seq.). OMB has approved the information collection approved the information collection' requirements contained in this part requirements contained in this part under control number 3150-0007.
under control number 3150-0007.
(b) The approved information (b) The approved information collection requirements contained in collection requirements contained in this part appear in Section 34.11, this part appear in 55 34.13, 34.24, 34.25, 34.26, 34.27, 34.28, 34.20, 34.25, 34.27, 34.29, 34.31, 34.29, 34.31, 34.32, 34.33, and 34.33, 34.35, 35.41, 34.43, 34.45, 34.43.
34.47, 34.49, 34.61, 34.63, 34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87, 34.89, 34.91, 34.101, 34.111, and Appendix A.
(c) This part contains (c) This part contains information collection requirements information collection requirements-in addition to those approved under in addition to those approved under the control number specified in the control number specified in paragraph (a) of this section, paragraph (a) of this section. The These information collection information collection requirement requirements and the control numbers and the control number under which under which they are approved are as it is approved are as follows.
follows:
(1) In Section 34.3, Form (1) In 5 34.11, NRC Form 313 NRC-313R is approved under control is approved under control number number 3150-0023.
3150-0120.
7 Subpart A -- Specific Subpart B -- Specific Licensing Licensing Requirements Requirements See i 34.3.
Section 34.11 Application for a specific license.
A person may file an application for specific license for use of sealed sources in radiography, in duplicate, on NRC 11
o Form 313, " Application for Material License," in accordance with the provisions of s 30.32 of this chapter.
Section 34.11 Issuance of specific Section 34.13 Specific license for licenses for use of sealed sources radiography.
in radiography.
An application for a specific The Commission will approve an license for use of sealed sources in application for a specific license radiography will be approved if:
for the use of licensed material in radiography if the applicant meets the following requirements:
(a) The applicant satisfies the (a) The applicant shall satisfy general requirements specified in the general requirements specified Section 30.33 of this chapter; in s 30.33 of this chapter for byproduct material, as appropriate, and any special requirements contained in this part.
(b) The applicant will have an (b) The applicant shall develop adequate program for training an adequate program for training radiographers and radiographers' radiographers and radiographers' assistants and submits to the assistants that meets the Commission a schedule or description requirements of 5 34.43, and submit of such program which specifies the:
to the Commission'a description of this program which specifies the --
(1) Initial training; (1) Initial training; (2) Periodic training; (3) On-the-job training; (2) On-the-job training; (3)' Annual safety reviews; and (4) Means to be used by the (4) Means the. applicant will licensen to determine the use to demonstrate the rar': arapher's knowledge and radiographer's and radiographer's understanding of and ability to assistant's knowledge and comply with Commission understanding of and ability to i
regulations and licensing comply with the Commission's requirements, and the operating and regulations and licensing emergency procedures of the requirements and the applicant's applicant; and (See s 34.ll(b)(6).)
operating and emergency procedures.
(c) The applicant shall establish and submit to the Commission a description of its procedures for verifying and documenting the certification status of its radiographers and for ensuring that the certification of individuals acting as_radiographers remains valid.
See s 34.ll(c).
(d) The applicant shall submit to the Commission written operating 12
and emergency procedures as described in 5 34.45.
See 6 34.ll(d).
(e) The applicant shall establish and submit to the Commission its program for annual inspections of the job performance of each radiographer and radiographer's assistant as described in 6 34.43(d).
- See 5 34.11(e).
(f) The applicant shall submit a description of its overall organizational structure as it applies to the. radiation safety responsibilities in radiography, including specified delegations of authority and responsibility.
(5) In lieu of describing its initial training program for radiographers in the subjects outlined in Appendix A of this part, and the description of and the means to determine the radiographer's knowledge and understanding of these subjects, the applicant affirms that all individuals acting as radiographers will be certified in radiation safety through the Certification Program for Industrial Radiography Radiation Safety Personnel of the American Society for Nondestructive Testing, Inc.
(ASNT-IRRSP) prior to commencing duties as radiographers.
From April 18, 1991, to the date of the renewal of an existing license, an approved license application is deemed to include the option, for individuals who are certified in radiation safety through the ASNT-IRRSP, to substitute ASNT-IRRSP certification i
in lieu of the described means to determine a. radiographer's knowledge i
and understanding of the subjects in 34.31(a)(1).
(This paragraph does not affect the licensee's 1
responsibility to assure that radiographers are properly trained in accordance with 9 34.31(a)).
(6)Means to be used by the See $ 34.13(b)(4).
licensee to determine the l
13
i radiographer's assistant's knowledge.
i and understanding of and ability to comply with the operating and emergency procedures of the applicant; (c) The applicant has See s 34.13(d).
established and submits to the Commission satisfactory written operating and emergency procedures as described in Section 34.32; (d) The applicant has See 5 34.13(e).
established and submits to the Commission a description of its inspection program adequate to 1
ensure that its radiographers and radiographers assistants follow the Commission's regulatory requirements and the applicant's operating and emergency procedures. The
' inspection program must:
(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed three months; (2) Provide that, if a radiographer or a radiographer's assistant has not participated in a radiographic operation for more than three months since the last inspection, that individual's performance must be observed and recorded the next time the individual participates in a
'l radiographic operation; and (3) Include the retention of inspection records on the performance of radiographers or radiographers' assistants for three u
years.
(e) The applicant submits a See s 34.13(f).
description of its over_-all organizational structure pertaining
-i to the radiography program, including specified delegations of authority and responsibility for operation of the program; and 14
~.
(g) The applicant s' hall designate and identify a Radiation Safety Officer responsible for' implementing the licensee's radiation safety program.
The Radiation Safety Officer shall meet the qualifications-and duties described in s 34.42.
(f) The applicant who desires (h) If an applicant' intends to.
~
to conduct his own leak tests has perform leak testing of sealed established adequate procedures to sources, the applicant shall be followed in leak testing sealed identify the manufacturers and the sources, for possible leakage and model numbers of the leak test kits contamination and submits to the to be used.
If the applicant Commission a description of such intends to analyze its own wipe procedures including:
samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the Commission. The description must include the --
(1) Instrumentation to be used, (1) Instruments to be.used; (2) Method of performing test, (2) Methods of performing the e.g., points on equipment to be analysis; and smeared and method of taking smear, and (3) Pertinent experience of the (3). Pertinent experience of the-person who will perform the test.
person who will. analyze the wipe-samples.
(1) The applicant-shall identify the location (s) of, and describe, all field stations and permanent radiographic installations.
(j) From (insert effective date of final rule) to (2 years after the final rule is published -in the Federal Register):
(1).
A license applicant may-affirm that all-individuals acting as radiographers will be certified in radiation safety by a. certifying entity before commencing duties as-radiographers.
This affirmation is-instead of describing its initial training program for radiographers in the subjects. outlined in-s 34.43(f), and the means used to determine the radiographer's knowledge and understanding of these subjects,'and; 15 j
u
(2)
A licensee may substitute radiographer l
certification in place of the description of the means to determine the radiographer's knowledge and understanding of the subjects outlined in 9 34.43(f).
(3)
After (2 years after the final rule is published in the Federal Register), a license-applicant 1and licensee shall comply i
with the requirement of 934.43(a)(2).
Subpart B --
Radiation Safety Requirements EQUIPMENT CONTROL Subpart C - - Equipment Section 34.20 Performance Section 34.20 Performance requirements for radiography requirements for radiography equipment.
equipment.
1 Equipment used in industrial Equipment used in industrial radiographic operations must meet radiographic operations must meet.
the following minimum criteria:
the following minimum criteria:
j (a) Each radiographic exposure (a) Each radiographic exposure 1
device and all associated equipment device and all associated equipment must meet the requirements specified must meet the requirements specified in American National Standard in American National Standard N432-1980 Radiological Safety for N432-1980 " Radiological Safety for
-)
the Design and Construction of the Design and Construction of j
Apparatus for Gamma Radiography,
Apparatus for Gamma Radiography,"
1 (published as NBS Handbook 136, (published as NBS Handbook 136, issued January 1981). This issued-January 1981).
This publication has been approved for publication has been approved for l
incorporation by reference by the incorporation by reference by the Director of the Federal Register in Director of the Federal Register in accordance with 5 U.S.C. 552(a).
accordance with 5 U.S.C. 552(a).
i This publication may be purchased This publication may be purchased from the Superintendent of from the Superintendent of Documents,-U.S. Government Printing Documents, U.S. Government Printing Office, Washington, DC 20402 and Office, Washington, DC 20402 and from the American National Standards from the American National Standards Institute, Inc., 1430 Broadway, Institute, Inc., 1430 Broadway, New New York, New York 10018, Telephone York, New York 10018, Telephone (212) 642-4900.
Copies of the (212) 642-4900.
Copies of the document are available for document are available for inspection at the Nuclear Regulatory inspection at the Nuclear Regulatory Commission Public Document Room, Commission Library, 7920 Norfolk 2120 L Street NW., Lower Level, Avenue, Lower Level, Bethesda, Washington, DC 20555.
A copy of the Maryland, 20814. A copy of the document is also on file at the 16 4
t l
Office of the Federal Register,1100 document is also on file at the L Street NW., Room 8301, Washington, Office of the Federal Register, 800 DC 20408.
North Capitol Street NW.,
Washington, DC 20408.
(b) In addition to the (b) In addition to the requirements specified in paragraph requirements specified in paragraph.
(a) of this section, the following (a) of this section, the following requirements apply to radiographic requirements apply to radiographic exposure devices and associated exposure devices and associated equipment.
equipment.
(1) Each radiographic exposure (1) Each radiographic. exposure device must have attached to it by device must have attached to it by the user, a durable, legible, the user, a durable, legible, clearly visible label bearing the --
clearly visible label bearing the --
(i) Chemical symbol and mass (i) Chemical symbol and mass aumber of the radionuclide in the number of the radionuclide in the device; device; (ii) Activity and the date on (ii) Activity and the date which this activity was last on which this activity was last measured; measured; (iii) Model number and serial (iii) Model number and number of the sealed source; serial number of the sealed source; (iv) Manufacturer of the sealed (iv) Manufacturer of the source; and sealed source; and (v) Licensee's name, address, (v) Licensee's name, and telephone number.
address, and telephone number.
(2) Radiographic exposure (2) Radiographic exposure devices intended for use'as Type B devices intended'for use as Type B transport containers must meet the transport containers must meet the applicable requirements of 10 CFR applicable requirements of 10 CFR H
part 71.
Part 71.
(3) Modification of any (3) Modification of exposure devices and associated radiographic exposure devices and equipment is prohibited, unless the associated equipment is prohibited.
design of any replacement component, including source holder, source I
assembly, controls or guide tubes would not compromise the design safety features of the system.
(c) In addition to the (c) In. addition to the requirements specified in paragraphs requirements specified in paragraphs (a) and (b) of this section, the (a) and (b) of this section, the following requirements apply to following requirements apply to radiographic exposure devices and radiographic exposure devices, associated equipment that allow the source assemblies, and associated source to be moved out of the device equipment that allow the source to for routine operation.
be moved out of the device for routine operation.
(1) The coupling between the (1) The coupling between the source assembly and the control source assembly and the control 17
o O
cable must-be designed in such a cable'must be designed in such a manner that the source assembly will manner that the source assembly will not become disconnected if cranked not become disconnected if cranked outside the guide tube.
The outside the guide tube. The coupling must be such that it cannot coupling must be such that it cannot be unintentionally disconnected be unintentionally disconnected under normal and reasonably under normal and reasonably foreseeable abnormal conditions.
foreseeable abnormal conditions.
(2) The device must (2) The device must automatically secure the source automatically secure the source assembly when it is cranked back assembly when it is cranked back into the fully shielded position into the fully shielded position within the device.
This securing within the device. This securing system may only be released by means system may only be released by means of a deliberate operation on the of a deliberate operation on the exposure device.
exposure device.
(3) The outlet fittings, lock (3) The outlet fittings, lock box, and drive cable fittings on box, and drive cable fittings on each radiographic exposure device each radiographic exposure device must be equipped with safety plugs must be equipped with safety plugs or covers which must be installed or covers which must be installed during storage and transportation to during storage and transportation to protect the source assembly from protect the source assembly from water, mud, sand or other foreign water, mud, sand or other foreign matter.
matter.
(4) Each sealed source or (4) Each' sealed source or source assembly must have attached source assembly must have attached to it or engraved in it, a durable, to it or engraved on it, a durable, legible, visible label with the legible, visible label with the words:
words:
DANGER -- RADI0 ACTIVE. The label
" DANGER -- RADI0 ACTIVE."
must not interfere with the safe The label must not interfere operation of the exposure device or with the safe operation of the associated equipment.
exposure device or associated equipment.
(5) The guide tube must have (5) The guide tube must have passed the crushing tests for the passed the crushing tests for the control tube as specified in ANSI control tube as specified in ANSI N432 and a kinking resistance test N432 and a kinking resistance test that closely approximates the that closely approximates the kinking forces likely to be kinking forces likely to be encountered during use.
encountered during use.
(6) Guide tubes must be used (6) Guide tubes must be used when moving the source out of the when moving the source out of the device.
device.
i (7) An exposure head or similar (7) An exposure head or similar e
device designed to prevent the device designed to prevent the source assembly from passing out of source assembly from passing out of the end of the guide tube must be the end of the guide tube must be attached to the outermost end of the attached to the outermost end of the guide tube during radiographic 18
operations.
guide _ tube during radiographic operations.
(8) The guide tube exposure (8) The guide tube exposure head connection must be able to head connection must be able to withstand the tensile test for withstand the tensile test for.
control units specified in ANSI control units specified in ANSI N432.
N432.
(9) Source changers must (9) Source changers must provide a system for assuring that provide a system for ensuring that the source will not be accidentally the source will not be accidentally withdrawn from the changer when withdrawn from the changer when connecting or disconnecting the connecting or disconnecting the drive cable to or from a source drive cable to or from a source assembly.
assembly.
(d) All newly manufactured (d) All newly manufactured radiographic exposure devices and radiographic exposure devices and associated equipment acquired by associated equipment acquired by licensees after January 10, 1992 licensees after January 10, 1992, must comply with the requirements of must comply with the requirements of this section.
this section.
(e) All radiographic exposure (e) All radiographic exposure devices and associated equipment in devices, source assemblies, and use after January 10, 1996 must associated equipment in use after comply with the requirements of this January 10, 1996, must comply with
- section, the requirements of this section.
(f) All associated equipment acquired after January 10, 1996, must be labelled identifying that the components have met the requirements of this section.
Section 34.21 Limits on levels of Section 34.21 Limits on levels of radiation for radiographic exposure radiation for radiographic-exposure e
devices and storage containers.
devices, storage containers, and source changers.
(a) Radiographic exposure (a) Radiographic exposure devices measuring-less than four (4) devices measuring less than 10 inches from the sealed source centimeters (4 inches) from the storage position to any exterior sealed source storage position to surface of the device shall have no any exterior. surface of the device radiation level in excess of 50 must not have a' radiation level in milliroentgens per hour at six (6) excess of 0.5 millisieverts (50 inches from any exterior surface of millirems) per hour at 15 the device. Radiographic exposure centimeters (6 inches) from any devices measuring a minimum of four exterior surface of the device.
(4) inches from the sealed source Radiographic exposure devices storage position to any exterior measuring a minimum of 10 i
surface of the device, and all centimeters (4 inches) from the storage containers for sealed sealed source storage position to sources or for radiographic any exterior surface of the device, 19
exposure devices, shall have no and all storage containers for radiation level in excess of 200 sealed sources or for radiographic milliroentgens per hour at any exposure devices, must not have a exterior surface, and ten (10) radiation level in excess of 2 milliroentgens per hour at one meter millisieverts (200 millirems) per from any exterior surface.
The hour at any exterior surface, and radiation levels specified are with 0.1 millisieverts (10 millirems) per the sealed source in the shielded hour at I meter from any exterior (i.e., off) position.
surface. The radiation levels specified are with the sealed source in the shielded (i.e., "off")
position.
(b) Paragraph (a) of this (b)
Paragraph (a) of this section applies to all equipment section applies to all equipment manufactured prior to January 10, manufactured before January 10, 1992. After January 10, 1996, 1992. After January 10, 1996, radiographic equipment other than radiographic equipment other than storage containers and source storage containers and source changers must meet the requirements changers must meet the requirements of Section 34.20, and Section 34.21 of 5 34.20.
Section 34.21 applies applies only to storage containers only to storage containers.
(source changers).
Section 34.22 Locking of Section 34.23 Locking and relocation radiographic exposure devices, of radiographic exposure devices, storage containers, and source storage containers, and source changers.
changers.
(a) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering.
(a) Each radiographic exposure (1) Each radiographic exposure device shall have a lock or outer device must have a lock or outer-
{
locked container designed to prevent locked container designed to prevent unauthorized or accidental removal unauthorized or accidental removal of the sealed source from its of the sealed source from its shielded position. The exposure shielded position. The exposure device or its container shall be device and/or its container must be kept locked when not under the kept locked (and if a keyed-lock, direct surveillance of a with the key removed at all times) radiographer or a radiographer's when not under the direct assistant or as otherwise may be surveillance of a radiographer or a authorized in Section 34.41.
In radiographer's assistant or as 1
addition, during radiographic otherwise may be authorized in 5 operations the sealed source 34.51.
In addition, during assembly shall be secured in the radiographic operations the sealed shielded position each time the source assembly must be manually i
source is returned to that position.
secured in the shielded position each time the source is returned to-20 1
L that position, in those exposure devices manufactured before January 10, 1992.
i (b) Each sealed source storage (2) Each sealed source storage container and source changer shall container and source changer must have a lock or outer locked have a lock or outer locked container. designed to prevent container designed to prevent unauthorized or accidental removal unauthorized or accidental removal-1 of the sealed source from its of the sealed source from its shielded position.
Storage shielded position.
Storage containers and source changers shall containers and source changers must
-be kept locked when containing be kept locked (and if a keyed-lock, sealed sources except when under the with the key removed at all times) direct surveillance of a when containing sealed sources radiographer or a radiographer's except-when under the direct assistant.
surveillance of a radiographer or a radiographer's assistant.
(b) Radiographic exposure devices, source changsrs, and storage containers, before being moved from one location to another, must have the guide tubes and control cables disconnected, safety plugs or covers applied, locked and physically secured to prevent accidental loss, tampering or removal of licensed material, and must be surveyed to assure that the sealed source is in the shielded position.
~
Section 34.23 Storage precautions.
See $ 34.35.
Locked radiographic exposure devices and storage containers shall i
be physically secured to prevent tampering or removal by unauthorized personnel.
Section 34.24 Radiation survey Section 34.25 Radiation survey instruments.
instruments.
The licensee shall maintain (a) The-licensee shall keep sufficient calibrated and operable sufficient calibrated and operable radiation survey instruments to make radiation survey instruments at each physical radiation surveys as location where radioactive material required by this part and Part 20 of is present to make the radiation this chapter.
Each radiation survey surveys required by this part and by 21
-+
5 4
instrument shall be calibrated at Part 20 of this chapter.
intervals not to exceed three months Instrumentation required by this and after each instrument servicing section must be capable of measuring and a record shall be maintained of a range from 0.02 millisieverts (2 the results of each instrument millirems) per hour through 0.01 calibration and date thereof for Sievert (I rem) per hour.
Survey.
~
three years after the date of instruments must be checked for calibration.
Instrumentation operability before use each day.
required by this section shall have This may be accomplished by a range such that two milliroentgens evaluating the instrument response per hour through one roentgen per to the previously measured fields at i
hour can be measured, the projection sheath port or the control cable sheath port on a radiographic exposure device.
(b) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated --
(1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes; (2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade;
+
j and for digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 millirems) per hour; and (3) So that an accuracy within l
plus or minus 20 percent of the calibration standard can be demonstrated at each point checked.
t l
(c) The licensee shall maintain l
records of the results of the instrument calibrations in accordance with 5 34.65.
i Section 34.25 Leak testing, repair, Section 34.27 Leak testing and tagging, opening, modification replacement of sealed sources.
l and replacement of sealed sources.
(a) The replacement of any (a) The replacement of any-l sealed source fastened to or sealed source fastened to or l
contained in a radiographic exposure contained in a radiographic exposure device and leak testing, repair, device and leak testing of any tagging, opening or any other 22 l
L t
i D
E modification of any sealed source sealed source must be performed only shall be performed only by persons by persons specifically authorized specifically authorized by the by the Commission or an Agreement Commission to do so.
State to do so.
(b) Each sealed source shall be (b) Testing and recordkeeping tested for leakage at intervals not requirements.
to exceed 6 months.
In the absence (1) Each licensee who uses a of a certificate from a transferor sealed source shall have the source that a test has been made within the tested for leakage at intervals not 6 months prior to the transfer, the to exceed 6 months.
sealed source shall not be put into (2) The licensee shall use until tested.
maintain records of the leak tests in accordance with 5 34.67.
(3) In the absence of a certificate from the transferor that a leak test has been made within the 6 months before the transfer, the sealed source may not be used until tested.
(c) The leak test must be (c) Method of testing.
The-capable of detecting the presence of wipe of a sealed source must be-0.005 microcurie of removable performed using a leak test kit or contamination on the sealed source.
method approved by the Commission or An acceptable leak test for sealed an Agreement State. The wipe sample sources in the possession of a must be taken from the nearest radiography licensee would be to accessible point to the sealed test at the nearest accessible point source where contamination might to the sealed-source storage accumul ate.
The wipe sample must be position, or other appropriate analyzed for radioactive measuring point, by a procedure to contamination.
The analysis must be be approved pursuant to Section capable of detecting the presence of
- 34. ll ( f).
Each record of leak test 185 Bq (0.005 microcurie) of results must be kept in units of radioactive material on the test microcuries [or disintegrations per sample and must be performed by a minute (dpm)] and retained for person specifically authorized by inspection by the Commission for the Commission or an Agreement State three years after it is made.
to perform the analysis.
(d) Any test conducted pursuant (d) Any test conducted pursuant to paragraphs (b) and (c) of this to paragraphs -(b) and (c) of this section which reveals the presence section which reveals the presence of 0.005 microcurie or more of of 185 Bq (0.005 microcurie) or more removable radioactive materiil shall of removable radioactive material be considered evidence that the must be considered evidence that the sealed source is leaking. The sealed source is leaking. The licensee shall immediately withdraw licensee shall immediately withdraw the equipment involved from use and the equipment involved from use and shall cause it to be decontaminated shall have it decontaminated and and repaired or to be disposed of, repaired or disposed of, in in accordance with Commission accordance with Commission regulations. A report shall be regulations. A report must be filed filed, within 5 days of the test, with the Director of Nuclear with the Director of Nuclear 23
Material Safety and Safeguards, U.S.
Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Nuclear Regulatory Commission, Washington, D.C. 20555 describing Washington, D.C. 20555, within 5 the equipment involved, the days of any test with results that test results, and the corrective exceed the threshold in this action taken. A copy of such report subsection, describing the equipment shall be sent to the Administrator involved, the test results, and the of the appropriate Nuclear corrective action taken. A copy of Regulatory Commission's Regional the report must be sent to the Office listed in Appendix D of Part Administrator of the appropriate 20 of this chapter Standards for Nuclear Regulatory Commission's Protection Against Radiation.
Regional Office listed in Appendix D i
of Part 20 of this chapter
" Standards for Protection Against Radiation."
(e) A sealed source which is (e) A sealed source which is not fastened to or contained in a not fastened to or contained in a radiographic exposure device shall radiographic exposure device must have permanently attached to it a have permanently attached to it a durable tag at least one (1) inch durable tag at least one (1) inch square bearing the prescribed square bearing the prescribed radiation caution symbol in radiation caution symbol in conventional colors, magenta or conventional colors, magenta, purple purple on a yellow background, and or black on a yellow background, and at least the instructions: Danger at least the instructions: " Caution
-- Radioactive Materia? -- Do Not (or Danger) -- Radioactive Material Handle -- Notify Civil Authorities
-- Do Not Handle -- Notify Civil if Found.
Authorities (or Name of Company)."
(f)
Each exposure det ice using depleted uranium (DU) shielding and an "S" tube configuration must be periodically tested for DU contamination.
This test can be performed by the licensee using available test kits or method approved by the Commission or an Agreement State, or the exposure device could be returned to the manufacturer for such testing.
The analysis must be capable of detecting the presence of 185 Bq (0.005 microcuries) of. radioactive material on the test sample and must be performed by a person specifically authorized by the.
i Commission or an Agreement State to perform the analysis.
This test must be undertaken at intervals not i
to exceed 12 months and should such testing reveal the presence of DU contamination, the exposure device must be removed from use and 24
i L
arrang'ments for repair or proper e
' disposal in a facility licensed under 10 CFR Part 61 must be made.
A record of the DU leak-test must be made in accordance with's 34.67.
Section 34.26 Quarterly inventory.
Section 34.29 Quarterly inventory.
Each licensee shall conduct a (a) Each licensee shall conjuct quarterly physical inventory to a quarterly physical inventory to-account for all sealed sources.
account for all sealed sources received and possessed under this received and possessed under this license.
The records of the license.
inventories shall be maintained for (b) The licensee shall maintain three years from the date of the records of the quarterly inventory inventory for inspection by the in accordance with 5 34.69.
Commission, and shall include the quantities and kinds of byproduct material, location of sealed sources, and the date of the inventory.
Section 34.27 Utilization logs.
See 9 34.71.
Each licensee shall maintain current logs, which shall be kept available for three years from the date of the recorded event, for inspection by the Commission, at the address specified in the license, snowing for each sealed source the following information:
(a) A description (or make and model number) of the radiographic exposure device or storage container in which the sealed source is located; (b) The identity of the radiographer to whom assigned; and (c) The plant or site where used and dates of use.
i 1
h Section 34.31 Inspection and Section 34.28 Inspectien and maintenance of radiographic exposure maintenance of radiojraphic exposure' devices, storage containers, 25 i
1 a
devices, storage containers, and associated equipment, and source i
source changers.
changers.
(a) The licensee shall visually (a) The licensee shall check check for obvious defects in for obvious defects in radiographic radiographic exposure devices, exposure devices, storage storage containers, associated containers, and source changers equipment, and source changers prior to use each day the equipment before use each day the equipment is is used.
used to ensure that the equipment is in good working condition and that required labeling is present.
If defects are found, the equipment must be removed from service until repaired, and a record must be made in accordance with 5 34.73.
(b) Each licensee shall have a (b) The licensee shall conduct program for inspection and routine a program for inspection and maintenance of radiographic exposure maintenance of radiographic exposure devices, source changers, associated devices, storage containers, and equipment and storage containers at source changers at intervals not to intervals not to exceed 3 months or exceed three months or prior to the before the first use thereafter to 1
first use thereafter to ensure ensure the proper funttioning of proper functioning of components components important to safety.
important to safety.
The licensee Records of these inspections and shall retain records of these maintenance performed must be made inspections and maintenance for in accordance with 5 34.73.
If three years.
defects are found, the equipment must be removed from service until repaired, and a record must be made in accordance with 5 34.73.
(c) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Commission or an Agreement State.
Section 34.33 Permanent radiographic Section 34.29 Permanent radiographic installations.
installations.
(a) Each entrance that is used
^
(a) Permanent radiographic for personnel access to the high installations having high radiation radiation area in a permanent area entrance controls of the types radiographic installation must have i
described in Section either --
20.203(c)(2)(ii), (2)(iii), or (4)
(1) Entrance controls of the of this chapter shall also meet the type described in s 20.1601(a)(1) following special requirement, of this chapter; or 26 m
l l
(b) Each entrance that is used (2) Both visible and audible for personnel access to the high warning signals to warn of the radiation area in a permanent presence of radiation.
The visible radiographic installation to which signal must be actuated by radiation this section applies shall have both whenever the source is exposed.
The visible and audible warning signals audible signal must be actuated when to warn of the presence of an attempt is made to enter the radiation. The visible signal shall installation while the source is be actuated by radiation whenever exposed.
the source is exposed.
The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed.
(c) The alarm system must be (b) The alarm system must be tested at intervals not to exceed tested for proper operation at the three months or prior to the first beginning of each day the use thereafter of the source in the installatior. is used for installation.
The licensee shall radiographic operations.
The test retain records of these tests for must include a check of the visible three years.
and audible signals by turning on the exposure device before using the room.
Entrance control devices must be tested monthly.
If a control device or alarm is operating.
improperly, it must be immediately labeled as defective and repaired before industrial radiographic operations are resumed.
Test records must be maintained in accordance with 5 34.75.
REPORTING Section 34.30 Reporting See s 34.101.
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; 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, 27
y a
o within 30 days of the occurrence of
-1 any of the following incidents
)
involving radiographic equipment-(1) Unintentional disconnection of the source assembly from the control cable.
(2) Inability to retract the i
source assembly to its fully l
shielded position and secure it in this position.
(3) Failure of any component (critical to safe operation of the i
device) to properly perform its intended function.
(b) The licensee shall include the following information in each i
report submitted 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.
(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 i
include the information specified in paragraph (b) of this section.
See s 34.23.
Section 34.35 Labels, storage, and transportation precautions.
(a) Labels.
(1) The licensee may not use a j
source changer or container to store licensed material unless the source changer or the container.has securely attached to it a durable, legible, and clearly visible label.
The label must contain the radiation 28
s symbol specified in s 20,1904 of this chapter and the wording CAUTION (OR DANGER).--
RADI0 ACTIVE MATERIAL--00 NOT HANDLE NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)
(2) The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR Part 71, including documentation of the Quality Assurance (QA) program requirements outlined in s 71.105.
(b) Security precautions during storage and transportation.
(1) Locked _ radiographic exposure devices and storage containers must be physically secured to prevent tampering or-removal by unauthorized personnel in accordance with the requirements in s 34.23.
The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.
(2) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the-licensed material from the vehicle.
Subpart D -- Radiation Safety Requirements Section 34.41 Conducting radiographic operations (a) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one' other qualified radiographer' or an individual who has at a minimum met the requirements of s 34.43(b).
The 29
]
additional qualified individual (s) shall observe the operations and be capable of providing immediate assistance to prevent unauthorized j
entry.
Radiography may not be performed if only one qualified individual is present.
(b) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the Commission.
Section-34.42 Radiation Safety Officer.
The Radiation Safety Officer (RS0) shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily o of the licensee's program. peration (a) The RS0's qualifications must include:
(1) Completion of the training and testing requirements of 5 34.43(a); and (2) 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented experience in industrial radiographic operations, with at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of formal classroom training with respect to the establishment and maintenance of a radiation protection program.
(b) The specific duties of the RS0 include, but are not limited to, the following:
(1) To establish and oversee operating, emergency, and ALARA~
procedures as required.by Part 20, and-to. review them regularly to ensure that the procedures are current and conform with these rules; (2) To oversee and approve all phases of the training program for radiographic personnel so that-30
i appropriate and effective radiation protection practices are taught-(3) To ensure that required radiation' surveys ~and leak tests are performed and documented in accordance with these rules, l
including any corrective measures-when levels of radiation exceed established limits; (4) To ensure that personnel monitoring devices are calibrated and used properly by occupationally-exposed perschnel, that records are kept of the.nonitoring results, and that timely notifications are made as required by 9 20.2203; and (5) To ensure that operations are conducted safely and to assume control and have the authority to institute corrective actions including stopping of operations when necessary in emergency situations or unsafe conditions.
Section 34.31 Training.
Section 34.43 Training.
(a) The licensee shall not (a)
The licensee may not permit any individual to act as a permit any individual to act as a radiographer until such individual:
radiographer until the individual --
(1) Has been instructed in the (1) Has been instructed in the subjects outlined in Appendix A of subjects outlined in paragraph (f) this part; of this part.
(2) Is certified through a radiographer certification program t
by a certifying entity in accordance with the criteria specified in Appendix A of this part.
An independent organization that would like to be recognized as a certifying entity shall submit its request to the Director, Office of-Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory.
Commission, Washington, DC. 20555.
(2) Has received copies of and (3) Has received copies of and instruction in NRC regulations instruction in the requirements contained in this part and in the described in NRC regulations applicable sections of Parts 19 and.
contained in this part; in- $ 5 30.7, 20 of this chapter, NRC license (s) 30.9, and 30.10;.in the applicable under which the radiographer will sections of Parts 19, 20, and 71 of perform. radiography, and the 31
m licensee's operating and emergency this chapter, in applicable DOT procedures; regulations as referenced in 10 CFR Part 71, in the NRC' license (s) under which the radiographer will perform radiography, and the licensee's operating and emergency procedures; (4) Has demonstrated understanding of NRC regulations, the licensee's license, and the licensee's operating and emergency procedures by successful completion of a written examination.
(3) Has demonstrated (5) Has demonstraud competence to use the licensee's competence in the use of the radiographic exposure devices, licensee's radiographic exposure sealed sources, related handling devices, sealed sources, related tools, and survey instruments; and handling tools, and survey instruments; and (4) Has demonstrated (6) Has demonstrated understanding of the instructions in understanding of the instructions in this paragraph (a) by successful paragraph (a)(3) and (5) of this completion of a written test and a section by successful completion of field examination on the subjects a field examination.
covered.
(b) The licensee shall not (b) The licensee may not permit permit any individual to act as a any individual to act as a radiographer's assistant until such radiographer's assistant until the individual:
individual --
(1) Has received copies of and (1) Has received copies of and instruction in the licensee's instruction in the requirements operating and emergency procedures; described in NRC regulations contained in this part; in $5 30.7, 30.9, and 30.10; in the applicable sections of Parts 19, 20, and 71 of this chapter, in applicable DOT regulations as referenced in 10 CFR Part 71, in the NRC license (s) under which the radiographer's assistant will perform radiography, and the licensee's operating and emergency procedures; (2) Has demonstrated (2) Has demonstrated competence competence to use, under the to use, under the personal personal supervision of the supervision of the radiographer, the radiographer, the radiographic radiographic exposure devices, exposure devices, sealed sources, sealed sources, related handling related handling tools, and tools, and radiation survey radiation survey instruments that instruments that the assistant will the assistant will use; and use; and (3) Has demonstrated (3) Has demonstrated understanding of the instructions in understanding of the instructions in this paragraph (b) by successfully 32
completing a written or oral test this paragraph (b) of this section and a field examination on the by successfully completing a written subjects covered.
test and a field examination on the subjects covered.
See s 34.ll(d).
(c) The licensee shall provide annual safety reviews for radiographers and radiographer's assistants at least once during each calendar year.
(d) The licensee shall conduct an annual inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency procedures are followed.
The inspection program must:
(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed 12 months; and (2) Provide that, if a radiographer or a radiographer's assistant has not participated in a radiographic operation for more than 6 months since the last inspection, the individual's performance must be observed and recorded when the individual next participates in a l
radiographic operation.
(c) Records of the above (e) The licensee shall training, including copies of maintain records of the above i
written tests and dates of oral training to include certification tests and field examinations, shall documents, written and field i
be maintained for three years.
examinations, annual safety reviews and annual inspections of job performance in accordance with i
l 5 34.79.
1 See Appendix A (f) The licensee shall include the following subjects in the training required in paragraph (a)(1) of this section:
(1) Fundamentals of radiation safety including --
(i) Characteristics of gamma radiation; (ii) Units of radiation dose I
and quantity of radioactivity; 33
a u
'(iii) Hazards of exposure to radiation; (iv) Levels of radiation from licensed material; and (v) Methods of controlling radiation dose (time, distance, and shielding);
(2) Radiation detection i
instruments including --
(i) Use, operation, calibration, and limitations of radiation survey instruments; (ii) Survey techniques; and (iii) Use of personnel monitoring equipment; (3) Equipment to be used l
including --
(i) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including
.i pictures or models of source assemblies (pigtails).
(ii) Storage, control, and disposal of licensed material; and (iii) Maintenance of equipment.
(4) The requirements of pertinent Federal regulations; and (5) Case histories of accidents in radiography.
(g) The licensee may, until (2 years after the final rule is published in the Federal Register),
allow an individual who has not met the certification requirements of paragraph (a)(2) of this section to act as a radiographer after the individual has received training in the subjects outlined in paragraph (f) of this section and demonstrated understanding of those subjects by successful completion of a _ written examination that was previously submitted to and approved by the Commission.
34 1
]
e T
Section 34.32 Operating and Section 34.45 Operating and emergency procedures.
emergency procedures.
The licensee shall retain a
-copy of current operating and emergency procedures as a record until the Commission terminates the license that authorizes the activity i
for which the procedures were developed and, if superseded, retain the superseded material for three years after each change. These (a) Operating and emergency procedures must include instructions procedures must include, as a in at least the following:
minimum, instructions in at least-the following:
(a) The handling and use of (1) The handling and use of licensed sealed sources and licensed sealed sources and radiographic exposure devices to be radiographic exposure devices to be employed such that no person is employed such that no person is likely to be exposed to radiation likely to be exposed to radiation doses in excess of the limits doses in excess of the limits established in Part 20 of this established in Part 20 of this chapter Standards for Protection chapter " Standards for Protection Against Radiation;
Against Radiation";
(b) Methods and occasions for (2) Methods and occasions for conducting radiation surveys; conducting radiation surveys; (c) Methods for controlling (3) Methods for controlling access to radiographic areas; access to radiographic areas; (d) Methods and occasions for (4) Methods and occasions for locking and securing radiographic locking and securing radiographic i
exposure devices, storage containers exposure devices, storage containers and sealed sources; and sealed sources; 1
(e) Personnel monitoring and (5) Personnel monitoring and the use of personnel monitoring the use of personnel monitoring equipment; equipment; (f) Transporting sealed sources (6) Transporting sealed sources-to field locations, including to field locations, including packing of radiographic exposure packing of radiographic exposure devices and storage containers in devices and storage containers in j
the vehicles, posting of vehicles the vehicles, placarding of and control of the sealed sources vehicles, when needed, and control' during transportation; of the sealed sources during transportation (refer to 49 CFR Parts'171-173),
j
\\
(g) Minimizing exposure of See 5 34.45(a)(11).
persons in the event of an accident; (h) The procedure for notifying See 5 34.45(a)(10).
proper persons in the event of an accident; and
{
35 1
O d
i (i) Maintenance of records.
See s 34.45(a)(13).
(j) The inspection and (7) The inspection and maintenance of radiographic exposure maintenance of radiographic. exposure devices and storage containers.
devices and storage containers; i
(k) Steps that must be taken (8) Steps that must be taken immediately by radiography personnel immediately by radiography personnel i
in the event a pocket dosimeter is in the event a pocket dosimeter is found to be off-scale.
found to be off-scale or an alarm e
ratemeter alarms; (1) The procedure (s) for (9) The procedure (s) for identifying and reporting defects identifying and reporting defects and noncompliance, as required by and noncompliance, as required by Part 21 of this chapter.
Part 21 of this chapter; See s 34.32(h).
(10) The procedure for notifying proper persons in the event of an accident; See s 34.32(g).
(11) Minimizing exposure of persons in the event of an accident; (12) Source recovery procedure if licensee will perform source recovery; and 1.
See 5 34.32(i).
(13) Maintenance of records.
(b) The licensee shall maintain copies of current operating and emergency procedures in accordance with 5 34.81.
See 5 34.44.
Section 34.46 Supervision of radiographers' assistants.
Whenever a radiographer's
[
assistant uses radiographic exposure devices, uses sealed sources or related source handling tools, or conducts radiation surveys required by s 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision must include:
(a) The radiographer's personal presence at the site where the sealed sources are being used; (b) The ability of the radiographer to give immediate assistance if required; and (c) The radiographer's watching the assistant's performance of the i
36
'u e
i operations referred to in this section.
Section 34.33 Personnel monitoring.
Section 34.47 Personnel monitoring.
(a) The licensee may not permit (a) The licensee may not permit any individual to act as a any individual to act as a radiographer or a radiographer's radiographer or a radiographer's assistant unless, at all times assistant unless, at all times during radiographic operations, each during radiographic operations, each such individual wears a direct individual wcars a direct reading reading pocket dosimeter, an alarm pocket dosimeter, an operating alarm ratemeter, and either a film badge ratemeter,-and either a film badge or a thermoluminescent dosimeter or a thermoluminescent dosimeter (TLD) except that for permanent (TLD). At permanent radiography radiography facilities where other installations where other appropriate alarming or warning appropriate alarming or warning devices are in routine use, the devices are in routine use, the wearing of an alarming ratemeter is wearing of an alarming ratemeter is not required.
Pocket dosimeters not required.
must have a range from zero to at (1)
Pocket dosimeters must least 200 milliroentgens and must be have a range from zero to 2 recharged at the start of each millisieverts (200 millirems) and shift.
Each film badge and TLD must must be recharged at the start of be assigned to and worn by only one each shift.
individual.
(2)
Each film badge and TLD must be assigned to and worn by only one individual.
(3)
Film badges and TLDs must i
be replaced at least monthly.
(4) After replacement, each film badge or TLD must be promptly processed.
(b) Pocket dosimeters must be (b) Pocket dosimeters must be read and exposures recorded daily.
read and the exposures recorded at The licensee shall retain each the beginning and end of each shift, record of these exposures for three and records must be maintained in years after the record is made.
accordance with 5 34.83.
(c) Pocket dosimeters shall be (c) Pocket dosimeters must be
+
checked at ;eriods not to exceed one checked at periods not to exceed 12 year for correct response to months for correct response to radiation. Acceptable dosimeters radiation, and records must be shall read within plus or minus 30 maintained in accordance with 5 percent of the true radiation 34.83. Acceptable dosimeters must exposure.
read within plus or minus 30 percent (d) If an individual's pocket of the true radiation exposure.
(d) If an individual's pocket dosimeter is discharged beyond its dosimeter is found to be off-scale range, his film badge or TLD shall be immediately sent for processing.
and the possibility of radiation 5
exposure cannot be ruled out as the cause, the individual's film badge 37 i
o or TLD:must be sent immediately for
. processing.
In addition, the individual may not wark with
~
licensed inaterial until a determination of'the individual's radiation exposure has been made.
This oetermination'must be made by the RSO or the RS0's designee.
The results of this determination must be included in the records maintained in accordance with s 34.83.
(e) If-a film ~ badge or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge or TLD is provided and the exposure is calculated for the time period from i
issuance to loss or damage.of the film badge or TLD.
The results of the calculated exposure and the time period for which the film badge or TLD was lost or damaged must be included in the records maintained in accordance with s 34.83.
(e) Reports received from the film (f) Reports received from the badge or TLD processor must be film badge or TLD processor must be retained for inspection until the retained in accordance with 9 Commission terminates each license 34.83.
that authorizes the activity that is subject to the recordkeeping requirement.
(f) Each alarm ratemeter must --
(g) Each alarm ratemeter must (1) Be checked to ensure that
.(1) Be checked to ensure that the alarm functions properly the alarm functions properly (sounds) prior to use at the start (sounds) before using at the start of each shift; of each shift; (2) Be set to give an alarm (2) Be set to give an alarm signal at a preset dose rate of 500 signal at a preset dose rate of 5 Mr/hr.;
mSv/hr (500 mrem /hr); with an accuracy of plus or minus 20 percent of the true radiation dose rate.
(3) Be adequate to alert the individual regardless of the environmental conditions (e.g., high ambient noise levels).
(4) Require special means to (3) Require special means to change the preset alarm function; change the preset alarm function; and and 38 l
e (4)'Be calibrated at periods (5).Be calibrated at periods not to exceed one year for correct not to exceed 12 months for correct response to radiation: Acceptable response to radiation.
The licensee ratemeters must alarm within plus or shall maintain records of alarm minus 20 percent of the true ratemeter calibrations in accordance radiation dose rate.
with s 34.83.
1 PRECAUTIONARY PROCEDURES IN RADIOGRAPHIC OPERATIONS Section 34.41 Security.
See s 34.51.
During each radiographic operation the radiographer or radiographer's assistant shall i
maintain a direct surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in Part 20 of this chapter, except (a) where the high radiation area is equipped with a control device or an alarm system as described in Section 20.203(c)(2) of this chapter, or (b) where the high radiation area is locked to protect against unauthorized or accidental entry.
Section 34.42 Posting.
.See 9 34.53.
Notwithstanding any provisions in Section 20.204(c) of this chapter, areas in which radiography is being performed shall be conspicuously posted as required by Section 20.203(b) and (c){l) of this chapter.
Section 34.43 Radia+1on surveys.
Section 34.49 Radiation surveys.
The licensee shall ensure that:
The licensee shall.
(a) At least one calibrated and (a) Conduct surveys with a I
operable radiation survey instrument calibrated and operable radiation is available at the location of its survey instrument that meets the radiographic operations whenever requirements of 5 34.25.
radiographic operations are being performed, and at the storage area, as defined in Section 34.2, whenever a radiographic exposure device, a 39 a
1
storage container, or source is being placed in storage.
(b) A survey with a calibrated (b) Conduct an adequate survey and operable radiation survey of the radiographic exposure device instrument is made after each with a radiation survey instrument exposure to determine that the after each exposure to determine sealed source has been returned to that the sealed source has been its shielded position.
The entire returned to its shielded position.
circumference of the radiographic (c) Conduct a survey when exposure device must be surveyed, approaching the guide tube before If the radiographic exposure device exchanging films, repositioning the has a source guide tube, the survey collimator, or dismantling must include the guide tube.
equipment.
(c) A survey with a calibrated (d) Conduct an adequate survey and operable radiation survey with a radiation survey instrument instrument is made at any time a any time the source is exchanged and radiographic exposure device is whenever a radiographic exposure placed in a storage area, as defined device is placed in a storage area in Section 34.2, to determine that (as defined in s 34.3) to ensure i
the sealed source is in its' shielded that the sealed source is in its position. The entire circumference shielded position.
of the radiographic exposure device (e) Conduct a survey of the must be surveyed.
storage area to ensure that radiation levels do not exceed the limits specified in 10 CFR 20.1301.
These surveys must be performed initially with radioactive material present in the. storage location and thereafter at the time of the quarterly inventory and whenever storage conditions change (i.e.,
increases in radioactive material present or changes in shielding or arrangement of the radioactive material).
(d) A record of the storage (f) Maintain records in survey required in paragraph (c) of accordance with 5 34.85.
this section is made and is retained for three years when that storage survey is the last one performed in the work day.
See s 34.41.
Section 34.51 Surveillance.
During each radiographic operation the radiographer or radiographer's assistant shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as 40
,r.,
3 defined in Part 20 of this chapter,-
except at permanent radiographic.
installations,'where all entryways are locked and the requirements of 9 34.33 are met.
See $ 34.42.
Section 34.53 Posting.
Areas in which radiography is being performed must be conspicuously posted as required by '
f i 20.1902(a) and (b) of this chapter.
Exceptions listed in i 20.1903 of this chapter do not apply to radiographic operations.
Section 34.44 Supervision of See $ 34.46.
radiographers' assistants.
Whenever a radiographer's assistant uses radiographic exposure devices, uses sealed sources or related source handling tools, or conducts radiation surveys required by Section 34.43(b) to determine that the sealed source has returned to the shielded position after an exposure, he shall be under.the personal supervision of a radiographer. The personal supervision shall include: (a) The-radiographer's personal presence at the site where the sealed sources are being used, (b) the ability of the radiographer to give immediate assistance if required, and (c) the
='
radiographer's watching the assistant's performance of the operations referred to in this section.
t EXEMPTIONS Section 34.51 Applications for See # 34.111.
exemptions.
41
a
^~o; 1
The Commission may,: upon application ~by any licensee or upon
.its own initiative, grant such-exemptions from the requirements of the. regulations in.this part as it-determines are authorized by law and will not result in undue hazard to-life or property.
i Section 34.61 Violations See s 34.121 (a) The Commission may obtain an i
injunction or other court order to prevent a violation of the provisions of-(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to these Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act; 1
(1) For violations of -
(1) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109
.i i
of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy I
Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(1) of this section.
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for j
which a license may be revoked under Section 188 of the Atomic Energy Act of 1954, as amended.
Section 34.63 Criminal penalties.
See 5 34.123 (a) Section 223 of the Atomic Energy Act of 1952, as amended, provides for criminal sanctions for 42 t
P r
s,,
n.
willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of sections 161b, 161i, or 1610 of the Act.
For purposes of section 223, all the regulations in Part 34 are issued under one or more of sections 161b,161i, or 1610, except for the. sections listed in paragraph (b) of this section.
(b) The regulations in Part 34 that are not issued under sections 161b, 1611, or 1610 for the purposes of section 223 are as follows:
5 34.1, s 34.2, s 34.3, s 34.8, 9 34.11, s 34.51, s 34.61, and s 34.63.
APPENDIX A See s 34.43(f).
I.
Fundamental s of Radiation Safety A.
Characteristics of gamma radiation.
B.
Units of radiation dose (mrem) and quantity of radioactivity (curie).
C.
Hazards of exposure to radiation.
D.
Levels of radiation from licensed material.
E.
Methods of controlling i
radiation dose:
1.
Working time.
2.
Working distances.
3.
Shielding.
II.
Radiation Detection Instrumentation To Be Used A.
Use of radiation survey instruments:
1.
Operation.
2.
Calibration.
3.
Limitations.
4 B.
Survey techniques.
C.
Use of personnel monitoring equipment:
43 f
i e
o-1.
Film badges and thermoluminescent dosimeters (TLD's).
2.
Pocket' dosimeters.
3.
Alarm ratemeters III.
Radiographic Equipment To Be Used A.
Remote handling equipment.
-B.
Radiographic exposure devices.
C.
Storage containers.
IV.
Inspection and Maintenance Performed by the Radiographers V.
Case Histories of Radiography Accidents
- END OF DOCUMENT ***
Subpart E -- Records Section 34.61 Records of specific license for radiography.
Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference,-and amendments to each of these items until superseded by new documents or until the Commission terminates the license.
Section 34.63 Records of receipt and transfer of sealed sources.
(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and retain each record for-3 years after it is made.
(b) These records must include the date, the individual making the record, the radionuclide, number of becquerels'(curies), and make, model, and serial number of each sealed source and device, as appropriate.
1 I
44 i
i
o o
See 5 34.24.
Section 34.65 Records of radiation survey instruments.
Each licensee shall maintain records of the calibrations of its radiation survey instruments and retain each record for 3 years after it is made.
See s 34.25(c).
Section 34.67 Records of leak testing and replacement of sealed sources.
Each licensee shall maintain records of leak test results in units of becquerels (curies) and retain each record for 3 years after it is made.
Section 34.69 Records of quarterly See 5 34.26.
inventory.
(a) Each licensee shall maintain records of the quarterly inventory and retain each record for 3 years after it is made.
(b) The record must include the quantities and kinds of byproduct material (including the model number, the serial number and manufacturer), location of sealed sources, the name of the individual conducting the inventory, and the date of the inventory.
See 6 34.27.
Section 34.71 Utilization logs.
I (a) Each licensee shall maintain current utilization logs at the address specified in the license, showing for each sealed source the following information:
(1) A description, including the make, model number, and serial number of the radiographic exposure device or storage container in which the sealed source is located; (2) The identity and signature of the radiographer to whom assigned; and (3) The plant or site where used and dates of use, including the dates removed and returned to storage.
45
4 0
(b) The. licensee sh:11 retain the logs required by paragraph (a) i of this section for 3 years after the log is made.
1 See s 34.28(b).
Section 34.73 Records of inspection-and maintenance of. radiographic exposure devices, storage containers, associated equipment, and source changers.
(a) Each licensee.shall maintain records of defects found in daily checks and quarterly inspections.and maintenance of radiographic exposure devices, storage containers, associated equipment, and source changers, and' retain each record for 3 years after-it is made.
(b) The record must include-the date of check, name of inspector, equipment involved, any defects found, and repairs made.
See s 34.29(c).
Section 34.75 Records of alarm system checks at permanent radiographic installations.
-Each licensee shall maintain records of alarm system and entrance control device tests and retain each
'l record for 3 years after it is made.
See s 34.31(c).
Section 34.79 Records of training and certification.
Each licensee shall maintain the following records (of training and certification) for 3 years after the record is made:
(a) Records of training of l
each radiographer and each radiographer's assistant.
The record must include radiographer certification documents, certification status verification, copies of written tests, dates of field examinations, and names of individuals conducting the field 4
examinations, and (b) Records of annual safety reviews and annual inspections for '
each radiographer and each l
46 I
1
t q
radiographer's assistant.
The 1
records must list the topics 1
discussed during the annual safety review, the dates the annual safety review was conducted, and names of the instructors and attendees.
For annual inspections, the records must also include a list showing the items checked and any regulatory non-compliances observed by the RSO.
See 5 34.32.
Section 34.81 Copies of operating-and emergency procedures.
Each licensee shall maintain a copy of current operating and emergency procedures until the Commission terminates the license.
Superseded material must be retained for 3 years after the change _is made.
Section 34.83 Records of personnel monitoring.
Each licensee shall maintain the following exposure records:
See 5 34.33(b).
(a) Daily pocket dosimeter readings and yearly operability checks for 3 years after the record is made.
.(b) Records of alarm ratemeter-calibrations for 3 years after the record is made.
See 5 34.33(e).
(c) Reports received from the film badge or TLD processor until' the Commission terminates the license.
(d) Records of estimates of exposures as a result of'off-scale pocket dosimeters'or lost or damaged film badges or TLDs until the Commission terminates the license.
See 5 34.43(d).
Section 34.85 Records of radiation surveys.
Each licensee shall maintain a record of each exposure device survey conducted before placing the device in storage in accordance with 5 34.49(e) for 3 years after _the record is made, if that survey is the last one performed in-the work day.
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See 5 34.4.
Section 34.87 Form of records.
i Each record required by this part must be legible throughout the specified retention period.
The record may be the original or a reproduced copy or.a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period.
The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.
Records, such as. letters, drawings, and specifications, must 1
include all pertinent information, such as stamps, initials,.and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
Section 34.89 Documents and records required at field stations and permanent installations.
Each licensee shall maintain copies of the following documents and records sufficient to demonstrate compliance at.the field station and permanent installation:
(a) A copy of Parts'19, 20, and 34 of NRC regulations; (b) The license authorizing the use of licensed material; (c) Operating and emergency procedures required by 9 34.45; (d) Records of radiation survey instrument calibrations required by 9 34.65; (e) Records of leak test results required by 5 34.67; (f) Quarterly inventory records required by 9 34.69; (g) Utilization records required by s 34.71; (h) Records of ir.spection and maintenance required by_ i 34.73; (1) For permanent installations, records of alarm 48
4 system and entrance control checks required by 5 34.75.
(j) Training and certification records required by 5 34. 79; (k) Survey records required by 5 34.85; (1) Personnel monitoring records as required by 5 34.83; and (m) Records of receipt and transfer of sealed sources required by 5 34.63.
Section 34.91 Documents and records required at temporary jobsites and use or storage locations exceeding 180 days.
t Each licensee conducting operations at a temporary jobsite shall maintain copies of the following documents and records at the temporary jobsite until the radiographic operation is completed and at any. storage location where radioactive material is stored for more than 180 days:
(a) Operating and emergency procedures required by 5. 34.45; (b) Evidence of latest calibration.of the radiation survey instruments in use at the site required by 5 34.65; (c) Evidence of latest calibrations of alarm ratemeters and operability checks of pocket dosimeters as required by 5 34.83; (d) Latest survey records required by 5 34.85; (e) The shipping papers for the transportation of radioactive materials required by 9 71.5 of this chapter; and (f) When operating under reciprocity pursuant to 5 150.20 of this chapter, a copy of the Agreement State license authorizing use of licensed materials.
Subpart F -- Notifications 49
4 i
See 5 '34.30.
Section 34.101 Notifications (a) In addition to the reporting requirements specified in s 30.50 and 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, 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; or (3) Failure of any component (critical to safe operation of the device) to properly perform its intended function; (b) The licensee shall include the following information in each report submitted under paragraph (a) of this section, and in each report of overexposure submitted under 10 CFR 20.2203. which involves failure of safety components of radiography equipment:
(1) A description.of the equipment problem; (2) Cause of each incident, if known; (3) Name of the manufacturer and model number of equipment involved in the incident; (4) Place, date and time of the incident; (5) Actions taken to establish normal operations; (6) Corrective actions taken or planned to prevent recurrence; and (7) Qualifications of perscnnel involved in the incident.
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L' (c) The licensee shall notify
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the appropriate NRC regional office in writing 30 days before conducting radiographic operations or storing radioactive material at any location not listed on the license in excess of 180 days.
Subpart G -- Exemptions Set 5 34.51.
Section 34.111 Applications for exemptions.
The Commission may, upon application of any interested person or upon its own initiative,_ grant' such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Subpart H - Violations See 5 34.61 5 34.121 Violations.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the
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provisions of (1) The Atomic Energy Act of l
1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3)'A regulation or order issued pursuant to these Acts.
(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act; (1) For violations of -
(i) Sections 53, 57,'62, 63, 81, 82, 101, 103, 104, 107, or 109.
of the Atomic Energy Act of 1954, as-amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the 51
sections specified in paragraph (b)(1)(i) of this section.
)
(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 188 of the Atomic Energy Act of 1954, as amended.
See 5 34.63 5 34.123 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1952, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of sections 161b, 161i, or 161o of the Act.
For purposes of section 223, all the regulations in Part 34 are issued under one or more of sections 161b, 161i, or 1610, except for the sections listed in paragraph (b) of this section.
(b) The regulations in Part 34 that are not issued under sections 161b, 1611, or 1610 for the purposes of section 223 are as follows:
s 34.1', s 34.3, s 34.5, s 34.8, s 34.11, s 34.13, 9 34.111, s 34.121, s 34.123.
APPENDIX A to Part 34 1.
Requirements for an Independent Certifying Organization.
An independent certifying organization shall:
1.
Be an organization such as a society or association, whose members participate in, or have an interest in, the fields of industrial radiography or non-destructive testing; 2.
Make its membership available to the general public nationwide that is not restricted because of race, color, religion, sex, age, national origin or handicap; 52
3.
Have a certification program open to nonmembers; 4.
Be an incorporated, nationally recognized organization, that is involved in setting national standards of practice within its fields of expertise; 5.
Have a permanent full-time staff, a viable system for j
financing its operations, and a -
policy-and decision-making review 4
board; 6.
Have a set of written i
organizational by-laws and policies 3
that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies; 7.
Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advi'.,e the organization's staff in implementing the certification program; 8.
Have.a committee, whose members can carry out their responsibilities impartially, to r
review complaints against certified individuals and to determine appropriate sanctions; 9.
Have written procedures describing all aspects of its certification program, maintain records of the current status of-each individual's certification and the administration.of its certification program; 10.
Have procedures to ensure.that certified individuals are provided due process with j
respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against 1
certified individuals; and i
11.
Have procedures to ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned i
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subsidiary of such company or corporation) as any of the examinees; 12.
Exchange information about certified individuals with the Commission and the independent certifying organizations and allow periodic review of its certification program and related records;.
13.
Provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment.
II.
Requirements for Certification Programs.
All certification programs must:
1.
Require that individuals (a) receive training in the topics set forth in s 34.34(f) of this part,-and (b) satisfactorily complete a written examination covering these topics; 2.
Require applicants for certification to provide documentation that demonstrates that the applicant has:
(a) received training in the topics set forth in section 34.43(f) to this part; (b) satisfactorily completed a minimum period of on-the-job training; and (c) has received verification by an Agreement State or a NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer;.
3.
Include procedures to ensure that all examination questions are protected from disclosure; 4.
Include procedures whereby an application or certification would be considered null and' void if the applicant or certified' individual is prohibited from acting as a radiographer by a regulatory agency at the time of making the application; 54
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Provide a certification period of not less than 3 years nor-more than 5 years; 6.
Include procedures for renewing the certifications and, if the procedures allow renewals without examination, require evidence of recent active full-time employment and annual refresher training; 7.
Include procedures whereby an individual's certification may be revoked, suspended, or restricted for willful or significant failure to comply with his or her employer's operating.
or emergency procedures, or'the Commission's or an Agreement State's regulations; 8.
Provide for automatic suspension of an individual's certification, based on Commission or Agreement State action prohibiting the individual from acting as a radiographer; 9.
Provide for sanctions imposed against certified individuals that are at least as severe as any action taken by the Commission or an Agreement State; and
.10.
Provide a timely response to inquiries. by telephone or letter, from members of the public, about an individual's certification status.
III.
Requirements for Written Examinations.
All examinations must be:
1.
Designed to test an individual's knowledge and understanding of the topics listed in section 34.43(f) or equivalent Agreement State requirements; 2.
Written in a multiple-choice format; 3.
Written at a ninth-grade reading comprehension level; 4.
Scientifically-analyzed, before use, to ensure that the questions are not biased or 55
misleading, and that the examination u
of one certifying entity will-produce a result equivalent to that of another certifying entity; 5.
Tested by at least 50:
individuals before being'used in an actual examination leading to certification of-individuals; and 6.
Composed of questions-randomly selected from a population-of questions.that contains ten times as many questions as may be needed' for any one examination, to' ensure that it is unlikely that an examinee would retake the same examination.
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g ENCLOSURE 2 FEDERAL REGISTER NOTICE e
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[7590-01]
1 NUCLEAR REGULATORY' COMMISSION 10 CFR Parts 34 and 150 1
1 RIN 3150-AE07 Licenses for Radiography 1
and Radiation Safety Requirements for Radiographic Operations AGENCY: Nuclear Regulatory Commission.
ACTION:
Proposed rule.
SUMMARY
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing industrial radiography. The proposed rule would include additional safety requirements to enhance the level of protection of radiographers and the public and would clarify the regulations so that licensees may have a better understanding of what is expected in radiographic operations.
The proposed rule includes a number of updated radiography regulations that have been adopted by the Agreement States.
The major changes in the proposed rule include requirements for: (1) two qualified individuals to be present whenever radiography-occurs at a temporary jobsite, I
(2) mandatory. certification of radiographers, (3) permanent radiographic installations, and (4) a radiation safety officer..The format of the radiography regulations would be revised to place requirements into descriptive categories.
i DATES:
Submit comments by (90. days after publication).
Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
ADDRESSES: Mail written comments to:
Secretary, U.S. Nuclear Regulatory Commission, Washington DC 20555, Attention: Docketing and Service Branch.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland between 7:45 am and 4:15 pm on Federal workdays.
Examine comments received, the environmental impact, and the regulatory analysis at: The NRC Public Document Room at 2120 L Street NW. (Lower Level),
Washington, DC.
l FOR FURTHER INFORMATION CONTACT: Dr. Donald O. Nellis or Mary L. Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC 20555; Telephone:
(301) 492-3628 or 492-3886.
SUPPLEMENTARY INFORMATION:
- 1. Background-4 Part 34 of Title 10 of the Code of Federal Regulations was firstL published in 1965 (30 FR 8192) as part of the recodification of Parts 30 and 31 for the purpose of simplifying and clarifying the format of the then-current requirements on. radiography so that persons subject to byproduct material licensing regulations could conveniently use and understand them.
Numerous modifications to the original Part 34 have been made since 1965, many 7
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of which have been directed toward the safety as~pects of field radiography.
These modifications include performance requirements on radiography equipment and requirements for the use of alarming ratemeters published in 1990 (55 FR 843; January 10, 1993).
There are approximately 200 NRC radiography licensees with an additional 500 Agreement State licensees.
Radiography licensees often conduct business under both HRC and Agreement State jurisdiction.
The NRC has not initiated an overall revision of Part 34 in many years.
However, a number of Agreement States have updated their radiography regulations..The decision to develop an overall revision to 10 CFR Part 34 was made with the intent of establishing new safety requirements for radiography licensees and clarifying the regulation so that licensees will have a better understanding of what is expected in radiographic operations.
The format of the radiography regulttions would be revised to place requirements into descriptive categories ' hat better describe the type of requirements found in the subpart.
The NRC solicited recommendations on radiography issues at the 1991 r
Agreement States' meeting in Sacramento, CA, as well as from NRC regional offices, radiography equipment manufacturers, and radiography licensees.
Public comments were solicited on the issue of radiographer certification at the May 19, 1991, annual meeting of the Conference of Radiation Control Program Directors (CRCPD), Inc. in Wichita, Kansas, and a public workshop on radiographer certification was held May 27-28, 1992, in Mobile, Alabama. A separate workshop was held on November 18, 1992, in Dallas, Texas, to discuss recommendations received from the Agreement States and licensees on revision of the i adiography regulations.
The transcripts of these meetings, which are 3
a available for inspection and copying in the NRC Public Document Room, were reviewed in further developing the proposed revision.
The NRC utilized Part E i
of the " Suggested State Regulations for Control of Radiation" developed by the CRCPD, Part 31 of the Texas Regulations for Control of Radiation, Chapter 5 of' i
the Louisiana regulations, and the Canadian " Atomic Energy Control i
Regulations," that apply to radiography in developing this proposed revision of Part 34.
i II. Petition for Rulemaking A petition was received on October 15, 1992, from the International Union of Operating Engineers (IU0E), local No. 2, requesting an amendment to i
the radiography regulations to require a minimum of two radiographic personnel
- i when performing industrial radiography at temporary jobsites. The petition was published in the Federal Register on December 4, 1992 (57 FR 57392).
Thirty-eight comment letters were received, 35 were in favor of granting the petition.
Resolution of this petition has been addressed in this proposed revision to Part 34.
The IU0E petition offered three options for the makeup of the two-person (1) two radiographers; (2) one radiographer and one radiographer's-I crew:
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assistant; and (3) one radiographer and one trainee, with the trainee having l
completed 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of approved radiation safety training and passed an
. i.
examination. The petitioners identified a number of problems associated with the use of licensed material by one radiographer at temporary jobsites.
These problems included:
(1) difficulty keeping the area-under constant surveillance while radiographic operations are ongoing; (2) difficulty in 4
I e
i maintaining surveillance when working in trenches; and (3) ' difficulty in obtaining assistance in the event of an emergency if there is only one individual.
The petitioners believe that the suggested change is necessary to ensure a safe working environment.
The comments received raised concerns regarding the combination of a radiographer and a trainee as a two-person team. Many stated that the trainee is an unskilled individual that may or may not achieve radiographer status and spending the time and money for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> training may not be financially feasible for some radiography companies.
This proposed rule if adopted, would constitute a partial granting of i
the petition in that it proposes to require, at a minimum, a two-person crew whenever radiographic operations are being conducted outside of a permanent radiographic installation.
The NRC has decided not to adopt the term l
" radiographer trainee," and is proposing that the second person be another qualified radiographer or an individual who has met, at a minimum, the requirements for a radiographer's assistant. The NRC recognizes that, in Agreement States, the training of those individuals designated as trainees would meet the NRC's training requirements for a radiographer's assistant.
The estimated cost of requiring the two-person crew could be significant for licensees which send only one radiographer to a temporary jobsite.
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However, the current regulation requires direct surveillance of the operation to prevent unauthorized entry into a high radiation area.
To comply with this regulation most licensees already must use more than one qualified individual in many situations.
For certain circumstances where a licensee could 1
demonstrate that adequate surveillance can be maintained by one radiographer, i
the Commission could consider granting an exemption through the process 5
described in the proposed 5 34.111. The Commission is concerned that this I
requirement could cause a sr<nificant impact on a number of small entities which currently do not use two-person crews, and is soliciting comments on the potential impact.
Furthermore, the Commission is interested in receiving proposals for alternatives to the two-person requirement which would achieve comparable enhancements in safety with less of a burden on licensees.
In summary, the Commission believes that by requiring at least two qualified individuals to always be present when radiographic operations are being conducted, there will be a significant increase in assurance that operational safety measures and emergency procedures will be effectively implemented. The expectation is that violations involving failures to perform adequate radiation surveys of radiographic exposure devices and the surrounding area, failures to adequately post and monitor the restricted area,-
and failures to lock and secure the camera when not in use will become less frequent.
Furthermore, if an incapacitating injury to a radiographer should t
occur at a remote location, the presence of a second individual could be an important factor in preventing unnecessary radiation exposures.
The Commission is considering amending the Enforcement Policy as a result of this proposed rulemaking to provide, as an example of a Severity Level III violation, the conduct of radiography operations'without the required second radiographer or individual with, at least, the qualifications of a radiographer's assistant as provided in the proposed 5 34.41.
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III. General Discussion of Proposed Rule Changes The proposed amendments contain requirements which are intended to improve radiography safety. The first major change is a proposal to require, at a minimum, two qualified individuals (two radiographers or a radiographe, and an individual who has met, at least, the requirements to be a' radiographer's assistant) to be present any time radiographic operations occur outside of a permanent radiographic installation.
This issue has already been addressed under Section II. Petition for Rulemaking.
On March 19, 1991 (56 FR 11504), the NRC published a final rule which provided for a voluntary third-party radiographer certification program through the ASNT, as discussed further in Section IV.
Experience with such a voluntary program could provide the basis for a mandatory certification program.
Several Agreement States have adopted mandatory' radiographer state administered examination programs. The promulgation of these programs, as well as other changes in their radiography regulations,_have contributed to an overall improvement in safety and a decrease in serious overexposures' in these l
Agreement States.
l
- The proposed rule would recognize other certifying organizations who meet the requirements outlined in Appendix A of the proposed rule.
Independent certifying organizations would be required to meet all of the requirements listed in Appendix A, while Agreement States that wish to become certifying entities would only be required to meet' the requirements listed in i
Part 11 and 111 of the Appendix.
The NRC plans to publish annually in the Federal Register an updated list of certifying entities and to provide the' 7
s I
list with license application forms. The NRC also plans to investigate the feasibility of establishing a toll-free telephone number whereby licensees could obtain information on approved certifying entities.
Another issue involves the definition of a permanent radiographic installation. The proposed rule changes the definition of a " permanent i
radiographic installation" to mean an enclosed shielded room, cell, or vault in which radiography is performed. The terms " designed or intended for radiography" and " regularly performed" have been removed from the definition to reduce any ambiguity as to what is intended. Under the existing' rule, if a licensee has a room, cell, or vault that meets the definition of a " permanent radiographic installation", then it must meet the special safety requirements of 9 34.33. The proposed rule adds two additional requirements:
(1) to perform a daily check of the visible and audible signals, and (2) to list all 5
permanent facilities on the license.
Under the proposed rule, radiography can only be performed in one of two ways: (1) in a permanent radiographic I
installation with a qualified radiographer, or (2) at any other location with at least two qualified individuals. The special safety requirements of 5 34.33 would not apply to the use of a shielded room at a temporary jobsite, although licensees would be permitted to submit a license amendment requesting I
approval to use a shielded room which meets the requirements of 5 34.33 as a permanent radiographic installation.
f The proposed rule includes requirements specifying the qualifications and duties of the Radiation Safety Officer (RS0).
The RSO is the key licensee individual charged with the responsibility to ensure that the requirements in the license are followed.
These requirements have been based on similar commitments previously included in specific license conditions on a case-by-
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case basis. The propos d rule would require additional special training for 1
RS0s. The Commission is considering permitting existing R50s to obtain_the additional training within 2 years from the effective date of the rule and is specifically requesting comment on this proposed requirement.
IV. An Independent Certifying Entity (ASNT)
The current ASNT program for certifying industrial radiographers was approved by its Board of Directors in March 1990 and offers certification for either isotope or e-rr users. The NRC staff has extensively reviewed this s
program, which includes a written examination developed by the State of Texas.
The application to become a certified radiographer requires 1
documentation of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom training in radiation safety topics specified by ASNT including those topics listed in the proposed 5 34.43(f),
documentation of 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> of direct hands-on experience with radiography sources and devices under the control of an NRC or Agreement State licensee, and proof of successful completion of a practical examination on safety
. procedures administered by an ASNT-recognized institution. Recognized ~
institutions, generally the candidates' employers, have been licensed by NRC or an Agreement State for the use of radiography sources.
After ASNT's approval of an application, a candidate radiographer takes i
the written examination. The examination is administered by ASNT or the Conference of Radiation Control Program Directors, Inc. (CRCPD) and-subsequently sent to the State of Texas for grading.
The results of the examination are forwarded to ASNT. The written examination covers the fundamental radiation safety principles outlined in 10 CFR Part 34, pe^tinent t
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m Federal and State regulations, basic radiographic equipment operation, general operating and emergency procedures, radiation detection instrumentation, and radiation safety procedures applicable to industrial radiography.
In addition, candidates are required to sign a pledge that they will abide by the ASNT Rules of Conduct. On successful completion of the required examinations and other requirements, a certified individual is provided with a wallet card identifying him/her as an ASNT-certified radiographer.
ASNT certification is valid for 3 years, unless suspended or revoked for cause.
Renewal of certification may be accomplished either with or without reexamination. A candidate for renewal without reexamination must document continuous active full-time employment in radiography for at least 6 of the last 12 months.
In addition, the candidate must document at least 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />, each year, of classroom refresher training covering basic radiation safety principles, equipment operations, emergency procedures, new safety regulations, license requirements, and other pertinent information.
If these criteria are not met, the candidate must retake the written examination.
The ASNT Rules of Conduct require certified individuals to comply with NRC and Agreement State regulations and the employer's procedures for radiation safety, routine and emergency operations, and to act in a professional manner in matters pertaining to industrial radiography or to the ASNT certification.
The certification program also contains complaint and hearing.
procedures.
For example, written allegations of unauthorized practice by an ASNT-certified individual are reviewed by the ASNT Ethics Subcommittee.
In some cases a formal hearing may be held.
If the ASNT Ethics Subcommittee 1
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determines that an unauthorized practice has been committed,' the subcommittee may take.one of the following actions:
1.
Revoke the individual's certification for a minimum of 1 year, f
2.
Suspend the individual's certification for 30 to 180 days.
3.
Formally reprimand the individual.
l More detailed information on the ASNT certification program is available from the American Society for Nondestructive Testing, Inc.,1711 Arlingate Plaza, P.O. Box 28518, Columbus, Ohio 43228-0518.
i V. Discussion of the Proposed Rule Table of Contents The new Table of Contents contains eight subparts.
The organization'is as follows:
s Subpart A-General Provisions Subpart B-Specific Licensing Provisions Subpart C-Equipment Subpart D-Radiation Safety Requirements a
Subpart E-Recordkeeping Requirements Subpart F-Notifications g
Subpart G-Exemptions Subpart-H-Violations Appendix A
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This organization follows the same general format used in 10 CFR Part 39 concerning radiation safety requirements for well logging.
Subpart A-General Provisions This subpart covers items of a general nature, such as listing definitions and OMB approvals.
It also describes the purpose and scope of the rule.
Section 34.1, Purpose and scope, is basically unchanged from the s
existing regulation. Other NRC regulations that apply to radiography licenses are referenced in this section.
Section 34.3, Definitions, contains the following new terms: ALARA, Annual safety review, Becouerel, Certifyino entity, Collimator, Field station, Gray, Independent certifying oroanization, Radiographer certification, Radiation Safety Officer, Sievert, S-tube, and Temporary _iobsite. These definitions were added to define terms used in requirements not previously addressed in Part 34.
The term ALARA, which means as low as reasonably achievable, has been added to describe a key element of the revised Part 20,
" Standards for Protection Against Radiation," that licensees must implement by-January 1994. The term Annual safety review was added to describe this activity in the proposed rule. The terms Becauerel, Gray, and Sievert were added to define the metric units used in all new or revised regulations.
The terms Certifying entity, Independent certifying organization, and Radiographer certification were added to describe terms associated with revised requirements for verification of radiographer training. The term Collimator was added to the proposed rule to describe a piece of equipment that is often used in conducting radiography operations.
The term S-tube was added to l
12 1
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s describe this component of a radiographic exposure for which there are new requirements in the proposed rule.
The terms Field station and Temporary jobsite were added to clarify the meaning of these terms. in the proposed rule.
The term Field station is being used to designate-those locations where i
radiography equipment is stored and from which equipment is dispatched.
The term Temporary jobsite is being used to describe locations not authorized on the license where radiography is conducted.
The term Radiation Safety Officer (RS0) was added to describe the role of this individual in the proposed rule.
The terms Associated equipment, Control tube, Exposure head, Field examination, Projection sheath, Radiographic Operations, Shielded position, and Source assembly, while used in the existing regulation, were not previously defined.
Both licensees and Agreement State representatives requested clarification of these terms.
Changing the definition of radiographer's assistant was discussed at the November 1992 workshop in Dallas, Texas.
Some Agreement States use the term " trainee" to refer to a radiographer's assistant and require training similar to that required of a radiographer. The NRC has decided-to retain the term radiographer's assistant i
and has proposed upgrading the training requirements to provide additional assurance that radiographers' assistants are sufficiently knowledgeable of NRC t'
regulations. Although the NRC is not adopting the term " trainee," the proposed rule has been written to provide the flexibility for the second person to have training beyond that of a radiographer's assistant.
This position could then equally be' filled by a " trainee."
The definition of a germanent radiographic installation was modified to remove ambiguities in the previous definition.
The definitions of storage-area and storage container were modified to remove references to 13 i
4 transportation.
Specific transportation requirements are addressed in s 34.35.
4 I
Section 34.5, Interpretations, is standard regulatory language to state lj that only the General Counsel of the NRC has the authority to provide
~
interpretations of the regulations which will be binding on the Commission.
Section 34.8, Information collection requirements: 0MB approval, is unchanged from the current regulation, except for changing the section numbers to conform to the new format of the proposed rule and to list any new
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requirements that require OMB approval.
The Commission has submitted the proposed rule for OMB clearance.
Final OMB clearance will be obtained before publication of a final rule.
Subpart B-Specific Licensing Provisions i
This proposed subpart provides the basic requirements for submittal of a license application.
The sections in this proposed subpart are basically unchanged from those in the current Subpart A of Part 34.
Section 34.11, Application for a specific license, is worded the same as s 34.3 in the current Part 34.
Section 34.13, Specific license for radiography, has several changes from 5 34.11 in the current Part 34. A proposed 5 34.13(c) would specify I
requirements for establishing procedures to verify the certification status of radiographers. The requirement for verifying an individual's certification would only apply to previously certified radiographers whom a licensee might hire.
A licensee would already know an individual's status if the individual is employed by the licensee at the time of certification.
However, the licensee would be required to ensure that all radiographers are certified.
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b
s a
Section 34.13(e) proposes a reduction in the frequency of field inspections of radiographers and radiographer's assistants from quarterly to annually for individuals regularly conducting radiographic operations.
For individuals who have not performed radiographic operations for more than six-months, an inspection of job performance would be required at the time they next participate in a radiographic operation.
This reduction is possible due primarily to the proposed two-person rule, adoption of mandatory certification for radiographers, and upgraded radiographer assistants training which would-reduce the need for inspection of job performance.
The basic requirements for conducting the field inspections have been relocated to 5 34.43(d) to more accurately reflect its role in the training program.
In addition, a requirement for conducting annual safety reviews has also been added in s 34.13(b)(1) and s 34.43(c) to clarify the intent of the current 5 34.11(b).
4 which requires periodic training.
Section 34.13(g) is proposed to require the licensee to designate an individual on the license to fulfill the duties of the RSO.
The qualifications and duties of this individual are specified in s-34.42.
Section 34.13(1) is a new paragraph which, as proposed, would require a list and description of all permanent radiographic installations and all field stations to be included in the license application.
Section 34.13(j) is a new paragraph which, as proposed, would permit i
licensees to have the option to use certified radiographers before the.
proposed rule is adopted in final form and becomes effective.
15
Subpart C-Equipment This proposed subpart describes the requirements for radiographic equipment performance and use. Some of the requirements in this proposed subpart are changed from the current Part 34 as described below.
Section 34.20, Performance requirements for radiography equipment, is slightly changed from 9 34.20 of the current rule.
Section 34.20(b)(3) is revised to prohibit modification of any exposure device. The proposed rule q
was modified to remove any ambiguity regarding permission to modify safety components.
The term Source assembly was added to 6 34.20(c) and (e) to make clear that it is one of the pieces of equipment that must meet the requirements of 9 34.20.
Section 34.20(f) is added to require labeling of all associated equipment acquired after January 10, 1996, to identify that the components have met the requirements of this section.
Section 34.21, Limits on levels of radiation for radiographic exposure devices, storage containers, and source changers, is basically unchanged from 9 34.21 of the current rule with the following exceptions. Metric equivalents to the values previously cited have been included.
While it is recognized that radiation exposure instruments currently use units of roentgens to measure radioactivity, the rule has been modified to use the-terms millisieverts and millirems.
Rather than making the transition from roentgens to coulombs per kilogram (in air), the terms millisieverts and millirems were chosen because a quality factor of 1 is appropriate in dealing f
with gamma-ray emitting radiography sources.
Under the proposed rule measurements taken in roentgens may continue to be recorded in terms of roentgens, provided the limits described in the rule, expressed in millisieverts or millirems, are not exceeded.
16
y Section 34.23, Locking.and relocation of radiographic exposure devices, storage containers, and source changers, is slightly changed from 5 34.22 of the current rule, as described below.
Section 34.23(a) describes locking of radiographic exposure devices. A requirement to remove the key of any keyed-lock is proposed.
Should the key remain in the radiographic exposure i
device, there is an increased likelihood of the accidental or intentional removal of the sealed source when the radiographic device is unattended. The l
word " manually" is added to clarify what is meant by securing the source i
assembly for radiographic exposure devices manufactured before January 10, 1992.
Section 34.23(b) is added which specifies requirements for ensuring that the sealed source is in the shielded position before moving the device and associated equipment because a number of overexposures have occurred while radiographic devices were being moved from one location to another.
Section 34.25, Radiation survey instruments, replaces s.34.24 in the current rule and has been updated to reflect current calibration standards for different types of survey meters.
This is to specify requirements to address the variety of survey instruments currently available. An additional requirement to perform an operability check before use is proposed. While P
this is routinely part of all survey instrument specifications, a failure to determine whether an instrument was operable before use has been a contributing factor in overexposures during radiographic operations'.
In s 34.27, Leak testing and replacement of sealed sources' the words
" repair, tagging, opening, and modification" of sealed sources have been removed because these activities are only approved for individuals specifically licensed to do so.
It was never intended that radiographers would be permitted to perform these activities without special authorization 17 5
from the Commission or an Agreement State.
Section 34.31 was modified to include a specific prohibition on the opening, repair, or modification of sealed sources. Most of the language in the proposed rule is the same as s 34.25 of the existing rule.
However, the organization has been modified for purposes of clarification. The requirement that performance of a' source-exchange or a leak test must be done by persons approved by the Commission has been modified to include Agreement States.
Recordkeeping requirements have been moved to 9 34.67.
Section 34.27(f) is proposed to require surveys for depleted uranium (DU) contamination in the "S" tube of radiographic. devices at -least once every 12 months. Depleted uranium is used as a shielding material in most radiographic devices and replaces the lead shielding that was used in older models. The presence of DV contamination in the "S" tube may be an indication that the control cable has worn a groove through the "S" tube into the 00 shielding. This condition could cause binding of the control cable in the 1
groove with the resultant inability to retract the source, and could result in-unwarranted exposures.
Recordkeeping requirements may be found in 134.67.
Section 34.29, Quarterly inventory, is basically unchanged from the l
existing regulation with the exception of moving all recordkeeping
' requirements to 9 34.69.
Section 34.31, Inspection and maintenance of radiographic exposure devices, storage containers, associated equipment, and source changers, includes several proposed changes from s 34.28 in the current rule. The term associated equipment has been included in the proposed rule, and includes various items used for specific tasks which may not be supplied with the radiographic device.
Experience has shown that defects in associated 18
t' equipment'can have an effect on safety. Therefore, associated equipment must be included in an inspection and maintenance program. Section 34.31(a) has.-
been revised to clarify the intent of the daily visual check and the required actions-if defects are found.
In s 34.31(b), the term routine maintenance is now used to clarify that licensees are not required to perform all maintenance. Many equipment repairs may require returning the device to the P
manufacturer.
Language has been added to specify that defective equipment must be removed from service until repaired and that a record of the defect, as well as corrective actions taken, must be made.
While this appears obvious, there have been numerous instances where the use of defective i
equipment continued and overexposures of personnel occurred as a direct result of the defects.
Recordkeeping requirements have been moved to 9 34.73.
The records required to be kept would now be specified in the. rule, and include:
date of check, individual performing check, equipment involved, any oefects found, and repairs made.
Section 34.33, Permanent radiographic installations, is basically unchanged from the existing requirements in Part 34, with the exceptions noted below.
Section 34.33(a) has been revised to clarify which entrance controls are required by incorporating the appropriate language from 10 CFR 20.1601 f
into Part 34.
Section 34.33(b) is revised to require an alarm system check at the beginning of each day of use.
This is to be performed by checking the warning light and audible alarm with the source exposed before using the room each day. A defective alarm would require repair before radiographic operations could resume.
This requirement is included because there have been instances where failures in alarm systems have resulted in personnel overexposures upon entry into a high radiation area.
19 1
0 f
-Section 34.35, Labels, storage, and transportation precautions, is a proposed new section that would place requirements that specify labeling and security precautions _ for radioactive material storage and transportation in Part 34.
Section 34.23 of the current rule describes storage precautions for exposure devices and storage containers but does not address transportation or labeling requirements.
In s 34.35 of the proposed rule, labeling requirements for source changers and storage containers are specified.
The.
proposed rule contains specific requirements to lock and physically secure transport packages.
The proposed rule would also require licensees to. store licensed material in a manner which minimizes the danger from explosions or fire. The requirement for a Quality Assurance (QA) program, as-described in s 71.105, has been added to the proposed rule.
While radiography. licensees have always had to comply with & 71.105, there have been numerous cases where radiography licensees were unaware of this requirement and, therefore, failed to comply. The addition of requirements addressing labeling and transportation is necessary because in the past personnel and public exposures have occurred from the failure to properly safeguard radioactive material during storage and transportation.
Subpart D-Radiation Safety Requirements This subpart describes basic radiation safety requirements for i
radiographic operations and includes training, safety procedures, personnel monitoring and surveys. New requirements describing the duties of the radiation safety officer are proposed.
20
Section 34.41, Conducting radiographic operations, would be added to address the practice of conducting radiography at sites where the special safety features of a shielded facility are not available.
The proposed requirement specifies that, as a minimum, either two radiographers or a radiographer and an individual who has met the requirements to be a radiographer's assistant must be present any time radiographic' operations occur outside a permanent installation. The basis for this proposed requirement is to ensure that, in the absence of the safety features outlined in 5 34.33, there wil1 be a significant increase in assurance that operational safety measures will be implemented effectively.
The expectation is that violations involving failures to perform adequate radiation surveys of radiographic exposure devices and the surrounding area, failures to adequately post and monitor the restricted area, and failures to lock'and secure the camera when not in use will become less frequent.
Furthermore, if an incapacitating injury to a radiographer.should occur at a remote location, the presence of a second individual could be an important ' factor in preventing unnecessary radiation exposures.
Section 34.41(b) is proposed to require that radiographic operations conducted at locations listed on the license be conducted in a permanent radiographic installation.
If licensees would need l
to perform radiography outside of a permanent facility due to some unique j
circumstances Commission authorization would be required, and the requirements i
of 6 34.41(a) would need to be met.
Section 34.42, Radiation Safety Officer (RS0), lists the qualifications
'I and duties of the RSO.
This section would be added to place in the regulations the requirements for this key individual.
Previously, these requirements were referenced in regulatory guides and included as license U
21
conditions on.a case-by-case basis, but not specified in the regulations. The NRC believes that the RSO is the key individual for ensuring safe operations.
.The qualifications listed for the RSO in the proposed rule include:
(1) completion of the training required for a radiographer as described in Part 34; and (2) 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented experience in industrial radiography with at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of formal classroom training with respect to the establishment and maintenance of radiation protection programs.
It is anticipated that most existing RS0s already meet these requirements.
It is proposed that licensees would have two years from the effective date of the rule to meet this 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> training requirement for existing RS0s. A key duty of the RS0 is to ensure the safe conduct of operations and to stop unsafe operations and institute corrective actions.
Other duties of the RSO in the proposed rule include overseeing procedure implementation and employee training, and monitoring radiation surveys, leak tests, and personnel monitoring results.
Section 34.43, Training, contains several new requirements.
Section 34.43(a) has been revised to require radiographers to be certified by a certifying entity meeting the criteria specified in Appendix A of'the proposed rule. To be recognized as a certifying entity, an independent' organization meeting the criteria specified in Part I of Appendix A would have to apply as specified in 5 34.43(a)(2).
Certifying programs would be periodically reviewed by the NRC to ensure that the conditions of approval are being met.
i 1
A list of approved certifying entities would be made available to licensees on request by contacting the appropriate regional office listed in Appendix D to 10 CFR Part 20, and would be published annually in the Federal Register.
Under the proposed rule licensees would have 2 years to implement the proposed 22
-1 1
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'5 F
change. The change in the verification of training requirements was included in the proposed rule to provide assurance of the quality of radiographers' training in the safe handling of radioactive material.
NRC and Agreement States must reciprocally recognize valid radiographer certifications issued by either an independent certifying entity approved by the NRC or an Agreement State certification program meeting the requirements of Appendix A, Parts II and III, of the proposed rule.
Also included in this section is training in 9 5 30.7, 30.9, and 30.10, applicable sections of 10 CFR Part 71, and some instructions in applicable Department of Transportation (DOT) regulations as referenced in 10 CFR Part 71 in addition to other parts of NRC regulations.
Section 34.43(b), which lists training requirements for radiographers' assistants, has been revised to require training in is 30.7, 30.9, 30.10, and Parts 19, 20, 34, 71, and instructions in applicable DOT regulations as referenced in 10 CFR Part 71, in addition to.the licensee's operating and emergency procedures. These changes are to ensure that radiographers and radiographers' assistants are knowledgeable of the safety requirements applicable to handling radioactive material in the conduct of radiography.
In 5 34.43(b)(3) the option of providing an oral test has been omitted.
The proposed rule would only allow a written test to be given.
Section 34.43(c) f describes a proposed requirement to conduct annual safety reviews of radiographers and radiographers' assistants.
In.the current rule, periodic training is required but required topics to be addressed are not included.
Because a number of violations involving personnel overexposures have-resulted from licensees' failures to provide adequate training, the proposed amendment for annual safety reviews includes training on revised operating and emergency procedures, new equipment, and' safety issues.
23
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i Section 34.43(d) has been relocated from l' 34.11(d), and describes the.
requirements for routine inspections of job performance for radiographers and radiographers' assistants.
The proposed rule reduces the frequency of these inspections from quarterly-to annually.
The NRC is proposing to reduce the frequency of inspections of job performance for individuals regularly conducting radiographic operations.
For individuals who have not performed l
radiographic operations for more than six months, an inspection of their job performance would be required at the time of their next participation in a radiographic operation.
With several of the other requirements proposed in this rulemaking, such as, certification of radiographers, and having at least two individuals at a temporary jobsite, the Commission believes that the 1
frequency of inspection of job performance can be reduced from quarterly to annually.
Proposed s 34.43(e) specifies that recordkeeping requirements can be found in s 34.79. The requirements for records are unchanged from the current Part 34 except for the addition of records verifying the certification status of radiographers.
Proposed 5 34.43(f) contains the subjects currently listed in Appendix A of Part 34.
Several additional requirements are proposed. These include: pictures or models of source assemblies; training in storage, control, and disposal of licensed materials; and pertinent Federal regulations, i.e., Department of Transportation. A new 5 34.43(g) would be added which would allow licensees to continue to permit uncertified individuals to act as radiographers for a 2-year period after the proposed rule becomes final.
In 5 34.45, Operating and emergency procedures, minor changes were made to include procedures for source recovery if the licensee intends to perform 24
I
.c emergency source recovery. These were added because many of the steps in a source recovery would be the same in any circumstance and, in the past, a e
number of personnel overexposures have occurred during emergency source recovery operations because basic radiation protection precautions were overlooked. Additional requirements are proposed for transportation procedures to include placarding of vehicles, and reference to the DOT regulations. A number of violations have resulted from licensees failing to follow 00T regulations in the transportation of radioactive material. Section 34.45(b) is proposed which specifies that the recordkeeping requirements can be found in s 34.81.
Sections 34.89 and 34.91 specify that copies of current i
operating and emergency procedures are to be maintained at field stations, permanent installations, and temporary jobsites, to ensure that adequate documents are available where radiographic operations occur.
Section 34.46, Supervision of radiographers' assistants, is unchanged from 5 34.44 of the current rule.
In 9 34.47, Personnel monitoring, several changes are proposed. The existing requirement specifies that pocket dosimeters have a range from zero to at least 200 milliroentgens.
The proposed rule has dropped the term "at least," to limit the range to be only from 0-200. This is to prevent the use of pocket dosimeters with very high ranges where the users would be unable to properly determine their exposure.
Use of pocket dosimeters with a range higher than 200 milliroentgens will be considered on a case-by-case basis.
d Additional requirements are proposed on the replacement frequency for film and i
TLDs. The existing regulation does not specify the replacement frequency for I
film and TLDs. _The high intensity sources used in radiography necessitate frequent monitoring. Monthly replacement is judged to be an' appropriate 25
o frequency to adequately track an individual's exposure.
With the new lower limits for occupational dose, less frequent monitoring could result in a worker receiving an overexposure.
Section 34.47(b) addresses the use of pocket dosimeters. A requirement to read dosimeters at the beginning and end of each shift is proposed. This is added to ensure that the dose is correctly estimated. The existing regulation only specifies a daily reading and does not provide sufficient instruction on how licensees should handle any readings which remain on the pocket dosimeter after recharging.
Because it is nearly inipossible to recharge a pocket dosimeter to zero, licensees must take a reading before and after use and determine the difference to determine the dose accurately.
Section 34.47(d) addresses an off-scale pocket dosimeter. The proposed rule would require that, in the case of a pocket dosimeter being off-scale, the individual will not be permitted to work with licensed material until the RSO or a designee of the RSO makes a determination of the worker's radiation exposure. The current rule requires that the worker's film badge or TLD be sent for processing, but does not specify when the individual can return to work. The proposed revision provides the criteria that must be met before permitting the individual to return to work. A provision is included which will permit the individual to return to work when the circumstances are clearly known and justified by the RS0 that there was no possibility of overexposure.
Section 34.47(e) is proposed to require that a worker cease work whenever a film badge or TLD is lost or damaged until a replacement is
\\
available. This is added to ensure that there is a means to accurately determine the worker's radiation dose.
i 26 l~
a a
Section 34.47 (g) has a proposed revision to require alarm ratemeters to be capable of alerting the wearer regardless of the environmental conditions.
In a recent radiography overexposure incident, a licensee reported that a radiographer who was wearing ear protection due to high workplace noise levels l
was overexposed because he was unaware that his ratemeter was alarming.
For use in high ambient noise areas, ratemeters could be supplied with either a vibrating alarm that could be felt by the wearer or a small speaker built into hearing protectors to meet this requirement.
NRC expects its licensees to determine the need for alarm ratemeters that incorporate these additional protective measures.
In 5 34.49, Radiation surveys, there are several proposed changes. The existing regulation requires a survey of the circumference of the radiographic
~ +
exposure device and the guide tube. A number of violations of NRC P
requirements have occurred due to a failure to comply with the requirement to survey the full circumference of the camera.
In reviewing the regulation, the NRC has decided to revise the survey requirements to specify that a survey be conducted of the radiographic exposure device to determine that the sealed source has returned to the shielded position, and specify that for the radiographer to conduct a survey as he/she approaches the guide tube to exchange film, reposition the collimator, or dismantle equipment.
The proposed rule places the responsibility with the licensee for ensuring that an adequate survey is conducted.
In the majority of cases, a survey of the radiographic exposure device's ports should be adequate to make this determination. A proposed requirement to survey storage areas when radioactive material is initially placed in storage, during each quarterly 27
Q 1
inventory, and whenever changes occur which could ' increase radiation levels, is added.
Section 34.51, Surveillance, is basically unchanged-from 5 34.41 of the l
current rule.
References to Part 20 have been updated to reflect the proposed revisions in 5 34.33.
Section 34.53, Posting, is basically unchanged from 9 34.42 of the current rule except to incorporate current references to Part 20.
Subpart E-Recordkeeping Requirements This subpart does not appear in the current Part 34.
This subpart is proposed to place all recordkeeping and notification requirements in one location. Most of the recordkeeping requirements are unchanged from those contained in the existing Part 34.
Proposed changes are discussed below.
Section 34.61, Specific license for radiography, requires the licensee to maintain a copy of the license until it is terminated by the Commission.
Section 34.63, Records of receipt and transfer of sealed sources, is added to provide a record showing the disposition of sources.
Section 34.65, Records of radiation survey instruments, is proposed as currently written in Section 34.24.
Licensees would be required to maintain calibration records for radiation survey instruments for 3 years after the record is made.
Section 34.67, Records of leak testing and replacement of sealed sources is proposed as currently written in 5 34.25(c) and requires licensees ~ to maintain records of leak tests for 3 years after the record is made.
28
s Section 34.69, Records of quarterly inventory is proposed as' currently written s 34.26 and requires licensees to maintain records of. quarterly inventories for 3 years after the record is made.
Section 34.71, Utilization logs, is proposed much as currently written in s 34.27. This section would require licensees to maintain utilization logs for 3 years after the record is made.
The proposed rule has added several additional pieces of information to the logs including the serial number of the device' in which the sealed source is located, the radiographer's signature, and the dates the device is removed and returned to storage.
This information is necessary in order to verify location of sources.
Section 34.73, Records of inspection and maintenance of radiographic exposure devi'es, storage containers, associated equipment, and' source changers, is proposed much as currently written in s 34.28(b).
This section requires licensees to maintain inspection and maintenance records for 3 years after the record is made.
The proposed rule would specify the information that must be included in the inspection records: date of check, name of inspector, equipment inspected, any defects found, and repairs made.
Section 34.75, Records of alarm system checks at permanent radiographic installations, is proposed as currently written in s 34.29(c)' and requires licensees to maintain records of alarm system checks for 3 years after the record is made.
H Section 34.79, Records of training, is proposed as currently written in s 34.31(c) with proposed additional requirements for maintaining records of 1
radiographer certification and annual safety reviews.
This paragraph would require licensees to maintain records verifying radiographer certification -
l status.
For annual safety reviews, the records would include copies of tests, 29
~
1
-dates administered, names of instructors and attendees, and the topics covered.
Under the proposed rule, records of the annual inspections would include a list of items checked, and any non-compliances observed by the RSO.
Section 34.81, Copies of operating and emergency procedures, is proposed as currently written in s 34.32 and requires licensees to maintain copies of emergency and operating procedures until-the Commission terminates the license.
Section 34.83, Records of personnel monitoring, is proposed as currently t
written in s 34.33(b), and requires licensees to maintain records of alarm ratemeter calibrations, pocket dosimeter readings, and operability checks for 3 years from the date the record was made, and to maintain records of film badge or TLD reports until the Commission terminates the license.
Section 34.85, Records of radiation surseys, is proposed as currently written in s 34.43(d) and requires records of the exposure device surveys for 3 years from the date the record was made.
Section 34.87, Form of records, is proposed as currently written in 5 34.4 and spccifies how records must be maintained, including permitting records to be stored in electronic media.
Section 34.89, Documents and records required at field stations and permanent installations, would be added to list documents and records required at field stations and permanent installations. This section is necessary-to ensure that licensees have available sufficient records to demonstrate compliance with NRC regulations.
Field stations and permanent installations may be far removed from the home office.
Therefore, records necessary to conduct operations safely should be readily available. These records include a copy of the current license, copies of pertinent regulations, copies of 30
i 1
operating and emergency procedures, instrument calibration records, leak test results, inventory records, utilization logs, training and survey records.
These records are those required for licensees to safely handle radioactive material, and are a subset of the records required at a licensee's normal l
place of business.
Section 34.91, Documents and records required at temporary jobsites and i
use or storage locations exceeding 180 days, would be added to list documents
)
and records required at temporary jobsites and locations where radioactive material will be in use or storage for more than 180 days..This section is e
necessary to ensure that licensees have available sufficient records to demonstrate compliance with NRC regulations and those records necessary to maintain safe operations. The records listed are a smaller subset of the-records required for a field station or permanent installation. These records include copies of pertinent regulations, evidence of latest instrument 1
calibrations, latest survey records, shipping papers, and Agreement State
-i license if operating under reciprocity. These records are those required for licensees to safely handle radioactive material.
i Subpart F - Notifications t
This subpart is basically unchanged from 9 34.30 with the exception of an additional requirement. Section 34.101(c) would require licensees to notify the appropriate NRC regional office in writing before using or storing radioactive material in one location for more than 180 days. This notification would be required within 30 days of exceeding the 180-day timeframe. This provision would be added to provide the NRC with'information i
6 31
6 in;a timely manner to permit inspection of radioactive material at these locations.
Subpart G - Exemptions I
This subpart addresses exemptions and is basically the same as 5 34.51 in the current Part 34 with the exception of minor wording changes to make it consistent with current language used in other parts of the rule.
See 5 39.91.
i t
Subpart H - Violations This subpart addresses violations and is basically the same as 134.61 and 5 34.63 in the current Part 34 with the exception of minor wording changes to make the sections referenced consistent with the proposed rule.
Appendix A to Part 34 This appendix is new. The requirements in Appendix A to the current Part 34 have been relocated to s 34.43(f).
Part I of the new Appendix A provides the proposed requirements for an independent certifying organization, and does not apply to Agreement States choosing to become a certifying entity.
t Parts II and III of the new Appendix A provide the proposed requirements for h
certification programs and written examinations for a certifying entity, which would include Agreement States. The proposed Appendix A would not impose new requirements on NRC's radiography licensees.
NRC is proposing that an independent certifying organization would have to be a national society or association involved in setting national standards i
of practice for industrial radiography or non-destructive testing to be 32 1
l
t recognized. Membership in the organization could not be restricted because of race, color, religion, sex, age, national origin or handicap and the organization's certification program would need to be open to nonmembers.
The independent certifying organization would need to' i
(1) Be. incorporated; l
(2) Have a permanent full-time staff; i
(3) Be nationally recognized; (4) Have a policy and decision-making review board; (5) Be governed by written organizational by-laws and policies; and (6) Have a viable system of financing its operations.
An independent certifying organization would also need to have (1) A committee to review and approve certification guidelines and procedures and to advise the organization's staff in implementing its certification program; (2) A committee to review complaints against certified individuals; (3) Written procedures describing its certification program; and (4) An agreement to exchange information about certified individuals i
with the Commission and the Agreement States.
For a certification program to be acceptable, NRC is proposing that it i
include provisions requiring individuals to receive training in the topics listed in 9 34.43(f), complete a written examination, complete a practical examination or equivalent, and require a minimum period of on-the-job experience.
The program would also have to include procedures that ensure due process whenever an individual's certification may need to be revoked, suspended, or restricted for willful or significant failure to comply with his 33 l
r
-or her employer's operating or emergency procedures, or the Commission's or an Agreement State'.s regulations.
For the written examination, NRC is proposing that it be: (1) designed
.to test ' knowledge and. understanding of the subjects listed in 1. 34.43(f); (2) written for a ninth-grade reading comprehension level; and (3) scientifically analyzed to ensure that the questions are not biased or misleading.
{
Agreement State Compatibility The rule will be a matter of compatibility between the NRC and the Agreement States, thereby providing consistency between Federal and State safety requirements. With regard to basic radiation equipment specifications, i
standards and definitions, identified as matters of Division 1 level of-compatibility, the Agreement States will be expected to adopt, essentially
- 1 verbatim, the proposed Part 34 standards and definitions into their equivalent regulations.
However, the NRC also recognizes that certain terms, such as radiographer assistant, may not be used in present Agreement State regulations.
Continued use of alternative terms, such as " trainee" will be considered acceptable so long as the underlying requirements of the position are consistent with those proposed by the Commission.
For Agreement States that wish to develop radiographer certification k
f programs, Parts II and III of the proposed Appendix A would also be Division 1 items of compatibility. The definitions and the requirements for certification-programs and written examinations contained in this rulemaking must be the same for all NRC and Agreement State licensees to maintain 34 s
i
a 1
consistency.
In practice, States that develop certification programs must
- develop regulatory language and regulations that implement Appendix A, Parts II and III criteria.
States would be permitted to include additional administrative requirements (such as State-issued cards).
States that do not develop certification programs would not be expected to implement Appendix A.
NRC or an Agreement State must reciprocally recognize valid radiographer certifications issued by either an independent certifying entity approved by the NRC or by an Agreement State certification program meeting the requirements of Appendix A, Parts II and III, of the proposed rule.
Part I of Appendix A of proposed 10 CFR Part 34, provides the requirements for independent certifying organizations to be acceptable to NRC.
The Commission reserves the right to make this determination and therefore this is a Division 4 item of compatibility.
Because it concerns' a regulatory i
function that will be reserved for the Commission pursuant to 10 CFR Part 150, the Agreement States will not need to adopt this provision of the proposed rulemaking. A new section proposed for Part 150 would make clear the Commission's intent to reserve this function and also to reserve the right to i
set minimum radiographer certification standards.
The remainder of the rule will be a Division 2 level of compatibility i
allowing the Agreement State regulators the flexibility to adopt similar or more stringent requirements based on their radiation protection experience, professional judgments, and community values.
35 1
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t Implementation The Commission intends to have different implementation dates for particular requirements of this proposed rule. The proposed requirements would become effective 90 days after publication of the final rule in the Federal Register.
For the proposed requirements in 5 34.41 to use, as a minimum, a two-person crew for radiographic operations not conducted in a permanent facility, licensees would have 1 year from the effective date of the rule to comply.
Licensees would be required to affirm that all radiographers have met the certification requirements of 34.43(a)(1) within 2 years from the effective date of the rule. This would allow radiography licensees operating in NRC jurisdiction 2 years to obtain certification for their employees who act as radiographers. This requirement would include radiographers employed
[
by Agreement State licensees operating in non-Agreement States under reciprocity pursuant to 10 CFR 150.20. The Commission notes that the State of Texas currently provides a 90-day grace period for non-Texas licensees operating in that State under reciprocity (TRC 31.90).
However, because this
- 1 proposed rule will be a matter of compatibility, the requirement for mandatory certification would apply to radiography licensees nationwide, i
Licensees would have one year from the effective date of the rule to comply with the additional training requirements specified in s 34.43(b).
Licensees could consider combining this training with the annual safety review.
For the proposed revision to 5 34.47(g) that would require alarm ratemeters be capable of alerting the wearer regardless of environmental 36 l
L-l l
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m
- m.
m conditions, licensees would have 1 year to obtain or modify a sufficient number of additional clarm ratemeters to meet anticipated needs.
For use/ storage locations not previously identified on the license 1
(e.g., field stations, permanent radiographic installations, and temporary jobsites exceeding 180 days) licensees must request amendments or notify the NRC, as appropriate, by the effective date of the rule.
Few amendment requests are anticipated.
All current RS0s would be granted a two-year extension to meet the proposed additional RSO training requirements specified in s 34.42(a).
The Commission requests that persons commenting on this proposed rulemaking particularly address any hardships that would result if the proposed rule were adopted and also address any hardships that would result if the proposed implementation schedule were adopted.
The NRC is particularly interested in. suggestions for alternative implementation schedules.
Finding of No Significant Environmental Impact: ' Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the rule, if adopted, would not be a major Federal action; therefore, an impact statement is not required.
The revision of 10 CFR Part 34 should have no environmentally significant impact because radiography only involves the use of sealed sources, and no environmental impact will be involved.
The environmental assessment and finding of no significant impact on which this determination is based are available for 37
4 e
inspection ~ at-the NRC Public Document Room at 2120 L Street, NW. (Lower Level), Washington DC.
Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
This rule has been submitted to the Office of Management and Budget for review and approval of the information collection requirements.
The public reporting burden for this collection of information is estimated to average 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per response, including the time for reviewing j
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send cWaments regarding this burden estimate or any other aspect of this collection i
of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555; and to the Desk Officer, Office of l
Information and Regulatory Affairs, NE0B-3019, (3150-0007), Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis d
The Commission has prepared a draft regulatory analysis on this proposed 1
regulation. The analysis examines the costs and benefits of the alternat ives
. l considered by the Commission.
The draft analysis is available for inspection l
38 I
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_'y ' _
'b in the NRC Public Document Room at 2120 L Street NW. -(Lower Level),_
Washington, DC.
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a.
L Regulatory, Flexibility Analysis The NRC has prepared an initial regulatory analysis of the impact of this proposed rule on small entities. A summary of this analysis appears as
' Appendix A to this document. A copy of the analysis is available for inspection in the NRC Public Document Room, 2120 L Street, NW. (Lower Level),
Washington, DC.
Single copies of the analysis may be obtained from Donald 0.
Nellis or Mary L. Thomas, Division of Regulatory Application, Office of Research, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Telephone (301)-492-3785. The NRC is seeking public comment on the initial regulatory flexibility analysis.
The NRC is particularly seeking comment from small entities (i.e., small businesses, tsa organizations, and small jurisdictions under the Regulatory Flexibility Act) as to how the regulations will affect them and how the regulhtions may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately j
protecting the public health and safety.
Those small entities which offer t
comments on how the regulations could be modified to take' into account-the differing needs of small entities should specifically discuss the following items:
(a) The size of their business and how the proposed regulations would result in a significant economic burden upon them as compared to larger organizations in the same business community.
(b) How the proposed regulations could be modified to take into account their differing needs or capabilities.
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4 (c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested by the commenter.
(d) How the proposed regulations, as modified, would more closely equalize the impact of NRC regulations or create more equal access to the-benefits of Federal programs as opposed to providing special' advantages to any individuals or groups.
(e) How the proposed regulations, as modified, would still adequately protect the public health and safety.
The comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attn:
Docketing and Service Branch.
1 Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule and, therefore, that a backfit analysis is not required for this proposed rule. The proposed rule does not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects 10 CFR Part 34 Byproduct material, Criminal penalties, Nuclear material, Packaging and containers, Radiation protection, Radiography, Reporting and recordkeeping requirements, Scientific equipment, Security measures.
l 41 i
10 CFR Part 150 Criminal penalties, Hazardous materials - transportation, Intergovernmental-relations, Nuclear materials, Reporting and recordkeeping requirements, Security measures, Source material, Special nuclear material.
For 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 proposing to adopt the following amendments to 10 CFR 34.
i 42 l
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+
r PART 34--LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS P
1.
The authority citation for Part 34 is revised to read as follows:
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 34.45 also issued under sec. 206, 88 Stat.1246 (42 U.S.C.
5846).
2.
The existing headings for Subparts A and B and each of the existing undesignated center headings are removed.
i 3.
A new heading for subpart A (5 5 34.1 - 34.8) is added to read as follows:
l Subpart A - General Provisions.
4.
Section 34.1 is revised to read as follows:
9 34.1 Purpose and scope.
This part prescribes requirements for the issuance of licenses for the use of sealed sources containing byproduct material and radiation safety l
requirements for persons using these sealed sources in industrial radiography.
The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter.
In particular, the requirements and provisions of Parts 19, 20, 21, 30, 71, 150, 170, and 171 of l
43
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this chapter' apply to_ applications and licenses subject to this part.
This rule does' not apply to medical uses of byproduct material.
5.
Section 34.3 is removed.
s 34.3 [ Removed) 6.
Section 34.2 is redesignated as s 34.3, and the new 5 34.3 is t
revised to read as follows:
s 34.3 Definitions.
i ALARA (acronym for as low as reasonably achievable) means making every reasonable effort to maintain exposures to radiation as far below the dose
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limits specified in Part 20 as is practical consistent with the purpose for.
which the licensed activity is undertaken, taking into account the state of technology,.the economics of improvements in relation to state of technology, the economics _of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic. considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest.
Annual safety review means a review conducted or provided by the-licensee for its employees on radiation safety aspects of radiography.
The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and I
opportunities for employees to ask safety questions.
Associated equipment means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, i
i guides, or comes in contact wi.th the source. (e.g., guide tube, control tuoe, control (crank-out device), removable source stop,' "J" tube).
Becquerel.(Bq) means one disintegrr. tion per second.
Certifying entity means an independent certifying organization meeting the requirements in Appendix A or an Agreement State meeting the requirements in Appendix A, Parts II and III.
Co77/mator means a device used to limit the size, shape, and direction of the primary radiation beam.
i Control tube means a protective sheath for guiding the control cable.
The control tube connects the control drive mechanism to the radiographic I
exposure device.
Exposure. head means a device that locates the gamma radiography.;ealed source in the selected working position.
(An exposure head is also known as a 1
)
source stop.)
Fie7d examination means a demonstration through practical application of i
the safety rules and principles in radiography including use of all appropriate quipnant and procedures.
Field station means a facility where licensed material may be stored or used and from which equipment is dispatched.
Gray means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 Joule / kilogram.
It is also equal to 100 rads.
Independent certifying organization means an independent organization that meets all of the criteria in Appendix A of this part.
Permanent radiographic installation means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.
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Projection sheath (guide tube) means a flexible or rigid tube (i.e., "J" tube) for guiding the source assembly and the attached control cable from the k
radiographic exposure device to the exposure head or working position.
t Radiation Safety Officer means an individual named by the licensee who has knowledge of, responsibility for, and authority to ensure compliance with appropriate radiation protection rules, standards, and practices on behalf of the licensee and who meets the requirements of s 34.42.
Radiographer means any individual who meets the requirements of 34.43, is in attendance at the site where the sealed source or sources are being used, personally supervises radiographic operations and who is responsible to the licensee for ensuring compliance with the requirements of the Commission's regulations and the conditions of the license.
t Radiographer certification means written approval received from a certifying entity stating that an individual has satisfactorily met certain-established radiation safety training, testing, and experience criteria.
I Radiographer's assistant means any individual, who under the personal supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in i
radiography.
Radiographic exposure device {also cal 1ed a camera or a projector) means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise
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Radiographic operations means all activities associated with the t
presence of radioactive sources in a radiographic exposure device during 46 i
i
-transport and use of the device, to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.
Radiography means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of byproduct materials.
S-tube means a tube (typically made of a hard metal, such as, titanium) through which the radioactive source travels in a radiographic exposure device.
Sealed source means any byproduct material that is encased in a capsule j
designed to prevent leakage or escape of the byproduct material.
Shielded position means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement. (In this position the radiation exposure will be at a minimum.
This position incorporates maximum shielding for the radioactive source.)-
Sievert means the SI unit of any of the quantities expressed as dose equivalent.
The absorbed dose in grays multiplied. by the quality factor is-equal to the dose equivalent in Sieverts.
For comparison ~l Sv = 100 rems.
Source assembly means an assembly that consists of the sealed source and a connector that attaches the source to the control cable.
The source assembly may also include a stop ball used to secure the source in the shielded position.
Source changer means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.
Storage area means any location, facility, or vehicle which is used to store or to secure a radiographic exposure device, a storage container, or a 47 i
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sealed source when it is not in use and which is' locked or has a physical-barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.
Storage container means a device in which sealed sources are stored.
Tem,porary jobsite means a place where radiographic operations are conducted other than the location (s) of use authorized on the license.
I 7.
Section 34.4 is removed.
534.4 [ Removed]
8.
Section 34.5 is added to read as follows:
-s 34.5 Interpretations.
Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of_the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission.
9.
Section 34.8 is revised to read as follows:
9 34.8 Information collection reouirements: 0MB approval.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management'and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number 31E0-0007.
(b) The approved information collection requirements contained in this part appear in 55 34.13, 34.20, 34.25, 34.27, 34.29, 34.31, 34.33, 34.35, 48 l
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35.41, 34.43, 34.45, 34.47, 34.49, 34.61, 34.63, 34 65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87, 34.89, 34.91, 34.101, 34.111, and Appendix A.
(c) This'part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section.
The information collection requirement and the control number under R
which it is approved are as follows:
(1) In 6 34.11, NRC Form 313 is approved under control number 3150-0120.
- 10. A new heading for Subpart B [5s 34.11-34.13) is added to read as follows:
Subpart B - Specific Licensing Provisions 11.
Section 34.11 is revised to read as follows:
9 34.11 Application for a specific license.
A person may file an application for specific license for use of sealed sources in radiography, in duplicate, on NRC Form 313, " Application for Material License," in accordance with the provisions of 5 30.32 of this chapter.
12.
Section 34.13 is added to read as follows:
5 34.13 Specific license for radiography.
The Commission will approve an application for a specific license for the use of licensed material in radiography if the applicant meets the following requirements:
(a) The applicant shall satisfy the general requirements specified in 49
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5.30.33 of this chapter for byproduct material, as appropriate, and any l
special requirements contained in this.part.
(b) The applicant shall develop an adequate program for training i
radiographers and radiographers' assistants that meets.the requirements of 5 34.43, and submit to the Commission a description of this program which-specifies the --
(
(1) Initial training; (2) On-the-job training; (3) Annual safety reviews; and (4) Means the applicant will use to demonstrate the radiographer's and radiographer's assistant's knowledge and understanding of and ability to comply with the Commission's regulations and licensing requirements and the applicant's operating and emergency procedures.
(c) The applicant shall establish and submit to the Commission a description of its procedures for verifying and documenting the certification status of its radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
1 (d) The applicant shall submit to the Commission written operating and emergency procedures as described in 5 34.45.
(e) The applicant shall establish and submit to the Commission its program for annual inspections of the job performance of each radiographer and i
radiographer's assistant as described in 6 34.43(d).
(f) The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in radiography, including specified delegations of authority and responsibility.
50
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(g) The applicant shall designate and identify a Radiation Safety Officer responsible for implementing the licensee's radiation safety program.
The Radiation Safety Officer shall meet the qualifications and duties described in -
s 34.42.
(h) If an applicant intends to perform leak testing of sealed sources, i
the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used.
If the applicant intends to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the Commission.
The description nust include the --
(1) Instruments to be used; (2) Methods of performing the analysis; and (3) Pertinent experience of the person who will analyze the wipe samples.
(i) The applicant shall identify the location (s) of, ;nd describe, all field stations and permanent radiographic installations.
(j) From (insert effective date of final rule) to (2 years after the final rule is published in the Federal Register):
(1)
A license applicant may affirm that all individuals acting as radiographers will be certified in radiation safety by a certifying entity-before commencing duties as radiographers. This affirmation is instead of describing its initial training program for radiographers in the subjects outlined in 5 34.43 (f) and the means used to determine the radiographer's knowledge and understanding of these subjects, and; (2)
A licensee may substitute radiographer certification in place of the description of the means to determine the radiographer's knowledge and understanding of the subjects outlined in 5 34.43(f).
51
i (3)
After (2 years after the final rule js published in the Federal.
Register), a license applicant and licensee shall comply with the requirement of 5 34.43(a)(2).
13.
A new heading for Subpart C [s s 34.20-34.35] is added to read as follows:
Subpart C - Equipment 14.
Section 34.20 is revised to read as follows:
s 34.20 Performance reouirements for radiography eauipment.
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 N432-1980 "Radiolockal Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 136, issued January 1981)'.
This-publication 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 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, Telephone _{212) c 642-4900.
Copies of the document are available for inspection at the Nuclear-
~
Regulatory Commission Library, 7920 Norfolk Avenue, Lower Level, Bethesda, Maryland, 20814. A copy of the document is also on file at the Office of the Federal Register, 800 North Capitol Street NW., Washington, DC 20408.
52
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. c (b) In addition to the requirements specified in paragraph (a) of this
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.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 radionuclide in the device; l
(ii) Activity and the date on which this activity was last measured; (iii) Model number and serial number of the sealed ' source; i
(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 transport t
containers must meet the applicable requirements of 10 CFR Part 71.
(3) Modification of radiographic exposure devices and associated i
equipment is prohibited.
(c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the following requirements apply to radiographic exposure devices, source assemblies, 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 4
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. This 53
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securing system may only be released by means of a deliberate operation 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 on it, a durable, legible, visible label with the words:
" DANGER - RADI0 ACTIVE."
The label must not interfere with the safe operation of the exposure t
device or associated equipment.
(5) The guide tube must have passed the crushing tests for the control 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.
e (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 i
outermost end of the guide tube during radiographic operations.
(8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432.
(9) Source changers must provide a system for ensuring that the source I
will not be accidentally withdrawn from the changer when connecting or
)
disconnecting the drive cable to or from a source assembly.
(d) All newly manufactured radiographic exposure devices and associated equipment acquired by licensees after January 10, 1992, must comply with the i
requirements of this section.
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(e) All radiographic exposure devices, source assemblies, and associated equipment in use after January 10, 1996, must comply with the requirements of this section.
(f) All associated equipment acquired after January 10, 1996, must be t
labelled to identify that the components have met the requirements of this section.
15.
Section 34.21 is revised to read as follows:
5 34.21 Limits on levels of radiation for radiographic exposure devices, storace containers. and source changers.
(a) Radiographic exposure devices measuring less than 10 centimeters (4 inches) from the sealed source storage position to any exterior surface of the device must not have a radiation level in excess of 0.5 millisieverts (50 millirems) per hour at 15 centimeters (6 inches) from'any exterior surface of the device.
Radiographic exposure devices measuring a minimum of 10 centimeters (4 inches) from the sealed source storage position to any exterior surface of the device, and all storage containers for sealed sources or for radiographic exposure devices, must not have a radiation level'in excess of 2 millisieverts (200 millirems) per hour at any exterior surface, and 0.1 millisieverts (10 millirems) per hour at I meter from any exterior surface.
The radiation levels specified are with the sealed source in the shielded (i.e., "off") position.
(b)
Paragraph (a) of this section applies to all-equipment manufactured before January 10, 1992. After January 10, 1996, radiographic I
equipment other than storage containers and source changers must meet the requirements of 5 34.20. Section 34.21 applies only to storage containers.
55 i
,,.i.1, 16.
Section 34.22 is removed.
9 34.22 [ Removed]
17.
Section 34.23 is revised to read as follows:
J 34.23 Locking and relocation of radiographic exposure devices, storage containers and cource changers.
(a) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering.
(1) Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if a keyed-lock, with the key removed at all times),
when not under the direct surveillance of a radiographer or a radiographer's-assistant or as otherwise may be authorized in f 34.51.
In addition, during radiographic operations the sealed source assembly must be manually secured in the shielded position each time the source is returned to that position, in those exposure devices manufactured before January 10, 1992.
(2) Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent' unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if a keyed-lock, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.
(b) Radiographic exposure devices, source changers, and storage containers, before being moved from one location to another, must have the guide tubes and control cables disconnected, safety plugs or covers i?t: 8ed, 56
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locked and physically secured to prevent accidental loss,.' tampering or removal of licensed material, and must be surveyed to assure th'at the sealed source is in the shielded position.
18.
Section 34.24 is removed.
s 34.24 [ Removed]
19.
Section 34.25 is revised to read as follows:
9 34.25 Radiation surve_y instruments.
(a) The licensee shall keep sufficient calibrated and operable radiation -
survey instruments at each location where radioactive material is present to make the radiation surveys required by this part and by Part 20 of this chapter.
Instrumentation required by this section must be capable of measuring a range from 0.02 millisieverts (2 millirems) per hour through 0.01 Sievert (I rem) per hour.
Survey instruments must be checked for operability-before use each day.
This may be accomplished by evaluating.the instrument-response to the previously measured fields at the projcetion sheath port or i
the control cable sheath port on a radiographic exposure device.
(b) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated --
' l (1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes; (2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one' decade; and for digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 millirems) per hour; and 57 r
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(3) So that an' accuracy within plus or minus 20 percent of the t
calibration standard can be demonstrated at each point checked.
(c) The licensee shall. maintain records of the results of the instrument calibrations in accordance with s 34.65.
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20.
Section 34.26 is removed.
I s 34.26 [ Removed]
21.
Section s 34.27 is revised to read as follows:
9 34.27 Leak testino and replacement of sealed sources.
(a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed only by persons specifically authorized by the Commission or an Agreement State to do so.
(b) Testing and recordkeeping requirements.
(1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed 6 months.
(2) The licensee shall maintain records of the leak tests in accordance f
with s 34.67.
(3) In the absence of a certificate from the transferor that a leak test has been made within the 6 months before the transfer, the sealed source may not be used until tested.
(c) Method of testing. The wipe of a sealed source must be performed using a leak test kit or method approved by the Commission or an Agreement State.
The wipe sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate.
The wipe sample must be 58 i
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analyzed for radioactive contamination.
The analysis must be capable of detecting the presence of 185 Bq (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis.
(d) Any test conducted pursuant to paragraphs (b) and (c) of this section which reveals the presence of 185 Bq (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of,'in-accordance with Commission regulations.
A report must be filed with the i
Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 5 days of any test with results that exceed the threshold in this subsection, describing the equipment involved, the test results, and the corrective action taken.
A. copy of.the report must be sent to the Administrator of the appropriate Nuclear Regulatory Commission's Regional Office listed in Appendix D of Part 20 of this chapter
[
" Standards for Protection Against Radiation."
(e) A sealed source which is not fastened to or contained in a radiographic exposure device must have permanently attached to it a durable tag at least one (1) inch square bearing the prescribed radiation caution symbol in conventional colors, magenta, purple or black on a yellow background, and at least the instructions: " Caution (or Danger) -- Radioactive Material -- Do Not Handle -- Notify Civil Authorities (or Name of Company)." '
(f)
Each exposure device using depleted uranium (DU) shielding and an "S" tube configuration must be periodically tested for DU contamination. This i
test can be performed by the licensee using available test kits or method 59 j
approved by the Commission or an Agreement State, or the exposure device could be returned to the manufacturer for such testing. The analysis must be f
capable of detecting the presence of 185 Bq (0.005 microcuries) of radioactive i
material on the test sample and must be performed by a person specifically authorized by the Commission'or an Agreement State to perform the analysis.
This test must be undertaken at intervals not to exceed 12 months and should such testing reveal the presence of DU contamination, the exposure device must-l be removed from use and arrangements for repair or proper disposal in a facility licensed under 10 CFR Part 61 must be made.
A record of the DU leak-i test must be made in accordance with 9 34.67.
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22.
Section 34.28 is removed.
i s 34.28 [ Removed]
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23.
Section 34.29 is revised to read as follows:
s 34.29 Ouarterl_y inventor _v.
(a) Each licensee shall conduct a quarterly physical inventory to account for all sealed sources received and possessed under this license, (b) The licensee shall maintain records of the quarterly inventory in-accordance with s 34.69.
24.
Section 34.30 is removed.
s s 34.30 [ Removed]
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25.
Section 34.31 is revised to read as follows:
5 34.31 Inspection and raaintenance of radiographic exposure devices, storage r
containers. associated eauipment, and source changers.
(a) The licensee shall visually check for obvious defects in radiographic exposure devices, storage containers, associated equipment, and source changers before use each day the equipment is used to ensure that the equipment is in good working condition and that required labeling is present.
If defects are found, the equipment must be removed from service until-repaired, and a record must be made in accordance with 5 34.73.
-j (b) Each licensee shall have a program for inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment and storage containers at intervals not to exceed 3 months or before tPe first use thereafter to ensure the proper functioning of components important to safety.
Records of these inspections and maintenance performed must be made in accordance with 5 34.73.
If defects are found, the equipment must be removed from service until repaired, and a record must be made in accordance with 9 34.73.
(c) The opening, repair, or modification of any sealed source must be-i performed by persons specifically authorized to do so by the Commission or an 1
Agreement State.
l 26.
Section 34.32 is removed.
9 34.32 [ Removed]
l
)
61 q
i l
e
.-n-
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-e
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r
.]
27.
Section 34.33 is revised to read as follows:
i s 34.33 Permanent radiographic installations.
]
(a) Each entrance that is used for personnel access to the high radiation l
area in a permanent-radiographic installation must have either
.i (1) Entrance controls' of the type. described in s 20.1601(a)(1) of this chapter; or (2) Both visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the t
i source is exposed.
The audible signal must be actu?ted when an attempt is made to enter the installation while the source is exposed.
(b) The alarm system must be tested for proper operation at the beginning of each day the installation is used for radiographic operations.
.The test must include a check of the visible and audible signals by turning on the exposure device before using the room.
Entrance control devices must be t
tested monthly.
If a control device or alarm is operating improperly, it must be immediately labeled as defective and repaired before industrial radiographic operations are resumed. Test records must be maintained in accordance with s 34.75.
28.
Section 34.35'is added to read as follows:
l
$ 34.35 Labels, storage, and transportation precautions'.
(a) Labels.
~i (1) The licensee may not use a source changer or container to store I
licensed material unless the source' changer or the container has securely attached to it a durable,. legible, and clearly visible label. The label.must h
62 t
t
.g.
ey i
contain the radiation symbol specified in s 20.1904 of this chapter and the i
wording' CAUTION (0R DANGER)
RADI0 ACTIVE MATERIAL--D0 NOT HANDLE NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)
(2) The licensee may not transport licensed material unless the material is packaged,. and.the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR ~
Part 71,-including documentation of the Quality Assurance (QA) program requirements outlined in 5 71.105.
(b) Security precautions during storage and transportation.
l (1) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel 5
in accordance with the requirements in 5 34.23.
The licensee shall store licensed material in a manner which will minimize danger from explosion or
.1 fire.
(2) The licensee shall lock and physically secure the. transport package f
containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the l
vehicle.
29.
A new heading for Subpart D [9 5 34.41-34.57] is added to read as follows.
Subpart 0 - Radiation Safety Requirements 63
r 30.
Section 34.41 is revised to read as follows:
5 34.41 Conducting radiographic operations
'i (a) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of 5 34.43(b).
The additional qualified individual (s) shall observe the operations and be capable of providir,g immediate assistance to prevent unaul'9rized entry.
Radiography may not be performed if only one qualified individual is present.
(b) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the Commission.
31.
Section 34.42 is revised to read as follows:
s 34.42 Radiation Safety Officer.
The Radiation Safety Officer (RS0) shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program.
(a) The RS0's qualifications must include:
(1) Completion of the training and testing requirements of s 34.43(a);
and (2) 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented experience in industrial radiographic operations, with at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of formal classroom training with respect to the-establishment and maintenance of a radiation protection program.
(b) The specific duties of the RSO include, but are not limited to, the following:
64
+
r
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9
' 9"-
(1) To establish and oversee operating, emergency, and ALARA procedures as required by Part 20, and to review them regularly to ensure that the.
i procedures are current and conform with these rules; i
(2) To oversee and approve all phases of the training program for radiographic personnel so that appropriate and effective radiation protection
)
practices are taught; (3) To ensure that required radiation surveys and. leak tests are performed and documented in accordance with these rules, including any corrective.
.l measures when levels of radiation exceed established limits; (4) To ensure that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by j
s 20.2203; and (5) To ensure that operations are conducted safely and to assume control and have the authority to institute corrective actions including stopping of operations when necessary in emergency situations or unsafe conditions.
32.
Section 34.43 is revised to read as follows:
$ 34.43 Training.
f (a)
The licensee may not permit'any individual to act as a radiographer until the individual --
(1) Has been instructed in the subjects outlined in paragraph (f) of this part.
(2) Is certified through a radiographer certification program by a i
certifying entity in accordance with the criteria specified in Appendix A ~of this part. An independent organization that would like to be recognized as a 65
\\;.
1 certifying entity shall submit its request to the Director, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC. 20555.
(3) Has received copies of and instruction in the requirements described 1
in NRC regulations contained in this part; in ss 30.7, 30.9, and'30.10; in the applicable sections of Parts 19, 20, and 71 of this chapter, in applicable D0T regulations as referenced in 10 CFR Part 71, in the NRC license (s) under which the radiographer will perform radiography, and the licensee's operating and emergency procedures; i
(4) Has demonstrated understanding of NRC regulations, the licensee's-license, and the licensee's operating and emergency procedures by successful-completion of a written examination.
(5) Has demonstrated competence in the use of the licensee's radiographic exposure devices, sealed sources, related handling tools, and survey instruments; and i
1 (6) Has demonstrated understanding of the instructions in paragraph (a)(3) and (a)(5) of this section by successful completion of'a field examination.
(b) The licensee may not permit any individual to act as a radiographer's assistant until the individual --
[
(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part; in s5 30.7, 30.9, and 30.10; in the applicable sections of Parts 19, 20, and 71 of this chapter, in applicable l
DOT regulations as referenced in 10 CFR Part 71, in the NRC license (s) under' v
66 i
d
which the radiographer's assistant will perform radiograpny, and the licensee's operating and emergency procedures; (2) Has demonstrated competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments that the assistant will use; and (3) Has demonstrated understanding of the instructions in this paragraph (b) of this section by successfully completing a written test and a field examination o'n the subjects covered.
(c) The licensee shall provide annual safety reviews for radiographers and radiographer's assistants at least once during each calendar year.
(d) The licensee shall conduct an annual inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency procedures are followed.
The inspection program must:
(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed 12 months; and (2) Provide that, if a radiographer or a radiographer's assistant has not participateu in a radiographic operation for more than 6 months since the last j
inspection, the individual's performance must be observed and recorded when the individual next participates in a radiographic operation.
(e) The licensee shall maintain records of the above training to include i
certification docunents, written and field examinations, annual safety reviews and annual inspections of job performance in accordance with 5 34.79.
i I
67
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u (f) The licensee shall include the following subjects in the training required in paragraph _(a)(1) of this section:
(1) Fundamentals of raaiation safety including --
(i) Characteristics of gamma radiation; (ii) Units of radiation dose and quantity of' radioactivity; (iii) Hazards of exposure to radiation; (iv) Levels of radiation from licensed material; and (v) Methods of controlling radiation dose (time, distance, and shielding);
(2) Radiation detection instruments including --
(i) Use, operation, calibration, and limitations of radiation survey instruments; (ii) Survey techniques; and (iii) Use of-personnel monitoring equipment; (3) Equipment to be used including --
(i) Operation and control of radiographic exposure equipment, remote haridling equipment, and storage containers, including pictures or models of source assemblies (pigtails).
(ii) Storage, control, and disposal of licensed material; and (iii) Maintenance of equipment.
(4) The requirements of pertinent Federal regulations; and (5) Case histories of. accidents in radiography,
'(g) The licensee may, until- (2 years after the final ~ rule is published in-
~
the Federal Register), allow an individual who has not met the~ certification requirements of paragraph (a)(2) of this section to act as a radiographer after the individual has received training in the subjects outlined in 68
~
paragraph (f) of this section and demonstrated understanding of those subjects by successful completion of a written examination that was previously submitted to and approved by the Commission.
34.
Section 34.44'is removed s 34.44 [Renoved]
35.
Section 34.45 is added to read as follows:
s 34.45 Operating and emergenc_y procedures.
(a) Operating and emergency procedures must include, as a minimum, instructions in at least the following:
(1) The handling and use of licensed sealed sources and radiographic exposure devices to be employed such that no person is likely to be exposed to radiation doses in excess of the limits established in Part 20 of this chapter
" Standards for Protection Against Radiation";
(2) Methods and occasions for conducting adiation surveys; (3) Methods for controlling access to radiographic areas; (4) Methods and occasions for locking and securing radiographic exposura devices, storage containers and sealed sources;-
(5)- Personnel monitoring and the use of personnel monitoring' equipment; (6) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles, when needed, and control of the sealed sources during transportation (refer to 49 CFR Parts 171-173);
(7) The inspection and maintenance of radiographic exposure devices and storage containers; 69 7
(8) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarm ratemeter alarms; (9) The procedure (s) for identifying and reporting defects and '
noncompliance, as required by Part 21 of this chapter; (10) The procedure for notifying proper persons in the event of an accident; (11) Minimizing exposure of persons in the event of an accident; (12) Source recovery procedure if licensee will perform source recovery; and (13) Maintenance of records.
(b) The licensee shall maintain copies of current operating and emergency procedures in accordance with 5 34.81.
36.
Section 34.46 is added to read-as follows:
s 34.46 Supervision of radiographers' assistants.
Whenever a radiographer's assistant uses radiographic exposure devices, uses sealed sources or related source handling tools,-or conducts radiation surveys required by 9 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer.
The personal supervision must include:
(a) The radiographer's personal presence at the site where the sealed sources are being used; (b) The ability of the radiographer to give immediate assistance if required; and 70 1
t V.
(c)-The radiographer's watching the assistant's performance of the operations referred to in.this section.
37.
Section 34.47 is added to read as follows:
s 34.47 Personnel monitorina.
(a) The licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears a direct reading pocket dosimeter, an operating alarm ratemeter, and either a film badge or a thermoluminescent dosimeter (TLD). At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required.
(1)
Pocket dosimeters must have a range from zero to 2 millisieverts (200 millirems) and must be recharged at the start of each shift.
(2)
Each film badge and TLD must be assigned to and worn by-only one individual.
(3)
Film badges and TLDs must be replaced at least monthly.
(4) After replacement, each f0m badge or TLD must be promptly processed.
(b) Pocket dosimeters must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance 1
with 6 34.83.
(c) Pocket dosimeters must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with 9 34.83. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation exposure.
71-
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,m-
a (d) If-an individual's pocket dosimeter is found to be off-scale and the possibility of radiation exposure cannot be ruled out as the cause, the individual's film badge or TLD must be sent immediately for processing.
In addition, the individual may not work with licensed material until a determination of the individual's radiation exposure has been made.
This determination must be made by the RSO or the RS0's designee. The results of
~
this determination must be included in the records maintained in accordance i
with s 34.83.
i (e) If a film badge or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge or TLD is provided' and the exposure is calculated for the time period from issuance to loss or damage of the film badge or TLD.
The results of the calculated exposure and the time 3
period for which the film badge or TLD was lost or damaged must be included in r
the records maintained in accordance with 5 34.83.
i (f) Reports received from the film badge or TLD processor must be retained in accordance with 9 34.83.
(g) Each alarm ratemeter must --
(1) Be checked to ensure that the alarm functions properly (sounds) before using at the start of each shift; i
(2) Be set to give an alarm signal at a preset dose rate of 5 mSv/hr (500 1
mrem /hr); with an accuracy of plus or minus 20 percent of the true radiation I
dose' rate.
i (3) Be adequate to alert the individual regardless of the environmental i
conditions (e.g., high ambient' noise levels).
(4) Require special means to change the preset alarm function; and 72
1 (5) Be calibrated at periods not to exceed'12 months for correct response to radiation. The licensee shall maintain records of alarm ratemeter calibrations in accordance with 9 34.83.
38.
Section 34.49 is added to read as follows:
s 34.49 Radiation surve_ys.
The licensee shall:
(a) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of s 34.25.
(b) Conduct an adequate survey of the radiographic exposure device with a radiation survey instrument after each exposure to determine that the sealed a
source has been returned to its shielded position.
(c) Conduct a survey when approaching the guide tube before exchanging films, repositioning the collimator, or dismantling equipment.
(d) Conduct an adequate survey with a radiation survey instrument-any time the source is exchanged and whenever a radiographic exposure device is placed in a storage area (as defined in s 34.3) to ensure that the sealed source is in its shielded position.
(e) Conduct a survey of the storage area to ensure that radiation levels do not exceed the limits specified in 10 CFR 20.1301.
These surveys must be performed initially with radioactive material present in the storage location and thereafter at the time of the quarterly inventory and whenever storage conditions change (i.e., increases in radioactive material present or changes in shielding or arrangement of the radioactive material).
(f) Maintain records in accordance with 9 34.85.
73
39.
Section 34.51 is revised to read as follows:
9 34.51 Surveillance.
During each radiographic operation the radiographer or radiographer's assistant shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as-defined in Part 20 of this chapter, except at permanent radi(graphic installations where all entryways are locked and the requiremt.nts of 9 34.33 are met.
40.
Section 34.53 is added to read as follows:
9 34.53 Posting.
Areas in which radiography is being performed must be conspicuously posted as required by 9 20.1902(a) and (b) of '.nis chapter.
Exceptions listed in 9 20.1903 of this chapter do not apply to radiographic operations.
k 41.
A new heading for Subpart E (9 9 34.61-34.91) is added to read as follows:
Subpart E - Recordkeeping Requirements 42.
Section 34.61 is revised to read as follows:
9 34.61 Records of specific license for radiography.
Each licensee shall maintain a copy of its license, license conditions, r
documents incorporated by reference, and amendments to each of these items until superseded by new documents or until the Commission terminates the license.
t c
74
a.
f 43.
Section 34.63 is revised to read as follows:
s 34.63 Records of-receipt and transfer of sealed sources.
'(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and retain each record for 3 years after it is made.
(b) These records must include the date, the individual making the record, the radionuclide, number of becquerels (curies), and make, model, and serial number of each sealed source and_ device, as appropriate.
44.
Sections 34.65 - 34.91 are added to Subpart E.to read as.follows:
s 34.65 Records of radiation survey instruments.
. Each licensee shall maintain records of the calibrations of its radiation survey instruments and retain each record for 3 years after it is made.
s 34.67 Records of leak testino of sealed sources.
Each licensee shall maintain records of leak test results in units of becquerels- (curies) and retain'each record for 3 years after it is made.
s 34.69 Records of quarterly inventory.
(a) Each licensee shall maintain records of the quarterly inventory and retain each record for 3 years after it is made.
(b) The record must include the quantities and kinds of byproduct material (including the model number, the serial number and manufacturer),
location of sealed sources, the name lof the individual conducting the inventory, and the date of the inventory.
75
s 34.71 Utilization loos.
(a) Each licensee shall maintain current utilization logs at the address specified in the license, showing for each sealed source the following information:
(1) A description, including the make, model number, and serial number of-the radiographic exposure device or storage container in which the sealed source is located; (2) The identity and signature of the radiographer to whom-assigned; and (3) The plant or site where used and dates of use, including the dates removed and returned to storage.
(b) The licensee shall retain the logs required by paragraph (a) of this-section for 3 years after the log is made.
I J 34.73 Records of inspection and maintenance of radiographic exposure devices, storace containers, associated eauipment, and source chanaers.
(a) Each licensee shall maintain records of defects found in daily checks and quarterly inspections and maintenance-of radiographic exposure devices, storage containers, associated equipment, and source changers, and retain each record for 3 years after it is made.
(b) The record must include the date of check, name of inspector, equipment involved, any defects.found, and repairs made.
l 5 34.75 Records of alarm system-and entrance control checks at permanent i
radicaraphic installations.
l' Each licensee shall maintain records of alarm system and entrance L
control device tests and retain each record for 3 years' after it is made, t
76 1
1
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s 34.79 Records of training and certification-.
Each licensee shall maintain the following records (of training and certification). for 3 years after the record is made:
(a) Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents, certification status verification, copies of written tests, dates of field l
examinations, and names of individuals conducting the field examinations, and (b) Records of annual safety reviews and annual ins'pections for'each radiographer and each radiographer's assistant.
The records must list the topics discussed during the annual safety review, the dates the annual safety review was conducted, and names of the instructors and attendees.
For annual inspections, the records must also include a list showing the items checked and any regulatory non-compliances observed by the RSO.
i s 34.81 Copies of operating and emeroency procedures.
Each licensee shall maintain a copy of current operating and emergency procedures until the Commission terminates the license.
Superseded material.
q must be retained for 3 years after the change is made.
s 34.83 Records of personnel monitorino.
Each licensee shall maintain the following exposure records:
(a) Daily pocket dosimeter readings and yearly operability checks for 3 years after the record is made.
(b) Records of alarm ratemeter calibrations for 3 years-after the record.
j R
is made.
'I 77
(c) Reports received from the film badge or TLD processor until.the Commission terminates the license.
(d) Records of estimates of exposures as a result of off-scale pocket dosimeters or lost or damaged film badges or TLDs until the Commission terminates the license.
5 34.85 Records of radiation surve_ys.
t Each licensee shall maintain a record of each exposure device survey conducted before placing the device in storage in accordance with 5 34.49(e) for 3 years after the record is made, if that survey is the last one performed in the work day.
5 34.87 Form of records t
Each record required by this part must be legible throughout the specified retention period.
The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.
Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
78
5 34.89 Documents and records reauired at field stations and permanent installations.
Each licensee shall maintain copies of the following documents and records sufficient to demonstrate compliance at the field station and permanent installation:
(a) A copy of Parts 19, 20, and 34 of NRC regulations; (b) The license authorizing the use of licensed material; (c) Operating and emergency procedures required by 5 34.45; (d) Records of radiation survey instrument calibrations required by 5 34.65; (e) Records of leak test results required by 5 34.67; (f) Quarterly inventory records required by 5 34.69; (g) Utilization records required by 5 34.71; (h) Records of inspection and maintenance required by s 34.73; (i) For permanent installations, records of alarm system and entrance control checks required by s 34.75; (j) Training and certification records required by 5 34.79; (k) Survey records required by 5 34.85; (1) Personnel monitoring records as required by 5 34.83; and (m) Records of receipt and transfer of sealed sources required by 5 34.63.
s 34.9) Documents and records required at temporary.iobsites and use or storage locations exceedino 180 days.
Each licensee conducting operations at a temporary jobsite shall maintain copies of the following documents and records at the temporary jobsite until 79
s the radiographic operation is completed and at any storage location where radioactive material is stored for more than 180 days:
(a) Operating and emergency procedures required by 5 34.45; (b) Evidence of latest calibration of the radiation survey instruments in use at the site required by 5 34.65; (c) Evidence of latest calibrations of alarm ratemeters and operability checks of pocket dosimeters as required by 5 34.83; (d) Latest survey records required by 5 34.85; (e) The shipping papers for the transportation of radioactive materials required by 5 71.5 of this chapter; and (f) When operating under reciprocity pursuant to 5 150.20 of this chapter, a copy of the Agreement State license authorizing use of licensed c
materials.
45.
A new Subpart F is added to read as.follows:
Subpart F - NOTIFICATIONS 46.
Section 34.101 is added to read as follows:
% 34.101 Notifications.
(a) In addition to the reporting requirements specified in-5 30.50 and under other sections of this'. chapter, each licensee shall provide a written report to the U.S. Nuclear Regulatory Commission, Division of-Industrial and Medic'al Nuclear Safety, Washington, DC 20555, with a copy to the Director,_
I Office for Analysis and Evaluation of Operational Data, U.S. Nuclear 80
s.
9' Regulatory Commission, Washington, DC 20555, within' 30 days of.the occurrence of any of the following incidents involving radiographic equipment:
f
-(1) Unintentional di.sconnection 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;.or (3) Failure of any component (critical to safe operation of the device)'
l to properly perform its intended function; (b) The licensee shall include the following information in each report submitted under paragraph (a) of this section, and in each report of overexposure submitted under 10 CFR 20.2203 which involves failure of safety components of radiography equipment:
(1) A description of the equipment problem; (2) Cause of each incident, if known; (3) Name of the manufacturer and model number of equipment involved in the incident; (4) Place, date and time of the incident;
)
(5) Actions taken to establish normal operations, (6) Corrective actions taken or planned to prevent recurrence; and (7) Qualifications of personnel involved in the incident.
(c) The licensee shall notify the appropriate NRC regional office in writing 30 days before conducting-radiographic operations or storing' i
radioactive material-at any location not listed on the license in excess of 180 days.
1 81
a 47.
A new subpart G is added to read as follows:
Subpart G - EXEMPTIONS 48.
Section 34.111 is added'to read as follows:
i 9 34.111 Applications-for exemptions,.
The Commission may, upon application of any interested person or upon-its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and'will not endanger life.
or property or the common defense and security and are otherwise in the public~
interest.
i 49.
A new Subpart H is added to read as follows:
Subpart H - Violations 50.
Section 34.121 is added to read as follows:
s 34.121 Violations.
(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of (1) The Atomic Energy Act of:1954, as amended;
.(2) Title II of the Energy Reorganization Act of-1974, as amended; or l
(3) A regulation or order-issued pursuant to these Acts.
(b) The Commission may obtain a court order for the payment of.a civil i
penalty imposed under section 234 of the Atomic Energy Act; (1) For violations of -
t (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the i
Atomic ~ Energy Act of 1954, as amended; 82 i
n
-4 (ii) Section 206 of the Energy Reorganization Act; (iii) Any' rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section.
(iv) Any term, condition, or limitation of any license issued under_ the sections specified in paragraph (b)(1)(i) of this section.
(2) For any violation for which a license may be revoked under section 188 of the Atomic Energy Act of 1954, as amended.
51.
Section 34.123 is added to read as follows:
5 34.123 Criminal penalties.
(a) Section 223 of the. Atomic Energy Act of 1952, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of sections 161b,1611, or 1610 of the Act.
For purposes of section 223, all the regulations in Part 34 are issued under one or more of sections 161b,1611, or.
1610, except for the sections listed in paragraph (b) of this section.
(b) The regulations in Part 34 that are not issued under sections 161b, 1611, or 1610 for the purposes of section 223 are as follows: 5 34.1, 5 34.3, 5 34.5, 5 34.8, 5 34.11, 5 34.13, 5 34.111, 9 34.121, 5 34.123.
r
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83
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d 52.
Appendix A is. revised to read as follows:
APPENDIX A to Part 34 1.
Requirements for an Independent Certifying Organization.
An independent certifying organization shall:
1.
Be an organization such as a society or association, whose members participate in, or have an interest in, the fields of industrial radiography or non-destructive testing; 2.
Make its membership available to the general public nationwide 1
that is not restricted because of race, color, religion, sex, age, national origin or handicap; 3.
Have a certification program open to nonmembers; 4.
Be an incorporated, nationally recognized organization, that is involved in setting national standards of practice within its fields of expertise; h
5.
Have a permanent full-time staff, a viable system for financing its operations, and a policy-and decision-making review board; 6.
Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies; Y
7.
Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization's staff in implementing the certification program; 8.
Have a committee, whose members can carry out their responsibilities. impartially, to review complaints against certified individuals and to determine appropriate sanctions; 84
9.
Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual's certification and the administration of its certificatica program; 10.
Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against-certified individuals; and 11.
Have procedures to ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees; 12.
Exchange information about certified individuals with the Commission and the independent certifying organizations and allow periodic review of its certification program and related records; 13.
Provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment.
i II.
Requirements for Certification Programs.
All certification programs must:
1.
Require that individuals (a) receive training in the topics set a
forth in 5 34.34(f) of this part, and (b) satisfactorily complete a written examination covering these topics; t
2.
Require applicants for certification to provide documentation that -
. demonstrates that the applicant has:
(a) received training in the topics set forth in section 34.43(f) to this part; (b) satisfactorily completed a minimum period of on-the-job training; and (c) has received verification by an 4
85
o t
Agreement State or a NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer; 7
3.
Include procedures to ensure that all examination questions are protected from disclosure; 4.
Include procedures whereby an application or certification would be considered null and void if the applicant or certified individual is prohibited from acting as.a radiographer by a regulatory agency at the time of making the application; 5.
Provide a certification period of not less than 3 years nor more.
than 5 years; 6.
Include procedures for renewing the certifications and, if the procedures allow renewals without examination, require evidence of recent t
active full-time employment and annual ' refresher training; 7.
Include procedures whereby an individual's certification may be revoked, suspended, or restricted for willful or significant failure to comply with his or her employer's operating or emergency procedures, or the Commission's or an Agreement State's regulations; 8.
Provide for automatic suspension of an individual's certification, based on Commission or Agreement State action prohibiting the individual from acting as a radiographer; 9.
Provide for sanctions imposed against certified individuals that.
are at least as severe as any action taken by the Commission'or an Agreement State; and 10.
Provide a timely response to inquiries, by telephone or letter, from members of the public, about an individual's certification status.
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e III. Requirements-for Written Examinatioris-All examinations must be:
1.
Designed to test an individual's knowledge and understanding of the topics listed in section 34.43(f) or equivalent Agreement State
-i requirements; 2.
Written in a multiple-choice format; 3.
Written at a ninth-grade reading comprehension level; 4.
Scientifically-analyzed, before use, to ensure that the questions are not biased or misleading, and that the examinationLof one certifying entity will produce a result equivalent to that of another certifying entity;-
5.
Tested by at least 50. individuals before being used in an actual examino. ion leading to certification of individuals; and 6.
Composed of questions randomly selected from a population of questions that contains ten times as many questions as may be needed for any-I one examination, to ensure that it is unlikely that an examinee would retake i
the same examination.
l PART 150 -- EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 53.
The authority citation for part 150 continues to read as follows:
AUTHORITY:
Sec. 161, 68 Stat. 948, as amended, sec. 274, 73 Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued under er r
lle(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84, 92 Stat. 3033, L,i9 (42 U.S.C. 2014e(2), 2111, 2113, 2114).
Section 150.14 also issued under 87
I sec. 53, 68 Stat. 930, as amended (42 U.S.C. 2073).
Section 150.15 also issued under secs. 135,141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
Section 150.17a also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).
Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C. 2282).
54.
A new 5150.15b is added to read as follows:
9 150.15b Continued Commission authority pertaining to independent certifyinq organizations.
The Commission reserves the authority to establish minimum standards regarding industrial radiographer certification programs and independent certifying organizations, as described in Part 34 of this Chapter, and to identify acceptable certifying entities.
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In L $ 150.33, paragraph (b) is revised to read as' follows:
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6 150.33 Criminal penalties.
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.(b)
The regulations in part 150 that are not issued under i
l sections 1Gib, 1611, or 1610 for the purposes of section 223 are as-follows:
s 5 150.1, 150.2, 150.3, 150.4,.150.5, 150.7, 150.8, 150.10, 150.11, 150.15, 150.15a, 150.15b, 150.30, 150.31,.150.32, 150.33.
Dated at Rockville, Maryland, this day of 1993.
i
!r For the Nuclear Regulatory Commission.
f Samuel J. Chilk,
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Secretary of the Commission.
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Appendix A - Initial Regulatory Flexibility Analysis
.for Revision of 10 CFR Part 34 i
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing industrial radiography.
The proposed rule would include additional safety-requirements to enhance.the level of protection of radiographers and the public and would clarify.the regulations so-that licensees may have a better understanding of what is expected in radiographic operations. The proposed rule includes a number of updated radiography regulations that have been adopted by many Agreement States.
The format of the radiography regulations would be adjusted to place requirements into descriptive categories.
The radiography industry in the United States consists of approximately 700 firms. employing about 20,000 individuals, that perform radioisotope f
radiography either at fixed locations or at multiple temporary job sites. Of these firms, approximately 200 are NRC licensees employing about 3,400 radiographers with an additional 2,000 radingraphy supervisors and radiographers' assistants. This estimate is based on 1990 data for the number of individuals monitored for radiation exposure to comply with la CFR Part 20.
The industry uses an estimated 3,500 radiographic exposure devices that employ either cobalt-60 or iridium-192 radioisotope sources.
Roughly one-quarter of the firms conduct radiography at a single location and the other three-quarters work at multiple locations generally referred to as temporary jobsites.
Approximately 90 percent are considered to be "small entities" under the-criterion established in Section 605(b) of the Regulatory Flexibility Act of 1
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-1980. Most of the radiography licensees are in the business of non-destructive testing in which radiography represents only a part of their-total income. A few small firms work only in radiography.
Much of the work in the field involves the inspection of welds in bridges, oil, gas, and other i
pipelines and in the steel framework of commercial buildings under t
construction so that the success and viability of the industry is closely tied to the economic health of the country.
NRC surveys indicated that 76 percent t.
of NRC radiography licensees had annual receipts of over $500,000, and most of the remainder had annual receipts exceeding $250,000.
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605' (b)), the Commission believes that this rule may, if promulgated, have a significant economic impact on a substantial number of small entities.
I The proposed revisions to Part 34 are intended to provide additional safety requirements to enhance the level of protection of radiographers and the public and to clarify the regulations so that licensees may have a better understanding of what is expected in radiographic operations.
The proposed rule includes a number of radiography regulations which have been adopted by the Agreement States.
The proposed revisions to Part 34 can be grouped into major and minor impacts.
Of the five major impacts, the proposed requirement to have a second qualified individual at temporary jobsites may have a significant effect on i
small entities, who would be more likely to use single-person crews.
It should be recognized that under the current rule many licensees already need to have, at least, two qualified individuals present at a temporary jobsite to f
maintain direct surveillance of radiographic operations so as to protect against any unauthorized entry into the restricted area.
Therefore, this 2
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s proposed requirement will only impact those operations where two individuals are not currently required.
It was assumed in the draft Regulatory Analysis I
l that approximately 25 percent of NRC licensees who perform radiography at j
temporary jobsites will need to hire and train additional staff to meet the proposed requirement. Other assumptions used in the draft Regulatory Analysis were that each of these 50 licensees would need to hire 3-4 additional workers, and that the cost of each assistant is $24,000 per year including benefits.
The other major impacts include mandatory certification requirements for radiographers, additional training for radiographers' assistants, a specific requirement for a Radiation Safety Officer (RS0) who meets certain training requirements, requirements for permanent installation alarms, and additional requirements for alarm ratemeters. The estimated costs for all of these changes are significantly less than the costs associated with adopting the two-person rule. The initial costs to certify radiographers is approximately' r
$4080. The initial costs for each licensee to provide an additional eight hours of training for radiographers' assistants is approximately-$1,200.
The initial costs to provide the additional training required to meet the proposed RSO requirements is $3,700 per RSO.
The initial costs to install alarms in permanent installations is estimated to be $3,000.
The initial costs to purchase additional upgraded alarm ratemeters is estimated to be $1800. The other proposed revisions which are of a minor nature, would result in initial costs of $700-5800 per licensee.
In addition, the proposed rule includes a reduction in the number of field inspections to be conducted, from quarterly to annual. This reduction would lead to an estimated annual savings to each NRC licensee of i
3
I approximately $16,000.
The proposed rule also includes a reduction in the frequency for radiation survey instrument calibrations from 3 months to 6 months. This reduction would lead to an estimated annual savings to each NRC licensee of approximately $1400, 9
Of these changes, the costs to adopt the two-person rule may have the most impact on a substantial number of 'small entities"; however, the Commission believes that by requiring at least two qualified individuals to always be present when radiographic operations are being conducted, there will' be a significant increase in assurance that operational safety measures and emergency procedures will be implemented effectively.
The potential for a lowering of the risk of unintended public exposure can be viewed as a potential cost savings to the industry.
This proposed rule does not duplicate or conflict with other Federal rules. No other alternative i
regulatory provisions that would minimize the economic impact on small entities were considered.
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ENCLOSURE 3 j
DRAFT REGULATORY ANALYSIS
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s DRAFT REGULATORY ANALYSIS OVERALL REVISICH Of 10 CFR PART 34 1.0 Statement of the Problem Part 34 of Title 10 of the Code of Federal Regulations was first published in 1565 as part of the recodification of Parts 30 and 31 for the purpose of simplifying and clarifying the format of the then-current regulations regarding radiography so that persons subject to byproduct material licensing regulations could better use and understand them.
Numerous modifications of the original Part 34 have been issued since 1965, such as the performance requirements for radiography equipment and additional requirements related to equipment malfunctions, both of which were published in 1990, and the modification which was published in 1991, gives licensees the option to have their radiographers certified by the American Society for Non-Destructive Testing (ASNT) in lieu of certain training requirements.
In spite of numerous modifications to the original Part 34, certain regulatory requirements have been frequently misinterpreted and have led to increased numbers of enforcement actions.
Also, the radiography. industry seems to be prone to incidents involving radiation overexposures of its personnel.
In the period 1980 through 1988, Nuclear Regulatory Commission (NRC) exposure data indicate that radiography accounted for'over 25 percent of
.t all radiation overexposures reported by NRC licensees, although radiographers make up only 4 percent of NRC non-reactor licensees.
It is believed that misinterpretation of some of the regulatory requirements could be at-least partially responsible.
In view of this, it has been recommended that an 1
overall revision to Part 34 be undertaken to make it clearer and more compatible with other radiography regulations currently in use.
Following the recs =Lendations of the Commission, the staff has reviewed Part E of the
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" Suggested State Regulations for Control of Radiation" developed by the Conference of Radiation Control Program Directors Inc. (CRCPD), Part 31 of the Texas Regulations for the Control of Radiation, Chapter 5 of the Louisiana Radiation Regulations, and Section 18 of the Canadian " Atomic Energy Control-Regulations" for the purpose of determining what revisions should be made to Part 34.
In addition, recommendations made at the CRCPD Annual Meeting held in Wichita, Kansas on May 14, 1991; the All Agreement States Meeting held in Sacramento, California, in October 1991; and at the Office of State Programs' Workshops held in Mobile, Alabama, in May 1992, and Dallas, Texas, in November 1992, have been taken into consideration in developing the proposed revision.
1.1 The Industr_y The radiography industry, which is the concern of this regulatory analysis, consists of approximately 700 firms in the United States that perform radioisotope radiography either at fixed locations or at multiple temporary jobsites.
This industry employs full-time about 20,000 radiographers and radiographers' assistants. Of these firms approximately 200 are NRC licensees, employing about 6,000 workers and the remainder are licensees of the~ Agreement States.
Roughly one quarter of the firms conduct -
radiography at a single location, the other three quarters work at multiple locations generally referred to as temporary jobsites.
Approximately 90 i
percent of the licensees are considered to be "small entities" under the criterion established in Section 605(b) of the Regulatory Flexibility Act of j
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1980. The industry uses-an estimated 3,500 devices, 1,400'of which are in use.
by NRC licensees.
Typically, radiographic exposure devices employ either cobalt-60 or iridium-192 radioisotope sources. Most of the radiography licensees are in the business of non-destructive testing, in which radiography represents only part of their total income. However, a few small firms work only in radiography. Much of the work in the field (e.g., temporary jobsites) involves the inspection of welds in bridges, oil, gas and other. pipelines, and in the steel framework of commercial buildings under construction.
1.2 Pronosed Changes The chan'es proposed in this revision of 10 CFR Part 34 are directed s
toward improving the safety performance in industrial radiography.
The proposed revision rpecifies new requirements for two-person crews, f
requirements for mandatory certification of radiographers, a re-definition of a permanent radiographic installation, the designation of and the qualifications for a Radiation Safety Officer (RS0), specification of required documents at various radiographic operations sites, some additional training i
for radiographers' assistants, recordkeeping and labeling requirements',.and a new requirement for leak testing of radiographic exposure devices.
In addition, a number of the changes involve a reorganization of the regulations for the purpose of clarification, and also includes some new definitions, as well as redefinition of some terms in the present regulation.
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2.0 Objectives J
The NRC is proposing to revise its regulations governing industrial radiography. The revision would include additional-safety requirements to 3
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enhance the. level of protection of radiographers and the public and would 1
clarify the regulations so that licensees will have a better understanding of
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what is expected in radiographic operations.
There has not been an overall revision of Part 34 in many years during which time the Agreement States have updated their radiography regulations.
This revision incorporates certain provisions of the updated Agreement State regulations.
The format of the q
proposed revision has been modified to place requirements into categories which describe the type of requirements that are found in each subpart.
3.0 Alternatives The alternatives are to revise Part 34 as planned, to take no action at this time and continue in the status quo, or to clarify and update the existing Part 34, but impose no new substantive requirements.
j Alternative 1 - Revise Part 34 as Planned Adoption of this alternative would result ie a comprehensive revision of 10 CFR Part 34.
Since many of the proposed changes involve rearrangement of sections of the current regulation and rewording to make them more understandable, adoption.of this alternative should serve to reduce the number of misinterpretations of the regulation which often result in enforcement actions for failing to follow safety requirements.
The revision would also make Part 34 more consistent with Agreement State regulations, T
The requirements for two-person crews, mandatory certification of radiographers, and Radiation Safety Officers are the most costly changes to Part 34. Most of the changes-to Part 34 that would be brought about by this-4
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- rulemaking, e.g., recordkeeping, labeling, additional training for j
'radiographers' assistants, and additional testing of certain radiographic i
exposure devices, should not have significant impacts on either large or small licensees. When compared to the potential safety benefits to be derived, the requirements for two-person crews should not pose an unnecessarily onerous burden since many licensees already use radiographers' assistants.
The major impact of imposing the two-person rule will be on small. licensees which E
currently only employ one or two radiographers and might need to double their workforce by hiring radiographers' assistants.
Alternative 2 - No Action Alternative 2 is to take no action at this time and continue in the status quo.
The principal impact of taking this alternative would be to continue a situation in'which radiography contributes disproportionately to the number of overexposures occurring each year.
In addition, this alternative would leave in place those portions of the current Part 34 that are inconsistent with the regulations of many Agreement States, which would continue to lead to confusion on what requirements are in place when radiographers work both in Agreement States and in States which are under NRC jurisdiction.
Alternative 3 - Clarify and Vodate the Existing Part 34, but Not Imoose the Two-person Rule.
Ur. der this alternative, the NRC would modify the current Part 34 to clarify and update ambiguous and out-moded requirements. However, the provision for the two-person rule that would impact on licensees would not be 5
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i proposed.
This alternative ignores some of the ~ primary benefits sought in the revision of Part 34.
4.0 Impacts Alternative 1 - Revise Part 34 as Planned
- 1. NRC Adopting Alternative 1 should not have a significant impact on NRC resources to review license applications since most of the additional requirements in the proposed revision will not require license amendments.
Little additional time will be needed to inspect implementation of the additional requirements. Currently, it takes a week to review a license application, and three-quarters to 1 day to inspect a licensee.
The additional requirements specified in the proposed rule should not substantially increase either application review or l inspection time.
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- 2. Licensees The discussion of the impacts lof the proposed rulemaking on.NRC licensees is divided into those that will have major impacts resulting from substantive new requirements, and those that will have minor impacts resulting from requirements such as additional recordkeeping and device testing.
The impacts for Agreement States were not included in this assessment since many l
Agreement States already require a number of the proposed requirements.
Although only the States of Texas, Illinois, and North Dakota have adopted mandatory radiographer certification requirements, the number of radiographers tested represent approximately 25 percent of the radiographers in all Agreement States.
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- a. Major Impacts l
- i. Two Person Crews l
Two-person crews may add to the costs of performing radiography. at locations where there is no permanent radiographic installation.
Nonetheless, a number of Agreement' States have had such a requirement in their regulations for several years, and consider it both necessary and beneficial.
In many of these States the requirement is to have a minimum of two fully-qualified radiographers to be in compliance.
In these States radiographers' assistants or radiographer trainees, although present and working at'the jobsite, are not considered to be part of the required two-person crews. The NRC, however, is proposing that the two-person crew needs to be composed of only one qualified i
radiographer and that the other person may be an individual who meets at least the qualifications of a radiographer's assistant.
Radiographer's helpers, who are used by some of the larger radiography licensees to patrol and' survey radiation boundaries and who are not trained in radiation safety to the level of a radiographer's assistant, would not be considered to be members of the two-person crews.
As stated previously, some three-quarters of the industrial isotope radiography occurs at locations other than permanent radiographic installations.
It is assumed that approximately one-third (2,000) of the radiography personnel discussed in Section 1.1 are radiographers' assistants.
It is further assumed, for the purpose of estimating the cost of the two-person crew amendment, that assistants are utilized at 85 percent of the jobsites under the present regulations.
NRC regulations have always required licensees to maintain surveillance of radiographic operations to protect 7
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,against unauthorized entry into a high radiation area.
In many cases, this P
would require the presence of more than one qualified individual, so that many NRC licensees are already using two or more individuals at temporary job sites.
This means that two-person crews that meet the minimal NRC requirements specified in the previous paragraph already exist Therefore, imposition of this requirement will impose additional costs only in those cases where licensees are in the habit of using only single person crews.
Further, it was pointed out at a recent All Agreement States meeting, that if this requirement were imposed on all radiography licensees uniformly (which would include Agreement State licensees, many of whom already require two-person crews), all licensees would be operating on "a level playing field" with no licensee having an economic advantage over the others by virtue of being able to use a single person crew.
The additional cost of implementing this requirement is estimated to be $24,000 per licensee to hire an additional assistant. This figure was arrived at using the following: a radiographer's assistant who is paid $12 per hour (including benefits), and works 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> 1
per year, earns $24,000 per year.
For the majority of licensees, this should not result in any impact since many are already using two-person crews.
It is estimated that approximately 25 percent of licensees who perform radiography at temporary jobsites would be required to hire additional staff to meet-this requirement.
These licensees could be expected to hire 3-4 additional workers, and at $24,000 per assistant per year, the resulting licensee cost 4
would be $96,000. The annual cost to industry would be approximately $4.8 million, if 50 NRC licensees each were required to hire 4 radiographers'
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assistants at a cost of $24,000 per assistant per year.
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l The primary reason for specifying a two-person crew is to reduce the j
likelihood that members of the public would be inadvertently exposed to 1
radiation resulting from improper surveillance of-the restricted area, or if an incapacitating injury to a radiographer-should occur at a remote location while the source is exposed, the presence of a second individual could be an important factor in preventing unnecessary radiation exposures, it should be noted that while the cost of hiring and maintaining an additional assistant may be more expensive than installing and maintaining alarms on a " permanent installation" (see below), licensees would have the option of constructing a l
" permanent installation" at jobsites, where feasible, in lieu of providing a second person.
However, the NRC recognizes that establishing a " permanent installation" per 5 34.33 at a jobsite is not possible in many, if not most, instances.
ii.
Mandator _y certification for radiographers.
The proposed revision to the training requirements in section 34.43(a) to require mandatory certification for radiographers would require all radiographers to be certified.
Currently, certification has been optional under Part 34, and to date about three hundred radiographers have been certified through the voluntary ASNT program.
In developing the voluntary radiographer certification rule (see 56 FR 11504; March 19, 1991), the ASNT estimated that the cost to-the industry for certification to be approximately $300 to $400 per radiographer. These estimated costs consist of $95 for examination and certification fees for ASNT members and $140 for examination and certification fees for non-members.
The remainder represents estimates for travel, food, and lodging for persons 9
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applying for certification.
Travel costs, which represented a significant j
fraction of the total cost, could not be estimated with certainty because the number of locations at which the examination would be offered was uncertain.
However, ASNT has indicated that it expects to offer the examination at as many locations as possible.
Therefore, most examinees could travel to and from the testing site by automobile the same day, thus eliminating lodging costs. Under these circumstances, the staff estimates the cost of travel and food to be about $100. The ASNT certification is valid for 3 years, and those who qualify for re-certification without examination will be charged $55 for members and $100 for non-members.
Individuals who fail the examination will be charged $60 to re-take the examination.
For the purpose of this analysis, the cost is estimated to be $240 ($140 ASNT fee and $100 travel costs) per radiographer, and $4,080 per NRC licensee, assuming 17 radiographers per NRC licensee.
The cost for re-certification is estimated to be $200 ($100 ASNT fee + $100 travel costs) per radiographer.
This may be an overestimate since many radiographers will not require re-testing.
This would result in an initial industry fee of $816,000 for all NRC licensees, and an annual estimated 0&M cost of $220,000, based on 1,100 radiographers being re-certified per year with each certification remaining valid for 3 years. This translates into an annual cost for each licensee of $1,100.
iii, Additional Training of Radiographers' Assistants The proposed paragraph 34.43(b)(1) will require that the radiographers' assistants be given instruction in the following portions of 10 CFR:
95 30.7, 30.9, 30.10, and applicable sections of Parts 19, 20, and 71. They must also be given instruction in applicable Department of Transportation 10 f
i O-(DOT) regulations and in the-NRC license (s) under which the radiographer will perform radiography.
This.is in addition to the current requirements to provide instruction in the licensees operating and emergency procedures.
It is estimated that this requirement will require an additional day of training for all radiographers' assistants. By assuming that there are 2,000 assistants for 200 NRC licensees, that the assistants are paid a salary of $12 per hour I
e (including benefits), and given 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of instruction, this would result in a cost of $96 per assistant per licensee, plus a cost of $240 ($30/hr X 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />) in salary and benefits of the Radiation Safety Officer's time to conduct the training.
By using the estimate that one-third of the workers are assistants, this would result in a one-time cost of $1,200 per licensee, assuming the RSO h
conducted the training of all assistants at the same time.
This would result in an additional one-time impact of $240,000 for the estimated 200 NRC licensees.
For licensees required to hire additional assistants (using the assumptions in Section i.), the cost would be an additional $624 per NRC licensee, or an additional one-time cost to industry of $31,200, assuming that 25 percent of licensees would need-to hire additional workers.
There could be an additional annual cost of $336 per licensee to train any additional staff hired, which would result in an annual industry. cost of $67,200, assuming each licensee had to hire one radiographer's assistant per year.
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iv. Radiation Safety Officer The requirement in Section 34.13(g) to. designate a Radiation Safety Officer (RS0) is new.
Currently, Regulatory Guide 10.6, which describes the
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information applicants must submit in applying for a license, requests the l
applicants to submit the name of the individual who would be responsible for 11
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the supervision of the radiation safety program.
In addition, the guide states that this individual should be a qualified radiographer and.have had a -
minimum of one year of actual experience as a radiographer, but the guide does E
-not specifically list the duties of this individual.
Proposed Section 34.42 would list both the qualifications and the specific duties of the RSO.
j The first item listed under the RS0's qualifications in proposed Section 34.42, namely, the requirement to complete the training and testing requirements for a qualified radiographer, should not have any significant i
impact.
The second item requires that the RSO have 2 years of documented experience in industrial radiography as a qualified radiographer with at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of additional formal classroom training with respect to management of radiation protection programs.
It is believed that the additional required 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of formal classroom training in management of radiation protection programs will cost each licensee $3,700 -- $1,500 for the training, $500 for the transportation to and from the training, $500 for the per diem while attending the training, and $1,200 in salary and benefits ($30/hr X 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />).
This results in an initial cost of $740,000 for the estimated 200 NRC licensees.
(It should be noted that this training is a one-time cost.) Also, this estimate assumes that there are currently no RS0s who would meet the requirements of the proposed revision, which is unlikely.
- v. Permanent Radiographic Installations Although the current regulation requires both visible and audible warning signals to be installed at " permanent radiographic installations,"
some licensees have misinterpreted the requirement and used as temporary 12
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a jobsites, what the NRC considered to be permanent installations without'the necessary warning signals.
The proposed rulemaking would both revise the definition of permanent radiographic installations and require two-person crews when radiographic operations are being conducted outside of a permanent radiographic installation. As noted above, one-quarter, or 50, of the NRC licensees operate at single locations. This would result in an initial cost of $3,000 per facility for installation of alarms, and an annual cost of $200 for maintenance and testing per NRC licensee.
It is unlikely that all NRC licensees.will need to install-additional alarms.
If an assumption is made that the 50 licensees cited above are the only ones with radiography cells, and that one-half would need to e
install additional alarms to meet the proposed requirements, there would be an~
initial industry cost of $75,000, and an annual maintenance rost of $5,000 for these licensees.
vi. Alarm Ratemeters The proposed section 34.47(g)(1) would require that the alarm ratemeter be capable of alerting the wearer regardless of the environmental conditions.
For use in high ambient noise areas, ratemeters could be equipped with either a vibrating alarm that could be felt by the wearer or a small speaker built into hearing protectors to meet this requirement.
By assuming that each licensee has an average of seven two-person teams, and three of these teams would need to have alarm ratemeters equipped with an 4
alternate means of alerting the wearer, each licensee would need to purchase six of the newly equipped devices. The current cost of an alarm ratemeter-is approximately $150.
It can be expected the cost for an alarm ratemeter with i
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'e an alternate means of alerting the wearer would be double that or $300. The impact on the industry will then be-$360,000 based on 200 licensees needing six devices each at a cost of $300 per device (51,800 per licensee).
The annual operating and maintenance (0&M) cost for these devices is assumed to be
$100 per device.
This results in the industry spending $120,000 on annual O&M based on 200 licensees having six devices each at an 0&M cost of $100 per device (5600 per licensee).
2.b. Minor Impacts
- i. Monthly Replacement of TLDs Exchange periods for either personnel film badge dosimeters or personnel thermoluminescent dosimeters (TLDs) are not included in the existing 10 CFR Part 34, but the proposed revision will require that both types of personnel dosimeters be replaced monthly.
Current practice is for film badge dosimeters to be replaced on a monthly basis because of their sensitivity to environmental factors which cause them to fog or fade, so that it.is unlikely there will be an impact on licensees who use film for their personnel dosimeters.
In the case of TLDs, however, the replacement period has customarily been three months, in part because the old 10 CFR 20.401 required reporting for periods of time not exceeding I calendar quarter.
Recent surveys of the dosimetry processing industry indicate that approximately 80 percent of personnel dosimetry is conducted using film badges and only 20 percent use TLDs.
In the case of NRC licensees this means that some 20 percent of the 6,000 radiographers and assistants (or 1200) use TLDs.
If NRC licensees are assumed to use a quarterly exchange of TLDs, the annual cost involves processing 4,800 (4 X 1,200) dosimeters at an average cost ei $4 per 14 5
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processing or a total'of $19,200. The proposed revision would' require the processing of 9,600 (8 X.1,200) additional TLDs at an annual cost of $38,400 to NRC licensees, or $192 per licensee.
ii. Testino for Depleted Uranium (DU)
The proposed revision requires that licensees leak-test those radiographic exposure devices containing DU shielding in which the source is moved from its shielded position in the device to an unshielded position outside the device by means of a control cable. The purpose of the leak-test is to verify that the "S" tube, through which the cable moves, has not been degraded to a state where the control cable is eroding the depleted uranium shielding.
Such leak-tests are to be performed at intervals not to exceed 12 months and may be performed by the licensee using acceptable leak-test N
kits. Alternatively, the licensee may return the device to the manufacturer for performance of the leak-test. The estimated cost for such a leak-test is estimated to be $25 if the licensee performs the leak-test and $75 if the leak-test is performed by the manufacturer.
Using an average cost of $50, the cost to NRC licensees to perform the leak-test on the approximately 1,400 devices in use is $70,000 annually, or approximately $350 per licensee.
iii. Documents Reauired at Field Stations, permanent Installations, and Temporary Jobsites Sections 34.89 and 34.91, respectively, will require certain documents to be available at field stations, permanent installations, and temporary jobsites. A field station is a location where radiography equipment is stored and from which equipment is dispatched to temporary jobsites where radiography is to be conducted.
Since most permanent installations are located at a 15
licensee's place of business where all. records are normally stored, this proposed requirement would only be an impact on any additional permanent i
installations at other locations. The impact on NRC licensees to have these documents available will be a $150 cost per licensee per year and to all NRC licensees the cost would be $3,000. This was determined assuming.a $10 per hour labor rate (including benefits), accomplished in 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />.
iv. Recordkeepina, Notifications and Labeling Other changes that appear in the proposed revision fall into the realm of recordkeeping and include the addition of required signatures, listing of serial numbers of devices in use in the utilization logs, records of DU tests performed, and written notifications whenever a material will be used or stored for more than 180 days at a location not listed on the license.
Except for new requirements for making certain documents and records present at field stations, permanent installations, and temporary jobsites (previously discussed), these changes should have little impact on licensees.
The impacts for the additional recordkeeping requirements are addressed in the OMB Clearance Package required under the Paperwork Reduction Act (P.L.96-511).
- v. Field Inspections of Radiographers and Radiographers' Assistants The frequency of field inspections of radiographers and radiographers' assistants has been changed from every 3 months to annual. These changes will provide some relief to licensees by reducing the costs of field inspections of radiographers by 75 percent.
Assuming that the licensee's RSO performs the field inspections and assuming further that each inspection takes 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> and the RS0's salary and benefits are of the order of $30 per hour, the cost to 16 i
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A each NRC licensee is about $590 per inspection, assuming a cost of $500 for travel expenses for the R50 per inspection.
Under the current regulation, inspections are required every 3 months for each worker. Assuming that'each licensee has an average of seven teams in the field based on the number of registered radiography devices, the current cost to each licensee is $165,200 per year or about $6,608,000 to the NRC licensed industry.
The proposed revision to change the inspection period to annually would result in an annual savings to all NRC licensees of $4,956,000 per year, or an average of about
.$24,780 per licensee.
vi Radiation Survey Instruments The existing rule requires that radiation survey instruments be calibrated at 3 month intervals and a record maintained of the calibrations.
The calibration interval is being extended from 3 months to 6 months because survey instruments are now sturdier and more reliable.
These changes will provide some relief to licensees by reducing the costs of radiation survey instrument calibration by 50 percent. The cost of calibrating a radiation survey instrument is approximately $100 per instrument. Assuming that there are 1,400 radiation survey instruments that must be calibrated every 6 months instead of every 3 months the reduction in burden would be $280,000 per year for all licensees or $1,400 per licensee.
Alternative 2 - No Action The primary consequences of this alternative would be that the NRC would not implement the Agreement States' recommendations and would. deny the International Union of Operating Engineers (IU0E) petition for rulemaking.
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' Licensees would be free to voluntarily implement some or all_ of the recommendations, however, they would not be required to do so under 10 CFR Part 34.
This would continue the status quo of having different standards in the Agreement States and would not have the potential benefit of reducing the frequency of overexposures in radiography.
Alternative 3 - Clarify and Update the Existing Part 34, but Not Impose the Two-Person Rule.
The consequences of this alternative would be threefold.
First, the modification would lessen the consistency of the revision with the Agreement States' regulations. A number of Agreement States presently have incorporated a two-person rule.
Second, the IU0E petition for the two-person rule would not be addressed. As identified in the petition, this could result in the following problems occurring:
- 1) When working in a congested area, it is extremely difficult to keep the area under constant surveillance; 2) When working in deep trenches, it is difficult to keep above ground areas under surveillance; 3) Whenever possible,. radiographers often work after other trades and crafts have left.the area.
In case of an accident involving licensed material, the radiographer cannot leave the area if a radiation danger exists in order to notify the proper authorities; and 4) In the event of an accident involving physical injury at a remote jobsite, the radiographer could be placed in a life-threatening situation. Third, in the case of a radiographer being injured,-the source may be left exposed and there would be i
no one available to place the source in its stored position or to prevent the i
public from entering into the area and receiving an unwarranted exposure to-radiation.
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5.0 Decision Rationale As indicated in the Alternative section above, the decisions available are to revise 10 CFR Part 34, take no action at this time, or modify the revision and proceed with the rulemaking.
The first alternative incorporates.
the recommendations of the Agreement States and thus improves:the consistency of the revision with Agreement States' regulations.
It also provides additional assurance of protection of public health and safety with the incorporation of the two-person rule.
The second alternative is to make'sno changes at all. The third alternative would not incorporate the two-person rule, thereby eliminating the added assurance of protection of public health and safety.
In addition, modification of the proposed revision would lessen the consistency of the revision with the Agreement States' regulations.
The changes presented in the proposed revision were carefully chosen on the basis of reconnendations from the radiography industry, including users and manufacturers of radiography equipment, and the Agreement States.
-t 6.0 Implementation The proposed revision will be published in the Federal Register and comments will be solicited on the rule as well as on the supporting documents, including this draft regulatory analysis.
Appropriate changes will be made to the proposed revision based on comments received, after which a final rule will be published in the Federal Reqisier.
The final rule will-include an effective date for implementation of the changes to allow licensees time to make the required changes.
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7.0 Costs A summary of the costs of the above amendments, based on the estimates made above are given in Tables 1 and 2.
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Table 1 Implementation and Annual Operating and Maintenance Costs for the New Requirements New Requirement implementation Costs Annual Operating and.
Maintenance Costs (US Dollars)
(US Dollars)
All NRC-Per NRC All NRC Per NRC Licensees Licensee Licensees Licensee Two-Person 4,800,000 96,000 4,800,000 96,000 Rule (a)
Mandatory 816,000 4,080 220,000 1,110 Certification of Radiographers j
Radiation Safety 740,000 3,700 0
0 Officer Permanent facility 75,000 3,000 5,000 200 Al arms (b)
Additional Training 240,000 1,200 67,200 336 for Radiographers' 31,200 624 Assistants (c)
Alarm Ratemeters 360,000 1,800 120.000 600 Additional TLD 38,400 192 38,8.
192 Exchanges Depleted Uranium 70,000 350 70,000 350 Tests Documents required 30,000 150 30,000 150 at Field Stations and Temporary Jobsites Recordkeeping and j
Labelling (d)
Reduced Rad. Su.vey
-280,000
-1,400
-280,000
-1,400 Inst. Calibrations Reduced Field
-4,956,000
-24,780
-4,956,000
-24,780 Inspection Costs Total (e) 1,964,600 84,916 1,368,600 72,748 S
(a) The costs f or the Two-Person Rule only reflect those licensees (25%) that would have to hire
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additional radiographer's assistants.
(b)) The cost of $3000 would only apply to those licensees who have permanent installations.
It is asstaned that this would af f ect 25 Licensees.
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i (c) The cost of $1,200 would apply to all adC licensees.
The additional costs of $31,200 and S624 only applies to those licensees that would have to hire additional radiographers' assistants.
(d)The cost for these is insignificant and has not been itemized.
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s Table 2 Implementation Costs for An Individual NRC Licensee I
New Requirement An NRC Licensee that An NRC Licensee that would have to hire four would not have to hire additional assistants four additional assistants
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(US Dollars)
(US Dollars)
Two-Person Rule 96,000 0
Mandatory Certification 4,080
'4,080 of Radiographers Radiation Safety 3,700 3,700 Officer Permanent Facility 3,000 3,000 l
Alarms i
Additional Training of 1,824 1,200 Radiographers' Assistants Alarm Ratemeters 1,800 1,800 Additional TLD 192 192 Exchanges Depleted Uranium Tests 350 350 Documents Required at 150 150 i
Field Stations
'l Recordkeeping and Labeling (f) t Reduced Rad. Survey
-1,400
-1,400 Inst. Calibrations i.
Reduced Field
-24,780
-24,780 l
Inspection Costs Total 84,916
-11,708 i
i (e) The total costs represent costs likely to be incurred by those licensees that would have to hire f our addi tional radiographers' assistants.
It is unlikely that these high costs will apply to more than 25% of NRC licensees.
For the majority of licensees, the initial costs will be-j
$332, with a net annual saving due to the reduction in field inspections.
(f) The cost for these is insignificant and has not been itemized.
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t ENCLOSURE 4 ENVIRONMENTAL ASSESSMENT I
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ENVIRONMENiAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT REVISION OF 10 CFR PART 34 SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHY The Nuclear Regulatory Commission is amending its. regulations that apply to
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industrial radiography to improve radiography safety.
Environmental Assessment Identification of Final Action Part 34 of Title 10 of the Code of Federal Regulations specifies the-radiation safety requirements for radiographic operations, including performance requirements for industrial radiographic exposure devices, personal radiation safety requirements for radiographers and precautionary i
procedures in radiographic operations.
This revision will specify requirements for the use of, at least, two qualified individuals'at temporary a
jobsites, additional training for radiographers' assistants L(9 34.43),
designation of a Radiation Safety Officer (5 34.42), and describing permanent i
radiographic installations including installation of alarms or access control devices.
Need for the Final Action A number of revisions to the suggested State Regulations have made'the i
NRC regulations different from many of the Agreement States' regulations.
There has not been an overall revision of Part 34 in many years while a number 1
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o of other NRC rules have been updated. A decision was made to develop an overall revision to 10 CFR Part 34 with the intent of clarifying the regulation so that licensees may.have a better understanding of what is expected in radiographic operations.
In addition, the format of the proposed rule has been revised to place requirements into categories which describe the type of requirements that are found in the subpart.
Environmental Impacts of the Final Action The revision of 10 CFR Part 34 should have no environmentally significant impact.
The changes proposed in this revision of 10 CFR Part 34 are directed toward improving the safety performance in industrial radiography. The proposed revision specifies new requirements for two-person crews, a re-definition of a permanent radiographic installation, the designation of and the qualifications for a Radiation Safety Officer (RS0),
specification of required documents at various radiographic operations sites, some additional training for radiographers' assistants, recordkeeping and labeling requirements, and a new requirement for leak testing of radiographic -
exposure device!.
In addition, a number of the changes involve a reorganization of the regulations for the purpose of clarification, and also includes some new definitions, as well as redefinition of some terms in the present regulation.
Any of the proposed changes involving requirements which would effect energy, water, or materials will be insignificant and no environmental or radiation impact will be involved.
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t Alternatives to the Final Action
-l As required by 5102(2)(E) of NEPA (42 USC 4322(2)(E)), possible alternatives to the final action have been considered.
The first alternative was to adopt the revisions.
A second alternative considered was to take no action.
A third alternative considered was to clarify and update the existing Part 34, but to impose no new substantive requirements.
Amendment of the existing regulations was chosen as the best e'
alternative, because it was the only option which would address the primary benefits sought in the revision to Part 34.
Alternative Use of Resources No alternative use of resources was considered.
Agencies and Persons Consulted Consultations on the rule have been held with both Agreement State and industry representatives at the November 1992 workshop, which was held in Dallas, Texas.
I Finding of No Significant Impact i
The Commission has determined not to prepare an environmental impact statement for the final rule.
Based on the foregoing environmental assessment, we conclude that this amendment will not have a significant effect of the quality of the environment.
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DRAFT PUBLIC ANNOUNCEMENT 4
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NRC PROPOSES AMENDMENTS TO REGULATIONS i
GOVERNING SAFETY OF RADIOGRAPHY OPERATIONS The Nuclear Regulatory Commission is proposing to amend its regulations governing the safety of radiography operations to
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further enhance the safety of radiographers and the public and to provide licensees with a better understanding of what is expected in radiography operations.
i Radiography involves the use of radioactive materials to produce shadow images on film.
The NRC has approximately 200 radiography licensees, and the 29 Agreement States (states which have assumed, by agreement, part of the NRC's regulatory authority) have an additional 500 licensees.
Both NRC and Agreement State licensees often conduct business under both NRC and Agreement State jurisdiction.
The radiography regulations first were promulgated in 1965 and numerous modifications have been made since that time, the most recent in 1990 when requirements governing the performance of radiography equipment.and additional reporting requirements governing equipment malfunctions were added.
As proposed, the new amendments, which have been coordinated with the Agreement States and are responsive to a 1992 petition for rulemaking from the International Union of Operating Engineers, would, among other things:
-- require that two radiographers, or a radiograpbv. and a radiographer's assistant, be present any time radiographic operations are conducted outside of a permanent radiographic installation, which would provide a significant increase in
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n assurance that operational safety measures and emergency procedures would be implemented effectively;
-- require that radiographers, in addition to meeting the existing' training and qualification requirements, be certified by a certifying entity, which could be either an independent certifying organization or an Agreement State;
-- change the definition of " permanent radiographic installation" to be an enclosed shielded room, cell or vault in which radiography is performed,'.thich should reduce any ambiguity as to what the term is intended ^-
tean; in addition, a requirement for a daily check of visible and audible alarm signals would be added;
-- add a requirement to provide additional training for radiographers' assistants; instead of just receiving copies of the licensees' operating and emergency procedures and being tested on those documents, assistants would have to receive additional training to ensure that they are knowledgeable in regard to all pertinent NRC requirements; and
-- specify the duties of the radiation safety officer (RSO) i and require additional training for this position.
Written comments on the proposed amendments to Part 34 of the Commission's regulations should be received by (date).
_They should be addressed to the Secretary of the Commission, Nuclear Regulatory Commission, Washington, D.C.
20555, Attention;.
'j Docketing and Service Branch.
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ENCLOSURE 6 ORAFT CONGRESSIONAL LETTER r
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NUCLEAR REGULATORY COMMISSION
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The Honorable Joseph I. Lieberman, Chairman Subcommittee on Clean Air and Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
I The NRC has sent to the Office of the Federal Register for publication the enclosed proposed amendment to the Commission's rules in 10 CFR Part 34. The amendment if adopted would, in part, require licensees to require at least two radiographers or a radiographer and a radiographer's assistant to be present any time radiographic operations occur outside of a permanent radiographic installation; to designate a Radiation Safety Officer (RS0); to describe all permanent radiographic installations; and to require all radiographers to be certified by a certifying entity.
The Commission is issuing the proposed rule for public comment.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
Public Announcement 2.. Federal Register Notice cc: Senator Alan K. Simpson l
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((lkRf1 j NUCLEAR REGULATORY COMMISSIOl4
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...a The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
The NRC has sent to the Office of the Federal Register for publication the enclosed proposed amendment to the Commission's rules in 10 CFR Part~34. The amendment if adopted would, in part, require licensees to require at least two radiographers or a radiographer and a radiographer's assistant to be present any time radiographic operations occur outside of a permanent radiographic installation; to designate a Radiation Safety Officer (RS0); to describe all permanent radiographic installations; and to require all radiographers to be certified by a certifying entity.
The Commission is issuing the proposed rule for public comment.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
Public Announcement 2.
Federal Register Notice cc:
Representative Michael Bilirakis
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t UNITED STATES
[ Is'kXf~. j NUCLEAR REGULATORY COMMISSION N
F WASHINGTON. D.C. 20555-0001 gv g The Honorable Richard H. Lehman, Chairman Subcommittee on Energy and Mineral Resources Committee on Natural Resources United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
The NRC has sent to the Office of the Federal Register for publication the enclosed proposed amendment to the Commission's rules in 10 CFR Part 34.
The amendment if adopted would, in part, require licensees to require at least two radiographers or a radiographer and a radiographer's assistant to be present any time radiographic operations occur outside of a permanent radiographic installation; to designate a Radiation Safety Officer (RS0); to describe all permanent radiographic installations; and to require all radiographers to be certified by a certifying entity.
The Commission is issuing the proposed rule for public comment.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
Public Announcement i
2.
Federal Register Notice cc: Representative Barbara Vucanovich