[Federal Register Volume 70, Number 248 (Wednesday, December 28, 2005)]
[Proposed Rules]
[Pages 76724-76728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7974]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 34
[Docket No. PRM-34-06]
Organization of Agreement States; Receipt of Petition for
Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; notice of receipt.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is publishing for
public comment a notice of receipt of a petition for rulemaking, dated
November 3, 2005, which was filed with the Commission by Barbara
Hamrick, Chair, Organization of Agreement States (OAS). The petition
was docketed by the NRC on November 16, 2005, and has been assigned
Docket No. PRM-34-06. The petitioner requests that the NRC amend its
regulations to require that an individual receive at least 40 hours of
radiation safety training before using sources of radiation for
industrial radiography, by clarifying the requirements for at least two
individuals to be present at a temporary job site, and by clarifying
how many individuals are required to meet surveillance requirements.
The petitioner also requests that NUREG-1556, Volume 2, be revised to
reflect the performance-based changes in the proposed amendments.
DATES: Submit comments by March 13, 2006. 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: You may submit comments by any one of the following methods.
Please include PRM-34-06 in the subject line of your comments. Comments
on petitions submitted in writing or in electronic form will be made
available for public inspection. Because your comments will not be
edited to remove any identifying or contact information, the NRC
cautions you against including any information in your submission that
you do not want to be publicly disclosed.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
[email protected]. Comments can also be submitted via the Federal eRulemaking
Portal http://www.regulations.gov.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
Publicly available documents related to this petition may be viewed
electronically on the public computers located at the NRC's Public
Document Room (PDR), Room O1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee. Selected documents, including comments,
may be viewed and downloaded electronically via the NRC rulemaking Web
site at http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the PDR Reference staff at 1-800-397-4209, 301-415-4737 or by
e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rules and
Directives Branch, Division of Administrative Services, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, Telephone: 301-415-7163 or Toll Free: 800-368-5642.
SUPPLEMENTARY INFORMATION:
Petitioner's Interest
The OAS is a non-profit, voluntary, scientific and professional
society
[[Page 76725]]
incorporated in the District of Columbia. The membership of OAS
consists of State radiation control program directors and staff from
the 33 Agreement States who are responsible for implementation of their
respective radioactive material programs. The purpose of the OAS is to
provide a mechanism for the Agreement States to work with each other
and with the NRC on regulatory issues associated with their respective
agreements.
The petitioner states that Agreement States are those States that
have entered into an effective regulatory discontinuance agreement with
the NRC under section 274b. of the Atomic Energy Act (Act). The
Agreement States regulate most types of radioactive material, including
reactor fission byproducts, source material (uranium and thorium) and
special nuclear materials in quantities not sufficient to form a
critical mass, in accordance with the compatibility requirements of the
Act. The petitioner notes that NRC periodically reviews the performance
of each Agreement State to assure compatibility with NRC's regulatory
requirements.
The petitioner states that Agreement States issue radioactive
material licenses and regulations, and enforce these regulations under
the authority of each individual State's laws. The Agreement States
exercise their licensing and enforcement programs under direction of
their governors in a manner that is compatible with the licensing and
enforcement programs of the NRC. The 33 existing Agreement States
currently license and regulate approximately 16,800 radioactive
material licenses, whereas the NRC regulates approximately 4,400
licensees.
The petitioner states that in the report of the NRC/State Working
Group on the National Materials Program, the concept of ``Centers of
Expertise'' was introduced. The concept optimizes resources of Federal,
State, professional, and industrial organizations and reduces duplicate
efforts. The petitioner states that some Agreement States and NRC
regions have, over time, developed considerable experience and
expertise with specific uses of radioactive materials. Examples of
areas of expertise include well logging, industrial radiography,
positron emission tomography, and intravascular brachytherapy. The
petitioner believes that Agreement States and NRC regions that have
developed expertise in specific uses should be identified and used as a
resource by other regulatory programs.
The petitioner further states that the Centers of Expertise
concerning industrial radiography regulation are the States,
specifically those States with a large oil and gas industry because
industrial radiography is closely tied to that industry. Texas is one
of those States and was a leader in promulgating comprehensive
industrial radiography requirements in 1986.
Background
Section 34.41(a) (the ``two-person rule''), published on May 28,
1997 (62 FR 28948), became effective on June 27, 1998. The petitioner
states that when this rule was developed, there was strong and
sustained support from the States, licensees, and industry for the
concept of having at least two qualified individuals present whenever
radiography is performed at temporary job sites. The petitioner states
that Texas has had a requirement for a two-person crew since 1986,
which was adopted at that time along with specific training
requirements. The petitioner states that by the effective date of the
NRC final rule, seven States were already nationally recognized as
having comparable industrial radiography program components and were
issuing industrial radiographer certifications.
The petitioner states that NRC's regulations require that ``the
additional qualified individual shall observe the operations and be
capable of providing immediate assistance to prevent unauthorized
entry.'' The petitioner believes that the expectation of the two-person
rule, as expressed in the May 28, 1997 final rule, is that at a
temporary job site the second qualified individual would be able to
secure the restricted area and the source, and provide aid as needed.
The petitioner states that in the final rule, the Commission stressed
that having a second qualified individual is particularly important
when radiography is performed where a radiographer alone may not be
able to control access to the restricted area. The petitioner also
states that, additionally, the second person should be trained to
provide a safe working environment for radiography personnel, workers,
and other members of the public at a temporary job site.
The petitioner states that safety was the basis for having two
individuals at a job site. The petitioner believes that requiring a
trainee/assistant to have more extensive training (e.g., completion of
a 40-hour radiation safety training course) before handling
radiographic equipment increases the probability that he or she would
be able to observe the area and provide assistance if needed. The
petitioner states that while there were many comments on the
desirability of the trainer/trainee or radiographer/assistant crew
combination as opposed to the two radiographer crew, and an acceptance
of the requirement that the trainee/assistant be under the direct
supervision of the trainer/radiographer, the issue regarding whether
both individuals of a two radiographer crew had to be physically
present during actual exposures was never addressed by the NRC. The
petitioner states that in several States, if a two-person crew consists
of two radiographers, one may be in the darkroom while the other is
exposing film, provided the surveillance requirement is met.
The petitioner states that during the NRC's 2001 Integrated
Materials Performance Evaluation Program (IMPEP) review of the Texas
radioactive materials program, the draft IMPEP Report concluded that
the Texas implementation of its two-person rule in its Title 25 Sec.
289.255(v)(7)(G), was not compatible with the NRC's two-person rule in
Sec. 34.41(a), which is designated as a Category B for compatibility
purposes.
The petitioner states that Texas indicated in its response to the
IMPEP Report that its rules were a comprehensive set of requirements
implemented to directly and prescriptively address the identified root
causes of the large number of over exposures that occurred in that
State before it implemented the requirements in 1986. The petitioner
states that Texas made several revisions to its industrial radiography
rules that became effective in April 1999. Texas sent the proposed
revisions to the NRC for review on October 23, 1998, and received no
comments concerning the two-person crew rule. The petitioner believes
that the NRC found the Texas rules to be compatible in this area at
that time.
The petitioner states that based on the IMPEP evaluation criteria,
in 2001, the review team recommended that Texas' performance with
respect to the indicator, Legislation and Program Elements Required for
Compatibility, be found satisfactory. The petitioner states that the
Management Review Board (MRB) believed that the Texas program presented
sufficient information to warrant reconsideration of how the rule could
be implemented. Therefore, the petitioner states that in June 2002, the
NRC's Office of Nuclear Material Safety and Safeguards coordinated with
the Office of State and Tribal Programs, the CRCPD, and the OAS to
establish a Working Group (WG) to re-evaluate the two-person rule to
assess the effectiveness of the intended outcomes, including experience
from past events, and propose a strategy and rule
[[Page 76726]]
interpretation that best achieves the goal of safety.
The petitioner presented the following observations made by the WG
during its review of the final rule:
Since its effective date, the NRC has consistently
implemented the two-person rule to require both qualified individuals
to maintain continuous direct visual surveillance when radiographic
operations are being conducted.
The WG interviewed nine Agreement States that are also
radiographer certifying States regarding the implementation of their
two-person rule. Six of the nine Agreement States allow licensees the
flexibility to determine if radiographic operations can be conducted
safely when the first radiographer is able to observe operations and
prevent intrusion into the restricted area while the second
radiographer is involved in a related activity nearby. The three
remaining States indicated that they required both radiographers to
provide direct visual surveillance during radiographic operations.
The actual words of the two-person crew requirement read
very similarly for each of these certifying States, and each State is
committed to the underlying safety objective for the two-person rule.
The differences lie in the latitude given by the various states to
their licensees in how efficiency in operations can be accomplished
without sacrificing safety. Worksite characteristics are considered,
whether it is in a populated or remote area, or is a multi-level
structure, and that the darkroom must be close by.
The nine States interviewed are the Centers of Expertise
in the industrial radiography and certification arenas. The Centers of
Expertise, concerning industrial radiography regulations, are the
States, specifically those States with a large oil and gas industry,
because industrial radiography is closely tied to that industry. These
nine States, together with Texas, have the clear majority share of the
radiography licenses and activity in the U.S. The potential for
differences in worksite settings in these States is great. Allowing one
of two radiographers to work in the darkroom will not work in all
instances. Some of these States have incorporated the opportunity to
accommodate these differences in their interpretation of this rule,
using a performance-based approach that offers flexibility in the
appropriate situations, with accountability to their licensees.
The WG was not able to attribute events involving
industrial radiography to the failure of the two-person rule, much less
to isolate the surveillance component of the regulation, because the
effectiveness of the two-person rule has not been isolated from the
other components in the regulatory framework.
The WG found that risk information obtained from NUREG/CR-
6642 does not support the manner in which the NRC requires the two-
person rule to be implemented as a requirement to enhance safety. The
WG found that during routine operations, the requirement to have an
additional qualified individual present may actually increase overall
worker occupational radiation exposure, thereby increasing the overall
societal latent cancer risk from routine operations.
The WG found that using only two persons to provide
surveillance of radiography operations may not always be adequate to
prevent unauthorized access to restricted areas by members of the
public. However, to be present and to be exposed to the radiation field
in instances when radiographic operations are performed at temporary
job sites merely to meet the requirements of the two-person rule, would
not be considered As Low as is Reasonably Achievable (ALARA).
When the two-person rule was enacted under the previous
compatibility designations, the Statements of Consideration indicated
Agreement State compatibility for operational safety standards (i.e.,
Subpart D--Radiation Safety Requirements, which includes Sec. 34.41,
as Division 2 Matters of Compatibility). The petitioner states that in
1997, the Joint Working Group on Adequacy and Compatibility transposed
those compatibility determinations to the current designations. The
petitioner states that while reviewing the compatibility designations,
the WG noted a difference in the designations between Sec. Sec. 34.41
and 34.51 for the same essential objective, surveillance. The
petitioner also states that in Sec. 34.41 the surveillance component
is designated compatibility Category B, while in Sec. 34.51 it is
designated as Category C.
The petitioner states that the WG noted that the final rule, which
discusses the requirements for a second qualified individual, also
states that this individual should be able to provide assistance when
required, rather than whenever radiographic operations are being
conducted. The petitioner states that the consensus opinion of the WG
provided risk-informed, performance-based implementation guidance for
the surveillance component of the two-person rule. The petitioner
states that the WG recommended that the NRC issue guidance in a
Regulatory Information Summary (RIS), modifying the NRC's current
interpretation of the two-person rule, but involving no rulemaking. The
RIS would indicate that the second qualified individual must remain at
the temporary job site and must be cognizant of the site-specific
circumstances when radiographic operations are in progress. The
petitioner states that licensees would have the flexibility to allow
the qualified individual to engage in other related activities such as
developing film in a nearby darkroom, rather than being required to
maintain constant visual surveillance when the radiographer alone, can
observe the restricted area and prevent unauthorized entry into it. The
petitioner believes that under this option, the NRC and the Agreement
States would align inspection and licensing guidance with the RIS. The
petitioner states that one member of the WG also provided a differing
view, which indicated that another approach was not needed to make the
rule more effective. The differing view recommended that the NRC notify
the Agreement States to align their implementation to be essentially
identical to that of the NRC.
The petitioner states that the MRB did not accept the WG's
consensus recommendation or the differing view. Instead, the MRB
recommended that the State of Texas, or OAS, file a petition for
rulemaking in accordance with Sec. 2.802 to revise Sec. 34.41(a). The
petitioner states that the MRB agreed that until the final decision is
made on the petition for rulemaking, the staff would defer
compatibility findings on the implementation of the surveillance
component of the two-person rule in Texas, and any other State that is
implementing Sec. 34.41(a) in a similar way.
The petitioner states that the final rulemaking has been
interpreted in guidance document NUREG-1556, Volume 2, to mean, ``Both
individuals must maintain constant surveillance of the operations and
be capable of providing immediate assistance to prevent unauthorized
entry to the restricted area.'' The petitioner states that if the
temporary job site presents a situation in which the surveillance
requirement of Sec. 34.51 is met, the NRC interpretation means that
even if a two-person crew consists of two certified radiographers, both
must be with the camera; or if one of the members is in the darkroom,
radiography cannot be performed. The petitioner believes that the
impact of this interpretation on the industry is that companies must
employ
[[Page 76727]]
an additional third person to develop film in the darkroom while two
individuals are exposing film and preventing unauthorized entry,
regardless of what the situation warrants. The petitioner also believes
that the licensee must use additional time at a job site to expose film
and then develop it. Either situation results in added, unnecessary
cost to the industry. The petitioner contends that in a temporary job
site situation in which the crew consists of two qualified
radiographers and the surveillance requirement can be met, the second
individual is available to provide immediate assistance, whether in the
darkroom or performing other job-related duties nearby.
The Proposed Amendment
The petitioner requests that the following amendments be made to
the NRC's regulations:
1. Section 34.41(a) would be revised to state: 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 individual(s) who has at a minimum met
the requirements of Sec. 34.43(c). Radiography may not be performed if
only one qualified individual is present.''
Section 34.43(a)(1) would be revised to state: ``Has successfully
completed an accepted course of at least 40 hours on the applicable
subjects outlined in paragraph (g) of this section, in addition to a
minimum of 2 months of on-the-job training, and 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 20555-0001.)''
3. In Sec. 34.43(c), paragraphs (1), (2), and (3) would be
redesignated as (2), (3), and (4), respectively, a new paragraph (c)(1)
would be added, and redesignated paragraph (c)(4) would be revised.
Paragraph (c)(1) would state: ``Has successfully completed the accepted
course of at least 40 hours on the applicable subject outlined in
paragraph (g) of this section;''. Paragraph (c)(4) would state: ``Has
demonstrated understanding of the instructions provided under paragraph
(c)(2) of this section by successfully completing a written test on the
subjects covered and has demonstrated competence in the use of hardware
described in section (c)(3) of this section by successful completion of
a practical examination on the use of such hardware.''
4. Section 34.51 would be revised to state: ``During each
radiographic operation, the radiographer shall ensure continuous direct
visual surveillance of the operation to protect against unauthorized
entry into a high radiation area, as defined in 10 CFR part 20 of this
chapter, except at permanent radiographic installations where all
entryways are locked and the requirements of Sec. 34.33 are met.''
5. Change guidance document NUREG-1556, Volume 2. In the first
paragraph under the Discussion, Temporary Job Sites, change the words
``Both individuals must maintain'' to ``The radiographer must ensure''.
Justification
The petitioner considers the requirement for a two-person crew to
be an important safety requirement, but believes the surveillance
component of that rule is more appropriately implemented and enforced
as a performance-based requirement, rather than the current
prescriptive interpretation of the rule. The petitioner states that at
least six Agreement States are currently implementing this component
differently than the NRC. The petitioner believes that a shift in the
NRC's focus to a performance-based implementation of the final rule,
based on its acceptance of the expertise in this arena derived from the
States, would foster a regulatory partnership that benefits the
licensed community by minimizing confusion for those licensees who
operate in multiple jurisdictions. The petitioner states that more than
10 years of information/data exist to demonstrate that the OAS's
recommended implementation of the surveillance component of the rule is
viable and achieves the safety goals of the regulation. The petitioner
states that the WG's review of the incidents that occurred in Texas
from January 1986 through May 2002, indicated that 349 incidents
involved industrial radiography at temporary field sites. The
petitioner states that of the 349 incidents during this 16-year period,
82 resulted in over exposures >5 rem. Causes of the incidents generally
fell into the following categories:
Failure to survey/improper survey--22 percent.
Unable to determine cause--23 percent.
Badge in exposure area/not on individual--27 percent.
Reporting delays from badge processor/heavy workload--11
percent.
Improper work techniques (other than surveys)--9 percent.
Equipment malfunction--6 percent.
Deliberate badge exposure--2 percent.
The petitioner also states that of the 82 incidents that resulted
in over exposures >5 rem, 17 occurred from June 1998 (the effective
date of the NRC's rule) through May 2002. Causes for these 17 incidents
are categorized as:
Failure to survey/improper survey--4 incidents.
Unable to determine cause--5 incidents.
Badge in exposure area/not on individual--2 incidents.
Reporting delays from badge processor/heavy workload--5
incidents.
Improper work techniques (other than surveys)--1 incident.
The petitioner states that none of the overexposure incidents in
Texas were directly attributable to a lapse in safety due to one
certified radiographer being unavailable (e.g., in the darkroom), while
the other certified radiographer was using the radiographic equipment.
The petitioner states that no negative performance regarding the Texas
implementation of the two-person crew requirement surfaced that would
warrant a different surveillance strategy.
The petitioner states that the Nuclear Materials Event Database
(NMED) information reviewed by the WG did not break down the data to
specify what effects the components of the two-person rule had as a
cause or a contributing factor (or as a prevention factor) for
radiation exposure events involving industrial radiography personnel or
members of the public. The petitioner states that, according to the WG
report, although NMED contained numerous incidents that involved
industrial radiography during a 7-year period from 1995 through 2002,
the event descriptions do not correlate the incidents to the two-person
rule. The petitioner states that similarly, the WG reviewed data from
the Enforcement Action Tracking System (EATS), in which 67 cases
occurred that involved industrial radiography during the same 7-year
period. The petitioner states that nine cases cited violation of the
two-person rule, however, none of the cases involved radiation over
exposures to radiography personnel or workers at the site, and other
members of the public.
The petitioner agrees with the opinion of the WG, as stated by the
petitioner, that the apparent inconsistency in the surveillance
component of Sec. Sec. 34.41(a) and 34.51, along with the conflicting
guidance found in NUREG-1556, Volume 2, raise substantial doubts as to
whether the NRC's current
[[Page 76728]]
interpretation of the rule is, in terms of safety, the most desired
approach. The petitioner states that the recommended language that
amends Sec. 34.51 puts the access control responsibility with the
radiographer, but allows him the latitude to use additional personnel
to control radiographic operations if needed. The petitioner believes
that this additional personnel may include persons not qualified as a
radiographer or radiographer's assistant, but capable of providing
needed support to control access to the restricted area while remaining
at the perimeter of the restricted area. The petitioner believes that,
as the rule recommends, the rule does not require two persons to
constantly monitor operations, nor does it limit it to two persons. The
petitioner believes that the rule allows the radiographer in charge to
make that decision. The petitioner states there is no justification for
imposing additional costs and negative impact on an industry that has
not demonstrated performance that would warrant this cost and impact.
The petitioner states that to assess the additional cost of
implementing the two-person crew as the NRC does, Texas contacted
several of its licensees who have both Texas and NRC licenses. The
petitioner states that the cost of an additional person would be a
minimum of $200 per day (including travel and per diem). The cost of
additional time would be $10-12 per hour (not including overtime pay).
The petitioner states that the licensees contacted indicated that an
even greater impact of enforcing the two-person crew as the NRC does,
would be the lack of availability of industrial radiographic personnel
to do the work. The petitioner states that the licensees indicated that
not only are there not enough certified radiographers to do the amount
of work the companies had at that time (one licensee indicated that an
average work week is 65 hours), there is a shortage of people
interested in obtaining the training and becoming certified.
Conclusion
The petitioner states that, while the OAS agrees with a requirement
for a two-person radiography crew at temporary job sites, the
organization disagrees with NRC's prescriptive interpretation of the
requirements for a two-person crew, the apparent conflict between NRC's
surveillance requirement and two-person crew requirement, and NRC's
omission of a radiation safety training requirement prior to an
individual using sources of radiation.
The petitioner believes that while it was encouraging that the NRC
adopted requirements in 1997 similar to those that had previously been
adopted by many States, it is disheartening that the NRC industrial
radiography requirements in 10 CFR part 34 do not address one of the
primary factors identified as a root cause of a large number of
industrial radiographer over exposures. The petitioner states that the
failure to require safety training before using sources of radiation is
failing to address one of the root causes of industrial radiography
incidents. The petitioner states that current NRC requirements allow a
radiographer assistant to use sources of radiation without attending a
safety course that addresses the basic radiation topics outlined in
rule. The petitioner believes that it is possible for an individual to
work for years as a radiographer assistant and never receive radiation
safety training. The petitioner states that the NRC regulations merely
require that the assistant pass a written exam on the regulation,
license, and the licensee's operating and emergency procedures and pass
a practical exam on the use of the radiographic equipment. Both written
and practical exams are administered by the licensee. The petitioner
believes that it is important to remember that not all radiography is
conducted by the larger radiography companies who have the resources to
establish and oversee adequate and often exemplary training programs.
The petitioner states that in contrast to the NRC's minimum training
requirements, many of the States' rules require that prior to using
sources of radiation, an individual must complete a 40-hour safety
course addressing radiation safety fundamentals specified in rule, in
addition to passing a licensee-administered written exam on the rules,
license conditions, and operating and emergency procedures and passing
a licensee-administered practical exam on the use of the equipment. In
many States this requirement applies equally to a radiographer's
assistant. The petitioner believes it is critical for an individual to
receive radiation safety training prior to operating sources of
radiation.
The petitioner states that the proposed actions will use risk-
informed, performance based requirements to ensure safety of workers
and the public, eliminate current compatibility discrepancies, provide
uniformity in regulations nationwide, and ensure consistency in
surveillance requirements. Accordingly, the petitioner requests that
the NRC amend its regulations concerning radiation safety training
before using sources of radiation for industrial radiography, as
previously discussed.
Dated at Rockville, Maryland, this 21st day of December 2005.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E5-7974 Filed 12-27-05; 8:45 am]
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