[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Proposed Rules]
[Pages 75423-75426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24250]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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. 70, No. 243 / Tuesday, December 20, 2005 / 
Proposed Rules  

[[Page 75423]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 31

[PRM-31-5]


Organization of Agreement States; Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; request for comment.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has received a 
petition for rulemaking filed by the Organization of Agreement States 
(OAS). The petitioner is requesting that the NRC amend its regulations 
to require specific licensing for devices that are currently regulated 
by a combination of general licensing and registration, and to revise 
the compatibility category for 10 CFR 31.6 from ``B'' to ``C''. The 
petitioner believes that these actions are needed to establish a higher 
national standard of regulation for higher risk generally licensed (GL) 
devices, and to allow retention of a tool used by Agreement States to 
track the location and movement of device manufacturers and service 
providers in their State.
    This action also addresses a request filed by the Bureau of 
Radiation Control (BRC) of the Florida Department of Health for the NRC 
to change the compatibility category of 10 CFR 31.5(c)(13)(I) from 
category ``B'' to category ``C''. Florida BRC believes that NRC 
regulations are less stringent and that assigning a compatibility 
category ``B'' will require the State to reduce its current health, 
safety, and security regulatory control of GL devices.

DATES: Submit comments by March 6, 2006. Comments received after this 
date will be considered if it is practical to do so, but assurance of 
consideration cannot be given except as to comments received on or 
before this date.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include PRM-31-5 in the subject line of your comments. Comments 
submitted in writing or in electronic form will be made available to 
the public for inspection. Because your comments will not be edited to 
remove any identifying or contact information, the NRC cautions you 
against including personal information such as social security numbers 
and birth dates in your submission. 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), 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 NRC Public Document Room (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, Office of 
Administration, U.S. Nuclear Regulatory Commission, Washington, DC 
20555. Telephone: 301 415-7163 or Toll Fee: 1-800-368-5642 or e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 18, 2000, (65 FR 79162), the NRC issued a final rule 
that amended the requirements applicable to certain generally licensed 
industrial devices containing byproduct material. The final rule, among 
other actions, included more explicit provisions for a registration and 
accounting program. The final rule also modified the quarterly transfer 
reporting requirements for manufacturers and initial distributors of 
these industrial devices.
    Section 274b of the Atomic Energy Act (Act) provides for agreements 
under which the NRC relinquishes and a State assumes regulatory 
responsibility for the use of byproduct, source and small quantities of 
special nuclear material within a State. The December 18, 2000, final 
rule was a matter of compatibility under the Policy Statement on 
Adequacy and Compatibility of Agreement Statements issued September 3, 
1997 (62 FR 46517). The provisions of 10 CFR 31.5 and 31.6 were 
designated as Category B because the provisions affected a program 
element with significant transboundary implications.

Petitioner's Issue

    The petitioner believes that certain devices containing higher 
level of activity, which are currently regulated under a general 
license in 10 CFR 31.5, would be best regulated under a specific 
license in 10 CFR part 30. The petitioner states that multiple 
Agreement States have already established more stringent requirements 
for GL devices to address accountability problems, source melt 
incidents and other issues related to such devices in their States, and 
that the decision by the NRC to revise the compatibility category of 10 
CFR 31.5 from ``D'' to ``B'' will require these Agreement States to 
reduce their current regulatory control of GL devices in order

[[Page 75424]]

to be compatible with less stringent NRC regulations. The petitioner 
states also that the NRC decision to revise the compatibility category 
of 10 CFR 31.6 from ``C'' to ``B'' removes the ability of Agreement 
States to directly track the movement of many individuals and companies 
servicing GL devices and thus indirectly verify the location of these 
devices. The petitioner asserts that regulation of GL devices 
containing higher levels of activity should be under more rather than 
less regulatory oversight to further enhance the accountability and 
security of these devices.

Petitioner's Interest

    The petitioner is a non-profit, voluntary, scientific and 
professional society incorporated in the District of Columbia. The 
membership of the 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 offers that Agreement States are those States that 
have entered into an Agreement with the NRC under section 274b. of the 
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 adequate protection of 
public health and safety and compatibility with its regulatory 
requirements.
    The petitioner further states that Agreement States issue 
radioactive material licenses, promulgate 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 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 
licenses.

History of Issue

    In July 1996, the joint NRC-Agreement State Working Group, approved 
by the Commission to evaluate problems with licensees maintaining 
control over and accountability for devices containing radioactive 
material provided their recommendations to the NRC. One of the 
recommendations was that the NRC establish a registration program for 
GL devices containing specific isotopes above certain quantity limits 
that posed a comparatively higher risk of exposure to the public or 
property damage.
    The petitioner states that on December 18, 2000, the NRC issued a 
final rule, effective on February 16, 2001, that revised portions of 10 
CFR parts 30, 31, and 32 to add new requirements for manufacturers, 
distributors and users of GL devices. The combined changes were called 
the ``Generally Licensed Device Rule,'' which included a revision that 
established a new registration program for certain GL devices in 10 CFR 
31.5(c)(13) that was based on the earlier recommendations of the 
working group. In addition, the petitioner states the NRC changed the 
compatibility category for 10 CFR 31.5 from ``D'' to ``B'' and for 10 
CFR 31.6 from ``C'' to ``B''. Agreement States were given until 
February 16, 2004 to adopt the new regulations.
    The petitioner states that in a letter dated July 28, 2004, the NRC 
presented the results of a survey of Agreement State compliance with 
adopting the new Generally Licensed Device Rule which showed that 12 of 
the 33 Agreement States had not adopted the new GL device requirements.
    The petitioner states further that during the May 2004 National 
Conference on Radiation Control and the September 2004 Organization of 
Agreement States annual meeting, the Agreement States discussed problem 
areas associated with the current system of regulating certain devices 
under a general license. These problem areas include:
     The compatibility change from ``D'' to ``B'' in 10 CFR 
31.5 limits States that choose to be more restrictive in regulating GL 
devices.
     The compatibility change from ``C'' to ``B'' in 10 CFR 
31.6 allows device manufacturers/service providers to service devices 
in Agreement States for less than 180 days without obtaining 
reciprocity or notifying State radiation control programs at a time 
when State programs believe enhanced tracking is required.
     New materials security requirements have not been factored 
into general license device regulations.
     Low awareness of regulatory requirements by some general 
licensees due to high turnover in the industrial sector and minimal 
interaction with regulator.

Petitioner's Proposal

    The OAS proposes the following amendments to 10 CFR part 31, and 
changes in compatibility category.
    1. Section 31.5 (a) would be revised to read as follows:
    (a) A general license is hereby issued to commercial and industrial 
firms and research, educational and medical institutions, individuals 
in the conduct of their business, and Federal, State or local 
government agencies to acquire, receive, possess, use or transfer, in 
accordance with the provisions of paragraphs (b), (c) and (d) of this 
section, byproduct material contained in devices designed and 
manufactured for the purpose of detecting, measuring, gauging or 
controlling thickness, density, level, interface location, radiation, 
leakage, or qualitative or quantitative chemical composition or for 
producing light or an ionized atmosphere, provided each device contains 
less than 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of 
strontium-90, 37 MBq (1 mCi) of cobalt-60 or 37 MBq (1 mCi) of 
americium-241 or any other transuranic element (i.e., element with 
atomic number greater than uranium (92)), based on the activity 
indicated on the label.
    2. In Sec.  31.5 paragraph (c)(13) would be deleted in its 
entirety.
    3. Revise the compatibility category of Sec.  31.6 from ``B'' to 
``C''.

Petitioner's Justification

    OAS stated that the newly formed OAS Rulemaking and Compatibility 
Committee surveyed the 33 Agreement State radiation control programs to 
determine the reaction to the change in compatibility of 10 CFR 31.5 
and 31.6 and the potential to specifically license devices currently 
regulated under a general license. Thirty-one States responded to the 
survey, as follows:
     Eighty-seven percent of the responding States disagree 
with the CY 2000 Commission decision to revise the compatibility 
category of 10 CFR 31.5 and 31.6 (27 of 31 States).
     Ninety percent of the responding States currently allow a 
specific license for devices that may be generally licensed (28 of 31 
states).
     Ninety-seven percent of the responding States support the 
OAS taking action in this area (30 of 31 states).
    The OAS believes that requiring specific licensing of the higher 
risk gauging devices identified by the 1995 NRC-Agreement State joint 
working group can further enhance control and

[[Page 75425]]

accountability of GL devices. OAS states that while the GL device rule 
was an improvement over past regulation of these devices, there are 
still on-going problems with the regulation of GL gauging devices, 
including:
     Low awareness of regulatory requirements by general 
licensees.
     No routine inspection of GL devices for compliance with 
requirements.
     No regulatory review prior to purchase.
     Continued incidents involving loss of control of real or 
suspected GL devices.
    OAS believes that specific licensing of higher activity GL gauging 
devices would provide the following advantages:
    1. Allow regulatory review (through the license application 
process) of higher-activity device purchases prior to receipt.
    2. Increase security of the higher risk gauging devices to minimize 
the possibility of these devices being used in malicious acts.
    3. Increase licensee awareness of regulatory requirements by virtue 
of the specific license application process and periodic inspections.
    4. Improve licensee control of devices, which may reduce the number 
of potential orphan sources.

Petitioner's Conclusion

    The OAS understands and agrees with the desire of the Commission 
and device manufacturers for more uniform regulation of devices within 
the NRC and Agreement States. At the same time, the Agreement States' 
desire to assure better accountability for sources and devices that are 
within the states' jurisdiction. The Agreement States believe that the 
manufacture and distribution of the devices is best addressed uniformly 
by the methods described in this petition. Therefore, the OAS is 
proposing that 10 CFR 31.5 be amended to require specific licensing for 
devices that are currently regulated by a combination of general 
licensing and registration. This action would establish a higher 
national standard of regulation for identified higher risk devices. In 
addition, the OAS is proposing that the compatibility category for 10 
CFR 31.6 be revised from ``B'' to ``C'' to allow retention of a tool 
used by States to track the location and movement of device 
manufacturers and service providers in their State. This would allow 
Agreement States the opportunity to assess and monitor the radiation 
safety programs of device manufacturer representatives working within 
the State. The OAS believes the NRC and Agreement States can implement 
the proposed changes with limited impact on regulatory agencies and 
licensees, resulting in improved regulation and control of radioactive 
materials.

Florida's Request

    In addition to requesting comment on the petition by the OAS, NRC 
is seeking comment on a request by the Florida BRC. The issues raised 
in Florida's request are closely related to those in the OAS petition, 
so NRC is seeking comment on both the OAS petition and the Florida 
request at the same time.
    Florida, an Agreement State, requested that the NRC change the 
compatibility category of 10 CFR 31.5(c)(13)(I) from category ``B'' to 
``C''. Florida believes that the decision of whether and how to 
register additional types and quantities of generally (GL) devices 
beyond what the NRC requires should be a decision left to the State 
with the authority for regulating the devices. Florida states that it 
has had well-established requirements for the registration and 
regulation of GL devices for many years before the NRC adopted 
regulations to register certain GL devices. Florida states that NRC's 
decision to assign a compatibility category ``B'' for 10 CFR 
31.5(c)(13)(I), will require it to reduce its current health, safety, 
and security regulatory control of GL devices in order to be compatible 
with the less stringent NRC regulations.
    Florida states that they issue and currently regulate over 1500 
radioactive material licenses, promulgate regulations and enforce these 
regulations under the authority of Chapter 404, Florida Statutes, and 
Chapter 64 E-5, Florida Administrative Code. Florida notes that the NRC 
periodically reviews the performance of its programs, thereby assuring 
compatibility with the NRC's regulatory requirements.
    Florida requires registration of all GL devices with the exception 
of some tritium exit signs. Their program includes source registration, 
fees, annual inventories and inspections.
    Florida is concerned that the December 18, 2000, final rule, 
effective on February 16, 2001, revised portions of 10 CFR parts 30, 
31, and 32 to add new requirements for manufacturers, distributors and 
users of GL devices, and that part of the revision established a new 
registration program for certain GL devices in 10 CFR 31.5 
[sscopy])(13) and assigned a compatibility category of ``B''. According 
to Florida, it has instituted a number of changes required by the rule 
as legally binding license conditions and also is working on 
promulgating rules to address these issues, with the exception of the 
new registration requirements that would force it to adopt less 
stringent registration and accountability standards for certain GL 
devices containing radioactive material.
    Florida notes that NRC's procedures in Management Directive 5.9, 
for categorizing program elements or regulations, states that to be 
included in Category ``B'', an NRC program element is to be one that 
applies to activities that have direct and significant effects in 
multiple jurisdictions (emphasis added). Examples include: 
transportation requirements, approval of products that are distributed 
nationwide, and definitions of products. Florida believes the 
registration of additional GL devices would not have a direct and 
significant effect in multiple jurisdictions.
    Florida asserts that States and the NRC have had different GL 
requirements for years with little discussion of any transboundary 
problems, and that any actions concerning the registration of 
additional GL devices in Florida would be between the State and 
individuals in Florida. According to Florida, this registration process 
does not have any direct and significant effect on device manufacturers 
or distributors, the transportation of the devices, the requirements 
for approval, or the movement of devices into or out of Florida.
    In the request, Florida cites its ability to register, inventory, 
and inspect all GL devices, as providing many benefits for the safety 
and security of its citizens and visitors and therefore to move to 
NRC's registration scheme would require it to cease to be able to 
register and account for over 1,000 radioactive sources in GL devices 
currently being regulated. Florida believes that its ability to 
continue to register all GL devices clearly meets the essential 
objective of NRC's Generally Licensed Device Rule.
    Florida notes also that NRC's categorization criteria further 
states that for a program element to be included in Category ``C'', it 
should be one that the essential objective should be adopted by an 
Agreement State to avoid conflicts, duplications, or gaps in the 
regulation of agreement material on a nationwide basis and that, if not 
adopted, would result in an undesirable consequence.
    Florida believes that 10 CFR 31.5(c)(13)(I) meets the criteria for, 
and should be categorized as, compatibility category ``C'' in 
accordance with NRC Management Directive 5.9.

    Dated at Rockville, Maryland, this 14th day of December, 2005.

[[Page 75426]]

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-24250 Filed 12-19-05; 8:45 am]
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