[Federal Register Volume 59, Number 39 (Monday, February 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4133]
[Federal Register: February 28, 1994]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 34 and 150
RIN 3150-AE07
Licenses for Radiography and Radiation Safety Requirements for
Radiographic Operations
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations governing industrial radiography. The proposed rule
would include additional safety requirements to enhance the level of
protection of radiographers and the public and would clarify the
regulations so that licensees may have a better understanding of what
is expected in radiographic operations. The proposed rule includes a
number of updated radiography regulations that have been adopted by the
Agreement States. The major changes in the proposed rule include
requirements for: (1) Two qualified individuals to be present whenever
radiography occurs at a temporary jobsite, (2) mandatory certification
of radiographers, (3) permanent radiographic installations, and (4) a
radiation safety officer. The format of the radiography regulations
would be revised to place requirements into descriptive categories.
DATES: Submit comments by May 31, 1994. Comments received after this
date will be considered if it is practical to do so, but the Commission
is able to assure consideration only for comments received on or before
this date.
ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington DC 20555, Attention: Docketing and Service
Branch. Hand deliver comments to 11555 Rockville Pike, Rockville,
Maryland between 7:45 am and 4:15 pm on Federal workdays.
Examine comments received, the environmental impact, and the
regulatory analysis at: The NRC Public Document Room at 2120 L Street
NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Dr. Donald O. Nellis or Mary L.
Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory
Commission, Washington DC 20555; Telephone: (301) 492-3628 or 492-3886.
SUPPLEMENTARY INFORMATION:
I. Background
Part 34 of Title 10 of the Code of Federal Regulations was first
published in 1965 (30 FR 8192) as part of the recodification of parts
30 and 31 for the purpose of simplifying and clarifying the format of
the then-current requirements on radiography so that persons subject to
byproduct material licensing regulations could conveniently use and
understand them. Numerous modifications to the original part 34 have
been made since 1965, many of which have been directed toward the
safety aspects of field radiography. These modifications include
performance requirements on radiography equipment and requirements for
the use of alarming ratemeters published in 1990 (55 FR 843; January
10, 1993).
There are approximately 200 NRC radiography licensees with an
additional 500 Agreement State licensees. Radiography licensees often
conduct business under both NRC and Agreement State jurisdiction.
The NRC has not initiated an overall revision of part 34 in many
years. However, a number of Agreement States have updated their
radiography regulations. The decision to develop an overall revision to
10 CFR part 34 was made with the intent of establishing new safety
requirements for radiography licensees and clarifying the regulation so
that licensees will have a better understanding of what is expected in
radiographic operations. The format of the radiography regulations
would be revised to place requirements into descriptive categories that
better describe the type of requirements found in the subpart.
The NRC solicited recommendations on radiography issues at the 1991
Agreement States' meeting in Sacramento, CA, as well as from NRC
regional offices, radiography equipment manufacturers, and radiography
licensees. Public comments were solicited on the issue of radiographer
certification at the May 19, 1991, annual meeting of the Conference of
Radiation Control Program Directors (CRCPD), Inc. in Wichita, Kansas,
and a public workshop on radiographer certification was held May 27-28,
1992, in Mobile, Alabama. A separate workshop was held on November 18,
1992, in Dallas, Texas, to discuss recommendations received from the
Agreement States and licensees on revision of the radiography
regulations. The transcripts of these meetings, which are available for
inspection and copying in the NRC Public Document Room, were reviewed
in further developing the proposed revision. The NRC utilized part E of
the ``Suggested State Regulations for Control of Radiation'' developed
by the CRCPD, part 31 of the Texas Regulations for Control of
Radiation, Chapter 5 of the Louisiana regulations, and the Canadian
``Atomic Energy Control Regulations,'' that apply to radiography in
developing this proposed revision of part 34.
II. Petition for Rulemaking
A petition was received on October 15, 1992, from the International
Union of Operating Engineers (IUOE), Local No. 2, requesting an
amendment to the radiography regulations to require a minimum of two
radiographic personnel when performing industrial radiography at
temporary jobsites. The petition was published in the Federal Register
on December 4, 1992 (57 FR 57392). Thirty-eight comment letters were
received, 35 were in favor of granting the petition. Resolution of this
petition has been addressed in this proposed revision to part 34.
The IUOE petition offered three options for the makeup of the two-
person crew: (1) Two radiographers; (2) one radiographer and one
radiographer's assistant; and (3) one radiographer and one trainee,
with the trainee having completed 40 hours of approved radiation safety
training and passed an examination. The petitioners identified a number
of problems associated with the use of licensed material by one
radiographer at temporary jobsites. These problems included: (1)
Difficulty keeping the area under constant surveillance while
radiographic operations are ongoing; (2) difficulty in maintaining
surveillance when working in trenches; and (3) difficulty in obtaining
assistance in the event of an emergency if there is only one
individual. The petitioners believe that the suggested change is
necessary to ensure a safe working environment.
The comments received raised concerns regarding the combination of
a radiographer and a trainee as a two-person team. Many stated that the
trainee is an unskilled individual that may or may not achieve
radiographer status and spending the time and money for 40 hours
training may not be financially feasible for some radiography
companies.
This proposed rule, if adopted, would constitute a partial granting
of the petition in that it proposes to require, at a minimum, a two-
person crew whenever radiographic operations are being conducted
outside of a permanent radiographic installation. The NRC has decided
not to adopt the term ``radiographer trainee,'' and is proposing that
the second person be another qualified radiographer or an individual
who has met, at a minimum, the requirements for a radiographer's
assistant. The NRC recognizes that, in Agreement States, the training
of those individuals designated as trainees would meet the NRC's
training requirements for a radiographer's assistant.
The estimated cost of requiring the two-person crew could be
significant for licensees who 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. For certain
circumstances where a licensee could demonstrate that adequate
surveillance can be maintained by one radiographer, the Commission
could consider granting an exemption through the process described in
the proposed Sec. 34.111. The Commission is concerned that this
requirement could cause a significant impact on a number of small
entities which currently do not use two-person crews, and is soliciting
comments on the potential impact. Furthermore, the Commission is
interested in receiving proposals for alternatives to the two-person
requirement which would achieve comparable enhancements in safety with
less of a burden on licensees.
In summary, the Commission believes that by requiring at least two
qualified individuals to always be present when radiographic operations
are being conducted, there will be a significant increase in assurance
that operational safety measures and emergency procedures will be
effectively implemented. The expectation is that violations involving
failures to perform adequate radiation surveys of radiographic exposure
devices and the surrounding area, failures to adequately post and
monitor the restricted area, and failures to lock and secure the camera
when not in use will become less frequent. Furthermore, if an
incapacitating injury to a radiographer should occur at a remote
location, the presence of a second individual could be an important
factor in preventing unnecessary radiation exposures. The Commission is
considering amending the Enforcement Policy as a result of this
proposed rulemaking to provide, as an example of a Severity Level III
violation, the conduct of radiography operations without the required
second radiographer or individual with, at least, the qualifications of
a radiographer's assistant as provided in the proposed Sec. 34.41.
III. General Discussion of Proposed Rule Changes
The proposed amendments contain requirements which are intended to
improve radiography safety. The first major change is a proposal to
require, at a minimum, two qualified individuals (two radiographers or
a radiographer and an individual who has met, at least, the
requirements to be a radiographer's assistant) to be present any time
radiographic operations occur outside of a permanent radiographic
installation. This issue has already been addressed under Section II.
Petition for Rulemaking.
On March 19, 1991 (56 FR 11504), the NRC published a final rule
which provided for a voluntary third-party radiographer certification
program through the American Society for Nondestructive Testing (ASNT),
as discussed further in Section IV. Several Agreement States have
adopted mandatory radiographer state administered examination programs.
The promulgation of these programs, as well as other changes in their
radiography regulations, have contributed to an overall improvement in
safety and a decrease in serious overexposures in these Agreement
States.
The proposed rule would recognize other certifying organizations
who meet the requirements outlined in Appendix A of the proposed rule.
Independent certifying organizations would be required to meet all of
the requirements listed in Appendix A, while Agreement States that wish
to become certifying entities would only be required to meet the
requirements listed in part II and III of the Appendix. The NRC plans
to publish annually in the Federal Register an updated list of
certifying entities and to provide the list with license application
forms. The NRC also plans to investigate the feasibility of
establishing a toll-free telephone number whereby licensees could
obtain information on approved certifying entities.
Another issue involves the definition of a permanent radiographic
installation. The proposed rule changes the definition of a ``permanent
radiographic installation'' to mean an enclosed shielded room, cell, or
vault in which radiography is performed. The terms ``designed or
intended for radiography'' and ``regularly performed'' have been
removed from the definition to reduce any ambiguity as to what is
intended. Under the existing rule, if a licensee has a room, cell, or
vault that meets the definition of a ``permanent radiographic
installation'', then it must meet the special safety requirements of
Sec. 34.33. The proposed rule adds two additional requirements: (1) To
perform a daily check of the visible and audible signals, and (2) to
list all permanent facilities on the license. Under the proposed rule,
radiography can only be performed in one of two ways: (1) In a
permanent radiographic installation with a qualified radiographer, or
(2) at any other location with at least two qualified individuals. The
special safety requirements of Sec. 34.33 would not apply to the use of
a shielded room at a temporary jobsite, although licensees would be
permitted to submit a license amendment requesting approval to use a
shielded room which meets the requirements of Sec. 34.33 as a permanent
radiographic installation.
The proposed rule includes requirements specifying the
qualifications and duties of the Radiation Safety Officer (RSO). The
RSO is the key licensee individual charged with the responsibility to
ensure that the requirements in the license are followed. These
requirements have been based on similar commitments previously included
in specific license conditions on a case-by-case basis. The proposed
rule would require additional special training for RSOs. The Commission
is considering permitting existing RSOs to obtain the additional
training within 2 years from the effective date of the rule and is
specifically requesting comment on this proposed requirement.
IV. An Independent Certifying Entity (ASNT)
The current ASNT program for certifying industrial radiographers
was approved by its Board of Directors in March 1990 and offers
certification for either isotope or x-ray users. The NRC staff has
extensively reviewed this program, which includes a written examination
developed by the State of Texas.
The application to become a certified radiographer requires
documentation of 40 hours of classroom training in radiation safety
topics specified by ASNT including those topics listed in the proposed
Sec. 34.43(f), documentation of 520 hours of direct hands-on experience
with radiography sources and devices under the control of an NRC or
Agreement State licensee, and proof of successful completion of a
practical examination on safety procedures administered by an ASNT-
recognized institution. Recognized institutions, generally the
candidates' employers, have been licensed by NRC or an Agreement State
for the use of radiography sources.
After ASNT's approval of an application, a candidate radiographer
takes the written examination. The examination is administered by ASNT
or the Conference of Radiation Control Program Directors, Inc. (CRCPD)
and subsequently sent to the State of Texas for grading. The results of
the examination are forwarded to ASNT. The written examination covers
the fundamental radiation safety principles outlined in 10 CFR part 34,
pertinent Federal and State regulations, basic radiographic equipment
operation, general operating and emergency procedures, radiation
detection instrumentation, and radiation safety procedures applicable
to industrial radiography. In addition, candidates are required to sign
a pledge that they will abide by the ASNT Rules of Conduct. On
successful completion of the required examinations and other
requirements, a certified individual is provided with a wallet card
identifying him/her as an ASNT-certified radiographer.
ASNT certification is valid for 3 years, unless suspended or
revoked for cause. Renewal of certification may be accomplished either
with or without reexamination. A candidate for renewal without
reexamination must document continuous active full-time employment in
radiography for at least 6 of the last 12 months. In addition, the
candidate must document at least 8 hours, each year, of classroom
refresher training covering basic radiation safety principles,
equipment operations, emergency procedures, new safety regulations,
license requirements, and other pertinent information. If these
criteria are not met, the candidate must retake the written
examination.
The ASNT Rules of Conduct require certified individuals to comply
with NRC and Agreement State regulations and the employer's procedures
for radiation safety, routine and emergency operations, and to act in a
professional manner in matters pertaining to industrial radiography or
to the ASNT certification.
The certification program also contains complaint and hearing
procedures. For example, written allegations of unauthorized practice
by an ASNT-certified individual are reviewed by the ASNT Ethics
Subcommittee. In some cases a formal hearing may be held. If the ASNT
Ethics Subcommittee determines that an unauthorized practice has been
committed, the subcommittee may take one of the following actions:
1. Revoke the individual's certification for a minimum of 1 year.
2. Suspend the individual's certification for 30 to 180 days.
3. Formally reprimand the individual.
More detailed information on the ASNT certification program is
available from the American Society for Nondestructive Testing, Inc.,
1711 Arlingate Plaza, P.O. Box 28518, Columbus, Ohio 43228-0518.
V. Discussion of the Proposed Rule
Table of Contents
The new Table of Contents contains eight subparts. The organization
is as follows:
Subpart A--General Provisions
Subpart B--Specific Licensing Provisions
Subpart C--Equipment
Subpart D--Radiation Safety Requirements
Subpart E--Recordkeeping Requirements
Subpart F--Notifications
Subpart G--Exemptions
Subpart H--Violations
Appendix A
This organization follows the same general format used in 10 CFR
part 39 concerning radiation safety requirements for well logging.
Subpart A--General Provisions
This subpart covers items of a general nature, such as listing
definitions and OMB approvals. It also describes the purpose and scope
of the rule.
Section 34.1, Purpose and scope, is basically unchanged from the
existing regulation. Other NRC regulations that apply to radiography
licenses are referenced in this section.
Section 34.3, Definitions, contains the following new terms: ALARA,
Annual safety review, Becquerel, Certifying entity, Collimator, Control
(drive) cable, Field station, Gray, Independent certifying
organization, Radiographer certification, Radiation Safety Officer,
Sievert, S-tube, and Temporary jobsite. These definitions were added to
define terms used in requirements not previously addressed in Part 34.
The term ALARA, which means as low as reasonably achievable, has been
added to describe a key element of the revised part 20, ``Standards for
Protection Against Radiation,'' that licensees must implement by
January 1994. The term Annual safety review was added to describe this
activity in the proposed rule. The terms Becquerel, Gray, and Sievert
were added to define the metric units used in all new or revised
regulations. The terms Certifying entity, Independent certifying
organization, and Radiographer certification were added to describe
terms associated with revised requirements for verification of
radiographer training. The terms Collimator and Control (drive) cable
were added to the proposed rule to describe pieces of equipment that is
often used in conducting radiography operations. The term S-tube was
added to describe this component of a radiographic exposure for which
there are new requirements in the proposed rule. The terms Field
station and Temporary jobsite were added to clarify the meaning of
these terms in the proposed rule. The term Field station is being used
to designate those locations where radiography equipment is stored and
from which equipment is dispatched. The term Temporary jobsite is being
used to describe locations not authorized on the license where
radiography is conducted. The term Radiation Safety Officer (RSO) was
added to describe the role of this individual in the proposed rule.
The terms Associated equipment, Control tube, Exposure head, Field
examination, Projection sheath, Radiographic Operations, Shielded
position, and Source assembly, while used in the existing regulation,
were not previously defined. Both licensees and Agreement State
representatives requested clarification of these terms. Changing the
definition of radiographer's assistant was discussed at the November
1992 workshop in Dallas, Texas. Some Agreement States use the term
``trainee'' to refer to a radiographer's assistant and require training
similar to that required of a radiographer. The NRC has decided to
retain the term radiographer's assistant and has proposed upgrading the
training requirements to provide additional assurance that
radiographers' assistants are sufficiently knowledgeable of NRC
regulations. Although the NRC is not adopting the term ``trainee,'' the
proposed rule has been written to provide the flexibility for the
second person to have training beyond that of a radiographer's
assistant. This position could then equally be filled by a ``trainee.''
The definition of a permanent radiographic installation was
modified to remove ambiguities in the previous definition. The
definitions of storage area and storage container were modified to
remove references to transportation. Specific transportation
requirements are addressed in Sec. 34.35.
Section 34.5, Interpretations, is standard regulatory language to
state that only the General Counsel of the NRC has the authority to
provide interpretations of the regulations which will be binding on the
Commission.
Section 34.8, Information collection requirements: OMB approval, is
unchanged from the current regulation, except for changing the section
numbers to conform to the new format of the proposed rule and to list
any new requirements that require OMB approval. The Commission has
submitted the proposed rule for OMB clearance. Final OMB clearance will
be obtained before publication of a final rule.
Subpart B--Specific Licensing Provisions
This proposed subpart provides the basic requirements for submittal
of a license application. The sections in this proposed subpart are
basically unchanged from those in the current subpart A of part 34.
Section 34.11, Application for a specific license, is worded the
same as Sec. 34.3 in the current part 34.
Section 34.13, Specific license for radiography, has several
changes from Sec. 34.11 in the current part 34. A proposed
Sec. 34.13(c) would specify requirements for establishing procedures to
verify the certification status of radiographers. The requirement for
verifying an individual's certification would only apply to previously
certified radiographers whom a licensee might hire. A licensee would
already know an individual's status if the individual is employed by
the licensee at the time of certification. However, the licensee would
be required to ensure that all radiographers are certified.
Section 34.13(e) proposes a reduction in the frequency of field
inspections of radiographers and radiographer's assistants from
quarterly to annually for individuals regularly conducting radiographic
operations. For individuals who have not performed radiographic
operations for more than six months, an inspection of job performance
would be required at the time they next participate in a radiographic
operation. This reduction is possible due primarily to the proposed
two-person rule, adoption of mandatory certification for radiographers,
and upgraded radiographer assistants training which would reduce the
need for inspection of job performance. The basic requirements for
conducting the field inspections have been relocated to Sec. 34.43(d)
to more accurately reflect its role in the training program. In
addition, a requirement for conducting annual safety reviews has also
been added in Sec. 34.13(b)(1) and Sec. 34.43(c) to clarify the intent
of the current Sec. 34.11(b) which requires periodic training. Section
34.13(g) is proposed to require the licensee to designate an individual
on the license to fulfill the duties of the RSO. The qualifications and
duties of this individual are specified in Sec. 34.42.
Section 34.13(i) is a new paragraph which, as proposed, would
require a list and description of all permanent radiographic
installations and all field stations to be included in the license
application.
Section 34.13(j) is a new paragraph which, as proposed, would
permit licensees to have the option to use certified radiographers
before the proposed rule is adopted in final form and becomes
effective.
Subpart C--Equipment
This proposed subpart describes the requirements for radiographic
equipment performance and use. Some of the requirements in this
proposed subpart are changed from the current part 34 as described
below.
Section 34.20, Performance requirements for radiography equipment,
is slightly changed from Sec. 34.20 of the current rule. Section
34.20(b)(3) is revised to prohibit modification of any exposure device.
The proposed rule was modified to remove any ambiguity regarding
permission to modify safety components. The term Source assembly was
added to Sec. 34.20 (c) and (e) to make clear that it is one of the
pieces of equipment that must meet the requirements of Sec. 34.20.
Section 34.20(f) is added to require labeling of all associated
equipment acquired after January 10, 1996, to identify that the
components have met the requirements of this section.
Section 34.21, Limits on levels of radiation for radiographic
exposure devices, storage containers, and source changers, is basically
unchanged from Sec. 34.21 of the current rule with the following
exceptions. Metric equivalents to the values previously cited have been
included. While it is recognized that radiation exposure instruments
currently use units of roentgens to measure radioactivity, the rule has
been modified to use the terms millisieverts and millirems. Rather than
making the transition from roentgens to coulombs per kilogram (in air),
the terms millisieverts and millirems were chosen because a quality
factor of 1 is appropriate in dealing with gamma-ray emitting
radiography sources. Under the proposed rule measurements taken in
roentgens may continue to be recorded in terms of roentgens, provided
the limits described in the rule, expressed in millisieverts or
millirems, are not exceeded.
Section 34.23, Locking and relocation of radiographic exposure
devices, storage containers, and source changers, is slightly changed
from Sec. 34.22 of the current rule, as described below. Section
34.23(a) describes locking of radiographic exposure devices. A
requirement to remove the key of any keyed-lock is proposed. Should the
key remain in the radiographic exposure device, there is an increased
likelihood of the accidental or intentional removal of the sealed
source when the radiographic device is unattended. The word
``manually'' is added to clarify what is meant by securing the source
assembly for radiographic exposure devices manufactured before January
10, 1992. Section 34.23(b) is added which specifies requirements for
ensuring that the sealed source is in the shielded position before
moving the device and associated equipment because a number of
overexposures have occurred while radiographic devices were being moved
from one location to another.
Section 34.25, Radiation survey instruments, replaces Sec. 34.24 in
the current rule and has been updated to reflect current calibration
standards for different types of survey meters. This is to specify
requirements to address the variety of survey instruments currently
available. An additional requirement to perform an operability check
before use is proposed. While this is routinely part of all survey
instrument specifications, a failure to determine whether an instrument
was operable before use has been a contributing factor in overexposures
during radiographic operations.
In Sec. 34.27, Leak testing and replacement of sealed sources, the
words ``repair, tagging, opening, and modification'' of sealed sources
have been removed because these activities are only approved for
individuals specifically licensed to do so. It was never intended that
radiographers would be permitted to perform these activities without
special authorization from the Commission or an Agreement State.
Section 34.31 was modified to include a specific prohibition on the
opening, repair, or modification of sealed sources. Most of the
language in the proposed rule is the same as Sec. 34.25 of the existing
rule. However, the organization has been modified for purposes of
clarification. The requirement that performance of a source exchange or
a leak test must be done by persons approved by the Commission has been
modified to include Agreement States. Recordkeeping requirements have
been moved to Sec. 34.67.
Section 34.27(f) is proposed to require surveys for depleted
uranium (DU) contamination in the ``S'' tube of radiographic devices at
least once every 12 months. Depleted uranium is used as a shielding
material in most radiographic devices and replaces the lead shielding
that was used in older models. The presence of DU contamination in the
``S'' tube may be an indication that the control cable has worn a
groove through the ``S'' tube into the DU shielding. This condition
could cause binding of the control cable in the groove with the
resultant inability to retract the source, and could result in
unwarranted exposures. Recordkeeping requirements may be found in
Sec. 34.67.
Section 34.29, Quarterly inventory, is basically unchanged from the
existing regulation with the exception of moving all recordkeeping
requirements to Sec. 34.69.
Section 34.31, Inspection and maintenance of radiographic exposure
devices, storage containers, associated equipment, and source changers,
includes several proposed changes from Sec. 34.28 in the current rule.
The term associated equipment has been included in the proposed rule,
and includes various items used for specific tasks which may not be
supplied with the radiographic device. Experience has shown that
defects in associated equipment can have an effect on safety.
Therefore, associated equipment must be included in an inspection and
maintenance program. Section 34.31(a) has been revised to clarify the
intent of the daily visual check and the required actions if defects
are found. In Sec. 34.31(b), the term routine maintenance is now used
to clarify that licensees are not required to perform all maintenance.
Many equipment repairs may require returning the device to the
manufacturer. Language has been added to specify that defective
equipment must be removed from service until repaired and that a record
of the defect, as well as corrective actions taken, must be made. While
this appears obvious, there have been numerous instances where the use
of defective equipment continued and overexposures of personnel
occurred as a direct result of the defects. Recordkeeping requirements
have been moved to Sec. 34.73. The records required to be kept would
now be specified in the rule, and include: Date of check, individual
performing check, equipment involved, any defects found, and repairs
made.
Section 34.33, Permanent radiographic installations, is basically
unchanged from the existing requirements in part 34, with the
exceptions noted below. Section 34.33(a) has been revised to clarify
which entrance controls are required by incorporating the appropriate
language from 10 CFR 20.1601 into part 34. Section 34.33(b) is revised
to require an alarm system check at the beginning of each day of use.
This is to be performed by checking the warning light and audible alarm
with the source exposed before using the room each day. A defective
alarm would require repair before radiographic operations could resume.
This requirement is included because there have been instances where
failures in alarm systems have resulted in personnel overexposures upon
entry into a high radiation area.
Section 34.35, Labels, storage, and transportation precautions, is
a proposed new section that would place requirements that specify
labeling and security precautions for radioactive material storage and
transportation in part 34. Section 34.23 of the current rule describes
storage precautions for exposure devices and storage containers but
does not address transportation or labeling requirements. In Sec. 34.35
of the proposed rule, labeling requirements for source changers and
storage containers are specified. The proposed rule contains specific
requirements to lock and physically secure transport packages. The
proposed rule would also require licensees to store licensed material
in a manner which minimizes the danger from explosions or fire. The
requirement for a Quality Assurance (QA) program, as described in
Sec. 71.105, has been added to the proposed rule. While radiography
licensees have always had to comply with Sec. 71.105, there have been
numerous cases where radiography licensees were unaware of this
requirement and, therefore, failed to comply. The addition of
requirements addressing labeling and transportation is necessary
because in the past personnel and public exposures have occurred from
the failure to properly safeguard radioactive material during storage
and transportation.
Subpart D--Radiation Safety Requirements
This subpart describes basic radiation safety requirements for
radiographic operations and includes training, safety procedures,
personnel monitoring and surveys. New requirements describing the
duties of the radiation safety officer are proposed.
Section 34.41, Conducting radiographic operations, would be added
to address the practice of conducting radiography at sites where the
special safety features of a shielded facility are not available. The
proposed requirement specifies that, as a minimum, either two
radiographers or a radiographer and an individual who has met the
requirements to be a radiographer's assistant must be present any time
radiographic operations occur outside a permanent installation. The
basis for this proposed requirement is to ensure that, in the absence
of the safety features outlined in Sec. 34.33, there will be a
significant increase in assurance that operational safety measures will
be implemented effectively. The expectation is that violations
involving failures to perform adequate radiation surveys of
radiographic exposure devices and the surrounding area, failures to
adequately post and monitor the restricted area, and failures to lock
and secure the camera when not in use will become less frequent.
Furthermore, if an incapacitating injury to a radiographer should occur
at a remote location, the presence of a second individual could be an
important factor in preventing unnecessary radiation exposures. Section
34.41(b) is proposed to require that radiographic operations conducted
at locations listed on the license be conducted in a permanent
radiographic installation. If licensees would need to perform
radiography outside of a permanent facility due to some unique
circumstances Commission authorization would be required, and the
requirements of Sec. 34.41(a) would need to be met.
Section 34.42, Radiation Safety Officer (RSO), lists the
qualifications and duties of the RSO. This section would be added to
place in the regulations the requirements for this key individual.
Previously, these requirements were referenced in regulatory guides and
included as license conditions on a case-by-case basis, but not
specified in the regulations. The NRC believes that the RSO is the key
individual for ensuring safe operations. The qualifications listed for
the RSO in the proposed rule include: (1) Completion of the training
required for a radiographer as described in part 34; and (2) 2000 hours
of documented experience in industrial radiography with at least 40
hours of formal classroom training with respect to the establishment
and maintenance of radiation protection programs. It is anticipated
that most existing RSOs already meet these requirements. It is proposed
that licensees would have two years from the effective date of the rule
to meet this 40 hour training requirement for existing RSOs. A key duty
of the RSO is to ensure the safe conduct of operations and to stop
unsafe operations and institute corrective actions. Other duties of the
RSO in the proposed rule include overseeing procedure implementation
and employee training, and monitoring radiation surveys, leak tests,
and personnel monitoring results.
Section 34.43, Training, contains several new requirements. Section
34.43(a) has been revised to require radiographers to be certified by a
certifying entity meeting the criteria specified in Appendix A of the
proposed rule. To be recognized as a certifying entity, an independent
organization meeting the criteria specified in part I of appendix A
would have to apply as specified in Sec. 34.43(a)(2). Certifying
programs would be periodically reviewed by the NRC to ensure that the
conditions of approval are being met. A list of approved certifying
entities would be made available to licensees on request by contacting
the appropriate regional office listed in appendix D to 10 CFR part 20,
and would be published annually in the Federal Register. Under the
proposed rule licensees would have 2 years to implement the proposed
change. The change in the verification of training requirements was
included in the proposed rule to provide assurance of the quality of
radiographers' training in the safe handling of radioactive material.
NRC and Agreement States must reciprocally recognize valid radiographer
certifications issued by either an independent certifying entity
approved by the NRC or an Agreement State certification program meeting
the requirements of appendix A, parts II and III, of the proposed rule.
Also included in this section is training in Secs. 30.7, 30.9, and
30.10, applicable sections of 10 CFR part 71, and some instructions in
applicable Department of Transportation (DOT) regulations as referenced
in 10 CFR part 71 in addition to other parts of NRC regulations.
Section 34.43(b), which lists training requirements for
radiographers' assistants, has been revised to require training in
Secs. 30.7, 30.9, 30.10, and parts 19, 20, 34, 71, and instructions in
applicable DOT regulations as referenced in 10 CFR part 71, in addition
to the licensee's operating and emergency procedures. These changes are
to ensure that radiographers and radiographers' assistants are
knowledgeable of the safety requirements applicable to handling
radioactive material in the conduct of radiography. In Sec. 34.43(b)(3)
the option of providing an oral test has been omitted. The proposed
rule would only allow a written test to be given. Section 34.43(c)
describes a proposed requirement to conduct annual safety reviews of
radiographers and radiographers' assistants. In the current rule,
periodic training is required but required topics to be addressed are
not included. Because a number of violations involving personnel
overexposures have resulted from licensees' failures to provide
adequate training, the proposed amendment for annual safety reviews
includes training on revised operating and emergency procedures, new
equipment, and safety issues.
Section 34.43(d) has been relocated from Sec. 34.11(d), and
describes the requirements for routine inspections of job performance
for radiographers and radiographers' assistants. The proposed rule
reduces the frequency of these inspections from quarterly to annually.
The NRC is proposing to reduce the frequency of inspections of job
performance for individuals regularly conducting radiographic
operations. For individuals who have not performed radiographic
operations for more than six months, an inspection of their job
performance would be required at the time of their next participation
in a radiographic operation. With several of the other requirements
proposed in this rulemaking, such as, certification of radiographers,
and having at least two individuals at a temporary jobsite, the
Commission believes that the frequency of inspection of job performance
can be reduced from quarterly to annually.
Proposed Sec. 34.43(e) specifies that recordkeeping requirements
can be found in Sec. 34.79. The requirements for records are unchanged
from the current part 34 except for the addition of records verifying
the certification status of radiographers. Proposed Sec. 34.43(f)
contains the subjects currently listed in Appendix A of part 34.
Several additional requirements are proposed. These include: Pictures
or models of source assemblies; training in storage, control, and
disposal of licensed materials; and pertinent Federal regulations,
i.e., Department of Transportation. A new Sec. 34.43(g) would be added
which would allow licensees to continue to permit uncertified
individuals to act as radiographers for a 2-year period after the
proposed rule becomes final.
In Sec. 34.45, Operating and emergency procedures, minor changes
were made to include procedures for source recovery if the licensee
intends to perform emergency source recovery. These were added because
many of the steps in a source recovery would be the same in any
circumstance and, in the past, a number of personnel overexposures have
occurred during emergency source recovery operations because basic
radiation protection precautions were overlooked. Additional
requirements are proposed for transportation procedures to include
placarding of vehicles, and reference to the DOT regulations. A number
of violations have resulted from licensees failing to follow DOT
regulations in the transportation of radioactive material. Section
34.45(b) is proposed which specifies that the recordkeeping
requirements can be found in Sec. 34.81. Sections 34.89 and 34.91
specify that copies of current operating and emergency procedures are
to be maintained at field stations, permanent installations, and
temporary jobsites, to ensure that adequate documents are available
where radiographic operations occur.
Section 34.46, Supervision of radiographers' assistants, is
unchanged from Sec. 34.44 of the current rule.
In Sec. 34.47, Personnel monitoring, several changes are proposed.
The existing requirement specifies that pocket dosimeters have a range
from zero to at least 200 milliroentgens. The proposed rule has dropped
the term ``at least,'' to limit the range to be only from 0-200. This
is to prevent the use of pocket dosimeters with very high ranges where
the users would be unable to properly determine their exposure. Use of
pocket dosimeters with a range higher than 200 milliroentgens will be
considered on a case-by-case basis. Additional requirements are
proposed on the replacement frequency for film and TLDs. The existing
regulation does not specify the replacement frequency for film and
TLDs. The high intensity sources used in radiography necessitate
frequent monitoring. Monthly replacement is judged to be an appropriate
frequency to adequately track an individual's exposure. With the new
lower limits for occupational dose, less frequent monitoring could
result in a worker receiving an overexposure.
Section 34.47(b) addresses the use of pocket dosimeters. A
requirement to read dosimeters at the beginning and end of each shift
is proposed. This is added to ensure that the dose is correctly
estimated. The existing regulation only specifies a daily reading and
does not provide sufficient instruction on how licensees should handle
any readings which remain on the pocket dosimeter after recharging.
Because it is nearly impossible to recharge a pocket dosimeter to zero,
licensees must take a reading before and after use and determine the
difference to determine the dose accurately. Section 34.47(d) addresses
an off-scale pocket dosimeter. The proposed rule would require that, in
the case of a pocket dosimeter being off-scale, the individual will not
be permitted to work with licensed material until the RSO or a designee
of the RSO makes a determination of the worker's radiation exposure.
The current rule requires that the worker's film badge or TLD be sent
for processing, but does not specify when the individual can return to
work. The proposed revision provides the criteria that must be met
before permitting the individual to return to work. A provision is
included which will permit the individual to return to work when the
circumstances are clearly known and justified by the RSO that there was
no possibility of overexposure.
Section 34.47(e) is proposed to require that a worker cease work
whenever a film badge or TLD is lost or damaged until a replacement is
available. This is added to ensure that there is a means to accurately
determine the worker's radiation dose.
Section 34.47(g) has a proposed revision to require alarm
ratemeters to be capable of alerting the wearer regardless of the
environmental conditions. In a recent radiography overexposure
incident, a licensee reported that a radiographer who was wearing ear
protection due to high workplace noise levels was overexposed because
he was unaware that his ratemeter was alarming. For use in high ambient
noise areas, ratemeters could be supplied with either a vibrating alarm
that could be felt by the wearer or a small speaker built into hearing
protectors to meet this requirement. NRC expects its licensees to
determine the need for alarm ratemeters that incorporate these
additional protective measures.
In Sec. 34.49, Radiation surveys, there are several proposed
changes. The existing regulation requires a survey of the circumference
of the radiographic exposure device and the guide tube. A number of
violations of NRC requirements have occurred due to a failure to comply
with the requirement to survey the full circumference of the camera. In
reviewing the regulation, the NRC has decided to revise the survey
requirements to specify that a survey be conducted of the radiographic
exposure device to determine that the sealed source has returned to the
shielded position, and specify that the radiographer conduct a survey
as he/she approaches the guide tube to exchange film, reposition the
collimator, or dismantle equipment. The proposed rule places the
responsibility with the licensee for ensuring that an adequate survey
is conducted. In the majority of cases, a survey of the radiographic
exposure device's ports should be adequate to make this determination.
A proposed requirement to survey storage areas when radioactive
material is initially placed in storage, during each quarterly
inventory, and whenever changes occur which could increase radiation
levels, is added.
Section 34.51, Surveillance, is basically unchanged from Sec. 34.41
of the current rule. References to part 20 have been updated to reflect
the proposed revisions in Sec. 34.33.
Section 34.53, Posting, is basically unchanged from Sec. 34.42 of
the current rule except to incorporate current references to part 20.
Subpart E--Recordkeeping Requirements
This subpart does not appear in the current part 34. This subpart
is proposed to place all recordkeeping and notification requirements in
one location. Most of the recordkeeping requirements are unchanged from
those contained in the existing part 34. Proposed changes are discussed
below.
Section 34.61, Specific license for radiography, requires the
licensee to maintain a copy of the license until it is terminated by
the Commission.
Section 34.63, Records of receipt and transfer of sealed sources,
is added to provide a record showing the disposition of sources.
Section 34.65, Records of radiation survey instruments, is proposed
as currently written in Section 34.24. Licensees would be required to
maintain calibration records for radiation survey instruments for 3
years after the record is made.
Section 34.67, Records of leak testing and replacement of sealed
sources is proposed as currently written in Sec. 34.25(c) and requires
licensees to maintain records of leak tests for 3 years after the
record is made.
Section 34.69, Records of quarterly inventory is proposed as
currently written Sec. 34.26 and requires licensees to maintain records
of quarterly inventories for 3 years after the record is made.
Section 34.71, Utilization logs, is proposed much as currently
written in Sec. 34.27. This section would require licensees to maintain
utilization logs for 3 years after the record is made. The proposed
rule has added several additional pieces of information to the logs
including the serial number of the device in which the sealed source is
located, the radiographer's signature, and the dates the device is
removed and returned to storage. This information is necessary in order
to verify location of sources.
Section 34.73, Records of inspection and maintenance of
radiographic exposure devices, storage containers, associated
equipment, and source changers, is proposed much as currently written
in Sec. 34.28(b). This section requires licensees to maintain
inspection and maintenance records for 3 years after the record is
made. The proposed rule would specify the information that must be
included in the inspection records: Date of check, name of inspector,
equipment inspected, any defects found, and repairs made.
Section 34.75, Records of alarm system checks at permanent
radiographic installations, is proposed as currently written in
Sec. 34.29(c) and requires licensees to maintain records of alarm
system checks for 3 years after the record is made.
Section 34.79, Records of training, is proposed as currently
written in Sec. 34.31(c) with proposed additional requirements for
maintaining records of radiographer certification and annual safety
reviews. This paragraph would require licensees to maintain records
verifying radiographer certification status. For annual safety reviews,
the records would include copies of tests, dates administered, names of
instructors and attendees, and the topics covered. Under the proposed
rule, records of the annual inspections would include a list of items
checked, and any non-compliances observed by the RSO.
Section 34.81, Copies of operating and emergency procedures, is
proposed as currently written in Sec. 34.32 and requires licensees to
maintain copies of emergency and operating procedures until the
Commission terminates the license.
Section 34.83, Records of personnel monitoring, is proposed as
currently written in Sec. 34.33(b), and requires licensees to maintain
records of alarm ratemeter calibrations, pocket dosimeter readings, and
operability checks for 3 years from the date the record was made, and
to maintain records of film badge or TLD reports until the Commission
terminates the license.
Section 34.85, Records of radiation surveys, is proposed as
currently written in Sec. 34.43(d) and requires records of the exposure
device surveys for 3 years from the date the record was made.
Section 34.87, Form of records, is proposed as currently written in
Sec. 34.4 and specifies how records must be maintained, including
permitting records to be stored in electronic media.
Section 34.89, Documents and records required at field stations and
permanent installations, would be added to list documents and records
required at field stations and permanent installations. This section is
necessary to ensure that licensees have available sufficient records to
demonstrate compliance with NRC regulations. Field stations and
permanent installations may be far removed from the home office.
Therefore, records necessary to conduct operations safely should be
readily available. These records include a copy of the current license,
copies of pertinent regulations, copies of operating and emergency
procedures, instrument calibration records, leak test results,
inventory records, utilization logs, training and survey records. These
records are those required for licensees to safely handle radioactive
material, and are a subset of the records required at a licensee's
normal place of business.
Section 34.91, Documents and records required at temporary jobsites
and use or storage locations exceeding 180 days, would be added to list
documents and records required at temporary jobsites and locations
where radioactive material will be in use or storage for more than 180
days. This section is necessary to ensure that licensees have available
sufficient records to demonstrate compliance with NRC regulations and
those records necessary to maintain safe operations. The records listed
are a smaller subset of the records required for a field station or
permanent installation. These records include copies of pertinent
regulations, evidence of latest instrument calibrations, latest survey
records, shipping papers, and NRC license or Agreement State license if
operating under reciprocity. These records are those required for
licensees to safely handle radioactive material.
Subpart F--Notifications
This subpart is basically unchanged from Sec. 34.30 with the
exception of an additional requirement. Section 34.101(c) would require
licensees to notify the appropriate NRC regional office in writing
before using or storing radioactive material in one location for more
than 180 days. This notification would be required within 30 days of
exceeding the 180-day timeframe. This provision would be added to
provide the NRC with information in a timely manner to permit
inspection of radioactive material at these locations.
Subpart G--Exemptions
This subpart addresses exemptions and is basically the same as
Sec. 34.51 in the current part 34 with the exception of minor wording
changes to make it consistent with current language used in other parts
of the rule. See Sec. 39.91.
Subpart H--Violations
This subpart addresses violations and is basically the same as
Sec. 34.61 and Sec. 34.63 in the current part 34 with the exception of
minor wording changes to make the sections referenced consistent with
the proposed rule.
Appendix A to Part 34
This appendix is new. The requirements in appendix A to the current
part 34 have been relocated to Sec. 34.43(f). Part I of the new
appendix A provides the proposed requirements for an independent
certifying organization, and does not apply to Agreement States
choosing to become a certifying entity. Parts II and III of the new
appendix A provide the proposed requirements for certification programs
and written examinations for a certifying entity, which would include
Agreement States. The proposed appendix A would not impose new
requirements on NRC's radiography licensees.
NRC is proposing that an independent certifying organization would
have to be a national society or association involved in setting
national standards of practice for industrial radiography or non-
destructive testing to be recognized. Membership in the organization
could not be restricted because of race, color, religion, sex, age,
national origin or handicap and the organization's certification
program would need to be open to nonmembers. The independent certifying
organization would need to:
(1) Be incorporated;
(2) Have a permanent full-time staff;
(3) Be nationally recognized;
(4) Have a policy and decision-making review board;
(5) Be governed by written organizational by-laws and policies; and
(6) Have a viable system of financing its operations.
An independent certifying organization would also need to have:
(1) A committee to review and approve certification guidelines and
procedures and to advise the organization's staff in implementing its
certification program;
(2) A committee to review complaints against certified individuals;
(3) Written procedures describing its certification program; and
(4) An agreement to exchange information about certified
individuals with the Commission and the Agreement States.
For a certification program to be acceptable, NRC is proposing that
it include provisions requiring individuals to receive training in the
topics listed in Sec. 34.43(f), complete a written examination,
complete a practical examination or equivalent, and require a minimum
period of on-the-job experience. The program would also have to include
procedures that ensure due process whenever an individual's
certification may need to be revoked, suspended, or restricted for
willful or significant failure to comply with his or her employer's
operating or emergency procedures, or the Commission's or an Agreement
State's regulations.
For the written examination, NRC is proposing that it be: (1)
Designed to test knowledge and understanding of the subjects listed in
Sec. 34.43(f); (2) written for a ninth-grade reading comprehension
level; and (3) scientifically analyzed to ensure that the questions are
not biased or misleading.
Agreement State Compatibility
The rule will be a matter of compatibility between the NRC and the
Agreement States, thereby providing consistency between Federal and
State safety requirements. With regard to basic radiation equipment
specifications, standards, and definitions identified as matters of
Division 1 level of compatibility, the Agreement States will be
expected to adopt, essentially verbatim, the proposed part 34 standards
and definitions into their equivalent regulations. However, the NRC
also recognizes that certain terms, such as radiographer's assistant,
may not be used in present Agreement State regulations. Continued use
of alternative terms, such as ``trainee'' will be considered acceptable
so long as the underlying requirements of the position are consistent
with those proposed by the Commission. The remainder of the rule will
be a Division 2 level of compatibility allowing the Agreement State
regulators the flexibility to adopt similar or more stringent
requirements based on their radiation protection experience,
professional judgments, and community values.
Appendix A of proposed 10 CFR part 34 provides the requirements for
certifying entities to be acceptable to NRC. The Commission reserves
the right to make this determination and therefore this is a Division 4
item of compatibility. Because it concerns a regulatory function that
will be reserved for the Commission pursuant to 10 CFR part 150, the
Agreement States will not need to implement this provision of the
proposed rulemaking. A new section proposed for part 150 would make
clear the Commission's intent to reserve this function and also to
reserve the right to set minimum radiographer certification standards.
Agreement States that wish to develop radiographer certification
programs would be expected to implement parts II and III of the
proposed appendix A. The definitions and the requirements for
certification programs and written examinations contained in this
rulemaking must be the same for all NRC and Agreement State licensees
to maintain consistency. In practice, States that develop certification
programs must develop regulatory language and regulations that
implement appendix A, parts II and III criteria. States would be
permitted to include additional administrative requirements (such as
State-issued cards). States that do not develop certification programs
would not be expected to implement appendix A. NRC or an Agreement
State must reciprocally recognize valid radiographer certifications
issued by either an independent certifying entity approved by the NRC
or by an Agreement State certification program meeting the requirements
of appendix A, parts II and III, of the proposed rule. Agreement States
would be expected to submit their proposed program for NRC review and
evaluation prior to implementing their certification program.
Implementation
The Commission intends to have different implementation dates for
particular requirements of this proposed rule. The proposed
requirements would become effective 90 days after publication of the
final rule in the Federal Register. For the proposed requirements in
Sec. 34.41 to use, as a minimum, a two-person crew for radiographic
operations not conducted in a permanent facility, licensees would have
1 year from the effective date of the rule to comply. Licensees would
be required to affirm that all radiographers have met the certification
requirements of 34.43(a)(1) within 2 years from the effective date of
the rule. This would allow radiography licensees operating in NRC
jurisdiction 2 years to obtain certification for their employees who
act as radiographers. This requirement would include radiographers
employed by Agreement State licensees operating in non-Agreement States
under reciprocity pursuant to 10 CFR 150.20. The Commission notes that
the State of Texas currently provides a 90-day grace period for non-
Texas licensees operating in that State under reciprocity (TRC 31.90).
However, because this proposed rule will be a matter of compatibility,
the requirement for mandatory certification would apply to radiography
licensees nationwide.
Licensees would have one year from the effective date of the rule
to comply with the additional training requirements specified in
Sec. 34.43(b). Licensees could consider combining this training with
the annual safety review.
For the proposed revision to Sec. 34.47(g) that would require alarm
ratemeters be capable of alerting the wearer regardless of
environmental conditions, licensees would have 1 year to obtain or
modify a sufficient number of additional alarm ratemeters to meet
anticipated needs.
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, by the effective date of
the rule. Few amendment requests are anticipated.
All current RSOs would be granted a two-year extension to meet the
proposed additional RSO training requirements specified in
Sec. 34.42(a).
The Commission requests that persons commenting on this proposed
rulemaking particularly address any hardships that would result if the
proposed rule were adopted and also address any hardships that would
result if the proposed implementation schedule were adopted. The NRC is
particularly interested in suggestions for alternative implementation
schedules.
Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, that the rule, if adopted, would not be a
major Federal action; therefore, an impact statement is not required.
The revision of 10 CFR part 34 should have no environmentally
significant impact because radiography only involves the use of sealed
sources, and no environmental impact will be involved. The
environmental assessment and finding of no significant impact on which
this determination is based are available for inspection at the NRC
Public Document Room at 2120 L Street, NW. (Lower Level), Washington
DC.
Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the information collection
requirements.
The public reporting burden for this collection of information is
estimated to average 108 hours per response, 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 regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to the Information and Records
Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission,
Washington, DC 20555; and to the Desk Officer, Office of Information
and Regulatory Affairs, NEOB-3019, (3150-0007 and 3150-0120), Office of
Management and Budget, Washington, DC 20503.
Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission. The draft analysis is
available for inspection in the NRC Public Document Room at 2120 L
Street NW. (Lower Level), Washington, DC.
Regulatory Flexibility Analysis
The NRC has prepared an initial regulatory analysis of the impact
of this proposed rule on small entities. A summary of this analysis
appears as Appendix A to this document. A copy of the analysis is
available for inspection in the NRC Public Document Room, 2120 L
Street, NW. (Lower Level), Washington, DC. Single copies of the
analysis may be obtained from Donald O. Nellis or Mary L. Thomas,
Division of Regulatory Application, Office of Research, U.S. Nuclear
Regulatory Commission, Washington, DC 20555. Telephone (301)-492-3785.
The NRC is seeking public comment on the initial regulatory flexibility
analysis. The NRC is particularly seeking comment from small entities
(i.e., small businesses, small organizations, and small jurisdictions
under the Regulatory Flexibility Act) as to how the regulations will
affect them and how the regulations may be tiered or otherwise modified
to impose less stringent requirements on small entities while still
adequately protecting the public health and safety. Those small
entities which offer comments on how the regulations could be modified
to take into account the differing needs of small entities should
specifically discuss the following items:
(a) The size of their business and how the proposed regulations
would result in a significant economic burden upon them as compared to
larger organizations in the same business community.
(b) How the proposed regulations could be modified to take into
account their differing needs or capabilities.
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulations were modified as suggested by the
commenter.
(d) How the proposed regulations, as modified, would more closely
equalize the impact of NRC regulations or create more equal access to
the benefits of Federal programs as opposed to providing special
advantages to any individuals or groups.
(e) How the proposed regulations, as modified, would still
adequately protect the public health and safety. The comments should be
sent to the Secretary of the Commission, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, Attn: Docketing and Service Branch.
Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this proposed rule and, therefore, that a backfit analysis
is not required for this proposed rule. The proposed rule does not
involve any provisions that would impose backfits as defined in 10 CFR
50.109(a)(1).
List of Subjects
10 CFR Part 34
Byproduct material, Criminal penalties, Nuclear material, Packaging
and containers, Radiation protection, Radiography, Reporting and
recordkeeping requirements, Scientific equipment, Security measures.
10 CFR Part 150
Criminal penalties, Hazardous materials--transportation,
Intergovernmental relations, Nuclear materials, Reporting and
recordkeeping requirements, Security measures, Source material, Special
nuclear material.
For reasons set out in the preamble and under the authority of the
Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of
1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the
following amendments to 10 CFR part 34.
PART 34--LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS
FOR RADIOGRAPHIC OPERATIONS
1. The authority citation for part 34 is revised to read as
follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
Section 34.45 also issued under sec. 206, 88 Stat. 1246 (42
U.S.C. 5846).
2. The existing headings for subparts A and B and each of the
existing undesignated center headings are removed.
3. A new heading for subpart A, consisting of Secs. 34.1-34.8, is
added to read as follows:
Subpart A--General Provisions
4. Section 34.1 is revised to read as follows:
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 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 [Removed]
5. Section 34.3 is removed.
6. Section 34.2 is redesignated as Sec. 34.3, and the new Sec. 34.3
is revised to read as follows:
Sec. 34.3 Definitions.
ALARA (acronym for as low as reasonably achievable) means making
every reasonable effort to maintain exposures to radiation as far below
the dose limits specified in part 20 as is practical consistent with
the purpose for which the licensed activity is undertaken, taking into
account the state of technology, the economics of improvements in
relation to state of technology, the economics of improvements in
relation to benefits to the public health and safety, and other
societal and socioeconomic considerations, and in relation to
utilization of nuclear energy and licensed materials in the public
interest.
Annual safety review means a review conducted or provided by the
licensee for its employees on radiation safety aspects of radiography.
The review may include, as appropriate, the results of internal
inspections, new procedures or equipment, accidents or errors that have
been observed, and 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).
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 device used to limit the size, shape, and
direction of the primary radiation beam.
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 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 examination means a demonstration through practical
application of the safety rules and principles in radiography including
use of all appropriate equipment and procedures.
Field station means a facility where licensed material may be
stored or used and from which equipment is dispatched.
Gray means the SI unit of absorbed dose. One gray is equal to an
absorbed dose of 1 Joule/kilogram. It is also equal to 100 rads.
Independent certifying organization means an independent
organization that meets all of the criteria in Appendix A of this part.
Permanent radiographic installation means an enclosed shielded
room, cell, or vault, not located at a temporary jobsite, in which
radiography is performed.
Projection sheath (guide tube) means a flexible or rigid tube
(i.e., ``J'' tube) for guiding the source assembly and the attached
control cable from the radiographic exposure device to the exposure
head or working position.
Radiation Safety Officer means an individual named by the licensee
who has knowledge of, responsibility for, and authority to ensure
compliance with appropriate radiation protection rules, standards, and
practices on behalf of the licensee and who meets the requirements of
Sec. 34.42.
Radiographer means any individual who meets the requirements of
Sec. 34.43, is in attendance at the site where the sealed source or
sources are being used, personally supervises radiographic operations
and who is responsible to the licensee for ensuring compliance with the
requirements of the Commission's regulations and the conditions of the
license.
Radiographer certification means written approval received from a
certifying entity stating that an individual has satisfactorily met
certain established radiation safety training, testing, and experience
criteria.
Radiographer's assistant means any individual, who under the
personal supervision of a radiographer, uses radiographic exposure
devices, sealed sources or related handling tools, or radiation survey
instruments in 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 transport and use of the device, to include surveys to confirm
the adequacy of boundaries, setting up equipment and any activity
inside restricted area boundaries.
Radiography means the examination of the structure of materials by
nondestructive methods, utilizing sealed sources of byproduct
materials.
S-tube means a tube (typically made of a hard metal, such as,
titanium) through which the radioactive source travels in a
radiographic exposure device.
Sealed source means any byproduct material that is encased in a
capsule designed to prevent leakage or escape of the byproduct
material.
Shielded position means the location within the radiographic
exposure device or source changer where the sealed source is secured
and restricted from movement. (In this position the radiation exposure
will be at a minimum. This position incorporates maximum shielding for
the radioactive source.)
Sievert means the SI unit of any of the quantities expressed as
dose equivalent. The absorbed dose in grays multiplied by the quality
factor is equal to the dose equivalent in Sieverts. For comparison 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 device in which sealed sources are
stored.
Temporary jobsite means a place where radiographic operations are
conducted other than the location(s) of use authorized on the license.
Sec. 34.4 [Removed]
7. Section 34.4 is removed.
8. Section 34.5 is added to read as follows:
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.
9. Section 34.8 is revised to read as follows:
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, 35.41, 34.43, 34.45, 34.47, 34.49, 34.61, 34.63, 34.65,
34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87,
34.89, 34.91, 34.101, and Appendix A.
(c) This part contains information collection requirements in
addition to those approved under the control number specified in
paragraph (a) of this section. The information collection requirement
and the control number under which it is approved are as follows:
(1) In Sec. 34.11, NRC Form 313 is approved under control number
3150-0120.
(2) [Reserved]
10. A new heading for subpart B, consisting of Secs. 34.11-34.13,
is added to read as follows:
Subpart B--Specific Licensing Provisions
11. Section 34.11 is revised to read as follows:
Sec. 34.11 Application for a specific license.
A person may file an application for specific license for use of
sealed sources in radiography, in duplicate, on NRC Form 313,
``Application for Material License,'' in accordance with the provisions
of Sec. 30.32 of this chapter.
12. Section 34.13 is added to read as follows:
Sec. 34.13 Specific license for radiography.
The Commission will approve an application for a specific license
for the use of licensed material in radiography if the applicant meets
the following requirements:
(a) The applicant shall satisfy the general requirements specified
in Sec. 30.33 of this chapter for byproduct material, as appropriate,
and any special requirements contained in this part.
(b) The applicant shall develop an adequate program for training
radiographers and radiographers' assistants that meets the requirements
of Sec. 34.43, and submit to the Commission a description of this
program which specifies the--
(1) Initial training;
(2) On-the-job training;
(3) Annual safety reviews; and
(4) Means the applicant will use to demonstrate the radiographer's
and radiographer's assistant's knowledge and understanding of and
ability to comply with the Commission's regulations and licensing
requirements and the applicant's operating and emergency procedures.
(c) The applicant shall establish and submit to the Commission a
description of its procedures for verifying and documenting the
certification status of its radiographers and for ensuring that the
certification of individuals acting as radiographers remains valid.
(d) The applicant shall submit to the Commission written operating
and emergency procedures as described in Sec. 34.45.
(e) The applicant shall establish and submit to the Commission its
program for annual inspections of the job performance of each
radiographer and radiographer's assistant as described in
Sec. 34.43(d).
(f) The applicant shall submit a description of its overall
organizational structure as it applies to the radiation safety
responsibilities in radiography, including specified delegations of
authority and responsibility.
(g) The applicant shall designate and identify a Radiation Safety
Officer responsible for implementing the licensee's radiation safety
program. The Radiation Safety Officer shall meet the qualifications and
duties described in Sec. 34.42.
(h) If an applicant intends to perform leak testing of sealed
sources, the applicant shall identify the manufacturers and the model
numbers of the leak test kits to be used. If the applicant intends to
analyze its own wipe samples, the applicant shall establish procedures
to be followed and submit a description of these procedures to the
Commission. The description 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) The applicant shall identify the location(s) of, and describe,
all field stations and permanent radiographic installations.
(j) From (insert effective date of final rule) to (Insert date 2
years after the final rule is published in the Federal Register):
(1) A license applicant may affirm that all individuals acting as
radiographers will be certified in radiation safety by a certifying
entity before commencing duties as radiographers. This affirmation is
instead of describing its initial training program for radiographers in
the subjects outlined in Sec. 34.43(f) and the means used to determine
the radiographer's knowledge and understanding of these subjects, and;
(2) A licensee may substitute radiographer certification in place
of the description of the means to determine the radiographer's
knowledge and understanding of the subjects outlined in Sec. 34.43(f).
(3) After (Insert date 2 years after the final rule is published in
the Federal Register), a license applicant and licensee shall comply
with the requirement of Sec. 34.43(a)(2).
13. A new heading for subpart C, consisting of Secs. 34.20-34.35,
is added to read as follows:
Subpart C--Equipment
14. Section 34.20 is revised to read as follows:
Sec. 34.20 Performance requirements for radiography equipment.
Equipment used in industrial radiographic operations must meet the
following minimum criteria:
(a) Each radiographic exposure device and all associated equipment
must meet the requirements specified in American National Standard
N432-1980 ``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). This publication may be purchased from
the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402 and from the American National Standards
Institute, Inc., 1430 Broadway, New York, New York 10018, Telephone
(212) 642-4900. Copies of the document are available for inspection at
the Nuclear Regulatory Commission Library, 7920 Norfolk Avenue, Lower
Level, Bethesda, Maryland, 20814. A copy of the document is also on
file at the Office of the Federal Register, 800 North Capitol Street
NW., Washington, DC 20408.
(b) In addition to the requirements specified in paragraph (a) of
this section, the following requirements apply to radiographic exposure
devices and associated equipment.
(1) Each radiographic exposure device must have attached to it by
the user, a 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 number and serial number of the sealed source;
(iv) Manufacturer of the sealed source; and
(v) Licensee's name, address, and telephone number.
(2) Radiographic exposure devices intended for use as Type B
transport containers must meet the applicable requirements of 10 CFR
Part 71.
(3) Modification of radiographic exposure devices and associated
equipment is prohibited.
(c) In addition to the requirements specified in paragraphs (a) and
(b) of this section, the following requirements apply to radiographic
exposure devices, source assemblies, and associated equipment that
allow the source to be moved out of the device for routine operation.
(1) The coupling between the source assembly and the control cable
must be designed in such a manner that the source assembly will not
become 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) 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''.
The label must not interfere with the safe operation of the exposure
device or associated equipment.
(5) The guide tube must have passed the crushing tests for the
control tube as specified in ANSI N432 and a kinking resistance test
that closely approximates the kinking forces likely to be encountered
during use.
(6) Guide tubes must be used when moving the source out of the
device.
(7) An exposure head or similar device designed to prevent the
source assembly from passing out of the end of the guide tube must be
attached to the outermost end of the guide tube during radiographic
operations.
(8) The guide tube exposure head connection must be able to
withstand the tensile test for control units specified in ANSI N432.
(9) Source changers must provide a system for ensuring that the
source will not be accidentally withdrawn from the changer when
connecting or disconnecting the drive cable to or from a source
assembly.
(d) All newly manufactured radiographic exposure devices and
associated equipment acquired by licensees after January 10, 1992, must
comply with the requirements of this section.
(e) All radiographic exposure devices, source assemblies, and
associated equipment in use after January 10, 1996, must comply with
the requirements of this section.
(f) All associated equipment acquired after January 10, 1996, must
be labelled to identify that the components have met the requirements
of this section.
15. Section 34.21 is revised to read as follows:
Sec. 34.21 Limits on levels of radiation for radiographic exposure
devices, storage containers, and source changers.
(a) Radiographic exposure devices measuring less than 10
centimeters (4 inches) from the sealed source storage position to any
exterior surface of the device must not have a radiation level in
excess of 0.5 millisieverts (50 millirems) per hour at 15 centimeters
(6 inches) from any exterior surface of the device. Radiographic
exposure devices measuring a minimum of 10 centimeters (4 inches) from
the sealed source storage position to any exterior surface of the
device, and all storage containers for sealed sources or for
radiographic exposure devices, must not have a radiation level in
excess of 2 millisieverts (200 millirems) per hour at any exterior
surface, and 0.1 millisieverts (10 millirems) per hour at 1 meter from
any exterior surface. The radiation levels specified are with the
sealed source in the shielded (i.e., ``off'') position.
(b) Paragraph (a) of this section applies to all equipment
manufactured before January 10, 1992. After January 10, 1996,
radiographic equipment other than storage containers and source
changers must meet the requirements of Sec. 34.20. Section 34.21
applies only to storage containers.
Sec. 34.22 [Removed]
16. Section 34.22 is removed.
17. Section 34.23 is revised to read as follows:
Sec. 34.23 Locking and relocation of radiographic exposure devices,
storage containers and source changers.
(a) Locked radiographic exposure devices and storage containers
must be physically secured to prevent tampering.
(1) Each radiographic exposure device must have a lock or outer
locked container designed to prevent unauthorized or accidental removal
of the sealed source from its shielded position. The exposure device
and/or its container must be kept locked (and if a keyed-lock, with the
key removed at all times), when not under the direct surveillance of a
radiographer or a radiographer's assistant or as otherwise may be
authorized in Sec. 34.51. In addition, during radiographic operations
the sealed source assembly must be manually secured in the shielded
position each time the source is returned to that position, in those
exposure devices manufactured before January 10, 1992.
(2) Each sealed source storage container and source changer must
have a lock or outer locked container designed to prevent unauthorized
or accidental removal of the sealed source from its shielded position.
Storage containers and source changers must be kept locked (and if a
keyed-lock, with the key removed at all times) when containing sealed
sources except when under the direct surveillance of a radiographer or
a radiographer's assistant.
(b) Radiographic exposure devices, source changers, and storage
containers, before being moved from one location to another, must have
the guide tubes and control cables disconnected, safety plugs or covers
applied, locked and physically secured to prevent accidental loss,
tampering or removal of licensed material, and must be surveyed to
assure that the sealed source is in the shielded position.
Sec. 34.24 [Removed]
18. Section 34.24 is removed.
19. Section 34.25 is revised to read as follows:
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 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. Survey
instruments must be checked for operability before use each day. This
may be accomplished by evaluating the instrument response to the
previously measured fields at the projection sheath port or the control
cable sheath port on a radiographic exposure device.
(b) The licensee shall have each radiation survey instrument
required under paragraph (a) of this section calibrated--
(1) At intervals not to exceed 6 months and after instrument
servicing, except for battery changes;
(2) For linear scale instruments, at two points located
approximately one-third and two-thirds of full-scale on each scale; for
logarithmic scale instruments, at midrange of each decade, and at two
points of at least one decade; and for digital instruments, at 3 points
between 0.02 and 10 mSv (2 and 1000 millirems) per hour; and
(3) So that an accuracy within plus or minus 20 percent of the
calibration standard can be demonstrated at each point checked.
(c) The licensee shall maintain records of the results of the
instrument calibrations in accordance with Sec. 34.65.
Sec. 34.26 [Removed]
20. Section 34.26 is removed.
21. Section Sec. 34.27 is revised to read as follows:
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 only by persons specifically authorized by the
Commission or an Agreement State to do so.
(b) Testing and recordkeeping requirements.
(1) Each licensee who uses a sealed source shall have the source
tested for leakage at intervals not to exceed 6 months.
(2) The licensee shall maintain records of the leak tests in
accordance with Sec. 34.67.
(3) In the absence of a certificate from the transferor that a leak
test has been made within the 6 months before the transfer, the sealed
source may not be used until tested.
(c) Method of testing. The wipe of a sealed source must be
performed using a leak test kit or method approved by the Commission or
an Agreement State. The wipe sample must be taken from the nearest
accessible point to the sealed source where contamination might
accumulate. The wipe sample must be analyzed for radioactive
contamination. The analysis must be capable of detecting the presence
of 185 Bq (0.005 microcurie) of radioactive material on the test sample
and must be performed by a person specifically authorized by the
Commission or an Agreement State to perform the analysis.
(d) Any test conducted pursuant to paragraphs (b) and (c) of this
section which reveals the presence of 185 Bq (0.005 microcurie) or more
of removable radioactive material must be considered evidence that the
sealed source is leaking. The licensee shall immediately withdraw the
equipment involved from use and shall have it decontaminated and
repaired or disposed of, in accordance with Commission regulations. A
report must be filed with the Director of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555,
within 5 days of any test with results that exceed the threshold in
this subsection, describing the equipment involved, the test results,
and the corrective action taken. A copy of the report must be sent to
the Administrator of the appropriate Nuclear Regulatory Commission's
Regional Office listed in Appendix D of part 20 of this chapter
``Standards for Protection Against Radiation.''
(e) A sealed source which is not fastened to or contained in a
radiographic exposure device must have permanently attached to it a
durable tag at least one (1) inch square bearing the prescribed
radiation caution symbol in conventional colors, magenta, purple or
black on a yellow background, and at least the instructions: ``Caution
(or Danger)--Radioactive Material--Do Not Handle--Notify Civil
Authorities (or Name of Company).''
(f) Each exposure device using depleted uranium (DU) shielding and
an ``S'' tube configuration must be periodically tested for DU
contamination. This test can be performed by the licensee using
available test kits or method approved by the Commission or an
Agreement State, or the exposure device could be returned to the
manufacturer for such testing. The analysis must be capable of
detecting the presence of 185 Bq (0.005 microcuries) of radioactive
material on the test sample and must be performed by a person
specifically authorized by the Commission or an Agreement State to
perform the analysis. This test must be undertaken at intervals not to
exceed 12 months and should such testing reveal the presence of DU
contamination, the exposure device must be removed from use and
arrangements for repair or proper disposal in a facility licensed under
10 CFR part 61 must be made. A record of the DU leaktest must be made
in accordance with Sec. 34.67.
Sec. 34.28 [Removed]
22. Section 34.28 is removed.
23. Section 34.29 is revised to read as follows:
Sec. 34.29 Quarterly inventory.
(a) Each licensee shall conduct a quarterly physical inventory to
account for all sealed sources received and possessed under this
license. (b) The licensee shall maintain records of the quarterly
inventory in accordance with Sec. 34.69.
Sec. 34.30 [Removed]
24. Section 34.30 is removed.
25. Section 34.31 is revised to read as follows:
Sec. 34.31 Inspection and maintenance of radiographic exposure
devices, storage containers, associated equipment, and source changers.
(a) The licensee shall visually check for obvious defects in
radiographic exposure devices, storage containers, associated
equipment, and source changers before use each day the equipment is
used to ensure that the equipment is in good working condition and that
required labeling is present. If defects are found, the equipment must
be removed from service until repaired, and a record must be made in
accordance with Sec. 34.73.
(b) Each licensee shall have a program for inspection and routine
maintenance of radiographic exposure devices, source changers,
associated equipment and storage containers at intervals not to exceed
3 months or before the first use thereafter to ensure the proper
functioning of components important to safety. Records of these
inspections and maintenance performed must be made in accordance with
Sec. 34.73. If defects are found, the equipment must be removed from
service until repaired, and a record must be made in accordance with
Sec. 34.73.
(c) The opening, repair, or modification of any sealed source must
be performed by persons specifically authorized to do so by the
Commission or an Agreement State.
Sec. 34.32 [Removed]
26. Section 34.32 is removed.
27. Section 34.33 is revised to read as follows:
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) Entrance controls of the type described in Sec. 20.1601(a)(1)
of this chapter; or
(2) Both visible and audible warning signals to warn of the
presence of radiation. The visible signal must be actuated by radiation
whenever the 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 at the
beginning of each day the installation is used for radiographic
operations. The test must include a check of the visible and audible
signals by turning on the exposure device before using the room.
Entrance control devices must be tested monthly. If a control device or
alarm is operating improperly, it must be immediately labeled as
defective and repaired before industrial radiographic operations are
resumed. Test records must be maintained in accordance with Sec. 34.75.
28. Section 34.35 is added to read as follows:
Sec. 34.35 Labels, storage, and transportation precautions.
(a) Labels.
(1) The licensee may not use a source changer or container to store
licensed material unless the source changer or the container has
securely attached to it a durable, legible, and clearly visible label.
The label must contain the radiation symbol specified in Sec. 20.1904
of this chapter and the wording
Caution (or Danger) Radioactive Material--Do Not Handle Notify Civil
Authorities (or Name of Company)
(2) The licensee may not transport licensed material unless the
material is packaged, and the package is labeled, marked, and
accompanied with appropriate shipping papers in accordance with
regulations set out in 10 CFR Part 71, including documentation of the
Quality Assurance (QA) program requirements outlined in Sec. 71.105 of
this chapter.
(b) Security precautions during storage and transportation.
(1) Locked radiographic exposure devices and storage containers
must be physically secured to prevent tampering or removal by
unauthorized personnel in accordance with the requirements in
Sec. 34.23. The licensee shall store licensed material in a manner
which will minimize danger from explosion or fire.
(2) The licensee shall lock and physically secure the transport
package containing licensed material in the transporting vehicle to
prevent accidental loss, tampering, or unauthorized removal of the
licensed material from the vehicle.
29. A new heading for subpart D, consisting of Secs. 34.41-34.57,
is added to read as follows:
Subpart D--Radiation Safety Requirements
30. Section 34.41 is revised to read as follows:
Sec. 34.41 Conducting radiographic operations.
(a) Whenever radiography is performed at a location other than a
permanent radiographic installation, the radiographer must be
accompanied by at least one other qualified radiographer or an
individual who has at a minimum met the requirements of Sec. 34.43(b).
The additional qualified individual(s) 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.
31. Section 34.42 is revised to read as follows:
Sec. 34.42 Radiation Safety Officer.
The Radiation Safety Officer (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 RSO's qualifications must include:
(1) Completion of the training and testing requirements of
Sec. 34.43(a); and
(2) 2000 hours of documented experience in industrial radiographic
operations, with at least 40 hours of formal classroom training with
respect to the establishment and maintenance of a radiation protection
program.
(b) The specific duties of the RSO include, but are not limited to,
the following:
(1) To establish and oversee operating, emergency, and ALARA
procedures as required by part 20 of this chapter, and to review them
regularly to ensure that the procedures are current and conform with
these rules;
(2) To oversee and approve all phases of the training program for
radiographic personnel so that appropriate and effective radiation
protection practices are taught;
(3) To ensure that required radiation surveys and leak tests are
performed and documented in accordance with these rules, including any
corrective measures when levels of radiation exceed established limits;
(4) To ensure that personnel monitoring devices are calibrated and
used properly by occupationally exposed personnel, that records are
kept of the monitoring results, and that timely notifications are made
as required by Sec. 20.2203 of this chapter; and
(5) To ensure that operations are conducted safely and to assume
control and have the authority to institute corrective actions
including stopping of operations when necessary in emergency situations
or unsafe conditions.
32. Section 34.43 is revised to read as follows:
Sec. 34.43 Training.
(a) The licensee may not permit any individual to act as a
radiographer until the individual--
(1) Has been instructed in the subjects outlined in paragraph (f)
of this part.
(2) Is certified through a radiographer certification program by a
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.
(3) 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 parts
19, 20, and 71 of this chapter, in applicable DOT regulations as
referenced in 10 CFR part 71, in the NRC license(s) under which the
radiographer will perform radiography, and the licensee's operating and
emergency procedures;
(4) Has demonstrated understanding of NRC regulations, the
licensee's license, and the licensee's operating and emergency
procedures by successful completion of a written examination.
(5) Has demonstrated competence in the use of the licensee's
radiographic exposure devices, sealed sources, related handling tools,
and survey instruments; and
(6) Has demonstrated understanding of the instructions in paragraph
(a)(3) and (a)(5) of this section by successful completion of a field
examination.
(b) The licensee may not permit any individual to act as a
radiographer's assistant until the individual--
(1) Has received copies of and instruction in the requirements
described in NRC regulations contained in this part; in Secs. 30.7,
30.9, and 30.10 of this chapter; in the applicable sections of parts
19, 20, and 71 of this chapter, in applicable DOT regulations as
referenced in 10 CFR part 71, in the NRC license(s) under which the
radiographer's assistant will perform radiography, and the licensee's
operating and emergency procedures;
(2) Has demonstrated competence to use, under the personal
supervision of the radiographer, the radiographic exposure devices,
sealed sources, related handling tools, and radiation survey
instruments that the assistant will use; and
(3) Has demonstrated understanding of the instructions provided
under paragraph (b)(1) of this section by successfully completing a
written test and a field examination on the subjects covered.
(c) The licensee shall provide annual safety reviews for
radiographers and radiographer's assistants at least once during each
calendar year.
(d) The licensee shall conduct an annual inspection program of the
job performance of each radiographer and radiographer's assistant to
ensure that the Commission's regulations, license requirements, and the
applicant's operating and emergency procedures are followed. The
inspection program must:
(1) Include observation of the performance of each radiographer and
radiographer's assistant during an actual radiographic operation at
intervals not to exceed 12 months; and
(2) Provide that, if a radiographer or a radiographer's assistant
has not participated in a radiographic operation for more than 6 months
since the last inspection, the individual's performance must be
observed and recorded when the individual next participates in a
radiographic operation.
(e) The licensee shall maintain records of the above training to
include certification documents, written and field examinations, annual
safety reviews and annual inspections of job performance in accordance
with Sec. 34.79.
(f) The licensee shall include the following subjects in the
training required in paragraph (a)(1) of this section:
(1) Fundamentals of radiation safety including--
(i) Characteristics of gamma radiation;
(ii) Units of radiation dose 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) Maintenance of equipment.
(4) The requirements of pertinent Federal regulations; and
(5) Case histories of accidents in radiography.
(g) The licensee may, until (Insert date 2 years after the final
rule is published in the Federal Register), allow an individual who has
not met the certification requirements of paragraph (a)(2) of this
section to act as a radiographer after the individual has received
training in the subjects outlined in paragraph (f) of this section and
demonstrated understanding of those subjects by successful completion
of a written examination that was previously submitted to and approved
by the Commission.
Sec. 34.44 [Removed]
34. Section 34.44 is removed.
35. Section 34.45 is added to read as follows:
Sec. 34.45 Operating and emergency procedures.
(a) Operating and emergency procedures must include, as a minimum,
instructions in at least the following:
(1) The handling and use of licensed sealed sources and
radiographic exposure devices to be employed such that no person is
likely to be exposed to radiation doses in excess of the limits
established in part 20 of this chapter ``Standards for Protection
Against Radiation'';
(2) Methods and occasions for conducting radiation surveys;
(3) Methods for controlling access to radiographic areas;
(4) Methods and occasions for locking and securing radiographic
exposure devices, storage containers and sealed sources;
(5) Personnel monitoring and the use of personnel monitoring
equipment;
(6) Transporting sealed sources to field locations, including
packing of radiographic exposure devices and storage containers in the
vehicles, placarding of vehicles, when needed, and control of the
sealed sources during transportation (refer to 49 CFR parts 171 through
173);
(7) The inspection and maintenance of radiographic exposure devices
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;
(9) The procedure(s) for identifying and reporting defects and
noncompliance, as required by part 21 of this chapter;
(10) The procedure for notifying proper persons in the event of an
accident;
(11) Minimizing exposure of persons in the event of an accident;
(12) Source recovery procedure if licensee will perform source
recovery; and
(13) Maintenance of records.
(b) The licensee shall maintain copies of current operating and
emergency procedures in accordance with Sec. 34.81.
36. Section 34.46 is added to read as follows:
Sec. 34.46 Supervision of radiographers' assistants.
Whenever a radiographer's assistant uses radiographic exposure
devices, uses sealed sources or related source handling tools, or
conducts radiation surveys required by 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 personal presence at the site where the
sealed sources are being used;
(b) The ability of the radiographer to give immediate assistance if
required; and
(c) The radiographer's watching the assistant's performance of the
operations referred to in this section.
37. Section 34.47 is added to read as follows:
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 a direct reading pocket
dosimeter, an operating alarm ratemeter, and either a film badge or a
thermoluminescent dosimeter (TLD). At permanent radiography
installations where other appropriate alarming or warning devices are
in routine use, the wearing of an alarming ratemeter is not required.
(1) Pocket dosimeters must have a range from zero to 2
millisieverts (200 millirems) and must be recharged at the start of
each shift.
(2) Each film badge and TLD must be assigned to and worn by only
one individual.
(3) Film badges and TLDs must be replaced at least monthly.
(4) After replacement, each film badge or TLD must be promptly
processed.
(b) Pocket dosimeters must be read and the exposures recorded at
the beginning and end of each shift, and records must be maintained in
accordance with Sec. 34.83.
(c) Pocket dosimeters must be checked at periods not to exceed 12
months for correct response to radiation, and records must be
maintained in accordance with Sec. 34.83. Acceptable dosimeters must
read within plus or minus 30 percent of the true radiation exposure.
(d) If an individual's pocket dosimeter is found to be off-scale
and the possibility of radiation exposure cannot be ruled out as the
cause, the individual's film badge or TLD must be sent immediately for
processing. In addition, the individual may not work with licensed
material until a determination of the individual's radiation exposure
has been made. This determination must be made by the RSO or the 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) Be adequate to alert the individual regardless of the
environmental conditions (e.g., high ambient noise levels).
(4) Require special means to change the preset alarm function; and
(5) Be calibrated at periods not to exceed 12 months for correct
response to radiation. The licensee shall maintain records of alarm
ratemeter calibrations in accordance with Sec. 34.83.
38. Section 34.49 is added to read as follows:
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) Conduct an adequate survey of the radiographic exposure device
with a radiation survey instrument after each exposure to determine
that the sealed source has been returned to its shielded position.
(c) Conduct a survey when approaching the guide tube before
exchanging films, repositioning the collimator, or dismantling
equipment.
(d) Conduct an adequate survey with a radiation survey instrument
any time the source is exchanged and whenever a radiographic exposure
device is placed in a storage area (as defined in Sec. 34.3) to ensure
that the sealed source is in its shielded position.
(e) Conduct a survey of the storage area to ensure that radiation
levels do not exceed the limits specified in 10 CFR 20.1301. These
surveys must be performed initially with radioactive material present
in the storage location and thereafter at the time of the quarterly
inventory and whenever storage conditions change (i.e., increases in
radioactive material present or changes in shielding or arrangement of
the radioactive material).
(f) Maintain records in accordance with Sec. 34.85.
39. Section 34.51 is revised to read as follows:
Sec. 34.51 Surveillance.
During each radiographic operation the radiographer or
radiographer's assistant shall maintain continuous direct visual
surveillance of the operation to protect against unauthorized entry
into a high radiation area, as defined in part 20 of this chapter,
except at permanent radiographic installations where all entryways are
locked and the requirements of Sec. 34.33 are met.
40. Section 34.53 is added to read as follows:
Sec. 34.53 Posting.
Areas in which radiography is being performed must be conspicuously
posted as required by Sec. 20.1902(a) and (b) of this chapter.
Exceptions listed in Sec. 20.1903 of this chapter do not apply to
radiographic operations.
41. A new heading for subpart E, consisting of Secs. 34.61-34.91,
is added to read as follows:
Subpart E--Recordkeeping Requirements
42. Section 34.61 is revised to read as follows:
Sec. 34.61 Records of specific license for radiography.
Each licensee shall maintain a copy of its license, license
conditions, documents incorporated by reference, and amendments to each
of these items until superseded by new documents or until the
Commission terminates the license.
43. Section 34.63 is revised to read as follows:
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 retain each record for 3 years after it
is made.
(b) These records must include the date, the individual making the
record, the radionuclide, number of becquerels (curies), and make,
model, and serial number of each sealed source and device, as
appropriate.
44. Sections 34.65--34.91 are added to subpart E to read as
follows:
Sec. 34.65 Records of radiation survey instruments.
Each licensee shall maintain records of the calibrations of its
radiation survey instruments and retain each record for 3 years after
it is made.
Sec. 34.67 Records of leak testing of sealed sources.
Each licensee shall maintain records of leak test results in units
of becquerels (curies) and retain each record for 3 years after it is
made.
Sec. 34.69 Records of quarterly inventory.
(a) Each licensee shall maintain records of the quarterly inventory
and retain each record for 3 years after it is made.
(b) The record must include the quantities and kinds of byproduct
material (including the model number, the serial number and
manufacturer), location of sealed sources, the name of the individual
conducting the inventory, and the date of the inventory.
Sec. 34.71 Utilization logs.
(a) Each licensee shall maintain current utilization logs at the
address specified in the license, showing for each sealed source the
following information:
(1) A description, including the make, model number, and serial
number of the radiographic exposure device or storage container in
which the sealed source is located;
(2) The identity and signature of the radiographer to whom
assigned; and
(3) The plant or site where used and dates of use, including the
dates removed and returned to storage.
(b) The licensee shall retain the logs required by paragraph (a) of
this section for 3 years after the log is made.
Sec. 34.73 Records of inspection and maintenance of radiographic
exposure devices, storage containers, associated equipment, and source
changers.
(a) Each licensee shall maintain records of defects found in daily
checks and quarterly inspections and maintenance of radiographic
exposure devices, storage containers, associated equipment, and source
changers, and retain each record for 3 years after it is made.
(b) The record must include the date of check, name of inspector,
equipment involved, any defects found, and repairs made.
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 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, certification status verification, copies of
written tests, dates of field examinations, and names of individuals
conducting the field examinations, and
(b) Records of annual safety reviews and annual inspections for
each radiographer and each radiographer's assistant. The records must
list the topics discussed during the annual safety review, the dates
the annual safety review was conducted, and names of the instructors
and attendees. For annual inspections, the records must also include a
list showing the items checked and any regulatory non-compliances
observed by the RSO.
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.
Each licensee shall maintain the following exposure records:
(a) Daily pocket dosimeter readings and yearly operability checks
for 3 years after the record is made.
(b) Records of alarm ratemeter calibrations for 3 years after the
record 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
pocket 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 placing the device in storage in accordance
with Sec. 34.49 (d) and (e) for 3 years after the record is made, if
that survey is the last one performed in the work day.
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 Documents and records required at field stations and
permanent installations.
Each licensee shall maintain copies of the following documents and
records sufficient to demonstrate compliance at the field station and
permanent installation:
(a) A copy of 10 CFR parts 19, 20, and 34;
(b) The license authorizing the use of licensed material;
(c) Operating and emergency procedures required by Sec. 34.45;
(d) Records of radiation survey instrument calibrations required by
Sec. 34.65;
(e) Records of leak test results required by Sec. 34.67;
(f) Quarterly inventory records required by Sec. 34.69;
(g) Utilization records required by Sec. 34.71;
(h) Records of inspection and maintenance required by Sec. 34.73;
(i) For permanent installations, records of alarm system and
entrance control checks required by Sec. 34.75;
(j) Training and certification records required by Sec. 34.79;
(k) Survey records required by Sec. 34.85;
(l) Personnel monitoring records as required by Sec. 34.83; and
(m) Records of receipt and transfer of sealed sources required by
Sec. 34.63.
Sec. 34.91 Documents and records required at temporary jobsites and
use or storage locations exceeding 180 days.
Each licensee conducting operations at a temporary jobsite shall
maintain copies of the following documents and records at the temporary
jobsite until the radiographic operation is completed and at any
storage location where radioactive material is stored for more than 180
days:
(a) The license authorizing the use of licensed material;
(b) Operating and emergency procedures required by Sec. 34.45;
(c) Evidence of latest calibration of the radiation survey
instruments in use at the site required by Sec. 34.65;
(d) Evidence of latest calibrations of alarm ratemeters and
operability checks of pocket dosimeters as required by Sec. 34.83;
(e) Latest survey records required by Sec. 34.85;
(f) The shipping papers for the transportation of radioactive
materials required by Sec. 71.5 of this chapter; and
(g) When operating under reciprocity pursuant to Sec. 150.20 of
this chapter, a copy of the Agreement State license authorizing use of
licensed materials.
45. A new subpart F, consisting of Sec. 34.101, is added to read as
follows:
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, each licensee
shall provide a written report to the U.S. Nuclear Regulatory
Commission, Division of Industrial and Medical Nuclear Safety,
Washington, DC 20555, with a copy to the Director, Office for Analysis
and Evaluation of Operational Data, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, within 30 days of the occurrence of any of the
following incidents involving radiographic equipment:
(1) Unintentional disconnection of the source assembly from the
control cable;
(2) Inability to retract the source assembly to its fully shielded
position and secure it in this position; or
(3) Failure of any component (critical to safe operation of the
device) to properly perform its intended function;
(b) The licensee shall include the following information in each
report submitted under paragraph (a) of this section, and in each
report of overexposure submitted under 10 CFR 20.2203 which involves
failure of safety components of radiography equipment:
(1) A description of the equipment problem;
(2) Cause of each incident, if known;
(3) Name of the manufacturer and model number of equipment involved
in the incident;
(4) Place, date and time of the incident;
(5) Actions taken to establish normal operations;
(6) Corrective actions taken or planned to prevent recurrence; and
(7) Qualifications of personnel involved in the incident.
(c) The licensee shall notify the appropriate NRC regional office
in writing 30 days before conducting radiographic operations or storing
radioactive material at any location not listed on the license in
excess of 180 days.
46-47. A new subpart G, consisting of Sec. 34.111, is added to read
as follows:
Subpart G--Exemptions
Sec. 34.111 Applications for exemptions.
The Commission may, upon application of any interested person or
upon its own initiative, grant such exemptions from the requirements of
the regulations in this part as it determines are authorized by law and
will not endanger life or property or the common defense and security
and are otherwise in the public interest.
48-49. A new subpart H, consisting of Secs. 34.121-34.123, is added
to read as follows:
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 sections 161b, 161i, or 161o of the Act. For purposes of
section 223, all the regulations in part 34 are issued under one or
more of sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in 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.
50-52. Appendix A is revised to read as follows:
Appendix A to Part 34--Radiographic 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 or non-destructive testing;
2. Make its membership available to the general public
nationwide that is not restricted because of race, color, religion,
sex, age, national origin or handicap;
3. Have a certification program open to nonmembers;
4. Be an incorporated, nationally recognized organization, that
is involved in setting national standards of practice within its
fields of expertise;
5. Have a permanent full-time staff, a viable system for
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 its
certification program, including the process of becoming certified
and any sanctions imposed against certified individuals; and
11. Have procedures to ensure that the individuals proctoring
each examination are not employed by the same company or corporation
(or a wholly-owned subsidiary of such company or corporation) as any
of the examinees;
12. Exchange information about certified individuals with the
Commission and other independent certifying organizations and/or
Agreement States and allow periodic review of its certification
program and related records;
13. Provide a description to the Commission of its procedures
for choosing examination sites and for providing an appropriate
examination environment.
II. Requirements for Certification Programs
All certification programs must:
1. Require that individuals:
(a) Receive training in the topics set forth in Sec. 34.34(f) of
this part, and
(b) Satisfactorily complete a written examination covering these
topics;
2. Require applicants for certification to provide documentation
that demonstrates that the applicant has:
(a) Received training in the topics set forth in section
34.43(f) to this part;
(b) Satisfactorily completed a minimum period of on-the-job
training; and
(c) Has received verification by an Agreement State or a NRC
licensee that the applicant has demonstrated the capability of
independently working as a radiographer;
3. Include procedures to ensure that all examination questions
are protected from disclosure;
4. Include procedures whereby an application or certification
would be considered null and void if the applicant or certified
individual is prohibited from acting as a radiographer by a
regulatory agency at the time of making the application;
5. Provide a certification period of not less than 3 years nor
more than 5 years;
6. Include procedures for renewing the certifications and, if
the procedures allow renewals without examination, require evidence
of recent active full-time employment and annual refresher training;
7. Include procedures whereby an individual's certification may
be revoked, suspended, or restricted for willful or significant
failure to comply with his or her employer's operating or emergency
procedures, or the Commission's or an Agreement State's regulations;
8. Provide for automatic suspension of an individual's
certification, based on Commission or Agreement State action
prohibiting the individual from acting as a radiographer;
9. Provide for sanctions imposed against certified individuals
that are at least as severe as any action taken by the Commission or
an Agreement State; and
10. Provide a timely response to inquiries, by telephone or
letter, from members of the public, about an individual's
certification status.
III. Requirements for Written Examinations
All examinations must be:
1. Designed to test an individual's knowledge and understanding
of the topics listed in section 34.43(f) or equivalent Agreement
State requirements;
2. Written in a multiple-choice format;
3. Written at a ninth-grade reading comprehension level;
4. Scientifically-analyzed, before use, to ensure that the
questions are not biased or misleading, and that the examination of
one certifying entity will produce a result equivalent to that of
another certifying entity;
5. Tested by at least 50 individuals before being used in an
actual examination leading to certification of individuals; and
6. Composed of questions randomly selected from a population of
questions that contains ten times as many questions as may be needed
for any one examination, to ensure that it is unlikely that an
examinee would retake the same examination.
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
53. The authority citation for part 150 continues to read as
follows:
Authority: Sec. 161, 68 Stat. 948, as amended, sec. 274, 73
Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as
amended (42 U.S.C. 5841).
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued
under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84,
92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 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, 68 Stat. 939 (42 U.S.C. 2152).
Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C.
2282).
54. A new Sec. 150.15b is added to read as follows:
Sec. 150.15b Continued Commission authority pertaining to independent
certifying organizations.
The Commission reserves the authority to establish minimum
standards regarding industrial radiographer certification programs and
independent certifying organizations, as described in part 34 of this
Chapter, and to identify acceptable certifying entities.
55. In Sec. 150.33, paragraph (b) is revised to read as follows:
Sec. 150.33 Criminal penalties.
* * * * *
(b) The regulations in part 150 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Secs. 150.1, 150.2, 150.3, 150.4, 150.5, 150.7, 150.8, 150.10, 150.11,
150.15, 150.15a, 150.15b, 150.30, 150.31, 150.32, 150.33.
Dated at Rockville, Maryland, this 17th day of February 1994.
For the Nuclear Regulatory Commission.
Samuel J. Chilk,
Secretary of the Commission.
Appendix A--Initial Regulatory Flexibility Analysis for Revision of 10
CFR Part 34
The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations governing industrial radiography. The proposed rule
would include additional safety requirements to enhance the level of
protection of radiographers and the public and would clarify the
regulations so that licensees may have a better understanding of
what is expected in radiographic operations. The proposed rule
includes a number of updated radiography regulations that have been
adopted by many Agreement States. The format of the radiography
regulations would be adjusted to place requirements into descriptive
categories.
The radiography industry in the United States consists of
approximately 700 firms, employing about 20,000 individuals, that
perform radioisotope radiography either at fixed locations or at
multiple temporary job sites. Of these firms, approximately 200 are
NRC licensees employing about 3,400 radiographers with an additional
2,000 radiography supervisors and radiographers' assistants. This
estimate is based on 1990 data for the number of individuals
monitored for radiation exposure to comply with 10 CFR Part 20. The
industry uses an estimated 3,500 radiographic exposure devices that
employ either cobalt-60 or iridium-192 radioisotope sources. Roughly
one-quarter of the firms conduct radiography at a single location
and the other three-quarters work at multiple locations generally
referred to as temporary jobsites.
Approximately 90 percent are considered to be ``small entities''
under the criterion established in Section 605(b) of the Regulatory
Flexibility Act of 1980. Most of the radiography licensees are in
the business of non-destructive testing in which radiography
represents only a part of their total income. A few small firms work
only in radiography. Much of the work in the field involves the
inspection of welds in bridges, oil, gas, and other pipelines and in
the steel framework of commercial buildings under construction so
that the success and viability of the industry is closely tied to
the economic health of the country. NRC surveys indicated that 76
percent of NRC radiography licensees had annual receipts of over
$500,000, and most of the remainder had annual receipts exceeding
$250,000.
In accordance with the Regulatory Flexibility Act of 1980 (5
U.S.C. 605 (b)), the Commission believes that this rule may, if
promulgated, have a significant economic impact on a substantial
number of small entities.
The proposed revisions to part 34 are intended to provide
additional safety requirements to enhance the level of protection of
radiographers and the public and to clarify the regulations so that
licensees may have a better understanding of what is expected in
radiographic operations. The proposed rule includes a number of
radiography regulations which have been adopted by the Agreement
States.
The proposed revisions to part 34 can be grouped into major and
minor impacts. Of the five major impacts, the proposed requirement
to have a second qualified individual at temporary jobsites may have
a significant effect on small entities, who would be more likely to
use single-person crews. It should be recognized that under the
current rule many licensees already need to have, at least, two
qualified individuals present at a temporary jobsite to maintain
direct surveillance of radiographic operations so as to protect
against any unauthorized entry into the restricted area. Therefore,
this proposed requirement will only impact those operations where
two individuals are not currently required. It was assumed in the
draft Regulatory Analysis that approximately 25 percent of NRC
licensees who perform radiography at temporary jobsites will need to
hire and train additional staff to meet the proposed requirement.
Other assumptions used in the draft Regulatory Analysis were that
each of these 50 licensees would need to hire 3-4 additional
workers, and that the cost of each assistant is $24,000 per year
including benefits.
The other major impacts include mandatory certification
requirements for radiographers, additional training for
radiographers' assistants, a specific requirement for a Radiation
Safety Officer (RSO) who meets certain training requirements,
requirements for permanent installation alarms, and additional
requirements for alarm ratemeters. The estimated costs for all of
these changes are significantly less than the costs associated with
adopting the two-person rule. The initial costs to certify
radiographers is approximately $4080. The initial costs for each
licensee to provide an additional eight hours of training for
radiographers' assistants is approximately $1,200. The initial costs
to provide the additional training required to meet the proposed RSO
requirements is $3,700 per RSO. The initial costs to install alarms
in permanent installations is estimated to be $3,000. The initial
costs to purchase additional upgraded alarm ratemeters is estimated
to be $1800. The other proposed revisions which are of a minor
nature, would result in initial costs of $700-$800 per licensee.
In addition, the proposed rule includes a reduction in the
number of field inspections to be conducted, from quarterly to
annual. This reduction would lead to an estimated annual savings to
each NRC licensee of approximately $16,000. The proposed rule also
includes a reduction in the frequency for radiation survey
instrument calibrations from 3 months to 6 months. This reduction
would lead to an estimated annual savings to each NRC licensee of
approximately $1400.
Of these changes, the costs to adopt the two-person rule may
have the most impact on a substantial number of ``small entities'';
however, the Commission believes that by requiring at least two
qualified individuals to always be present when radiographic
operations are being conducted, there will be a significant increase
in assurance that operational safety measures and emergency
procedures will be implemented effectively. The potential for a
lowering of the risk of unintended public exposure can be viewed as
a potential cost savings to the industry. This proposed rule does
not duplicate or conflict with other Federal rules. No other
alternative regulatory provisions that would minimize the economic
impact on small entities were considered.
[FR Doc. 94-4133 Filed 2-25-94; 8:45 am]
BILLING CODE 7590-01-P
