[Federal Register Volume 62, Number 102 (Wednesday, May 28, 1997)]
[Rules and Regulations]
[Pages 28948-28973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13786]
[[Page 28947]]
_______________________________________________________________________
Part IV
Nuclear Regulatory Commission
_______________________________________________________________________
10 CFR Parts, 30, 34, 71 and 150
Licenses for Industrial Radiography and Radiation Safety Requirements
for Industrial Radiographic Operations; Final Rule
Revision of the NRC Enforcement Policy; Notice
Federal Register / Vol. 62, No. 102 / Wednesday, May 28, 1997 / Rules
and Regulations
[[Page 28948]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 34, 71 and 150
RIN 3150-AE07
Licenses for Industrial Radiography and Radiation Safety
Requirements for Industrial Radiographic Operations
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations governing industrial radiography. This final rule updates
radiation safety requirements in order to enhance the level of
protection of radiographers and the public. By a separate action
published today in the Federal Register, the Commission has issued a
modification to the Enforcement Policy that reflects these amendments
to 10 CFR Part 34.
EFFECTIVE DATE: June 27, 1997.
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) 415-6257 or 415-6230.
SUPPLEMENTARY INFORMATION:
I. Background.
II. Final Rule Provisions and Response to Public Comments on the
Proposed Rule.
III. Conforming Rule Changes.
IV. Agreement State Compatibility.
V. Implementation.
VI. Finding of No Significant Environmental Impact: Availability.
VII. Paperwork Reduction Act Statement.
VIII. Regulatory Analysis.
IX. Regulatory Flexibility Analysis.
X. Backfit Analysis.
I. Background
Part 34 of Title 10 of the Code of Federal Regulations was first
published in 1965 (30 FR 8185; June 26, 1965) during the recodification
of existing 10 CFR Parts 30 and 31. Part 34 established a new part
devoted specifically to regulating the safe use of sealed sources of
byproduct material in industrial radiography. Numerous modifications
made by a number of Agreement States to corresponding regulations led
to a decision, in 1991, to develop an overall revision to 10 CFR Part
34. Subsequently, the NRC published a proposed rule on February 28,
1994 (59 FR 9429), that incorporated a number of recommendations made
at meetings with the Agreement States and industry in 1991 and 1992.
The NRC also reviewed the radiography regulations from Texas,
Louisiana, Canada, and the ``Suggested State Regulations for Control of
Radiation,'' developed by the Conference of Radiation Control Program
Directors (CRCPD), Inc., in developing the proposed regulation.
The proposed rule also addressed the potential resolution of a
petition from the International Union of Operating Engineers (IUOE),
Local No. 2, requesting an amendment to the radiography regulations to
require the presence of a minimum of two radiographic personnel when
performing industrial radiography at temporary jobsites (PRM-34-4).
Based on comments received on this petition (35 out of 38 comments) in
favor of a two person requirement, the proposed revision to 10 CFR Part
34 included a provision for at least two qualified individuals to be
present anytime radiographic operations are undertaken outside a
permanent installation.
The other major provisions of the proposed rule were to: (1)
Require mandatory certification of radiographers, (2) specify the
qualifications and duties for a radiation safety officer, (3) include
additional training requirements for radiographers' assistants, and (4)
clarify the definition of a permanent radiographic installation. The
proposed rule also revised the format of 10 CFR Part 34 to place
requirements into categories that more accurately describe the
requirements found in the rule.
II. Response to Public Comments on the Proposed Rule and Final Rule
Provisions
The comment period on the proposed rule closed May 31, 1994, but
the NRC continued to receive comments while developing the final rule.
By mid-December 1994, a total of 58 public comment letters were
received on the proposed rule. Many commenters expressed opinions and
recommendations on several sections of the proposed rule while others
commented on only a single section. In developing a final rule, the NRC
held a workshop in Houston, Texas, on December 13-15, 1994, to discuss
the resolution of public comments received up to that date on the
proposed rule. In addition, the NRC discussed its views and sought
comments on several of the key provisions of the proposed rule at an
industry workshop held in Las Vegas, Nevada, on March 20, 1995, and the
April 1995 workshop for Agreement State program managers. The
transcripts of these meetings, which are available for inspection and
copying in the NRC Public Document Room, 2120 L Street NW. (Lower
Level), Washington DC, were reviewed in developing the final rule.
Following these workshops, an additional 31 comment letters were
received, bringing the total to 89 public comment letters.
This final rule includes a partial granting of the petition, PRM-
34-4, in that it requires, 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
``radiographer trainee,'' (which was one of the options proposed in the
petition) but is requiring instead 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 and generally exceed the NRC's training
requirements for a radiographer's assistant. Trainees are required to
successfully complete the 40-hour course on the subjects listed in
Sec. 34.43(g), while a radiographer's assistant has to meet only those
requirements in Sec. 34.43(c) and is not required to complete the 40-
hour course described.
The estimated cost of requiring the two-person crew could be
significant for licensees who currently send only one radiographer to a
temporary jobsite. 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.
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. Louisiana and Texas adopted
two-person crews several years ago and report a significant reduction
in incidents and exposures. Many of the other Agreement States have
since adopted the requirement because of the implicit safety benefit
implied in having two persons available to cope with emergency
situations. Furthermore, if an incapacitating injury to a radiographer
should occur at a remote location, the
[[Page 28949]]
presence of a second individual could be an important factor in
preventing unnecessary radiation exposures. The Commission is amending
the Enforcement Policy as a result of this final 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 Sec. 34.41.
The remaining issues addressed in the comments received on the
proposed rule and the NRC responses to those comments are discussed
under the applicable CFR section.
Section 34.1: Purpose and Scope
This section of the final rule is basically unchanged from the
existing regulation, with the exception of minor clarifying changes.
Other NRC regulations, such as, Parts 19, 20, 21, 30, 71, 150, 170, and
171, that apply to radiography licensees are now referenced by number
in this section, and ``radiography'' is changed to ``industrial
radiography'' to distinguish it from medical uses. No comments were
received on this section.
Section 34.3: Definitions
This section provides definitions for terms used in this part. The
proposed rule included a number of new definitions, as well as proposed
revisions to a number of existing definitions.
The proposed rule contained definitions for the following new terms
not previously addressed in 10 CFR Part 34: ALARA, Annual safety
review, Associated equipment, Becquerel, Certifying entity, Collimator,
Control tube, Exposure head, Field examination, Field station, Gray,
Independent certifying organization, Projection sheath, Radiation
safety officer, Radiographer certification, Radiographic operations, S-
tube, Shielded position, Sievert, Source assembly, and Temporary
jobsite.
The term ALARA (as low as is reasonably achievable) was added to
describe a key element of the revised standards for protection against
radiation in 10 CFR Part 20. The terms Becquerel, Gray, and Sievert
were added to define the metric units used in all new or revised
regulations. The term Annual safety review was added to clarify what
was meant by the term periodic training used previously in Sec. 34.11.
The terms Certifying entity, Independent certifying organization, and
Radiographer certification were added to describe terms associated with
the proposed requirements for verification of radiographer training.
The terms Collimator and S-tube were added to describe pieces of
equipment that are used in conducting radiographic operations. The
terms Field station and Temporary jobsite were added to clarify the
meaning of these commonly used terms. The term Radiation safety officer
was added to define the role of this individual in industrial
radiography. The terms Associated equipment, Control tube, Exposure
head, Practical examination, Projection sheath, and Source assembly
were added because, while used in the regulation, they were not
previously defined.
The proposed rule presented modifications to the definitions of
Permanent radiographic installation, Storage area, and Storage
container. The definition of Permanent radiographic installation was
modified to remove ambiguities in the existing definition concerning
what the phrase, ``intended for radiography,'' meant. The definitions
of Storage area and Storage container were modified to remove
references to transportation.
Comment
The six comment letters that addressed this section requested
several additions, clarifications, and changes to the proposed and
existing definitions. One commenter requested adding a section
addressing the unique aspects of underwater, offshore platform, and
lay-barge radiography. Another commenter requested defining the term
``control drive mechanism'' because it is used in the definition of
control tube. Clarification of the meaning of the terms ``annual safety
review,'' ``field examination,'' and ``radiographer's assistant'' was
requested. One Agreement State (Illinois) requested that the definition
of permanent radiographic installation not be changed as proposed, that
the definition of radiographer certification be broadened to included
authorization by an Agreement State, that the Commission adopt the term
radiographer trainee, and the term working position be explained. They
further requested that definitions of malfunction, defect, transport,
and transport container be added and suggested a number of editorial
changes to the definitions to make them similar to definitions in the
Suggested State Regulations used by many of the Agreement States.
Response
In response to public comments, the NRC has added five new
definitions to the final rule: Control cable, Control drive mechanism,
Lay-barge radiography, Offshore platform radiography, and Underwater
radiography. Some of the definitions in the proposed rule were changed
in response to comments. Annual safety review was changed to Annual
refresher safety training to clarify that its purpose is training.
Projection sheath was changed to the more commonly used term, Guide
tube, and Beam limiter was changed back to its original term,
Collimator. The term working position as used in the definition of
Exposure head means the location of the equipment during operation.
Radiography was changed to Industrial radiography to reduce any
confusion with medical uses. Field examination was changed to Practical
examination to clarify that it need not occur in the field. In response
to a comment raised on Sec. 34.43, Training, a definition for hands-on
experience was added to the final rule. The other new definitions in
the proposed rule are adopted in the final rule without change.
Definitions for defect and malfunction, which are defined in 10 CFR
Part 21 were not added to 10 CFR Part 34 to avoid the potential for
confusion should 10 CFR Part 21 be revised without any subsequent
revision to 10 CFR Part 34, and as a result these terms were to be
defined differently in Parts 34 and 21. The definition of Radiographer
certification already includes individuals certified by certifying
entities (i.e., Agreement States) and therefore no change was made to
the final rule. No definition was added for transport or transport
container, although the Agreement States are free to adopt or use
definitions for 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
also require training in the subjects in Sec. 34.43(g). NRC only
requires this training for radiographers. Although the NRC is not
adopting the term trainee or requiring radiographers' assistants to
have the same training as radiographers, the Agreement States are not
prohibited from using the term in their requirements or from requiring
the additional training.
Section 34.5: Interpretations
This section, while not in 10 CFR Part 34 previously, was added to
the proposed rule because this is standard regulatory language used to
state that only the General Counsel of the NRC has the authority to
provide interpretations of the regulations which
[[Page 28950]]
will be binding on the Commission. No comments were received on this
section.
Section 34.8: Information Collection Requirements: OMB Approval
This section was basically unchanged in the proposed rule, except
for changing the section numbers to conform to the new format of the
proposed rule and to list any new requirements that require OMB
approval. No comments were received on this section.
Section 34.13: Specific License for Industrial Radiography
This section (previously Sec. 34.11), provides the basic
requirements for submittal of a license application which must be met
satisfactorily before NRC will approve the application. A number of
changes to this section were proposed, including a reduction in the
inspection frequency of job performance for radiographers and
assistants, a requirement for submitting procedures for verifying and
documenting the certification status of radiographers, a requirement to
designate and identify a Radiation Safety Officer (RSO) responsible for
the licensee's radiation safety program, provisions for leak testing
for depleted uranium leakage on those radiographic exposure devices
that use depleted uranium for shielding, and a requirement to provide
the location and description of all field stations and permanent
radiographic installations.
The requirement for conducting field inspections of job performance
of radiographers and assistants was moved to Sec. 34.43 to more
accurately reflect its role in the training program. In addition, a
requirement for conducting annual refresher safety training was
substituted for the previously used term of periodic training. These
changes are described more fully under the discussion of Sec. 34.43.
The requirement to conduct tests to identify depleted uranium (DU)
contamination was added to detect wear through the ``S'' tube into the
DU shielding. Such a condition could cause binding of the control cable
in the groove and possibly prevent the radiographer from retracting the
source. A new requirement was proposed to identify procedures for
conducting leak tests for sealed sources and radiographic exposure
devices containing (DU) shielding if the licensee intends to perform
the leak testing.
Comment
Nine comment letters addressed this section. Six opposed changing
the frequency of required licensee inspections of radiographers and
radiographers' assistants from quarterly to annually. They stated that
there is great benefit in conducting quarterly inspections and
recommended keeping the quarterly requirement. Three commented
favorably on the requirement to designate and identify an RSO
(Sec. 34.13(g)). One commenter suggested that the RSO should only be
responsible for ensuring that a radiation safety program was
implemented rather than being the one who must implement it as the
proposed rule had suggested.
Response
Although some commenters suggested that the quarterly inspections
of radiographers and radiographers' assistants should be maintained,
the Commission believes that the increased training required for
radiographers' assistants, the requirement for the certification of
radiographers, and the appointment of an RSO to oversee training and
job performance, will compensate for the reduction in the numbers of
inspections performed. However, the Commission agrees with the
commenters that the benefits gained by these inspections indicate that
a semiannual frequency may be preferable and has modified the final
rule to require semiannual inspections. The requirement for conducting
the field inspections for radiographers and radiographers' assistants
has been moved to Sec. 34.43 to more accurately reflect its role in the
training program. Additional information concerning the specifics of
these inspections is given in Sec. 34.43(e).
Paragraph (b) specifies that training for industrial radiographers
and radiographers' assistants must meet the requirements of Sec. 34.43.
The new requirement to establish procedures to verify the certification
status of radiographers applies to previously certified radiographers
hired by the licensee. However, the licensee will be required to ensure
that all radiographers are certified when this requirement becomes
effective, (2 years after the final rule is published in the Federal
Register). Section 34.13(b)(2) permits licensees to use certified
radiographers before the mandatory 2-year implementation date in lieu
of describing its initial training program in the subjects outlined in
Sec. 34.43(g). With the adoption of mandatory certification for
industrial radiographers, the final rule has been revised to delete the
requirement that licensees include a description of their training
program in the radiation safety topics in Sec. 34.43(g) for
radiographers in their license application.
The final rule specifies that licensees must designate an RSO and
potential RSO designees. No change was made in the final rule as
requested in the comment described above, because the rule is clear
that the RSO's responsibility is to ensure that the radiation safety
program is implemented in accordance with NRC regulations and with the
licensee's operating and emergency procedures. Further discussion on
the qualifications and duties of this individual are addressed under
Sec. 34.42.
In response to comments on Sec. 34.27 that testing of radiographic
devices for DU contamination should be incorporated in the section on
testing of sealed sources for leakage, Sec. 34.13(h) was added. This
paragraph requires that DU shielding, in addition to sealed sources, be
tested for leakage. In response to comments received on Sec. 34.89 that
provisions in the proposed rule requiring retention of records at
specific locations was overly burdensome, a new Sec. 34.13(k) was added
to require license applicants to identify the locations where all
records will be maintained. This provides the licensees with greater
flexibility.
Section 34.20: Performance Requirements for Industrial Radiography
Equipment
This section specifies requirements for industrial radiographic
equipment performance and use. Only a few changes to this section were
presented in the proposed rule. The proposed changes primarily
addressed equipment modifications and labelling requirements. The
proposed rule would have prohibited modification of radiographic
exposure devices, and associated equipment. The term, source assembly,
was added to Sec. 34.20(c) to make it clear that it is one of the
pieces of equipment that must meet the requirements of Sec. 34.20.
Section 34.20(f) was added in the proposed rule to require labeling of
all associated equipment acquired after January 10, 1996, to identify
that the components have met the requirements of Sec. 34.20.
Comment
Six comment letters addressed this section. Three commenters were
concerned that Sec. 34.20(b)(1) specifies that the label required for
the device was to be attached by the user when in practice most of the
information required is supplied or attached by the supplier.
Two commenters expressed concern that the proposed rule did not
seem to allow modifications whether they compromised safety or not,
which
[[Page 28951]]
differed from the existing Sec. 34.20(b)(3). One commenter requested
examples of ``reasonably foreseeable abnormal conditions'' discussed in
Sec. 34.20(c)(1). One commenter expressed concern over the crushing and
kinking tests for the guide tube listed in Sec. 34.20(c)(5) and stated
that the rule implied that each guide tube had to be tested instead of
testing a prototype and then using Quality Assurance/Quality Control
(QA/QC) procedures in the design of subsequently manufactured guide
tubes.
Finally, one commenter was concerned with Sec. 34.20(f) in the
proposed rule that requires labeling of all associated equipment
acquired after January 10, 1996. The commenter was concerned that a
large amount of associated equipment that meets ANSI N432-1980 and 10
CFR 34.20, and is currently in use is not labelled. Because compliance
can be determined only at the time equipment is manufactured, the
commenter was concerned that qualified associated equipment may not be
authorized for use. The commenter also raised another concern as to
what components would have to be labelled. The commenter stated that
control gears, guide tube fittings, or outlet nipples are examples of
items that it may not be practical to label. The commenter also pointed
out that a properly labelled control assembly may not meet the ANSI
requirements if one of its components is replaced by a labelled
replacement component from a different manufacturer.
Response
Sections 34.20(a) and (b)
Minor changes were made in each of these paragraphs to clarify what
is meant by radiographic equipment. The terms ``source assembly'' and
``sealed source'' were added to Sec. 34.20(a) and (b) because these
items are addressed in the ANSI Standard N432-1980.
Section 34.20(b)
The Commission recognizes that the manufacturer generally provides
much of the information required concerning the equipment initially and
generally affixes a label to the device. If a replacement source or
source assembly is installed or a licensee's name, telephone number,
etc., changes, it is the licensee's responsibility to make appropriate
changes to the label. Although the requirement to have the label
attached to the radiographic exposure device by the user has been part
of the regulation since 1990 and was not a change made in the proposed
rule, the paragraph has been rewritten in the final rule to state that
the licensee shall ensure that the information required is attached,
whether the information is added by the licensee or by the
manufacturer.
In light of the comments received, paragraph (b)(3) of the proposed
rule, which prohibited any modification of exposure devices and
associated equipment, has been deleted and the existing (b)(3)
modification language is retained.
Section 34.20(c)
In response to a comment requesting an example of a ``reasonably
foreseeable abnormal condition'' one example would be where the
coupling between the source assembly and the control cable cannot be
unintentionally disconnected should the guide tube be severed.
Section 34.20(c)(5)
With respect to the comment received relating to this paragraph,
stating that the rule implied that each guide tube had to be tested;
this is neither true nor practical. It is the NRC's intent that the
tests prescribed involve prototype devices and components. The ANSI
Standard N432 covers criteria for the design of new devices and for
qualifying prototypes to performance standards. This paragraph,
Sec. 34.20(c)(5), is included in the rule because ANSI N432-1980
contains crushing and kinking tests that are specific for the control
cable and the control cable sheath (tube) only. The existing paragraph
(c)(5) was intended to apply the crushing tests specified for the
controls to the guide tubes, and to apply a kinking resistance test
that approximated the forces encountered during use. However, the NRC
received a few requests for the use of guide tubes in special
applications where the guide tubes could not comply with the crushing
test criteria stipulated in the standard. Comments received from the
airline industry on the 1990 equipment rule (55 FR 843), indicated that
the special guide tubes used in testing aircraft engines would not pass
either the kinking test or crushing test specified in the ANSI
standard. The NRC's response, at that time, was to state that persons
with special requirements apply for an exemption under Sec. 34.51.
However, the Commission has reconsidered its decision, and while
concluding that the crushing tests specified in ANSI N432 should be
adequate for the majority of guide tubes in use, the NRC also
recognizes that the tests specified in ANSI N432 are not sufficient for
all cases and that other tests may provide an equal level of safety and
may be more appropriate, provided the tests used closely approximate
the crushing forces likely to be encountered in normal use. Rather than
continue to review case specific exemptions to achieve this, the rule
has been modified to specify the use of both crushing and kinking tests
appropriate to the conditions of use.
Section 34.20(f)
Paragraph 34.20(f) in the proposed rule, which specified that all
associated equipment acquired after January 10, 1996, had to be
labelled to identify that components met the requirements of
Sec. 34.20, is deleted in the final rule. The NRC is currently re-
evaluating the applicability of the ANSI Standard N432-1980 for
associated equipment. In response to comments raised on the proposed
rule and subsequent comments from a number of licensees requesting
interpretation of Information Notice 96-20, issued on April 4, 1996,
the NRC will consider the need for an amendment to Sec. 34.20. In the
interim, NRC inspections will focus on safety issues and incidents
relating to associated equipment.
Section 34.21: Limits on Levels of Radiation for Storage Containers and
Source Changers
This section specifies the limits on radiation exposure levels for
various equipment associated with industrial radiography. Metric
equivalents to values previously cited were added to the proposed rule.
Because radiation exposure instruments currently use units of roentgens
to measure radioactivity, the proposed rule specified that measurements
taken in roentgens could continue to be recorded in terms of roentgens,
provided the limits described in the rule would not be exceeded.
Comment
One comment was received on this section that indicated
Sec. 34.21(b) was confusing as written because the language in the
proposed rule stated that Sec. 34.21 would only apply to storage
containers.
Response
NRC agrees and has rewritten Sec. 34.21 in the final rule to
specify the radiation exposure limits for storage containers and source
changers and to delete requirements for radiographic exposure devices
from this section. Because all radiographic equipment in use after
January 10, 1996, will be required to meet ANSI N432-1980, the
reference to requirements for equipment manufactured before January 10,
1992,
[[Page 28952]]
is no longer needed and has been deleted from the final rule.
Section 34.23: Locking of Radiographic Exposure Devices, Storage
Containers and Source Changers
This section requires locking of radiographic equipment to protect
the public from inadvertent exposure to radiation. The proposed rule
included additional requirements for locking radiographic exposure
devices before movement and, if there is a keyed-lock, for removing the
key at all times, when not under the direct surveillance of a
radiographer or a radiographer's assistant.
Comment
Twelve comments were received on the new proposed Sec. 34.23(b),
ten opposed the provision and two suggested word changes. Examples
were:
(1) The requirement to disconnect the control cables from the
exposure device before moving from one location to another in the same
immediate area involves too much wear and tear on the source assembly
connection. This could lead to equipment fatigue.
(2) Industrial radiographers work under less than friendly
situations in deep and muddy ditches and often under stress. They may
also work in situations where one pipeline is tied into another and
many radiographs, all within a short distance of each other, are
required. Stress is high on the radiographer under these conditions
because people are waiting. Requiring the disconnecting and re-
connecting of cables before moving the radiographic exposure device for
successive exposures only a few feet apart would only add to that
stress and result in judgment errors which in turn could result in
possible overexposures.
(3) Because many exposure devices now have, and all will soon be
required to have, an automatic source securing device, requiring that
the control cables be removed before moving the device as little as a
few feet is unnecessary and adds no additional measure of radiation
safety.
(4) All of this connecting and disconnecting would drastically
increase the introduction of contaminants into the control tube or
guide tube and cause excessive wear and would also increase radiation
exposure to the extremities of the radiographers concerned.
Response
The NRC agrees with the commenters and has deleted the proposed
Sec. 34.23(b) from the final rule and modified the proposed
Sec. 34.23(a). The final rule contains requirements that the source be
secured after each exposure [Sec. 34.23(a)]. Paragraph (a) in the final
rule requires the radiographic exposure device to have a lock or a
locked outer container and specifies that it shall be kept locked with
the key removed, when not under the direct surveillance of a
radiographer or a radiographer's assistant. In addition, Sec. 34.49(b)
requires the licensee to survey the radiographic exposure device and
guide tube after each exposure when approaching the device or the guide
tube to ensure that the source has been returned to the shielded
position. The Commission has determined that this requirement provides
for adequate safety without the need for additional requirements to
disconnect guide tubes before any movement. The proposed rule included
the statement that the source be manually secured in those exposure
devices manufactured before January 10, 1992. This statement has been
deleted in the final rule because all devices in use after the
effective date of this final rule, must meet the requirements of
Sec. 34.20 including automatic securing.
Section 34.25: Radiation Survey Instruments
This section (previously Sec. 34.24) specifies requirements for
radiation survey instruments. The proposed rule included a requirement
to perform an operability check before use. The proposed rule also
reduced the frequency of survey meter calibrations from quarterly to
semiannually and provided specific calibration protocols for linear,
logarithmic, and digital scale instruments, including an accuracy
requirement of plus or minus 20 percent. These changes were made to
reflect current calibration standards and to address the variety of
survey meters currently available. In addition, the proposed rule
required that records of the instrument calibrations be maintained.
Comment
Ten comments were received on this section. Three commented on the
necessity for performing a daily operability check. One commenter
objected to using the projection sheath (guide tube) port of a
radiographic exposure device as a suitable radiation field for the
operability check, and stated that if the source were not properly
locked and shielded within the device, it would be possible for the
operator to receive an overexposure if the survey meter being checked
for operability were malfunctioning. This commenter suggested that a
safer method was to use an appropriate check source for the radiation
field. Two commenters suggested that some of the newer instruments
could retain their calibration for up to 6 months as required by
Sec. 34.25(b)(1), but five felt that a 3-month calibration period
should be maintained, citing the rough treatment and hostile
environment in which field radiography was performed. One commenter
suggested that the calibrations should be made by persons licensed by
the NRC or an Agreement State.
Response
The operability check, originally proposed for Sec. 34.25, has been
moved to Sec. 34.31 because this section is a more appropriate location
for the requirement. As recommended, the suggested method for
performing an operability check has been changed to use a check source
or other appropriate means. The suggestion that the regulations specify
that persons performing calibrations be licensed by the Commission or
an Agreement State is not adopted at this time. The Commission does not
believe that the suggested requirement is necessary because licensees
must submit operating and emergency procedures with their application
under Sec. 34.13. Because these would include a licensee's calibration
procedures, an adequacy review of the calibration procedures would be
conducted prior to granting a license. These procedures are reviewed in
detail as part of the licensing process, thus adopting an additional
requirement to license individuals performing these calibrations could
be an unnecessary burden.
The time interval for calibration under Sec. 34.25(b)(1) was not
changed from the 6-month frequency specified in the proposed rule.
However, a requirement to conduct inspection and maintenance of these
instruments on a quarterly basis has been included in Sec. 34.31.
Equipment malfunctions are generally not due to the instrument being
out of calibration, but to some other failure. The Commission believes
that more frequent calibrations are not needed because significant
changes in instrument response should be detected during the daily
operability check.
Section 34.27: Leak Testing and Replacement of Sealed Sources
This section (previously Sec. 34.25) stipulates that licensees leak
test sealed sources while in use and radiographic exposure devices that
employ DU for shielding. The proposed rule included a requirement that
the performance of a source exchange or a leak test must be
[[Page 28953]]
made by persons authorized by the Commission or an Agreement State. The
proposed rule also included a requirement that radiographic exposure
devices using DU shielding be tested for contamination at intervals not
to exceed 12 months unless the device was in storage. The presence of
DU contamination could be an indication of ``S'' tube wear that could
lead to the binding of the control cable with the resultant inability
to retract the source. The proposed rule also specified that leaking
radiographic exposure devices be disposed of at a facility licensed to
handle low-level waste.
Comment
Six comments were received on this section. One commenter stated
that the additional test requiring a check for DU contamination could
probably not discriminate between a leaking source and DU
contamination. Two commenters suggested that DU testing not be required
for devices in storage. Another suggested that the DU testing be
integrated into the required 6-month leak test for the sealed source.
One commenter stated that disposal should not be limited to a facility
licensed under 10 CFR Part 61. The last commenter pointed out that DU
testing was important since the drive cable travels through the worn
part of the ``S'' tube, and if the wear is significant, the cable picks
up uranium contamination and users are exposed to this contamination
during connecting and disconnecting controls etc., and while the
contamination level is low, it is poor health physics practice to allow
individuals to have unprotected contact with contaminated items.
Response
The NRC recognizes that the detection of DU contamination does not
imply that the wear on the ``S'' tube is sufficient to remove the
exposure device from use. However, it is sufficient to require that a
borescope or other suitable inspection be made to establish the degree
of wear. Most nondestructive evaluation (NDE) firms have the capability
to conduct their own inspection. Firms that do not have this capability
could send the device to the manufacturer or to some other inspection
service company for the inspection and evaluation.
The NRC has determined that leak testing services are available
that can discriminate between DU contamination and sealed source
contamination. The NRC has no objection to increasing the frequency for
the DU contamination tests so that they are performed concurrently with
the sealed source leak tests. However, the interval between the DU
tests must not exceed 12 months, unless the device is in storage, with
the provision that it be tested before use or transfer. Section
34.27(e) in the final rule has been modified to reflect this change.
The requirement for disposal of a DU contaminated device in a facility
licensed under 10 CFR Part 61 has been deleted since 10 CFR 40.13(c)(6)
exempts natural or depleted uranium metal used as a shielding
constituent in a shipping container, provided it is appropriately
labelled and the metal is encased in mild steel or equally fire
resistant metal of minimum wall thickness of \1/8\ inch (3.2
millimeters).
Section 34.29: Quarterly Inventory
This section (previously Sec. 34.26) specifies requirements for
conducting a quarterly inventory. The proposed rule was essentially
unchanged from the existing regulation, with the exception of moving
all recordkeeping requirements to Sec. 34.69.
Comment
One commenter requested an editorial change to this section.
Response
In response to the comment, the final rule clarifies that an
inventory of all devices that utilize DU shielding is also required.
Section 34.31: Inspection and Maintenance of Radiographic Exposure
Devices, Transport and Storage Containers, Associated Equipment, Source
Changers, and Survey Instruments
This section (previously Sec. 34.28) addresses requirements for the
various types of inspection and maintenance activities that licensees
must perform to ensure that equipment is in good operating condition,
sources are properly shielded, required labels are present, and
components important to safety are functioning properly. Records of
these inspections and maintenance performed are to be kept for 3 years.
The proposed rule extended inspection and maintenance checks to
include associated equipment. Associated equipment includes various
items used for specific tasks which may not be supplied with the
radiographic exposure device. Experience has shown that defects in
associated equipment can have an effect on safety. The term routine
maintenance was used in the proposed rule to clarify that licensees are
not required to perform all maintenance. Many equipment repairs may
require returning the device to the manufacturer. A requirement to
remove defective equipment from service until repaired was also
included, and that a record of the defect, as well as the corrective
actions taken, must be made.
Comment
Three comments were received on this section. Commenters indicated
that the daily checks should be more than just visual checks and that
they should include operability checks to reveal any equipment
problems. The commenters indicated that the components should be
maintained in accordance with the manufacturer's specifications and
that the recording requirements should include maintenance performed
even if this is performed by another, such as the manufacturer.
Response
The NRC agrees that both visual and operability checks of equipment
should be made daily and has modified paragraph (a) accordingly. The
proposed rule would have only required that survey instrument
operability be evaluated daily with a check source or other appropriate
means. By requiring a daily operability check, the likelihood of the
radiographer relying on a defective instrument should be reduced.
Although it may be a good practice to maintain the equipment in
accordance with the manufacturer's specifications, requiring this in
the final rule is not necessary, provided the licensee has appropriate
procedures for conducting routine inspection and maintenance. The final
rule will now require the licensee to have written procedures for the
inspection and routine maintenance of radiographic equipment.
In response to a comment on Sec. 34.35 regarding moving the
transportation requirements in 10 CFR Parts 71 and 34 to reduce the
confusion to licensees, the QA requirements for maintenance of
transport packages have been included in this section. This, together
with a minor conforming change to 10 CFR Part 71, will relieve an
existing burden on radiography licensees, who will no longer need to
separately submit a transport package QA program description for
approval. The prescribed written procedures must include procedures
necessary to inspect and maintain Type B packaging used to transport
radioactive material.
Section 34.33: Permanent Radiographic Installations
This section (previously Sec. 34.29) specifies the safety
requirements that must be in place for any permanent radiographic
installation. The proposed rule was basically unchanged from the
existing regulation except that daily
[[Page 28954]]
checks would be required for both the visible and audible alarms in
place of testing the alarm systems at intervals not to exceed three
months. Entrance controls of the type described in Sec. 20.1601(a)(1)
would be tested monthly under the proposed rule, instead of every 3
months.
Finally, the proposed rule would have required that, if an entrance
control device or an alarm is operating improperly, it would be
labelled as defective and repaired before operations are resumed.
Comment
Six comments were received on this section. Two of the commenters
believed that the monthly testing of entrance controls was redundant if
there was also a requirement for a daily test. Two others were
concerned that no provision was made for surveillance of high radiation
areas around the roof of those installations where the shielding is
insufficient to reduce the radiation below the level of a high
radiation area. One commenter expressed a concern that there was no
provision for use of the facility should the visual and audible alarms
become defective and require some time to repair. Two commenters also
suggested that the alarm system be tested with a source rather than by
turning on the exposure device.
Response
The NRC agrees that the exposure device need not be used to check
the alarm system and has changed paragraph (b) in the final rule
accordingly. The NRC has added words to help clarify the difference
between entrance control devices described in Sec. 20.1601(a)(1) and
the alarm systems described in Sec. 34.33(a)(2). Daily testing is
required for the audible and visual alarms described in
Sec. 34.33(a)(2). Systems whereby the radiation level is automatically
reduced upon entry (Sec. 34.33(a)(1)) require monthly testing. The
final rule has been revised to allow licensees to continue to use the
facility if the alarm system is found to be defective, for a period of
up to 7 calendar days, provided the controls needed for a temporary
jobsite are in place. The NRC will review any applications where high
radiation areas exist outside the permanent installation on a case-by-
case basis to ensure that adequate safety controls are in place for
these installations.
Section 34.35: Labeling, Storage, and Transportation
This is a new section that specifies requirements for labeling,
storage, and transportation of radioactive material used in industrial
radiography. The proposed rule contained requirements to lock and
physically secure transport packages and to store licensed material in
a manner that minimizes the danger from explosions or fire. The
proposed rule also contained a requirement for a QA program, as
described in Sec. 71.105.
Comment
Three comments were received on this section. All requested that
the applicable Department of Transportation (DOT) regulations,
including the QA requirements on packages, be included in 10 CFR Part
34.
Response
The NRC agrees that certain requirements in 10 CFR Part 71 relating
to a QA program should be relocated in 10 CFR Part 34. The Commission
has made a determination that inspection programs for industrial
radiography containers meeting the requirements of Sec. 34.31(b) will
satisfy the requirements in Sec. 71.101. While radiography licensees
have always had to comply with the QA requirement for transport
packages in 10 CFR Part 71, there have been numerous cases where they
were unaware of this requirement and, therefore, failed to comply. The
inclusion of this requirement in 10 CFR Part 34 will reduce the burden
on radiography licensees to submit a QA program for NRC approval
separately. Much of the same information on inspection and maintenance
that was required as part of the license application was similar to
that information required for a QA program under 10 CFR Part 71. A
revision to Sec. 71.101 has been made to state that the inspection and
maintenance programs for radiographic exposure devices, source
changers, or packages transporting these devices that meet the
provision of Sec. 34.31(b) or equivalent Agreement State regulations,
need not be submitted separately as a QA program for Commission
approval. This change eliminates the potential for duplicate submission
of information and reduces the monetary burden on radiography licensees
because they will no longer be required to pay the fees associated with
the QA program in 10 CFR Part 71. This change, however, does not
relieve radiography licensees from complying with the transport
requirements in 10 CFR Part 71.
Section 34.41: Conducting Industrial Radiographic Operations
This new section specifies certain conditions that must be met
before performing radiographic operations in order to ensure that
adequate safety measures are in place before conducting radiographic
operations. The proposed rule specified that all radiographic
operations conducted at locations of use listed on the license must be
conducted in a permanent radiographic installation. The NRC has always
believed that radiography performed in a fixed facility, meeting the
requirements of Sec. 34.33, would provide a safer environment for
workers and the public. If licensees need to perform radiography at
their place of business outside of a permanent facility due to some
unique circumstances, i.e., item to be radiographed is too large for
the facility, Commission authorization would be required. The proposed
rule included a requirement for two individuals to be present whenever
radiographic operations occur outside of a permanent installation. One
of these individuals is required to be a fully qualified radiographer
and the other individual is required to be a radiographer's assistant
meeting the requirements specified in Sec. 34.43(c).
Comment
More than 50 comments were received on this section, 42 in favor
and 11 opposed. Those not in favor of adopting the two-person
requirement cited the additional cost for the second individual as the
major reason. Some suggested modifying the requirement to allow use of
less qualified people such as security guards for the second
individual. Another suggestion was to allow the RSO to determine when a
second individual was required. One comment addressed radiography
performed within a factory environment where access could be controlled
by one radiographer who could lock access to the site to prevent
persons from entering during radiography operations. Those in favor of
the requirement cited the increased safety provided by having two
individuals present at all times. Several commenters pointed out that
the additional cost of this provision would be borne by the users with
little impact on the licensees. One commenter was concerned that unless
explicitly stated, unqualified individuals could be asked to perform
duties that should be performed by qualified individuals, for example,
rather than using a 2-person crew comprised of a radiographer and a
radiographer's assistant, the customer may propose the use of one of
its employees as a method to reduce the nondestructive testing
company's fees.
Response
The Commission has decided to adopt the requirement for at least
two
[[Page 28955]]
qualified individuals to be present whenever radiographic operations
are performed outside of a permanent radiographic installation. The
Commission believes that the safety issues involved mandate the
adoption of this requirement, particularly when radiography is
performed in high places or in trenches, where problems can most often
occur, and where the radiographer alone is not able to control access.
It should also be evident that in case of accident or injury, the
second person needed at the site must be more than an observer. The
person should have sufficient radiography and safety training to allow
him/her to take charge and secure the radioactive material, provide aid
where necessary, and prevent access to radiation areas by unauthorized
persons, whereas an untrained person, such as a security guard or
contractor's employee as suggested by one commenter, would be unable to
perform these functions in a safe manner. The text of this section has
been modified to emphasize that the purpose of the second individual is
to provide immediate assistance when required and to prevent
unauthorized entry into the restricted area.
Section 34.41(d) was added to include a requirement to have
approved procedures before conducting specific types of radiographic
operations such as lay-barge, underwater, and off-shore platform
radiography to make NRC regulations more compatible with Agreement
State requirements.
Section 34.42: Radiation Safety Officer for Industrial Radiography
This new section identifies the qualifications and duties of the
RSO for industrial radiography. Previously, these requirements were
referenced in regulatory guides and included as license conditions on a
case-by-case basis, but not spelled out in the regulations. The NRC
believes the RSO is the key individual for oversight of the licensee's
radiography program and the person responsible for ensuring safe
operation of the program.
The proposed rule specified that to be considered eligible for the
RSO position, an individual must have a minimum of 2000 hours of
documented experience as a qualified radiographer in industrial
radiographic operations. Among the responsibilities of the RSO
specified in the proposed rule, were the establishment and oversight of
all operating, emergency, and ALARA procedures and conduct of the
annual review of the radiation protection program required by
Sec. 20.1101(c).
Comment
Twenty comment letters were received on this section in the
proposed rule. More than half opposed the provision, primarily on the
grounds that mandatory certification and the required 2000 hours of
experience in radiographic operations would cause many well trained
persons to be disqualified. Several commenters stated that they used
RSOs with broad radiation protection experience and academic training
for oversight of the radiography and other programs but not for active
supervision of radiographic operations. Other commenters stated that
NRC should modify its requirement of 2000 hours documented experience
in radiographic operations partly because the documented experience
could be difficult to verify. One commenter pointed out that there is
no existing 40-hour course to prepare someone to be an RSO for a
radiography license. This commenter also pointed out that there was a
2-day course available entitled Administrators Seminar that covered the
specific regulations pertaining to radiography and how to implement an
effective program. One Agreement State requested that the experience
required for the RSO be broad enough to encompass X-ray radiography.
Another commenter suggested that the NRC should consider modifying its
requirements to permit fulfillment of the qualifications by more than
one individual.
Response
The requirement for 2000 hours of documented experience in
radiographic operations has been changed to read 2000 hours of hands-on
experience in industrial radiographic operations as a qualified
radiographer, which is essentially 1 year full-time of field experience
after reaching the level of a qualified radiographer, and formal
training in the establishment and maintenance of a radiation protection
program. What is meant by ``hands-on experience'' is experience in all
those areas considered to be directly involved in the radiography
process. These include taking radiographs, surveying devices and
radiation areas, calibration of survey instruments, operational and
performance testing of survey instruments and devices, film
development, posting of radiation areas, transportation of radiography
equipment and travel to temporary jobsites, posting of records and
radiation area surveillance etc. Excessive time spent in only one or
two of these operations (such as film development or radiation area
surveillance) should not be counted toward the 2000 hours under
consideration. Limited experience with radiography utilizing X-rays can
be included. However, because there are greater safety concerns
associated with the use of exposure devices utilizing gamma radiation
than there is with use of an X-ray device where the radiation field can
be shut off, the majority of this experience should be in isotope
radiography. The 2000 hours time period was selected to ensure that the
RSO has sufficient radiographic experience to be able to clearly
oversee the safety aspects associated with industrial radiography.
Because utilization logs are already kept for 3 years, no additional
documentation of a radiographer's experience would need to be
maintained. This change is based in part on the comments received at
the December 1994, workshop held in Houston, Texas. A number of
licensees attending the workshop maintained that requiring
documentation of 2000 hours would be overly burdensome.
A provision for the NRC to consider alternatives, based upon the
licensee's submittal of the proposed RSO's credentials, has also been
added to provide flexibility for licensees that engage in other
activities involving NRC licensed material where the RSO would not
likely be a radiographer but would be a radiation protection
professional. The qualifications, training, and experience required of
the RSO will vary depending upon the complexity of the licensee's
operations and the number of individuals potentially involved.
In response to comments at the December 1994, workshop in Houston,
Texas, the requirement for the RSO to have formal classroom training
related to the radiation protection program, has been modified to
delete the requirement that it be a 40-hour course. The primary
requirement is that the training properly addresses the appropriate
subjects without regard to specification of the hours spent. Other
minor word changes have been made for clarification. In response to a
comment, paragraph (c)(5) has been changed to clarify that the RSOs
must have the authority to assume control for instituting corrective
actions, including stopping operations when necessary in emergency
situations or unsafe conditions.
Section 34.43: Training
This section addresses training requirements for industrial
radiographers and radiographers' assistants. Section 34.43(a) in the
proposed rule was revised to require radiographers to be certified by a
[[Page 28956]]
certifying entity meeting the criteria specified in Appendix A to 10
CFR Part 34.
In addition, the proposed rule incorporated some additional
training in NRC regulations for radiographers' assistants, required
written tests for radiographers' assistants, required annual refresher
safety training for radiographers and assistants, and reduced the
frequency of inspection of radiographers and assistants from quarterly
to annually.
Training subjects previously listed in Appendix A were moved to
Sec. 34.43 (g) in the proposed rule. Several additional topics were
also included: pictures or models of source assemblies; training in
storage, control, and disposal of licensed materials; and other
pertinent Federal regulations (i.e., DOT). The requirement for annual
refresher safety training was included in the proposed rule to clarify
what was meant by the term ``periodic training'' in the existing
regulation. Licensees are expected to address new information since the
employee's last training, such as new equipment or revised operating
and emergency procedures, and safety issues.
Comment
Sixty-one comment letters were received on this section, most
commenting on the certification provision. Four of the comment letters
were directed against Sec. 34.43(d), which reduced the inspection of
the job performance of radiographers and radiographers' assistants to
an annual inspection in place of the current quarterly inspections. The
remainder of the comments addressed mandatory certification. Forty-
three were in favor and 14 opposed to certification. Some of the larger
licensees stated that their training programs were superior to what was
being proposed and that adopting this requirement would force them into
having to participate in a duplicate program without any corresponding
safety benefit. Other commenters were opposed because of the cost
involved in implementing the program. Also, some licensees believed
that they should be granted exemptions because their in-house
certification programs were somewhat site specific and specialized and
would not qualify their radiographers to compete in the commercial
industrial radiography market without further, more generalized
training.
Response
After consideration of the comments received, the Commission has
decided to adopt mandatory certification requirements for industrial
radiographers to provide a consistent standard by which training of all
radiographers can be measured. Individual licensees will have less of a
burden in confirming the training status of a newly hired radiographer
through a national certification system. While the final rule reduces
the burden on licensees by no longer requiring them to submit
descriptions of their training programs for the subjects listed in
Sec. 34.43(g), licensees still must ensure that newly hired individuals
have completed, or are provided, the appropriate training in the
subjects listed in Sec. 34.43(g) and a period of on-the-job training.
Licensees still must provide instruction in emergency and operating
procedures, as well as any specific requirements in their NRC license.
The final rule includes additional flexibility, in that, either written
or oral tests may be used to test a radiographer's knowledge of this
information but that in either case, the records required by Sec. 34.79
must be maintained as specified.
To be recognized as a certifying entity, an independent
organization meeting the criteria specified in Part I of Appendix A
will have to apply as specified in Sec. 34.43(a)(1). A list of
certifying entities will be made available to licensees on request by
contacting the appropriate regional office listed in Appendix D to 10
CFR Part 20 and will be published annually in the Federal Register.
Licensees will have 2 years to implement this certification
requirement. During this time, the licensee may allow an individual who
has not met the certification requirements to act as a radiographer if
the individual has received training in the subjects outlined in
paragraph (g) of this section and has successfully completed a written
test approved by the NRC.
The Commission recognizes that some of the larger licensees may
believe they have a superior program to that currently being offered by
the existing certifying organizations. These licensees will still be
able to provide training as they currently do. Any additional burden
from having their radiographers tested by an independent certifying
organization should be minimal.
In response to comments, Sec. 34.43(e) is modified in the final
rule to require inspections of radiographers and radiographers'
assistants on at least a semiannual basis. With the required
certification of radiographers and the additional training required of
radiographers' assistants, the Commission believes that reducing these
inspections from a quarterly to a semiannual basis is justified.
Nothing in the regulations prevents a licensee from conducting these
inspections more frequently. Radiographers or radiographers' assistants
who have not participated in industrial radiographic operations for
more than 6 months will be required to demonstrate their knowledge of
the training requirements of Sec. 34.43(b)(3) and Sec. 34.43(c)(3),
respectively, by a practical examination before their next
participation in radiographic operations. Flexibility has been provided
in Sec. 34.43(e) of the final rule for situations where the RSO also
serves as a radiographer. In such cases, licensees must include
information in their application as to how they will ensure that the
proficiency of the radiographer is maintained.
Section 34.45: Operating and Emergency Procedures
This section (previously Sec. 34.32) identifies the procedures that
licensees must develop and submit to the NRC in their application. The
proposed rule included only minor changes to this section to assure
that all activities (e.g. source recovery) carried out by the licensee
involving radioactive material were covered by appropriate procedures.
Comment
Four commenters addressed this section. One commenter was opposed
to allowing an organization to retrieve a source unless they had
submitted extensive emergency and training procedures to the NRC.
Another commenter stated that, although there are basic principles that
apply to any source recovery, each specific source recovery exhibits
unique characteristics and/or peculiarities and that specifics for
source recovery would be better addressed in a separate procedure that
is referenced in the regulation. The third commenter requested adding a
requirement for inspection, maintenance, and operability checks on
survey instruments, clarification of procedures for identifying and
reporting defects and malfunctions under 10 CFR Part 21 and
Sec. 34.101, and recommended that source recovery procedures should
include the topics: advance preparations, initial response, retrieval
planning guidelines, retrieval operation guidelines, and post-retrieval
tasks. The fourth commenter noted that each source recovery is unique
so the procedures need to be kept generic and flexible. Comments on
another section suggested that the Commission should address procedures
for lay-barge, offshore platform, and underwater
[[Page 28957]]
radiography because licensees may elect to perform these activities.
Response
Because the Commission believes that licensees should have the
flexibility to recover sources, no change has been made in the final
rule concerning source recovery procedures. In response to other
comments, survey instruments and transport containers have been
included in the paragraph requiring inspection, maintenance, and
operability checks. With regard to clarification of procedures for
identifying and reporting defects and malfunctions, Sec. 34.101
requires notification of the NRC only when a defect or malfunction is
observed that corresponds to any of the incidents described under
Sec. 34.101(a). Additional reporting may be required for incidents that
meet the definition of a ``defect'' under 10 CFR Part 21, and do not
fall into any of the three categories in Sec. 34.101.
In response to comments made at the December 1994 workshop in
Houston, Texas, paragraph (a)(8) was revised to clarify that corrective
action is not required if the alarm ratemeter alarms at an expected
time, such as when the source is being cranked in or out of the device.
The NRC did not adopt a provision for submitting procedures for
lay-barge, offshore platform, or underwater radiography for licensees
who intend to perform these activities. Licensees who elect to perform
these activities must address the applicable procedures with license
submission.
Section 34.46: Supervision of Radiographers' Assistants
This section (previously Sec. 34.44) specifies requirements for
radiographers' assistants to handle equipment associated with
radiographic operations. The proposed rule included no changes to this
section.
Comment
No comments were received on this section.
Section 34.47: Personnel Monitoring
This section (previously Sec. 34.33) addresses requirements for
monitoring radiation exposures to radiographic personnel. The proposed
rule specified that pocket dosimeters must have a range of 0-200
millirems, and included a requirement to read pocket dosimeters at the
beginning and end of each shift to ensure that the dose is correctly
estimated. This requirement was included because it is nearly
impossible to recharge a pocket dosimeter to zero. Therefore, licensees
must take a reading before and after use and determine the difference.
The proposed rule provided criteria for allowing a worker to return to
work when a pocket dosimeter is found to be off-scale. Paragraph (a) of
the final rule requires workers to wear their dosimeters on the trunk
of the body in order to measure whole body dose as defined in 10 CFR
20.1003. The dose to the extremities (again as defined in 10 CFR
20.1003) is to be measured only with appropriate extremity dosimeters.
Paragraph (e) in the proposed rule specified that a worker must cease
work whenever a film badge or a thermoluminescent dosimeter (TLD) is
lost until a replacement is provided to ensure that there is an
accurate means to determine the worker's dose. The proposed rule
included a provision that, after replacement, each film badge and TLD
must be promptly processed and that alarming ratemeters be capable of
alerting the wearer regardless of the environmental conditions.
Comment
The NRC received twenty-eight comment letters on this section.
Several commenters wanted to be able to use additional dosimeters with
higher ranges to supplement those specified in Sec. 34.47(a)(1). One
commenter asked whether digital dosimeters (electronic personal
dosimeters) could be used in place of pocket dosimeters since their
range was considerably greater than the range specified for pocket
dosimeters and also asked whether they could be used in place of an
alarm ratemeter. Two commenters opposed replacing TLDs on a monthly
basis because of the additional cost with no discernable increase in
safety. A commenter wanted pocket dosimeters to be calibrated every 6
months in place of the specified 12 months and requested that the
acceptable range for dosimeter readings be set within plus or minus 20
percent. Nine commenters opposed Sec. 34.47(g)(3) because it required
alarm ratemeters to alert the wearer regardless of environmental
conditions. A number of comments were received at the December 1994
workshop in Houston, Texas relating to proposed requirements for TLD
exchanges, alarming ratemeters, and the use of electronic personnel
dosimeters. Suggestions were made to lower the preset dose rate
specified in the rule below 5 mSv/hr to allow licensees the flexibility
of using a lower dose rate if they choose. Other comments indicated
that radiographers often rely on alarming ratemeters to alert them that
the source has not been retracted into the camera rather than
performing a survey to verify that the source is properly stored.
Because of this, these commenters believed that the requirement to
always wear an alarming ratemeter should be removed from the
regulations. A number of licensees at the workshop stated that it would
be extremely difficult and costly to obtain ratemeters that are capable
of alerting the wearer in the wide variety of environmental conditions
under which they work. A number of commenters at the workshop did not
agree with lengthening the replacement frequency for TLDs to quarterly
on the basis that frequent checks of workers' doses were needed due to
the potential for high doses. Several commenters requested flexibility
to use electronic personnel dosimeters in place of pocket dosimeters
and stated that pocket dosimeters were increasingly difficult to
obtain. One commenter recommended continued use of pocket dosimeters
rather than electronic personal dosimeters and reported that supplies
of pocket dosimeters were still available.
Response
The final rule allows replacement of TLDs on a 3-month basis. The
comments of the Agreement States requesting continuation of the monthly
frequency were not adopted. The RSO is responsible for ensuring that
worker doses are maintained ALARA. The purpose for requiring pocket
dosimeter readings to be recorded daily is to ensure that worker doses
are maintained ALARA. The requirement to replace film badges monthly
was not changed because film badges are not rugged enough to withstand
environmental conditions for 3 months without the film housing
developing light leaks or absorbing moisture.
The NRC did not change the final rule to permit use of pocket
dosimeters with ranges greater than 0-200 millirems. This ensures that
emergency procedures are implemented when doses exceed 200 mrem.
Licensees are free to use additional pocket dosimeters with higher
ranges for informational purposes. The NRC has agreed to change the
accuracy requirement for pocket dosimeters to 20 percent to
more closely match the recommendations in ANSI N322 and ANSI N13.5. The
calibration period of pocket dosimeters was not changed because this is
the maximum period recommended in ANSI N323.
The requirement that alarming ratemeters be sufficient to alert the
wearer regardless of environmental conditions has been dropped from the
final rule. Licensees are expected to make a reasonable attempt to
select
[[Page 28958]]
alarming ratemeters that will function properly for the conditions
under which they will be used.
Although a number of individuals at the December 1994 workshop in
Houston, Texas, believed that the use of alarming ratemeters results in
radiographers failing to make the proper surveys, the evidence the
Commission has seen demonstrates that overexposures have decreased
since this requirement went into effect. Therefore, the NRC continues
to believe that the proper use of alarming ratemeters may be an
effective means for preventing overexposures. The NRC has decided not
to make any changes in the alarm point requirement. The use of a lower
limit would likely result in frequent alarms that could have a negative
impact because the wearer would be more likely to turn off the
ratemeter to avoid an alarm. The purpose of alarming ratemeter is to
alert the wearer of an abnormal condition requiring prompt action to
reduce the likelihood of an inadvertent overexposure.
Finally, in response to comments from licensees at the Houston,
Texas, workshop, the final rule has been revised to allow the use of
electronic personnel dosimeters in lieu of pocket dosimeters as a
direct reading dosimeter. Those electronic personal dosimeters that
also have alarm ratemeter capabilities are not to be used as a
substitute for alarm ratemeters at the present time. Individuals acting
as a radiographer or radiographer's assistant must wear direct reading
dosimeters, an operating alarm ratemeter, and either a film badge or a
TLD during radiographic operations.
Section 34.49: Radiation Surveys
This section (previously Sec. 34.43) addresses requirements for
surveys that must be made during and after radiographic operations to
ensure that the radioactive source is safely secured when radiographic
operations are not being performed and that public dose limits in 10
CFR Part 20 are met. The proposed rule included a number of revisions
to this section. The first of these was to replace the 360 deg. survey
of the exposure device with a requirement to conduct a survey when
approaching the exposure device and the guide tube prior to exchanging
film, repositioning the collimator, or dismantling equipment. The
proposed rule also required conducting an adequate survey any time the
source is exchanged and whenever a radiographic exposure device is
placed in storage.
Comment
Eight comment letters were received on this section. One commenter
noted that a number of NRC licensees have been fined in the past for
failing to do the 360 deg. survey of the radiographic exposure device
and the guide tube exactly as designated and now the NRC is deleting
the requirement. One commenter pointed out that it is unnecessary to
survey the storage area at the time of quarterly inventory because
there is already a requirement for surveying whenever storage
conditions change, i.e., whenever radioactive material is added to or
removed from the storage area. The last commenter noted that
Sec. 34.49(f) would require the maintenance of records per Sec. 34.85,
which in turn states that survey records to be maintained are those of
the last survey performed in the work day as specified in
Sec. 34.49(d). The commenter was concerned that records would be
interpreted as measurements of all of the 12 to 18 measurements
specified in Sec. 34.21, and suggested a single measurement made at the
outlet port of the radiography device each day would provide an
adequate record and also any significant change in the reading obtained
at this position would be an indication that the source was not in its
fully shielded position.
Response
In response to these comments and additional comments from the
workshop in Houston, Texas, the final rule has been changed to clarify
that the intent of the requirements in Secs. 34.49(b) and (c) is to
conduct a survey to ensure that the source is in the shielded position.
This can be accomplished by surveying the radiographic exposure device
and comparing the reading obtained to the reading expected when the
source is known to be in the device.
The requirement in the proposed rule to survey the storage area
initially and at the time of the quarterly inventory has been removed.
Because Sec. 34.49(c) requires a survey whenever a radiographic
exposure device is placed in storage, and Sec. 20.1302 already requires
licensees to demonstrate compliance with the public dose limits,
licensees are expected to establish a program to ensure that storage
areas meet these requirements. Section 34.49(d) requires that a record
of the last survey be maintained for each device prior to placing the
device in storage for the day.
Section 34.51: Surveillance
This section (previously Sec. 34.41) specifies requirements for
radiographers to maintain surveillance of a high radiation area during
industrial radiographic operations to protect against unauthorized
entry. The proposed rule was basically unchanged from the existing rule
except the requirement specified ``continuous'' direct surveillance.
References to 10 CFR Part 20 were updated to reflect the changes made
to Sec. 34.33, Permanent Radiographic Installations. In response to
comments at the December 1994, workshop in Houston, Texas, the final
rule has been amended to clarify that, for radiographic operations that
employ 2-person crews, surveillance may be performed by the
radiographer's assistant.
Comment
No comments were received on this section.
Section 34.53: Posting
This section addresses requirements for identifying areas where
radioactive material is being used to comply with radiation protection
requirements discussed in 10 CFR Part 20. The proposed rule made only
minor changes to this section.
Comment
One comment letter was received on this section. The commenter
suggested that areas where radiography was being performed should be
posted with signs bearing the words ``KEEP OUT'' because the usual
``CAUTION'' and ``DANGER'' signs are inadequate at temporary job sites.
The commenter also suggested that the rope or tape used to post
restricted areas for radiography be colored magenta and yellow. The
commenter believed that it was important to clarify that ``Very High
Radiation Areas'' need not be posted during industrial radiography
because radiographic operations may create areas which meet the posting
requirements of Sec. 20.1903(c).
Response
No change was made to the final rule to exempt posting of very high
radiation areas. Most industrial radiography programs are limited to
the use of sources that do not create very high radiation areas as
defined in Sec. 20.1003. For licensees who intend to use radiation
devices capable of creating very high radiation areas, considerations
of posting and restricting these areas will be dealt with on a case-by-
case basis during the licensing process.
Subpart E-Recordkeeping Requirements
This new subpart places all recordkeeping and notification
[[Page 28959]]
requirements for 10 CFR Part 34 in one location.
Section 34.61: Records of Specific Licenses for Industrial Radiography
This new section in the proposed rule requires licensees to
maintain a copy of their licenses until their licenses are terminated
by the Commission.
Comment
No comments were received on this section.
Section 34.63: Records of Receipt and Transfer of Sealed Sources
This new section in the proposed rule requires licensees to
maintain records of receipt and disposition of radioactive sources used
under their license. The requirement includes any devices containing
shielding material using DU. In the case of such devices, the mass of
DU designated by the manufacturer would be included in place of the
activity.
Comment
Only minor editorial comments were received on this section.
Section 34.65: Records of Radiation Survey Instruments
This new section of the proposed rule contains the recordkeeping
requirements for radiation instruments required under Sec. 34.25. The
recordkeeping requirements were previously included in existing
Sec. 34.24. This section would require licensees to maintain
calibration records for radiation survey instruments for 3 years after
the record is made.
Comment
One comment letter was received on this section. The commenter
requested that the operability check required under Sec. 34.25 be
included in the records maintained under this section.
Response
The financial burden involved in recording daily operability checks
under this section is felt to be prohibitive. Section 34.73 has been
modified in the final rule to only require records of any problems
encountered during operability checks.
Section 34.67: Records of Leak Testing and Replacement of Sealed
Sources
This new section contains recordkeeping requirements previously
included in Sec. 34.25(c) and requires licensees to maintain records of
leak tests for 3 years after the record is made.
Comment
No comments were received on this section.
Section 34.69: Records of Quarterly Inventory
This new section contains recordkeeping requirements previously
contained in Sec. 34.26 and requires licensees to maintain records of
quarterly inventories for 3 years after the record is made. The
proposed rule required some additional information be kept, such as
model number, serial number, and manufacturer of the sealed source.
Comment
One comment letter was received stating that the record should
include all licensed devices whether or not they contain a sealed
source at the time of inventory.
Response
Section 34.29 was revised in the final rule to include devices
containing depleted uranium.
Section 34.71: Utilization Logs
This new section contains recordkeeping requirements previously
included in Sec. 34.27. The proposed rule would have required
additional pieces of information 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 from and returned to
storage. This information is needed to assist in verifying the location
of sources.
Comment
Three comment letters were received on this section. One commenter
pointed out that the RSO may control the utilization log at the main
office and, because the device could be at a field station many miles
from the main office, signatures of the radiographers on the
utilization log was not practical. The second commenter stated that the
utilization log should include all devices removed from storage, not
only those containing a sealed source at the time of removal. The third
commenter requested removal of the requirement to include the
radiographer's signature.
Response
Licensees at the December 1994 workshop in Houston, Texas, stated
that their radiographers were signing the log as required and either
mailing or faxing a copy of the document to the RSO after all
signatures for the day were collected. The radiographer's signature is
needed to ensure that only a qualified individual has checked out a
radiographic exposure device. This provision was retained in the final
rule.
An exposure device not containing a sealed source will not be
utilized within the context intended in Sec. 34.71. If the radiographer
intends to load a sealed source into the empty exposure device, then a
storage container which contains a sealed source must be checked out as
specified in Sec. 34.71(a)(1) and an entry made in the utilization log.
This provision was retained in the final rule.
Section 34.73: Records of Inspection and Maintenance of Radiographic
Exposure Devices, Storage Containers, Associated Equipment, Source
Changers, and Survey Instruments
This new section contains recordkeeping requirements previously
contained in Sec. 34.28(b). The proposed rule specified that inspection
and maintenance records must be maintained by the licensee for 3 years.
Licensees must maintain records of equipment problems and of any
maintenance performed under Sec. 34.21 (a) and (b). The records must
include information, such as dates of checks, name of inspector,
equipment inspected, any defects found, and repairs made.
Comment
Two comment letters were received addressing this section. The
first letter requested that the highest radiation level measured at the
beginning of each day from devices or source changers removed from
storage should be recorded and used as a reference to provide a
baseline for comparison with measurements taken from later surveys to
ensure no change in the shielding was occurring. The second letter
requested that the records compiled under Sec. 34.73 should include
inspection records of survey instruments, equipment problems, and
records of maintenance performed.
Response
The first comment was not adopted because sufficient requirements
are already in place under Sec. 34.49 and Sec. 20.1302 to ensure that
licensees are in compliance with the public dose limits. Licensees may
choose to include additional information in their records to assist
them in assuring that there are no changes occurring in the shielding
integrity. The requests of the second commenter have been incorporated
in Sec. 34.31 in the final rule.
[[Page 28960]]
Section 34.79: Records of Training and Certification
This new section includes recordkeeping requirements previously
included in Sec. 34.31(c). The proposed rule also specified that
records verifying radiographer certification and annual safety reviews
are to be retained for 3 years after the record is made. For annual
safety reviews, the records include copies of tests, dates
administered, names of instructors and attendees, and the topics
covered. The proposed rule also specified that records of inspections
of radiographers and radiographers' assistants must include a list of
items checked and any non-compliances observed by the RSO.
Comment
Two comment letters were received on this section. One requested
that the wording be changed to eliminate ``copies of written tests''
and replace it with ``licensee administered written tests.'' The other
requested minor editorial changes.
Response
The wording has not been changed because in many cases the training
and testing may be given by outside consultants or companies that
specialize in such training and testing. The term ``annual safety
review'' was changed in the final rule to ``annual refresher safety
training'' to clarify its role in the licensees'' training program.
Section 34.81: Copies of Operating and Emergency Procedures
This new section includes requirements previously included in
Sec. 34.32 and would have required licensees to maintain copies of
emergency and operating procedures until the Commission terminates the
license.
Comment
No comments were received on this section.
Section 34.83: Records of Personnel Monitoring
This new section includes recordkeeping requirements previously
included in Sec. 34.33(b) and would have required 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
maintain records of film badge or TLD reports until the Commission
terminates the license(s).
Comment
One commenter requested that records of daily operability checks
and quarterly inspections of survey instruments should be included in
this section.
Response
These records are already required under Sec. 34.65. Therefore, no
change was made to this section.
Section 34.85: Records of Radiation Surveys
This section (previously Sec. 34.43(d)) was essentially unchanged
in the proposed rule. The proposed rule would require the licensee to
maintain records of exposure device surveys conducted before the
radiographic exposure device is placed in storage for 3 years from the
date the record was made.
Comment
No comments were received on this section.
Section 34.87: Form of Records
This section (previously Sec. 34.4) of the proposed rule was
unchanged from the current regulations. This section of the proposed
rule specified how records must be maintained, including storage by
electronic media.
Comment
No comments were received on this section.
Section 34.89: Location of Documents and Records
This new section addresses requirements for licensees to maintain
certain records at locations where radiographic operations occur, such
as at a permanent installation, temporary jobsite, or field station,
where radioactive material is stored and from which it is dispatched
for use at a temporary jobsite. Two sections were included in the
proposed rule to ensure that licensees have records available at the
appropriate locations to maintain safe operations. The records include
a copy of the license, copies of pertinent NRC regulations, utilization
records for the devices in use at the temporary jobsite, records of
equipment problems, records of alarm system checks for permanent
installations located at a temporary jobsite or field station,
personnel monitoring records, operating and emergency procedures,
evidence of latest calibrations and operability checks of personnel
monitoring devices, latest survey records, and shipping papers.
Comment
Three comment letters addressed this section. One commenter
believed that the licensee should have more discretion regarding which
records to keep at each particular site, while all three commenters
stated that the requirements were confusing and would lead to
voluminous record keeping.
Response
In the final rule, Sec. 34.89 specifies requirements for the
minimum set of records to be maintained at field stations and temporary
jobsites. This set of records is the minimum needed to ensure that the
licensee can conduct radiographic operations safely and to demonstrate
that they are in compliance with NRC regulations. The licensee has the
discretion to determine the location for all other records required to
be kept under 10 CFR Part 34 and other applicable parts of NRC
regulations.
Section 34.101: Notifications
This section of the proposed rule addressed requirements previously
in Sec. 34.30, for licensees to notify the NRC of incidents having
safety significance. The proposed rule contained a new requirement to
inform the appropriate NRC regional office (generally, where the
license was issued) in writing before using or storing radioactive
material in any location for more than 180 days.
Comment
One comment was received requesting clarification between
malfunctions that are to be reported under this section and defects
that require reporting under 10 CFR Part 21.
Response
The final rule was changed to acknowledge the reporting
requirements in 10 CFR Parts 21 and 30. However, as noted in the
response to Sec. 34.45, Sec. 34.101 requires NRC notification when a
defect or malfunction is observed that corresponds to any of the
incidents described under that Sec. 34.101(a), regardless of whether
additional reporting is required by other parts of this chapter, such
as 10 CFR Parts 21 and 30.
Section 34.111: Applications for Exemptions
This section of the proposed rule addressed exemptions and was
basically the same as Sec. 34.51 in the existing 10 CFR Part 34, with
the exception of minor wording changes to make it consistent with
current language used in other parts of the rule.
Comment
No comments were received on this section.
[[Page 28961]]
Section 34.121: Violations
This section in the proposed rule addressed violations and was
basically the same as Sec. 34.61 in the current 10 CFR Part 34.
Comment
No comments were received on this section.
Section 34.123: Criminal Penalties
This section of the proposed rule addressed criminal penalties and
was basically the same as Sec. 34.63 in the current 10 CFR Part 34.
Comment
No comments were received on this section.
Appendix A
This appendix was new in the proposed rule. The requirements in
Appendix A in the current 10 CFR Part 34 were relocated to
Sec. 34.43(g). Part I of Appendix A in the proposed rule provided the
requirements for an independent certifying organization and only
applied to organizations other than the Agreement States. Parts II and
III of Appendix A in the proposed rule provided the requirements for
certification programs and written examinations for a certifying
entity, and included the Agreement States.
The proposed rule specified that to be recognized as an independent
certifying organization, the applicant should be a national society or
association involved in setting national standards of practice for
industrial radiography.
An acceptable certification program would include training in the
subjects listed in Sec. 34.43(g), completion of a written and practical
examination, and a minimum period of on-the-job experience.
Comment
Four comment letters addressing this section were received. One
commenter questioned how the technical content of the examination could
be at a ninth-grade reading level and expressed a view that the
requirement for a scientifically analyzed question base in III.4. was
vague and should be clarified. Another commenter felt that III.4., 5.,
and 6. should be deleted and combined into a new section that should
specify analysis using nationally-recognized psychometric examination
methods. Several of the commenters asked why such a large population of
questions was required. The G-34 Committee of the Conference of
Radiation Control Program Directors (CRCPD) on Industrial Radiography
provided numerous comments of a clarifying nature, including that:
An independent certifying organization should be open to nonmembers
as well as members;
A full-time staff may not be needed if the program is small;
References to applicable 10 CFR Part 34 sections should also
include ``applicable Agreement State regulations'';
Provisions in II.4, 6, and 8 (revocation, sanctions, and renewals)
be incorporated into one section;
Written procedures should be required for all aspects of the
program, including safeguards for ensuring adequate proctoring of
examinations.
Response
The final rule was changed to clarify that the certification
program for any independent organization should be open to nonmembers
as well as members. The provision in I.5 of the proposed rule that
specified a full-time staff has been changed to specify an ``adequate
staff'' to reduce any possible burden on organizations operating a
small program. The organization would still have to demonstrate that
the staff was adequate to administer the program. Section I.11 was
expanded to specify that independent certifying organizations must have
procedures for proctoring examinations, including proctor
qualifications, which clarify that there are other qualifications
beside the proctor not being employed by the same corporation as the
examinees. Sections II. 4, 8, and 9 were removed and replaced with a
revised requirement that the certifying entity must have procedures for
denying an application, revoking, suspending, and reinstating a
certification, because a number of Agreement States expressed concern
at the December 1994 workshop in Houston, Texas, that they would be
prohibited from revoking a certificate without providing an opportunity
for due process.
In regard to the questions relating to the scientific analysis of
tests and to the number of questions required in the question bank, the
NRC consulted experts in the testing field and has revised the final
rule to specify that test items must be drawn from a question bank
containing psychometrically valid questions. Additional guidance on the
creation and analysis of tests will be provided in Regulatory Guide
10.6.
10 CFR Part 150: Exemptions and Continued Regulatory Authority in
Agreement States and in Offshore Waters Under Section 274
Section 150.15b of the proposed rule was added to clarify that the
Commission reserves the authority to establish minimum standards
regarding radiographer certification and independent certifying
organizations, and to identify acceptable certifying entities.
Comment
Two comments were received regarding this section from Agreement
States objecting to the language that reserves the authority over
certification to the NRC. Part of the objection was based on the fact
that the first testing for radiographer certification began in Texas
and that the current state of the national certification program is the
result of cooperative development by a working partnership of Agreement
States, the NRC, ASNT, CRCPD, and others. The commenters believe that
the current wording of this section is contrary to the working
partnership that led to the current state of certification development.
The commenters also believe that the restriction imposed by this
section would prevent current certifying entities from making
improvements in their programs as the process for certifying
radiographers continues to evolve. They also expressed concern that the
language could result in automatic noncompliance for many and suggests
that the Commission consider grandfathering those entities already
operating and established at the effective date of the revision to 10
CFR Part 34.
Response
The use of the language in Sec. 150.15b was chosen in the proposed
rule because the requirements identified in Appendix A only apply to
independent certifying organizations and certifying entities. The
Commission agrees that certain States may wish to identify an
independent certifying organization and has deleted this section from
the final rule. The Commission does not intend to retain sole authority
for establishing standards for independent certifying organizations or
certifying entities. However, in order to maintain a national
certification program, whereby radiographers would be able to work in
several States without needing to be recertified in each State,
uniformity of these programs is essential. Any State choosing to
identify an independent certifying organization or choosing to be
[[Page 28962]]
a certifying entity would be expected to follow criteria compatible
with those in Appendix A. NRC will continue to work cooperatively with
the Agreement States to coordinate activities associated with the
implementation of the radiographer certification program.
III. Conforming Rule Changes
As a result of the overall revision to 10 CFR Part 34, conforming
changes to 10 CFR 30.4 and 10 CFR 150.20 are required. These changes
include removal of definitions in 10 CFR Part 30 for Radiographer,
Radiographer's assistant, Radiography. These definitions are different
from those in the final 10 CFR Part 34, and because they are not used
in 10 CFR Part 30, they are being deleted from this part. Section
150.20 (b) is being revised to include the new subparts that were added
to the final 10 CFR Part 34.
IV. Agreement State Compatibility
Sections of the rule will be a matter of compatibility between the
NRC and the Agreement States, providing consistency between Federal and
State safety requirements. Under current NRC procedures, radiographic
equipment safety standards, training standards, operational safety
standards, and technical definitions, are identified as Division 2
matters of compatibility. The final rule is retaining the existing
Division 2 designations for most requirements.
The definitions and sections that will not be compatibility
Division 2 are as follows:
A. The definitions for ALARA, becquerel, gray, sealed source, and
sievert are compatibility division 1 in this rule. These definitions,
however, duplicate definitions contained in other parts of this
Chapter. The States will only need to adopt them once.
B. The definitions for lay-barge radiography, radiographer's
assistant, and underwater radiography are considered to be special
cases of Division 2. If a State does not authorize licensees to perform
lay-barge, or underwater radiography, or does not permit the use of
radiographer's assistants, then it will not be required to adopt these
definitions.
C. The following sections are compatibility Division 3: Secs. 34.1,
34.5, 34.11, 34.111, 34.121, and 34.123.
D. The following definitions and sections are compatibility
Division 4: The definition of offshore platform radiography in
Secs. 34.3, 34.8, and 34.41(d) as it relates to offshore platform
radiography. An Agreement State will need to adopt a definition of
platform radiography if it authorizes such activity on inland waters or
tidal waters subject to the State's jurisdiction.
E. Although Appendix A is designated as compatibility Division 2,
the Agreement States are not required to implement a program unless
they choose to become a certifying entity and then would only need to
adopt Sections II and III of Appendix A. If an Agreement State chooses
to identify an independent certifying organization, then it would need
to also adopt Section I of Appendix A.
V. Implementation
The new requirements become effective 30 days after publication of
the final rule in the Federal Register, although the Commission intends
to have different implementation dates for particular requirements of
this final rule.
For use/storage locations not previously identified on the license
(e.g., field stations, permanent radiographic installations, and
temporary jobsites exceeding 180 days), licensees must request
amendments or notify the NRC, as appropriate, within 60 days of the
effective date of the rule. Few amendment requests are anticipated.
Licensees will have 1 year from the effective date of the rule to
comply with the additional training requirements specified in
Sec. 34.43 (a) and (b). Licensees should consider combining this
training with the annual refresher safety training.
Licensees will have 1 year from the effective date of the rule to
hire and train individuals to meet the requirements of Sec. 34.41(a).
All current RSOs will have two years to implement the additional
RSO training requirements specified in Sec. 34.42(a), and to comply
with the mandatory certification requirements in Sec. 34.43(a)(2).
Licensees will have 2 years from the effective date of the rule to
affirm that all radiographers have met the certification requirements
of Sec. 34.43(a)(1). This will allow industrial radiography licensees
operating in NRC jurisdiction 2 years to obtain certification for their
employees who act as radiographers.
Licensees are required within 60 days of the effective date of the
rule to develop and implement revised procedures needed to implement
the final rule. Procedures requiring submittal to the NRC will not need
to be submitted until the next license renewal.
Regarding changes to Sec. 71.101, Quality assurance requirements,
providing that 10 CFR Part 34 licensees are no longer required to apply
for separate approval of their QA program for transport packages
provided they meet the requirements of Sec. 34.31(b), or equivalent
Agreement State requirements, those licensees who already have NRC
approval of their QA program are deemed to have acceptable procedures.
Those licensees without a prior QA program approval must develop these
procedures before using applicable transport packages. Licensees are
expected to implement any necessary procedural changes into their
programs within 60 days of the effective date of the rule, but will not
need to amend their licenses until the next renewal. Expiration dates
of any existing QA program approvals will no longer be valid.
VI. 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 is not a major Federal
action significantly affecting the quality of the human environment and
therefore, an environmental impact statement is not required.
The revision of 10 CFR Part 34 involves some revisions to
regulations authorizing the use of sealed sources in the field of
industrial radiography. In particular, the revisions include: upgrades
in the testing of radiographers, qualifications and duties for
radiation safety officers, reductions in inspection frequencies for
radiographers and assistants, requirements for periodic testing of the
shielding integrity of the radiography device and operability checks of
radiation survey equipment, and new recordkeeping and labeling
requirements. No requirements for significant quantities of materials,
water, electricity or other forms of energy have been identified, and
no environmental or radiation impacts will be involved.
The environmental assessment and finding of no significant impact
on which this determination is based are available for inspection at
the NRC Public Document Room at 2120 L Street, NW. (Lower Level),
Washington DC. Single copies of the environmental assessment and
finding of no significant impact are available from Dr. Donald O.
Nellis, Radiation Protection and Health Effects Branch, Division of
Regulatory Applications, Office of Research, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-6257.
[[Page 28963]]
VII. Paperwork Reduction Act Statement
This final rule amends information collection requirements that are
subject to the Paperwork Reduction Act of 1996 (44 U.S.C. 3501 et
seq.). These requirements were approved by Office of Management and
Budget; approval number 3150-0007.
The public reporting burden for this collection of information is
estimated to average 83 hours per licensee, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. Send comments on any aspect of this
collection of information, including suggestions for reducing this
burden, to the Information and Records Management Branch (T-6F33), U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001; and to the
Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202,
(3150-0007), Office of Management and Budget, Washington, DC 20503.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
VIII. Regulatory Analysis
The Commission prepared a regulatory analysis on this final rule.
The analysis examines the costs and benefits of the alternatives
considered by the Commission. See the discussion in the Regulatory
Flexibility Certification concerning the final regulatory analysis.
This analysis is available for inspection in the NRC Public Document
Room at 2120 L Street NW. (Lower Level), Washington, DC.
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)),
the Commission certifies that this rule does not have a significant
adverse economic impact on a substantial number of small entities. The
NRC has prepared a final regulatory analysis of the impact of this rule
on small entities. A copy of the final regulatory analysis is available
for inspection or copying in the NRC Public Document Room, 2120 L
Street, NW. (Lower Level) Washington, DC. The regulation affects about
170 industrial radiography licensees, of which most are small entities.
The regulatory analysis for the final rule shows that there will be an
average net savings of $18,000 per licensee per year for most
licensees. For those licensees who will need to hire additional
assistants to meet the two-person requirement, the cost used in the
regulatory analysis was between $5,000 and $53,000 per year.
X. Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
``major rule'', and has submitted this determination to the General
Accounting Office and the Congress, as required.
XI. Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this rule and, therefore, that a backfit analysis is not
required for this rule. The final rule does not involve any provisions
that impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
10 CFR Part 34
Byproduct material, Criminal penalties, Nuclear material, Packaging
and containers, Radiation protection, Radiography, Reporting and
recordkeeping requirements, Scientific equipment, Security measures.
10 CFR Part 71
Criminal penalties, Hazardous materials transportation, Nuclear
materials, Packaging and containers, Reporting and recordkeeping
requirements.
10 CFR Part 150
Hazardous materials transportation, Intergovernmental relations,
Nuclear materials, Penalties, 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. 552 and 553, the NRC is adopting the
following amendments to 10 CFR Parts 30, 34, 71, and 150.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948,
953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended (42
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846).
Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat.
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
Sec. 30.4 [Amended]
2. In Sec. 30.4, the definitions of Radiographer, Radiographer's
assistant, and Radiography are removed.
3. Part 34 is revised to read as follows:
PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY
REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
Subpart A--General Provisions
Sec.
34.1 Purpose and scope.
34.3 Definitions.
34.5 Interpretations.
34.8 Information collection requirements: OMB approval.
Subpart B--Specific Licensing Provisions
34.11 Application for a specific license.
34.13 Specific license for industrial radiography.
Subpart C--Equipment
34.20 Performance requirements for industrial radiography
equipment.
34.21 Limits on external radiation levels from storage
containers and source changers.
34.23 Locking of radiographic exposure devices, storage
containers, and source changers.
34.25 Radiation survey instruments.
34.27 Leak testing and replacement of sealed sources.
34.29 Quarterly inventory.
34.31 Inspection and maintenance of radiographic exposure
devices, transport and storage containers, associated equipment,
source changers, and survey instruments.
34.33 Permanent radiographic installations.
34.35 Labeling, storage, and transportation.
Subpart D--Radiation Safety Requirements
34.41 Conducting industrial radiographic operations.
[[Page 28964]]
34.42 Radiation Safety Officer for industrial radiography.
34.43 Training.
34.45 Operating and emergency procedures.
34.46 Supervision of radiographers' assistants.
34.47 Personnel monitoring.
34.49 Radiation surveys.
34.51 Surveillance.
34.53 Posting.
Subpart E--Recordkeeping Requirements
34.61 Records of the specific license for industrial
radiography.
34.63 Records of the receipt and transfer of sealed sources.
34.65 Records of radiation survey instruments.
34.67 Records of leak testing of sealed sources and devices
containing depleted uranium.
34.69 Records of quarterly inventory.
34.71 Utilization logs.
34.73 Records of inspection and maintenance of radiographic
exposure devices, transport and storage containers, associated
equipment, source changers, and survey instruments.
34.75 Records of alarm system and entrance control checks at
permanent radiographic installations.
34.79 Records of training and certification.
34.81 Copies of operating and emergency procedures.
34.83 Records of personnel monitoring procedures.
34.85 Records of radiation surveys.
34.87 Form of records.
34.89 Location of documents and records.
Subpart F--Notifications
34.101 Notifications.
Subpart G--Exemptions
34.111 Applications for exemptions.
Subpart H--Violations
34.121 Violations.
34.123 Criminal penalties.
Appendix A to 10 CFR Part 34--Radiographer Certification.
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).
Subpart A--General Provisions
Sec. 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 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 10
Parts 19, 20, 21, 30, 71, 150, 170, and 171 of this chapter apply to
applications and licenses subject to this part. This rule does not
apply to medical uses of byproduct material.
Sec. 34.3 Definitions.
ALARA (acronym for ``as low as is reasonably achievable'') means
making every reasonable effort to maintain exposures to radiation as
far below the dose limits specified in 10 CFR 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 refresher safety training means a review conducted or
provided by the licensee for its employees on radiation safety aspects
of industrial radiography. The review may include, as appropriate, the
results of internal inspections, new procedures or equipment, new or
revised regulations, accidents or errors that have been observed, and
should also provide 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 (drive) cable, removable source stop, ``J'' tube
and collimator when it is used as an exposure head.
Becquerel (Bq) means one disintegration per second.
Certifying Entity means an independent certifying organization
meeting the requirements in appendix A of this part or an Agreement
State meeting the requirements in appendix A, Parts II and III of this
part.
Collimator means a radiation shield that is placed on the end of
the guide tube or directly onto a radiographic exposure device to
restrict the size of the radiation beam when the sealed source is
cranked into position to make a radiographic exposure.
Control (drive) cable means the cable that is connected to the
source assembly and used to drive the source to and from the exposure
location.
Control drive mechanism means a device that enables the source
assembly to be moved to and from the exposure device.
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
sealed source in the selected working position. (An exposure head is
also known as a source stop.)
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.
Guide tube (Projection sheath) means a flexible or rigid tube
(i.e., ``J'' tube) for guiding the source assembly and the attached
control cable from the exposure device to the exposure head. The guide
tube may also include the connections necessary for attachment to the
exposure device and to the exposure head.
Hands-on experience means experience in all of those areas
considered to be directly involved in the radiography process.
Independent certifying organization means an independent
organization that meets all of the criteria of Appendix A to this part.
Industrial radiography (radiography) means an examination of the
structure of materials by nondestructive methods, utilizing ionizing
radiation to make radiographic images.
Lay-barge radiography means industrial radiography performed on any
water vessel used for laying pipe.
Offshore platform radiography means industrial radiography
conducted from a platform over a body of water.
Permanent radiographic installation means an enclosed shielded
room, cell, or vault, not located at a temporary jobsite, in which
radiography is performed.
Practical Examination means a demonstration through practical
application of the safety rules and principles in industrial
radiography including use of all appropriate equipment and procedures.
Radiation Safety Officer for industrial radiography means an
individual with the responsibility for the overall radiation safety
program on behalf of the licensee and who meets the requirements of
Sec. 34.42.
Radiographer means any individual who performs or who, in
attendance at the site where the sealed source or sources are being
used, personally supervises industrial radiographic operations and who
is responsible to the licensee for assuring compliance with the
requirements of the Commission's
[[Page 28965]]
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, testing, and experience criteria.
Radiographer's assistant means any individual who under the direct
supervision of a radiographer, uses radiographic exposure devices,
sealed sources or related handling tools, or radiation survey
instruments in industrial radiography.
Radiographic exposure device (also called 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 changed, 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 use of the device or transport (except when being transported by
a common or contract transport), to include surveys to confirm the
adequacy of boundaries, setting up equipment and any activity inside
restricted area boundaries.
S-tube means a tube through which the radioactive source travels
when inside a radiographic exposure device.
Sealed source means any byproduct material that is encased in a
capsule 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.
Sievert means the SI unit of any of the quantities expressed as
dose equivalent. The dose equivalent in sieverts is equal to the
absorbed dose in grays multiplied by the quality factor (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 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 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 container in which sealed sources are
secured and stored.
Temporary jobsite means a location where radiographic operations
are conducted and where licensed material may be stored other than
those location(s) of use authorized on the license.
Underwater radiography means industrial radiography performed when
the radiographic exposure device and/or related equipment are beneath
the surface of the water.
Sec. 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.
Sec. 34.8 Information collection requirements: OMB 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 3150-0007.
(b) The approved information collection requirements contained in
this part appear in Secs. 34.13, 34.20, 34.25, 34.27, 34.29, 34.31,
34.33, 34.35, 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, and 34.101.
(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 which it is approved are as follows:
(1) In Sec. 34.11, NRC Form 313 is approved under control number
3150-0120.
(2) [Reserved]
Subpart B--Specific Licensing Provisions
Sec. 34.11 Application for a specific license.
A person may file an application for specific license for use of
sealed sources in industrial radiography, in duplicate, on NRC Form
313, ``Application for Material License,'' in accordance with the
provisions of Sec. 30.32 of this chapter.
Sec. 34.13 Specific license for industrial radiography.
An application for a specific license for the use of licensed
material in industrial radiography will be approved if the applicant
meets the following requirements:
(a) The applicant satisfies the general requirements specified in
Sec. 30.33 of this chapter for byproduct material, as appropriate, and
any special requirements contained in this part.
(b) The applicant submits an adequate program for training
radiographers and radiographers' assistants that meets the requirements
of Sec. 34.43.
(1) After May 28, 1999, a license applicant need not describe its
initial training and examination program for radiographers in the
subjects outlined in Sec. 34.43(g).
(2) From June 27, 1997 to May 28, 1999 a license applicant may
affirm that all individuals acting as industrial radiographers will be
certified in radiation safety by a certifying entity before commencing
duty as radiographers. This affirmation substitutes for a description
of its initial training and examination program for radiographers in
the subjects outlined in Sec. 34.43(g).
(c) The applicant submits procedures for verifying and documenting
the certification status of radiographers and for ensuring that the
certification of individuals acting as radiographers remains valid.
(d) The applicant submits written operating and emergency
procedures as described in Sec. 34.45.
(e) The applicant submits a description of a program for
inspections of the job performance of each radiographer and
radiographers' assistant at intervals not to exceed 6 months as
described in Sec. 34.43(e).
(f) The applicant submits a description of the applicant's overall
organizational structure as it applies to the radiation safety
responsibilities in industrial radiography, including specified
delegation of authority and responsibility.
(g) The applicant identifies and lists the qualifications of the
individual(s) designated as the RSO (Sec. 34.42) and potential
designees responsible for ensuring that the licensee's radiation safety
program is implemented in accordance with approved procedures.
(h) If an applicant intends to perform leak testing of sealed
sources or exposure devices containing depleted uranium (DU) shielding,
the applicant must describe the procedures for
[[Page 28966]]
performing and the qualifications of the person(s) authorized to do the
leak testing. If the applicant intends to analyze its own wipe samples,
the application must include a description of the procedures to be
followed. The description must 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) If the applicant intends to perform ``in-house'' calibrations
of survey instruments the applicant must describe methods to be used
and the relevant experience of the person(s) who will perform the
calibrations. All calibrations must be performed according to the
procedures described and at the intervals prescribed in Sec. 34.25.
(j) The applicant identifies and describes the location(s) of all
field stations and permanent radiographic installations.
(k) The applicant identifies the locations where all records
required by this part and other parts of this chapter will be
maintained.
Subpart C--Equipment
Sec. 34.20 Performance requirements for industrial radiography
equipment.
Equipment used in industrial radiographic operations must meet the
following minimum criteria:
(a)(1) Each radiographic exposure device, source assembly or sealed
source, and all associated equipment must meet the requirements
specified in American National Standards Institute, N432-1980
``Radiological 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)and 1 CFR part 51. This publication may be purchased from
the American National Standards Institute, Inc., 1430 Broadway, New
York, New York 10018 Telephone (212) 642-4900. Copies of the document
are available for inspection at the Nuclear Regulatory Commission
Library, 11545 Rockville Pike, Rockville, Maryland 20852. A copy of the
document is also on file at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
(2) Engineering analysis may be submitted by an applicant or
licensee to demonstrate the applicability of previously performed
testing on similar individual radiography equipment components. Upon
review, the Commission may find this an acceptable alternative to
actual testing of the component pursuant to the above referenced
standard.
(b) In addition to the requirements specified in paragraph (a) of
this section, the following requirements apply to radiographic exposure
devices, source changers, source assemblies and sealed sources.
(1) The licensee shall ensure that each radiographic exposure
device has attached to it a durable, legible, clearly visible label
bearing the--
(i) Chemical symbol and mass number of the radionuclide in the
device;
(ii) Activity and the date on which this activity was last
measured;
(iii) Model (or product code) and serial number of the sealed
source;
(iv) Manufacturer's identity of the sealed source; and
(v) Licensee's name, address, and telephone number.
(2) Radiographic exposure devices intended for use as Type B
transport containers must meet the applicable requirements of 10 CFR
part 71.
(3) Modification of radiographic exposure devices, source changers,
and source assemblies and associated equipment is prohibited, unless
the design of any replacement component,including source holder, source
assembly, controls or guide tubes would not compromise the design
safety features of the system.
(c) In addition to the requirements specified in paragraphs (a) and
(b) of this section, the following requirements apply to radiographic
exposure devices, source assemblies, and associated equipment that
allow the source to be moved out of the device for radiographic
operations or to source changers.
(1) The coupling between the source assembly and the control cable
must be designed in such a manner that the source assembly will not
become disconnected if cranked outside the guide tube. The coupling
must 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 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)(i) Each sealed source or source assembly must have attached to
it or engraved on it, a durable, legible, visible label with the words:
``DANGER--RADIOACTIVE.''
(ii) The label may not interfere with the safe operation of the
exposure device or associated equipment.
(5) The guide tube must be able to withstand a crushing test that
closely approximates the crushing forces that are likely to be
encountered during use, and be able to withstand a kinking resistance
test that closely approximates the kinking forces that are likely to be
encountered during use.
(6) Guide tubes must be used when moving the source out of the
device.
(7) An exposure head or similar device designed to prevent the
source assembly from passing out of the end of the guide tube must be
attached to the outermost end of the guide tube during industrial
radiography operations.
(8) The guide tube exposure head connection must be able to
withstand the tensile test for control units specified in ANSI N432-
1980.
(9) Source changers must provide a system for ensuring that the
source will not be accidentally withdrawn from the changer when
connecting or disconnecting the drive cable to or from a source
assembly.
(d) All radiographic exposure devices and associated equipment in
use after January 10, 1996, must comply with the requirements of this
section.
(e) Notwithstanding paragraph (a)(1) of this section, equipment
used in industrial radiographic operations need not comply with
Sec. 8.9.2(c) of the Endurance Test in American National Standards
Institute N432-1980, if the prototype equipment has been tested using a
torque value representative of the torque that an individual using the
radiography equipment can realistically exert on the lever or
crankshaft of the drive mechanism.
Sec. 34.21 Limits on external radiation levels from storage containers
and source changers.
The maximum exposure rate limits for storage containers and source
changers are 2 millisieverts (200 millirem) per hour at any exterior
surface, and 0.1 millisieverts (10 millirem) per hour at 1 meter from
any exterior surface with the sealed source in the shielded position.
Sec. 34.23 Locking of radiographic exposure devices, storage
containers and source changers.
(a) Each radiographic exposure device must have a lock or outer
locked
[[Page 28967]]
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 except at permanent
radiographic installations as stated in Sec. 34.51. In addition, during
radiographic operations the sealed source assembly must be secured in
the shielded position each time the source is returned to that
position.
(b) 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.
Sec. 34.25 Radiation survey 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 10 CFR 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 (1 rem) per hour.
(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 mid-range of each decade, and at two
points of at least one decade; and for digital instruments, at 3 points
between 0.02 and 10 millisieverts (2 and 1000 millirems) per hour; and
(3) So that an accuracy within plus or minus 20 percent of the
calibration source can be demonstrated at each point checked.
(c) The licensee shall maintain records of the results of the
instrument calibrations in accordance with Sec. 34.65.
Sec. 34.27 Leak testing 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 by persons authorized to do so by the NRC or an
Agreement State.
(b) 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.
(c) 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. The leak
testing of the source must be performed using a method approved by the
Commission or by an Agreement State. The wipe sample should be taken
from the nearest accessible point to the sealed source where
contamination might accumulate. The wipe sample must be 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.
(2) The licensee shall maintain records of the leak tests in
accordance with Sec. 34.67.
(3) Unless a sealed source is accompanied by a certificate from the
transferor that shows that it has been leak tested within 6 months
before the transfer, it may not be used by the licensee until tested
for leakage. Sealed sources that are in storage and not in use do not
require leak testing, but must be tested before use or transfer to
another person if the interval of storage exceeds 6 months.
(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 Director of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, 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 10 CFR part 20 of
this chapter ``Standards for Protection Against Radiation.''
(e) Each exposure device using depleted uranium (DU) shielding and
an ``S'' tube configuration must be tested for DU contamination at
intervals not to exceed 12 months. 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 Commission or an Agreement State to
perform the analysis. Should such testing reveal the presence of DU
contamination, the exposure device must be removed from use until an
evaluation of the wear of the S-tube has been made. Should the
evaluation reveal that the S-tube is worn through, the device may not
be used again. DU shielded devices do not have to be tested for DU
contamination while in storage and not in use. Before using or
transferring such a device however the device must be tested for DU
contamination, if the interval of storage exceeds 12 months. A record
of the DU leak-test must be made in accordance with Sec. 34.67.
Sec. 34.29 Quarterly inventory.
(a) Each licensee shall conduct a quarterly physical inventory to
account for all sealed sources and for devices containing depleted
uranium received and possessed under this license.
(b) The licensee shall maintain records of the quarterly inventory
in accordance with Sec. 34.69.
Sec. 34.31 Inspection and maintenance of radiographic exposure
devices, transport and storage containers, associated equipment, source
changers, and survey instruments.
(a) The licensee shall perform visual and operability checks on
survey meters, radiographic exposure devices, transport and storage
containers, associated equipment and source changers before use on each
day the equipment is to be used to ensure that the equipment is in good
working condition, that the sources are adequately shielded, and that
required labeling is present. Survey instrument operability must be
performed using check sources or other appropriate means. If equipment
problems are found, the equipment must be removed from service until
repaired.
(b) Each licensee shall have written procedures for:
(1) Inspection and routine maintenance of radiographic exposure
devices, source changers, associated equipment, transport and storage
containers, and survey instruments at intervals not to exceed 3 months
or
[[Page 28968]]
before the first use thereafter to ensure the proper functioning of
components important to safety. Replacement components shall meet
design specifications. If equipment problems are found, the equipment
must be removed from service until repaired.
(2) Inspection and maintenance necessary to maintain the Type B
packaging used to transport radioactive materials. The inspection and
maintenance program must include procedures to assure that Type B
packages are shipped and maintained in accordance with the certificate
of compliance or other approval.
(c) Records of equipment problems and of any maintenance performed
under paragraphs (a) and (b) of this section must be made in accordance
with Sec. 34.73.
Sec. 34.33 Permanent radiographic installations.
(a) Each entrance that is used for personnel access to the high
radiation area in a permanent radiographic installation must have
either:
(1) An entrance control of the type described in Sec. 20.1601(a)(1)
of this chapter that reduces the radiation level upon entry into the
area, or
(2) Both conspicuous visible and audible warning signals to warn of
the presence of radiation. The visible signal must be actuated by
radiation whenever the source is exposed. The audible signal must be
actuated when an attempt is made to enter the installation while the
source is exposed.
(b) The alarm system must be tested for proper operation with a
radiation source each day before the installation is used for
radiographic operations. The test must include a check of both the
visible and audible signals. Entrance control devices that reduce the
radiation level upon entry (designated in paragraph (a)(1) of this
section) must be tested monthly. If an entrance control device or an
alarm is operating improperly, it must be immediately labeled as
defective and repaired within 7 calendar days. The facility may
continue to be used during this 7-day period, provided the licensee
implements the continuous surveillance requirements of Sec. 34.51 and
uses an alarming ratemeter. Test records for entrance controls and
audible and visual alarm must be maintained in accordance with
Sec. 34.75.
Sec. 34.35 Labeling, storage, and transportation.
(a) The licensee may not use a source changer or a container to
store licensed material unless the source changer or the storage
container has securely attached to it a durable, legible, and clearly
visible label bearing the standard trefoil radiation caution symbol
conventional colors, i.e., magenta, purple or black on a yellow
background, having a minimum diameter of 25 mm, and the wording
CAUTION*
RADIOACTIVE MATERIAL
NOTIFY CIVIL AUTHORITIES (or ``NAME OF COMPANY'')
*________ or ``DANGER''
(b) 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.
(c) Locked radiographic exposure devices and storage containers
must be physically secured to prevent tampering or removal by
unauthorized personnel. The licensee shall store licensed material in a
manner which will minimize danger from explosion or fire.
(d) 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
Sec. 34.41 Conducting industrial 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 Sec. 34.43(c).
The additional qualified individual shall observe the operations and be
capable of providing immediate assistance to prevent unauthorized
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.
(c) A licensee may conduct lay-barge, offshore platform, or
underwater radiography only if procedures have been approved by the
Commission or by an Agreement State.
Sec. 34.42 Radiation Safety Officer for industrial radiography.
The RSO 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 minimum qualifications, training, and experience for RSOs
for industrial radiography are as follows:
(1) Completion of the training and testing requirements of
Sec. 34.43(a);
(2) 2000 hours of hands-on experience as a qualified radiographer
in industrial radiographic operations; and
(3) Formal training in the establishment and maintenance of a
radiation protection program.
(b) The Commission will consider alternatives when the RSO has
appropriate training and/or experience in the field of ionizing
radiation, and in addition, has adequate formal training with respect
to the establishment and maintenance of a radiation safety protection
program.
(c) The specific duties and authorities of the RSO include, but are
not limited to:
(1) Establishing and overseeing all operating, emergency, and ALARA
procedures as required by 10 CFR part 20 of this chapter, and reviewing
them regularly to ensure that the procedures in use conform to current
10 CFR part 20 procedures, conform to other NRC regulations and to the
license conditions.
(2) Overseeing and approving all phases of the training program for
radiographic personnel, ensuring that appropriate and effective
radiation protection practices are taught;
(3) Ensuring that required radiation surveys and leak tests are
performed and documented in accordance with the regulations, including
any corrective measures when levels of radiation exceed established
limits;
(4) Ensuring 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 Sec. 20.2203 of this chapter; and
(5) Ensuring that operations are conducted safely and to assume
control for instituting corrective actions including stopping of
operations when necessary.
(d) Licensees will have until May 28, 1999 to meet the requirements
of paragraph (a) or (b) of this section.
Sec. 34.43 Training.
(a) The licensee may not permit any individual to act as a
radiographer until the individual--
(1) Has received training in the subjects in paragraph (g) of this
section, in addition to a minimum of 2 months of on-the-job training,
and is certified
[[Page 28969]]
through a radiographer certification program 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. 20555-0001.) or
(2) The licensee may, until May 28, 1999, allow an individual who
has not met the requirement of paragraph (a)(1) of this section, to act
as a radiographer after the individual has received training in the
subjects outlined in paragraph (g) of this section and demonstrated an
understanding of these subjects by successful completion of a written
examination that was previously submitted to and approved by the
Commission.
(b) In addition, the licensee may not permit any individual to act
as a radiographer until the individual--
(1) Has received copies of and instruction in the requirements
described in NRC regulations contained in this part; in Secs. 30.7,
30.9, and 30.10 of this chapter; in the applicable sections of 10 CFR
parts 19 and 20, of this chapter, in applicable DOT regulations as
referenced in 10 CFR part 71, in the NRC license(s) under which the
radiographer will perform industrial radiography, and the licensee's
operating and emergency procedures;
(2) Has demonstrated understanding of the licensee's license and
operating and emergency procedures by successful completion of a
written or oral examination covering this material.
(3) Has received training in the use of the licensee's radiographic
exposure devices, sealed sources, in the daily inspection of devices
and associated equipment, and in the use of radiation survey
instruments.
(4) Has demonstrated understanding of the use of radiographic
exposure devices, sources, survey instruments and associated equipment
described in paragraphs (b)(1) and (b)(3) of this section by successful
completion of a practical examination covering this material.
(c) 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 Secs. 30.7,
30.9, and 30.10 of this chapter, in the applicable sections of 10 CFR
parts 19 and 20 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 industrial radiography, and the
licensee's operating and emergency procedures;
(2) Has developed competence to use, under the personal supervision
of the radiographer, the radiographic exposure devices, sealed sources,
associated equipment, and radiation survey instruments that the
assistant will use; and
(3) Has demonstrated understanding of the instructions provided
under (c)(1) of this section by successfully completing a written test
on the subjects covered and has demonstrated competence in the use of
hardware described in (c)(2) of this section by successful completion
of a practical examination on the use of such hardware.
(d) The licensee shall provide annual refresher safety training for
each radiographer and radiographer's assistant at intervals not to
exceed 12 months.
(e) Except as provided in paragraph (e)(4), the RSO or designee
shall conduct an 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 industrial radiographic
operation, at intervals not to exceed 6 months; and
(2) Provide that, if a radiographer or a radiographer's assistant
has not participated in an industrial radiographic operation for more
than 6 months since the last inspection, the radiographer must
demonstrate knowledge of the training requirements of Sec. 34.43(b)(3)
and the radiographer's assistant must re-demonstrate knowledge of the
training requirements of Sec. 34.43(c)(2) by a practical examination
before these individuals can next participate in a radiographic
operation.
(3) The Commission may consider alternatives in those situations
where the individual serves as both radiographer and RSO.
(4) In those operations where a single individual serves as both
radiographer and RSO, and performs all radiography operations, an
inspection program is not required.
(f) The licensee shall maintain records of the above training to
include certification documents, written and practical examinations,
refresher safety training and inspections of job performance in
accordance with Sec. 34.79.
(g) The licensee shall include the following subjects required in
paragraph (a) of this section:
(1) Fundamentals of radiation 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 handling equipment, and storage containers, including pictures
or models of source assemblies (pigtails).
(ii) Storage, control, and disposal of licensed material; and
(iii) Inspection and maintenance of equipment.
(4) The requirements of pertinent Federal regulations; and
(5) Case histories of accidents in radiography.
(h) Licensees will have until May 28, 1998 to comply with the
additional training requirements specified in paragraphs (b)(1) and
(c)(1) of this section.
Sec. 34.45 Operating and emergency procedures.
(a) Operating and emergency procedures must include, as a minimum,
instructions in the following:
(1) Appropriate handling and use of licensed sealed sources and
radiographic exposure devices so that no person is likely to be exposed
to radiation doses in excess of the limits established in 10 CFR part
20 of this chapter ``Standards for Protection Against Radiation'';
(2) Methods and occasions for conducting radiation surveys;
(3) Methods for controlling access to radiographic areas;
(4) Methods and occasions for locking and securing radiographic
exposure devices, transport and 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
[[Page 28970]]
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, maintenance, and operability checks of
radiographic exposure devices, survey instruments, transport
containers, and storage containers;
(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 unexpectedly.
(9) The procedure(s) for identifying and reporting defects and
noncompliance, as required by 10 CFR 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;
(13) Maintenance of records.
(b) The licensee shall maintain copies of current operating and
emergency procedures in accordance with Secs. 34.81 and 34.89.
Sec. 34.46 Supervision of radiographers' assistants.
Whenever a radiographer's assistant uses radiographic exposure
devices, associated equipment or sealed sources or conducts radiation
surveys required by Sec. 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 physical presence at the site where the
sealed sources are being used;
(b) The availability of the radiographer to give immediate
assistance if required; and
(c) The radiographer's direct observation of the assistant's
performance of the operations referred to in this section.
Sec. 34.47 Personnel monitoring.
(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, on the trunk of the
body, a combination of direct reading dosimeter, an operating alarm
ratemeter, and either a film badge or a 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. Electronic personal dosimeters may only be used in place of
ion-chamber pocket dosimeters.
(2) Each film badge and TLD must be assigned to and worn by only
one individual.
(3) Film badges must be replaced at periods not to exceed one month
and TLDs must be replaced at periods not to exceed three months.
(4) After replacement, each film badge or TLD must be processed as
soon as possible.
(b) Direct reading dosimeters such as pocket dosimeters or
electronic personal dosimeters, must be read and the exposures recorded
at the beginning and end of each shift, and records must be maintained
in accordance with Sec. 34.83.
(c) Pocket dosimeters, or electronic personal dosimeters, must be
checked at periods not to exceed 12 months for correct response to
radiation, and records must be maintained in accordance with
Sec. 34.83. Acceptable dosimeters must read within plus or minus 20
percent of the true radiation exposure.
(d) If an individual's pocket dosimeter is found to be off-scale,
or if his or her electronic personal dosimeter reads greater than 2
millisieverts (200 millirems), and the possibility of radiation
exposure cannot be ruled out as the cause, the individual's film badge
or TLD must be sent for processing within 24 hours. In addition, the
individual may not resume work associated with licensed material use
until a determination of the individual's radiation exposure has been
made. This determination must be made by the RSO or the RSO's designee.
The results of this determination must be included in the records
maintained in accordance with Sec. 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
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 Sec. 34.83.
(f) Reports received from the film badge or TLD processor must be
retained in accordance with Sec. 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;
(2) Be set to give an alarm signal at a preset dose rate of 5 mSv/
hr (500 mrem/hr); with an accuracy of plus or minus 20 percent of the
true radiation dose rate;
(3) Require special means to change the preset alarm function; and
(4) 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 Sec. 34.83.
Sec. 34.49 Radiation surveys.
The licensee shall:
(a) Conduct surveys with a calibrated and operable radiation survey
instrument that meets the requirements of Sec. 34.25.
(b) Using a survey instrument meeting the requirements of paragraph
(a) of this section, conduct a survey of the radiographic exposure
device and the guide tube after each exposure when approaching the
device or the guide tube. The survey must determine that the sealed
source has returned to its shielded position before exchanging films,
repositioning the exposure head, or dismantling equipment.
(c) Conduct a survey of the radiographic exposure device with a
calibrated radiation survey instrument any time the source is exchanged
and whenever a radiographic exposure device is placed in a storage area
(as defined in Sec. 34.3), to ensure that the sealed source is in its
shielded position.
(d) Maintain records in accordance with Sec. 34.85.
Sec. 34.51 Surveillance.
During each radiographic operation the radiographer, or the other
individual present, as required by Sec. 34.41, shall maintain
continuous direct visual surveillance of the operation to protect
against unauthorized entry into a high radiation area, as defined in 10
CFR part 20 of this chapter, except at permanent radiographic
installations where all entryways are locked and the requirements of
Sec. 34.33 are met.
Sec. 34.53 Posting.
All areas in which industrial radiography is being performed must
be conspicuously posted as required by Sec. 20.1902 of this chapter.
Exceptions listed in Sec. 20.1903 of this chapter do not apply to
industrial radiographic operations.
Subpart E--Recordkeeping Requirements
Sec. 34.61 Records of the specific license for industrial radiography.
Each licensee shall maintain a copy of its license, license
conditions,
[[Page 28971]]
documents incorporated by reference, and amendments to each of these
items until superseded by new documents approved by the Commission, or
until the Commission terminates the license.
Sec. 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 devices using DU for shielding and
retain each record for 3 years after it is made.
(b) These records must include the date, the name of the individual
making the record, radionuclide, number of becquerels (curies) or mass
(for DU), and manufacturer, model, and serial number of each sealed
source and/or device, as appropriate.
Sec. 34.65 Records of radiation survey instruments.
Each licensee shall maintain records of the calibrations of its
radiation survey instruments that are required under Sec. 34.25 and
retain each record for 3 years after it is made.
Sec. 34.67 Records of leak testing of sealed sources and devices
containing depleted uranium.
Each licensee shall maintain records of leak test results for
sealed sources and for devices containing DU. The results must be
stated in units of becquerels (microcuries). The licensee shall retain
each record for 3 years after it is made or until the source in storage
is removed.
Sec. 34.69 Records of quarterly inventory.
(a) Each licensee shall maintain records of the quarterly inventory
of sealed sources and of devices containing depleted uranium as
required by Sec. 34.29 and retain each record for 3 years after it is
made.
(b) The record must include the date of the inventory, name of the
individual conducting the inventory, radionuclide, number of becquerels
(curies) or mass (for DU) in each device, location of sealed source
and/or devices, and manufacturer, model, and serial number of each
sealed source and/or device, as appropriate.
Sec. 34.71 Utilization logs.
(a) Each licensee shall maintain utilization logs showing for each
sealed source the following information:
(1) A description, including the make, model, and serial number of
the radiographic exposure device or transport 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.
Sec. 34.73 Records of inspection and maintenance of radiographic
exposure devices, transport and storage containers, associated
equipment, source changers, and survey instruments.
(a) Each licensee shall maintain records specified in Sec. 34.31 of
equipment problems found in daily checks and quarterly inspections of
radiographic exposure devices, transport and storage containers,
associated equipment, source changers, and survey instruments; and
retain each record for 3 years after it is made.
(b) The record must include the date of check or inspection, name
of inspector, equipment involved, any problems found, and what repair
and/or maintenance, if any, was done.
Sec. 34.75 Records of alarm system and entrance control checks at
permanent radiographic installations.
Each licensee shall maintain records of alarm system and entrance
control device tests required under Sec. 34.33 and retain each record
for 3 years after it is made.
Sec. 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 and verification of certification status,
copies of written tests, dates of oral and practical examinations, and
names of individuals conducting and receiving the oral and practical
examinations; and
(b) Records of annual refresher safety training and semi-annual
inspections of job performance for each radiographer and each
radiographer's assistant. The records must list the topics discussed
during the refresher safety training, the dates the annual refresher
safety training was conducted, and names of the instructors and
attendees. For inspections of job performance, the records must also
include a list showing the items checked and any non-compliances
observed by the RSO.
Sec. 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.
Sec. 34.83 Records of personnel monitoring Procedures.
Each licensee shall maintain the following exposure records
specified in Sec. 34.47:
(a) Direct reading dosimeter readings and yearly operability checks
required by Sec. 34.47(b) and (c) for 3 years after the record is made.
(b) Records of alarm ratemeter calibrations for 3 years after the
record is made.
(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
personal direct reading dosimeters, or lost or damaged film badges or
TLDs, until the Commission terminates the license.
Sec. 34.85 Records of radiation surveys.
Each licensee shall maintain a record of each exposure device
survey conducted before the device is placed in storage as specified in
Sec. 34.49(c), if that survey is the last one performed in the workday.
Each record must be maintained for 3 years after it is made.
Sec. 34.87 Form of records.
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.
Sec. 34.89 Location of documents and records.
(a) Each licensee shall maintain copies of records required by this
part and other applicable parts of this chapter at the location
specified in Sec. 34.13(k).
(b) Each licensee shall also maintain copies of the following
documents and records sufficient to demonstrate compliance at each
applicable field station and each temporary jobsite;
[[Page 28972]]
(1) The license authorizing the use of licensed material;
(2) A copy of 10 CFR parts 19, 20, and 34 of NRC regulations;
(3) Utilization records for each radiographic exposure device
dispatched from that location as required by Sec. 34.71.
(4) Records of equipment problems identified in daily checks of
equipment as required by Sec. 34.73(a);
(5) Records of alarm system and entrance control checks required by
Sec. 34.75, if applicable;
(6) Records of direct reading dosimeters such as pocket dosimeter
and/or electronic personal dosimeters readings as required by
Sec. 34.83;
(7) Operating and emergency procedures required by Sec. 34.81;
(8) Evidence of the latest calibration of the radiation survey
instruments in use at the site, as required by Sec. 34.65;
(9) Evidence of the latest calibrations of alarm ratemeters and
operability checks of pocket dosimeters and/or electronic personal
dosimeters as required by Sec. 34.83;
(10) Latest survey records required by Sec. 34.85;
(11) The shipping papers for the transportation of radioactive
materials required by Sec. 71.5 of this chapter; and
(12) When operating under reciprocity pursuant to Sec. 150.20 of
this chapter, a copy of the Agreement State license authorizing the use
of licensed materials.
Subpart F--Notifications
Sec. 34.101 Notifications.
(a) In addition to the reporting requirements specified in
Sec. 30.50 and under other sections of this chapter, such as
Sec. 21.21, each licensee shall provide a written report to the U.S.
Nuclear Regulatory Commission, Division of Industrial and Medical
Nuclear Safety, Washington, DC 20555-0001, with a copy to the Director,
Office for Analysis and Evaluation of Operational Data, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, 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 personnel involved in the incident.
(c) Any licensee conducting radiographic operations or storing
radioactive material at any location not listed on the license for a
period in excess of 180 days in a calendar year, shall notify the
appropriate NRC regional office listed in Sec. 30.6(a)(2) of this
chapter prior to exceeding the 180 days.
Subpart G--Exemptions
Sec. 34.111 Applications for exemptions.
The Commission may, upon application of any interested person or
upon its own initiative, grant an exemption from the requirements of
the regulations in this part if it determines the exemption is
authorized by law and would not endanger life or property or the common
defense and security and is otherwise in the public interest.
Subpart H--Violations
Sec. 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
(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
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 186 of the Atomic Energy Act of 1954, as amended.
Sec. 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 Secs. 161b, 161i, or 161o of the Act. For purposes of
Section 223, all the regulations in 10 CFR part 34 are issued under one
or more of Secs. 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in 10 CFR part 34 that are not issued under
sections 161b, 161i, or 161o for the purposes of Section 223 are as
follows: Secs. 34.1, 34.3, 34.5, 34.8, 34.11, 34.13, 34.111, 34.121,
34.123.
Appendix A to 10 CFR Part 34--Radiographer Certification
I. 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;
2. Make its membership available to the general public
nationwide that is not restricted because of race, color, religion,
sex, age, national origin or disability;
3. Have a certification program open to nonmembers, as well as
members;
4. Be an incorporated, nationally recognized organization, that
is involved in setting national standards of practice within its
fields of expertise;
5. Have an adequate 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;
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;
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 respect to the administration of
[[Page 28973]]
its certification program, including the process of becoming
certified and any sanctions imposed against certified individuals;
11. Have procedures for proctoring examinations, including
qualifications for proctors. These procedures must 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 other independent certifying organizations and/or
Agreement States and allow periodic review of its certification
program and related records; and
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 applicants for certification to (a) receive training
in the topics set forth in Sec. 34.43(g) or equivalent Agreement
State regulations, 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 Sec. 34.43(g) or equivalent Agreement State
regulations; (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 for denying an application, revoking,
suspending, and reinstating a certificate;
5. Provide a certification period of not less than 3 years nor
more than 5 years;
6. Include procedures for renewing certifications and, if the
procedures allow renewals without examination, require evidence of
recent full-time employment and annual refresher training.
7. 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 Sec. 34.43(g) or equivalent Agreement State
requirements;
2. Written in a multiple-choice format;
3. Have test items drawn from a question bank containing
psychometrically valid questions based on the material in
Sec. 34.43(g).
PART 71--PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
4. The authority citation for Part 71 continues to read as follows:
Authority: Secs. 53, 57, 62, 63, 81, 161, 182, 183, 68 Stat.
930, 932, 933, 935, 948, 953, 954, as amended, secs. 1701, 106 stat.
2951, 2952, 2953 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201,
2232, 2233, 2297f); secs. 201, as amended, 202, 206, 88 Stat. 1242,
as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 71.97 also issued under sec. 301, Pub. L. 96-295, 14 stat.
789-790.
5. In Sec. 71.101 a new paragraph (g) is added to read as follows:
Sec. 71.101 Quality assurance requirements.
* * * * *
(g) Radiography containers. A program for transport container
inspection and maintenance limited to radiographic exposure devices,
source changers, or packages transporting these devices and meeting the
requirements of Sec. 34.31(b) or equivalent Agreement State
requirement, is deemed to satisfy the requirements of Secs. 71.12(b)
and 71.101(b) of this chapter.
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
6. 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 secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84,
92 Stat. 3033, 3039 (42 U.S.C. 201.4(e), 2111, 2113, 2114). Section
150.14 also issued under 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. 122.66 Stat. 939 (42 U.S.C. 2152). Section
150.30 also issued under sec. 234.83 Stat. 444 (42 U.S.C. 2282).
7. In Sec. 150.20, paragraph (b) introductory text is revised to
read as follows:
* * * * *
Sec. 150.20 Recognition of agreement State licenses.
* * * * *
(b) Notwithstanding any provision to the contrary in any specific
license issued by an Agreement State to a person engaging in activities
in a non-Agreement State, in an area of exclusive Federal jurisdiction
within an Agreement State, or in offshore waters under the general
licenses provided in this section, the general licenses provided in
this section are subject to all the provisions of the Act, now or
hereafter in effect, and to all applicable rules, regulations, and
orders of the Commission including the provisions of Secs. 30.7 (a)
through (f), 30.9, 30.10, 30.14(d), 30.34, 30.41, and 30.51 to 30.63,
inclusive, of part 30 of this chapter; Secs. 40.7 (a) through (f),
40.9, 40.10, 40.41, 40.51, 40.61, 40.63 inclusive, 40.71 and 40.81 of
part 40 of this chapter; Secs. 70.7 (a) through (f), 70.9, 70.10,
70.32, 70.42, 70.51 to 70.56, inclusive, 70.60 to 70.62, inclusive, and
to the provisions of 10 CFR parts 19, 20 and 71 and subparts C through
H of part 34, Secs. 39.15 and 39.31 through 39.77, inclusive, of part
39 of this chapter. In addition, any person engaging in activities in
non-Agreement States, in areas of exclusive Federal jurisdiction within
Agreement States, or in offshore waters under the general licenses
provided in this section:
* * * * *
Dated at Rockville, Maryland, this 19th day of May, 1997.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-13786 Filed 5-27-97; 8:45 am]
BILLING CODE 7590-01-P
