[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Proposed Rules]
[Pages 3640-3646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1523]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 /
Proposed Rules
[[Page 3640]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 31
[Docket No. PRM-31-5; NRC-2005-0018; NRC-2008-0272]
Withdrawal of Proposed Rule and Closure of Petition for
Rulemaking: Organization of Agreement States and Florida Department of
Health, Bureau of Radiation Control
AGENCY: Nuclear Regulatory Commission.
ACTION: Withdrawal of proposed rule and closure of petition for
rulemaking.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission)
is closing a petition for rulemaking (PRM-31-5) submitted by the
Organization of Agreement States, Inc. (OAS). The petition requested
that the NRC amend its regulations to strengthen the regulation of
radioactive materials by requiring a specific license for higher-
activity devices that are currently available under a general license,
and change the compatibility designation of applicable regulations from
category B to category C. The petition also addresses a request filed
by the Florida Department of Health, Bureau of Radiation Control, to
change the compatibility category of a certain part of the applicable
regulation from category B to category C. In response to the petition,
the NRC developed a proposed rule that would have changed the
compatibility of the applicable regulations, and would have limited the
quantity of byproduct material contained in a generally-licensed device
to below one-tenth of the International Atomic Energy Agency (IAEA)
Category 3 thresholds. After further review, the NRC has decided to
withdraw the proposed rule and to change the compatibility designation
of the applicable regulations from category B to category C.
DATES: The proposed rule to limit the quantity of byproduct material
contained in a generally licensed device (74 FR 38372; August 3, 2009)
is withdrawn on January 25, 2012. The docket for PRM-31-5 is closed on
January 25, 2012.
ADDRESSES: You can access publicly available documents related to
proposed rule or the petition using the following methods:
NRC's Public Document Room (PDR): The public may examine
and have copied, for a fee, publicly available documents at the NRC's
PDR, Room O-1F21, 11555 Rockville Pike, Rockville, Maryland 20852.
NRC's Agencywide Document Access and Management System
(ADAMS): Publicly available documents created or received at the NRC
are available online at the NRC's Library at http://www.nrc.gov/NRC/reading-rm/adams.html. From this page, the public can gain entry into
ADAMS, which provides text and image files of the 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 NRC PDR
Reference staff at 1-(800) 397-4209, (301) 415-4737, or by email to
[email protected].
Federal Rulemaking Web Site: Public comments and
supporting materials related to this document can be found at http://www.regulations.gov by searching on Docket ID NRC-2005-0018 or NRC-
2008-0272. Address questions about NRC dockets to Carol Gallagher,
telephone: (301) 492-3668; email: [email protected].
FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
3781, email: [email protected].
SUPPLEMENTARY INFORMATION:
The Petition
In its PRM, the OAS requested that the NRC amend its regulations to
require specific licensing for devices exceeding the registration
quantity limits in Title 10 of the Code of Federal Regulations (10 CFR)
31.5(c)(13)(i). Additionally, OAS requested that the NRC revise the
compatibility category of 10 CFR 31.6 from category B to category C,
which OAS believes would allow States to better track service providers
and distributors of generally-licensed devices. In addition, the
Florida Department of Health, Bureau of Radiation Control, submitted a
separate request to change the compatibility category of 10 CFR
31.5(c)(13)(i) from category B to category C, which would allow the
State to continue to require registration of other generally-licensed
devices in addition to those currently registered by the NRC. Florida's
request (ADAMS Accession No. ML052700236) was included with the OAS
petition under PRM-31-5 (ADAMS Accession No. ML051940187).
Public Comments on the Petition
The NRC published a Federal Register notice requesting public
comment on PRM-31-5 on December 20, 2005 (70 FR 75423). The comment
period closed on March 6, 2006, and the NRC received four comment
letters from States and industry. The commenters had differing views on
using the registration levels to require general licensees to become
specific licensees, and on changing the compatibility categories.
Comments on requiring some general licensees to become specific
licensees.
Comment: One commenter supported adding a requirement to
specifically license higher-activity-level devices that are currently
available under a general license. The commenter argued that the
requirement would enhance security and accountability of these devices,
and would prevent aggregation of radioactive sources in the devices to
quantities of concern. The commenter noted that the regulatory change
to require higher-activity-level, generally-licensed devices to have a
specific license was long overdue from a safety and security
perspective, and that the rule would not impose a significant burden to
implement.
Comment: Three commenters did not support requiring higher-
activity-level, generally-licensed devices to obtain a specific
license. The commenters include an Agreement State and two generally-
licensed device manufacturers and distributors. These commenters
believed that the general-license regulatory approach should remain as
is. The Agreement State commenter stated that, in its jurisdiction,
generally-licensed devices are registered and tracked to a very high
standard. Another commenter stated that the proposed change would break
with the established procedures for device
[[Page 3641]]
review conducted during the device-approval process.
This commenter also stated that the current criteria in 10 CFR
32.51 is used to determine if a particular device warrants being
specifically or generally licensed. These criteria take into account
additional factors other than the activity of the source and include
requirements for prototype testing, potential dose considerations, etc.
This commenter stated that the NRC and the Agreement States have been
using these criteria for many years and that these proposed changes
would be inconsistent with established policy. Another commenter, who
represents several manufacturers, distributors, and providers of
services for radiological devices, stated that there is no demonstrated
safety or security justification for the changes requested in the PRM.
This commenter also stated that the changes would not increase the
security or the safety of generally-licensed devices, and he is not
aware of any safety or security concerns that could not be equally, and
in some cases better, addressed by the current registration program.
Under the current registration process, general licensees must submit
signed annual reports to the NRC or the Agreement State detailing what
devices they possess and any changes from their previous reports. Thus,
each licensee has a designated employee review their inventory and
compliance on an annual basis. This process also allows the NRC or the
Agreement State to annually review the general licensees. If there are
unresolved discrepancies between annual reports, then the NRC or the
Agreement State can require immediate clarification by the licensee.
The commenter also stated that under most fixed-gauge specific
licenses, there is a 5-year inspection cycle with no interaction
between the NRC or the Agreement State and the licensee during that
period. Thus, there would be a net decrease in oversight if this
proposal is adopted.
These commenters stated that the registration program has been very
successful in maintaining awareness of generally-licensed devices and
they would not be opposed to seeing the registration and the annual
reporting requirements extended to all general licensees, not limited
to only certain isotopes and activities.
NRC Response:
In response to the PRM, the NRC developed a proposed rule that
would have implemented many of the suggestions in the PRM (74 FR 38372;
August 3, 2009). The NRC received public comments on the proposed rule,
and considered those comments as part of the development of a draft
final rule.
The Commission reviewed the draft final rule, and in the Staff
Requirements Memorandum (SRM) for the draft final rule, dated December
2, 2010, the Commission disapproved publication of the final rule
(ADAMS Accession No. ML103360262). In their voting records, several
Commissioners, like some of the commenters, noted that they did not see
a clear safety risk reduction or security enhancement that would
justify the proposed threshold for requiring a specific license, or
sufficient information on the aggregation of generally-licensed devices
for malevolent purposes (ADAMS Accession No. ML103370094).
Comments on the compatibility change.
Comment: Two commenters supported changing the compatibility of 10
CFR 31.5(c)(13)(i) and 10 CFR 31.6 from category B to category C.
According to these commenters, multiple Agreement States have long
required more stringent regulation of generally-licensed devices than
the NRC. As early as 1963, States began to establish additional
regulatory requirements, ranging from specific licensing to
registration of all generally-licensed devices, to address problems in
their States. For the NRC and the Agreement States that did not have a
generally-licensed device registration program, the general-license
rule was a step forward. However, for those Agreement States that
already had a registration program or required a specific license for
generally-licensed devices, the general-license rule was a major step
backward. The commenters believe that the Commission's decision to
broadly apply compatibility B to 10 CFR 31.5 and 10 CFR 31.6 threatens
to cancel long-standing State regulatory programs and activities that
have helped to improve device accountability and reduce the number of
lost sources. The commenters believe that the changes requested in the
petition are necessary to enhance the security and accountability of
generally-licensed devices. Further, the commenters believe that the
change in compatibility category will provide those Agreement States
with more stringent regulatory programs the flexibility to continue to
impose more stringent requirements than the NRC.
NRC Response:
The NRC agrees with the commenters that the category C designation
will allow Agreement States the flexibility to enhance accountability,
address issues specific to their jurisdictions, continue programs that
have proven beneficial, and adopt requirements based on their specific
circumstances and needs.
Comment: Two commenters disagreed with the proposal to revise the
compatibility of 10 CFR 31.6 from B to C.
One commenter stated that many States have adopted equivalent
provisions to 10 CFR 31.6 in their regulations; however, as a matter of
policy, these States still require reciprocity for the servicing of
generally-licensed devices even if there are no specifically-licensed
materials or activities involved. The purpose of this policy is to
track generally-licensed device vendors in the same manner as specific
licensees working under reciprocity. The commenter believes that this
policy is inconsistent with the intent of the regulations, which are
supposed to make it easier for vendors to service generally-licensed
devices.
The second commenter stated that the change in compatibility would
be overly burdensome and financially detrimental to both manufacturers
and licensees that possess generally-licensed devices. According to
this commenter, under the current designation of compatibility category
B, device manufacturers and service providers are basically working
under one set of nationwide regulations. The commenter believes that
this situation is far superior to the confusing alternative that would
be caused by changing the compatibility of 10 CFR 31.6 to category C.
Working under one set of regulations is significantly easier to comply
with than working under as many as thirty sets of constantly changing
regulations. The commenter believes that this possibility indicates
that there are transboundary implications associated with this change.
Further, the commenter stated that current 10 CFR 31.6 grants a general
license, and changing the compatibility designations from category B to
C would allow Agreement States to charge fees for reciprocal
recognition of licenses from other Agreement States and the NRC. The
commenter believes that general licensees would then pass the cost of
these fees on to customers. According to the commenter, the overall
purpose of the Atomic Energy Act and the NRC's regulations is to
safeguard the public. Changing 10 CFR 31.6 from compatibility category
B to C will not enhance either the radiological safety or security of
byproduct material. The current compliance level with 10 CFR 31.6 for
manufacturers and service providers is very high because the
regulations are concise and easy to understand. This commenter believes
that a change in the compatibility could result in a significantly more
confusing
[[Page 3642]]
situation and a decrease in the overall compliance with the
regulations.
NRC Response:
The NRC disagrees with the commenters. Changing the compatibility
designation of these regulations will not result in increased cost and
burden to licensees operating in multiple jurisdictions. The NRC is
confident that the Agreement States will exercise this new flexibility
in a responsible manner that will continue to allow device
manufacturers and service providers to work in multiple jurisdictions
without undue burden or cost.
The commenter is correct that the purpose of the Atomic Energy Act
is to ensure the protection of public health and safety. The Atomic
Energy Act also establishes the Agreement State program, which allows
States to assume regulatory authority over the licensing of certain
radioactive materials that are used within their borders. As part of
the implementation of this program, the NRC established ``compatibility
categories'' for its regulations, which determine the degree of
flexibility that States have in adopting their regulations. The
compatibility category determination for each regulation involves
careful review by the NRC to ensure that the national regulatory
program is consistent. Where the NRC believes that there are
transboundary implications associated with a regulation, the regulation
is assigned to compatibility category B, which requires Agreement
States to adopt essentially identical requirements. Where the NRC
believes that there are not transboundary implications, but that the
essential objectives of the regulation need to be adopted, the
regulation is assigned to compatibility category C. When adopting
compatibility-category-C regulations, the Agreement States can adopt
regulations that are more stringent than the NRC's regulations. After
extensive review, the NRC has determined that the compatibility changes
requested in the PRM do not appear to raise significant transboundary
issues. Based upon this determination, the NRC has decided to assign
these regulations to compatibility category C.
In its SRM adopting these compatibility changes, the Commission
acknowledged that these compatibility changes could result in
transboundary problems, if there are unforeseen implementation
problems. As directed by the Commission, the staff plans to: (1) Report
back within 18 months on which Agreement States, if any, acted to
modify their programs as a result of the change in compatibility
category, (2) discuss how the programs were modified, (3) analyze the
impacts to regulated entities, particularly those operating in more
than one State; and (4) suggest corrective actions, if necessary (ADAMS
Accession No. ML103360262).
The Proposed Rule
After considering the OAS petition and Florida Department of Health
request, the NRC decided to grant the petition (i.e., the NRC agreed to
start a rulemaking that would consider the issues raised in the
petition; granting a petition does not mean that the NRC will adopt any
or all of the requests in a petition) (ADAMS Accession No.
ML072640423). On August 3, 2009, the NRC published a proposed rule,
``Limiting the Quantity of Byproduct Material in a Generally Licensed
Device'' (74 FR 38372). This proposed rule would have improved the
safety and security of devices currently authorized under a general
license by requiring a subset of these devices to be specifically
licensed. The rulemaking would have amended the NRC's regulations to
limit the quantity of certain byproduct material allowed in a
generally-licensed device to below one-tenth of the IAEA's Category 3
thresholds; licensees with devices containing byproduct material at or
above this limit would be required to obtain a specific license. The
NRC also proposed to change the compatibility category of 10 CFR
31.5(a), 10 CFR 31.5 (c)(13)(i), and 10 CFR 31.6 from category B to C.
Public Comments on the Proposed Rule
The comment period for the proposed rule ended on October 19, 2009,
and 55 comment letters were received. The commenters on the proposed
rule included Federal agencies, States, licensees, industry
organizations, environmental advocacy groups, and individuals.
The comments addressed the following areas: (1) The general
provisions of the proposed rule; (2) alternatives to the proposed rule;
(3) alternative threshold values; (4) proposed changes in compatibility
categories from B to C, and discussion of any transboundary issues
related to this approach; and (5) the additional revision to 10 CFR
31.5, which would have prohibited specific licensees from possessing a
device under a general license. A discussion of each major comment area
is summarized as follows:
Comments on the general provisions of the proposed rule.
Comments: Twenty commenters supported the provisions of the
proposed rule that would have established a threshold value of one-
tenth of Category 3 for material in generally-licensed devices. These
20 commenters included the OAS and 9 individual Agreement States. About
the same number of commenters did not support any threshold value for
generally-licensed devices; some of these commenters believe that the
general license regulatory approach should remain as is, while others
offered suggestions for modifying the general license program to
achieve the objectives of the proposed rule.
The commenters who supported the proposed rule argued that the
proposed rule would increase the safety and security of the sources, by
protecting against aggregation of sources to quantities of concern.
These commenters noted that the regulatory change to limit the
quantity of byproduct material in a generally-licensed device was long
overdue from a safety and security perspective, and that the rule would
not impose a significant burden to implement. Finally, the commenters
stated that the one-tenth of Category 3 threshold was a reasonable
compromise between the need for increased safety and security and the
burden imposed by these requirements on affected licensees.
Some of the commenters who opposed the proposed rule questioned
whether the NRC had a technical basis to support limiting the material
in a generally-licensed device for safety and security reasons. In
particular, they argued that there was no credible risk of aggregating
generally-licensed devices that are used by industry for manufacturing
process control applications. Also, they stated that it was unrealistic
to believe that these devices and their sources would be removed from
their assemblies. They noted, for example, that these sources are
important and vital to the operation of a manufacturing facility. They
also argued that the sources are: (1) Firmly mounted in process
equipment; (2) surrounded by mechanical components moving at a high
rate of speed with restricted access; and (3) within a security
perimeter, which includes safeguards against entry by unauthorized
people.
These commenters also believe that implementation of the proposed
rule would cause a significant cost increase because of the additional
requirements associated with a specific license, including training,
administration, annual fees, and hiring of a radiation safety officer.
Another comment from an industry trade group noted that small companies
with few customers spread across a large number of States would
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find it prohibitively expensive to conduct business in States that
require specific licenses.
Many of the commenters stated that it was unnecessary to require
generally-licensed devices to be specifically licensed if they were at
or above the threshold level in the proposed rule. These commenters
suggested alternatives to enhance the current general license program:
(1) A combination of features such as: (a) Maintaining the existing
general license framework, while requiring additional hardening and
design features in the devices to make it difficult to remove the
sources from the devices; (b) imposing new security requirements in the
regulations and in the device registries that would apply to users of
the devices; (c) requiring regulators to periodically inspect the
generally-licensed devices that meet or exceed the one-tenth of
Category 3 threshold values; and (d) requiring device leak tests and
shutter checks at 3- or 6-month intervals to improve source
accountability;
(2) Strengthening the current general license regulations by: (a)
Adding an annual physical inventory requirement for all licensees who
possess a generally-licensed device under 10 CFR 31.5; (b) adding a
requirement for generation and retention of written records of the
physical inventories for review during regulator inspections; and (c)
adding a requirement for general licensees to report their physical
inventory results to the regulator;
(3) Amending 10 CFR 31.5(a) to exclude all portable devices, to
require a specific license for portable devices regardless of their
activity level; and
(4) Offering manufacturers and distributors a Master Materials
License or a single licensing mechanism that would be valid for work in
different regulatory jurisdictions.
Some commenters who supported the proposed rule suggested
alternative threshold values for material in a generally-licensed
device. These alternatives included: (1) Setting a threshold at IAEA
Category 3; (2) considering the aggregate level of byproduct material
at a site; (3) applying the threshold to the current activity level of
the source instead of the licensed activity; and (4) setting a
threshold below one-tenth of Category 3, such as the registration
levels in 10 CFR 31.5(c)(13)(i).
NRC Response:
The NRC has decided not to adopt a final rule and is withdrawing
the proposed rule. The Commission disapproved the staff's proposal to
limit the quantity of byproduct material contained in generally-
licensed devices under 10 CFR Part 31 to one-tenth of the IAEA Category
3 threshold. The Commission determined that there is not a clear safety
risk reduction or security enhancement that would justify the proposed
threshold for requiring a specific license and there is insufficient
information to determine that the aggregation of generally-licensed
devices for malevolent purposes is a likely scenario.
Comments on changing the compatibility of 10 CFR 31.5(c)(13)(i) and
10 CFR 31.6 from category B to category C.
The NRC received 20 comments on the proposal to change the
compatibility of 10 CFR 31.5(c)(13)(i) and 31.6 from category B to
category C. The OAS and 13 Agreement States supported the proposal; 5
commenters (2 Agreement States and 3 companies that manufacture,
distribute, and service generally-licensed devices) opposed the
proposal; and 1 Agreement State supported the compatibility change to
10 CFR 31.5(c)(13)(i) and opposed the compatibility change to 10 CFR
31.6. Commenters who supported the changes noted that the changes in
the compatibility categories would allow States to continue to impose
more rigorous requirements on their licensees. Many of these States
commented that they would not support the proposed rule without an
accompanying change in compatibility. The commenters who opposed the
proposed compatibility changes noted that current regulations are very
clear and that compatibility B ensures a single national standard for
generally-licensed devices. These commenters noted that the change in
compatibility could result in different sets of rules and guidelines in
every State, and would allow Agreement States to arbitrarily set limits
on the activity levels of generally-licensed devices that are not based
on the risk to public health and safety. Some commenters stated that a
change in compatibility would have a significant adverse impact on
companies that service generally-licensed devices.
More detailed comment summaries, along with the NRC's responses,
are included below.
Comment: The NRC should be adopting more stringent compatibility
for its generally-licensed device regulations, which would allow
installers and service providers to do their jobs without additional
restrictions imposed by the States.
NRC Response:
The NRC appreciates the commenter's concern, but does not believe
that compatibility B is necessary in this case. Under the Agreement
State program, the NRC has relinquished its regulatory authority over
certain radioactive materials in each Agreement State. As part of its
oversight of the program, the NRC has established compatibility
categories that allow it to ensure that there is a consistent national
program in place, while also providing Agreement States with the
flexibility to adopt different requirements when possible. In this
case, the NRC has concluded that the additional requirements that would
be imposed by Agreement State regulators are not a threat to a
consistent national program. However, the NRC does recognize that there
is the possibility for the Agreement States to adopt regulations in
this area that would negatively affect a national program. The NRC is
therefore planning to look at any modifications that the Agreement
States make in response to this compatibility change, analyze the
impacts to the regulated entities and suggest corrective actions, if
necessary (ADAMS Accession No. ML103360262).
Comment: One commenter argued that the change in compatibility
would result in no increase in security, safety, or accountability.
NRC Response:
The change in compatibility does not have to result in an increase
to security, safety, or accountability. The purpose of the
compatibility is to ensure that there is a consistent national
regulatory program across the Agreement States and NRC states. In some
cases, it's not necessary for the NRC and the Agreement States to have
identical regulations. In this case, the NRC has determined that these
regulations do not involve the transboundary issues that would trigger
concern about a consistent national program. The NRC has therefore
determined that compatibility category C is acceptable. This
compatibility designation will allow Agreement States to adopt more
stringent regulations.
Comment: A number of commenters argued that less restrictive
compatibility will result in severe transboundary effects, which could
drive some companies out of business. Less restrictive compatibility
will make it more difficult for small companies that work in multiple
States to stay in business. Also, the administrative burden of
complying with different rules in each state and having to apply for
reciprocal recognition before entering a State could become ``an
administrative nightmare.''
An Agreement State and an industry commenter expressed opposition
to the change in compatibility. One State
[[Page 3644]]
expressed concerns similar to some industry commenters that the
compatibility change to 10 CFR 31.5(a) could result in 36 different
sets of requirements, which would ``make compliance extremely difficult
for any company that does not confine its activities to NRC
jurisdiction or a particular Agreement State.'' Further, this commenter
is concerned that the change in compatibility to 10 CFR 31.6 could
result in improper disposal of generally-licensed devices because
Agreement States might start to impose reciprocity or licensing fees
for out-of-State general licensees that want to do business in the
Agreement State.
In 2000, as part of the general-license-rule amendments, the NRC
evaluated the compatibility of these regulations and concluded that
this rule should not be open to the type of broad interpretation that
would be allowed by a compatibility C designation (65 FR 79184-79185;
December 18, 2000). The justification for this conclusion was the
transboundary implications of allowing States to impose more strict
criteria on generally-licensed devices under their jurisdiction.
NRC Response:
The 2000 general-license-rule amendments, which then designated the
requirements in 10 CFR 31.5 and 10 CFR 31.6 as compatibility category
B, were based on the concern that essentially identical regulations
were needed to ensure reciprocal recognition of licenses and licensing
requirements among Agreement States and the NRC. The commenter
indicated that individual State variations in the regulations do not
add any increase in safety or security at any level and only make more
complicated and costly the compliance process for the general
licensees, distributors, and service providers. After evaluating the
post-2000 general-license-rule amendments, the NRC has reassessed its
position. Since 2000, Agreement States have taken a variety of actions
that are not consistent with the rule, despite its designation as
compatibility category B. As a result, different practices already
exist in different Agreement States; however, the NRC has not observed
any transboundary problems from these different practices that would
indicate compatibility category B is necessary. Further, complexity and
cost are not aspects of determining significant transboundary health
and safety impacts under the Commission's 1997 Policy Statement for
Adequacy and Compatibility (62 FR 46517). The NRC disagrees with the
commenter and believes it is appropriate to change the compatibility
category to C for 10 CFR 31.5 and 10 CFR 31.6. This action acknowledges
the current practice of many Agreement States to continue the practices
they have already implemented and take additional steps they deem
appropriate based on local circumstances.
The NRC does, however, recognize that if many more States change
their regulations, there could potentially be transboundary impacts. As
directed by the Commission, the NRC plans to determine the degree to
which the Agreement States modify their programs as a result of the
change in compatibility category and to analyze any transboundary
impacts to regulated entities, particularly those operating on a
multistate basis. The NRC may take corrective actions, if any are
needed (ADAMS Accession No. ML103360262).
Comment: Another commenter is concerned that changing the existing
regulations to compatibility C could ``be a step backward'' and could
result in arbitrary limits on generally-licensed devices that are not
based on public health and safety.
NRC Response:
The NRC has a program in place, Integrated Materials Performance
Evaluation Program (IMPEP), which allows the NRC to evaluate the status
of an Agreement State's program. If the NRC determines that a program
is deficient, they will work with the Agreement State to correct the
deficiencies.
Comment: One commenter is concerned that the change in
compatibility could limit the ability of service providers to provide
timely repairs, which could affect production at plants that rely on
generally-licensed devices (delays range from three to five days,
depending on the State).
NRC Response:
The NRC shares the commenter's concerns and will be evaluating any
regulatory changes that the Agreement States make in response to this
change in compatibility. The NRC will gather data and may take action,
if necessary (ADAMS Accession No. ML103360262).
Comment: One commenter asked that, if the change in compatibility
is adopted, the NRC offer manufacturers and distributors the option to
obtain a Master Materials License that would be valid for work in any
NRC State or Agreement State.
NRC Response:
The NRC cannot issue a Master Materials License to non-federal
licensees; the NRC only issues these licenses to Federal organizations.
Comment: One commenter argued that some Agreement States want the
revised compatibility designation because they believe that they will
be able to generate more fees through reciprocal recognition and
inspection, without any clear benefit to health and safety.
NRC Response:
The NRC disagrees with the comment. The commenter did not provide
any support for its statement and the NRC is not aware of any
statements by Agreement State employees or representatives that would
support this claim.
Comment: A number of Agreement States supported some or all of the
compatibility changes. One State supported only the change to 10 CFR
31.5(c)(13)(i), but noted that due to recent issues with tritium exit
signs, the NRC might want to revise the list of isotopes that require
registration.
Other States noted that their regulations were more rigorous than
the NRC's general-license requirements, and that this difference has
not resulted in any transboundary issues. Further, these commenters
believe that the revised compatibility would allow for better tracking
of generally-licensed devices, and that the more strict requirements
result in increased health and safety. Finally, these states argue that
the change in compatibility will allow States with more rigorous
requirements to leave those requirements in place.
Other Agreement States simply noted their agreement with the NRC's
proposed compatibility change. Another State noted that allowing states
to adopt more strict licensing requirements might allow the NRC to make
a better informed decision about using IAEA Category 4 as the threshold
for general licensees. The OAS even indicated it would not support the
proposed rule without the change in compatibility.
NRC Response:
The NRC agrees with the commenters. The change in compatibility
will allow the Agreement States to adopt regulations that are stricter
than the NRC's regulations, while the regulatory floor established by
the NRC will continue to ensure that there is reasonable assurance of
public health and safety.
Comment: Some commenter's suggested that the NRC amend 10 CFR 31.5
to require specific licenses for portable gauges and leave the
compatibility category as B, which they believed would address the
concerns of many States because a number of these States do not allow
portable gauges to be held under a general license.
NRC Response:
The Commission has decided not to adopt the proposed rule. Further,
the NRC appreciates the commenter's
[[Page 3645]]
concern about the compatibility change. The NRC staff will monitor the
compatibility changes to ensure that there aren't unforeseen
transboundary problems. If the NRC discovers that the compatibility
change has caused transboundary problems, such as reciprocity problems
for licensees that operate in multiple jurisdictions, the staff will
provide that information to the Commission as part of its 18-month
report (ADAMS Accession No. ML103360262).
Comment: With regard to transboundary issues, several Agreement
States indicated that there would be no significant transboundary
issues in changing the compatibility category from B to C. Some of
these commenters said that for many years, under the current general
license regulatory framework, there have been no transboundary issues
resulting from their State having more rigorous requirements than
neighboring States for generally-licensed devices. One Agreement State
indicated that it has never authorized out-of-State generally-licensed
devices under reciprocal recognition in accordance with its State
regulations.
One commenter stated that transboundary issues would only occur if
some States choose to specifically license portable devices. The
commenter stated that there would be a significant effect on the
movement of these devices because licensees would need to pay fees and
could be subject to reciprocity inspections. Other commenters,
primarily manufacturers and service providers, believed that there
would be significant transboundary issues in changing compatibility
from category B to category C and supported the retention of category
B.
NRC Response:
The NRC is unaware of any significant transboundary issues with the
current system. Although the change in compatibility may require a
change in licensing process for some companies (including any
reciprocity changes and fee payments), these actions are not considered
a significant transboundary issue since a similar nationwide system is
already used for specific licensees. However, the NRC plans to assess
the degree to which the Agreement States modify their programs as a
result of the change in compatibility category and analyze any
transboundary impacts to regulated entities, particularly those
operating on a multistate basis. The NRC may take corrective actions if
needed (ADAMS Accession No. ML103360262).
Comments on the proposal to prohibit specific licensees from
possessing generally licensed devices.
Comment: The NRC did not receive any comments that supported the
proposal to prohibit specific licensees from possessing a generally-
licensed device. One commenter opposed this proposal because current
regulations already include incentives for licensees to transfer their
generally-licensed devices to a specific license. The transfer process
takes significant time and effort by both the licensee and the
regulator and can make the specific license cumbersome to maintain and
enforce due to the large number of low-activity sealed sources. Several
commenters believe that the proposal would be unfair to specific
licensees because it is likely that companies that possess generally-
licensed devices and do not have a specific license would continue
operations under the general license, while companies with both
generally-licensed devices and a specific license would be required to
move their generally-licensed devices to their specific license. This
change would arbitrarily impose more stringent regulations on specific
licensees.
Comments from universities and research and development specific
licensees argued that the proposal would place a substantial burden on
them, requiring the revision of device authorizations by the
responsible Radiation Safety Committee for a very large number of
generally-licensed devices subject to 10 CFR 31.5. The commenters noted
that placing these generally-licensed devices under the authority of a
specific license would require the users of those devices to have a
minimum amount of documented training and experience, and could require
personnel radiation monitoring because some specific licensees require
dosimetry for all users. The commenters also argued that the users of
these generally-licensed devices are students and researchers who
continuously change; and these new requirements would require
additional training and documentation that is not necessary under the
current general-license program. The commenters believe that there
would be no reduction in the hazard to workers or students due to the
transfer of these devices to the broad-scope specific license. Several
Agreement States, research organizations, and large corporations
supported the existing regulations, which allow licensees the
flexibility to decide whether they want to add generally-licensed
devices to their specific licenses. A number of universities stated
that they would prefer to keep the numerous generally-licensed devices
used in health care and research environments under the requirements of
a general license.
NRC Response:
The NRC agrees with the commenters that the proposal to amend 10
CFR 31.5(b)(3) could cause confusion. The NRC intended to preserve the
flexibility that licensees currently have to decide whether to transfer
generally-licensed devices under the authority of a specific license
for a site, but to specify that if generally-licensed devices were
transferred to a specific license then the terms and conditions of the
specific license would apply to the generally-licensed devices. The NRC
agrees with the commenters and has decided not to adopt this proposed
change to amend 10 CFR 31.5(b)(3). This amendment would be too
burdensome on numerous licensees with little or no improvement in the
accountability of the sources in those generally-licensed devices.
Withdrawal of the Proposed Rule
On December 2, 2010, the Commission disapproved publication of the
final rule, which would have limited the quantity of byproduct material
in a generally-licensed device to below one-tenth of IAEA's Category 3
threshold (ADAMS Accession No. ML103360262). The Commission that there
is not a clear safety risk reduction or security enhancement that would
justify the proposed rule and that the current safety and security
requirements for these generally-licensed devices are adequate (ADAMS
Accession No. ML103370094). Consequently, the NRC is withdrawing the
proposed rule.
Agreement State Compatibility
On December 2, 2010, the Commission approved revising the
compatibility designation of all 10 CFR 31.5 and 10 CFR 31.6 from B to
C (ADAMS Accession No. ML103360262). The Commission recognized the
desire on the part of the States to exercise greater control over the
actions of their licensees and to enhance regulation for higher
activity generally-licensed devices (ADAMS Accession No. ML103370094).
The current compatibility designation for these sections is category B.
This designation was primarily based on transboundary implications.
Despite this designation, many Agreement States have implemented more
strict regulation of generally-licensed devices. These regulations
include registration with annual reporting requirements and periodic
inspection, expanded registration of more types of generally-licensed
devices, specific licensing of
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certain generally-licensed devices, and specific licensing of all
generally-licensed devices currently registered by the NRC.
The NRC believes that the change to compatibility category C will
allow Agreement States the flexibility to enhance accountability;
retain use of tools to track the location and movement of devices,
manufacturers and service providers within the State limit; address
issues specific to their jurisdictions; continue programs that have
proven beneficial; and to adopt requirements based on their specific
circumstances and needs. As directed by the Commission, the NRC staff
will assess the degree to which the Agreement States modify their
programs as a result of the change in compatibility category and
analyze any transboundary impacts to regulated entities, particularly
those operating on a multistate basis. If transbounday problems are
identified, the staff will suggest any corrective actions that might be
necessary (ADAMS Accession No. ML103360262). The Commission also plans
to consider proposed updates to the Policy Statement on Adequacy and
Compatibility of Agreement State Programs and associated guidance
documents to include both safety and source security considerations in
the determination process.
Closure of the Petition for Rulemaking
In its SRM, the Commission addressed all of the issues raised in
the PRM: The Commission disapproved publication of the final rule and
approved the change in compatibility for 10 CFR 31.5 and 10 CFR 31.6.
The NRC is closing this PRM because all of the petitioners' requests
have been resolved.
Dated at Rockville, Maryland, this 22nd day of December 2011.
For the Nuclear Regulatory Commission.
R.W. Borchardt,
Executive Director for Operations.
[FR Doc. 2012-1523 Filed 1-24-12; 8:45 am]
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