Withdrawal of Proposed Rule and Closure of Petition for Rulemaking: Organization of Agreement States and Florida Department of Health, Bureau of Radiation Control, 3640-3646 [2012-1523]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Proposed Rules]
[Pages 3640-3646]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 
pdr.resource@nrc.gov.
     Federal Rulemaking Web Site: Public comments and 
supporting materials related to this document can be found at https://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: Carol.Gallagher@nrc.gov.

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: Solomon.Sahle@nrc.gov.

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

[[Page 3643]]

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]
BILLING CODE 7590-01-P