[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]
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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. 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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